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Florida Attorney General Reports·Decided September 10, 1976·Published

Opinion

QUESTION: Does the doctrine of sovereign immunity operate to confer sovereign immunity on independently insured private institutions which volunteer their services to the Florida Department of Health and Rehabilitative Services?

SUMMARY: Pursuant to Pub.L. 94-380, the Department of Health and Rehabilitative Services and volunteer private institutions acting on its behalf and under its guidance in the administration of swine flu vaccine are "program participants." The United States will be primarily liable for all claims for damages but will have a claim against any "program participant" for negligence in carrying out any obligation or responsibility in connection with the swine flu program. Since the State of Florida has enacted a limited waiver of sovereign immunity, the state will, to the extent of that waiver, be liable to the United States pursuant to the provisions of Pub.L. 94-380. Volunteer private institutions not acting in bad faith, maliciously, or in a manner exhibiting wanton and willful disregard of human rights, safety, and property would be entitled to have the State of Florida pay any civil judgment not to exceed $50,000 per claimant or $100,000 per occurrence for damages as a result of any act or omission of action within the scope of its agency or function in the swine flu program. No opinion is expressed as to the liability to the United States of either the State of Florida or the volunteer private institutions for amounts in excess of the limits of s. 768.28, F. S. Your question is answered to a large extent by Pub.L. 94-380, which was enacted by Congress on August 12, 1976. The purpose of the act, as indicated by its title, is: To amend the Public Health Service Act to authorize the establishment and implementation of an emergency national swine flu immunization program and to provide an exclusive remedy for personal injury or death arising out of the manufacture, distribution, or administration of the swine flu vaccine under such program. (Emphasis supplied.) Congressional intent is set forth in the act in the newly created42 U.S.C. § 274b(k)(1)(A)(i) and (ii): (k)(1)(A) The Congress finds that — (i) in order to achieve the participation in the program of the agencies, organizations, and individuals who will manufacture, distribute, and administer the swine flu vaccine purchased and used in the swine flu program and to assure the availability of such vaccine in interstate commerce, it is necessary to protect such agencies, organizations, and individuals against liability for other than their own negligence to persons alleging personal injury or death arising out of the administration of such vaccine; (ii) to provide such protection and to establish an orderly procedure for the prompt and equitable handling of claims by persons alleging such injury or death, it is necessary that an exclusive remedy for such claimants be provided against the United States because of its unique role in the initiation, planning, and administration of the swine flu program; and (Emphasis supplied.) 42 U.S.C. § 247b(k)(2)(A) then provides that: (2)(A) The United States shall be liable with respect to claims submitted after September 30, 1976 for personal injury or death arising out of the administration of swine flu vaccine under the swine flu program and based upon the act or omission of a program participant in the same manner and to the same extent as the United States would be liable in any other action brought against it under such section 1346(b) and chapter 171. . . . [Exceptions, not relevant here, have been omitted; emphasis supplied.] A "program participant" is then defined by42 U.S.C. § 247b(k)(2)(B) to include: the public or private agency or organization that provided an inoculation under the swine flu program without charge for such vaccine or its administration and in compliance with the informed consent form and procedures requirements prescribed pursuant to subparagraph (b) or paragraph (1) of this subsection, and the medical and other health personnel who provided or assisted in providing an inoculation under the swine flu program without charge for such vaccine or its administration and in compliance with such informed consent form and procedures requirements. (Emphasis supplied.) Thus, both the Department of Health and Rehabilitative Services and any volunteer private health agency participating in the swine flu immunization program are "program participants" if either agency provides inoculation without charge and in compliance with certain consent form procedures. I might note at this point that the words "without charge" would seem to refer to the administration of vaccine to citizens "without charge" to the citizen. I understand that, after you wrote your letter to me, you have been asked whether a private health agency may be reimbursed for its expenses and still qualify as a "program participant." Since the program is to be administered by the United States Department of Health, Education and Welfare, and liability claims are to be handled by the United States Attorney General, it would be more appropriate for you to direct that question to the officials directly responsible for administering the federal program. Public Law94-380 establishes an exclusive method for handling claims against "program participants." 42 U.S.C. § 247b(k)(3) provides: (3) The remedy against the United States prescribed by paragraph (2) of this subsection for personal injury or death arising out of the administration of the swine flu vaccine under the swine flu program shall be exclusive of any other civil action or proceeding for such personal injury or death against any employee of the Government (as defined in section 2671 of title 28, United States Code) or program participant whose act or omission gave rise to the claim. (Emphasis supplied.)

The United States Attorney General shall defend all civil actions brought against a "program participant." 42 U.S.C. § 247b(k)(4). Public Law 94-380 does not, however, completely shield a "program participant" from all potential liability. Subsection (7) of42 U.S.C. § 247b(k) provides that, if the United States makes payment to a claimant injured in the administration of the vaccine, the United States may recover from the "program participant" . . . that portion of the damages so awarded or paid, as well as any costs of litigation, resulting from the failure of any program participant to carry out any obligation or responsibility assumed by it under a contract with the United States in connection with the program or from any negligent conduct on the part of any program participant in carrying out any obligation or responsibility in connection with the swine flu program. The United States may maintain such action against such program participant in the district court of the United States in which such program participant resides or has its principal place of business.

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