The U.S. Supreme Court has determined that the National Childhood Vaccine Injury Act of 1986 (Vaccine Act) preempts state-law design-defect claims for injuries allegedly caused by vaccines. Brusewitz v. Wyeth LLC, No. 09-152 (U.S., decided February 22, 2011). The issue arose in a case involving a child who purportedly developed a seizure disorder and developmental delay after her pediatrician administered a diphtheria, tetanus and pertussis (DTP) vaccine. Additional details about the case appear in the March 18, 2010, Issue of this Report.

The child’s parents sought compensation under the federal vaccine compensation program and were awarded attorney’s fees and costs, but were otherwise denied compensation. They rejected the judgment and filed a lawsuit against the vaccine maker in state court, alleging that the vaccine’s defective design was responsible for their child’s injury. The case was removed to federal court, where both the district court and Third Circuit Court of Appeals determined that the claim was preempted by the following provision of the Vaccine Act:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

The U.S. Supreme Court majority agreed with the lower courts and interpreted this text to mean, “Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State-law design-defect claims are therefore preempted.” Writing for the majority, Justice Antonin Scalia notes that the section’s “silence regarding design-defect liability was not inadvertent. It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA [Food and Drug Administration] and the National Vaccine Program rather than juries.”

The Court majority began its analysis by considering the policy reasons for creating a vaccine compensation program, noting the importance of limiting liability to stabilize the vaccine market and facilitate compensation. This prompted dissenting justices Sonia Sotomayor and Ruth Bader Ginsburg to contend that by preempting all design-defect cases under the Vaccine Act, “the Court imposes its own bare policy preference over the considered judgment of Congress.”

According to the dissenters, the majority “excises 13 words from the statutory text, misconstrues the Act’s legislative history, and disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market.” They argue that the decision will leave “a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.” They interpret the “even though” clause in the law as referring to the absence of manufacturing and labeling defects only and contend that the “if” clause sets forth a condition (unavoidable side effects) to invoke the section’s defense to tort liability, which they would find is preserved under the law as to design defects