On February 22, 2011, the U.S. Supreme Court decided Bruesewitz v. Wyeth LLC, No. 09-152, holding that the National Childhood Vaccine Injury Act of 1986 preempts all design-defect claims against vaccine manufacturers in which the plaintiff seeks compensation for injury or death caused by a vaccine's side effects.

Hannah Bruesewitz was born in 1991. She received a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by Lederle (which was later acquired by Wyeth) when she was six months old. Within 24 months of her vaccination, she developed residual seizure disorder and was developmentally delayed.

Hannah's parents sued Wyeth in the Court of Federal Claims in accordance with the special procedure required by the National Childhood Vaccine Injury Act of 1986 (NCVIA). The special master denied their claim on various grounds. The Bruesewitzes rejected the unfavorable judgment and filed suit in state court, after which Wyeth removed to federal court.

The district court granted summary judgment to Wyeth, holding that the Bruesewitzes' state-law strict-liability and negligent-design claims were preempted by the NCVIA, which provides that "[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." The Third Circuit affirmed the dismissal on appeal.

The Supreme Court affirmed in a 6-2 decision. The Court held that under the NCVIA, as long as the vaccine was "properly prepared and accompanied by proper directions and warnings," any side effects are deemed to have been "unavoidable" and therefore not actionable. If people could sue for defective design, the word "unavoidable" would do no work, because a vaccine's side effect could always be avoided through use of a differently-designed vaccine. The Court bolstered its conclusion by observing that of the three well-known grounds for products liability—defective manufacture, inadequate warning, and defective design—the NCVIA expressly preserved two of them (defective manufacture and inadequate warning). It is unlikely that Congress intended to preserve two grounds expressly while preserving a third (defective design) only by implication.

Justice Scalia delivered the opinion of the Court, in which Chief Justice Roberts and Justices Kennedy, Thomas, Breyer, and Alito joined. Justice Sotomayor filed a dissenting opinion, in which Justice Ginsburg joined.

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