NJ Court Affirms Role of Learned Intermediary Doctrine

A New Jersey court overseeing the centralized litigation regarding the human tissue product AlloDerm has issued a noteworthy ruling in a bellwether case on the duty to warn. See Simineri, et al. v. LifeCell Corp., No. L-5972-11 (Super. Ct. N.J.).

Plaintiffs moved for partial summary judgment on the issue of the learned intermediary doctrine under the New Jersey Products Liability Act. The FDA regulates AlloDerm as a banked human tissue product, not as a drug or medical device, so the motion raised the issue whether the doctrine applied to this type of product. 

Under the Act, N.J.S.A. Sect. 2A:58C-4, an adequate warning must be given to the persons by whom the product is intended to be used, or in the case of prescription drugs and devices, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. Under New Jersey law, a pharmaceutical manufacturer discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities. To the extent that the pharmaceutical manufacturer is relived of the duty to warn the ultimate user, the treating physician as the learned intermediary assumes the responsibility to warn the patient of the risks involved in using the prescription product.

The court here noted that the NJ Supreme Court has established several rationales for favoring application of the learned intermediary doctrine, including: 1) the desire to avoid intrusion into the doctor-patient relationship; 2) the superior position of doctors to communicate important information about risks to their patients; 3) the inability of drug makers to communicate effectively and directly with patients; and 4) the nearly impossible task of translating complex medical information and risk factors into terms understandable to the average consumer.

Plaintiffs argued that the LID was inapplicable to AlloDerm because it was not regulated by the FDA as a prescription drug or medical device and that it was supposedly “well-established” that the LID somehow only applies to FDA-approved drugs and devices. Plaintiffs cited a variety of cases, but, said the court, none of the cases relied on actually based their application of the LID on the FDA’s classification of medical products as drugs or devices. Rather, the cases cited by plaintiffs focused on the traditional rationales underpinning the LID: that where the product is available only through the intervention of a licensed physician, any duty to warn is owed to the physician and not the patient. The cases instead stood for the proposition that prescribing physicians act as learned intermediaries between the manufacturer and consumer, and those doctors stand in the best position to evaluate the patient’s needs and assess the risks and benefits of a particular treatment. What was sufficient, and what plaintiffs seemed to ignore, was the fact that AlloDerm is regulated by the FDA. Plaintiffs were unable to explain how the particular FDA classification had any real bearing on the application of the doctrine.

The court next disagreed with plaintiff’s argument that applying the LID to the product would somehow be an expansion of the doctrine. The court believed it was simply considering the well-established rationales underlying the LID and applying them to the product.  It was significant that the product was not marketed or sold directly to patients. It can only be obtained through a licensed healthcare professional. Indeed it must be implanted into the patient by the physician. The patient is necessarily relying upon the doctor’s knowledge, skill, and services, weighing the risks and benefits before the implantation of the product.

Under these circumstances, to require the defendant “to communicate would unnecessarily intrude on the doctor-patient relationship. In a surgical context…the doctor has even more prominent role in evaluating and selecting the most appropriate course of treatment.” The surgeon, rather than the manufacturer, concluded the court, is best positioned to convey the appropriate information to the patient, who was unlikely ever to inspect the product.   A physician choosing to implant this product must consider a number of factors such as the patient’s medical history and co-morbidities, as well as the specific surgical techniques employed. The physician is in the best position with regard to this product to take into account the susceptibilities of the patient, and to give an individualized warning to the ultimate user.

Plaintiff's motion denied.  

Drug and Device Seminar Approaches

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

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


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

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

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

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

Class Certification Denied Under Ascertainability Analysis

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


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

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

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

Motion for class certification denied.

Defense Equal Access to Potential Experts Upheld in Device Case

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

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

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

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

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

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

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

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

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

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

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

House Passes FDA Reauthorization Bill

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

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

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

 

Bill Introduced to Amend Post-Market Review of Medical Devices

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

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

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

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

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

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

 

IOM Releases Controversial 510K Device Report

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

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

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

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

 

State Supreme Court Upholds Verdict For Device Maker

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

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

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

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

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

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

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

 

Upcoming Drug and Medical Device Seminar

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

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

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

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

Federal Court Dismisses Device "Consumer" Claims

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

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

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

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

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

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

 

Appeals Court Upholds Summary Judgment on Negligence Per Se Claim

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

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

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

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

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

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

Summary judgment affirmed.

Seventh Circuit Affirms Exclusion of Plaintiff Expert in Device Case

Just about a year ago, we posted about an interesting device case in which 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. Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09).

Last week  the federal appeals court affirmed the judgment for the knee implant maker.  Fuesting v. Zimmer Inc., 2010 WL 271728 (7th Cir. 1/25/10).  Fuesting had 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.

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. The expert testimony as to defect also failed.

On appeal, the Seventh Circuit stated that Dr. Rose's testimony did not show that his theory that these knee implants oxidize “in vivo” had sufficient acceptance in the scientific community.  He failed to point to any peer reviewed studies that discuss the oxidation rates of this type of implant in vivo.  Dr. Rose failed to cite any articles or studies that he or any one else conducted regarding how one can discern whether the alleged oxidation occurred before or after implantation.  Dr. Rose also did not rule out possible alternative methods of causation.  Nor did he explain how the device's oxidation caused the device to fail, as the mere presence of oxidation does not prove that the oxidation caused the device to malfunction.

