Merck Sharp & Dohme Corp. v. Albrecht

Decided May 20, 2019. Stephen Gerald Breyer delivered the opinion of the Court.

Docket 17-290 · 587 U.S. 299 · Cited 108 times

“Clear evidence” that the FDA 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.

The Court’s statement of the holding, from the opinion’s syllabus. The syllabus is prepared by the Reporter of Decisions and is not part of the opinion of the Court — read the official opinion for authority.

Read the official opinion (PDF, supremecourt.gov) (opens primary source in a new tab)

Stephen Gerald Breyer’s profile · All opinions since October Term 2017 · The Supreme Court

Source: Supreme Court of the United States, slip opinions (2019). Citation count from the Free Law Project’s CourtListener bulk data. Data last verified 2026-07-02. Informational only; verify against the primary source before relying. Not a consumer report (FCRA).