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Bruesewitz v. Wyeth, Inc. - 508 F. Supp. 2d 430


The National Childhood Vaccine Injury Act of 1986 (Vaccine Act), 42 U.S.C.S. § 300aa-1 et seq., limits a manufacturer's liability for design defects regardless of the cause of action. The phrase "a civil action for damages" encompasses products liability claims based on negligence as well as those based on strict liability. While the Restatement (Second) of Torts § 402A comment k is restricted to strict liability claims, 42 U.S.C.S. § 300aa-22(b) is not. 

The National Childhood Vaccine Injury Act of 1986 (Vaccine Act), 42 U.S.C.S. § 300aa-1 et seq., clearly bars failure-to-warn claims based on a failure to directly warn the injured party or the injured party's legal representatives. 42 U.S.C.S. § 300aa-22(c). However, allegations of a failure to warn doctors and medical intermediaries are not subject to the prohibition of § 22(c). Even so, the Vaccine Act also grants a vaccine manufacturer the presumption of a proper warning if the manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act. 42 U.S.C.S. § 300aa-22(b)(2). The Vaccine Act imposes a burden of production on the manufacturer to show material compliance with Food & Drug Administration (FDA) regulations. Once the manufacturer meets that burden, however, the burden shifts to the plaintiff to present evidence that the manufacturer engaged in fraud or wrongful withholding of information from the Secretary of Health and Human Services either during or after the approval process, or by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with the laws and regulations regarding drug approval proceedings. 42 U.S.C.S. §§ 300aa-22(b)(2)(A) and (B)


Minor plaintiff, Hannah Bruesewitz, received her third diphtheria-pertussis -tetanus ("DPT") vaccine in April, 1992. At the time of this vaccination, the Advisory Committee on Immunization Practices recommended administration of the DPT vaccine five times, at approximately 2, 4, 6 and 15-18 months, and 4-6 years of age. Born on October 20, 1991, Hannah received the first three doses of the DPT vaccine according to this recommendation. After her third vaccination, Hannah suffered a seizure, and was subsequently diagnosed with "residual seizure disorder" and "developmental delay." 

At the time of Hannah's vaccination, the Food and Drug Administration ("FDA") had already approved defendant's application for an alternative DPT vaccine (trade name, ACEL-IMUNE(R)) that contained "an acellular pertussis component."

The parents sued the manufacturers of the vaccine alleging that the manufacturers negligently failed to produce a safer vaccine despite knowledge of the existence and feasibility of such safer alternatives. The complaint also alleged that the manufacturers negligently failed to warn of the actual dangers associated with the particular batch DPT vaccine administered to their child and that the manufacturers were strictly liable for a design defect. Finally, the complaint also alleged strict liability for a manufacturing defect.


Whether the Vaccine Act preempted the allegations of design defect.




The court found that the Vaccine Act preempted the allegations of design defect because Congress did not intend to allow a case-by-case determination as to whether a vaccine was unavoidably unsafe. While the failure to warn claim was not preempted because it involved the warning to the doctor, the manufacturers were entitled to the presumption of proper warning with their approved vaccine and the parents failed to rebut the presumption.

Defendant relied on the Declaration of Dennis J. Foley, Ph.D., and the exhibits attached thereto to demonstrate that throughout its history of use, from 1943 until it was taken from the market in 1998, TRI-IMMUNOL(R) was licensed by the appropriate federal agency. Moreover, the FDA approved the package insert containing the warning provided along with the vaccine administered to Hannah Bruesewitz. Most importantly, plaintiffs did not dispute that the warning provided by defendant complied with the relevant federal laws and regulations. Defendant was therefore entitled to the presumption that TRI-IMMUNOL(R) was "accompanied by proper directions and warnings." Plaintiffs failed to present "clear and convincing" evidence that defendant failed to exercise due care.

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