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."
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