Congress enacted the NCVIA in 1986. The Act establishes a no-fault compensation program, whereby a person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. A special master then makes an informal adjudication of the petition within (except for two limited exceptions) 240 days. The Court of Federal Claims must review objections to the special master’s decision and enter final judgment under a similarly tight statutory deadline. At that point, a claimant has two options: to accept the court’s judgment and forgo a traditional tort suit for damages, or to reject the judgment and seek tort relief from the vaccine manufacturer. Manufacturers are generally immunized from liability for failure to warn if they have complied with all regulatory requirements (including but not limited to warning requirements) and have given the warning either to the claimant or the claimant’s physician. They are immunized from liability for punitive damages absent failure to comply with regulatory requirements, fraud, intentional and wrongful withholding of information, or other criminal or illegal activity. And the Act expressly eliminates liability for a vaccine’s unavoidable, adverse side effects: “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.” The Special Master rejected the claims brought by the Bruesewitz family, who elected to file a complaint in Pennsylvania State Court alleging that the defective design of the DTP vaccine caused the teenage daughter’s severe disabilities, and that the manufacturer was therefore subject to liability under Pennsylvania common law. Rejecting the claims as a matter of law, the Court held as follows: “The ‘even though’ clause clarifies the word that precedes it. It delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered ‘unavoidable’ under the statute. Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. If 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. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. Which plainly implies that the design itself is not open to question.” See Bruesewitz v. Wyeth, 131 S.Ct. 1068 (2011).
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