New Drug Law in Canada

With a tip of the cap to our old friend, Peter Pliszka, north of border: Earlier this month, the so-called Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) received royal assent and became law in Canada. This new legislation on paper was intended to protect Canadians from the potential risks related to drugs and medical devices by substantially increasing Health Canada's pre- and post-market powers over industry stakeholders, and changing the consequences for violating the Food and Drugs Act and its regulations.

Peter suggests that Vanessa's Law introduces the most significant amendments to the Food and Drugs Act in 50 years, and represents in some ways a new chapter in Canadian drug and medical device regulatory enforcement.

Peter notes that the new powers granted to Health Canada include:

• The power to order any person to provide information related to a drug or medical device where Health Canada believes that the product may present a serious risk of injury to human health;
• The power to order a manufacturer to conduct an assessment of a drug or medical device and to provide Health Canada with the results;
• The power to order a manufacturer to conduct additional tests or studies, or monitor experience, in relation to a drug or medical device for the purpose of obtaining additional information about the product's effects on health or safety, and to provide Health Canada with the results;
• The power to order a manufacturer to modify the label of a drug or medical device or to replace its packaging, where Health Canada believes that doing so is necessary to prevent injury to health; and
• The power to order any person who sells a drug or medical device to recall the product where Health Canada believes that a drug presents a serious risk of injury to health.

It appears that new regulations may be coming down the pike as well, on issues such as clinical trials information and product label issues outside of Canada.

PhRMA Submits Amicus Brief on First Amendment Issues

The Pharmaceutical Research and Manufacturers of America recently submitted an amicus brief urging a federal court to dismiss a whistleblower's False Claims Act suit because the off-label claims in the case violate the defendants' free speech rights. See U.S. ex rel. Solis v. Millennium Pharmaceuticals Inc. et al., No. 2:09-cv-03010 (E.D. Cal. Brief August 15, 2014). The Pharmaceutical Research and Manufacturers of America (“PhRMA”) is a voluntary, nonprofit association representing the nation’s leading research-based pharmaceutical and biotechnology companies.

Readers know that physicians may lawfully prescribe FDA-approved drugs to treat any condition or disease, including unapproved uses, based on their independent medical judgment. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). Indeed, many unapproved uses are integral to the practice of medicine, and reflect the standard of patient care. E.g., Joseph W. Cranston et al., Report of the Council on Scientific Affairs: Unlabeled Indications of Food and Drug Administration-Approved Drugs, 32 Drug Info. J. 1049, 1050 (1998). The case here involved a qui tam False Claims Act (FCA) suit against defendants. This case raises serious First Amendment concerns, said amicus, because relator’s and the United States’ construction of the FCA would impose liability on manufacturers for engaging in truthful speech about “off-label” uses of their drugs, i.e., particular uses of an FDA-approved medication that the FDA has not yet approved. The First Amendment unquestionably protects such truthful and non-misleading speech. E.g., Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2659 (2011).  The prevalence of unapproved—but fully legal—uses of many FDA-approved prescription medicines to treat patients makes it critical that healthcare professionals have access to accurate, comprehensive, and current information about such uses. 

Notably, pointed out amicus, neither relator nor the government alleged that the speech at issue here—relaying reprinted articles about unapproved uses of the drug Integrilin from peer-reviewed journals, and summarizing the results of clinical trials—was false or misleading. Relator and the United States did not even agree on why the FCA proscribes this speech, or how this speech somehow causes others to submit false claims. But their interpretations of the FCA shared a critical flaw according to the Brief: both threaten core First Amendment rights and should be rejected under principles of constitutional avoidance. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Const. Trades Council, 485 U.S. 568, 575 (1988).

These constitutional concerns seem well-founded: “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” Sorrell, 131 S. Ct. at 2659. Interpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and the identity of the speaker, and thus triggers heightened scrutiny. These First Amendment concerns apply with particular force to the speech that relator targeted here. The Complaint alleged that the manufacturer merely distributed reprints of medical studies published in reputable independent journals like Cardiology, the American Heart Journal, and the American Journal of Cardiology, and sent letters accurately relaying summaries of clinical trials.  There was no question that the authors of the reprints, the studies’ investigators, physicians, or anyone other than manufacturers can speak about the reprints and trial results as much as they wish. Indeed, everyone but manufacturers apparently can talk to physicians about prescribing Integrilin for unapproved uses without penalty. Relator even conceded that the manufacturer can distribute reprints promoting unapproved uses so long as physicians request such information.

Physicians who received the reprints or other information from the manufacturer in this case received precisely the type of educational information that a trained physician would wish to receive about his patients. Physicians were not only free to disregard these reprints; their Hippocratic Oath obligated them to use their own, independent medical judgment as to whether a given prescription was warranted. And after those physicians prescribed the FDA-approved drug for an unapproved use, hospitals then made additional, independent determinations whether the prescriptions were reimbursable. Only after that did hospitals submit claims to the government.

A good summary of the issues from defense perspective.

 

Industry Comments on Draft FDA Guidance

Several leading drug manufacturers have worked to shed light on serious issues with the social media guidance issued earlier this year by the U.S. Food and Drug Administration.

Readers may recall the draft guidance was intended to describe FDA’s current thinking about how manufacturers and distributors can fulfill regulatory requirements for postmarketing submissions
of interactive promotional media for their FDA-approved products.  A number of industry members have submitted formal comments

PhRMA and its member companies highlighted two fundamental concerns with the Draft Guidance. First, the Draft Guidance assumes that a biopharmaceutical manufacturer can be held accountable for content written by third-parties on third-party web sites if the company merely somehow "influences" the third-party. This premise is overbroad and is inconsistent with the FDCA. Put simply, third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA‘s authority to regulate promotional labeling or advertising. Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance.

WLF echoed the latter concern. noting serious problems with the Draft Guidance at Section IV (entitled, "Factors Considered in Determining Postmarket Submission Requirements for Interactive Promotional Media"). The Draft Guidance's basic premise seems to be that everything a manufacturer posts on-line: (1) qualifies as "promotional" material; (2) falls within FDA's statutory purview; and (3) is not protected from FDA regulation by the First Amendment. Those premises are 
demonstrably incorrect. Accordingly, agency policy in this area ought to begin with guidance
regarding where FDA draws the line between speech that it is and is not permitted to regulate.
The Draft Guidance brushes aside such concerns and seems to indicate that FDA intends to regulate everything that a manufacturer says regarding its products on social media sites.

It will be interesting to see how the FDA reacts to these valid comments.

 

Certification Rejected in Dietary Supplement Claim

The important issues of ascertainability and choice of law led a federal court to deny class certification in litigation relating to the dietary supplement VPX Meltdown Fat Incinerator.  See Karhu v. Vital Pharm., Inc., No. 13-60768 (S.D. Fla., 3/3/14).

Plaintiff filed a class complaint against Vital Pharmaceuticals Inc.  to recover damages based upon VPX's alleged false advertisements, and to enjoin any further alleged misrepresentations. He sought to bring the suit on behalf of all persons in the United States who have purchased Meltdown for purposes other than resale since April 4, 2008. The claims included:  (1) breach of express warranty under the Magnuson-Moss Warranty Act ("MMWA"), 15 U.S.C. § 2301, et seq.; (2) breach of
express warranty; (3) unjust enrichment; and (4) violation of the Florida Deceptive and Unfair Trade Practices Act ("FDUTPA"), Fla. Stat. § 501.201, et seq.

The court concluded that the case would be unmanageable as a class action. First, the court saw no practical method of verifying membership in the proposed Class of Meltdown purchasers. No central record of Meltdown customers existed, and it was unlikely that each Meltdown purchaser since 2008 has retained a proof of purchase. Second, the claims of the Nationwide Class would implicate the laws of multiple states. The varied requirements of the states' laws would require different proof on each claim depending on the locations of the class members. These legal permutations would render an eventual trial unwieldy, and would overshadow the common factual questions that otherwise allegedly united the class members' claims.

Regarding ascertainability, a plaintiff seeking class certification must first craft a class definition clear enough to allow the court to understand whether a particular individual is a member of the class, and that membership is ascertainable. A class is ascertainable only if the court can determine whether a given person is a class member through administratively feasible methods. See In re Checking Account Overdraft Litig., 286 F.R.D. 645, 650–51 & n.7 (S.D. Fla. 2012). Here, plaintiff failed to propose a realistic method of identifying the individuals who purchased Meltdown. The courts have come to recognize that purchasers are less likely to retain receipts or other records of minor purchases, and thus cannot rely on those proofs to ascertain the identities of class members. See Red v. Kraft Foods, Inc., 2012 U.S. Dist. LEXIS 186948, at *14–19 (C.D. Cal. Apr. 12, 2012).

Nor could the court trust individuals to identify themselves as class members through the submission of affidavits. Accepting affidavits of Meltdown purchases without verification would deprive VPX of its due process rights to challenge the claims of each putative class member.  On the other hand, having VPX contest each affidavit would require a series of mini-trials and defeat the purpose of class-action treatment. Using affidavits to determine class membership would also invite fraudulent submissions and could dilute the recovery of genuine class members, said the court.

Regarding predominance, the court noted that the MMWA does not define a stand-alone federal cause of action for breach of express written warranty, but instead borrows state law causes of action for breach of both written and implied warranties. Under choice of law analysis, the law governing each class member's warranty claim is the law of the state where he or she purchased the Meltdown. The court noted that state law varied on issues such as privity and reliance. In short, varied state laws would govern the MMWA claims of class members across the country, imposing different legal requirements and overshadowing the allegedly common factual bases of the claims. Moreover, some of these laws would require individualized proof inappropriate for class treatment. In light of the differences among applicable laws and the potential need for individualized proof, the court found that individualized legal and factual issues predominate over the common aspects of the proposed class MMWA claims, rendering class certification inappropriate under Rule 23(b)(3).

Class certification denied.

FDA Seeks Comments on DTC Study

The Food and Drug Administration is seeking public comment on its investigation of the impact of communicating risks in direct-to-consumer prescription drug television advertisements.  Readers know of the importance of the DTC context in drug litigation.

The notice announcing the comment period notes that prescription drug advertising regulations (21 CFR 202.1) require that broadcast (TV or radio) advertisements present the product's major risks in either audio or audio and visual parts of the advertisement; this is often called the "major statement." There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects. Not all agree; one possible resolution is to limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad. For example, the disclosure could be, "This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it."

The Office of Prescription Drug Promotion  plans to investigate the effectiveness of this "limited risks plus disclosure" strategy through empirical research, with the hypothesis that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks. 

 

The FDA invites comments by 4/21 on: 

• whether the proposed collection of information is necessary for the proper performance of the FDA's functions;
•the validity of the methodology and assumptions used;
• ways to enhance the quality, utility and clarity of the information to be collected.

.

FDA Issues Draft Guidance on Social Media

The U.S. Food and Drug Administration recently took a small step towards providing industry with the long-awaited guidance on how pharmaceutical makers may communicate about their products on social media like Twitter. 

In July, 2012, Congress gave the FDA two years to come up with comprehensive policies on Internet promotion, and FDA has now released for comment the draft guidance document entitled, "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics." It is the first of what is certain to be a series of guidance documents on this subject. 

This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. 

FDA states that a company will be responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm. Such product promotional communications may include firm-sponsored microblogs (e.g., Twitter), social networking sites (e.g., Facebook), firm blogs, and other sites that are under the control or influence of the firm. In determining whether a firm must submit promotional material about its product to FDA, the Agency considers whether the firm, or anyone acting on its behalf, is influencing or controlling the promotional activity or communication in whole or part. Thus, a firm is responsible if it exerts influence over a site in any particular, even if the influence is limited in scope. For example, if the firm collaborates on or has editorial, preview, or review privilege over the content provided, then it is going to be responsible for that content, says the document. A firm is responsible for promotion on a third-party site if the firm has any control or influence on the third-party site, even if that influence is limited in scope. For example, if a firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that  the site is subject to submission to FDA to meet postmarketing submission requirements. 

FDA said it recognizes the challenges of submitting promotional materials that display real-time information and thus in the draft makes recommendations for submitting interactive promotional media. The main point of this part of the draft guidance is that marketers don’t always need to obtain FDA pre-clearance on planned tweets or an online posting before it is sent out.  If a firm submits interactive promotional media in the manner described in this draft guidance, FDA intends to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions related to promotional labeling and advertising.

The draft does not address such things as how risks can be communicated within the character-limits of media like Twitter, and  what constitutes acceptable use of hyperlinks. Clearly, more to come.

 

Report Issued on "New Lawsuit Ecosystem"

The U.S. Chamber of Commerce Institute for Legal Reform has released a report examining the developing lawsuit “ecosystem” and areas of litigation of most concern to the business community. The report examines the trends and players in six key litigation areas, offers insights into new emerging liability threats, and explores the growing alliance between state attorneys general and the plaintiffs’ bar.  One key feature notes how alleged deceptive marketing claims against food and beverage makers are on the rise.  Readers will recall our many posts about the trend for plaintiffs to parse labels and bring putative class actions even when they were not injured by the product. The report is entitled "The New Lawsuit Ecosystem.”

The report delves into the areas of law where entrepreneurial plaintiffs’ lawyers have been prospecting for new liability: Class actions against food makers alleging misleading advertising;
Data privacy suits against businesses over allegations that they inadvertently violated released or misused customer information; Claims against brand-name drug manufacturers for injuries allegedly stemming solely from generic products they did not make or sell; Speculative theories of liability seeking to recover for risks of harm or “economic loss,” not actual injuries.

The report also looks at the increasingly troubling trend of state attorneys general turning over the keys to their offices and litigation powers to private plaintiffs’ lawyers. Plaintiffs’ lawyers often develop the legal theories, decide whom to target, and then “recruit” state attorneys general
to retain them on a contingency fee basis to bring the lawsuits. This process provides significant advantages to plaintiffs’ lawyers: it eliminates the need to represent individuals who were actually injured by a defendants’ product or conduct; avoids any contribution those individuals may have
made to their own injuries; reduces traditional defenses; heightens the plaintiffs’ lawyers’ subpoena power; and gives them the ability to seek fines, not just damages. State attorneys general have these powers because they are to be used sparingly, and only to advance appropriate public policies. They are not to be used to maximize personal profit, which is the goal
of private contingency fee lawyers who are often personal or political allies of the state attorneys general.

Very interesting read.


Among those contributing to the report were my colleagues Mark Behrens, Phil Goldberg, Victor E. Schwartz and Cary Silverman.

Summary Judgment Granted on Product Identification

Sometimes simpler is better.  In product liability litigation nothing is more basic, perhaps, than proof the plaintiff used defendant's product.  Last week, a federal judge granted summary judgment against two plaintiffs' making claims in multi-district litigation over injuries allegedly related to the painkillers Darvocet and Darvon. See In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, No. 2:11-md-02226 (E.D. Ky.). The issue was this basic cause in fact element.

Summary judgment is appropriate when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

Defendant argued that it was entitled to summary judgment because neither plaintiff demonstrated the ingestion of a propoxyphene product manufactured, sold, or distributed by the defendant. In their Amended Complaint, both plaintiffs allege that they ingested propoxyphene products manufactured by Lilly. It is indeed a general principle of products liability law in Texas and Georgia (the applicable rules under choice of law in an MDL) that a plaintiff must allege sufficient facts to allow the reasonable inference that the injury-causing product was sold, manufactured, or distributed by the defendant. Plaintiffs could not dispute that they failed to establish the ingestion of a Lilly  product.

Instead, Lilly presented evidence demonstrating that plaintiffs represented that they intended to pursue only claims that relate to generic drugs; that is, they would seek to hold Lilly liable for
the injuries allegedly arising out of their taking of generic drugs made by someone else.

Such arguments were already rejected by the Court in this MDL.  The Court had previously found unpersuasive the plaintiffs’ argument that a brand-name manufacturer may be held liable under a misrepresentation theory of liability to a plaintiff who ingested generic propoxyphene. The prevailing rule regarding misrepresentation claims against brand-name manufacturers has its origins, noted the Court, in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), which rejected “the contention that a name brand manufacturer’s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer’s drug.” Id. at 170.

The majority of courts that have addressed similar claims have followed the Fourth Circuit’s lead. Notably, federal district courts in Texas have repeatedly found that “the Texas Supreme Court would conclude that a brand-name manufacturer does not owe a duty to warn users of the risks related to another manufacturer’s product.” Finnicum v. Wyeth, Inc., 708 F. Supp. 2d 616, 621 (E.D. Tex. 2010); see also Burke v. Wyeth, Inc., No. G-09-82, 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29,
2009).  And, similarly, there can be no recovery under Georgia law, “[u]nless the manufacturer’s defective product can be shown to be the proximate cause of the injuries . . .” Hoffman v. AC&S, Inc., 548 S.E.2d 379, 382 (Ga. Ct. App. 2001) (“To survive summary judgment, [the plaintiff] clearly
needed to present evidence that she was exposed to defendants’ products.”).

Defendant thus sufficiently established that there was no genuine dispute concerning the only
material fact that determined the viability of these plaintiffs’ misrepresentation claims: the identity
of the propoxyphene product ingested.  Therefore, the plaintiffs’ claims failed as a matter of law.

 

 

 

Summary Judgment for Defendant in Drug Case

A federal court recently granted summary judgment against Illinois plaintiffs who alleged that the blood clotting drug Trasylol caused the husband's kidney failure. See Miller v. Bayer Corp., No. 09-81262 (S.D. Fla., 7/3/13). (One of the remaining cases in the MDL.)

Plaintiff underwent double coronary artery bypass graft and aortic valve replacement surgery. At the time of his surgery, he was a former smoker with a lengthy medical history which included hypertension, hyper-lipidemia, chronic renal insufficiency, and coronary artery disease. The surgeon used Trasylol during the surgery to help control the bleeding. Plaintiff had signed an informed consent which enumerated the potential risks and benefits of cardiac surgery including infection, bleeding, heart damage, stroke, kidney damage, or even death.

After his surgery, Mr. Miller experienced a small acute left hemispheric stroke;  he also experienced a transient rise in his serum creatinine which peaked at 2.4 on postoperative day eight. (Creatinine is a waste product formed by the breakdown of a substance important for converting food into energy; if the kidneys are damaged and cannot function normally, the amount creatinine in the blood can increase.)

Plaintiffs sued for personal injuries allegedly caused by the use of the drug during surgery. Defendant moved for summary judgment as to each of Plaintiffs’ claims, asserting (1) under Illinois law, causation is an element of each of Plaintiff’s claims, and Plaintiffs’ expert’s causation testimony was inadmissible; (2) even if Plaintiffs’ expert’s testimony were admissible, their apparent claims failed because they were seeking damages for Mr. Miller’s stroke, and their
expert was not qualified to render an opinion as to the cause of the stroke. Plaintiffs responded that despite some confusion, ultimately they were not seeking damages due to Mr. Miller’s stroke, but for his “acute renal failure”; that the expert was qualified to testify; and “the temporal connection" between Mr. Miller’s acute renal failure and the injection of Trasylol, together with the alleged absence of renal issues prior to the surgery and the fact that Trasylol is supposedly a nephrotoxic agent, were sufficient to support an opinion that Trasylol was a substantial contributing factor in causing Mr. Miller’s injuries. 

The court noted that expert medical opinion evidence is usually required to show the cause of an injury or disease because the medical effect on the human system of the infliction of injuries is generally not within the sphere of the “common knowledge of the lay person.” See Fuesting v. Zimmer, Inc., 421 F.3d 528, 536 (7th Cir. 2005), rev’d on other grounds by Fuesting v. Zimmer, Inc., 448 F.3d 936 (7th Cir. 2006); Ancho v. Pentek Corp., 157 F.3d 512, 519 (7th Cir. 1998); Goffman v. Gross, 59 F.3d 668, 672 (7th Cir. 1995); Wallace v. McGlothan, 606 F.3d 410, 420 (7th Cir. 2010). Claims for negligence, strict liability, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, violation of consumer protection statutes, wrongful death, and loss of companionship, as well as a survival claim  all will fail where a plaintiff has no evidence of specific causation. See Schrott v. Bristol-Myers Squibb Co., 403 F.3d 940 (7th Cir. 2005). To avoid summary judgment, the Plaintiffs therefore must come forward with evidence that would allow a reasonable jury to find causation. Causation must be established by provable facts; it cannot be based on guess, conjecture, surmise, possibility, speculation, or mere allegation. 

In summary, plaintiffs' expert opined that in all medical certainty causation of Mr. Miller’s
alleged renal failure was likely multifactorial, with significant contributing factors including
cardiopulmonary bypass surgery, associated blood pressure fluctuations, and the use of the medication.  The drug, he said, "in all medical certainty, was a significant contributing factor.”
Additionally  he opined that the physicians caring for Mr. Miller “would not have used” this drug
had they been aware of the association of mortality and acute kidney injury.  Plaintiffs argued the expert had conducted a legally sufficient differential diagnosis which emphasized the  "temporal connection between Mr. Miller’s acute renal failure and the injection of Trasylol, together with the absence of renal disease or issues prior to the surgery.

This court falls in the camp of those who conclude that a differential diagnosis, properly performed, constitutes a reliable methodology for determining medical causation under Daubert. See Guinn v. Astrazeneca Pharms. LP, 602 F.3d 145, 153 (11th Cir. 2010); Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 904 (7th Cir. 2007).  Readers will recall that we have explained how plaintiffs have mis-used the notion of differential diagnosis, jumping from a medical method to figure out what disease a patient has to a legal method to figure out why the patient has the disease.  In any event, the court noted that an expert does not establish the reliability of his techniques or the validity of his conclusions simply by claiming that he performed a differential diagnosis on a patient.  Instead, a court must examine whether the expert correctly applied the differential diagnosis methodology. 

As applied in several courts, the method requires an expert to rule in all the potential causes of a patient’s ailment and then by systematically ruling out causes that would not apply to the patient, the physician arrives at what is the likely cause of the ailment. Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir. 1999)).  Plaintiff experts routinely make a couple mistakes:  Expert testimony that rules in a potential cause of a patient’s symptoms that is not so capable is unreliable.  At the rule out step, the expert must at least consider the other causes that could have given rise to Plaintiffs’ injury.  Courts vary on whether the expert must rule out all possible alternative causes, or the most likely ones, or at least consider other factors that could have been the sole cause of the plaintiff's injury.  A differential diagnosis that fails to take serious account of other potential causes may be so lacking that it cannot provide a reliable basis for an opinion on causation.  And an expert must provide a reasonable explanation as to why he or she has concluded that any alternative cause suggested by the defense was not the sole cause of the plaintiff’s injury.

The court then noted that  a temporal connection between exposure to chemicals and an onset of
symptoms, standing alone, is entitled to little weight in determining causation. See McClain v.
Metabolife Int’l, Inc., 401 F.3d 1233, 1254 (11th Cir. 2005); Happel v. Walmart Stores, Inc., 602 F.3d 820 (7th Cir. 2010).  Temporal proximity is especially unreliable where conditions independent of
exposure to the drug could have been the sole cause of the plaintiff’s injury, and the expert fails to
explain the relative contribution of the drug to the injury.  Here, one flaw in the expert's methodology was his failure to account for or appropriately address numerous risk factors at both the rule in and rule out stage., factors which either alone or in combination could explain Mr. Miller’s alleged renal injury. These factors include, but were not limited to: pressure stabilizing medications; extended pre-surgical and post-operative hypertension; and pre-surgical chronic renal failure. Even to those factors which the expert did rule in, he either gave them short shrift at the rule-out stage, or dismissed them without discussion.  In neither his report nor deposition did the expert provide any explanation for why he concluded that Mr. Miller’s various risk factors other than exposure to Trasylol were not the sole cause of his injuries. In fact, during his deposition, he conceded several additional risk factors for Mr. Miller that he had failed to consider in rendering his opinion, and further testified that many of those risk factors, either alone or in concert, could have caused Mr. Miller’s transient creatinine rise. He was forced to admit that Mr. Miller, without Trasylol, “could have had the same postoperative course.”


Thus there was no way to determine that one factor had more of an effect than the others. That led plaintiff to argue that Trasylol somehow tipped the scales causing his renal injury (the so-called straw that broke the camel's back).  But after sorting through these opinions and the Plaintiffs’ response to Defendants’ Motion, the court found that exclusion of the expert was warranted because of the absence of a reliable methodology, the failure to provide a plausible explanation for why he concluded that Mr. Miller’s various risk factors other than exposure to Trasylol were not the sole cause of his renal injury. Under Illinois law, a party cannot create a genuine issue of fact merely by presenting an expert witness who is willing to express an unsupported opinion that favors the party’s position. See Lewis v. CITGO Petroleum Corp, 561 F.3d 698, 705 (7th Cir. 2009).

 

 

 


 

Second Circuit Rejects Claims Over Scientific Literature

The Second Circuit recently held that scientific opinions voiced during debate of unsettled questions generally cannot support false advertising or deceptive business practices claims. See ONY Inc. v. Cornerstone Therapeutics Inc., No.12-2414 (2d Cir. June 26, 2013).

Defendants in this case were various corporate sponsors, authors, and publishers of a scientific journal article comparing the effectiveness of several types of medical surfactants -- biological substances that line the surface of human lungs. Surfactants are critical to lung function: they facilitate the transfer of oxygen from inhaled air into the blood stream.  Plaintiff ONY and defendant Chiesi Farmaceutici are two of the biggest producers of surfactants for medical treatment.  These parties vigorously contested the relative effectiveness of their products – in the marketplace, in the scientific literature, and in this lawsuit. The parties agreed that two variables are particularly relevant to this comparison: mortality rate and length of stay. Mortality rate means the percentage of patients (typically infants) treated with a particular surfactant who do not survive. Length of stay refers to the amount of time a patient infant remains in the hospital for treatment.

The dispute stemmed from a study funded by Chiesi, carried out by a private research firm, and then promoted and ultimately published by three doctors, which concluded that Chiesi's surfactant product allegedly led to lower infant mortality rates than ONY's product. The doctors submitted their article to the Journal of Perinatology, a leading journal in the field of neonatology. .After the article’s publication, Chiesi issued a press release touting its conclusions and distributed promotional materials that cited the article’s findings.  Plaintiff complained that the article – and the distribution of selections from it – violated the Lanham Act and New York General Business Law § 349, and also constituted tortious injurious falsehood and interference with prospective economic advantage.

The district court concluded that plaintiff failed to state a claim based on publication of the article because the challenged statements were protected scientific opinion. The Second Circuit agreed, concluding that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate cannot give rise to liability for damages sounding in defamation.

Plaintiff claimed that the article made statements about scientific findings that were intentionally deceptive and misleading, and that it therefore constituted false advertising. Plaintiff’s theory was that scientific claims made in print purport to be statements of fact that are falsifiable, and such statements can be defamatory or represent false advertising if known to be false when made. Plaintiff argued on appeal that the district court based its conclusion that the article’s statements were non-actionable solely on its determination that the assertions were statements of opinion, without conducting a more vigorous inquiry. 

The court of appeals noted that scientific academic discourse poses several problems for the fact-opinion paradigm of traditional First Amendment jurisprudence. Many conclusions contained in a scientific journal article are, in principle, “capable of verification or refutation by means of objective proof,” Phantom Touring, Inc. v. Affiliated Publ’ns, 953 F.2d 724, 728 n.7 (1st Cir. 1992). Indeed, it is the very premise of the scientific enterprise that it engages with empirically verifiable facts about the universe. At the same time, however, it is the essence of the scientific method that the conclusions of empirical research are tentative and subject to revision, because they represent inferences about the nature of reality based on the results of experimentation and observation. Importantly, those conclusions are presented in publications directed to the relevant scientific community, ideally in peer reviewed academic journals that warrant that research approved for publication demonstrates at least some degree of basic scientific competence. These conclusions are then available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design or the validity of the inferences drawn from the results.

In a sufficiently novel area of research, propositions of empirical “fact” advanced in the literature may be highly controversial and subject to rigorous debate by qualified experts. Needless to say, courts are ill-equipped to undertake to referee such controversies. Instead, the trial of ideas plays out in the pages of peer-reviewed journals, and the scientific public sits as the jury.

Where, as here, a statement is made as part of an ongoing scientific discourse about which there is considerable disagreement, the traditional dividing line between fact and opinion is not entirely helpful. While statements about contested and contestable scientific hypotheses constitute assertions about the world that are in principle matters of verifiable “fact,” for purposes of the First Amendment and the
laws relating to fair competition and defamation, they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities.

In that regard, said the court, it was relevant that plaintiff did not allege that the data presented in the article were fabricated or fraudulently created. If the data were falsified, the fraud might not be easily detectable by even the most informed members of the relevant scientific community. Rather, plaintiff here alleged that the inferences drawn from those data were the wrong ones, and that competent scientists would have included other data that were available to the defendant authors but that were not sufficiently taken into account in their analysis.

But when the conclusions reached by experiments are presented alongside an accurate description of the data taken into account and the methods used, the validity of the authors’ conclusions may be
assessed on their face by other members of the relevant discipline or specialty.The appeals panel therefore concluded that, to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising. Even if the conclusions that the authors drew from the results of their data could be actionable, such claims would be suspect when, as here, the authors readily disclosed the potential shortcomings of their methodology and their potential conflicts of interest

This analysis properly reflected a worry about the chilling impact on crucial and valuable research, including comparative effectiveness research, of lawsuits by competitors who are unhappy with or disagree with the results of such studies. Such a debate belongs in the marketplace of scientific ideas, not in the court room. 

Supreme Court Issues Important Preemption Ruling

The Supreme Court last week reversed the First Circuit decision in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S., 6/24/13).

Readers will recall that in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that state tort law claims against generic drug manufacturers based on the alleged inadequacy of the drug labeling are preempted; under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act, generic drug labeling must be the same as the labeling of the reference-listed drug. Because generic drug manufacturers cannot independently change the labeling, state law failure to warn claims are preempted.

Plaintiffs proceeded to hunt for exceptions, ways around the ruling.  One of the strategies was to resurrect design defect theories, which traditionally were not a major aspect of most drug plaintiff claims. This case was tried on a design defect theory of liability after the plaintiff’s failure to warn claims were dismissed prior to trial and the district court rejected the generic manufacturer’s preemption defense on the design claim.  The jury found for plaintiff, and defendant appealed, arguing that just as the manufacturer cannot alter the label, once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved new drug application.  In Bartlett, the First Circuit held that the plaintiff’s state law theory of liability could nevertheless be reconciled with federal law because, although the generic manufacturer could change neither the design nor the labeling, it could avoid liability if it stopped selling the drug entirely within the state.

The Supreme Court reversed.

New Hampshire imposes design defect liability where the design of the product created a defective condition unreasonably dangerous to the user. To determine whether a product is “unreasonably dangerous,” the New Hampshire Supreme Court employs a risk/utility approach under which a product is defective as designed if the magnitude of the danger outweighs the utility of the product. The New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry: the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.  

In the drug context, either increasing the “usefulness” of a product or reducing its “risk of danger” would require redesigning the drug: a drug’s usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. Here, said the Supreme Court, redesign was not possible, as the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, as the brand-name drug on which it is based. Given the impossibility of redesigning the drug, the only way for the defendant to ameliorate the drug’s “risk-utility” profile—and thus to escape liability—was to strengthen the presence and efficacy of the warning in such a way that the warning avoided an unreasonable risk of harm from hidden dangers or from foreseeable uses.

That was, of course, preempted.  When federal law forbids an action that state law requires, the state law is “without effect.” Because it is impossible for generic manufacturers to comply with both state and federal law, New Hampshire’s warning-infused design defect cause of action was pre-empted with respect to FDA-approved drugs sold in interstate commerce.

The Supreme Court rejected the argument that a defendant could satisfy both laws by paying tort judgments or refraining from selling its product in that particular state. And rejected the “stop-selling” rationale as incompatible with its pre-emption jurisprudence. The Court's pre-emption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. The incoherence of the stop-selling theory becomes plain when viewed through the lens of the previous cases. In every instance in which the Court has found impossibility pre-emption, the direct conflict between federal and state law duties could easily have been avoided if the regulated actor had simply ceased acting.

Interestingly, there is nothing in the Court's rejection of “stop-selling” limiting it to generic drugs; the rejection seems applicable to all federally regulated products because it's not based on the FDCA but is an argument “incompatible with our pre-emption jurisprudence.”

 

Supreme Court Declines to Review Defense Win in Drug Case

The Supreme Court declined earlier this month to review a decision by the Second Circuit affirming a defense verdict in the Fosamax litigation.  See Secrest v. Merck, Sharp & Dohme Corp., U.S., No. 12-1318, cert. petition denied 6/3/13).  The case explicates an interesting and somewhat rare evidentiary issue.

Readers may recall that a jury in the Southern District of New York handed down a defense verdict for Merck in October, 2011. One of the key evidentiary issues was the trial court's decision to exclude one of the expert witnesses for plaintiff under the so-called “sham issue of fact” doctrine. Dr. Epstein initially was designated a fact witness, and deposed as such.  After Merck moved for summary judgment, Dr. Epstein was designated as an expert, and he was re-deposed, and changed his testimony.  The second time around the witness testified that plaintiff took Fosamax in 2004 and 2005, but earlier had said he did not know about her alleged usage.

Because the physician’s expert testimony contained contradictions that were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to Secrest’s failure-to-warn claim, the Second Circuit held that the District Court did not err in determining that there was no genuine dispute of material fact raised by the later testimony.  The Supreme Court refused to entertain plaintiff's appeal.

Specifically, the District Court was entitled to disregard Dr. Epstein’s new testimony relating to his knowledge based on the “sham issue of fact” doctrine, which prohibits a party from defeating summary judgment simply by submitting an affidavit that contradicts the party’s previous sworn testimony. See Perma Research & Dev. Co. v. Singer Co., 410 F.2d 572, 578 (2d Cir. 1969). Although courts more typically apply the sham issue of fact doctrine where a party submits an affidavit that contradicts the party’s own prior statements, it may also apply when a party attempts to use evidence from an expert witness to defeat summary judgment.


Here, said the Second Circuit, the doctrine applied to stop Secrest from manufacturing a factual dispute by submitting testimony from an expert whom she tendered, where the relevant contradictions between the first and second depositions were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to the claim at issue.  See Rivera v. Rochester Genesee Reg’l Transp. Auth., No. 11-762-cv, 2012 WL 6633938, at *7 (2d Cir. Dec. 21, 2012) (concluding that summary judgment was inappropriate because the inconsistencies in the plaintiff’s testimony were not “real, unequivocal, and inescapable contradiction[s]”).  Here, Dr. Epstein’s February 2011 expert deposition testimony inescapably and unequivocally contradicted the testimony he gave in August, 2008.

Also, the relevant contradiction was not only unequivocal but was left unexplained – indeed, was inexplicable – so the trial court could properly determine that plaintiff had manufactured a sham issue of fact. See Rojas, 660 F.3d at 105-06; AEP Energy, 626 F.3d at 735-36. Finally, the sham issue of fact doctrine applied here, continued the Second Circuit, because the relevant contradictions in Dr. Epstein’s testimony were central to Secrest’s failure-to-warn claim. Applicable Florida law required Secrest to show that her treating physician would have recommended that she cease taking the drug if a different, adequate warning had been provided. Here, no reasonable juror could find that Dr. Epstein would have recommended that Secrest cease taking Fosamax if he did not even know she was taking it at the relevant time. 

The Supreme Court then denied plaintiff's cert petition. 

 

 

Drug and Device Seminar Approaches

It is spring time -- although you might not know it from the weather -- and it is time for one of the premier educational and networking conferences for the pharmaceutical and medical device defense bar – the DRI Drug and Medical Device Seminar.  Your hosts this year include my partner and Drug and Medical Device Committee Chair Scott Sayler, and my old pal Jeffrey A. Holmstrand, Flaherty Sensabaugh Bonasso PLLC, Wheeling, West Virginia.

The 2013 DRI Drug and Medical Device Seminar  will be held May 16-17 in New York City at the Sheraton Hotel in Midtown. Most of my readers are familiar with the Seminar and many routinely attend. Here are just a few highlights of the program this year.


• Judge Arnold New of the Philadelphia Court of Common Pleas will present on recent changes in that busy Court.
•  Judge Raymond Lohier of the Second Circuit will speak at the Diversity Luncheon.
• A presentation on how to get the most from Comment K in a medical device case.
• A discussion of  the conflict between free speech and off-label promotion.

  • Observations from the American Tort Reform Association on tough venues.
     

Other benefits-  I am told in-house counsel can attend for FREE, either as a member of DRI or via sponsorship by an outside counsel. FREE wi-fi in the conference room (so, yes, you can multi-task and read this blog.)  All of the usual networking events will be in full swing. 

For more information or to register, go to http://www.dri.org/Event/20130070.

DES Plaintiff's Reach for Market Share Liability Rejected Again

If asbestos is the grandfather of mass torts, the DES litigation may be the grandmother, with claims continuing today for harm allegedly caused by in utero exposure to diethylstilbestrol decades ago. DES is a drug once prescribed during pregnancy to prevent miscarriages or premature deliveries. In the U.S. an estimated 5 to 10 million persons were exposed to DES from 1938 to 1971, including pregnant women prescribed DES and their children. So we are 40 years out now, with some litigation remaining.

Recently, a federal court in New York held that a DES plaintiff could not meet the product identification requirement under applicable Texas law.  See Bezuidenhout v. Abbott Laboratories,  No. 10-CV-1011(E.D.N.Y., 1/17/13).

Readers may recall that what is often termed "product identification" is part of the cause in fact requirement of every tort claim.  A plaintiff must show that he or she has been injured not just by a type of product but by a product actually made or sold by the defendant.  In the context of DES, product identification may be especially challenging because the plaintiff's exposure may be in utero and the manifestation of the injury may not come for many years after the exposure.  A tiny minority of jurisdictions have flirted with weakening the traditional cause in fact requirement by adopting some form of the "market share" doctrine, under which defendants may be held proportionately liable to a plaintiff who cannot show which manufacturer sold the product that caused the injury, based on that defendant's sales of the product in the "relevant market."  Flawed and unfair, the concept did not gain wide acceptance.

Bezuidenhout was born in 1957 in Texas. While pregnant, her mother allegedly took DES, which was prescribed to her in Texas, according to the amended complaint. Decades later, plaintiff alleged various personal injury and increased risk of future injuries.  Defendants moved for summary judgment, asserting that plaintiff could not identify which manufacturer made the DES her mother took, as required under Texas law.

Plaintiff argued that Texas law was unsettled, that Texas courts had not clearly rejected the market share theory.  The court said it  need not wade too deeply into Bezuidenhout's "pool of hypotheticals", since it rested upon a false premise—that Texas law, as to proof of causation, is unsettled..."It is not.”  Indeed, the court opined that one of the goals of this case was to unsettle it. Texas does not permit recovery under a collective liability or market share theory. The courts in In re Fibreboard Corp., 893 F.2d 706 (5th Cir. 1990), and Cimino v. Raymark Indust., Inc., 151 F.3d 297, 312 (5th Cir. 1998), held that in Texas, it is a fundamental principle of traditional products liability law that the plaintiff must prove that the defendants supplied the product which caused the injury. Plaintiff tried to bootstrap to an "alternate reality," said the court. The Texas Supreme Court has never chosen to adopt market share liability.  

With the market share approach rejected, plaintiff had not proffered sufficient evidence to identify the defendant as a manufacturer of her mother's DES. Her mother's affidavit contradicted her prior sworn deposition testimony about whose product she might have used.  And, at best, a log from the pharmacist indicated that defendant's DES was among the many medications available at the pharmacy, but did not show which DES her mother took. The court thus found plaintiff failed to raise a genuine issue of material fact regarding the identity of the DES manufacturer.

Follow-up to Fennell

Recently, we posted about the decision of the Illinois Supreme Court interpreting (and putting more teeth in) the forum non conveniens doctrine.  See Fennell v. Illinois Central.

A  tip of the hat to faithful reader Brendan Kenny at Blackwell Burke for noting that the decision is already having important effects.  Here, and here, are three recent Illinois appellate decisions overturning lower court denials of defendants’ forum non conveniens motions.


 

Solomon Court Issues Wise Decision in Drug Case

The federal court in New Jersey recently granted summary judgment to a drug manufacturer in a failure to warn claim under Texas law.  See Solomon v. Bristol-Myers Squibb Co., No. 07-1102 (D.N.J., 1/3/12).  The opinion offers a number of useful observations.

The case involved Plavix, a drug that inhibits blood platelets from forming clots. The drug is often used in patients with recent heart attack, stroke, or diagnosed peripheral vascular disease, to prevent dangerous clots.Taking Plavix, like any medicine, is not without risk. Because it functions by inhibiting the formation of blood clots, Plavix increases the risk of bleeding. The manufacturer warned of this risk extensively on the label. 

In November 2002, Plaintiff suffered a heart attack, and his doctors placed two metal stents in his arteries to maintain blood flow to his heart. At that time, one of his doctors prescribed Plavix with aspirin in order “to prevent clots.” Subsequently, Plaintiff’s treating cardiologist continued this prescription. In July 2005, Plaintiff began suffering gastrointestinal bleeding, which led him to sue Defendants asserting product liability related causes of action, under Texas state law, for defective design, manufacturing defect, failure to warn, and negligence.  All these  claims essentially turned on whether Defendants adequately warned that Plavix carried a risk of bleeding complications.

Defendants moved for summary judgment, relying in large measure on the learned intermediary doctrine. Readers will recall that within the prescription drug context, where a plaintiff sues the manufacturer of a prescription drug for failing to adequately warn of the drug’s effects, Texas courts employ the learned intermediary doctrine. As the Texas Supreme Court has explained, the underlying premise for the learned intermediary doctrine is that prescription drugs are complex and vary in effect, depending on the unique circumstances of an individual user, and for this reason, patients can obtain them only through a prescribing physician. Indeed, a patient’s doctor, who stands between the patient and the drug manufacturer, is in the best position to professionally evaluate the patient's needs, assess the risks and benefits of available drugs, prescribe one, and supervise its use. Hence, if the doctor is properly warned of the possibility of a side effect and is advised of the symptoms normally accompanying the side effect, it is anticipated that injury to the patient will often be avoided. Recognizing the doctor-patient relationship, the doctrine excuses a drug manufacturer from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.

In arguing the warning claim, Plaintiff contended that he was entitled to a heeding presumption that proper warnings would have a made a difference and that this presumption excused him from proving causation. However, Texas law creates no such presumption. The Fifth Circuit has noted that neither Texas nor federal courts applying Texas law have applied the read-and-heed
presumption to pharmaceutical cases involving learned intermediaries. Indeed, Texas has explicitly rejected the Restatement (SECOND) Of Torts § 402A, Comment j's read-and-heed presumption for policy reasons and, said the court, because it has been superseded by Restatement (THIRD) Of Torts::Products Liability § 2.

On the factual assertions of failure to warn, the court found that although Plaintiff presented various studies and articles challenging the efficacy of Plavix in certain types of patients, none of those studies were  relevant to Plaintiff’s medical situation. For example, the studies upon which Plaintiff tried to rely regarding Plavix’s alleged ineffectiveness for patients 75 years or older had no relevance since Plaintiff was well under 75 years old when he stopped taking the drug. More fundamentally, many of Plaintiff's arguments seemed to center on an alleged lack of efficacy; Plaintiff’s efficacy arguments were not relevant in the context of a failure-to-warn analysis. Plaintiff’s claim was essentially premised on the fact that he suffered substantial bleeding, while his response to the motion argued Plavix did not work. A proper warning should adequately alert any danger or harm that may result from ingesting the drug; efficacyis a separate issue. Permitting Plaintiff to pursue his failure-to-warn claim on an efficacy theory would, as has been found in other jurisdictions with similar laws, impermissibly expand liability under Texas law on the adequacy of pharmaceutical warning labels.

Focusing on the alleged inadequacy of the warning, Texas law is clear that when a warning appropriately and specifically mentions the circumstances complained of, the warning is adequate as a matter of law. First and foremost, said the court, the warning label here clearly cautioned users that PLAVIX use with aspirin was associated with an increase in bleeding. Plaintiff failed to provide any evidence to show that the risk levels published on the Plavix warning label were inaccurate, insofar as the warnings concerned the risk of bleeding.

Another ground for summary judgment. In addition to proving inaccuracy, Plaintiff had to show that
the allegedly defective warning label was the producing cause of Plaintiff’s injury. Thus, it was Plaintiff’s burden to demonstrate that the treating physician would not have used or prescribed the product but for the inadequate warning. However, the cardiologist insisted that despite the risks, it was important that these drugs were prescribed to Plaintiff to prevent a life-threatening problem.  The doctor acknowledged that the therapy could cause serious risk of bleeding in patients.   Nevertheless, the cardiologist insisted that despite the risks, it was important to prescribe the drug.  Furthermore, throughout the prescribing doctor's deposition, he  consistently testified that he did not rely on Plavix warning labels.  Texas law is clear on causation: when the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries.  It was clear that  the doctors were aware of the serious risks of bleeding when placing Plaintiff on the medicine. 

Plaintiff’s failure-to-warn claim failed for the additional  reason that, under Texas law, Defendants are presumed not liable because the Plavix warning labels were approved by the FDA. In Texas, where prescription drug manufacturers comply with the FDA regulations, Texas law creates a rebuttable presumption of non-liability in prescription drug suits. See Tex. Civ. Prac. & Rem.
Code. Ann. § 82.007.

Summary judgment granted.

Drug Maker Defeats AG Motion to Dismiss Action Challenging Private Contingency Counsel

We have warned readers before about the dangerous and growing practice of governmental agencies delegating state police powers to private (plaintiff) attorneys on a contingency fee basis.  The latest round in this nationwide battle comes from Kentucky, where the court recently ruled that Merck can continue its suit alleging violation of its due process rights after the state hired such outside counsel.  See Merck Sharp & Dohme Corp. v. Conway, No. 3:11-cv-51 (E.D. Ky., 12/19/12).

The matter underlying this action arose from Merck’s marketing and distribution of the prescription medication Vioxx. The AG filed suit against Merck in the Franklin County Circuit Court in 2009, alleging a violation of the Kentucky Consumer Protection Act (“KCPA”). Merck removed the case to federal court, and the action was then transferred to the Eastern District of Louisiana on April 15, 2010, as part of the multidistrict litigation, In re Vioxx Product Liability Litigation, MDL No. 1657.  But on January 3, 2012, the District Court for the Eastern District of Louisiana granted the AG’s motion to remand, concluding that the case was improperly removed from state court. In re Vioxx Prods. Liab. Litig., MDL No. 1657, 2012 WL 10552, at *14 (E.D. La. Jan. 3, 2012).

Now, approximately one year into the proceeding, the AG had retained outside counsel to take over the Vioxx KCPA litigation.  Under the contract executed, private counsel agreed to be compensated by a contingency fee “to be withheld from any settlement award resulting from the litigation.” Merck filed suit against the AG in federal court in August, 2011, seeking a declaratory judgment and injunctive relief. In its complaint,  Merck alleged that the AG had “delegated his coercive powers to private lawyers having a clear, direct and substantial financial stake in the outcome...."  The case was "a punitive enforcement action that must be prosecuted in the public interest or not at all.”  As a result, Merck asserted, its “right to due process under the Fourteenth Amendment had been infringed.” 

The AG moved to dismiss, and the issue in this decision focused on the abstention doctrine announced in Younger v. Harris, 401 U.S. 37 (1971); it provides that when a state proceeding is pending, principles of federalism dictate that any federal constitutional claims should be raised and decided in state court without interference by the federal courts. See Pennzoil Co. v. Texaco, Inc., 481 U.S. 1, 17 (1987).  If a federal district court concludes that its resolution of the case before it would directly interfere with ongoing state proceedings, then it must determine whether to abstain from hearing the case altogether, under the following: (1) there must be an ongoing state
judicial proceeding; (2) the proceeding must implicate important state interests; and (3) there
must be an adequate opportunity in the state proceeding to raise constitutional challenges.

Merck argued that the AG’s active litigation in federal court — through the filing of answers, motions to dismiss, and motions for summary judgment — was sufficient to establish that proceedings of substance had taken place before the remand, i.e., before an action had been pending in state court.  The court agreed that the abstention doctrine did not require a strict view of the federal action timeline nor a formalistic approach to the abstention analysis. Using a "common sense approach," several factors weighed in favor of a conclusion that proceedings of substance had taken place: (1) the federal action had been pending for over seven months when the state court proceeding was remanded on March 20, 2012; (2) on the date of the remand, there were two important motions that were fully briefed and ripe for adjudication; and (3) the court had held a scheduling conference during which the parties advised the court about their positions on those two motions. Based on these facts, the court concluded that the federal action was well beyond an “embryonic stage.” Because the state proceeding was not “ongoing” in a meaningful sense, abstention was not appropriate under the principles of Younger.

Your humble blogger notes that the legal policy of many states strongly favors open, competitive bidding for contracts involving state funds. Such requirements, included in some state Constitutions and various statutes, are designed to prevent fraud, eliminate bias and favoritism, and thus protect vital public interests. Those same goals of open and good government reside in the requirement that state officials give their undivided loyalty to the people of a state. Many of the contingent fee contracts used by state officials to bring mass tort actions violate the core principle that attorneys pursuing actions on behalf of the state represent a sovereign whose obligation to govern impartially is essential to its right to govern. Government attorneys must exercise independent judgment as a ministers of justice and not act simply as advocates. The impartiality required of government lawyers cannot be met where the private pecuniary interest inherent in the contingent fee is the primary motive force behind the bringing of the action. By turning over sovereign prosecutorial-like power to contingency counsel, a state effectively creates a new branch of government – motivated by the prospect of private gain rather than the pursuit of justice or the public welfare. This subversion of neutrality does more than implicate the due process rights of those confronting such tainted prosecutions. Direction of state prosecutions by financially interested surrogates also damages the very public interest that such litigation is supposed to advance. 
 

Supreme Court Denies Cert in Case Excluding Treater Opinions

Readers may recall our post about Simmons v. Novartis Pharmaceutical Corp., a case in which the Sixth Circuit affirmed the exclusion of plaintiff's expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. The issue was specific causation, and the court helpfully noted that a treating physician’s testimony is subject to Daubert; that an expert's statement that he found “a very close association” between ONJ and the class of drugs is not enough; and that while a treater may be qualified to diagnose a patient, a diagnosis is merely a hypothesis, which does not by itself satisfy Daubert and Rule 702.

The Supreme Court earlier this month denied the plaintiff's cert petition. See Simmons v. Novartis Pharmaceutical Corp., U.S., No. 12-283, cert. denied 11/5/12).

Plaintiff had argued that when a case involves medication that has not been widely studied, and thus published about, a different standard should apply.  She also argued that the opinions would have been admissible under the law of Maryland which, she said, requires only that expert opinions be expressed “to within a reasonable degree of medical/dental probability.”

Novartis has had a number of victories in similar cases, challenging treating physicians who seek to offer expert causation opinions. 

Court of Appeals Applies CAFA Mass Action Provision

The Seventh Circuit has resolved a conflict between district court decisions about whether a motion to consolidate and transfer related state court cases to one circuit court constitutes a proposal to try the cases jointly triggers the “mass action” provision of the Class Action Fairness Act (“CAFA”).  The court held that plaintiffs’ motion to consolidate did propose a joint trial, and thus removal was proper. See In re Abbott Laboratories Inc., No. 12-8020 (7th Cir. 10/16/12).
 

Between August 2010 and November 2011, several hundred plaintiffs filed ten lawsuits in three different Illinois state courts for personal injuries they alleged were caused by Depakote, a prescription medication.  Later, plaintiffs moved the Supreme Court of Illinois to consolidate and
transfer their cases to one venue, St. Clair County. In the memorandum in support of their motion, plaintiffs indicated they were requesting consolidation of the cases through trial and not solely for pretrial proceedings. Defendant removed each of the cases to federal court (in two districts) asserting that the motion to consolidate brought the cases under CAFA’s “mass action” provision, which allows the removal of any case where 100 or more people propose to try their claims jointly. Plaintiffs moved to remand in both courts.

The Southern District granted the motion to remand, concluding that the language in the motion to consolidate did not propose a joint trial. The Northern District court denied plaintiffs’ motion to
remand, noting that the motion to consolidate clearly sought to consolidate the 10 complaints for all purposes, including for purposes of conducting a trial.  Plaintiffs argued on appeal that they did not specifically propose a joint trial because their motion to consolidate did not address how the trials of the various claims in the cases would be conducted, other than proposing that they all take
place in St. Clair County. In plaintiffs’ view, for the mass action provision to apply, they would have needed to take the further step of requesting a joint trial or an exemplar trial that would affect the remaining cases.

The court of appeals noted that plaintiffs argued that they never specifically asked for a joint trial, but a proposal for a joint trial can be implicit. See Bullard v. Burlington Northern Santa Fe Railway
Co., 535 F.3d 759 (7th Cir. 2008).  A joint trial does not have to encompass joint relief. For example, a trial on liability could be limited to a few plaintiffs, after which a separate trial on damages could be held. Similarly, a trial that involved exemplary plaintiffs, followed by application of issue or claim preclusion to more plaintiffs without another trial, would be one in which the claims of 100 or more persons are being tried jointly. In short, said the court of appeals, a joint trial can take different forms as long as the plaintiffs’ claims are being determined jointly.

Here, plaintiffs may not have explicitly asked that their claims be tried jointly, but the language in their motion came close. Plaintiffs requested consolidation of their cases “through trial” and “not solely for pretrial proceedings.” They further asserted that consolidation through trial “would also facilitate the efficient disposition of a number of universal and fundamental substantive questions applicable to all or most Plaintiffs’ cases without the risk of inconsistent adjudication
in those issues between various courts...”  It is difficult to see how a trial court could consolidate the cases as requested by plaintiffs and plaintiffs’ claims would somehow not be tried jointly. Although the transferee court will decide how their cases proceed to trial, it does not matter whether a trial covering 100 or more plaintiffs actually ensues; the statutory question is whether one has been proposed.

The court thus reversed the Southern District's grant of the plaintiff's motion to remand and affirmed the Northern District's ruling. 

Defense Verdict Upheld on Post-trial Motion in Levaquin MDL

About 1700 federal cases sit in the MDL for the product Levaquin makers.  Levaquin is an antibiotic used to treat a variety of bacterial infections, including upper respiratory infections. Plaintiffs in the MDL allege they have been prescribed Levaquin, and allege that it causes tendons to rupture. They claim that defendants' warnings about this alleged side effect were inadequate.  Defendants deny these allegations.

In this mass tort, the MDL court has begun to try bellwether cases. Recently the MDL court rejected a plaintiff's post-trial motion after he lost the third such trial. See Straka v. Johnson & Johnson, No. 08-5742 (D. Minn., 9/28/12).  A jury found that the alleged failure to warn Straka's prescribing physician about the risk of tendon rupture did not cause the plaintiff's injuries. After trial, one issue was the ubiquitous and almost never prevailing "verdict against the weight of the evidence" argument.  The court disposed of this by noting the sufficient evidence at trial supporting the jury's finding in that Straka's injuries were caused by something other than Levaquin, and that a different warning would not have changed his physician's decision to prescribe Levaquin. Defendants presented evidence about Straka’s steroid use and testimony that steroid use can contribute to tendon injury without the use of Levaquin.  And defendants did a good job presenting evidence that the prescriber could not remember reading the Levaquin label and did not learn of the tendon-associated risks of Levaquin until well after the black box warning was added and a Dear Doctor letter was distributed.

Perhaps more interesting for the trial lawyers among our readers is the argument for a new trial because one juror worked for a company that had a business connection to one of the defendants. Specifically the juror disclosed after trial began that her employer provided services to one of the defendants' (J&J) disability insurance carrier. Straka contended the doctrine of “implied bias” required the court to strike this juror. But the juror could not recall having ever worked on a Johnson & Johnson issue, and she indicated that she was unaware what proportion of her work came indirectly from Johnson & Johnson. When asked if her company’s connection with Johnson & Johnson would affect her ability to be fair and impartial, she said no. 

The doctrine of implied bias (also referred to in some cases as “implicit bias”) requires a court to strike a juror in extreme situations where the relationship between a prospective juror and some aspect of the litigation is such that it is highly unlikely that the average person could remain impartial in his deliberations under the circumstances. See Sanders v. Norris, 529 F.3d 787, 792 (8th Cir. 2008).  The juror here did not have the type of financial relationship that would require the Court to presume implied bias: she was not employed by defendants, or even employed by a company that worked directly for Johnson & Johnson.  Nor was it unlikely that the average person could remain impartial in deliberations in this situation. She was sufficiently removed from Johnson & Johnson that she did not realize that her company did any work relating to the defendants until a co-worker recognized it. So no error in proceeding.

[FYI, according to the court, some MDL parties discussed have discussed a tentative settlement agreement reached on September 25, 2012, in a conference held in front of Chief Magistrate Judge Boylan. This tentative settlement agreement is being drafted, and involves the case inventories of 6 law firms. The effect of this settlement would reduce the MDL case count by 845 cases and plaintiffs. At the time of the status conference several other plaintiffs' firms have expressed an interest in exploring settlement, but there remain firms that are interested in going forward with the litigation, according to the court.]


 

Another Federal Court Applies Mensing

A federal court in Ohio recently ruled that a plaintiff who used only the generic form of the drug  metoclopramide has no cause of action under the Ohio Product Liability Act against makers of the brand-name drug. Hogue v. Pfizer Inc., No. 10-805 (S.D. Ohio, 9/27/12).

