In the U.S. Supreme Court’s first major vaccine-related ruling in more than 15 years, the justices held that design defect claims against vaccine manufacturers are pre-empted under the National Childhood Vaccine Injury Act. 42 U.S.C.A. § 300aa-22(b)(1). The decision in Bruesewitz v. Wyeth, 131 S. Ct. 1068 (Feb. 22, 2011), represented a broad application of the act’s scope and means that vaccine manufacturers will no longer be subject to liability under state tort law under most circumstances. Although much of the Court’s analysis centered on statutory interpretation, public policy considerations were evident in both the majority and dissenting opinion.

In 1986, Congress enacted the statute, which established a federal no-fault system for compensating vaccine-related injuries. According to Court submissions, the act was prompted by an increase in vaccine tort litigation that resulted in a numerical decrease in firms producing and distributing vaccinations — from 26 in 1967 to four by 1985. Brief for GlaxoSmithKline PLC, et al. as Amici Curiae Supporting Respondents at 7, Bruesewitz, No. 09-152 (U.S. July 23, 2010). Consequently, the declared purpose of the statute was to stabilize the vaccine market by limiting insurance and litigation costs for manufacturers, while providing a streamlined adjudication process for claimants.

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