Labeling Preemption Questions are for the Court, not the Jury, Holds U.S. Supreme Court in Fosamax Decision That Clarifies the “Clear Evidence” Standard


A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held today.

The Court also clarified the “clear evidence” standard governing an impossibility preemption defense to failure-to-warn claims.

Fosamax’s Warnings

In Merck Sharp & Dohme Corp. v. Albrecht, et al., petitioner Merck Sharp & Dohme (Merck) manufactured  Fosamax, a drug designed to treat and prevent osteoporosis in postmenopausal women by affecting the process through which bones are continuously broken down and built back up. Questions were eventually raised about a potential side-effect involving an increased risk of atypical femoral factures.

In 1995, the FDA approved a Fosamax label that did not warn of the then-speculative risk of atypical femoral fractures. Merck’s scientists were “aware of at least a theoretical risk of those fractures” at that time, and evidence of “a statistically significant incidence of femur fractures” developed in the years that followed. Merck sought to add a warning of the risk of atypical femoral fractures in 2008; the request was denied. It was not until 2011 that the FDA concluded the evidence was strong enough to add such a warning to the  Fosamax label,  based on the FDA’s own updated analyses.

Plaintiffs/Respondents, more than 5,000 individuals who sustained atypical femoral fractures while taking Fosamax, argued that state law imposed a duty to warn patients and their doctors about the risk of these fractures associated with Fosamax use. Merck argued that their claims were preempted by federal law because the FDA had rejected Merck’s attempt to warn of the risk based on concerns that the evidence of a causal link between Fosamax and atypical femoral factures was not strong enough to require a warning until 2010. The District Court granted Merck’s summary judgment motion on federal preemption grounds. The Third Circuit Court of Appeals vacated and remanded, finding that the issue of whether there was “clear evidence” that a warning would not be permitted was one of fact for the jury, subject to a “clear and convincing evidence” standard, and presented a triable issue of fact. The Supreme Court granted certiorari.

Federal Preemption Is a Question for the Court and Not the Jury

The U.S. Supreme Court unanimously reversed and remanded to the Third Circuit to decide, as a question of law,  whether the suits could proceed even though the FDA had rejected Merck’s attempt  to add a warning to Fosamax’s label about the fracture risk. And a more fractured Court elaborated on the “clear evidence” standard that judges are required to apply.

Regarding whether the question of federal preemption is one for the judge or the jury, Justice Beyer, writing on behalf of the entire Court, explained: “The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination.” For questions concerning federal preemption, the “‘better positioned’ decisionmaker is the judge.”

Clarification of the Clear Evidence Standard

Justice Breyer also clarified the standard governing the federal impossibility preemption defense to failure-to-warn claims. The Court had previously held in Wyeth v. Levine, 555 U.S. 555, 571 (2009) that “‘clear evidence’ that the FDA would not have approved a change to the drug’s label pre-empts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.” Today, the Court rejected the Third Circuit’s interpretation of Wyeth and adoption of the familiar “clear and convincing evidence” standard of proof without further defining the evidentiary standard. Instead, it held that the issue is one of law and therefore “the judge must simply ask … whether the relevant federal and state laws ‘irreconcilably conflict.’” Also, the Court clarified that for purposes of demonstrating the requisite impossibility of complying with both state and federal law, the drug manufacturer must show  “that it  fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve  changing the drug’s label to include that warning.”

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