Litigation Alert: Supreme Court Rules the National Childhood Vaccine Injury Act of 1986 Bars State-Law Design-Defect Claims Against Vaccine Manufacturers

Date: Mar 01, 2011

On February 22, 2011, the United States Supreme Court held that the National Childhood Vaccine Injury Act of 1986 (NCIVIA or Act) bars state-law design-defect claims against vaccine manufacturers. The Bruesewitz family sued Wyeth, then the parent company of the maker of the diphtheria, tetanus, and pertussis (DTP) vaccine that Hannah Bruesewitz received as an infant, arguing that Wyeth was responsible for Hannah's condition and should be held accountable. The high court disagreed. Justice Antonin Scalia delivered the opinion.

Section 22(a) of the Vaccine Act sets forth the rule that "State law shall apply to a civil action brought for damages for a vaccine-related injury or death." 42 U.S.C. Sect. 300aa-22(a). This rule is subject to three narrow exceptions, one of which was at issue in this case. Specifically, section 22(b)(1) of the Act 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."

Before addressing the merits of the case, Justice Scalia explored the evolution of the vaccine industry and the Act, noting that in the 1970's and the 1980's, vaccines became "victims of their own success," in that "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." The DTP vaccine, associated with children's disabilities and developmental delays, led to a massive increase in vaccine-related tort litigation, said Scalia. "This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer, Lederle Laboratories [purchased by Respondent Wyeth in 1994], estimated that its potential tort liability exceeded its annual sales by a factor of 200."

To "stabilize the vaccine market and facilitate compensation," Congress enacted the Vaccine Act in 1986. Under the Act, a person injured by a vaccine can file a petition for compensation in the United States Court of Federal Claims. A special master makes an informal adjudication of the petition within 240 days; the Court of Federal Claims then reviews any objections to that decision and enters final judgment under a similarly tight statutory deadline. The claimant can either accept the court's judgment, or reject the judgment and seek tort relief from the vaccine manufacturer. The quid pro quo for the generous compensation of the scheme under the Act, said Scalia, "was the provision of significant tort liability protections for vaccine manufacturers." Specifically, the Act requires claimants to seek relief through the compensation program before filing suit for more than $1,000; immunizes manufacturers from liability for failure to warn if they have complied with all regulatory requirements and have given warnings either to the claimant or her physician; and eliminates liability for a vaccine's unavoidable, adverse side effects under section 22(b)(1), said Justice Scalia.

Turning to the merits of the case, Scalia noted that Hannah Bruesewitz, born on October 20, 1991, was administered doses of the DTP vaccine according to the Centers for Disease Control's (CDC) recommended childhood immunization schedule. Within 24 hours of her 1992 vaccination, she started experiencing seizures and suffered over 100 such seizures during the next month. Her doctors diagnosed her with "residual seizure disorder" and "developmental delays." Hannah's parents first filed a vaccine injury petition in the US Court of Federal Claims, alleging that Hannah suffered from on-Table residual seizure disorder and other injuries. Their claims were denied. Rejecting the unfavorable judgment, the Bruesewitz's filed this lawsuit in Pennsylvania state court in October of 2005. The complaint alleged that "defective design of [the] DTP vaccine caused Hannah's disabilities, and that [Wyeth] was subject to strict liability, and liability for negligent design, under Pennsylvania common law." Wyeth removed the suit to the US District Court for the Eastern District of Pennsylvania, which granted summary judgment on the strict-liability and negligence claims, holding that the Pennsylvania law providing those causes of action was preempted by the Act. The Third Circuit affirmed and the Supreme Court granted certiorari.

The majority held that to the extent there was "proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable" under the Act. Thus, "[s]tate-law design-defect claims are … preempted," said Scalia. The majority argued that "[i]f a manufacturer could be held liable for failure to use a different design, the word "unavoidable" would do no work. A side effect of a vaccine 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."