In late 2000, Ms. Hogue's physician prescribed Reglan® to treat plaintiff''s abdominal pain and digestive problems. Ms. Hogue then began to take generic metoclopramide and continued to do so until about August 2009. The parties stipulate she ingested only the generic version of metoclopramide, which the Brand Defendants did not manufacture. She later allegedly suffered side effects and sued both the branded and the generic manufacturers for an alleged failure to warn. And so  we have two rulings to reflect the status of each kind of defendant.

The generic defendants filed a motion to dismiss, arguing that the United States Supreme Court held in PLIVA, Inc. v. Mensing that such state law tort claims against generic drug manufacturers are preempted by federal law. Generic defendants pointed out that the Mensing case involved the same generic medication at issue in this case, the same alleged injuries, some of the same generic drug manufacturer defendants, the same claims, etc.  Plaintiff argued that nonetheless the Mensing holding was somehow more limited.  The court agreed with the defendants: First, the Supreme Court rejected the theories that generic drug manufacturers could use the "changes-being-effected" ("CBE") process to change their labels to satisfy the state law. The FDA interprets the CBE process to allow generic manufacturers to change generic drug labels only to match an updated brand-name label or to follow the FDA's instructions. Any unilateral change to labels by generic drug manufacturers would violate the federal requirement that generic drugs be identical to brand name drugs in both substance and labeling.

Second, the court noted that  the Supreme Court has considered and rejected the plaintiff's argument that the generic drug manufacturers could have sent "Dear Doctor" letters as additional
warnings. Dear Doctor letters qualify as "labeling" and therefore must be consistent with, and not
contrary to, the rest of the drug's approved labeling.  Any Dear Doctor letter containing substantially new warnings would not conform to the approved labeling. Moreover, if generic drug
manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the branded and generic drugs and thus could be impermissibly misleading.

Third, the Supreme Court already considered whether the generic drug  manufacturers could have complied with the state laws by proposing stronger warning labels to the FDA. Even assuming such a duty exists on the part of generics, which is not clear, fulfillment of that duty would not have satisfied the state law requirements. Because it was impossible to comply with both federal law and state law, the plaintiff's state law claims were preempted.

Plaintiff further argued that Mensing didn't apply when the FDA has designated a defendant's drug as a reference listed drug ("RLD"). But the designation of a drug as an RLD does not change the manufacturer's status as an Amended New Drug Application ("ANDA'') holder,  the RLD designation does nothing to alter an ANDA holder's duties concerning labeling changes.

On the legal side, even if a failure to warn was preempted, plaintiff argued that several of her legal claims were not based on a theory of failure to warn. For example, plaintiff stated her breach of warranty claims did not conflict with any federal requirement regarding labeling and thus were not preempted. But the required analysis here is to focus not on the label or caption of the count, but the substance of the claim; and the other claims such as breach of warranty were in fact predicated on the failure to provide adequate warnings and were preempted. See also Smith v. Wyeth, 657 F.3d 420, 423 (6th Cir. 2011 ), cert. denied 132 S. Ct. 2103.

Brand defendants moved for summary judgment, arguing that Ohio law requires a plaintiff to prove the defendant manufactured the product that caused her injuries. Because they did not manufacture the metoclopramide Ms. Hogue ingested, her claims against them should fail as a matter of law.

The court noted that under Ohio law the defendant must have sold the actual product that was the cause of harm for which the claimant seeks to recover compensatory damages, and proof that a manufacturer designed or sold the type of product in question is not proof that the manufacturer did so for the actual defective product in the product liability claim. The Ohio Product Liability Act displaced plaintiff's common law claims, and required plaintiff to prove the defendant manufactured the product that caused her injuries.  They did not, so summary judgment was warranted.

(Note SHB works for the defense in part of this litigation.)
 

 

 

Supreme Court Declines to Review Medical Device Case

Earlier this week, the Supreme Court declined to hear plaintiff's challenge to the Fourth Circuit's decision on an important aspect of medical device law in Walker v. Medtronic Inc., No. 11-1418 (U.S. 10/1/12). 

The Court denied the petition for a writ of certiorari from plaintiff Walker, who appealed a Fourth Circuit decision that held that the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act preempted her suit alleging that defendant's medical device caused her husband's death.  The denial may help to clarify the standard set forth in Riegel v. Medtronic, which held that state law requirements are generally preempted by the MDA.  More specifically, the case relates to the so-called “parallel violation claim” exception to the general rule of medical device preemption.  Readers may recall that some dicta in Riegel noted a theoretical possible exception for when a claim of a violation was "parallel" to and not different than the FDA's actual requirements.

The court of appeals, 2012 WL 206036, slip op. (4th Cir. Jan. 25, 2012), offered a very narrow view of this exception, a good thing for manufacturers.  Walker alleged he had used a Class III device designed to infuse a preset amount of  medicine into the fluid that surrounded his spinal cord.  Plaintiff passed away, and a claim was filed alleging that the device was defective, leading to a fatal overdose.  Plaintiff's attempt to evade the reach of preemption turned on language in the product literature that the device would give the specified dosages ±15%, language plaintiff said was a “guarantee of performance,” creating an un-preempted “parallel” violation claim. 

The court held the parallel exception is quite narrow. The FDA has performance standards, under which a manufacturer must guarantee a particular level functioning or performance.  The FDA may condition its grant of premarket approval upon such performance standards if it determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. See 21 U.S.C. §360d(a)(1).  But the establishment of a performance standard is a highly formal process, requiring notice, findings of fact on risks, and comments from interested stakeholders.  

So, when a plaintiff asserts that a statement or representation or feature that hasn’t gone through the formal FDA procedure is a “performance standard,”  that is in fact asserting something different from or in addition to the FDA standards for the product within the meaning of the Act’s preemption clause. Thus, it is preempted.  The court of appeals concluded that the only mechanism for creating a binding, ongoing performance requirement is the creation of a performance standard. And the plus or minus 15 percent specification was not a performance standard.

That makes complete sense because the device in question was manufactured in full compliance with what the FDA required.   Expectations that may have been generated by literature surrounding the product are not the same thing as FDA standards. The device was not required to always dispense medication within the range of the plus or minus 15 percent.  And for plaintiff to try to sue over this feature would be to seek to impose a more demanding standard than that of the FDA, rather than just a parallel one.

Walker appears to be one of the first appellate court decisions to reject this type of claim on the basis that a mere device malfunction that does not relate to a formal performance standard is not going to be enough to establish a “parallel” violation claim. And the Supreme Court leaves it in place.

Report Issued on Use of Science in Regulatory Decisions

Scientists and policy experts from industry, government, and various nonprofit sectors worked on a report released recently by the Research Integrity Roundtable, designed to offer ways to improve the scientific analysis and independent expert reviews which underpin many important regulatory decisions. The primary audience for the report is federal agencies and their scientific advisory committees, but the ideas in the report may be relevant to others who work at the intersection of science and regulatory policy, including in Congress, the judiciary, and readers of MassTortDefense.  These issues can have important implications for persons interested in issues associated with chemicals, energy, land use, natural resources, agriculture, pharmaceuticals, and other areas in which science informs public policy.

Critics of the manner in which science is used in regulatory decision-making processes tend to raise two kinds of concerns. They question the composition of committees that are empaneled to recommend or review the science behind a possible regulatory decision and they question the way an agency or committee has reviewed the relevant scientific literature, charging that the reviewers used or omitted the wrong studies, and/or that the studies were not appraised appropriately. Obviously, some disputes over the "politicization" of science actually arise over differences about policy choices that science can inform, but not determine.

With that in mind, this report attempts to lay out some broad principles, guidelines, and practices designed in the view of the authors to limit the battling over conflict of interest and bias, and systematic reviews.  Accordingly, this report focuses on:

 How should panels be composed and the qualifications of prospective advisory panelists be vetted?
 How should concerns about biases and conflicts of interest of advisory panelists be handled?
 Which studies should agencies review when examining the scientific literature related to a regulatory policy issue?
 How should contending views regarding the relevance of particular scientific results to a regulatory issue and the credibility of those results be addressed?

For panel formation, the report concludes that a reasonable balance must be established between transparency and privacy. In the realm of qualifications, for example, balancing how much personal information should be revealed to the public by a prospective panelist who may be willing to serve in an advisory capacity, but may not want every aspect of his or her personal life or financial status released to the public.

In dealing with scientific studies, the report suggests a balance must be established in developing and applying objective and transparent criteria for establishing data relevance and reliability between the desire for complete data-sets and the reality that the relevant scientific literature is populated with studies from a wide variety of sources with varying degrees of data availability. In some cases, when proprietary information is involved, an appropriate balance must be struck between the public’s right to know and the legally based need to protect proprietary formulas, production processes, and related intellectual property. 

Challenge to Federal-State Court Coordination Overture Prompts Response

One of the challenges of our system of federalism, and dual jurisdiction between state and federal courts, is the coordination of related cases pending in the two systems.  Perhaps nowhere does this happen more regularly than in the realm of mass torts.  Federal cases may be coordinated in an MDL, and several states, such as New Jersey, have a procedure to centralize mass tort filings in their state court system. See Hermann, et al. Statewide Coordinated Proceedings (2d ed. West 2004). But coordination between the state and federal level has been more difficult, more informal, more experimental. That is, state and federal judges, faced with the lack of a comprehensive statutory scheme, have undertaken innovative efforts to coordinate parallel or related litigation so as to try to reduce the costs, delays, and duplication of effort that can stem from such dispersed litigation. State judges, for example, can bring additional resources that might enable an MDL transferee court to implement a nationwide discovery plan or a coordinated national calendar

Recently, plaintiffs in state court cases in the Actos litigation sent the Actos federal MDL court a letter complaining that the judge improperly "intervened" by discussing the litigation "ex parte" with the state court judge.  The plaintiffs asserted that the federal court persuaded the state court judge to rule in a certain fashion on scheduling issues, including the time for discovery and trial dates. Plaintiffs complained that such "intervention" would prevent them from properly litigating their cases; violated the important policy of comity (citing the Anti-Injunction Act); and raised "objectivity" concerns.  Plaintiffs requested the federal court refrain from such communications in the future with any state court judges handling Actos cases, citing the Canons of Judicial Ethics.  Finally, the letter asked that plaintiffs further be heard on this issue at an upcoming MDL hearing.

At first blush, this seemed like an over-reaction by plaintiffs, and perhaps an attempt to intimidate the court into not doing what seems like a perfectly acceptable thing, informally coordinating litigation which raises similar issues, involves many of the same counsel, and likely will implicate many of the same discovery requests, fact and expert witnesses. We leave it to the loyal readers of MassTortDefense to decide for themselves about the tone of this letter.

So how did the federal court react? Judge Doherty is overseeing the federal multidistrict litigation, In re: Actos (Pioglitazone) Products Liability Litigation (MDL-2299). Her reaction came in the form of a "Memorandum Response." The court read the original letter as possibly alleging improper and unethical conduct by both the federal and state court judges, and doing so by making "completely specious" arguments. On the merits, the court began by noting that the Manual for Complex Litigation recommends cooperation and coordination among federal and state court judges in these mass tort contexts.  So does the state court-focused manual, Managing Mass Tort Cases: A Resource for State Court Judges, published by the Conference of Chief Justices. The important notion of comity was respected because the communication from the MDL court was merely an invitation asking whether state courts might see any benefit in talking about the litigation posture. An invitation to chat is not an "intervention." And any communications were in that same spirit.

The court's memorandum turned to the MDL schedule, its internal logic and consistency, and the ample opportunity all parties had to comment on and object to any of its provisions. The court then points out, logically, that an improper ex parte conversation involves a communication between the court and one , but not all parties -- not a conversation between two independent judges.

The court than labeled a "cautionary tale" those cases that warn attorneys against unsubstantiated allegations that bring the judiciary into disrepute. Finally, the court noted that the letter inaccurately cites the Code of Judicial Conduct. The canons clearly do not prohibit a judge from consulting with other judges to aid the judge in carrying out his or her responsibilities.

The court gave the authors the benefit of the doubt, deciding ultimately to view the letter as over-zealous, ill-advised, poorly thought out, regrettable hyperbole, and empty rhetoric, as opposed to something more troubling.   An interesting read for all our readers, especially those with MDL practices.

 

Federal Court Offers Cogent Analysis of Warning Causation in Drug Case

A New Jersey federal court granted summary judgment last week to a pharmaceutical defendant in a failure to warn case. See Baker et al. v. APP Pharmaceuticals LLP et al., No. 3:09-cv-05725 (D.N.J.).  The case should be interesting to our readers in part because there really isn't a huge amount of law on warning causation in the busy jurisdiction of New Jersey.

During a hospital stay, plaintiff Baker was administered the commonly prescribed drug heparin. Heparin is an anticoagulant: it prevents blood clots. The opinion noted that the drug is associated  with heparin induced thrombocytopenia (“HIT”), or low blood platelet count. HIT may in a few patients progress to a more serious adverse reaction called heparin induced thrombocytopenia  and thrombosis (“HITT”). Plaintiff received heparin during and after her surgery, and a few days later her  platelet count was down; but according to the opinion it was not known at what point her platelet count reached serious levels because no one measured her platelet level for several days, despite the hospital’s stated protocol to monitor a patient’s platelet count periodically in order to detect possible HIT.

Plaintiff suffered injury to her left foot and leg, and thereafter sued several manufacturers of heparin, asserting they failed to adequately warn of the serious side-effects associated with heparin use. The parties agreed that defendant’s heparin has always contained FDA-approved labeling, including risk disclosures and warnings. In 2001, the heparin label specifically disclosed the risk of HIT and HITT in the “Precautions” section.  In 2005, defendant submitted a supplemental NDA via the “changes being effected” process to include additional HIT and HITT information the “Warnings” section of its heparin labeling. See 21 C.F.R. 314.70. The FDA suggested several alterations, all of which defendant incorporated into the labeling, and the FDA found the updated labeling “acceptable” in June 2007. 

In New Jersey, product liability actions are governed by the New Jersey Products Liability Act (“PLA”). N.J. Stat. Ann. §2A:58C-1, et seq. Under the PLA, in failure to warn cases involving prescription drugs, if the warning or instruction given in connection with a drug has been approved or prescribed by the FDA, there is a rebuttable presumption that the warning is adequate. This is no ordinary rebuttable presumption, remarked the court. Compliance with FDA regulations gives rise to “what can be denominated as a super-presumption.” Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 544 (N.J. 2012).  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced" in the rules of evidence. Bailey v. Wyeth, Inc., 37 A.3d 549, 571 (N.J. Super. Ct. Law Div. 2008), aff’d sub nom. Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super Ct. App. Div. 2011).

In this case, there is no dispute that the heparin labeling was approved by the FDA. Therefore, defendant was entitled to the statutory presumption that its heparin labeling satisfied its duty to warn. Plaintiff tried to rebut the presumption, first, with allegations of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects by the pharmaceutical company, and second with allegations of an economically-driven manipulation of the post-market regulatory process. See McDarby v. Merck & Co., Inc., 949 A.2d 223, 256 (N.J. Super. Ct. App. Div. 2008).

However, significantly, all of the information plaintiff accused defendant of withholding was publicly available in published scientific and medical literature.  And defendant did in fact disclose much
of what plaintiff claimed was deliberately concealed or withheld. For example, when submitting its proposed updated label to the FDA in 2005, Baxter included several scientific articles and a number of adverse event reports relating to HIT and HITT.  As to the second rebuttal effort, plaintiff offered no real evidence that Baxter rejected the FDA’s proposed changes to heparin labeling, or asked pharmaceutical representatives to avoid discussing HIT and HITT when speaking to physicians, or manipulated the conclusions of heparin clinical trials, or did anything sufficient to "manipulate" the regulatory process.

The more interesting part of the opinion arises from the fact that even if a plaintiff is able to demonstrate that a prescription drug’s warning is inadequate, that plaintiff still must prove that the inadequate warning proximately caused her injury. See Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 311 (N.J. 1984). “To satisfy this burden, a plaintiff must show that adequate warnings would have altered her doctors’ decision to prescribe.” Strumph v. Schering Corp., 606 A.2d 1140 (N.J. Super. Ct. App. Div. 1992) (Skillman, J., dissenting), rev’d 626 A.2d 1090 (1993) (adopting Judge Skillman’s dissent).

The court noted that “a heeding presumption may be applicable to claims of failure to warn of the dangers of pharmaceuticals.” McDarby, 949 A.2d at 267. A heeding presumption allows one to presume that the plaintiff’s physician would not have prescribed the drug to the plaintiff if there had been an adequate warning; in other words, the plaintiff’s physician would have heeded the adequate warning. The heeding presumption is rebuttable and can be rebutted if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted. Also. a manufacturer who allegedly fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and already considered the risk in prescribing the product. In that context, the physician’s conduct is the superseding, intervening cause that breaks the chain of liability between the manufacturer and the patient.

Here, the doctor stood by his decision to administer heparin to Mrs. Baker. She required heparin by standard medical procedure, and well documented clinical knowledge, at several different  points during her operation and for several different reasons, he opined.  Since he was aware of the risks of the drug that he prescribed and, having conducted a risk-benefit analysis, nonetheless determined its use to be warranted, the presumption was rebutted as a matter of law.

Moreover, the prescriber testified in his deposition that he does not read the label of drugs he frequently prescribes, which includes heparin. Therefore, a different warning would not have made a difference in plaintiff's treatment or outcome because there was no evidence he would have reviewed it.

Finally, there was a third causation problem; the opinion notes that it was undisputed that, despite doctors orders, the Hospital failed to follow its own heparin treatment protocol. Had that monitoring occurred, Mrs. Baker’s physicians would have discovered the onset of HIT sooner. Plaintiff's own expert admitted that her injuries “would have been substantially mitigated” with a “good chance of avoiding" them.   Therefore, plaintiff failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the conduct of the hospital, that caused her injury.

 Summary judgment on the warning claim.

JPML Declines MDL Status for Surgical Robots

We have posted before about the MDL process and the importance of the initial decision by the Panel on ordering coordination. Last week the Judicial Panel on Multidistrict Litigation declined to consolidate the suits by plaintiffs alleging injuries from da Vinci surgical robots. See In re Da Vinci Robotic Surgical System Products Liability Litigation, MDL No. 2381 (J.P.M.L., , 8/3/12).

We like to flag for readers, for any insights they may offer, the less common decisions rejecting MDL status, see also here and here. Also here. See here.

At the time of the decision there were five cases pending in five different federal courts. Defendant Intuitive Surgical, Inc. also supported the motion. The parties even agreed on centralization in the Northern District of California.

But the Panel was not persuaded that Section 1407 centralization would serve the convenience of the parties and witnesses or further the just and efficient conduct of this litigation. Each action, said the Panel, alleged personal injuries arising out of alleged defects in the da Vinci Robotic Surgical System. These are "relatively straightforward personal injury or wrongful death actions,"   and the litigation may focus to a large extent on individual questions of fact concerning the circumstances of each patient’s alleged injuries.

Given the "minimal number of actions currently pending," the proponents of centralization failed to convince the Panel that any factual questions shared by these actions are sufficiently complex or
numerous to justify Section 1407 transfer. The court noted that the proponents maintained that this litigation may eventually encompass “hundreds” of cases or “over a thousand” cases. But the Panel declined to accept such predictions, and considered voluntary coordination among the parties and the involved courts of these relatively actions to be a preferable alternative to centralization at this time.

Class Certification Denied Under Ascertainability Analysis

We typically focus on appellate decisions regarding class certification, but wanted to note for you a recent lower court federal decision in case involving a proposed class of patients who claim they were implanted with a medical device for treating acid reflux . See Haggart v. Endogastric Solutions Inc., No. 2:10-cv-00346 (W.D.Pa. 6/28/12).


Readers will want to note the discussion of ascertainability. The implicit requirement of ascertainability is an important but sometimes overlooked prerequisite to class certification. A plaintiff must offer a definition of a class that is precise, objective and presently ascertainable. A threshold requirement to a Rule 23 action is the actual existence of a class which is sufficiently definite and identifiable. See, e.g., Kline v. Sec. Guards, Inc., 196 F.R.D. 261, 266 (E.D. Pa. 2000); Reilly v. Gould, Inc., 965 F. Supp. 588, 596 (M.D. Pa. 1997); Clay v. Am. Tobacco Co., 188 F.R.D. 483 (S.D. Ill. 1999). The initial inquiry on class definition is distinct from the analysis required by Federal Rule of Civil Procedure 23. See, e.g., Sanneman v. Chrysler Corp., 191 F.R.D. 441, 446 n. 8 (E.D. Pa. 2000). This notion means, in part, that the court can see sufficient administrative feasibility in determining whether a particular person belongs to a class -- that the court can identify class members in a practical and non-burdensome manner. A “proposed class must be sufficiently identifiable,” and it must be “administratively feasible to determine whether a given individual is a member of the class.”Mueller v. CBS, Inc., 200 F.R.D. 227, 233 (W.D. Pa. 2001). A class may not be ascertainable if it will require individual inquiry into each class member’s particular situation to determine whether that plaintiff suffered the injury alleged. Similarly, a class is not ascertainable if membership depends on a particular subjective state of mind. And even when plaintiffs offer ostensibly objective criteria for membership, the court must be able to apply that objective criteria to determine who is in the class without addressing numerous fact-intensive questions. Certification is denied when determining membership in the class essentially requires a mini-hearing as to each prospective class member. E.g., Agostino v. Quest Diagnostics Inc., 256 F.R.D. 437, 478 (D.N.J. 2009); Solo v. Bausch & Lomb Inc., 2009 WL 4287706, (D. S.C. Sept. 25, 2009) (class not appropriate for certification where determining class membership would require “fact-intensive mini-trials”).
 

Here, plaintiff claimed that defendant had misrepresented implantation of a medical device for treatment of acid reflux — describing it as “reversible” rather than “revisable.”  Plaintiff offered one class definition as “all individuals who have undergone the [procedure] . . . and who have relied upon representations” related to its reversibility and/or revisability,  This, the court said, was "simply a non-starter."  The determination of class membership under this definition would require the court to adjudicate on a person-by-person basis whether each proposed class member relied on defendant’s representations. That is, class membership would not be ascertainable without the imposition of serious administrative burdens incongruous with the efficiencies expected in a class action.

Plaintiff then went to an alternate class defined as “all individuals who have undergone the EsophyX procedure in the United States since September 24, 2007.” But this very broad proposed class failed the typicality requirement owing to marked differences as to information received and relied upon, the legal theory underlying plaintiff’s claims, and other factors.  Specifically, there would be numerous, inevitable questions regarding the information received by individual patients - from their physicians or other sources - and their reliance on particular representations. While named plaintiff was unhappy, plaintiff conceded that most patients undergoing an EsophyX procedure have had a successful result.  Putative class members received information regarding the procedure primarily from their physicians, which information likely varied for reasons related to both the physicians themselves and the individual patient’s medical circumstances; the amount and content of information received by a patient directly from defendant’s marketing or other materials likely differed from plaintiff’s and as between putative class members as well; and individual decisions to undergo the procedure were likely influenced by and premised on varying individual considerations -- all of which also undercut predominance.

Motion for class certification denied.

Busy Mass Tort Court Revises Punitive Damages Rule

The Philadelphia Court of Common Pleas, a busy mass tort jurisdiction, to say the least, has continued to tinker with its mass tort general rules, last week issuing General Court Regulation No. 2012-03, amending the protocols for cases in the mass tort program.

The biggest change was to allow punitive damages in some pharmaceutical cases subject to the approval of the Complex Litigation Center coordinating judges, Judge Sandra Mazer Moss and Judge Arnold L. New. The Court said it continues to review recommendations concerning
punitive damages and will likely further amend this rule. But until a final version is established, the following procedure was adopted: Punitive damage claims may be litigated in pharmaceutical mass tort cases provided that the Coordinating Judges, following appropriate motion practice by defense counsel at least 60 days in advance of trial, rule that there are sufficient requisite proofs to support the claim going to trial.

Philadelphia is of course the home base of MassTortDefense, and we have posted on the evolving rules before.  Other than a few outliers, the defense bar had generally supported the continuation of the deferral of punitive damages because this practice furthered the Court’s stated goal of meeting the American Bar Association’s suggested standards for the disposition of cases. Deferral of punitive damages claims in these cases can remove a major obstacle to settlement of mass tort litigation and open the way for the prompt resolution of the damage claims of many thousands of injured plaintiffs. 

Furthermore, when mass tort claims involve pharmaceutical and medical device defendants that market life-saving or life-enhancing products, additional policy considerations support deferral. Drugs and devices are subject to comprehensive regulation by the FDA. Absent extraordinary circumstances, a defendant that has complied with the FDA requirements should not be deemed to have engaged in punishable conduct with the potential for repeat sanctions.

We will keep an eye on this one for you.
 

Court of Appeals Affirms Exclusion of Plaintiff Expert Testimony

The Sixth Circuit earlier this month affirmed the exclusion of plaintiff expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. See Simmons v. Novartis Pharmaceuticals Corp., No. 11-5053 (6th Cir., 6/5/12).

Simmons developed osteonecrosis of the jaw (ONJ), a bone disease affecting the jaw, allegedly as a result of using the prescription medications Zometa and Aredia. He sued and the Judicial Panel on Multidistrict Litigation transferred the action under 28 U.S.C. § 1407 to the United States District Court for the Middle District of Tennessee and assigned it to Chief Judge Todd Campbell.

To prove specific causation, plaintiff offered two experts. Plaintiff offered Dr. Obeid, a board-certified oral and maxillofacial surgeon who saw the plaintiff, and Dr. Edward Gutman an experienced oral surgeon. Defendant moved to exclude, inter alia, the testimony of Drs. Obeid and Gutman, on the issue of causation. The MDL court granted the motion to exclude any testimony by Dr. Obeid as
to the cause of Simmons’s injury, and by a separate order the district court granted defendant’s motion to exclude Dr. Gutman’s causation testimony. The court then granted defendant’s motion for summary judgment on all of plaintiff’s claims because plaintiff no longer had proof of an essential element of a product-liability claim under Maryland law, i.e., specific causation. Plaintiff appealed.

The court of appeals noted that a treating physician’s testimony is subject to Daubert. See Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419, 426 (6th Cir. 2009). Plaintiff was therefore required to demonstrate that Dr. Obeid’s reasoning or methodology was scientifically valid and that he properly applied that reasoning or methodology to the facts at issue. Plaintiff relied on Dr. Obeid’s statement that he found “a very close association” between ONJ and the class of drugs. However, Dr. Obeid also specifically acknowledged that he “didn’t establish causation” in evaluating Simmons’s ONJ.  Readers know that association is not causation.  Furthermore, Dr. Obeid agreed that the current level of evidence did not support a cause-and-effect relationship between bisphosphonate exposure and ONJ. While there were references to the medication in Dr. Obeid’s medical records, even if this was a "diagnosis," a diagnosis is merely a hypothesis, which does not satisfy Daubert and Rule 702. Moreover, nowhere in his testimony did Dr. Obeid rule out other conditions as the sole cause of Simmons' ONJ.

As to Dr. Gutman, the court noted that he had no knowledge of the etiologies of ONJ prior to meeting Simmons, and then gained only a limited familiarity based on literature supplied to him by plaintiff’s counsel. He had never treated any patients who were taking Aredia or Zometa or any other bisphosphonate, had never diagnosed a patient with ONJ, or determined a cause of
a patient’s ONJ.  Dr. Gutman admitted that he was not an expert on Zometa, Aredia, bisphosphonates, or ONJ, except as to Simmons’s case. He had no independent expertise from any other source other than six medical articles plaintiff’s counsel gave him; other than these
articles, there was no other "methodology" supporting his opinion.

The district court also did not abuse its discretion in excluding Dr. Gutman’s specific causation
opinion as unreliable because it was not derived from scientifically valid principles but
rather relied exclusively on the scientific literature provided by counsel. Dr. Gutman
made no attempt to verify this information, such as by doing his own research for other articles, and then drawing an independent conclusion. Courts view with special caution expert testimony prepared solely for purposes of litigation, rather than flowing from an expert’s line of scientific or technical work.  

Exclusions upheld; summary judgment affirmed.

Defense Victory in Bellwether Drug Trial Affirmed

A state appeals court recently upheld a judgment for defendant in the first bellwether trial in consolidated litigation in New Jersey over claims concerning the cancer drugs Aredia and Zometa. See Bessemer et al. v. Novartis Pharmaceuticals Corp., No. A-2069-10T1 (Sup. Ct. NJ, App. Div.)


Plaintiff allegedly developed osteonecrosis of the jaw (ONJ), and had sued alleging that defendant knew or should have known that Aredia and Zometa could cause ONJ and should have issued warnings to plaintiff and her treating dentists and oral surgeons, as well as to her prescribing oncologist.  The jury returned a verdict in defendant's favor; plaintiff appealed claiming that the pre-trial grant of partial summary judgment to defendant constituted reversible error. The trial judge had decided that defendant had no duty to warn non-prescribing dentists or oral surgeons under the NY Product Liability Act. The trial judge applied the learned intermediary doctrine, rejecting plaintiff's allegation that the so-called DTC exception applied pursuant to Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 14-15 (1999).

The court of appeals affirmed the "well-considered and thorough opinions" of the trial court. The two relevant opinions are: Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6052544 (N.J. Super. L.D. Nov. 12, 2010) (denying post trial motion), and Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6257855 (N.J. Super. L.D. April 30, 2010) (partial summary judgment).

Thus, the direct-to-consumer advertising exception to the learned intermediary doctrine did not apply to plaintiff; even if the drug was advertised to consumers, and even if plaintiff had seen a magazine advertisement for Zometa while taking the drug, it was not a substantial factor in her use of the medication.  The appeals court ruling also confirms that the defendant did not have a duty to warn dentists and oral surgeons (that is, doctors in a different field) of the drugs' possible risks, in addition to actual prescribing physicians. 

    

Learned Intermediary Adopted in Texas

We cannot comment, but commend to your study the recent decision by the Texas Supreme Court on the applicability of the learned intermediary doctrine under state law. See Centocor Inc. v. Hamilton et al., No. 10-0223 (6/8/12, Texas).

In the context of prescription medication, the learned intermediary doctrine holds that a drug manufacturer satisfies its duty to warn when it informs a prescribing physician about the drug's potential risks. Most but not all jurisdictions have adopted the doctrine. 

Congratulations to my colleagues at Shook, Hardy & Bacon, including Gene Williams. and Manuel Lopez

Defense Equal Access to Potential Experts Upheld in Device Case

A Joe Friday post today- just the facts with no commentary.  A state appellate court earlier this month overturned a trial court order that had limited one side's ability to consult with or retain knowledgeable physicians as witnesses. See In re Pelvic Mesh Gynecare Litigation, No. A-5685-10T4 (N.J. Super. Ct. App. Div., 6/1/12).

The issue arose in the mass tort involving medical devices used primarily to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs in the New Jersey cases had filed suit against
defendants alleging injuries sustained as a result of the surgical implantation of the pelvic mesh product. As is not atypical, some of the most qualified experts had previously prescribed or implanted the device at issue. And it was possible that some former patients would or had become plaintiffs. In January 2011, defendants moved to establish a protocol similar to ones used in some federal litigation for consulting with and possibly retaining as defense experts physicians who had treated a different plaintiff in the pelvic mesh litigation.  Defendants proposed that a treating physician would have no communication with the defense about his or her own patient-plaintiff an would not be used as an expert witness in the patient-plaintiff's own case. Plaintiffs' counsel opposed the motion and cross-moved for a protective order barring defendants from retaining or consulting with any physician who at any time had treated any of the plaintiffs in the pelvic mesh litigation.

The lower court issued an order in May, 2011, barring defendants from consulting with or retaining any physician who had at any time treated any plaintiff in the pelvic mesh litigation. Defendants estimated that more than 1,000 physicians were disqualified as potential defense experts.

The appellate court granted defendants' motion for leave to appeal, and subsequently stayed discovery to the extent it applies to defense experts.

The appellate division vacated the protective order because, it concluded, the order profoundly
impaired defendants' ability to defend the lawsuits because it prevented them from employing qualified experts in cases against plaintiffs other than their own current or past patients; not only did the order severely limit the pool of qualified and willing physicians that defendants could consult and engage as expert witnesses but it placed defendants in the precarious position of consulting and preparing experts only to have them later disqualified if new plaintiffs were added to the litigation.

On the issue of doctor-patient privilege, the court concluded that a plaintiff in these cases cannot claim the privilege as to the diagnosis and treatment of her medical condition that is the
subject of the lawsuit, and a treating physician can be compelled to testify as a fact witness regarding those subjects, including the doctor's determination of the cause of the plaintiff's disorder. Doctors can be expected to understand they are subject to ethical constraints against disclosure of confidential patient information. The court said that the key issue in this appeal was not whether the physician-patient privilege prevented engagement of a treating physician as an expert for the defense. The issue is whether some other rule or judicial or public policy categorically bars a treating physician from serving as an expert witness against the "litigation interests" of his or her patient, although in a different plaintiff's case.The court concluded that the trial court's ruling was a mistaken exercise of authority to manage this litigation. It inappropriately equated a plaintiff's "litigation interests" with a patient's "medical interests," and it elevated those "litigation interests" to a preemptive level not previously recognized by binding authority.

In many types of personal injury cases, said the court, physicians who testify for the defense or consult with defense counsel provide those services contrary to the interests in litigation
of other patients they have treated or continue to treat. For example, radiologists, orthopedists, and neurologists who routinely testify as experts for the defense in numerous personal injury cases in state courts are likely to be treating or consulting physicians for other patients with similar injuries, and some of those patients may also have filed lawsuits or may do so in the future. "Our system of civil justice does not bar a physician from expressing a position in litigation of one plaintiff that is contrary to the litigation interests of a current or past patient in another case."

Here, said the appellate division, the physician's information that defendants seek to use is neither the particular diagnosis or condition of a patient that the physician treated nor the fruit of expert
consultation to assess or prepare plaintiffs' claims. Rather, it is the physician's overall knowledge regarding the nature, use, risks, and safety of defendants' pelvic mesh products and the conditions that patients may experience as a result of their use. The fact that plaintiffs filed suit in New Jersey and invoked the rules for joint case management should not affect the availability of relevant evidence to both sides.

Moreover, the "litigation interests" of one patient may or may not be consistent with or contrary to the "medical interests" of the physician's other patients. For instance, specialists in gynecology, urology, or urogynecology may disagree with the claims of plaintiffs in this litigation that  defendants' products are defective and caused their injuries. Those specialists may believe that defendants' pelvic mesh products are not only safe but necessary or the most beneficial treatment
for conditions suffered by their patients. They may believe that supporting the defense in this litigation will be beneficial to most of their patients. The trial court's order not only bars physicians from truthfully expressing opinions favorable to the defense but it may potentially harm the
"medical interests" of other patients and interfere with the ability of physicians to provide the best available care for all their patients.

Rather than disqualifying as a group all treating physicians who ever treated any plaintiff, said the appeals court, the trial court should address such concerns by allowing plaintiffs to demonstrate why a particular expert retained by defendants should not be permitted to testify or assist in the
case of a different plaintiff. The fact that this litigation involves coordinated case management did not justify a broad finding of presumed prejudice to plaintiffs and the blanket ban. If plaintiffs make such a particularized showing, the court was directed to consider appropriate protective measures, including disqualification where lesser measures are not sufficient or feasible.
 

In summary, said the appeals court, both sides in this litigation should have the opportunity to present evidence from the most qualified physicians who can serve as experts. The trial court's order unfairly impeded defendants' access to many of those physicians, and so, must be reversed. 

Mass Tort Seminar Held in Philadelphia

Earlier this week I attended the Mass Tort Litigation Conference in my home base of Philadelphia; this is the annual conference chaired by former Judge Marina Corodemus, who was the Mass Torts Judge in NJ for several years.

Other faculty included Judge Lee Rosenthal, Judge Ed Kinkeade, and Judge David Katz; plaintiff's lawyers such as Sol Weiss and Chris Seeger; and various members of the defense mass tort bar. It was great to see old colleagues and meet some new folks.

The program followed a hypothetical mass tort, involving an allegedly defective medical device, through government investigations, Daubert/Frye issues, MDL and other coordinations, through to settlements. Of course, Shook Hardy has tons of experience with all aspects of medical device litigation.

Anyway, among the interesting tidbits: beware of the growing use by plaintiffs of "medical ethicists" to condemn defendant's conduct as not only negligent but unethical and evil; and plaintiff's use of "mind-reading" experts who profess to divine the intent of the defendant corporation by reading between the lines of the emails and other discovered documents. We have posted on this before.

Plaintiff's counsel talked a bit about their mass tort intake process and the "screening" they use on potential new cases.  One interesting observation was the great level of concern expressed over the issue of product identification, and how it can be exacerbated by multiple defendant manufacturers, multiple versions or designs in play, and when the nature of the product somehow makes easy identification impossible.

The e-discovery panel (can't have a seminar without one) talked about the draft principles in discovery across borders, out for comment from Sedona Working Group 6.  Readers with thoughts should weigh in.

 

 

Court Again Dismisses Claim Against "Non-Conventional" Alcohol Beverage

We posted last year about the dismissal of a motorcycle passenger's claim against the maker of a caffeinated alcoholic drink, seeking to hold the company liable for her crash-related injuries.See Cook v. MillerCoors LLC, No. 11-1488 (M.D. Fla.).

The operator of the motorcycle in the accident was killed, and the plaintiff Cook, who was a passenger, was injured. Prior to the crash, the driver allegedly had consumed several alcoholic beverages containing caffeine and other stimulants, manufactured by the defendant. Cook argued that such beverages were “uniquely dangerous” because they appeal to younger drinkers and because the addition of caffeine allegedly enables one to drink more alcohol without feeling as intoxicated as one normally would. Thus, she contended, consumers of these beverages are more likely to “engage in dangerous behavior such as driving.” She asserted the driver did not appear impaired, even though toxicology reports from his autopsy revealed that his blood alcohol level was 0.10 at the time of the crash.

The district court found flaws with the duty, breach, and causation elements of the claim. The court found that Cook had not established a duty to warn because “the dangers inherent in alcohol consumption are well known to the public.”  Readers can readily see why the court was reluctant to make an exception to the rule for the so-called "unconventional" beverage. There are hundreds of alcohol-containing products that are arguably not "conventional" in one way or another, by taste, ingredients, color, manufacturing process, advertising... To shift responsibility from the person who over-consumes one of these and then drives impaired is to send the absolutely wrong policy message.

Courts have typically recognized no duty on the beverage maker, regardless of a plaintiff's attempt to differentiate either themselves or the product. See, e.g., Malek v. Miller Brewing Co., 749 S.W.2d 521 (Tex. App. 1988) (finding no duty to warn despite claim that advertising led plaintiff to believe that “Lite” beer was less intoxicating than other beer); Pemberton v. Am. Distilled Spirits Co., 664 S.W.2d 690 (Tenn. 1984); Greif v. Anheuser-Busch Cos., Inc., 114 F. Supp. 2d 100 (D. Conn. 2000)(particular, alleged tolerance of an individual consumer); MaGuire v. Pabst Brewing Co., 387 N.W.2d 565 (Iowa 1986).

Plaintiff attempted to re-plead her claim, again alleging that the addition of stimulants that mask the intoxicating effects of alcohol was a defect, but also focusing on the supposed risks this formulation posed to youth. The court again found the complaint lacking. Alcoholic beverages are not considered unreasonably dangerous as defined by the Restatement (Second) of Torts, because the dangers associated with alcohol are well known.  Cook asserted that the risks are not common knowledge to youthful drinkers having experience only with conventional alcoholic beverages. This court was not convinced that “the special risks posed to youth” made the drink unreasonably dangerous from the perspective of the general public.  More significantly, Cook’s argument overlooked an important point: the alleged “special risks” manifest themselves only if the consumer chooses to drink in excess. The case law recognizes that anyone who drinks alcohol may become impaired and yet may not be able to discern his or her impairment. That does not make alcoholic beverages unreasonably dangerous or absolve the drinker of responsibility.

Moreover, the youth-based allegations did not change Florida law on causation, under which voluntary drinking of alcohol is the proximate cause of such an injury, rather than the manufacture or sale of those intoxicating beverages to that person. As to the plaintiff's warning theory, persons engaging in the consumption of alcoholic beverages may not be able to ascertain precisely when the concentration of alcohol in their blood, breath, or urine reaches the proscribed level, so they should in the exercise of reasonable intelligence, understand what type of conduct places them in jeopardy of violating the law. The degree of intoxication to be expected from any particular brand (or formulation) of alcoholic beverage does not require a special duty to warn, or give rise to a fact question about the warnings here.

The court distinguished Cuevas v. United Brands Co., Inc., 2012 WL 760403 (S.D. Cal. Mar. 8, 2012), as an economic injury claim brought under various consumer protection statutes and warranty theories which focused on the sale of the product allegedly in violation of FDA rules rather than its consumption.


 

House Passes FDA Reauthorization Bill

The House of Representatives last week passed a bill (387 to 5 vote) that would reauthorize the Food and Drug Administration's user fee programs and amend the rules regarding marketing exclusivity, medical device safety, drug importation, and other FDA programs. The "FDA Reform Act of 2012," H.R. 5651, reauthorizes and amends various user fee statutes, creates new and additional user fees, reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, changes the rules for public comment on draft guidance documents, and contains new provisions dealing with drug shortages.  The fees are supposed to reflect agreements negotiated between the FDA and industry regarding about $2.8 billion in user fees over five years.

The vote came shortly after the Senate approved its own version of FDA legislation, S. 3187 (the FDA Safety and Innovation Act). The Senate bill was also passed with bipartisan support.

The differences between the House and Senate bills now must be worked out in conference. The bills differ in a variety of ways, such as which antibiotics will be eligible for incentives, which include a five-year extension of market exclusivity. The bills also differ on the details of a national  track-and-trace system for drugs. The Senate bill also included language about Risk Evaluation and Mitigation Strategies (REMS) which is not in the House version. See a comparison of the bills here.  Various observers report that House and Senate leaders expect to have a compromise bill for the President to sign in early July.

 

Court of Appeals Rejects RICO Claim in Drug Case

One of the things we like to do here at MassTortDefense is keep an eye on the non-traditional claims plaintiffs concoct -- to evade the requirements of traditional torts, or to expand the group of "injured" plaintiffs.  Earlier this month the Third Circuit knocked down just such an attempt. See In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, Nos. 10-3046 and 10-3047 (3d Cir. May 16, 2012).

The issue here was an attempt by two groups of plaintiffs to hold a drug manufacturer liable for violating the federal Racketeer Influenced and Corrupt Organizations Act (RICO) by allegedly marketing drugs for off-label uses. The court of appeals affirmed that neither had standing to maintain this cause of action, primarily for failure to allege a plausible nexus between the assailed marketing campaign and the physicians‘ decisions to prescribe certain drugs for off-label use.

While off-label marketing is prohibited, prescription drugs frequently have therapeutic uses other than their FDA-approved indications. The FDCAct does not regulate the practice of medicine, and so physicians may lawfully prescribe drugs for off-label uses. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (recognizing off-label usage as an accepted and necessary corollary of the FDA‘s mission to regulate in this area without directly interfering with the practice of medicine); Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000) (physician may prescribe a legal drug to serve any purpose that he or she deems appropriate, regardless of whether the drug has been approved for that use by the FDA).

Plaintiffs' claims, as is so common, attempted to piggy-back off of prior government investigations. They alleged that Schering‘s marketing practices caused physicians to prescribe the drugs for off-label uses instead of equally effective alternative treatments that were approved for the prescribed uses or no medication at all. They assert that these marketing techniques led to a significant increase in prescriptions of the drugs for off-label uses, and contend that this caused the plaintiffs an "ascertainable loss" (key concept) because they supposedly paid millions of dollars for the drugs that they otherwise would not have paid.

The district court granted a motion to dismiss, and the plaintiffs appealed.

A motion to dismiss for lack of standing implicates Rule 12(b)(1) because standing is a jurisdictional matter, and 12(b)(6) with the Twombly/Iqbal guidance.  While the plausibility standard of those cases does not impose a probability requirement, it does demand more than a sheer possibility that a defendant has acted unlawfully. The plausibility determination is a context-specific task that requires the reviewing court to draw on its judicial experience and common sense; and some claims require more factual explication than others to state a plausible claim for relief.

The Constitution imposes a requirement that there be an actual case or controversy. Federal courts have developed several justiceability doctrines to enforce the case-or-controversy requirement, and perhaps the most important of these doctrines is the requirement that a litigant have standing to invoke the power of a federal court. The standing question is whether the plaintiff has alleged such a personal stake in the outcome of the controversy as to warrant his invocation of federal-court jurisdiction and to justify exercise of the court's remedial powers on his behalf. The plaintiff bears the burden of meeting the irreducible constitutional minimum of Article III standing by establishing three elements: First, the plaintiff must have suffered an injury in fact—an invasion of a legally protected interest which is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical. Second, there must be a causal connection between the injury and the conduct complained of—the injury has to be fairly traceable to the challenged action of the defendant, and not the result of the independent action of some third party not before the court. Third, it must be likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.

In addition to meeting the constitutional standing requirements, plaintiffs seeking recovery under RICO must satisfy additional standing criterion set forth in section 1964(c) of the statute: that the plaintiff suffered an injury to business or property; and that the plaintiff‘s injury was proximately caused by the defendant‘s violation.

The Union plaintiff on behalf of a proposed class of third-party payors alleged economic loss based on paying for ineffective drugs. Accordingly, to establish standing, it must allege facts showing a causal relationship between the alleged injury—payments for a specific drug that was ineffective or unsafe for the use for which it was prescribed—and Schering‘s alleged wrongful conduct. However, there were no averments that came close to satisfying this standard. It was pure conjecture to conclude that because Schering‘s misconduct supposedly caused other doctors to write prescriptions for ineffective off-label uses for other products, the Union ended up paying for prescriptions for a different drug due to the same kind of alleged misconduct. (Again, attempted piggy-backing on government allegations.)

The court of appeals spent considerable effort reviewing claims of a proposed class of plaintiff consumers, who tried to prove standing by incorporating materials from the government investigation and concocting a series of purported links between drug trials, marketing activities and prescribing doctors' behavior.  The district court rejected this, and plaintiffs' focus on appeal on the pleading standards for each of these claims was secondary to the threshold issue that the consumers did not adequately allege an injury fairly traceable to Schering‘s alleged misconduct. Although the complaint was replete with factual allegations and indeed asserted them with somewhat greater specificity than the third-party payor complaint, they do not present a plausible allegation actually linking the injuries to any type of miscommunication or false claim about the drugs that were actually prescribed.

No standing. Dismissal affirmed. 

State Supreme Court Rejects Tolling Based on Prior Class Action

A state's supreme court ruled earlier this month that the filing of a putative class action in another state does not stop the clock on the running of the Virginia statute of limitations for absent class members.  See Casey v. Merck & Co.,  No. 111438 (Va., 3/2/12).

The issue arose in the context of the Fosamax litigation and the somewhat unique civil procedure of Virginia.  On September 15, 2005, a putative class action, Wolfe v. Merck & Co., was filed in the United States District Court for the Middle District of Tennessee. The putative class included "[a]ll persons who consume or have consumed FOSAMAX, whether intravenously or by mouth." The representative plaintiffs in the class action asserted claims of strict liability, negligence, and medical monitoring against Merck.  The case became part of the MDL for this product, and the MDL court denied class certification in 2008.  But prior to the dismissal of the Wolfe putative class action, four plaintiffs, all residents of Virginia, filed individual state law based actions against Merck in the Southern District of New York, asserting federal diversity jurisdiction. It was undisputed that all four plaintiffs filed suit more than two years after the latest possible date that they sustained their respective alleged injuries, and that Virginia law applied to their claims.

Defendant naturally moved for summary judgment, alleging that the four plaintiffs’ actions were untimely under Virginia's two-year statute of limitations for personal injuries. In response, the plaintiffs claimed that the Wolfe putative class action, which was filed within the two-year limitation period, tolled the running of the Virginia statute of limitations on their individual actions because they would have been members of the proposed class had certification been granted.

The district court agreed with defendant, but on appeal the Second Circuit certified, asking the Virginia Supreme Court to determine whether Virginia law permits equitable or statutory tolling of a Virginia statute of limitations due to the pendency of a putative class action in another jurisdiction.

The court began from the proposition that limitations periods are a creature of statute, and a statute of limitations may not be tolled, or an exception applied, in the absence of a clear statutory enactment to such effect. Any doubt must be resolved in favor of the enforcement of the statute. Given these principles, there was no authority in Virginia jurisprudence for the equitable tolling of a statute of limitations based upon the pendency of a putative class action in another jurisdiction.

As for statutory tolling, Virginia Code § 8.01-229(E)(1) provided that, “If any action is commenced within the prescribed limitations period and for any cause abates or is dismissed without determining the merits, the time such action is pending shall not be computed as part of the period within which such action may be brought, and another action may be brought within the remaining period.”  The plaintiffs contended that Code § 8.01-229(E)(1) statutorily tolled the statute of limitations for plaintiffs’ claims during the pendency of the putative class action, and that the court's decision in Welding, Inc. v. Bland Cnty. Serv. Auth., 261 Va. 218, 541 S.E.2d 909 (2001), indicated that Virginia had recognized cross-jurisdictional putative class action tolling.

In Welding, the court had stated that, under Virginia law, an action filed in a foreign jurisdiction may indeed trigger tolling under the Code section. Although there is no particular type of action that must be filed and no particular jurisdiction in which that action must be brought for the commencement of an action to trigger tolling under Code § 8.01-229(E)(1), for tolling to be permitted, the subsequently filed action must be filed by the same party in interest on the same cause of action in the same right.  Welding differed from the instant case because it concerned a situation where the same plaintiff initially sued in federal court on the same cause of action he subsequently pursued in state court. The plaintiff in both actions was clearly the same. In the instant matter, said the court, it is undisputed that the four plaintiffs were not named plaintiffs in the putative class action that they claim triggered the tolling. They were merely absent members of a putative class that included everyone in the country who had taken this drug.

For the filing of an action to toll the statute of limitations from running on a subsequently filed action, there must be a true identity of the parties in the two lawsuits. In other words, for the statute of limitations to be tolled for a subsequent action, the party who brought the original action must be the same as the plaintiff in the subsequent action or a recognized representative of that plaintiff asserting the same cause and right of action. A putative class action is a representative action in which a representative plaintiff attempts to represent the interests of not only named plaintiffs, but also those of unnamed class members. But Virginia jurisprudence does not recognize class actions. Under Virginia law, a class representative who files a putative class action is not recognized as having standing to sue in a representative capacity on behalf of the unnamed members of the putative class. Thus, under Virginia law, there is no identity of parties between the named plaintiff in a putative class action and the plaintiff in a subsequent action filed by a putative class member individually. Accordingly, a putative class action cannot toll the limitations period for unnamed putative class members under Virginia law.

Certified questions answered in the negative.

  

Busy Mass Tort Court Revamps Procedures

Our readers recognize that Philadelphia (home base for MassTortDefense) is a hot-bed of mass tort activity, administering those cases through a Complex Litigation Center.  Now comes important news that the Honorable John W. Herron, Administrative Judge of the Trial Division of the Philadelphia Court of Common Pleas, recently issued an order that will alter and impact the handling of mass tort cases in this busy jurisdiction.

General Court Regulation No. 2012-01 represents the first general overhaul of the Complex Litigation Center’s practices in many years. The order  will revise and streamline the conduct of mass tort litigation in Philadelphia in a number of ways.   More on that in a minute.  What is also significant is the reason for the changes.  The order notes the pronounced upward trend in mass tort filings in this court, and the fact that the court’s disposition rate has not kept pace with filings; thus, a significant backlog has developed.  The order notes the impact of past policy which invited the filing of cases from other jurisdictions.  A "dramatic increase in these filings" occurred after the court’s leadership invited claims from other jurisdictions. In 2009, when published comments were offered encouraging the filing of claims in Philadelphia, out-of-state filings rose to 41%, and in 2011 reached 47%.

So, in response, Judge Herron’s order:

  • ends reverse bifurcation in all mass tort cases,
  • significantly limits the consolidation of non-asbestos cases,  unless agreed by all parties,
  • requires the deferral of all punitive damage claims,
  • requires, except upon showing of exigent circumstances, all discovery to take place in Philadelphia,
  • re-emphasizes mediation of cases,
  • limits expediting of cases based on exigent medical or financial reasons until the backlog of pending cases has been resolved, unless otherwise agreed by a majority of the defendants.

The Honorable Arnold New will be reassigned as a Coordinating Judge of the Complex Litigation Center. Judge New is an experienced and respected member of the Philadelphia Court of Common Pleas, having served on the bench for more than 20 years. He currently administers another of the Court’s innovative programs, the Commerce Program. To ensure a smooth transition, Regulation No. 2012-01 provides that Judge New will act as Co-Coordinating Judge of the Complex Litigation Center, sitting in tandem with the Honorable Sandra Mazer Moss. Judge Moss will assume senior status as of December 31, 2012, at which time Judge New will thereupon serve as the sole Coordinating Judge of the Complex Litigation Center and its Mass Tort Program.

The order advises that the court will entertain additional suggestions from the bar, and will open a comment period in November, 2012, to allow interested parties the opportunity to address the new procedures and to suggest any further changes that may be needed. 

There is little doubt that this court's Complex Litigation Center faces a daunting task in handling a large number of cases involving complex and sophisticated claims and defenses, while seeking to resolve them both fairly and efficiently.  Time will tell,  but the new procedures ordered by Judge Herron should improve the functioning of the Complex Litigation Center, and the ongoing process of review and comment invited by the order will allow interested parties the opportunity to see that the Center keeps moving in the right direction.
 

 

Consumer Fraud Class Action Decertified in Drug Case

A state appeals court last week de-certified a class action by consumers over alleged misrepresentations in marketing a drug.  See Merck & Co. v. Ratliff, No. 2011-000234 (Ky. Ct. App.,  2/10/12).

The case involved the drug Vioxx, which was a highly effective medication formerly in widespread use for patients with arthritis and other conditions causing chronic or acute pain.  Plaintiff was a former user of Vioxx for his chronic osteoarthritis.  Although Ratliff’s insurance paid for most of the cost of the drug, which was at the time approximately $66 per month, Ratliff contributed about $5 each month out of pocket.  Ratliff discontinued using Vioxx in early 2004.

Plaintiff brought a putative class action on behalf of product users who had not suffered cardio-vascular side effects, alleging that the defendant deceived the members of the proposed class in violation of the state Consumer Protection Act by promoting and/or allowing the sale of Vioxx with the use of unfair, false, misleading or deceptive acts or practices.  As a result, the class purchased the drug when it wouldn't have otherwise.

The case followed a twisting path, to federal court, to the MDL, back to state court, up to the state supreme court on mandamus, and back.  Long story short, the class was certified by the trial court, and that decision eventually became ripe for review by the court of appeals.

The Kentucky rules are similar to the federal class action rules. The trial court certified the class under the prong (like b3) requiring that the questions of law or fact common to members of the class predominate over any questions affecting only individual members, and that a class action
is superior to other available methods for the fair and efficient adjudication of the controversy. The trial court found that common questions of law and fact did predominate, stating that there was a common nucleus of facts from which the potential plaintiffs’ claims arose. All of the potential
plaintiffs were prescribed Vioxx by doctors who supposedly relied on Merck’s assertions that it was safe and effective.

On appeal, Merck contended that plaintiff’s claims would require individualized proof such that common questions would not predominate. Merck argued that individual proof would be necessary to show that Merck made fraudulent or negligent misrepresentations toward each putative class member or his or her physician through the marketing and sale of Vioxx, that the alleged
misrepresentations were received by each putative member’s physician, that each putative member’s physician relied on such representations in his or her decision to prescribe Vioxx over another drug, and the amount of any damages suffered by each putative member.

The court of appeals noted that the common law misrepresentation claims would require proof of causation in the nature of reliance, and while "there are fewer obstacles to a class claim proceeding under the" state consumer protection act, that law still requires loss as a result of the wrongful act. Plaintiffs alleged that there was supposedly a consistent pattern of deception lasting essentially the entire time that Vioxx was on the market, and thus that generalized proof could be used to show the elements of fraud and misrepresentation in this case. This theory concerning generalized proof regarding Merck’s alleged conduct was similar to the rebuttable presumption of reliance and causation known in securities litigation as "fraud-on-the-market." The court of appeals noted that the “fraud-on-the-market” approach had never been recognized in the state for a fraud or misrepresentation case. Indeed, pretty much every other jurisdiction which has been confronted with the theory has rejected it outside of the securities litigation context. See, e.g., Kaufman v. i-Stat Corp, 754 A.2d 1188, 1191 (N.J. 2000); International Union of Operating Engineers Local No. 68 Welfare Fund v. Merck & Co., Inc, 929 A.2d 1076, 1088 (N.J. 2007); Mirkin v. Wasserman, 858 P.2d 568, 584-95 (CA. 1993); Southeast Laborers Health and Welfare Fund v. Bayer Corp., 2011 WL 5061645 (11th Cir. 2011); Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

Accordingly, causation, reliance, and damages must be shown on an individual basis. Thus, if the action were tried as a class, even after the alleged common questions of Merck’s representations were decided, the case would essentially fragment into a series of amalgamated “mini-trials” on each of these individualized questions. Because these individualized questions would substantially overtake the litigation, and would override any common questions of law or fact concerning defendant’s alleged conduct, the court found that a class action was not the superior mechanism by which to try these cases. See, e.g., Zinser v. Accufix Research Institute, Inc., 253 F.3d 1180, 1192 (9th Cir. 2001).

