Source: https://supreme.justia.com/cases/federal/us/486/531/
Timestamp: 2019-10-17 12:37:55
Document Index: 550400347

Matched Legal Cases: ['§ 262', '§ 73', '§ 601', '§ 351', '§ 262', '§ 73', '§ 601']

Berkovitz v. United States :: 486 U.S. 531 (1988) :: Justia US Supreme Court Center
Justia › US Law › US Case Law › US Supreme Court › Volume 486 › Berkovitz v. United States
Governments are shielded from liability in tort actions under the discretionary function exemption if the conduct leading to the victim's harm involved a policy judgment by a government official.
A child, Berkovitz, received a dose of a polio vaccine that had been produced by Lederle Laboratories. As a result, he contracted polio and ultimately suffered from paralysis that left him dependent on a respirator. Once it was determined that the vaccine was responsible for his illness, he sued the federal government for licensing the laboratory to make the vaccine and approving the release of the vaccine.
In response, the U.S. argued that the claim should be dismissed under the discretionary function exemption of the Federal Tort Claims Act, which removed this type of matter from the jurisdiction of the courts. The trial court denied the government's motion, but the appellate court granted it.
Reviewing the specific allegations in the claim, it appeared that the government never received the necessary data from the laboratories before approving the application to make the vaccine. This decision to grant a license without the necessary data does not fall within the discretion of the government, since it was prohibited by law and its own regulations from doing so. While the government did not have an obligation to examine all of the lots of the vaccine under its own regulations, the government had voluntarily assumed the responsibility of testing vaccine lots for compliance with safety standards and withholding non-compliant lots from the public. There was no discretion regarding the implementation of this policy either. Thus, the discretionary function exemption under the FTCA did not apply.
For discretionary immunity to apply, the government must have had the ability to make a choice that depended on decisions of social, economic, or political policy. In other words, there must be not only discretion but discretion regarding a protected government function.
(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
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
In restating and clarifying the scope of the discretionary function exception, we intend specifically to reject the Government's argument, pressed both in this Court and the Court of Appeals, that the exception precludes liability for any and all acts arising out of the regulatory programs of federal agencies. That argument is rebutted first by the language of the exception, which protects "discretionary" functions, rather than "regulatory" functions. The significance of Congress' choice of language is supported by the legislative history. As this Court previously has indicated, the relevant legislative materials demonstrate that the exception was designed to cover not all acts of regulatory agencies and their employees, but only such acts as are "discretionary" in nature. [Footnote 4] See Dalehite v. United States, supra, at 346 U. S. 33-34.
Petitioners' suit raises two broad claims. First, petitioners assert that the DBS violated a federal statute and
Under federal law, a manufacturer must receive a product license prior to marketing a brand of live oral polio vaccine. See 58 Stat. 702, as amended, 42 U.S.C. § 262(a). In order to become eligible for such a license, a manufacturer must first make a sample of the vaccine product. See 42 CFR § 73.3 (Supp.1964); 21 CFR § 601.2 (1987). [Footnote 7] This process
Petitioners' first allegation with regard to the licensing of Orimune is that the DBS issued a product license without first receiving data that the manufacturer must submit showing how the product, at the various stages of the manufacturing process, matched up against regulatory safety standards. See App. 12-13; Brief for Petitioners 5-6. The discretionary function exception does not bar a cause of action based on this allegation. The statute and regulations described above require, as a precondition to licensing, that the DBS receive certain test data from the manufacturer relating to the product's compliance with regulatory standards. See § 351(d), 58 Stat. 702-703, as amended, 42 U.S.C. § 262(d) (providing that a license shall issue "only upon a showing" by the manufacturer); 42 CFR § 73.3 (Supp.1964); 21 CFR § 601.2 (1987) (providing that application for license shall be deemed as filed only upon receipt of relevant test data). The DBS has no discretion to issue a license without first receiving the required test data; to do so would violate a specific statutory
Petitioners' other allegation regarding the licensing of Orimune is difficult to describe with precision. Petitioners contend that the DBS licensed Orimune even though the vaccine did not comply with certain regulatory safety standards. See App. 12; Brief for Petitioners 4-6. [Footnote 9] This charge may be understood in any of three ways. First, petitioners may mean that the DBS licensed Orimune without first making a determination as to whether the vaccine complied with regulatory standards. Second, petitioners may intend to argue that the DBS specifically found that Orimune failed to comply with certain regulatory standards, and nonetheless issued a license for the vaccine's manufacture. Third, petitioners may concede that the DBS made a determination of compliance, but allege that this determination was incorrect. Neither
If petitioners' claim is that the DBS made a determination that Orimune complied with regulatory standards, but that the determination was incorrect, the question of the applicability of the discretionary function exception requires a somewhat
The regulatory scheme governing release of vaccine lots is distinct from that governing the issuance of licenses. The former set of regulations places an obligation on manufacturers to examine all vaccine lots prior to distribution to ensure that they comply with regulatory standards. See 21 CFR
Given this regulatory context, the discretionary function exception bars any claims that challenge the Bureau's formulation of policy as to the appropriate way in which to regulate the release of vaccine lots. Cf. id. at 467 U. S. 819-820 (holding that discretionary function exception barred claim challenging FAA's decision to establish a spot-checking program). In addition, if the policies and programs formulated by the Bureau allow room for implementing officials to make independent policy judgments, the discretionary function exception protects the acts taken by those officials in the exercise of this discretion. Cf. id. at 467 U. S. 820 (holding that discretionary function exception barred claim that employees charged with executing the FAA's spot-checking program made negligent policy judgments respecting the proper inspection of airplanes). The discretionary function exception, however, does not apply if the acts complained of do not involve the permissible exercise of policy discretion. Thus, if the Bureau's policy leaves no room for an official to exercise policy judgment in performing a given act, or if the act simply does
Viewed in light of these principles, petitioners' claim regarding the release of the vaccine lot from which Kevan Berkovitz received his dose survives the Government's motion to dismiss. Petitioners allege that, under the authority granted by the regulations, the Bureau of Biologics has adopted a policy of testing all vaccine lots for compliance with safety standards and preventing the distribution to the public of any lots that fail to comply. Petitioners further allege that, notwithstanding this policy, which allegedly leaves no room for implementing officials to exercise independent policy judgment, employees of the Bureau knowingly approved the release of a lot that did not comply with safety standards. See App. 13; Brief for Petitioners 20-21; Reply Brief for Petitioners 15-17. Thus, petitioners' complaint is directed at a governmental action that allegedly involved no policy discretion. Petitioners, of course, have not proved their factual allegations, but they are not required to do so on a motion to dismiss. If those allegations are correct -- that is, if the Bureau's policy did not allow the official who took the challenged action to release a noncomplying lot on the basis of policy considerations -- the discretionary function exception does not bar the claim. [Footnote 13] Because petitioners may yet show,