119-hr4668

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4668 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 4668

To amend the Public Health Service Act to end the liability shield for 
 vaccine manufacturers, and for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 July 23, 2025

 Mr. Gosar (for himself, Mr. Biggs of Arizona, Ms. Boebert, Mr. 
 Brecheen, Mr. Burchett, Mr. Burlison, Mr. Collins, Mr. Crane, Mr. 
 Davidson, Mr. Donalds, Ms. Greene of Georgia, Ms. Hageman, Mr. Harris 
of Maryland, Mr. Higgins of Louisiana, Mr. Jackson of Texas, Mrs. Luna, 
Ms. Mace, Mr. Massie, Mrs. Miller of Illinois, Mr. Mills, Mr. Moore of 
 Alabama, Mr. Nehls, Mr. Norman, Mr. Ogles, Mr. Roy, Mr. Self, Mrs. 
 Spartz, Mr. Steube, and Mr. Weber of Texas) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

 A BILL

To amend the Public Health Service Act to end the liability shield for 
 vaccine manufacturers, 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. SHORT TITLE.

 This Act may be cited as the ``End the Vaccine Carveout Act''.

SEC. 2. ENDING LIABILITY SHIELD FOR VACCINE MANUFACTURERS.

    (a) National Vaccine Injury Compensation Program.--

    (1) Petitions for compensation.--

Section 2111 of the Public 
 Health Service Act (42 U.S.C. 300aa-11) is amended--
        (A) in subsection

    (a) --
            (i) by striking paragraphs

    (2) ,

    (3) ,

    (5) , 
 and

    (6) ;
            (ii) by inserting after paragraph

    (1) the 
 following:
 ``

    (2) Beginning on the date of enactment of the End the 
 Vaccine Carveout Act, and subject to paragraph

    (4)
        (B) , 
 irrespective of whether a person has filed a petition for 
 compensation under the Program in relation to a vaccine-related 
 injury or death, such person may bring a civil action against a 
 vaccine administrator or manufacturer in a State or Federal 
 court for damages arising from such injury or death.'';
            (iii) by redesignating paragraph

    (4) as 
 paragraph

    (3) ;
            (iv) by redesignating paragraphs

    (7) through

    (10) as paragraphs

    (4) through

    (7) , 
 respectively; and
            (v) by amending paragraph

    (4) (as so 
 redesignated) to read as follows:
 ``

    (4)
        (A) If in a civil action brought against a vaccine 
 administrator or manufacturer for a vaccine-related injury or 
 death damages are awarded under a judgment of a court or a 
 settlement of such action, the person who brought such action 
 may not file a petition under subsection

    (b) for such injury or 
 death, and any pending petition for such injury or death shall 
 be dismissed.
 ``
        (B) If compensation is awarded for a petition filed under 
 the Program for a vaccine-related injury or death, the person 
 who filed such petition may not bring a civil action against a 
 vaccine administrator or manufacturer for such injury or death, 
 and any pending civil action for such injury or death shall be 
 dismissed.''; and
        (B) in subsection
            (c) (1)
        (B)
            (i) 
            (III) , by striking 
 ``not later than 6 months''.

    (2) Limitations of actions.--
        (A) In general.--

Section 2116 of the Public Health 
 Service Act (42 U.S.C. 300aa-16) is amended--
            (i) in subsection

    (a) --
            (I) in paragraph

    (2) , by striking 
 ``no petition may be filed for 
 compensation under the Program for such 
 injury after the expiration of 36 
 months after the date of the occurrence 
 of the first symptom or manifestation 
 of onset or of the significant 
 aggravation of such injury'' and 
 inserting ``unless prohibited by 
 

section 2111

    (a)

    (4)
        (A) , a petition may 
 be filed for compensation under the 
 Program for such injury at any time''; 
 and
            (II) in paragraph

    (3) , by striking 
 ``no petition may be filed for 
 compensation under the Program for such 
 death after the expiration of 24 months 
 from the date of the death and no such 
 petition may be filed more than 48 
 months after the date of the occurrence 
 of the first symptom or manifestation 
 of onset or of the significant 
 aggravation of the injury from which 
 the death resulted'' and inserting 
 ``unless prohibited by 

section 2111

    (a)

    (4)
        (A) , a petition may be filed 
 for compensation under the Program for 
 such death at any time''; and
            (ii) in subsection

    (b) --
            (I) by striking ``notwithstanding 
 

section 2111

    (b)

    (2) '' and inserting 
 ``notwithstanding 

section 2111

    (b)

    (2) , 
 and unless prohibited by 

section 2111

    (a)

    (4)
        (A) '';
            (II) by striking ``not later than 2 
 years after the effective date of the 
 revision'' and inserting ``at any 
 time'';
            (III) by striking ``table if--'' 
 and inserting ``table if such vaccine-
 related injury or death occurred before 
 the effective date of this part.''; and
            (IV) by striking paragraphs

    (1) and

    (2) .
        (B) Retroactivity.--The amendments made by 
 subparagraph
        (A) shall apply as if included in the 
 enactment of 

section 2116 of the Public Health Service 
 Act (42 U.S.C. 300aa-16).