 

 

Dismissal of Actimmune Proposed Class Action Affirmed

The Ninth Circuit late last month upheld the dismissal of a proposed class action concerning alleged off-label marketing of the drug Actimmune.  In re: Actimmune Marketing Litigation, Nos. 10-17237 and 10-17239 (9th Cir. 12/30/11).

The panel, in an unpublished opinion, affirmed the judgment of the district court “for the reasons set forth in the district court's orders.”  See In re Actimmune Marketing Litig., 614 F.Supp.2d 1037
(N.D. Cal. 2009) (Actimmune I); In re Actimmune Marketing Litig., 2009 WL 3740648 (N.D. Cal. Nov. 6, 2009)(Actimmune II ); In re Actimmune Marketing Litig., 2010 WL 3463491 (N.D. Cal. Sept. 1, 2010) (Actimmune III).

In September 2010, the trial court had issued a ruling dismissing the amended complaints filed by consumers and an insurer, who alleged that defendants had improperly marketed Actimmune as a treatment for idiopathic pulmonary fibrosis.  Despite the additional allegations included in plaintiffs' latest amended pleadings, plaintiffs still failed to properly allege that defendants' conduct caused plaintiffs' injuries. Therefore, plaintiffs lacked standing to pursue their off-label marketing claims under the asserted consumer fraud claims.  Establishing that a defendant violated a law only accomplishes part of a plaintiff's burden; plaintiffs were also required to prove that they were injured “as a result of” defendants' alleged law-violating conduct.

In the context of the instant case, the “as a result of” language placed the burden on plaintiffs to establish that they actually relied upon the representations delivered through defendants' off-label marketing. Plaintiffs failed to allege a plausible causal chain of injury as required by Iqbal/Twombly.

The shortcoming in the consumer plaintiffs' pleadings was simple: all of the consumer plaintiffs failed to allege that their doctors believed that Actimmune was an effective treatment for IPF “as a result of” defendants' off-label promotion of Actimmune. With respect to each plaintiff, the complaint alleged only that their doctors were “exposed to at least some of InterMune's unfair and unlawful off-label marketing.”  That was not enough;  claims dismissed.

Bill Introduced to Amend Post-Market Review of Medical Devices

Three U.S. Senators recently introduced legislation that would alter the U.S. Food and Drug Administration's post-market surveillance of medical devices.

Sens. Chuck Grassley, R-Iowa, Richard Blumenthal, D-Conn., and Herb Kohl, D-Wis. introduced the The Medical Device Patient Safety Act, S. 1995. Currently, the FDA can approve new moderate-risk medical devices through the 510(k) process if the product is found to be as safe and effective as a substantially similar medical device already on the market.  Though the agency can request clinical study data on proposed new devices under the 501(k) process, it is still viewed as a fast-track approval process, compared to the premarket approval process for new products in the high-risk device category.

The bill would give the FDA the authority require companies to submit post-market data as a condition for gaining approval for moderate-risk medical devices under the fast-track process.  The FDA could also order companies to conduct additional safety studies of devices after they are approved, and could grant conditional approvals pending the result of any ongoing trials. The proposed legislation would also require the FDA to assess recalls to determine whether they were implemented effectively.

The legislation follows concern from a GAO  study of the FDA's post-market surveillance of medical devices, and after a controversial Institute of Medicine report last July suggesting the FDA amend its current clearance system for medical devices. FDA had commissioned the IOM to conduct an analysis of the § 510(k) system in 2009. The IOM Committee was composed of twelve members: five doctors, three lawyers, and four academics. Specifically missing were innovators or any product developers familiar with the clearance process, and any representatives of patients or patient advocacy groups that have benefited from the development of medical devices under the current system.

As noted by the Advanced Medical Technology Association, however, expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given that the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k).  The bill does not appear to limit when FDA may conditionally clear a device, thus leaving open the possibility that conditions of approval will simply become a regular part of 510(k) clearances. 

As to recalls, what may be "effective" for one type of device may not be as effective for another. It is important for the America public to realize that the medical technology industry has a well-documented safety record. Several recent studies have shown that for the vast majority of products cleared by the FDA, less than 0.5 percent are involved in a serious recall, a point GAO has emphasized as well. In addition, nothing in the GAO’s recommendations suggested a lack of diligence or inadequacy in medical technology companies’ implementation of recalls.

 

Appeals Court Unhappy With Plaintiffs' Advocacy

Today we note an opinion that, in its opening words, is about "two appeals that raise concerns about appellate advocacy." Both are appeals from grants of forum non conveniens in multidistrict litigation. See Gonzalez-Servin et al. v. Ford Motor Co. et al., No. 11-1665; Kerman et al. v. Bayer Corp. et al., No. 08-2792 (7th Cir. 2011).

The Ford case was an appeal from an order to transfer a case from the U.S. District Court for the Southern District of Indiana to the courts of Mexico, and was one of many offshoots of litigation arising out of vehicular accidents allegedly caused by defects in Bridgestone/Firestone tires installed on Ford vehicles.  All these cases have been consolidated in an MDL.

The 7th Circuit found the lower court's careful and thorough analysis demonstrated that it was acting well within its discretion in deciding that the Mexican courts would be a more appropriate forum for the adjudication of this lawsuit by Mexican citizens arising from the death of another Mexican citizen in an accident in Mexico.

What seemed to bother the panel is that plaintiffs did not cite an FNC case seemingly on all fours with the appeal in their opening brief, though the district court’s decision in their case was issued in 2011—long after the prior case.  In their response the defendants cited the case repeatedly and asserted that its circumstances were “nearly identical” to those of the present case. Yet, in their reply brief the appellants still didn't mention it, let alone try to distinguish it, said the panel.

The second case involved litigation against manufacturers of blood products used by hemophiliacs, which turned out to be contaminated by HIV.  This particular suit was brought by Israeli citizens allegedly infected by the blood products in Israel. The defendants, invoking forum non conveniens, moved to transfer the case to Israel.  There were two prior appellate decisions on point, said the panel, including Chang v. Baxter Healthcare Corp., 599 F.3d 728 (7th Cir. 2010), which arose from the same multidistrict litigation.  The court said that these plaintiffs' short treatment of the prior cases "left much to be desired." 

Overall, said the court, the plaintiffs' "advocacy is unacceptable." The panel then invoked a well-known symbol: "The ostrich is a noble animal, but not a proper model for an appellate  advocate."  The “ostrich-like tactic of pretending that potentially dispositive authority against a litigant’s contention does not exist" is "pointless,” said the court.

The opinion closes with pictures of an ostrich burying his head in the sand, and of a man in a suit doing the same.  The reminder here is, when there is apparently dispositive precedent, an appellant may urge its overruling, or distinguish it, or reserve a challenge to it for a petition for certiorari, but may not ignore it. 

 

Strict Liability Does Not Apply to Medical Devices

Another court has recognized that strict liability or breach of implied warranty claims do not lie against medical device makers. Horsmon v. Zimmer Holdings Inc., No. 11-1050 (W.D. Pa., 11/10/11).

Plaintiff had a total hip replacement whereby her right hip joint was replaced with implant components designed, manufactured, and sold by defendants. Ms. Horsmon alleeged she later began to experience pain in her right hip, which eventually required further surgery. She alleged this was due to a defect in the original liner that was used during the hip replacement.  She sued, and defendants moved to dismiss.

Defendants asserted that plaintiff‟s claim for strict liability was barred by Pennsylvania law. The Supreme Court of Pennsylvania in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), held that strict liability claims cannot be brought against prescription drug manufacturers. The court relied on Comment k to the Restatement (Second) of Torts § 402A, regarding unavoidably unsafe products. The Superior Court of Pennsylvania and several United States District Courts applying Pennsylvania law have extended Hahn to bar strict liability claims against medical device manufacturers. E.g., Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006).  This court agreed that the reasoning of Hahn extends to medical devices.

Defendants further asserted that plaintiff's breach of implied warranties claim was also barred by Pennsylvania law. In a claim for breach of implied warranty of merchantability, the essence of the warranty of merchantability is that the item sold is fit for the ordinary purposes for which such goods are used. Under Pennsylvania law, the very nature of prescription drugs precludes the imposition of a warranty of fitness for ordinary purposes, as each individual for whom they are prescribed is a unique organism who must be examined by a physician who is aware of the nature of the patient's condition as well as the medical history of the patient. Breach of implied warranty of merchantability claims, therefore, are precluded for prescription drugs. Again, several courts have extended this reasoning to preclude claims against medical device manufacturers for breach of implied warranties of merchantability and fitness for a particular purpose.  And the district court here agreed; there was no compelling reason to distinguish between prescription drugs and medical devices.

The court then turned to the express warranty claim. Under Pennsylvania law, any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.  Here, plaintiff alleged that defendants expressly warranted in written literature, advertisements and representations of representatives and agents that the systems, bone screws, liners and other related components were safe, effective, fit, and proper for the use for which they were intended. But plaintiff did not allege any particular affirmation of fact or promise, as required under federal pleading rules, that would give rise to a reasonable inference that defendants expressly warranted that its products were safe, effective, fit, and proper for the use for which they were intended. Plaintiff failed to allege that any particular affirmation of fact or promise was made in any of those sources.  Plaintiff's allegations also did not support a reasonable inference that any affirmation of fact or promise by defendants became part of the basis of the bargain in plaintiff's purchase. (Of course, plaintiff could not allege that any particular affirmation of fact or promise became “part of the basis of the bargain” without alleging any particular affirmation of fact or promise.)  Thus, plaintiff failed to state a plausible claim for breach of express warranties under Pennsylvania law. (However, the court gave Horsmon another chance to amend and replead her breach of express warranty claim.)

 

Defect Allegations Insufficient in Drug Case

We may be accustomed to talking about whether a product was "defective" and, as counsel for defendant sellers, working hard to show that the product contained no "defect."  Earlier this month came a decision reminding us that, in some contexts, a defect, even one that caused the injury, may not be all plaintiffs need to allege and prove. Mills v. Bristol-Myers Squibb Co., No. 11-00968 (D. Ariz., 10/7/11).

Plaintiff was prescribed Clopidogrel (branded as "Plavix") for the treatment of peripheral vascular disease.  Two years later, plaintiff initiated this action alleging that the drug caused excessive rectal bleeding. The court dismissed, and plaintiff eventually sought leave to file a Second Amended Complaint. Defendants argued that leave to amend should be denied as futile.  And the court agreed.

The interesting part of the opinion for our readers is the discussion of strict products  liability, premised on two theories: design defect and failure to warn. (Plaintiff also premised her negligence claim on these theories.)  For plaintiff to prevail under both theories she had to show that the product left the defendants' hands in a defective condition, the defect rendered the product unreasonably dangerous, and the defect was a proximate cause of plaintiff's injuries. Sw Pet Prods., Inc. v. Koch Indus., Inc., 273 F. Supp. 2d. 1041, 1051 (D. Ariz. 2003).

Plaintiff alleged that Plavix was allegedly defective when ingested along with aspirin by people who have peripheral vascular disease, and that the defect caused her injury.  So there you have it.   But wait... simply pleading a defect is not enough. To prevail on a design defect claim in Arizona, a plaintiff must also show that the defective product is unreasonably dangerous.  Although plaintiff's design defect claim was apparently pled pursuant to the Restatement (Second) of Torts § 402(a), the federal court concluded that Arizona would now use the Restatement (Third) of Torts, particularly its definition of an unreasonably safe prescription drug or medical device in a design defect claim.  Section 6(c) of the Third Restatement, noted the court, declares that a prescription drug or medical device is unreasonably unsafe due to defective design only if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Here, although plaintiff alleged that no reasonable health-care provider would prescribe Plavix
for plaintiff knowing of the alleged risks to Caucasian patients who genetically are poor metabolizers of Plavix, and who are diagnosed with peripheral vascular disease and concomitantly ingest aspirin, nowhere did the plaintiff allege that Plavix would not be prescribed for any class of patients. (We leave for a later post the interesting and scary theory that the drug was defective because it had greater adverse effects among a narrow group with a genetic pre-disposition.)

And arguably even under a traditional risk/benefit analysis used to determine whether a product is unreasonably dangerous based on the Restatement (Second) of Torts, plaintiff's pleading did not state a plausible claim.  Although detailed factual allegations are not necessary in pleadings, "labels and conclusions" are insufficient. Bell Atlantic Corp v. Twombly, 550 U.S. 544, 555 (2007).  And that's what she offered on risk benefit elements.

As to the warning claim, plaintiff needed to allege, then show, that had a proper warning been given, the injury would not have happened. See Gosewisch v. Am. Honda Motor Co., Inc., 153 Ariz. 400, 403, 737 P.2d 376, 379 (1987) (superseded by statute on other grounds).  Here, plaintiff averred only on information and belief that her doctor would not have prescribed Plavix had he known of its true risks for patients like plaintiff.   But the court noted that plaintiff could simply have contacted her physician to determine the facts, which were not solely in the control of defendants. She did not do so, and her allegations thus fell short. This may be an important use of the clarified pleading standard, particularly in those jurisdictions in which defendants are precluded from informally contacting the plaintiff’s prescriber.  


 

FDA Issues Draft Guidance on Informed Consent Language

The FDA has issued draft guidance on the use of "Exculpatory Language in Informed Consent" agreements. The document applies to non-exempt human subject research conducted or supported by the Department of Health and Human Services, and is intended for clinical investigators, institutional review boards, and funding agencies that may be responsible for review or oversight of human subject research conducted or supported by HHS or regulated by FDA.

This document provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent in clinical trials and other research. Readers may know that under federal regulations, no informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

The document includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider improperly exculpatory.

CHPA Comments on Draft FDA Guidance on Nanotechnology

Last week, the Consumer Healthcare Products Association (CHPA) submitted comments on the FDA’s draft guidance on nanotechnology, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, "  which we posted on before.

CHPA is the not-for-profit association representing the makers of over-the-counter medicines and dietary supplements, and the consumers who rely on these healthcare products. CHPA is one of the oldest trade associations in the United States. Nanotechnology holds great promise for this industry.

CHPA agreed with the FDA that proposing a "definition" for nanotechnology is not a straight forward process; applying a strict, universal definition of nanotechnology to the fields of drug research, drug product development and drug manufacturing would not be, in CHPA's view, an appropriate science-based approach.

Defining a nanomaterial as a structure between 1 and 100 nm, and using this definition to establish new regulations on products containing nano-sized materials, would, they asserted,  erroneously group drug products together to form a new category based on size of ingredients.  Nanotechnology is not a separate drug category, but a technology used to, among other things, generate nanometer-sized ingredients and excipients. Inclusion of nanometer-sized active ingredients or excipients in a drug product does not by itself determine a product's safety and efficacy (i.e. size alone is not itself an indicator of toxicity). 

CHPA agreed that the agency should distinguish between engineered nanomaterials and those
naturally occurring at the nanoscale.  There exist common pharmaceutical ingredients with a long history of use that should not be considered as "engineered nanomaterials" or as agglomerates of nanomaterials but which may have particles whose size naturally falls within this range.

CHPA also noted that NIOSH accurately refers to nanotechnology as the manipulation of matter on a near-atomic scale to produce new structures, materials, and devices.  Nanomaterials are mainly engineered for their novel chemical, physical, and quantum mechanical properties; at the nanometer size, many materials exhibit such unique beneficial properties that may not exist when at the micron size. CHPA argued it is appropriate to include in the description the notion of particles that are deliberately manipulated and controlled at the nanoscale, which also exhibit changes in physical, chemical, or electromagnetic properties, the existence of unique phenomena to enable novel applications.

For example, milling, a beneficial process for the manufacturing of many individual pharmaceutical ingredients, may create particles with a portion of the particle size distribution under 1 micron; however, the chemical properties of the milled ingredient usually do not differ drastically from that of the bulk ingredient.

The agency should give further consideration, said CHPA,  to the possibility that not all materials should be considered equal; each material must be evaluated on a case-by-case basis. For example, soluble nanomaterials might not be treated the same as insoluble ones.  

FDA Releases New Strategic Plan for Regulatory Science

This week the FDA released a plan for fostering innovative science. It is entitled the “Strategic Plan for Regulatory Science,” and it focuses on the agency’s goal to enhance the processes for developing and evaluating new medical products and materials.

The strategic plan describes the agency’s intent to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It reportedly also underscores the agency’s emphasis on food safety.

The plan also emphasizes the agency’s intention to study and improve how it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive that information.

The priority areas listed in the report are:

  • Modernize Toxicology to Enhance Product Safety
  • Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
  • Support New Approaches to Improve Product Manufacturing and Quality
  • Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
  • Harness Diverse Data through Information Sciences to Improve Health Outcomes
  • Implement a New Prevention-Focused Food Safety System to Protect Public Health
  • Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
  • Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products
     

 

IOM Releases Controversial 510K Device Report

Earlier this week, an Institute of Medicine’s Committee released its report on the Public Health Effectiveness of the FDA 510(k) Clearance Process.  The report offers a variety of recommendations and suggested reforms for FDA’s 510(k)  premarket notification pathway, describing the device clearance process as badly flawed.

Readers of MassTortDefense know how the regulatory clearance process has impacted preemption of state law product liability claims, and the significant medical device litigation we have covered here.

The recommendations will likely spark a heated debate within the larger struggles over the need for future medical device regulations. But even before that step, a variety of observers, including the Washington Legal Foundation, have asserted that the FDA is statutorily barred from adopting any of the report’s recommendations.  The charge has been made that the Institute of Medicine failed to adequately balance the panel, in violation of §15 of the Federal Advisory Committee Act. Section 15(a) provides that an agency may not use any advice or recommendation developed by the committee unless it has complied with a requirement that the committee membership be “fairly balanced.”  Using advice from a committee that lacks fair balance would encroach upon the Congressional mandate that each Advisory Committee should be representative of a broad
range of viewpoints. 

FDA had commissioned the IOM to conduct an analysis of the § 510(k) system in 2009.  The IOM
Committee was composed of twelve members:  five doctors, three lawyers, and four academics. Specifically missing were innovators or any product developers familiar with the clearance process, and any representatives of patients or patient advocacy groups that have benefited from the development of medical devices under the current system.
 

 

Yaz Court in NJ Issues Bellwether Trial CMO

The court overseeing the coordinated litigation in New Jersey state court over the birth control pills Yaz, Yasmin, and Ocella recently issued a case management order.  See CMO No. 25 - Bellwether Trial Selection Plan.

Here at MassTortDefense we are always interested in the nuts and bolts of how mass tort litigation is managed, and have posted about bellwether trials before. The NJ court order calls for creation of a pool of 18 cases from which the first trials will come. Nine will be selected by plaintiffs and nine by defendant. Of the nine on each side, 3 must allege each of the three main alleged injuries in this litigation.

Case specific discovery for the cases in the pool will begin in August, 2011, and must be completed in November, 2011. The order establishes a schedule for expert discovery and challenges to experts.

The bellwether trials will be selected from the group of 18.  If the parties cannot agree on a sequence, the Court will decide. The first trial is set for September, 2012.

There are about 1,000 cases pending in the New Jersey proceedings. The Court stated it had not yet decided whether there will be individual trials or consolidations. See In re Yaz, Yasmin, and Ocella Litigation, N.J. Super. Ct., No. 287 (7/8/11). 
 

Supreme Court Declines To End Multiple Class Action Mischief

The second of our Supreme Court trilogy for the week.  The Court ruled last week in Smith v. Bayer Corp., No. 09-1205, that a federal district court was prevented by the the Anti-Injunction Act from enjoining a state court from entertaining plaintiff's motion to certify a class action even when that federal court had earlier denied a similar motion to certify an overlapping class in a closely related case.

Generally, the Anti-Injunction Act bars a federal court from granting injunctions to stay proceedings in state courts except where specifically authorized by Congress, or "where necessary in aid of its jurisdiction, or to protect or effectuate its judgments."  Most of our readers hoped that the Court would agree with the lower courts' ruling that this was just such an exception.

The Smith case involved the issue whether a federal court can enjoin class members from bringing a product liability class suit in a state court after the federal court declined to certify a similar class. Specifically, the Baycol MDL court in Minnesota had denied class certification, and the court of appeals upheld the injunction barring plaintiffs from bringing virtually the same suit in West Virginia state court. The federal court of appeals in fact unanimously affirmed, holding that the injunction was authorized by the All Writs Act and the re-litigation exception to the Anti-Injunction Act, and that petitioners did not have a due process right to re-litigate class certification.

The Supreme Court, unfortunately, reversed, in a decision that may encourage forum shopping.

-The decision encourages "creative" case structuring strategies by the plaintiffs' bar to give themselves a second bite at the apple (or more) in class claims, even after the federal court properly denies certification, and even when the state class law mirrors Federal Rule 23; here, the Court found that an application of West Virginia's Rule 23 did not present the same exact issue as the application of the federal rule version, even though the language of the rules is nearly identical.

-The decision highlights the double-edged sword that is federalism; now, the preclusive effect of a certification denial, if any, will be decided by state courts applying the notions of res judicata rather than by the enjoining court.  This comports with the general notion that the second court looking back decides the impact, not the first court looking forward.  But readers are well aware of the hard-to-fathom preclusion decisions some state courts have fashioned in the class action context.  E.g., the Engle class in Florida. And, as plaintiffs told Justice Ginsburg in oral argument of the case, a state has the right to apply and interpret a rule of civil procedure "as it sees fit to manage its own docket and administrate its own docket as it sees fit."

-As a practical matter, it invites "if at first you don't succeed, try, try again," with plaintiffs seeking to bring similar cases again and again, shopping for a forum or judge that will finally agree to certify something. Plaintiffs will recruit a new named plaintiff, and recreate the risks associated with class certification, even after the defendant has seemingly won that important battle. Justice Alito asked petitioners at oral argument whether after a class certification denial is entered in one federal court, a plaintiff's attorney could simply substitute the name of a new named plaintiff and file the same complaint in another federal court. Plaintiffs answered that an attorney could do that.

-Note that petitioners had not been foreclosed from seeking relief on their individual claims, but only from seeking to represent other people through a class action. Whether a class should be certified had been fully and fairly litigated in proceedings that ought to be binding on petitioners and in which petitioners’ interests were adequately represented by an identically situated named plaintiff -- one whom plaintiff's counsel promised was an adequate representative, was typical, with common claims and no adverse interests. The Court apparently did not consider the possible argument that an absent class member who is adequately represented might be in sufficient privity with the named plaintiff such that he can be precluded from litigating the certification decision a second time.

-Even though in dicta, the Court discouraged the application of preclusion to absent class members.   It may be of little comfort to defendants faced with the costs and risks of serial class claims that, as the Court put it, the "legal system generally relies on principles of stare decisis and comity among courts to mitigate the sometimes substantial costs of similar litigation brought by different plaintiffs."

-The Court agreed that the policy concerns were the defendant's "strongest argument, " and seemingly recognized the mischief it was permitting, because the opinion noted that nothing in this holding forecloses legislation to modify established principles of preclusion should Congress decide that CAFA does not sufficiently prevent re-litigation of class certification motions. Nor does the opinion at all address the permissibility of a change in the Federal Rules of Civil Procedure pertaining to this question.  The Court said the trial court could not call on the "heavy artillery" of an injunction, but perhaps an even mightier weapon is needed.

 


 

FDA Releases Draft Guidance on Nanotechnology

The U.S. Food and Drug Administration last week released draft guidance designed to move the process forward of providing its regulated industries with greater certainty about the use of nanotechnology (which generally involves materials made up of particles that are one billionth of a meter in size). The guidance outlines the agency’s current view on certain issues about regulated products that contain nanomaterials or involve the application of nanotechnology.

FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms. The term is perhaps most commonly used to refer to the engineering (i.e., deliberate manipulation, manufacture or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers. For example, theNational Nanotechnology Initiative Program defines nanotechnology as the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. Other factors such as function, shape, charge, the ratio of surface area to volume, or other physical or chemical properties have also been mentioned in various published definitions.

Our readers know that nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bio-availability of a drug, improving food packaging, and in cosmetics.

The draft guidance document, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” represents a first step toward providing some regulatory clarity on the FDA’s approach to nanotechnology. Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related to the regulatory status, safety, effectiveness, or public health impact of these products can be adequately addressed.

In 2006, the FDA formed the Nanotechnology Task Force, charged with identifying and addressing ways to better enable the agency to evaluate possible adverse health effects from FDA-regulated nanotechnology products.  The agency issued a report by the task force in 2007 that recommended that the FDA issue additional guidance and take steps to address the potential risks and benefits of drugs, medical devices and other FDA-regulated products using nanotechnology.

 

Supreme Court Declines to Clarify Tolling Effect of Mass Tort Class Actions

Earlier this week, the Supreme Court declined to take a case raising the tricky issues of cross-jurisdictional class action tolling.  Novartis Pharmaceuticals Corp. v. Stevens, No. 10-1196 (U.S., certiorari denied 5/31/11).

The question presented in the cert petition was whether was whether tolling the statute  of limitations for individual claimants based on the pendency of a mass personal injury class action violates fundamental federal due process protections where the class action provides no notice to a defendant of the identity of unnamed class members, thus absolutely precluding the timely preservation of evidence and testimony critical to presenting an effective defense.

Defendant/petitioner has been involved for several years in litigation claiming that the drug Zometa is linked to osteonecrosis of the jaw or “ONJ.”  Plaintiff below obtained a jury verdict on such a claim, affirmed by the Montana Supreme Court . 358 Mont. 474, 247 P.3d 244 (2010). The sole aspect of the Montana Supreme Court’s opinion at issue here was its ruling that the pendency of a never-certified federal class action on ONJ acts to resurrect respondent’s otherwise time-barred personal injury claims. The Montana Supreme Court determined as a matter of first impression in Montana that federal class action tolling should apply to render timely respondent’s complaint against petitioner. The Montana court noted that the concept of federal class action tolling was articulated by the Supreme Court in American Pipe & Construction Co. v. Utah, 414 U.S. 538 (1974). In American Pipe, the Court held that in some contexts, the commencement of the class action suit satisfied the purpose of the limitation provision as to all those who might subsequently participate in the suit as well as for the named plaintiffs. One reason was concerns of judicial economy, as a contrary holding might invite a multiplicity of activity that the federal rules of procedure were designed to avoid, as individual plaintiffs would be forced to file preventative motions to join or intervene as parties if the class action status was still pending at the expiration of the statute of limitations.

The problem is that in the specific context of a personal injury mass tort, the application of American Pipe federal class action tolling seems to infringe on a defendant’s ability to defend itself -- in violation of due process principles. Suspending statutes of limitation indefinitely for all purported members of the kinds of  “worldwide” classes we see of personal injury plaintiffs, based on nothing more than the filing a Rule 23 federal class action, introduces systemic unfairness to defendants. 

A  pharmaceutical personal injury case may be an especially poor vehicle for federal class action tolling. Virtually no pharmaceutical personal injury class action has been certified over opposition and survived appeal in the federal system for a decade now. See, e.g., Jolly v. Eli Lilly & Co., 751 P.2d 923, 933-38 (Cal. 1988) (en banc) (rejecting tolling due to pending personal injury class action because such torts are not susceptible to class action certification). Tolling individual  actions based on a pending personal injury class action renders limitations periods impermissibly uncertain and invites unnecessary litigation by giving plaintiffs’ counsel everywhere an incentive to add putative class relief to every federal complaint just to toll statutes of limitations to the benefit of unknown future plaintiffs -- knowing there will never be a certified class.  Some lower courts have thus concluded that class action tolling should not be applied in the mass tort context unless the defendant had actual notice of the identities of unnamed class members.

Petitioner argued that tolling the limitations period for all purported members of the class during the pendency of class certification proceedings – which in a mass class action can take years – creates an unacceptable risk that by the time the claims of unnamed individuals are adjudicated, evidence critical to defending claims of that individual plaintiff will have been lost.  Issues relating to exposures, learned intermediaries, concurrent risk factors, specific (as opposed to general) causation, proximate causation regarding warnings, and assumption of the risk, all involve evidence that can be both peculiar to the individual plaintiff, and turn out to be the central evidence in the action.

Perhaps because of unique procedural issues below (involving fictitious parties), however, the Court passed on the opportunity to address these serious issues.


 

Class Certification Denied in YAZ MDL

The federal judge managing the multidistrict litigation over the birth control pill Yaz last week declined to certify a proposed national class of users allegedly harmed by the contraceptive, and struck the class action allegations from the complaint.  In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, No. 3:09-md-02100 (S.D. Ill.).

In the opinion, Judge Herndon noted that named plaintiff Plaisance was a 44-year-old citizen of the State of Louisiana who was prescribed YAZ in May of 2006 by her physician. During the summer of 2006, plaintiff was hospitalized due to a deep vein thrombosis (“DVT”) in her left leg.  She alleged that the DVT, as well as other adverse effects, were caused by her ingestion of YAZ.  Plaintiff sought class certification of a nationwide class of YAZ purchasers who contracted DVT, but in the alternative proposed separate state-wide classes.

Plaintiff asserted claims for negligence, strict product liability, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, medical monitoring, and fraud and deceit.

Plaintiff maintained that the putative nationwide and state wide classes met the requirements of Rule 23(a) and 23(b)(3). In addition, plaintiff contended that the unitary application of the law of Louisiana was appropriate and somehow resolved issues related to the application of the substantive laws of multiple jurisdictions.

Here, the Court’s analysis began and ended with Rule 23(b)(3); it was "evident" to the court that individual questions of law and fact predominated, and therefore the case was not manageable as a nationwide or statewide class action.  Rule 23(b)(3)’s predominance and manageability  requirements also precluded any proposed “issue” certification under Rule 23(c)(4).

To satisfy the requirements of Rule 23(b)(3), a plaintiff must show that common questions of factor law predominate over individual questions and that class treatment is superior to other available methods of adjudication.Fed. R. Civ. P. 23(b)(3). Assessing the predominance factor requires consideration of the substantive elements of a plaintiff’s claims and the proof necessary to establish those elements. See Szabo v. Bridgeport Machines, Inc., 249 F.3d 672, 673-74, 677-78 (7th Cir. 2001); In re Bridgestone/Firestone, Inc., 288 F.3d 1012, 1015-19 (7th Cir. 2002). In addition, a court must consider issues pertaining to manageability and choice of law.

On that last point, this action was transferred from the United States District Court for the Eastern District of Louisiana. Therefore, Louisiana choice of law rules governed the complaint. See Chang v. Baxter Healthcare Corp., 599 F.3d 728, 732 (7th Cir. 2010). Under Louisiana’s codified choice of law rules, the substantive law of each plaintiff’s home state would govern the merits of the case. Accordingly, the laws of all fifty states plus the District of Columbia would be applicable to the putative nationwide class members’ claims. Amongst the states, there are differences in the law of product liability as well as in the applicable theories of recovery and their subsidiary concepts. These differences, said the court, "are not insignificant." See e.g., Rhone-Poulenc Rorer Inc., 51 F.3d 1293, 1300-1301 (7th Cir. 1995). Indeed, “such differences have led [the Seventh Circuit] to hold that other warranty, fraud, or products-liability suits may not proceed as nationwide classes”). In re Bridgestone/Firestone, Inc., 288 F.3d at 1015.See also Isaacs v. Sprint Corp., 261 F.3d 679 (7th Cir.2001); Szabo v. Bridgeport Machines, Inc., 249 F.3d 672 (7th Cir.2001); In re Rhone-Poulenc Rorer Inc., 51 F.3d 1293 (7th Cir.1995).  In the class action context differences in state law cannot be swept away by electing to apply the law of a single state to all class members’ claims. See Id. at 1017-1020. Although the unitary application of a single state’s law might promote  efficiency, it would also constitute an unacceptable violation of principles of federalism.   Differences across states may be costly for courts and litigants alike, but they are a fundamental aspect of our federal republic and must not be overridden in a quest to clear the queue in court.

The court went on to correctly note that mass product liability suits are rarely sustainable as class actions. Establishing the requisite elements of product liability claims sounding in strict liability, negligence, warranty, and/or fraud generally requires fact intensive inquiries unique to each plaintiff(such as questions related to causation, injury, affirmative defenses, and damages). In the instant case, almost every element of the asserted claims would have required highly individualized factual inquiries unique not only to each class member but also to each class member’s  prescribing physician. For example, establishing causation would require (1) an examination
of each class member’s medical history, including pre-existing conditions and use of other medications; (2) an evaluation of potential alternate causes for the alleged injury; and (3) an assessment of individualized issues pertaining to each class member’s prescriber, including how the doctor balances the risks and benefits of the medicine for that particular patient, the particular doctor’s prescribing practices, the doctor’s knowledge about the subject drug, and the doctor’s sources of information with regard to the subject drug. Establishing elements of the fraud and warranty claims would also turn on facts unique to each plaintiff, particularly with regard to questions of materiality and reliance.

On the (c)(4) issue, the court recognized that Seventh Circuit jurisprudence indicates that Rule 23(b)(3)’s requirements of predominance and manageability are applicable to “issue” certification under Rule 23(c)(4).  There is disagreement amongst district courts with regard to whether, under Rule 23(c)(4), the predominance evaluation is a limited inquiry, focusing only on the individual issue for which class treatment is sought, or requires consideration of the cause of action as a whole. See e.g., In re Fedex Ground Package System, Inc., Employment Practices Litigation, 2010 WL 1652863, *1-2 (N.D. Ind. Apr. 21, 2010); In re General Motors Corp. Dex-Cool Prods., 241 F.R.D. 305, 313-314 (S.D.Ill.2007).  The Fifth Circuit Court of Appeals in particular has been critical of district courts that fail to consider the case as a whole when evaluating predominance under Rule 23(c)(4). See Castano v. Am. Tobacco Co., 84 F.3d 734, 745 n. 21 (5th Cir. 1996). 

Here, the court felt no need to choose a side, because In the instant case, the putative common issues, including matters such as whether the subject drugs were defective or whether these defendants failed to give adequate warnings,  were enmeshed with the same individual issues of law and fact as affected certification of the putative class as a whole. The allegedly common issues had subsidiary concepts (such as causation, duty of care, and reliance) which would present questions that can only be answered by considering facts that are unique to each putative class member and her prescribing physician.

In addition, many – if not all – of the proposed common issues could not be certified without triggering the Seventh Amendment concerns discussed in Rhone-Poulenc Rorer. See Rhone-Poulenc Rorer, 51 F.3d at 1303. A trial court must divide issues between separate trials in such a way that the same issue is reexamined by different juries. Here, multiple juries in follow-up trials would have to examine such issues as comparative negligence and proximate cause after a first jury examined the alleged negligence.

Seminar Worth Checking Out

A head's up for our readers about an upcoming seminar worth checking out. DRI’s Drug and Medical Device Committee will hold its 27th annual Seminar on May 5-6, 2011 at the Sheraton Hotel and Towers in Chicago, Illinois. 

 

The Seminar offers an outstanding program for practitioners and in-house counsel who practice pharmaceutical and medical device law.  The Seminar features nationally recognized attorneys, both in-house and outside counsel, who will speak on a variety of cutting edge topics relevant to the life sciences industry.  The program offers a variety of presentations including moderated panel discussions, individual presentations from leading practitioners and practical demonstrations of trial skills.  There is also a Young Lawyers Blockbuster session. 

 

In addition to the outstanding educational opportunities, the Seminar provides great networking opportunities to connect or reconnect with counsel and clients from around the country. Attendees may earn up to 12 hours of CLE, including 1 hour of ethics credit.

 

More information available here. 

 

Supreme Court Hears Oral Argument in Class Action Preclusion Case

This week, we are going to explore some of the more interesting cases pending before the Supreme Court. In Smith v. Bayer Corp., No. 09-1205 (U.S., oral argument 1/18/11), the Court took up a case involving the preclusive impact of a decision denying class certification. We recently posted on a case involving the significant problem of plaintiffs hopping from court to court, state to state, shopping for a court that will certify their class after it has already been denied.

The Smith case involves the issue whether a federal court can enjoin class members from bringing a product liability class suit in state court after the federal court declined to certify a similar class.  Specifically, the Baycol MDL court in Minnesota had denied class certification, and the court of appeals upheld the injunction barring plaintiffs from bringing the same suit in state court. The court of appeals in fact unanimously affirmed, holding that the injunction was authorized by the All Writs Act and the re-litigation exception to the Anti-Injunction Act, and that petitioners did not have a due-process right to re-litigate class certification.

Plaintiffs have argued that they should not be enjoined, nor barred under the doctrine of collateral estoppel, because the state's (West Virginia's) rule for class certification is not identical to the federal rule:  while a putative class may not meet one test, it may meet the other. As plaintiffs told Justice Ginsburg, a state has the right to apply and interpret that rule of civil procedure "as it sees fit to manage its own docket and administrate its own docket as it sees fit."

The defendants argue that class members were adequately represented in the first class action, and whatever the technical differences may be, the heart of the West Virginia rule is substantively identical to the federal rule. Petitioners have not been foreclosed from seeking relief on their individual claims, but only from seeking to represent other people through a class action. Whether a class should be certified has been fully and fairly litigated in proceedings that are binding on petitioners and in which petitioners’ interests were adequately represented by an identically situated named plaintiff.  The plaintiffs' position is that class certification is a “heads-I-win, tails-you-lose” proposition. Under this theory, every unnamed plaintiff could re-litigate class certification, no matter how large the putative class, no matter how many times certification had already been denied, and no matter how adequately the class members’ interests were represented in the prior proceedings.

Part of the issue facing the Court is the application of preclusion to a non-party (as the class was not certified, absent class members were not "parties" for some purposes), and this was explored at oral argument. In response to questioning from the Court, plaintiffs argued that the re-litigation exception to the Anti-Injunction Act did not apply here. Because the plaintiffs are not the same "parties" that litigated the federal class action, and because the same issues were not litigated in the prior case -- that is, West Virginia's own class certification rule vs. Federal Rule 23.  Counsel argued that the state court has said "we do not want our legal analysis to be nothing more than a mere Pavlovian response to Federal decisional rules."

A number of Justices wondered what were the supposed differences, and part of the response to Justice Sotomayor was that the federal "court's not only trying to bind us on the procedural ruling, but is also trying to bind us in a substantive ruling as to what the elements of the claims in West Virginia are and as to what's needed to prove those claims." The state court was free to disagree with that federal ruling, counsel argued. In response to Justice Kagan, Bayer noted that the predominance requirement under the West Virginia version of Rule 23 is essentially identical to the Federal version, and there is no evidence of any content that's different from the Federal version on this point. But Justice Ginsburg pressed defendant on the issue that "sometimes Federal judges, they try their best, they're not the last word on what the State law is."

Several Justices raised the issue of forum shopping in their questions for petitioners' counsel. Justice Alito asked petitioners, whether after a class certification denial is entered in one federal court, a plaintiff's attorney could simply substitute the name of a new named plaintiff and file the same complaint in another federal court. Plaintiffs agreed that an attorney could do that.

Justice Alito asked about some of the possible implications of the plaintiffs' argument. If part of the issue is notice, would that compel federal courts to engage in a lengthy and expensive class notice period even in cases in which the class is denied? Plaintiff responded that notice would be required to bind the absent class members. Bayer argued in response to similar questions from Justice Sotomayor that the preclusion test focuses on whether the parties' interests are aligned, and the class members' interests were identical,  the first named plaintiffs understood that they was acting in a representative capacity, and the federal court took normal steps to protect the interests of non-parties, i.e., absent class members.  All that was met here. But Justice Scalia asked whether the counsel had ever been found adequate since the class was denied certification on other grounds.

Justice Kagan asked about CAFA, and Congressional intent to prevent forum shopping with classes and keep state courts from too freely certifying these kinds of class actions, which plaintiff had to concede.

Plaintiff had a hard time with the Court's questions about due process and how it affects procedural rights as opposed to substantive or property rights, particularly, as Justice Sotomayor asked, where the Federal litigation has applied essentially the same standard that the State has, and there has been adequate representation on the procedural question, and where no substantive right of a plaintiff has been extinguished. Chief Justice Roberts similarly asked about line-drawing, with a hypo about the second court limiting discovery because of what happened in the first court: "So now it's not only that you're entitled to your day in court substantively; you're entitled to your day in court procedurally as to some procedural aspects but not others?"

Justice Ginsburg asked counsel for Bayer whether there was a difference between preclusion being applied by the state court and the federal court issuing the injunction based on preclusion, calling the latter a "heavy gun.”  Meaning we're "not going to trust the West Virginia court to apply issue preclusion. We're going to stop that court from proceeding altogether."  Bayer replied that the injunction was very important because trial courts in West Virginia need not follow other trial courts, and there is no intermediate appeals court.  Thus plaintiff could go from county to county until they found a court that refused to apply preclusion.  

 

Proof of General Causation in Drug Case Not Automatic

A West Virginia federal court has granted summary judgment against a plaintiff alleging that the heartburn drug metoclopramide caused her tardive dyskinesia.  Meade v. Parsley, et al., 2010 WL 4909435 (S.D.W.Va.,  11/24/10).

Since its approval by the Food and Drug Administration in 1980, metoclopramide has been widely used to treat gastroesophageal reflux disease (“GRD”), nausea, and gastroparesis.  Plaintiff's treater, Dr. Deidre Parsley, prescribed metoclopramide to Mrs. Meade in order to treat her
GRD, nausea, and loss of appetite. Plaintiff  never read any written materials accompanying her metoclopramide prescriptions, which included a statement that therapy longer than 12 weeks has not been evaluated and cannot be recommended.  Dr. Parsley likewise did not read the metoclopramide package insert or any other written materials produced by PLIVA before prescribing the drug to Mrs. Meade. After the drug usage, the FDA added a black box warning about tardive dyskinesia.  But, save for the placement of the warning in a black box, the previous warning seemed not too different.

Plaintiffs contended that the warnings were inadequate in that they misleadingly invited long term use that has never been approved by the FDA, despite the fact that the warning did state that therapy longer than 12 weeks has not been evaluated and cannot be recommended. In addition,
plaintiffs claim that the warnings downplayed the seriousness and potential irreversibility of the risk of tardive dyskinesia in long term use, but the warning did state that the risk is highest among the elderly, especially elderly women (like this plaintiff), and that the likelihood of irreversibility is believed to increase with the duration of treatment and the total cumulative dose. 

Defendant moved for summary judgment, contending that there were no genuine issues of material fact inasmuch as (1) plaintiffs could not establish causation; (2) Dr. Parsley was aware of the risks of using metoclopramide when she prescribed the drug to Mrs. Meade; (3) PLIVA satisfied any alleged duty to warn by providing a package insert explaining potential side effects of
metoclopramide.  The court never had to reach the third argument.

In a pharmaceutical products liability action, a plaintiff must initially establish both general and specific causation for his injuries. Bourne ex rel. Bourne v. E.I. Dupont de Nemours & Co., 189 F. Supp. 2d 482, 485 (S.D. W. Va. 2002).  General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. In re Rezulin Prods. Liab. Litig., 369 F.
Supp. 2d 398, 402 (S.D.N.Y. 2005); In re Hanford Nuclear Reservation Litig., 292 F.3d 1124, 1129 (9th Cir. 2002). General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease.

In addition to general and specific causation, plaintiffs must establish proximate causation.To
show proximate causation in a failure-to-warn case based on an allegedly inadequate drug label, a plaintiff must show that a different label or warning would have avoided the plaintiff’s injuries. The court noted that the West Virginia Supreme Court has not had occasion to clarify whether a drug manufacturer must warn both the patient and the physician, or just the patient.  But it did not need to resolve this issue in evaluating proximate causation, however, because the undisputed evidence shows that an adequate warning would not have changed either Mrs. Meade’s or Dr. Parsley’s behavior in a manner which would have avoided Mrs. Meade’s injury.  Rather than merely showing that “adequate warnings would have changed behavior,”  as plaintiff argued, plaintiffs must
establish that an adequate warning would have changed behavior in a manner which would have avoided the plaintiff’s injury.  Mrs. Meade testified that she never read the package insert or any other documents accompanying her metoclopramide prescription.  Dr. Parsley likewise testified that she did not read the metoclopramide warning. And while Dr. Parsley did read the PDR for
the brand name version of the drug, it is undisputed that the defendant did not create that PDR.

The more interesting part of the opinion for our readers is the treatment of the issue of general causation.  It seems that none of plaintiffs’ retained experts offered any opinions regarding general
causation. So plaintiffs were left to argue that several of Mrs. Meade’s treating physicians (whom plaintiffs began referring to as “non-retained experts”) testified regarding the causal link between metoclopramide and tardive dyskinesia. None of these non-retained experts provided written
reports, and in deposition none of these physicians testified directly as to general causation. They assumed causation as a prelude to a specific causation opinion, but this mere assumption does not establish general causation. The law is clear that a mere possibility of causation and, more
specifically, indeterminate expert testimony on causation that is based solely on possibility is not sufficient to allow a reasonable juror to find causation. 

As an alternative basis for general causation, plaintiffs tried to rely on the fact that defendant's own package inserts and brand name warnings refer to a "causal link” between metoclopramide and tardive dyskinesia. Plaintiffs could cite no authority for the proposition that a plaintiff in a pharmaceutical products liability case can satisfy his or her burden of proving general causation by relying on the defendant manufacturer’s drug label warnings. Moreover, this contention was undermined by the general principle that causation evidence in toxic tort cases must be in the form of expert scientific testimony.  PLIVA’s drug label, which merely warns of metoclopramide’s potential side-effects without explaining the scientific basis for the warning, was no substitute for expert testimony that establishes causation in terms of reasonable probability.

Third, plaintiffs also tried to cite, as evidence of general causation, the subsequent FDA directive requiring drug manufacturers to insert a black box warning on metoclopramide labels to convey a
greater risk of tardive dyskinesia. The court, as have several other courts have, however, rejected reliance on agency determinations as a basis for general causation. Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concluded that the FDA-mandated tardive dyskinesia warning cannot establish general causation.

 Summary judgment granted.

Lone Pine Order Adopted in Avandia MDL

In the right case, we are big fans of the "Lone Pine" order as a tool of case management.  Named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986), Lone Pine orders are designed to handle the complex issues and potential burdens on the parties and the court in mass tort and toxic tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).   The term refers to case management orders that require the plaintiffs to make a showing regarding causation, injury, and/or damages to demonstrate, typically at an early stage, some minimal level of evidentiary support for the key components of their claims which will be in dispute.

While the 1986 New Jersey Superior Court case involved traditional toxic tort claims, the device has gotten good use in drug cases as well.  E.g., In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010). After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement.  The order required non-settling plaintiffs to notify their health-care providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply eventually resulted in dismissal of several of the plaintiffs' claims with prejudice.

And the federal judge overseeing the MDL for Celebrex and Bextra found that a “Lone Pine” order was appropriate for managing the claims of the remaining, non-settling plaintiffs. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No. M:05-cv-01699 (N.D. Cal.) (Pretrial Order No. 29, Aug. 1, 2008).

In the drug context, a Lone Pine order might require plaintiffs to submit a case-specific expert report on the issue of medical causation; or to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and/or proof of dosage in relation to the injury. The benefit to the court of requiring plaintiffs to supply this information is that the parties will not have to engage in protracted discovery in hundreds or thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence is simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Requiring plaintiffs to identify basic information about injuries and causation is not unreasonable given the costs that mass tort claims have on the legal system, and on defendants in particular. Lone Pine orders allow courts to weed out the frivolous suits where there is insufficient exposure, or no sufficient scientific connection between injury and exposure. Accordingly, Lone Pine orders can be effective when entered early in the game. Early disposal of frivolous claims allows the parties to focus their attention on the serious cases. Ideally, the order will actually phase discovery, and motions practice as well, with the Lone Pine issues pushed up front.

But the device also has a role later in mature mass torts when, as seen above, a chunk of the litigation has settled and there still remain numerous claims of questionable strength.

In the MDL involving the the diabetes medication Avandia, In re Avandia Marketing, Sales Practices, and Products Liab. Litig., MDL No. 1871 (Pretrial Order No. 121)(E.D. Pa. Nov. 15, 2010), the federal court has recently adopted a Lone Pine order.  The court found that many of the remaining claims lacked sufficient support or detail even after submission of the Plaintiff Fact Sheets.  Thus, additional detail about the plaintiffs' claims was necessary in furtherance of settlement agreements, for the selection of cases for bellwether trials, and for the timely remand of cases to the transferor courts for resolution.

The court's overriding concern was having sufficient information to objectively identify which of the many thousands of remaining plaintiffs have injuries that could credibly be linked to the drug usage.  The order calls for information that the court said the plaintiffs should have had before filing their claims.

Specifically, plaintiffs have to have a licensed physician identify the plaintiff's Avandia usage, the alleged injury, the time lag between drug usage and injury, and a certification that the drug usage caused the injury.

Failure of a plaintiff to submit these required expert certification (and supporting documents) in a timely fashion may result in the dismissal of that plaintiff's claims with prejudice.

A defendant in such litigation should not bear the burden of winnowing cases that never should have been filed, nor should the court be saddled with consideration of claims that would not have survived reasonable pre-complaint investigation.

 

No Second Bite of the Apple for HT Plaintiffs

A federal court granted summary judgment in litigation brought by hormone replacement drug plaintiffs whose suits were previously ruled untimely by a New York court. See Rick v. Wyeth Inc.,  No. 08-1287 (D. Minn., 9/23/10).

Plaintiffs, all citizens of New York, were women, and spouses of women, who allegedly used
hormone therapy drugs manufactured and sold by defendants. Plaintiffs further alleged that they developed breast cancer as a result of the use of HT drugs.  Plaintiffs had previously brought suit individually in New York state court where their claims were consolidated into a single
coordinated proceeding. In the New York proceeding, defendants moved for summary judgment based on the New York statute of limitations. Foreseeing the end of their suits, plaintiffs moved for a discontinuance without prejudice. While the dueling motions in the New York proceeding were pending, plaintiffs commenced another action in federal court in Minnesota (where there is a much longer, highly controversial statute of limitations; none of plaintiffs, nor any of the claims at issue, had any connection to Minnesota. Instead, it seems this case, like hundreds of others involving HT drugs, was brought solely to take advantage of Minnesota’s six-year statute of limitations.)

The New York trial court granted the defendants’ motion for summary judgment and denied the
plaintiffs’ motion for "discontinuance without prejudice." In doing so, the New York trial court reasoned that the defendants would be unfairly prejudiced by allowing the litigation to re-start in another forum after having completed discovery and reached the summary judgment phase in the New York proceeding.

In the federal court proceeding, defendants then moved for summary judgment arguing that the New York judgment was entitled to preclusive effect.  The traditional rule for claim preclusion was that dismissal for untimeliness does not bar a second action in another jurisdiction with a longer, unexpired statute of limitations. Semtek Int’l Inc. v. Lockheed Martin Corp., 531 U.S. 497, 504 (2001). However, the actual test for a federal court determining the preclusive effects of a prior state-court judgment is to ask ask what preclusive effect that state intends other jurisdictions to accord its judgments.  Here, the federal court determined that New York has not definitively answered that question in this context. Therefore, the court had to determine what rule New York would likely apply.

On one hand, the New York Court of Appeals has stated that, in general, New York views statutes of limitations as procedural rather than substantive. However, the New York Court of Appeals has also held that, in the narrow context of claim preclusion, statutes of limitations “in a practical sense may also be said to be substantive.”  Thus, said the federal court, the procedural/substantive distinction that formed the foundation of plaintiffs’ argument here was hardly clear under New York law. Indeed, while the procedural/substantive distinction may be a useful tool in some instances, a clear line between procedure and substance is not always ascertainable.

In interpreting this ambiguous area of New York law, the federal court was also mindful of the overarching principals of claim preclusion. Claim preclusion doctrine values judicial economy, preventing parties from burdening courts with claims already litigated.

Against this backdrop, the federal court found the procedural posture of the case decisive.  In the New York proceeding, the plaintiffs moved for a discontinuance without prejudice. Under New York law, an element of granting such a motion is whether the adverse party will suffer prejudice. The NY trial judge believed that a discontinuance without prejudice would not have preclusive effects in the federal action, and noted that granting the plaintiffs’ motion might thus allow plaintiffs’ Minnesota action to continue. Concluding that defendants would be highly prejudiced if forced to continue litigation in another forum, the trial judge denied the plaintiffs' motion. Implicit in that reasoning was that the grant of summary judgment instead would have preclusive effect in the federal litigation. Indeed, the New York trial court specifically stated that defendants had a right to judgment on the merits.

Thus, at the summary judgment phase, the timeliness issues were “sufficiently close to the
merits” to implicate claim preclusion. Plaintiffs chose to bring their claims in New York and continued litigation up to summary judgment.

 

Democrats Release Discussion Draft of FDA Bill

Five Democratic Congressmen released a discussion draft of possible legislation that would alter the powers of the U.S. Food and Drug Administration.  The bill would increase FDA's authority and funding to regulate the importation of foreign-manufactured drugs, and also give the FDA the authority to mandate recalls for unsafe drugs.

Rep. John D. Dingell, Chairman Emeritus of the Energy and Commerce Committee, Rep. Henry A. Waxman, Chairman of the Energy and Commerce Committee, Rep. Frank Pallone, Chairman of the Subcommittee on Health, and Rep. Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, released a discussion draft proposal, which builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak last year.

The discussion draft calls for "parity" between foreign and domestic drug facility inspections, would increase the number of pre-approval drug inspections, and would prohibit the importation of drugs into the United States lacking appropriate documentation of safety.  The legislation would also require manufacturers to take steps to ensure the safety of their supply chain.

The sponsors noted that the byproduct of Internet communications and a rapidly-evolving international marketplace is an increase in the purchase of medications from foreign sources. Cong. Pallone claimed that, “One of the downsides is quality control and one of the dangers is the threat to the health and safety of consumers. We need to find the best ways to vest the FDA with the ability and the authority to ensure the safety of medications consumed by Americans.”

Cong. Waxman said he would work with the FDA "and all stakeholders to move this legislation forward as soon as possible." But the current Congress is heading home for the November elections, and the measure's fate is unclear if Republicans take control of the House next year.

State Supreme Court Upholds Verdict For Device Maker

The Connecticut Supreme Court recently took a second look at a case offering guidance on the application of the learned intermediary defense, and affirming a judgment for pacemaker manufacturer Medtronic Inc. See Hurley v. Heart Physicians PC, 298 Conn. 371, 2010 WL 3488962 (9/14/10).

The plaintiff was born with a congenital complete heart block condition that interfered with her heart's capacity to produce a safe heart rhythm. When she was seven days old, her physicians implanted a cardiac pacemaker manufactured by the defendant. Every few years, plaintiff received a new pacemaker manufactured by the defendant, allowing her to grow and live a normal life. When the plaintiff was fourteen years old, her pacemaker's elective replacement indicator signaled that the pacemaker battery was nearing the end of its life cycle and was wearing down. The plaintiff's cardiologist asked a representative of the defendant, to attend an examination of the plaintiff and to test the battery in her pacemaker. In so doing, in part because of issues about replacing the entire unit, the rep allegedly presented to the doctor the option of lowering the rate. He explained that, by taking the rate from sixty to forty paces per minute, it would give them more time before a device would hit the "end point," and thus more time to work on the "replacement situation."

The approach was taken, but a few weeks later the plaintiff went into cardiac arrest while at school, and allegedly suffered permanent brain damage.  Plaintiff sued, and the trial court granted summary judgment in favor of the device company on the failure to warn claim, based on the learned intermediary doctrine. The state supreme court reversed this judgment with respect to the plaintiff's product liability claim, finding that an issue of material fact existed as to whether the rep's words and actions were in derogation of the pacemaker's technical manual --whether he undercut the warning that was given. After remand, a jury trial was held, and the jury returned a verdict in favor of the defendant. The trial court rendered judgment in accordance with the verdict, and this (second) appeal followed.

The plaintiff's claim before the trial court (both times) was based on the assertion that the defendant's representative had made statements to plaintiff's treating physician, and had engaged in conduct (recommending that the pacemaker's function level be reduced), which nullified the warnings regarding battery replacement that were contained in the pacemaker's technical manual.  The plaintiff claimed that, because the statements and conduct nullified the pacemaker's adequate published warnings about the risks inherent in setting the pacemaker at a reduced level, the defendant had, net, failed to properly warn her of the potential risks associated with reducing the pacemaker's function in lieu of replacing the battery.  Defendant contended that the plaintiff's physician was a learned intermediary and stood in the best position to evaluate and to warn the plaintiff of any risks associated with reducing the pacemaker's function and, as a result, it was not their obligation to warn the plaintiff.

Concerning the trial after remand, plaintiff claimed that the trial court improperly required her to prove that the rep's advice and conduct “actually contradicted,” and therefore “vitiated” and “nullified” the warnings in the manual. She contended that she should have been required to prove only that his actions were “inconsistent” with the manual, which she contended was a less onerous requirement than the one applied by the trial court.

On appeal again, the state supreme court found that the trial court properly reviewed its mandate within the context of the entire opinion and proceeded properly with a jury trial in order to secure a factual finding by the jury as to whether the advice and conduct were in accordance with the pacemaker's manual. The trial court based the relevant jury charge and the jury interrogatory on the factual issue that it had determined could not be resolved as a matter of law. Indeed, the trial court carefully tracked the language used in the first appeal.  The relevant interrogatory asked the jury to determine whether “the [p]laintiff [has] proven by a fair preponderance of the evidence that [rep], by his oral communications to [doctor] that turning down the pacemaker was an option, accompanied by his physical adjustment of the pacemaker to forty paces per minute, actually contradicted the technical manual thereby vitiating and nullifying the manual's warnings....” 

