Draft:Berkovitz v. United States

Berkovitz v. United States, 486 U.S. 531 (1988), was a case decided by the Supreme Court of the United States.

Facts
Petitioner Kevan Berkovitz, a two-month-old infant, contracted a severe case of polio after ingesting a dose of Orimune, an oral polio vaccine manufactured by Lederle Laboratories. Berkovitz, joined by his parents as petitioners, filed a lawsuit under the Federal Tort Claims Act (FTCA), alleging violations of federal law and policy by the Division of Biologic Standards (DBS) of the National Institutes of Health, which had licensed 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 the does received by Berkovitz.

A provision of the 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". 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. 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 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."

The predominant legal question was whether the discretionary function exception of the FTCA shielded the government from liability in this case. The FTCA allows for lawsuits against the United States for certain torts committed by federal employees, but the discretionary function exception excludes liability for actions that involve the exercise of discretion and policy judgment.

The Supreme Court, in a unanimous opinion delivered by Justice Thurgood Marshall, ruled that the discretionary function exception did not apply in this case. The Court held that the DBS and FDA did not have discretion to act contrary to specific statutory and regulatory directives. Specifically, the agencies were required to ensure compliance with safety standards before licensing and releasing the vaccine. Because the plaintiffs alleged that the agencies had failed to follow these mandatory procedures, their actions did not fall under the discretionary function exception. As such, the United States could be held liable for the alleged negligence.

The decision clarified the scope of the discretionary function exception, and was described as "an important evolution in the interpretation of the exception". It emphasized that federal agencies must adhere to specific legal mandates and cannot claim immunity when failing to follow established safety regulations. This case reinforced the accountability of government agencies in regulatory matters, particularly those involving public health and safety.

"The plaintiffs alleged that the negligent conduct of the Food and drug administration in licensing a polio vaccine was related to the onset of polio in their child, who had ingested the vaccine. the court introduced a two-step test to evaluate if the discretionary function exception was applicable to the case. First, the judges must assess whether the conduct was discretionary or not: conduct cannot be discretionary if that course of action is imposed by law, regulation, or other agency prescription. in the case that the conduct is discretionary, the second limb of the test must be verified. in such a case, the judges must assess whether the conduct involves the kind of discretion that was intended to be protected through the exception. This is the case when the choices made by the governmental body are based on public policy considerations, such as balancing safety concerns with budgetary issues. In Berkovitz, the court focused mainly on the first part of the test, ruling that the discretionary function exception covers the choice of the criteria used to test the vaccine's safety, but if such criteria, once set, were violated, then the exception would not operate. Three years later, in 1991, the Supreme Court gave a judgment clarifying the second limb of the test set out in Berkovitz. According to the judges in Gaubert, the reasons behind the granting of discretion to a governmental body must be compared to the (discretionary) action taken by such a body."

"A two-part test determines when the discretionary function exception applies".

"The Supreme Court applied specific governing statutes as limits on the discretion of federal agents in Berkovitz v. United States. The plaintiff in Berkovitz, who had contracted polio after taking an oral polio vaccine, claimed that the government licensing agency had violated federal statutes and regulations that specifically governed such licensing by not collecting the required data before issuing the license for the drug. The Court ruled that the agency had no discretion to issue a license without first receiving the required test data because "to do so would violate a specific statutory and regulatory directive." The "directive" in this case was embodied both in the statute and in the regulations that governed the issuance of such a license. According to the Berkovitz Court, when a federal statute, regulation, or policy specifically prescribes a course of action for a federal agent, she has "no rightful option but to adhere to the directive.""

"Prior to Berkovitz there were three leading Supreme Court cases interpreting the discretionary function exception, Dalehite v. United States, Indian Towing Co. v. United States, and United States v. Varig. In addition, there was one court of appeals decision summarily affirmed by the Supreme Court" [Eastern Airlines v. Union Trust Co.].