Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

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.

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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. 

 
 

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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.

 

 

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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.

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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.

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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.

 

 

 

 

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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.

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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.

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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. 

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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.
 

 

 

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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.

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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.

 

 

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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.
 

 

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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 pumps.  Cox 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.

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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.

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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. 
 

 

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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®.
 

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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.

 

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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.
 

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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.

 

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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.

 

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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.
 

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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.
 

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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. 

 

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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.

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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.
 

 

 

 

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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.]

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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.

 

 

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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.

 

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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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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.
 

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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.

 

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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.

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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.

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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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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.

.
 

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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.
 

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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.”
 

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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.

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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.   

 

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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.

 

 

 

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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. 

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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.

 

 

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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).

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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.

 

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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.”

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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.
 

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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.
 

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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
   

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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.
 

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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.

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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 led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his products 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).

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 showing 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, although they surely have limitations, have been considered valuable in ascertaining causation because they measure a patient's reaction to a drug, said the appellate court.

The New Jersey court recognized that it was issuing a causation decision contrary to the ruling in the Accutane MDL.  The court declined to follow the federal court's decision because (1) the causation expert in the Florida 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 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.

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 a 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."

 

 

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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.

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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.
 

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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.
 

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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.

 

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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." 

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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.
 

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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.

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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?
 

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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.
 

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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.
 

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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.
 

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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.
 

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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.
 

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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.
 

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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.

 

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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?
 

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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.
 

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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.

 
 

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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.
 

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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.
 

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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.

 

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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.

 

 

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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.
 

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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.
 

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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.
 

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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.
 

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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). 
 

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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.
 

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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 by, federal law. The Buckman Court gave two primary reasons for this holding. First, allowing state law claims of fraud on the FDA would interfere with the FDA's objectives and judgment. See id. at 350-51. Second, such claims could cause the FDA to face a deluge of unnecessary information in the approval process by drug companies attempting to avoid state law liability, jamming up the regulatory system.

The court decided that the decision in Buckman did not directly reach the issue presented here. In this case, unlike in Buckman, the state statute does not predicate liability on fraud on the FDA, but rather would allow certian damages based on such fraud. The question of whether this type of statute is preempted, said the court, has created a split of authority. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir.2004)(extending Buckman's logic to a statute similar to Utah's), with Desiano v. Warner-Lambert & Co., 467 F.3d 85, 97 (2d Cir.2006)(same Michigan statute was not preempted by Buckman), affirmed sub nom, Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168 (2008)(4-4 vote).

Despite a mention of the so-called presumption against preemption, the court found that the Sixth Circuit's decision in Garcia was more persuasive here. The chief problems that Buckman sought to counteract are present whenever a plaintiff, as a prerequisite to collecting damages, is required to put on evidence that there was what amounts to fraud on the FDA. When such evidence is considered, state courts are essentially second-guessing the FDA, and drug companies, nervous about state litigation, will have an incentive to flood the FDA with information. To the extent that the Utah law allows for an exception in cases where a plaintiff puts on his or her own independent evidence of information being withheld from the FDA, this statute was found to be preempted. There is no preemption, however, in a situation where a plaintiff invokes the Act to seek punitive damages in cases where the FDA itself has found that there was fraud in the application process.
 

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A federal district court has granted summary judgment to drugmaker defendants Hoffmann-LaRoche Inc. and Roche Laboratories Inc. in an Accutane failure to warn case. Snyder v. Hoffman-LaRoche, Inc., 2008 WL 4790666 (M.D.Fla., October 30, 2008). Plaintiffs alleged their teenage son was prescribed Accutane in 2000 to treat young Snyder's severe acne condition. He had three courses of treatment through April, 2003. On February 28, 2005, Snyder committed suicide.

Prior to prescribing Snyder's first course of Accutane treatment, Dr. Kalb received and reviewed the drug’s 1998 Package Insert, the 1998 Dear Doctor Letter, the 1999 issue of the PDR, the February 25, 1998 FDA Talk Paper, and the Seventh Edition of the Accutane Brochure, all of which discussed the suicide risks. Dr. Kalb testified that he discussed the risks and benefits of Accutane with Snyder before prescribing the drug, including specifically the risk of depression and suicide. Such discussion was consistent with his regular practice, as was his practice of providing each patient with a copy of the Seventh Addition Accutane Brochure. Throughout Snyder's courses of treatment, Dr. Kalb continued to monitor him for symptoms of depression. According to Dr. Kalb, no symptoms of depression were reported or observed while Snyder was taking Accutane.

Plaintiff's Complaint included claims for negligence, strict products liability, breach of implied warranty, and negligent and fraudulent misrepresentation. Each of these claims was predicated upon defendants' alleged failure to warn that Accutane could cause Snyder to commit suicide. Defendants moved for summary judgment on the issue of the adequacy of the warnings. Snyder resided and was prescribed Accutane in the State of New York. Accordingly, the Court considered whether Defendant's warnings were adequate under New York law.

Under New York law, a prescription drug manufacturer may avoid liability for injuries that would ordinarily render the manufacturer strictly liable by distributing proper directions and warnings with the drug. To avoid liability, a manufacturer must warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist. New York employs the learned intermediary doctrine, under which physicians act as “informed intermediaries” between manufacturers and patients regarding warnings for prescription drugs. Thus, a manufacturer's duty to caution against a drug's side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.

Because the defendant had issued a warning about this specific risk, plaintiffs argued that defendant's warnings were not direct, unequivocal and sufficiently forceful to convey the risk of suicide. Plaintiff argued defendants' warnings equivocated in stating that Accutane “may” cause depression and suicidal ideation, that emotional instability “may” bear no relation to therapy, and that the side effect of suicide is “uncommon” and/or “rarely” occurs. Moreover, Plaintiff argued that the defendants' statement that “no one knows if Accutane caused these suicidal behaviors” further dilutes the warning.

The Court disagreed with plaintiffs. The February 1998 warnings specifically warned that Accutane treatment may cause suicide. MassTortDefense notes that the drug does not always cause suicide, so “may” is perfectly accurate. The statements that Accutane “may” cause suicide, or that such a result “rarely” occurs, do not inappropriately diminish the seriousness of the warning. The Court properly viewed the extensive warning language as a prescriber would, in full context, not isolating a word or phrase. Taken as a whole, the warnings clearly, accurately, and consistently conveyed to Dr. Kalb that Accutane might cause suicide, with or without prior symptoms of depression. Accordingly, the Court concluded that defendants' warnings were adequate as a matter of law. Defendants were entitled to summary judgment as to plaintiff's failure to warn claims

 

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Those readers defending PMA medical device defendants should review Parker v. Stryker Corp., 2008 WL 4716879 (D. Colo. Oct. 22, 2008); the district court granted a preemption-based Rule 12(b)(6) motion to dismiss.

Plaintiff underwent a total hip arthroplasty during which she was implanted with the Trident Ceramic Acetabular System, an artificial hip implant device developed, manufactured, and sold by defendants. After the surgery, plaintiff claims she noticed an audible sound coming from the device. She alleges that she had experienced constant irritation and discomfort, as well as “additional and resultant bone loss,” and that she was at an increased risk for requiring a premature revision surgery. She sued under Colorado state law for failure to warn, manufacturing defect, design defect, breach of express and implied warranties, breach of implied warranty of fitness, breach of implied warranty of merchantability, and negligence. Defendants moved to dismiss, claiming that all of plaintiff's state law causes of action were preempted.

Resolution of the motion turned in part on the recent Supreme Court decision interpreting the preemptive scope of the 1976 Medical Device Amendments (“MDA”), 21 U.S.C. §§ 360c-360n, to the Federal Food, Drug and Cosmetic Act of 1938 (“FDCA”), 21 U.S.C. §§ 301-399a, Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008). In that case, the Court concluded that state claims that would impose on manufacturers requirements that are different from, or in addition to, those prescribed by the MDA are preempted. Id. at 1011.

Plaintiff, however, insisted that her claims were not preempted because they did not seek to impose different or additional requirements, but only those parallel to the federal requirements of the MDA. The court here noted first that a "parallel" violation claim is not stated by reference to provisions of the FDCA that govern the sale of adulterated and misbranded devices, because there is no private right of action under the FDCA.

The district court found, second,  that although so-called parallel claims may be recognized, plaintiff had not properly pled them here. Conclusory allegations or legal conclusions masquerading as factual conclusions will not suffice to prevent a motion to dismiss.  Fernandez-Montes v. Allied Pilots Association, 987 F.2d 278, 284 (5th Cir.1993); see also Ruiz v. McDonnell, 299 F.3d 1173, 1181 (10th Cir. 2002), cert. denied, 538 U.S. 999 (2003). Plaintiffs’ conclusory allegations standing alone were not sufficient to sustain plaintiff's burden of pleading under Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1969, 1974 (2007). Specifically, under Twombly a plaintiff can't state a claim simply by alleging that the defendant violated FDA regulations without alleging sufficient facts to back up the claim. And citing FDA warning letters is not sufficient to state a claim without some facts tying the letters to the plaintiff's case.

The only claim not clearly preempted by Reigel was plaintiff's breach of express warranty claim. Federal courts are divided as to whether breach of express warranty claims are preempted. The Third and Seventh Circuits have held that such claims are not preempted because any “requirements” imposed by the warranty are voluntarily assumed by the warrantor, not imposed by the state. See Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir.1997), cert. denied, 523 U.S. 1020, (1998); Michael v. Shiley, Inc., 46 F.3d 1316, 1327-28 (3rd Cir.), cert. denied, 516 U.S. 815 (1995), overruled on other grounds as stated in In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817, 825 (3rd Cir.1998). See also In re Medtronic, Inc. Implantable Defibrillators Litigation, 465 F.Supp.2d 886, 898 (D.Min.2006); Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 433 (E.D.Pa.2004); Steele v. Depuy Orthopaedics, Inc., 295 F.Supp.2d 439, 455-56 (D.N.J.2003). Other courts have found this reasoning unpersuasive given the comprehensive nature of the PMA process. Because all representations regarding the device in its labeling must be approved by the FDA as part of the PMA process, these courts have held that any claim that such representations are inadequate is preempted. See Enlow v. St. Jude Medical, Inc., 210 F.Supp.2d 853, 861-62 (W.D.Ky.2001) (citing Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1100 (6th Cir.1997), cert. denied, 522 U.S. 1075 (1998)).

None of these cases was decided with the benefit of the Supreme Court's decision in Reigel. In light of that decision, the district court decided that the better-reasoned approach would find plaintiff's breach of express warranty claims based on the labeling of the Trident System preempted. The FDA evaluates labeling as part of the PMA process, it noted. Moreover, once approved, labels cannot be changed without FDA approval. Parker's express warranty claim would contradict the FDA's determination that the representations made on the label were adequate and appropriate and, thus, impose requirements different from or in addition to the federal requirements.
 

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The second week of December in New York marks the return of one of the premier products liability litigation events, geared to the pharmaceutical and medical device industries. Now in its 13th year, ACI’s DRUG AND MEDICAL DEVICE LITIGATION is a gathering of many of those involved in defense of product liability litigation, with a faculty of in-house and outside counsel (including your faithful blogger) and 8 renowned federal and state jurists.

Readers of MassTortDefense know that in the past year, the Supreme Court ruled in favor of preemption for PMA-approved medical devices, and it is now poised to make a potentially significant decision on preemption for drugs that could change that aspect of the product liability landscape. The liberal Democratic Congressional backlash against preemption has already started, with attempts to legislatively overturn the Reigel decision. In addition, government enforcement agencies and State Attorneys General have stepped-up investigations against drug and device manufacturers, and plaintiffs’ attorneys are taking every opportunity to highlight this fact in civil litigation. So, plenty to talk about.

This year’s conference takes place in the 1903 landmark Hudson Theatre at the Millennium Broadway Hotel. And MassTortDefense is looking forward to the visit the the Big Apple.
 

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The much anticipated preemption case, Wyeth v. Levine, was argued yesterday before the US Supreme Court. Seth P. Waxman argued for Wyeth; Ed Kneedler for the FDA as amicus; and David Frederick for Ms. Levine.

While veteran Court watchers know it can be risky to read too much into questions asked, here is what jumped out at MassTortDefense from the oral argument.

1. Justice Kennedy: making a “comment” that it was not necessarily impossible for Wyeth to comply with the State law and at the same time the Federal label, as a textual matter, as a logical matter.

2. Each of the advocates being asked by multiple Justices, beginning with Justice Ginsberg, whether and to what degree the FDA specifically considered the risks and benefits of IV push versus IV administered the usual way by a drip bag. Frederick eventually agreeing with Chief Justice Roberts that if there was specific consideration of IV push as opposed to simply arterial exposure, then plaintiff below should lose.

3. Justice Ginsberg seemingly second-guessing the FDA’s assessments of risk and benefit because the drug was not a life-saving drug, and on the risk side you have the risk of gangrene. “No matter what benefit there was, how could the benefit outweigh that substantial risk?” Waxman responded that the right question was would this method ever be medically warranted? The testimony in this case and in the administrative record was “yes.”

Frederick told the Chief Justice that there was no way FDA could have made this determination because the risks of IV push are so catastrophic compared to the benefit. But Justice Scalia chimed in that he was “just contradicting the label. The fact is they could not have approved that label unless they made that determination.”

4. Waxman offered the Court a way to think about a narrow reversal: “members of this Court are concerned about applying a broad, vague, or free-wheeling analysis of implied conflict pre-emption, but this case is heartland. A jury was asked to look at the same information and conclude that the precise language that the FDA just didn't allow, the FDA required Wyeth to use, rendered that drug unreasonably unsafe.”

5. Kneedler conceding that there would be no preemption if the state law failure-to-warn claim was based on new information that the company didn’t furnish the FDA. Which got him into the quandary of when the information is brought it to the FDA's attention and the FDA just hasn't acted on it. He had some trouble with that one.

6. Frederick had a hard time clarifying whether his case depended upon the Court determining that the risk at issue here was a new risk that the FDA did not consider.

7. Frederick more or less conceded to Justice Alito that a claim would be pre-empted when the FDA considered and rejected a label change proposed on the basis of the same information or similar information that underlies the State claim.

8. Justice Scalia pointed out the difference between what juries do and the promotion of public safety through a balancing of benefits and costs. The former may be simply eliminating certain drugs which people could be benefited by.

9. Waxman doing an effective job of contrasting plaintiff’s current argument with what Levine argued to the jury. Plaintiff had not argued that the FDA hadn’t gotten information about the risks. Plaintiff below “stood up and said the FDA doesn't decide this question. You [the jury] decide this question. And there was never, ever a suggestion in the record in this case, nor could there have been, that Wyeth ever failed to bring every single adverse-event report to the FDA's attention, every analysis that it did to the FDA's attention.”

10.  Justices Breyer and Scalia indirectly sparring through questions about who would have the "burden of proof" of bringing up new risk information, and who should lose if they did not do so. Justice Scalia noted that new information was not brought up by either side below, and he clearly did not buy the notion that it is the burden of the drug company to show an absence of new information.

It is always difficult to predict Supreme Court decisions. That being said, given the tenor of the Court’s questions, and some of the arguments advanced, the Court has plenty of ammunition to arrive at a relatively narrow decision, which could result in additional litigation concerning whether preemption is available under any different set of facts. 

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The Food & Drug Administration (FDA) should be opening its new China office later in 2008. In the past couple years, as posted here at MassTortDefense, multiple imports from China have been at the center of safety concerns. Earlier this year, heparin allegedly contaminated with a counterfeit ingredient was blamed by some plainitff attorneys for some patient deaths; FDA has issued recalls of several foods imported from China that may have apparently been tainted with the industrial chemical melamine, which has been added to dairy products and resulted in hospitalization of thousands of children in China.

FDA staff posted at the China office will inspect facilities, provide guidance on U.S. quality standards, and later train local experts to conduct inspections on behalf of the FDA. The FDA will eventually open offices in the Chinese cities of Shanghai and Guangzhou, for a total of eight planned FDA staffers. The agency hopes a greater on the ground presence in China will help prevent unsafe imports, and the opening of a Beijing, China office later this year is just the first step in the FDA’s plan to expand its presence overseas. Over the next year, the agency plans to place as many as 60 food and drug regulators in offices worldwide, focusing on India, Latin America and the Middle East. The plan for permanent outposts marks a break from the agency's current practice of sending inspectors abroad on individual assignments.

Part of an updated import inspection plan may be to allow voluntary inspection, where manufacturers would pay third-party inspectors to verify that their plants meet FDA standards, although past attempts at a voluntary inspections system haven’t been well received by some overseas manufacturers. Democrats in the House of Representatives, offering yet another alternative, have proposed a program that would require companies to pay mandatory user fees to help finance additional FDA inspections.

Health and Human Services Secretary Michael Levitt is scheduled to travel to China next month to meet with health officials there to review joint efforts to ensure the safety of food and medical imports. The Consumer Product Safety Commission also worked to get people stationed in China. Under the current plan, the CPSC staffers who will be sent there eventually are not full inspectors. Their purpose will be to provide technical assistance to Chinese manufacturers and regulators.
 

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The FDA has announced a forthcoming meeting of the Science Board to the Food and Drug Administration, on the topic of BPA. The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific community in industry and academia.  At the meeting, on October 31, 2008, the Science Board will hear about and discuss a review of the draft assessment of Bisphenol A for use in food contact applications by the Science Board BPA Subcommittee. The Board will also hear an overview of current methods for detection of contaminants in FDA-regulated products.

In early 2008, FDA formed an agency-wide BPA task force to facilitate cross-agency review of current research and new information on BPA for all FDA regulated products. Medical devices containing the chemical are now also on the FDA’s radar screen. See the note in FDA News.  BPA is used in dialysis tubing, blood oxygenators, and dental sealants. And now that an evaluation examining migration of BPA from food contact materials has been drafted, the agency is apparently planning to publish a document assessing the safety of BPA exposure from regulated devices, biologics and pharmaceuticals.

The FDA's recent assessment was particularly focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel, based on animal data. FDA concluded that this data was insufficient to merit a change in the exposure levels the agency currently allows for BPA. FDA concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. This assessment represents a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances, the FDA said.

 

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As previewed by MassTortDefense, the Food and Drug Administration held a public hearing on October 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which published a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. These products contain ingredients that have been classified by the FDA as generally recognized as safe and effective since the 1970’s Recently, some potential safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products.

FDA is developing a proposed rule to revise the pediatric labeling guidance contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.  Each year, U.S. consumers buy about 95 million packages of oral pediatric cough and cold medicines. 

Some doctors at the hearing urged regulators to seek removal of children's cough and cold medicines from store shelves until the products are found safe and effective. For example, Dr. Michael Shannon, professor at Harvard Medical School, testified that it is time for these products to be re-evaluated regarding their risk-benefit ratio. The American Academy of Pediatrics doesn't recommend any use of OTC cold and cough  medicines in children. In January, the FDA recommended against their use in children up to 2 years old. Treatment alternatives include providing fluids, nose drops, humid air and appropriate pain relievers.

The Consumer Healthcare Products Association pointed out that most reported side effects are caused by accidental overdose and misuse, which might suggest that changed packaging and improved education, rather than other measures, might be appropriate. The Association has begun a comprehensive, national education program that focuses on the root causes of adverse events and speaks directly to parents, day care providers, healthcare providers, and other caregivers. CHPA is partnering with a number of organizations in these efforts, including the American Pharmacists Association and the American Association of Family Physicians. These education campaigns underscore the importance of following the directions on the label, using the correct dose, storing medicines safely and consulting with a doctor if there are any questions.

Arguably, if pediatric cough and cold products are no longer available over the counter, parents may turn to other alternatives that may result in even more dangerous consequences for children. The industry is undertaking a comprehensive and scientifically rigorous efficacy and safety program for children age 2 to 12 in order to advance the science and ensure the highest level of scientific rigor. This program includes pharmacokinetic studies to confirm the dosing for the eight most commonly used OTC oral cough and cold ingredients. Once these dosing studies are finalized, they will begin other studies to revalidate the effectiveness of these medicines.

In reaction to the public hearing, FDA did not call for an immediate ban on over-the-counter cough and cold medicines for young children. John Jenkins, director of the FDA's Office of New Drugs, said the agency will propose changing its rules which could further restrict use of the products in children.

In response to the issues, following the hearing, makers of OTC cold and cough drugs announced they would start adding warnings against use in children younger than 4 years. That is, the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state “do not use” in children under four years of age.  (The risk of overdose is greatest in 2- and 3-year-olds, according to the Consumer Healthcare Products Association.) Pediatric antihistamines will also carry new labels telling parents not to use the medicines to sedate children of any age. The move comes out of an abundance of caution in an effort to promote the safe and effective use of these medicines.  FDA was quoted as being in support of these voluntary actions by CHPA, in part because the rulemaking process can take significant time.
 

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The Third Circuit recently upheld a judgment for the U.S. following a bench trial, in a suit by a couple who alleged that contaminated polio vaccine caused the husband's brain cancer. Gannon v. United States, 2008 WL 4151665 (3d Cir. 2008).

Plaintiffs alleged that an oral polio vaccine (OPV) received between 1973 and 1976 was contaminated with SV40, a simian virus found in both monkeys and humans. The Gannons claimed that the government was negligent in failing to prevent the manufacturer from making the OPV available to the public, and as a result, the contaminated vaccine caused Mr. Gannon to develop a form of brain cancer. Gannon and his wife filed an administrative claim against the government under the Federal Tort Claims Act and, later, a suit in the Eastern District of Pennsylvania.

The Court, for the convenience of the witnesses and to prevent recalling the experts later in the trial, decided to combine a Daubert hearing with the expert bench trial testimony on the issue of causation. Thus, the trial began with the Daubert examination of plaintiffs' expert, Dr. Adi Gazdar, who presented his full testimony on the issue of causation. He testified that SV40 plays a causal role in this type of cancer.

The district court denied the Daubert motion, but rejected the testimony as insufficient on the issue of general causation.  Safe approach in a bench trial, here it and then decide. The ruling came pursuant to Rule 52(c), which states that a trial court can enter judgment after hearing evidence on only one issue, provided the party against whom judgment has been entered is fully heard. (The appeals court rejected the plaintiffs' argument that they were not fully heard on causation: The plaintiffs asserted they would have called two other witnesses to testify, but those witnesses were not relevant to causation because their testimony would principally address the issue of contamination.) Interestingly, the United States did not offer an alternate source of causation but merely asserted that SV40 did not cause brain tumors and offered expert testimony to that effect.

Although Dr. Gazdar testified that it was his opinion that to a reasonable degree of medical certainty SV40 plays a causal role in the formation of medulloblastomas, the Court decided that the plaintiffs had not met their burden of proof on causation. Specifically, the Court found that Dr. Gazdar's testimony failed to satisfy the “Bradford Hill” criteria. The Bradford Hill criteria are broadly accepted criteria for evaluating general causation based on epidemiology;  they are: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biologic Gradient, (6) Plausibility, (7) Coherence, (8) Experimental Evidence, and (9) Analogy.

On appeal, the Third Circuit observed that causation is an essential part of the plaintiffs' negligence claim. Based upon its thorough consideration of the record evidence, the Third Circuit could not say that the district court clearly erred in its findings of fact or that it erred in concluding that the Gannons had not met their burden of proof on the issue of causation.
 

• The Court relied upon the fact that all three defense experts used established scientific frameworks and cited both biological and epidemiological evidence. Each of those experts opined that the evidence did not support the conclusion that SV40 causes human cancer.
• The Court relied upon a 2003 Institute of Medicine report, which concluded that “ ‘the evidence is inadequate to accept or reject a causal relationship’ “ between SV40 and cancer.
• Dr. Gazdar, the plaintiffs' expert, testified that he agreed that current epidemiological evidence does not support the conclusion that SV40 causes brain cancer.
• He relied upon testing on rodents, which defense experts stated were not a good brain model for humans; even Dr. Gazdar admitted the results could not necessarily be extrapolated to humans.

Most importantly, the court considered each of the nine Bradford Hill criteria for causation and found that Dr. Gazdar's opinion did not meet the criteria.  The general causation opinion was thus rejected on the merits.
 

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Two interesting developments in the ongoing discovery battles in the Zyprexa MDL, which involves claims by several states and health entities alleging that defendant Eli Lilly made misleading statements about the medication. The states allege that they would not have funded Medicaid patients taking Zyprexa had they known about the risks of the drug...But don't seem eager to prove it.

First, the magistrate judge denied defendant’s motion for sanctions against Montana, New Mexico, Louisiana, and Mississippi, but ordered the states that have not yet produced their complete Medicaid databases as requested to do so on pain of sanctions.

Second, the court ordered the states to produce non-party medical records requested by Lilly. The defendant, not surprisingly, wanted to be able to compare the records of other antipsychotic medications in the relevant periods. As the court said, "the records are in fact relevant to Lilly’s defenses. For example, as Lilly notes, the use of a statistically significant sample of Medicaid patient records can help to explain information obtained from Medicaid databases, and may provide information on potential confounding variables."

The states argued that their respective physician-patient privilege laws prohibited discovery of the patient medical records. It is axiomatic that state privilege laws do not govern in federal question cases. Although several of the plaintiff states did not allege violations of federal law in their
complaints, and each has vigorously challenged the basis for federal jurisdiction, Judge
Weinstein has held that jurisdiction lies under federal law. 

The court also felt that the states’ doctor-patient privilege argument was not well taken, because the order was for the production of de-identified medical records with patient names redacted. Federal statutes and regulations make clear that de-identified health information is discoverable in litigation in federal court, with or without patient consent, and it appears that the states’
respective privilege laws would not apply to de-identified information either.

The court also denied the states' request that Lilly subpoena the records, as a step that would needlessly prolong discovery.  Significantly, Lilly does not know the identities of the patients whose medical records it seeks. Moreover, the states are in a better position to ensure that the medical records produced are a randomly selected, statistically significant sample. If Lilly were constrained to subpoena the medical records, it would likely target only certain records, which would inevitably lead to protracted argument over whether the records subpoenaed represent a statistically significant sample, said the court.

