
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document affected by Public Law 106-310 Section 1701(a)]
[Document affected by Public Law 106-310 Section 1701(b)]
[CITE: 42USC300aa-11]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                        SUBCHAPTER XIX--VACCINES
 
          Part 2--National Vaccine Injury Compensation Program
 
                     subpart a--program requirements
 
Sec. 300aa-11. Petitions for compensation


(a) General rule

    (1) A proceeding for compensation under the Program for a vaccine-
related injury or death shall be initiated by service upon the Secretary 
and the filing of a petition containing the matter prescribed by 
subsection (c) of this section with the United States Court of Federal 
Claims. The clerk of the United States Court of Federal Claims shall 
immediately forward the filed petition to the chief special master for 
assignment to a special master under section 300aa-12(d)(1) of this 
title.
    (2)(A) No person may bring a civil action for damages in an amount 
greater than $1,000 or in an unspecified amount against a vaccine 
administrator or manufacturer in a State or Federal court for damages 
arising from a vaccine-related injury or death associated with the 
administration of a vaccine after October 1, 1988, and no such court may 
award damages in an amount greater than $1,000 in a civil action for 
damages for such a vaccine-related injury or death, unless a petition 
has been filed, in accordance with section 300aa-16 of this title, for 
compensation under the Program for such injury or death and--
        (i)(I) the United States Court of Federal Claims has issued a 
    judgment under section 300aa-12 of this title on such petition, and
        (II) such person elects under section 300aa-21(a) of this title 
    to file such an action, or
        (ii) such person elects to withdraw such petition under section 
    300aa-21(b) of this title or such petition is considered withdrawn 
    under such section.

    (B) If a civil action which is barred under subparagraph (A) is 
filed in a State or Federal court, the court shall dismiss the action. 
If a petition is filed under this section with respect to the injury or 
death for which such civil action was brought, the date such dismissed 
action was filed shall, for purposes of the limitations of actions 
prescribed by section 300aa-16 of this title, be considered the date the 
petition was filed if the petition was filed within one year of the date 
of the dismissal of the civil action.
    (3) No vaccine administrator or manufacturer may be made a party to 
a civil action (other than a civil action which may be brought under 
paragraph (2)) for damages for a vaccine-related injury or death 
associated with the administration of a vaccine after October 1, 1988.
    (4) If in a civil action brought against a vaccine administrator or 
manufacturer before October 1, 1988, damages were denied for a vaccine-
related injury or death or if such civil action was dismissed with 
prejudice, the person who brought such action may file a petition under 
subsection (b) of this section for such injury or death.
    (5)(A) A plaintiff who on October 1, 1988, has pending a civil 
action for damages for a vaccine-related injury or death may, at any 
time within 2 years after October 1, 1988, or before judgment, whichever 
occurs first, petition to have such action dismissed without prejudice 
or costs and file a petition under subsection (b) of this section for 
such injury or death.
    (B) If a plaintiff has pending a civil action for damages for a 
vaccine-related injury or death, such person may not file a petition 
under subsection (b) of this section for such injury or death.
    (6) If a person brings a civil action after November 15, 1988 \1\ 
for damages for a vaccine-related injury or death associated with the 
administration of a vaccine before November 15, 1988, such person may 
not file a petition under subsection (b) of this section for such injury 
or death.
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    \1\ So in original. Probably should be followed by a comma.
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    (7) If in a civil action brought against a vaccine administrator or 
manufacturer for a vaccine-related injury or death damages are awarded 
under a judgment of a court or a settlement of such action, the person 
who brought such action may not file a petition under subsection (b) of 
this section for such injury or death.
    (8) If on October 1, 1988, there was pending an appeal or rehearing 
with respect to a civil action brought against a vaccine administrator 
or manufacturer and if the outcome of the last appellate review of such 
action or the last rehearing of such action is the denial of damages for 
a vaccine-related injury or death, the person who brought such action 
may file a petition under subsection (b) of this section for such injury 
or death.
    (9) This subsection applies only to a person who has sustained a 
vaccine-related injury or death and who is qualified to file a petition 
for compensation under the Program.
    (10) The Clerk of the United States Claims Court \2\ is authorized 
to continue to receive, and forward, petitions for compensation for a 
vaccine-related injury or death associated with the administration of a 
vaccine on or after October 1, 1992.
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    \2\ See Change of Name note below.
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(b) Petitioners

