Merck Sharp & Dohme Corp. v. Albrecht

Summary

The Court clarified the “clear evidence” standard for pre‑emption, holding that it requires a manufacturer to have fully informed the FDA of the warning’s justification and to have received FDA’s indication that it would not approve the label change, and it ruled that the pre‑emption question is a matter of law for a judge, not a jury, vacating and remanding the Third Circuit’s judgment.