MassTortDefense has posted on this litigation before. It continues to be an excellent example of the type of attenuated and indirect injury claim that requires in-depth and detailed discovery to defend. Also an example of plaintiffs who are more willing to assert complex damages theories than to provide the evidence to test those claims.
 

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The Magistrate Judge in the Kugel Mesh Hernia Repair Patch MDL has refused to allow defendants to retain as experts any physicians who have treated any of the plaintiffs. See In re: Kugel Mesh Hernia Repair Patch Litigation, MDL Docket No. 07-1842ML (Order 9/19/08).

The Court had previously ordered that defendants were precluded from engaging in substantive ex parte communications with plaintiffs’ treating physicians. Defendants proposed, however, to have the ability to retain a plaintiff’s treating physician as a consulting or testifying expert as long as they do not call the expert in his/her patient’s case and refrained from discussing with him/her the medical history of that patient/plaintiff.

The Court saw the motion as requiring it to balance the trust and confidentiality embodied
in the physician-patient relationship against a litigant’s right to reasonably assemble and present a defense.

The reality of some mass torts is that:

-the sheer number of plaintiffs may preclude defendants from retaining any consultants who are not also treating physicians of some plaintiffs;

-this is especially true in the case of medical devices in which the experts in the devices are experts mainly because they treat people using those devices;

-in mass torts, with thousands of cases in multiple venues, defendants need multiple experts;

-allowing defendants access to treaters -- who are not automatically experts for the plaintiff, but who possess knowledge needed by both sides – may accelerate the discovery process.

The Court here, however, adopted the balancing performed by the Rhode Island Superior Court, which currently sees more than 1000 of these cases. See In re: All Individual Kugel Mesh Cases, 2008 R.I. Super. LEXIS 101 (R.I. Super. August 26, 2008). The state court concluded that any “potential inconvenience” to defendants in engaging experts was “significantly outweighed” by plaintiffs’ right to confidentiality in their medical matters. Id. at *9.

The Court may have given insufficient weight to the protection available from the fact that the treater, if consulted by the defense on plaintiff X, is under an independent ethical duty not to disclose confidential information about patient Y. And the doctor is always available to be deposed about whether he or she was even asked any questions about a patient.

The Court criticized the defendants for not specifically identifying the “small group of hernia repair specialists” who were inevitable, likely treaters of one or more plaintiffs. (“The fact that only one surgeon to date has fallen into the consultant/treating physician category belies Defendants’ claims of prejudice.”) However, generally, and without any knowledge of this specific MDL, MassTortDefense would assert that the issue was not whether defendants had already identified many potential experts who were also treaters. The prejudice comes when defendants cannot find qualified experts who are not treaters and thus must turn to the treater pool –even if they haven’t already done so and thus cannot identify the specific overlapping people. Defendant has no easy way, absent revealing substantial confidential work product, of showing that it cannot find adequate and sufficient experts without resort to the treater pool. Courts, particularly MDL courts, may need to seek a deeper understanding of the reality of expert retention.
 

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Maryland's top court recently affirmed summary judgment for defendant Eli Lilly & Co., in a case brought by a widow whose husband was killed in an auto accident. His car was allegedly hit by a diabetic who blacked out while under treatment with two insulin medications. Gourdine v. Crews, No. 134 (Md. Ct. App. 9/4/08).

Background
Ellen Crews, a Type I diabetic who was taking a combination of insulin medications from Lilly, while operating her car, allegedly suffered some kind of debilitating episode and struck a vehicle driven by Isaac Gourdine, resulting in his death. The issue for the Court was whether Lilly owed a duty to Mr. Gourdine, the third-party who did not ingest the drugs. Plaintiff, the wife of Mr. Gourdine, argued that it was somehow foreseeable to Lilly that Ms. Crews, might allegedly suffer an adverse reaction to the medications, which in turn would cause injury and death to third persons while she was operating a motor vehicle. If she had not been adequately warned about the dangers that allegedly were associated with the specified medications, that would supposedly impact a duty owed to Mr. Gourdine.

Specifically, Ms. Crews took a combination of Humalog, a quick-acting form of insulin taken with meals, and Humulin N, a medication designed to supply a constant source of insulin to the body. Ms. Gourdine contended that, at the time of the accident, Ms. Crews suffered a hypoglycemic reaction and experienced a “blackout” causing her to lose control of her vehicle. Defendant Lilly, plaintiff alleged, owed a duty to protect users of the highway from drivers suffering from hypoglycemia induced by the allegedly misbranded drug.

Lilly sought and obtained summary judgment below on the basis it owed no duty to decedent Gourdine, a nonuser of the drug, to warn about alleged risks associated with the medications. Plaintiff appealed, and the Maryland Court of Special Appeals affirmed; the case then went up again.

Reasoning
The Court began with a discussion of the elements of plaintiff’s causes of action, noting that duty is an essential element of both negligence and strict liability causes of action for failure to warn. In contrast to the reasoning of the lower courts, however, the Court stated that the duty issue should not be analyzed in the context of the learned intermediary rule – which holds that the manufacturer’s duty to warn is to the prescriber – but as an issue of the common law of torts.

At its core, the determination of whether a duty exists represents a policy question whether the specific plaintiff is entitled to protection from the acts of the defendant; ultimately, the determination of whether a duty should be imposed is made by weighing the various policy considerations and reaching a conclusion that the plaintiff's interests are, or are not, entitled to legal protection against the conduct of the defendant. The foreseeability test relied on by plaintiff  “is simply intended to reflect current societal standards with respect to an acceptable nexus between the negligent act and the ensuing harm.”  While foreseeability is often considered among the most important of the relevant factors, its existence alone does not suffice to establish a duty under Maryland law.

In this case, there was no direct connection between Lilly’s warnings, or the alleged lack thereof, and Mr. Gourdine’s in jury. In fact, there was no contact between Lilly and Mr. Gourdine whatsoever. To impose the requested duty from Lilly to Mr. Gourdine would expand traditional tort concepts beyond manageable bounds, because such duty could apply to all individuals who could have been affected by Mr. Crews after her ingestion of the drugs. Essentially, Lilly would owe a duty to the world, an indeterminate class of people, for which the Court has “resisted the establishment of duties of care.”

Gourdine attempted to draw support from cases in other jurisdictions, in which she asserted that a doctor's duty to warn his or her patient of the risks associated with medication extends to nonpatients who are foreseeably at risk. The Court responded that it has not historically embraced the belief that duty should be defined mainly with regard to foreseeability, without regard to the size of the group to which the duty would be owed, which the courts in Alabama, Hawaii, and Washington, according to plaintiff, have.

On the other hand, numerous jurisdiction had rejected this kind of universal duty, the Court noted. See Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387 (Ill. 1987); Gilhuly v. Dockery, 615 S.E.2d 237, 239 (Ga. Ct. App. 2005) (patient who was involved in a car accident in which sons were injured filed suit on their behalf based on physician’s alleged failure to warn patient not to drive after taking certain medications; the Court of Appeals of Georgia rejected the claims on behalf of the sons because “[t]o expand a doctor’s duty to his patient to generally include members of the public at large in a case such as this one would be contrary to Georgia public policy”); Lester ex rel. Mavrogenis v . Hall, 970 P.2d 590, 597 (N.M. 1998) (holding that physician owed no duty non-patient injured in automobile accident with patient because the “consequences of placing a legal duty on physicians to warn may subject them to substantial liability even though their warnings may not be effective to eliminate the risk in many cases”); Rebollal v. Payne, 145 A.D.2d 617, 618 (N.Y. App. Div. 1988) (“There is no duty on the part of the operator of a methadone clinic to control the travel activities of a methadone patient giving rise to liability for accidents to a third party such as plaintiff’s decedent.”); Praesel v. Johnson, 967 S.W.2d 391, 398 (Tex. 1998) (stating that treating physicians do not owe a duty to third parties to warn epileptic patients not to drive, for purposes of negligence claims against physicians for failure to warn if patient has accident and injures third party during seizure; “Balancing both the need for and the effectiveness of a warning to a patient who already knows that he or she suffers from seizures against the burden of liability to third parties, we conclude that the benefit of warning an epileptic not to drive is incremental but that the consequences of imposing a duty are great.”).

Gourdine also argued that the Federal Food, Drug, and Cosmetic Act, which prohibits drug manufacturers from placing a misbranded product into interstate commerce, conferred a duty on Lilly. This statute and its regulations, however, are framed to protect the public in general, and, a statutory obligation which “runs to everyone in general and no one in particular” cannot impose a duty between two parties.
 

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The U.S. Senate Special Committee on Aging held a hearing last week to examine issues related to direct-to-consumer (DTC) advertising for medical devices. The amount of medical device advertising directed to consumers on television or over the Internet was an estimated $193 million last year, a figure that is a small fraction of the volume of consumer advertising for prescription drugs. Yet, device DTC is getting increased attention.

At the hearing, medical, advertising, and consumer experts shared with the committee their opinions about DTC medical device advertisements, including whether health risks are appropriately conveyed to consumers. The hearing was called by liberal Democratic Committee Chairman Herb Kohl (D-WI), who has apparently already decided that Congress ought to be prepared to call for a future moratorium on DTC ads for new medical devices.

Dr. Daniel Schultz, the director of the Center for the Center for Devices and Radiological Health (CDRH) at the FDA, discussed the current status of their enforcement activities related to DTCA for medical devices. The CDRH is the division of the FDA responsible for the regulation of restricted medical device advertisements.

The head of Advanced Medical Technology Association (AdvaMed), related the organization’s current policy on DTC advertising and reaffirmed the medical technology industry’s strong support for truthful, non-misleading advertising of its innovative products. AdvaMed believes that in addition to being truthful and not misleading, all DTC advertising should use consumer-friendly language, disclose relevant risk information, and encourage patients to speak with their doctors in more detail. Current FDA rules governing direct-to-consumer advertising are adequate. FDA and FTC already have extensive legal authority to regulate false or misleading advertising for medical devices. FDA has a full range of potential remedies it can bring to bear, from issuing a warning letter to removing a product from the marketplace.

Indeed, while it is unproven that any advertisement will cause a patient to take a drug – as opposed to discuss a possible prescription with a physician – it seems even less likely that a medical device ad will do anything other than stimulate a patient to ask a doctor about a device: a patient does not agree to undergo surgery unless they think they have a serious need for it.

Direct to consumer advertising is a powerful educational tool that allows patients to learn of new technologies and treatment options in a timely fashion and can help to initiate important discussions between physicians and patients. DTC advertising is an invaluable tool to enhance the exchange of information and empower patients to ask questions about their own health. 
 

Nevertheless, the rest of the hearing lineup was stacked with opponents of DTC advertising: Dr. Kevin Bozic, a professor of orthopedic surgery at the University of California, San Francisco, provided an opinion of how DTC advertising supposedly has the potential to adversely impact the doctor-patient relationship, patient education, and health care costs and quality. Next, Dr. William Boden, a professor of medicine and public health at the University of Buffalo, and Dr. George Diamond, a senior research scientist at the Cedars-Sinai Medical Center, shared the findings of their recent article in the New England Journal of Medicine, offering their opinions about how DTC advertising can theoretically affect patient understanding of medical device effectiveness and risks.

Dr. Ruth Day presented expert testimony on how DTC advertising may influence consumer behavior. Also on the first panel was Ami Gadhia, policy counsel for the Consumers Union, who testified about her organization’s petition to the FDA in December, 2007 for pre-review and specific risk disclosures for medical device advertisements.
 

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Wyeth has filed its reply brief in the Levine case.

The reply stresses that this case is not a conventional failure to warn case, but an alleged failure to contraindicate case. Thus, plaintiff is directly challenging the FDA’s balancing of the risks and benefits of a labeled, warned-about indication. State law cannot obstruct federal regulation of pharmaceuticals by seeking to impose a different outcome to this balancing process than the one reached by the FDA.

When the FDA did address the risks and benefits of the particular method of drug delivery at issue, the agency told the defendant to use labeling which the state court jury held was inadequate under state law. 

Wyeth also stressed what the case was not: no allegations of concealment from the agency or of failure to make a label change in response to any new risk information. The FDA had all the important information, and made a regulatory decision, which plaintiffs told the jury they could, and should, simply reject.

Note also an interesting discussion of CBE issues, with the arguments that this was not a CBE case, especially where methods of use are at issue, and that the FDA's interpretation of the CBE is entitled to Auer- level deference. (As noted in a post by MassTortDefense, the CBE regulation was always intended to apply solely to new, emerging, significant information.) Finally the plaintiff’s argument that the defendant must prove that a CBE submission would have been unsuccessful before qualifying for preemption would create the untenable and frequently dis-approved situation in which juries are deciding hypothetical situations full of what-ifs.
 

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The large shadow being cast by the Levine v. Wyeth case pending before the U.S. Supreme Court covers a multitude of issues in ongoing pharmaceutical cases.  One is the question whether to stay pending litigation until the Court reaches a decision. See Forst v. Smithkline Beecham Corp., 2008 WL 2337283 (E.D.Wis., 2008)(denying plaintiff's opposed motion for stay); Horne v. Novartis Pharmaceuticals Corp., 2008 WL 1847077 (W.D.N.C. 2008)(denying parties' Joint Motion to Stay Proceedings without prejudice to renewal of said motion after the completion of discovery).

Stay requests assume that defendant will file, or follow the filing of, a dispositive motion asserting that the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et. seq., preempts plaintiffs’ state law claims that a prescription drug manufactured by defendant lacked adequate warnings. The argument would be that the Supreme Court’s decision in the Levine v. Wyeth case may have a potentially significant impact on the pending case. A stay may conserve defendant’s resources and avoid an expensive trial which would then need to be repeated following the Supreme Court’s ruling.

So why not file such a stay motion? Why might a defendant oppose one?

Putting aside those situations in which the preemption issue seems not central to the pertinent drug case, and putting aside the impossible to know for sure chance that the Supreme Court’s ruling will be narrow and have no direct impact on some cases, other potential issues exist that defendants need to contemplate.

One factor is that defendants may want and need to develop facts during discovery that support dispositive motions based on other, independent grounds. One example may be the learned intermediary doctrine. A stay may, in some cases, hamper the defendant’s ability to conduct the discovery necessary for developing motions on non-preemption issues, upon which Levine has no bearing. A stay might prevent the defendant from developing the record and preserving evidence. 

It will thus be a weighing process, a cost/benefit analysis each defendant must make, factoring in the time and costs, status of the case, proximity of trial, relationship of the specific preemption issues to those before the Court, nature of the forum, etc.
 

 

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The U.S. Food and Drug Administration has posted on its website its first quarterly report listing certain drugs that are being evaluated for potential safety issues. FDA posted the reports in accordance with Section 921 of the Food and Drug Administration Amendments Act of 2007, which, among other things, directs FDA to inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports. Specifically, FDA is to "conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter."

FDA released the first quarterly report, listing 20 drugs. The information is provided based on a review of reports in AERS. The FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a possible risk is identified from AERS data, it is entered as a possible safety issue into CDER's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER's Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports.

Drugs that appear on the agency's new "Potential Signals of Serious Risks/New Safety Information," are thus identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is some reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk. Each year, FDA receives about 400,000 reports of adverse events that people experienced around the same time period in which they were taking a drug.

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.”).

MassTortDefense notes, that in contrast to how plaintiff attorneys seek to use the adverse event reports, or how the media has portrayed this new list, the appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. It may be too early to know whether there is an actual safety problem, and FDA’s analysis may ultimately conclude that there is no safety problem. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk. FDA also emphasizes that the listing of a drug does not mean that FDA is suggesting that prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. 

Thus, the new quarterly reports should not change the existing view of the majority of courts that adverse event reports are ordinarily too unreliable to be used as proof of causation. See McClain, 401 F. 3d at 1250; Hollander v. Sandoz Pharmaceuticals Corp., 289 F. 3d 1193, 1211 (10th Cir. 2001); cert. denied, 537 U.S. 1088 (2002) (characterizing the case reports before the court as unreliable evidence of causation); Haggerty v. Upjohn Co., 950 F.Supp. 1160, 1165 (S.D. Fla. 1996), aff’d, 158 F. 3d 588 (11th Cir. 1998); In re Accutane Products Liability Litig., 511 F. Supp.2d 1288, 1298-1303 (M.D. Fla. 2007); Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp. 2d 1316, 1327 (M.D. Ala. 2006); Leathers v. Pfizer, Inc., 233 F.R.D. 687, 694 (N.D. Ga. 2006). See also Glastetter v. Novartis Pharmaceuticals Corp., 252 F. 3d 986, 990-91 (8th Cir. 2001) (“Case reports make little attempt to screen out alternative causes for a patient’s condition. They frequently lack analysis. And they often omit relevant facts about the patient’s condition.”); Dunn v. Sandoz Pharmaceutical Corp., 275 F. Supp.2d 672, 682 (M.D.N.C. 2003) (“Case reports are not scientific proof of causation.”); Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1046, 1050 (S.D. Ill. 2001) (rejecting expert opinions insofar as they relied upon case reports); Nelson v. American Home Products Corp., 92 F. Supp. 2d 954, 969 (W.D. Mo. 2000) (“At most, these case reports relay a basis for scientific hypotheses; they do not demonstrate a causal link sufficient for admission to a finder of fact in court.”); DeLuca v. Merrell Dow Pharmaceuticals, Inc., 791 F. Supp. 1042, 1051 (D. N.J. 1992), aff’d, 6 F. 3d 778 (3d Cir. 1993), cert. denied, 510 U.S. 1044 (1994) (ADEs “are not of a type of data that are reasonably relied upon by experts in the fields of epidemiology and public health.”); Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp. 2d 1347, 1359-63 (N.D. Ga. 2001); Cartwright v. Home Depot USA, Inc., 936 F. Supp. 900, 905 (M.D. Fla. 1996).
 

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A federal appeals court last week affirmed a district court's grant of summary judgment against plaintiffs who alleged the acne drug Accutane caused irritable bowel disease (IBD). Rand v. Hoffmann-LaRoche Inc., 2008 WL 3977611 (11th Cir., 8/26/08). After considering the briefs, the relevant parts of the record, and the opinion by the district court, In re Accutane Prods. Liab., 511 F.Supp.2d 1288 (M.D.Fla .2007), the appeals court concluded that the district court did not abuse its discretion by excluding the plaintiffs’ expert causation evidence and had properly granted summary judgment.

This trial court order dealt with the general causation issue of the IBD track cases. General causation is concerned with whether an agent is capable of causing a disease and not whether the agent caused any given individual's disease. In this case, plaintiffs’ expert, Dr. Fogel, opined that Accutane is a cause of IBD. The issue before the trial court was whether the methodology Dr. Fogel employed in reaching this opinion met the legal standard of reliability set forth in Daubert v. Merrell Dow Pharmaceuticals.

Dr. Fogel pointed to several data sources to support his opinion. First was an alleged analogy to animal and cell culture studies. The court found that Dr. Fogel relied on certain studies of dogs, rats and cell cultures, but had simply ignored the parts of those studies that do not support his opinion, particularly the dose relationship. He further drew conclusions not supported by the authors of those studies, said the court. Furthermore, there were other studies, both of dogs and humans, that were contrary to Dr. Fogel's opinions, but he failed to explain why these other studies have no significance or to otherwise somehow differentiate them from the ones upon which he relied.

On the important issue of dose, the court noted that dose is critical to any evaluation of toxicity of a drug. In fact, dose may be the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect. Indeed, the basic dictum of toxicology as stated by the 16th century physician/philosopher, Paracelsus, was “All substances are poisonous-there is none which is not; the dose differentiates a poison from a remedy.”  An expert who ignores the dose-response relationship casts suspicion on the reliability of his entire methodology. Often low dose exposures -even for many years- will have no consequence at all, since the body is often able to completely detoxify low doses before they do any damage. Furthermore, for most types of dose-response relationships following chronic (repeated) exposure, certain thresholds exist, such that there is some dose below which even repeated, long-term exposure would not cause an effect in any individual.

The expert also tried to rely on defendants' own internal documents purportedly expressing conclusions on causation. But contrary to Dr. Fogel's conclusion about these “admissions,” the court determined that the causality assessments referred to by Dr. Fogel did not evidence any conclusion that the adverse events reported were caused by Accutane. Instead, they constituted a synopsis of complaints received by the defendant from various reporters (patient, parent, doctor, or even attorney) regarding their subjective beliefs as to the causes of particular ailments. That is, they reflect the reporter's opinion as to causality, not the company’s. And they do not necessarily contain information regarding the patient's medical history, family medical history, or information concerning other risk factors of IBD that would even allow the company to make any conclusions. While a review of the assessments may possibly support a conclusion that there was an association between Accutane and IBD, an association is not equivalent to causation. This review may serve as a basis for forming an hypothesis, but certainly did not equate with causation.

Lastly, Dr. Fogel relied on anecdotal consumer complaints themselves (“adverse event reports” or “case reports”) reported to the company or the FDA, or published to the medical community. However, these reports concerned events that occurred without any medical controls or scientific assessment. Uncontrolled anecdotal information offers one of the least reliable sources to justify opinions about both general and individual causation, said the court. The reports were unreliable as proof of causation because, in general, the events were not observed in such a way as to rule out coincidence or other potential causes.
 

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The Food and Drug Administration has announced a public hearing on October 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which published a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, some potential safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA is developing a proposed rule to revise the pediatric labeling guidance contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rule-making and reviews new drug applications (NDAs) for these ingredients.

MassTortDefense notes that there has been significant litigation in the past concerning ingredients used in many over-the-counter and prescription cough and cold medications as a decongestant to relieve stuffy nose or sinus congestion. At one point, Americans took 6 billion doses of the ingredient PPA each year from as many as 400 over-the-counter products containing PPA. A Yale Univ. study suggesting possible increased hemorrhagic stroke risks led manufacturers to remove PPA from their products. This in turn led to a mass tort, MDL and all. The epidemiology of the Yale study, according to plaintiffs, indicated that there were about 10,000 PPA-related strokes in the ten years preceding the FDA withdrawal. As it turned out, of nine PPA verdicts 2000-2006, only one was a plaintiff victory. As a result, PPA defendants were reportedly able to settle hundreds of the plaintiffs' best PPA cases for relatively modest amounts. Multiple PPA cases have been dismissed, either by plaintiffs lawyers or by the MDL court.

Today, FDA estimates that there are approximately 10,000 products being marketed for cold, cough, or combined indications under the OTC Drug Review. Depending on the dosage form and strength of these products, many of them are labeled for pediatric use, including some that are labeled for use in both adults and children. There are approximately 38 active ingredients in the final Monograph. Some combination cough and cold products contain as many as four of these active ingredients in a single dosage form, meaning that patients may be exposed to four different active ingredients when using a single product. From 2002 to 2006, there were approximately 36 billion units of combination cough and cold products sold each year in the United States. For liquid formulations used for the youngest children, there were approximately 190 million units sold each year in the combined cough and cold categories during this period. Cough and cold products are commonly used in children. A recent report suggested that 1 in 10 children uses one or more cough and cold products during a given week with exposure being highest among 2 to 5 year-olds.

FDA is interested in obtaining public comment on several issues, including:
1. What types of studies should be conducted to assess effectiveness and/or safety, and determine appropriate dosing of cough and cold ingredients in the pediatric population?
2. Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available only by prescription?
3. If the pediatric indications and dosing for cough and cold products were no longer available OTC, would the public use the adult formulations of the products for children, and thus create a greater potential risk of misuse or overdose?
4. Current standards permit extrapolation of pediatric efficacy  -- but not safety-- based upon sufficient adult data. Does it remain appropriate to recommend in the cough and cold monograph that children 12 and over should receive the same dose of medication as adults, without requiring any additional studies in children in this age group?
 

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The Food and Drug Administration has finalized the updated rule on using supplemental applications for changes to prescription drug, biologics, and medical device labels. The final rule, 73 Fed. Reg. 49603, allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information. These supplements are commonly referred to as "changes being effected supplements" or "CBE supplements." The final rule becomes effective on Sept. 22, 2008. The final rule modifies 21 C.F.R. Sections 314, 601 and 814.

MassTortDefense would disagree with the media reports describing this as a “new” rule. In fact, the final rule affirms FDA’s longstanding position that a CBE supplement is appropriate to amend the labeling for an approved product only to reflect newly acquired information. But even though when it originally adopted this regulation FDA intended it as a limited, narrow, emergency exception to the general rule of Agency pre-approval of changes to prescription drug labeling, after preemption became a huge issue in prescription drug product liability litigation the regulation has been at times cited by courts as applying far more broadly than the FDA intended.

Plaintiffs argued that, since manufacturers are supposedly free to change their labels without prior FDA approval, there can be no conflict with state law holding them liable for not doing what the regulation supposedly allows. The plaintiffs thus have argued that the narrow exception swallows the rule that drug labeling changes are subject FDA pre-approval. Some courts have accepted this argument, and for example ruled that pharmaceutical defendants should have unilaterally strengthened suicide warnings for antidepressants – despite the FDA having evaluated the evidence of this alleged risk multiple times, concluding that there is no sufficient scientific basis for including a suicide warning. Compare McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006) with Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 523, 527-28 (E.D. Pa. 2006). The Third Circuit's  take on this split is at Colacicco v. Apotex, 521 F.3d 253 (3d Cir. 2008).

FDA proposed the CBE procedure in 1982, making clear at the time that CBE supplements were intended to apply only if the sponsor became aware of newly discovered safety information that was appropriate for inclusion in the labeling for the product. Since then, the FDA has repeatedly tried, through amicus briefs, and in the 2006 preemption preamble, to inform courts of the limited scope of the regulation, with arguably mixed success. In briefs recently filed in the Supreme Court and in testimony before Congress, FDA has also stated a more generally applicable rule that is consistent with the examples of  cases finding preemption, and the principles set forth in the preamble to the 2006 Physician Labeling Rule,  that: (1) The labeling requirements are not a mere minimum safety standard, but rather strike a balance between risks and benefits, and (2) FDA's regulations permit changes in labeling without prior approval only in narrow circumstances. Specifically, FDA has explained that State law claims that "challenge labeling that FDA approved after being informed of the relevant risk" are preempted.

