On May 20, 2019, the Supreme Court of the United States decided Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, holding that the judge, not the jury, must decide whether state-law failure-to-warn claims are preempted by federal law on the ground that there is “clear evidence” that the U.S. Food and Drug Administration (FDA) would not have approved the warning that state law requires.

Merck makes an osteoporosis drug called Fosamax. The original Fosamax label that the FDA approved in 1995 did not warn of the risk of atypical femoral fractures. In 2008, Merck applied to the FDA for permission to change Fosamax’s label to refer (in the Adverse Reactions section of the label) to the risk of “low-energy femoral shaft fractures” and to include (in the Precautions section of the label) a longer discussion on the risk of “stress fractures.” The FDA approved the first proposed change, but not the second. Merck withdrew its application but added the reference to “low-energy femoral shaft fractures” in the Adverse Reactions section of the label through a different regulatory procedure. In 2011, the FDA ordered Merck to warn about “atypical femoral fractures.” Merck asked to refer to the risk of “stress fractures,” but the FDA rejected that request.

More than 500 people who took Fosamax and who suffered atypical femoral fractures between 1999 and 2010 sued Merck, seeking tort damages on the ground that, during the relevant period, state law required Merck to warn them and their doctors about the risk of atypical femoral fractures associated with Fosamax. Merck argued that the plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that FDA regulations would have allowed it to try to change the label to add a warning before 2010, but it argued that the FDA would have rejected that attempt. In particular, Merck pointed to the FDA’s rejection of its 2008 attempt to amend the label to warn of the risk of “stress fractures” associated with Fosamax. The district court agreed with Merck that federal law preempted the plaintiffs’ claims, but the Third Circuit reversed. It ruled that the question of whether the FDA would have rejected a proposed label change is a question of fact that a jury must resolve, and it asked the Supreme Court to clarify or build on its statement in Wyeth v. Levine, 555 U. S. 555 (2009): A claim is preempted only if there is “clear evidence” that the FDA would not have approved a change to the drug’s label.

The Supreme Court vacated and remanded the Third Circuit’s decision. The Court first held that a manufacturer meets the “clear-evidence” requirement in Wyeth only if the manufacturer can 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.” The Court then held that the question of whether this standard is satisfied is for a judge, and not a jury, to decide. The Court explained that “judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination” and that judges are more experienced in the construction of written instruments such as those that a federal agency produces to explain its decisions.

Because the Third Circuit treated the preemption question as one of fact, not law, and because it did not have an opportunity to consider fully the “clear-evidence” requirement as explained in the Court’s opinion, the Court vacated the judgment and remanded the case for further proceedings.

Justice Breyer delivered the opinion of the Court, joined by Justices Thomas, Ginsburg, Sotomayor, Kagan, and Gorsuch. Justice Thomas filed a concurring opinion. Justice Alito filed a concurring opinion in which Chief Justice Roberts and Justice Kavanaugh joined.

Download Opinion of the Court.