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Preemption Defense Prevails in Failure to Warn Case Where 'Clear Evidence' That FDA Would Not Have Approved Drug Label Change Is Demonstrated

Thursday, August 1, 2013

By Jennifer L. Klem, McDermott Will & Emery  

On June 27, 2013, a United States District Court in New Jersey found that defendant Merck, Sharp & Dohme Corp's (“Merck”) was entitled to judgment as a matter of law, based on a finding that federal law preempted the state law failure to warn claims at issue in that case (11 PLIR 833, 7/5/13). Merck's ability to persuade the multi-district litigation judge that the U.S. Food and Drug Administration (“FDA”) would not have approved stronger warnings for its product, Fosamax, may offer hope to other pharmaceutical companies that they might be able to similarly prevail in failure to warn product liability cases under a FDA preemption theory. In reFosamax (Alendronate Sodium) Prods. Liab. Litig., Bernadette Glynn and Richard Glynn v. Merck Sharp & Dohme Corp., No. 11-5304, 08-08, Dkt. No. 234 (D.N.J. June 27, 2013).

As part of a multi-district litigation, the Glynn plaintiffs in this case alleged that Merck was aware of the possible association between the development of atypical femur fractures (“AFFs”) and the use of Fosamax, and yet failed to warn consumers of those risks via its product labeling. Fosamax, a bisphosphonate, is FDA-approved for the treatment and prevention of osteoporosis. In a post-trial ruling, the Court granted Merck's combined motions for summary judgment and judgment as a matter of law, finding that the plaintiffs' failure to warn claims were preempted because the undisputed facts supported Merck's defense that it had requested the inclusion of these possible risks to the Precautions and Adverse Reactions section of Fosamax's label via a Prior Approval Supplement (“PAS”) submission to the FDA, and that this request was rejected.

While this ruling certainly reflects the unique factual circumstances relating to Fosamax, it has the potential to shift the existing legal landscape of the FDA preemption defense, which had come to be viewed as somewhat obsolete since the 2009 Supreme Court decision in Wyeth v. Levine, 555 U.S. 555 (2009). In Wyeth, the Supreme Court rejected defendant Wyeth's preemption argument, determining that the plaintiff in that case was entitled to sue Wyeth because no evidence was presented to indicate that the FDA would have rejected an application from Wyeth to enhance the warning on its product label. Wyeth, 555 U.S. at 571-573. However, the Wyeth decision left open the possibility of a successful preemption defense under other circumstances where a pharmaceutical company facing failure to warn claims could provide “clear evidence that the FDA would not have approved a change,” making it impossible for a manufacturer to comply with both federal and state requirements. Id. at 571.

The absence of successful preemption defenses in the last four years demonstrates that the theoretical potential left open by Wyeth—for showing the impossibility of complying with both the FDA and state requirements—has proved difficult in application. The Merck case provided an opportunity for an application of the Wyeth exception, however. Merck's trial evidence showed that, despite the FDA's earlier conclusion that the use of bisphosphonate (including Fosamax) did not necessarily increase a risk of fractures, Merck submitted to the FDA a PAS in September 2008 to add language to Fosamax's product label that would describe a possible risk of bone fractures. Glynn at *4. In May 2009, several months after Merck's submitted proposed label change, and also one month after the injured plaintiff's alleged fracture occurred, the FDA formally rejected Merck's proposal to modify the Precautions language on the Fosamax label. Id. at *5. The Court's ruling on the motions emphasized that Merck's experts, one of whom had worked in FDA's Center for Drug Evaluation and Research and had fifteen years of FDA experience, testified at trial that this action by the FDA constituted a rejection of Merck's proposed labeling change. Id. at *13-14.

Interestingly, the FDA also warned Merck that Fosamax may even be considered “misbranded” if Merck included its proposed enhanced warning on its product label without FDA approval. Id. at *5. It appears that a publication by the American Society for Bone and Mineral Research (“ASBMR”), wherein ASBMR recommended that product labeling should be changed to warn consumers of an association between long-term bisphosphonate use and AFFs, eventually prompted the FDA to inform bisphosphonate manufacturers, including Merck, to add this warning to the Precautions and Indications and Usage sections of their labels in October 2010. Id. at *6-7.

In analyzing Merck's preemption arguments, the Court cautioned that preemption “is a demanding defense,” and that because the Wyeth Court did not define “clear evidence,” its analysis would be fact specific. Glynn at *12-13, citing Wyeth, 555 U.S. at 573. The Court ultimately agreed with Merck's preemption arguments, however, finding that preemption was warranted because “there is clear evidence that the FDA would not have approved a change to the Precautions section of the Fosamax label prior to Mrs. Glynn's fracture.” Glynn at *13. The circumstances of the Merck case were contrasted with the facts in Wyeth, where the plaintiff had “failed to demonstrate that it was impossible for [it] …to comply with both federal and state requirements” and never argued “that it attempted to give” a warning but “was prohibited from doing so by the FDA.” Glynn at *13, citing Wyeth, 555 U.S. at 571-72.

The Merck ruling is promising for pharmaceutical companies in similar situations who are considering a preemption defense to a products liability lawsuit. While the standard of “clear evidence” has yet to be clearly defined, a preemption challenge may prevail in circumstances where a manufacturer can demonstrate that they proactively submitted a formal application for modification of their product labeling to the FDA reflecting product risks before the plaintiff suffered an alleged adverse event. Companies will also want to focus on the extent to which these applications were rejected by the FDA.

Whether this ruling will also provide an additional reason for companies to respond to adverse event developments with proposed label changes is yet to be seen, although doing so may help to protect them from a failure to warn claim.

Jennifer L. Klem, a partner in the Los Angeles office of McDermott Will & Emery, focuses her practice on the defense of white collar criminal litigation, health care fraud and government investigations.  

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