
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300aa-22]

 
                 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


(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 warnings

    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) 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, title XXI, Sec. 2122, as added Pub. L. 99-660, 
title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3773; amended Pub. L. 
100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330-221.)

                       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, as amended, which 
is classified generally to chapter 9 (Sec. 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''.

                  Section Referred to in Other Sections

    This section is referred to in section 300aa-23 of this title.
