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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-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
-HEAD-
Sec. 300aa-11. Petitions for compensation
-STATUTE-
(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withdrawn under such section.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
(FOOTNOTE 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.
(FOOTNOTE 1) So in original. Probably should be followed by a
comma.
(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 (FOOTNOTE 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.
(FOOTNOTE 2) See Change of Name note below.
(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.
-SOURCE-
(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, Sec. 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.)
-COD-
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.
-MISC3-
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-
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.
-MISC4-
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.
-SECREF-
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.
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