1.This Act may be cited as the
Ending Defensive Medicine and
Encouraging Innovative Reforms Act of 2011
.
2.The table of contents
is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Title I—Nationwide Reforms
Subtitle A—In General
Sec. 101. Authorization of payment of future damages to
claimants in health care lawsuits.
Sec. 102. Fair Share Rule.
Sec. 103. Certificate of Merit.
Sec. 104. Practice guidelines.
Sec. 105. Payment determination.
Sec. 106. Definitions.
Subtitle B—Safety Net Providers
Sec. 121. Protection for emergency and related services
furnished pursuant to EMTALA.
Subtitle C—Community health center volunteers
Sec. 131. Protection for health center volunteer
practitioners.
Subtitle D—Disaster Relief Volunteers
Sec. 141. Protection for disaster relief
volunteers.
Title II—State Reform Incentives
Sec. 201. Public Health Service Act amendment.
<enum>I</enum><header>Nationwide
Reforms</header>
<subtitle id="H127F305D90554386A07A310CE68DCFFA"><enum>A</enum><header>In
General</header>
<section id="HCAA474335F4E4E54B0FC39EC2D975191"><enum>101.</enum><header>Authorization
of payment of future damages to claimants in health care lawsuits</header>
<subsection id="H20D7F174BFB245F8BA36F3BA5AEBAFB5"><enum>(a)</enum><header>Compensating
Patient Injury</header><text>In any health care lawsuit, if an award of future
damages, without reduction to present value, equaling or exceeding $50,000 is
made against a party with sufficient insurance or other assets to fund a
periodic payment of such a judgment, the court shall, at the request of any
party, enter a judgment ordering that the future damages be paid by periodic
payments. In any health care lawsuit, the court may be guided by the Uniform
Periodic Payment of Judgments Act promulgated by the National Conference of
Commissioners on Uniform State Laws.</text>
</subsection><subsection id="H7BE8D314F52640C5935A0B2C610B72AF"><enum>(b)</enum><header>Applicability</header><text>This
section applies to all actions which have not been first set for trial or
retrial before the date of enactment of this Act.</text>
</subsection></section><section id="HBEA94C7439C84F2DBEF4CD36E0A79767"><enum>102.</enum><header>Fair Share
Rule</header><text display-inline="no-display-inline">In any health care
lawsuit, each party shall be liable for that party’s several share of any
damages only and not for the share of any other person. Each party shall be
liable only for the amount of damages allocated to such party in direct
proportion to such party’s percentage of responsibility. Whenever a judgment of
liability is rendered as to any party, a separate judgment shall be rendered
against each such party for the amount allocated to such party. For purposes of
this section, the trier of fact shall determine the proportion of
responsibility of each party for the claimant’s harm.</text>
</section><section id="H003799BFC4D74745B0847FF96F1EACD6"><enum>103.</enum><header>Certificate of
Merit</header>
<subsection id="HBD83E86CDD714268876F7ABE56016410"><enum>(a)</enum><header>Preliminary
procedure</header><text display-inline="yes-display-inline">Within 30 days of
the filing of a health care lawsuit, the court shall appoint a qualified
specialist whose appointment is agreed to by one qualified specialist chosen by
the claimant and one qualified specialist chosen by the defendant. If a
qualified specialist is not agreed to by the qualified specialist chosen by the
claimant and the qualified specialist chosen by the defendant within such 30
days, then the court shall appoint such qualified specialist at its discretion.
The qualified specialist appointed by the court shall, within 45 days of such
appointment, submit to the court an affidavit that includes such specialist’s
statement of opinion whether, based on a review of the available medical record
and other relevant material, there is a reasonable and meritorious cause for
the filing of the action against the defendant. If such specialist does not
submit such affidavit to the court within 45 days of such appointment, the
court shall dismiss such health care lawsuit. Such affidavit shall also contain
a statement by the qualified specialist of specific breaches in the standard of
care and the approximate negligence causation. Such affidavit shall not be
admissible in any health care lawsuit or other court proceedings, or any
arbitration proceeding. However, such affidavit, and information relevant to
the determinations made by such specialist in such affidavit, shall be
discoverable by the plaintiff and the defendant. In the case of multiple
defendants, a separate affidavit shall be required for each defendant. The
court shall set a reasonable fee that shall be paid by the claimant for the
preparation of such affidavit by such qualified specialist. The plaintiff’s
attorney shall be given 90 days to obtain the certificate of merit affidavit in
cases where the period to file the claim is due to expire because of the
statute of limitations. If a case is filed without a certificate of merit
affidavit, dismissal of the case is automatic without an extension permitted
under the applicable statute of limitation exemption provision.</text>
</subsection><subsection id="H7B990868ADDB4DB59622C0F436BA5D50"><enum>(b)</enum><header>Loser
pays</header><text display-inline="yes-display-inline">In a health care
lawsuit, in the event the statement of opinion by a qualified specialist
appointed by the court in an affidavit is that there is no reasonable and
meritorious cause for the filing of the action against the defendant, and the
claimant does not substantially prevail by judgment, settlement, mediation,
arbitration, or any other form of alternative dispute resolution, the court
shall order the claimant, or such claimant’s attorneys, to pay the costs and
reasonable attorneys fees incurred by the defendant as a direct result of the
health care lawsuit in which such qualified specialist’s opinion was filed.
Claimants and their attorneys shall share liability for such costs and
reasonable attorneys fees incurred, as determined by the court in the interests
of justice.</text>
</subsection><subsection id="HEABED3203E244B8DA5B9813E541F41D8"><enum>(c)</enum><header>Definition</header><text>In
this section, the term <quote>qualified specialist</quote> means, with respect
to a health care lawsuit—</text>
<paragraph id="H04A8AD481A5541EBAAD5A00792166C3A"><enum>(1)</enum><text>a
health care professional who—</text>
<subparagraph id="H99D2586C66F2415C99FB5E00D32905D3"><enum>(A)</enum><text display-inline="yes-display-inline">is appropriately credentialed or licensed
in one or more States to deliver health care services;</text>
</subparagraph><subparagraph id="H815298C3530E4233BCF8F780C6B603B1"><enum>(B)</enum><text>typically treats
the diagnosis or condition or provides the type of treatment under
review;</text>
</subparagraph><subparagraph id="H21A449CD0EE3413C9833ADCAFF5CE361"><enum>(C)</enum><text>can demonstrate by
competent evidence that, as a result of training, education, knowledge, and
experience in the evaluation, diagnosis, and treatment of the disease or injury
which is the subject matter of the lawsuit against the defendant, the health
care professional is substantially familiar with applicable standards of care
and practice on the date of the incident as they relate to the act or omission
which is the subject of the lawsuit; and</text>
</subparagraph><subparagraph id="H4BA0FAC7D2634C7BA8829D2435511D9C"><enum>(D)</enum><text display-inline="yes-display-inline">has not been out of practice for more than
5 consecutive years; and</text>
</subparagraph></paragraph><paragraph id="HA43F3C9A12D34F7FAFD550FB7F8F3562"><enum>(2)</enum><text display-inline="yes-display-inline">if the claim in the health care lawsuit
involved treatment that is recommended or provided by a physician (allopathic
or osteopathic), with respect to issues of negligence concerning such
treatment, a physician whose medical specialty or subspecialty is the same as
