Supreme Court of the United States
Merck Sharp & Dohme Corp. v. Albrecht
May 20, 2019587 U.S. 299
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.
Holding
- What is the proper “clear evidence” standard for determining FDA disapproval in a pre‑emption analysis?. “Clear evidence” means the manufacturer fully informed the FDA of the justifications for the warning required by state law and the FDA, in turn, informed the manufacturer that it would not approve a label change to include that warning.
- Is the question of whether FDA would disapprove a label change a question of law for the judge or a question of fact for a jury?. The pre‑emption question is a question of law for the judge to decide, not a factual question for a jury.
- What is the appropriate disposition of the Third Circuit’s judgment on Merck’s pre‑emption defense?. The Court vacates the Third Circuit’s judgment and remands for further proceedings consistent with the clarified “clear evidence” standard and the determination that the issue is a matter of law.
Docket 17-290
Cited authorities
- 21 U.S.C. §§355
- 21 U.S.C. § 355(b)
- 21 U.S.C. § 355(d)(7)
- 21 C.F.R. § 314.105
- 52 Stat. 1040
- 21 U.S.C. §301
- 21 U.S.C. §355
- 21 U.S.C. §321