So now, the agency decided to change the regulation to say precisely what the agency has said it meant all along, with the hope that the lawyers and judges who have been ignoring it can’t do so any longer.

In January, several liberal Democrats in Congress wrote a letter to FDA questioning the basis for the proposed CBE rule, saying it appeared to be designed to shield pharmaceutical and medical device companies from liability sustained by consumers. But the rule does not alter the agency's current practices with respect to accepting or rejecting labeling changes proposed by a CBE supplement, reiterating the agency's longstanding view that the changes-being-effected mechanism is a narrow exception to the FDA's requirement of prior approval for labeling changes to approved products.

Under the rule, newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) -- if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA. The final rule thus clarifies the meaning of "newly acquired information," such that the data, whether derived from new clinical studies, reports of adverse events, etc., needs to be new and different -- of a different type or greater severity or frequency than previously submitted to FDA. This limitation applies to data derived from new clinical studies, reports of adverse events, and new analyses of previously submitted data, alike. The final rule notes thus that there must be reasonable evidence of a causal association before a CBE supplement may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction language.

The FDA rejected comments suggesting that a lower standard should be used under CBE for when a sponsor may warn, reiterating that it "interprets the Act to establish both a 'floor' and a 'ceiling', such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading." 

The new rule may be of some assistance in dealing with those courts that seem reluctant to recognize the longstanding view of the narrow scope of the CBE rule.  The rule limits the scenarios in which manufacturers of drugs, biologics, or medical devices can change a previously approved label in advance of the FDA’s formal review and approval mechanism. And the smaller the scope of things permitted in a CBE change, the greater the scope of conflict between FDA-approved labels and state court second-guessing of the warnings.  

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Professor Lester Brickman, of Cardozo School of Law, has published a fascinating article entitled, "The Use of Litigation Screenings in Mass Torts: A Formula for Fraud?"

At MassTortDefense, we would simply remove the question mark.

Plaintiff lawyers obtain the "mass" for some mass tort litigation by conducting screenings to sign-up potential litigants. These "litigation screenings" have no intended medical benefit, and thus this entrepreneurial response to highly profitable opportunities that arise in certain mass tort litigation should not be confused with true medical screening. In a litigation screening, potential litigants are solicited by lawyers or their agents by use of mass mailings, television and newspaper advertisements providing “800” telephone numbers, and by use of web sites purporting to provide medical information about toxic exposures, drugs, devices, or specific diseases but which are, in fact, “fronts” for law firms to whom the web site visitor is referred.

Screenings can be held in motels, shopping center parking lots, local union offices, and even lawyers' offices. There, an occupational history is taken by persons typically with no medical training, a doctor may do a cursory physical exam, and non-doctor technicians administer tests, such as X-rays, pulmonary function tests, echocardiograms and blood tests. The sole purpose of screenings is to generate "medical" evidence of the existence of an injury to be attributed to exposure to or ingestion of defendants' products – all pre-planned. Usually a handful of doctors ("litigation doctors") provide the vast majority of the thousands of medical reports prepared for that litigation.

By the good professor’s count, at least 1,500,000 potential litigants have been screened in the asbestos, silica, fen-phen (diet drugs), silicone breast implant, and welding fume litigation. Litigation doctors found that approximately 1,000,000 of those screened had the requisite condition that could qualify for compensation under plaintiffs’ legal theory, such as asbestosis, silicosis, moderate mitral or mild aortic value regurgitation or a neurological disorder. He further estimates that litigation doctors and screening companies have been paid well in excess of $250 million – huge number, but a tiny fraction of the contingency fees earned well in excess of $13 billion by his estimates.

The professor concludes that approximately 90% claims generated from the screenings were based on "diagnoses" of the type that U.S. District Court Judge Janis Jack, in the silica MDL, found were "manufactured for money."

He also presents the case that bankruptcy courts adjudicating asbestos related bankruptcies have effectively legitimized the use of these litigation screenings.

Professor Brickman's areas of expertise include legal ethics, contingency fees, mass torts, and asbestos litigation. He notes the significant volume of literature about the use of junk science in the court, even today, especially to try to prove general causation in mass torts. But his analysis is particularly valuable because it turns an empirical light on the use of litigation screenings to try to prove specific causation.
 

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The U.S. Judicial Panel on Multidistrict Litigation has rejected requests for MDL status for litigation involving injuries allegedly caused by pain pumps that directly delivered anesthetics to joint tissue following surgery. See In re Shoulder Pain Pump--Chondrolysis Products Liability Litigation, MDL No. 1966 (8/11/08).

On the surface, the denial may have seemed surprising in that suits had been filed in eight different federal district courts, and the plaintiffs all claimed that the direct delivery systems caused the degeneration of joint tissue, leading to a condition called chondrolysis. The cases involve high volume pain pumps that deliver pain medication directly to afflicted areas through flexible plastic catheters. Physicians temporarily implant the catheters into patients following surgery to manage postoperative pain. A 2007 study published in the American Journal of Sports Medicine apparently spurred the litigation.

In denying the motion, the panel said it was not persuaded that centralization would serve the convenience of the parties and witnesses, or further the just and efficient conduct of this litigation at the present time. Although these personal injury actions seemed to have some commonality, a number of different pain pumps made by different manufacturers are at issue, as are different anesthetic drugs made by different pharmaceutical companies. Moreover, not all of the thirteen constituent actions involve pharmaceutical company defendants, and many defendants are sued only in a minority of those actions.

Because of this, the proponents of centralization could not convince the panel that the efficiencies that might be gained by centralization would not be overwhelmed by the multiple individualized issues (including ones of liability and causation) that these actions present.

MassTortDefense notes that whether the JPML grants or denies a motion to centralize cases can have a significant effect on product liability litigation. The vast majority of motions in products cases are granted. But it is not unheard of for the panel to deny MDL status when the underlying actions raise primarily individual, not common, issues, as exemplified by many defendants, diverse plaintiffs, or different kinds of exposure to the relevant product. Here, the panel pointed out, for example, that five pharmaceutical defendants were each named in only one of the underlying actions. And the panel noted that that none of the underlying actions was a class action, implying the presence of numerous individual issues.
 

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A number of entities have continued to weigh in as amici in the Wyeth v. Levine preemption case pending before the Supreme Court. In an amicus brief filed earlier this summer, BIO and PhRMA argued from a policy perspective that state law tort suits challenging the adequacy of FDA approved prescription drug labeling pose significant risks to public health. (BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,150 members worldwide.) Those suits imperil FDA's ability to accomplish its mission because they allow state court juries to second guess FDA's balancing of the risks and benefits of a prescription medicine. State court verdicts inconsistent with FDA guidance will simply encourage manufacturers to warn physicians and patients about risks that are speculative and scientifically unsupported; this ultimately dilutes the impact of scientifically valid warnings and can discourage physicians from prescribing and patients from using beneficial drugs.

On the legal side, these amici argued that the Vermont Supreme Court's decision now on appeal was at odds with a core premise of the Supremacy Clause: that state law cannot require what federal law prohibits. Absent new scientific information, federal regulations prohibit a manufacturer from changing prescription drug labeling without prior FDA approval. In this case, FDA knew of and considered the relevant risk over a long period of time, and approved carefully crafted warnings and instructions designed to minimize those risks while still encouraging beneficial drug use.

The Latest

Last week, in what appears to be a first, the editors of the New England Journal of Medicine  weighed in on the preemption legal battle -- on the side of the plaintiff below, Levine. While the brief attacks the track record of the FDA, arguing that the agency lacks the resources to do its job, it does not answer the next question: whether experts at the FDA, even with allegedly inadequate funding, are more or less likely to decide difficult scientific questions correctly than are juries of lay people “educated” by trial lawyers. The NEJM spouts the rhetoric of juries "policing" the industry.  But a dramatic gulf separates the competence of the FDA from that of state jurors who, absent preemption, are called on to assess the safety of prescription drugs and second-guess federal regulators. Laypersons applying state law cannot substitute for the FDA, the expert agency congressionally delegated the role of meticulously balancing nuanced and sometimes competing nationwide goals. The FDA’s regulation of prescription drugs is governed by a sweeping network of federal law individually applied to each drug. A lay jury lacks the expertise and the broader perspective of the FDA, and thus cannot adequately adjudicate individual plaintiff/patient risks in the context of population benefits – quintessentially the kind of issue that the FDA must confront every day. Without preemption, however, state juries are asked to do just that.

Similarly, the NEJM brief bemoans the fact that FDA is reliant upon information gathered and produced by the drug company, but the fact is that no entity other than the drug company has any incentive or ability to study a not-yet-approved drug. And permitting after the fact tort suits to second-guess the FDA won’t change that. Moreover, how is the situation any different in a tort suit? If a new study comes out about the risks or benefits of a drug or device after a tort suit has been concluded, we don’t go back and start the case again. Would the NEJM advise unwinding the results in Bendectin litigation? Breast implants? The state of the art is by definition time-dependent.

And as pointed out in DRI’s amicus brief, there was an enhancement of the FDA’s powers by the recent FDAAA. This contrasts a one possible way (congressional action) and a clearly worse way (complaining in state court litigation) to deal with perceived deficiencies in FDA action.
 

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The U.S. District Court for the Western District of Missouri has dismissed a medical monitoring claim brought against the manufacturer of a medical device, finding that the applicable state law permits such a claim only in a true toxic tort case. Ratliff v. Mentor Corp., 2008 WL 3126300 (W.D. Mo.,  Aug. 5, 2008).

Plaintiff Toni Ratliff had a Mentor UB-Tape sling surgically implanted in her pelvis area to treat a condition. She brought a putative class action, including “all persons or entities in the State of Missouri who were treated, implanted or otherwise received the UB-Tape, designed, tested, manufactured, distributed and/or sold by Mentor Corporation.” Excluded from the class were all people with claims for personal injury or wrongful death. She alleged the device caused extrusions, infections and abscesses, often requiring secondary surgical procedures to correct the problem.

The relief sought included a notification, research, and medical monitoring fund for tests to catch those problems. Mentor moved to dismiss, arguing that a medical monitoring claim is not recognized in Missouri outside of the toxic torts context.

The court noted that Meyer v. Fluor Corp., 220 S.W.3d 712 (Mo. 2007) is the first and only Missouri Supreme Court case dealing with medical monitoring claims. It has been cited for the general proposition that Missouri recognizes a claim for medical monitoring. However, in Meyer, children allegedly exposed to lead sued smelter operators to recover damages for the expense of medical monitoring. The Missouri Supreme Court held that the children were entitled to recover such damages under a “medical monitoring claim” that “seeks to recover the costs of future reasonably necessary diagnostic testing to detect latent injuries or diseases that may develop as a result of exposure to toxic substances.” Id. at 716. Thus, by the Missouri Supreme Court’s own definition of a medical monitoring claim, the Meyer decision does not apply to potential latent injuries resulting from anything other than exposure to toxic substances.

The strict holding of Meyer is that, in Missouri, medical monitoring claims are available in toxic tort cases. Meyer does not necessarily support recognition of medical monitoring claims in garden variety products liability cases like plaintiff contended. This explicit limitation in Meyer led the district court to believe that the Missouri Supreme Court would dismiss medical monitoring claims that do not result from exposure to toxic substances.

Although the court did not get into policy issues, MassTortDefense notes that there is a growing recognition that medical monitoring should not be available in the context of drugs and medical devices. The voluntary use of a medical device or medicine prescribed by a health care professional is arguably far removed from the original medical monitoring notion of involuntary exposure to a chemical in the environment. In a case involving HRT, Vitanza v. Wyeth, Inc., 2006 WL 462470 (N.J. Super. Ct. Jan. 24, 2006), plaintiffs 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 was 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 selling a product screened by the FDA.

The absence of these policy factors in a life sciences context was also observed in a recent Vioxx case. Sinclair v. Merck & Co., 195 N.J. 51, 948 A.2d 587 (N.J. 2008). The state supreme court ruled as a matter of law that plaintiffs could not maintain an action for medical monitoring in a pharmaceutical product liability action because they did not allege a presently manifested injury. The court held that the New Jersey Products Liability Act requires present manifest injury and therefore bars medical monitoring unless the present manifest injury element is satisfied. The court also examined prior precedents where medical monitoring was approved, and found those precedents were limited to personal injury stemming from asbestos exposure and exposure to environmental contamination. The majority declined to recognize any common law medical monitoring remedy. See also Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *5, n.6 (D.N.J.,  Jan.  14, 2008)(applying similar reasoning to device context). Similarly, in Conway v. A.I. DuPont Hosp. for Children, 2007 WL 560502 (E.D. Pa., Feb. 14, 2007), the court denied the defendant's motion to dismiss a medical monitoring claim regarding a medical device used in children with congenital heart defects. The court did, however, note that while medical monitoring was "suitable" in toxic substance exposure cases, the "same argument cannot be made for medical monitoring relief in products liability cases where diseases" are not caused by exposure to toxic substances.
 

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Two liberal Senators have followed the lead of liberal Democratic House lawmakers and introduced a Senate counterpart to the proposed Medical Device Safety Act of 2008. The bill would overturn the Supreme Court’s decision in Reigel v. Medtronic, which properly confirmed preemption of state tort suits for FDA-approved medical devices. The bill would permit individuals to sue device makers under state tort laws, and permit state court juries to second-guess the expert decisions of federal regulators. The bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with.

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) introduced the companion bill to H.R. 6381, which has 62 co-sponsors in the House, and which was introduced in the House in June by Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.). The Senators’ introductory statement can be viewed here. 

MassTortDefense has posted on preemption, including here and here.

The Wall Street Journal weighed in on these issues in an editorial August 13th. Describing the Supreme Court's “sensible 8-1 ruling earlier this year” in Riegel v. Medtronic, the Journal noted how the FDA's authority to approve a drug or device pre-empts state product liability laws. “The Court's decision makes sense for many reasons, not least to avoid creating a sort of double-jeopardy for companies -- first having to run the FDA approval maze, then allowing a nationwide quilt of different laws and standards to second-guess that approval.” In 1976 Congress passed the Medical Device Amendments, establishing a national standard with express pre-emption language barring states from imposing their own requirements.

Democratic House member Henry Waxman said the decision "strips consumers of the rights they've had for decades." Who writes this stuff for Henry?, asks the WSJ. Far from representing a radical departure in the law, “the Court's reasoning upheld what had become a common opinion in the federal court system. In half a dozen holdings, federal circuit courts had already ruled in favor of pre-emption, covering states from Texas to Illinois to Pennsylvania.”

The Journal observed, “What Mr. Waxman really wants to restore is the trial lawyer bingo that can net jackpot jury awards while wreaking havoc on national standards. The FDA approval process is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective.” Of the 8-1 vote, the editorial mentioned, “You've got to love it when the tort bar and Democrats accuse those notorious right-wing Justices Stephen Breyer, Anthony Kennedy and David Souter -- who joined the majority opinion -- of being the greedy tools of business. Another liberal, John Paul Stevens, joined the majority with some caveats.”
 

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The FDA will hold a public meeting on September 8, 2008, to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidance documents concerning nanotechnology. The primary purpose of the meeting is to determine what factors the agency should consider in providing guidance on:

1) The information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials; and

2) The circumstances under which a product’s regulatory status might change due to the presence or use of nanoscale materials.

Nanotechnology allows scientists to work on the scale of molecules to create, explore, and manipulate materials measured in nanometers; billionths of a meter. MassTortDefense has posted on nano-issues here and here.

In July 2007, FDA issued a report analyzing scientific and regulatory considerations relating to the safety and effectiveness of FDA-regulated products containing nanoscale materials regulated by FDA, and making recommendations regarding these considerations. The Nanotechnology Task Force Report made recommendations which covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. Additionally, the Report summarized the state of the science for biological interactions with nanoscale materials.

In addition, FDA is working with the National Institutes of Health (particularly the NanoHealth Enterprise) to explore methods for receiving and sharing data relating to, for example, general product development, including research on failed product candidates, and biological interactions of certain characteristics of nanoscale materials.

The meeting will begin with a plenary session at which FDA will review the goals of the meeting and give a general overview of the analysis and findings of the Nanotechnology Task Force and agency activities since publication of the Report in July 2007. Following will be breakout sessions on medical devices, including diagnostics; prescription drugs, including
biological drugs, animal drugs and OTC drugs, including sunscreens; food and color additives, including food contact substances; dietary supplements; and cosmetics.
 

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The federal judge overseeing the MDL for Celebrex and Bextra has sided with defendants' view that a “Lone Pine” order is 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).

“Lone Pine” orders take their name from a 1986 New Jersey Superior Court case involving toxic tort claims; they refer 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.

Defendants had first asked the court for a Lone Pine order in late June, arguing that each plaintiff should be required to submit a case-specific expert report on the issue of medical causation. The motion also sought to compel each plaintiff to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and proof of dosage in relation to the confirmed injury. The benefits to the court of requiring plaintiffs to supply this information is that the parties would not have to engage in protracted discovery in thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence was argued to be simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Plaintiffs argued that the proposed order would be overly burdensome, was not needed, and was a retaliation for not settling. Plaintiffs also suggested that Lone Pine orders are generally issued as sanctions against plaintiffs who provide no other information to the defendants about the filed case. But the court disagreed with plaintiffs.

The court appeared mindful of what had happened on the eve of the first trial in the MDL, as the scheduled cases began to disappear. Thus, under the Order, plaintiffs will have 45 days to have a physician or other medical expert offer a case-specific expert report for each plaintiff including a review of the plaintiffs’ medical records, the dates they used Celebrex and/or Bextra, and whether they experienced a myocardial infarction, ischemic stroke, sudden death, or any other injury while taking the medications.

The court observed that all of this information should be already readily available to plaintiffs through the plaintiff fact sheets process. The court apparently expects that cases in which plaintiffs cannot show drug usage, injury, or causation, will drop from the docket before being scheduled for trial. Without threshold proof of Celebrex or Bextra usage, a compensable injury, and a link between usage and an injury, there could have been no good-faith basis for a lawsuit in the first place.

Moreover, 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. 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.

With their focus on causation, Lone Pine orders are especially useful when multiple plaintiffs claim a variety of different injuries, allege injuries incurred over a long period of time, and/or when plaintiffs allege diverse exposures.

 

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Novartis Pharmaceuticals Corp. has prevailed in a motion to end certain failure-to-warn claims in cases in the MDL relating to its bone cancer drugs Aredia and Zometa. The U.S. District Court for the Middle District of Tennessee granted defendant’s motion for partial summary judgment, dismissing claims of eight Texas-based plaintiffs. In Re: Aredia and Zometa Products Liability Litigation, No. 06-md-01760 (M.D. Tenn.) Opinion found here.

The motion was based upon a Texas statute which protects a defendant from any products liability claims involving failure to provide adequate warnings if the drug at issue and accompanying warnings were approved by the FDA. The statute creates the presumption such warnings were adequate, and then specifically explains how a claimant can rebut this presumption:

(b) The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that: (1) the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury. Tex. Civ. Prac. & Rem. Code Ann. § 82.007(b)(1).

The court noted that plaintiffs were correct that the language of the Texas statute specifically creates a rebuttable presumption that a defendant is not liable for failure-to-warn claims if the warnings provided with the product were approved by the FDA. The Texas Legislature, however, went on to establish certain evidentiary standards for rebutting this presumption. The presumption of adequate warnings, therefore, is unrebuttable unless one of the specific statutory provisions applies.  Here, the only possible exception was the so-called fraud-on-the-FDA exception. However, in Buckman Co. v. Plaintiffs’ Legal Comm., 121 S.Ct. 1012 (2001), the Supreme Court found that the plaintiffs’ state law fraud-on-the-FDA claims conflicted with and were therefore impliedly preempted by the Federal Food, Drug and Cosmetic Act. Noting that policing fraud against federal agencies is hardly a “field which the States have traditionally occupied,” the Court held that it is the FDA’s exclusive responsibility to police fraud or wrongdoing in connection with approval of products before the FDA. Id. at 1017.   The Court stated that fraud-on-the-FDA claims would “inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.” Id. at 1018. In sum, the Court opined, this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore preempted by that scheme. Id. at 1020.

Under the Texas law, in order to rebut the presumption plaintiffs must establish that defendant withheld or misrepresented “required information” to the FDA. The Court found that the task of determining whether certain information was “required” by the FDA would raise the federalism concerns expressed in Buckman.

Second, the Texas statute also requires that the information which was withheld or misrepresented be “material and relevant” to the performance of the product. Because subsection (b) concerns misrepresentations to the FDA, it is reasonable to infer that the information must be “material and relevant” to the FDA. Determining what information would have been important to the FDA would also create the federalism concerns noted by the Court in Buckman.

Finally, the information which was allegedly withheld or misrepresented must, under the Texas statute, be causally related to plaintiffs’ injuries. Unless the withheld information would have resulted in some definite change by the FDA, such as either non-approval of the drug or a labeling change, such withheld information could not be causally related to a plaintiff’s injury. Again, in order to establish that the FDA would have acted differently if defendant had submitted accurate information, plaintiffs would have to “go behind” the FDA processes, raising the concerns sought to be avoided in Buckman.

The Court thus found that the requisite showing under the Texas statute is analogous to and sufficiently equivalent to asserting a claim of fraud on the FDA that the fraud claim/presumption defense/statutory exception is itself preempted under Buckman. For all these reasons, Defendant’s Motion for Partial Summary Judgment was granted.

The ruling on the Texas claims follows the MDL court's April ruling dismissing claims by Michigan plaintiffs. The court had relied on Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), for the proposition that the Michigan fraud exception was also preempted under the U.S. Supreme Court's decision in Buckman.

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A recent trial court decision shows the state of flux in applying the preemption doctrine in pharmaceutical cases. In the Celexa/ Lexapro MDL, the court denied without prejudice the defendant’s preemption motion, to allow further discovery and expressly because the United States Supreme Court has granted certiorari in Levine v. Wyeth, 128 S.Ct. 1118 (2008), to consider the extent to which prescription drug labeling judgments imposed on manufacturers by the FDA, pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. See In re Celexa and Lexapro Products Liability Litigation, 2008 WL 2906713 (E.D.Mo. July 24, 2008), found here.

 

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The FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology met last week. Among the agenda topics was a discussion of current thinking on issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products. (The general function of this committee is to provide advice and recommendations to the agency on regulatory issues.) Scheduled to speak were representatives of the Office of Pharmaceutical Science at CDER, nano-medicine industry leaders, and academics.

MassTortDefense has posted on nano-technology here.

As CDER grapples with questions regarding how to regulate nanomaterial-containing products, several issues have surfaced, including 1) what are the types of nanotechnology applications that will be reviewed by CDER, 2) what are the unique features of these applications that may pose a scientific and/or regulatory challenge to reviewers, 3) are FDA’s current regulatory requirements adequate for the evaluation of nanomaterial-containing products, and 4) what can FDA do to expedite the development of safe and effective nanomaterial-based pharmaceuticals.

Nanotechnology applications in drug development are likely to have a significant impact on the products that FDA regulates. Products containing nanomaterials are being investigated for potential applications as therapeutics, and some products containing nanoscale materials are already on the market. While some of these nanomaterials are nanoscale versions of larger materials used in approved products, other nanomaterials are novel and have never been used in drug products. CDER has initiated a number of activities in order to evaluate how this new technology fits into the current regulatory framework. There have been questions raised about the need for “nano”-specific requirements, in part to aid the development of products containing nanomaterials, and in part because nanomaterial containing products may need to fulfill different regulatory requirements prior to approval.

The FDA established a Nanotechnology Task Force, which issued a report in July 2007. In the task force report, recommendations were made regarding FDA’s future direction for regulating nanomaterial-containing products. Guidance development was included as one the recommendations. FDA believes, however, that the preclinical studies currently required of sponsors are very comprehensive, and include many studies that measure endpoints that could predict possible injury in many organ systems. While general issues have been raised, no one has clearly communicated in what respect the current requirements might be lacking in their capacity to assess safety concerns from such products, and what might be other tests that would improve the predictive value of the current regulatory preclinical requirements.

Nevertheless, because it is widely accepted that there are unique features associated with
nanotherapeutic products, these unique features may lead to future challenges for the development, manufacturing, and possibly safety evaluation and review of these products. Accordingly, the committee was set to discuss:

1. Is CDER guidance needed for the development of nanotechnology-derived drug applications?
2. If guidance is needed from CDER, what areas should this guidance focus on?
3. In light of the many definitions of nanotechnology available, how should CDER define nanotechnology, for the purposes of guidance development?
4. Should particle size information be routinely requested of drug developers, regardless of whether nanomaterials are included in the product? How might this information help in the assessment of safety and efficacy of drugs?

Clearly this is no small issue.

 

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Judge David F. Hamilton of the U.S. District Court for the Southern District of Indiana has reversed a prior decision and reinstated a Paxil suicide case that had been dismissed – properly in the view of MassTortDefense --  on preemption grounds last year. See Tucker v. SmithKline Beecham Corp./d/b/a Glaxosmithkline, No. 04-1748, (S.D. Ind. 7/18/08). See opinion here.  In granting plaintiff’s motion for reconsideration, the court violated the rule “if it ain’t broke, don’t fix it.”

Plaintiff Debra Tucker sued GSK on behalf of her brother, Rick Tucker, alleging that her brother committed suicide in September 2002 as a result of taking Paxil for three weeks. The claim was that GSK breached a duty to warn of an alleged increased suicide risk among Paxil patients. (MassTortDefense notes that the scientific evidence actually does not establish that paroxetine (the active ingredient in Paxil) causes suicide, suicide attempts, self-harm or suicidal thinking. On the basis of research in tens of thousands of patients taking antidepressants, including Paxil, there is no significantly increased risk of suicidal thinking or behavior in people age 24 and older and, in fact, in patients older than 65, there was a reduction in risk in suicidal thoughts and behavior.)

The defendant sought summary judgment on preemption grounds. The court correctly determined in September, 2007, that her claims conflicted with the FDA's labeling requirements for Paxil. The court said it believed the record showed that the FDA had rejected the hypothesis that there is a causal link between Paxil and suicide.

