Drug warnings and lawsuits
Merck Sharp & Dohme v. Albrecht
In brief
The Court defined what counts as “clear evidence,” wiped out the appeals court’s ruling, and sent the case back without deciding whether Merck’s defense succeeds.
- Where it stands
- Decided
Decided 9-0 · May 20, 2019 · Opinion by Justice Breyer
- What it’s about
- Fosamax users sued Merck over its warning label; Merck said FDA action barred their claims.
- Who it affects
- The appeals court must use the Court’s “clear evidence” standard to assess Merck’s argument that federal FDA action blocked the users’ claims; whether that argument succeeds remains unresolved.
Summary: written with AI from the case record.
What it's about
The Court defined “clear evidence” as Merck fully informing the FDA why state law required the warning and the FDA telling Merck it would not approve it; it wiped out the appeals ruling (vacated it) and sent the case back (remanded), leaving the preemption issue unresolved.
The dispute centered on whether the FDA’s rejection of a proposed Fosamax warning showed the agency would not approve the warning state law allegedly required.
Question presented
Whether the FDA’s rejection of a proposed warning constitutes clear evidence that it would not have approved a change to the drug’s label, preempting state-law failure-to-warn claims?
What the Court decided
Holding
1. “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. 852 F. 3d 268, vacated and remanded.
- Result
- Vacated
The Court's reasoning
The Court said “clear evidence” requires proof that Merck fully explained to the FDA why state law required the warning and that the FDA then told Merck it would not approve adding it to the label. It did not decide whether Merck met that standard.
The vote
- Joined the judgment
- Concurred in a separate opinion
- Wrote an opinion
- Majority · 6joined the Court's opinion
What's next
The case goes back to the Third Circuit for further proceedings under the Court’s standard. Whether Merck can use FDA action to defeat the users’ claims remains unresolved.
Documents
Docket activity
New analysis added
AI analysis generated: Case Briefing
AI analysis generated: Decision Record
Case data updated: summary, question_presented, generation_metadata
Case data updated: question_presented, extraction_metadata
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Opinion added: Albrecht
Opinion added: opinion
Brief added: Questions Presented
More questions
- Why did Justice Alito agree only with the result?
- He agreed that courts should decide whether federal law allowed Merck to add the warning, but worried the Court’s discussion could mislead the lower court.
Sources
Primary materials plus reporting. Best-effort analysis: this explainer relies on a mix of primary materials and trusted secondary sources. Official filings and opinions remain authoritative.