the defendant’s or in addition to a showing of substantial familiarity in
accordance with this section, there is a showing that the standards of care and
practice in the two specialty or subspecialty fields are similar.</text>
</paragraph></subsection></section><section id="H774BABC026D24F71AF100A58B9146790"><enum>104.</enum><header>Practice
guidelines</header><text display-inline="no-display-inline">Notwithstanding any
other provision of Federal, State, or local law the following shall
apply:</text>
<paragraph id="H9C4F44E05D28420BB39A1ABA76115FBE"><enum>(1)</enum><text display-inline="yes-display-inline">In a health care lawsuit or proceeding
brought against a health care provider, such provider shall not be liable for
the care provided if, in delivering such care, such provider acted consistent
with accepted clinical practice guidelines established by the specialty of
which the defendant is board certified or if guidelines established by the
specialty are not available, accepted clinical practice guideline listed in the
National Guideline Clearinghouse. Non-compliance with accepted clinical
practice guidelines established by the specialty of which the defendant is
board certified, or if guidelines established by the specialty are not
available, accepted clinical practice guidelines listed in the National
Guideline Clearinghouse shall not, in a health care lawsuit or proceeding
brought against a health care provider, constitute a breach of the applicable
medical standard of care, or be otherwise admissible to prove a breach of the
standard of care, negligence or other tortious conduct.</text>
</paragraph><paragraph id="H66230D26E3534C569FBA09F275FB1713"><enum>(2)</enum><text>Compliance or
non-compliance with regulations, directives, or guidelines established by or on
behalf of the Secretary of Health and Human Services pursuant to authority set
forth in title XVIII of the Social Security Act (42 U.S.C. 1395–1395ccc) shall
not, in a health care lawsuit or proceeding brought against a health care
provider, constitute a breach of the medical standard of care, or be otherwise
admissible to prove a breach of the medical standard of care, negligence or
other tortious conduct.</text>
</paragraph><paragraph id="HE1B129FAA78F4C1DB4C3EFB9250AA852"><enum>(3)</enum><text>Compliance or
non-compliance with regulations, directives, or guidelines established by or on
behalf of the Secretary of Health and Human Services or any State official or
entity administering Medicaid programs under title XIX of the Social Security
Act (42 U.S.C. 1396–1396v) and Children’s Health Insurance Programs under title
XXI of the Social Security Act (42 U.S.C. 1397aa–1397jj) shall not, in a health
care lawsuit or proceeding brought against a health care provider, constitute a
breach of the applicable medical standard of care, or be otherwise admissible
to prove a breach of the standard of care, negligence or other tortious
conduct.</text>
</paragraph><paragraph id="H893C385123144D22A88D35075F787FDC"><enum>(4)</enum><text>Compliance or
non-compliance with Comparative Effectiveness Research and any regulations,
directives, or guidelines based in whole or in part upon such research shall
not, in a health care lawsuit or proceeding brought against a health care
provider, constitute a breach of the applicable medical standard of care, or be
otherwise admissible to prove the medical standard of care, negligence or other
tortious conduct.</text>
</paragraph></section><section id="H2CEBF3891B38468BAF53AA2DD6F6F536"><enum>105.</enum><header>Payment
determination</header><text display-inline="no-display-inline">Notwithstanding
any other provision of Federal, State, or local law the following shall
apply:</text>
<paragraph id="H80D38753E7B849A29B0A08627B40B094"><enum>(1)</enum><text>Evidence of
payments and reimbursements made to health care providers pursuant to title
XVIII of the Social Security Act (42 U.S.C. 1395–1395ccc) and evidence of
payment rates, payment mechanisms, and payment policies established on or
behalf of the Secretary of Health and Human Services for services provided
pursuant to the programs set forth in title XVIII of the Social Security Act
(42 U.S.C. 1395–1395ccc) shall not, in a health care lawsuit or proceeding
brought against a health care provider, constitute a determination that a
health care provider has or has not met the medical standard of care or be
otherwise admissible to prove breach of the medical standard of care,
negligence or other tortious conduct.</text>
</paragraph><paragraph id="H8C1233D4612A4413A6BE47813ED3FFAA"><enum>(2)</enum><text>Compliance or
non-compliance with payment rates, payment mechanisms, or payment policies
established by or on behalf of the Secretary of Health and Human Services or
any State official or entity administering Medicaid programs under title XIX of
the Social Security Act (42 U.S.C. 1396–1396v) and Children’s Health Insurance
Programs under title XXI of the Social Security Act (42 U.S.C. 1397aa–1397jj)
shall not, in a health care lawsuit or proceeding brought against a health care
provider, constitute a determination that a health care provider has or has not
met the applicable medical standard of care or be otherwise admissible to prove
a breach of the medical standard of care, negligence or other tortious
conduct.</text>
</paragraph></section><section id="HACEBCCE536D74C90BF999084700FF00F"><enum>106.</enum><header>Definitions</header><text display-inline="no-display-inline">In this subtitle:</text>
<paragraph commented="no" id="H1AF004E491234FE0934CA5DC32086985"><enum>(1)</enum><header>Health care
lawsuit</header><text>The term <quote>health care lawsuit</quote> means any
health care liability claim concerning the provision of health care goods or
services or any medical product affecting interstate commerce, or any health
care liability action concerning the provision of health care goods or services
or any medical product affecting interstate commerce, brought in a State or
Federal court or pursuant to an alternative dispute resolution system, against
a health care provider, a health care organization, or the manufacturer,
distributor, supplier, marketer, promoter, or seller of a medical product,
regardless of the theory of liability on which the claim is based, or the
number of claimants, plaintiffs, defendants, or other parties, or the number of
claims or causes of action, in which the claimant alleges a health care
liability claim. Such term does not include a claim or action which is based on
criminal liability; which seeks civil fines or penalties paid to Federal,
State, or local government; or which is grounded in antitrust.</text>
</paragraph><paragraph id="H3B4774A3B3284A119087782FFED69CA4"><enum>(2)</enum><header>Claimant</header><text display-inline="yes-display-inline">The term <quote>claimant</quote> means any
person who brings a health care lawsuit, including a person who asserts or
claims a right to legal or equitable contribution, indemnity, or subrogation,
arising out of a health care liability claim or action, and any person on whose
behalf such a claim is asserted or such an action is brought, whether deceased,
incompetent, or a minor.</text>
</paragraph><paragraph id="HAF0DB0FBAB1641E7A1524B2883C368B9"><enum>(3)</enum><header>Health care
provider</header><text display-inline="yes-display-inline">The term ‘health
care provider’ means any person or entity—</text>
<subparagraph id="H69A1DB7223164FB980FA9CA977281CC1"><enum>(A)</enum><text>required by State
or Federal law or regulations to be licensed, registered, or certified to
provide health care services; and</text>
</subparagraph><subparagraph id="HEA7C85DFB092411386743366BA9CCDA6"><enum>(B)</enum><text>being either so
licensed, registered, or certified, or exempted from such requirement by other
law or regulation.</text>
</subparagraph></paragraph></section></subtitle><subtitle id="H1B8198A8335149CB9DF5106CF81AAA77"><enum>B</enum><header>Safety Net
Providers</header>
