By Jonah M. Knobler, a Partner with Patterson Belknap Webb & Tyler LLP in the firm’s New York, NY office and Co-Editor of

Last month, the Supreme Court issued its decision in Merck Sharpe & Dohme Corp. v. Albrecht, No. 17-290 (May 20, 2019), once again addressing preemption in the pharmaceutical context.  Merck makes official what the Court first suggested a decade ago: when expert scientists at the Food and Drug Administration (FDA) actually conclude that a particular safety warning is unjustified, their view must prevail, and state-law tort claims based on a manufacturer’s failure to issue that warning are preempted.  In addition to unequivocally recognizing this principle, Merck sweeps away some lower-court misconceptions that had made it unduly difficult for defendants to invoke its protection.  In these respects, Merck is a major win for pharmaceutical innovation.  At the same time, some dicta in the Court’s opinion are less clear than they could have been, and have the potential to sow unnecessary confusion. 

Merck is a follow-up to Wyeth v. Levine, 555 U.S. 555 (2009).  There, the Court considered the argument that the FDA’s approval of a prescription drug’s label—including its safety warnings—is necessarily preclusive of state-law tort claims challenging the adequacy of those warnings.  A divided Court rejected this argument, holding that the plaintiff could bring her state-law failure-to-warn claim with respect to Wyeth’s name-brand drug, Phenergan, even though the FDA had approved the drug’s label and warnings.  Importantly, however, the Wyeth majority opinion included a cursory comment suggesting that the result would have been different if there were “clear evidence that the FDA would not have approved [the label] change” that the plaintiff argued was necessary.  In that scenario, the Court suggested, a state-law failure-to-warn claim would be preempted.