In granting the plaintiff's motion for reconsideration, the court said it had "failed to appreciate the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer." In its new decision, the court first noted that under 21 C.F.R. §201.80, a manufacturer must revise labeling "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Under 21 C.F.R. §314.70(c), a manufacturer may unilaterally add or strengthen a contraindication, warning, precaution or adverse reaction upon submission of a "changes being effected" [CBE] supplement. The court now thinks that the FDA's power to disapprove a label "does not make the manufacturer's voluntarily strengthened label a violation of federal law, which is what it would take to establish an actual conflict between state tort law and federal law.”  If the agency disapproves the revised label, the manufacturer simply stops distribution; there is no retroactive illegality.

The court’s new order rejected the FDA’s position that such failure to warn claims are preempted, calling the agency's position on preemption an "180-degree reversal" of its earlier stance. On reconsideration, the court thus gave "relatively little weight to the FDA's opinion on the preemptive effects of its regulations." In 2006, the FDA amended its regulations governing prescription drug labeling, clarifying the preemption of certain warning claims. The court adopted plaintiff’s argument that the 2006 Preamble was promulgated without notice-and-comment.

GSK argued that drug manufacturers will be forced to place scientifically unsubstantiated warnings on their drug products unless state law tort claims are preempted. But the causation requirements on plaintiffs will guard against this risk, the court said. In fact, thought the court, failure to warn litigation can reinforce the FDA's regulations, which already place the obligation to strengthen the warnings on a drug's label “squarely on the shoulders of the drug's manufacturer."  GSK's possible future risk of prosecution for distributing a misbranded drug would present a conflict only if GSK could say with absolute certainty that it will never have new evidence sufficient to trigger its regulatory obligations to revise its label to strengthen a warning with Paxil-specific language, but is forced to do so by state tort law, stated the new opinion.

Here’s why the new opinion got it wrong.
Regarding CBE, proposed changes in labeling typically are first submitted to the FDA for
approval. 21 C.F.R. § 314.70(a)-(d). A limited exception is with the use of a changes being effected supplement. 21 C.F.R. § 314.70(c). When a new safety issue emerges with a product, the pharmaceutical company may temporarily add to the product's labeling under this rule, which describes "changes that may be made before FDA approval." 21 C.F.R. § 314.70(c). Nonetheless, the FDA must still be notified and will subsequently review the modified labeling to ensure compliance with FDA regulations. In 1982, when the CBE procedure was proposed, the FDA stated, "these supplements would describe changes placed into effect to correct concerns about newly discovered risks from the use of the drug." 73 Fed. Reg. 2849 (Jan. 16, 2008) (quoting 47 Fed. Reg. 46622, 46623 (Oct. 19, 1982)). FDA’s longstanding position is that a CBE supplement “is appropriate to amend the labeling for an approved product only to reflect newly acquired information . . . to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association." 73 Fed. Reg. 2848 (Jan. 16, 2008). The FDA explicitly defines "newly acquired" as "data, analyses, or other information not previously submitted to the agency." Id. at 2850.

The holding of the court that any label change adding or strengthening warnings could always be made unilaterally, without FDA pre-approval, would lead to absurd and unreasonable results. If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval based on information that was previously available to the agency, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted. And plaintiff’s proposed reading of the rule would require manufacturers to make the same CBE change over and over again – despite FDA rejection of the change – in order to avoid liability, because a jury would be free to say – despite the FDA decision – that the manufacturer was free to make the change anyway. It just doesn’t make any sense for the CBE process to permit (and thus obligate, under plaintiffs’ view), a manufacturer to ignore an FDA-mandated label by unilaterally changing the warning to something else. Plaintiffs' construction of the current CBE regulation would permit (and thus obligate) manufacturers to repeat such changes again and again, each time the FDA rejects the proposed change – all without any new scientific evidence to warrant any change at all. Plaintiffs could argue that the “weight” or “accumulation” of evidence required a label change, even as the FDA has rejected changes based on each individual “new” evidence. The only way to prevent the CBE exception from becoming a vehicle for ignoring FDA labeling decisions is to limit it to new information. Any changes to a drug’s labeling without prior FDA approval must be based on new information establishing that risks arising from use of the drug are of a different type or greater severity than the risks of which FDA had previously been made aware – not cumulative new information that does not add to the information that was previously available to the agency.

Second, since this part of the argument is about interpretation of the scope of the FDA’s own CBE regulation, government views concerning that regulation are entitled to substantial deference, not the little weight given. Judicial deference to administrative positions on preemption, typically expressed in amicus briefs, has more or less been the rule, rather than the exception.

Third, regarding the supposed “reinforcing” aspect of tort claims, the new decision in this case would allow a jury to determine whether an FDA-approved label adequately informs physicians about a medication's risks and benefits, as the label generally has to be found to be inadequate before the manufacturer can be held liable. This could result in a patchwork of labels/warning information that vary from state to state for no good reason – the science in Maine is the same in California, even if the juries are not. And this would place doctors and patients in an untenable position. Indeed, state common-law tort actions based on the manufacturers’ failure to warn present the pharmaceutical manufacturers with particular difficulties. State standards of care undoubtedly would differ from state to state. Absent a determination that the FDA-approved labeling and the FDA’s refusal to require the warnings suggested by plaintiffs in this case preempt state tort actions, the manufacturers may be subjected to considerable liability based on varying standards, with no benchmark that they should follow.

The FDA, rather than a jury, has the responsibility to determine whether the labels on medicines offered in the U.S. are appropriate. The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years, and has concluded that the suicide warnings desired by plaintiffs are without sufficient scientific basis and would therefore be false and misleading. This claim of supposed harmony or reinforcement by tort law is belied by what the plaintiffs always ask for:  that state courts provide a check on agency power; that state juries be allowed to make their own judgment on whether the label was adequate; and that FDA approval of a label, or rejection of an alternate label, doesn’t mean anything to the company’s potential liability.

Finally, regarding misbranding, a pharmaceutical company that independently institutes a change in labeling may be subject to penalty or seizure if the drug is deemed misbranded by the FDA. See 21 U.S.C. § 333 (authorizing penalties); 21 U.S.C. § 334 (authorizing seizure); 21 C.F.R. § 7.45(a) (providing authority to request recall). And it has never been required, for a conflict to exist, to show how many times the federal law was applied, or how significant the sanctions were. That the federal agency has the legal power to enforce the federal rule is, and ought to be, sufficient.

In its next term, the U.S. Supreme Court will take up a preemption question in Wyeth v. Levine, and we may see if the court got it right the first time or the second time.

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Managing the potentially vast scope of discovery requests in life sciences industry litigation can be daunting. The discovery requests in such litigation may be quite broad, following the product through its entire life cycle, and under the new(ish) Federal Rules can be even broader than in the past. They may now involve requests for samples, requests for access to databases, requests for technical support and IT depositions.

Companies in the life sciences area know well that multiple kinds of litigation now regularly arise from same product issue or nucleus of facts, including
– product liability
– medical monitoring
– securities
– consumer fraud class action
– DOJ and government investigations

The vast array of litigation raises the potential for inconsistent positions in the different parts of the litigation concerning same subject. In addition, defendants must be on guard against spoliation attacks and the plaintiffs’ new favorite, the “Gotcha” Game, in which plaintiffs seek discovery not for information, but to find and challenge wherever defendant drew the line in document or data preservation. All in all, the management and conduct of e-discovery has become an area of true specialization.

Defendants may have wondered whether discovery is a two-way street under the new rules. Plaintiffs don’t have as much data, perhaps, and courts have been reluctant to hold individual plaintiffs to the same standards as corporate defendants. In a recent decision in the Zyprexa litigation, a governmental plaintiff may have been, however.

The magistrate judge overseeing discovery in the MDL has weighed in on the state of New Mexico’s apparent failure to properly respond to discovery requests in a lawsuit it filed against Eli Lilly & Co. over Zyprexa. Madrid v. Eli Lilly & Co., No. 07-cv-1749 (MDL-1596 E.D.N.Y.).

As is typical in this branch of the litigation, the state alleges that it would not have spent Medicaid funds on Zyprexa if it had known more about the supposed risks of the drug. The lawsuit was removed to the U.S. District Court for the District of New Mexico in 2006 after it was originally filed in state court. It was transferred for pretrial proceedings to the U.S. District Court of the Eastern District of New York by the panel on multidistrict litigation.

Earlier this month, Eli Lilly challenged the adequacy of the state's responses to interrogatories and document demands it had made in June. The magistrate judge's Order concluded that New Mexico had neither replied to Lilly's attempts to confer in good faith on this issue nor had it provided the court with any justification whatsoever for its boilerplate objections. The state's silence on this issue “underscores the indefensible nature of its responses.” Apparently, the state had ignored the specificity requirement for objection and merely labeled each request as “unintelligible” or “irrelevant.” The court also faulted the state for not including a privilege log.

Discovery is supposed to be a two-way street.

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Pfizer and the other defendants in the Mirapex litigation are seeking a bifurcated trial plan. In motions filed with the U.S. District Court for the District of Minnesota, where MDL-1310 is based, the defendants asked for separate liability and punitive damages phases. Defendants raised the legitimate concern that the jury may be swayed by financial considerations when determining liability.

In this litigation, plaintiffs allege that the drug causes a compulsive urge to gamble. The plaintiffs claim that Mirapex triggered compulsive behaviors, and that the defendants knew the risks but failed to properly study the effects or warn patients. As is so often the case, a label change (in February 2006) seems to have prompted litigation.

Defendants assert that bifurcation is warranted because evidence of defendants' finances is irrelevant to the issues of liability; introduction of such evidence during the liability phase would be unduly prejudicial. Bifurcation is thus necessary to prevent unfair prejudice to defendants during the liability determination. The motions note that the 8th Circuit has recognized bifurcated trial plans in a number of settings. Indeed, bifurcation is a common feature of pharmaceutical mass torts.

Plaintiffs oppose the proposal, arguing that the issue of liability and punitive damages are somehow “intertwined.” Meaning, of course, that they would like for the jury to consider the company’s financials when judging its conduct. Plaintiffs insist on a single trial where the fact finder considers “all the evidence at once.” To the extent some of that evidence should not be considered on the issues of liability, plaintiffs propose that the jury could be instructed to consider the financial information only in the proper context.

MassTortDefense has posted on the importance of proper trial plans here. The Mirapex motions present perhaps the most basic form of bifurcation or trial plan issue.  The timing of the punitive damages issues in class actions or other complex aggregated litigation can become highly complex and controversial. The questions as to punitive damages may include: a) whether they can be awarded; b) if so, whether as a lump sum, as a multiplier of individual compensatory damages, or on a per class member basis, c) whether they can be tried before individual liability as to specific class members, or as to absent class members, or non-bellwether plaintiffs has been decided; d) whether they can be awarded before the actual amount of compensatory damages has been determined; and e) how punitive damages are allocated among class members or the aggregated plaintiffs if not determined on a per plaintiff basis. State Farm Mutual Auto Insurance Co. v. Campbell, 538 U.S. 408 (2003). See In re Simon II, 407 F.3d 125 (2d Cir. 2005); Beck v. Boeing Co., 60 Fed. Appx. 38 (9th Cir. 2003); Allison v. Citgo Petroleum Corp., 151 F.3d 402 (5th Cir. 1998); Johnson v. Ford Motor Co., 35 Cal.4th 1191,113 P.3d 82 (Cal. 2005) (rejecting aggregate disgorgement); Engle v. Liggett Group, Inc., 945 So.2d 1246, 1265 (Fla. 2006); In re Chevron Fire Cases, 2005 WL 1077516, at *14-15 (Cal. App. May 6, 2005); Colindres v. QuitFlex Manufacturing, 235 F.R.D. 347, 378 (S.D. Tex. 2006).

Punitive damages are designed to punish a defendant for egregious conduct and deter future reprehensible conduct on the part of the defendant or others. Particularly in the context of juries unchecked by proper legal instructions and unorthodox trial plans that prematurely address the punitive damages issue, they constitute a serious litigation threat to product sellers today. In aggregated litigation, such damages have the potential to lead to crippling verdicts, and thus the threat of punitive damages may coerce “blackmail” settlements.

In recent years, the United States Supreme Court has identified a variety of constitutional limits on punitive damage awards. Specifically, such awards cannot be arbitrary punishments and cannot be grossly excessive. In Philip Morris USA v. Williams, 127 S.Ct. 1057 (2007), the Court confirmed a significant constitutional principle limiting punitive damages awards: the Due Process Clause prohibits juries from basing punitive damages awards in part upon the desire to punish a defendant for harm to persons that are not before the court. Williams arose from an Oregon trial wherein a jury awarded $821,000 in compensatory damages and $79.5 million in punitive damages against cigarette manufacturer Philip Morris. At trial, the plaintiff’s attorney had urged the jury to punish Philip Morris for alleged harm to smokers other than the plaintiff by referring to the defendant’s market share and the number of smokers not only in the state of Oregon, but nationwide, who had allegedly contracted a smoking-related illness in the last 40 years. The Supreme Court held that the Due Process Clause forbids a jury from assessing punitive damages to punish a defendant for injury that it inflicts upon non-parties or “strangers” to this litigation. While a jury may consider the actual or potential harm to non-parties in the narrow context of determining “reprehensibility” of the conduct, which in turn is one of the factors relevant to an analysis whether the punitive damages award is excessive or not, it may not punish the defendant for the impact of its alleged misconduct on other people, who may bring lawsuits of their own in which other juries can resolve their claims. The Court cautioned state courts that they must make sure that the “jury will ask the right question, not the wrong one.” That is, evidence regarding alleged injuries of those not before the court must be used solely to judge the reprehensibility of the conduct, not to assess damages for the harm caused to those strangers. While the Court commented on the Oregon court’s refusal to give a jury instruction clarifying this distinction, it noted that state courts cannot authorize any procedures that create an unreasonable and necessary risk of any such confusion occurring. When evidence is introduced or argument made that risks this confusion, the state court must take steps to protect against that risk.

One implication of the Court’s emphasis on avoiding misuse of evidence of harm to “strangers” clearly relates to the employment of reverse-bifurcated trial plans in aggregated cases, in particular trial plans in which the entitlement and amount of punitive damages (by ratio or dollar amount) is set in an early phase of the trial, well before the jury has considered whether the vast bulk of the plaintiffs have actually been injured by the alleged conduct of the defendant. E.g., In re Tobacco Litigation, 624 S.E.2d at 740 (W. Va. 2005)(holding that an aggregated, reverse-bifurcated punitive damage multiplier trial before adjudication of any affirmative defense would not be per se invalid). Some state courts favor this approach because it puts pressure on defendants to settle by creating the risk of a huge punitive damages burden before it has even been established whether many or most of the plaintiffs have any compensatory damages. Such a trial plan clearly creates an unnecessary and unreasonable risk of a due process violation under Williams, one that a simple jury instruction about the distinction between entitlement and reprehensibility cannot hope to address adequately. See, e.g., In re Simon II Litig., 407 F.3d at 138 (“In certifying a class that seeks an assessment of punitive damages prior to an actual determination and award of compensatory damages, the district court’s Certification Order would fail to ensure that a jury will be able to assess an award that, in the first instance, will bear a sufficient nexus to the actual and potential harm to the plaintiff class, and that will be reasonable and proportionate to those harms.”); Allison v. Citgo Petroleum Corp., 151 F.3d at 417–418 (stating that “because punitive damages must be reasonably related to the reprehensibility of the defendant’s conduct and to the compensatory damages awarded to the plaintiffs, . . . recovery of punitive damages must necessarily turn on the recovery of compensatory damages”); Southwestern Ref. Co. v. Bernal, 22 S.W.3d at 433 (“Under the [trial plan], the jury would decide punitive damages for the entire class without knowing the severity of the offense or the extent of compensatory damages, if any, for each of the 885 plaintiffs…. the modified trial plan is … prejudicial because it fails to ensure that punitive damages have some understandable relationship to compensatory damages and are not grossly out of proportion to the severity of the offense for each of the 885 plaintiffs.”).

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Judge Stewart Dalzell of the U.S. District Court for the Eastern District of Pennsylvania granted summary judgment to Novartis Pharmaceuticals Corp. in a suit that alleged the company's eczema drug, Elidel, caused plaintiff’s lymphoma. Perry v. Novartis Pharmaceuticals Corp., 2008 WL 2683047 (E.D. Pa. July 09, 2008). Although we typically focus on appellate opinions at MassTortDefense, this well-reasoned opinion is worth a look.

The Perrys filed suit against Novartis in October, 2005 alleging that the company had failed to warn about the risks of Elidel. Their son allegedly developed eczema shortly after his birth, and a pediatrician prescribed Elidel in 2003. He was diagnosed with lymphoma a few months later.

Defendant challenged plaintiffs’ expert evidence on causation. As is frequently the case, if plaintiffs’ expert testimony does not meet the Daubert standard, summary judgment for failure of proof on causation follows. The court noted that the core issue that the jury would have to address in this case is whether Perry's exposure to Elidel was a substantial cause of his disease. Courts in toxic tort cases often separate the causation inquiry into general causation (whether the substance is capable of causing the observed harm in general), and specific causation (whether the substance actually caused the harm a particular individual suffered). Plaintiffs' experts did the same, each drawing conclusions about both the capacity of the drug to cause Non-Hodgkins Lymphoma (NHL) in humans and its particular effect in Perry's case.

An expert's journey from general causation to specific causation need not be just a two-step process. So long as, taken together, the expert is able to draw a chain of scientifically reliable causal links that meets plaintiff's requirements under the substantive tort law, the evidence is admissible, and it will be left to the jury to establish the relative credibility of the parties' competing experts. Where, however, the expert reports leave wide, unexplained gaps in the causal chain, the evidence is not helpful to the trier of fact and must be excluded. In Daubert terms, just as there is no fit where there is simply too great an analytical gap between the data and the opinion offered, see Soldo v. Sandoz Pharms. Corp., 244 F.Supp.2d 434, 527 (W.D. Pa. 2003) (quoting General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997)), “there is also no fit when there is too great an analytical gap between an expert's general causation conclusion and the specific causation question the jury must ultimately answer,” said the court.

One problematic gap concerned epidemiology. Although it has not been held by the Third Circuit that epidemiological studies are an indispensable element in the presentation of a prima facie drug product liability case, Lanzilotti v. Merrell Dow Pharms. Inc., 1986 WL 7832 (E.D.Pa. July 10, 1986) at *2, epidemiology is the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or a disease. See Soldo, 244 F.Supp. at 532 (quoting Conde v. Velsicol Chem. Corp., 804 F.Supp. 972, 1025-26 (S.D. Ohio 1992)). Thus, while an expert's conclusions reached on the basis of other studies could perhaps be sufficiently reliable where no epidemiological studies have been conducted, no reliable scientific approach can simply ignore the epidemiology that does exist.

A second issue concerned the state of the art. The court made clear that the non-existence of good data does not allow expert witnesses to speculate or base their conclusions on inadequate supporting science. In cases where no adequate study shows the link between a substance and a disease, expert testimony will generally be inadmissible, even if there are hints in the data that some link might exist. This may mean that early victims of toxic torts are left without redress because they are unable to prove their cases with the scientific data that currently exists. While this is a “regrettable result in those individual cases,” said the court, it is an unavoidable reality of the structure of our legal system and is necessary to protect the interests of defendants who might otherwise be subject to crippling verdicts on the basis of slender scientific evidence. As the Seventh Circuit has noted, the courtroom is not the place for scientific guesswork, even of the inspired sort. “Law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996).

Focusing next on specific causation, the court noted that each plaintiff expert engaged in a differential diagnosis. MassTortDefense notes the increasing use, and misuse, by plaintiffs of so-called differential diagnosis. The process by which a doctor views symptoms and test results to rule out possible alternative diseases in the diagnostic process to arrive at a conclusion concerning what ails the patient, has morphed into a process by which experts can tell the jury what caused the condition of the plaintiff – a far different thing. Here, after finding that no other risk factor for NHL was present, the experts concluded that because the drug was the only risk factor present and because the disease is rare, plaintiff’s treatment with Elidel was a substantial factor in his presentation with the disease. However, in order to result in an admissible conclusion, a differential diagnosis should reliably rule out reasonable alternative causes of the alleged harm including idiopathic causes. Soldo, 244 F.Supp.2d at 567. Admissible expert testimony need not rule out all alternative causes, but where a defendant points to a plausible alternative cause and the doctor offers no explanation for why he or she has concluded that it was not the sole cause, that doctor's methodology is unreliable.

Here, the differential diagnoses by plaintiff experts failed to exclude the likelihood that Perry's lymphoma had no known cause. Most NHL cases are idiopathic, having no known cause. Courts have excluded experts' differential diagnoses where they failed to adequately account for the likelihood that the disease was caused by an unknown factor. Doe v. Ortho-Clinical Diagnostics, Inc., 440 F.Supp.2d 465, 478 (M.D.N.C. 2006); Whiting v. Boston Edison Co., 891 F.Supp. 12 (D. Mass.1995). This is not to say, cautioned the court, that where most diagnoses of a disease are idiopathic it is impossible to prove specific causation. But in those cases, analysis beyond a differential diagnosis will likely be required.

Plaintiffs' experts' general causation conclusions were primarily based on animal studies and their failure to satisfactorily address epidemiology (and the gap related to dosage levels in the studies vs. plaintiff’s exposure) undermined the usefulness of those conclusions to a jury. Since plaintiffs' experts failed to form a scientifically grounded chain of inference between their general causation finding and their specific causation finding, their opinions were excluded. Summary judgment followed.

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Last year’s Food and Drug Administration Amendments Act gave the FDA increased authority to require Risk Evaluation and Mitigation Strategies (REMS)— safety plans similar to those previously known as Risk Minimization Action Plans (RiskMAP). A recent article in Corporate Counsel offers in-house counsel a note of caution concerning the relationship between REMS and the claims made in a typical personal injury or consumer fraud litigation.

For example, the authors note that if REMS are needed, identifying and implementing the appropriate measures will involve a substantial amount of internal work by the manufacturer as well as significant interaction with the FDA. Both include opportunities and pitfalls 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 warnings to the health care  and patient communities, the authors (full disclosure: colleagues of MassTortDefense) suggest it may constitute a solid defense against the assertion that the manufacturer failed to provide adequate warnings.

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For those readers of MassTortDefense thinking about a new book to read on the beach this weekend, a recent contribution to the Wall Street Journal by Mark Herrmann entitled “The Plaintiff Was Unhappy” reviews, critiques, and balances the recent release Side Effects by Alison Bass. The book is an attack on the FDA and the drug industry in the context of antidepressant medications.

Herrmann shows how one-sided the book/attack is, concluding that Side Effects “belongs to a genre of investigative journalism that involves talking to plaintiffs, their lawyers and their expert witnesses, taking their stories as gospel, and denigrating the opposing view because corporate money (apparently less pure than money from the plaintiffs' side) supposedly has a corrupting effect” on science. 

Herrmann (along with Jim Beck) is an author of the popular Drug and Device Law blog.

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Preemption of state law claims, particularly in the area of medical devices and drugs, has been a hot topic lately. MassTortDefense has posted on it here and here, and there are numerous good posts on the topic at Drug and Device Law.

In the latest development, Congressman Henry A. Waxman (D-Calif.), Chair of the House Committee on Oversight and Government Reform recently sent a letter to Food and Drug Administration Commissioner Andrew C. von Eschenbach, requesting information about the agency's stance on federal preemption issues under the Bush administration.

The FDA believes, correctly, that state product liability lawsuits which challenge or undermine or invite conduct inconsistent with the federal agency's authority can have a detrimental effect on public health.  Waxman calls this a "reversal of FDA's long-standing position on preemption.”  Waxman’s view about the FDA’s position isn’t so firmly grounded, as seen in the back and forth between the majority and the dissent in Colacicco v. Apotex Inc., 2008 WL 927848 (3d Cir. Apr. 8, 2008), concerning whether the FDA has been “inconsistent” in its positions towards preemption. Going back to the Clinton era (Bill), for example, the FDA has repeatedly stated that FDA regulations may displace both state legislative requirements and state common law duties. In 2000, the FDA fretted that consumers in court would have to prove that harm was linked to the substance based on a standard that might vary by jurisdiction or at the “whim of a jury.” 65 Fed. Reg. 43269, 43278-79 (FDA July 13, 2000). And in an FDA final rule regarding FDA-mandated adverse event reports in state-law civil litigation, the agency stated that implied preemption was appropriate because state or local laws, rules, regulations, or other requirements would impede FDA’s ability to monitor product safety after approval to ensure that human drug products, biologics, and medical devices are safe and effective for their intended uses. “Thus, under principles of preemption law, congressional intent to preempt State law can be inferred.” 60 Fed. Reg. 16962, 16963 (FDA Apr. 3, 1995). See also 59 Fed. Reg. 3944, 3948 (FDA Jan. 27, 1994).

Nevertheless, Waxman is asking for numerous documents from the agency, including:

-all documents since Jan. 20, 2001, concerning communications between FDA and private individuals about preemption;
-all documents since that date, relating to internal FDA communications about preemption;
-all documents since Jan. 20, 2001, relating to communications between FDA officials and officials in the Department of HHS, the White House, and other federal agencies about preemption;
-all amicus briefs since Jan. 20, 2001, filed by FDA in product liability suits; and
-all drafts since that date of the final drug labeling rules issued Jan. 24, 2006.

Liberal Democrats in Congress have been buzzing about the Supreme Court’s decision in Riegel v. Medtronic Inc., in which the Court held that federal law preempted state-law claims against the manufacturer of a medical device that went through the Food and Drug Administration's premarket approval process. And they introduced H.R. 6381 that would reverse the effects of Riegel in medical device lawsuits. Waxman’s letter also comes in anticipation of the Court’s consideration of the extent to which the Food, Drug and Cosmetic Act impliedly preempts state law claims against drug makers. See Wyeth v. Levine, U.S., No. 06-1249, review granted 1/18/08. Of course, DOJ/FDA filed an amicus brief arguing in favor of preemption in that case.

