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PRODUCT LIABILITY: AIDS VACCINE MANUFACTURERS SHOULD BE PROTECTED

Executive Summary

PRODUCT LIABILITY: AIDS VACCINE MANUFACTURERS SHOULD BE PROTECTED from strict liability for vaccines approved by FDA, Genentech Chief Counsel Paul DeStefeno, suggested at an April 6 hearing of the Presidental Commission on the Human Immunodeficiency Virus Epidemic. "Our proposal is that manufacturers be shielded from strict liability for [those] vaccines (1) which are approved by the FDA as being safe and efficacious; (2) for which there was full disclosure to the FDA during the course of clinical trials -- there were no potential side effects or adverse reactions" hidden from FDA; (3) which are sold in accordance with FDA labeling; and (4) for which the known effects are disclosed to the potential consumer," DeStefeno said. The commission held the hearing to discuss with experts the societal and legal issues of HIV disease, including: liability for vaccines; costs to society; drug abuse; liability for transmission of the virus; epidemics of the past and implications for the future; and boarder babies and foster care. DeStefeno pointed out that "the limitations on liability that industry is talking about are not complete insulation of potential manufacturers from liability for injuries resulting from the vaccines, it is the elimination of liability [when] there is no fault." "Those who believe that there is a liability problem may propose shielding vaccine producers from liability for adverse reactions as a solution," Wendy Mariner, associate professor of health law at Boston University, noted. "What may not be widely recognized is that special immunity for liability would be a major change in the law." Mariner said that she has yet to hear reasons why AIDS vaccines "should be treated differently from all other vaccines or all other drugs or all other products." She added: "If we make an exception, we have to have a good reason unless we are prepared to make changes for the rest of the liability system." DeStefeno pointed to California's liability statute (AB4250) as a possible model for the federal government's response to the AIDS vaccine liability issue. He noted that the California law is specific to AIDS vaccines and provides protection against strict liability for certain adverse effects from AIDS vaccines manufactured by California companies. DeStefeno stressed the need for a federal response. "I believe that the process of going through state legislatures will result in dramatic inconsistency state to state, and we're trying to provide equitable, agreeable incentives to research for vaccine innovation," he said. "I can't see any way except to go around the tort system, go around the tort system, go around the lawyers, [and] put caps on it," AIDS commission panel member Burton James Lee III, MD, Memorial Sloan-Kettering Cancer Center, remarked. He noted that the pharmaceutical industry is "terrified of the liability problem because you can destroy their economy." DeStefeno and Mariner agreed that one would have to deviate from the tort system in order to solve the liability issue. "I would love to see the tort system shaped up," Mariner said. She added, however, that complete elimination of liability for manufacturers would mean a "reliance upon the FDA's approval process, and as much respect as I have for FDA, I'm not convinced that that should be the only basis for being able to insure that the drugs and vaccines that you have are safe and effective." Commission Chairman James Watkins noted that the issues and recommendations discussed at the hearing will aid in preparation of the panel's final report to President Reagan, due June 24. The commission's interim report was sent to the President on March 15. An early draft of the report was presented by Watkins at a Feb. 24 press conference ("The Pink Sheet" Feb. 29, p. 5).
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