On February 22, 2011, the United States Supreme Court ruled that the National Childhood Vaccine Injury Act1 (Vaccine Act or Act) shields vaccine manufacturers from product liability suits alleging defects in a vaccine’s design.2 The 6-2 decision3 in Bruesewitz v. Wyeth LLC affirmed that the only way parents can be compensated for the negative side effects that in rare cases accompany vaccinations is to go before a special tribunal set up by Congress to decide vaccine-injury claims. That program, established under the Vaccine Act, pays “no fault” monetary awards to individuals found to be injured by vaccines subject to the Act. This compensation program is secured by a trust fund supported by an excise tax on each vaccine dose. Fast adjudication is made possible by the Act’s Vaccine Injury Table, which lists the vaccines covered by the Act; describes each vaccine’s compensable, adverse side effects; and indicates how soon after vaccination those side effects should first manifest themselves. Claimants who show that a listed injury occurred at the appropriate time are entitled to “no fault” compensation. Unlike in tort actions, claimants are not required to show that the administered vaccine was defectively manufactured, labeled, or designed.

Lower courts had been divided over the preemptive scope of the Vaccine Act. In the decision that was affirmed by the Supreme Court, the United States Court of Appeals for the Third Circuit had held that the Act preempts all design defect claims, including those involving both negligence and strict liability claims. In contrast, the Georgia Supreme Court had held only a few years earlier that a vaccine design-defect claim is not preempted unless the vaccine manufacturer demonstrates on a case-by-case basis that there was no safer design that could have avoided the injury giving rise to the claim (American Home Products Corporation v. Ferrari, 248 Ga. 384 (2008)).

The vaccine at issue in Bruesewitz is a diphtheria-tetanus-pertussis (DPT) vaccine first approved by the federal government in 1948, with supplemental approvals in 1953 and 1970. Manufacturing of the vaccine ended in 1998. Hannah Bruesewitz’s parents filed a vaccine injury petition pursuant to the Vaccine Act’s compensation program, alleging that their daughter suffered a residual seizure disorder and developmental delay as a result of the DPT vaccine. Their claim was denied on various grounds, and they filed this lawsuit in Pennsylvania state court alleging that defective design of the DPT vaccine caused Hannah’s disabilities and that the vaccine manufacturer was subject to strict liability and liability for negligent design under Pennsylvania common law. Wyeth removed the suit to federal court, which granted summary judgment on the strict liability and negligent design claims, holding that these claims were preempted by the Vaccine Act. The Third Circuit affirmed, and the Supreme Court granted certiorari to determine whether the Vaccine Act preempts vaccine design defect claims categorically, or whether a vaccine manufacture must show, case-by-case, that the side effects at issue could have been avoided by some differently designed vaccine.

Writing for the majority, Justice Antonin Scalia affirmed the preemption holding, stating that the Vaccine Act “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries” (Bruesewitz v. Wyeth LLC (U.S. Sup. Ct. No. 09-152, February 22, 2011)). The primary statutory text at issue provides:

“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))

The majority held that under this section of the Act a vaccine’s design is not open to question in a tort action. If a vaccine manufacturer could be held liable in a civil action for failure to use a different design, the Court concluded that the overall purposes of the Vaccine Act would be frustrated. The Court reasoned that “[a] side effect could always have been avoidable by use of a differently designed vaccine not containing the harmful element. The language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design.” Accordingly, the Court concluded that the Act “plainly implies that the design itself is not open to question,” and noted the Vaccine Act expressly provides other means for achieving the beneficial effects of design-defect tort actions: (1) prompting the development of improved designs, and (2) providing compensation for inflicted injuries.

Justice Sontomayor, joined by Justice Ginsburg, in a dissenting opinion read the statutory language to mean the opposite and opined that the majority “imposes its own bare policy preference over the considered judgment of Congress.” The dissent argued that in enacting the Vaccine Act and providing for a “no fault compensation program” in lieu of state tort actions, Congress intended that the exemption from tort liability for vaccine manufacturers would only occur upon a showing by the manufacturer in each case that the vaccine was properly manufactured and labeled and the side effects stemming from the vaccine’s design could not have been prevented by a feasible alternative design that would have eliminated the adverse side effects without compromising the vaccine’s cost and utility. However, the majority of the Court rejected this position, noting that the dissent offered an insufficient explanation for how this case-by-case evaluation would be harmonious with the overall framework of the Vaccine Act.

The Court’s holding is welcome news for vaccine manufacturers and those who feared that without this preemptive effect the development and distribution of vaccines in the United States might be adversely affected. Indeed, the result takes a key legal tool out of the hands of those who contend various conditions suffered by their children, including autism, was caused by vaccines. As a practical matter, parents of children who have been injured by vaccines now have one essential chance for compensation: the “no fault” compensation program established under the Vaccine Act. Left open is whether parent’s concerns about vaccine injuries may further depress vaccination rates in the United States. The ability of the Vaccine Act to spur scientific and technological advances in the design of vaccines and for the Act’s compensation program to work faster and with greater effectiveness than the civil tort system in compensating injuries will likely play a significant role in answering that ultimate question.