Loge v. United States
1980 U.S. Dist. LEXIS 14698, 494 F. Supp. 883 (1980)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
The discretionary function exception of the Federal Tort Claims Act (FTCA) immunizes the government from liability for actions involving policy judgment and regulatory decisions, but does not apply when government employees fail to follow mandatory regulations. However, even if the discretionary function exception does not apply, the government can only be held liable under the FTCA if a private person would be liable under like circumstances, and states generally do not impose a tort duty on private persons for analogous regulatory activities.
Facts:
- Mr. and Mrs. Roger Loge decided to have their infant son inoculated with a live polio vaccine.
- Mrs. Loge chose not to subject herself to the risk involved in being vaccinated.
- On July 26, 1976, their infant son received a trivalent live poliomyelitis vaccine manufactured under the tradename “Orimune.”
- After the infant's inoculation, Mrs. Lora Loge contracted polio, which rendered her permanently paralyzed.
- Mrs. Loge's poliomyelitis was caused by the 'shed virus' from the inoculation given to her child.
- Non-shed-virus vaccines were available at the time.
Procedural Posture:
- Mr. and Mrs. Roger Loge (plaintiffs) filed a lawsuit against the United States (defendant) in the United States District Court, seeking damages under the Federal Tort Claims Act and for constitutional rights violations.
- The United States filed a motion to dismiss the Loges' complaint.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Does the discretionary function exception of the Federal Tort Claims Act bar a claim against the government for negligence in licensing a vaccine and approving a vaccine lot, and if not, does the government owe a tort duty for such actions under state law that would allow a cause of action?
Opinions:
Majority - Paul X Williams, Chief Judge
No, the discretionary function exception of the Federal Tort Claims Act does not bar a claim against the government for failing to comply with mandatory regulations when licensing a vaccine or approving a vaccine lot, but the government does not owe a tort duty under state law in such circumstances to allow a cause of action. The court first rejected the government’s argument that the FTCA imposes liability only for acts actionable if performed by individuals, citing Indian Towing Co. v. United States for the principle that the government is liable if a private person would be liable under 'like circumstances.' The court then analyzed the discretionary function exception, holding that the promulgation of regulations, policy decisions regarding vaccine types (shed-virus versus non-shed-virus), and the content of package warnings are discretionary functions protected by immunity, consistent with Dalehite v. United States. However, the court found that the government’s actions were not discretionary regarding two specific allegations: (1) licensing Orimune without requiring data establishing its freedom from harmful effect on one million susceptible persons, as mandated by 21 C.F.R. § 630.10(b), and (2) failing to follow mandatory tests when approving Lederle Lot Number 451-162. The court concluded that adherence to mandatory regulations is not discretionary. Despite these two allegations not being barred by the discretionary function exception, the court ultimately held that they failed to state a cause of action because, under Arkansas and Washington D.C. law, no tort duty is imposed on a private person for activities analogous to the granting or denial of drug licenses, referencing Gelley v. Astra Pharmaceutical Products, Inc. Applying Restatement (Second) of Torts § 324A, the court determined that licensing the vaccine did not increase the inherent risk, did not constitute undertaking the drug manufacturer's duty, and the harm suffered was not caused by reliance on the government. Finally, the court dismissed the constitutional claims, stating that the Constitution does not guarantee freedom from personal injury under these circumstances.
Analysis:
This case significantly limits the scope of government liability under the Federal Tort Claims Act (FTCA), particularly regarding regulatory activities. It clarifies that while the government is not immune when it fails to adhere to its own mandatory regulations (thus bypassing the discretionary function exception), plaintiffs still face the hurdle of establishing a common law tort duty under state law for actions analogous to government licensing and approval. The decision emphasizes the principle that the FTCA merely waives sovereign immunity where a private person would be liable, not to create new causes of action for purely governmental functions. This ruling makes it challenging to sue the government for regulatory failures unless there's a clear state law analogue creating such a duty.
