## Facts

- Kevan Berkovitz, an infant, ingested an oral polio vaccine (Orimune) manufactured by Lederle Laboratories and allegedly contracted paralytic polio.
- The parents sued the United States under the Federal Tort Claims Act (FTCA), alleging negligence by federal officials involved in vaccine oversight.
- The complaint alleged that the Division of Biologic Standards (NIH) licensed the vaccine without first receiving and reviewing required safety data and without making required safety determinations.
- The complaint also alleged that FDA officials approved release of a specific vaccine lot that did not comply with safety standards and that mandatory policies required withholding unsafe lots.
- The district court denied the government’s motion to dismiss for lack of subject-matter jurisdiction based on the FTCA discretionary function exception.
- The Third Circuit reversed, concluding that vaccine licensing and lot release were discretionary and therefore barred by 28 U.S.C. § 2680(a).
- The Supreme Court granted review to determine how the discretionary function exception applies to these allegations.

## Issues

1. Whether the FTCA discretionary function exception shields all conduct arising from federal regulatory programs.
2. Whether § 2680(a) bars FTCA claims when plaintiffs allege federal employees failed to follow specific, mandatory statutory, regulatory, or policy directives in licensing a vaccine and releasing a vaccine lot.

## Decision

- The Supreme Court unanimously reversed and remanded.
- The discretionary function exception does not categorically immunize regulatory activity; it applies only to conduct that involves judgment or choice and is of the kind grounded in public policy.
- Allegations that agencies issued a license or released a lot in violation of specific mandatory directives are not barred by § 2680(a).
- On remand, lower courts were to determine, on a developed record, whether any challenged decisions involved protected policy-based judgment or instead reflected noncompliance with mandatory requirements.

## Legal Principles

- The discretionary function exception turns on the nature of the challenged conduct, not the actor’s status or the general label “regulatory.”
- Step one: If a statute, regulation, or policy specifically prescribes a course of action, the employee has no lawful option to depart from it; failure to follow the directive is not protected by § 2680(a).
- Step two: If the conduct involves judgment or choice, the exception applies only when that judgment is the type grounded in social, economic, or political policy that Congress intended to shield.
- Claims asserting that an agency failed to act in accord with a specific mandatory directive fall outside the discretionary function exception, even when the conduct occurs within a regulatory program.

## Conclusion

The Court held that the FTCA’s discretionary function exception is not a blanket bar for regulatory actions and does not preclude suits alleging that federal officials violated mandatory requirements in vaccine licensing and lot release; such claims may proceed subject to factual determinations on remand regarding whether any challenged decisions were protected policy-based judgments.


Berkovitz v. United States, 486 U.S. 531 (1988)