Dr. Rose also failed to “bridge the analytical gap” between the accepted fact that GIA sterilization causes at least some amount of oxidation and his ultimate conclusion that Fuesting's knee implant in particular failed because GIA, rather than another sterilization method, was used. Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He concluded, in one sentence of his report, and without any support, that the industry standard was to sterilize implants in an inert gas instead of air. In fact, no manufacturer at that time employed any of  the proffered methods, and Dr. Rose cited no contemporary articles counseling the use of such methods.  For all these reasons, the district court did not abuse its discretion in excluding Dr. Rose's testimony.


 

New Paper On Reduced Legal Oversight of FDA Warning Letters

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

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

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

MDL Court Denies Class Certification in Device Litigation

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

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

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

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

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

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

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

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

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

IOM To Study 510(k) Process for Medical Devices

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

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

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

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

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

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

State Supreme Court Decision Turns On Absence Of Causation Proof

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

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

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

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

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

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

 

Medical Monitoring Decision Set For Interlocutory Appeal

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

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

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

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

Device Group Comments on FDA Draft Guidance on Risk Information

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

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

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

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

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

 

 

Senator Writes Letter To NIH About "Ghostwriting"

Plaintiffs in pharmaceutical and other biomedical litigation have frequently resorted to allegations of “ghostwriting” to attack various aspects of scientific articles that defendants seek to rely on.  “Ghostwriting” is a somewhat pejorative term used to vilify some versions of a common practice – the use of biomedical communications companies to provide professional assistance in medical research and/or writing. Plaintiffs often imply that the named author had little or nothing to do with the direction or content of the article.

Several courts have rejected such generally overblown allegations. In the HRT litigation, In re Prempro Products Liability Litigation, 554 F. Supp.2d 871 (E.D. Ark. 2008), the court noted that while plaintiff focused heavily on the evidence that Wyeth collaborated with authors to have articles written about HRT, there was no evidence that this practice is inappropriate or that Wyeth supported articles that it knew were false or misrepresented the science. Rather, the articles supported Wyeth’s position on the state of the science. Additionally, there was evidence that ghostwriting was a common practice in the industry.  Similarly, in In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, slip op. at 3-5 (M.D. Fla. Jan. 30, 2009), Judge Conway held that plaintiffs could not use the words "ghostwriting" or "plagiarism" to characterize the process by which articles were written.

A “ghostwriter” may:
– Analyze data
– Research issues, gather review data
– Organize/format materials
– Assist in writing by, e.g., drafting publications

Such third-parties can save busy scientists time and effort- by doing time-consuming preliminary tasks. Having medical communications specialists involved can make the articles easier to read, more informative The fact is, a great doctor does not mean a great writer; outside writers can expedite publication and eliminate artificial drag in the process.

Nevertheless, Senator Charles E. Grassley, an Iowa Republican, has written a letter to NIH asking for information about possible ghostwriting:
I1) What is the current NIH policy on ghostwriting with regards to NIH researchers?  2) What is the current NIH policy on ghostwriting with regards to NIH grantee institutions? 3) What is the current NIH policy on ghostwriting with regards to primary investigators of NIH grants? 4) Has NIH received any complaints about individual grantee institutions, primary investigators and/or NIH researchers regarding possible ghostwriting, and if so how has NIH handled these complaints? 5) What is the current NIH policy regarding primary investigators found to have violated medical ethics and/or have medical licenses that have been suspended or revoked?

The response, when it comes, may be significant because the N.I.H. underwrites much of the country’s medical research. Many doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could influence new publication guidelines more broadly.

In reality, typically, the named author has access to all data. The authors can reorganize the presentation of the data and edit the article. The articles are subjected to extensive peer review before publication, often in journals the author selects.  In litigation, the plaintiff’s prescriber may not have read or relied on any such articles. And doctors who prescribe are well familiar with the industry practice and custom. Plaintiff’s “ghostwriting” claims also fail to offer proof that the articles which were, in any event, peer-reviewed and medically sound, affected the FDA’s actions.

Any debate on “ghost writing” of medical publications ought to include an understanding of the realities of supply and demand for published research, of the time pressures, needs, and priorities of leading researchers, and the evidence demonstrating the author's control over final publication.

Readers of MassTortDefense interested in these issues should look at the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication;  the American Medical Writers Association's Position Statement and Code of Ethics; and the  World Association of Medical Editors' Policy Statement on Ghost-writing Initiated by Commercial Companies.

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Senate Holds Hearing On Medical Device Safety Bill

The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enacted would overturn the Supreme Court's interpretation of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act in Reigel v. Medtronic.  The Supreme Court ruled that the MDA bars state law product liability claims against medical device companies based on alleged defects in products that had received approval through FDA's stringent premarket approval (PMA) process. The PMA process is used only in class III devices—devices FDA deems to be “high risk,” like pacemakers. The devices that are marketed as PMAs represent cutting edge science and are critical to public health.
 

We have posted on this legislation before here at MassTort Defense.  In addition to ignoring the important benefits of a uniform federal standard and the chaos of allowing devices to be regulated by litigation, the bill would would stifle innovation in the medical device industry and result in lost jobs, especially at smaller device companies. Obviously the bill is favored by overzealous trial lawyers and the legislators they support.

