The case of Bruesewitz v. Wyeth LLC, No. 09-152 was among the more closely watched this Term, with the possibility of a broad ruling concerning the preemptive effect of federal administrative regimes on state tort law. Earlier this week, the Court issued its decision, holding that the National Childhood Vaccine Injury Act preempts state law design defect claims. While the decision represents an important victory for vaccine manufacturers, the Court’s rationale was ultimately quite narrow and rooted in the text of the Act itself.
The case arose from a state law claim alleging that a vaccine for diphtheria, tetanus, and pertussis (DTP) was defectively designed. The lower courts held that the claim was preempted by the Act, and the Supreme Court affirmed. As the majority opinion explained, “in the 1970’s and 1980’s vaccines became, one might say, victims of their own success. They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases, and much more concerned with the risk of injury from the vaccines themselves.” As a result, product liability suits climbed dramatically by the mid-1980’s, to the point that two of the three manufacturers of DTP vaccine withdrew from the market, and the third estimated that its potential tort liability exceeded annual sales by a factor of 200. At the same time, vaccination rates were declining, in part because of concerns about obtaining compensation for vaccine-related injuries.
To address these problems, in 1986, Congress passed the National Childhood Vaccine Injury Act. The Act provides a no-fault, administrative compensation program based on a table that lists side effects for each vaccine and a time period within which such side effects typically occur. For listed side effects occurring within the listed time period, causation is deemed established; for non-listed side effects, or side effects outside the listed period, compensation is still available, but a showing of causation is required. Successful claimants are paid from a fund created by an excise tax on each vaccine dose. Attorney’s fees are also covered, even for unsuccessful claimants. Claimants seeking more than $1,000 must proceed via this administrative process. After final judgment is rendered by a special master, claimants have the option of accepting the judgment, or rejecting it and filing a tort suit.
The Act also includes limits on vaccine manufacturers’ tort liability, include the following provision: “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.” 42 U.S.C. § 300aa-22(b)(1).
In a 6-2 decision, the Court held that this provision preempts design defect claims: “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.” The majority opinion, written by Justice Scalia, is principally a close interpretation of the statutory text. The majority also emphasizes the fact that the Act provides not only federally prescribed compensation but also “federal agency improvement of vaccine design,” including by FDA licensing and by provisions requiring vaccine manufacturers to report adverse side effects, thus reflecting a choice by Congress “to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”
In addition, the majority made a point of noting that, notwithstanding the Court’s prior expression of “doubt” that Congress would “quietly preempt product-liability claims without providing a federal substitute, … we have never suggested we would be skeptical of preemption unless the congressional substitute operated like the tort system.” This is the closest the majority comes to addressing the presumption against preemption addressed in previous cases. (The dissent, in contrast, references the presumption in a footnote as “an additional reason” against finding preemption).
The majority also discussed the legislative history, albeit grudgingly: “Since our interpretation of [the statute] is the only interpretation supported by the text and structure of the [Act], even those of us who believe legislative history is a legitimate tool of statutory interpretation have no need to resort to it.” Most significantly, the majority declined to rely on legislative history attached to a subsequent funding measure for the Act, bluntly stating: “Post-enactment legislative history (a contradiction in terms) is not a legitimate tool of statutory interpretation…. Many provisions of federal law depend on appropriations or include sunset provisions; they cannot be made the device for unenacted statutory revision.”
Justice Breyer, though joining the majority opinion in full, concurred to express his view that “the textual question considered alone is a close one,” and thus he would “look to other sources, including legislative history, statutory purpose, and the views of the federal administrative agency, here supported by expert medical opinion.” In an opinion joined by Justice Ginsburg, Justice Sotomayor dissented. Justice Kagan did not participate.