Bruesewitz v. Wyeth LLC

562 U.S. 223 (2011)

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Issues

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Nature Of The Case

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Facts

To stabilize the vaccine market and facilitate compensation, Congress enacted the NCVIA in 1986. It 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 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. A special master then makes an informal adjudication of the petition within 240 days. The Court of Federal Claims must review objections to the special master's decision and enter final judgment under a similarly tight statutory deadline. 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. The Act's Vaccine Injury Table lists the vaccines covered under the Act; describes each vaccine's compensable, adverse side effects; and indicates how soon after vaccination those side effects should first manifest themselves. A claimant who shows that a listed injury first manifested itself at the appropriate time is prima facie entitled to compensation. No showing of causation is necessary; the Secretary bears the burden of disproving causation. A claimant may also recover for unlisted side effects, and for listed side effects that occur at times other than those specified in the Table, but for those, the claimant must prove causation. Claimants under the Act are not required to show that the administered vaccine was defectively manufactured, labeled, or designed. Successful claimants receive compensation for medical, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths. Attorney's fees are provided, not only for successful cases, but even for unsuccessful claims that are not frivolous. The awards are paid out of a fund created by an excise tax on each vaccine dose. Manufacturers are generally immunized from liability for failure to warn if they have complied with all regulatory requirements and have given the warning either to the claimant or the claimant's physician. They are immunized from liability for punitive damages absent failure to comply with regulatory requirements, “fraud,” “intentional and wrongful withholding of information,” or other “criminal or illegal activity.” The Act expressly eliminates liability for a vaccine's unavoidable, adverse side effects. The vaccine at issue here is a DTP vaccine manufactured by D. P was administered doses of the DTP vaccine according to the Centers for Disease Control's recommended childhood immunization schedule. Within 24 hours, she started to experience seizures. After 100 seizures in 30 days, her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” In April 1995, Ps filed a vaccine injury petition. A Special Master denied their claims on various grounds, though they were awarded $126,800 in attorneys' fees and costs. Ps rejected the unfavorable judgment, and in October 2005, filed this lawsuit in a Pennsylvania state court. Ps alleged a defective design. After the suit was removed to federal court, the court granted D summary judgment on the strict-liability and negligence design-defect claims, holding that the Pennsylvania law providing those causes of action was pre-empted by 42 U.S.C. § 300aa-22(b)(1). The Court of Appeals affirmed. P appealed.

Rule Of Law

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Holding & Decision

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Legal Analysis

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