Testifying at the hearing were a variety of supporters of the bill, including academics who argued that preemption deprives victims of their right to compensation from the wrongdoers who injured them -- without convincingly responding to the concerns that would be raised by the new regime which allow juries throughout the country not only to impose requirements that are inconsistent with FDA determination, but that differ from one state court to another. The witness panel had no representative from the device industry.

The legislation would take away primary responsibility for device safety from the FDA and put it in the hands of lay jurors who have little to no understanding to the science involved, and who will listen to plaintiff's lawyers arguing about a single alleged injury without regard to the many of patients potentially safely aided by the device. Democratic supporters argued that no matter how diligently and effectively the FDA does its job, it simply cannot "guarantee that no defective, dangerous, and deadly medical device will reach consumers." The notion that any regulatory regime can "guarantee" defect-free products is misguided.  And to think that lay juries will do a better job of balancing product risks and benefits is foolish. Risk is inherent in all medical devices, and small numbers of patient injuries does not mean a device is defective.
 

The Advanced Medical Technology Association (AdvaMed) has urged Congress to reject the legislation, noting it would increase health care costs and decrease patient access to life-saving medical technology.  As the debate is ongoing about health care reform, legislation that will create more litigation, increase health care costs, and render it harder for medical device manufacturers to invest in promising new technology, hardly seems wise.

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FDA Commissioner Outlines New Enforcement Plans

Readers of MassTortDefense know how FDA actions can instigate and affect potential mass tort litigation involving drugs and devices. Last week, in a presentation to the Food and Drug Law Institute (FDLI), new FDA Commissioner Margaret A. Hamburg revealed that the FDA will implement procedural reforms designed to allow the agency to act more quickly and aggressively on the enforcement of food, drug, and medical device regulations. The FDA commissioner told FDLI that the federal watchdog will be a leaner and meaner organization under her leadership.


In her remarks, the Commissioner noted that while impressed by the commitment to compliance that many companies have made – both in terms of their corporate culture and their investment in compliance systems -- her goal is for all companies to make and implement such a commitment in order to prevent harm to the public. A key part of the strategy to support private sector compliance is more effective enforcement against violations of the law. She suggested that such enforcement helps industry too – by maintaining a level playing field for safe products. Making sure that offenders are held legally accountable prevents companies from having to choose between doing the right thing and staying competitive.

An effective enforcement strategy depends on several key elements she said:

  • The FDA must be vigilant. Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems early. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, FDA will.
  • The FDA must be strategic, she continued. The agency must place greater emphasis on significant risks and violations, and use meaningful penalties to send a strong message to discourage future offenses.
  • The FDA must be quick. The agency must be able to respond rapidly to egregious violations or violations that jeopardize public health.

More specifically, she said the pathways for enforcement action can be too long and arduous. To address this, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, it will expect a prompt response to the findings, generally no more than fifteen working days before the FDA moves ahead with a warning letter or enforcement action.

Second, the FDA will take steps to speed the issuance of warning letters. There will be a new policy to limit warning letter review to significant legal issues.

Third, the FDA will work more closely with regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA.

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, FDA will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.

Fifth, she said, the FDA will no longer issue multiple warning letters to non-compliant firms before taking enforcement action. And, in the case of significant health concerns or egregious violations, FDA will consider immediate action – even before issuing a formal warning letter.

Finally, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, it will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. One can imagine how the obtaining or failure to obtain a close-out letter may be anissue in litigation.
 

Presidential Memo On Preemption Sends A Warning

Along with my partner Andy Gaddes, I taught a recent CLE seminar on products liability issues.  One of the topics the attendees -- in-house counsel from a variety of industries -- were most interested in was President Obama's May, 2009 memorandum to federal agencies reversing the Bush administration's well-reasoned preemption policy.
 
The new policy is contained in a memo, not a formal executive order, but it clearly expresses a new view of preemption. Cloaked somewhat ironically in the guise of "state's rights", the policy comes from an administration that apparently has no trouble expanding the role of the federal government in unprecedented ways, taking over the auto companies, banks, and others.
 
The memo provides that heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.  Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the Administration's new interpretation of the legal principles governing preemption.  Finally, heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under the new interpretation of the applicable legal principles governing preemption.
 
The legal basis of the doctrine is not really that malleable. Federal preemption is derived from the supremacy clause of the Constitution that says federal law is the supreme law of the land and any conflicting state law or regulation is without effect.  The policy basis of the doctrine is equally clear: allowing each state to set diverse and individual safety standards can undercut needed uniformity and can subject manufacturers to expensive, unfair, and confusing requirements. It forces product sellers to potentially navigate a confusing, often contradictory patchwork quilt of up to 50 sets of laws and regulations.  Of course, the preemption issue affects more than traditional administrative regulation by the states: companies may become subject to regulation by litigation at the hands of the plaintiffs' bar. 
 
The new policy has the potential to create a real chilling effect in agencies that should be clear about the preemptive intent and reach of their regulations.  While the Obama administration claims its approach breaks no new ground, it may well fundamentally weaken the federal government's ability to address problems on a national level and thus may have untended consequences by allowing states to interfere with parts of the Obama administration's domestic agenda. Regulations for health care and climate change, for example, arguably cannot work absent preemption.
 
Preemption has been applied to drugs and medical devices, vehicular roof crush standards issued by the National Highway Traffic Safety Administration, mattress flammability standards issued by the Consumer Product Safety Commission, pesticides regulated by the EPA and a variety of other products.  A majority of the regulations containing preemptive language were issued by the FDA and NHTSA.   
 

