Mut. Pharm. Co. v. Bartlett
570 U.S. 472
| SCOTUS | 2013Background
- Bartlett sues Mutual over sulindac, a generic NSAID, in NH state court; trial centers on NH design-defect liability and warnings as to unreasonably dangerous drugs.
- FDA approved Clinoril sulindac in 1978; after patent expiry, generics including Mutual entered market under Hatch-Waxman; generics must copy brand labeling and cannot unilaterally change labels.
- NH law imposes a duty to ensure products are not unreasonably dangerous, which can be satisfied by design changes or by stronger warnings; sulindac could not be redesigned under federal law and chemistry, so labeling was the avenue to mitigate risk.
- FDA later reviewed NSAID risks and recommended labeling changes to warn of toxic epidermal necrolysis; 2005 labeling revisions occurred after Bartlett’s injury.
- Bartlett prevailed at trial with a verdict against Mutual for design defect; NH Court of Appeals held NH design-defect claims not pre-empted; Supreme Court granted certiorari.
- Court holds that federal law pre-empts state-law warning-based design-defect claims for FDA-approved drugs in interstate commerce under PLIVA/Mensing framework; ruling reverses the NH appellate decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether NH design-defect claims based on warnings are pre-empted by federal law. | Bartlett argues NH duty to warn is valid design defect. | Mensing pre-empts state-law to strengthen labels on generics. | Pre-emption applies; design-defect claims related to warnings pre-empted. |
| Whether there is an impossibility conflict between NH design-defect liability and federal labeling rules. | NH law requires labeling changes to avoid danger. | Federal law forbids changing labeling for generics; impossibility. | Impossibility pre-emption established; cannot comply with both. |
| Whether the stop-selling rationale undermines impossibility pre-emption. | Stopping sale could comply with both regimes. | Stop-selling would import a workaround contrary to pre-emption doctrine. | Stop-selling rejected as misreading impossibility; not required to exit market. |
| Whether NH design-defect claim constitutes a mischaracterization of the duty as a labeling obligation. | Claim rests on design defect linked to warnings. | Labeling strength is an optional response, not a required action by state law. | NH duty to render product reasonably safe may be satisfied by warnings; not a mandated labeling change under NH law in this context. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (impossibility pre-emption for generic-label-warnings claims)
- Mensing v. Wyeth, Inc., 564 U.S. ---- (2011) (holding impossibility to strengthen labeling against federal constraints)
- Maryland v. Louisiana, 451 U.S. 725 (1981) (Supremacy Clause pre-emption of conflicting state laws)
- Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963) (impossibility analysis in dual compliance scenarios)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (design-defect claims not necessarily labeling requirements; setting precedent for pre-emption)
- Wyeth v. Levine, 555 U.S. 555 (2009) (preserves state-law remedies alongside federal drug regulation; informs pre-emption analysis)