Opinion ID: 404179
Heading Depth: 2
Heading Rank: 2

Heading: Liability Under the Swine Flu Act.

Text: 41 Many of the claims under the Swine Flu Act that were consolidated in the Multidistrict Litigation for pretrial procedures have now been tried. 7 No reported decision by a federal court of appeals has yet considered claims of liability against the United States arising under the Swine Flu Act. These issues, therefore, present matters of first impression to this court. 42 The district court in this case held the United States liable for its negligence in failing to give Robert Petty adequate warning of the risks and benefits of receiving the swine flu vaccine. The court based its conclusion of liability on the Government's failure to comply with 42 U.S.C. § 247b(j)(1)(F), which provided for 43 (t)he development, in consultation with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and implementation of a written informed consent form and procedures for assuring that the risks and benefits from the swine flu vaccine are fully explained to each individual to whom such vaccine is to be administered. Such consultation shall be completed within two weeks after enactment of this Act, or by September 1, 1976, whichever is sooner. Such procedures shall include the information necessary to advi(s)e individuals with respect to their rights and remedies arising out of the administration of such vaccine. (Footnote omitted.) 44 We do not agree with the district court's pronouncement that the Government's duty was explicitly set forth in section 247b(j)(1)(F)   , or that the language of this provision of the Act established the statutory standard. Petty v. United States, 536 F.Supp. 860 at 865 (N.D.Iowa 1981). 45 Section 247b(j)(1)(F) appears among the provisions outlining the establishment of the Program. It directs the Government to develop a written consent form as part of the Program, and to establish procedures for explaining the risks and benefits of the swine flu vaccine to all recipients. This section does not, however, specify statutory standards or establish a duty of care on the part of the Government or program participants. Rather, it is one of seven subsections introduced by the phrase, The swine flu program shall be limited to the following:   . (Emphasis added.) 46 Indeed, the Swine Flu Act does not contain a particularized formulation of the duty imposed on the Government or program participants. As under the Federal Tort Claims Act, liability under the Swine Flu Act depends on the law of the place where the act or omission occurred. See 42 U.S.C. § 247b(k)(2)(A) (1976). Thus, when a vaccinee sues the United States for negligently carrying out one of its tasks under the Program by failing to provide adequate warning to potential vaccinees, state law supplies the applicable standard of care. 47