    (1)(A) Except as provided in subparagraph (B), any person who has 
sustained a vaccine-related injury, the legal representative of such 
person if such person is a minor or is disabled, or the legal 
representative of any person who died as the result of the 
administration of a vaccine set forth in the Vaccine Injury Table may, 
if the person meets the requirements of subsection (c)(1) of this 
section, file a petition for compensation under the Program.
    (B) No person may file a petition for a vaccine-related injury or 
death associated with a vaccine administered before October 1, 1988, if 
compensation has been paid under this part for 3500 petitions for such 
injuries or deaths.
    (2) Only one petition may be filed with respect to each 
administration of a vaccine.

(c) Petition content

    A petition for compensation under the Program for a vaccine-related 
injury or death shall contain--
        (1) except as provided in paragraph (3), an affidavit, and 
    supporting documentation, demonstrating that the person who suffered 
    such injury or who died--
            (A) received a vaccine set forth in the Vaccine Injury Table 
        or, if such person did not receive such a vaccine, contracted 
        polio, directly or indirectly, from another person who received 
        an oral polio vaccine,
            (B)(i) if such person received a vaccine set forth in the 
        Vaccine Injury Table--
                (I) received the vaccine in the United States or in its 
            trust territories,
                (II) received the vaccine outside the United States or a 
            trust territory and at the time of the vaccination such 
            person was a citizen of the United States serving abroad as 
            a member of the Armed Forces or otherwise as an employee of 
            the United States or a dependent of such a citizen, or
                (III) received the vaccine outside the United States or 
            a trust territory and the vaccine was manufactured by a 
            vaccine manufacturer located in the United States and such 
            person returned to the United States not later than 6 months 
            after the date of the vaccination,

            (ii) if such person did not receive such a vaccine but 
        contracted polio from another person who received an oral polio 
        vaccine, was a citizen of the United States or a dependent of 
        such a citizen,
            (C)(i) sustained, or had significantly aggravated, any 
        illness, disability, injury, or condition set forth in the 
        Vaccine Injury Table in association with the vaccine referred to 
        in subparagraph (A) or died from the administration of such 
        vaccine, and the first symptom or manifestation of the onset or 
        of the significant aggravation of any such illness, disability, 
        injury, or condition or the death occurred within the time 
        period after vaccine administration set forth in the Vaccine 
        Injury Table, or
            (ii)(I) sustained, or had significantly aggravated, any 
        illness, disability, injury, or condition not set forth in the 
        Vaccine Injury Table but which was caused by a vaccine referred 
        to in subparagraph (A), or
            (II) sustained, or had significantly aggravated, any 
        illness, disability, injury, or condition set forth in the 
        Vaccine Injury Table the first symptom or manifestation of the 
        onset or significant aggravation of which did not occur within 
        the time period set forth in the Table but which was caused by a 
        vaccine referred to in subparagraph (A),
            (D)(i) suffered the residual effects or complications of 
        such illness, disability, injury, or condition for more than 6 
        months after the administration of the vaccine, or (ii) died 
        from the administration of the vaccine, and
            (E) has not previously collected an award or settlement of a 
        civil action for damages for such vaccine-related injury or 
        death,

        (2) except as provided in paragraph (3), maternal prenatal and 
    delivery records, newborn hospital records (including all 
    physicians' and nurses' notes and test results), vaccination records 
    associated with the vaccine allegedly causing the injury, pre- and 
    post-injury physician or clinic records (including all relevant 
    growth charts and test results), all post-injury inpatient and 
    outpatient records (including all provider notes, test results, and 
    medication records), if applicable, a death certificate, and if 
    applicable, autopsy results, and
        (3) an identification of any records of the type described in 
    paragraph (1) or (2) which are unavailable to the petitioner and the 
    reasons for their unavailability.

