Preemption of Vaccine Injury Lawsuits Upheld

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The Supreme Court decides that federal statutes preempt state lawsuits over vaccinations.

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Few issues of medical science and tort liability have riled public disagreement like that of vaccine safety in the past two decades.   Despite an overwhelming scientific and medical consensus that common childhood vaccines are safe and effective, and that their public health benefits far outweigh their incremental risks, many members of the public and the news media have perpetuated the notion that various dire diseases – most notably autism – are caused by vaccines.

This skepticism has produced both public health and litigation system consequences. In certain localities in the United States, parental objections to vaccination have resulted in a high proportion of children forgoing immunization.  Some of these areas have seen a resurgence of illnesses and deaths caused by measles, mumps, and pertussis (whooping cough) – ailments which Paul Offit has called the “diseases of [our] grandparents” since they had been successfully eradicated in the United States for decades.

Less poignant than these public health tragedies, but highly relevant to the continued availability of vaccines on the U.S. market, has been a surge of state tort lawsuits over vaccine safety. Although high-profile appellate courts in both the U.S. and U.K. have resolutely rejected unsubstantiated claims of vaccine dangers, individual state trial court litigation has continued to proliferate.

Last month, the U.S. Supreme Court entered the fray for the first time in years, ruling definitively that a certain type of vaccine design defect lawsuit was preempted by federal law. By a 6-2 ruling in the case of Bruesewitz v. Wyeth, the Court held that the National Childhood Vaccine Injury Act (NCVIA) of 1986 completely preempts state law design defect claims against makers of vaccines covered by the Act.

The NCVIA establishes a no-fault compensation system administered by the U.S. Court of Claims for claims arising from a variety of side effects associated with childhood vaccines. The Act relieves claimants of the burden of proving causation, but limits their recovery to a schedule of damages set by administrative rule.

Writing for the Court in Bruesewitz, Justice Antonin Scalia held that the NCVIA’s express preemption provision trumps the plaintiffs’ state law defective design suit alleging that the diphtheria, tetanus, and pertussis (DTP) vaccine had caused their young daughter seizures and permanent injury. The preemption provision forbids any vaccine lawsuit where “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 Court reasoned that this language “preempts all design-defect claims . . . brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”

Justices Kennedy, Thomas, Breyer, Alito and Chief Justice Roberts joined the Court’s majority. Justices Sotomayor and Ginsburg dissented on the grounds that the statutory term “unavoidable” meant unavoidable even with a significant product redesign. Justice Kagan recused herself.

The Court’s decision in Bruesewitz has important implications both for preemption jurisprudence and vaccine public policy.

On the first point, this case is the third one in three years to consider whether a federal regime for regulating therapeutic products preempts state lawsuits over those same products. In the case of vaccines and medical devices, the Court held in Riegel v. Medtronic that where Congress includes an express preemption provision in a regulatory statute, the Court will read that clause fairly broadly to preempt state tort litigation.   But in Wyeth v. Levine the Court rejected an implied preemption claim involving prescription drugs that the FDA initially supported and drug manufacturers pressed ardently. The different results in these cases suggest that, at least in the medical products area, the touchstone for the Court’s preemption inquiry will be the existence of an express statutory preemption provision.

The Court’s Bruesewitz opinion also illustrates a judicial sensitivity to the economics of vaccine production and to the public health imperatives of ensuring adequate vaccine supply and high immunization rates. Justice Scalia, the Court’s most ardent textualist, begins his opinion for the Court not with a close textual exegesis (though he would turn to that soon enough) but with a nuanced history of the tort liability explosion and the resulting crisis of limited vaccine availability that led Congress to adopt the NCVIA. Scalia reads this history to indicate that Congress sought to “stabilize the vaccine market” and, to this end, provide “significant tort liability protections for vaccine manufacturers.”  Scalia interprets the statutory preemption provision to further such goals.

In a separate concurring opinion, Justice Breyer emphasizes more completely this public policy imperative. Breyer writes that the NCVIA’s central purpose was “to protect the lives of children” by ensuring widespread vaccine availability. Breyer gives great weight to the views of health experts and the Department of Health and Human Services (HHS) that a contrary result in this case would threaten this goal.

In an era where courts are often pilloried for being tone-deaf to scientific nuance and expertise, Bruesewitz offers a contrary exemplar of a broad array of Justices effectively endorsing the consensus position of the public health and scientific establishments.

Theodore Ruger

Theodore Ruger, Professor of Law at the University of Pennsylvania Law School, teaches food and drug regulation and is a contributing author to Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation