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BERKOVITZ V. UNITED STATES, 486 U. S. 531 (1988)

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U.S. Supreme Court

Berkovitz v. United States, 486 U.S. 531 (1988)

Berkovitz v. United States

No. 87-498

Argued April 19, 1988

Decided June 13, 1988

486 U.S. 531


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.


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. 486 U. S. 535-539.

2. The Court of Appeals erred in holding that the discretionary function exception bars petitioners' claims. Pp. 486 U. S. 539-548.

(a) Statutory and regulatory provisions require the DBS, prior to issuing a license for a product such as Orimune, to receive all data which the manufacturer is required to submit, to examine the product, and to make a determination that it complies with safety standards. Thus, a cause of action based on petitioner's allegation that the DBS licensed Orimune without first receiving the required safety data is not barred by the discretionary function exception, since the DBS has no discretion to chanroblesvirtualawlibrary

Page 486 U. S. 532

issue a license under such circumstances, and doing so would violate a specific statutory and regulatory directive. Petitioners' other claim -- that the DBS licensed Orimune even though the vaccine did not comply with certain regulatory safety standards -- if interpreted to mean that the DBS issued the license without determining compliance with the standards or after determining a failure to comply, also is not barred by the discretionary function exception, since the claim charges the agency with failing to act in accordance with specific mandatory directives, as to which the DBS has no discretion. However, if this claim is interpreted to mean that the DBS made an incorrect compliance determination, the question of the discretionary function exception's applicability turns on whether the DBS officials making that determination permissibly exercise policy choice, a point that is not clear from the record and therefore must be decided by the District Court if petitioners choose to press this interpretation. Pp. 486 U. S. 540-545.

(b) Although the regulatory scheme governing the public release of vaccine lots allows the FDA to determine the appropriate manner in which to regulate, petitioners have alleged that, under the authority granted by the regulations, the FDA has adopted a policy of testing all lots for compliance with safety standards and of preventing the public distribution of any lot that fails to comply, and that, notwithstanding this mandatory policy, the FDA knowingly approved the release of the unsafe lot in question. Accepting these allegations as true, as is necessary in reviewing a dismissal, the holding that the discretionary function exception barred petitioners' claim was improper, since the acts complained of do not involve the permissible exercise of discretion to release a noncomplying lot on the basis of policy considerations. Pp. 486 U. S. 545-548.

822 F.2d 1322, reversed and remanded.

MARSHALL, J., delivered the opinion for a unanimous Court. chanroblesvirtualawlibrary

Page 486 U. S. 533

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