<section id="H5ADA0285DBFF40E28BE2C0B3AB9313BC"><enum>121.</enum><header>Protection for
emergency and related services furnished pursuant to EMTALA</header><text display-inline="no-display-inline">Section 224(g) of the Public Health Service
Act (42 U.S.C. 233(g)) is amended—</text>
<paragraph id="H4732D14824364F408C0F2BECB5C060C2"><enum>(1)</enum><text>in paragraph (4),
by striking <quote>An entity</quote> and inserting <quote>Subject to paragraph
(6), an entity</quote>; and</text>
</paragraph><paragraph id="H91E086DA7EB24AA29B5D81AFEA33A3FB"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block id="HB7A0758F84B54F34896FB9A3212B8ED6" style="OLC">
<paragraph id="H2CB2E0A41692445FB4887971C37F5E75"><enum>(6)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HD6752C6E2B3A435F9923C3F6E400E096"><enum>(A)</enum><text>For purposes of this
section—</text>
<clause id="H277C3AF331694532A55A42184632E23E" indent="up1"><enum>(i)</enum><text>an entity described in subparagraph
(B) shall be considered to be an entity described in paragraph (4); and</text>
</clause><clause id="HB5230DF1EC1543E3AD384AC91F9B6239" indent="up1"><enum>(ii)</enum><text>the provisions of this section
shall apply to an entity described in subparagraph (B) in the same manner as
such provisions apply to an entity described in paragraph (4), except
that—</text>
<subclause id="HD71C7A23D82741A3A6D6A865E4B330C5"><enum>(I)</enum><text>notwithstanding paragraph (1)(B), the
deeming of any entity described in subparagraph (B), or of an officer,
governing board member, employee, contractor, or on-call provider of such an
entity, to be an employee of the Public Health Service for purposes of this
section shall apply only with respect to items and services that are furnished
to an individual pursuant to section 1867 of the Social Security Act and to
post stabilization services (as defined in subparagraph (D)) furnished to such
an individual;</text>
</subclause><subclause id="H75388A32B6CC41C68A4C38EE86BDE660"><enum>(II)</enum><text>nothing in paragraph (1)(D) shall be
construed as preventing a physician or physician group described in
subparagraph (B)(ii) from making the application referred to in such paragraph
or as conditioning the deeming of a physician or physician group that makes
such an application upon receipt by the Secretary of an application from the
hospital or emergency department that employs or contracts with the physician
or group, or enlists the physician or physician group as an on-call
provider;</text>
</subclause><subclause id="HEF4B618C7CD84F6CACCD077DF6B144DC"><enum>(III)</enum><text>notwithstanding paragraph (3), this
paragraph shall apply only with respect to causes of action arising from acts
or omissions that occur on or after January 1, 2010;</text>
</subclause><subclause id="H1A6654C674304012B8AB2532C217DF49"><enum>(IV)</enum><text>paragraph (5) shall not apply to a
physician or physician group described in subparagraph (B)(ii);</text>
</subclause><subclause id="H36B69B005A23428F9121C03149EFBBC7"><enum>(V)</enum><text>the Attorney General, in consultation
with the Secretary, shall make separate estimates under subsection (k)(1) with
respect to entities described in subparagraph (B) and entities described in
paragraph (4) (other than those described in subparagraph (B)), and the
Secretary shall establish separate funds under subsection (k)(2) with respect
to such groups of entities, and any appropriations under this subsection for
entities described in subparagraph (B) shall be separate from the amounts
authorized by subsection (k)(2);</text>
</subclause><subclause id="H8102AD38C49747D6ACE02217F86305C9"><enum>(VI)</enum><text>notwithstanding subsection (k)(2), the
amount of the fund established by the Secretary under such subsection with
respect to entities described in subparagraph (B) may exceed a total of
$10,000,000 for a fiscal year; and</text>
</subclause><subclause id="HA1DB83A32CE646FCAFA26EE17038896E"><enum>(VII)</enum><text>subsection (m) shall not apply to
entities described in subparagraph (B).</text>
</subclause></clause></subparagraph><subparagraph id="HF4205480FC9B49DDB384BC500D499942" indent="up1"><enum>(B)</enum><text>An entity described in this
subparagraph is—</text>
<clause id="H413C39806022423F9CA165F5C683AFE0"><enum>(i)</enum><text>a hospital or an emergency
department to which section 1867 of the Social Security Act applies; and</text>
</clause><clause id="HA188BE25F30F42EEB97143616BBAF59A"><enum>(ii)</enum><text>a physician or physician group
that is employed by, is under contract with, or is an on-call provider of such
hospital or emergency department, to furnish items and services to individuals
under such section.</text>
</clause></subparagraph><subparagraph id="H8912064B0EAB4ABEBF9CD21E3BDA3570" indent="up1"><enum>(C)</enum><text>For purposes of this paragraph, the
term <term>on-call provider</term> means a physician or physician group
that—</text>
<clause id="H92CFCF5503E74ACBB965106F75A1948F"><enum>(i)</enum><text>has full, temporary, or locum
tenens staff privileges at a hospital or emergency department to which section
1867 of the Social Security Act applies; and</text>
</clause><clause id="HBF94D743B5C94CD894AA98B717E657B5"><enum>(ii)</enum><text>is not employed by or under
contract with such hospital or emergency department, but agrees to be ready and
available to provide services pursuant to section 1867 of the Social Security
Act or post stabilization services to individuals being treated in the hospital
or emergency department with or without compensation from the hospital or
emergency department.</text>
</clause></subparagraph><subparagraph id="H5A327E0B4082424DAA1E4DE2F4699EDE" indent="up1"><enum>(D)</enum><text>For purposes of this paragraph, the
term <term>post stabilization services</term> means, with respect to an
individual who has been treated by an entity described in subparagraph (B) for
purposes of complying with section 1867 of the Social Security Act, services
that are—</text>
<clause id="H8B6C3A7ED2C14E0B80C765420BFA72D1"><enum>(i)</enum><text>related to the condition that was
so treated; and</text>
</clause><clause id="H65CC9EF8B2514DD7837E134C6F829779"><enum>(ii)</enum><text>provided after the individual is
stabilized in order to maintain the stabilized condition or to improve or
resolve the condition of the individual.</text>
</clause></subparagraph><subparagraph id="H8FEE6B452F0C401B9EF83CD497F1D9BA" indent="up1"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="HAD5C74FCE86F4022A147B15C4989B97B"><enum>(i)</enum><text>Nothing in this
paragraph (or in any other provision of this section as such provision applies
to entities described in subparagraph (B) by operation of subparagraph (A))
shall be construed as authorizing or requiring the Secretary to make payments
to such entities, the budget authority for which is not provided in advance by
appropriation Acts.</text>
</clause><clause id="H9EEAF9D2E57E4031B0473EB97DBE2AA9" indent="up1"><enum>(ii)</enum><text>The Secretary shall limit the total
amount of payments under this paragraph for a fiscal year to the total amount
appropriated in advance by appropriation Acts for such purpose for such fiscal
year. If the total amount of payments that would otherwise be made under this
paragraph for a fiscal year exceeds such total amount appropriated, the
Secretary shall take such steps as may be necessary to ensure that the total
amount of payments under this paragraph for such fiscal year does not exceed
such total amount
appropriated.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section></subtitle><subtitle id="H03B9A376B3984B5E8305EA7BF0E1D03B"><enum>C</enum><header>Community health
center volunteers </header>
<section id="HC1D7AE838A84432A84F48F534337EF66"><enum>131.</enum><header>Protection for
health center volunteer practitioners</header>
<subsection id="H87231FFD5CD94062B1B29975AF8D31B8"><enum>(a)</enum><header>In
General</header><text>Section 224 of the Public Health Service Act (42 U.S.C.
