Please help us improve our site!
Skip to main content(a) General rule
Except as provided in subsections (b), (c), and (e) 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 deathassociated 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— (B)by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and
regulationsissued under such provisions).
(c) Direct warningsNo 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 manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
(d) ConstructionThe 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) PreemptionNo 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 TextThe 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.
Amendments1987—Subsecs. (b)(1), (c). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.
{'misc': '', 'cleanpath': '/uscode/text/42/300aa-22', 'headtext': ' Standards of responsibility', 'cfr_titles': [{'title': '42', 'parts': [{'part': '100', 'cleanpath': '/cfr/text/42/part-100', 'headtext': 'VACCINE INJURY COMPENSATION'}]}], 'section': '300aa-22'}