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SUPREME COURT OF THE UNITED STATES



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Berkovitz by Berkovitz v United States of America 486 U S 531 June 13 1988 SUPREME COURT OF THE UNITED STATES CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT The opinion of the court was delivered by Marshall A provision of the Federal Tort Claims Act FTCA excepts from statutory liability any claim based upon a federal agency s or employee s exercise or performance or the failure to exercise or perform a discretionary function or duty Upon contracting a severe case of polio after ingesting a dose of Orimune an oral polio vaccine manufactured by Lederle Laboratories petitioner Kevan Berkovitz a minor joined by his parents also petitioners as guardians filed an FTCA suit alleging violations of federal law and policy by the National Institutes of Health s Division of Biologic Standards DBS in licensing Lederle to produce Orimune and by the Bureau of Biologics of the Food and Drug Administration FDA in approving the release to the public of the particular lot of vaccine containing Berkovitz s dose The District Court denied the Government s motion to dismiss the suit for lack of subject matter jurisdiction but the Court of Appeals reversed Although rejecting the Government s argument that the discretionary function exception bars all claims arising out of federal agencies regulatory activities the court held that the licensing and release of polio vaccines are wholly discretionary actions protected by the exception Held 1 The language purpose and legislative history of the discretionary function exception as well as its interpretation in this Court s decisions establish that the exception does not preclude liability for any and all acts arising out of federal agencies regulatory programs but insulates from liability only those governmental actions and decisions that involve an element of judgment or choice and that are based on public policy considerations Pp 535 539 2 The Court of Appeals erred in holding that the discretionary function exception



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