 

Summary Judgment For Manufacturer in Pain Pump Litigation

In what appears to be the first substantive decision to come out of the multiple suits alleging that a pain pump medical device damages patients, a federal court has granted summary judgment to the defendant. Kilpatrick v. Breg, Inc., No. 4:08-cv-10052 (S.D. Fla. 6/26/09). Judge Michael Moore ruled in favor of medical device manufacturer Breg, finding that the plaintiff, who alleged damage to his shoulder cartilage, did not provide enough reliable expert evidence to link the condition to the defendant's shoulder pain pump.

Plaintiff Kilpatrick underwent arthroscopic shoulder surgery in 2004 after an orthopedic specialist discovered a tear in his shoulder socket.  To help with post-operative pain, the surgeon inserted a pain pump into plaintiff's shoulder, which would allow the doctor to administer an anesthetic via a catheter in the patient's arm. The surgeon injected bupivacaine into the pump's attached catheter and further filled it with 100 cc's of anesthetic, which was to be delivered into Kilpatrick's shoulder over the next 48 hours.  Plaintiff alleges that he began experiencing severe pain in his shoulder in 2006. An orthopedic surgeon diagnosed the pain as glenohumeral chondrolysis, a deterioration of the cartilage, and Kilpatrick underwent shoulder replacement surgery. He then brought suit, alleging negligence, strict products liability, and violations of Florida's Deceptive and Unfair Trade Practices Act.  Kilpatrick claimed that using the Breg pain pump to administer local anesthetic directly into his shoulder joint caused him to develop post-arthroscopic glenohumeral chondrolysis.

The reliability prong of the Rule 702 analysis was the central issue.  Breg argued, and plaintiff apparently did not contest, that the case should be treated like a toxic tort case for purposes of the Daubert inquiry, in that plaintiff had to offer proof of both general and specific causation. “If anything, determining causation in this case requires an even more complex logical chain than the typical toxic tort case, because the key issue is not merely whether a chemical compound could and did cause injury, but whether that compound as delivered via a particular medical device inserted in a particular location (within Kilpatrick's shoulder joint) could and did cause injury,” the court found.

The summary judgment motion focused first on general causation, and the ability of plaintiff's expert to opine adequately under Daubert that the device can cause this type of injury.  The causes of chondrolysis remain disputed, and experts in the medical community have pointed to autoimmune deficiencies, certain kinds of sutures, thermal energy procedures and contrast dyes made from gentian violets as possible risk factors.  Plaintiff's expert admitted it was a still developing science.

Plaintiff's expert relied on several published studies to attempt to show causation, which were not directly on point, and the Court found that his extrapolations from the studies were not warranted either.  None of the articles were based on controlled, randomized epidemiological studies of human beings, which are the best evidence. “Significantly, none of the articles explains the mechanism by which bupivacaine damages cartilage, each has important limitations that Poehling does not take into account, and none of them offers an ultimate conclusion as to the general causation of glenohumeral chondrolysis,” the court noted. At most they suggest a possible association.  Association is not causation.  As for the animal studies, the expert did not explain the possible differences in dose-response relationship between humans and rabbits, an important factor to consider in evaluating whether an alleged exposure caused an adverse effect. 

As to specific causation, as is typical of many plaintiff experts, Poehling described a process of so-called "differential diagnosis," trying to rule out other suspected causes such as thermal energy and gentian violet, the contrast dye sometimes used during arthroscopic surgery. This approach cannot, observed the court, make up for a fundamental lack of adequate proof about the general toxicity of the substance.  To "rule in" one cause, even while ruling out other causes, requires a sufficient general causation proof.  At its base, however, the conclusion on specific causation still would be unreliable, the court said, as it was "ultimately rooted in nothing more than temporal relationship.”   That before/after focus is not the basis of good science, the court said, “and Poehling's dependence upon it further weakens the reliability of his methodology.”  Significantly, the expert had not offered a sufficient explanation of the background risk for genohumeral chondrolysis, casting further doubt on the reliability of the chosen method. He admitted that not only the pain pump — as a kind of drug delivery system — could have caused the injury, but also the anesthetic delivered via the pain pump.  Poehling's concession that the current state of medical literature is still unsettled about the cause of the plaintiff's condition seriously undermines the reliability of his methodology, the court concluded.  His methodology had no known rate of error, and thus all he had was a hypothesis that “may be exactly right,” but that currently is “merely plausible, not proven.”

It will be interesting to see what impact the approximately 300 suits pending against pain pump manufacturers in state and federal courts.   


 

Administration Releases Memorandum On Preemption

The Democratic assault on the preemption doctrine has taken its next step with the release last week by the White House of a Presidential memorandum which restricts federal agency statements on preemption and directs those agencies to review preemption pronouncements made in the past decade under the Bush Administration.


Ironically, the directive ostensibly rests on the grounds of States rights: noting State law and national law often operate concurrently to provide independent safeguards for the public, and that throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national government.  “An understanding of the important role of State governments in our Federal system is reflected in longstanding practices by executive departments and agencies, which have shown respect for the traditional prerogatives of the States,” argues the memorandum.

