The Secretary of Health, Education and Welfare has no discretion to disregard the mandatory regulatory commands pertaining to criteria a vaccine must meet before licensing its manufacture or releasing a particular lot of vaccine for distribution to the public.
Plaintiff polio victim and husband appealed from an order of the United States District Court for the Western District of Arkansas, which dismissed their complaint alleging liability of defendant United States and unknown employees of the Department of Health, Education, and Welfare (HEW) under the Federal Tort Claims Act (FTCA), 28 U.S.C. §§ 1346(b), 2671 et seq., on the ground that it failed to state a cause of action. Victim contracted polio after her infant son was inoculated with a live virus vaccine that also immunized persons who came into contact with the recipient through a "shed virus." The polio victim contracted the disease through exposure to the shed virus, and she and her husband filed suit against the United States and the HEW under the FTCA, based on the HEW's alleged negligence in licensing the live virus without certain safety testing, including certain testing mandated by the HEW's existing regulations. The trial court dismissed the complaint for failure to state a cause of action.
To the extent that the plaintiff’s amended complaint may be construed to state a claim attacking the government for a regulatory omission, did the district court err in concluding that a discretionary function is implicated, thus immunizing the government from suit?
The court affirmed the dismissal of all but two of the claims, holding that the FTCA did not waive sovereign immunity from claims based upon an agency's failure to perform a discretionary function, and the alleged failure to require testing of the shed virus involved the nonperformance of such a function. The court reversed as to two claims that HEW negligently failed to enforce existing regulations because the alleged failure to enforce was not a discretionary function, but was a failure for which HEW could be liable under Arkansas law.The case was remanded for further proceedings as to the dismissal of claims of polio victim and husband under the FTCA alleging that the United States negligently violated its own regulations requiring a pharmaceutical company to test a live virus vaccine before receiving a license to manufacture the vaccine.