LIFE SCIENCES CLIENT ALERT: United States Supreme Court holds that the judge, not the jury, makes pre-emption determination in failure-to-warn pharmaceutical cases.

It is the role of the district judge—not the jury—to determine if the FDA would have approved a drug’s warning label that state law requires when deciding whether a failure-to-warn claim is pre-empted, the United States Supreme Court held on Monday. The unanimous decision provides clarity to the high court’s “clear evidence” standard it introduced over a decade ago in Wyeth v. Levine, and resolves a split between the circuit courts in how to apply the standard.

In Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. ___ (2019), a class of plaintiffs alleged that pharmaceutical manufacturer Merck failed to properly warn of increased instances of atypical femoral fractures related to the use of Merck’s osteoporosis treatment drug Fosamax.  Merck claimed that plaintiffs’ state law claims were preempted by federal law, specifically the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (“FDCA”), and the FDA’s statutory authority to approve drug warnings, which prohibited Merck from changing its label without first obtaining approval from the FDA. 

While Merck admitted that it was aware of an increased risk of atypical femoral fractures associated with the use of Fosamax, it claimed that the FDA would have rejected its attempt to change the Fosamax labeling identifying this risk and, thus, plaintiffs’ state law failure-to-warn claims were pre-empted by the FDCA. To support its argument, Merck pointed to its attempt to identify the increased risk of stress fractures in a revised label in 2007 and the FDA’s rejection of the proposed label in 2008. The FDA’s refusal to amend the warning in 2008, Merck argued,  was “clear evidence” that the FDA would not have approved the label that plaintiffs maintained that state law required. While Merck was granted summary judgment by the district court, the Third Circuit Court of Appeals reversed, holding that whether “clear evidence” existed that showed the FDA would have approved the plaintiffs’ proposed labeling was an issue of fact to be determined by a jury.

The Supreme Court disagreed. After reiterating that “a failure-to-warn claim grounded in state law is pre-empted where there is ‘clear evidence that the FDA would not have approved a change to the…label,’” quoting Wyeth v. Levine, 555 U.S. 555, 571 (2009), the Court clarified that the determination regarding “clear evidence” of the FDA’s refusal is one to be made by the district judge as opposed to the jury. It explained that the “clear evidence” standard was not an evidentiary one, but rather a question of law that requires a judge to ask whether the relevant state and federal laws “‘irreconcilably conflict.’” Quoting Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982). The Court consequently remanded the case to the Third Circuit for it to determine whether Merck made a sufficient showing that the FDA would not have approved the plaintiffs’ proposed labeling, pre-empting their failure-to-warn claims.

The Supreme Court’s decision clarifies that the “clear evidence” standard is not a heightened one, as plaintiffs nationwide have repeatedly argued since Wyeth was decided, but simply a legal determination to be made by judges that are “better suited…to understand and to interpret agency decisions in light of the governing statutory and regulatory context.”


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