Mutual Pharmaceutical Co. v. Bartlett
133 S. Ct. 2466
| SCOTUS | 2013Background
- FDCA requires FDA approval before marketing drugs; after approval, generics cannot unilaterally change label or active ingredients.
- Bartlett received a generic sulindac from Mutual; she developed toxic epidermal necrolysis, severely injuring her; FDA later urged stronger NSAID warnings.
- Bartlett sued in NH state court; Mutual removed to federal court; trial found design-defect liability based on inadequate warnings and the First Circuit affirmed.
- Supreme Court held that state-law design-defect claims premised on warnings are pre-empted by federal law under PLIVA; the generic-label-change prohibition makes compliance with both laws impossible.
- Court rejected the First Circuit’s “stop-selling” solution as incompatible with precedent; impossibility pre-emption here negates Bartlett’s NH claim for an FDA-approved drug sold interstate.
- Dissent argued for obstacle pre-emption and greater FDA deference, but the majority grounded pre-emption in the impossibility of dual compliance.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does NH design-defect claim conflict with federal labeling rules? | Bartlett: NH design-defect claim is valid despite labeling limits; design defects can be based on warnings and redesign, which conflicts with PLIVA. | Mutual: PLIVA pre-empts any claim requiring label changes by a generic; impossible to comply with both laws. | Yes; pre-empted under PLIVA as to warnings-based design defect |
| Is there an impossibility pre-emption that bars NH claims on generic drugs? | Bartlett: dual compliance is possible or, at least, not literally impossible; stop-selling is not mandated. | Mutual: cannot change labeling; continuing to sell while modifying law is impossible under federal scheme. | Impossibility pre-emption applies; dual compliance impossible |
| Does the law allow obstacle pre-emption argument to reach NH design-defect claims? | Bartlett: FDA may permit state remedies that complement regulation; preemption should not be read to erase state rights. | Mutual: obstacle pre-emption may apply but is outweighed by federal labeling regime in design-defect context. | Court did not base decision on obstacle pre-emption |
| What is the correct framework for evaluating pre-emption in prescription drugs? | Bartlett: state tort law can compensate and incentivize safety; FDA and Congress did not intend broad pre-emption. | Mutual: FDA's role and premarket approval create a safety regime that pre-empts design-defect claims not parallel to misbranding. | Majority relies on impossibility framework; minority argues obstacle pre-emption and FDA deference |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. _ (2011) (failure-to-warn claims pre-empted when label changes forbidden)
- Maryland v. Louisiana, 451 U.S. 725 (1981) (Supremacy Clause pre-emption framework)
- English v. General Electric Co., 496 U.S. 72 (1990) (implied pre-emption where dual compliance is impossible)
- Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963) (impossibility when federal and state requirements conflict)
- Mensing, 564 U.S. _ (2011) (impossibility principle applied to labeling)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (design-defect and labeling pre-emption considerations; elements-focused)
- Levine v. Wyeth, 555 U.S. 555 (2009) (state-law complements federal drug regulation; no general pre-emption)
- Riegel v. Medtronic, 552 U.S. 312 (2008) (design-defect/regulated-device pre-emption context)
- Crosby v. National Foreign Trade Council, 530 U.S. 363 (2000) (obstacle pre-emption concept in some regimes)