233) is amended—</text>
<paragraph id="H0E820F49B8DE4FF59D3FF693D9D0405D"><enum>(1)</enum><text>in subsection
(g)(1)(A)—</text>
<subparagraph id="H6C37E36078EB4A00B50E40071243C3ED"><enum>(A)</enum><text>in the first
sentence, by striking <quote>or employee</quote> and inserting <quote>employee,
or (subject to subsection (k)(4)) volunteer practitioner</quote>; and</text>
</subparagraph><subparagraph id="HAA4BC0FBE6AC4558AA013EEA157CD553"><enum>(B)</enum><text>in the second
sentence, by inserting <quote>and subsection (k)(4)</quote> after
<quote>subject to paragraph (5)</quote>; and</text>
</subparagraph></paragraph><paragraph id="H2EFE8797AF9A40CC9441A15FDEFBCCA8"><enum>(2)</enum><text>in each of
subsections (g), (i), (j), (k), (l), and (m)—</text>
<subparagraph id="H8454649FA54B46BFA316963629593D33"><enum>(A)</enum><text>by striking the
term <quote>employee, or contractor</quote> each place such term appears and
inserting <quote>employee, volunteer practitioner, or
contractor</quote>;</text>
</subparagraph><subparagraph id="HFE40375D7CD641AEB0FB31A32CD07974"><enum>(B)</enum><text>by striking the
term <quote>employee, and contractor</quote> each place such term appears and
inserting <quote>employee, volunteer practitioner, and
contractor</quote>;</text>
</subparagraph><subparagraph id="HAA2300392E2C41F2ADD553CB5A59D8B6"><enum>(C)</enum><text>by striking the
term <quote>employee, or any contractor</quote> each place such term appears
and inserting <quote>employee, volunteer practitioner, or contractor</quote>;
and</text>
</subparagraph><subparagraph id="H763B0DABCA394E1BB38286F0B7B0BF15"><enum>(D)</enum><text>by striking the
term <quote>employees, or contractors</quote> each place such term appears and
inserting <quote>employees, volunteer practitioners, or
contractors</quote>.</text>
</subparagraph></paragraph></subsection><subsection id="HFAA3B469DC5F4D2EA2A96C406DDAE6A1"><enum>(b)</enum><header>Applicability;
Definition</header><text>Section 224(k) of the Public Health Service Act (42
U.S.C. 233(k)) is amended by adding at the end the following paragraph:</text>
<quoted-block id="HA1A32A7D313847A0A992809007C45EA7" style="OLC">
<paragraph id="H50A92B2BE3024DDC9094C49F900C8F78" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H5BA247DFDDC4457C887FAC4B539A71C3"><enum>(A)</enum><text>Subsections (g) through
(m) apply with respect to volunteer practitioners beginning with the first
fiscal year for which an appropriations Act provides that amounts in the fund
under paragraph (2) are available with respect to such practitioners.</text>
</subparagraph><subparagraph id="H479DEF47307B49B8A32BD5ABDD2A5F57" indent="up1"><enum>(B)</enum><text>For purposes of subsections (g)
through (m), the term <quote>volunteer practitioner</quote> means a
practitioner who, with respect to an entity described in subsection (g)(4),
meets the following conditions:</text>
<clause id="H14DAAC5D3CB64F739E42ED17EC195793"><enum>(i)</enum><text>In the State involved, the
practitioner is a licensed physician, a licensed clinical psychologist, or
other licensed or certified health care practitioner.</text>
</clause><clause id="H52C880166B68456487494E9CD737FE10"><enum>(ii)</enum><text>At the request of such entity, the
practitioner provides services to patients of the entity, at a site at which
the entity operates or at a site designated by the entity. The weekly number of
hours of services provided to the patients by the practitioner is not a factor
with respect to meeting conditions under this subparagraph.</text>
</clause><clause id="H817140028EE6455CB37A42CFE5F85604"><enum>(iii)</enum><text>The practitioner does not for the
provision of such services receive any compensation from such patients, from
the entity, or from third-party payers (including reimbursement under any
insurance policy or health plan, or under any Federal or State health benefits
program).</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section></subtitle><subtitle id="H90DB42278F05418FBAABB41A1F362C58"><enum>D</enum><header>Disaster Relief
Volunteers</header>
<section id="H429D766C4FBE42A6B7C7ACFBEE012507"><enum>141.</enum><header>Protection for
disaster relief volunteers</header>
<subsection id="H5218B16597E640278381A851C139D6CC"><enum>(a)</enum><header>Liability of
disaster relief volunteers</header><text>A disaster relief volunteer shall not
be liable for any injury (including personal injury, property damage or loss,
and death) caused by an act or omission of such volunteer in connection with
such volunteer’s providing or facilitating the provision of disaster relief
services if—</text>
<paragraph id="H07670EE5248741B78E3AA3914FFC21E6"><enum>(1)</enum><text>the injury was not
caused by willful, wanton, or reckless misconduct by the volunteer; and</text>
</paragraph><paragraph id="HA3E9A7D4669F4F349271E1C00EB45F75"><enum>(2)</enum><text>the injury was not
caused by the volunteer’s operating a motor vehicle, vessel, aircraft, or other
vehicle for which the state requires the operator or the owner of the vehicle,
craft, or vessel to—</text>
<subparagraph id="H3A840485F67B4DBFBF156EB2C2172330"><enum>(A)</enum><text>possess an
operator’s license; or</text>
</subparagraph><subparagraph id="H090AFBDA9C3F46ED8C17F3DF4221EFB9"><enum>(B)</enum><text>maintain
insurance.</text>
</subparagraph></paragraph></subsection><subsection id="H40AD7D2CA6CA4F41B5DE79E698C2BB69"><enum>(b)</enum><header>Liability of
employer or partner of disaster relief volunteer</header><text>An employer or
business partner of a disaster relief volunteer shall not be liable for any act
or omission of such volunteer in connection with such volunteer’s providing or
facilitating the provision of disaster relief services.</text>
</subsection><subsection id="HEDCE494688A6463CB08FECF6BEDD59A3"><enum>(c)</enum><header>Liability of
host or enabling person, entity, or organization</header><text>A person or
entity, including a governmental entity, that works with, accepts services
from, or makes its facilities available to a disaster relief volunteer to
enable such volunteer to provide disaster relief services shall not be liable
for any act or omission of such volunteer in connection with such volunteer’s
providing such services.</text>
</subsection><subsection id="HE7547C0692AA4250B525DFE8CC4086FD"><enum>(d)</enum><header>Liability of
nonprofit organizations</header><text>A nonprofit organization shall not be
liable for any injury (including personal injury, property damage or loss, and
death) caused by an act or omission in connection with such nonprofit
organization’s providing or facilitating the provision of disaster relief
services if the injury was not caused by willful, wanton, or reckless
misconduct by the nonprofit organization.</text>
</subsection><subsection id="HB8FE372D62B34A0E8BF56DB8CFCD16E4"><enum>(e)</enum><header>Liability of
governmental and intergovernmental entities for donations of disaster relief
goods</header><text>A governmental or intergovernmental entity that donates to
an agency or instrumentality of the United States disaster relief goods shall
not be liable for any injury (including personal injury, property damage or
loss, and death) caused by such donated goods if the injury was not caused by
willful, wanton, or reckless misconduct by such governmental or
intergovernmental entity.</text>
</subsection><subsection id="HFD4CEF2DF5AF42E5AC6BDFE07BCF41D3"><enum>(f)</enum><header>Limitation on
Punitive and Noneconomic Damages Based on Actions of Disaster Relief Volunteers
and Governmental Donors</header>
<paragraph id="H003D845B7880453080D5BDB9E36A0CCC"><enum>(1)</enum><header>Punitive
damages</header><text>Unless the claimant establishes by clear and convincing
evidence that its damages were proximately caused by willful, wanton, or
reckless misconduct by either—</text>
<subparagraph id="HB7A3B2F0A37E486197D4690CE007D94A"><enum>(A)</enum><text>a disaster relief
volunteer in any civil action brought for injury caused by the volunteer’s
providing or facilitating the provision of disaster relief services; or</text>
</subparagraph><subparagraph id="HDE7012AFA88A4F96A5A45C83B4630AE2"><enum>(B)</enum><text>a governmental or
