Berkovitz v. United States

Brief Fact Summary. Berkovitz received polio from the vaccine Orimune. Berkovitz alleged that the United States was liable for his injuries because it had acted wrongfully in licensing the production of 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.

Synopsis of Rule of Law. The discretionary function exemption in government torts actions bars suits against the government for liability only if the act complained about involves exercise of the government’s policy judgment.

Facts. 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. It was determined that Berkovitz had contracted polio from the vaccine. Berkovitz and his parents (Plaintiffs) sued the United States in Federal District Court. The complaint alleged that the United States was liable for his injuries under the FRTCA because the Division of Biologic Standards (DBS) 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. 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.

Issue. Does the discretionary function exception of the Federal Tort Claims Act bar a suit against the government if the act complained about does not involve the government’s permissive policy judgment?

Held. No. Judgment for Plaintiffs. Reversed and remanded.
* It is the nature of the conduct, rather than the status of the actor, that governs whether the discretionary function exception applies in a given case. The discretionary function exception will not apply when a federal statute, regulation, or policy specifically prescribes a course of action for an employee to follow. If the employees’ conduct cannot appropriately be the product of judgment of choice, then there is no discretion in the conduct for the discretionary function exception to protect.
* The exception protects only governmental actions and decisions based on considerations of public policy. The discretionary function insulates the Government from liability if the action challenged in the case involves the permissible exercise of policy judgment.
* The Court specifically rejected the Government’s argument that the exception precludes liability for any and all acts arising out of the regulatory programs of federal agencies. The discretionary function exception applies only to conduct that involves the permissible exercise of policy judgment. The question in this case is whether the governmental activities challenged by petitioners are of this discretionary nature.
* 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. The discretionary function exception does not apply if the acts complained of do not involve the permissible exercise of policy discretion. Petitioner’s claim regarding the release of the vaccine lot from which Kevan Berkovitz received his dose survives the Government’s motion to dismiss.

Discussion. In this case, the court envisioned a kind of two-part test for the discretionary immunity. (1) Did the government have room fro choice? (2) If so, did the choice depend upon decisions grounded in social, economic, and political policy? If the answer to either question is no, then the discretionary function does not protect the government. The first part of the test asks whether any discretion was involved at all. The second part of the test asks whether the discretion is the kind that is protected-discretion in decision making that involves social, economic, or political policy judgment.