42-U.S.C.-300AA-22
§300Aa-22 – §300Aa-22. Standards of Responsibility
Pathway
Title 42 > Chapter 6A > Subchapter XIX > Part 2 > Subpart b > Section 300aa-22
Details
- Reference: Section 300aa-22
- Legend: §300Aa-22 – §300Aa-22. Standards of Responsibility
- USCode Year: 2011
Provision Content
(a) General rule
Except as provided in subsections (b), (c), and (e) of this section State law shall apply to a civil action brought for damages for a vaccine-related injury or death.
(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa–23(d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
(c) Direct warnings
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturers failure to provide direct warnings to the injured party (or the injured partys legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
(d) Construction
The standards of responsibility prescribed by this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death.
(e) Preemption
No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this part.
(July 1, 1944, ch. 373, title XXI, §2122, as added Pub. L. 99–660, title III, §311(a), Nov. 14, 1986, 100 Stat. 3773; amended Pub. L. 100–203, title IV, §4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables.
Codification
In subsecs. (b)(1), (c), “October 1, 1988” was substituted for “the effective date of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.
Amendments
1987—Subsecs. (b)(1), (c). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.
U.S. Encyclopedia of Law Coverage
42-U.S.C.-300AA-1 in the Legal Encyclopedia: Public Health
In this entry about 42-U.S.C.-300AA-1, find legal reference material, bibliographies and premiere content related to public health in the American Encyclopedia of Law, presenting a comprehensive view of the United States public health-specific issues, written by authorities in the field.
42-U.S.C.-300AA-22 in the Legal Encyclopedia: Vaccines
In this entry about 42-U.S.C.-300AA-22, find legal reference material, bibliographies and premiere content related to vaccines in the American Encyclopedia of Law, presenting a comprehensive view of the United States vaccines-specific issues, written by authorities in the field.
42-U.S.C.-300AA-4 in the Legal Encyclopedia: Public Health Service
In this entry about 42-U.S.C.-300AA-4, find legal reference material, bibliographies and premiere content related to public health service in the American Encyclopedia of Law, presenting a comprehensive view of the United States public health service-specific issues, written by authorities in the field.
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