(d) Additional information

    A petition may also include other available relevant medical records 
relating to the person who suffered such injury or who died from the 
administration of the vaccine.

(e) Schedule

    The petitioner shall submit in accordance with a schedule set by the 
special master assigned to the petition assessments, evaluations, and 
prognoses and such other records and documents as are reasonably 
necessary for the determination of the amount of compensation to be paid 
to, or on behalf of, the person who suffered such injury or who died 
from the administration of the vaccine.

(July 1, 1944, ch. 373, title XXI, Sec. 2111, as added Pub. L. 99-660, 
title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758; amended Pub. L. 
100-203, title IV, Secs. 4302(b), 4304(a), (b), 4306, 4307(1), (2), Dec. 
22, 1987, 101 Stat. 1330-221, 1330-223, 1330-224; Pub. L. 101-239, title 
VI, Sec. 6601(c)(1)-(7), Dec. 19, 1989, 103 Stat. 2285, 2286; Pub. L. 
101-502, Sec. 5(a), Nov. 3, 1990, 104 Stat. 1286; Pub. L. 102-168, title 
II, Sec. 201(h)(1), Nov. 26, 1991, 105 Stat. 1104; Pub. L. 102-572, 
title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516; Pub. L. 103-43, 
title XX, Sec. 2012, June 10, 1993, 107 Stat. 214; Pub. L. 105-277, div. 
C, title XV, Sec. 1502, Oct. 21, 1998, 112 Stat. 2681-741.)

                          Codification

    In subsecs. (a)(2)(A), (3), (4), (5)(A), (8), and (b)(1)(B), 
``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.


                            Prior Provisions

    A prior section 300aa-11, act July 1, 1944, Sec. 2112, was 
successively renumbered by subsequent acts and transferred, see section 
238i of this title.
    A prior section 2111 of act July 1, 1944, was successively 
renumbered by subsequent acts and transferred, see section 238h of this 
title.