The memorandum comes two months after the Supreme Court’s ruling on preemption in the context of drugs in Wyeth v. Levine, and concurrently with democratic efforts in Congress to overturn Medtronic v. Riegel in the medical device context.


The memorandum sets for the general policy of the new Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the “legitimate prerogatives of the States and with a sufficient legal basis for preemption.” Specifically, it orders that agencies should not include in regulatory preambles statements that the department intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation. Also, agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the (presumably re-assessed) legal principles governing preemption.

Finally, departments should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the agency to preempt State law, in order to decide whether such statements or provisions are justified under (again, re-interpreted) applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.


The memorandum is a political statement as much as a legal document, and is consistent with President’s Obama’s comments while a candidate. As it eventually evolves into specific agency statements and policy, it promises to create a hodge-podge regulatory quilt, under which business will struggle with product safety decisions which will comply with federal, national standards, be upheld in some state jurisdictions, but nevertheless be subject to review by lay juries in others.

 

White Paper Explains Detrimental Impact of Proposed Medical Device Anti-Preemption Bill

Much of the debate over the preemption doctrine, certainly in the media and even in many legal circles, has focused on the alleged inadequacy of the FDA to regulate drugs and devices, and the purported consequent  need to have state juries of lay people “police” the health industry. Comparatively little attention has been given to the other impacts of eliminating federal preemption.

A new white paper demonstrates that erasing this doctrine would decrease access to life-enhancing medical devices, increase health care costs, and reduce medical device industry employment. Congressional Democrats are seeking to do just this in the device context -- the Medical Device Safety Act of 2009 was crafted in response to the U.S. Supreme Court's 8-1 ruling in February, 2008 in Riegel v. Medtronic, upholding preemption for certain medical devices when the devices, and their warning labels, had been approved by the U.S. Food and Drug Administration.


The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” was authored by Ernst Berndt, professor in applied economics at MIT's Sloan School of Management, and Mark Trusheim. They argue that among the effects of the bill would be:

 • Reduced patient access to products and the health benefits they provide

• Unreliable, variable patient access to products and the health benefits they provide as varying state regulations and tort liabilities discourage or eliminate products in some regions but not others

• Increased medical costs and lower net public health compared to what could be achieved with increased medical device innovation and product introductions

• Increased defensive medical practices by physicians to avoid possible litigation, raising health costs and exposing patients to greater risks from the added unnecessary procedures

• Reduction in the number of products being developed as manufacturers and their investors respond to greater uncertainty regarding product approval and economic sustainability

• Transfer of health regulatory decisions to untrained, non-expert juries who are exposed to only a biased fraction of the scientific fact base on which to base their decisions


The authors compare the bill to what happened with vaccines: from 1967 to 2004 the number of vaccine makers plummeted from 26 to 3, leading to reduced access, higher costs, no new products, shortages of existing products, a fragile vaccine supply chain, reduced employment and increases in preventable illness. Congress had to step in and take the vaccines out of the traditional tort system.

Under the bill, the authors note, state juries would be asked to render decisions regarding device safety and efficacy based on a limited range of information focused on individual risk versus broad benefit at a trial typically lasting at most several weeks. Allowing state tort suits to do this will place state juries in the position of replacing, by overriding, professionally trained federal regulators in evaluating and quantifying the risks of medical devices. And unlike federal regulators, state juries will not balance, perhaps not even consider, the benefits to those for whom the medical devices enhances health and quality of life -- who of course are not parties to the action.
 

FDA To Hold Meeting on Risk Communication Strategies

The Food and Drug Administration’s Risk Communication Advisory Committee will be holding a public meeting on April 30, 2009, and May 1, 2009, at the Center for Drug Evaluation and Research Advisory Committee Conference Room, in Rockville, MD. On both days the Committee will discuss the Agency’s draft risk communication strategic plan and will be asked for comment and further advice on strategic priorities for research on effective risk communication.

That draft plan describes FDA’s strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their own health and well-being. FDA has been looking to improve how it produces communications about the risks and benefits of regulated products, as well as how it oversees those communications produced by regulated entities. For example, as the Internet and emerging technologies have both enabled and fed the public’s demand for greater transparency and communication frequency, the traditional waiting periods for FDA guidance have given way to communication in real time. Designing a contemporary risk communication strategy is key to FDA’s efforts to reposition itself to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology.

Effective communication supports both optimal use of medical products and safe consumption of foods to maximize health. The IOM report on The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006) focused on drug safety, but also highlighted communication more generally, referencing FDA’s mission of helping the public get the accurate, science-based information it needs. In response to an IOM recommendation, FDA launched its Risk Communication Advisory Committee in 2007 to give advice about FDA’s risk communication approaches for all FDA-regulated products.

The FDA has begun to identify research needs in this area, including on the broad topics of:

  • When and what to communicate
  • Reaching the audience (dissemination)
  • Ensuring audience understanding
  • Motivating audiences
  • Evaluating effectiveness of communications
     

FDA Introduces Nanotechnology Initiative

Last week the FDA introduced the "Nanotechnology Initiative", a collaborative effort between FDA and the Alliance for NanoHealth (ANH) and its eight member institutions. The alliance's eight academic institutions are the Baylor College of Medicine, the University of Texas' M.D. Anderson Cancer Center, Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A & M Health Science Center, the University of Texas Medical Branch at Galveston and the Methodist Hospital Research Institute in Houston.


