## Facts

- In 1992, Hannah Bruesewitz received a DTP vaccine manufactured by Lederle Laboratories (later owned by Wyeth).
- Within hours, she developed seizures, was hospitalized, and later suffered ongoing seizure-related impairments requiring substantial care, according to her parents.
- Her parents filed a petition for compensation in the federal Vaccine Court under the National Childhood Vaccine Injury Act of 1986 (NCVIA).
- The Vaccine Court denied compensation, concluding the claim did not satisfy the applicable standards after regulatory changes removed her alleged condition from the compensable injury table.
- The parents then sued Wyeth under Pennsylvania law, alleging the vaccine was defectively designed and seeking damages under strict-liability and negligent-design theories.
- Wyeth obtained summary judgment on the ground that NCVIA § 300aa-22(b)(1) preempts state-law design-defect claims; the Third Circuit affirmed.

## Issues

1. Whether 42 U.S.C. § 300aa-22(b)(1) preempts state-law design-defect claims against vaccine manufacturers for injuries allegedly caused by vaccine side effects.

## Decision

- The Supreme Court affirmed, holding (6–2) that the NCVIA preempts all state-law design-defect claims against vaccine manufacturers for vaccine-related injury or death.
- The Court interpreted § 300aa-22(b)(1) to bar civil liability for “unavoidable” side effects when the vaccine was properly prepared and accompanied by proper directions and warnings.
- The majority reasoned that allowing design-defect suits would render the statute’s “even though” clause largely ineffective because plaintiffs could always assert that side effects were avoidable through an alternative design.
- The Court relied on the statute’s structure and purpose—creating a no-fault compensation program funded by an excise tax while providing manufacturers substantial tort protections to stabilize vaccine supply.
- Justice Breyer concurred, emphasizing legislative history and regulatory context supporting preclusion of juries second-guessing federally regulated vaccine design.
- Justice Sotomayor, joined by Justice Ginsburg, dissented, reading “unavoidable” as preserving some design-defect claims where a safer feasible design could have prevented the injury.

## Legal Principles

- NCVIA § 300aa-22(b)(1) expressly preempts state-law design-defect claims against vaccine manufacturers for injuries resulting from vaccine side effects, provided the vaccine was properly prepared and carried proper directions and warnings.
- “Unavoidable” in § 300aa-22(b)(1) is read within the Act’s integrated compensation-and-liability scheme, not as importing common-law design-defect standards that require case-by-case inquiry into alternative feasible designs.
- The NCVIA channels most vaccine-injury compensation into a federal, no-fault administrative process, while preserving limited tort avenues chiefly for manufacturing defects and inadequate warnings.

## Conclusion

The Court held that Congress, through the NCVIA, displaced state tort design-defect litigation for covered vaccines by providing a federal compensation program and granting manufacturers immunity from design-defect liability for unavoidable side effects when statutory conditions are satisfied.


Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011)