The court disagreed with the plaintiff that the trial court imposed a heightened burden of proof because, first, the trial court directly cited what the supreme court had determined to be the remaining triable factual issue, and, second, the words “contradict” (used by the trial court)and “inconsistent”  (used by the supreme court) are interchangeable.  In this context, the words are synonymous, said the court.  No error in the instruction, so no reversal of the jury verdict.

 

Federal Appeals Court Vacates Third Party Payor Class Certification

A federal appeals court last week reversed an order by a district court certifying a class action of insurers, labor unions, and pension funds who alleged that they overpaid for a drug when the manufacturer allegedly didn't reveal all of the drug's adverse side effects. UFCW Local 1776, et al. v. Eli Lilly & Co., No. 09-0222 (2d Cir. 9/10/10).

Plaintiffs acted as third-party payors (TPP) who underwrite the purchase of prescription drugs by their members or insureds; they brought a putative class action against Eli Lilly, manufacturer of the drug Zyprexa, alleging that Lilly had misrepresented Zyprexa’s efficacy and side effects to physicians. The putative class alleged they paid for the many Zyprexa prescriptions. Plaintiffs argued that they were injured in two ways: first, by paying for Zyprexa prescriptions that would not have been issued but for the alleged misrepresentations; and second, by paying a higher price for Zyprexa than would have been charged, absent the alleged misrepresentations.

In a nearly 300-page opinion issued in  2008, Judge Jack Weinstein of the Eastern District of New York granted class certification to the third-party payors. Specifically, the district court certified a class of TPPs on RICO claims predicated on the overpricing theory of damages, but refused to certify a class related to state consumer protection law claims. The lower court concluded that the proposed TPP class presented common questions of law and fact because the “only difference among class third-party payors is how much of the total overcharge each shall receive in damages.” The lower court  had  addressed whether the losses suffered by the class could be established with sufficient precision, a huge issue in these kinds of cases, concluding that damages could be estimated based on the difference between what was paid for Zyprexa and the actual value of the product. The computation would supposedly require: (i) estimating the total out-of-pocket expenditures for the class members and (ii) using "well-accepted  techniques" in applied economics to determine the actual value or appropriate launch price of Zyprexa.

The district court also found that reliance could be proven for the class simply because the alleged fraud was “directed through mailings and otherwise at doctors who relied, causing damages in overpayments by plaintiffs.” This reliance, the district court concluded, could appropriately be shown by generalized proof, but without resort to the “fraud on the market” theory rejected in cases like McLaughlin v. Am. Tobacco Co., 522 F.3d 215 (2d Cir. 2008).

Defendant appealed.  The Second Circuit noted that to determine whether the proposed TPP class was properly certified, it had to consider whether substantial elements of the claim against Lilly may be established by generalized, rather than individualized, proof.  (Predominance of common or individual issues under Rule 23(b) was the focus.)  Even if the issue whether an act of marketing of the drug was in violation of RICO is considered common, Lilly disputed that the other elements required to recover damages – proof of an injury and proof that such injury was by reason of the RICO violation – were common to the proposed class.  To show injury by reason of a RICO violation, a plaintiff must demonstrate that the violation caused his injury in two senses. First, he must show that the RICO violation was the proximate cause of his injury, meaning there was a direct relationship between the plaintiff’s injury and the defendant’s injurious conduct. Second, he must show that the RICO violation was the but-for (or transactional) cause of his injury, meaning that but for the RICO violation, he would not have been injured.

Traditionally, to show causation in a fraud context, reliance needed to be shown. But in Bridge v.
Phoenix Bond & Indemnity Co
., 128 S. Ct. 2131, 2134 (2008), the Court lessened the emphasis on traditional reliance as an element of the RICO fraud claim to show causation in some cases.  But how a plaintiff can or must prove causation is bound up in what the factual claim is. The Bridge Court also said that in “most cases, the plaintiff will not be able to establish even but-for causation if no one relied on the misrepresentation.” 128 S.Ct. at 2144.  Here, while reliance may not be an element of the cause of action, there was no question that the plaintiffs alleged, and thus had to prove, third-party reliance as part of their factual chain of causation.  Plaintiffs alleged an injury that was caused by physicians relying on Lilly’s supposed misrepresentations and prescribing Zyprexa accordingly. Because reliance was a necessary part of the factual causation theory advanced by the plaintiffs, they had to show it to prevail, and show it by generalized proof if they wished to proceed in a class action.

The court of appeals concluded that plaintiffs’ excess price theory was not susceptible to generalized proof with respect to either but-for or proximate causation, and therefore class certification based on this theory was an abuse of discretion.

The evidence in the record made clear that prescribing doctors do not generally consider the price of a medication when deciding what to prescribe for an individual patient. Any reliance by doctors on alleged misrepresentations as to the efficacy and side effects of a drug, therefore, was not a but-for cause of the price that TPPs ultimately paid for each prescription.  Moreover, the TPP plaintiffs, who unlike the doctors were in a position to negotiate the prices of drugs in their formularies, were unable to show proximate causation.  The TPP plaintiffs drew an alleged chain of causation in which Lilly distributed misinformation about Zyprexa, physicians relied upon that misinformation and prescribed Zyprexa for their patients, and then the TPPs overpaid.  But this narrative skipped several crucial steps: after the doctors prescribe the drug, TPPs relying on the advice of Pharmacy Benefit Managers and their Pharmacy and Therapeutics Committees, placed Zyprexa on their formularies as approved drugs, and then TPPs failed to negotiate the price of Zyprexa below the level set by Lilly.  Thus, in this case, the conduct directly causing the harm was distinct from the conduct giving rise to the fraud. The plaintiff TPPs could not and did not allege that they themselves relied on Lilly’s alleged misrepresentations. But because only the TPPs were in a position to negotiate the price paid for Zyprexa, the only factual reliance that might show proximate causation with respect to price was reliance by the TPPs, not reliance by the doctors.

Since plaintiffs could not show the entire factual causal chain by generalized proof, individual issues would abound, and class certification was improper. The court of appeals also remanded for reconsideration of defendant's summary judgment motion in light of its ruling.

 

Third Circuit Rejects Medical Monitoring in Device Case

The Third Circuit has properly recognized that a claim for medical monitoring claim does not lie against the manufacturer of a medical device product. See M.G. v. A.I. DuPont Hospital for Children, No. 09-1426 (3d Cir., 8/24/10).

Readers may recall the post about this appeal last year.  Doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, had implanted a Cheatham Platinum stent (“CP stent”) in plaintiffs, who alleged that they had been injured or were at risk of injury from the use of the CP stent. After discovery, the trial court granted summary judgment to defendants on a number of the claims, but summary judgment was denied on Count VI, the medical monitoring claim. The trial court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action if presented with the facts of these cases.

The trial court recognized that there were substantial grounds for disagreement over whether Delaware will actually recognize a cause of action for medical monitoring. Even if the Delaware Supreme Court were to recognize a medical monitoring claim, there were substantial grounds for disagreement over whether plaintiffs here could state a claim. Plaintiffs' specific theory that medical devices can be the basis for a medical monitoring claim is novel, at best (and has been rejected in many states: Drugs and devices do not present the same policy issues as involuntary exposure to environmental toxins). The trial court was satisfied that plaintiff's novel theory here was one in which certification of an interlocutory order for appeal was appropriate.

The Third Circuit noted that plaintiff’s claim entitled “Medical Monitoring” contended that “[a]s a direct result of defendants’ acts, omissions, and conduct, plaintiffs . . . who have received NuMED CP stent have been exposed to a hazardous procedure and product, and suffered a significantly increased risk of the side effects caused by this device. This increased risk makes periodic diagnostic and medical examinations reasonable and necessary.”

While the district court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action, the appeals court didn't have to reach that broader question because it concluded that plaintiffs were unable to establish the elements necessary to state a claim for medical monitoring.

Defendants contended on appeal  that the trial court erred in extending Delaware law beyond the bounds of the recognized medical monitoring claim (in those minority of states that accept it) in which a plaintiff alleges long-term involuntary exposure to a proven toxic substance with known tendencies to produce serious future medical injuries. The Third Circuit agreed, finding no persuasive cases anywhere in which a free-standing medical monitoring claim has been allowed to proceed although the plaintiff has not demonstrated significant exposure to a toxic (poisonous) or proven hazardous substance. The lower court’s prediction that the Delaware Supreme Court would permit a claim for medical monitoring on this record thus requires several “leaps” from the current state of the law, generally, let alone Delaware law.

Specifically, here, there was no toxic or hazardous substance, as such. While unapproved devices are termed “adulterated”, they are not necessarily harmful, and certainly not toxic. Moreover, the risk here is not a risk of  “contracting a serious latent disease.” Rather, it is a risk of the need for further care. Further examinations are not to “monitor” the risk of disease, but to perform routine
oversight of the device. Thus, even if the Delaware Supreme Court would recognize a “standard” medical monitoring claim --one which requires a plaintiff to demonstrate that a defendant’s
negligence caused the plaintiff to be exposed to a proven hazardous substance that resulted in a significantly increased risk of contracting a serious latent disease -- the plaintiff here could not demonstrate that she had been exposed to a proven hazardous substance, nor could she prove that such exposure resulted in a significantly increased risk of contracting a serious latent disease.

Accordingly, the court found that plaintiff was unable to establish the elements necessary to make out a claim for medical monitoring.  Summary judgment should have been granted.

On a personal note, also on the winning brief was my former partner, the late R. Nicholas Gimbel, Esq., an outstanding advocate, in one of his last cases.  On the amicus brief for PLAC was my colleague James M. Beck, Esq.
 

State Court Misses Opportunity to End Unconstitutional Arrangements With Contingency Fee Counsel

The Pennsylvania Supreme Court this week missed an opportunity to protect the due process rights of companies facing litigation from the improper alliance of government officials and private contingency fee counsel.  See Commonwealth of Pennsylvania, Office of General Counsel v. Janssen Pharmaceutica, Inc., No. 24 EAP 2009 (Aug. 17, 2010).

Back in 2008, OGC filed a complaint against Janssen, raising various statutory and common law tort claims related to Risperdal, a prescription antipsychotic medication marketed by Janssen.
Instead of prosecuting the action itself, OGC had retained Bailey Perrin, a private law firm based in Houston, Texas, to prosecute the action on a contingent fee basis.  The Commonwealth’s retention of contingent fee private counsel in this matter raised significant issues including whether and when state law authorizes the Office of General Counsel to enter into a contingent fee contract with outside counsel; whether the Commonwealth’s hiring of outside litigation counsel on a contingent fee basis violates the state constitution, including the separation-of-powers mandate of the Pennsylvania Constitution; and whether the Commonwealth’s hiring of outside litigation counsel on a contingent fee basis violates the due process rights of the defendant company.

This case was an appeal of the trial court’s order denying the motion of appellant Janssen to disqualify contingent fee counsel retained by appellee, the Commonwealth’s Office of General Counsel (“OGC”). The Court took the case on a grant of extraordinary relief pursuant to 42 Pa.C.S.§ 726.

(Note: Just last month the California supreme court took a major step backward by modifying a 1985 decision that had properly limited the power of government agencies to retain private plaintiffs attorneys on a contingency fee basis to prosecute nuisance litigation.)

The majority never reached the merits, finding no standing and narrowly construing some of Janssen's arguments to get to that result. The Court focused on the threshold question of whether Janssen had standing to challenge Bailey Perrin’s representation of the OGC. The Court acknowledged that the OGC did not even argue statutory standing to the trial court, but then concluded that Janssen didn't argue that the standing issue was thereby waived.

Thus free to inquire, the Court found no standing, and then made "clear that the standing question we are asked to decide is one of statutory interpretation" only, under the Commonwealth's Attorneys Act, which allegedly gave the OGC authority to retain outside counsel. But Janssen argued that it also had standing to move to disqualify Bailey Perrin because nothing in the Attorneys Act prevents a litigant from challenging OGC’s unconstitutional usurpation of the General Assembly’s spending powers, or from litigating due process claims deriving from the Commonwealth’s retention of private contingent fee counsel.

Indeed, Justice Saylor stated in his Dissenting Opinion that he would apply traditional standing principles; that the Constitution is obviously the supreme law of the land that cannot be trumped by a statute; and that, therefore, Janssen’s constitutional claims may not be barred by the standing limitations of the statute.

The majority dismissed that by asserting that, under the theory Justice Saylor proposed, application of the standing restriction in the Commonwealth Attorneys Act to limit standing here would be unconstitutional. But Janssen never argued that traditional standing analysis should apply, says the majority. So, while Justice Saylor has formed "a cogent argument concerning traditional standing and the constitutionality" of the act, it is not the argument the majority perceived to be advanced by Janssen. The majority refused to read Janssen’s challenge as involving a constitutional challenge to the statutory standing limitation, with a consequent resort to traditional standing principles.

That may leave the door open for defendants in a future case who are victims of the unchecked alliance of elected officials and private contingency fee plaintiff lawyers, who are not elected and have their own separate interests. 

The legal policy of many states strongly favors open, competitive bidding for contracts involving state funds. Such requirements, included in some state Constitutions and various statutes, are designed to prevent fraud, eliminate bias and favoritism, and thus protect vital public interests. Those same goals of open and good government reside in the requirement that state officials give their undivided loyalty to the people of a state.  Many of the contingent fee contracts used by state officials to bring mass tort actions violate the core principle that attorneys pursuing actions on behalf of the state represent a sovereign whose obligation to govern impartially is essential to its right to govern. Government attorneys must exercise independent judgment as a ministers of justice and not act simply as advocates. The impartiality required of government lawyers cannot be met where the private pecuniary interest inherent in the contingent fee is the primary motive force behind the bringing of the action. By turning over sovereign prosecutorial-like power to contingency counsel, a state effectively creates a new branch of government – motivated by the prospect of private gain rather than the pursuit of justice or the public welfare.

This subversion of neutrality does more than implicate the due process rights of those confronting such tainted prosecutions. Direction of state prosecutions by financially interested surrogates also damages the very public interest that such litigation is supposed to advance. Here, the allegations of the complaint were crafted more for the pecuniary goals of counsel than for the needs of the patients served by the allegedly affected state programs. 

[Your faithful blogger was able to contribute to the amicus brief of the Washington Legal Foundation, the public interest law and policy center, in this matter.]
 

Appeals Court Vacates Verdict On Exclusion of Context Evidence

Comic Dimitri Martin notes, "I'm sorry" and "I apologize" mean the same thing -- unless you are speaking to the widow at a funeral.  The lesson? Context is key.

The New Jersey appeals court last week vacated a jury verdict for a woman who used the acne drug Accutane and allegedly developed inflammatory bowel disease (IBD).  See Kendall v. Hoffmann-LaRoche Inc.,No. A-2633-08T3 (N.J. Super. Ct.,  8/5/10). The court found that the trial court erred by restricting the defendant's use of evidence concerning the incidence of IBD in the general population to set a proper context.

Readers know that defendants frequently want to put evidence in a fuller context and give the jury a full picture.  Plaintiffs seem much less concerned that a jury will take evidence (a word in an email, a phrase in a memo, a point of data) out of context.

Some background- In 1982 the Food and Drug Administration approved the use of Accutane to treat recalcitrant nodular acne. Patients using Accutane have reported a number of common side effects. The alleged side effect that was centrally at issue in this case was the alleged propensity of Accutane to cause patients to suffer from inflammatory bowel disease. The exact scientific causes of IBD have not been conclusively established, said the court. IBD has been statistically associated with several factors, including family history, prior infections, frequent use of antibiotics, and possibly the use of contraceptives and nonsteroidal anti-inflammatory drugs.

Plaintiff underwent several courses of treatment. She had taken four courses of Accutane before she developed IBD, with no apparent gastrointestinal effects. Her medical records indicated that plaintiff's mother informed the treating physician that plaintiff had been diagnosed with an IBD, and that disease "has nothing to do with her Accutane use, according to her G.I. doctors."  Plaintiff took two courses of Accutane after she developed IBD, with "no evidence of exacerbation" of the
IBD.  But in early 2005, plaintiff suffered from excessive diarrhea, bowel incontinence, bloody diarrhea, fatigue, cramping, and abdominal pain. As 2005 progressed, plaintiff's symptoms
worsened, leading to surgery.

Plaintiff contends that if she had been warned that Accutane use could cause, or exacerbate, her IBD, she would not have taken the drug. She alleged that there was no specific reference to IBD, or that Accutane use could cause IBD, in any of the materials she personally received from 1997 to 2003.  However, prior to the use of Accutane by plaintiff, defendant revised the various warnings that it supplied concerning the drug. Roche amended the "WARNINGS" section of the Accutane package insert provided to physicians to include language about Inflammatory Bowel Disease.  In a "Dear Doctor" letter, dated August 1998, which was sent to board-certified dermatologists, Roche warned that patients taking Accutane should be monitored for IBD. Roche subsequently revised its product warnings for Accutane, with FDA approval, in 2000 and again in 2002. Plaintiff's expert opined, not surprisingly, that even the amended warnings contained in the later label were inadequate.

The appeal presented several issues, including statute of limitations, but for our readers we want to focus on the argument that the trial court abused its discretion in preventing Roche from adducing evidence as to the number of Accutane users and in limiting Roche's arguments to the jury concerning such data.

In opening, in her trial proofs, and in her counsel's closing arguments to the jury, plaintiff relied heavily upon the number of adverse case reports for Accutane and other quantitative evidence as
proof of at least two critical issues: (1) that a patient's use of Accutane can cause IBD and other gastrointestinal problems, and (2) that Roche allegedly acted too slowly and ineffectively in
responding to those risks with more forceful product warnings. Roche contended that the trial court unfairly curtailed its ability at trial to defend that numbers-oriented evidence and advocacy.

Prior to the trial in this case, plaintiff moved to bar defense counsel from presenting certain proofs and arguments concerning the background incident rates of IBD in the general population. That makes complete sense; how often do people get the disease when they aren't exposed? But, in
essence, plaintiff argued those general background rates are unreliable because symptoms of IBD are allegedly frequently under-reported.  The trial court agreed and precluded Roche from referring at trial to the background rates of IBD in the general population to disprove causation. The order did allow Roche only to present "factual testimony" to show that it acted reasonably based on such background rates, and only if "the numbers are not told to the jury."  The trial court did not, however, impose any restrictions upon plaintiff in her own use of numerical proofs at trial, other than a restriction against using the numbers in a specific formula.

Thus, during opening statements, plaintiff's counsel noted that she would present proof that Roche was aware of at least 104 reported cases of IBD, of which thirty-three cases were supposedly given a causality rating of possible or probable by the company. Plaintiff's counsel also cited in opening argument to an internal Roche report supposedly stating that, in 2002, there had been sixty-four reports of Crohn's disease (BTW, a form of IBD with no epidemiological link to the drug in any reputable study).  The trial court ruled that Roche could not argue that a comparison of those AERs vs. the background rate was a scientifically valid way to help evaluate the risk of a drug. Defendant was also curtailed in cross-examination of plaintiff's labeling expert,  particularly with regard to how Roche had analyzed certain data on Accutane that it had in fact presented to the FDA.

During the defense case in chief, the trial court did loosen her ruling and did permit a defense expert to explain to the jury that, in calculating the number of IBD cases in the exposed population, Roche had assessed the reported adverse events. Because it was suspected such events are under-reported, Roche already  factored in under-reporting. In calendar year 1988, when approximately one million patients took Accutane, there were only seven reports of IBD. From 1982 to 1999, when more than 32 million patients took the drug, there were only 206 case reports of IBD.

(Readers know that an adverse event report does not establish a causal relationship between the drug and a particular event. The FDA itself has warned that for any given ADE case, there is no certainty that the suspected drug caused the event. This is because physicians and consumers are encouraged to report all suspected ADEs, not just those that are known or even suspected to be caused by the drug. The adverse event may have been related to an underlying disease for which the drug was given, to other concomitant drug usage, or may have occurred by chance at the same time the suspect drug was administered. The courts have characterized ADEs as “complaints called in by product consumers without any medical controls or scientific assessment.” McClain v. Metabolife Intern., Inc., 401 F. 3d 1233, 1250 (11th Cir. 2005). Because the reporting system is not subject to scientific controls, data from it is subject to various statistical biases. It is likely that the mix of reported events does not represent an accurate sampling of those events that can occur while a person is taking any medication. Moreover, medical or media attention can stimulate reporting in a distorted manner, and known adverse reactions are more likely to be diagnosed and reported than others. See DeLuca v. Merrell Dow Pharmaceuticals, Inc., 791 F. Supp. 1042, 1050 (D. N.J. 1992), aff’d 6 F. 3d 778 (3d Cir. 1993), cert. denied, 510 U.S. 1044 (1994) (ADEs “have inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions.”).)

However, the trial court here gave the jury a limiting instruction on this evidence that defendant on appeal argued was especially harmful, by accentuating to the jurors that Roche's internal corporate use of background numbers was supposedly, at least in some respects, "unscientific."  Defendant argued that the trial court's directive to the jurors that at least one use of the background numbers was not "scientifically accepted," placed a prejudicial and unnecessary spin on the proofs, to Roche's detriment.

The appellate court concluded it lacked confidence that this trial, when considered as a whole, provided a full and fair opportunity for Roche to contest, present, and advocate the relevant "numbers" evidence. Specifically, the trial court erred in forbidding Roche from placing into
evidence (and arguing) statistics about Accutane usage that could have made Roche's conduct and labeling decisions appear far more reasonable to the jury. The number of users evidence  could have given the jurors very relevant contextual background, and possibly led the jury to view differently Roche's pacing in upgrading the risk information on Accutane's label and package insert.  Even accepting, for the sake of argument, plaintiff's contention that adverse events are heavily under-reported, the quantity of actual users of a drug logically is a significant part of the
numerical landscape. At a minimum, the actual usage data for Accutane would go to "safety signaling" concerns, i.e., whether Roche had received sufficiently frequent adverse "signals" to take corrective action. Had Roche been allowed to fully present the statistics on users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's conduct in changing its label. See McCarrell v. Hoffman-La Roche, Inc., No. A-3280-07 (App. Div. Mar. 12, 2009), certif. denied, 199 N.J. 518 (2009).

The court recognized that the trial court's attempted conceptual boundary between using background data for purposes of evaluating "signals" and company conduct, but not for "causation," is a technical and somewhat elusive distinction. Increased reports of a medical condition occurring in a drug's users, as contrasted with the general population, may well provoke a drug maker to strengthen its labeling, even if such adverse reports may suggest only an association and not that the product is, in fact, "causing" such adverse results. In any event, the court of appeals felt there was no need here to draw the boundaries between causation and conduct with precision or with definiteness. The point remains that, even accepting, arguendo, as reasonable the trial court's prohibition upon Roche using background numbers to disprove causation (because of a concern about reporting), the trial as a whole did not provide Roche with a sufficient opportunity to make full and legitimate uses of such contextual evidence as part of its trial advocacy.  In particular, the jury instruction issued by the court went too far in characterizing to the jurors the use of background numbers to prove or disprove causation as "unscientific."

The case was remanded for a new trial.  And on remand, the defense will not be foreclosed from attempting to use the numbers evidence to show not only that the company acted reasonably in the manner in which it developed and modified the Accutane product warnings, but also to attempt (if it chooses to do so) to disprove general causation (along with the multiple epidemiological studies refuting causation).

Roche has successfully defended IBD claims in the federal cases brought to date, obtaining dismissals in each case that have been affirmed on appeal by the United States Court of Appeals for the Eleventh Circuit.

 

Failure to Warn Even When You Warn? Court Rejects Plaintiff's Theory

One of the fascinating and disturbing things about failure to warn claims is the endless supply of creative, far-fetched, fantastic, implausible, fanciful, incredible, questionable, even bizarre theories that plaintiff lawyers sometimes come up with to support this type of claim.

Last week, a Pennsylvania appeals court rejected just such a theory. Specifically, plaintiff alleged that a failure to warn caused her injury -- nothing strange there.  But the manufacturer DID warn specifically of the condition she developed.  So, what was the plaintiff's failure to warn theory?  That a drug maker may be liable for failure to warn despite warning of the condition plaintiff developed, because a warning about a different medical issue —one that she did not develop— would somehow have caused her doctor to not prescribe the drug.  Cochran v. Wyeth Inc., 2010 WL 2902717 (Pa. Super. Ct., 7/27/10).

Plaintiff ingested the prescription weight-loss drug dexfenfluramine, which was manufactured by Wyeth and sold under the brand name Redux. Wyeth informed the prescriber that Redux may cause primary pulmonary hypertension (“PPH”). The doctor, in turn, warned plaintiff of the risk of PPH prior to prescribing her Redux. At the time of his decision, however, the prescriber claimed he was unaware of the risk that Redux may cause valvular heart disease (“VHD”).  Later, plaintiff was diagnosed with PPH, which she had been warned about.  But she claimed that the doctor would not have prescribed Redux to her had he been warned that Redux could cause VHD.

Proximate cause is an essential element in a failure to warn case.  A proximate, or legal cause, is defined under Pennsylvania law as a substantial contributing factor in bringing about the harm in question. That is, a plaintiff must establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.   Wyeth argued that even if its warnings with regard to VHD were inadequate, its failure to warn of VHD was not the proximate cause of plaintiff's PPH.  To establish proximate causation, plaintiff must prove that the warnings failed to disclose the risk of her particular injury (PPH).

The trial court agreed. On appeal, the court found an absence of clear authority on the issue, but strong guidance in those cases that have addressed a plaintiff's burden of proving proximate causation in the informed consent context.  Finding the torts of informed consent and failure to warn analogous, the superior court was persuaded by those jurisdictions that have concluded a plaintiff cannot establish proximate causation where the non-disclosed risk never materialized into an injury.

Here, the risk of VHD did not develop into the actual injury of VHD. Although the prescriber testified in deposition that he would not have prescribed Redux had he known of the risk of VHD, this does not alter the fact that while Wyeth allegedly failed to disclose the risk of VHD the plaintiff suffered from PPH. In these circumstances, the relationship between the legal wrong (the alleged failure to disclose the risk of VHD) and the injury (PPH) was  "not directly correlative and is too remote" for proximate causation.

Summary judgment for defendant affirmed.

 

Court Rebuffs Forum Shopping - But Shoppers Get Bargain Anyway?

A federal court recently ordered the transfer of an action involving an allegedly defective pain pump from Minnesota to plaintiffs' home state of North Carolina, in an apparent rebuff of attempted forum-shopping. Powell v. I-Flow Corp., No. 10-1984 (D. Minn. 7/14/10).

This case is one of thousands of product liability actions filed in recent years in the District of Minnesota by plaintiffs who have no connection to Minnesota against defendants who have no connection to Minnesota regarding events that did not occur in Minnesota and that had
no impact within Minnesota.  Here, defendants are  Delaware corporations with their principal places of business in California. Plaintiff underwent shoulder surgery in North Carolina in 2001, and he and his wife sued defendants for damage to his joint that allegedly resulted from the treatment of his post-surgical pain with a pain pump made by the defendants. In short, this case had no discernible connection to Minnesota.

Presumably the plaintiffs did not file this action in North Carolina — where they live,
where the pain pump was implanted, and where plaintiffs' alleged injuries occurred —
because it is too late to sue the defendants there.  Indeed, observed the court, the vast majority of these kinds of unconnected actions have been filed in this district because, if they were filed by the plaintiffs in their home states (or almost anywhere else), they would be dismissed under the applicable statutes of limitations. The Minnesota Legislature has, however, enacted unusually long statutes of limitations, and the state court has applied them to cases such as this.  See Fleeger v. Wyeth, 771 N.W.2d 524, 525 (Minn. 2009).

The federal court noted that such forum shopping imposes heavy burdens on the District Court and
diverts the court’s limited resources away from litigants and cases that have much stronger
connections to the District of Minnesota.

Defendants moved to transfer. Section 1404(a) provides: “For the convenience of parties and
witnesses, in the interest of justice, a district court may transfer any civil action to any other
district or division where it might have been brought.” 28 U.S.C. § 1404(a). Deciding whether
to order a transfer under § 1404(a) requires a case-by-case evaluation of the particular
circumstances at hand and a consideration of all relevant factors. See Terra Int’l, Inc. v. Miss.
Chem. Corp.
, 119 F.3d 688, 691 (8th Cir. 1997). The relevant factors fall generally into three
categories: (1) the convenience of the parties; (2) the convenience of the witnesses; and (3) the
interests of justice.

All these factors, said the court, overwhelmingly favor transfer. Because none of the parties is located in Minnesota, none of the relevant events occurred in Minnesota, none of the alleged injuries has been suffered in Minnesota, and none of the evidence is present in Minnesota, Minnesota does not appear to be convenient for anyone — including the Powells, who live in North Carolina.  In fact, any state with any connection to this lawsuit would be more convenient than Minnesota.  It is true that, as a general rule, courts afford some deference to a plaintiff’s
choice of forum; but this deference “is based on an assumption that the plaintiff’s choice of forum will be a convenient one.” In re Apple, Inc., 602 F.3d 909, 913 (8th Cir. 2010). When that assumption does not hold — when, as here, the plaintiff has chosen an inconvenient forum — the plaintiff’s choice of forum fades in importance.

The plaintiffs also argued that keeping all of the pain-pump cases like this one in Minnesota would further the interests of justice because the cases could be litigated more efficiently if they were all
litigated in the same district. But by this logic, plaintiffs’ lawyers could routinely force a “de facto” MDL on a district simply by filing enough similar cases in that district. This would allow plaintiffs’ lawyers to sidestep the MDL process — the very mechanism that federal courts have implemented for handling mass-tort actions.  In fact, the JPML has twice declined to consolidate pain-pump cases into an MDL. See In re Ambulatory Pain Pump-Chondrolysis Prods. Liab. Litig., MDL No. 2139, 2010 WL 1790214 (JPML May 5, 2010); In re Shoulder Pain Pump-Chondrolysis Prods. Liab. Litig., 571 F. Supp. 2d 1367 (JPML 2008).

One interesting tidbit, even though transferred, because the plaintiffs originally filed suit in Minnesota, the Minnesota statutes of limitations may travel with this case.  That is, if, under Minnesota’s choice-of-law rules, the Powells are entitled to the benefit of Minnesota’s statute of limitations, they may retain that benefit in the Eastern District of North Carolina. See Ferens v. John Deere Co., 494 U.S. 516, 523 (1990) ( § 1404(a) transfer does not change the law applicable in a diversity case); Eggleton v. Plasser & Theurer Export Von Bahnbaumaschinen Gesellschaft, MBH, 495 F.3d 582, 586 (8th Cir. 2007) (after a § 1404(a) transfer, “the transferee court applies the
choice-of-law rules of the state in which the transferor court sits”).  Thus, it may have been a rewarding shopping trip.

Lone Pine Ruling Affirmed in Vioxx

The Sergeant Joe Friday character on Dragnet was created and played by actor Jack Webb.  Like so many famous lines, the immortal words, "Just the facts, ma'am," were apparently never uttered by the character.  What Friday actually said in early episodes is "All we want are the facts, ma'am."  

Either way, that's our motto when we post about litigation the firm has been involved in.  But with that limitation, a noteworthy decision is In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010).

After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement (MSA).  PTO 28 required non-settling plaintiffs to notify their healthcare providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply could result in dismissal of the plaintiffs' claims with prejudice.

PTO 28 is characterized as a Lone Pine order, named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986). Lone Pine orders are designed to handle the complex issues and potential burdens on the aprties and the court in mass tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).

The trial court extended deadlines, but eventually defendant Merck moved for an Order to Show Cause as to sixty-one plaintiffs for alleged failure to provide a case-specific expert report as required by PTO 28. The plaintiffs filed responses, arguing that they were in substantial compliance with PTO 28 and that state substantive law only required general forms of causation proof. In April 2009, the district court dismissed these plaintiffs' complaints with prejudice for failure to comply with PTO 28.

A district court's adoption of a Lone Pine order and decision to dismiss a case for failing to comply with a Lone Pine order are reviewed for abuse of discretion. Acuna, 200 F.3d at 340-41. The district court stated that “it is not too much to ask a plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury.”

The court of appeals had previously held that such orders are issued under the wide discretion afforded district judges over the management of discovery under Federal Rule 16. The court had held that the Lone Pine orders essentially required information which plaintiffs should have had before filing their claims pursuant to Rule 11.  Each plaintiff should have at least some information regarding the nature of his injuries, the circumstances under which he could have been exposed to harmful substances, and the basis for believing that the named defendants were responsible for his injuries.

The Fifth Circuit reaffirmed its view that it is within a trial court's discretion to take steps to manage the complex and potentially very burdensome discovery that these mass tort cases would require. The court of appeals thus affirmed the judgment of the district court.
 

Supreme Court Passes On Chance to Clarify Punitive Damages Issue

We posted before about an important punitive damages issue, hoping the Supreme Court would take a look.  However, last week the Court declined to review the federal appeals court decision ordering a re-trial on punitive damages. Wyeth LLC v. Scroggin, U.S., No. 09-1123, review denied 6/21/10.

The case involves a woman who allegedly developed cancer after taking hormone therapy drugs. (The FDA continues to approve the drugs as safe and effective.) The plaintiff contended that Wyeth was negligent in failing to include a stronger warning on its label, and that she would not have taken the drug if the warning had been stronger. The district court conducted a bifurcated trial
before a single jury, with liability determined first and punitive damages determined second. In the first phase, the jury found for plaintiff and awarded $2.7 million in compensatory damages. In the second phase, the same jury determined that defendant was liable for punitive damages of $19.4 million. Wyeth LLC v. Scroggin, 554 F.Supp.2d 571 (E.D. Ark. 2008). On appeal, the U.S. Court of Appeals for the Eighth Circuit overturned the punitive damages award, ruling that the award was tainted by the admission of improper evidence during the punitive damages phase of the trial. But rather than ordering an entirely new trial, the appeals court ordered a partial new trial limited to punitive damages only. Scroggin v. Wyeth, 586 F.3d 547 (8th Cir.2009).

We would argue that the Seventh Amendment prohibits such partial retrials limited to punitive damages. The Seventh Amendment “right to trial by jury” has long been understood to constitute those jury trial rights that existed under the English common law when the Seventh Amendment was adopted in 1791. At common law there was no practice of setting aside a verdict in part. If the verdict was erroneous as to any issue, a new trial was directed as to all issues, so that all related issues could be decided by a single jury. Where the issue to be re-tried is related to issues already decided by the first jury, partial re-trials create a danger that the second jury will be confused when told that some issues have already been decided. Moreover, there is considerable empirical evidence suggesting that permitting partial re-trials regarding punitive damages exacerbates the unpredictability of punitive damages awards.

Chief Justice John G. Roberts Jr. took no part in the consideration or decision of the petition.
 

Court of Appeals Rejects Consumer Fraud Class Action for Pet Medication

The First Circuit affirmed last week the lower court's dismissal of a putative consumer fraud class action involving a re-called heartworm medication for dogs. Rule v. Ford Dodge Animal Health Inc., 2010 WL 2179794 (1st Cir. 6/2/10).

Plaintiff, Rule, purchased two doses of ProHeart 6, a medicine for preventing heartworm in dogs, and had them administered to her dog Luke. She later filed a putative class action against Wyeth, alleging that defendant had sold ProHeart 6 without disclosing safety concerns revealed in initial testing and in subsequent use.  She alleged these concerns ultimately led Wyeth to recall the product at the FDA's request. According to plaintiff, adverse reactions were suffered by dogs after receiving ProHeart 6 during trials and in general use after the product was released. Importantly, the class representative conceded that Luke had not suffered any harm from the drug, and that Luke had not developed heartworm while using the drug.

Plaintiff's first cause of action was based on breach of the implied warranty of merchantability and the other based on the state consumer fraud statute, Mass. Gen. Laws ch. 93A. For damages on these two counts, Rule asserted that she and others similarly situated were entitled to the difference between the price they actually paid for ProHeart 6 and what it would have been worth had safety risks been adequately disclosed; for the chapter 93A count, she sought statutory damages if greater than actual damages and also trebling of damages. 

On the warranty count, the alleged unmerchantability (unfitness for ordinary use) of ProHeart 6 lay in its potential for causing harm to a dog. Rule conceded, however, that neither of the two doses injured Luke. So, while the sale to Rule may have been of an "unfit" drug, its unfitness did not give rise to any injury to Rule against which the warranty was designed to guard. Nor did she suggest that Luke became more susceptible to injury, as might be the case where one bought and installed a defective car tire that has not yet run its life. Recovery generally is not available under the warranty of merchantability where the defect that made the product unfit caused no injury to the claimant, the threat is gone, and nothing now possessed by the claimant has been lessened in value.

On the consumer fraud count, the act provides a cause of action for a plaintiff who has been injured by unfair or deceptive acts or practices. In Rule's view, she purchased Proheart 6 because of a deception (failure to disclose the risk), the product was “in reality” worth less than she paid for it (because of that undisclosed risk), and so she suffered damage measured by the difference between what she paid and what she would have paid if the risk had been disclosed. One problem with plaintiff's scenario was that she also alleged that had the risks been known, ProHeart 6 could not be sold at all, given FDA requirements.

But even assuming otherwise, Rule's suit was brought after her purchases and use of the drug, and she admitted that she got both the protection and convenience she sought and that the risk did not manifest itself in injury to her or her dog. Nor was she still holding a product that was worth less than she paid for it; she used the product up entirely and in fact suffered no economic injury at all. Indeed, her theory would not be adopted by deceived buyers whose dogs were actually injured or killed; they could seek not some modest reduction in price but the full cost of added veterinary bills and, if the dog died, its value.

So to the extent chapter 93A injury requires that a plaintiff who seeks to recover show “real” economic damages, Rule did not qualify. If, instead, a different notion of injury had sufficed - such as injury as a violation of some abstract “right” like the right not to be subject to a deceptive act that happened to cause no economic harm - then she would arguably have had a claim under chapter 93A and perhaps could obtain statutory damages.  The First Circuit observed some "tension" in the language used as between the earlier and the later state SJC decisions on the statute and especially where deception and risk are involved. However, said the court of appeals, the most recent SJC cases on point appear to have reaffirmed the notion that injury under chapter 93A means economic injury in the traditional sense.

Finally, the First Circuit addressed plaintiffs' typical policy-based argument that deceptive conduct needs to be deterred through a class action. While the alleged conduct such as that attributed to defendant needs to be deterred, that need not necessarily come from those who bought the product but were not injured.  It could be deterred by those with actual injury.
 

Digitek Class Action Denied in MDL

The federal judge in the multidistrict litigation concerning the heart drug Digitek has denied class certification in the MDL's six remaining class actions.  In re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W. Va.).

Quick history. Digitek® is a trade-name for a drug called digoxin. Digoxin was approved by the FDA to treat various heart problems. At some point, a handful of non-conforming dose tablets were found in a lot of 4.8 million tablets.  Defendant initiated a voluntary Class I nationwide product recall.  A flood of civil actions were instituted in state and federal courts across the country. The plaintiffs claimed a variety of injuries and losses resulting from the recalled Digitek®. In 2008, the Judicial Panel on Multidistrict Litigation established an MDL proceeding.

The MDL court addressed several overlapping motions for class certification. The class representatives each sought some kind of economic loss class certified pursuant to Federal Rule of Civil Procedure 23. Two of the class complaints sought only a single-state class. Others sought a nationwide class of all persons residing in the United States who purchased Digitek® pursuant to prescription, during the time period when the recalled Digitek® was manufactured, or sold, who suffered economic losses, including, but not limited to, payments for recalled Digitek®, out-of-pocket expenses for diagnostic testing, medical visits, and/or new prescriptions, as a result of having received recalled Digitek®.

Generally, the plaintiffs focused not on the distinct and highly individualized alleged injuries to the class, but -- as is typical -- on defendants’ alleged misconduct that led to the recall.  In doing so, the plaintiffs tried to paint New Jersey as the nerve center for certification purposes. In fact, they said New Jersey law should control all of the potentially hundreds of thousands of class members’ claims and recoveries throughout the United States. They thus downplayed the individual issues that would arise, including choice of law. They stressed instead that the damages  allegedly suffered by each individual class member were modest and, absent a certified class, millions of consumers would be left without remedy.

The court first addressed the choice of law issues in a nationwide class, as the state in which each claimant was injured has an overriding interest in having its laws applied to redress any wrong done to its citizens.  For example, state consumer protection laws vary considerably, and courts must respect these differences rather than just apply one state's law to sales in other states with different rules.  In re St. Jude Medical, Inc., 425 F.3d 1116, 1120 (8th Cir. 2005).  See generally Kanner, Consumer Class Actions After CAFA, 56 Drake L. Rev. 303, 334 (2008).  Unjust enrichment law varies considerably throughout the United States as well.  Tyler v. Alltel Corp., 265 F.R.D. 415, 422 (E.D. Ark. 2010).  The court reached the same conclusion with the express and implied warranty claims.  See, e.g., Walsh v. Ford Motor Co., 807 F.2d 1000, 1016-17 (D.C. Cir.1986).  The differences impact the class certification factors of typicality, predominance, and manageability.

Putting aside the choice of law issue (that is, assuming a class of New Jersey residents alone and applying only New Jersey law to their claims), the court found that common issues still did not predominate. Violation of the NJ Consumer Fraud Act is subject to proof of a number of
elements, including that plaintiff suffered an ascertainable loss as a result of the unlawful conduct; and a causal relationship between the unlawful practice and the loss sustained.  That is, the New Jersey Consumer Fraud Act affords a right to monetary relief only if there has been an  ascertainable loss in consequence of the consumer receiving something other than what he bargained for, and losing the benefits of the product which he was led to believe he had purchased.  Plaintiffs' contention here that everyone in the class sustained an ascertainable loss presumes that the drug was worthless. But the drug was enormously beneficial to many patients; most got the right dose. Those patients presumably got their money's worth and suffered no economic injury. And the question whether an individual class member got his or her money's worth is inherently individual. Indeed, it involves very much the same questions as would a claim for money damages for personal injury.

This was seen in the differences between the class representatives: one returned Digitek® following the recall. But he received, in return, replacement digoxin at no charge. Another wanted a co-payment for a doctor visit that he had post-recall. He admitted, though, that the appointment was scheduled pre-recall. If certification were granted, this type of fact-intensive investigation and specific explanation would likely be necessary for all claimants to assure that their claims were compensation worthy.

The individual questions also proliferate to the extent the jury is ultimately required to determine which class members received defective Digitek® and which did not. In other words, it may ultimately be inappropriate, said the court, to treat all the recalled Digitek® as a single “defective” product for purposes of making the determination of whether it was unsafe.  Thus product identification would have individual, as opposed to collective, hallmarks.

Another individual issue was the vast array of individualized damages the representatives were seeking. The plaintiffs tried to sweep this concern aside. But even if not controlling,  individualized damage determinations cut against class certification under Rule 23(b)(3).  Ward v.
Dixie Nat. Life Ins. Co.
, 595 F.3d 164, 180 (4th Cir. 2010).

Finally, the court confronted the individualized process of sorting out those potential class members who were already fully compensated by the defendants' refund process. Mitigation was  another highly individualized matter.  Certification appropriately denied. 

Expert on "Ethics" Rejected in Device MDL

The federal court overseeing the MDL concerning an allegedly defective stress urinary incontinence device has issued a number of rulings on defendant Mentor Corp.'s motions to exclude various plaintiff experts. The one we want to focus our readers on is the order granting the company's motion to exclude the testimony of a so-called "business ethicist," who was proffered to testify about the supposed inappropriateness of Mentor's conduct relating to the warnings about the ObTape device.  In re Mentor Corp. ObTape TransObdurator Sling Prods. Liab. Litig., 2010 WL 1727828 (M.D. Ga. Apr. 27, 2010).

Mentor developed a device called ObTape Transobturator Tape (“ObTape”), which was used to treat women with stress urinary incontinence. Plaintiffs contended that the allegedly defective design of ObTape caused complications that resulted in significant injuries, including serious infections and erosion of the tape. Of course, every ObTape package included an FDA-approved Product Insert Data Sheet which listed vaginal erosion, urethral erosion, and infection as possible complications associated with ObTape. The Judicial Panel on Multidistrict Litigation transferred the several federal products liability cases to the Middle District of Georgia in 2008. Ahead of the upcoming trials in the bellwether cases, both parties filed various motions in limine to exclude the other's expert  witnesses.

Plaintiffs intended to offer Professor Ann Buchholtz, Ph.D., as an "ethics" expert. Prof. Buchholtz proposed to opine about defendant's alleged ethical duty to protect the safety of patients and its ethical duty to provide information to physicians and patients. Specifically, she asserted, based on a review of selected internal Mentor documents, that certain information about ObTape should have been reported to the FDA and to physicians and patients. Mentor contended that Prof. Buchholtz’s ethics opinions should not be permitted because (1) the opinions would not assist the jury, (2) the opinions are unreliable, and (3) Prof. Buchholtz is not qualified to render the opinions.

For an expert’s testimony to “assist” the trier of fact, the evidence must have a valid scientific connection to the disputed facts in the case. A court may exclude expert testimony that is imprecise and unspecific, or whose factual basis is not adequately explained. Cook ex rel. Tessier v. Sheriff of Monroe County, Fla., 402 F.3d 1092, 1111 (11th Cir. 2005).  Expert testimony is generally only admissible if it concerns matters that are beyond the understanding of the average lay person. Proffered expert testimony generally will not help the trier of fact when it offers nothing more than what lawyers for the parties can argue in closing arguments.

And that is the precise problem with so-called business ethics experts who testify merely to highlight plaintiff counsel's interpretation of cherry-picked internal documents; to testify as to ethical standards that are not legal standards at issue in the case; to invade the province of the jury by substituting the witness' conclusions about the appropriateness of the defendant's conduct; and to work the jury into a lather with a subjective, supposedly expert view of that conduct. See generally In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531 (S.D.N.Y. 2004). Personal views on corporate ethics and morality are not expert opinions. See In re: Diet Drugs Prod. Liab. Litig., 2001 WL 454586 at *9 (E.D.Pa. Feb. 1, 2001); see also In re Trasylol Products Liab. Litig., MDL-1928, 2010 WL 1489793 (S.D.Fla.Feb. 24, 2010).  Expert testimony about a company's "intent" is merely conjecture based on the expert's impressions of the physical evidence, and must be excluded as not based on any reliable methodology or scientific principle. J.B. Hunt Transport, Inc. v. Gen. Motors Corp., 243 F.3d 441, 444-45 (8th Cir.2001); In re Baycol Products Litigation, 532 F.Supp.2d 1029.  Similarly, an expert cannot be presented to the jury solely for the purpose of constructing a factual narrative based upon record evidence.  In re Diet Drugs Prods. Liab. Litig., MDL No. 1203, 2000 WL 876900, at *9 (E.D.Pa. June 20, 2000); see also In re Fosamax Products Liab. Litig., MDL 1789, 645 F.Supp.2d 164 (S.D.N.Y.July 27, 2009).

Here, the court found the expert was not qualified to render an opinion regarding what information Mentor should have disclosed to the FDA or to physicians and patients. Prof. Buchholtz is not a physician, a medical researcher, or a medical ethicist. She had no expertise in the fields that would
qualify a witness to testify about what scientific information should be reported to the FDA or to testify about medical device industry standards for warning physicians and patients about potential adverse effects of a medical device.  Therefore, she was not qualified to offer an opinion about the appropriateness of Mentor’s conduct regarding its alleged failure to warn the FDA, physicians, and
patients about certain risks associated with ObTape.

Beyond the qualification issue, the court went on to note that even if the “Code of Ethics” that Prof. Buchholtz relied on was somehow relevant to a medical device company’s standard of care in the context of product development and marketing, anyone who reads and understands the English language can interpret and apply the principles underlying that “Code of Ethics.” So Prof. Buchholtz’s testimony on the subject was unnecessary, and not beyond the understanding of a lay jury. 

Brand Name Drug Maker Not Liable To Plaintiff Who Used Generics

A federal trial court in Texas has held that a plaintiff who admitted using only generic products cannot maintain failure to warn claims against brand-name drug manufacturers. Finnicum v. Wyeth Inc.,  2010 WL 1718204 (E.D. Tex., 4/28/10). 

Finnicum alleged that her doctor prescribed metoclopramide to treat her heartburn sometime in 2003 and that she regularly ingested a generic form of the drug until at least 2007. Finnicum stipulated, however, that she never ingested any form of metoclopramide manufactured or distributed by defendants Wyeth or Schwarz. In mid-2007, Finnicum alleged she began exhibiting symptoms of tardive dyskinesia, a neurological disorder characterized by involuntary movements, especially of the lower face. Finnicum contended that her long-term ingestion of metoclopramide caused her to develop the disease.

She brought suit, asserting causes of action against Wyeth and Schwarz for negligence, strict products liability, breach of warranty, fraud, and violations of the Texas Deceptive Trade Practices Act.

Although plaintiff never ingested any form of metoclopramide that defendants manufactured or distributed, she alleged that manufacturers of generic metoclopramide are required by federal law to use brand name warnings when selling their products. Finnicum further contended that physicians rely on brand-name warnings when prescribing generic drugs. Finnicum maintained that defendants, as manufacturers of the brand name drug (Reglan), failed to provide adequate warnings of the long-term effects of metoclopramide use. And that impacted the warnings she did get.

The court granted summary judgment to the defendants, joining the majority of courts that have considered this question. Texas law applied. The Texas Supreme Court has stated that a manufacturer generally does not have a duty to warn or instruct about another manufacturer's products, even though a third party might use those products in connection with the manufacturer's own products. Thus, Texas law does not permit a plaintiff who ingested another manufacturer's drug to maintain a failure-to-warn claim against a brand-name manufacturer.  This result is in accord with, for example, the Eighth Circuit in Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir.2009); see also Foster v. American Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994).

The court expressly rejected the California decision, Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal.Ct.App.2008). In Conte, the court extended a brand name drug manufacturer's duty of care regarding product information to patients who were injured by generic brands. This ruling would impose a duty that would stretch the concept of foreseeability too far.

Senator Urges House to Amend FDA Powers on Drugs

Like a cross-over episode from two bad TV shows, Sen. Chuck Grassley, ranking member of the Senate Committee on Finance testified before a subcommittee of the U.S. House of Representatives Committee on Appropriations last week.  His Senate Committee staff is generally regarded as having issues presenting a balanced or complete view of the FDA and industry's efforts to monitor the safety and efficacy of approved medication.

In his testimony, the Senator urged Congress to give the U.S. Food and Drug Administration more power to monitor drugs' safety after they enter the market.

He raised questions about whether or not various post-marketing studies sanctioned by the FDA were properly performed.  He talked about his twice-introduced legislation to establish an independent office of drug safety at the FDA, a Center for Postmarket Drug Evaluation and Research.  This entity would tackle the alleged lack of equality between the Office of New Drugs (OND), which decides whether to approve a drug, and the Office of Surveillance and Epidemiology (OSE). OSE, he said, is the office that monitors a drug’s safety once it’s on the market and being sold to patients.

The supposed imbalance between OND and OSE was apparent, he argued, in various drug safety issues that developed into major mass torts. Individuals in the office responsible for post-market surveillance should be allowed to provide an “independent opinion” based on the best available evidence, he asserted. He claimed vaguely that FDA physicians and scientists committed to post-market monitoring of drugs have sometimes been suppressed or ignored.

Other speakers included a Yale School of Medicine Professor who testifies for plaintiffs in pharma cases, and the Director of the anti-industry Health Research Group of Public Citizen.  More fair balance? Maybe after November.

 

Court Should Review Punitive Damages Re-Trial Issue

Readers concerned about punitive damages law have their eyes on Wyeth LLC v. Scroggin.  The case involves a woman who allegedly developed cancer after taking hormone therapy drugs. (The FDA continues to approve the drugs as safe and effective.) The plaintiff contends that Wyeth was negligent in failing to include a stronger warning on its label, and that she would not have taken the drug if the warning had been stronger. The district court conducted a bifurcated trial
before a single jury, with liability determined first and punitive damages determined second. In the first phase, the jury found for plaintiff and awarded $2.7 million in compensatory damages. In the second phase, the same jury determined that defendant was liable for punitive damages of $19.4 million. Wyeth LLC v. Scroggin, 554 F.Supp.2d 571 (E.D. Ark. 2008). On appeal, the U.S. Court of Appeals for the Eighth Circuit overturned the punitive damages award, ruling that the award was tainted by the admission of improper evidence during the punitive damages phase of the trial. But rather than ordering an entirely new trial, the appeals court ordered a partial new trial limited to punitive damages only. Scroggin v. Wyeth, 586 F.3d 547 (8th Cir.2009).

Wyeth is seeking Supreme Court review of the denial of its request for an entirely new trial.  Permitting a tort plaintiff to preserve his compensatory damages award at the same time that he pursues punitive damages before a separate jury is unfair to defendants, and it is likely to lead to increases in punitive damages awards. Partial retrials limited to punitive damages violate jury trial rights protected by the Seventh Amendment. The Petition for Cert here, 78 USLW 3566 (3/16/10), describes in detail the sharply conflicting views of the federal appeals courts regarding the circumstances under which partial retrials in jury cases are consistent with the Seventh Amendment, both generally, and specifically with respect to partial retrials confined to punitive damages. It is fair to say some lower courts have struggled to apply the Seventh Amendment standards set forth in Supreme Court precedent, and that the appeals courts have adopted divergent and irreconcilable approaches.

The Washington Legal Foundation submitted an amicus brief on this issue. In its brief urging the Supreme Court to grant review, WLF argued that the Seventh Amendment prohibits such partial retrials limited to punitive damages. WLF argued that the Seventh Amendment “right to trial by jury” has long been understood to constitute those jury trial rights that existed under the English common law when the Seventh Amendment was adopted in 1791. At common law there was no practice of setting aside a verdict in part. If the verdict was erroneous as to any issue, a new trial was directed as to all issues, so that all related issues could be decided by a single jury. Where the issue to be re-tried is related to issues already decided by the first jury, partial retrials create a danger that the second jury will be confused when told that some issues have already been decided.  WLF has argued that in this case the principal issue at any retrial on punitive damages (whether defendant acted sufficiently culpably in failing to provide stronger cancer warnings to merit a punitive award) is substantially similar to an issue decided in the first trial (whether it acted sufficiently culpably in failing to provide stronger cancer warnings to merit an award of compensatory damages).  The similarity of the two issues creates a significant danger of jury confusion, and the Seventh Amendment requires the plaintiff either to accept $2.7 million as her total compensation or to retry her entire case before a new jury.

WLF notes that considerable empirical evidence suggests that permitting partial retrials regarding punitive damages exacerbates the unpredictability of punitive damages awards. Moreover, the evidence suggests that permitting such partial retrials is a considerable disadvantage to tort defendants, who on average are likely to face larger monetary judgments than if a single jury considers all related tort claims.

JPML Denies MDL Status to Pain Pump Litigation- Again

For the second time, the JPML has declined to consolidate the federal product liability cases involving pain pumps. In re Ambulatory Pain Pump-Chondrolysis Products Liability Litigation, J.P.M.L., MDL No. 2139 (4/14/10).

In the litigation, plaintiffs allege that they developed chondrolysis, i.e., damage to their joint cartilage, after pumps were used to directly send anesthetic into their shoulder joints following surgery.

In August, 2008 the Panel had denied the motion for centralization in MDL No. 1966, at at time the  docket involved a total of thirteen actions, as well as eighteen potential tag-along actions.  At that point, the panel noted that an indeterminate number of different pain pumps made by different manufacturers were at issue, as were different anesthetic drugs made by different pharmaceutical companies. Moreover, not all of the then-thirteen constituent actions involved pharmaceutical company defendants, and many defendants were sued only in a minority of those actions.

When the litigation grew to 102 actions in 26 districts, and 70 tag-alongs, the plaintiffs tried again. Most defendants opposed the renewed effort. But although the number of related actions had certainly grown, the Panel found that the issues that weighed against centralization in that earlier docket remain. An indeterminate number of different pain pumps made by different manufacturers are still at issue, as are different anesthetics made by different pharmaceutical companies. Most, if not all, defendants are named in only a minority of actions; and several defendants are named in but a handful of actions. Many actions involve no anesthetic manufacturers at all.

In the current litigation, individual issues of causation and liability continue to appear to  predominate, and remain likely to overwhelm any efficiencies that might be gained by centralization. Pain pumps come in different sizes and designs, with differing volume, duration, and flow capacities. The same anesthetic was not used in all surgeries. Plaintiffs have different medical histories (indeed, some have undergone more than one surgery involving a pain pump).

Third, said the Panel, the constituent actions are at widely varying procedural stages. In many, fact
discovery is either over or nearly over. The record showed that expert discovery is underway or has
been completed in a number of actions. It was also noted that while most plaintiffs supported the motion, others requested exclusion on the ground that their cases were too far advanced.

Thus, the Panel was not convinced that centralization would serve the convenience of the parties or promote the just and efficient conduct of the litigation taken as a whole.


 

Third Circuit Decides Wrongful Life Case

A federal appeals court has upheld a district court decision denying the product liability claims of a plaintiff against a tissue bank which allegedly sold defective sperm with a genetic mutation that allegedly caused her child's developmental disabilities. D.D. v. Idant Laboratories, 2010 WL 1257705  (3d Cir. 4/1/10). The case presents some of the interesting issues when traditional products doctrine confronts 21st century medical technology.

Plaintiff sought to be artificially inseminated with semen provided by defendant Idant. She selected the semen of a specific donor, and was told the specimen had been tested in conformity with New York Health Regulations. Following successful insemination, the child was born, but according to plaintiff, was soon displaying abnormalities such as “trouble sleeping, tantrums, and anxiety as well as developmental delays.”  Plaintiff found an expert who opined that there was a connection between the purchase from defendant and the child's developmental problems.