The initiative is designed to push for the development of safe and effective implementation of nanotechnology into medical products. Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. The nanotechnology initiative with the Alliance for NanoHealth is an effort to engage resources and technical expertise in this rapidly advancing field.

FDA recognizes that nanotechnology holds great promise for the advancement of novel medical products. All outcomes from this public-private partnership will be placed in the public domain.
Readers of MassTortDefense know that nanotechnology involves the creation and use of materials at the level of molecules and atoms; it presents opportunities but also challenges for the FDA's entire regulatory product jurisdiction, from food to medical devices to therapeutics. Products from the new technology may also present product liability issues for manufacturers.

New Voluntary Guidelines For Device DTC Ads

The Advanced Medical Technology Association has just released a set of “Guiding Principles for Direct to Consumer Device Advertising. “ The principles are intended to help assure that patients have accurate and meaningful information about health care treatment options and encourage them to speak with their physician. Direct-to-consumer (DTC) advertising can be an important tool for educating patients about advanced medical technologies, which are making life better for patients through faster recovery and better outcomes and in many cases, reducing health care costs.

The Advanced Medical Technology Association (AdvaMed) is the world’s largest
association representing manufacturers of medical devices, diagnostic products, and
medical information systems. AdvaMed members and subsidiaries manufacture nearly
90 percent of the health care technology products purchased annually in the United
States and more than 50 percent of the health care technologies purchased annually
around the world.

The voluntary guidelines contain 13 principles that support compliance with the Food and Drug Administration’s and Federal Trade Commission’s existing direct-to-consumer regulations. They also include additional principles, which include revising or withdrawing ads when new safety-risk information comes to light; excluding any content designed to minimize risk information; educating healthcare professionals about new products or new-use indications before the launch of an ad campaign; and submitting TV ads for restricted devices to the FDA at the time of an ad’s release.

The principles were not an effort to ward off regulation from Congress and the new Administration, but to respond to concerns that have been raised in the media in recent months about some DTC ads. 

Readers of MassTortDefense know that plaintiffs try to make an issue of DTC advertising in failure to warn claims, and have succeeded in some contexts in having DTC advertising undermine the traditional learned intermediary rule.
 

Members of Congress to Re-introduce Medical Device "Safety" Bill

Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Medtronic, which held  that the Medical Device Act Amendments of 1976 specifically pre-empt product liability lawsuits against makers of FDA-approved class III medical devices. The FDA approval process for such devices is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective. The bills would permit lay juries to second-guess regulatory decisions of the FDA resulting from that process.

Sponsors of the planned legislation include Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone, head of its health subcommittee, and Senators Edward M. Kennedy and Patrick J. Leahy.  The lawmakers claim that the Supreme Court’s decision has left patients legally powerless against what they criticize as incomplete oversight of products by the FDA. Of course, if there is concern about the FDA’s efficacy, the answer is to increase the agency's resources, as the FDA is the appropriate body to set nationwide safety standards; allowing juries to second-guess such decisions would stifle product innovation. Such a bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with. What the sponsors may really want is to restore the trial lawyer lotto that can net jackpot jury awards while wreaking havoc on national standards.
 

Similar legislation, the Medical Device Safety Act of 2008, was introduced last session to overturn the Supreme Court’s decision in Reigel v. Medtronic.  H.R. 6381 garnered 62 co-sponsors last time.  Officials for the "American Association for Justice" f/k/a ATLA,  recently released a legislative agenda for 2009 and cited as their top priority efforts to pass this pro-litigation legislation.

Daubert Lessons From Two Medical Device Cases

Two recent federal cases illustrate important Daubert principles in the medical device context.

In Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09), the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product.  In contrast, in Jaske v. Zimmer Inc., 2009 WL 150946 (N.D. Ill., 1/20/09), the Northern District of Illinois reversed an earlier decision to exclude two expert witnesses for the plaintiff. On a motion for reconsideration, the court ruled that plaintiff can present testimony from two experts in polymer science as to why his prosthetic knee, manufactured by defendant Zimmer, allegedly failed.


Fuesting alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

Under Rule 702 and the Daubert standard, expert testimony must be both relevant and reliable. The district court must act as a “gatekeeper” making a preliminary assessment of the reasoning or methodology underlying the testimony. Daubert factors include: (1) whether the scientific theory can be and has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the theory's known or potential rate of error when applied; and (4) whether the technique or theory has been ‘generally accepted’ in the scientific community. 


On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. To bridge the gap, rhe expert needed to show, with respect to Fuesting's implant in particular, what quantum of each variable is required to set the alleged causal chain reaction in motion. That is, the causation opinion must be specific to the plaintiff, and each chain in the causal link must be supported by adequate science. Gaps included how much radiation does it take to cause oxidation, and to what degree? How much oxidation must occur to render polyethylene more susceptible to delamination? And once polyethylene becomes more susceptible to delamination, how then does oxidation affect delamination? Are all forms of polyethylene, including that used by Zimmer (which the company claims to be oxidation-resistant), susceptible to delamination? What effect, if any, does implantation into the human body have on the rate of oxidation?

The expert testimony as to defect also failed. Oxidation can occur in implants sterilized by any method. However, plaintiff’s expert did not know of any peer-reviewed studies or articles that compared oxidation rates for implants sterilized by GIA to those sterilized through other methods. While the prosthesis showed significant oxidation when it was tested, that testing occurred more than six years after the knee joint was explanted, and plaintiff failed to account for oxidation that may have occurred after the joint was removed.

