Summary of Berkowitz v. U. S., S. Ct 486 US 531 
Defenses: Govt/Govt Contractor Immunity
Relevant Facts: Kevan Berkowitz, a two month old infant, ingested a dose of Orimune, an oral polio vaccine. W/i one month he contracted a severe case of polio which left him almost completely paralyzed and unable to breath w/o assistance. The Communicable Disease Center, a Fed agency determined that he had contracted polio from the vaccine. His parents complaint alleged US is liable for his injuries b/c Division of Biologic Standards (DBS) had acted wrongfully in licensing Orimune which violated federal law and policy regarding inspection/approval of polio vaccines.
Legal Issue(s): Whether the discretionary function exception of the Fed Tort Claims Act bars a suit based on the Govt’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?
Court’s Holding: The discretionary function exception does not bar a claim that does not involve policy discretion.
Procedure: Govt filed Motion to Dismiss in D. Ct. DENIED; D. Ct certified its decision for immediate appeal to Ct App; REVERSED; Cert granted; REVERSED.
Law or Rule(s): No liability shall lie for any claim based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of the federal agency or an employee of the Govt, whether or not the discretion involved be abused.
Court Rationale: 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. The exception, protects only governmental actions and decisions based on considerations of public policy. The exception insulates the Govt from liability if the action challenged involves the permissible exercise of policy judgment. A claim challenging the decision by DBS to issue a license w/o having received the required test data is not barred by the exception. The PET’s claim charges a failure to perform its clear duty under federal law. When a suit charges an agency w/ failing to act in accord w/ a specific mandatory directive, the exception does not apply. Pet’s claim regarding the release of the vaccine lot from which Kevan received his dose survives the Govt’s Motion to Dismiss. The Pet’s complaint is directed at a governmental action that allegedly involved no policy discretion, Pets are not required to prove their factual assertions to overcome the Motion to Dismiss.
Plaintiff’s Argument: DBS violated federal statute and regulations in issuing a license to produce Orimune. The Bureau of Biologics violated federal regs and policy in approving the release of the particular lot of Orimune.
Defendant’s Argument: The exception precludes liability for any and all acts arising out of the regulatory programs of federal agencies.