The district court dismissed the child's claims, under NY law, for strict products liability, third party beneficiary breach of express warranty, third party beneficiary breach of implied warranty of merchantability, and third party beneficiary breach of contract, as claims based on an impermissible "wrongful life theory."

Guided by the principle that, whether it is better never to have been born at all than to have been born with even gross deficiencies, is a mystery more properly to be left to philosophers and theologians, see Becker v. Schwartz, 46 N.Y.2d 401, 411, 413 N.Y.S.2d 895, 386 N.E.2d 807 (1978), New York courts have held that a cause of action may not be maintained on behalf of an infant plaintiff based on a claim of wrongful life. Sheppard-Mobley v. King, 4 N.Y.3d 627, 797 N.Y.S.2d 403, 830 N.E.2d 301, 305 (N.Y.2005).  Wrongful life cases pose particularly thorny problems of injury and in the damages context: “Simply put, a cause of action brought on behalf of an infant seeking recovery for wrongful life demands a calculation of damages dependent upon a comparison between the Hobson's choice of life in an impaired state and nonexistence. This comparison, the law is not equipped to make.” Becker, 46 N.Y.2d at 412, 413 N.Y.S.2d 895, 386 N.E.2d 807.

The Third Circuit agreed that regardless of whether a particular cause of action is denominated as one of contract, products liability, or something else, all of the claims on behalf of the child here suffered from the same legal defect: the lack of a cognizable injury. In arguing that the defective semen left the child impaired and in need of costly treatment, plaintiff was essentially saying that the genetic makeup was the injury. But New York law, which controlled here, states that she, like any other child, does not have a protected right to be born free of genetic defects. To find the contrary would invite litigation for any number of claimed injuries and, even more problematic, would require courts to identify certain traits below some arbitrarily established marker of perfection as “injuries.”  Accordingly, the court of appeals concluded that, applying New York law, the causes of action asserted failed to identify damages different from those for wrongful life.

If readers are interested in wrongful life issues, see also Daniels v. Delaware, 120 F. Supp. 2d 411 (D. Del. 2000); Reed v. Campagnolo, 810 F. Supp. 167 (D. Md. 1993), certifying questions to 630 A.2d 1145 (Md. 1993); Gildiner v. Thomas Jefferson Univ. Hosp., 451 F. Supp. 692 (E.D. Pa. 1978) (interpreting Pennsylvania law); Phillips v. United States, 575 F. Supp. 1309 (D.S.C. 1983) (interpreting South Carolina law); DiNatale v. Lieberman, 409 So. 2d 512 (Fla. Dist. Ct. App. 1982); Atlanta Obstetrics & Gynecology Group v. Abelson, 398 S.E.2d 557 (Ga. 1990); Blake v. Cruz, 698 P.2d 315 (Idaho 1984); Goldberg v. Ruskin, 499 N.E.2d 406 (Ill. 1986); Cowe v. Forum Group, Inc., 575 N.E.2d 630 (Ind. 1991); Bruggeman v. Schimke, 718 P.2d 635 (Kan. 1986); Taylor v. Kurapati, 600 N.W.2d 670 (Mich. Ct. App. 1999); Wilson v. Kuenzi, 751 S.W.2d 741 (Mo. 1988); Greco v. United States, 893 P.2d 345 (Nev. 1995); Smith v. Cote, 513 A.2d 341 (N.H. 1986); Karlsons v. Guerinot, 57 A.D.2d 73 (N.Y. App. Div. 1977); Azzolino v. Dingfelder, 337 S.E.2d 528 (N.C. 1985); Ellis v. Sherman, 515 A.2d 1327 (Pa. 1986); Nelson v. Krusen, 678 S.W.2d 918 (Tex. 1984); James G. v. Caserta, 332 S.E.2d 872 (W. Va. 1985). 

Seventh Circuit Issues Forum Non Conveniens Ruling

The Seventh Circuit has affirmed a district court's ruling which dismissed Taiwanese plaintiffs' claims against blood product manufacturers on statute of limitations and forum non conveniens grounds. Chang v. Baxter Healthcare Corp., 2010 WL 1136521 (7th Cir. 3/26/10).

Because my colleague Dave Walk was part of the winning defense team, just the facts here without alot of commentary. 

The case was filed originally in California by residents of Taiwan but transferred by the multidistrict panel to the district court in Illinois with the other suits in the clotting-factor mass tort for pretrial proceedings.  The main tort claim was that the defendants acquired blood from "high-risk" donors, processed it improperly in California where they manufactured clotting factors, and after discovering that the factors were contaminated by HIV nevertheless continued to distribute the product in foreign countries (while withdrawing them from distribution in the United States). Thus, plaintiffs in this case, or the hemophiliac decedents whom they represented, in fact resided, and obtained and injected the clotting factor, in a foreign country.

The court addressed first the claims that were dismissed as untimely. The critical issue so far as these dismissals on the merits were concerned, said the court, was choice of law. When a diversity case is transferred by the multidistrict litigation panel, the law applied is that of the jurisdiction from which the case was transferred, in this case California. The California statutes of limitations don't begin to run until the plaintiff discovers, or should in the exercise of reasonable diligence have discovered, that he has a claim against the defendant.  But this discovery rule, even if applicable, would not save the plaintiffs' tort claims from dismissal for untimeliness. Plaintiffs argued that they didn't have enough information on which to base a suit until a New York Times article about the contamination of clotting factors with HIV was published on May 22, 2003, and therefore that their suit, filed in 2004, was timely.  But as the district court found, the plaintiffs had a reasonable basis to suspect that they had a cause of action more than five years before the article appeared, when their counsel actually had begun negotiations with two of the defendants to settle negligence claims arising from the alleged contamination of the defendants' clotting factors with HIV. (These negotiations culminated in the settlement in 1998 on which the plaintiffs' breach of contract claim was based.)

The plaintiffs argued that the limitations period should have been tolled by defendants' “fraudulent concealment” because when entering into the settlement agreement they claimed that they had done nothing wrong and that they were offering financial aid purely as a humanitarian gesture. The plaintiffs were mistaken in this. Denial of liability when negotiating a settlement agreement is the norm; it is not evidence of fraudulent concealment of anything.

The district court was also correct in ruling in the alternative that a California court would apply the Taiwanese 10-year statute of repose, because the plaintiffs' tort claims arose under Taiwanese law. The hemophiliacs whom the plaintiffs represented were infected in the 1980s, more than a decade before these suits were brought. If the plaintiffs' tort claims arose in Taiwan, California law makes the Taiwanese statute of repose applicable to those claims. The reason is California's “borrowing” statute, which is sensibly designed to discourage forum shopping, would bar the action in California if it would have been barred in Taiwan. The plaintiffs tried to argue that their claims arose in California, not Taiwan, because it was in California that the defendants allegedly failed to process their clotting factors in a way that would prevent contamination by HIV. But generally there is no tort without an injury. That is the rule in California.  And the injury alleged occurred in Taiwan.

Turning to the claims that the district court dismissed not as untimely but on the basis, rather, of forum non conveniens, the court noted that the contract was negotiated and signed in Taiwan.  The key language at issue, the so-called scale-up clause, was ambiguous.  Evidence beyond the language of the settlement agreement would be necessary to "disambiguate the clause," said the court, and it seemed that most of the persons who are in a position to give such evidence live in Taiwan, including the plaintiffs' Taiwanese counsel who negotiated the settlement, a Taiwanese patient representative, members of the Taiwanese department of health, defendants' Taiwanese outside counsel, and an employee of defendants in Taiwan.

Taiwanese law makes it difficult to gather evidence for use in a trial in a foreign country because Taiwan is not a party to the Convention on the Taking of Evidence Abroad in Civil or Commercial Matters; the alternative method of obtaining evidence in a foreign country, sending a letter rogatory to the foreign court, seemed to not be a very satisfactory means of obtaining evidence.  So this important factor pointed to Taiwan. The only circumstance that would favor holding the trial in California rather than in Taiwan would be the greater convenience for the defendants, since they are American companies. But as they didn't want the case to be tried in California, or indeed anywhere else in the United States, really there was nothing in favor of the American forum, said the court. When application of the doctrine of forum non conveniens would send the plaintiffs to their home court, the presumption in favor of giving plaintiffs their choice of court is little more than a tie breaker.  But, said the panel, "there is no tie here."

 

FDA Proposes Regs on Direct-to-Consumer Prescription Drug Ads

The Food and Drug Administration has proposed to amend its regulations concerning direct-to-
consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. See 75 Fed. Reg. 15,376 (3/29/10). FDA is also proposing standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.

Readers of MassTortDefense know how DTC ads have impacted products litigation, from effects on the learned intermediary doctrine, to influence on the jury pool, to forming part of the basis of substantive information-based claims.

Under the current regulations the presentation of risk information in an advertisement for a prescription human or animal drug is required to be comparable in prominence and readability to the presentation of effectiveness information in the advertisement. If an advertisement presents effectiveness information in a clear and conspicuous manner, risk information is required to be presented in a comparable manner.  The new proposal would require disclosure of the major side effects and contraindications of the drug in a clear, conspicuous, and neutral manner, regardless of the manner in which effectiveness information is presented in the advertisement.

The proposed regulations would define the required clear, conspicuous, and neutral manner, as being met if:

1. Information is presented in language that is readily understandable by consumers;
2. Audio information is understandable in terms of the volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major
statement.

FDA said it recognizes that these standards require judgment in their application. Therefore, the agency does not intend to prescribe a set formula for ‘‘clear, conspicuous, and neutral’’ major
statements because there is more than one way to achieve these standards in a television or radio ad. FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads. Sponsors have the flexibility to be creative in designing their ads as long as all of the standards listed here are complied with such that the major statement is communicated effectively to consumers and the overall message
that the advertisement conveys to consumers is accurate and non-misleading.

Comments on the proposed rule are due by June 28, 2010.

Upcoming Drug and Medical Device Seminar

DRI’s Drug and Medical Device Committee will hold its 26th annual Seminar on May 20-21, 2010, at the San Francisco Marriott, in San Francisco, California.

The Seminar is one of the best of its kind, highly useful to practitioners who represent pharmaceutical and/or medical device manufacturers. This year's Seminar will feature a number of nationally recognized attorneys, both in-house and outside counsel, who will address cutting-edge topics that are relevant to all who practice in this area, whether they are associates, lead trial counsel, or in-house counsel.

This year’s program will offer a mixture of presentations, such as trial skills demonstrations, panel discussions, and individual presentations from leaders in their practice areas. In addition to the outstanding program, there will be numerous networking opportunities, including the annual Young Lawyers Blockbuster. 

See the Seminar Brochure to register or to learn additional information. The advanced registration deadline is April 30, 2010.
 

Federal Court Dismisses Device "Consumer" Claims

A federal court last month dimissed claims by plaintiffs concerning hip implants, with an analysis important for other consumer protection-type class action claims. Watkins v. Omni Life Science, Inc., 2010 WL 809820 (D.Mass. 2010).

Plaintiffs were recipients of the Apex Model Replacement Hip. Although neither plaintiff alleged an Apex Hip malfunction, they claimed that the allegedly relatively high rate of failure of the Apex Hip placed them and members of the proposed class at serious risk of future harm.  The failure rate was also alleged to have diminished the market value of their hip implants and those of the putative class members. Plaintiffs claimed that they would not have selected the model Hip over other alternative devices but for the representations made by the defendant manufacturer. Plaintiffs asserted claims for breach of implied warranty, breach of contract, unjust enrichment and constructive trust, violations of the Massachusetts consumer protection statute, and violations of the consumer protection laws of all other states (for the class).

Omni filed a motion to dismiss pursuant to Fed.R.Civ.P. 12(b)(6), arguing that no legally cognizable injury was pled in any of plaintiffs' claims. Plaintiffs' reply argument, as is typical, was a benefit of the bargain theory. Plaintiffs claimed that an accident-related injury or a manifested defect need not be shown as a predicate of recovery on their consumer claims. They claimed that their sufficient injuries consisted of: (1) the apprehension caused by the prospect of an increased risk of hip failure and (2) the extra money that they paid for an overvalued Apex Hip.

First, the court said, although plaintiffs' claims were styled as contract and breach of warranty claims, they actually were tort allegations. A plaintiff cannot disguise a tort claim with mere contract langauge. In Massachusetts, the economic loss doctrine applies, and purely economic losses cannot be recovered in tort or product liability actions in the absence of personal injury or property damage. The court added that the economic loss rule applied to the plaintiffs' consumer protection act claims as well.

As tort claims, plaintiffs failed to allege sufficient injury. Apprehension of a heightened risk stemming from an allegedly defective product that has not failed or caused harm to this plaintiff is insufficient as a matter of law to support a claim. See Anderson v. W.R. Grace & Co., 628 F.Supp. 1219, 1231 n. 6 (D.Mass.1986) (“The weight of authority would deny plaintiffs a cause of action solely for increased risk because no ‘injury’ has occurred.”). Plaintiffs' overpayment argument was also based on a theory of economic loss that has no place in a tort context. See Iannacchino v. Ford Motor Co., 451 Mass. 623, 633, 888 N.E.2d 879 (2008).

To the extent an allegation sounding in fraud was underlying some of the claims, read in the aggregate, the court found that Omni's alleged misrepresentations, as pled, lacked the capacity to mislead consumers, acting reasonably under the circumstances, to act differently from the way they otherwise would have acted. Under Rule 9b, in alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.  This was not done.

 

Fifth Circuit Affirms Exclusion of Plaintiff's Causation Experts

A federal appeals court recently affirmed a judgment for the maker of a drug used to treat Parkinson's disease in litigation alleging that the drug caused plaintiff's compulsive gambling.  Wells v. SmithKline Beecham Corp., 2010 WL 1010591 (5th Cir. 2010).

Wells sued GlaxoSmithKline, the manufacturer of Requip, alleging that GSK had failed to warn patients about the alleged side effect of pathological gambling.  For Wells to win under Texas law,  he had to show that the failure to warn caused his injury.  Causation has two levels, general and specific, and a plaintiff must prove both. General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. Sequence matters, said the 5th Circuit: a plaintiff must establish general causation before moving to specific causation. Without the predicate proof of general causation, the tort claim fails.

Wells engaged three expert witnesses to address general causation, that the drug supposedly could cause pathological gambling. In reaching their conclusions, the experts relied upon: (1) published articles documenting case-specific correlations between Requip and gambling; (2) a single unpublished study allegedly showing a nexus between Parkinson's medicines generally and gambling; (3)  internal data supposedly revealing case-specific associations between Requip and gambling; and (4) the fact that GSK has since changed the Requip label to warn about possible gambling side-effects. (Of course, on the last point a regulatory agency can require a warning based on a lesser level of proof than is required to recover in a tort action.) Defendant challenged the evidence under Daubert, and the district court granted summary judgment.  Plaintiff appealed.

Readers know that Daubert requires admissible expert testimony to be both reliable and relevant.  This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.  Although there are “no certainties in science,” the expert must present conclusions grounded in the methods and procedures of science.  In short, the expert must employ in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.

The court of appeals found that each of the three experts had, in deposition, in essence conceded that there exists no scientifically reliable evidence of a cause-and-effect relationship between Requip and gambling, that the state of the art was mere association, not cause.  That alone would doom the plaintiff's case.

But more interesting for readers is when the court went on, in the alternative, to address the methodologies and fit. 

The studies relied on were, each expert conceded, not statistically significant epidemiology. They were, in fact, case studies. Although case-control studies are not per se inadmissible evidence on general causation,  the courts have frowned on causative conclusions bereft of statistically significant epidemiological support. While the court agreed that in epidemiology hardly any single study is ever conclusive, and it did not suggest that an expert must back his or her opinion with multiple published studies that unequivocally support his or her conclusions, here there was simply too great an analytical gap between the data and the opinion proffered.  Bottom line-- the bases for the experts' conclusions passed none of the applicable Daubert factors: that Requip causes problem gambling is not generally accepted, has not been subjected to peer review and publication, and is not backed by studies meeting requisite scientific standards.

Without the expert testimony, Wells could not prove general causation.  Here's a useful quote:  "Wells urges the law to lead science -- a sequence not countenanced by Daubert."  See also Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996) (“Law lags science; it does not lead it.”).

 

Supreme Court Grants Cert. In Vaccine Case

A case to watch:  earlier this month the Supreme Court granted certiorari in Bruesewitz v. Wyeth, 2010 WL 757696, which raises important issues under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) , 42 U.S.C. §§ 300aa-1 et seq.  The Act expressly preempts state law claims against vaccine manufacturers if the injury or death giving rise to such a claim results from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning. 

But the lower courts have split on the meaning of that provision. Does the Vaccine Act preempt all design defect claims against vaccine manufacturers, or must the preemption of particular design claims be decided on a case-by-case basis?

In this case, the 3rd Circuit correctly held that the Vaccine Act preempts all design defect claims,  including negligence and strict liability design claims. 561 F.3d 233 (3d Cir. 2009). The Georgia Supreme Court, by contrast, is  one court that had previously held that a design defect claim is not preempted unless the manufacturer demonstrates, on case-by-case basis, that there was no safer design that could have avoided the injury giving rise to the claim. Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga.2008).

One of the many ways that the Ferrari court's construction is contrary to the structure of the Act and intent of Congress is that it does not necessarily bar any design defect claims. If the court interpret the Vaccine Act to allow case-by-case analysis of whether particular vaccine side effects are avoidable, then every design defect claim is subject to evaluation by a court, and theoretically every one of them could be found not-preempted by the state courts around the country. That clearly is not what Congress meant. 
 

Appeals Court Affirms Summary Judgment Based on Learned Intermediary Rule

A federal appeals court recently affirmed judgment for the maker of an anti-depressant drug, ruling that the plaintiff could not show that an allegedly inadequate warning caused the injury at issue. Dietz v. Smithkline Beecham Corp., 2010 WL 744273 (11th Cir. 2009).

The case reminds readers about the importance of the testimony of the prescriber in a pharmaceutical case. The plaintiff's physician diagnosed him with major depression and offered him hospitalization for psychiatric treatment, which Dietz declined. The doctor then prescribed him Paxil, a selective serotonin reuptake inhibitor (“SSRI”) antidepressant.  Eight days after having filled and begun his Paxil prescription, Dietz apparently committed suicide by throwing himself in front of a train.

Appellant filed a diversity suit. During discovery, the parties deposed Dietz's physician, who testified that he had considered the potential risks and benefits of prescribing Paxil to Dietz when he wrote the prescription in 2002.  He also testified that, even in retrospect, he agreed with his decision to treat Dietz with Paxil and would do so again today under the same circumstances.

Within the context of prescription drugs, Georgia employs the learned intermediary doctrine, which alters the general rule which imposes liability on a manufacturer for failing to warn an end user of the known risks or hazards of its products. According to the doctrine, the manufacturer of a prescription drug does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the manufacturer. The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication involves professional assessment of potential medical risks in light of the physician's knowledge of a patient's particular needs.

Here the court affirmed summary judgment for the manufacturer since the appellant could not demonstrate that any alleged failure to warn the treater about increased suicide risks associated with Paxil proximately caused Dietz to commit suicide. The doctor provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, he still would have prescribed Paxil for Dietz's depression. Pursuant to Georgia's learned intermediary doctrine, this assertion severs any potential chain of causation through which appellant could seek relief. 

FDA Official Testifies Before Congress on REMS and Sentinel

Last week, the House Energy and Commerce Committee's Health Subcommittee held a hearing on drug safety.  A quick report: Chairman Waxman's opening comments indicated that the committee was eager to hear about FDA’s implementation of the 2007 FDA Amendments Act, giving FDA the authority to require manufacturers to implement “Risk Evaluation and Mitigation Strategies” or “REMS.”

FDA Principal Deputy Commissioner Joshua Sharfstein indicated that using this REMS authority is “a work in progress” and acknowledged a "lack of clarity" in certain provisions of the law with respect to REMS. FDA recognizes that designing and implementing the most comprehensive REMS requires a careful balancing of the need to adequately manage risks and also to maintain patient access to important medications. In the design of REMS with elements to ensure safe use (the most comprehensive REMS programs), FDA is mindful, he said, that the elements to ensure safe use must not be unduly burdensome on patient access to the drug, and be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.

If FDA determines that a REMS is necessary to ensure that the benefits of a drug continue to outweigh the risks of the drug, FDA can require manufacturers to have a REMS in place when a drug comes on the market, or implement one later if FDA becomes aware of new safety data. Most of the REMS with elements to ensure safe use include educating prescribers about the risks and appropriate use of the drug as a condition of certification or enrollment in the REMS program. Some programs require the prescriber to monitor the patient immediately following drug administration and for a period of time afterwards. 

The FDA official also gave a brief update on the Sentinel Initiative. FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system to link and analyze health care data from multiple sources. On May 22, 2008, FDA officially launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System—a national, integrated, electronic system for monitoring medical product safety. The Sentinel System, testified the Commissioner, once up and running, will enable FDA to actively gather information about the post-market safety and performance of its regulated products—a significant change from the current, primarily passive safety surveillance systems. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012.

FDA has gathered public input on issues related to the creation and development of Sentinel, held numerous meetings and a public workshop, and established a working group consisting of representatives of numerous federal agencies to share information and discuss issues related to ongoing efforts that are complementary to Sentinel. FDA has awarded key contracts for a pilot project to gather information that will be essential to fully implementing the Sentinel System. As we posted about before, there is still work to be done to address significant issues with this plan.

One risk is that plaintiffs’ attorneys will find a way to misuse the system, to “find” spurious associations between drugs and effects, to assert a causal link based on the “government approved, government sanctioned” database program, and to blame the drug companies for not having seen that same link sooner. Fundamentally, the system creates a corresponding need to improve the ability to determine as quickly as possible which findings reflect a genuine and health risk. That determination may take epidemiological investigations or clinical trials before any conclusion about whether a product actually caused an event. And the new system doesn’t change the reality that sometimes patients suffer adverse events after receiving drugs because they are sick, not because the drug has any issues. Plaintiffs have no incentive to place the new product information uncovered in a context of the continuing benefits of the product for many patients, the lack of certainty in the findings, the limitations of the data, etc.

 

Summary Judgment for Drug Company in Pain Pump Case

A federal court has granted defendant summary judgment in a case which alleged that cartilage damage sustained by the plaintiff, a former high school athlete, was caused by the post-surgery use of the drug company’s pain medication in an automated pump device. Jensen Meharg, et al. v. I-Flow Corp., et al., No. 1:08-cv-00184 (S.D. Ind. 3/1/10).

The former high school athlete underwent shoulder surgery, after which a pain pump was utilized. The pain pump in question was manufactured and sold by I-Flow Corporation; the local anesthetic–bupivacaine Hcl – was manufactured and sold by defendant AstraZeneca.  AstraZeneca did not in any way promote the use of bupivacaine with pain pumps, and that use was not mentioned in the instructions and warnings provided with the drug -- an off-label use. Several months later, plaintiff began to experience shoulder pain again. An MRI allegedly revealed that plaintiff had developed chondrolysis in her shoulder, which she alleged was caused by the post-surgery administration of the bupivacaine with the pain pump.

The strict liability claim was for alleged failure to warn; a warning defect claim requires that defendant had a duty to warn.  Duty is generally a legal issue.  In the context of a prescription drug manufacturer, the duty to warn does not arise until the manufacturer knows or should know of the risk.  In cases that involve an off-label use of a prescription drug that is not promoted by the manufacturer, the requisite knowledge of the risk, at a minimum, includes that the manufacturer must know (or be charged with knowledge of) both that the off-label use is occurring and that the off-label use carries with it the risk of the harm at issue – in this case, damage to cartilage.

The court found as a matter of law that the information allegedly possessed by defendant was insufficient to trigger AstraZeneca’s duty to warn of the risk of cartilage damage from continuous infusion of bupivacaine into a patient’s joint. Simply put, the plaintiff failed to point to sufficient evidence that demonstrated that at the time of plaintiff’s surgery AstraZeneca knew of that risk or that it should have known of the risk because experts in the relevant field had such knowledge.

More interesting was plaintiff's other theory. Plaintiff's expert also opined that prior to plaintiff’s surgery the defendant supposedly knew that bupivacaine was being used in pain pumps, and that this knowledge triggered an alleged duty to “investigate the nature of that use, determine whether the drug was being promoted in accordance with approved indications, conduct or sponsor those studies necessary to ensure that the promoted use was safe, and to warn physicians that long-term risks to the joint had not been scientifically established but that the risks should be weighed seriously, given that the anticipated use was for elective post-operative pain therapy for which multiple alternatives existed.”  The court noted that such a  “duty” does not exist under relevant (Indiana) law.  The duty to warn does not arise until the manufacturer knows or should know of the risk.  The alleged far broader duty  – a  duty, in essence, to warn physicians that there might be a risk, although we don’t know yet because neither we or the scientific community at large has studied it yet -- doesn't exist.

Such a duty would cause physicians to be inundated with such pseudo-warnings and quasi-risk information distracting them from heeding real warnings of actual risk; and it would add very little to the fact that physicians already know, i.e., that if a use is omitted from a prescription drug’s label, that use has not been tested sufficiently to demonstrate to the FDA that it is safe and effective.

House Committee to Hold Hearing on FDA

The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing titled, "Drug Safety: An Update from the FDA" -- tomorrow, Wednesday, March 10, 2010.

 At the hearing, the Food and Drug Administration will detail the Agency's views on current challenges and successes in the area of drug safety. Set to testify is Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug Administration. 

 
 

Companion Bill Introduced To Ease Suits Against Foreign Manufacturers

Previously we alerted readers to the introduction of The Foreign Manufacturers Legal Accountability Act of 2009 (S. 1606),  introduced in the Senate in August 2009 by Sen. Sheldon Whitehouse (D-R.I.). The bill followed up on hearings last Spring during which witnesses testified about the perceived delays and difficulties with serving foreign manufacturers with process and establishing jurisdiction.

Last week, Rep. Betty Sutton (D-Ohio) and several co-sponsors introduced in the House their own version of the Foreign Manufacturers Legal Accountability Act of 2010 (H.R. 4678). The operative provisions of the House bill overlap those in the Senate bill, although the Senate bill also includes a section which discusses the alleged need for the legislation.

The proposed legislation would impact five categories of products: drugs, devices and cosmetics; biological products; chemical substances; pesticides; and consumer products. The bills only apply to manufactured products “in excess of a minimum value or quantity established by the head of the applicable agency" in regulations applying the legislation.

Both bills make consent to jurisdiction and service of process a condition of importing products into the United States. That is, the bills instruct several relevant product-regulating agencies to issue regulations requiring foreign manufacturers and producers to designate a registered agent. A person would not be able to import into the United States a covered product (or component part that will be used in the United States to manufacture a covered product) if such product or any part of such product (or component part) was manufactured or produced outside the United States by a manufacturer or producer who does not have a registered agent. 

Such a system which requiring an agent for service of process for every foreign manufacturer or producer who imports products into the U.S. would render the Hague Convention's  methods for service abroad unnecessary for such companies, and raises the risk that other countries may choose to create similar rules, subjecting U.S. companies to litigation in those other countries where their products may be sold.

Under the bills, a foreign manufacturer or producer of covered products that registers an agent as above thereby consents to the personal jurisdiction of the State or Federal courts of the State in which the registered agent is located for the purpose of any civil or regulatory proceeding.  Presumably, the expanded jurisdiction would also make it easier for U.S. companies to pursue indemnification claims against foreign manufacturers who were upstream suppliers.

Currently, foreseeing that one's product may enter a state is not, on its own, a sufficient basis for that state to assert jurisdiction. Asahi Metal Industry Co., Ltd. v. Superior Court, 480 U.S. 102, 112(1987); but cf. Nicastro v. McIntyre Machinery America Ltd., No. A-29-08 (N.J. 2/2/10).  It has been argued that Congress cannot create jurisdiction where the Constitution would forbid it. And it may be that a constitutional challenge would lie to some applications of the proposed bills. E.g., Texas Trading & Milling Corp. v. Federal Republic of Nigeria, 647 F.2d 300 (2d Cir. 1981). Presumably, the sponsors are looking to bypass the due process concerns by providing for consent to jurisdiction.

It is unclear what the effect of the bills might be on countries around the world regarding their willingness to enforce judgments entered in the United States, as the issue of the lack of foreign manufacturer assets in the U.S. is not addressed by the proposed legislation.


 

 

Appeals Court Upholds Summary Judgment on Negligence Per Se Claim

Last week, the Ninth Circuit upheld summary judgment for the maker of an artificial disc on a claim that the company's alleged off-label promotion of the device constituted negligence per se. See Carson v. DePuy Spine Inc.,  No. 08-56698 (9th Cir., 2/16/10)(unpublished).

Readers know that alleged violations of state or federal regulations can be used by plaintiffs in a number of ways, including the allegation that the violation constitutes negligence per se under state law.  The artificial disc involved in this action was a class III medical device that had received pre-market approval from the FDA in 2004. All devices approved by the agency carry labels that describe the uses and patient conditions for which they may be used. Any use by a physician that differs from the label is considered an off-label use.  Here, plaintiff argued that the defendant was negligent in allegedly promoting off-label use for its product. 

The court noted that he FDCAct expressly protects off-label use: “Nothing in this chapter shall be
construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” 21U.S.C. § 396. In addition, the Supreme Court has emphasized that off-label use by medical professionals is not only legitimate but important in the practice of medicine. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). And a manufacturer is not liable merely because it sells a device with knowledge that the prescribing doctor intends an off-label use.
 

Plaintiffs argued  that the FDA has adopted regulations that limit a drug or device manufacturer’s
ability to promote a drug or device for off-label use. Therefore, while doctors may use a drug or device off-label, the marketing and promotion of a Class III device for an unapproved use violates Section 331 of the FDCA, 21 U.S.C. § 331, claimed plaintiff.  Thus, plaintiff asserted a state law negligence per se theory predicated on violation of federal law.   

In California, negligence per se is not a separate cause of action but is the application of an evidentiary presumption. Quiroz v. Seventh Avenue Center, 140 Cal. App. 4th 1256, 1285-86 (Cal. 2006). In California, there are four elements required to establish a viable negligence per se theory: (1) the defendant violated a statute or regulation; (2) the violation caused the plaintiff's injury; (3) the injury resulted from the kind of occurrence the statute or regulation was designed to prevent; and (4) the plaintiff was a member of the class of persons the statute or regulation was intended to protect. See Alejo v. City of Alhambra, 75 Cal.App.4th 1180, 1184-1185 (Cal.App. 1999).

The court of appeals found that the district court had correctly concluded that Carson had failed to present sufficient evidence to create a genuine issue as to two of the elements: violation of
federal law and causation. There was no evidence in the record to support the claim that defendant illegally promoted an off-label use of the products, that the physician was influenced by such promotion, or that the off-label use of the disk caused the injury. Indeed, there was uncontroverted testimony that plaintiff developed a spinal condition that put undue stress on the device, and that the surgeon broke the disc himself during revision surgery.

Summary judgment affirmed.

British Journal Finally Retracts Autism Article

The British medical journal "The Lancet" has  finally issued a full retraction of a study it ran in 1998 purporting to link the measles-mumps-rubella (MMR) vaccines to autism.  Wakefield, et al., "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children," Lancet 1998; 351: 637-641.

The journal noted that following the judgment of the U.K. General Medical Council's "Fitness to Practice Panel" concerning the lead author, it had become clear to the journal that several elements of the 1998 paper by Wakefield, et al., were "incorrect," and contrary to the findings of an earlier investigation. Therefore, the journal "fully retracted" this paper from the published record.

Readers of MassTortDefense know how one article purporting to link a drug to a side effect, a chemical to an adverse effect, a product to an illness, can spawn significant products litigation, and even a mass tort.  Here, the study not only influenced a decade of litigation, it spurred a public health crisis by sending parents in the U.K. and the U.S. into confusion over the safety of having their children vaccinated.  The overwhelming scientific evidence shows vaccines to be safe, but The Lancet stuck by its article even when it was revealed that the study was connected to plaintiff lawyers' pursuit of litigation. In the meantime, all children were put at risk as Great Britain's child vaccination rates plummeted to below 70% in some areas, and by 2008 there were more than 1000 cases of measles, including fatalities, in  England and Wales.

The Lancet article issues demonstrate how even reputable publications can become conduits for plaintiffs' junk science and political junk science.  It's hard to fathom why it took so long for the retraction.  It calls again for an overhaul of the peer review process, which the Supreme Court in Daubert noted as a hallmark of good science.  Most importantly, it reminds the defense bar and their clients how important it is to have a thorough, searching examination of the science that plaintiffs rely on for general or specific causation.  Nothing can be taken at face value, and sometimes only a dogged pursuit of discovery will uncover the many flaws in a seemingly well-regarded study.

Autism and related developmental disorders are an extremely challenging medical issue, deserving of time and resources.  But the questions cannot be answered by junk science.

MDL Court Addresses Ex Parte Communication With Treating Physicians

A recent federal court  decision explores a seemingly small but potentially crucial issue involving a product liability plaintiff's treating physicians.  In Re: Ortho Evra Products Liability Litigation, No. 1:06-40000, MDL Docket No. 1742 (N.D. Ohio).

Many product liability suits turn on a battle of the experts on issues of injury and causation.  In many cases, a key set of witnesses, therefore, are the plaintiffs' treating physicians. When the views of the treater are on the side of one party, that party will typically emphasize the "neutral" status of the witness and the fact that the treater has had more and closer contacts with the plaintiff.  Whichever side disagrees with the treater will try to emphasize that the doctor is not the "world class" expert on the relevant scientific issues, and that his or her real function was to treat the injury/illness, not figure out whether a particular product caused it.  Accordingly, the deposition of treating physicians -- and the preparation for those depositions -- can be a critical stage of products liability litigation.

In this MDL, defendants moved to regulate ex parte contacts with plaintiffs’ treating physicians. Defendants sought to prevent what many see as an unfair advantage by plaintiffs lobbying their theories of liability and causation upon the treating physicians during such ex parte contact -- often on the eve of deposition. 

Defendants asserted that this issue had been taken up by the New Jersey court in the Zometa/Aredia Litigation litigation.  In that New Jersey litigation, Gaus v. Novartis Pharmaceuticals Corp., No. MID-L-007014-07-MT (New Jersey, Oct. 29, 2009), the court emphasized the “unique set of practical concerns presented in mass tort cases” as well as the number of plaintiffs in determining that the court’s resources would be impaired by a flood of discovery disputes regarding each treating physician. To ensure the same right of access and promote an efficient discovery process, the court there ordered all parties to proceed by way of formal deposition of plaintiffs’ treating physicians. See also In re NuvaRing Products Liability Litigation, 2009 WL 775442 (E.D. Mo., 2009).

Here, the MDL court allowed plaintiffs’ counsel to have ex parte contact with treating physicians with an important limitation. Specifically, plaintiffs’ counsel can meet ex parte to discuss the physicians’
records, course of treatment and related matters, but not as to liability issues or theories, product warnings, defendant's research documents, or related materials. Violations of this approach, the court said, will result in sanctions.

 

 

 

 

State Supreme Court Reverses Class Certification on Predominance Grounds

The Alabama Supreme Court has recently reversed a lower court's certification of a class of third-party payers of health care services who complained about damages allegedly flowing from the recall of a drug from the market.  Wyeth, Inc. v. Blue Cross and Blue Shield of Alabama, 2010 WL 152123 (Ala. Jan. 15, 2010).

Defendant Wyeth voluntarily withdrew Duract from the market, notifying the public of its decision to do so through a press release.  As part of the process of withdrawing Duract from the market, Wyeth voluntarily instituted a customer refund program for customers who still had Duract capsules in their possession. The third-party payers sued Wyeth solely on a theory of unjust enrichment, alleging that their payment for the drug had conferred an inappropriate benefit on Wyeth in light of the withdrawal.

After a hearing on the class certification motion, the trial court entered an order certifying a nationwide class of TPPs who paid for the prescription drug Duract that was not used as of the date of its withdrawal from the market.  On appeal, the defendant argued that predominance of common issues had not been established, a requirement of Alabama Rule 23 analogous to FRCP 23 (b)(3).

As in many states, Alabama recognizes that unjust enrichment claims are particularly unsuitable for class treatment. Funliner of Alabama, L.L.C. v. Pickard, 873 So.2d 198, 211 (Ala.2003) (unjust enrichment claims based on allegations of mistake or fraud require an individualized inquiry into the state of mind of each plaintiff).  The trial court distinguished this body of law, finding that this particular enrichment claim was not based on fraud or mistake, but on the somehow different theory that “equity and good conscience” required the defendant to disgorge money that belongs to the plaintiff.

The court observed that Wyeth probably had the better of the argument on this, meaning that the trial court had fashioned on a distinction without a difference.  But the state high court did not need to resolve the unjust enrichment issue under Alabama law, because the plaintiffs sought a nationwide class. Regardless of what Alabama law was, there had been no adequate showing, either to the trial court or to the Supreme Court, that the laws of all (or even most of) the 49 other states would allow unjust enrichment claims to proceed on such a "good conscience" basis somehow distinct from a traditional claim. 

Even a cursory examination showed that variances exist in state common laws of unjust enrichment. The actual definition of unjust enrichment varies from state to state. Some states do not specify the misconduct necessary to proceed, while others require that the misconduct include dishonesty or fraud. See Clay v. American Tobacco Co., 188 F.R.D. 483, 501 (S.D.Ill.1999).

Accordingly, common issues could not predominate.  Certification was vacated.

New Paper On Reduced Legal Oversight of FDA Warning Letters

The WLF has just published a thought piece, co-authored by your humble blogger and colleagues Jim Beck and Vincent Gallo, on how "Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks."
 

Last summer, the Commissioner of the Food and Drug Administration reversed existing, sound policy that required prior legal review of regulatory letters (Untitled and Warning Letters) by the Agency's Office of Chief Counsel. This reversal -- eliminating review of regulatory letters for legal integrity except in cases of "significant legal issues" -- is one of several changes instituted by the Commissioner to increase enforcement activity and purportedly to limit enforcement delays.

Our paper explores the potential problems with this policy reversal and the risks for industry.

MDL Court Rejects Consolidation of Bellwether Trials

Readers of MassTortDefense know how significant the earliest few trials in any mass tort can be, influencing later trials and shaping settlement strategies.  Accordingly, which cases go first, from among the hundreds or thousands in the mass tort, and how they are tried, can be extremely significant.  The federal court overseeing the MDL concerning the antibiotic Levaquin recently denied plaintiffs' motion to consolidate three bellwether cases for the first trial. In re Levaquin Products Liability Litigation, MDL No. 08-1943, (D. Minn.). 

In the Order, the court noted that it had initially selected fifteen cases for evaluation and initial case-specific fact discovery in the bellwether-selection process. Directed by the court to meet and confer on an ordering of these cases for the first trials, the parties narrowed the field to seven remaining bellwether cases for selection for trial. Plaintiffs then moved to consolidate three of the cases for the first trial.  They asserted that the cases share similar characteristics that are central to this litigation and that consolidation would promote judicial efficiency and the interests of justice, while testing the merits of plaintiffs’ arguments. Defendants opposed the motion, arguing that plaintiffs had not met their burden of showing that a consolidated trial’s benefits would outweigh individual
issues in the case. Specifically, defendants argued that individual issues – including each
plaintiff’s unique medical history, each prescribing physician’s knowledge of warnings in the Levaquin package insert, and each plaintiff’s alleged injuries – precluded consolidation.

Federal Rule of Civil Procedure 42(a)(2) affords a court broad discretion to consolidate for trial actions involving common questions of law or fact. The party seeking consolidation bears the burden of showing that consolidation would promote judicial convenience and economy. Consolidation is inappropriate, however, if it leads to inefficiency, inconvenience, or unfair prejudice to a party.

Plaintiffs also argued that judicial economy would be served by consolidation because common sources of evidence established the supposedly common facts. For example, the same generic
expert witnesses would testify on behalf of each individual plaintiff, and the regulatory and
corporate history of the drug is the same for each plaintiff. Because of these alleged commonalities and claimed efficiencies, plaintiffs argued that consolidation of the three cases would save the court twenty trial days, not insignificant.
 
In opposition, defendants argued that individual issues, including what dose of Levaquin each physician prescribed to treat each plaintiff’s infection, and each individual plaintiff’s medical history, including their various risk factors for the injury alleged such as age, concomitant medication use including corticosteroids, prior injury, and other factors, all made consolidation inappropriate.

Moreover, defendants argued that consolidation would be prejudicial to them because there are complicated causation issues in each case, and multiple plaintiffs would testify regarding similar injuries, which could cause jury confusion. See In re Consol. Parlodel Litig., 182 F.R.D. 441, 447 (D.N.J. 1999) (“A consolidated trial . . . would compress critical evidence of specific causation and
marketing to a level which would deprive [the defendant] of a fair opportunity to defend itself.”).

At this stage of the MDL, the court concluded, consolidation was not merited. With respect to
the consolidation of cases, the Manual for Complex Litigation notes, “If there are few prior verdicts, judgments, or settlements, additional information may be needed to determine whether aggregation is appropriate. The need for such information may lead a judge to require a number of single-plaintiff, single-defendant trials, or other small trials.” Manual for Complex Litigation § 22.314, at 359 (4th ed. 2004). In the mass tort involving breast implants, the courts noted that that “[u]ntil enough trials have occurred so that the contours of various types of claims within the . . .
litigation are known, courts should proceed with extreme caution in consolidating claims.” In re Bristol-Myers Squibb Co., 975 S.W.2d 601, 603 (Tex. 1998).

To date, there are over 240 federal court cases in this MDL and just under 100 state court cases addressing claims similar to those brought by the bellwether plaintiffs. Indeed, this is a still growing MDL, found the court, the exact factual and legal contours of which are still undefined. The parties continue to conduct critical discovery, including deposing plaintiffs’ prescribing physicians. The merits of the parties’ arguments have not been tested at trial or in dispositive motions.

The court recognized that "the stakes are high" because the initial bellwether trials in this MDL may serve as the basis for the parties’ resolution of remaining, pending cases. Thus, although plaintiffs
appear to have demonstrated some commonalities in fact and law among the three
individual plaintiffs’ cases, this motion was denied at this time. 

Digitek MDL Update

Recent developments in the Digitek MDL.  The presiding judge in the federal Digitek multidistrict litigation has selected five bellwether cases to be tried.  Readers of MassTortDefense know that an increasingly common case management technique in consolidated or coordinated litigation is the use of bellwether trials, with the hope that early verdicts will impact the resolution of cases down the line.  Judge Goodwin issued Pretrial Order (PTO) No. 47, which assigned the following five cases for trial, in this order:

 • David Kelch, et al. v. Actavis Totowa, LLC, et al., 2:08-cv-01282

 • William J. Young, et al. v. Actavis Totowa, LLC, et al., 2:09-cv-00498

 • Jacquelyn K. Fox, et al. v. Actavis Totowa, LLC, et al., 2:09-cv-00389

 • Karen Sheahan, et al. v. Actavis Group, et al., 2:08-cv-01051

 • Scottie Vega, et al. v. Actavis Group hf., et al., 2:09-cv-00768

Readers may recall that the federal Digitek product liability cases, alleging that Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC released Digitek tablets containing more than the appropriate dosage to the public in 2008, were transferred to an MDL  last August. The plaintiffs allege that the tablets can cause digitalis toxicity in patients with renal failure. This condition can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

The MDL court also recently ordered the plaintiffs to file their class certification motion and brief in support of their "economic loss" class by Jan. 20, 2010.  Defendants’ response brief shall be filed and served thirty days after the filing of such class certification motion and accompanying brief, said the order.

The court also entered amended PTO #48 (Joint Hearing to Address Challenges to Scientific and Technical Evidence). In the spirit of cooperation and collegiality evident since the inception of this MDL, said the court, several distinguished state judicial officers presiding over certain consolidated Digitek actions have graciously agreed to conduct a joint hearing to address the scientific and technical issues presented in this litigation for resolution pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its federal and state progeny. Those issues are best addressed, said the MDL court,  through coordinated proceedings, albeit with each presiding judicial officer giving separate and individualized attention, and disposition, to the evidence and arguments as they relate to his or her assigned consolidated civil actions. The court recognized that each state may have its own standards and procedures for expert testimony designed to ensure the reliability and relevance of evidence based upon scientific, technical and other specialized knowledge.  That joint hearing is scheduled for October, 2010.

This is just the latest step in efforts for such coordination. Pretrial Order (PTO) No. 11 concerned state and federal coordination. It ordered lead and liaison counsel for the plaintiffs and defense to endeavor to coordinate activities between the federal and state litigation. It also ordered the creation of a joint document depository for use by parties in the federal-state litigation. The Order provided a mechanism for cross-noticing depositions. The next status conference is scheduled for Thursday, February 11, 2010 at 9:00 a.m.
 

 

 

CAFA Mass Tort Removal in Drug Case

A federal court in Illinois recently denied remand of approximately 100 cases involving Trasylol, an anti-bleeding drug, citing the Class Action Fairness Act. Gilmore v. Bayer Corp., 2009 WL 4789406(N.D. Ill., 12/10/09). (Federal Trasylol litigation was consolidated in 2008 in the Southern District of Florida. In re Trasylol Prods. Liab. Litig., No. 08-MD-1928 (S.D. Fla.). The plaintiffs typically assert that the product causes heart and kidney complications, and that the defendants allegedly failed to warn of the risks.)

The suit was originally filed in state court. The defendants removed the case, but Judge G. Patrick Murphy remanded it for lack of federal jurisdiction. Additional plaintiffs were added in October, followed by a second removal motion. The defendants asserted diversity of citizenship under CAFA. The plaintiffs again sought remand.

The Southern District of Illinois ruled that the removing defendants asserted correctly that this case was a removable “mass action” within the meaning of CAFA. Among the actions covered by CAFA is a “mass action,” defined by the statute as “any civil action ... in which monetary relief claims of 100 or more persons are proposed to be tried jointly on the ground that the plaintiffs' claims involve common questions of law or fact,” and in which there is minimal diversity of citizenship (at least one plaintiff is not a citizen of the same state as at least one defendant) and the plaintiffs each seek a recovery exceeding $75,000, exclusive of interest and costs. 28 U.S .C. § 1332(d)(11)(B)(i).

The court concluded that an independent review “discloses plainly that the removal of this case is proper under the CAFA.”  The operative complaint asserted claims on behalf of one hundred persons, the minimum number of plaintiffs required for the exercise of jurisdiction pursuant to CAFA's “mass action” provisions.  Further, this case obviously presented questions of law and fact common to the claims of all one hundred plaintiffs, said the court. Common questions of fact and law included, for example, what information Bayer, Bayer LLC, and Bayer Healthcare possessed concerning the alleged harmful effects of Trasylol, what information they elected to disclose to physicians and patients about those harmful effects, and what information they were required by law to disclose about those effects, according to the court.

With respect to the requirement of minimal diversity of citizenship, this jurisdictional prerequisite was satisfied in this case as plaintiff Thomas Gilmore is a citizen of Washington and Bayer is incorporated under Indiana law and has its principal place of business in Pennsylvania.

Finally, with respect to the jurisdictional amount in controversy under the CAFA's “mass action” provisions, the Court noted that in other cases involving allegations of personal injuries allegedly caused by the drug similar to the allegations contained in the operative complaint in this case that the plaintiffs' claims individually exceeded $75,000.

Our readers know that Congress enacted CAFA to allow more interstate class actions to be heard in federal court, and to address class action abuse.  "Mass actions" were recognized as class actions in disguise, and included in CAFA the provision to prevent the statute's objectives from being undermined by these "close substitutes that escape the statute's application." The courts increasingly offer a common sense reading of CAFA  that thwarts any attempt by plaintiffs' counsel to avoid federal court through the class-action substitute.

Summary Judgment in Remicade Case

Defendants were granted summary judgment in a case in which the parents of a young woman alleged her death was caused by the infusion treatment Remicade.  Mack v. AmerisourceBergen Drug Corp., 2009 WL 4342513 (D. Md. 11/24/09).  The lesson here for defendants is to put plaintiffs to their proof on every element of a claim.

Crystal Ann Mack was diagnosed with a severe form of Crohn's disease, an inflammatory disease affecting the gastrointestinal tract. In the autumn of 2006, Ms. Mack was hospitalized on two occasions and ultimately diagnosed with anemia, vomiting, weight loss, and various other symptoms. Her treating physician recommended that Ms. Mack undergo Remicade treatments. She received four infusions, in accordance with the medication's dosing instructions. Later, Mack fell unconscious in her home and died. Mack's parents sued three defendants, the drug makers and the distributor, alleging that Mack died of a cardiac arrhythmia that was proximately caused by Remicade.

The defendants sought summary judgment.  Analyzing the product liability claims first, the court concluded that plaintiffs' claims cannot survive summary judgment because they did not establish an issue of fact on whether Remicade is a defective product. Plaintiffs made great efforts to prove specific and general causation, but they made no adequate showing with respect to the issue of defect. Because a showing of defect is an independent prerequisite for a products liability claim, the court didn't even feel the need not address whether plaintiffs satisfied their burden on the issue of causation.

In order to recover on a product defect claim, under the applicable state law, a plaintiff must prove that a defect which renders the product unreasonably dangerous might arise from the design of the product, a deficiency in its manufacture, or from the absence or inadequacy of any instructions or warnings as to its safe and appropriate use. The court noted that the plaintiffs did not assert a failure-to-warn theory.

Under Maryland law, courts may apply both the “risk/utility” test and the “consumer expectation” test when evaluating the efficacy of design defect claims. The “risk/utility” test involves an assessment of “whether the benefits of a product outweigh the dangers of its design.”  Alternatively, a drug could be deemed unreasonably dangerous if it is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. Here, plaintiffs merely cited the legal standards for alleging and proving defect. 

Moreover, plaintiffs failed to present expert testimony on the issue of defect.  The testimony of the doctors largely focused on the issue of causation, and they failed to explain how Remicade was unreasonably dangerous. This shortcoming was especially damaging to plaintiffs' claims, because the issue of defect in this case involved technical medical questions beyond the common knowledge of laypersons.

Nor was there sufficient circumstantial evidence of defect. Plaintiffs' counsel proffered several miscellaneous documents, including internal corporate memoranda and correspondence that referred to the exhibited side effects of Remicade. However, such documents did not militate for the submission of the defect issue to a jury. The fact that a drug may exhibit certain adverse side effects does not, by itself, create an issue of material fact on whether the drug is unreasonably dangerous. The courts have recognized that all drugs involve risks of adverse side effects in those who take them.  In the face of FDA approval, plaintiffs would need to provide a much greater evidentiary showing to establish that the medication's attendant risks outweigh its benefits, the necessary showing under the “risk/utility” test.

 


 

MDL Status Denied in Pharma Case

The JPML has denied centralization of the litigation accusing a drug maker of fraudulently promoting and allegedly misrepresenting the safety of 11 prescription drugs including Viagra
and Zoloft.  In re: Pfizer Inc. Marketing and Sales Practices Litigation, MDL Number 2115.

The Panel said that these actions do, on their face, share some allegations that defendants engaged in a fraudulent scheme to promote different prescription drugs: Geodon, Zyvox, Lyrica, Aricept, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec. According to
plaintiffs, the company (1) promoted the drugs to physicians by offering them inducements, (2) promoted the drugs at doses or for durations of use that were not medically safe or efficacious, (3) made false representations about the safety and efficacy of the drugs, and (4) promoted certain of the drugs for non-indicated “off-label” uses.

But, the named plaintiffs allege that they themselves each took only one of those eleven drugs, and that they did not take the same drugs.  Given that each of the eleven drugs necessarily has a different clinical, regulatory, medical, and promotional history, and that it is at least questionable whether a plaintiff can prosecute claims regarding drugs that he or she never actually took, the Panel was not convinced that centralization under Section 1407 was appropriate.

The cases thus seemed to fall in that category of litigation which the Panel may be less likely to centralize because the underlying actions raise primarily individual, not common, issues, as when they involve many different defendants, diverse plaintiffs, or different modes of exposure to the allegedly offending products.
 

 

Summary Judgment Granted on Successor Liability Claim

The issue of successor liability is a recurring one in products liability, and the specter of mass tort liability should be an important aspect of due diligence in corporate acquisitions. This point is illustrated by a recent case in which the federal court in Oregon granted summary judgment to alleged successor corporations of a company that manufactured allegedly defective pain pumpsCox v. DJO LLC, Case No. 07-1310 (D. Or. 11/16/09).

Plaintiffs underwent arthroscopic shoulder surgery in which surgeons inserted pain pump devices in their shoulder joints to deliver pain medication via catheter.  Plaintiffs alleged they subsequently developed glenohumeral chondrolysis - a condition involving the deterioration and loss of cartilage in the shoulder joint.  McKinley LLC manufactured the pain pumps devices, part of product lines known commercially as the Accufuser and beeLINE.  Plaintiffs alleged strict products liability and negligence against McKinley LLC as the manufacturer, and against Moog Inc. and Curlin Medical Inc. as successors in interest. Defendants Moog and Curlin moved for summary judgment on plaintiffs' claims that they were liable as the successor corporations, arguing that the acquisition of the Accufuser and beeLINE product lines was nothing more than a purchase of assets that cannot establish successor liability.

Under Oregon law, as is the general rule, when a corporation purchases the assets of another corporation, the purchasing corporation generally does not assume the debts and liabilities of the selling corporation. However, the purchaser may be responsible for the seller's liabilities if: 1) the purchasing corporation expressly or impliedly agrees to assume those liabilities; 2) the transaction
constitutes a consolidation or merger of the corporations; 3) the purchasing corporation is a "mere continuation" of the selling corporation; or 4) the corporations effectuated the transaction for
fraudulent purposes to escape liability.

The court reviewed the possible exceptions. First, Moog and Curlin did not expressly or impliedly agree to assume liability arising from pain pump products manufactured and sold by McKinley LLC prior to the conveyance of assets. To the contrary, the Assignment and Merger Agreement expressly and specifically identified the existing liabilities that were transferred after the merger.

Second, despite plaintiffs' repeated assertions, neither Moog nor Curlin merged or consolidated with McKinley LLC. Instead, it is undisputed that Curlin merged with McKinley Medical Corp., a separate corporation,  and acquired the Accufuser and beeLINE product lines as a result. That is, Moog and its wholly owned subsidiary, Curlin, entered into an agreement to purchase McKinley LLC's Accufuser and beeLINE product lines. Under the terms of the agreement, McKinley LLC transferred these product lines to McKinley Medical Corp., a subsidiary it created solely for purposes of the asset transfer. Curlin then merged with McKinley Medical Corp. and acquired the product lines. Plaintiffs tried to imply that this transaction constituted a de facto merger between McKinley LLC and Moog/Curlin, because it effectively continued the pain pump business of McKinley LLC. Plaintiffs emphasize that the manufacture, distribution, and sales of the Accufuser and beeLINE pain pumps continued uninterrupted. However, Oregon has explicitly rejected a "product line" exception to the general rules governing successor liability.

Third, the evidence did not support a finding that Moog or Curlin is a "mere continuation" of McKinley LLC. "A successor corporation is merely a continuation of the predecessor
corporation, despite a business transformation, if it is substantially the same as the predecessor corporation." Alicki v. Intratec USA, Inc., 769 F. Supp. 336, 340 (D. Or. 1991). Here, importantly, McKinley LLC retained assets after the Assignment and Merger Agreement and distributed the Walkmed pain pumps until 2007. McKinley LLC remains an existing, separate corporate entity and an active defendant in this cases.  Moreover, no continuity of management, directors, or
shareholders exists between McKinley LLC and Curlin or Moog.

Finally, plaintiffs presented no persuasive evidence that the corporate forms of McKinley LLC, Curlin, or Moog were improperly manipulated for purposes of fraud, or that the Assignment and
Merger Agreement left McKinley LLC insolvent or otherwise unable to answer for its debts.

MDL Court Denies Class Certification in Device Litigation

The court overseeing the MDL concerning panacryl sutures declined last week to certify a proposed national class action. In re Panacryl Sutures Products Liability Cases, 2009 WL 3874347 (E.D.N.C. 11/13/09).

Panacryl Sutures are synthetic, braided, un-dyed, absorbable surgical sutures, designed to remain in the body for 24-36 months after surgery to provide wound support. Various plaintiffs alleged that Panacryl Sutures were defective in that they allegedly caused a high rate of foreign body reactions when used as directed. Plaintiffs alleged also that defendants failed to provide adequate warning of the dangers associated with the devices. Plaintiffs eventually filed a Motion to Certify a National Class Action.

The court first addressed the difficult choice of law issue -- a central, overarching issue in a proposed national class.  The court analyzed the choice of law factors -- interests of interstate comity, the interests underlying the field of tort law, the interests of the parties, the interests of judicial administration, and the competing interests of the various states, and concluded that under New Jersey's choice of law rules it should apply the substantive laws of each class member's home jurisdiction to his or her claims.  Again, a not unusual result, and is one which directly impacts the class certification elements.

Turning to the Rule 23(a) requirements, the court first focused on Rule 23(a)(3), commonly referred to as the “typicality” requirement, which states that the claims and defenses of the class representatives must be typical of the claims of the other class members.  Here, because plaintiffs had not shown that the prospective class representatives' claims can encompass or would take into account the varying substantive laws governing every class member, this element was not met.