    (3) Repeals.--
        (A) Election.--

Section 2121

    (a) of the Public Health 
 Service Act (42 U.S.C. 300aa-21

    (a) ) is repealed.
        (B) Standards of responsibility.--

Section 2122 of 
 the Public Health Service Act (42 U.S.C. 300aa-22) is 
 repealed.
            (C) Trial.--

Section 2123 of the Public Health 
 Service Act (42 U.S.C. 300aa-23) is repealed.

    (4) Conforming amendments.--
        (A) Attorneys' fees.--

Section 2115

    (e) of the Public 
 Health Service Act (42 U.S.C. 300aa-15

    (e) ) is amended--
            (i) by striking paragraph

    (2) ; and
            (ii) by redesignating paragraph

    (3) as 
 paragraph

    (2) .
        (B) Payment of compensation.--

Section 2115

    (f) of 
 the Public Health Service Act (42 U.S.C. 300aa-15

    (f) ) 
 is amended--
            (i) by striking paragraph

    (1) ;
            (ii) by redesignating paragraphs

    (2) through

    (4) as paragraphs

    (1) through

    (3) , 
 respectively;
            (iii) in paragraph

    (1) (as so 
 redesignated), by striking ``Such compensation 
 may not be paid after an election under 

section 2121

    (a) to file a civil action for damages for 
 the vaccine-related injury or death for which 
 such compensation was awarded.''; and
            (iv) in paragraph

    (3)
        (B) (as so 
 redesignated), by striking ``If the 
 appropriations under subsection

    (j) are 
 insufficient to make a payment of an annual 
 installment, the limitation on civil actions 
 prescribed by 

section 2121

    (a) shall not apply 
 to a civil action for damages brought by the 
 petitioner entitled to the payment.''.
            (C) State limitations of actions.--

Section 2116
            (c) of the Public Health Service Act (42 U.S.C. 300aa-
 16
            (c) ) is amended by striking ``an election is made 
 under 

section 2121

    (a) to file the civil action'' and 
 inserting ``judgment is entered by the United States 
 Court of Federal Claims (or, if an appeal is taken 
 under 

section 2112

    (f) , the appellate court's mandate is 
 issued) with respect to the petition''.
            (D) Termination of program.--

Section 2134

    (b)

    (1) of 
 the Public Health Service Act (42 U.S.C. 300aa-
 34

    (b)

    (1) ) is amended--
            (i) by striking ``and accepted under 
 

section 2121

    (a) ''; and
            (ii) by striking ``

Section 2111

    (a) and part 
 B shall not apply to civil actions for damages 
 for a vaccine-related injury or death for which 
 a petition may not be filed because of 
 subparagraph
        (B) .''.

    (b) Excluding COVID-19 Vaccines From Definition of Covered 
Countermeasure.--

Section 319F-3
            (i) (1) of the Public Health Service Act 
(42 U.S.C. 247d-6d
            (i) (1) ) is amended to read as follows:
 ``

    (1) Covered countermeasure.--The term `covered 
 countermeasure'--
 ``
        (A) means--
 ``
            (i) a qualified pandemic or epidemic 
 product (as defined in paragraph

    (7) );
 ``
            (ii) a security countermeasure (as 
 defined in 

section 319F-2
            (c) (1)
        (B) );
 ``
            (iii) a drug (as such term is defined in 
 

section 201

    (g)

    (1) ) of the Federal Food, Drug, 
 and Cosmetic Act (21 U.S.C. 321

    (g)

    (1) ), 
 biological product (as such term is defined by 
 

section 351
            (i) of this Act), or device (as such 
 term is defined by 

section 201

    (h) of the 
 Federal Food, Drug and Cosmetic Act (21 U.S.C. 
 321

    (h) )) that is authorized for emergency use 
 in accordance with 

section 564, 564A, or 564B 
 of the Federal Food, Drug, and Cosmetic Act; or
 ``
            (iv) a respiratory protective device that 
 is approved by the National Institute for 
 Occupational Safety and Health under part 84 of 
 title 42, Code of Federal Regulations (or any 
 successor regulations), and that the Secretary 
 determines to be a priority for use during a 
 public health emergency declared under 

section 319; and
 ``
        (B) does not include any vaccine used to 
 mitigate, prevent, or treat COVID-19.''.
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