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The pharmaceutical industry has been under litigation siege for several years. Plaintiff lawyers regularly seize upon FDA regulatory action, label changes, and new scientific studies concerning potential side effects, as a basis for significant product liability litigation. It matters not that a learned intermediary prescribed the medication. It matters not that the warnings information comported with the state of the art of medical knowledge. The alluring stream of revenue generated by a successful product can be like blood in the water. Plaintiff lawyers have become adept at recruiting clients, utilizing the internet, and product liability actions may descend into mass torts, with tens of thousands of named plaintiffs. From Accutane to Zyprexa, no product seems immune, and few manufacturers seem safe, no matter how robust their pre-launch efforts. That a drug is still approved and on the market does not necessarily prevent significant litigation.

One disturbing feature of today’s litigation concerning pharmaceutical products is its potential breadth. Product liability claims require significant defense efforts, and potentially extensive resources. Cases may arise in multiple jurisdictions at once, including the so-called “judicial hellholes” so favorable to plaintiffs. Increasingly, plaintiff lawyers coordinate, such that maximum discovery obtained in one case becomes a mere minimum for what plaintiffs in other cases seek. Defense counsel facing this must bring a variety of skills, including e-discovery experience, medical/scientific expertise, and top trial talent.

In addition to traditional products liability claims based on alleged negligence or strict liability, pharmaceutical mass torts may include securities law claims. When the adverse publicity concerning a new study or FDA action affects stock prices, plaintiffs cry fraud. The litigation may include claims based on state consumer fraud statutes, in which plaintiffs argue they need not show that they actually suffered a side effect, merely that the allegedly undisclosed side effect caused them to pay more for the product than they should have. Those few dollars multiplied in a class action by all the prescriptions written can generate frightening damages. Other plaintiffs, again not even injured, may allege that they are at risk of contracting the side effect in the future, and seek expensive medical monitoring. Yet another group of potential plaintiffs, beyond those patients who actually suffered an alleged injury, are the third-party payers, such as union health funds, who may assert that on behalf of their subscribers they were allegedly economically damaged by the company’s conduct regarding a medication. Finally, in addition to direct FDA regulatory review, other government agencies may pile on, including the DOJ/US Attorney. Prosecutors may bring criminal or civil charges, seek significant fines, and put in jeopardy the company’s ability to participate in vital government health care programs.

Companies facing product liability cases must be pro-active in this environment. First, they must assess the risks whether the litigation will expand, by factoring in the posture of the FDA, the level of media and interest group interest, and any attention being paid by the DOJ. The status of the key scientific issues must be frankly acknowledged, as well as potential future developments that may affect the state of the art. Lessons may be profitably learned from other mass torts: how vulnerable is the company to the allegations typically made in these cases, such as alleged ghostwriting, improper handling of key opinion leaders in the medical community, and the degree of off-label usage.

Second, a company that detects a risk of expanding litigation will want to be proactive in setting in place a mechanism to deal with the potential problem. It may be that FDA review leads to no significant label changes; or that prosecutors review basic documents and decline to proceed. A dozen or fifteen cases do not always turn into a mass tort. But if they do, the development can be sudden, and one lesson of history is that early decisions in the litigation can affect – for better or worse – the entire course of the mass tort.

How, then, does a pharmaceutical (or medical device company, for that matter) prepare for a battle that may include many different types of claims, in many different jurisdictions, by many coordinating plaintiff firms? And how does a company secure the quality resources needed to battle what may potentially be hundreds or even thousands of claims?

In recent years, a model that has sometimes been used with success is the so-called “virtual law firm” (“VLF”). In this defense scheme, a company hires lawyer teams from several (typically 4-6) defense firms. Those lawyers are expected to, and indeed are hired on the condition that they will, strive to work with each other seamlessly, as if they were in one law firm rather than several. Hence, the term virtual law firm.

The potential advantages to the client are numerous. First, it allows the client to select what is akin to an all-star team, taking the best trial lawyers from each firm to try the cases, the best legal thinkers from each to draft motions and briefs, the most scientifically adept lawyers at each firm to work up expert witnesses, etc. Second, each firm can concentrate on offering its strengths and true expertise. So, for example, a firm that has great regulatory expertise regarding the product may be invaluable on FDA issues, even outside the regulatory setting, but may not have the capacity or expertise to try cases. The model allows for that firm to handle its niche and also share its expertise with other lawyers in the virtual firm. Third, it allows the client to coordinate among the various kinds of litigation. For example, it may not be efficient to have one firm collecting documents and producing them to the DOJ and a different firm collecting and producing data to personal injury plaintiffs. The need to coordinate among the various types of cases cannot be overstated. Rulings in one case may impact all the other types of cases. Discovery in one may become quickly available in all, despite “protective orders,” because of competing jurisdictions. Depositions taken in one kind of matter may be used in another.

An effective virtual law firm can address many of these issues. A client pursuing this strategy must put together a team that covers each of the major needs, brings talent to each of the essential areas, and can – as a whole – expand and contract to meet the size and scope of the litigation over time. But there is more to a working VLF than selecting the team. The process involves clear communication of needs and expectations. It requires the set-up of appropriate communication tools, from regular meetings and calls, to a secure website database each firm can contribute to and access.

Many clients will appoint one firm as the captain of the team, the steward of the VLF, with responsibility to help in-house counsel make the system work. Attractive candidates for this role will have served as national counsel, co-national counsel, and regional counsel in prior significant litigation. Even if the steward firm will not be handling all phases of the litigation, that they have experience in all phases, or many, is a plus. Clients should seek a firm (all other things being equal) with a reputation for setting the tone for amicable and advantageous relationships in these arrangements.

Managing a VLF can be more daunting than hiring a single firm.  The coordination and communication aspects are constant challenges.  It may be inevitable that some "sharp elbows" appear.  But several companies in the industry have made this model work for them in recent years.

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The Pharmaceutical Research and Manufacturers of America (PhRMA) has just adopted measures to enhance the PhRMA Code dealing with Interactions with Healthcare Professionals. (PhRMA represents research-based pharmaceutical and biotechnology companies.) Attacks on the marketing practices of drug makers is a common feature in pharmaceutical mass torts, including criticisms of the relationships between healthcare providers and pharmaceutical companies.

Informative professional relationships between healthcare providers and pharmaceutical research companies are instrumental to effective patient care. While plaintiffs frequently malign interactions between the companies and prescribers, doctors appropriately rely on information about new medicines in order to enhance the quality of care they give patients. Providing doctors with up-to-date information on the medicines they prescribe improves patient care. Thus, reasons for interaction include:

• inform healthcare professionals about the benefits and risks of products to help advance appropriate patient use,
• provide scientific and educational information,
• support medical research and education, and
• obtain feedback and advice about our products through consultation with medical experts.

The new code will take effect in January, 2009. The code is voluntary, reflecting the fact that different companies may approach the issues differently, all well within the range of choices available to a reasonable manufacturer in a competitive environment.

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A federal district court has thrown out a jury award of more than $27 million in punitive damages awarded to a Little Rock, Ark. woman who developed breast cancer allegedly as a result of taking hormone replacement therapy. In re: Prempro Products Liability Litig. (Scroggin v. Wyeth, et. al.), MDL No. 1507-WRW, 4:04CV01169.  Plaintiff Donna Scroggin developed breast cancer and had a double mastectomy, and blamed the hormone drugs she allegedly took for 11 years to combat menopausal symptoms. Defendants noted their products have carried a label warning of a heightened risk of breast cancer at all relevant times. In February, a federal jury returned a verdict in favor of Scroggin in her lawsuit against drug makers Wyeth and Upjohn, awarding her $2.75 million in compensatory damages and $27 million in punitive damages.

In an opinion July 8th on post-trial motions, Judge Wilson, of the E.D. of Arkansas, threw out the punitive damages award, finding he should not have permitted certain key testimony from a former Food and Drug Administration official, Dr. Suzanne Parisian. She had testified as the plaintiff's regulatory expert. The Court concluded, as defendants had asserted, that Dr. Parisian testified to a bottom line conclusion without sufficient explanation, failed to provide expert analysis, testified beyond limitations established by pretrial orders, testified in areas beyond her expertise, and invaded areas that required no expert testimony. Specifically, the expert failed to provide convincing testimony that Wyeth's actions had violated FDA regulations in any way that would warrant a punitive award.

In a part of the ruling particularly useful for readers of MassTortDefense, the judge said the expert did little more than read select portions of exhibits without providing further comment. Contrary to plaintiff’s position during the Daubert hearing, and during the punitive damages stage, Dr. Parisian, generally, did not give the jury the tools they need to look at those documents, or to understand them in the context of a regulatory background -- she simply read the documents to the jury. He hadn’t admitted such “so that [the expert] could simply engage in recitation of those exhibits; jurors are capable of reading documents.” Ironically, on cross-examination, Dr. Parisian, on at least one occasion, took the position that the document “speaks for itself.”

If an expert does nothing more than read exhibits, is there really any point in her testifying as an expert? The Court said “no.” As was seen during the punitive damages stage, the use of the “regulatory expert” to deal with large volumes of conduct documents is subject to abuse. MassTortDefense has seen this same technique in asbestos, in tobacco, in other pharma cases. The expert here did not explain the documents, provide summaries, or tie them in to her proposed regulatory testimony. Dr. Parisian did not provide analysis or expertise. Instead, improperly, she was a mere document delivery device.

The promised expert testimony simply was not delivered, said the Court, “so I should have struck this testimony at the time.”  Without Parisian's testimony, plaintiff had not presented sufficient other evidence to meet the clear and convincing standard required for punitive damages. The Court said plaintiff tried to present evidence of what, out of context and at first blush, might be considered questionable practices (e.g., alleged ghostwriting, countering negative press, etc.), but all this fell far short of establishing a submissible jury issue on punitives.

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On July 11, 2008, the mass tort judge handling hormone replacement cases in New Jersey granted summary judgment dismissing Bailey v. Wyeth, No. L-999-06 MT (N.J. Super.), ruling that the labels used by defendants Wyeth and Upjohn were adequate as a matter of law. The failure to warn claims were dismissed because the plaintiffs could not overcome the presumption of adequacy of FDA-approved labels created by the New Jersey Products Liability Act (NJ PLA). The claims for fraud, negligent misrepresentation, and consumer fraud likewise failed because they are subsumed by the NJ PLA and could not be asserted as independent causes of action.

Because our firm is involved in HRT litigation, and because of past and current client relationships, MassTortDefense policy is to not offer extensive commentary on such decisions.  Here, however, for interested readers is the actual opinion.

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On July 11, 2008, the mass tort judge handling hormone replacement cases in New Jersey granted summary judgment dismissing Bailey v. Wyeth, No. L-999-06 MT (N.J. Super.), ruling that the labels used by defendants Wyeth and Upjohn were adequate as a matter of law. The failure to warn claims were dismissed because the plaintiffs could not overcome the presumption of adequacy of FDA-approved labels created by the New Jersey Products Liability Act (NJ PLA). The claims for fraud, negligent misrepresentation, and consumer fraud likewise failed because they are subsumed by the NJ PLA and could not be asserted as independent causes of action.

Because our firm is involved in HRT litigation, and because of past and current client relationships, MassTortDefense policy is to not offer extensive commentary on such decisions.  Here, however, for interested readers is the actual opinion.

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Two recent decisions illustrate 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.  However, Canada appears not to be mimicking the trend against personal injury class actions in the U.S.

Background

Quebec was the first Canadian province to enact class action procedures in 1978, and a 2003 amendment to the Quebec Code of Civil Procedure simplified the class “authorization” process. In practice, the amendment may have made it easier for plaintiffs to obtain certification. The requirements are that the claims of the members raise identical, similar or related questions of law or fact (true commonality not required); the facts alleged seem to justify the conclusions sought; the composition of the group makes joinder difficult or impracticable; and the member to whom the court intends to ascribe the status of representative is in a position to represent the members adequately. Not a daunting challenge in some fact patterns.  Notice the absence of predominance, superiority, and manageability as explicit factors.

In Ontario, class action procedures were developed much more recently, dating back only to 1992. They permit certification when there is an identifiable class of two or more persons that would be represented by the representative plaintiff or defendant; the claims or defenses of the class members raise common issues; a class proceeding would be the preferable procedure for the resolution of the common issues; and there is a representative plaintiff who would fairly and adequately represent the interests of the class, has produced a plan for the proceeding that sets out a workable method of advancing the proceeding on behalf of the class and of notifying class members of the proceeding, and does not have an interest in conflict with the interests of other class members.

Wyeth

First, in the latest ruling in the HRT litigation against Wyeth, the Supreme Court of British Columbia refused to dismiss a putative class action in which plaintiffs in Canada allege that Premarin and Premplus therapy treatments caused breast cancer. Stanway v. Wyeth Canada Inc., 2008 BCSC 847 (June 27, 2008). The company denies the claims alleged in the litigation, insisting the products have carried an adequate label warning of a heightened risk of breast cancer, based on state of the art. Indeed, HRT drugs are still approved by the FDA as safe and effective and remain on the market.

The Canadian plaintiffs asserted two causes of action against the defendants. The first is for negligence, and the second is a statutory cause of action for deceptive acts and practices under the province's Business Practices and Consumer Protection Act. Wyeth’s motion asserted that the court lacked “territorial competence” over the U.S. entities of the company pursuant to the Court Jurisdiction and Proceedings Transfer Act, S.B.C. 2003, c. 28 (the “CJPTA”).

The U.S. Wyeth entities offered the position that there is no real and substantial connection between British Columbia and the facts upon which the proceeding against the U.S. defendants is based. Wyeth presented affidavits showing that the executives and staff of the U.S. defendants have not managed and do not manage North America as a single market. They have not interfered and do not interfere with the Canadian market. The U.S. defendants do not play a controlling or decision-making role in the pharmaceutical operations of the Canadian defendants. Individuals within Wyeth Canada reported directly or indirectly to the president of Wyeth Canada, not to anyone at Wyeth Pharmaceuticals. Employees of Wyeth Canada may have liaised with counterparts at Wyeth Pharmaceuticals but did not answer to them. Wyeth Canada owns the Canadian patents and trademarks for Premarin, holds various approvals for Premarin from Health Canada.

Moreover, Wyeth Canada runs its own marketing campaign and designs its own packaging, independently from U.S. Wyeth. The U.S. defendants do not conduct any sales or promotional activity related to Premarin or Premplus in Canada. Wyeth Canada runs its own marketing campaigns and designs its own packaging. Wyeth Canada generates its own promotional literature and a copy review committee of Wyeth Canada signs off. Warnings and other information are the responsibility of Wyeth Canada. It has its own independent training group and there is no functional reporting relationship between Wyeth Canada and Wyeth. Wyeth Canada’s marketing employees meet with their worldwide counterparts to exchange ideas and practices. Wyeth Canada tracks sales and decides whether or not to market a particular product.

The only Premarin tablets sold in Canada during the period the plaintiff says that she was prescribed the product would have been manufactured in Canada. At no time have any packages of Premarin or Premplus sold in Canada identified any association with U.S. Wyeth.

The plaintiff’s allegation was that Premarin and Premplus were introduced into and maintained within the Canadian stream of commerce. She alleged that the defendants are jointly involved with or responsible for the negligent manufacturing, testing, marketing, labeling, distribution, promotion and sale of Premarin and Premplus to consumers in British Columbia, and that they failed to warn her about the dangers of taking these drugs.

The Court noted that the plaintiff must prove circumstances that constitute a real and substantial connection between British Columbia and the facts on which a proceeding is based. The statute gives a non-exhaustive list of relevant factors, including whether the tort was committed in British Columbia, and whether the claim concerns a business carried on in British Columbia.

Despite the powerful showing by Wyeth, the Court concluded that the plaintiff successfully established a link between British Columbia and the tort allegedly committed by the U.S. defendants under the CJPTA. The Court concluded that there is no dispute that the plaintiff alleges that she suffered damage in British Columbia. It is in the interest of the forum to protect the legal rights of its residents, and to allow injured plaintiffs "generous access" to litigation. The defendants engaged in “harmonization” and “coordination” of matters involving core monograph and labeling requirements, the efficacy of the products, and the collecting and sharing of other clinical research or trial information, said the Court.  Wyeth Pharmaceuticals’ role as a central repository and coordinator for adverse event reporting for all the Wyeth affiliates worldwide demonstrated, the Court concluded, a sufficient involvement of the U.S. defendants in promoting the efficacy of the drug and its safety.

Lilly
In the second recent decision, involving Eli Lilly and its Zyprexa schizophrenia drug, an Ontario appeal court affirmed the lower court's decision that class action plaintiffs may proceed with an attempt to recover damages tied to company sales rather than individual damages. Andrea Heward vs. Eli Lilly & Co., No. 181/07, Ontario Superior Court of Justice, Divisional Court (Toronto) (July 2, 2008).

Plaintiffs accused Lilly of failing to warn that Zyprexa may allegedly cause diabetes and other disorders. Zyprexa is approved by the FDA and Canadian regulators to treat schizophrenia and bipolar disorder. The proposed national class (excluding British Columbia and Quebec) has an estimated 575,000 members. In addition to claims sounding in negligence, plaintiffs allege a so-called “waiver of tort” theory that resembles an unjust enrichment theory seeking disgorgement of profits and/or a constructive trust of the proceeds of the defendants’ sale of the drug. The interlocutory appeal was confined to the issues whether the motion court had erred in concluding that the damages (accounting, disgorgement, constructive trust) was a common issue, and whether the class proceeding is the preferable procedure to resolve the claim of waiver of tort.

Defendants asserted that the amount of damages would implicate individual issues because all class members would not have taken Zyprexa even if they had been warned as plaintiffs asserted they should have been, and plaintiffs could not show that Health Canada would not have approved Zyprexa for sale if the warnings had been different. Indeed, Zyprexa continued to be used for years after the label was amended to change the language about diabetes risks.

 
The Superior Court noted that “waiver of tort” is confusing nomenclature. It does not refer to waiving a right to sue, but an election to base a claim in restitution. The Court acknowledged the debate over whether the waiver of tort theory constitutes an independent cause of action or a remedy in Ontario. It is an “uncertain area of law” raising “policy concerns” which “require clarification in our jurisprudence.”

However, the Court concluded that the embryonic nature of the waiver of tort doctrine simply meant that no decisions should be made absent a full evidentiary record. The class action procedures provide options for the common issues phase to create subclasses, and craft the boundaries of the remedy of disgorgement to fit the requisite causal link, and even decertify common issues when necessary. The Court concluded that individual issues that factor into the determination of the quantum of the restitutionary disgorgement or constructive trust would not undermine the applicability of waiver of tort on a class-wide basis. This seems to confuse two issues: individual issues on quantum of damage might not alone defeat certification, but that does not make them common questions, which was the issue on appeal.

 
Regarding the second issue, the Court concluded that even if the amount of relief based in waiver of tort cannot be assessed in aggregate, a class action remains the preferable procedure for this claim. In potentially troubling language for defendants, the Court noted that “the only necessary evidence with respect to waiver of tort may well be simply the wrongful conduct of the defendants.” While conditional, such an interpretation of this type of claim may affect future certification decisions and stands to make future defendants liable for truly enormous amounts of damages unless clarified.

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Just when you thought it was safe to head outside to your Fourth of July picnic, parade, and swim party, an investigation by the Environmental Working Group (EWG) is released alleging that nearly 1,000 brand-name sunscreen products either fail to adequately protect consumers or contain chemicals that may pose health hazards.

Before we all cancel our plans, note the EWG study is based on non-standard methods and data, as well as subjective judgments, admittedly “customized” safety and effectiveness ratings, and “on a unique, in-house compilation” of industry, government and academic data sources. For what its worth, the study concludes that only 15% of products analyzed met EWG's subjective criteria for safety and effectiveness, blocking both UVA and UVB radiation, remaining stable in sunlight, and containing few if any ingredients with “suspected” health hazards.  It thus ignores a fairly extensive, long-standing body of scientific data, as sunscreen products have been thoroughly studied and tested, and used safely for more than 30 years.

Interestingly, the study asserts that many sunscreens contain nano-scale ingredients that raise "concerns.”  (MassTortDefense has posted on nano-technology here.) EWG asserts that powder and spray sunscreens with nano-scale ingredients raise concerns, since the small particles might be absorbed through the lungs. EWG also asserts that some sunscreens absorb into the blood and thus also raise safety concerns. “Some release skin-damaging free radicals in sunlight, some could disrupt hormone systems, several are strongly linked to allergic reactions, and others may build up in the body or the environment.”

EWG complains that the FDA has not established rigorous safety standards for sunscreen ingredients that fully examines these effects. The activist group also asserts that FDA has approved just 17 sunscreen chemicals for use in the U.S., while at least 29 are approved for use in the E.U.

However, there are currently FDA safety and effectiveness regulations that govern the manufacture and marketing of all sunscreen products. Sunscreens are classified as drugs by the FDA, and the agency requires significant safety and efficacy data on every active ingredient before it is approved for use in a sunscreen product. The agency also has broad authority to inspect manufacturers, require adherence to strict manufacturing practices, and enforce rigorous, science-based regulations to ensure that sunscreen products are safe and effective for consumers.

Moreover, the FDA in 2007 did propose a new regulation that would set standards for formulating, testing and labeling over-the-counter sunscreen products with ultraviolet A (UVA) and ultraviolet B (UVB) protection. The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

The finalization of the sunscreen safety standards is a complicated regulatory undertaking, addressing complex scientific principles involving countless submissions of data. FDA must thoroughly evaluate all of this information in making the best possible regulatory and scientific decision for consumers.

In the proposed regulations, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning would say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." While the warning is intended to increase awareness that sunscreens are one part of a sun protection program, it seems likely that most adults today understand that exposure to the sun may cause skin damage, up to and including skin cancer. Skin cancer is the most common form of cancer in the United States.The American Cancer Society has long designated May as Skin Cancer Awareness Month.

Many manufacturers provide significant science and risk information on websites, as well as links to organizations such as the American Cancer Society, the American Skin Association,  the Skin Cancer Foundation, and the National Cancer Institute.

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In this week’s New England Journal of Medicine, 359 NEJM 88 (July 3, 2008), the FDA responds in a letter to harsh criticism published in the Journal earlier this year on the issue of medical device approval. Dr. Daniel Schultz expresses concern “about several statements” in the earlier article that “may have misled readers.”  Readers of MassTortDefense know that significant product liability litigation has arisen over recalled medical devices in recent years.

In the earlier “Perspective,” Dr. William H. Maisel criticized the FDA’s decision to approve a device (an implantable cardioverter–defibrillator (ICD) lead) in 2004. See Maisel WH., “Semper fidelis -- consumer protection for patients with implanted medical devices,” 358 NEJM 985 (2008). Dr. Maisel is apparently a consultant for the FDA and a member of the Medicare Coverage Advisory Committee.

Obviously, no complex device can be 100% free of design, manufacturing, and performance flaws. Malfunctions inevitably occur, and manufacturers should be rewarded, not criticized, for identifying and correcting any problems. The demands placed on ICD leads, in particular, are intense: they must withstand hundreds of millions of repetitive cardiac cycles, survive in the hostile environment of the human body, and allow delivery of high-voltage energy at a moment's notice. A recent editorial in the Wall Street Journal opined that "the real danger to public health is the overreaction to medical risk," noting that some patients refuse to have a device implanted because of concern about potential malfunctions.

 
Maisel argued, however, that the agency is failing to fulfill its mission of helping the public get the accurate, science-based information they need. Essential consumer protections are currently lacking, allegedly. He argued it was “increasingly apparent” that improvement will require Congressional action.

Specifically, Maisel criticized the FDA for approving changes in the device/lead on the basis of bench testing rather than clinical data. However, FDA regulations allow manufacturers to apply for marketing of a modified device on the basis of bench testing, and many devices are approved in this way. This is not an inherently unsafe approach, Dr. Schultz noted. In evaluating an application involving a modified device, the FDA will analyze the proposed modification, determine the potential types of failure, and tailor testing requirements accordingly. In many cases, agency questions are best answered by performing appropriate engineering analyses, but in other cases, FDA may also require clinical data.  To require that these modified devices undergo clinical trials across the board as a condition of FDA approval would limit the availability of improved products. Also, most of these trials would, in any event, have insufficient power to detect small but clinically meaningful differences in performance.

 
Maisel also criticized some device manufacturers for continuing to market existing models while modified models await FDA approval. But there is nothing inherently wrong with doing so unless the older models pose undue health risks.

 

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In our last post, MassTortDefense began a discussion of the need for and process of evaluating mass torts in a merger or acquisition context. An important aspect of evaluating the possible acquisition of a target company is the potential litigation liability that may be acquired simultaneously. Even in the absence of an actual merger or stock acquisition, it may be that a buyer of corporate assets will still face exposure to product litigation liability risks.

Mass Tort Due Diligence: Goals and Methodology

The due diligence analysis to help answer the question “What am I buying into?” may involve actual data and dollars. But, requiring as it does judgments about the future litigation environment, it may not result in a precise numerical risk estimate. Thus, the buyer will ultimately make a business judgment about the range of risks that are acceptable in light of numerous factors, including assets available to cover the risks (such as insurance and indemnifications), and the financial benefits of the deal.

Experience has shown the optimal approach to the mass tort due diligence inquiry is to approach the risk question from numerous distinct perspectives, and then combine the learning from the approaches to help minimize the impact of gaps in knowledge. This allows extrapolations to be made with greater confidence. (Such due diligence is best conducted by counsel with experience in the mass tort arena and the ability to apply an understanding of the forces driving product liability claims. )


Due Diligence Approaches: Claims History

If the target company has been involved in the litigation, the current claims status, the past claims history, and the trends that may be emerging will be analyzed. Together, the claims picture will be a useful, albeit imperfect, predictor of future litigation risks. New waves of plaintiffs, new scientific studies, and new revelations from internal documents are not unusual features that can morph mass tort litigation and impact the number of claims.

The due diligence process may include the number of claims filed and the current status of all filed cases. It may be important to know the types of cases, the injuries alleged, the occupations of plaintiffs, exposure scenarios alleged, and the dates of exposure to the product. In some instances, the legal theories involved may be important, as well as the status of any case aggregations. The jurisdictions in which the claims are filed can have a significant impact on claim value. The due diligence inquiry may also explore the identity of the plaintiff firms involved.

