U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

Opinion highlights importance of a "clear" record at FDA

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.

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