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Vaccine Manufacturers Are Immunized Against Design-Defect Claims

by Greg Marcum, JD, PE on February 23rd, 2011

The U.S. Supreme Court ruled yesterday that federal law preempts state law tort claims for injury or death caused by design-defects in vaccines. Under a federal statute, the National Childhood Vaccine Injury Act of 1986 (NCVIA), vaccine manufacturers are protected from “costly tort litigation” through preemption of all state court claims for injury or death caused by vaccine side-effects. The only recourse available to  injured parties is filing a claim in the Court of Federal Claims (CFC), which may pay out of a fund created by an excise tax on each vaccine dose.

A Pennsylvania couple (Bruesewitzes) alleged their infant daughter became disabled after receiving the DTP vaccine in 1992. The CFC rejected their claim and the couple filed a products liability action in state court. Wyeth (vaccine manufacturer) removed the case to federal court where it obtained summary judgment based on preemption of Pennsylvania law by the NCVIA. The Supreme Court affirmed, holding vaccine manufacturers cannot be held liable for civil damages arising from vaccine-related injury or death associated with a vaccine after 10/01/1986. Justice Scalia delivered the opinion of the Court; J. Sotomayor and J. Ginsburg dissented. Scalia’s closing rationale was that taxing the product manufacturers, but leaving them open to design defect liability “would hardly coax them back into the market.” Hannah Bruesewitz, now 19, suffers from residual seizure disorder and will require lifelong care.

Four firms supply vaccines for the U.S. market – Wyeth, GlaxoSmithKline PLC, Merck & Co., and Sanofi-Aventis SA. They contend their products are generally safe, but rare side-effects can occur. They also contend the vaccine business is not profitable and they need the liability protection to ensure such drugs are available and affordable.

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