The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) , 42 U.S.C. §§ 300aa-1 et seq., expressly preempts state-law claims against vaccine manufacturers if the injury or death giving rise to such a claim “resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning.” 42 U.S.C. § 300aa-22(b)(1). The lower courts are divided over the scope of that provision. On March 8, 2010, the Supreme Court granted certiorari in Bruesewitz v. Wyeth, No. 09-152, to decide whether the Vaccine Act categorically preempts all design-defect claims against vaccine manufacturers, or whether instead the preemption of particular design-defect claims must be decided on a case-by-case basis.

This case is, obviously, of greatest interest to vaccine manufacturers. If the Court holds that preemption under the Vaccine Act must be determined on a case-by-case basis, manufacturers will likely be exposed to increased litigation brought by plaintiffs alleging injuries from vaccinations. But, as the latest in a series of preemption cases heard by the Court over the past decade, the case could, depending on the breadth of the Court’s analysis, also prove significant to participants in other highly regulated industries in which state-law claims remain a threat.

In the decision below, the Third Circuit held that the Vaccine Act preempts all design-defect claims, including both negligence and strict-liability claims. See 561 F.3d 233 (3d Cir. 2009). The Georgia Supreme Court, by contrast, had previously held that a design defect claim is not preempted unless the manufacturer demonstrates, on case-by-case basis, that there was no safer design that could have avoided the injury giving rise to the claim.

Absent extensions, amicus briefs in support of the petitioner will be on due April 29, 2010, and amicus briefs in support of the respondent will be due on June 1, 2010. Any questions about the case should be directed to Andrew Tauber (+1 202 263 3324) in our Washington, DC office.

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