Holding: “Clear evidence” that the Food and Drug Administration would not have approved a change to a drug’s label – thus pre-empting a state-law failure-to-warn claim – is evidence showing 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; the question of agency disapproval is primarily one of law for a judge to decide.
Judgment: Vacated and remanded, 9-0, in an opinion by Justice Breyer on May 20, 2019. Justice Thomas filed a concurring opinion. Justice Alito filed an opinion concurring in the judgment, in which Chief Justice Roberts and Justice Kavanaugh joined.
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