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

[CITE: 42USC300aa-23]

 
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-23. Trial
 
-STATUTE-
    (a) General rule
      A civil action against a vaccine manufacturer for damages for a
    vaccine-related injury or death associated with the administration
    of a vaccine after October 1, 1988, which is not barred by section
    300aa-11(a)(2) of this title shall be tried in three stages.
    (b) Liability
      The first stage of such a civil action shall be held to determine
    if a vaccine manufacturer is liable under section 300aa-22 of this
    title.
    (c) General damages
      The second stage of such a civil action shall be held to
    determine the amount of damages (other than punitive damages) a
    vaccine manufacturer found to be liable under section 300aa-22 of
    this title shall be required to pay.
    (d) Punitive damages
      (1) If sought by the plaintiff, the third stage of such an action
    shall be held to determine the amount of punitive damages a vaccine
    manufacturer found to be liable under section 300aa-22 of this
    title shall be required to pay.
      (2) If in such an action the 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 this
    chapter applicable to the vaccine and related to the vaccine injury
    or death with respect to which the action was brought, the
    manufacturer shall not be held liable for punitive damages unless
    the manufacturer engaged in -
        (A) fraud or intentional and wrongful withholding of
      information from the Secretary during any phase of a proceeding
      for approval of the vaccine under section 262 of this title,
        (B) intentional and wrongful withholding of information
      relating to the safety or efficacy of the vaccine after its
      approval, or
        (C) other criminal or illegal activity relating to the safety
      and effectiveness of vaccines,
    which activity related to the vaccine-related injury or death for
    which the civil action was brought.
    (e) Evidence
      In any stage of a civil action, the Vaccine Injury Table, any
    finding of fact or conclusion of law of the United States Court of
    Federal Claims or a special master in a proceeding on a petition
    filed under section 300aa-11 of this title and the final judgment
    of the United States Court of Federal Claims and subsequent
    appellate review on such a petition shall not be admissible.
 
-SOURCE-
    (July 1, 1944, ch. 373, title XXI, Sec. 2123, as added Pub. L.
    99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3774;
    amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), 4307(9), Dec.
    22, 1987, 101 Stat. 1330-221, 1330-225; Pub. L. 101-239, title VI,
    Sec. 6601(o), Dec. 19, 1989, 103 Stat. 2292; Pub. L. 102-572, title
    IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.)
 
-REFTEXT-
                             REFERENCES IN TEXT
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (d)(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 subsec. (a), ''October 1, 1988'' 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
      1992 - Subsec. (e). Pub. L. 102-572 substituted ''United States
    Court of Federal Claims'' for ''United States Claims Court'' in two
    places.
      1989 - Subsec. (e). Pub. L. 101-239 substituted ''finding of fact
    or conclusion of law'' for ''finding'', ''special master'' for
    ''master appointed by such court'', and directed substitution of
    ''the United States Claims Court and subsequent appellate review''
    for ''a district court of the United States'' which was executed by
    inserting ''and subsequent appellate review'' after ''the United
    States Claims Court'' the second place it appeared to reflect the
    probable intent of Congress and the amendment by Pub. L. 100-203,
    Sec. 4307(a), see 1987 Amendment note below.
      1987 - Subsec. (a). Pub. L. 100-203, Sec. 4302(b)(1), substituted
    ''effective date of this subpart'' for ''effective date of this
    part''.
      Subsec. (e). Pub. L. 100-203, Sec. 4307(9), substituted ''the
    United States Claims Court'' for ''a district court of the United
    States'' in two places.
                      EFFECTIVE DATE OF 1992 AMENDMENT
      Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section
    911 of Pub. L. 102-572, set out as a note under section 171 of
    Title 28, Judiciary and Judicial Procedure.
                      EFFECTIVE DATE OF 1989 AMENDMENT
      For applicability of amendments by Pub. L. 101-239 to petitions
    filed after Dec. 19, 1989, petitions currently pending in which the
    evidentiary record is closed, and petitions currently pending in
    which the evidentiary record is not closed, with provision for an
    immediate suspension for 30 days of all pending cases, see section
    6601(s)(1) of Pub. L. 101-239, set out as a note under section
    300aa-10 of this title.
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in section 300aa-22 of this title.



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