42 USC 300aa-22 - Standards of responsibility

U.S Code last checked for updates: Nov 23, 2024

§ 300aa–22.

Standards of responsibility

(a)

General rule

(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

(d)

Construction

(e)

Preemption

(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.)

cite as: 42 USC 300aa-22