SCOTUS Grants Review in Vaccination Preemption Case
Yesterday the U.S. Supreme Court granted a petition for writ of certiorari in Bruesewitz v. Wyeth, Inc. and will review the Third Circuit’s holding that a plaintiffs’ design defect claims against the manufacturer of a vaccination were expressly preempted by the 1986 National Childhood Vaccination Injury Act (“NCVIA”) and that plaintiffs failed to establish a manufacturing defect or a warning defect claim under the Act.
In a footnote in the Bruesewitz opinion the Third Circuit had distinguished the Supreme Court’s opinion in Wyeth v. Levine in which the Court held that federal law did not preempt state tort claims that alleged that a drug manufacturer failed to adequately warn of the dangers associated with a drug on the basis that unlike the NCVIA, there was no express preemption provision in the Food, Drug, and Cosmetic Act (“FDCA”). Another distinguishing factor was Congress’ silence on the issue of preemption in the FDCA “coupled with its certain awareness of the prevalence of state tort litigation” which was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” as the Court stated in Levine. In addition, the Third Circuit noted that Levine recognized that under federal law, a drug manufacturer could strengthen a drug’s label without preapproval from the FDA, which “stands in contrast to the FDA’s far-more extensive control and oversight of the drug’s design and alternation.”
Also the Third Circuit had disagreed with the interpretation of the Georgia Supreme Court on this issue. In American Home Products Corp. v. Ferrari (in which a petition for writ of certiorari is pending), the Georgia high court had ruled that the Vaccine Act “clearly did not preempt all design defect claims against vaccine manufacturers, but rather provides that such a manufacturer cannot be held liable for defective design, if it is determined, on a case-by-case basis, that a particular vaccine was unavoidably unsafe.” The Third Circuit noted in Bruesewitz that if the NCVIA was interpreted to permit a case-by-case analysis of whether “particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court.”
It will be interesting to see how the Supreme Court resolves the split between the Third Circuit and the Georgia Supreme Court on this issue.
