Skip to content

Note: Immunity for Vaccine Manufacturers: The Vaccine Act and Preemption of Design Defect Claims

By Eva B. Stensvad. Full text here.

Vaccines are one of the most important medical advancements in history. Childhood immunization efforts are widely promoted by state and federal governments as well as medical professionals and institutions. While routine pediatric vaccines prevent many lethal and debilitating diseases, they also carry the potential to cause injury. Predictably, the occurrence of these injuries often leads to litigation against the vaccine manufacturers. The National Childhood Vaccine Injury Act of 1986 sought to address the issues of vaccine safety, compensation for vaccine-related injuries, and liability protection for vaccine manufacturers. The Act expressly preempts design defect claims for “unavoidable” side effects. Two courts have recently clashed in their interpretations of this language—the Georgia Supreme Court held that the language requires a case-by-case determination that the injury or side effect was unavoidable, while the Court of Appeals for the Third Circuit held that it preempts all design defect claims. After granting a writ of certiorari, the U.S. Supreme Court is now poised to determine the preemptive scope of the Vaccine Act.

The Note argues that the holdings of both courts are incorrect. While the Georgia Supreme Court correctly asserts that the Vaccine Act requires some case-by-case analysis, it fails to address who should undertake this analysis and whether it has already been performed with respect to routine childhood vaccines. Congress, and the institutions and agencies through which it operates, is the appropriate body for determining whether the benefits of particular vaccines justify their risks. In encouraging and, in some cases, mandating particular childhood vaccines, Congress has already made these determinations, rendering these vaccines “unavoidably unsafe” and shielding their manufactures from design defect claims. The federal government leads the way in national vaccine policy and must continue to do so to ensure the stability and supply of the vaccine market. Allowing such design defect claims could cripple the nation’s immunization programs and threaten the health and life of every American.