Similarly, although the named plaintiffs interests are in some ways similar to the interests of class, the “adequate representation requirement overlaps with the typicality requirement because in the absence of typical claims, the class representative has no incentive to pursue the claims of the other class members.” In re American Med. Sys., 75 F.3d 1069, 1083 (6th Cir., 1996). Plaintiffs here did not meet their burden of showing that the claims of the prospective class representatives would take into account the variations in state law. The court found that therefore the prospective class representatives here did not satisfy Rule 23(a)(4).

Turning to Rule 23(b), the court observed that in class actions governed by the laws of several states, variations in state law will often overwhelm any common issues. See Ward v. Dixie Nat'l. Life Ins. Co., 257 F. App'x 620, 628-29 (4th Cir. 2007), cert denied, 128 S.Ct. 82 (2008), Castano v. Am. Tobacco, 84 F.3d 741 (5th Cir.1996).  To have any shot here, plaintiffs must provide an “extensive analysis” of the laws of the interested jurisdictions showing that variations among the applicable state laws do not pose “insuperable obstacles” to class certification. Walsh v. Ford Motor Co., 807 F.2d 1000, 1017 (D.C.Cir.1986); Gariety v. Grant Thornton, LLP, 368 F.3d 356, 370 (4th Cir.2004). Plaintiffs did not carry this burden.

Moreover, courts have generally founds that common questions of fact do not predominate in medical products liability cases. See In re American Med. Sys., 75 F.3d at 1074 (decertifying class of users of penile implants because “complications ... may be due to a variety of factors, including surgical error, improper use of the device, anatomical incompatibility, infection, device malfunction, or psychological problems.”); Zinser v. Accufix Research Inst., Inc., 253 F.3d 1180 (9th Cir.2001) (affirming denial of class certification in an action involving allegedly defective pacemakers). Here, plaintiffs alleged a variety of complications from the product, each of which has potential other causes. And Panacryl Sutures were used in a variety of surgical procedures which require different skills and techniques on the part of the surgeon and present different risks of post-surgical complications. These individual facts would have to be weighed against the alleged defects of Panacryl Sutures in light of the normal background rate of the various post-surgical complications identified by plaintiffs.  So no predominance of common issues.

This in turn led the court to conclude that the difficulties in managing the class proposed here would undermine the theoretical efficiencies that might be obtained through class certification.

Perhaps most importantly to readers of MassTortDefense, plaintiffs' last-ditch effort turned to the "issue class." But, noted the court, Rule 23(c)(4) may not be used to manufacture predominance for the purposes of Rule 23(b)(3). See Castano v. Am. Tobacco Co., 84 F.3d 734, 745 n.21 (5th Cir.1996) (“A district court cannot manufacture predominance through the nimble use of subdivision (c)(4).”); Peoples v. Wendover Funding, Inc., 179 F.R.D. 492, 501 n.4 (D.Md.1998) (“Rule 23(c)(4) does not permit a federal district court to certify a class under Rule 23(b)(3) by splitting a class action to create predominance.”). Plaintiffs' proposed issues trial plan did not eliminate the necessity of applying the laws of several jurisdictions or the individualized inquiry into whether Panacryl Sutures caused each plaintiff's injuries. And even under plaintiffs' proposed c4 trial plan, the difficulty of applying the laws of several states to the issues of liability and general causation would remain.  Lots of reasons to deny class certification.

Causation Proof Still Insufficient In Drug Case

A while back we posted about an interesting toxic tort case involving important causation issues. See Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.).  A Minnesota appeals court recently refused to rehear its prior affirmance of summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer.  2009 Minn. LEXIS 648. 

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone replacement therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants. In November 2001, Zandi alleges she was diagnosed with "hormone-dependent breast cancer." She contended that the HRT drugs caused her cancer. 

The trial court found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony. Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to try to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Zandi's claims were based on the following propositions: 1) it is supposedly generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual. The appellate issues revolved around the second.

Plaintiff's experts based their specific causation opinions in part on "differential diagnosis."  As readers of MassTortDefense know,  differential diagnosis, sometimes called “differential etiology”  is a process through which all the scientifically plausible causes of an injury are “ruled in,” and the expert then “rules out” the less plausible causes until reaching the one that theoretically cannot be ruled out.  If you've watched "House" on TV, you have seen the use of differential diagnosis to discover what disease a patient is suffering from.  Less traditional, and more questionable, is the use of the technique to discover what is the cause of the disease in the patient.  Most doctors don't care as much about the cause of the disease as getting the right disease and treating it.  As used by toxic tort plaintiffs, differential diagnosis adopts a process of elimination to identify not just the injury (which may be debated) but also the cause; in theory, it seeks to eliminate the possibility of competing causes or confounding factors. 

Again, in performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains. Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one or a few causes would necessarily implicate another. For differential diagnosis to be sufficiently reliable to even come close to proving causation, even assuming one accepts the method in this context, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable. But additional risk factors that plaintiff failed to adequately account for here in this case included family history. When faced with this dilemma, as is common when a disease has many idiopathic cases, plaintiff's experts simply suggest that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses, as long as "major" or "most" explanations are ruled out.  Courts should be wary of this.

Courts generally recognize that the proffered expert must have a sufficient basis to “rule in” the drug or toxic substance at issue as a plausible cause of plaintiff’s injury. E.g., Jazairi v. Royal Oaks Apts., 217 Fed. Appx. 895 (8th Cir. 2007).  But this case is a good reminder that the plaintiff's expert testimony must also reliably “rule out” the other plausible causes of the injury--  again, especially difficult when its causes are largely unknown.  On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”  See also Perry v. Novartis, 564 F. Supp.2d 452 (E.D. Pa. 2008).

This clear reasoning can be contrasted with the inexplicable finding of the 8th Circuit in Scroggin v. Wyeth, 2009 WL 3518245 (8th Cir. Nov. 2, 2009), which accepted plaintiff's carefully constructed circular reasoning.  Unable to prove that the breast cancer was caused by hormone therapy drugs, plaintiff's expert simply re-diagnosed the disease as hormone-induced breast cancer.  This allowed the expert to engage in a so-called differential diagnosis to determine the cause of the breast cancer simply by ruling out the two possible sources of these hormones: (1) plaintiff produced the hormones herself, or (2) they came from the hormone replacement therapy she had allegedly taken for the past eleven years.  Under this circular reasoning, any form of cancer can easily be linked to the defendant's product because it will be re-characterized as the sub-type of disease caused by the substance at issue. 
 

 

Update on Digitek Litigation

In the Digitek MDL, the parties have been wrangling over the defense motion for a Lone Pine order. See generally Lore v. Lone Pine, No. L-336006-85, 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986).

Dozens of product liability cases alleging that defendants Actavis Totowa LLC, Actavis Inc. and Actavis Elizabeth LLC marketed Digitek tablets containing double the appropriate dosage were transferred to an MDL assigned to Chief Judge Goodwin of the Southern District of West Virginia last summer. In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.).
 

Defendants recently moved for a Lone Pine order under which each plaintiff must submit an "affidavit from a medical expert in each case establishing that there is medical evidence of digoxin toxicity." Readers of MassTortDefense recognize this important and logical procedural tool for management of mass toxic tort litigation.  When the major factual battles will be over injury and causation, it may make sense to focus discovery on these issues, and prior to resorting to expensive and time-consuming discovery, to require plaintiffs to come forward with some prima facie showing of injury and specific causation, or as the court put it, "some evidence of certain elements of their claims, e.g. medical causation, to support a credible claim."

The plaintiffs in the federal Digitek multidistrict litigation filed a brief opposing the motion, arguing that the discovery in the MDL is still in its "incipient stages."  As they typically do, the plaintiffs argued that such orders "effectively function as untimely and unjust summary judgment devices and violate the discovery rules for expert witness disclosures and reports." They also argued that they have provided significant case-specific discovery in the form of Plaintiffs' Fact Sheets and records authorizations.

The court entered PTO #43 (Order re Request for Lone Pine Order), saying the motion is taken under advisement pending completion of basic fact discovery of Group 1 cases. Under the latest schedule, Plaintiff shall serve their reports from liability experts no later than March 15, 2010.  The parties shall complete their depositions of Plaintiffs’ liability experts no later than May 28, 2010.  Defendants shall serve their reports from liability experts no later than June 15, 2010. The parties shall complete their depositions of Defendants’ liability experts no later than August 31, 2010. 

At the November 20, 2009, conference each party is to present to the court their choice of five cases that they believe to be representative plaintiffs for trial in accordance with PTO #38, governing the creation of a trial pool upon completion of basic fact discovery, including but not limited to the depositions of plaintiffs, plaintiffs’ physicians who prescribed Digitek® to them, physicians who treated Plaintiffs for alleged digoxin toxicity, and pharmacists who filled plaintiffs’ prescriptions for Digitek®.
 

MDL Created For Zicam Litigation

The Judicial Panel on Multidistrict Litigation has decided to consolidate multiple federal cases arising from the Zicam product line.  IN RE: ZICAM COLD REMEDY MARKETING AND SALES PRACTICES LITIGATION, MDL No. 2096.  Plaintiffs moved, pursuant to 28 U.S.C. § 1407, for coordinated or consolidated pretrial proceedings of multiple proposed class actions.  By the time the Panel issued its Order, there were 40 related actions pending in 26 federal districts.

Many of the pending cases were consumer fraud class actions against Matrixx Initiatives, Inc., and its subsidiaries Zicam, LLC, and Zicam Swab, LLC.  Plaintiffs opposed centralization of any actions alleging personal injury claims. But the Panel found that both kinds of actions involved sufficient common questions of fact, and that centralization of the actions under Section 1407 would serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. The actions share factual questions regarding, inter alia, the marketing and sale of three Zicam nasal cold remedy products, and alleged injuries sustained by the use and/or purchase of those products, particularly whether the products cause anosmia (the loss of sense of smell). Centralization under Section 1407, the court found, would eliminate duplicative discovery, prevent inconsistent pretrial rulings (particularly with respect to class certification), and conserve the resources of the parties, their counsel and the judiciary.

The Panel declined to separate purported consumer class actions from other actions alleging personal injury. Centralization of all actions in this docket would, said the court, allow a single judge to structure pretrial proceedings to accommodate all parties’ discovery needs while ensuring that the common parties and witnesses are not subjected to discovery demands that duplicate activity that will or has occurred in other actions.

The court chose the District of Arizona as the appropriate transferee forum. The defendants are based within the District of Arizona, and relevant documents and witnesses are likely found there, observed the Panel. In addition, centralization in the District of Arizona will allow for coordination of the federal actions with related litigation pending in Arizona state court.

 

Third-Party Payor Class Action Alleging Off-Label Marketing Dismissed by Federal Court

The federal court has dismissed a putative class action brought by a group of municipal benefit funds over a pharmaceutical company's alleged efforts to market drugs for uses that did not have regulatory approval. Central Regional Employees Benefit Fund, et al. v. Cephalon Inc., No. 09-cv-03418 (D.N.J. Oct. 15, 2009).

Plaintiffs commenced this putative class action against defendants alleging violations of the New Jersey Consumer Fraud Act (“NJCFA”), and for fraudulent concealment, and “illegal fraud.”  The plaintiffs defined their putative class as including “all governmental entities in the United States of
America who have been caused to expend monies" for certain drugs as a "result of the off label promotion by the defendants.”  They alleged that defendant Cephalon promoted drugs for uses other than those approved by the FDA, and that as part of its “off label” marketing efforts, Cephalon allegedly made false representations regarding the use and application of several in particular, Provigil, Gabitril, Actiq and Fentora.

The case, thus, falls in the growing body of cases by governmental third-party payors searching for a windfall in revenue by challenging the marketing practices of pharmaceutical companies over drugs that are effective, are safe, are prescribed by physicians, and are often affirmatively recommended by other branches of the entity bringing suit.  As many courts have held, off-label use is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine. E.g., Southard v. Temple University Hospital, 566 Pa. 335, 340 781 A.2d 101, 104 (2001) (quoting Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001)). Such use, necessary because medical practice inevitably runs ahead of the slower pace of governmental regulation, is generally accepted, widespread in the medical community, and often is essential to giving patients optimal medical care. Buckman, 531 U.S. at 351 & n.5 (citation omitted).  Thus, a physician, using his or her best medical judgment for the benefit of his patient, generally is free to use an approved product in a manner different from that for which the FDA has approved. Cabiroy v. Scipione, 767 A.2d 1078, 1082 (Pa. Super. 2001).

The FDA has accepted off-label use for decades:

  • Accepted medical practice often includes drug use that is not reflected in approved drug labeling. . . . a physician may prescribe a drug for. . .patient populations that are not included in approved labeling. Such. . .‘unlabeled’ uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature. . . . Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations.

FDA, “Use of Approved Drugs for Unlabeled Indications,” 12 FDA Drug Bulletin 4, 5 (1982). 

It is clear that physicians may prescribe a drug off-label for an unapproved population without FDA knowledge or approval.  Blain v. Smithkline Beecham Corp., 240 F.R.D. 179, 182 (E.D. Pa. 2007). And courts are “not willing to accept that a plaintiff could somehow be injured by purchasing a drug that is as effective, or more effective, than alternative treatments simply because the drug is marketed off-label.”  In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *10 (D.N.J. July 10, 2009). Absent some “adverse effects,” a “theory under which [plaintiffs] would be entitled to reimbursement for some or all of the purchase price of [a drug] whose benefits they clearly enjoyed. . . is patently absurd.”  Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 380 (D.N.J. 2004).  

Cephalon moved to dismiss the NJCFA and common law fraud claims, contending that the plaintiffs failed to plead specific acts of fraud to support the legal conclusions contained in the Complaint. The plaintiff’s factual allegations must be enough to raise a right to relief above the speculative level. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555-56 (2007). Also, the plaintiffs’ common law fraud claims were subject to the heightened pleading standards of Rule 9(b), which requires that in all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particularity. Fed.R.Civ.P. 9(b).

Cephalon argued that the plaintiffs, as third-party payors of prescription medication benefits, are not “consumers” under the NJCFA. The court said that the nature of the transaction, not the identity of the purchaser, determines whether the NJCFA is applicable. J & R Ice Cream Corp. v. Cal. Smoothie Lic. Corp., 31 F.3d 1259, 1273 (3d Cir. 1994).  For a NJCFA plaintiff to be a consumer respecting the transaction in question, the business entity must be one who uses economic goods, and so diminishes or destroys their utilities. However, third-party payors essentially serve as middlemen or insurers, paying all or part of the cost of a beneficiary’s drugs in return for a stream of payments from the beneficiary.  Because third-party payors do not use or consume prescription medications themselves, they are not “consumers” within the meaning of the NJCFA, and that statute was therefore inapplicable to the circumstances alleged in the Complaint.

Next, the court found that the plaintiffs’ common law fraud claims failed to meet the pleading requirements of Twombly, Iqbal, and Rule 9(b). Count II of the Complaint, fraudulent concealment, referred merely to an unspecified “transaction and/or providing of the prescription drugs Provigil,
Gabitril, Actiq and Fentora.” The court was at a loss to discern to what transaction the plaintiffs were
referring, as the Complaint fails to identify or explain the who,what, where, why, and how of any “transaction.”  Mere allegations that Cephalon provided prescription drugs, without saying to whom or under what circumstances, wholly failed to state a claim for fraud. 

The plaintiffs attempted to rely on a reference in the Complaint to a proceeding in the Eastern District of Pennsylvania in 2003, brought pursuant to the False Claims Act, 31 U.S.C. § 3729 et seq., wherein Cephalon was alleged to have engaged in “misbranding” of its products. However, referring to a plea agreement and civil settlement in another action does not satisfy the plaintiffs’ burden; it is well-established that off-label marketing of an approved drug is itself not inherently fraudulent. Merely alleging that Cephalon marketed the drugs at issue for off-label purposes did not state a claim for fraud.

The court thus also dismissed the claims for fraudulent concealment and illegal fraud, but without prejudice.
 

PhRMA Issues New Principles on Clinical Trials

Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs frequently assert that drug makers missed or ignored safety signals present in those trials. 

In reality, developing new therapies to treat disease and to improve quality of life is a long and complex process. And a critical part of that process is clinical research -- without clinical research studies, no new medicines could be made available to patients.

Last week PhRMA issued revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results with a goal of helping assure that the clinical research conducted by pharmaceutical research and biotechnology companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients.

Among the key changes in the updated Principles: Increased transparency about clinical trials for patients and healthcare professionals; enhanced standards for medical research authorship; and improved disclosure to better manage potential conflicts of interest in medical research.

PhRMA members have indeed had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. And actually, many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.

The key issues addressed are:
• Protecting Research Participants
• Conduct of Clinical Trials
• Ensuring Objectivity in Research
• Providing Information About Clinical Trials

Of particular note to my readers may be the document's call for consistency with standards of the International Committee of Medical Journal Editors as journal guidelines for authorship;  under these, anyone who: (1) provides substantial contributions into the conception or design of a study, or data acquisition, or data analysis and interpretation; and/or (2) writes or revises the manuscript involving important intellectual content; and/or (3) has final approval of the version to be published, should receive appropriate recognition as an author when the manuscript is published. Conversely, individuals who do not contribute in this manner do not warrant authorship. We have posted about this issue before.

As always, the guidelines are purely voluntary, and even member companies are free to adopt their own best practices and mold general guidance to their particular situations.

 

FDA Issues Strategic Plan For Risk Communication

The U.S. Food and Drug Administration last week issued a Strategic Plan for Risk Communication, outlining the agency’s new efforts to disseminate public health information. The plan lays out a framework for the FDA to provide information about regulated products to health care professionals, patients, and consumers. The purpose of the document is to describe the FDA’s strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment, where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their health and well-being.

The plan defines three key areas – FDA’s science base, its operational capacity, and its policy and processes – in which new strategic actions might help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years.

 They include:

  • Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
  • Producing a research agenda for public dissemination
  • Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
  • Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
  • Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes

The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure their effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations. FDA noted that the public may not understand the context within which FDA makes decisions, for example, about recalls of particular foods or medical products.  By helping the public better understand how it approves and/or recalls products, FDA hopes to complement its premarket review and postmarket actions. In the past, FDA’s communication efforts arguably were largely restricted to overseeing the key vehicle for communicating risk information to the public—the labeling of FDA-regulated products. The process of negotiating with product manufacturers about changes to labeling or decisions to recall a product can be lengthy. Now, as the Internet and emerging technologies both enable and feed the public’s demand for greater transparency and communication frequency, these protracted waiting periods are giving way to communication in real time. Thus, designing a contemporary risk communication strategy is critical, says the plan, to FDA’s efforts to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology.

The plan comes three years after a study by the Institute of Medicine opined that the FDA had fallen short of its task of making sure that the drugs that come to the market are safe for use.  The IOM's recommendations included clarification of the FDA's role in gathering and communicating
additional information on the risks and befits of marketed products.  The FDA then created a new risk communication advisory panel to develop best practices for communicating the risks and benefits to the public.


 

FDA Releases Draft Guidance on Risk Evaluation and Mitigation Strategies

The FDA has released its draft guidance on Risk Evaluation and Mitigation Strategies, or REMS, laying out guidelines for how pharmaceutical companies should follow the plans, and describing the consequences for not doing so. The draft guidance for industry entitled ‘‘Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,’’  follows on the Food and Drug Administration Amendments Act of
2007 (FDAAA) which added new provisions to the Federal Food, Drug, and Cosmetic Act giving FDA the authority to require REMS.

For every drug approved by the FDA, the risks associated with its use are communicated through the labeling/product package insert. The manufacturer or the FDA may determine that a formal ongoing effort may be needed to monitor and manage risk issues, and thus that a Risk Evaluation and Mitigation Strategy is necessary to go beyond traditional product labeling to ensure that the benefits outweigh the risks on an ongoing basis.  FDA may now require REMS for any NDA, ANDA, or BLA, at any stage of the product life-cycle.  REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.  About 60 medicines are currently sold with such plans.

We have posted before about the opportunities and pitfalls in REMS that could have a significant effect on future litigation involving the product. The REMS process may engender “bad documents” (a paper trail that casts the company or its products in a bad light). On the other hand, one of the common claims asserted in product litigation is that a manufacturer was aware of and failed to adequately warn about its product’s risk. As the REMS process is specifically designed to increase the effectiveness of warnings to the health care and patient communities, it may bolster a defense against the assertion that the manufacturer failed to provide adequate warnings.

The new draft guidance describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents, and how to communicate with FDA about a REMS. The draft guidance was issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the format and content of proposed REMS, REMS assessments, and proposed REMS modifications.

REMS required by the FDA are subject to regulatory inspection and are enforceable under the FDCA as amended by FDAAA.  A drug may be considered misbranded if the responsible person for that drug fails to comply with a requirement of the approved strategy.  Firms that don't follow their plans will face fines of up to $10 million for a continued violation, according to the FDA guidance.
 

IOM To Study 510(k) Process for Medical Devices

The U.S. Food and Drug Administration announced recently that it had commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States. (Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine is supposed to provide independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.)

The IOM study will examine a premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will apparently convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

The FDA classifies medical devices into three categories according to their level of risk. Class III devices (highest level of risk) generally require premarket approval to support their safety and effectiveness before they may be marketed. Class I and Class II devices pose lower risks and most Class II devices and some Class I devices can be marketed after submission of certain premarket notifications— the 510(k) applications.  A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective -- that is, substantially equivalent -- to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to pre-marketing approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and thus may require premarket approval.

The 510(k) process was established under the Medical Device Amendments of 1976 with two goals: to make safe and effective devices available to consumers, and to promote innovation in the medical device industry. FDA says that during the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for a review of the adequacy of the premarket notification program in meeting these two goals.

As part of the study, the IOM will convene a committee to answer two principal questions: Does the current 510(k) process optimally protect patients and promote innovation in support of public  health? If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process? The IOM review is supposed to be completed in 2011.

The study comes after the U.S. House Subcommittee on Health held hearings concerning medical devices last June.  The Democratic majority said there is evidence of an approval system that is "broken" - - that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with sufficient confidence in their safety.  However, while critics point to a handful of device recall issues, more than 250,000 devices have gone through the 510(k) process.
 

State Supreme Court Decision Turns On Absence Of Causation Proof

The Indiana Supreme Court issued a decision recently, reminding us of the importance of fully developing the causation case, in addition to the response to plaintiff's defect allegations. Kovach v. Caligor Midwest, 2009 WL 2871172 (Ind. September 8, 2009).

The plaintiffs alleged their son was given a fatal overdose of pain medication by a nurse after a surgical procedure. The plaintiffs sued the manufacturers and distributors of the medicine cup used to administer the medication, alleging that defects in design of the cup made it unsuitable for the precise measurements necessary for drugs, and alleging a failure to warn that the cup was not suitable for precision measurement. The interior of the cup bore translucent markings to measure its contents, and graduations delineated both 15 and 30 mL. The nurse had used that type of cup frequently, both at this surgical center and at other hospitals, and she had no difficulty reading its markings. The nurse testified she filled the cup approximately half-way and administered 15 mL of medication to plaintiff's decedent.  According to decedent's father, however, who was present when the drug was administered, the nurse gave the son a full cup of medicine.

So, as is frequently the case, a potential malpractice claim is turned into a product liability claim against an ostensibly deeper pocket, unencumbered by med mal tort reform restrictions.

The plaintiffs presented expert evidence opining that the cup was defective in design and warnings, evidence that was challenged by the defense.  Plaintiffs also argued that if the medicine cup had been better suited as a precision measuring device or had contained a warning that it was not suitable for precision measurement, the decedent would not have received an overdose -- the alleged causal link.  The court did not have to reach the issues surrounding the alleged defects and the expert affidavit which plaintiffs had put forward to support their theory of defect, because the facts established that there was no such causal connection. The results of an autopsy revealed that the decedent had more than twice the recommended therapeutic level of codeine in his blood stream. The undisputed evidence thus demonstrated that if there was an overdose in this case, it was not caused by an imprecise measurement of medication attributable to less than readily discernible marks. (The plaintiff expert had estimated that the cup's imprecision could result in up to a 20% to 30% margin of error.) Rather, if the drug was the medical cause of the death, it was due to an erroneous, double dosage; the accident therefore cannot be attributed in a legal cause sense to any alleged defects in the cup itself.

Plaintiffs tried to then rely on the "read-and-heed" presumption -- i.e., the notion in some jurisdictions that the jury can presume that if an adequate warning had been given it would have been heeded. Such a presumption may aid a defendant when a warning was given.  Plaintiffs often try to use the presumption to attempt to clear the causation hurdle when no warning is given.  But the presumption does not completely dispose of the causation issue in a failure-to-warn case, said the court. The most the presumption does is establish that a warning would have been read and obeyed. It does not necessarily establish that the defect in fact caused the plaintiff's injury. The plaintiff invoking the presumption must still show that the danger which allegedly would have been prevented by an appropriate warning was the danger that actually materialized in the plaintiff's case.  

Plaintiffs could not show that element, given the circumstances of the drug usage. The judgment of the trial court granting summary judgment in favor of the cup defendants was affirmed. 

 

Medical Monitoring Decision Set For Interlocutory Appeal

Readers of MassTortDefense interested in the issues surrounding medical monitoring will want to keep their eyes on Hess v. A.I. DuPont Hosp. For Children, 2009 WL 2776606 (E.D.Pa., August 28, 2009).  The court recently granted Defendants' Petition for Certification of Immediate Appeal (to the Third Circuit).

Doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, implanted a Cheatham Platinum stent (“CP stent”) in plaintiffs, who alleged that they had been injured or were at risk of injury from the use of the CP stent. After discovery, the trial court granted summary judgment to defendants on a number of the claims, but summary judgment was denied on Count VI, the medical monitoring claim. The trial court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action if presented with the facts of these cases.

The trial court recognized that there are substantial grounds for disagreement over whether Delaware will actually recognize a cause of action for medical monitoring. While Delaware courts, including the Delaware Supreme Court, have had medical monitoring claims before them on several occasions and have not totally disavowed medical monitoring as a legally cognizable cause of action, neither have they formally recognized the tort as a legally cognizable cause of action.  (In some jurisdictions it is a remedy, not a cause of action.)

Even if the Delaware Supreme Court were to recognize a medical monitoring tort, there are substantial grounds for disagreement over whether plaintiffs here could state a claim. Plaintiffs' theory that medical devices can be the basis for a medical monitoring claim is novel, at best  (and has been rejected in many states: Drugs and devices do not present the same policy issues as involuntary exposure to environmental toxins).   Indeed, there appear to be no cases precisely like this one in which a plaintiff has alleged and a court has recognized a medical monitoring claim where the plaintiff has had a Class III medical device implanted that did not have FDA premarket approval and where the plaintiff did not offer evidence that the device was defective. The court was satisfied that plaintiff's novel theory here is one in which certification of an interlocutory order for appeal is appropriate.

Motion To Dismiss Filed in Combination Aspirin MDL

Bayer Healthcare LLC moved last week to dismiss the master complaint in the federal MDL involving combination aspirin products. In Re: Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litigation, No. 1:09-md-02023 (E.D. N.Y.). Aspirin has been sold in the United States for more than a hundred years; a daily regimen of low-dose aspirin is widely recognized as useful in preventing heart attacks and strokes.

Plaintiffs are consumers who claim to have purchased Bayer combination aspirin and dietary supplement products. They do not claim that they were injured by these products or that the products were ineffective. Instead, plaintiffs seek damages because they say they would not have purchased these products if they had known that Bayer, instead of submitting a New Drug Application (“NDA”) for each of these combination products, relied on the preexisting separate regulatory review of aspirin and the supplements. Plaintiffs allege that Bayer misled and deceived
consumers into believing that the products had been proven to be safe and effective for their marketed purposes.
 

The Motion argues that plaintiffs’ claims fail, first, because they are, in essence, private attempts to enforce the FDCA, 21 U.S.C. §301 et seq.  MassTortDefense notes that courts have repeatedly refused to construe such private attempts to enforce the FDCA as valid state law causes of action like the plaintiffs have brought in this litigation. Under the FDCA, the United States government has the exclusive power to enforce the FDA’s regulatory requirements (which include provisions relating to the approval of new prescription and over-the-counter drugs, as well as regulation of dietary supplements and food additives). The FDCA provides that “[a]ll such proceedings for the enforcement, or to restrain violations, of this Act, shall be by and in the name of the United States.” 21 U.S.C. § 337(a) (2009).

Even if a state were to recognize it, a cause of action based on a failure to obtain FDA approval would be preempted as interfering with the FDA’s approval processes. Courts have repeatedly held that private plaintiffs fail to state a claim where they, in essence, seek redress for a violation of the FDCA. Courts have applied this doctrine to dismiss a variety of causes of action, from RICO and the Lanham Act, to state law unfair competition and consumer fraud act claims. See, e.g., Mylan Labs. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993) (dismissing Lanham Act claim); In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp. 2d 1282, 1290 (C.D. Cal. 2008) (dismissing state consumer fraud and false advertising and RICO claims); Ethex v. First
Horizon Pharm. Corp
., 228 F. Supp. 2d 1048, 1055 (E.D. Mo. 2002) (dismissing deceptive trade practices claims and Lanham Act claim).

Additionally, defendant argues that plaintiffs, who do not claim harm or that their products did not work, have not alleged a cognizable injury. Accordingly, plaintiffs have not stated a claim for any of the causes of action they have brought. Under Fed. R. Civ. P. 12(b)(6), a complaint must be dismissed if it fails to articulate grounds upon which relief can be granted. Under Rule 8(a), a plaintiff’s obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do. Bell Atlantic Corp. v. Twombly, 550 US 544, 555 (2007).   The Supreme Court recently reaffirmed these principles in Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009).

These standards apply to injury and loss requirements as well as to other elements of a claim. As the Second Circuit recently explained, to state a claim for relief, a plaintiff must do more than simply allege an injury or loss – that theory must be “plausible.” McLaughlin v. American Tobacco Co., 522 F.3d 215, 227 (2d Cir. 2008). Legally cognizable theories of injury must also not require a court to “engage in a series of speculative calculations to ascertain whether, or in what amount, plaintiffs suffered a loss.” Id. at 230.  Like many convoluted consumer fraud actions, plaintiffs' claims here fail to allege a plausible theory that is open to private plaintiffs.
 

 


 

 

State Supreme Court To Address Government Use Of Contingency Fee Private Counsel

Next month the Supreme Court of Pennsylvania will hear argument in a pharmaceutical case that has implication for all readers of MassTortDefense, regardless of what industry they may represent. See Commonwealth of Pennsylvania, C/O Office of General Counsel v. Janssen Pharmaceutica, Inc., No. 24 Eap 2009 (S.Ct. Pa.).  This case presents not only significant constitutional and statutory issues, but also impacts policies affecting the public interest in open government, health care policy, and the regulation of the practice of law in the context of governmental litigation.

In the underlying case, the Commonwealth seeks damages for asserted financial harm allegedly caused by Janssen’s supposed deceptive marketing practices in promoting its anti-psychotic drug, Risperdal, for off-label uses. This action was originally filed in the Court of Common Pleas of Philadelphia County in February 2007. In June 2008, Janssen filed a Motion to Disqualify Plaintiff’s Counsel, the private Texas-based plaintiff personal injury firm of Bailey Perrin & Bailey, which had been hired by the state on a contingency fee basis.   Public records indicate that during the precise time period that the fee contract was negotiated and executed, one of Bailey Perrin’s founding partners made repeated and significant contributions, totaling more than $100,000, to Pennsylvania Governor Rendell’s re-election campaign and to the Democratic Governors Association, according to defendant.

The Commonwealth opposed the Motion; the trial court denied the Motion on December 8, 2008. Janssen thereafter sought extraordinary appellate relief in the state Supreme Court, which was granted.

The Commonwealth’s retention of contingent fee private counsel in this matter raises significant issues including whether and when state law authorizes the Office of General Counsel to enter into a contingent fee contract with outside counsel; whether the Commonwealth’s hiring of outside litigation counsel on a contingent fee basis violates the state constitution, including the separation-of-powers mandate of the Pennsylvania Constitution; and whether the Commonwealth’s hiring of outside litigation counsel on a contingent fee basis violates the due process rights of the defendant company.

In many contexts, the legal policy of the Commonwealth -- like many states -- strongly favors open, competitive bidding for contracts involving state funds. Such requirements, included in the state Constitution and various statutes, are designed to prevent fraud, eliminate bias and favoritism, and thus protect vital public interests.

Those same goals of open and good government reside in the requirement that state officials give their undivided loyalty to the people of the Commonwealth. The antithesis of these goals and policies is “pay-to-play,” the award of government contracts to major campaign contributors. This case threatens to expand the scope of pay-to-play in unprecedented fashion. The very sovereignty of the Commonwealth itself – its legal enforcement authority and parens patriae powers – should not be subject to sale. Public records reveal hundreds of thousands of dollars of contributions to the benefit of the state governor in close proximity to the issuance of a no-bid, contingency fee contract to one of the contributors, according to defendant.  The media has widely and correctly assailed the appearance of impropriety thus created.


Aside from its questionable origins, the contingent fee contract violates the core principle that attorneys pursuing actions on behalf of the Commonwealth represent a sovereign whose obligation to govern impartially is essential to its right to govern. Government attorneys must exercise independent judgment as a ministers of justice and not act simply as advocates. The impartiality required of government lawyers cannot be met here, where the private pecuniary interest inherent in the contingent fee is the primary motive force behind the bringing of this very action. By turning over sovereign prosecutorial power to contingency counsel, the Governor effectively created a new branch of government – motivated by the prospect of private gain rather than the pursuit of justice or the public welfare.

This subversion of neutrality does more than implicate the due process rights of those confronting such tainted prosecutions. Direction of state prosecutions by financially interested surrogates also damages the very public interest that such litigation is supposed to advance. Here, it is already clear that Pennsylvania’s in-force health care policies concerning the use of atypical anti-psychotic medications dramatically conflict with the reckless allegations of contingent fee counsel’s complaint. Those (typical plaintiff) allegations broadly equate all “off-label” use of prescription drugs with “medically unnecessary” use, and blindly assert that all such “medically unnecessary” use is “illegal.” The law, however, recognizes off-label use as generally accepted by the medical community and the FDA, and as perfectly legal, and does not consider prescription drugs unsuitable for use merely due to lack of FDA approval. The allegations of the complaint – crafted more for the pecuniary goals of counsel than for the needs of the patients served by the affected state programs – risk the public health by threatening to deprive some of our neediest citizens of a medicine that the Commonwealth’s own unbiased administrators consider “preferred” for the same off-label indications that the complaint brands “illegal.”

It will be interesting to see how the Supreme Court approaches these significant issues int he coming weeks.

[Your faithful blogger was able to contribute to the amicus brief of the Washington Legal Foundation , the public interest law and policy center, in this matter.]

Device Group Comments on FDA Draft Guidance on Risk Information

Readers of MassTortDefense know how FDA regulatory treatment of advertising and promotion can impact product liability litigation involving drugs and medical devices. Earlier this year, the FDA issued draft Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion.  This draft guidance describes factors FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations. The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors. The recommendations contained in this draft guidance apply to promotional materials directed to both consumers and healthcare professionals.

As the comment period has drawn to a close, the medical device trade group AdvaMed has weighed in, arguing that the FDA's draft guidance on presentation of risk information in advertisements fails to adequately distinguish between devices and drugs.  The group asserts that the draft lacks content and specificity for device makers, and that a separate guidance document for medical devices is probably warranted. One example is the discussion in the draft of the important concept of over-warning, which is done solely with drug examples.

The comments also not the inherent differences between drugs as therapy and a device which requires a separate intervention (surgery) to be used. Because devices are often used in conjunction with other devices and drugs, communications with consumers of medical devices may need to focus more on a broader spectrum of risks and benefits of ongoing therapies, with a larger group of health care professionals.

AdvaMed also questions the draft's notion that risk information should be spread throughout a promotional piece, rather than located in one easy spot for the consumer to find.  Overall, the draft appears to focus on risk information without adequately discussing the intersection with benefit information.

The group agrees with a move towards the "reasonable consumer" standard for evaluating promotional pieces, and suggests the same direction be taken with DTC advertisements. Highly trained regulators cannot easily evaluate DTC ads as would an average consumer.   Finally, the group argues the draft should provide more specific guidance on use of the Internet for promotion, and the use of hyperlinks.  Increasingly the Internet is a source of information for medical consumers.

 

 

Consumer Fraud Class Action Rejected In Supplement Case

A putative class action of purchasers of the asserted mood enhancer and belly fat reducer Relacore was recently rejected by a New Jersey appeals court.  Lee v. Carter-Reed Co., 2009 WL 2475314 (N.J. Super. Ct. App. Div. 8/14/09).  The court affirmed a lower court's decision not to certify the class action, in which plaintiffs had alleged that the defendant falsely advertised the benefits of the product.

Plaintiff Melissa Lee alleged she purchased Relacore, manufactured and distributed by Carter-Reed Co., and asserted that she purchased the product based on the promise that it would reduce belly fat. But, she averred, she actually gained belly weight during the time she took the product.  She claims that defendant's advertising campaigns touted that Relacore helps reduce stress-induced belly fat. Lee claimed that the defendant devised and utilized a fraudulent, deceptive advertising campaign for Relacore. She sought relief under the New Jersey Consumer Fraud Act, and related common law fraud theories.

Following discovery limited to class suitability, plaintiff moved for class certification. Defendants opposed the motion. Following oral argument, the trial court denied the application for class certification, citing absence of superiority,  manageability, and predominance. In an unpublished per curiam opinion, the Superior Court affirmed and held that individual issues predominated over issues allegedly common to the class.

The court noted first that the superiority requirement requires an analysis that includes: (1) an informed consideration of alternative available methods of adjudication of each issue, (2) a comparison of the fairness to all whose interests may be involved between such alternative methods and a class action, and (3) a comparison of the efficiency of adjudication of each method. Manageability of the class is a consideration, as well, but it is “disfavored” in NJ to deny class certification on this basis alone. In order to justify denial of class certification on this basis, the management issues must be of great magnitude. 

Here, the issues of superioirty and of manageability were subordinate to the issue of predominance.  A party asserting a CFA claim in New Jersey must establish wrongful conduct, an ascertainable loss, and a causal relationship or nexus between the wrongful conduct and the loss. A common law fraud claim requires proof of  a material representation of a presently existing or past fact, made with knowledge of its falsity and with the intention that the other party rely thereon, resulting in reliance by that party to his detriment. 

In this case, the central issue for the consumer fraud claim was the existence of a causal nexus between the wrongful conduct and any loss.  Plaintiff asserts that she relied on a false marketing campaign and she was induced by the false representations to purchase and use the product. Neither plaintiff nor the court knew, however, what caused others to purchase and use the product. Neither plaintiff nor the court knew whether putative class members even saw the alleged print or Internet advertisements or whether they purchased the product due to a recommendation from a friend or family member or for some other reasons.

Moreover, the Relacore market campaign was multi-faceted. In some ads, it was touted as a belly fat retardant; in others, a mood elevator; in others, a stress reducer.  There was no way to know on a common basis the reason any putative class members purchased the product, even assuming they heard or saw any advertising. This distinguished the case from Varacallo v. Massachusetts Mutual Life Insurance Co., 332 N.J. Super. 31 (N.J. Super. Ct. App. Div. 2000), in which the court certified a class of those who purchased “vanishing premium” life insurance, and in which the advertising approach was uniform and common to all class members.

The lack of predominance was even more obvious in the context of plaintiff's common law fraud claim. For this claim, the putative class must prove reliance -- which they could not on a common basis.

The case is useful as it analyzes establishing a causal nexus between the challenged conduct and an ascertainable loss.  Properly viewed, that causal link ought to be a major impediment to class certification because it requires individualized factual determinations for absent class members. Plaintiff's argument to extend Varacallo to false advertising product cases brought forth numerous opposing amici, including PLAC.


 

Digitek MDL Plaintiffs Ordered To Respond To Discovery

The federal court has ordered plaintiffs in the MDL concerning the heart medication Digitek to respond to discovery relating to whether the individuals in each identified case had sufficient evidentiary support to justify filing their claim.  The decision is also interesting for all those in mass torts struggling with plaintiffs' typically inadequate responses to initial fact discovery and Plaintiff Fact Sheets. In re: Digitek Products Liability Litigation, MDL-1968 (S.D. W.Va.).

In April, 2008, the FDA announced a recall of the drug Digitek® (Digoxin) distributed by Mylan Bertek Pharmaceuticals, Inc. and UDL Laboratories, Inc. The recall stated that certain lots of the tablets may have contained more than the approved level of the drug’s active ingredient, thereby exposing patients with renal failure who consumed the drug to the risk of digitalis toxicity. Soon thereafter, the plaintiffs filed civil actions against the defendants in state and federal courts across the country. In August, 2008, the Judicial Panel on Multidistrict Litigation entered an order establishing a multidistrict litigation proceeding, which consolidated federal Digitek® related actions for joint case management. The plaintiffs generally allege that the defendants manufactured, marketed, tested, promoted, and/or distributed Digitek® with inconsistent amounts of the active ingredient.

As is fairly typical, plaintiffs were required to fill out basic fact information about their use of the drug and alleged injuries in Plaintiff Fact Sheets.  Such fact sheets are often used instead of  interrogatories, and allow the parties and the court to assess the various types of cases in the mass tort. They can be crucial to decide on trial plan, the scope and timing of additional discovery, and even settlement analysis. 

Defendants served three requests for admission in 39 individual cases, seeking information relating to whether the plaintiff in each identified case had sufficient evidentiary support to justify filing a claim. The requests at issue asked the plaintiff or their counsel  to "admit that you did not serve Defendants with any of Plaintiff’s medical records when you served the Plaintiff Fact Sheet;"  to "admit that you did not have any of Plaintiff’s medical records or pharmacy records in your possession when you filed the Complaint in this case;" and to "admit that you did not have Plaintiff’s medical records or pharmacy records in your possession when you served Defendants with the Plaintiff Fact Sheet."

The Plaintiffs’ Steering Committee in the MDL submitted the plaintiffs’ master objections to the defendants’ requests. They argued that the discovery was premature: before the parties may begin
discovery on an individual case, that case must be selected for inclusion in a trial group. Second, they allege that the defendants are attempting to cure deficient Plaintiff Fact Sheets with the
requests, rather than through the deficiency process outlined in previous pre-trial orders.  Third, in a preemptive strike, they argued that since the Plaintiff Fact Sheets constitute discovery responses,  defendants cannot pursue sanctions for them under Rule 11.  Finally, plaintiffs also asserted that the requests were not reasonably calculated to lead to the discovery of admissible evidence, and alleged that the targeted information is protected by the attorney-client privilege and/or the work product doctrine.

The court noted that the defendants have expressed serious concerns about the merits of many of the cases filed in the MDL. They believe that a large number of cases lack sufficient evidentiary support demonstrating that the identified plaintiffs exhibited digitalis toxicity as a result of ingesting nonconforming Digitek® tablets. The defendants are attempting to determine whether the plaintiffs served with the requests possessed their medical and pharmacy records at the time their complaints were filed and the Plaintiff Fact Sheets were submitted. The defendants suspect they were not. If their suspicions prove true, the answers to the requests may be used to support future Rule 11 motions for sanctions.

The court first held that the provisions and stipulations contained in previously entered pretrial orders do not prohibit the defendants from serving requests for admission on individual plaintiffs at this time.

Next, regarding the deficiency process, the court noted that the defendants were not seeking information that must be contained in a Plaintiff Fact Sheet. Rather, they are seeking Rule 11 information relating to whether the plaintiffs had a sufficient evidentiary basis to file suit. The requests specifically target information concerning whether the plaintiffs possessed their medical and pharmacy records at particular times. This information is outside the scope required to be disclosed in a Plaintiff Fact Sheet. The deficiency process described in pretrial orders has no application in determining whether the defendants’ requests for admission are proper.

Third, while the plaintiffs are correct that Plaintiff Fact Sheets are considered discovery responses according to the case management order, their argument about Rule 11 is premature because the defendants have not yet filed a Rule 11 motion for sanctions. Even so, the plaintiffs again missed the point of the defendants’ requests. The defendants were not attempting to discover whether the plaintiffs committed sanctionable conduct in their Plaintiff Fact Sheets. Instead, they were trying to gather information as to whether there were appropriate Rule 11 prefiling investigations.

Also, the court found that the requests were specifically aimed at discovering information relevant
to the defendants’ defense. If the plaintiffs in the 39 cases in fact failed to comply with Rule 11, serious issues arise as to the merits of those plaintiffs’ claims. The defendants would
be able to use the information gathered from the requests to support a defense that the claims lack
evidentiary basis. Thus, the information sought by the defendants is within the scope of discoverable material under Rule 26(b)(1).

Finally, the court acknowledged that information relating to Rule 11 may raise potential privilege
and conflict issues. However, if the information received by an attorney from a client is relevant to
whether a complaint is well-founded, it probably will eventually be disclosed, either in a pleading
or in later discovery. Schwarzer, Sanctions Under the New Federal Rule 11--A Closer Look, 104
F.R.D. 181, 199 (1985). Thus, the fact that information may be incorporated into work product does
not immunize it from disclosure.

In summary, based upon the allegations contained in the complaints, a prefiling investigation without first obtaining medical and pharmacy records would be reasonable only in an extremely
limited set of circumstances. The records would be essential in determining whether the plaintiffs
have a colorable claim. Rule 11 applies to the same extent in mass tort and multidistrict litigation as it does in more conventional disputes.The defendants’ requests for admission were sufficiently and narrowly tailored to reveal whether the plaintiffs were in possession of the relevant records at the time suit was initiated. The requests would not cause the plaintiffs any undue burden or hardship as the information necessary to answer the requests should be readily ascertainable. 

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Canadian Court Rejects Pharmaceutical Class Action

We have posted before about just how difficult Canada is becoming as a jurisdiction for class actions defendants, particularly companies in the pharmaceutical industry. Frequently, identical consumer products, drugs, and medical devices are marketed in Canada as well as the U.S.  When a product is recalled, or new science suggests risks in a product leading to American product liability and mass tort litigation, Canadian plaintiff attorneys have not been bashful about bringing copycat litigation, borrowing from U.S.-conducted theories and discovery.

A ray of hope to the north?  The Quebec Superior Court last week declined to certify (authorize is the term they use) a class action for Canadians claiming to have experienced side effects from the use of GlaxoSmithKline Inc.’s antidepressant Paxil.  This is the first time a Quebec court has rejected a class action involving a prescription pharmaceutical product -- ever as far as we can tell. See Goyette v. GlaxoSmithKline Inc., Quebec Superior Court, No. 500-06-000157-020 (8/17/09).

Plaintiff sought to represent a national class of Paxil users. Three issues were prominent: Did the claims of the class members raise identical, similar or related questions of law or fact?  Did the facts alleged seem to justify the relief sought? And was the plaintiff an adequate class representative?  Importantly, at the time of the complaint, the class rules required plaintiff to submit a supporting affidavit (on which she was cross-examined).  Since that time, Quebec has sought to minimize the amount of factual material presented to the court in support of class certification (making opposition a bit more difficult).

The first issues sounds like the commonality aspect of U.S. class procedure. GSK argued that the highly subjective nature of the alleged symptoms in the present case, such as headaches, nausea, vertigo, the infinite variations on the symptoms, and the intensity and duration are so subjective that they cannot be decided collectively and so cannot satisfy the common question element.  Nevertheless, the court found that while the claim for exemplary damages was not common, there were common questions concerning the warnings GSK had given.

However, even in the absence of a true predominance requirement, some Canadian courts will look at whether and what issues will require individual determination. Here, the court agreed that the underlying question is whether allowing the suit to proceed as a representative one will avoid duplication of fact-finding or legal analysis. Thus an issue will be “common” only where its resolution is necessary to the resolution of each class member’s claim. The court found that if  "a class action were permitted here, there would be no saving in judicial time since there is no real common question and each case must be litigated on its on merits."  The court noted that each year there was a different set of information in the CPS (Canadian PDR), and accordingly, there would be different sub-classes depending on changes in the relevant wording in each of the years.

Similarly, in this case, civil liability must be determined by assessing the specific risks disclosed for each individual patient which risks vary depending on multiple factors:

 a) whether the adverse effects occur during the use of the product and lead to discontinuation;

 b) whether adverse effects follow discontinuation;

c) whether the user was advised prior to use, by either their physician or pharmacist, of whether they may experience dependency or withdrawal symptoms;

d) whether the symptoms suffered were described in the C.P.S. (PDR);

e) whether the symptoms were not described in the C.P.S. but are proved to be directly related to the use of Paxil; or

f) to the extent that the symptoms arose following discontinuation, whether such symptoms were "mild and transient" and were described in the C.P.S.

Next, the court determined that the facts alleged do not support the relief requested. All of the symptoms that Ms. Goyette alleges to have experienced were mentioned by GSK in the C.P.S. and that any fault must have been through the misreading of the C.P.S. by Ms. Goyette's prescribing physician.  And she made no specific allegations about the injuries of the absent class members.  Accepting as true the well-pleaded allegations, in essence, the facts that are taken as proven do not include impressions, opinion, legal argument, inferences or hypotheses that are not verified.

Finally, adequacy of representation is evaluated on three criteria:

 1- an interest in undertaking the legal proceedings;

 2- an ability to instruct counsel; and

 3- absence of a conflict with the other group members.
 

Based on the previous analysis, the court found that Ms. Goyette could not represent a class since she herself does not have a valid cause of action.  Moreover, plaintiff had shown a singular lack of interest in that she never sought to speak with any of the other members of the proposed class, none of whom she knows; she has never sought to communicate with any of the individuals alleged to have signed up at her attorneys' website; and she could provide no explanation as to why these legal proceedings which started on May 2, 2002 remained dormant for several years.

An analysis with a little bit of teeth.
 

Court Dismisses Counts Of Trileptal Complaint Pursuant to Twombly

Add to your list of recent cases applying the recent U.S. Supreme Court decisions that clarified pleading standards, the decision in Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471 (S.D.Ohio). 

The federal trial court dismissed a plaintiff's manufacturing and design defect claims against the maker of an epilepsy drug that allegedly caused her to develop multi-organ sensitivity, citing Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Under Iqbal, a claim is facially plausible when the plaintiff  sufficiently “pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” 

Plaintiff  used Trileptal for a short time in 2005. A label change was made in Spring, 2005, adding a precaution regarding multi-organ sensitivity. Novartis sent a Dear Doctor letter, advising of the label change, in April.  Plaintiff contended that the drug caused her to develop multi-organ sensitivity and related complications. Plaintiff sued, alleging various claims, including defective design and manufacture. Novartis moved for a partial dismissal under Fed. R. Civ. P. 12(b)(6).

According to the court, plaintiff's first cause of action for strict liability for defect in the manufacture of Trileptal under Ohio law must be dismissed pursuant to Rule 12(b)(6) for failure to state a plausible claim for relief. Plaintiff did nothing more than provide a formulaic recitation of the elements of a claim under the statute.  She failed to allege any facts that would permit the court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of Frey's alleged injuries. Plaintiff's allegations in this regard fall far short of the sufficiency standard set forth in Twombly.

Similarly, the court said, the design defect claim would be dismissed because plaintiff once again simply provided a formulaic recitation of the elements of a claim under the statute. She did not allege any facts that would permit the court to conclude that there was a defect in the design or formulation of Trileptal and that the defect was the proximate cause of Frey's alleged injuries. Because plaintiff's allegations fall far short of the sufficiency standard set forth in Twombly, the claim for design defect must be dismissed.

Importantly, the court rejected plaintiff's argument that plaintiffs cannot be expected to particularly allege that the scientific makeup of the drug is defective for a specific reason without conducting discovery.

Finally, the court denied the plaintiff's motion to amend the complaint, saying she had not shown that they were able to allege facts that would state plausible claims for relief to satisfy the pleading standard.




 

Plaintiffs' Causation Expert Excluded in Viagra MDL

The federal judge overseeing the multidistrict litigation involving the erectile dysfunction drug Viagra has decided to exclude the testimony of the plaintiffs' key expert witness on causation. In re: Viagra Products Liability Litigation, case number 06-md-01724 (D. Minn. 8/19/09).

The litigation stems largely from an announcement in July, 2005 by the FDA that it was updating its labeling requirements for Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to nonarteritic anterior ischemic optic neuropathy (NAION), an eye condition that can result in partial or total blindness.  An MDL consolidated hundreds of product liability lawsuits alleging a link between Viagra and NAION.
 

Judge Paul Magnuson of the U.S. District Court for the District of Minnesota had ruled last year that the general causation opinions of three of  the plaintiffs' experts should be excluded.  This motion related to plaintiffs' sole remaining general causation expert, Dr. Gerald McGwin.  This expert had authored a study, published in the British Journal of Opthalmology, which indicated that male Viagra users with a history of heart attacks had a statistically significant increased risk of suffering NAION. The court had originally denied Pfizer’s Daubert challenge to Dr. McGwin, largely because his study was peer-reviewed, published, contain[ed] known rates of error, and seemingly resulted from generally accepted epidemiological research.  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1081 (2008). In January, Judge Magnuson ruled that Pfizer could seek additional discovery related to McGwin's study, and in July, the judge denied the plaintiffs’ motion to have McGwin provide live testimony at a Daubert rehearing.
 

That additional discovery revealed that the study contained discrepancies that raised “serious concerns” about its reliability. In fact, the study contained numerous “acknowledged inaccuracies,” chief among them the inclusion of numerous patients in McGwin's data-set who had not taken Viagra until after they were diagnosed with NAION.  Dr. McGwin acknowledged that the statistics
in his study would have been different had those individuals (11 of 27 patients who
reported drug use) been coded as unexposed rather than as exposed. The discrepancies between the dates of first use on the original survey forms and in Dr. McGwin’s later electronic data set weaken the McGwin study’s assessment of temporality, thereby impair the study’s ability to contribute meaningfully to Dr. McGwin’s opinion about general causation.

Second, the statistical methods actually used to produce the numbers in the McGwin study as published were not the statistical methods that the study said were used. Even if a later reanalysis purportedly confirmed  the findings of the original study, the fact that the methodologies described in the study were not the actual methodologies used clearly also undermines the reliability of the McGwin study as published.

Third, the study was unreliable because it mischaracterizes one of its main findings—that men with a personal history of myocardial infarction and drug use have a significantly higher risk of NAION. The patients were actually asked whether they had a family history of myocardial infarction; no one was asked about personal history. These mis-codings regarding myocardial infarction added yet another layer of unreliability to the McGwin study as published.

The judge concluded that "Almost every indicia of reliability the Court relied on in its previous
Daubert Order regarding the McGwin Study has been shown now to be unreliable. Peer
review and publication mean little if a study is not based on accurate underlying data."

Lastly, Judge Magnuson denied the plaintiffs' motion for leave to file a supplement to McGwin's expert report, which included a reanalysis of the data, concluding that the report's untimely
submission was neither harmless nor justified. The reanalysis lacked even the basic indications of reliability — peer review and publication — that the original had seemingly had, and it had also been produced simply in response to concerns raised in the litigation.

FDA Proposes That Adverse Event Reports Be Submitted Electronically

The Food and Drug Administration last week proposed new rules that would require adverse event reports related to approved devices, drugs and biologic products to be submitted electronically.  (Readers of MassTortDefense know how plaintiffs in mass tort litigation will attempt to use such reports to show the defendant company missed or ignored a "signal" of a safety issue with the product.)

When a drug or biological product is approved and enters the market, the product is introduced to a larger patient population in settings that may be different from clinical trials. New information generated during the post-marketing period can offer further insight into the benefits and risks of the product, and thus evaluation of this information is important to ensure the safe use of these products.

The FDA receives information regarding post-marketing adverse drug experiences from safety reports submitted to the agency. For nearly 35 years, FDA has received these post-marketing safety reports on paper. In recent years, some companies have voluntarily submitted these reports to
the agency in electronic format. Data from both electronic and paper reports are entered into FDA’s Adverse Event Reporting System (AERS) database. AERS is a computerized information database designed to support FDA’s post-marketing safety surveillance program for drug and biological products. The AERS database is used to store and analyze data received in post-marketing safety reports.

The FDA is proposing to amend its post-marketing safety reporting regulations to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the agency’s systems for collecting and analyzing post-marketing safety reports. The proposed change would help the agency, it believes, to more rapidly review post-marketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA’s public health mission. In addition, the proposed amendments would be a key element in harmonizing FDA’s post-marketing safety reporting regulations with international standards for the electronic submission of safety
information.

The FDA said the change will expedite the agency’s access to safety information and provide data to the agency in a format that would support more efficient and comprehensive reviews, and would enhance its ability to rapidly communicate information about suspected problems to health care
providers, consumers, applicants, and sponsors.

The agency says it is mindful of the security issues related to the confidentiality of data when safety
reports are submitted electronically, and will be prepared to respond promptly to changing
technology to ensure secure transmission of data.

Senator Writes Letter To NIH About "Ghostwriting"

Plaintiffs in pharmaceutical and other biomedical litigation have frequently resorted to allegations of “ghostwriting” to attack various aspects of scientific articles that defendants seek to rely on.  “Ghostwriting” is a somewhat pejorative term used to vilify some versions of a common practice – the use of biomedical communications companies to provide professional assistance in medical research and/or writing. Plaintiffs often imply that the named author had little or nothing to do with the direction or content of the article.

