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Law School Case Brief

Bruesewitz v. Wyeth LLC - 562 U.S. 223, 131 S. Ct. 1068 (2011)


The National Childhood Vaccine Injury Act of 1986 establishes a no-fault compensation program designed to work faster and with greater ease than the civil tort system. A person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. 42 U.S.C.S. § 300aa-11(a)(1). A special master then makes an informal adjudication of the petition within (except for two limited exceptions) 240 days. 42 U.S.C.S. § 300aa-12(d)(3).The Court of Federal Claims must review objections to the special master's decision and enter final judgment under a similarly tight statutory deadline. § 300aa-12(e)(g). At that point, a claimant has two options: to accept the court's judgment and forgo a traditional tort suit for damages, or to reject the judgment and seek tort relief from the vaccine manufacturer. 42 U.S.C.S. § 300aa-21(a).


The National Childhood Vaccine Injury Act of 1986 (“NCVIA” or “Act”) created a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult. The Act provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the Health and Human Services Secretary as the respondent; that the court must resolve the case by a specified deadline; and that the claimant can then decide whether to accept the court's judgment or reject it and seek tort relief from the vaccine manufacturer. Awards are paid out of a fund created by an excise tax on each vaccine dose. As a quid pro quo, manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine's unavoidable, adverse side effects.

Hannah Bruesewitz's parents filed a vaccine injury petition in the Court of Federal Claims, claiming that Hannah became disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by Lederle Laboratories (now owned by respondent Wyeth). After that court denied their claim, they elected to reject the unfavorable judgment and filed suit in Pennsylvania state court, alleging, inter alia, that the defective design of Lederle's DTP vaccine caused Hannah's disabilities, and that Lederle was subject to strict liability and liability for negligent design under Pennsylvania common law. Wyeth removed the suit to the Federal District Court. It granted Wyeth summary judgment, holding that the relevant Pennsylvania law was preempted by 42 U.S.C. § 300aa-22(b)(1), 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.


Was Hannah Bruesewitz's parents’ claim for their child's disability preempted by the National Childhood Vaccine Injury Act of 1986?




Affirming, the Supreme Court of the United States held that the National Childhood Vaccine Injury Act of 1986 preempted the parents' design-defect claim against the manufacturer seeking compensation for injury to the child allegedly caused by the vaccine's side effects. The design of the vaccine was not subject to question in a tort action since a vaccine side-effect could always be avoidable by use of a different vaccine not containing the harmful element, and what the Vaccine Act established as a complete defense was unavoidability, given safe manufacture and warning, with respect to the particular design. Further, although products-liability law established three grounds for liability--defective manufacture, inadequate warnings, and defective design--the Vaccine Act mentioned only manufacture and warnings, and the failure to mention design-defect liability was by deliberate choice, not inadvertence.

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