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Executive Summary

FDA LIABILITY FOR APPROVALS WILL BE CONSIDERED BY U.S. SUPREME COURT, with the upcoming review of a case involving a Pennsylvania boy who was paralyzed with poliomyelitis after receiving Lederle's Orimune oral live trivalent polio vaccine. Lederle has settled with the petitioner, Kevan Berkovitz, who when less than three months old in 1979, was given Orimune. The high court, which announced on Jan. 11 the cases it has agreed to review, will focus on the liability of a federal government agency with authority to approve such products and regulate them. The case could be heard at any time before the end of the current term, which lasts until Sept. 30, or, possibly, into the next term. In asking the Supreme Court to review the case, the petitioners representing Berkovitz charged that the federal government was negligent both in approving Orimune and in clearing a virus production "seed" for use in manufacture. Petitioners charged that "agency employees acted without lawful authority in issuing a license" for Orimune because the "attenuated live poliovirus strain which had been developed by Dr. Alber Sabin and tested in the Soviet Union . . . was not tested in accordance with these regulations." Secondly, the petition contends that the dose received by Berkovitz, which was produced from a "seed virus" designated "45 B 85," was "excessively neurovirulent." The seed virus "had not been subjected by the manufacturer to all required testing and had failed some of the tests which were performed." Therefore, the petition argues, "agency employees acted without lawful authority in licensing 45 B 85 for vaccine production in the absence of the required showing that the virus had been subject to all required testing and complied with all regulatory standards." Further, "the agency employee who reviewed the test results knew" the lot was excessively neurovirulent, the petition maintains. Both the petition and the government response, signed by U.S. Solicitor General Charles Fried and Assistant Attorney General Richard Willard, asked the Supreme Court to grant the petition for a writ of certiorari and review the case. The petitioners point out that the Third Circuit ruling in the Berkovitz case is at odds with decisions by the Eight and Ninth Circuit Courts, which ruled that the government has no discretion to waive legislative and regulatory standards for polio vaccine products. The government said the Ninth Circuit ruling permits lawsuits seeking damages based on a federal agency decision to approve the oral polio vaccine. Such tort actions "pose a serious threat to the continued availability of this life-saving vaccine," the government maintained, because each year "a small number of persons suffer adverse reactions to the Sabin oral polio vaccine." The government argued that it has a "discretionary function exception," as described in a 1984 Supreme Court ruling involving an airline accident that occurred after spot checking by the Federal Aviation Administration. Such discretion in applying standards is appropriate "where the government seeks to walk a razor's edge between overcaution and undue haste," the response states.

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