On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a judge, not a jury, to decide. In doing so, the court reversed a March 2017 Third Circuit decision that had revived product liability litigation regarding Fosamax and remanded the case to that court for reconsideration. The opinion in Merck Sharpe & Dohme v. Albrecht addresses drugmakers' preemption defense to state law failure-to-warn claims. Since the Supreme Court's 2009 decision in Wyeth v. Levine, a defendant is not liable for alleged inadequate warnings if there was "clear evidence" that the U.S. Food and Drug Administration (FDA) would not have approved a labeling change to address the inadequacy. Per Albrecht, whether that defense is viable is the province of the judge.
Authored by Lauren Colton, Susan Cook, David M. Fox, Heidi F. Gertner, Philip Katz and Sydney Fairchild