42 U.S.C. § 300aa–22 | Standards of responsibility

(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)

October 1, 1988 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 , 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)

21 U.S.C. 301 section 262 of this title 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 [ et seq.] and (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)

section 300aa–23(d)(2) of this title that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of , 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

October 1, 1988No 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 , 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)

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 Pub. L. 99–660, title III, § 311(a)Nov. 14, 1986100 Stat. 3773 Pub. L. 100–203, title IV, § 4302(b)(1)Dec. 22, 1987101 Stat. 1330–221 (, title XXI, § 2122, as added , , ; amended , , .)

Editorial Notes

References in Text

act June 25, 1938, ch. 675 52 Stat. 1040 The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2), is , , 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

October 1, 1988section 323 of Pub. L. 99–660 section 300aa–1 of this titleIn subsecs. (b)(1), (c), “” was substituted for “the effective date of this subpart” on authority of , as amended, set out as an Effective Date note under .

Amendments

Pub. L. 100–2031987—Subsecs. (b)(1), (c). substituted “effective date of this subpart” for “effective date of this part”.

Section text and notes