intergovernmental entity in any civil action brought for injury caused by
disaster relief goods donated by such governmental or intergovernmental
entity;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">punitive
damages may not be awarded in any civil action against such a volunteer or
governmental entity.</continuation-text></paragraph><paragraph id="HF785F951331E4A36A40D8D36A84DE3B1"><enum>(2)</enum><header>Noneconomic
damages</header>
<subparagraph id="H13689C27B9964643B814184AC5F0B027"><enum>(A)</enum><header>General
rule</header><text>In any civil action brought against—</text>
<clause id="HAB26E636614240D3B3B8D23ADD162301"><enum>(i)</enum><text>a
disaster relief volunteer for injury caused by such volunteer’s providing or
facilitating the provision of disaster relief services; or</text>
</clause><clause id="H0805B656A1724DC29997091DCF23BF2C"><enum>(ii)</enum><text>a
governmental or intergovernmental entity for injury caused by disaster relief
goods donated by such governmental entity;</text>
</clause><continuation-text continuation-text-level="subparagraph">liability
for noneconomic loss, if permitted under subsection (a) or (e) of this section,
shall be determined in accordance with this subparagraph.</continuation-text></subparagraph><subparagraph id="H662828CFA28248038E738BF18EF67BDF"><enum>(B)</enum><header>Amount of
liability</header><clause commented="no" display-inline="yes-display-inline" id="H153EDD7F1B5348D7BAED0DCCA2E305FC"><enum>(i)</enum><text>The amount of
noneconomic loss allocated to the disaster relief volunteer or governmental or
intergovernmental entity defendant shall be in direct proportion to the
percentage of responsibility of that defendant (determined in accordance with
clause (ii)) for the harm to the claimant with respect to which that defendant
is liable. The court shall render a separate judgment against each defendant in
an amount determined pursuant to this section.</text>
</clause><clause id="HDAA5B1FA5AE44C259C5108D03D35F36A" indent="up1"><enum>(ii)</enum><text>For purposes of determining the
amount of noneconomic loss allocated to a defendant, the trier of fact shall
determine the percentage of responsibility of each person or entity responsible
for the claimant’s harm, whether or not such person or entity is a party to the
action.</text>
</clause></subparagraph></paragraph></subsection><subsection id="H3E30A97C40B24928AED2AF6F2A56F147"><enum>(g)</enum><header>Construction</header><text>Nothing
in this section shall be construed to abrogate or limit any protection that a
volunteer, as defined in the Volunteer Protection Act of 1997 (42 U.S.C. 14501
et seq.), may be entitled to under that Act. Neither shall anything in this
section be construed to confer any private right of action or to abrogate or
limit any protection with respect to either liability or damages that any
disaster relief volunteer or governmental or intergovernmental entity may be
entitled to under any other provision of law.</text>
</subsection><subsection id="H154F8942E0164005B5A996139C646AD2"><enum>(h)</enum><header>Supplemental
declaration</header><text>If a Disaster Declaration is issued, the President,
the Secretary of Health and Human Services, or the Secretary of Homeland
Security may issue a Supplemental Declaration under this section.</text>
<paragraph id="H2656DF369DDD4229895D823FED753DC1"><enum>(1)</enum><header>Temporal
effect</header><text>Such Supplemental Declaration may provide that, for
purposes of this section, such Disaster Declaration shall have such temporal
effect as the President or the Secretary may deem necessary or appropriate to
further the public interest, including providing that such Disaster Declaration
shall have an effective date earlier than the date of the declaration or
determination of such Disaster Declaration.</text>
</paragraph><paragraph id="H03ECD61F0BEC427D8D6549FE0E8426D7"><enum>(2)</enum><header>Geographic and
other conditions</header><text>Such Supplemental Declaration may provide that,
for purposes of this section, such Disaster Declaration shall have such
geographic or other conditions as the President or the Secretary may deem
necessary or appropriate to further the public interest.</text>
</paragraph></subsection><subsection id="H8CBB14EFA19C426A812C1A7C9FF9310F"><enum>(i)</enum><header>Licensing,
certification, and authorization</header><text>This section shall not apply to
a disaster relief volunteer where the disaster relief service such volunteer
provides is of a type that generally requires a license, certificate, or
authorization, and the disaster relief volunteer lacks such license,
certificate, or authorization, unless—</text>
<paragraph id="H5DB81F42BC334AE0989F4CA2CDE2FE0C"><enum>(1)</enum><text>such volunteer is
licensed, certified, or authorized to provide such services in any State to the
extent required, if any, by the appropriate authorities of that State, even if
such State is not the State in which the disaster relief volunteer provides
disaster relief services; or</text>
</paragraph><paragraph id="HA8A6B88BEDCE48D192DD5D84B4C89127"><enum>(2)</enum><text>otherwise
specified in a Disaster Declaration or Supplemental Declaration under this
section.</text>
</paragraph></subsection><subsection id="HDDBB48F65A4F48669C6114A6C290D4AA"><enum>(j)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph id="HC3A2AEF6FB444C97B3DDDB813F537122"><enum>(1)</enum><text>The term
<quote>Disaster Declaration</quote> means—</text>
<subparagraph id="HC5ABE54699C74684BEDBEAA3A7CBBABF"><enum>(A)</enum><text>a public health
emergency declaration by the Secretary of Health and Human Services under
section 319 of the Public Health Service Act (42 U.S.C. 247d);</text>
</subparagraph><subparagraph id="HFA2B9C07CE004796A9BEB0F0E52A114E"><enum>(B)</enum><text>a declaration of a
public health emergency or a risk of such emergency as determined by the
Secretary of Homeland Security in accordance with clause (i) or clause (ii) of
section 2811(b)(3)(A) of such Act (42 U.S.C. 300hh–11(b)(3)(A)) and section
503(5) of the Homeland Security Act of 2002 (6 U.S.C. 313(5)); or</text>
</subparagraph><subparagraph id="H9806275CF97C45CF9716371024D85807"><enum>(C)</enum><text>an emergency or
major disaster declaration by the President under section 401 or 501 of the
Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5170
or 5191).</text>
</subparagraph></paragraph><paragraph id="HAE90DAA67BF54EA89A00AC4638A84C80"><enum>(2)</enum><text>The term
<quote>disaster relief volunteer</quote> means an individual who provides
disaster relief services in connection with a Disaster Declaration without
expectation or receipt of compensation in exchange for providing such
services.</text>
</paragraph><paragraph id="HFBDC16F63DB64FE8A8EBDE979A066126"><enum>(3)</enum><text>The term
<quote>disaster relief services</quote> means services or assistance provided
in preparation for, response to, or recovery from any event that is the subject
of a Disaster Declaration, including but not limited to health, medical, fire
fighting, rescue, reconstruction, and any other services or assistance
specified by a Supplemental Declaration under this section as necessary or
desirable to prepare for, respond to, or recover from an event that is the
subject of a Disaster Declaration.</text>
</paragraph><paragraph id="H285DA60173A14EC88421C4BF8C338639"><enum>(4)</enum><text>The term
<quote>disaster relief good</quote> means either—</text>
<subparagraph id="H5CF8FFBC99DA4627816C0B771310ECB2"><enum>(A)</enum><text>those goods
provided in preparation for, response to, or recovery from any event that is
the subject of a Disaster Declaration and reasonably necessary to such
preparation, response, or recovery; or</text>
</subparagraph><subparagraph id="H30619F4EB80B4862B3699CC8535B8885"><enum>(B)</enum><text>those goods
defined by a Disaster Declaration or Supplemental Declaration under this
section.</text>
</subparagraph></paragraph><paragraph id="H99C9A2EFC8814C7ABAD1B9C8561494B9"><enum>(5)</enum><text>The term
<quote>noneconomic loss</quote> means losses for physical and emotional pain,
