PRIA Logo™
Title 42, The Public Health and WelfareRelease 119-73not60

§300aa–22 Standards of Responsibility

Title 42 › Chapter 6A— PUBLIC HEALTH SERVICE › Subchapter XIX— VACCINES › Part 2— National Vaccine Injury Compensation Program › Subpart b— additional remedies › § 300aa–22

Last updated Apr 5, 2026|Official source

Summary

State law decides most lawsuits for vaccine-related injury or death, but there are important limits set by federal law. Vaccine makers cannot be held responsible in a lawsuit for injuries or deaths tied to vaccines given after October 1, 1988, when the harm came from side effects that could not be avoided even though the vaccine was properly made and carried proper directions and warnings. Warnings are assumed proper if the maker followed the Federal Food, Drug, and Cosmetic Act and section 262 and their rules, unless the injured person proves the maker did serious misconduct listed elsewhere in the law or proves by clear and convincing evidence that the maker failed to use due care despite following those laws. A maker also cannot be sued just for not giving a direct warning to the injured person. If a prior suit was denied or dismissed with prejudice, the person may not bring a new suit for the same injury. States may not stop people from bringing suits that federal law allows.

Full Legal Text

Title 42, §300aa–22

The Public Health and Welfare, Source: USLM XML via OLRC

(a)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)(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)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 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)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)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.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

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, 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”.

Reference

Citations & Metadata

Citation

42 U.S.C. § 300aa–22

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60