Supreme Court Sends Merck’s Fosamax Product Liability Case Back to Appeals Court. Clear Evidence Company Submitted a Label Change to the FDA

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The US Supreme Court vacated and remanded a products liability case involving claims alleging a failure to warn about risks of stress fractures related to the use of Fosamax, which is manufactured by Merck Sharpe & Dohme Corp. (“Merck”). Fosamax is a drug that treats and prevents osteoporosis in post-menopausal women. Merck argued that the claims should be dismissed as they submitted “clear evidence” that FDA regulations prohibited them from changing the Fosamax label to include the stress fracture risk warnings. The Supreme Court held that the Third Circuit incorrectly determined that “clear evidence” is a question of fact for a jury; rather, the Court held that “clear evidence” is a question of law as it involves a legal determination about an agency decision.

The FDA approved the sale of Fosamax in 1995. At that time, the Fosamax label did not warn of the risk of atypical femoral fracture, a type of stress fracture in the thigh bone. However, through post-market surveillance, Merck later concluded that the use of Fosamax was associated with an increase risk of these fractures. In 2008, Merck submitted to the FDA a labeling change proposal that would have included the risk of “stress fractures,” however the FDA rejected that proposal. Merck contends that FDA would also have rejected a labeling change proposal with the more specific language warning of the risk of “atypical stress fracture.”

500 individuals who took Fosamax between 1999 and 2010 and suffered atypical femoral fractures sued Merck under state tort laws with the theory that state laws imposed on Merck a duty to warn of the risk of these atypical femoral fractures. In the District Court, Merck argued that the respondents’ state law claims should be dismissed as pre-empted by federal law, as it would have been impossible for Merck to comply with both state law (which requires risk warnings) and federal law (which prohibits labeling changes unless approved by the FDA). The District Court agreed with Merck, and granted summary judgment dismissing the suit.

The Third Circuit, however, vacated and remanded the decision. The Third Circuit cited case law which indicated that “a state-law failure-to-warn claim is pre-empted when there is ‘clear evidence’ that the FDA would not have approved a change to the label.” At issue in this case is what constitutes “clear evidence.” Specifically, the Third Circuit concluded that the “term ‘clear evidence’ … does not refer directly to the type of facts that a manufacturer must show, … [but] [r]ather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change.” In other words, the Third Circuit determined that “clear evidence” is an evidentiary standard, similar to “beyond a reasonable doubt” or “a preponderance of evidence.” Thus, the Third Circuit held that this inquiry is a question of fact to be determined by a jury.

The Supreme Court, rejecting the Third Circuit’s evidentiary definition, held that “clear evidence” is “evidence that shows the court that the drug manufacturer fully informed the FDA of the justification for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.”

The Supreme Court also held that the question of agency disapproval is primarily one of law for a judge to decide. The Court noted that in cases such as this, the facts are often not in dispute. Rather, the issue centers around a “legal determination about the meaning and effect of an agency decision,” and further that such decisions are not well suited to lay juries. Thus, since the Court of Appeals incorrectly treated the pre-emption question as one of fact, the justices vacated and remanded the case to the Third Circuit for further proceedings.


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