suffering, inconvenience, physical impairment, mental anguish, disfigurement,
loss of enjoyment of life, loss of society and companionship, loss of
consortium (other than loss of domestic service), hedonic damages, injury to
reputation, and all other nonpecuniary losses of any kind or nature.</text>
</paragraph><paragraph id="HABDD146E5CF44160BC001BDC4B90E2BD"><enum>(6)</enum><text>The term
<quote>State</quote> means each of the several States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American
Samoa, the Northern Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such State, territory, or
possession, and (for purposes of subsection (h)) any foreign country.</text>
</paragraph><paragraph id="H37771AE1C05C4B68AC6543F5B20C6975"><enum>(7)</enum><text>The term
<quote>compensation</quote> means monetary or other compensation of any kind
provided in exchange for an individual’s services, but does not include—</text>
<subparagraph id="H1DACF5D1FC1F43B586EE2C9144C6CEE9"><enum>(A)</enum><text>reasonable
reimbursement or allowance for expenses actually incurred by such an
individual;</text>
</subparagraph><subparagraph id="H1E8C370ADAC94888BBFC9A4D08FD3DF7"><enum>(B)</enum><text>provision of
reasonable supplies, lodging, or transportation to such an individual;
or</text>
</subparagraph><subparagraph id="HC6666D8DBA87430ABEA16A71813E8E06"><enum>(C)</enum><text>such an
individual’s ordinary salary or compensation paid by his or her employer while
such individual is on leave from his or her ordinary duties with such employer
in order to provide disaster relief services.</text>
</subparagraph></paragraph></subsection></section></subtitle><enum>II</enum><header>State Reform
Incentives</header>
<section id="HEF98C914382245478F9BAF2035693491"><enum>201.</enum><header>Public Health
Service Act amendment</header><text display-inline="no-display-inline">The
Public Health Service Act is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD0E901F0724846FA98639AB27A623D6D" style="OLC">
<title id="HF76ACB03DA10495EB66DA71FBD42561A"><enum>XXXIV</enum><header>Medical
Liability Alternatives</header>
<subtitle id="HC939ABD6505E4219BEB734E2A80FA80D"><enum>A</enum><header>Incentive
payments</header>
<section id="HE743E7E22DB4415F8E7B5EBCB6EFA4D5"><enum>3401.</enum><header>Incentive
payments for medical liability reform</header>
<subsection id="HDE38F8C34A484C3F8A6A82C8BF717026"><enum>(a)</enum><header>Eligibility</header><text>A
State that has enacted and is implementing an alternative medical liability law
is eligible to receive an incentive payment in an amount determined by the
Secretary, subject to the availability of appropriations for that
purpose.</text>
</subsection><subsection id="HBE4BB21977F144A7B239CA34DAF60FDF"><enum>(b)</enum><header>Contents of
alternative medical liability law</header><text display-inline="yes-display-inline">An alternative medical liability law shall
contain any one or a combination of the following litigation
alternatives:</text>
<paragraph id="H367EF1A3FDFC46DCB0C27B3CC12F73DA"><enum>(1)</enum><header>Early
offer</header><text display-inline="yes-display-inline">Within a time period to
be determined by the State, a health care provider may offer to pay economic
damages to an injured party. The injured party must be provided an equal amount
of time to accept or reject the offer. Notification would not constitute an
admission of liability. Evidence of an offer would be inadmissible in a health
care lawsuit. Providers should be incentivized to make good faith offers as
early as possible and patients should be incentivized to accept legitimate
offers of compensation.</text>
</paragraph><paragraph id="H670F9027632744BD9074EF32FEEA681B"><enum>(2)</enum><header>Healthcare
Court</header><text display-inline="yes-display-inline">Health Courts would
provide a forum, either a bench or jury trial, where medical liability actions
could be heard by judges specially trained in medical liability matters and who
hear only medical liability cases.</text>
</paragraph><paragraph id="H14AE83A320A14B17A84841B7A3439AB3"><enum>(3)</enum><header>I’m Sorry
Provision</header><text display-inline="yes-display-inline">In any medical
liability action, any and all statements, affirmations, gestures, or conduct
expressing apology, sympathy, commiseration, condolence, compassion, fault, or
a general sense of benevolence which are made by a healthcare provider to the
plaintiff or a relative of the plaintiff which relate solely to the discomfort,
pain, suffering, injury, or death as the result of the unanticipated outcome of
the medical care shall be inadmissible as evidence of an admission of liability
or as evidence of an admission against interest.</text>
</paragraph><paragraph id="H003AAF3036E04749A3E71D9D58D9923F"><enum>(4)</enum><header>Voluntary
Alternative Dispute Resolution</header><text display-inline="yes-display-inline">Alternatives to medical liability trials
would be pursued through binding and nonbinding dispute processes and
techniques, including but not limited to mediation and arbitration. Mediation
is a private, facilitated negotiation in which parties discuss their dispute
with the help of a neutral third party, whose role is to help the parties
communicate with one another to reach an agreement or settlement. Arbitration
is different from mediation in that the neutral arbitrator actually has the
authority to make a decision about the dispute.</text>
</paragraph><paragraph id="HB97FD2D8926F4527AC840D18145E2C0F"><enum>(5)</enum><header>Expert Witness
Qualifications</header><text>Amendments to State statutory qualifications for
those who may serve as medical expert witnesses at trial, including the
creation of additional standards that medical expert witnesses must meet in
order to ensure the testimony juries receive is presented by an individual with
particularized expertise in the matter in question.</text>
</paragraph><paragraph id="H4005BB4C538349A38B1C1AB60E2D5C7B"><enum>(6)</enum><header>Other
Alternatives Approved by the Secretary</header><text>Any other alternative the
Secretary approves by rule as carrying out the purposes of this
subtitle.</text>
</paragraph></subsection><subsection id="H4D755E75BBDD40718C1C035202798B84"><enum>(c)</enum><header>Use of Incentive
Payments</header><text display-inline="yes-display-inline">The State shall, not
later than 3 years after receipt of an incentive payment under this title, use
that incentive payment to improve health care in that State.</text>
</subsection></section><section id="HEFFA720817424F35A3AC30610D064511"><enum>3402.</enum><header>State
reports</header>
<subsection id="HA9FD2B9C63674453A8F388A9DBD8AA71"><enum>(a)</enum><header>Duty To
report</header><text display-inline="yes-display-inline">Each State that
accepts an incentive payment under this title shall thereafter submit annual
reports to the Secretary describing the progress of that State in the
implementation of that State’s alternative medical liability law.</text>
</subsection><subsection id="H2407A421EAB44A369E8FA063DF6B0575"><enum>(b)</enum><header>Required
contents of reports</header><text display-inline="yes-display-inline">Each such
report shall contain, for the period covered by the report—</text>
<paragraph id="HEA0EDB015622400A8882C7609A6CEC39"><enum>(1)</enum><text display-inline="yes-display-inline">the number of health care lawsuits
initiated in the State;</text>
</paragraph><paragraph id="HECFDB2EB55D34C819F885936142C7D1D"><enum>(2)</enum><text>the average amount
of time taken to resolve each lawsuit that is resolved in the State; and</text>
</paragraph><paragraph id="H34B32E51E3244815B05B55A10A3A0BC8"><enum>(3)</enum><text>the average cost
of malpractice insurance in the State.</text>
</paragraph></subsection></section><section id="HB7584B2F587A429691F573348B95081F"><enum>3403.</enum><header>Reports by
Secretary to Congress</header>
<subsection id="H8C501F1E862F4E858CBA55B591346458"><enum>(a)</enum><header>Annual reports
by Secretary</header><text display-inline="yes-display-inline">Beginning not
later than one year after the date of the enactment of this title, the
