---
kind: "section"
citation: "42 U.S.C. § 300aa–22"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300aa–22"
heading: "Standards of responsibility"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300aa-22"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter XIX — Vaccines"
  - "Part 2"
  - "Subpart b — additional remedies"
---

# §300aa–22. Standards of responsibility

- (a) **General rule—** Except as provided in subsections [(b)](#b), [(c)](#c), and [(e)](#e) [State](/usc/42/201.md?p=f) law shall apply to a civil action brought for damages for a [vaccine-related injury or death](/usc/42/300aa–33.md?p=5).
- (b) **Unavoidable adverse side effects; warnings—**
  - (1) No vaccine [manufacturer](/usc/42/300aa–33.md?p=3) shall be liable in a civil action for damages arising from a [vaccine-related injury or death](/usc/42/300aa–33.md?p=5) 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)](#b-1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine [manufacturer](/usc/42/300aa–33.md?p=3) shows that it complied in all material respects with all requirements under the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] and [section 262 of this title](/usc/42/262.md) (including [regulations](/usc/42/201.md?p=d) issued under such provisions) applicable to the vaccine and related to [vaccine-related injury or death](/usc/42/300aa–33.md?p=5) for which the civil action was brought unless the plaintiff shows—
    - (A) that the [manufacturer](/usc/42/300aa–33.md?p=3) engaged in the conduct set forth in subparagraph (A) or (B) of [section 300aa–23(d)(2) of this title](/usc/42/300aa–23.md?p=d-2), or
    - (B) by clear and convincing evidence that the [manufacturer](/usc/42/300aa–33.md?p=3) failed to exercise due care notwithstanding its compliance with such Act and section (and [regulations](/usc/42/201.md?p=d) issued under such provisions).
- (c) **Direct warnings—** No vaccine [manufacturer](/usc/42/300aa–33.md?p=3) shall be liable in a civil action for damages arising from a [vaccine-related injury or death](/usc/42/300aa–33.md?p=5) associated with the administration of a vaccine after October 1, 1988, solely due to the [manufacturer](/usc/42/300aa–33.md?p=3)’s failure to provide direct warnings to the injured party (or the injured party’s [legal representative](/usc/42/300aa–33.md?p=2)) of the potential dangers resulting from the administration of the vaccine manufactured by the [manufacturer](/usc/42/300aa–33.md?p=3).
- (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](/usc/42/300aa–33.md?p=3) for a [vaccine-related injury or death](/usc/42/300aa–33.md?p=5) in which damages were denied or which was dismissed with prejudice to bring a new civil action against such [manufacturer](/usc/42/300aa–33.md?p=3) for such injury or death.
- (e) **Preemption—** No [State](/usc/42/201.md?p=f) may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine [manufacturer](/usc/42/300aa–33.md?p=3) for damages for a [vaccine-related injury or death](/usc/42/300aa–33.md?p=5) if such civil action is not barred by this part.

## Source credit

(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.)

## Notes

### 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”.