                               Amendments

    1998--Subsec. (c)(1)(D)(i). Pub. L. 105-277 struck out ``and 
incurred unreimbursable expenses due in whole or in part to such 
illness, disability, injury, or condition in an amount greater than 
$1,000'' before ``, or (ii) died''.
    1993--Subsec. (a)(10). Pub. L. 103-43 added par. (10).
    1992--Subsec. (a)(1), (2)(A)(i)(I). Pub. L. 102-572 substituted 
``United States Court of Federal Claims'' for ``United States Claims 
Court'' wherever appearing.
    1991--Subsec. (a)(2)(A)(i), (ii). Pub. L. 102-168 realigned margins 
of cls. (i) and (ii).
    1990--Subsec. (a)(2)(A). Pub. L. 101-502, Sec. 5(a)(1), substituted 
``unless a petition has been filed, in accordance with section 300aa-16 
of this title, for compensation under the Program for such injury or 
death and--'' and cls. (i) and (ii) for ``unless--
        ``(i) a petition has been filed, in accordance with section 
    300aa-16 of this title, for compensation under the Program for such 
    injury or death,
        ``(ii) the United States Claims Court has issued a judgment 
    under section 300aa-12 of this title on such petition, and
        ``(iii) such person elects under section 300aa-21(a) of this 
    title to file such an action.''
    Subsec. (a)(5)(A). Pub. L. 101-502, Sec. 5(a)(2), struck out 
``without prejudice'' after ``without prejudice or costs''.
    Subsec. (a)(5)(B). Pub. L. 101-502, Sec. 5(a)(3), substituted 
``plaintiff'' for ``plaintiff who''.
    Subsec. (d). Pub. L. 101-502, Sec. 5(a)(4), struck out ``(d) except 
as provided in paragraph (3),'' before ``(d) Additional information''.
    Subsec. (e). Pub. L. 101-502, Sec. 5(a)(5), substituted ``(e) 
Schedule'' for ``(e)(e) Schedule''.
    1989--Subsec. (a)(1). Pub. L. 101-239, Sec. 6601(c)(1), substituted 
``filing of a petition containing the matter prescribed in subsection 
(c) of this section'' for ``filing of a petition'' and inserted at end 
``The clerk of the United States Claims Court shall immediately forward 
the filed petition to the chief special master for assignment to a 
special master under section 300aa-12(d)(1) of this title.''
    Subsec. (a)(2)(A)(i). Pub. L. 101-239, Sec. 6601(c)(2), struck out 
``under subsection (b) of this section'' after ``section 300aa-16 of 
this title,''.
    Subsec. (a)(5)(A). Pub. L. 101-239, Sec. 6601(c)(3)(A), substituted 
``petition to have such action dismissed without prejudice or costs'' 
for ``elect to withdraw such action''.
    Subsec. (a)(5)(B). Pub. L. 101-239, Sec. 6601(c)(3)(B), substituted 
``has pending'' for ``on October 1, 1988, had pending'' and struck out 
``does not withdraw the action under subparagraph (A)'' after ``vaccine-
related injury or death''.
    Subsec. (a)(6). Pub. L. 101-239, Sec. 6601(c)(4), substituted 
``November 15, 1988'' for ``the effective date of this subpart'' in two 
places.
    Subsec. (a)(8). Pub. L. 101-239, Sec. 6601(c)(5), added par. (8). 
Former par. (8) redesignated (9).
    Subsec. (a)(9). Pub. L. 101-239, Sec. 6601(c)(5), (7), redesignated 
par. (8) as (9) and realigned margin.
    Subsec. (c)(1). Pub. L. 101-239, Sec. 6601(c)(6)(A), inserted 
``except as provided in paragraph (3),'' after ``(1)'' in introductory 
provisions.
    Subsec. (c)(2). Pub. L. 101-239, Sec. 6601(c)(6)(B), (C), added par. 
(2) and redesignated former par. (2) as subsec. (d).
    Pub. L. 101-239, Sec. 6601(c)(6)(A), inserted ``except as provided 
in paragraph (3),'' after ``(2)''.
    Subsec. (c)(3). Pub. L. 101-239, Sec. 6601(c)(6)(C), (D), added par. 
(3). Former par. (3) redesignated subsec. (e).
    Subsec. (d). Pub. L. 101-239, Sec. 6601(c)(6)(B), redesignated 
former subsec. (c)(2) as subsec. (d), expanded margin to full measure, 
inserted subsec. designation and heading, substituted ``A petition may 
also include other available'' for ``all available'', struck out 
``(including autopsy reports, if any)'' after ``relevant medical 
records'', and substituted ``administration of the vaccine.'' for 
``administration of the vaccine and an identification of any unavailable 
records known to the petitioner and the reasons for their 
unavailability, and''.
    Subsec. (e). Pub. L. 101-239, Sec. 6601(c)(6)(D), redesignated 
former subsec. (c)(3) as subsec. (e), expanded margin to full measure, 
inserted subsec. designation and heading, and substituted ``The 
petitioner shall submit in accordance with a schedule set by the special 
master assigned to the petition'' for ``appropriate''.
    1987--Subsec. (a)(1). Pub. L. 100-203, Sec. 4307(1), which directed 
that par. (1) be amended by substituting ``with the United States Claims 
Court'' for ``with the United States district court for the district in 
which the petitioner resides or the injury or death occurred'', was 
executed making the substitution for ``with the United States district 
court for the district in which the petitioner resides or in which the 
injury or death occurred'', as the probable intent of Congress.
    Subsec. (a)(2)(A). Pub. L. 100-203, Sec. 4306, substituted ``vaccine 
administrator or manufacturer'' for ``vaccine manufacturer''.
    Pub. L. 100-203, Sec. 4302(b)(1), substituted ``effective date of 
this subpart'' for ``effective date of this part''.
    Subsec. (a)(2)(A)(ii). Pub. L. 100-203, Sec. 4307(2), substituted 
``the United States Claims Court'' for ``a district court of the United 
States''.
    Subsec. (a)(3). Pub. L. 100-203, Sec. 4306, substituted ``vaccine 
administrator or manufacturer'' for ``vaccine manufacturer''.
    Pub. L. 100-203, Sec. 4302(b)(1), substituted ``effective date of 
this subpart'' for ``effective date of this part''.
    Subsec. (a)(4). Pub. L. 100-203, Sec. 4306, substituted ``vaccine 
administrator or manufacturer'' for ``vaccine manufacturer''.
    Pub. L. 100-203, Sec. 4302(b)(1), substituted ``effective date of 
this subpart'' for ``effective date of this part''.
    Subsec. (a)(5)(A). Pub. L. 100-203, Sec. 4302(b)(2), substituted 
``after the effective date of this subpart'' for ``after the effective 
date of this subchapter''.
    Pub. L. 100-203, Sec. 4302(b)(1), substituted ``who on the effective 
date of this subpart'' for ``who on the effective date of this part''.
    Subsec. (a)(5)(B). Pub. L. 100-203, Sec. 4302(b)(1), substituted 
``effective date of this subpart'' for ``effective date of this part''.
    Subsec. (a)(6). Pub. L. 100-203, Sec. 4302(b)(1), substituted 
``effective date of this subpart'' for ``effective date of this part'' 
in two places.
    Subsec. (a)(7). Pub. L. 100-203, Sec. 4306, substituted ``vaccine 
administrator or manufacturer'' for ``vaccine manufacturer''.
    Subsec. (a)(8). Pub. L. 100-203, Sec. 4304(a), added par. (8).
    Subsec. (b)(1)(A). Pub. L. 100-203, Sec. 4304(b)(1), substituted 
``may, if the person meets the requirements of subsection (c)(1) of this 
section, file'' for ``may file''.
    Subsec. (b)(1)(B). Pub. L. 100-203, Sec. 4302(b)(1), substituted 
``effective date of this subpart'' for ``effective date of this part''.
    Subsec. (c)(1)(D). Pub. L. 100-203, Sec. 4304(b)(2), substituted 
``for more than 6 months'' for ``for more than 1 year'', ``and 
incurred'' for ``, (ii) incurred'', and ``(ii)'' for ``(iii)''.