Secretary shall submit to Congress an annual report on the effect of the laws
of each State that has received an incentive payment under this title in
restoring reliability to that State’s medical justice system. Such report shall
include any determination made by the Secretary under subsection (b).</text>
</subsection><subsection id="H2416F9C77BB1410AAF1EE7729CF8B70E"><enum>(b)</enum><header>Determination of
effectiveness of laws</header>
<paragraph id="H9C54E39ECEC54200824546AF9354FCF9"><enum>(1)</enum><header>General
rule</header><text>Except as provided in paragraph (2), after a State makes 3
reports under section 3402, the Secretary shall determine whether, during the
period covered by such reports, those laws have brought about—</text>
<subparagraph id="HE22CDF49F0A44054AB3F57FC573ABDE0"><enum>(A)</enum><text display-inline="yes-display-inline">a reduction in the number of health care
lawsuits initiated in the State;</text>
</subparagraph><subparagraph id="H60D2C69DD519416581AA58C7CC9907C5"><enum>(B)</enum><text>a reduction in the
amount of time required to resolve lawsuits in the State; and</text>
</subparagraph><subparagraph id="H77BDD72712E546B49AA7B464927D2FAB"><enum>(C)</enum><text>a reduction in the
cost of malpractice insurance in the State.</text>
</subparagraph></paragraph><paragraph id="H589DC2E584EE421E98D8D7594234636E"><enum>(2)</enum><header>Exception</header><text>If
the Secretary finds that litigation about the implementation of a State’s
alternative medical liability laws has prevented those laws from having their
expected effect, the Secretary may defer making the determination under
paragraph (a) until the Secretary finds that 3 years have passed since that
litigation ceased preventing those laws from having their expected
effect.</text>
</paragraph></subsection></section><section id="H609C8297973A40EEBC6A558EF41DB1FB"><enum>3404.</enum><header>Application of
subtitle B to States with ineffective laws</header>
<subsection id="H9C1414B1C6E348EFB8ED9400DE8FF923"><enum>(a)</enum><header>General
rule</header><text display-inline="yes-display-inline">Except as otherwise
provided in this section, if the Secretary determines under section 3403(b)
that a State’s alternative medical liability laws have not brought about the
results described in that section, beginning on the first day of the next
succeeding year after that determination, that State, and any health care
lawsuit commenced under the law of that State on or after that day, shall be
subject to the provisions of subtitle B.</text>
</subsection><subsection id="HC307F685E5C84C438A6470DEE144A0EE"><enum>(b)</enum><header>Statute of
limitation for certain cases</header><text>Any health care lawsuit commenced in
a State while that State is subject to subtitle B, but arising from an injury
that occurred before subtitle B began to apply in that State, shall continue to
be governed by the statute of limitations in effect at the time the injury
occurred.</text>
</subsection></section><section id="H6C2DD99C6564493896D242E73E20EBB3"><enum>3405.</enum><header>Application
required for payment</header>
<subsection id="H140B1EF11A3D41ED8401A8D4D1B7FC52"><enum>(a)</enum><header>Application
required</header><text display-inline="yes-display-inline">Each State seeking
an incentive payment under this title shall submit to the Secretary an
application, at such time, in such manner, and containing such information as
the Secretary may require.</text>
</subsection><subsection id="H9DC07CCF2A5A44289B1F381AA0ACD1DB"><enum>(b)</enum><header>Time limit for
submission of applications</header><text>The Secretary may not accept any
application under this subtitle later than 5 years after the date of the
enactment of this Act.</text>
</subsection></section><section id="HF66F3C9B1A9242248B80F8B89FB25A20"><enum>3406.</enum><header>Technical
assistance</header><text display-inline="no-display-inline">The Secretary may
provide technical assistance to the States applying for or awarded an incentive
payment under this title.</text>
</section><section id="H736AF7BFE0DF4F2B90A178C5466BC1FA"><enum>3407.</enum><header>Rulemaking</header><text display-inline="no-display-inline">The Secretary may make rules to carry out
this title.</text>
</section><section id="H9CD5E4D250AB4AD2889B08B07D19940E"><enum>3408.</enum><header>Authorization
of appropriations</header><text display-inline="no-display-inline">There are
authorized to be appropriated to carry out this title such sums as may be
necessary, to remain available until expended.</text>
</section><section id="HD5E61072FD07484E843B7B61F8FB38DA"><enum>3409.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title—</text>
<paragraph id="HE0F7B5ED846643E2A893CE70BCE1C0B1"><enum>(1)</enum><text>the term
<quote>Secretary</quote> means the Secretary of Health and Human Services;
and</text>
</paragraph><paragraph id="H285F0FB0683F4BD1A73B0996BF597D26"><enum>(2)</enum><text>the term
<quote>State</quote> includes the District of Columbia, Puerto Rico, and each
other territory or possession of the United States.</text>
</paragraph></section></subtitle><subtitle id="HE98D5133346F4FF4811945F1FF975083"><enum>B</enum><header>Liability limits
for States with ineffective laws</header>
<section id="HA2E64B8ABA0943B4B4C46EF8F581F32E"><enum>3411.</enum><header>Application</header><text display-inline="no-display-inline">This subtitle applies only in those States
to which it is made applicable by subtitle A.</text>
</section><section id="HD32527B46B76477D8DBDEFC9981FA160"><enum>3412.</enum><header>Encouraging
speedy resolution of claims</header><text display-inline="no-display-inline">The time for the commencement of a health
care lawsuit shall be 3 years after the date of manifestation of injury or 1
year after the claimant discovers, or through the use of reasonable diligence
should have discovered, the injury, whichever occurs first. In no event shall
the time for commencement of a health care lawsuit exceed 3 years after the
date of manifestation of injury unless tolled for any of the following—</text>
<paragraph id="HDF89988F00074387A374BE9DC6D6CBCA"><enum>(1)</enum><text>upon proof of
fraud;</text>
</paragraph><paragraph id="H8B11AD2675EF4DF0B1ACADC551F068E1"><enum>(2)</enum><text>intentional
concealment; or</text>
</paragraph><paragraph id="H4B0701EC80744904BB424CABBC4E1F85"><enum>(3)</enum><text>the presence of a
foreign body, which has no therapeutic or diagnostic purpose or effect, in the
person of the injured person.</text>
</paragraph><continuation-text continuation-text-level="section">Actions by a
minor shall be commenced within 3 years from the date of the alleged
manifestation of injury except that actions by a minor under the full age of 6
years shall be commenced within 3 years of manifestation of injury or prior to
the minor’s 8th birthday, whichever provides a longer period. Such time
limitation shall be tolled for minors for any period during which a parent or
guardian and a health care provider or health care organization have committed
fraud or collusion in the failure to bring an action on behalf of the injured
minor.</continuation-text></section><section id="HCAFCADFF505342ADA3DD38E887C71C45"><enum>3413.</enum><header>Compensating
patient injury</header>
<subsection id="H8D7B25BAB2794A458D2AFD08504A3CB2"><enum>(a)</enum><header>Unlimited Amount
of Damages for Actual Economic Losses in Health Care Lawsuits</header><text>In
any health care lawsuit, nothing in this subtitle shall limit a claimant’s
recovery of the full amount of the available economic damages, notwithstanding
the limitation in
<internal-xref idref="HFEA3E499A73741D6B9EEEB5BA538F6A4" legis-path="4.(b)">subsection (b)</internal-xref>.</text>
</subsection><subsection id="HFEA3E499A73741D6B9EEEB5BA538F6A4"><enum>(b)</enum><header>Additional
Noneconomic Damages</header><text>In any health care lawsuit, the amount of
noneconomic damages, if available, may be as much as $250,000, regardless of
the number of parties against whom the action is brought or the number of
separate claims or actions brought with respect to the same injury.</text>
