Quick Summary
Kevan Berkovitz (plaintiff) contracted polio from a vaccine licensed and released by U.S. government agencies (defendant). His family sued under the FTCA, claiming wrongful licensing and release.
The issue was whether these actions were protected by the discretionary function exception of the FTCA. The Supreme Court determined that if no permissible policy judgment was involved in these actions, then the exception did not apply, reversing the lower court’s decision.
Facts of the Case
Kevan Berkovitz (plaintiff) was a 2-month-old infant when he ingested an oral polio vaccine manufactured by Lederle Laboratories. Tragically, within a month, he developed a severe case of polio, which resulted in paralysis and respiratory issues.
The vaccine, including the specific lot containing Berkovitz’s dose, had been licensed and released by the U.S. government through the Division of Biologic Standards (DBS) and the Bureau of Biologics of the Food and Drug Administration (FDA), collectively referred to as the defendant.
The Berkovitz family brought a lawsuit against the United States under the Federal Tort Claims Act (FTCA), alleging that the government acted wrongfully in licensing the vaccine and approving its release to the public. They claimed these actions violated federal law and policies regarding the inspection and approval of polio vaccines.
Procedural History
- The district court ruled in favor of Berkovitz, rejecting the argument that the government’s actions were protected under the discretionary function exception of the FTCA.
- The United States appealed to the Court of Appeals, which reversed the district court’s decision.
- The Supreme Court of the United States granted certiorari to resolve a conflict regarding this matter.
I.R.A.C. Format
Issue
Whether the discretionary function exception of the Federal Tort Claims Act bars a suit based on the government’s licensing of an oral polio vaccine and approval of the release of a specific lot of that vaccine to the public.
Rule of Law
The discretionary function exception of the FTCA bars lawsuits that arise from governmental actions that involve judgment or choice related to policy decisions. However, if a federal statute, regulation, or policy specifically prescribes a course of action for an employee to follow, then there is no discretion for the discretionary function exception to protect.
Reasoning and Analysis
The Supreme Court analyzed whether the actions taken by the government agencies involved an element of judgment or choice. The Court found that if an agency is required by law to act in a certain way without discretion, then the discretionary function exception does not apply.
In Berkovitz’s case, if the DBS issued a license without receiving necessary test data or made a determination contrary to regulatory standards, it would not be protected by this exception.
The Court also noted that policy decisions on how to regulate vaccine lot releases are protected by the discretionary function exception. However, if the Bureau of Biologics had a policy to test all lots and not release non-compliant ones, and employees released a non-compliant lot anyway, this action would not involve protected policy judgment and could be subject to liability.
Conclusion
The Supreme Court reversed the Court of Appeals’ decision, holding that the discretionary function exception did not bar Berkovitz’s claims regarding vaccine licensing and lot release if those claims involved actions that did not include permissible policy judgment.
Key Takeaways
- The discretionary function exception of the FTCA does not apply when there is a specific directive for an employee’s action, leaving no room for discretion.
- If policy decisions are involved in carrying out an action, such as determining how to regulate vaccine lot releases, these are generally protected under the discretionary function exception.
- The Supreme Court will reverse lower court decisions if it finds that alleged wrongful acts do not involve permissible policy discretion.
Relevant FAQs of this case
What constitutes discretionary function within the scope of governmental immunity?
Discretionary functions are those that involve judgment, choice, and considerations of public policy, where government employees have the freedom to decide the best course of action among a range of options. These functions often cannot be second-guessed by courts due to separation of powers concerns.
- For example: When city planners decide where to allocate limited road maintenance resources, they use discretion that is generally protected by governmental immunity.
How does a court determine if an action is shielded by the discretionary function exception when evaluating claims under the FTCA?
The court looks for established policies or procedures that mandate a specific action by government employees. If there is a clear directive with no room for interpretation or choice, the action falls outside the discretionary function exception.
- For example: An FAA regulation requires inspectors to ground aircraft with specific critical deficiencies. If an inspector fails to do so, this mandated action would not be covered by the discretionary function exception.
In what situations can government agencies be held liable for their regulatory decisions under the FTCA?
Agencies can be held liable if they violate mandatory regulations or policies that leave no room for discretion, or if they fail to perform a nondiscretionary duty, thus causing harm. The conduct must be operational rather than discretionary and policy-based.
- For example: A building inspector who ignores clear code violations resulting in a building collapse could lead to government liability since they failed in their nondiscretionary duty to enforce safety regulations.
References
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