Having granted Zimmer's motion to exclude the expert testimony, the court had no alternative but to also grant the company's motion for summary judgment.

In Jaske, Plaintiff had his left knee replaced with a prosthesis to alleviate recurring pain. When the prosthesis allegedly failed, he filed suit against the manufacturer. Last year, the district court granted defendant's motion to exclude the testimony of two of plaintiff's experts in polymer science, who, while qualified to offer some opinions, used a test as the basis for their opinions that was not reliable. (A Fourier Transform Infrared Spectroscopy (“FTIR”)). Plaintiff moved for reconsideration.


The court had determined that the proffered testimony was unreliable for two reasons. First, the results of the FTIR test may have been skewed because lipids and proteins from Jaske's body had permeated the product. And, second, even if the test results were accurate, they did not determine when the oxidation took place. Originally, plaintiff offered nothing but a naked expert opinion on this issue. On reconsideration, plaintiff presented new evidence that any biological material present would absorb the infrared spectrum used in the FTIR at a different frequency than oxidized polyethylene, and that the FTIR is the accepted standard of the American Society of Testing and Manufacturing for this purpose.

The court had also originally noted that the FTIR test measured the amount of oxidation present in the prosthesis only at the time the test was conducted. It did not provide historical readings. Plaintiff clarified that his experts developed their theory independent of the test results. Instead of relying on the FTIR results to arrive at their theory, they said, the FTIR simply provided support for it. In other words, the results of the FTIR are merely consistent with the theory. The theory that gamma irradiation sterilization in air causes oxidation has been recognized, asserted plaintiff, for some time in the scientific community.


This second case demonstrates one of the potential dangers of the Daubert challenge: if the court is going to give plaintiff a second bite of the apple, the Daubert motion turns into a roadmap for the plaintiff on what holes to fix.  See our post on reasons why you might not file a credible motion.
 

Preemption Found In Medtronic MDL

The federal judge in the Medtronic Sprint Fidelis Leads MDL has ruled that all claims in the plaintiffs' master consolidated complaint are preempted. In Re: Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 35467 (D.Minn. 2009).

The Judicial Panel on Multidistrict Litigation transferred related cases involving Medtronic Inc.'s recalled Sprint Fidelis defibrillator leads to the District of Minnesota last February. The leads were recalled in late 2007, because of the potential for fracture, which can potentially cause unnecessary shocks or failure, possibly resulting in injury. 

Relying on the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), the MDL court noted that Congress has decided to limit medical-device manufacturers' liability in order to spur innovation. Plaintiffs' remedy, therefore, lies with Congress, and not with the courts. 

Every medical device intended for human use is placed into one of three categories by the FDA, based on the risks of injury or illness the device presents; each category is subjected to a different level of FDA scrutiny. Devices that either support or sustain human life or present a potential unreasonable risk of illness or injury” are categorized as “Class III” devices. Class III devices are subject to the greatest level of FDA scrutiny and “must complete a thorough review process with the FDA before they may be marketed.”  Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001). Through this process, known as pre-market approval (“PMA”), a device maker must provide the FDA with “reasonable assurance” that its device is both safe and effective.

The PMA process is “a rigorous one.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. When analyzing that information, the FDA weighs the probable benefit to health from the use of the device against any probable risk of injury or illness from such use. Accordingly, the FDA sometimes grants PMA to potentially life-threatening devices, if they offer great benefits in light of available alternatives. Riegel, 128 S.Ct. at 1004.

Here, the MDL court rejected arguments that a recall of the leads invalidated their premarket approval. Medtronic correctly noted that the PMA process is governed by a completely separate statutory and regulatory regime than that governing withdrawal of a PMA. Also, the PMA for the leads was in place at the time they were implanted, a crucial fact because liability under plaintiffs' various legal theories hinges upon whether the leads were defective at that time. More fundamentally, the federal interest that preemption is designed to protect is the PMA process, and preemption necessarily looks backward (to the time of PMA) rather than forward.

The court also rejected the plaintiffs' claims that they have asserted "parallel" claims and therefore preemption does not apply. For example, plaintiffs purported reliance on Good Manufacturing Practice or Quality Control guidance did not save the claims. In the absence of any specific requirement in the CGMPs/QSR that Medtronic weld the Sprint Fidelis leads in a certain fashion [that was plaintiffs' beef], holding Medtronic liable for such a welding “defect” would have imposed requirements “different from, or in addition to” those under federal law. This is equally true of plaintiffs' allegation that Medtronic used inadequate testing and quality-assurance methods. Plaintiffs simply could not identify any specific requirements in the CGMPs/QSR that were purportedly violated by Medtronic.

It is noteworthy that the court found dismissal with prejudice was appropriate. This complaint was filed after extensive preparation by the Plaintiffs' Steering Committee, which is made up of lawyers who are experienced in federal preemption litigation. In the MDL Court's estimation, if plaintiffs were aware of sufficient facts in order to avoid preemption, they would have already pleaded them.
 

GAO Adds To Critiques of FDA

The Government Accountability Office issued a report last week that listed the FDA as a "high-risk" area of the federal government. The GAO said the U.S. Food and Drug Administration was being hampered by globalization, more complex products, and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs, and medical devices. GAO says its work examining a variety of issues at FDA echoes the conclusions reached by others (think IOM) that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.
 

