486 U.S. 531 (1988), 87-498, Berkovitz v. United States
|Docket Nº:||No. 87-498|
|Citation:||486 U.S. 531, 108 S.Ct. 1954, 100 L.Ed.2d 531, 56 U.S.L.W. 4549|
|Party Name:||Berkovitz v. United States|
|Case Date:||June 13, 1988|
|Court:||United States Supreme Court|
Argued April 19, 1988
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE THIRD CIRCUIT
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 [108 S.Ct. 1956] 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. 535-539.
2. The Court of Appeals erred in holding that the discretionary function exception bars petitioners' claims. Pp. 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
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. 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. 545-548.
822 F.2d 1322, reversed and remanded.
MARSHALL, J., delivered the opinion for a unanimous Court.
MARSHALL, J., lead opinion
JUSTICE MARSHALL delivered the opinion of the Court.
The question in this case is whether the discretionary function exception of the Federal Tort Claims Act (FTCA or Act), 28 U.S.C. § 2680(a), bars a suit based on the Government's licensing of an oral polio vaccine and on its subsequent approval of the release of a specific lot of that vaccine to the public.
On May 10, 1979, Kevan Berkovitz, then a 2-month-old infant, ingested a dose of Orimune, an oral polio vaccine manufactured by Lederle Laboratories. Within one month, he contracted a severe case of polio. The disease left Berkovitz almost completely paralyzed and unable to breathe without the assistance of a respirator. The Communicable Disease Center, an agency of the Federal Government, determined that Berkovitz had contracted polio from the vaccine.
Berkovitz, joined by his parents as guardians, subsequently filed suit against the United States in Federal District Court.1 The complaint alleged that the United States was liable for his injuries under the FTCA, 28 U.S.C. §§ 1346(b), 2674, because the Division of Biologic Standards (DBS), then a part of the National Institutes of Health, had acted wrongfully in licensing Lederle Laboratories to produce Orimune, and because the Bureau of Biologics of the Food and Drug Administration (FDA) had acted wrongfully in approving release to the public of the particular lot of vaccine containing Berkovitz's dose. According to petitioners, these actions violated federal law and policy regarding the inspection and approval of polio vaccines.
The Government moved to dismiss the suit for lack of subject matter jurisdiction on the ground that the agency actions fell within the discretionary function exception of the FTCA. The District Court denied this motion, concluding
that neither the licensing of Orimune nor the release of a specific lot of that vaccine to the public was a "discretionary function" within the meaning of the FTCA. Civ. Action No. 84-2893 (WD Pa., Apr. 30, 1986). At the Government's request, the District Court certified its decision for immediate appeal to the Third Circuit pursuant to 28 U.S.C. § 1292(b), and the Court of Appeals accepted jurisdiction.
A divided panel of the Court of Appeals reversed. 822 F.2d 1322 (1987). The court initially rejected the Government's argument that the discretionary function exception bars all claims arising out of the regulatory activities of federal agencies. The court stated that "the discretionary function exception is inapplicable to nondiscretionary regulatory actions," id. at 1328, and noted that employees of regulatory agencies have no discretion to violate the command of federal statutes or regulations. Contrary to petitioners' claim, however, the court held that federal law imposed no duties on federal agencies with respect to the licensing of polio virus vaccines or the approval of the distribution of particular vaccine lots to the public. Likening the applicable regulatory scheme to the scheme found to confer discretionary regulatory authority in United States v. Varig Airlines, 467 U.S. 797 (1984), the court concluded that the licensing and release of polio vaccines were wholly discretionary actions and, as such, could not form the basis for suit against the United States. A dissenting judge argued that the relevant statutes and regulations obligated the DBS to require [108 S.Ct. 1958] the submission of test data relating to a vaccine from the manufacturer and to deny a license when the test data showed that the vaccine failed to conform with applicable safety standards. Reading the complaint in this case as alleging a failure on the part of the DBS to act in accordance with these directives, the dissenting judge concluded that the discretionary function exception did not bar petitioners' suit.
We granted certiorari, 484 U.S. 1003 (1988), to resolve a conflict in the Circuits regarding the effect of the discretionary
function exception on claims arising from the Government's regulation of polio vaccines. Compare 822 F.2d 1322, supra, with Baker v. United States, 817 F.2d 560, 564-566 (CA9 1987) (holding that discretionary function exception did not bar suit alleging a negligent decision to license a polio vaccine); Loge v. United States, 662 F.2d 1268, 1272-1273 (CA8 1981) (holding that discretionary function exception did not bar suit alleging negligence in both the licensing of a polio vaccine and the release of a particular vaccine lot). We now reverse the Third Circuit's judgment.
The FTCA, 28 U.S.C. § 1346(b), generally authorizes suits against the United States for damages
for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.2
The Act includes a number of exceptions to this broad waiver of sovereign immunity. The exception relevant to this case provides that no liability shall lie for
[a]ny claim . . . based upon the exercise or performance or the failure to...
To continue readingFREE SIGN UP