To amend titles III and XXI of the Public Health Service Act to hold vaccine manufacturers liable for injuries caused by vaccines subject to a public mandate, and for other purposes.
Bill: H.R.9366 | Sponsor: Rep. Gohmert, Louie (R-TX)
Policy area: Health

Summary:
This bill imposes liability on manufacturers and distributors for claims for losses arising from the administration or use of certain vaccines. The bill also limits the authority of the Department of Health and Human Services (HHS) to incorporate new vaccines into the National Vaccine Injury Compensation Program (VICP), which compensates individuals for injuries or deaths associated with routinely administered vaccines.
Current law generally provides liability protections for manufacturers and distributors of pandemic and epidemic products and security countermeasures (which include vaccines). This bill specifies that the liability protections shall not apply to the administration of vaccines that are (1) licensed biological products or approved for use under emergency procedures, and (2) required by federal or state governments (or federally funded entities). The bill also permits individuals to sue manufacturers and distributors in state or federal courts without first seeking compensation through the VICP process for injuries or deaths caused by the administration of such vaccines.
Additionally, HHS may not add a vaccine to the Vaccine Injury Table (which lists the vaccines that are covered by the VICP) if the vaccine (1) is required by the federal government or a federally funded entity, and (2) is administered without obtaining informed consent or providing a religious exemption (if requested by the individual receiving the vaccine).

To amend titles III and XXI of the Public Health Service Act to hold 
vaccine manufacturers liable for injuries caused by vaccines subject to 
               a public mandate, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. MANDATED VACCINE MANUFACTURER LIABILITY.

    (a) Pandemic and Endemic Products.--Section 319F-3(d) of the Public 
Health Service Act (42 U.S.C. 247d-6d(d)) is amended--
            (1) in paragraph (1), by striking ``subsection (f)'' and 
        inserting ``paragraph (2) of this subsection and subsection 
        (f)'';
            (2) by redesignating paragraph (2) as paragraph (3); and
            (3) by inserting after paragraph (1) the following:
            ``(2) Vaccines.--The immunity from suit and liability of 
        covered persons set forth in subsection (a) shall not apply 
        with respect to the administration of a vaccine licensed under 
        section 351 or authorized for emergency use under section 564 
        of the Federal Food, Drug, and Cosmetic Act if any agency of 
        the Federal Government, any official of the Government, any 
        agency of any State government, any official of any State 
        government, or any entity that receives Federal or State 
        funding, either directly or indirectly, requires the 
        administration of such vaccine or provides for any penalty or 
        loss of privileges for the refusal to consent to administration 
        of such vaccine.''.
    (b) Vaccine Injury Compensation Program.--Section 2111(a)(2) of the 
Public Health Service Act (42 U.S.C. 300aa-11(a)(2)) is amended--
            (1) in subparagraph (A), by striking ``No person may'' and 
        inserting ``Subject to subparagraph (C), no person may''; and
            (2) by adding at the end the following:
            ``(C) Subparagraph (A) shall not apply with respect to a 
        vaccine licensed under section 351 or authorized for emergency 
        use under section 564 of the Federal Food, Drug, and Cosmetic 
        Act if any agency of the Federal Government, any official of 
        the Government, any agency of a State government, any official 
        of a State government, or any entity that receives Federal or 
        State funding, either directly or indirectly requires the 
        administration of the vaccine or provides for any penalty or 
        loss of privileges for the refusal to consent to administration 
        of the vaccine.''.
    (c) Vaccine Injury Table.--Section 2114(c) of the Public Health 
Service Act (42 U.S.C. 300aa-14(c)) is amended--
            (1) in paragraph (1), by inserting ``and subject to 
        paragraph (5)'' after ``paragraph (3)''; and
            (2) by adding at the end the following:
    ``(5) Beginning on the date of the enactment of this paragraph, the 
Secretary may not add a vaccine to the Vaccine Injury Table if--
            ``(A) the administration of such vaccine is required by any 
        agency of the Federal Government, any official of the 
        Government, or any entity that receives Federal funding, either 
        directly or indirectly; and
            ``(B) the vaccine was administered--
                    ``(i) without first obtaining from the person 
                receiving the vaccine the informed consent of that 
                person; or
                    ``(ii) without such person being provided a 
                religious or medical exemption if a request was made 
                for such an exemption.''.
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