The process will almost certainly explore those cases resolved already, and the facts that have been important to settlements, motions practice, and verdicts, favorable or not. The target should provide detailed information on all settlement terms. The due diligence review should not overlook other claims costs to the target, including attorney fees and disbursements for experts. Any changing patterns in the claims or dollars should be explored as well.

There are numerous sources that may be consulted for the claims information, beyond information from the seller’s deal counsel. These include SEC filings, annual reports, press releases, court dockets, and published case reports. Another useful set of resources may include the in-house counsel managing the litigation, the outside defense attorney of the target, and the seller’s insurance company.

The Product Dimension: Usage and Sales History

A complementary approach is to gain an understanding of the product involved, its uses, marketing, and warnings; the nature of the alleged defects; and the regulatory environment governing such products. Product usage and sales can help form an estimate of the population from which actual claimants may arise. This approach might include a historical dimension, if the product changed at any point in design or in its warnings. The useful life of the product can help determine whether the hazards are confined to a certain time frame or may extend beyond sales dates. An underrated factor is how easy it would be for plaintiffs to identify the target’s brand as the actual brand they used. Due diligence may want to examine the sales records that would allow plaintiffs to identify the acquisition target as the relevant manufacturer.

The chain of distribution may be traced to analyze the consumers the target sold to, and thus the potential plaintiffs. For example, the customers may be part of an older population which is diminishing actuarially. Similarly, it may be provident to assess how claimants could have been exposed to the product, with an eye to the credibility of alleged exposure scenarios. Beyond end users, other potential plaintiffs may be involved, including installers, repairers, and bystanders.

While plaintiffs’ lawyers are often unencumbered by such products facts when they sue, the number of units sold, over what time period, and used by which consumers in what ways, may still be instructive of future risk.

The Medicine and Science of Potential Claims

The third recommended approach begins with the proposition that the science of plaintiffs’ claims can dramatically impact the litigation in either direction. For example, even if a company has stopped selling a product, if the latency period is 30 years, the company can theoretically see claims for three decades after stopping sales. Another science issue may be “general causation,” the ability of the product to cause the type of injury alleged. There may also be a need to assess “specific causation” in the litigation. That is, even if a product is capable of causing a disease, it does not necessarily mean that all product users with the disease got it from the product.

These medical and scientific issues associated with a product’s hazards can impact the size of the potential universe of claimants, the causation issue, and even the availability of additional, novel claims against the target company, such as medical monitoring.

The Rest of the Story: Assets

The due diligence inquiry may also include an investigation of the assets available to respond to possible litigation costs, including defense costs. This may involve contractual indemnification, or possible contribution or indemnification claims available as a matter of statutory or common law against others in the product’s chain of distribution. It may include a review of insurance and the status of any coverage litigation.

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For today’s post, MassTortDefense takes a step away from our usual fare of recent decisions and current events to discuss a broader topic: evaluating mass torts in a merger or acquisition context.

Acquiring Litigation Liability and Structural Considerations

An important aspect of evaluating the possible acquisition of a target company is the potential litigation liability that may be acquired simultaneously. If a target company is involved, or could potentially become involved, in mass tort litigation, it presents both risk and opportunity to the acquirer. The threat of this type of litigation may result in the opportunity to acquire a target at a below-market valuation multiple, and the uncertainty caused by mass tort exposure can result in valuation discounts that make the attendant risk acceptable. There are potentially significant risks, however, associated with mass tort litigation exposure, and thus buyers must proceed carefully. In the private equity context, in particular, mass tort litigation exposure can adversely impact the ability to secure third-party debt financing and can have an adverse impact on investment exit. Private equity purchasers may have shorter investment time frames than strategic buyers, and mass tort litigation often takes a substantial amount of time to resolve itself.

The general rule of law, and the typical structure of an asset purchase agreement, is that an acquirer of the assets of another corporation for cash does not acquire the liability for prior injuries caused by products sold by the target company prior to closing. Even when the parties purport to allocate such liability to the target, however, the buyer may find itself responsible for the litigation through the operation of various legal doctrines that are exceptions to the general rule.

The Restatement (Third) of Product Liability Law notes that a business entity that acquires assets of a predecessor business entity is subject to liability for harm caused by a defective product sold by the predecessor if the acquisition results from a fraudulent conveyance to escape liability for the liabilities of the predecessor, or results in the successor becoming a mere continuation of the predecessor. A few states also add the so-called “product line” exception, which allows a plaintiff to recover for injuries caused by a defective product sold by the predecessor in cases in which the successor corporation has continued the predecessor’s product line.

Thus, even in the absence of an actual merger or stock acquisition, it may be that a buyer of corporate assets will still face exposure to product litigation liability risks. Attempting to structure the deal to try to minimize the possible application of such theories will often be the first line of defense. In an asset sale, the buyer may also want to seek a provision that the seller shall not dissolve for some set period of time, so that the mass tort plaintiffs’ remedies seemingly are not destroyed. Special indemnification by the seller for the underlying exposure is another alternative. This indemnification should survive for a sufficient period of time, and ideally would not be subject to a special cap higher than is typical for representations made by a “clean” company. The use of a special escrow to set aside funds for the litigation indemnification may be important.

When the target company is involved in mass tort litigation, the successor liability risks to the buyer must be examined even more carefully. Buyers must recognize that the successor liability determination may be made by a state court confronting thousands of tort suits and applying the law of the home state of the plaintiff who, absent a finding of successor liability, may be without an adequate remedy. It may not be possible for a buyer to negotiate indemnification that lasts long enough, or is backed by a large enough escrow to eliminate material risks. Thus, it may be a mistake to rely too readily on contractual safeguards without a clear understanding of the future litigation risks.

Mass Tort Risks
A mass tort’s numerous claims pose incredible financial risks, as evidenced by the bankruptcies of large, otherwise prosperous entities because of such litigation. A simple snapshot of any current litigation may understate the potential number of claims, especially if there is a long latency period—the time between exposure to the product at issue and manifestation of the disease allegedly caused by the product. Aggregation of many claims in one procedure, such as a class action, may create an all-or-nothing risk for defendants, compelling what some courts term “blackmail settlements.” Even if the risks of being found liable as a successor seem small, the magnitude of the possible harm generated by the mass tort dictates that the due diligence process carefully evaluate the potential liability.

Mass Tort Due Diligence: Goals and Methodology

The due diligence analysis to help answer the question “What am I buying into?” may involve actual data and dollars. But, requiring as it does judgments about the future litigation environment, it may not result in a precise numerical risk estimate. Thus, the buyer will ultimately make a business judgment about the range of risks that are acceptable in light of numerous factors, including assets available to cover the risks (such as insurance and indemnifications), and the financial benefits of the deal.

Experience has shown the optimal approach to the mass tort due diligence inquiry is to approach the risk question from numerous distinct perspectives, and then combine the learning from the approaches to help minimize the impact of gaps in knowledge. This allows extrapolations to be made with greater confidence.

In the next post, MassTortDefense will describe three such perspectives that can offer insight.

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A Cardiovascular and Renal Drugs Advisory Committee to the FDA held a public meeting last week to discuss safety considerations in the development of ultrasound contrast agents. Briefing information from the FDA found here.

The meeting comes in the midst of litigation concerning this important type of medical product. For example, about 70 cases have been filed in more than a dozen jurisdictions alleging that gadolinium-based injectable contrast agents cause serious health problems. Plaintiffs claim that gadolinium in contrast solutions used in magnetic imaging causes Nephrogenic Systemic Fibrosis. The federal suits were consolidated in February into an MDL in the U.S. District Court for the Northern District of Ohio. IN RE: GADOLINIUM BASED CONTRAST AGENTS PRODUCTS LIABILITY LITIGATION, MDL No. 1909. The parties made science presentations to the the Court in April, 2008.

Representatives for the makers told panelists this week that the agents are not unduly unsafe and noted that many patients given the agents are already very sick. A number of physicians speaking to the panel urged further study, but said medical information gathered through use of the contrast agents outweighed their side effects. The agents give life-saving information.

Ultrasound contrast agents are "microbubble" (or "microsphere") drugs that are injected into the vascular system in order to improve the diagnostic information obtained from ultrasound-based images. The ultrasound contrast agents approved by the FDA are used in ultrasounds, such as echocardiography, and assist in the diagnosis of various conditions. The uniqueness of the physical and chemical properties of the ultrasound contrast agents, the technicalities of the ultrasound field and its rapid technical advances, combined with the unique design considerations for clinical studies of diagnostic imaging agents have all presented special challenges in the clinical development and optimal use of these agents.

The advisory committee was created to provide a public forum for review of the history of the currently marketed ultrasound contrast agents, to obtain opinions from the advisors regarding safety considerations in the development of these agents, and to begin to familiarize the committee members with the review of diagnostic imaging agents.

According to the FDA, post-marketing reports and new animal data prompted label changes for certain of these products in October, 2007. These changes included a black-box warning and contraindication for use of the products in certain patients with underlying cardiopulmonary conditions.

FDA has most recently been working with the manufacturers to develop a risk assessment and management program. In addition to physician education and enhanced oversight of clinical studies, this program consists of two studies. One is an observational study to be conducted using an administrative database in which mortality will be compared between critically ill patients who receive a contrast-enhanced echocardiogram and critically ill patients who undergo echocardiography without contrast. The second study will obtain pulmonary hemodynamic data from patients who are undergoing right heart catheterization as well as contrast-enhanced echocardiography.

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A report just released by the Center For Medical Progress At The Manhattan Institute indirectly undercuts a favorite theme of plaintiffs in pharmaceutical mass torts.

Entitled “The Truth About Drug Innovation: Thirty-Five Summary Case Histories On Private Sector Contributions To Pharmaceutical Science,” the analysis assesses -- and rejects -- the argument that most of the important scientific advances that yield new and improved medicines do not result from private sector research, but instead are the fruits of research efforts financed or conducted by public agencies, such as the National Institutes of Health. The paper also indirectly undercuts a favorite plaintiff theme that scientific research undertaken by, or funded by, private industry is biased, tainted, poor science, and not worthy of a jury’s serious consideration.

The study compiled summary case histories of thirty-five drugs and drug classes (a group of drugs used to treat a given medical condition in similar ways) identified in the scholarly literature as important and/or that were among the most prescribed in 2007. The authors’ conclusions:

• the scientific contributions of the private sector were crucial for the discovery and/or development of virtually all of the thirty-five drugs and drug classes examined in this study.
• The companies’ scientific advances included topics within the basic science of biology and disease, processes relevant for given medical conditions, the applied science of discovering compounds that treat particular conditions; and the development of compounds with improved clinical (medical) effects.

In short, almost all of the drugs and drug classes examined in this study would not have been developed—or their development would have been delayed significantly—in the absence of the scientific or technical contributions of the pharmaceutical firms.

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The Senate Committee on the Judiciary recently held a hearing entitled “Short-Change for Consumers and Short-Shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement.”

On June 11, 2008, the Committee discussed recent preemption decisions by the Supreme Court, and heard from several witnesses including consumers, academics, a representative of the United States Chamber of Commerce, and attorneys. See details here.

Committee Chair Senator Leahy (D. Vt.) took up the cry of Democrats who have suggested that the Supreme Court has narrowly interpreted the laws designed to protect Americans who rely on medical devices to keep them alive. This Supreme Court interpretation has transformed the law, he said, into one that takes away protections from people by extinguishing long-standing state law remedies which hold corporations accountable when they are aware of potential dangers but hide them from consumers. As a result, Americans are allegedly not only deprived of a remedy under state law but are offered no replacement remedy under Federal law.

Sen. Orrin Hatch’s questioning brought out the U.S. Supreme Court's decision in Riegel v. Medtronic, preempting state law claims relating to FDA approval of certain medical devices, was correctly decided. FDA approval of a device pre-marketing-approval application constitutes approval of the physical aspects of a device and its labeling, which results from a comprehensive review of the scientific and medical information relevant to the effectiveness and safety of the particular device. It also reflects FDA’s detailed resolution of tensions between aspects of the device that confer therapeutic benefits and aspects that present risks to safety.

Where the FDA has weighed the advantages and disadvantages of, and has approved, the design and labeling of a particular product, decision-makers applying state law should not be permitted to second-guess FDA’s approval, or re-weigh benefits and risks, or revise trade-offs FDA has already found acceptable, by finding the product’s design or labeling inadequate, Hatch was told.

Hatch noted that it would be difficult to characterize the Supreme Court's 8-1 decision as a ruling by an "activist" court. The court's decision was foreshadowed by prior Supreme Court and federal appeals court rulings.

The hearing was cut off before all witnesses testified live due to procedural issues in the Senate. Clearly, however, certain members of Congress are paying attention to the preemption issues.

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For those readers of MassTortDefense following the Levine v. Wyeth matter, here is the BRIEF FOR THE UNITED STATES AS AMICUS CURIAE SUPPORTING PETITIONER.

The agency, via the Solicitor General, argues that the FDA’s decision to approve a drug and its labeling reflects the agency’s expert evaluation of the health risks and benefits the product can provide; respondent’s claims are preempted because they challenge labeling that FDA approved after being informed of the relevant facts. When federal regulation is designed to strike a balance between competing risk/benefit considerations, state laws that strike a different balance are impliedly preempted because they interfere with the federal balancing. The amicus brief also notes that FDA’s labeling requirements do not qualify as a mere minimum safety standard, or floor, upon which state laws could add more stringent requirements.

The SG also addresses the Vermont Supreme Court’s conclusion that the FDA’s regulations allow drug manufacturers to easily change drug labels unilaterally. “Petitioner was not free to disregard FDA’s judgment concerning previously known risks.” Brief at 21. The “limited exception” to the general rule requiring FDA to approve any label changes requires submission of a supplemental new drug application to, albeit not prior approval by, the agency. And substantive changes may be made without prior FDA approval only to correct concerns about newly discovered risks from the use of the drug. If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval based on information that was previously available to the agency, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted.

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The Supreme Court of New Jersey has just issued its opinion in the closely watched medical monitoring case, Phyllis Sinclair v. Merck & Co. Because your faithful blogger’s firm is involved in the Vioxx litigation, MassTortDefense presents you with the opinion and, as Joe Friday said, just the facts. No commentary or editorializing.

In this products liability case the Court considered whether plaintiffs may recover the costs of medical monitoring despite their failure to allege a physical injury. This litigation arises from the use of Vioxx, a prescription drug manufactured and sold by Merck. In November 2004, plaintiffs filed a class action complaint on behalf of a proposed national class of individuals who ingested Vioxx and who allegedly may suffer from serious latent injury for which they may require medical monitoring. Plaintiffs later refined the factual allegations advanced in the complaint and alleged that as a result of the direct consumption of Vioxx, they are at enhanced risk of serious undiagnosed and unrecognized myocardial infarction, and other latent injuries. Plaintiffs sought the cost of medical testing in the form of a court-administered screening program to provide medical diagnostic tests for each member of the proposed class and follow-up with an epidemiologist.

The trial court reviewed the standards governing pleadings and motions to dismiss, as well as the
facts and holdings of several cases that addressed medical monitoring: Ayers v. Township of Jackson, 106 N.J. 557 (1987), Mauro v. Raymark Industries, Inc., 116 N.J. 126 (1989), and Theer v. Philip Carey Co., 133 N.J. 610 (1993). The trial court granted Merck’s motion and dismissed plaintiffs’ complaint. It found that the PLA limits compensation to harm as defined by N.J.S.A. 2A:58C-1b(2), and reasoned that medical monitoring has not been applied to a products liability action to which the PLA applies. Additionally, the trial court noted that the medical monitoring is an unavailable remedy under the New Jersey Consumer Fraud Act.

On appeal, the Appellate Division reversed and remanded for further proceedings. Sinclair v. Merck & Co., 389 N.J. Super. 493 (2007). The panel noted the lack of facts and expert testimony at the motion stage of the proceedings, and remanded for discovery and an evidentiary hearing. The state Supreme Court granted Merck’s petition for certification and also granted amicus curiae status to various entities.

Today’s opinion holds that the N.J. Products Liability Act, which is the sole source of remedy for plaintiffs’ defective product claim, does not include the remedy of medical monitoring when no manifest injury is alleged. This Court reads the PLA to require a physical injury. And thus medical monitoring plaintiffs cannot satisfy the definition of harm to state a product liability claim under the PLA. The Court further holds that claims for harm caused by a product are governed by the PLA irrespective of the theory underlying the claim. The heart of plaintiffs’ case is the alleged potential for harm allegedly caused by Merck’s drug. It is thus a product liability claim. Consequently, plaintiffs may not maintain a CFA claim.

Chief Justice Rabner and Justices Lavecchia, Rivera-Soto and Hoens joined in Justice Wallace’s majority opinion. Justice Long filed a separate, dissenting opinion. Justice Albin did not participate.

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The American Council on Science and Health has recently published an interesting analysis of an issue of potential importance to all MassTortDefense readers involved in the defense of significant product liability claims. See Bailey, Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest (ACSH 2008). The report can be obtained at  their site.

It is virtually impossible to litigate toxic torts or complex products liability litigation without the benefit of scientific experts. Indeed, most of today’s mass torts, whether they be in the drug or medical devices context, chemicals, or consumer products, implicate significant scientific questions on issues of product defect, warnings, specific causation, general causation, injury and damages. Novel claims such as medical monitoring turn as well on scientific issues such as risk levels, and the availability of scientific tests to early detect diseases.

Defendants in mass torts may face the reality of a gap or hole in the existing science, and confront the issue of whether to sponsor research to fill in the gaps.  Outside litigation, in the ordinary course of business, industry spends billions of dollars on research annually, generating scientific data related to their products' safety and efficacy. Within the court room, Daubert and Frye challenges to experts are a common, and important, feature of many such cases as courts seek to exercise a gate-keeping function to exclude junk science from the courtroom. In that context, as well as in cross examination of experts who are permitted to testify, the search for “bias” that may undermine the validity or credibility of opinions offered by the scientific experts is a crucial undertaking. Insulating one’s own experts from the reach of a bias attack, inoculating the finder of fact from the impact of a bias challenge, is often an important task for defense counsel.

But what is bias? And what should properly be viewed by the jury as a “connection” that fundamentally undermines a proffered expert opinion? As the new ACSH publication notes, for approximately a century, industry has been a powerful motivating force in the creation of new technology and the underwriting of scientific research. Yet, the last two decades have seen the development of a sweeping movement aimed at convincing everyone that any connection with industry taints research or the researcher, and also is aimed squarely at curtailing academic/industry (particularly biomedical) research collaborations and restricting membership on government scientific advisory boards from researchers in any way associated with industry.

Conflicts of interest activists assert that ties between researchers and industry are harming patients and consumers, undermining public trust in research, food safety and environmental regulation and boosting the costs of medicine and other products. The activists seek to demonize researchers whose work receives support from commercial sponsors, especially drug companies and the makers of synthetic chemicals used in agriculture, industry and consumer products. Significantly, it may be that the campaign to purge any experts with industry ties—no matter how slender—from advisory panels is chilling scientific debate and depriving regulators and the public of valuable insights. The problem here is that industry often hires the most qualified and experienced researchers for their advice and research acumen. Those are precisely the people who should be advising.

The paper notes that the intense focus on the alleged effects of financial conflicts of interest ignores how other conflicts can bias scientific research and advice to government agencies. People are influenced by all sorts of interests besides money. “Why should having once consulted with Pfizer or DuPont disqualify a scientist from serving on a government advisory board or writing a review article in a scientific journal, while being a lifelong member of Greenpeace does not? And if owning $10,000 in Dow stock represents a potential conflict of interest, surely $10,000 in funding from the Union of Concerned Scientists does too,” observes the ACSH report.

The paper argues that the current obsession with conflicts of interest is not merely wrong yet harmless. The activists have provoked the development of unnecessary and complex academic regulations and restrictions that are interfering with the speedy translation of scientific discoveries into effective treatments and new products and technologies. Instead of improving public health or making the environment safer and cleaner, the activities of conflict of interest activists are harming them. Researchers are abandoning universities and some are even leaving the country for settings in which academic-industry collaboration is encouraged rather than denigrated and penalized. Government agencies are being denied access to sound scientific advice, which distorts regulatory priorities, risks lives and raises costs.

That is not to say that no mistakes have been found, but private solutions including the advent of permanent online peer-review of scientific studies and the requirement by scientific journals that all clinical trials be registered go a long way to deal with such situations.

There appears to be very little evidence that alleged conflicts of interests are significantly distorting scientific research, harming consumers and patients, or misleading public policy. Most conflicts of interest activists clearly have prior strong ideological commitments against free markets and corporations. They view the conflicts of interest campaign as another tool to attack an enterprise which they already despise on other grounds. 

The paper concludes that this crusade is anti-industry ideology masquerading as a patient safety and consumer advocacy campaign.

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Wyeth filed its brief yesterday in the U.S. Supreme Court in the Levine case, the closely-watched, much-anticipated, case regarding FDA preemption. The drug at issue is the company’s anti-nausea drug, Phenergan. Levine claims that the drug's labeling should have foreclosed IV push injection of Phenergan because of the risk of injury. Wyeth has argued that the FDA's approval of the Phenergan labels/warnings preempted any such state-law claims over the product.

In October 2006, the Vermont Supreme Court upheld a $7 million judgment for Levine and ordered Wyeth to modify the drug's label to reflect the alleged risk, citing a “presumption against preemption.”

The Supreme Court granted cert in January, and in the brief, Wyeth notes that the FDCA prohibited it from modifying the drug's label in most cases without approval from the FDA. Vermont law, by contrast, imposed a tort-law requirement that Wyeth alter that labeling (to foreclose IV administration) regardless of FDA action.

In the FDCA, Congress established a drug-approval regime in which an expert scientific agency makes uniform, national judgments about the safety and effectiveness of prescription drugs by balancing therapeutic benefits against safety risks ex ante, taking into account the interests of all potential patients. Wyeth argues that FDA struck precisely that type of balance in approving IV administration of Phenergan and in determining what warnings and instructions were appropriate to manage its associated risks.

Plaintiff has until August 1 to file the reply brief.

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On May 22, 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, once in place, will 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 are never reported.

Once the Sentinel System is up and running, FDA will have the tools to query specific adverse event data in large databases, like the Medicare database and in claims data and electronic health information maintained by private and federal entities who volunteer to participate in the Sentinel System. That is, the System will be created through public-private partnerships. It will rely on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.

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 includes 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.” The report is available at here.

Such a system could also ultimately facilitate data mining and other research-related activities. Researchers have said its full effects would take years to realize, however.

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 issues, the Pharmaceutical Research and Manufacturers of America supported the FDA initiative, see here,  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. 

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The MDL

The parties in the MDL concerning the bone cancer drugs, Aredia and Zometa, have proposed 10 bellwether cases for the first round of trials. The MDL court reported last week that it had received the list of cases the plaintiffs and Novartis propose for “Wave 1-A” of the trials. The court set a status conference for May 28 to discuss the list and make further decisions for the first round of trials.

The MDL No. 1760 consists of about 285 cases alleging that the bone-cancer drugs cause osteonecrosis of the jaw, a condition involving the deterioration of the jawbone. The cases were consolidated in the U.S. District Court for the Middle District of Tennessee in April 2006. In October, 2007, the court denied certification of a class of asymptomatic persons treated with Aredia and/or Zometa, seeking medical monitoring. Plaintiffs had alleged that they were at an increased risk for developing osteonecrosis of the jaw because of their treatments with the drugs, and sought periodic dental monitoring, including dental radiographs, which they claimed would help prevent the development the disease. In re: Aredia & Zometa Products Liability Litigation, No. 3:06-MD-1760  (M.D. Tenn. October 10, 2007).

Bellwether Cases

This raises an important issue and gives MassTortDefense the opportunity to make some general observations about bellwether trials.

Particularly in non-class mass tort litigation, such as MDL’s, statewide coordinated proceedings, and large consolidations, judges often resort to use of bellwether trials. Such trials may force plaintiffs' counsel to prepare their standard trial package, and the trials may give some sense of how sound that package is. The bellwether trials may give the court a context to resolve legal questions that arise at a trial as witnesses begin to take the stand. Bellwether trials may test the expert witnesses and theories, and give both parties a sense of how much it costs to try a case to verdict. In theory, test trials are to produce valuable information that will allow the parties to assess the strength and settlement value of all the related cases. Cf. In re Bridgestone/Firestone, Inc. Tires Prods. Liab. Litig., 288 F.3d 1012, 1020 (7th Cir. 2002) (central planning model: one case, one court, one set of rules, one settlement price for all involved, suppresses information that is vital to accurate resolution), cert. denied, 537 U.S. 1105 (2003).

In order for that to occur, however, it is imperative that there be a sufficient number of cases tried, and that the cases selected be representative of the range of cases. Trying one or two cases out of a collection of hundreds, or thousands, certainly doesn't give any statistically significant information about the value of the cases. Test cases should produce a sufficient number of representative verdicts to enable the parties to determine what range of value the cases may have if resolved in the aggregate. Manual For Complex Litigation (4th) § 22.315. If the cases are randomly selected, they will reflect the full range and diversity of the claims at issue, including in terms of factual issues, choice of law, legal theories and defenses, and perhaps counsel as well.

At times, courts have permitted each side to select one-half of the test cases, a practice that will likely not offer a representative sample, but rather a mix of the “best” and “worst” cases for each side. See In re Chevron USA, Inc., 109 F.3d 1016, 1019 (5th Cir. 1997). This approach has an element of fairness, and may offer the benefit of allowing each side to test out issues that are important to its strategy, or which each party feels will be persuasive to the other side once resolved.

