2010 US Code
Title 42 - THE PUBLIC HEALTH AND WELFARE
CHAPTER 6A - PUBLIC HEALTH SERVICE
SUBCHAPTER XIX - VACCINES
Part 2 - National Vaccine Injury Compensation Program
subpart b - additional remedies
Sec. 300aa-22 - Standards of responsibility
View MetadataPublication Title | United States Code, 2006 Edition, Supplement 4, Title 42 - THE PUBLIC HEALTH AND WELFARE |
Category | Bills and Statutes |
Collection | United States Code |
SuDoc Class Number | Y 1.2/5: |
Contained Within | Title 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE SUBCHAPTER XIX - VACCINES Part 2 - National Vaccine Injury Compensation Program subpart b - additional remedies Sec. 300aa-22 - Standards of responsibility |
Contains | section 300aa-22 |
Date | 2010 |
Laws in Effect as of Date | January 7, 2011 |
Positive Law | No |
Disposition | standard |
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. |
Statutes at Large References | 52 Stat. 1040 100 Stat. 3773 101 Stat. 1330-221 |
Public Law References | Public Law 99-660, Public Law 100-203 |
§300aa–22. Standards of responsibility (a) General rule
Except as provided in subsections (b), (c), and (e) of this section 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 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 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.
CodificationIn 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.
Amendments1987—Subsecs. (b)(1), (c). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.
Disclaimer: These codes may not be the most recent version. The United States Government Printing Office may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the US site. Please check official sources.