Mutual Pharmaceutical v. Bartlett
In brief
The Supreme Court ruled for Mutual Pharmaceutical: federal law blocks state design-defect claims when they turn on whether a drug’s warnings were adequate.
- Where it stands
- Decided
Decided 5-4 · June 24, 2013 · Opinion by Justice Alito
- What it’s about
- Karen Bartlett brought a New Hampshire design-defect claim against generic-drug maker Mutual Pharmaceutical.
- Who it affects
- State design-defect claims against generic-drug makers cannot go forward when liability turns on whether the drug’s warnings were adequate.
Summary: written with AI from the case record.
What it's about
The Supreme Court ruled that federal law blocks design-defect claims when they turn on whether a drug’s warnings were adequate, overturning the First Circuit’s ruling.
The Court applied PLIVA, an earlier case about federal law and generic-drug warning claims, to Bartlett’s design-defect case.
Question presented
Does federal law preempt a state design defect claim against a generic drug manufacturer?
What the Court decided
Holding
State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. Pp. 6– 20. 678 F. 3d 30, reversed.
- Result
- Reversed
The Court's reasoning
The Court applied its PLIVA decision, concluding that federal law overrides state design-defect claims when they depend on whether a drug’s warnings were adequate.
The vote
From the opinions
“Today, the Court unnecessarily and unwisely extends its holding in Mensing to pre-empt New Hampshire’s law governing design-defects with respect to generic drugs.”
What's next
The Supreme Court has finished its work on this case; no further step is stated.
Documents
Opinions
Docket activity
New analysis added
AI analysis generated: Impact Analysis
AI analysis generated: Opinion Summary
New analysis added
AI analysis generated: Case Briefing
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AI analysis generated: Decision Record
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Opinion added: Bartlett
More questions
- What did the justices who disagreed argue?
- Justice Breyer and Justice Kagan said Mutual could comply with both laws by leaving New Hampshire or paying state damages, but that could still undermine federal goals. Justice Sotomayor and Justice Ginsburg said Bartlett’s design-defect claim was distinct, not a failure-to-warn claim in disguise.
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.