The Supreme Court recently heard oral argument in Merck, Sharp & Dohme Corp. v. Albrecht, a case that may foreshadow the Court's position on whether aviation manufacturers may claim FAA preemption in the face of state law claims. The issue before the Merck Court is the extent to which a federal agency's rejection of a proposed warning label change preempts state law failure to warn claims. The case centers around allegations by hundreds of women that Merck failed to warn users of the drug Fosamax of an associated increased risk of femoral fractures. The case is on appeal from the Third Circuit, which held that a plaintiff's state law tort claims are not federally preempted absent evidence that it was "highly likely" the Food and Drug Administration would have rejected the label change.
Merck claimed, and amicus curiae United States agreed, that the FDA's informed rejection of a proposed label change prevented it from altering the Fosamax warning label to include the proposed warnings. Merck argued the plaintiffs' claims are impliedly conflict preempted because it could not have satisfied the state law duties plaintiffs would foist upon it while simultaneously complying with federal law―particularly where the FDA purportedly was aware of the risk of the injury addressed in the warning through Merck's proposal package (although the parties disputed whether Merck's proposal package provided a clear warning).
Plaintiffs argued that the FDA rejected only a specific phrasing of the proposed warning―one that included a warning for a lesser risk without explicitly including femoral fracture―and that Merck was free to propose other warnings related to the plaintiff's claimed injury. Drug makers, the plaintiffs claimed, "are responsible at all times for keeping their labels up to date," even where the FDA has rejected a certain label or evidences some uncertainty about the proper way to warn about a certain risk. They claim this issue is one that is routinely decided by jurors, which, if the Court agrees, would largely thwart subsequent efforts by defendants to win summary judgment on preemption grounds.
Although Merck differs from the typical aviation preemption case, where the proposed modification or warning never was sent to or reviewed by the FAA, the case still may prove instructive as to the extent to which the Supreme Court is likely to entertain preemption arguments. Indeed, the Court will soon decide whether to grant certiorari in Sikkelee v. AVCO Corp., after the Third Circuit held that a manufacturer must adduce clear evidence that the FAA would have rejected the plaintiff's proposed alternative design before it could benefit from conflict preemption. Merck, Sharp & Dohme Corp. v. Albrecht, No. 17-290 (S. Ct.)
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