Justice Stephen Breyer concurred, but like the dissent, relied on other sources, including legislative history, statutory purpose, and the views of the federal administrative agency to decide the close, but "purely textual" question. For example, Justice Breyer noted that the House Committee Report (Report) lists two specific kinds of tort suits that the clause does not pre-empt – suits based on improper manufacturing and improper labeling. The Report then says that compensation for other tort claims, such as design-defect claims, lies in the Act's no-fault "compensation system, not the tort system." Like the majority, Breyer ascribed significance to routine vaccination, noting that it is "one of the most spectacularly effective public health initiatives this country has ever undertaken." Breyer also noted that threats of tort suits had a tendency of forcing manufacturers out of the vaccine business. Finally, Justice Breyer argued that "Congress sought to provide generous compensation to those whom vaccines injured." Thus, "to read the preemption clause as preserving design-defect suits seems anomalous."

Justice Sonia Sotomayor and Justice Ruth Bader Ginsburg dissented, noting that vaccine manufacturers "have long been subject to a legal duty, rooted in basic principles of products liability law, to improve the designs of their vaccines in light of advances in science and technology. Until today, that duty was enforceable through a traditional state-law tort action for defective design." Criticizing the majority opinion, Justice Sotomayor writes:

"In holding that [the Act] pre-empts all design defect claims for injuries stemming from vaccines covered under the Act, the Court imposes its own bare policy preference over the considered judgment of Congress. In doing so, the Court 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. Its decision leaves 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."

Justice Sotomayor argued that because Sect. 22(b)(1) is "invoked by vaccine manufacturers as a defense to tort liability, it follows that the ‘even though' clause requires a vaccine manufacturer in each civil action to demonstrate that its vaccine is free from manufacturing and labeling defects to fall within the liability exemption of Sect. 22(b)(1)." Finally, Justice Sotomayor argued that the majority's decision was based on "a policy preference" that it is better "to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries." Whatever the merit of that contention, "the decision to bar all design-defect claims against vaccine manufacturers is one that Congress must make, not this Court." "[G]iven the lack of robust competition in the vaccine market, [manufacturers] will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins," said Sotomayor.

Authors' Note: This is yet another in the Supreme Court's long line of unpredictable and irreconcilable federal preemption of state-law product liability lawsuits.[1] Just one day after issuing this opinion, for example, the high court decided Williamson v. Mazda, unanimously holding that the federal Department of Transportation (DOT) regulation that gave manufacturers some leeway in what kinds of seatbelts to install did not preempt a defective design claim that Mazda should have installed both shoulder and lap belts in a seat in the plaintiffs' minivan. On March 30, 2011, the high court will also hear oral arguments in Demahy v. Actavis and Mensing v. Wyeth. In those cases, the Fifth and Eighth Circuit extended the Supreme Court's decision in Wyeth v. Levine, 129 S. Ct. 1187 (2009) - that FDA labeling approval for brand-name drugs does not preempt state laws - to generic drugs as well. The Ninth Circuit followed suit in Gaeta v. Perrigo. The question before the Supreme Court is whether Wyeth v. Levine in fact applies to claims against generic drug makers, as three circuit courts have now held. We will continue to monitor and report on this important line of cases..

[1] See also, Cipollone v. Liggett Group, Inc. 505 U.S. 504 (1992) - federally mandated warnings do not bar smokers from suing manufacturers under state personal-injury laws; Riegel v. Medtronic, Inc. 552 U.S. 312 (2008) – the Medical Device Amendments of 1976 (MDA) and its preemption clause bar common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA; Sprietsma v. Mercury Marine, 537 U.S. 51 (2002) – the Federal Boat Safety Act of 1971 (FBSA) does not preempt state common-law claims related to propeller safety; Geier v. American Honda Motor Co., Inc. 529 U.S. 861 (2000) - the National Traffic and Motor Vehicle Safety Act of 1996 preempts a stricter state rule requiring automobile manufacturers to install a driver-side airbag; Bates v. Dow AgroSciences LLC, 544 U.S. 431 (2005) – Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) does not preempt farmers' state tort claims alleging that Dow's herbicide damaged their crops; and Wyeth v. Levine, 129 S. Ct. 1187 (2009) – Federal regulatory approval of a medication does not shield manufacturer from liability under state law.