Several courts have rejected such generally overblown allegations. In the HRT litigation, In re Prempro Products Liability Litigation, 554 F. Supp.2d 871 (E.D. Ark. 2008), the court noted that while plaintiff focused heavily on the evidence that Wyeth collaborated with authors to have articles written about HRT, there was no evidence that this practice is inappropriate or that Wyeth supported articles that it knew were false or misrepresented the science. Rather, the articles supported Wyeth’s position on the state of the science. Additionally, there was evidence that ghostwriting was a common practice in the industry.  Similarly, in In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, slip op. at 3-5 (M.D. Fla. Jan. 30, 2009), Judge Conway held that plaintiffs could not use the words "ghostwriting" or "plagiarism" to characterize the process by which articles were written.

A “ghostwriter” may:
– Analyze data
– Research issues, gather review data
– Organize/format materials
– Assist in writing by, e.g., drafting publications

Such third-parties can save busy scientists time and effort- by doing time-consuming preliminary tasks. Having medical communications specialists involved can make the articles easier to read, more informative The fact is, a great doctor does not mean a great writer; outside writers can expedite publication and eliminate artificial drag in the process.

Nevertheless, Senator Charles E. Grassley, an Iowa Republican, has written a letter to NIH asking for information about possible ghostwriting:
I1) What is the current NIH policy on ghostwriting with regards to NIH researchers?  2) What is the current NIH policy on ghostwriting with regards to NIH grantee institutions? 3) What is the current NIH policy on ghostwriting with regards to primary investigators of NIH grants? 4) Has NIH received any complaints about individual grantee institutions, primary investigators and/or NIH researchers regarding possible ghostwriting, and if so how has NIH handled these complaints? 5) What is the current NIH policy regarding primary investigators found to have violated medical ethics and/or have medical licenses that have been suspended or revoked?

The response, when it comes, may be significant because the N.I.H. underwrites much of the country’s medical research. Many doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could influence new publication guidelines more broadly.

In reality, typically, the named author has access to all data. The authors can reorganize the presentation of the data and edit the article. The articles are subjected to extensive peer review before publication, often in journals the author selects.  In litigation, the plaintiff’s prescriber may not have read or relied on any such articles. And doctors who prescribe are well familiar with the industry practice and custom. Plaintiff’s “ghostwriting” claims also fail to offer proof that the articles which were, in any event, peer-reviewed and medically sound, affected the FDA’s actions.

Any debate on “ghost writing” of medical publications ought to include an understanding of the realities of supply and demand for published research, of the time pressures, needs, and priorities of leading researchers, and the evidence demonstrating the author's control over final publication.

Readers of MassTortDefense interested in these issues should look at the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication;  the American Medical Writers Association's Position Statement and Code of Ethics; and the  World Association of Medical Editors' Policy Statement on Ghost-writing Initiated by Commercial Companies.

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Senate Holds Hearing On Medical Device Safety Bill

The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enacted would overturn the Supreme Court's interpretation of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act in Reigel v. Medtronic.  The Supreme Court ruled that the MDA bars state law product liability claims against medical device companies based on alleged defects in products that had received approval through FDA's stringent premarket approval (PMA) process. The PMA process is used only in class III devices—devices FDA deems to be “high risk,” like pacemakers. The devices that are marketed as PMAs represent cutting edge science and are critical to public health.
 

We have posted on this legislation before here at MassTort Defense.  In addition to ignoring the important benefits of a uniform federal standard and the chaos of allowing devices to be regulated by litigation, the bill would would stifle innovation in the medical device industry and result in lost jobs, especially at smaller device companies. Obviously the bill is favored by overzealous trial lawyers and the legislators they support.

Testifying at the hearing were a variety of supporters of the bill, including academics who argued that preemption deprives victims of their right to compensation from the wrongdoers who injured them -- without convincingly responding to the concerns that would be raised by the new regime which allow juries throughout the country not only to impose requirements that are inconsistent with FDA determination, but that differ from one state court to another. The witness panel had no representative from the device industry.

The legislation would take away primary responsibility for device safety from the FDA and put it in the hands of lay jurors who have little to no understanding to the science involved, and who will listen to plaintiff's lawyers arguing about a single alleged injury without regard to the many of patients potentially safely aided by the device. Democratic supporters argued that no matter how diligently and effectively the FDA does its job, it simply cannot "guarantee that no defective, dangerous, and deadly medical device will reach consumers." The notion that any regulatory regime can "guarantee" defect-free products is misguided.  And to think that lay juries will do a better job of balancing product risks and benefits is foolish. Risk is inherent in all medical devices, and small numbers of patient injuries does not mean a device is defective.
 

The Advanced Medical Technology Association (AdvaMed) has urged Congress to reject the legislation, noting it would increase health care costs and decrease patient access to life-saving medical technology.  As the debate is ongoing about health care reform, legislation that will create more litigation, increase health care costs, and render it harder for medical device manufacturers to invest in promising new technology, hardly seems wise.

.
 

FDA Commissioner Outlines New Enforcement Plans

Readers of MassTortDefense know how FDA actions can instigate and affect potential mass tort litigation involving drugs and devices. Last week, in a presentation to the Food and Drug Law Institute (FDLI), new FDA Commissioner Margaret A. Hamburg revealed that the FDA will implement procedural reforms designed to allow the agency to act more quickly and aggressively on the enforcement of food, drug, and medical device regulations. The FDA commissioner told FDLI that the federal watchdog will be a leaner and meaner organization under her leadership.


In her remarks, the Commissioner noted that while impressed by the commitment to compliance that many companies have made – both in terms of their corporate culture and their investment in compliance systems -- her goal is for all companies to make and implement such a commitment in order to prevent harm to the public. A key part of the strategy to support private sector compliance is more effective enforcement against violations of the law. She suggested that such enforcement helps industry too – by maintaining a level playing field for safe products. Making sure that offenders are held legally accountable prevents companies from having to choose between doing the right thing and staying competitive.

An effective enforcement strategy depends on several key elements she said:

  • The FDA must be vigilant. Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems early. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, FDA will.
  • The FDA must be strategic, she continued. The agency must place greater emphasis on significant risks and violations, and use meaningful penalties to send a strong message to discourage future offenses.
  • The FDA must be quick. The agency must be able to respond rapidly to egregious violations or violations that jeopardize public health.

More specifically, she said the pathways for enforcement action can be too long and arduous. To address this, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, it will expect a prompt response to the findings, generally no more than fifteen working days before the FDA moves ahead with a warning letter or enforcement action.

Second, the FDA will take steps to speed the issuance of warning letters. There will be a new policy to limit warning letter review to significant legal issues.

Third, the FDA will work more closely with regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA.

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, FDA will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.

Fifth, she said, the FDA will no longer issue multiple warning letters to non-compliant firms before taking enforcement action. And, in the case of significant health concerns or egregious violations, FDA will consider immediate action – even before issuing a formal warning letter.

Finally, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, it will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. One can imagine how the obtaining or failure to obtain a close-out letter may be anissue in litigation.
 

State Court Excludes Plaintiff's Causation Expert Under Frye Test

A Minnesota appeals court recently affirmed summary judgment for defendants in a suit by a woman who alleged hormone replacement drugs caused her breast cancer. Zandi v. Wyeth, 2009 WL 2151141 (Minn.App.)

Plaintiff alleged that between approximately 1981 and 2001, she ingested hormone-replacement-therapy (HRT) drugs manufactured, designed, packaged, marketed, and distributed by defendants.   In November 2001, Zandi was diagnosed with "hormone-dependent breast cancer."  She contended that the HRT drugs caused her cancer.  She brought claims for negligence, strict liability, breach of implied warranty, breach of ex-press warranty, fraud, misrepresentation, and violation of the Minnesota fraudulent advertising act, the Minnesota Prevention of Consumer Fraud Act, and the Minnesota Uniform Deceptive Trade Practices Act.


The trial court  found that plaintiff's specific causation evidence did not satisfy Minnesota's standard for admissibility of expert testimony.  Zandi offered testimony from Dr. Lester Layfield and Dr. Gail Bender to prove that HRT drugs caused her cancer. Minnesota courts use the Frye standard to determine the admissibility of novel scientific evidence. Goeb v. Tharaldson, 615 N.W.2d 800, 814 (Minn.2000). Under Minnesota's version of this standard, the proponent of scientific evidence must establish that the scientific theory is generally accepted in the relevant medical or scientific community and that the principles and methodology used are reliable.  McDonough v. Allina Health Sys., 685 N.W.2d 688, 694 (Minn.App.2004). When novel scientific evidence is offered, (1) the trial court must determine whether it is generally accepted in the relevant scientific community; (2) the particular scientific evidence in each case must be shown to have foundational reliability.

Zandi's claims were based on the following propositions: 1) it is generally accepted that HRT causes hormone-dependent breast cancer, and 2) there is a generally accepted method of diagnosing the cause of hormone-dependent breast cancer in an individual.  The appellate issues revolved around the second.  Defendants alleged that even if one assumes the relevant scientific community generally accepts that HRT causes hormone-dependent breast cancer, Zandi had failed to establish that the relevant scientific community generally agrees that there is a method of diagnosing the cause of breast cancer in a particular person.

Plaintiff's experts based their specific causation opinions on epidemiological studies and differential diagnosis. But  the science of epidemiology does not address the cause of an individual's disease. Epidemiology is concerned with the incidence of disease in populations and does not address the question of cause of an individual's disease. Epidemiology has its limits at the point where an inference is made that the relationship between an agent and a disease is causal (general causation) and where magnitude of excess risk attributed to the agent has been determined; that is, epidemiology addresses whether an agent can cause disease, not whether an agent did cause a specific plaintiff's disease. See Green et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 333, 381-82 (Fed.Jud.Ctr.2d ed.2000).

Plaintiff's experts also relied on differential diagnosis. As used by plaintiffs, differential diagnosis adopts a process of elimination to identify cause; it  seeks to eliminates the possibility of competing causes or confounding factors. Goeb, 615 N.W.2d at 815.  In performing a differential diagnosis, a physician begins by ruling in all scientifically plausible causes of the patient's injury. The physician then rules out the least plausible causes of injury until the most likely cause remains.  Yet, breast cancer does not lend itself to such a differential diagnosis because the scientific community has not accepted that breast cancer has a limited number of discrete and recognized possible causes such that ruling out one cause would implicate another. For differential diagnosis to be sufficiently reliable to prove causation, the diagnostician should rule out all other hypotheses, or at least explain why the other conceivable causes are excludable.

Additional risk factors that plaintiff failed to adequately account for here included family history. Indeed, plaintiff's experts suggested that it is possible to conduct a reliable differential diagnosis without ruling out other hypotheses.

On this record, the court said, “We conclude that there is not a method of diagnosing the specific cause of a particular woman's breast cancer that is generally accepted in the relevant scientific community. This reality leaves Zandi without a legally sufficient ability to prove specific causation.”
 

Presidential Memo On Preemption Sends A Warning

Along with my partner Andy Gaddes, I taught a recent CLE seminar on products liability issues.  One of the topics the attendees -- in-house counsel from a variety of industries -- were most interested in was President Obama's May, 2009 memorandum to federal agencies reversing the Bush administration's well-reasoned preemption policy.
 
The new policy is contained in a memo, not a formal executive order, but it clearly expresses a new view of preemption. Cloaked somewhat ironically in the guise of "state's rights", the policy comes from an administration that apparently has no trouble expanding the role of the federal government in unprecedented ways, taking over the auto companies, banks, and others.
 
The memo provides that heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.  Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the Administration's new interpretation of the legal principles governing preemption.  Finally, heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under the new interpretation of the applicable legal principles governing preemption.
 
The legal basis of the doctrine is not really that malleable. Federal preemption is derived from the supremacy clause of the Constitution that says federal law is the supreme law of the land and any conflicting state law or regulation is without effect.  The policy basis of the doctrine is equally clear: allowing each state to set diverse and individual safety standards can undercut needed uniformity and can subject manufacturers to expensive, unfair, and confusing requirements. It forces product sellers to potentially navigate a confusing, often contradictory patchwork quilt of up to 50 sets of laws and regulations.  Of course, the preemption issue affects more than traditional administrative regulation by the states: companies may become subject to regulation by litigation at the hands of the plaintiffs' bar. 
 
The new policy has the potential to create a real chilling effect in agencies that should be clear about the preemptive intent and reach of their regulations.  While the Obama administration claims its approach breaks no new ground, it may well fundamentally weaken the federal government's ability to address problems on a national level and thus may have untended consequences by allowing states to interfere with parts of the Obama administration's domestic agenda. Regulations for health care and climate change, for example, arguably cannot work absent preemption.
 
Preemption has been applied to drugs and medical devices, vehicular roof crush standards issued by the National Highway Traffic Safety Administration, mattress flammability standards issued by the Consumer Product Safety Commission, pesticides regulated by the EPA and a variety of other products.  A majority of the regulations containing preemptive language were issued by the FDA and NHTSA.   
 

 

Sanctions Against Plaintiffs in HRT Litigation

The judge in charge of multidistrict litigation involving Wyeth Pharmaceuticals' hormone replacement pill, Prempro, has decided to sanction a law firm representing hundreds of plaintiffs, for its failure to timely produce completed client fact sheets. In re: Prempro Products et al., No. 4:03-cv-01507 (E.D. Ark.). 

Judge Wilson of the U.S. District Court for the Eastern District of Arkansas recently granted Wyeth's motion for sanctions against a Texas-based firm, although he declined to dismiss the plaintiffs.

Readers of MassTortDefense know the role plaintiff fact sheets (PFT) play in mass tort litigation, replacing some aspects of basic fact discovery; allowing defendants to gather information for early case assessment; beginning the process that winnows the number of cases that will be subjected to fuller case-specific fact discovery and expert discovery; and eventually informing the pool of cases available for initial trials if the case management process includes bellwether trials. 

The information requested on the PFT is often a negotiated topic, but typically includes information that any plaintiff's attorney who has done a good faith, Rule 11 assessment of the claim should have, or could readily access. The Manual for Complex Litigation notes that in lieu of interrogatories, questionnaires directed to individual plaintiffs in standard, agreed-on forms were used successfully in the breast implant and diet drug litigation.  It also includes sample case management orders regarding, inter alia, plaintiff fact sheets. (For other examples of plaintiff fact sheets, see In re Baycol Products Litigation, MDL 1431, Pretrial Order No. 10 (D. Minn. Mar. 18, 2002) and In re Phenylpropanolamine (PPA) Products Liability Litigation, MDL No. 1407, Case Management Order No. 6 (W.D. Wash. Mar. 21, 2002)).

Wyeth showed the court that the plaintiff firm missed several court deadlines to serve completed fact sheets for each of its clients. Wyeth first argued in 2008 that plaintiffs represented by the firm had repeatedly submitted incomplete fact sheets in which they provided merely a “will supplement” answer to several questions. Judge Wilson agreed and issued an order on Dec. 17, 2008,
directing the firm to produce completed fact sheets by Feb. 2, 2009.  In February, defendant again complained to the court that hundreds of fact sheets had not been served by the deadline and that many of those that had been produced remained incomplete, with plaintiffs replacing “will supplement” with the vague language that plaintiffs do "not recall and do not have reasonable access to the information that would be responsive to this question without undue burden or cost.”
Plaintiffs were then given until April 13 to resubmit the fact sheets in accordance with the order, and the responses led Wyeth to renew its bid for sanctions including dismissal.

The judge directed the firm to pay $5,000 to Wyeth to partially compensate it for the time and effort involved in seeking adequate fact sheets.  The firm must also assign an associate or paralegal to immediately contact all plaintiffs identified by Wyeth as still having insufficient fact sheets and to have the documents filled out by August 5th.

The court warned that it was likely that additional sanctions — and perhaps considerably more severe sanctions — will be imposed if substantial effort is required to review the adequacy of fact sheets filed by Aug. 5, 2009. 

The court indicated it had seriously considered dismissing all the affected cases without prejudice, and with the proviso that if a case was refiled it must have a reasonably accurate fact sheet attached and that sanctions against counsel would likely be imposed if additional fact sheets were attached with non-answers.  Only the administrative burden of dealing with amended complaint filings prevented this.

Summary Judgment For Manufacturer in Pain Pump Litigation

In what appears to be the first substantive decision to come out of the multiple suits alleging that a pain pump medical device damages patients, a federal court has granted summary judgment to the defendant. Kilpatrick v. Breg, Inc., No. 4:08-cv-10052 (S.D. Fla. 6/26/09). Judge Michael Moore ruled in favor of medical device manufacturer Breg, finding that the plaintiff, who alleged damage to his shoulder cartilage, did not provide enough reliable expert evidence to link the condition to the defendant's shoulder pain pump.

Plaintiff Kilpatrick underwent arthroscopic shoulder surgery in 2004 after an orthopedic specialist discovered a tear in his shoulder socket.  To help with post-operative pain, the surgeon inserted a pain pump into plaintiff's shoulder, which would allow the doctor to administer an anesthetic via a catheter in the patient's arm. The surgeon injected bupivacaine into the pump's attached catheter and further filled it with 100 cc's of anesthetic, which was to be delivered into Kilpatrick's shoulder over the next 48 hours.  Plaintiff alleges that he began experiencing severe pain in his shoulder in 2006. An orthopedic surgeon diagnosed the pain as glenohumeral chondrolysis, a deterioration of the cartilage, and Kilpatrick underwent shoulder replacement surgery. He then brought suit, alleging negligence, strict products liability, and violations of Florida's Deceptive and Unfair Trade Practices Act.  Kilpatrick claimed that using the Breg pain pump to administer local anesthetic directly into his shoulder joint caused him to develop post-arthroscopic glenohumeral chondrolysis.

The reliability prong of the Rule 702 analysis was the central issue.  Breg argued, and plaintiff apparently did not contest, that the case should be treated like a toxic tort case for purposes of the Daubert inquiry, in that plaintiff had to offer proof of both general and specific causation. “If anything, determining causation in this case requires an even more complex logical chain than the typical toxic tort case, because the key issue is not merely whether a chemical compound could and did cause injury, but whether that compound as delivered via a particular medical device inserted in a particular location (within Kilpatrick's shoulder joint) could and did cause injury,” the court found.

The summary judgment motion focused first on general causation, and the ability of plaintiff's expert to opine adequately under Daubert that the device can cause this type of injury.  The causes of chondrolysis remain disputed, and experts in the medical community have pointed to autoimmune deficiencies, certain kinds of sutures, thermal energy procedures and contrast dyes made from gentian violets as possible risk factors.  Plaintiff's expert admitted it was a still developing science.

Plaintiff's expert relied on several published studies to attempt to show causation, which were not directly on point, and the Court found that his extrapolations from the studies were not warranted either.  None of the articles were based on controlled, randomized epidemiological studies of human beings, which are the best evidence. “Significantly, none of the articles explains the mechanism by which bupivacaine damages cartilage, each has important limitations that Poehling does not take into account, and none of them offers an ultimate conclusion as to the general causation of glenohumeral chondrolysis,” the court noted. At most they suggest a possible association.  Association is not causation.  As for the animal studies, the expert did not explain the possible differences in dose-response relationship between humans and rabbits, an important factor to consider in evaluating whether an alleged exposure caused an adverse effect. 

As to specific causation, as is typical of many plaintiff experts, Poehling described a process of so-called "differential diagnosis," trying to rule out other suspected causes such as thermal energy and gentian violet, the contrast dye sometimes used during arthroscopic surgery. This approach cannot, observed the court, make up for a fundamental lack of adequate proof about the general toxicity of the substance.  To "rule in" one cause, even while ruling out other causes, requires a sufficient general causation proof.  At its base, however, the conclusion on specific causation still would be unreliable, the court said, as it was "ultimately rooted in nothing more than temporal relationship.”   That before/after focus is not the basis of good science, the court said, “and Poehling's dependence upon it further weakens the reliability of his methodology.”  Significantly, the expert had not offered a sufficient explanation of the background risk for genohumeral chondrolysis, casting further doubt on the reliability of the chosen method. He admitted that not only the pain pump — as a kind of drug delivery system — could have caused the injury, but also the anesthetic delivered via the pain pump.  Poehling's concession that the current state of medical literature is still unsettled about the cause of the plaintiff's condition seriously undermines the reliability of his methodology, the court concluded.  His methodology had no known rate of error, and thus all he had was a hypothesis that “may be exactly right,” but that currently is “merely plausible, not proven.”

It will be interesting to see what impact the approximately 300 suits pending against pain pump manufacturers in state and federal courts.   


 

Report Offers Another Reason To Reject Medical Monitoring

The Medicare Payment Advisory Commission reported this month the results of a study suggesting that when physicians have a financial interest in medical imaging equipment, they are more likely to order imaging tests and incur higher overall spending on their patients' care.  The June MedPAC report is titled Report to the Congress: Improving Incentives in the Medicare Program.  Such an issue seems important to the current debate on health care reform and efforts to curb the rising costs of health care.  But is it of interest to readers of MassTortDefense?

Imaging, particularly the use of PET scans and CT scans, is a favorite tool of plaintiffs' lawyers seeking medical monitoring. Currently before the Massachusetts Supreme Judicial Court is a case involving a proposed class action seeking CT scans for lung cancer. See Kathleen Donovan, et al. v. Philip Morris USA, Inc., SJC No. 10409 (Mass. SJC, argued June 9, 2009)

Multiple policy grounds support the decision to reject  medical monitoring. Metro-North Commuter Railroad Company v. Buckley, 521 U.S. 424 (1997). This imaging issue stands as yet another reason courts need to be careful with claims for medical monitoring and wary of plaintiff experts opining that imaging is reasonably medically necessary ( a typical element of a medical monitoring claim) because it is supposedly becoming more widely used. See Redland Soccer Club, Inc. v. Dept. of the Army and Dept. of Defense of the U.S., 548 Pa. 178, 696 A.2d 137, 145-46 (1997) (requiring the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles); Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla.App. 3 Dist.2006) (same).

MedPAC is an independent advisory body charged with providing policy analysis and advice concerning the Medicare program, and issued its most recent report to Congress on imaging, among other topics.  The commission noted that rapid technological progress in diagnostic imaging over the last decade has enabled physicians to more effectively diagnose and treat certain illnesses. At the same time, use of medical imaging has grown in certain areas of the country, without a clear benefit in terms of the quality of care.   The report also noted that recent research indicates a particular expansion of in-office imaging as many physicians buy and use machines in their offices, rather than refer patients out.

The report cites the 2008 Government Accountability Office report which ties the growth in Medicare spending to the increase in physicians who perform advanced imaging services in their office. That GAO report found that Medicare spending for imaging services performed by doctors doubled from 2000 to 2006. In particular, costs for advanced imaging such as computed tomography (CT) scans and nuclear medicine rose faster than other standard previous imaging services such as MRIs.

 

 

 

JPML Declines to Consolidate Metoclopramide Litigation

Some have expressed the sentiment that the the Judicial Panel on Multidistrict Litigation always grants requests for MDL status.  In reality, that is not the case, although opposition to MDL status can be an uphill battle in burgeoning mass torts. (FYI Volume 82, Number 6 (June 2008) issue of the Tulane Law Review is devoted to "The Problem of Multidistrict Litigation." )

The JPML recently declined to consolidate federal litigation involving the heartburn medication metoclopramide, finding that the pending actions do not share sufficient factual issues concerning whether the drug causes neurological injuries. (In re Reglan/Metoclopramide Products Liability Litigation, MDL No. 2049, 6/3/09).

The Panel was not persuaded that Section 1407 centralization would serve the convenience of the parties and witnesses or further the just and efficient conduct of this litigation at the present time. The eleven actions at issue did share some factual issues as to whether the drug metoclopramide causes neurological injuries (principally, tardive dyskinesia). But there is no single common defendant, and some entities, are named in only one or two actions. Moreover, several of the actions appear to be substantially more advanced (five were commenced in either 2006 or 2007). Metoclopramide litigation thus has a somewhat lengthy history, and the record indicates that a significant amount of the common discovery has already taken place in some cases. The proponents of centralization failed to convince the Panel that any remaining common questions of fact among these actions are sufficiently complex and/or numerous to justify Section 1407 transfer at this time. Alternatives to transfer exist that may minimize whatever possibilities there might be of duplicative discovery and/or inconsistent pretrial rulings, concluded the Panel. 

FDA Issues New Draft Guidance on Presenting Risk Information

The FDA recently issued a new draft Guidance for Industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”  This new guidance document represents a comprehensive and fairly detailed overview of the FDA’s approach to reviewing drug and device advertising, albeit with a somewhat surprising omission regarding Internet-specific guidance.

As readers of MassTortDefense know, promotional pieces: (1) cannot be false or misleading, (2) must reveal material facts, including facts about consequences, and (3) should present information about effectiveness and risk in a balanced manner. The guidance confirms that promotional pieces will be judged based on the “reasonable consumer” standard, essentially adopting the definition used by the Federal Trade Commission. Importantly, the FDA also adopts the FTC position that multiple interpretations of a claim are possible if they are all reasonable, and a violation will be found if any one reasonable interpretation violates regulations.

Finally, while the guidance acknowledges the different levels of expertise of consumers and healthcare professionals and notes that the FDA takes account the intended audience in determining compliance, the guidance specifically highlights the social science research finding that experts are “subject to the same cognitive biases and processing limitations as non-experts.”  As a result, it arguably gives insufficient credit to physicians’ abilities to understand important information and make appropriate prescribing decisions;  the recommendations listed in the guidance seemingly apply equally to promotional materials directed to consumers and healthcare professionals.

The general considerations the FDA will use in assessment include (1) use of language appropriate for the target audience, (2) appropriate use of signals (e.g., headlines, change of announcer), (3) appropriate framing of risk information (e.g., severity, specificity), and (4) hierarchy of risk information (i.e., most important risk information should come first).

More specifically, the FDA considers the quantity, materiality, and comprehensiveness of the risk information contained in the piece. Concerning quantity, the FDA notes that risk information should be comparable to benefit information and should include enough detail to convey an “accurate” impression of the product. Among the relevant factors are (1) the number of statements about benefits and risk, (2) the completeness and depth of detail about benefits and risks, (3) the amount of time or space devoted to benefits and risks, and (4) the use of components that enhance or distract from the presentation of risk or benefit information. In assessing materiality and comprehensiveness, the guidance notes that material risks are those that would influence a reasonable member of the target audience—often the most serious and the most frequently occurring risks.

Despite the guidance’s clear and intentional application to Internet advertisements, it makes no special mention of such advertisements and provides no specific guidance on issues unique to Internet promotion.

The comment period for this draft guidance ends August 25, 2009. Additional information, including information on how to submit comments, can be found here.

 

 

Court Refuses To Consolidate Class Action Into Lexapro MDL

A federal court last week rejected an attempt to consolidate a newly filed proposed class action over Lexapro and Celexa with the multidistrict litigation involving the drugs. In Re: Celexa and Lexapro Products Liability Litigation, MDL No. 1736 (E.D. Mo.).

Judge Rodney W. Sippel said in his ruling that plaintiffs had not demonstrated that consolidation would be appropriate. The MDL is currently comprised of 42 cases brought by individual plaintiffs who claim Lexapro or Celexa caused or induced a suicide or suicide attempt. In originally creating this MDL in 2006, the Judicial Panel on Multidistrict Litigation noted that the actions shared allegations relating to the safety of Celexa or Lexapro and the adequacy of Forest's warnings concerning the possible adverse effects of using the drugs, in particular, the potential for each product to induce its users to commit, or attempt to commit, suicide. The JPML recently declined to transfer two personal injury cases to the MDL because they involved injuries other than suicide.

The new suit, Universal Care, Inc., et al. v. Forest Laboratories, Inc., et al., on the other hand, involves allegations relating to Forest Laboratories Inc.'s marketing of the drugs, and economic damages allegedly caused from the sale of Celexa or Lexapro. Specifically, the new suit alleges violations of the Missouri Merchandising Practices Act and makes claims for unjust enrichment,  fraudulent concealment , and misrepresentation. The plaintiffs in this case claim that Forest engaged in improper promotional activities, causing third-party payors to reimburse patients and health care institutions for prescriptions of Lexapro and Celexa that were written for patients for whom the drugs were not indicated.

Moreover, the cases pending in the MDL are individual actions, not a putative class actions. The extensive discovery and motion practice relating to the alleged appropriateness of class-wide treatment and the adequacy of the class representatives are not part of the current MDL. These factors could significantly delay the progress of the MDL proceedings, prejudicing both the MDL plaintiffs and Forest. A final factor is that the MDL is already more than 2 years old, with significant pretrial proceedings already haven taken place.

Even in the MDL context, Rule 42 applies, and the court has discretion to assess the impact of allegedly common questions.  Consolidation is inappropriate if it causes confusion or leads to delay, inefficiency, inconvenience, or unfair prejudice to a party. E.g., EEOC v. HBE Corp., 135 F.3d 543, 551 (8th Cir. 1998).

Administration Releases Memorandum On Preemption

The Democratic assault on the preemption doctrine has taken its next step with the release last week by the White House of a Presidential memorandum which restricts federal agency statements on preemption and directs those agencies to review preemption pronouncements made in the past decade under the Bush Administration.


Ironically, the directive ostensibly rests on the grounds of States rights: noting State law and national law often operate concurrently to provide independent safeguards for the public, and that throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national government.  “An understanding of the important role of State governments in our Federal system is reflected in longstanding practices by executive departments and agencies, which have shown respect for the traditional prerogatives of the States,” argues the memorandum.

The memorandum comes two months after the Supreme Court’s ruling on preemption in the context of drugs in Wyeth v. Levine, and concurrently with democratic efforts in Congress to overturn Medtronic v. Riegel in the medical device context.


The memorandum sets for the general policy of the new Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the “legitimate prerogatives of the States and with a sufficient legal basis for preemption.” Specifically, it orders that agencies should not include in regulatory preambles statements that the department intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation. Also, agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the (presumably re-assessed) legal principles governing preemption.

Finally, departments should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the agency to preempt State law, in order to decide whether such statements or provisions are justified under (again, re-interpreted) applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.


The memorandum is a political statement as much as a legal document, and is consistent with President’s Obama’s comments while a candidate. As it eventually evolves into specific agency statements and policy, it promises to create a hodge-podge regulatory quilt, under which business will struggle with product safety decisions which will comply with federal, national standards, be upheld in some state jurisdictions, but nevertheless be subject to review by lay juries in others.

 

Daubert Ruling In Zyprexa: A Lesson For Mature Mass Torts

Zyprexa is a mature mass tort, as the defendant has settled approximately 31,000 individual product liability lawsuits over the drug, which was widely used in the treatment of psychiatric disorders. The federal court overseeing the multidistrict litigation over Eli Lilly and Co.'s product has made an important ruling on a Daubert challenge to a plaintiff expert in 13 cases involving 20 of the remaining claimants. In re Zyprexa Products Liability Litigation, MDL No. 1596 (E.D.N.Y. May 12, 2009).

Plaintiffs proposed to call an expert to establish the specific causal relationship between the Zyprexa taken and the onset or worsening of their diabetes. After briefing and an extensive evidentiary hearing, Senior Judge Jack B. Weinstein granted Eli Lilly's motion to disqualify Dr. Stephen J. Hamburger, M.D. While the expert met the necessary educational and experiential qualifications warranting the admissibility of his expert opinions, the court found his testimony lacked sufficient scientific reliability.

The court noted that in longstanding and highly complex litigation (read mass tort), particular emphasis must be placed on the reliability and scientific validity of the expert's opinions. Particularly in a mature mass tort ("advanced stage" described the court) when the issues of the benefits and risks of the drug have been a focus of the scientific community for some time, precision with respect to the relevant scientific knowledge and its application to the facts of the individual cases is expected, said the court.

The record demonstrated to the court that this expert's opinions relied on "a subjective methodology, a fast and loose application of his scientific theories to the facts, and conclusion-driven assessments on the issues of causation in the cases on which he proposes to testify,” the order said. In particular, the court pointed to the opinion that Zyprexa supposedly has a direct adverse effect on cells essential to the body's production of insulin, even in cases in which there was no documented weight gain. This opinion was not based on sufficient facts or data, nor was it the product of a reliable method.

In applying this theory to the facts of the cases (the "fit" required by Daubert), the expert had been, in the view of the court, “shockingly careless” about the scientific facts in these cases, including whether weight gain preceded or followed the plaintiffs' use of Zyprexa, and whether there was any weight gain at all. When confronted with these issues, he merely "shrugged off" factual discrepancies in his analyses or shifted to new theories on the fly.

Significantly, the court correctly observed that other mass torts had been subject to a kind of junk science, and it it could not "permit a major pharmaceutical litigation to become the subject of the kind of 'rubber-stamp' expert opinions that have so marred mass litigations such as those involving asbestos and breast implants.”

Plaintiffs Denied Discovery In Class Certification Phase

The certification decision in a proposed class action may be the most important aspect of such litigation. Few certified class actions go to jury verdict (they settle), and, frequently, cases in which class certification is denied are dismissed without even named plaintiffs’ claims being adjudicated. Accordingly, the preparation for the class certification hearing/briefing is crucial. Both sides have important tactical decisions to make about the amount and nature of pre-certification discovery they wish to conduct. Discovery of named plaintiffs and absent class members, when available, can show important distinctions among the class members, which in turn demonstrate an absence of commonality, a predominance of individual issues, and manageability problems. Not infrequently, plaintiffs object to defendants’ attempted discovery as allegedly "going to the merits" and thus as inappropriate for the certification stage. In an interesting, recent little decision in the Ketek antibiotic litigation, the show was on the other foot.

Plaintiffs, who alleged the maker of the antibiotic Ketek fraudulently concealed the drug's dangers, were denied the right to depose various non-party witnesses at the certification stage of this litigation. Sergeants Benevolent Association Health and Welfare Fund v. Sanofi-Aventis U.S. LLP, 2009 WL 1181808 (E.D.N.Y., 4/30/09). The plaintiffs are employee benefit plans that paid for Ketek, known generically as telithromycin. The FDA approved Ketek in 2004 for treatment of three medical conditions. Plaintiffs assert that this approval was based in part on data generated in a study that allegedly “was contaminated by fraudulent activity.”

As part of class certification discovery, plaintiffs proposed to take the deposition of nine non-party witnesses, all of whom were involved with the challenged study and the FDA's approval of Ketek. The court found “unconvincing” plaintiffs' assertion that the proposed non-party depositions were necessary to establish common impact through a “loss of value” methodology; the court found that plaintiffs had misunderstood that methodology in the Zyprexa litigation, which they claimed to be mirroring. Second, the proposed non-party depositions were highly unlikely to produce or lead to evidence relevant to numerosity, typicality, or adequacy of representation. Evidence relating to the complexity of attempting to prove plaintiffs' civil RICO claim may be relevant to predominance and superiority, but plaintiffs need not actually prove their RICO claim, or conduct the discovery necessary to prove that claim, in order to make this showing. Third, defendants did not dispute that the evidence relating to the study was common to all members of the putative class. Thus, discovery postponed to merits phase.
 

White Paper Explains Detrimental Impact of Proposed Medical Device Anti-Preemption Bill

Much of the debate over the preemption doctrine, certainly in the media and even in many legal circles, has focused on the alleged inadequacy of the FDA to regulate drugs and devices, and the purported consequent  need to have state juries of lay people “police” the health industry. Comparatively little attention has been given to the other impacts of eliminating federal preemption.

A new white paper demonstrates that erasing this doctrine would decrease access to life-enhancing medical devices, increase health care costs, and reduce medical device industry employment. Congressional Democrats are seeking to do just this in the device context -- the Medical Device Safety Act of 2009 was crafted in response to the U.S. Supreme Court's 8-1 ruling in February, 2008 in Riegel v. Medtronic, upholding preemption for certain medical devices when the devices, and their warning labels, had been approved by the U.S. Food and Drug Administration.


The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” was authored by Ernst Berndt, professor in applied economics at MIT's Sloan School of Management, and Mark Trusheim. They argue that among the effects of the bill would be:

 • Reduced patient access to products and the health benefits they provide

• Unreliable, variable patient access to products and the health benefits they provide as varying state regulations and tort liabilities discourage or eliminate products in some regions but not others

• Increased medical costs and lower net public health compared to what could be achieved with increased medical device innovation and product introductions

• Increased defensive medical practices by physicians to avoid possible litigation, raising health costs and exposing patients to greater risks from the added unnecessary procedures

• Reduction in the number of products being developed as manufacturers and their investors respond to greater uncertainty regarding product approval and economic sustainability

• Transfer of health regulatory decisions to untrained, non-expert juries who are exposed to only a biased fraction of the scientific fact base on which to base their decisions


The authors compare the bill to what happened with vaccines: from 1967 to 2004 the number of vaccine makers plummeted from 26 to 3, leading to reduced access, higher costs, no new products, shortages of existing products, a fragile vaccine supply chain, reduced employment and increases in preventable illness. Congress had to step in and take the vaccines out of the traditional tort system.

Under the bill, the authors note, state juries would be asked to render decisions regarding device safety and efficacy based on a limited range of information focused on individual risk versus broad benefit at a trial typically lasting at most several weeks. Allowing state tort suits to do this will place state juries in the position of replacing, by overriding, professionally trained federal regulators in evaluating and quantifying the risks of medical devices. And unlike federal regulators, state juries will not balance, perhaps not even consider, the benefits to those for whom the medical devices enhances health and quality of life -- who of course are not parties to the action.
 

FDA To Hold Meeting on Risk Communication Strategies

The Food and Drug Administration’s Risk Communication Advisory Committee will be holding a public meeting on April 30, 2009, and May 1, 2009, at the Center for Drug Evaluation and Research Advisory Committee Conference Room, in Rockville, MD. On both days the Committee will discuss the Agency’s draft risk communication strategic plan and will be asked for comment and further advice on strategic priorities for research on effective risk communication.

That draft plan describes FDA’s strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their own health and well-being. FDA has been looking to improve how it produces communications about the risks and benefits of regulated products, as well as how it oversees those communications produced by regulated entities. For example, as the Internet and emerging technologies have both enabled and fed the public’s demand for greater transparency and communication frequency, the traditional waiting periods for FDA guidance have given way to communication in real time. Designing a contemporary risk communication strategy is key to FDA’s efforts to reposition itself to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology.

Effective communication supports both optimal use of medical products and safe consumption of foods to maximize health. The IOM report on The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006) focused on drug safety, but also highlighted communication more generally, referencing FDA’s mission of helping the public get the accurate, science-based information it needs. In response to an IOM recommendation, FDA launched its Risk Communication Advisory Committee in 2007 to give advice about FDA’s risk communication approaches for all FDA-regulated products.

The FDA has begun to identify research needs in this area, including on the broad topics of:

  • When and what to communicate
  • Reaching the audience (dissemination)
  • Ensuring audience understanding
  • Motivating audiences
  • Evaluating effectiveness of communications
     

Preemption Decision in Wake of Levine

Much attention has been focused on what aspects of the preemption doctrine were restricted by the U.S. Supreme Court's recent decision in Wyeth v. Levine. A recent decision holds that claims that a drug was “unreasonably dangerous” and that no warning would have been adequate, are preempted. Longs v. Wyeth, 2009 WL 754524 (N.D. Ohio, 3/20/09). Plaintiff sued Wyeth and asserted strict liability and negligence claims concerning the diet drug Redux. Wyeth argued that plaintiff's claim that Redux was an unreasonably dangerous drug, for which no warning would have been adequate, directly conflicts with the FDA's authority to determine which drugs are sufficiently safe and effective to be marketed. The court affirmed its grant of summary judgment, finding that the strict liability and negligence claims related to pre-FDA approval were preempted by federal law, and that the claims that were not preempted failed on their merits.

The Court rejected plaintiff’s claim that Wyeth v. Levine called for reconsideration. In Wyeth, the Court considered the narrow issue of whether the FDA's drug labeling judgments preempt certain state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. The court noted that the Supreme Court emphasized that it was Congress' intent to have state law complement federal drug regulation because manufacturers may have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.

The instant case was distinguishable from Wyeth v. Levine because it did not involve a failure to warn claim, and because Levine arose out of the actions of the manufacturer post-FDA approval. A post-FDA approval duty is distinguishable from a manufacturer's duty prior to approval by the FDA, a circumstance that the Supreme Court did not explicitly address. Whatever Wyeth v. Levine may stand for regarding whether post-FDA approval claims are preempted, it does not purport to hold anything for pre-FDA approval claims, held the court.
 

Latest Update on Digitek MDL

The Digitek MDL Judge, on March 5th,  entered PTO # 16, which details important case management and scheduling deadlines in this mass tort. 

For those interested in some of the nuts and bolts of managing an MDL: the Order  requires that within 45 days, each defendant named in the Master Complaint shall file a Master Answer or a Fed. R. Civ. P. 12 motion in response to the Master Complaint.

The Order sets deadline for plaintiffs to request and brief class certification of any wrongful death, personal injury or medical monitoring putative class in September, 2009.

Plaintiffs are required to fill out and sign Plaintiff Fact Sheets, providing basic fact discovery.  It sets up a process for handling deficiencies in the responses.

Plaintiffs are to provide signed undated authorizations for the gathering of medical records, and addresses for each health care provider, including hospitals, clinics and outpatient treatment centers, and any other custodian of records identified in a plaintiff’s Fact Sheet.

Plaintiffs are ordered to produce medical and pharmacy records in their  possession establishing that the plaintiff was prescribed Digitek and the date(s) on which each prescription issued.

The Order set up a procedure for governing the oft-debated ex parte contact by defendants of treating physicians.

Defendants are ordered to provide organizational chart information as well as QC/QA structures. Also specifications, instructions, test methods and standard operating procedures relating to the manufacture of  Digitek;  quality assurance/control and testing records for Digitek, and any of its component ingredients, including but not limited to records related to batch sampling, post-manufacturing testing and finished goods testing. 

The Order establishes a procedure for privilege logs. The parties were directed to reach an agreement concerning a document production protocol to include the production format of paper and electronic documents, objective coding and metadata, privilege logs and any other applicable issues. In the event the parties cannot agree, the issues will be presented to Magistrate Judge Stanley for resolution.

The PTO also sets deadlines for service of interrogatories, document requests, and company witness depositions. As to expert discovery: Plaintiffs shall serve their reports from liability experts no later than January 1, 2010. The parties shall complete their depositions of Plaintiffs’ liability  experts no later than March 12, 2010.  Defendants shall serve their reports from liability experts no later than March 31, 2010.  The parties shall complete their depositions of Defendants’ liability experts no later than June 11, 2010.

To efficiently manage discovery for all currently pending and future cases in the MDL, the cases will be divided into groups, with each group having a separate scheduling order. Following completion of the first wave of Plaintiffs’ Fact Sheets the Court shall schedule a hearing for purposes of  selecting the initial trial pool of cases (“Group 1”). No later than 5 days before the hearing, Plaintiffs shall select 15 cases and the Defendants shall select 15 cases, and each side shall exchange lists of such selections and submit them to the Court.  Within 10 days after the scheduled hearing, the Court shall select a total of no more than twenty of the proposed trial pool cases to constitute Group 1.

Case specific discovery is set up by Group, with staggered dates of initial discovery (DID),  corresponding discovery deadlines, and Daubert and dispositive motions deadlines 310 days after  DID.

State Appellate Accutane Decision Reverses Verdict

The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week.  See  McCarrell v. Hoffman-La Roche, Inc., And Roche Laboratories, Inc., 2009 WL 614484 (N.J.Super.A.D.) (March 12, 2009).

Plaintiff alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease ("IBD"). The IBD allegedly led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his product liability claim against Roche, but not on his consumer fraud claim, and awarded him compensatory damages.

By order dated May 2, 2005, the state Supreme Court had designated all pending and future statewide actions involving Accutane as a mass tort.  Thus, all Accutane cases, including plaintiff's lawsuit, were transferred to Atlantic County to be heard on a coordinated basis. Discovery in the state cases proceeded in tandem with discovery in the federal Accutane multidistrict ("MDL") litigation.

On appeal from the jury verdict, Roche specifically argued, inter alia, that the trial court erred in admitting the opinion testimony of plaintiff's causation expert Dr. Sachar because his methodology was unreliable and thus improper under  N.J.R.E. 702; and that the trial court denied Roche a fair trial in admitting the testimony about causality assessments based on Accutane ADEs, but in restricting the defense in presenting competing quantitative proofs to put the ADEs in context, including the actual number of Accutane users.

On the issue whether Dr. Sachar's causation testimony was sufficiently reliable in the field of scientific research to be admitted, the court noted that in New Jersey the standard of review of such
rulings under Rule 702 is a narrow one. "In reviewing a trial court's evidential ruling, an appellate court is limited to examining the decision for abuse of discretion."

On the merits, the defendant objected to the expert's heavy reliance on animal studies. The NJ  Supreme Court has previously recognized that animal studies can be an accepted scientific method to study the safety and efficacy of drugs.  Even though the dose administered in the animal studies was far different than the medicinal dose, "trained experts commonly extrapolate from existing data." Gen. Elec. v. Joiner, 522 U.S. 136, 146 (1997). In assessing the results of animal studies, which frequently involve high doses, experts should be careful to consider the dose-response differential between animals and humans. Magistrini v. One Hour Martinizing
Dry Cleaning
, 180 F. Supp. 2d 584, 593 (D.N.J. 2002), aff'd, 68 Fed. App'x. 356 (3d Cir. 2003). (Readers also know that the biological differences between commonly used animals such as rats and humans make the models inappropriate for many comparisons, regardless of dose.)

Defendants also challenged the use of anecdotal case reports as a basis for the causation opinion. The court recognized that "[c]ausal attribution based on case studies must be regarded with caution." Federal Judicial Center, Reference Manual on Sci. Evidence 497 (2d ed. 2000).
That is so because case reports typically reflect reported observations, and do not themselves contain scientific analyses. For instance, case reports may lack controls, may fail to screen out alternative causes, and may omit relevant facts about the patient's condition that can be pertinent to a causation assessment. Consequently, a number of courts have concluded that anecdotal case reports are not a scientifically reliable basis for an expert's opinion on causation.

Nevertheless, some other courts have allowed consideration of case reports as an acceptable basis for trying to show causation, particularly when accompanied by other reliable scientific evidence. New Jersey courts have previously upheld the admission of expert testimony that has relied, at least in part, upon case reports or comparable anecdotal evidence. The court also found significant that the case reports here included dechallenge and rechallenge reports. Dechallenge and rechallenge reports are a type of case report. Dunn v. Sandoz Pharms. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003). Such reports have limitations, but have been considered useful in some contexts in ascertaining causation because they measure a patient's reaction to a drug, said the appellate court.  (Readers will note that the dechallenge/rechallenge concept appears to make little sense when the effect of the drug is supposedly a permanent disease!)

The New Jersey court recognized it was issuing a causation decision contrary to the ruling in the Accutane MDL.  The state court declined to follow the federal court's decision because (1) the causation expert in the federal case was not Dr. Sachar, and that particular expert's methodology was not as "demonstrably sound" as that of Dr. Sachar; (2) the standards for expert admissibility under N.J.R.E. 702 are not identical to F.R.E. 702; and (3) the testimonial record in this case, having proceeded to trial, was more developed than it was in the Florida case on a pretrial motion, lending greater confidence to a conclusion to sustain the trial judge's decision to admit Dr. Sachar's testimony.

Defendant also challenged the expert's testimony about the company's alleged intent and motive and mind-set, a typical plaintiffs' tactic in mass torts.  Totally improper, highly prejudicial, and ignored by some courts because they seem overwhelmed by the plaintiff's characterization of the defendant's conduct.  Well-reasoned opinions exclude such testimony. See In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1053 (D.Minn. 2007) (observing that "[p]ersonal views on corporate ethics and morality are not expert opinions"); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (holding that the objected-to opinions of expert witnesses on intent, motives, or state of mind of a corporation had no basis in any relevant body of knowledge or expertise).  Here, the court seemed not to understand the impact and purpose of this improper testimony, finding that although Dr. Sachar's testimony sharply criticized Roche, his criticisms did not rise to "such an inflammatory level" that would cause the appeals court to find an abuse of discretion by the trial court in not excluding it.  The issue is not only a Rule 403 prejudice issue; there is a fundamental relevance issue, and a serious issue about fit, foundation, and reliability.

Finally, there was what has been described as the "numbers" issue. The issue refers to the fact that the trial court allowed plaintiff's witnesses and counsel to refer, on repeated occasions, to the number of adverse incidents reported from Accutane users or from other sources while, at the same time, the court restricted Roche's attempt at trial to place those adverse numbers into any larger quantitative context. Specifically, the judge precluded Roche witnesses from more
fully informing the jury about the large number of persons who had taken Accutane before it was prescribed to plaintiff in 1995, and the comparative significance of those figures.

The court ultimately concludes that it was unfair to Roche for the trial court to have precluded such "numbers" counter-proof and that the court abused its discretion on this evidentiary issue. Had Roche been allowed to present the statistics showing five million Accutane users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's actions in changing its label. "Principles of completeness and fairness warranted the presentation of this contextual information to the fact-finder."

 

 

FDA Introduces Nanotechnology Initiative

Last week the FDA introduced the "Nanotechnology Initiative", a collaborative effort between FDA and the Alliance for NanoHealth (ANH) and its eight member institutions. The alliance's eight academic institutions are the Baylor College of Medicine, the University of Texas' M.D. Anderson Cancer Center, Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A & M Health Science Center, the University of Texas Medical Branch at Galveston and the Methodist Hospital Research Institute in Houston.


The initiative is designed to push for the development of safe and effective implementation of nanotechnology into medical products. Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. The nanotechnology initiative with the Alliance for NanoHealth is an effort to engage resources and technical expertise in this rapidly advancing field.

FDA recognizes that nanotechnology holds great promise for the advancement of novel medical products. All outcomes from this public-private partnership will be placed in the public domain.
Readers of MassTortDefense know that nanotechnology involves the creation and use of materials at the level of molecules and atoms; it presents opportunities but also challenges for the FDA's entire regulatory product jurisdiction, from food to medical devices to therapeutics. Products from the new technology may also present product liability issues for manufacturers.

New Voluntary Guidelines For Device DTC Ads

The Advanced Medical Technology Association has just released a set of “Guiding Principles for Direct to Consumer Device Advertising. “ The principles are intended to help assure that patients have accurate and meaningful information about health care treatment options and encourage them to speak with their physician. Direct-to-consumer (DTC) advertising can be an important tool for educating patients about advanced medical technologies, which are making life better for patients through faster recovery and better outcomes and in many cases, reducing health care costs.

The Advanced Medical Technology Association (AdvaMed) is the world’s largest
association representing manufacturers of medical devices, diagnostic products, and
medical information systems. AdvaMed members and subsidiaries manufacture nearly
90 percent of the health care technology products purchased annually in the United
States and more than 50 percent of the health care technologies purchased annually
around the world.

The voluntary guidelines contain 13 principles that support compliance with the Food and Drug Administration’s and Federal Trade Commission’s existing direct-to-consumer regulations. They also include additional principles, which include revising or withdrawing ads when new safety-risk information comes to light; excluding any content designed to minimize risk information; educating healthcare professionals about new products or new-use indications before the launch of an ad campaign; and submitting TV ads for restricted devices to the FDA at the time of an ad’s release.

The principles were not an effort to ward off regulation from Congress and the new Administration, but to respond to concerns that have been raised in the media in recent months about some DTC ads. 

Readers of MassTortDefense know that plaintiffs try to make an issue of DTC advertising in failure to warn claims, and have succeeded in some contexts in having DTC advertising undermine the traditional learned intermediary rule.
 

Supreme Court Decides Levine v. Wyeth

The Supreme Court has issued its decision in the much-anticipated Levine preemption case.

Readers of MassTortDefense will recall that Wyeth manufactures the anti-nausea drug Phenergan. After a clinician injected plaintiff Levine with Phenergan by the “IV push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The jury determined that Levine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a musician. The trial court rejected Wyeth’s argument that Levine’s failure-to-warn claims were pre-empted by federal law because Phenergan’s labeling had been approved by FDA. The Vermont Supreme Court affirmed.


Today, the Supreme Court affirmed, 6-3, J. Stevens writing for the majority, holding that federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration. The argument that Levine’s state law claims are pre-empted because it is impossible for Wyeth to comply with both the state law duties underlying those claims and its federal labeling duties was rejected. Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency’s “changes being effected” (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, said the Court, as there was no good evidence that the FDA would ultimately have rejected such a labeling change. Wyeth’s reading of the CBE regulation and its assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the “fundamental misunderstanding” that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.

The Court also rejected Wyeth’s argument that requiring it to comply with a state law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions, because it relies on an overbroad view of an agency’s power to preempt state law. The history of the FDCA shows that Congress did not intend to pre-empt state law failure to warn actions, said the majority. The preamble to the 2006 FDA regulation declaring that state law failure to warn claims threaten the FDA’s statutorily prescribed is merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. The weight the Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA’s 2006 preamble did not merit much deference, said the Court. It was limited in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation.

Quick reactions: The Court was able to get around some facts that made the case appear strong for Wyeth, noting the findings below that that a stronger warning would have made a factual difference (getting around the issues of possible medical malpractice), and that this was indeed a failure to warn and not a duty to contraindicate case. Second, it seems that congressional intent is the touchstone of not only express preemption, but also implied preemption. Third, the presumption against preemption, which some argued really applies only in express cases, also applies to implied preemption cases. Fourth, the Court recognized that some state-law claims might well frustrate the achievement of congressional objectives, but “this is not the case." Defendants will have to carefully explore that opening, develop a robust regulatory record, and see where that may take them.
 

Seventh Circuit Affirms Defense Verdict, Exclusion of Subsequent Remedial Measures

The Seventh Circuit has affirmed a defense jury verdict in a suit by a woman whose husband killed himself two days after starting the drug Effexor to treat major depression. Giles v. Wyeth, 2009 WL 331290 (7th Cir. Feb. 12, 2009).

Before the trial in this case, Wyeth filed a motion in limine asking the district court to exclude: (1) all suicide-related warnings that accompanied Effexor after Mr. Giles's death in 2002, and (2) scientific data related to suicidality in pediatric patients taking anti-depressants. The district court granted the motion in part, ruling that evidence of post-2002 suicide-related warnings was not admissible. It also denied the motion in part and allowed the use of scientific evidence relating to pediatric patients, including such evidence from after Mr. Giles's death. After a three-week trial, the jury returned a verdict in Wyeth's favor. Mrs. Giles appealed the judgment.

The district court excluded the later warning evidence based upon its determination that FDA-mandated warnings were “subsequent remedial measures” within the scope of Federal Rule of Evidence 407, and also under Federal Rule of Evidence 403, which allows a district court to exclude relevant evidence when its “probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence."

The 7th Circuit focused on Rule 403, as the standard of review here was abuse of discretion,  The warnings that accompanied Effexor after Mr. Giles's death had little, if any, probative value. First, and most significantly, the excluded warnings did not help establish that Wyeth knew or should have known about an increased risk of suicidality in adults of Mr. Giles's age. Mr. Giles was forty-six years old when he took Effexor. The excluded post-2002 warnings, however, focused on children and adults younger than twenty-five years old. In fact, instead of suggesting an increased risk of suicidality, the Effexor warnings after 2002 actually more directly disclaimed any increased risk of suicidality in adults of Mr. Giles's age.

Plaintiff identified no evidence that the excluded post-2002 warnings were based on information Wyeth knew or reasonably could have known at the time of Mr. Giles's death. The later warning was based on conclusions the FDA drew after the death, based mostly on data gathered after the death.  Moreover, it drew these conclusions from an analysis of adult clinical trial data from all antidepressant manufacturers, not just from Wyeth. There was no proof Wyeth could have known about other company's data.

The tendency of the later warnings to prove that Wyeth knew of an increased risk of suicidality in persons of Mr. Giles's age "was essentially nil in this case." The later warnings, which focused on children, adolescents, and persons who were much younger than Mr. Giles, could have confused the jury. That is, the jury might have thought that the warnings that antidepressants had increased suicidal thinking and behavior in certain adolescents and young adults also had application to Mr. Giles, when there was no evidence to support that.

As a result, the court of appeals did not find an abuse of discretion in the district court's determination that the probative value of the post-2002 warnings was substantially outweighed by the danger of confusing the jury.

 

Digitek MDL Court Issues Federal-State Coordination Order

An important aspect of mass tort case management involves the level of coordination between cases in a federal MDL and those cases in state courts involving the same product. The MDL judge in the Digitek products liability multidistrict litigation, In Re: Digitek Products Liability Litigation, MDL No. 1968, No. 08-md-1968( S.D. W.Va.), issued an order coordinating activities between the federal litigation and the mass tort litigation recently coordinated before the state court in West Virginia's Circuit Court. In Re: Digitek Litigation, No. 08-C-5555, (W.Va. Cir., Kanahwa Co.).

Readers of MassTortDefense will recall the nationwide recall of Digitek products, involving tablets with higher dosage than called for which may have been released to the public. Approximately 60 cases arising from the recall were transferred last August to a multidistrict litigation assigned to Chief U.S. Judge Joseph R. Goodwin of the Southern District of West Virginia. Later in the Fall, multiple Digitek stats court cases were coordinated in the Kanawha County Circuit Court.


Pretrial Order (PTO) No. 11 concerns state and federal coordination. The court found that the state and federal litigation share common issues and will involve common discovery.  The court said proper coordination will avoid unnecessary conflicts and expense, conserve judicial resources, and expedite the disposition of all the cases. 

He ordered lead and liaison counsel for the plaintiffs and defense to endeavor to coordinate activities between the federal and state litigation. He also ordered the creation of a joint document depository for use by parties in the federal-state litigation. The Order provides a mechanism for cross-noticing depositions.  Also, counsel in the West Virginia state litigation who obtain confidential documents are subject to the confidentiality/protective order issued in the MDL.


