Monday, May 20, 2019
Today the Supreme Court handed down its decision in Merck Sharp & Dohme Corp. v. Albrecht. Justice Breyer authored the majority opinion, which was joined by Justices Thomas, Ginsburg, Sotomayor, Kagan, and Gorsuch. It begins:
When Congress enacted the Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. §301 et seq., it charged the Food and Drug Administration with ensuring that prescription drugs are “safe for use under the conditions prescribed, recommended, or suggested” in the drug’s “labeling.” §355(d). When the FDA exercises this authority, it makes careful judgments about what warnings should appear on a drug’s label for the safety of consumers.
For that reason, we have previously held that “clear evidence” that the FDA would not have approved a change to the drug’s label pre-empts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug. See Wyeth v. Levine, 555 U. S. 555, 571 (2009). We here determine that this question of pre-emption is one for a judge to decide, not a jury. We also hold that “clear evidence” is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.
Justice Thomas joins the majority opinion but also writes a separate concurring opinion arguing that the preemption defense should fail as a matter of law. (The majority remands the case for the lower courts to address whether the plaintiff’s state-law tort claim is preempted in this case).
Justice Alito writes a concurring opinion, joined by Chief Justice Roberts and Justice Kavanaugh. Justice Alito agrees that this is a question of law to be decided by courts rather than juries, but he is “concerned that [the majority’s] discussion of the law and the facts may be misleading on remand.”