Bruesewitz v. Wyeth LLC
179 L. Ed. 2d 1, 2011 U.S. LEXIS 1085, 562 U.S. 223 (2011)
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Rule of Law:
The National Childhood Vaccine Injury Act's provision shielding manufacturers from liability for a vaccine's 'unavoidable' side effects, when the vaccine is properly prepared and accompanied by proper warnings, pre-empts all state-law tort claims alleging defective design.
Facts:
- Hannah Bruesewitz was born on October 20, 1991.
- In April 1992, as part of a routine immunization schedule, Hannah received a dose of the DTP vaccine manufactured by Lederle Laboratories.
- Within 24 hours of receiving the vaccination, Hannah began to experience seizures.
- She suffered over 100 seizures in the following month.
- Doctors eventually diagnosed Hannah with a 'residual seizure disorder' and 'developmental delay.'
- Respondent Wyeth later purchased Lederle Laboratories.
Procedural Posture:
- The Bruesewitzes filed a petition in the U.S. Court of Federal Claims under the National Vaccine Injury Compensation Program.
- A Special Master denied their claim.
- The Bruesewitzes rejected the judgment of the Court of Federal Claims.
- The Bruesewitzes filed a tort action against Wyeth in Pennsylvania state court, alleging defective design and failure to warn.
- Wyeth removed the case to the U.S. District Court for the Eastern District of Pennsylvania.
- The District Court granted summary judgment for Wyeth, holding that the NCVIA pre-empted the design-defect claims.
- The U.S. Court of Appeals for the Third Circuit affirmed the District Court's judgment.
- The U.S. Supreme Court granted certiorari to resolve the pre-emption question.
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Issue:
Does the National Childhood Vaccine Injury Act of 1986, which bars liability for a vaccine's 'unavoidable' side effects if the vaccine was properly prepared and accompanied by proper warnings, pre-empt state-law tort claims alleging that a vaccine was defectively designed?
Opinions:
Majority - Justice Scalia
Yes. The National Childhood Vaccine Injury Act pre-empts state-law design-defect claims against vaccine manufacturers. The statute's text at 42 U.S.C. § 300aa-22(b)(1) grants manufacturers immunity from liability for a vaccine's 'unavoidable' side effects 'even though the vaccine was properly prepared and was accompanied by proper directions and warnings.' The 'even though' clause clarifies that if a vaccine is properly manufactured and labeled, any remaining side effects from its design are legally deemed 'unavoidable.' To allow a design-defect claim would render the word 'unavoidable' meaningless, as a plaintiff could always argue a side effect was avoidable through a different design. Furthermore, the statute's specific mention of manufacturing and warning defects, while omitting design defects, suggests a deliberate choice to exclude the latter as a basis for liability. The Act's overall structure, which establishes a no-fault compensation program in exchange for tort protection, reinforces the conclusion that Congress intended to leave complex vaccine design judgments to the FDA rather than to juries.
Dissenting - Justice Sotomayor
No. The National Childhood Vaccine Injury Act does not pre-empt all state-law design-defect claims; it only provides a defense if the manufacturer proves in each case that the vaccine's side effects were truly 'unavoidable.' The conditional 'if' clause in the statute ('if the injury... resulted from side effects that were unavoidable') necessitates a case-specific inquiry. The term 'unavoidable' is a term of art derived from comment k of the Restatement (Second) of Torts, which required a showing that no feasible alternative design existed. The majority's interpretation renders 13 words of the statute superfluous; had Congress intended a categorical ban, it would have simply conditioned immunity on proper preparation and warnings. This reading also ignores the Act's default rule preserving state law and leaves a 'regulatory vacuum' where neither the FDA nor tort law provides an incentive for manufacturers to improve vaccine designs.
Concurring - Justice Breyer
Yes. While the text alone presents a close question, the statute's purpose, legislative history, and relevant expert opinion all support pre-emption of design-defect claims. The legislative history indicates Congress intended for those who cannot prove a manufacturing or warning defect to use the no-fault compensation system, 'not the tort system.' Allowing design-defect claims would undermine the Act's core purpose of stabilizing the vaccine market by reintroducing the unpredictability of jury verdicts. It would anomalously substitute the 'less expert' judgment of juries for the 'more expert judgment' of the FDA and other health agencies, which Congress empowered to make these complex scientific determinations.
Analysis:
This decision provides a robust shield for vaccine manufacturers against a major category of tort liability, solidifying the 'quid pro quo' arrangement at the heart of the NCVIA. By foreclosing design-defect claims, the Court significantly narrows the avenues for recovery in the traditional tort system for those who reject the Act's no-fault compensation program. This interpretation shifts the ultimate authority for determining the appropriateness of a vaccine's design from state-court juries to federal regulators like the FDA. The ruling reduces litigation risk and market uncertainty for manufacturers but also limits the role of the tort system in incentivizing the development of safer alternative vaccine designs.
