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.