Berkovitz v. United States

Background

Kevan Berkovitz was a two-month-old infant who received a dose of Orimune, an oral polio vaccine made by Lederle Laboratories, and within a month developed severe polio. The Communicable Disease Center concluded the disease came from the vaccine. Berkovitz and his parents sued the United States under the Federal Tort Claims Act, arguing the Division of Biologic Standards (later the FDA’s Bureau of Biologies) wrongly licensed the vaccine and approved release of the particular lot containing his dose without following required safety procedures.

Reasoning

The Court examined whether the FTCA’s discretionary-function exception — which protects government policy choices from suit — bars these claims. The Court explained that the exception applies only when officials exercise genuine policy judgment. Where a statute or regulation mandates a specific act, like receiving required test data, examining a product, and determining compliance before issuing a license, officials have no discretion and the exception does not apply. For claims that an agency simply made a wrong scientific judgment, the Court left it to the lower court to decide whether that judgment involved protected policy discretion. For lot-release rules, the Court said policy choices are protected, but alleged approvals made in violation of a mandatory internal policy or without discretion are not barred.

Real world impact

The Court reversed the appeals court and sent the case back for further proceedings. Claims that an agency failed to follow mandatory licensing or lot-release requirements can go forward, while claims that challenge discretionary regulatory policy remain protected. This decision requires courts to examine whether officials had real discretion in safety approvals.