And while it would seem self-evident that trial of plaintiffs selected by one side only will not provide meaningful information (unless the other side manages to prevail anyway), it is not unusual for courts to allow plaintiffs to select the “test” cases, as has occurred in aspects of the Vioxx mass tort. In re Vioxx Lit., Case. No. 619 (N.J. Super. Ct., Atlantic Cty.) (ordering plaintiff to select a grouping of eight plaintiffs, with trials consisting of two or more plaintiffs). The danger is, of course, how a few early trial results can have significant unfortunate effects, decreasing rather than increasing the prospects of any early global resolution, raising to unreasonable heights the expectations of the plaintiffs' bar. That plaintiffs secure verdicts in their handful of best cases out of hundreds or thousands, which may bear no resemblance to the best few, should come as no surprise. And may not encourage rational defendants to alter their views about the merits of the bulk of cases.

Even when the court randomly selects bellwethers, or permits the defendants to select some bellwethers, plaintiffs' counsel often seek to exercise control over the process by refusing to go forward with the selected unfavorable cases, either by convincing the client to dismiss or by withdrawing as counsel. This has happened in tobacco, HRT, and Vioxx litigation, for example. Defendants should ask the court to put safeguards in place to minimize plaintiffs’ ability to undermine the selection process, and in no event should plaintiff who dismisses rather than proceed with the selected bellwether have the ability to select the next bellwether. There really ought to be a system to supply substitutes that achieves the same goals as the original selections.

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In yesterday’s post, MassTortDefense began discussion of a peer review issue commented on in this week's New England Journal of Medicine. The editorial comments on two cases in which Pfizer served discovery on the journal, seeking peer-review and other editorial documents on manuscripts concerning Pfizer's Bextra and Celebrex, which of course have been the subject of litigation. Pfizer sought peer-review documents, including the critiques prepared by reviewers for the authors. The logic is that the critiques might help reveal flaws in methodology in the research. This was seen as particularly important given significant imprimatur of the NEJM and the use of its published studies in the cases.

In the case In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation,
2008 WL 859207 (D.Mass. March 31, 2008) the court rejected the discovery, and granted the journal’s motion for a protective order. The court began by noting that the NEJM is the world's oldest and most frequently-cited medical journal. Physicians rely on information presented in the NEJM to follow medical developments and improve patient care. Manuscripts submitted for publication by the NEJM are subject to “peer review,” i.e., to screening and analysis conducted by experts in the subject matter discussed within the submitted articles. Peer reviewers are given a draft manuscript and are asked to provide a confidential, frank, honest evaluation of the manuscript's scientific validity and to provide an overall opinion with respect to a manuscript's “worthiness for publication.” Information from peer reviewers which is communicated to the authors does not reveal the identity of the peer reviewer. The NEJM informs prospective peer reviewers that it will maintain the confidentiality of their identities, unless the reviewer grants specific permission to the contrary. None of the peer reviewers for the eleven Bextra and Celebrex articles published had given the NEJM permission to disclose his or her identity.

The published articles were relevant to the MDL litigation and to plaintiffs’ allegations that Pfizer failed to act upon the results of studies described in the scientific literature, and that it was on notice from those studies of the alleged risks presented by the drugs.

 
At a hearing on the motion, Pfizer apparently narrowed the scope of its request, and withdrew its requests seeking certain documents reflecting the peer reviewer comments which were not shared with the authors, internal editorial comments or processes

Rule 26 and Rule 45 require application of a balancing test looking at whether the information can be obtained from some other source that is more convenient, less burdensome, or less expensive, the burden or expense of the proposed discovery, and its likely benefit, considering the needs of the case, the amount in controversy, the parties' resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues. Specifically here that would include the objector's interest in confidentiality and the potential injury to the free flow of information that disclosure may create. Another factor entitled, said the court, to special weight in conducting this balancing test is that the NEJM was a non-party to the MDL.

The district court concluded that the materials were relevant, but their probative value was limited. The reasoning was that plaintiffs' claims focus on what Pfizer knew, or should have known, via published articles in the scholarly literature. The peer reviewers' confidential comments don’t speak directly to that issue, the court thought. Of course, what a product seller should take from a published article does depend in great measure on the quality of the article, its methodology, is biases, its power, and other aspect peer reviewers are likely to comment upon. But the court felt that Pfizer's own experts were able to review and analyze the articles for flaws in methodology, and the peer reviewer comments contain no new data.

Peer review comments could also potentially be useful to impeach any causation experts of plaintiffs who rely on the studies, and to provide ammunition for defense causation experts. The court however, worried that this reflected a “growing problem” with the use of subpoenas to compel the giving of evidence and information by unretained experts. That seems a somewhat narrow and uniformed view of what defendants typically do when confronted with a mass tort or MDL: they retain as many of the best experts they can find.

Balancing against that probative value, the court analogized the peer review process to the level of protection offered academics engaged in pre-publication research. Because the peer review contributes to the advancement of medicine and science by helping to ensure that faulty, incomplete, or misleading results are not published, and because a journal’s ability to advance medical knowledge in this way might be impaired, resulting in adverse consequences for physicians, patient care, and for society as a whole, the Journal’s objections seemed persuasive to the court. If reviewers thought their names or reviews would be subject to disclosure in unrelated litigation, there would be “chilling effect” on the peer review process and as a result, upon the medical community. The comments are both part of scholarly research efforts as well as part of the editorial process of a print publication. The court concluded that any wholesale disclosure by the NEJM of the peer reviewer comments communicated to authors will be harmful to the NEJM's ability to fulfill both its journalistic and scholarly missions, and by extension harmful to the medical and scientific communities, and to the public interest. Thus the subpoena was quashed.

The Northern District of Illinois, similarly, declined to compel compliance with similar subpoenas served by Pfizer in the same MDL on the Journal of the American Medical Association and the Archives of Internal Medicine. In re Bextra and Celebrex, C.A. No. 08C 402 (N.D.Ill. March 14, 2008). The district court there found that the any probative value of the requested information was outweighed by the burden imposed on the journals in invading the sanctity of the peer review process. In short, it was not unreasonable to believe that compelling production of peer review documents would compromise the process.

But it raises an interesting, perhaps test-able, question whether disclosure of comments would discourage people from submitting articles to the journal, or peer reviewers from commenting on manuscripts.  Isn't a prestigious thing to be able to say "I am a peer reviewer for the NEJM"? After all, a large part of the the academic world involves defending one's scholarly work in public, in symposia, in class rooms, etc.  And scientists frequently publish comments, letters to the editor, publicly critiquing others' work. Wonder if any respected journal conduct peer review in which complete confidentiality is not promised the reviewers?

Yesterday’s editorial commented that confidential peer review is a key component of the manuscript selection process. The Journal’s stand was consistent with the views of the International Committee of Medical Journal Editors. The ICMJE is a group of about 500 general medical journal editors whose participants meet annually and has produced a number of editions of uniform requirements for manuscripts submitted to biomedical journals. See Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication.

In its Uniform Requirements, the ICMJE states that unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Reviewers have rights to confidentiality, which must be respected by the editor. Editors must not disclose information about manuscripts (including their receipt, content, status in the reviewing process, criticism by reviewers, or ultimate fate) to anyone other than the authors and reviewers. “This includes requests to use the materials for legal proceedings.”

It will be interesting to watch and see if the issue arises again in a case in which the party seeking the information -- and might it be plaintiffs under the proper facts? -- can show a higher degree of probative value.

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The new England Journal of Medicine weighed in today with an editorial on a topic that should be important for readers of MassTortDefense – peer review. Curfman, et al., Peer Review in the Balance, 358 NEJM 2276 (May 22, 2208).

The editorial weighs in on two recent decisions in the Celebrex litigation involving product liability defendant’s attempts to go beyond the veil of the published article and obtain discovery on information created in the peer review process as manuscripts were assessed. Those manuscripts related to studies of science relevant to the litigation, and the argument was advanced that commentary, discussion, and analysis of those studies by expert peer reviewers likely also contained relevant information about that pertinent science.

Legal Setting

Expert testimony is essential in virtually every mass tort or complex product liability litigation. Under the gate-keeping function of the trial judge, designed to keep junk science out of the courtroom, the Daubert opinion lists important factors to consider in admission of expert testimony, including whether the theory or technique has been subjected to peer review and publication. This factor is relevant, but not dispositive, because sometimes well-grounded but innovative theories will not yet have been published, and sometimes a topic may be of too limited interest to be published. But the Court believed that peer review increases likelihood that substantive flaws will be detected in an article, and publication places the work within the test of the marketplace of ideas. The theory is available to be scrutinized, and has been scrutinized by experts in the relevant field. In essence, submission of the method, theory, reasoning, to scrutiny of scientific community is considered component of good science.

The Daubert Court was aware from amicus briefing of another view of peer review, emphasizing that the peer review system is not a litmus test for truth, not a guarantor of scientific certainty, and does not guarantee that the particular data, research and analytical methodologies, or conclusions of the accepted papers represent the consensus opinion of the relevant community. Brief of Amici Curiae Chubin et al., Daubert, 1992 U.S. S.Ct. Briefs LEXIS 938. But the Court generally rejected this view.

There is some lower court variation in application of Daubert and Frye on peer review; some courts emphasize the mere fact of peer review, Doe v. Ortho-Clinical Diagnostics Inc., 440 F.Supp. 2d 465 (M.D.N.C. 2006)(thimerosal), with others offering a more nuanced view of peer reviewed publication serving as a validity enhancer. The presence of the limited view encourages plaintiffs to seek to get theory published somewhere to “check the box” of peer reviewed publication. The more rigorous view reads the Supreme Court as clearly intending that judges use their own evaluation of peer review and publication as a tool for exploring whether substantive flaws in an expert's methodology have been or could have been exposed. Black v. Rhone-Poulenc, Inc., 19 F.Supp.2d 592 (S.D.W.Va. 1998) (depends upon how the peer review was performed; who did it; plaintiffs failed to provide sufficient information to assess).

Now, before getting into the two recent decisions and the editorial, a brief background on peer review.

Brief History of Peer Review

Modern medical journals came into existence during the 19th century. They were originally a vehicle for personal journalism, with the models for medical editors including the crusading newspaper writer. Publication was a personal vehicle for the editor. Over time, newspapers came to resemble newspapers, with correspondents to cover medicine in different geographic and specialty areas. But in many medical journals, the editors wrote much or all of content. A second type of journal also arose, in addition to those journals that followed the newspaper model, and that was the official publications of research institutes, typically specializing in one kind of research.

In the 19th century editors often could not fill their columns. The problem was finding publishable manuscripts, not turning down original contributions. Editorial board members would help round up material for the editor to publish, rather than review and reject manuscripts. In the 20th century, the supply/demand ratio gradually reversed. The number of passable manuscripts began to increase greatly, so that choosing among good articles became an option. Between 1913 and 1925, the Journal of the American Medical Association received 1500-2000 manuscripts for consideration. And the end of World War II marked the beginning of a dramatic increase in the volume of research and the subsequent reporting of research results. So by the 1990’s, JAMA was receiving 4500 papers/year, plus 5500 letters to editor. Yet JAMA publishes about 500 articles a year. Or the NEJM, which was getting more than 4000 article submissions/year, and publishing less than 10%.

Today there are more than 10,000 medical and scientific journals, and more than 2 million scientific and medical articles published each year. Most are never cited again.

There are examples of historical scientific journals in France and England with well thought-out peer review process to select reports to be published in journals and memoirs. In 1752, the Royal Society of London, a medical society, began publishing Philosophical Transactions and established a "Committee on Papers" to review articles submitted for publication. But in the U.S., most journals were personal fiefdoms of editors. (E.g., James McKeen Cattell, who for 50 years edited (and owned) Science and other major journals at the same time. ) As noted, editors wrote much of the content; they considered themselves as expert as anyone to assess content. The only mechanism that resembled modern peer review, perhaps, was book publishers seeking outside advice regarding textbook manuscripts in technical fields.

Peer review developed in part to deal with situations in which an editor lacked the specialized knowledge to make decisions about highly technical articles. Particularly after WWII, more specialists in subject matter, in terms of technique and, especially, in medicine, and laboratory materials were needed. And when physicians began to specialize in particular fields, it also spawned a demand for specialized journals catering to that specialty.  The supply/demand ratio gradually reversed and there was a growing need to discriminate high-quality articles and turn down others in the growing volume of at least plausibly good submissions that they had to consider.

Fast Forward to Today
An example of rigorous peer review is the New England Journal of Medicine, which publishes less than 10% of the unsolicited manuscripts it receives. There is a multi-step process including an initial screen by and editor; and internal review by an associate editor; submission to at least 2 peer reviewers/referees; presentation of the article to an editorial meeting; a statistical/math review, etc. There is a step for an additional review and revision by the author.

Today, scientific and medical journal have a significant role in shaping the views and behavior of scientists, clinicians, and policy makers. Contrary to the theory that journals act as passive conduits for scientific content, studies show the impact of an article is strongly influenced by which journal published it, and authors know that. There is a potential for a few high-impact journals to shape heavily the use of scientific information. At the same time, the increasing number of biomedical journals, the advent of online publication, and the increasingly interdisciplinary nature and impact of research, are forcing journals to compete for the best research.

With that background, the current controversy in the next posting.

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The House Committee on Oversight and Government Reform held a hearing last week entitled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” Chairman Waxman’s opening statement opined that preemption was a "radical legal doctrine" being advocated by the pharmaceutical and device industries and the Food and Drug Administration (FDA). Patients allegedly injured by defective drugs and medical devices would no longer have the ability to seek compensation. “The result is that one of the most powerful incentives for safety - the threat of liability - would vanish.”  Waxman and other Democrats are of the view that FDA approval of drugs and medical devices before they are marketed “does not necessarily guarantee safety.”

Of course, the politicos' simplistic view ignores the fundamental reality that prescription products are typically unavoidably unsafe. Nothing guarantees complete safety.  They are complex products that carry risks, at least to some users. That is why the FDA weighs the risks and benefits for an indicated population, and a learned intermediary – doctor – is needed to obtain the product, someone who can balance the risks with the benefits for the particular patient.

The hearing follows on the Supreme Court decision in Riegel v. Medtronic,128 S. Ct. 999 (2008), and in anticipation of the Court’s decision in Levine v. Wyeth.

The witnesses included some leading opponents of preemption, from actor Dennis Quaid (who has a suit against Baxter), former FDA official David Kessler, and an editor from the New England Journal of Medicine (who editorializes against preemption). No one from the industry was scheduled to appear, apparently. The only two witnesses in favor of preemption were buried in later witness panels.  This led Congressman Christopher Shays (R-Conn.) to note that the hearing was more about plaintiff lawyers than public health. 

Most of the press coverage focused on Quaid (MassTortDefense liked him in “The Rookie”), who urged Congress on Wednesday to preserve patients' rights to sue drug makers for injuries, and recounted the story of his newborn twins’ medical scare – which apparently resulted from human error at the hospital and was unrelated to the safety and efficacy of Baxter's product. "I believe if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats," Quaid said.

The FDA currently and correctly believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not be second-guessed by state court juries.  But should the Supreme Court recognize the role of preemption in the Levine case, this is yet another sign that some in Congress may seek to take action to overturn any ruling in favor of the doctrine.

 

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Although coming as no big surprise, it is good to note that the 3d Circuit refused to revisit its recent decision that federal law preempts claims against antidepressant manufacturers for failing to warn of suicide-related risks (Colacicco v. Apotex Inc., 3d Cir., No. 06-3107, 5/5/08).

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 EDPA found preemption. However, the DNJ reached the opposite conclusion in a claim by plaintiff McNellis, whose father allegedly committed suicide while taking Zoloft. Both decisions were appealed, and the appeals were consolidated. 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’s clarified guidance on the issue.

Plaintiffs sought a rehearing. Only two judges on the panel, including Judge Thomas L. Ambro, who dissented from the panel’s preemption decision, would have granted the petition for rehearing en banc. (Judge Fisher also would have granted the petition for rehearing en banc.)

Many eyes turn now to Wyeth v. Levine, in the US Supreme Court, on the crucial issue of preemption. 

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Further procedural developments in the Gadolinium-based contrast agent litigation.

The New Jersey Supreme Court recently ordered all litigation in the state over gadolinium-based contrast dyes centralized as a mass tort in Middlesex County (In re: Gadolinium-Based Contrast Agents Litigation, N.J. Super. Ct., Middlesex Cnty., No. 279, 4/10/08). The cases were assigned to Judge Jamie D. Happas, who scheduled a case management conference for May 13. 

Readers of MassTortDefense are familiar with the MDL Panel. And readers probably know that some, but not all, states have “mini MDL” procedures for coordinating cases in state court systems.  More NJ procedural  info here.

This litigation involves suits by patients who allege harm from exposure to gadolinium-based contrast dyes used in medical imaging. The plaintiffs assert that they developed a medical condition called nephrogenic systemic fibrosis (NSF) or nephrogenic systemic dermopathy (NSD) as a result of having contrast agents injected into their veins during such tests as magnetic resonance imaging.

Litigation apparently was spurred when the FDA issued a health advisory Dec. 22, 2006, noting that gadolinium-based contrast agents have been associated with the development of NSF/NFD in patients with renal insufficiency. Manufacturers added a boxed warning to gadolinium-based agents in September 2007, cautioning against use of these products in patients with kidney disease.

In February, 2008, the Judicial Panel on Multidistrict Litigation consolidated federal cases in the U.S. District Court for the Northern District of Ohio. In Re: Gadolinium Contrast Dyes Products Liability Litigation, MDL No. 1909 (JPML). The Panel rejected the argument of one defendant that the cases do not share common fact issues because each defendant’s contrast agents are chemically and pharmacologically different. Other defendants supported centralization and requested that the Northern District of Ohio be designated as the transferee court. The federal cases are assigned to Judge Dan. A. Polster.  Plaintiffs' Steering Committee has a website.

Such pre-trial consolidations are not surprising, given the courts’ desire for a mechanism to efficiently administer and mange multiple cases raising at least some common issues. However, they do risk the “Field of Dreams” effect: build it and they (plaintiffs) will come. The distortion of the process and the potential impact on defendants’ due process rights is a central and often overlooked aspect to mass tort aggregation.

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In a recent posting, here, MassTortDefense examined the less than happy reaction of some members of the Arkansas Supreme Court to medical device preemption as defined by the U.S. Supreme Court. In Despain v. Bradburn, No. 07-714 2008 WL 1067202, (Ark., April 10, 2008), notions of “federalism,” the asserted importance of the common law, and the desire to compensate injured plaintiffs, compelled members of the court to decry (even as they applied) the guidance of the Supreme Court, and to call for the legislative reversal of the Riegel v. Medtronic,128 S. Ct. 999 (2008), decision.

A week later, the Texas Supreme Court decided an interesting preemption case, and relied on the rationale of Riegel to apply preemption outside the medical device area. Obviously, the government regulates the design and hazard communications of numerous other non-medical products for important safety reasons. And one of the things we love to do at MassTortDefense is point out how successful ideas in one mass tort may help in another significant product litigation as well. In Bic Pen Corp. v. Carter, 2008 WL 1765550 (Tex. Apr. 18, 2008), the Texas Supreme Court considered a case involving a disposable lighter and federal standards for child-proofing them promulgated by the CPSC.

Background

A six-year-old was severely burned when her five-year-old brother allegedly set fire to her dress with a J-26 model BIC lighter. Plaintiff claimed the injuries resulted from manufacturing and design defects in the J-26 lighter. The jury found for Carter, awarding three million dollars in actual damages and two million dollars in exemplary damages. A variety of issues were raised on appeal including spoliation and causation. But we focus here on preemption. The Court concluded that plaintiff’s manufacturing defect claim was not preempted, which simply asserted that the particular lighter involved in the case deviated “in its construction or quality” from the manufacturer’s design specifications. 2008 WL 1765550 at *6. It did not depend on standards different from what the CPSC had promulgated for child-proof lighters, and thus did not require a state court jury to set a state-law design standard that differed from the federal standard.

Design Defect

More interesting, however, is the Court’s conclusion that plaintiff’s design defect claim was preempted by federal law. The CPSC is charged with protecting the public against unreasonable risks of injuries from consumer products in the 1972 Consumer Product Safety Act. Specifically, the J-26 lighter is subject to the federal standards for child-proof lighters and must be certified as compliant by the Consumer Product Safety Commission. CPSC evaluated data regarding disposable lighters and promulgated regulations for child-proofing them. The Commission adopted regulations requiring disposable lighters to be child-resistant and setting a protocol for testing a lighter's child resistance. The regulations set forth specific requirements for compliance, and required the manufacturer to submit a description of all child-resistant features. The J-26 lighter underwent qualification testing in 1994. Bic completed the other requirements for the disposable lighter at issue in the case, and received a certificate of compliance from the CPSC.

In the Consumer Product Safety Act, Congress included both a preemption clause and a savings clause. The preemption clause states that no State “shall have any authority either to establish or to continue in effect any provision of a safety standard or regulation which prescribes any requirements as to the ... design” if it is “designed to deal with the same risk of injury” that the CPSC addressed through its regulations. 2008 WL 1765550 at *3. The savings clause, however, specifically allowed some common law tort lawsuits. The Texas Supreme Court considered the interplay between saving clauses and express preemption provisions based on the guidance of Geier v. American Honda Motor Co., 529 U.S. 861, 869-73 (2000). The combination of express preemption and savings clauses do not bar the ordinary working of conflict preemption principles. If the state law claim conflicts with federal regulations, it is still preempted. Because Carter maintained that the J-26 lighter was unreasonably dangerous under common law because more effective child-resistant lighter designs were available, the issue for preemption purposes was whether Carter's claim of a need for a higher standard of child resistance under the common law is compatible with federal regulation under the CPSA.

The opinion noted that one other trial court had rejected implied preemption in a child-proof lighter case, Colon v. BIC USA, Inc., 136 F. Supp. 2d 196 (S.D.N.Y. 2000), with the reasoning that the goal of reducing injuries to children was best served by supplementing the federal minimum standard on a case-by-case basis, according to the stricter requirements, if any, imposed by state common law. See id. at 209.

Analysis of the Regulatory Scheme

However, the Texas Court found preemption. Analyzing the CPSC scheme, the Court noted that the Commission weighed several factors, including child resistance, overall safety, the realities of manufacturing, the variability and randomness of child testing, the product's utility, and the importance of consumer acceptance. Indeed, one of the CPSC's primary objectives was to create a standard that encouraged the manufacture of child-resistant lighters and yet did not discourage adults from using them. The Commission was concerned that if adults were unable or unwilling to use child-resistant lighters, they might switch to non-child-resistant lighters or matches, which could expose children to an even greater risk. 2008 WL 1765550 at *4. The Commission, moreover, was aware that greater child resistance might be achieved but specifically rejected imposing higher standards, finding that a higher standard would reduce the utility and convenience of the product and increase costs disproportionate to the benefits.

Thus, interpreting federal regulation in this area merely as a liability floor that may be enhanced by state law, as plaintiff argued, undercut the federal regulations and the Commission's conclusion that the chosen standard “strikes a reasonable balance between improved safety for a substantial majority of young children and other potential fire victims and the potential for adverse competitive effects and manufacturing disruption.” Id. at *4. As the Commission judged, a stricter design requirement might “on its face, appear to increase safety,”  but the practical effect would be otherwise. Id.

Riegel Analysis Relevant

Although Riegel addressed an express preemption provision, the Texas court found its policy analysis applicable here, id. at *6, in part because both cases involved a balancing of factors by the regulators that ensure the product meets carefully prescribed safety standards. Significantly, the Texas Court quoted the Supreme Court’s admonition that that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation that state regulation, because it does not include the cost-benefit analysis similar to that applied by the experts at the FDA. Instead, a jury sees only the cost of a more dangerous design, and is not concerned with its benefits. Id. at *5.

Particularly where a federal agency has balanced the relevant factors and rejected the idea of more stringent standards, this case is more support for the notion that under Riegel a common-law tort claim could impose duties that conflict with the federal regulatory scheme and therefore would stand as an obstacle to the accomplishment and execution of the full purpose and objections of Congress, even outside the medical device area.

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In a previous post, MassTortDefense began analysis of the 5th Circuit's decision in Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), in which the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. The Court emphasized that the prescriber testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the proposed warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it, but it would not have changed his prescription decision. What about the heeding presumption?

Heeding Presumption 

Appellant also contended that, regardless of Dr. Sonn’s testimony, Texas law created a presumption supporting a causal link between Wyeth’s inadequate warning and her husband’s death. The Court rejected that broad argument: Texas law creates no such presumption. In general, when a manufacturer fails to give adequate warnings or instructions, a rebuttable presumption arises that the product user would have read and heeded such warnings or instructions (the “read and heed” presumption). This presumption’s effect is to shift the burden of producing evidence to the party against whom it operates. But, significantly, the Court found that neither Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries. In fact, Texas has explicitly rejected the Restatement (Second) of Torts  § 402A, Comment j’s “read-and-heed” presumption for policy reasons, and because it has been superseded by the Third Restatement  § 2. See Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 336–37 (Tex. 1998). 2008 WL 1821379 *6. [Indeed the comment 1 to Section 2 calls the prior language “unfortunate.”]

Further, the Fifth Circuit doubted that the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. The read-and heed presumption has been justified because it excuses plaintiff from the necessity of making self-serving assertions that he would have followed adequate instructions, simply to put the issue of causation in sufficient dispute to avoid summary judgment or directed verdict, and it assists plaintiffs in cases where the person injured has died and evidence of what he would have done is unavailable for that reason. In the learned-intermediary context, however, it is the prescribing physician, not plaintiff, who has to testify about his or her decision to prescribe. 2008 WL 1821379 *7.

Moreover, MassTortDefense would point out that applying the read and heed presumption to prescription product contexts confuses two very different warnings: unavoidable risk warnings, and preventable risk warnings. The latter describe risks that can be avoided by the consumer by using a product in certain manner. The former, however, associated with prescription products, can only be avoided if the consumer chooses not to use the product at all. Thus, the question becomes whether the potential benefit of the prescription product outweighs a potential risk. The choice is not between a safe, or less safe use, or unsafe use, of the product, but whether to use the product at all. With prescription products, the FDA has determined that for indicated populations, the risks do not outweigh the benefits. A good albeit older discussion of why the heeding presumption doesn't make sense in this context is found in Thomas v. Hoffman-LaRoche, 949 F.2d 806, 812-14 (5th Cir. 1992).

