From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[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
 
-HEAD-
    Sec. 300aa-22. Standards of responsibility
 
-STATUTE-
    (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.
 
-SOURCE-
    (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.)
 
-REFTEXT-
                             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.
 
-COD-
                                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.
 
-MISC3-
                                 AMENDMENTS
      1987 - Subsecs. (b)(1), (c). Pub. L. 100-203 substituted
    ''effective date of this subpart'' for ''effective date of this
    part''.
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in section 300aa-23 of this title.