                         Change of Name

    References to United States Claims Court deemed to refer to United 
States Court of Federal Claims, see section 902(b) of Pub. L. 102-572, 
set out as a note under section 171 of Title 28, Judiciary and Judicial 
Procedure.


                    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 1991 Amendment

    Section 201(i) of Pub. L. 102-168 provided that:
    ``(1) Except as provided in paragraph (2), the amendments made by 
this section [amending this section and sections 300aa-12, 300aa-15, 
300aa-16, 300aa-19, and 300aa-21 of this title and provisions set out as 
a note under section 300aa-1 of this title] shall take effect on the 
date of the enactment of this Act [Nov. 26, 1991].
    ``(2) The amendments made by subsections (d) and (f) [amending 
sections 300aa-12, 300aa-15, 300aa-16, and 300aa-21 of this title] shall 
take effect as if the amendments had been in effect on and after October 
1, 1988.''


                    Effective Date of 1990 Amendment

    Section 5(h) of Pub. L. 101-502 provided that: ``The amendments made 
by subsections (f)(1) and (g) [amending section 300aa-21 of this title 
and provisions set out as a note under section 300aa-1 of this title and 
enacting provisions set out as a note under section 300aa-12 of this 
title] shall take effect as of November 14, 1986, and the amendments 
made by subsections (a) through (e) and subsection (f)(2) [amending this 
section and sections 300aa-12, 300aa-13, 300aa-15, 300aa-16, and 300aa-
21 of this title] shall take effect as of September 30, 1990.''


                    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 sections 300aa-12, 300aa-13, 300aa-
14, 300aa-15, 300aa-16, 300aa-21, 300aa-23, 300aa-34 of this title.
