
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-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
 
Sec. 300aa-23. Trial


(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.

(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, Secs. 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.)

                       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.

                          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.


                               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.

                  Section Referred to in Other Sections

    This section is referred to in section 300aa-22 of this title.