Further, even if the presumption applied, it arguably would not have changed the result here. It is a rebuttable presumption, and Dr. Sonn remained firm in stating that even if Ackermann’s proposed “black box” warning had been given to him, he would have considered it -- but it would not have changed his decision to prescribe Effexor. For all these reasons, the Fifth Circuit concluded that the district court properly granted summary judgment to Wyeth on appellant’s failure-to-warn and strict-liability claims because she failed to show that an inadequate warning was a producing cause of her husband’s death.

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In Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. Readers of MassTortDefense recognize that the LI doctrine is an important exception to the rule that a manufacturer must warn the end user or consumer of its product. In the case of prescription drugs and medical devices, which a patient may receive through the advice and with the permission of a prescribing physician, the duty to warn extends to this learned intermediary, who in turn uses his or her expertise, judgment, and knowledge of the specific patient, to decide not only which product the patient should receive, but which aspects of the long and detailed warning information should be emphasized with the patient.

Background of Decision

In Ackermman, plaintiff’s decedent alleged that defendant Wyeth failed adequately to warn about the drug-induced risk of suicide from its drug Effexor, and this deficiency led to her husband’s suicide. Effexor is a member of the class of drugs referred to as “selective serotonin and norepinephrine reuptake inhibitors” (“SNRI”). SNRIs are used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and social anxiety disorder. The FDA generally groups Effexor with the selective serotonin reuptake inhibitor (“SSRI”) class of antidepressants, which includes Celexa, Prozac, Paxil, and Zoloft.

Plaintiff apparently suffered from clinical depression brought on by severe business and family problems. Martin sought treatment from psychiatrist Dr. Thomas Sonn on January 4, 2002. Martin saw Dr. Sonn four times in the following eight days. During that time, Dr. Sonn changed Martin’s medication to Effexor. On January 12, Martin complained to Dr. Sonn of various side effects he attributed to Effexor, including anxiety. Martin announced he would no longer take the medication. Dr. Sonn changed Martin’s medication from Effexor to Celexa because of the apparent side effects. Plaintiff terminated his relationship with Dr. Sonn. Nevertheless, Martin continued to take Celexa for five days until January 17, 2002, when he apparently committed suicide with a revolver. At the time of his death, Martin had detectable levels of Celexa, but not Effexor, in his bloodstream. 2008 WL 1821379 *1.

Dr. Sonn testified at deposition that he believed the package insert for Effexor as it existed in January 2002 adequately warned him of the risks of suicide and that he would continue to prescribe the drug to depressed patients. Wyeth filed for summary judgment, which was granted by the district court on the basis of the learned intermediary doctrine.

The Learned Intermdiary Doctrine

The Fifth Circuit noted that under the doctrine, a patient-purchaser’s doctor stands between the patient and the manufacturer, professionally evaluating the patient’s needs, assessing the risks and benefits of available drugs, prescribing one, and supervising its use. 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 be avoided. Accordingly, 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.” Porterfield v. Ethicon, Inc., 183 F.3d 464, 467–68 (5th Cir. 1999). Under Texas law, the learned-intermediary doctrine is not an affirmative defense, but it delineates to whom a defendant owes the duty to warn. 2008 WL 1821379 *2-3.

To recover for failure to warn under this doctrine, a plaintiff typically must show that (1) the warning was defective, and (2) the failure to warn was a producing cause of the injury. In other words, under Texas law, a plaintiff who complains that a prescription drug warning is inadequate must also show that the alleged inadequacy caused her doctor to prescribe the drug for her. If the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury and the plaintiff’s recovery must be denied. And even if the physician is not aware of a risk, the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product. 2008 WL 1821379 *3.

Application To The Facts

Applying that review to the facts here, the Fifth Circuit noted that the January 2002 package insert warning mentions the risk for suicide twice, cautions that close supervision of high-risk patients should accompany initial drug therapy, and identifies the frequencies of suicidal behavior observed in patients taking Effexor. Even if not as explicit as plaintiff demanded post hoc, taken all together, the insert’s discussions of suicide establish that at least some risk of suicide exists when a patient takes Effexor.

The Court allowed the possibility that some issue of fact could be made out about whether the defendant’s characterization of the infrequent risks, was within a requisite degree of accuracy or was misleading. 2008 WL 1821379 *4.

However, the appeal could be resolved on the second prong of the analysis, namely, whether any defect in the Effexor warning was a substantial cause of Martin’s death. There must be a genuine issue of material fact whether the physician, here Dr. Sonn, would have prescribed Effexor even had the warning been “adequate” in plaintiff's terms. Here the court had to look at Dr. Sonn’s testimony about the certainty of his decision to prescribe Effexor, and alternatively, at the so-called “read-and-heed” presumption presuming that when an adequate warning is given by the manufacturer, it is heeded by the learned intermediary. 

Prescriber Testimony Key

Dr. Sonn testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the [proposed] warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it “but it would not have changed my decision to prescribe Effexor XR to Martin Ackermann to treat his depression, beginning with low-dose pills. It also would have not changed my decision to monitor and observe Martin Ackermann closely for suicide-related risks as I did… and as I did with Martin Ackermann, I would address the suicide-related risks reflected in that warning by close monitoring and observation, rather than through discussions with the patient expressly mentioning the risk of suicide or drug-triggered suicide.” 2008 WL 1821379 *5.

The Court rejected plaintiff’s argument that this was somehow contradictory testimony; his testimony was unequivocal. That he said he would have read it and heeded it did not mean anything other than he would have considered it, would have included it in his decision-making calculus. In his deposition and in his later declaration, Dr. Sonn affirmed that he would have prescribed Effexor to Martin and adhered to the treatment regimen he used regardless whether he had received the proposed stronger warning. In December 2005, he testified that he would not have warned Martin about the possibility of an increased risk of suicide primarily based on his belief that the suggestion would either plant seeds in the patient’s mind that suicide was an option or would discourage the patient from pursuing pharmacological treatment. And that, MassTortDefense readers, is a crucial notion. Any argument from the plaintiff that the prescriber was or would be legally required to pore over all the details of the warnings with a sick patient [and thus scare plaintiff into not taking the drug] is fundamentally inconsistent with the ethical duties of the physician.

Dr. Sonn was also asked to review the warning label accompanying Effexor that was in effect at the time of his deposition in December 2005, which included a “black box” warning for potential increased suicide in children and adolescents. When asked a follow-up question about a proposed similar warning for adults, Dr. Sonn reiterated his prior testimony and confirmed that it would not have changed his decision to prescribe Effexor XR to Martin Ackermann to treat his depression.

Because she construed this as a “no warnings” case, plaintiff's decedent argued that Wyeth completely sabotaged the intermediary, who, in turn, failed to warn of the risk of suicide. For this reason, she viewed Dr. Sonn’s testimony that he would have given a required warning to mean, “if Wyeth had given me a better warning, I would have warned.” This interpretation, however, is incompatible with Dr. Sonn’s testimony that his treatment protocol would not have changed and he still would have prescribed Effexor regardless of the warning given by the manufacturer.

This part of the decision is consistent with some other useful cases out there, including Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004)(Zoloft); Porter v. Eli Lilly & Co., 2008 WL 544739 (N.D. Ga. Feb. 25, 2008)(Prozac); Longs ex rel. Estate of Buchanan v. Wyeth, 536 F.Supp.2d 843 (N.D. Ohio 2008)(Redux); Allgood v. Glaxosmithkline Plc, 2008 WL 483574 (E.D. La. Feb.20, 2008)(Paxil); Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kans. 2008)(Paxil).


In our next post, MassTortDefense will switch focus to the 5th Circuit's handling of the heeding presumption.

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Much has been written about the U.S. Supreme Court decision in Riegel v. Medtronic Inc., 128 S.Ct. 999 (2008), in which the Court found preempted the design and warnings claims made by plaintiff concerning a medical device regulated by the FDA pursuant to the MDA. And MassTortDefense thought it might be interesting to also not how some lower courts are dealing with the decision.

In Despain v. Bradburn, No. 07-714, 2008 WL 1067202, (Ark., April 10, 2008), the Arkansas state supreme court revisited the attempt of plaintiff to recover damages allegedly suffered as the result of a defective hearing device. Despain alleged that the hearing device was defective because of the way it reacted to a strong magnetic field and that defendant failed to adequately warn Despain of this danger. “He does not allege that any particular part of the device should have been designed in any specific [other] manner.”

Previous Ruling

The Arkansas Court had just ruled in February that the lower court had erroneously granted summary judgment for defendant in plaintiff's state law tort suit. See 2008 WL 324356, Ark., February 07, 2008. The state supreme court expressly ruled that the Medical Device Amendments (MDA) to the federal Food, Drug and Cosmetic Act did not preempt Despain's claims. The state high court, noting a perceived presumption against preemption, asserted that the general state common-law requirements in this suit were not specifically developed “with respect to” medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements.

But Riegel

A few weeks later, the U.S. Supreme Court reached the opposite conclusion. Common law liability is premised on the existence of a legal duty, and thus a tort judgments establishes that the defendant has violated a state-law obligation. 128 S.Ct. at 1108. An award of damages can be, and is designed to be, a potent method of governing conduct and controlling policy. State law that requires a manufacturer to change a design, making the product safer but less effective than the design approved by the FDA disrupts the federal scheme, whether it be through tort judgments mandated by application of the common law or a specific state regulation. State juries, however, do not conduct an FDA-like risk-benefit analysis. A jury sees only the cost of the more dangerous design, and is not concerned with its benefits, as the patients who reaped the benefit of the existing demand are not before the court. Id. 

Rehearing
The defendant petitioned for rehearing in light of Riegel. The Arkansas high court, in an opinion by Justice Glaze, granted the petition. The earlier opinion had reasoned that the defendant had not provided evidence of any federal device-specific requirements related to the hearing device and nothing in the complaint would have required specific changes in the way the device was designed or manufactured. Those arguments had been rejected.
Chief Justice Hannah, joined by Justice Brown, concurred in the opinion granting the petition for rehearing, noting that the U.S. Supreme Court is, of course, "the court of last resort” on questions of whether United States Congressional acts preempt state law.

Now the more interesting part of the opinion…. C.J. Hannah, concurring, expressed "deep concern" with Riegel. While clearly the MDA preempts states from setting up regulatory systems that compete with the regulatory systems set up by the federal government under the MDA, the state's common law on tort is no such regulatory system. “It does not compete with the MDA,” according to the Chief Justice. He disagreed with the core premise underlying the Riegel decision that common-law tort damages constitute requirements preempted under the MDA because the award of damages may affect how medical devices are designed, manufactured, and sold. He though unfounded the “fear that changes made by medical device providers as a consequence of tort damage suits will be made based on what must be done to avoid future tort damages as opposed to increasing safety and effectiveness.” He disagreed with the Supreme Court’s belief “that the FDA is more reliable than juries in dealing with the issue of defective medical devices.”

He suggested the need for actual evidence to show that a state used its common-law tort damages as a means to set requirements for the safety and effectiveness of medical devices. “Arkansas does not use common-law tort damages as a means to set requirements for the safety and effectiveness of medical devices. Arkansas has no special tort law that applies only to medical devices. The tort law that applies to medical devices in Arkansas applies to any other causes of action in tort.”

The justice was “also compelled to express dismay at the summary abandonment of venerable principles of state common law that have been developed over many generations. By a conclusory and incomplete analysis, our law is dismissed. In the place of well-reasoned judicial decisions reaching back to the England of Blackstone, injured plaintiffs are told that instead of looking to their common law for redress they must look to a regulatory agency that has no power to grant them any redress.”

After extolling the virtues of the venerable common law, the opinion argues that preemption undermines “the MDA, which was enacted to protect the public against defective and unsafe medical devices through federal regulation.” He then deplores the “injury done to the ….principles of federalism [which] will not be so easily healed.”

The opinion concludes with a prediction that the United States Congress will step in to amend the MDA and “heal the injury caused in this case.” (Indeed, Senator Kennedy and Representative Waxman have already proposed that Congress reverse the decision. See Medical Device Safety Act of 2008.)

While the Arkansas court got the ultimate decision right, the language of the concurrence ought to be of continuing concern to product makers. MassTortDefense was once involved in a case in which a trial judge refused to grant a valid motion in limine because the preemption doctrine “boggles the mind and boils the blood.” The resistance to the notion that federal law is the supreme law of the land continues in many legal circles. Notions of “federalism” – read states’ rights-- the asserted importance of the common law, and the desire to compensate injured plaintiffs may compel many lower courts to resist the guidance of the Supreme Court, to narrow the scope of the such preemption rulings, to force defendants to fight for every application of the rule, and to look with skepticism at attempts to base preemption motions on the policies and reasoning of the Supreme Court decision.

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Today, let’s continue mining the depths of the Eight Circuit’s recent decision, In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274, 522 F.3d 836
(8th Cir. April 9, 2008). The case offers a number of potential lessons for mass tort defendants, and not just those in the medical device arena. We already made some medical monitoring observations here.

CFA Claims Abound

Today’s focus is consumer fraud act (CFA) claims. Virtually every state has some version of an unfair or deceptive trade practice act, or some form of consumer-protection oriented fraud act. Often these statutes permit a private cause of action, in addition to possible enforcement by the state attorney general. Plaintiffs in the Silzone case relied on three Minnesota statutes, the False Advertising Act (MFAA), Minn. Stat. § 325F.67, the Consumer Fraud Act (MCFA), Minn. Stat. § 325F.69, and the Deceptive Trade Practices Act, Minn. Stat. § 325D.44.

Plaintiffs have been increasingly aggressive in recent years in seeking to apply such statutes to the traditional product liability world. Expanding the potential plaintiff group from those who actually suffered disease or personal injury as a result of a product, and beyond those who claim to be at increased risk of future personal injury (medical monitoring), such CFA claims seemingly permit anyone who used or purchased a product to seek economic damages (and sometimes punitives, and sometimes attorney fees, and sometimes treble or multiple damages). Thus, we now see CFA-type claims against drug and device makers, consumer product manufacturers, and a growing list of other industries.

Moreover, the elements of the CFA claims seem, superficially, more amenable to class action treatment. In particular, the courts’ treatment of the reliance element of CFA claims has been confused at times, shallow at others, and not always helpful to the defeat of class certification. Judge Colloton goes right to the heart of this issue: “This case exemplifies the difficulty with class treatment of cases alleging fraud or misrepresentation.” Id. at 838. In a typical common law fraud claim or negligent misrepresentation claim, a plaintiff must show he or she saw or heard the fraudulent statement and reasonably relied on it. Because proof virtually always varies among plaintiffs concerning what they saw and heard and the degree to which they relied, if at all, and the reasonableness of the reliance, such fraud claims generally shouldn’t be and don’t get certified as class actions.

Lower Court Got It Wrong

However, the District Court held that proof of individual reliance is unnecessary under the Minnesota consumer protection law (which the court was applying to all plaintiffs from 17 states). This conclusion was based on Group Health Plan Inc. v. Philip Morris Inc., 621 N.W.2d 2 (Minn. 2001), which stated that the state legislature had "eliminated the requirement of pleading and proving traditional common law reliance as an element of a statutory misrepresentation claim." The absence of any need to prove reliance, said the plaintiffs, eliminated this as an individual issue. And thus the allegedly common issue of the defendant’s fraudulent conduct predominated.

Unlike common law fraud, many consumer fraud statutes do not explicitly require a showing of reliance.  For this reason, plaintiffs have repeatedly argued that manufacturers can be held liable to
an entire class of plaintiffs for an alleged misrepresentation— even if most members of the
class never saw the misrepresentation, or saw it but purchased the item for some other, unrelated
reason. Consumer fraud defendants have fought back against this line of attack, with
varying degrees of success, by arguing that causation, which is required under most consumer
fraud statutes, cannot be proven in such situations.

8th Circuit Offers Deeper Analysis

The Court of Appeals, in a more nuanced analysis here, noted that while it was not necessary for plaintiffs to plead individual consumer reliance, and need not provide direct evidence of reliance by individual consumers as part of their burden of proof, that was not the end of the analysis. Plaintiffs must – and this is true generally beyond Minnesota – prove a causal nexus between the allegedly wrongful conduct of the defendant and the plaintiff’s damages. Thus, “reliance” evidence about the relationship between the claimed damages and the alleged conduct is relevant and probative of the causation issue – even when presented by the defendant.

The 8th Circuit believed that there was a “reliance component” to the causation element, at least where as a practical matter it is not possible that the damages could be caused by the alleged violation without some kind of reliance on the statements or conduct alleged to violate the statute.

But even if plaintiffs were not required to present any direct proof of individual reliance, this would not prevent a defendant from presenting direct evidence that an individual plaintiff, or his or her physician, did not rely on any representations from the company. "Whatever Group Health means about the need for these plaintiffs to present direct evidence of individual reliance, it does not eliminate the right of a defendant to present evidence negating a plaintiff's direct or circumstantial showing of causation and reliance.”  2008 WL 942274 at *3, 522 F.3d at 840.

Why This Matters?

This is a huge issue for defendants in many kinds of class action, including but not limited to CFA claims. Too often, courts addressing certification rely on an analysis of plaintiffs’ burden of proof and the elements of their claim. Sometimes, courts will look at affirmative defenses – but often relegating such to later phases of a bifurcated proceeding to give the impression that common issues dominate the first phase. More rarely, courts conduct the full analysis we see here: in addition to plaintiffs’ burden of proof, and formal affirmative defenses, defendant has a due process right to offer relevant, probative evidence tending to negate or defeat plaintiffs’ cause of action. If that evidence raises individual issues, if the nature of that evidence will require individual discovery and particularized assessment by the finder of fact, those individual issues are just as relevant to the class certification decision as individual or common issues raised by the elements of the cause of action itself.

The defendant here planned to present evidence of non-reliance by individual plaintiffs, and thus an absence of causation, and this made it clear to the appeals court that resolving the issue of the company's liability to each plaintiff under the Minnesota consumer fraud statutes would depend on individual issues of causation and reliance. Specifically, “St. Jude has presented evidence that a number of implant patients did not receive any material representation about the heart valve.” The doctors who prescribed the valves had “learned about St. Jude’s heart valve in different ways.” One doctor heard about the valve “from a senior partner, another discovered it at a cardiology conference, and a third learned about the valve from a St. Jude sales representative and a St. Jude advertisement.” (Two of the five named plaintiffs couldn’t remember hearing anything about the valve.)  Any trial thus would require a physician-by-physician inquiry into each doctor’s sources of information about the valve. “Given the showing by St. Jude that it will present evidence concerning the reliance or non-reliance of individual physicians and patients on representations made by St. Jude, it is clear that resolution of St. Jude’s potential liability to each plaintiff under the consumer fraud statutes will be dominated by individual issues of causation and reliance.”  Id.

The court recognized that there may be certain issues that are common to all plaintiffs, such as whether certain published representations about the valve were materially false. But without even reaching the issue of choice of law and the questionable application of one state’s law to plaintiffs from 17 jurisdictions, the court found it clear that the common issues do not predominate over the individual issues that must be litigated to resolve the plaintiffs' CFA claims. Increasingly, courts are being asked to certify sweeping consumer fraud class actions based on abstract and unproven economic injuries. St. Jude provides precedent for defendants’ right to present a defense based on lack of reliance/causation, and its impact on class certification.

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The Eight Circuit’s recent decision, In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274 (8th Cir. April 9, 2008), offers a number of potential lessons for mass tort defendants, and not just those in the medical device arena. (As always at MassTortDefense, we try to cross-pollinate from industry to industry and mass tort to mass tort those theories, rulings, etc. that can potentially assist a broad range of defendants.) So many lessons, in fact, that one posting can’t do them all justice. So let’s break it down into some sub-parts and see if we can’t gain some insights.

Today’s focus is medical monitoring, which of course is near and dear to MassTortDefense ever since having tried to a defense verdict a medical monitoring class action in West Virginia a few years back.

Some Background

As readers may know, before the 8th Circuit decertified a class of an estimated 11,000 plaintiffs who received one of St. Jude Medical Inc.’s allegedly defective Silzone heart valves, the case had a bit of an up and down history. The district court originally certified two subclasses of plaintiffs seeking damages and injunctive relief, respectively. Then in In re St. Jude Med., Inc., 425 F.3d 1116 (8th Cir. 2005), the appeals court reversed the district court’s certification of a subclass of plaintiffs seeking injunctive relief, which was described as a “medical monitoring class,” because the class presented “a myriad of individual issues making class certification improper.” Id. at 1122.

With respect to the subclass seeking damages and described as a “consumer protection class,” the 8th Circuit held that the district court should have conducted a more thorough choice-of-law analysis before it determined to apply Minnesota law to the claim of every plaintiff. Id. at 1121. It remanded the case to the district court for further consideration. On remand, the district court determined that Minnesota law should apply to all claims in the nationwide class, and recertified the consumer protection class pursuant to Federal Rule of Civil Procedure 23(b)(3). In re St. Jude Medical, Inc., No. 01-1396, 2006 WL 2943154 (D. Minn. 2006). St. Jude’s appeal of this certification of the class led to the April decision we discuss here.

Medical Monitoring

Among the individual issues that would predominate over so-called common questions were several related to the "highly individualized remedy of medical monitoring.” 2008 WL 942274 at *4. Medical monitoring, generally defined, is periodic testing and/or examination to facilitate the diagnosis and treatment of a latent disease by early detection. It is not the diagnostic testing that accompanies symptoms, but rather testing of seemingly healthy, asymptomatic persons who have been exposed to a potentially harmful substance and are at risk of future disease or injury.

Medical monitoring is almost always seen as a potential class action claim, for several reasons:

• First, the individual damages associated with periodic testing of a so-far healthy plaintiff may not be all that financially attractive to plaintiff attorneys.
• Secondly, a number of the elements of the claim (or remedy) of medical monitoring seem, on the surface, amenable to “common” proof in the form of epidemiological evidence. For example, the increased risk that typically must be shown.

Plaintiffs’ attempts to certify medical monitoring classes have come under both Rule 23 (b)(2) and (b)(3). The 23(b)(2) claim typically alleges that the defendant has acted on grounds generally applicable to the class (for example, making a defective product or failing to warn of its hazards) and that injunctive relief for the class is appropriate in the form of a requirement that the defendant provide medical monitoring for the class. Claimants seeking certification under Rule 23(b)(2) often seek a court-established monitoring program, alleging it to be a claim for injunctive relief (see In re Sulzer HipProsthesis and Knee Prosthesis Liab. Litig., 455 F.Supp.2d 709 (N.D. Ohio 2006) ). Such a claim, however, may simply be an artful pleading of a simple pass-through mechanism in which claimants seek monetary damages for the payment of medical test bills for class members: essentially, a suit for damages. Thomas v FAG Bearings Corp., 846 F. Supp. 1400 ( W.D. Mo. 1994 ). The 23(b)(3) claim typically asserts that the defendant’s conduct, the significant exposure of class members, the hazardous nature of the product in question and the increased risk of future disease each class member faces, are common issues that predominate over any questions affecting only individual class members.

The 8th Circuit previously rejected certification of a medical monitoring class under Rule 23 (b)(2), saying in its 2005 opinion that whether an individual plaintiff will require additional monitoring "is an individualized inquiry depending on that patient's medical history, the condition of the patient's heart valves at the time of implantation, the patient's risk factors for heart valve complications, the patient's general health, the patient's personal choice, and other factors." Now, even if one assumed Minnesota law would apply to all the claims, the need for these detailed and individual factual inquires concerning the appropriate remedy weighed against a (b)(3) class certification as well. 2008 WL 942274 at *4-5.

This language is useful for defendants opposing (b)(2) or (b)(3) medical monitoring putative classes. While plaintiff’s proposed medical monitoring plan is typically a one-size fits all program, and hence seemingly a common issue, the court noted as a potential individual issue what the appropriate monitoring may be -- turning, as it does, on the class member’s medical history, condition, risk factors for complications, and general health. The court also noted that a class member who had been implanted with the device might already require future medical monitoring – some type of periodic follow-up medical checks – as an ordinary part of his or her follow-up care.

Whenever this is the case, plaintiffs will stumble on the typical medical monitoring element that the testing being sought would not be done as part of the ordinary standard of medical care. Often called the “over and above” element, most courts that have adopted some form of medical monitoring require that the testing that defendant is being asked to pay for is something that is needed because of the harmful exposure to the defendant’s product, and not something that plaintiff needed and would or should have gotten even in the absence of exposure to defendant’s product. Very often, whether the recipient of an implant, the taker of a prescription drug, the user of a consumer product, might or would or should have undergone the same periodic medical testing is provable, and at the least, is an individual inquiry that depends on the specific facts concerning each putative class member.

Same Notion Seen in HRT

This notion was also explored in Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla. 3d Dist. Ct. App. 2006),
review denied, 950 So.2d 413 (Fla. 2007). The Florida appellate court reversed the decision of the state trial court to certify a state-wide medical monitoring class of about 300,000 women who took Prempro. The court saw the proposed monitoring plan for the HRT class as nearly the same medical testing recommended for all post-menopausal women. A person seeking medical monitoring must show that, given her own unique medical and other exposure history, the exposure caused by the defendants significantly increased her risk and necessitated the monitoring recommended for her. The HRT schemes proposed by plaintiffs are not programs for at risk Prempro users, but for any woman who had any breast cancer risk factor, including age, family history, weight or alcohol use. As a jury issue, the over and above notion has worked well for the tobacco industry, which has been subjected to multiple putative class actions seeking medical monitoring.

Medical monitoring remains a potential threat. While the Mississippi Supreme Court rejected medical monitoring in Paz v. Brush Engineered Materials, Inc., 949 So.2d 1 (Miss. 2007), the Missouri Supreme Court recognized a medical monitoring remedy in Meyer ex rel. Coplin v. Fluor Corp., 220 S.W.3d 712 (Mo. 2007). And the American Law Institute (ALI) has released a “Council Draft” of a Restatement (Third) Torts: Economic Torts and Related Wrongs, which would recognize a “limited” form of medical monitoring claim. Clear and careful analysis like that of Judge Colloton and the 8th Circuit panel is useful in responding to the threat.

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