Chief Judge Goodwin also said he is prepared to conduct "consolidated hearings and status conferences with the presiding state judicial officers, and to enter joint rulings, except to the extent that differences may be mandated by different laws or rules governing this court or justified by particular circumstances of the cases before this court." 

Eleventh Circuit Affirms Exclusion of Expert Testimony on General Causation

The 11th Circuit has affirmed a trial court’s exclusion of key expert causation proof in a suit against the manufacturer of Remicade, finding the expert evidence was not adequately supported by scientific studies or literature. Goldstein v. Centocor Inc., 2009 WL 275322 (11th Cir. 2/05/09).

Plaintiff-appellant contended that the prescription medication Remicade caused his pulmonary fibrosis, requiring a bilateral lung replacement. The trial court excluded plaintiff’s expert testimony on general causation, pursuant to Fed.R.Evid. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). The court of appeals reviews a trial court's Daubert rulings under an abuse of discretion standard. McClain v. Metabolife Intern'l, Inc., 401 F.3d 1233, 1238 (11th Cir.2005).

Plaintiff’s expert did not rely on any epidemiological studies that connect Remicade with pulmonary fibrosis. This is not necessarily fatal, said the 11th Circuit, but it makes a plaintiff’s task to show general causation more difficult. See Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1198 (11th Cir.2002).

In the absence of epidemiological studies, the expert reviewed four sources to make his general causation assessment. The first category, plaintiff's lung and bowel pathology reports, was not relevant to general causation; its focus on the plaintiff made it relevant to specific causation. See McClain, 401 F.3d at 1239 (“General causation is concerned with whether an agent increases the incidence of disease in a group and not whether the agent caused any given individual's disease.”). The second category, MedWatch case reports submitted by doctors who observed possible reactions to Remicade, have a limited weight. Such reports are made without medical controls or scientific assessment, and while they may support other proof of causation, alone they cannot prove causation. Id. at 1199. (putting aside an expert’s reliance on such reports, they are hearsay and do not fall within any of the exceptions to the hearsay rule; also, the prejudicial effect of these reports outweighs their probative value.)

The third category, a review of medical textbooks, revealed no relevant general causation information, only extended analogies. The fourth category, a review of abstracts of four articles linking Remicade with pulmonary fibrosis, is relevant to general causation but provided only very limited information.

A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. General Elec. Co. v. Joiner, 522 U.S. 136, 146, (1997). The district court did so here, and the 11th Circuit found no abuse of discretion in its determination.
 

Members of Congress to Re-introduce Medical Device "Safety" Bill

Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Medtronic, which held  that the Medical Device Act Amendments of 1976 specifically pre-empt product liability lawsuits against makers of FDA-approved class III medical devices. The FDA approval process for such devices is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective. The bills would permit lay juries to second-guess regulatory decisions of the FDA resulting from that process.

Sponsors of the planned legislation include Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone, head of its health subcommittee, and Senators Edward M. Kennedy and Patrick J. Leahy.  The lawmakers claim that the Supreme Court’s decision has left patients legally powerless against what they criticize as incomplete oversight of products by the FDA. Of course, if there is concern about the FDA’s efficacy, the answer is to increase the agency's resources, as the FDA is the appropriate body to set nationwide safety standards; allowing juries to second-guess such decisions would stifle product innovation. Such a bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with. What the sponsors may really want is to restore the trial lawyer lotto that can net jackpot jury awards while wreaking havoc on national standards.
 

Similar legislation, the Medical Device Safety Act of 2008, was introduced last session to overturn the Supreme Court’s decision in Reigel v. Medtronic.  H.R. 6381 garnered 62 co-sponsors last time.  Officials for the "American Association for Justice" f/k/a ATLA,  recently released a legislative agenda for 2009 and cited as their top priority efforts to pass this pro-litigation legislation.

Federal Court Predicts Delaware Would Recognize Medical Monitoring In Device Context- But Why?

Two recent, related federal court opinions illustrate just how unsettled the law of medical monitoring continues to be. Molly Guinan V. A.I. Dupont Hospital For Children, 2009 WL 311113 (E.D.Pa. Feb. 6, 2009); Molly Guinan V. A.I. Dupont Hospital For Children, 2009 WL 307019 (E.D.Pa. Feb. 6, 2009).

Plaintiff is one of several infants who had what the court called a “controversial” procedure to correct a congenital heart defect performed on her by doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware. Cardiologists implanted a covered stent manufactured by NuMed, Inc., a New York corporation that is one of the few developers of pediatric medical devices in the United States. The stent had not been approved by the Food and Drug Administration when implanted. Plaintiff developed serious conditions that were allegedly side effects of the treatment, and there were factual disputes surrounding the treatment plaintiff received when her injuries first began manifesting themselves.

Plaintiffs sued the doctors, hospital, and device maker. Plaintiff articulated two different theories of negligence against the treaters: (1) medical negligence premised on malpractice; and (2) lack of informed consent. (The plaintiff parents claimed they weren’t told anything, and the defendant doctors claimed they told the parents everything.) At bottom, Guinan is another of an increasing number of cases in which what are in reality malpractice cases are being twisted into product liability litigation. Even worse when they get stretched into medical monitoring claims. Multiple summary judgment motions were filed.

The first question was choice of law. Plaintiffs were residents of New Jersey, and the complained-of surgery occurred in Delaware. Plaintiffs sued in the Eastern District of Pennsylvania, where the child was then being treated for the complications. The aspect of most interest for readers of MassTortDefense is not the malpractice claim, but the medical monitoring claim. The court noted that Pennsylvania and New Jersey recognize medical monitoring as a cause of action. However, there are differences between the laws of the two states that created a conflict. See In re Paoli R.R. Yard PCB Litig. (Paoli II), 35 F.3d 717, 787-88 (3d Cir.1994) (identifying potential conflict between Pennsylvania and New Jersey medical monitoring causes of action). In Delaware, the court said that it is not clear whether medical monitoring is an independent tort or whether medical monitoring is simply a remedy. However, while some Delaware decisions have mentioned medical monitoring, Mergenthaler v. Asbestos Corp. of Am., 480 A.2d 647, 651 (Del.1984), the state has never adopted medical monitoring.

The court concluded that Delaware had the greatest interest in seeing its law applied to this action and thus Delaware law would control. Again, Delaware has never recognized medical monitoring as a legally cognizable cause of action. See Mergenthaler, 480 A.2d at 649 (affirming Delaware Superior Court's dismissal of plaintiffs' “claim for the expenses of medically required surveillance ... where there [was] no present physical injury,”). Going through an Erie analysis, the district court predicted that the Delaware Supreme Court would permit a claim for medical monitoring if it were confronted with the facts of this case. Such a prediction seems in direct contrast to 3d Circuit guidance on the issue. E.g., Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003) (federal court in a diversity case should be reluctant to expand the common law); Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002)(court should opt for the interpretation that restricts liability, rather than expands it).

Several considerations militated in favor of allowing plaintiff to proceed with a medical monitoring claim, said the court. It is undisputed that plaintiff has a Class III medical device in her body. Moreover, it is undisputed that the device did not have premarket approval from the FDA. The FDA, NuMed, and the Institutional hospital defendants have all suggested that plaintiff should receive follow-up care to monitor the stent. “This is compelling, if not conclusive, evidence that medical monitoring is appropriate in this case.”

The court rejected any countervailing policy considerations. See, e.g., Metro-North Commuter R.R. Co. v. Buckley, 521 U.S. 424, 443-44, 117 S.Ct. 2113, 138 L.Ed.2d 560 (1997) (discussing potential for a “ ‘flood’ of less important cases” that could “entail systemic costs without corresponding benefits” if the Supreme Court were to recognize a “full-blown” medical monitoring tort in the context of the Federal Employers' Liability Act (FELA). In sum, considerations of fairness, efficiency, and deterrence favored recognizing a cause of action for medical monitoring, according to the court.

The second, companion opinion’s choice of law analysis included New York, NuMed's state of incorporation. The court found again that Delaware has the greatest interest. And while Delaware has not expressly adopted a medical monitoring claim, for the same reasons as above, the court again predicted that the Delaware Supreme Court would adopt a claim for medical monitoring.

The surprisingly simplistic analysis boils down to bad facts make bad law (or bad predictions of the law). The plaintiff's novel theory that a tort claim for medical monitoring can be applied to medical procedures and devices raises serious policy issues that the court never analyzed. In a case involving HRT, Vitanza v. Wyeth, Inc., 2006 WL 462470 (N.J. Super. Ct. 24 Jan. 2006), claimants sought class certification of a group defined as all persons in New Jersey who had taken the drug Prempro and were not suffering from breast cancer, but who wanted medical monitoring for an alleged increased risk of future cancer. The court dismissed the claim, noting that the state's recognition of medical monitoring came in the unique context of manifest exposure to toxic substances in environmental tort actions, and is to be applied sparingly. The policy reasons applicable to the environmental exposure context (including the difficulty in proving exposure levels and duration, and even the identity of the chemicals at issue) are not present in the prescription drug context where claimants have access to relevant information through the label, pharmacy records, and their prescribing physician. The need to deter polluters, perceived to be present in the toxic tort context, does not apply to life sciences companies. See also Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *5, n.6 (D.N.J. 14 Jan. 2008)(applying similar reasoning to device context). See generally Sinclair v. Merck & Co., 195 N.J. 51, 948 A.2d 587 (N.J. 2008)(plaintiffs could not maintain an action for medical monitoring in a pharmaceutical product liability action). That the device was not approved yet for this use doesn't change the fact that the FDA has primary responsibility for regulating use of the product.

Moreover, from a doctrinal perspective, medical monitoring requires an underlying tort or tortious conduct. Redland Soccer Club, Inc. v. Department of the Army, 696 A.2d 137, 145 (Pa. 1997); Potter v. Firestone Tire & Rubber Co., 863 P.2d 795, 823 (Cal. 1993) (“as a result of a defendant's tortious conduct”); Meyer v. Fluor Corp., 220 S.W.3d 712, 717 (Mo. 2007); (“consequences of the defendant’s tortious conduct”); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993) (“which exposure was caused by the defendant’s negligence”); (“through the tortious conduct of the defendant”); Bower v. Westinghouse Electric Corp., 522 S.E.2d 424, 432 (W. Va. 1999); Petito v. A.H. Robins Co., 750 So.2d 103, 106 (Fla. App. 1999) (“caused by the defendant’s negligence”). Here, the negligence claim was dismissed for lack of any viable expert opinion on either liability or damages. There was no viable product defect claim, because of the experimental product. There was no proof of fraud. Bottom line, there was no tort upon which to predicate medical monitoring. Was the court predicting that Delaware would not only adopt the claim, but would do so without this essential element?
 

Federal Claims Court Finds Against Plaintiffs On Vaccine General Causation Link To Autism

The U.S. Court of Federal Claims ruled last week in three bellwether cases that thimerosal vaccines do not cause autism in children. Three special masters of the Court ruled against plaintiffs in three separate test cases, finding insufficient evidence of a casual link between autism and the MMR (measles, mumps, rubella) vaccine.


Thimerosal has been widely used for decades as a preservative in a number of biologic and pharmaceutical products, including vaccines. It prevents life-threatening contamination. Increasing concern over the potential toxicity of the chemical has led to the removal or reduction to trace amounts of the preservative in most vaccines routinely given children aged 6 and under.


That same concern is behind numerous legal claims alleging that that routine childhood shots are to blame for the rising incidence of autism. The National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq., governs such claims, requiring plaintiffs to file a special no-fault compensation petition with the Court of Federal Claims, rather than a traditional suit against manufacturers. Part of the policy behind the program is the potential impact on public health of a traditional mass tort type of litigation involving life-saving vaccines, ranging from polio to chicken pox. Approximately 12,000 cases have been filed under the program.

To be eligible for compensation under the Vaccine Act, a petitioner must either demonstrate a "Vaccine Table" injury, to which a statutory presumption of causation attaches, or prove by a preponderance of the evidence that a vaccine listed caused or significantly aggravated an alleged injury. Althen v. Sec’y, HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005).  Autism claims fall in that latter category.  In 2002, the Court set up an Omnibus Autism Proceeding to test the three main theories of general causation: that the vaccines and thimerosal combine to cause autism; that thimerosal-containing vaccines cause autism; or that MMR vaccines can cause autism.


Separate opinions covered the Snyder, Hazelhurst, and Cedilllo test cases, but each represent the first, and major, theory, that the vaccines and thimerosal somehow combine to cause autism. The three cases involved some 5,000 pages of transcripts, 939 medical articles and 50 expert reports. The vast majority of credible scientific studies have shown -- and all federal health agencies have strenuously argued -- that there is no connection between vaccines and autism. And public health officials have repeatedly warned that fewer immunizations will endanger children. Indeed, at least in part because of the scare, about one in 12 children does not receive the MMR vaccine in the United States.


The Cedillos contended that their daughter fell sick a week after she received an MMR shot when she was about 16 months old. Today, at age 14, she requires round-the-clock care, suffers from seizures, has lost nearly all her vision and has constant abdominal pain.The Court found that the Cedillos have been misled by physicians who are guilty, in the Court’s view, of gross medical misjudgment on the issue of causation.


The Snyders argued that the MMR vaccine, or the mercury-based preservative in it, had triggered in their son pervasive developmental disorder -- part of the autism spectrum. But, the Court found that the experts contending there is no link between autism and vaccines were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention.


In the Hazlehurst claim, parents alleged that the MMR vaccine had caused "regressive autism" in their son. Agreeing with the other special masters, the Court found their causation evidence fell short, concluding that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism and therefore, could not have contributed to the development of their child's autism. The weight of the presented evidence that is scientifically reliable and methodologically sound does not support petitioners’ claims.
 

Daubert Lessons From Two Medical Device Cases

Two recent federal cases illustrate important Daubert principles in the medical device context.

In Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09), the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product.  In contrast, in Jaske v. Zimmer Inc., 2009 WL 150946 (N.D. Ill., 1/20/09), the Northern District of Illinois reversed an earlier decision to exclude two expert witnesses for the plaintiff. On a motion for reconsideration, the court ruled that plaintiff can present testimony from two experts in polymer science as to why his prosthetic knee, manufactured by defendant Zimmer, allegedly failed.


Fuesting alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

Under Rule 702 and the Daubert standard, expert testimony must be both relevant and reliable. The district court must act as a “gatekeeper” making a preliminary assessment of the reasoning or methodology underlying the testimony. Daubert factors include: (1) whether the scientific theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the theory's known or potential rate of error when applied; and (4) whether the technique or theory has been ‘generally accepted’ in the scientific community. 


On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. To bridge the gap, rhe expert needed to show, with respect to Fuesting's implant in particular, what quantum of each variable is required to set the alleged causal chain reaction in motion. That is, the causation opinion must be specific to the plaintiff, and each chain in the causal link must be supported by adequate science. Gaps included how much radiation does it take to cause oxidation, and to what degree? How much oxidation must occur to render polyethylene more susceptible to delamination? And once polyethylene becomes more susceptible to delamination, how then does oxidation affect delamination? Are all forms of polyethylene, including that used by Zimmer (which the company claims to be oxidation-resistant), susceptible to delamination? What effect, if any, does implantation into the human body have on the rate of oxidation?

The expert testimony as to defect also failed. Oxidation can occur in implants sterilized by any method. However, plaintiff’s expert did not know of any peer-reviewed studies or articles that compared oxidation rates for implants sterilized by GIA to those sterilized through other methods. While the prosthesis showed significant oxidation when it was tested, that testing occurred more than six years after the knee joint was explanted, and plaintiff failed to account for oxidation that may have occurred after the joint was removed.

Having granted Zimmer's motion to exclude the expert testimony, the court had no alternative but to also grant the company's motion for summary judgment.

In Jaske, Plaintiff had his left knee replaced with a prosthesis to alleviate recurring pain. When the prosthesis allegedly failed, he filed suit against the manufacturer. Last year, the district court granted defendant's motion to exclude the testimony of two of plaintiff's experts in polymer science, who, while qualified to offer some opinions, used a test as the basis for their opinions that was not reliable. (A Fourier Transform Infrared Spectroscopy (“FTIR”)). Plaintiff moved for reconsideration.


The court had determined that the proffered testimony was unreliable for two reasons. First, the results of the FTIR test may have been skewed because lipids and proteins from Jaske's body had permeated the product. And, second, even if the test results were accurate, they did not determine when the oxidation took place. Originally, plaintiff offered nothing but a naked expert opinion on this issue. On reconsideration, plaintiff presented new evidence that any biological material present would absorb the infrared spectrum used in the FTIR at a different frequency than oxidized polyethylene, and that the FTIR is the accepted standard of the American Society of Testing and Manufacturing for this purpose.

The court had also originally noted that the FTIR test measured the amount of oxidation present in the prosthesis only at the time the test was conducted. It did not provide historical readings. Plaintiff clarified that his experts developed their theory independent of the test results. Instead of relying on the FTIR results to arrive at their theory, they said, the FTIR simply provided support for it. In other words, the results of the FTIR are merely consistent with the theory. The theory that gamma irradiation sterilization in air causes oxidation has been recognized, asserted plaintiff, for some time in the scientific community.


This second case demonstrates one of the potential dangers of the Daubert challenge: if the court is going to give plaintiff a second bite of the apple, the Daubert motion turns into a roadmap for the plaintiff on what holes to fix.  See our post on reasons why you might not file a credible motion.
 

Second Circuit to Hear Appeal of Class Certification Decision in Zyprexa RICO Case

The U.S. Court of Appeals for the Second Circuit recently agreed to hear Eli Lilly’s appeal of a federal district court's orders granting class certification and denying summary judgment in litigation over its anti-psychotic medication, Zyprexa. See In re Zyprexa Products Liability Litigation, 08-4685-mv (2d Cir. 1/15/09).

Judge Jack B. Weinstein of the the Eastern District of New York had granted class certification last fall to a group of third-party payers, including insurance companies, who were suing Eli Lilly for alleged overpayment after the company allegedly exaggerated the benefits of the drug and supposedly failed to disclose certain side effects. The 2d Circuit has now granted the 23(f) motion for leave to appeal.

Readers of MassTortDefense may recall that the 2d Circuit just last year in McLaughlin v. American Tobacco Co., 522 F.3d 215 (2d Cir. 2008), overruled Judge Weinstein's certification of a class of “light” cigarette smokers, finding that individualized issues regarding reliance, loss causation, damages and injury all precluded a finding that common issues predominated over individualized ones as required by Federal Rule of Civil Procedure 23(b)(3). The Zyprexa class claim was brought under the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. § 1964, as plaintiffs seek to take advantage of their reading of the U.S. Supreme Court’s ruling in Bridge v. Phoenix Bond & Indemnity Co., 128 S. Ct. 2131 (2008), regarding reliance in a RICO fraud claim.

In certifying the class in Zyprexa, Judge Weinstein applied his take on the reasoning in Bridge, finding that third-party payers had colorable claims based on the allegedly fraudulent statements made to and relied upon by doctors who prescribed the drugs (not parties). As warned of in our post here last year, the Supreme Court had appeared to reject the defense argument that the proximate cause requirement inherent in the “by reason of” language of the RICO statute demands that a civil RICO plaintiff asserting a claim based on fraud establish his reliance on a misrepresentation by the defendant. In the context of a civil RICO claim predicated on fraud, the required causal link demands a showing that the plaintiff relied on an alleged misrepresentation made to the plaintiff by the defendant. Otherwise, the causal relationship between the alleged injury and the alleged fraud is too attenuated.

The Court appeared to reject petitioners' arguments that under the “common-law meaning” rule, Congress should be presumed to have made reliance an element of a civil RICO claim predicated on a violation of the mail fraud statute. And rejected the argument that a plaintiff bringing a RICO claim based on mail fraud must show reliance on the defendant's misrepresentations in order to establish proximate cause. The Court felt it had no ability to respond to the policy argument that RICO should be interpreted to require first-party reliance for fraud-based claims in order to avoid the “overfederalization” of traditional state law claims. A RICO plaintiff who alleges injury by reason of a pattern of mail fraud cannot prevail without showing that someone relied on the defendant's misrepresentations. But that does not mean, under one reading of Bridge, that the only injuries proximately caused by the misrepresentation are those suffered by the recipient.

The Court’s decision on reliance was based on statutory interpretation, rather than logic or common sense. We predicted that the absence of a clear reliance requirement may in fact make this type of claim even more popular with mass tort plaintiffs. And we are seeing its potential effect on class certification decisions in some district courts.
 

Update on Digitek Litigation

As posted by MassTortDefense, the Digitek MDL judge late in 2008 issued a pretrial order regarding multi-plaintiff complaints. In Pretrial Order No. 7, the court ordered the severance of most multi-plaintiff cases (other than spouses). In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.). The court noted that several complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they allegedly ingested the drug at issue. Other MDL judges have noted the case management, tracking, and other difficulties often accompanying that joinder practice, citing Vioxx and diet drugs.

Plaintiffs’ Co-Lead Counsel were to submit to the court a report identifying multi-plaintiff actions docketed prior to this Order that are subject to severance, and submit a suitable proposed severance order. One of the reasons plaintiffs resist such severance is the need to pay separate filing fees for all the separate claims filed, but the Order required the fees.


The plaintiffs in the Digitek multidistrict litigation then identified five class actions that they say meet the court's requirements for severance under Pretrial Order No. 7. The plaintiffs said that the five cases they identified have multiple class representatives, but  -- despite the order -- they propose that they be continued with multiple class representatives until "class certification issues are addressed and determined by the Court to ascertain suitability and typicality of the class representatives' claims."  These kinds of personal injury claims are typically inappropriate for class treatment.  Individual issues of causation, injury, and damages predominate over any alleged common issues.  Choice of law issues can make the class device unmanageable.

MassTortDefense also posted before about defendants' proposal to centralize the cases filed in New Jersey, and plaintiffs' proposal to designate the New Jersey cases as a mass tort.

New Jersey state court Digitek cases have now been designated a mass tort by a New Jersey Supreme Court Order, and have been assigned to the Bergen County Superior Court. The centralized mass tort docket has been assigned to Judge Jonathan N. Harris.

The state’s mass tort website states that Digitek is a medication used to treat heart failure and abnormal heart rhythm. The NJ complaints seek damages, medical monitoring and other relief due to the purchase or ingestion of allegedly defective Digitek tablets which the plaintiffs claim were released with as much as twice the appropriate thickness. The complaints further allege that patients were thus taking twice the intended dosage. A Class I recall was initiated by the defendants after receiving some reports of illness and injuries consistent with potential overdoses of Digitek. It is alleged that this condition is dangerous especially among individuals suffering from renal failure because the Digitek may accumulate in the body of such individuals, rather than be excreted normally in urine. 

The pattern of federal case MDL and mass tort treatment of multiple filings in a given state's court has been seen in numerous other pharmaceutical cases, including Vioxx and Seroquel.
 

Preemption Found In Medtronic MDL

The federal judge in the Medtronic Sprint Fidelis Leads MDL has ruled that all claims in the plaintiffs' master consolidated complaint are preempted. In Re: Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 35467 (D.Minn. 2009).

The Judicial Panel on Multidistrict Litigation transferred related cases involving Medtronic Inc.'s recalled Sprint Fidelis defibrillator leads to the District of Minnesota last February. The leads were recalled in late 2007, because of the potential for fracture, which can potentially cause unnecessary shocks or failure, possibly resulting in injury. 

Relying on the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), the MDL court noted that Congress has decided to limit medical-device manufacturers' liability in order to spur innovation. Plaintiffs' remedy, therefore, lies with Congress, and not with the courts. 

Every medical device intended for human use is placed into one of three categories by the FDA, based on the risks of injury or illness the device presents; each category is subjected to a different level of FDA scrutiny. Devices that either support or sustain human life or present a potential unreasonable risk of illness or injury” are categorized as “Class III” devices. Class III devices are subject to the greatest level of FDA scrutiny and “must complete a thorough review process with the FDA before they may be marketed.”  Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001). Through this process, known as pre-market approval (“PMA”), a device maker must provide the FDA with “reasonable assurance” that its device is both safe and effective.

The PMA process is “a rigorous one.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. When analyzing that information, the FDA weighs the probable benefit to health from the use of the device against any probable risk of injury or illness from such use. Accordingly, the FDA sometimes grants PMA to potentially life-threatening devices, if they offer great benefits in light of available alternatives. Riegel, 128 S.Ct. at 1004.

Here, the MDL court rejected arguments that a recall of the leads invalidated their premarket approval. Medtronic correctly noted that the PMA process is governed by a completely separate statutory and regulatory regime than that governing withdrawal of a PMA. Also, the PMA for the leads was in place at the time they were implanted, a crucial fact because liability under plaintiffs' various legal theories hinges upon whether the leads were defective at that time. More fundamentally, the federal interest that preemption is designed to protect is the PMA process, and preemption necessarily looks backward (to the time of PMA) rather than forward.

The court also rejected the plaintiffs' claims that they have asserted "parallel" claims and therefore preemption does not apply. For example, plaintiffs purported reliance on Good Manufacturing Practice or Quality Control guidance did not save the claims. In the absence of any specific requirement in the CGMPs/QSR that Medtronic weld the Sprint Fidelis leads in a certain fashion [that was plaintiffs' beef], holding Medtronic liable for such a welding “defect” would have imposed requirements “different from, or in addition to” those under federal law. This is equally true of plaintiffs' allegation that Medtronic used inadequate testing and quality-assurance methods. Plaintiffs simply could not identify any specific requirements in the CGMPs/QSR that were purportedly violated by Medtronic.

It is noteworthy that the court found dismissal with prejudice was appropriate. This complaint was filed after extensive preparation by the Plaintiffs' Steering Committee, which is made up of lawyers who are experienced in federal preemption litigation. In the MDL Court's estimation, if plaintiffs were aware of sufficient facts in order to avoid preemption, they would have already pleaded them.
 

GAO Adds To Critiques of FDA

The Government Accountability Office issued a report last week that listed the FDA as a "high-risk" area of the federal government. The GAO said the U.S. Food and Drug Administration was being hampered by globalization, more complex products, and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs, and medical devices. GAO says its work examining a variety of issues at FDA echoes the conclusions reached by others (think IOM) that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.
 

The perception of the FDA and its ability to do an effective job is a crucial underlying feature in product liability litigation involving regulated drugs, devices, and food products. Jurors’ perceptions of the agency can affect a myriad of issues and themes the defense may wish to present.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the issue is a need for more resources for the FDA, to keep drugs safe. The agency “is being asked to do more than it can do” with current resources, the trade group says. Specifically, FDA needs more resources to conduct foreign inspections so the drug supply can be kept safe. PhRMA also said that FDA needs more resources to modernize because, for example, the agency still looks at clinical trial information on paper.
 

FDA Issues Guidelines and Rule On Institutional Review Boards

FDA issued guidelines last week that identify which adverse events arising during clinical studies need to be reported to institutional review boards (IRBs) and that clarify the process for reporting unanticipated events. FDA also released a final rule requiring all U.S. IRBs that review FDA-regulated trials to register with FDA. Adverse events often become fodder for plaintiff attorneys in mass tort litigation concerning approved products, as plaintiffs attempt to argue that early risk “signals” were missed or downplayed-- as they employ the benefit of 20-20 hindsight.

FDA regulates clinical studies under sections 505(i) (drugs and biologics) and 520(g) (devices) of the Food, Drug, and Cosmetic Act. All such clinical studies must be reviewed and approved by an IRB before the study is initiated, in accordance with the requirements of 21 CFR part 50 (Protection of Human Subjects), part 56 (Institutional Review Boards), and either part 312 (Investigational New Drug Application) or part 812 (Investigational Device Exemptions) (see §§ 50.1, 56.101, 312.23(a)(1)(iv), 312.40(a), 812.2(b)(1)(ii), 812.2(c) and 812.62(a)).

After the initial review and approval of a clinical study, an IRB must conduct continuing review of the study at intervals appropriate to the degree of risk presented by the study, but at least annually. The primary purpose of both initial and continuing review of the study is to assure the protection of the rights and welfare of the human subjects. To fulfill its obligations during the conduct of a clinical study, an IRB must have, among other things, information concerning unanticipated problems involving risk to human subjects in the study, including adverse events that are considered unanticipated problems

This new guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the institutional review board. FDA developed this guidance in response to concerns raised by the IRB community, including concerns raised at a March, 2005 public hearing, that increasingly large volumes of individual adverse event reports submitted to IRBs—often lacking in context and detail—are inhibiting, rather than enhancing, the ability of IRBs to protect human subjects.


 

Current ABA Leader Wrong On Preemption

The president of the ABA recently wrote to leaders of the House and Senate to express his personal support for H.R. 6381, the so-called “Medical Device Safety Act” that was introduced in the 110th Congress. The letters urged Congress to reintroduce in 2009 this legislation, which is designed to overturn the Supreme Court’s decision in Riegel v. Medtronic that a product liability lawsuit filed against Medtronic in state court was pre-empted because the device had received approval from the FDA.

Among the inaccurate and misleading statements in the letters is the claim that the plea is “on behalf of the American Bar Association and its over 400,000 members.” In fact, MassTortDefense knows a number of members of the ABA who understand the appropriate role of the preemption doctrine, its constitutional basis, and the need for a national test balancing risks and benefits.

As the Supreme Court has noted, state tort law that requires a manufacturer’s catheters to be “safer” in the eyes of a lay jury may require them to be less effective than the model the FDA has approved. State court juries do not ask how many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm. A jury sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. Why is it that the understandable solicitude for those few injured by FDA-approved devices must necessarily overcome a solicitude for those many patients who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations?
 

FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage

The FDA has finalized guidelines for how manufacturers can distribute information to doctors about unapproved uses for drugs or medical devices. The ‘‘Good Reprint Practices for the
Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices’’
allows for the limited dissemination of medical journal articles describing off-label uses. The FDA proposed the guidelines in February, 2008 and took public comments before finalizing them.
 

Allegations of off-label promotion are common in mass tort litigation involving drugs and medical devices. Off-label promotion is illegal, but many critics of the industry and plaintiff lawyers seem to forget that doctors can prescribe drugs for any use they see as medically appropriate. The FDA in its guidelines confirms that the public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses. It will likely help practitioners to receive timely and accurate medical information in an environment where off-label use is common. The FDA's guidance will help assure that medical professionals receive timely and accurate medical information prior to the lengthy process of securing FDA approval for wider use. Such off-label use can save lives, especially in practice areas where there are few effective treatments. These off-label uses or treatment regimens thus may be quite important and may even constitute the medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications on unapproved new uses of approved or cleared medical products that are truthful and not misleading.

This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115), and suggest that the distribution be in the form of an unabridged reprint, copy of an article, or reference publication;  not be marked, highlighted, summarized, or characterized by the manufacturer in any way (except to provide the accompanying disclosures discussed in the guidance), and be accompanied by the approved labeling for the drug or medical device.

The guidance represents the agency’s current thinking on the dissemination of medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities.
 

Eighth Circuit Affirms Dismissal of Nuisance Claim Against OTC Drug Makers

The 8th Circuit has affirmed the dismissal of nuisance claims against the makers of over-the-counter cold and cough medicines containing ephedrine or pseudoephedrine. Ashley County v. Pfizer, No. 08-1491, slip op. (8th Cir. Jan. 5, 2009) (here's a link to the opinion at the Eighth Circuit website).  Important to readers of MassTortDefense, this may be the first appellate court to address whether the lawful distribution of an FDA-approved product can be actionable under a nuisance theory.

Several Arkansas Counties sought to hold the drug companies liable because the lawful cold medicines were being converted by criminals into methamphetamine, an addictive illegal drug. The Counties pleaded theories of unjust enrichment, statutory unfair trade practices, nuisance, and the Arkansas crime victims civil liability statute.

The Counties claimed that the defendants were unjustly enriched at the Counties' expense when methamphetamine cooks purchased the defendants' products for use in the illegal manufacture of methamphetamine. Unjust enrichment is an equitable doctrine that allows a party to recover for benefits conferred on another. It is restitutionary in nature and focuses on the benefit received. It is not enough, however, to establish a benefit received by another party. There must also be some operative act, intent, or situation to make the enrichment unjust and compensable. A party who is free from fault cannot be held to be unjustly enriched merely because it has chosen to exercise a legal or contractual right.

Here, the Counties did not provide the services for which they sought compensation, i.e., law enforcement, inmate housing, social services, and treatment, with the expectation that the defendants–manufacturers and wholesalers of products containing pseudoephedrine–would pay for those services. In other words, the cold medicine manufacturers cannot be said to be the beneficiaries of the services provided by the Counties. The circumstances connecting the sales of cold medication to the provision of these government services were simply too attenuated to give rise to an implied contract between the manufacturers and the county providers to state a cause of action for unjust enrichment.

The remaining nuisance and statutory claims all failed for lack of proximate cause. Arkansas law incorporates the doctrine of intervening acts, which reflects the limits that society places on a defendant's liability for his actions. An original act is eliminated as a proximate cause by an intervening cause if the latter is of itself sufficient to stand as the cause of the injury, and the intervening act is independent of the original act. On this, the Eighth Circuit relied on a Third Circuit gun case, City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415 (3d Cir. 2002), to hold that intervening criminal misconduct can break the chain of proximate cause to product manufacturers. The allegations in the Third Circuit case were nearly identical to the allegations here–that the defendant manufacturers failed to take steps to restrict access to the products containing pseudoephedrine when they knew (an alleged fact the court had to take as true at the judgment on the pleadings stage) that the pseudoephedrine-containing products were being purchased and used illegally to make methamphetamine. "The criminal actions of the methamphetamine cooks and those further down the illegal line of manufacturing and distributing methamphetamine are 'sufficient to stand as the cause of the injury' to the Counties in the form of increased government services, and they are 'totally independent' of the Defendants' actions of selling cold medicine to retail stores . . . . " Slip opin. at 15.

 
 

New Article: Platitudes From Plaintiffs About Product Stewardship

A recent academic paper may be worth a look. Noah, Lars, “Platitudes about 'Product Stewardship' in Torts: Continuing Drug Research and Education,” 15 Michigan Telecommunications and Technology Law Review 2009.

This paper focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, might portend a dramatic (and potentially counterproductive, in the author’s view) expansion in the prescription drug industry's exposure to liability. A growing number of liberal commentators would seek to impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of "product stewardship"). This paper explains some of  the serious flaws in such proposals.

The article is thus part of the overall debate about what role tort law may have to play in drug research and development. Does the threat of liability create important safety incentives (and make up for perceived, alleged failings in regulatory oversight), or, instead, does it unduly interfere with innovation and patient access to life-saving therapies? These and related questions have
inspired an active debate among commentators, the author notes;  courts and legislators have also made occasional forays into the area by constricting the scope of potential tort liability in particular circumstances. The Restatement (Third) of Torts: Products Liability, which ALI published a decade ago, included special provisions governing prescription drug cases, and the pitched battle over using implied preemption as a defense, which the United States Supreme Court may address in 2009, represents only the latest manifestation of these sharp disagreements.

Worth a read.
 

Severance Ordered In Digitek MDL

The Digitek MDL judge earlier this month issued a pretrial order regarding multi-plaintiff complaints. In Pretrial Order No. 7, the court ordered the severance of most multi-plaintiff cases (other than spouses). In Re: Digitek Products Liability Litigation, MDL No. 1968 (S.D. W.Va.). The court noted that several complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they allegedly ingested the drug at issue. Other MDL judges have noted the case management, tracking, and other difficulties often accompanying that joinder practice, citing Vioxx and diet drugs.
 

No later than December 31, 2008, plaintiffs’ Co-Lead Counsel are to submit to the court a report identifying multi-plaintiff actions docketed prior to this Order that are subject to severance, and submit on that same date a suitable proposed severance order. One of the reasons plaintiffs resist such severance is the need to pay separate filing fees for all the separate claims filed, but the Order requires the fees.

MassTortDefense has posted on this MDL.  Defendant initiated a nationwide recall of Digitek products, saying tablets with double the appropriate dosage may have been released to the public, with possible side effects. More than 50 Digitek product liability cases were transferred to Chief Judge Joseph R. Goodwin of the Southern District of West Virginia in August.

Consolidated trials are something most mass tort defendants may want to oppose. The pre-trial severance of multi-plaintiff actions here is without prejudice to any party’s right under Federal Rule of Civil Procedure 42 to request consolidation of severed actions upon future remand to a transferor court for trial. But better that plaintiffs have the burden of putting cases together than defendant have to overcome the "inertia" of cases that have been consolidated since day one.
 

9th Circuit Affirms Summary Judgment In Failure To Warn Case

The Ninth Circuit has affirmed that the trial court did not err in granting summary judgment for defendant Merck under California's learned intermediary doctrine in a failure to warn case. Latiolais v. Merck & Company, Inc., 2008 WL 5157705 (9th Cir. 2008).

Latiolais appealed the district court's grant of summary judgment on her claim that Merck failed to adequately warn, as a result of inadequate testing, of claimed suicide risks associated with the cholesterol-lowering medication Zocor.

Under California's learned intermediary doctrine, a prescription drug manufacturer's duty to warn runs to the physician. A product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the prescribing physician's conduct. See Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir.2004).

Here, there was no genuine issue of material fact as to causation made out by the prescriber’s deposition testimony. It indicated that the drug inserts accompanying Zocor did not play a role in his decision to prescribe that medication. Furthermore, Dr. Oppenheim was not equivocal regarding whether he would have prescribed Zocor in light of a supposed warning of suicide risk associated with Zocor. Such a warning was deemed “hypothetical” by the court, and, in any event, could come into play only after one makes several assumptions on issues that include whether Merck was obligated to issue a suicide risk warning for Zocor, whether Dr. Oppenheim would have read or heeded such a warning, and what information Mr. Davis would have disclosed to Dr. Oppenheim with respect to his mental state. Such speculation did not create an issue of fact.

 

Opposition To Cert Petition In Colaccico: That Other Preemption Case

While much preemption focus has been on Levine v. Wyeth, including by posts here at MassTortDefense, other preemption decisions are winding there way through the federal appellate courts. Defendants Pfizer Inc., GlaxoSmithKline, and Apotex Inc. last week asked the U.S. Supreme Court to uphold a ruling by the U.S. Court of Appeals for the Third Circuit that failure to warn claims are impliedly preempted by federal law based on the regulatory history of the antidepressants at issue. Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008), Petition for Certiorari Filed, 77 USLW 3229 (Oct 02, 2008). 

Readers of MassTortDefense know that plaintiff Colacicco filed suit after his wife allegedly committed suicide while under treatment with a generic equivalent to Paxil. The district court for the E.D. of Pennsylvania found preemption. The appeal was consolidated with a contrasting preemption decision in the McNellis case out of the district court in New Jersey, involving Zoloft. The Third Circuit's decision was the first by a federal appeals court to address the preemptive effect of prescription drug law and regulation since the FDA had expanded on its guidance on the issue.

Plaintiffs sought certiorari, asking the Court to review the Third Circuit's decision; alternatively, they asked the court to hold the petition pending resolution of Levine, argued last month. But the Court should do neither, the manufacturers argued, and cert should just be denied.

Pfizer Brief

According to Pfizer's brief, the Third Circuit properly determined that plaintiff below McNellis sought a warning about suicidal behavior that conflicted with the federal warning requirements for Zoloft. For more than 15 years, the FDA had considered whether SSRIs were associated with an increased risk of suicidality in adult patients. The agency repeatedly determined that the scientific evidence did not support such a warning.

Pfizer notes there is no disagreement among appellate courts (a well-established basis for Supreme Court review) on preemption in SSRI litigation.  No other federal appeals court has ruled in a contrary way on the preemptive effect of the type of conflict at issue here. The 3d Circuit found preemption based on “the direct, real conflict” between plaintiff’s claim that New Jersey law required a warning about adult suicidality and the FDA's requirement—based on its repeated finding of no reasonable evidence of such an association—that only the FDA's approved warning be given. McNellis relied on the Court's decision in Sprietsma v. Mercury Marine, 537 U.S. 51 (2002) to argue that the FDA merely failed to act with respect to suicidality warnings, and that a federal agency's failure to act does not create a federal requirement triggering preemption. But the FDA “regulated with great specificity and care” in repeatedly finding no reasonable association between SSRIs and suicidality, and by requiring the manufacturer to provide the specified warnings.

As to the claim that the manufacturers failed to disclose information to the FDA, defendants assert that the lower court correctly found that this claim should be presented to the FDA first. In addition, Buckman preemption likewise prevents plaintiffs from evading a definitive FDA regulatory record by arguing that the FDA was somehow defrauded; the appellate court found that the preemption doctrine of Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), bars claims that the manufacturer withheld information from the FDA.

Direct Conflict

Arguing against even staying the petition until Levine is decided, Pfizer said the issues in the cases are distinct, asserting that the 3d Circuit's decision in this case is correct regardless of whether Levine is affirmed or reversed. Respondents point out what they see as distinct regulatory facts in that case, involving contraindication claims.

Brief for Apotex, GlaxoSmithKline

Apotex, a maker of generic Paxil, and GlaxoSmithKline, the maker of brand-name Paxil, also argued against review. Like Pfizer, they contended the 3d Circuit properly concluded that the FDA's repeated rejection of suicidality warnings preempts plaintiff Colacicco's claims.

The brief also argued that state law failure to warn claims challenging FDA-approved labeling should be preempted. To allow this sort of tort action to continue would place state-law juries in the position of second-guessing FDA decisions regarding the proper warnings for drugs. Lay juries should not be able to undermine the agency's expertise by second-guessing the agency's warning decisions. At its base, Colacicco's argument against preemption is the theory that a court, applying state law, has authority to decide whether GSK could have under federal law, and should have under state law, unilaterally added a suicidality warning to the Paxil labeling, despite FDA regulation.

Courts do not share concurrent jurisdiction with the FDA over drug labeling; there should be no preemption test that would require a court to delve deeply into internal FDA decision making. Specifically, the lower courts do not share jurisdiction with the FDA over the CBE regulation, which is the basis for the “could have, should have” argument, Apotex and GSK both wrote. FDA has made clear that CBE supplements fall squarely within its regulatory jurisdiction. Under Colacicco's theory, the lower court would be authorized to decide, without reference to the FDA, that a CBE supplement adding the putative warning could have been submitted, that the added warning would have been consistent with the FDCAct, and that FDA would have approved it. Thus, the lower courts would become “shadow” FDAs. That is not the scheme adopted by Congress for drug regulation.

 


 

New Report From National Research Council On Nanotechnology

A new report from the National Research Council questions the government's current plan for research on the possible health and environmental risks posed by nanomaterials, which are increasingly being used in consumer products and other industry. The report emphasizes the need for an effective national plan for identifying and managing potential risks, a step seen as essential to the successful development and public acceptance of nanotechnology-enabled products.

Nanoscale engineering manipulates materials at the molecular and atomic level to create structures with unique and useful properties – materials that are both very strong and very light, for example. More than 600 products involving nanomaterials are already on the market, the majority of them health and fitness products, such as skin care and cosmetics. And over the next decade, nanomaterials will be used increasingly in products ranging from medical therapies to food additives to electronics. MassTortDefense has posted about nano-issues before.

Growing use of nanomaterials means that more workers and consumers may be exposed to them, and uncertainties remain in the minds of some about their health and environmental effects; while nanomaterials can yield tremendous, special utility, they may also have possibly toxic risk properties.

The National Nanotechnology Initiative, which coordinates federal agency investments in nanoscale R&D, developed a research plan to investigate these risks, and the office that oversees NNI asked the National Research Council to review the plan.  (The NRC report was sponsored by the National Nanotechnology Coordination Office. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter.)  The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering.

The committee report did not focus on current uses of nanomaterials and any potential risks to the public. Rather, the report focused on what would constitute an effective national research strategy for ensuring that current and future uses of nanomaterials are without significant impacts on human health or the environment.

The current plan, involving nano-risk research across several federal agencies, lacks an overarching research strategy needed to gain public acceptance and realize the promise of nanotechnology, according to the report.  NNI's plan identifies broad research categories for assessing health and environmental risks, and many of the research needs listed within these categories will aid risk assessment, the report says. But the plan fails to identify some important other areas that should be investigated; for example, "Nanomaterials and Human Health" should include a more comprehensive evaluation of how nanomaterials are absorbed and metabolized by the body and how toxic they are at realistic exposure levels. Furthermore, the current research plan, according to the report, does not provide a clear picture of the current understanding of these risks or where it should be in 10 years. And though the research needs listed in the plan are valuable, the NRC committee thinks they are incomplete, in some cases missing elements crucial for progress in understanding nanomaterials' health and safety impacts.

In its assessment of gaps in existing research, the current NNI plan overstates the degree to which already funded studies are meeting the need for research on health and environmental risks, the report says. For example, more than half of the currently funded projects on nanotechnology and human health are aimed at developing therapies for diseases. While this research is important, it will not shed light on health risks that may be posed by nanomaterials. Moreover, the plan does not note the current lack of studies on how to manage consumer and environmental risks, such as how to manage accidents and spills or mitigate exposure through consumer products.

A truly robust national strategic plan would involve a broader group of stakeholders, and would consider the untapped knowledge of nongovernment researchers and academics, the committee said. The current structure of NNI would make developing a new strategy difficult, says the report. NNI should continue to foster successful interagency coordination, with the aim of ensuring that the federal research strategy on the health and safety impacts of nanotechnology is an integral part of the broader national strategic plan.
 

FDA To Hold Workshop On "Sentinel" Initiative

The Food and Drug Administration is holding a public workshop entitled Sentinel Initiative: Structure, Function, and Scope. The workshop is co-sponsored by the FDA and the eHealth Initiative Foundation, and convened by the Engelberg Center for Health Care Reform at the Brookings Institution. The workshop is intended to bring together academia, government, patient, consumer, and provider groups, health care data owners, the pharma industry; and other interested organizations for an update on the current status of the Sentinel Initiative, and to allow for comment from all interested stakeholders.

In May, 2008, FDA launched the “Sentinel Initiative” – a new program with the goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety.

The Sentinel System is being designed to enable FDA to pose targeted queries (consistent with privacy and security safeguards) of patient registry data, insurance claims data, and other large health care information databases, for information about medical products. FDA says this new system will strengthen the agency's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health.

FDA's current post-market surveillance programs generate very important new risk information, but the adverse event reporting system depends on health care professionals and patients first recognizing a potential association between an adverse effect and a medical product, and then report it to FDA or the manufacturer. Some adverse events may never get reported.

Date and Time: The public workshop will be held on December 16, 2008, from 9 a.m. to 3:30 p.m. Location: The public workshop will be held at the Omni Shoreham Hotel, 2500 Calvert Street NW., Washington, DC 20008.
 

Creating an advanced surveillance system like Sentinel was one of the recommendations made by the Institute of Medicine in its 2006 report on ways to improve the safe use of drugs. The Food and Drug Administration Amendments Act of 2007 included provisions that call for the development of such a system. FDA believes patients will benefit because the agency will be able to identify potential problems sooner, better understand those problems, and ultimately, help health professionals and patients use medical products more safely.

The overall initiative is described in an FDA white paper titled, “The Sentinel Initiative—A National Strategy for Monitoring Medical Product Safety.” 
 

It is interesting to speculate about the potential impact of the system, especially on products liability litigation. Medicare collects data typically only when a medical provider is seeking payment. This claims data is less complete, and potentially less accurate than actual patient health records. Thus, utilizing Medicare data to assess health outcomes of drug use may be problematic. Of course, the new system doesn’t change the reality that sometimes patients suffer adverse events after receiving drugs because they are sick, not because the drug has a problem. And Medicare recipients use an average of 28 prescriptions in a year, compared with an average among all Americans of something like 12 prescriptions. Sorting out which medicine caused any single problem – if any did -- can be difficult.

In mass tort litigation, as readers of MassTortDefense know, plaintiffs frequently will attack defendants’ AER system, the resources devoted, the quality of the reporting. Even more frequently, plaintiffs will allege that the AE reports revealed a “signal” far sooner and far more clearly than the company thought; that the defendant missed or ignored the signal about potential adverse events in order to avoid the financial impact of a new label with a stronger warning. But if the FDA will eventually be able to query databases of tens of millions of patients almost simultaneously, presumably it will no longer have to wait for reports from the field, and the allegations of “missed signals” may lose all force.

To assess the accuracy of the Sentinel system, the FDA will initially conduct studies of drug side-effects that are already well known. And despite the potential issues, the Pharmaceutical Research and Manufacturers of America supported the FDA initiative, because it will allow regulators and health care professionals to move from reliance on voluntary reporting of side effects to a more proactive monitoring of medicines.
 

FDA Issues Guidance For Industry On Retaining Data From Clinical Trials

Limiting mass tort/class action exposure is a key part of the role of in-house litigators. In the drug and device areas, limiting plaintiffs' ability to take unfair advantage of clinical trials research is becoming a real focus. Issues include limiting liability due to alleged inadequate monitoring during trials, and preventing off-label and product liability claims associated with alleged under-reporting and over-reporting of data. Litigators need to offer their input on the company's determination of the extent to which data from ongoing clinical trials will be distributed, helping the company to assess the liability risks of disclosing and failing to disclose clinical trial data related to off-label uses. A thorny legal issue is the degree to which the First Amendment is a viable defense, and in a complex regulatory world the company needs to understand and comply with state as well as federal disclosure obligations.


Ideally, the company will be developing a framework for deciphering where scientific exchange ends and drug promotion begins, as a guide to avoiding language in describing clinical trials that could be construed as promotional while still providing fair and balanced information on clinical trials involving their products. The most prudent may be developing a strategic, long-term plan to protect clinical trial information from turning into grist for the plaintiff ’s case (and outside counsel can help with that too). That program may include training employees to recognize the litigation potential arising from clinical trials; maintaining protocols as to the language and terms that will be used in clinical trial reports; and minimizing common liability risks arising from posting of data by establishing thorough review processes.


Into this complex situation the FDA has issued new guidance for drug, biologic, and medical device companies about retaining data from clinical trial participants who no longer are participating in the trial, according to a notice just published in the Federal Register (73 Fed. Reg. 72807). The guidance document on Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials states that data must be retained for participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, or who were discontinued from participation by the clinical investigator.
FDA's reasoning is that data resulting from these clinical investigations are used to support research applications and new product approvals;  thus it is critical that it has a complete and accurate data set available. While it may be appropriate to remove data from various reported figures, based on the study protocols, FDA worries that if data were to be removed from the study database altogether, the FDA may miss something that may be relevant to their decision-making.
 

The agency said it issued this guidance for immediate implementation to prevent the potential loss of important clinical trial data. If comments are received on the guidance, FDA said it will review the comments and revise the guidance as appropriate.
 

Senator Raises Issue Of Dental Implants With Lead

Dental implants are traceable to early Egyptians and to ancient Central and South American cultures. But the modern versions from China are in the products liability news again. A few months back, there were media reports about a dental patient in Ohio who claimed to have lead contamination in her dental restoration. The affected patient, a senior citizen, received a three-unit dental bridge from a dentist in Ohio. Reportedly, the prescription was sent to an offshore dental laboratory and made in China. A lab analysis apparently showed levels of lead in the porcelain on the restoration.

When the story broke in February, the American Dental Association notified the CDC and the FDA, and asked the agencies to address any safety concerns. (The not-for-profit ADA is the nation's largest dental association, representing more than 156,000 dentist members.)  The FDA regulates the materials used to make dental crowns and bridges, and the CDC has extensive information and expertise in the area of lead exposure.

According to the CDC’s response, many consumer products contain lead in trace amounts; federal regulations limit the amount of lead in consumer products based on the way the body absorbs lead, the potential hazard, and the lead level product manufacturers can achieve using good manufacturing practices. According to the CDC, trace amounts of lead at a level of 200 ppm, such as the amount the Ohio dentist reportedly found in dental crowns, are extremely unlikely to cause adverse health effects. The CDC also states that given the current information at hand, they do not recommend that individuals defer needed dental treatment or have existing dental crowns, bridges or other prostheses removed.

However, U.S. Senator Sherrod Brown (D-OH) has now called on the Food and Drug Administration to revisit the issue. In a letter to FDA, Brown cites reports of tainted implants with higher levels of lead than that ceiling. He is requesting that FDA delineate the actions it is taking to assess the prevalence, source, and impact of lead-containing dental implants in the United States. And address:

• What standards exist for domestic and international dental products and the dental labs that produce them?
• What is the estimated volume of China-produced dental implants in the country today, and what is the annual volume of such products?
• What tracking mechanisms are in place to prepare for potential contamination by tainted dental implants?
• What inspection mechanisms are in place to ensure the safety of dental implants?
• What are the risks posed by dental implants with lead levels above those that the CDC has determined are safe?
 

Meanwhile, the ADA is testing both foreign- and domestic-made dental crowns to determine:
• The degree to which lead may be present;
• Where the lead may be located (i.e., in the metal alloy, the porcelain, etc.); and
• How much, if any, lead may be released from dental crowns.
 

White Paper On Combination Products

Dr. Steven Richter has issued a white paper, “Combination Products: Navigating Two FDA Quality Systems.” Dr. Richter founded the consulting firm Microtest after working at the U.S. Food & Drug Administration. Combination products involve medical devices embedded with pharmaceutical or biologics components, like a drug-coated stent.

While none currently exist, the white paper predicts that FDA will issue guidelines specific to combination products, and the result will be increased GMP regulatory action that affects both laboratory and manufacturing.

The combination products market is moving forward with a new direction and emphasis regarding product safety and FDA requirements. The paper quotes an estimate that the market for such products will reach approximately $9.5 billion in 2009. The FDA received 275 combination product submissions in 2005, and that number has been growing. According to one survey, an estimated 30% of new products under development are “combo products.”

Such combination products can raise thorny legal issues if products liability litigation arises.  E.g., In re St. Jude Medical, Inc. Silzone Heart Valves Products Liability, 2004 WL 45503
(D. Minn., January 05, 2004)(discussing which preemption doctrine may apply to such). 
 

Digitek MDL Proceeds And State Mass Tort Designation Looms

Certain plaintiffs in the Digitek litigation have filed for mass tort designation in the State of New Jersey, according to a notice filed on the New Jersey Judiciary mass tort web site. Earlier this year, defendant initiated a nationwide recall of Digitek products, stating that tablets with double the appropriate dosage had possibly been released to the public. It said digitalis toxicity was possible in patients with renal failure.

Previously, some plaintiffs had moved for centralized management, but not mass tort designation, of all New Jersey state-court litigation involving the drug Digitek and assignment of that litigation to Bergen County. Anyone wishing to comment on or object to this second application regarding the Digitek  state-court litigation is to provide such comments or objections in writing, with relevant supporting documentation, to the Administrative Office of the Courts, by December 1, 2008. After that date the N.J. Supreme Court will consider and act on both applications regarding Digitek and any comments received.

At the federal level, the judge in the newly-created Digitek federal multidistrict litigation issued an order appointing lead and liaison counsel for the plaintiffs as well as the Plaintiffs' Steering Committee. See In Re: Digitek Products Liability Litigation, MDL No. 1968, JPMDL.; No. 08-md-1968, S.D. W.Va.). Chief Judge Joseph R. Goodwin of the Southern District of West Virginia appointed Carl N. Frankovitch of Frankovitch, Anetakis, Conatonio & Simon, Fred Thompson III of Motley Rice, and Harry F. Bell Jr. of Bell & Bands, as co-lead counsel for the plaintiffs. Bell is also liaison counsel for the plaintiffs. Previously, Chief Judge Goodwin appointed Rebecca A. Betts of Allen, Guthrie & Thomas as defendants' liaison counsel.


Earlier in the fall, the federal court held a pretrial conference jointly with Magistrate Judge Mary E. Stanley and advised the parties of its intention to coordinate heavily with the judges and counsel involved in the state Digitek cases, especially in West Virginia and New Jersey where a majority of the state cases have been filed.
 

Punitive Damages Claim Against Patch Maker Found Preempted

A federal court has found that federal law preempts a state law that allows plaintiffs to seek punitive damages from the makers of defective drug products if the drug company knowingly withheld information from the Food and Drug Administration. Grange v. Mylan Laboratories Inc., 2008 WL 4813311 (D.Utah 10/31/08).

Plaintiffs’ estate sued over an allegedly defective drug patch. Defendants sold the Fentanyl Patch, which is applied directly to the skin to deliver fentanyl, a strong pain medicine. Doctors prescribe the Fentanyl Patch to relieve chronic moderate to severe pain. The patch should be worn for seventy-two hours and is supposed to deliver the medicine at a regulated rate. Plaintiff alleged that due to a design and/or manufacturing defect, some Fentanyl Patches contain and deliver fentanyl in amounts far in excess of what is advertised. Plaintiff alleged that defendants knew that the Fentanyl Patch was defective, but did not warn of the potential risk of overdose.

Defendants moved to dismiss the claims for punitive damages. A Utah statute, Utah Code Ann. § 78B-8-203, completely bars punitive damages for harm caused by FDA approved drugs. But that statute has an exception for cases where a plaintiff can show that a defendant withheld information from the FDA. Plaintiffs, of course, alleged that the exception applied here. But defendants contended that this exception is preempted by federal law.

As the court noted, this statutory limitation on liability for punitive damages does not apply if it is shown by clear and convincing evidence that the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration under its regulations, which information was material and relevant to the claimant's harm. Defendants contended that the statutory exception amounts to a de facto “fraud on the FDA” claim, which is preempted by federal law.

In support of this argument, defendants relied on Buckman Co. v. Plaintiff's Legal Comm'n., 531 U.S. 341, 348 (2000), which held that state law fraud-on-the-FDA claims conflict with, and are therefore impliedly preempted b