The perception of the FDA and its ability to do an effective job is a crucial underlying feature in product liability litigation involving regulated drugs, devices, and food products. Jurors’ perceptions of the agency can affect a myriad of issues and themes the defense may wish to present.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the issue is a need for more resources for the FDA, to keep drugs safe. The agency “is being asked to do more than it can do” with current resources, the trade group says. Specifically, FDA needs more resources to conduct foreign inspections so the drug supply can be kept safe. PhRMA also said that FDA needs more resources to modernize because, for example, the agency still looks at clinical trial information on paper.
 

FDA Issues Guidance For Industry On Retaining Data From Clinical Trials

Limiting mass tort/class action exposure is a key part of the role of in-house litigators. In the drug and device areas, limiting plaintiffs' ability to take unfair advantage of clinical trials research is becoming a real focus. Issues include limiting liability due to alleged inadequate monitoring during trials, and preventing off-label and product liability claims associated with alleged under-reporting and over-reporting of data. Litigators need to offer their input on the company's determination of the extent to which data from ongoing clinical trials will be distributed, helping the company to assess the liability risks of disclosing and failing to disclose clinical trial data related to off-label uses. A thorny legal issue is the degree to which the First Amendment is a viable defense, and in a complex regulatory world the company needs to understand and comply with state as well as federal disclosure obligations.


Ideally, the company will be developing a framework for deciphering where scientific exchange ends and drug promotion begins, as a guide to avoiding language in describing clinical trials that could be construed as promotional while still providing fair and balanced information on clinical trials involving their products. The most prudent may be developing a strategic, long-term plan to protect clinical trial information from turning into grist for the plaintiff ’s case (and outside counsel can help with that too). That program may include training employees to recognize the litigation potential arising from clinical trials; maintaining protocols as to the language and terms that will be used in clinical trial reports; and minimizing common liability risks arising from posting of data by establishing thorough review processes.


Into this complex situation the FDA has issued new guidance for drug, biologic, and medical device companies about retaining data from clinical trial participants who no longer are participating in the trial, according to a notice just published in the Federal Register (73 Fed. Reg. 72807). The guidance document on Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials states that data must be retained for participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, or who were discontinued from participation by the clinical investigator.
FDA's reasoning is that data resulting from these clinical investigations are used to support research applications and new product approvals;  thus it is critical that it has a complete and accurate data set available. While it may be appropriate to remove data from various reported figures, based on the study protocols, FDA worries that if data were to be removed from the study database altogether, the FDA may miss something that may be relevant to their decision-making.
 

The agency said it issued this guidance for immediate implementation to prevent the potential loss of important clinical trial data. If comments are received on the guidance, FDA said it will review the comments and revise the guidance as appropriate.
 

Punitive Damages Claim Against Patch Maker Found Preempted

A federal court has found that federal law preempts a state law that allows plaintiffs to seek punitive damages from the makers of defective drug products if the drug company knowingly withheld information from the Food and Drug Administration. Grange v. Mylan Laboratories Inc., 2008 WL 4813311 (D.Utah 10/31/08).

Plaintiffs’ estate sued over an allegedly defective drug patch. Defendants sold the Fentanyl Patch, which is applied directly to the skin to deliver fentanyl, a strong pain medicine. Doctors prescribe the Fentanyl Patch to relieve chronic moderate to severe pain. The patch should be worn for seventy-two hours and is supposed to deliver the medicine at a regulated rate. Plaintiff alleged that due to a design and/or manufacturing defect, some Fentanyl Patches contain and deliver fentanyl in amounts far in excess of what is advertised. Plaintiff alleged that defendants knew that the Fentanyl Patch was defective, but did not warn of the potential risk of overdose.

Defendants moved to dismiss the claims for punitive damages. A Utah statute, Utah Code Ann. § 78B-8-203, completely bars punitive damages for harm caused by FDA approved drugs. But that statute has an exception for cases where a plaintiff can show that a defendant withheld information from the FDA. Plaintiffs, of course, alleged that the exception applied here. But defendants contended that this exception is preempted by federal law.

As the court noted, this statutory limitation on liability for punitive damages does not apply if it is shown by clear and convincing evidence that the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration under its regulations, which information was material and relevant to the claimant's harm. Defendants contended that the statutory exception amounts to a de facto “fraud on the FDA” claim, which is preempted by federal law.

In support of this argument, defendants relied on Buckman Co. v. Plaintiff's Legal Comm'n., 531 U.S. 341, 348 (2000), which held that state law fraud-on-the-FDA claims conflict with, and are therefore impliedly preempted 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.
 

PMA Device Preemption Recognized Despite "Parallel" Allegation

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.
 

FDA Announces Meeting On BPA

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.


 

Defense Use Of Plaintiffs' Treaters As Experts In MDL Disallowed

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.
 

JPML Denies MDL Status in Pain Pump Litigation

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.
 

Federal Court Restricts Medical Monitoring To Toxic Torts

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.
 

Senate Bill Introduced To Overturn Riegel

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.”
 

FDA Advisory Committee Discusses Nano-technology Issues

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.

 

Waxman Seeks Preemption Drafts From FDA

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.

FDA Responds to NEJM Article on Medical Device Approval Process

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.

 

Senate Judiciary Committee Holds Hearing on Preemption

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.