</subsection><subsection id="HC8D00FC426E940079DA6759A24D2D77C"><enum>(c)</enum><header>No Discount of
Award for Noneconomic Damages</header><text>For purposes of applying the
limitation in
<internal-xref idref="HFEA3E499A73741D6B9EEEB5BA538F6A4" legis-path="4.(b)">subsection (b)</internal-xref>, future noneconomic damages
shall not be discounted to present value. The jury shall not be informed about
the maximum award for noneconomic damages. An award for noneconomic damages in
excess of $250,000 shall be reduced either before the entry of judgment, or by
amendment of the judgment after entry of judgment, and such reduction shall be
made before accounting for any other reduction in damages required by law. If
separate awards are rendered for past and future noneconomic damages and the
combined awards exceed $250,000, the future noneconomic damages shall be
reduced first.</text>
</subsection><subsection id="H666379CC58EB4556AA6DC9F4738A6D5E"><enum>(d)</enum><header>Fair Share
Rule</header><text>In any health care lawsuit, each party shall be liable for
that party’s several share of any damages only and not for the share of any
other person. Each party shall be liable only for the amount of damages
allocated to such party in direct proportion to such party’s percentage of
responsibility. Whenever a judgment of liability is rendered as to any party, a
separate judgment shall be rendered against each such party for the amount
allocated to such party. For purposes of this section, the trier of fact shall
determine the proportion of responsibility of each party for the claimant’s
harm.</text>
</subsection></section><section id="H23743ED126A44029AD11479FEFA4C99B"><enum>3414.</enum><header>Maximizing
patient recovery</header>
<subsection id="HEE25EFAAA8C946E49E1A19648B25402E"><enum>(a)</enum><header>Court
Supervision of Share of Damages Actually Paid to Claimants</header><text>In any
health care lawsuit, the court shall supervise the arrangements for payment of
damages to protect against conflicts of interest that may have the effect of
reducing the amount of damages awarded that are actually paid to claimants. In
particular, in any health care lawsuit in which the attorney for a party claims
a financial stake in the outcome by virtue of a contingent fee, the court shall
have the power to restrict the payment of a claimant’s damage recovery to such
attorney, and to redirect such damages to the claimant based upon the interests
of justice and principles of equity. In no event shall the total of all
contingent fees for representing all claimants in a health care lawsuit exceed
the following limits:</text>
<paragraph id="H58D85F54BCF54176A1753F319547320D"><enum>(1)</enum><text>Forty percent of
the first $50,000 recovered by the claimant(s).</text>
</paragraph><paragraph id="H8E97994CEAB64A94A5D5E738FE633947"><enum>(2)</enum><text>Thirty-three and
one-third percent of the next $50,000 recovered by the claimant(s).</text>
</paragraph><paragraph id="H38F8A4E578F04B4EBE2CF971D629E3C9"><enum>(3)</enum><text>Twenty-five
percent of the next $500,000 recovered by the claimant(s).</text>
</paragraph><paragraph id="H576D8A6F04DB41648D61D00695B95C10"><enum>(4)</enum><text>Fifteen percent of
any amount by which the recovery by the claimant(s) is in excess of
$600,000.</text>
</paragraph></subsection><subsection id="H492CAF9058E34B1DA0EFED97532BA267"><enum>(b)</enum><header>Applicability</header><text>The
limitations in this section shall apply whether the recovery is by judgment,
settlement, mediation, arbitration, or any other form of alternative dispute
resolution. In a health care lawsuit involving a minor or incompetent person, a
court retains the authority to authorize or approve a fee that is less than the
maximum permitted under this section. The requirement for court supervision in
the first two sentences of
<internal-xref idref="HEE25EFAAA8C946E49E1A19648B25402E" legis-path="5.(a)">subsection (a)</internal-xref> applies only in civil
actions.</text>
</subsection></section><section id="HF3CDD5601902420C9CD23376958A8396"><enum>3415.</enum><header>Additional
HEALTH benefits</header><text display-inline="no-display-inline">In any health
care lawsuit involving injury or wrongful death, any party may introduce
evidence of collateral source benefits. If a party elects to introduce such
evidence, any opposing party may introduce evidence of any amount paid or
contributed or reasonably likely to be paid or contributed in the future by or
on behalf of the opposing party to secure the right to such collateral source
benefits. No provider of collateral source benefits shall recover any amount
against the claimant or receive any lien or credit against the claimant’s
recovery or be equitably or legally subrogated to the right of the claimant in
a health care lawsuit involving injury or wrongful death. This section shall
apply to any health care lawsuit that is settled as well as a health care
lawsuit that is resolved by a fact finder. This section shall not apply to
section 1862(b) (42 U.S.C. 1395y(b)) or section 1902(a)(25) (42 U.S.C.
1396a(a)(25)) of the <act-name parsable-cite="SSA">Social Security
Act</act-name>.</text>
</section><section id="H1872A549073C4E7B8AF5F9B5CD04C729"><enum>3416.</enum><header>Punitive
damages</header>
<subsection id="HA4A7380B0C07482DBD6894CFC23FD934"><enum>(a)</enum><header>In
General</header><text>Punitive damages may, if otherwise permitted by
applicable State or Federal law, be awarded against any person in a health care
lawsuit only if it is proven by clear and convincing evidence that such person
acted with malicious intent to injure the claimant, or that such person
deliberately failed to avoid unnecessary injury that such person knew the
claimant was substantially certain to suffer. In any health care lawsuit where
no judgment for compensatory damages is rendered against such person, no
punitive damages may be awarded with respect to the claim in such lawsuit. No
demand for punitive damages shall be included in a health care lawsuit as
initially filed. A court may allow a claimant to file an amended pleading for
punitive damages only upon a motion by the claimant and after a finding by the
court, upon review of supporting and opposing affidavits or after a hearing,
after weighing the evidence, that the claimant has established by a substantial
probability that the claimant will prevail on the claim for punitive damages.
At the request of any party in a health care lawsuit, the trier of fact shall
consider in a separate proceeding—</text>
<paragraph id="HCD666565BCB2439CAB4B965FEAD0B591"><enum>(1)</enum><text>whether punitive
damages are to be awarded and the amount of such award; and</text>
</paragraph><paragraph id="H3B0E2921B1914A6A9135928462F5A449"><enum>(2)</enum><text>the amount of
punitive damages following a determination of punitive liability.</text>
</paragraph><continuation-text continuation-text-level="subsection">If a
separate proceeding is requested, evidence relevant only to the claim for
punitive damages, as determined by applicable State law, shall be inadmissible
in any proceeding to determine whether compensatory damages are to be
awarded.</continuation-text></subsection><subsection id="H45323C4BB8924472B318F02CFBBB931B"><enum>(b)</enum><header>Determining
Amount of Punitive Damages</header>
<paragraph id="HEEB83FC966F34AF29BA15206E01D10BA"><enum>(1)</enum><header>Factors
considered</header><text>In determining the amount of punitive damages, if
awarded, in a health care lawsuit, the trier of fact shall consider only the
following—</text>
<subparagraph id="H3AD307A8C64E44BBAC46FFA76DB21399"><enum>(A)</enum><text>the severity of
the harm caused by the conduct of such party;</text>
</subparagraph><subparagraph id="H31426F8CC8024A24998B22F93D20F600"><enum>(B)</enum><text>the duration of
the conduct or any concealment of it by such party;</text>
</subparagraph><subparagraph id="H24EC59A718C841C48DCEF908454C7A6E"><enum>(C)</enum><text>the profitability
of the conduct to such party;</text>
</subparagraph><subparagraph id="H4B7CEF641DCD48EDB03F418FA42C91D8"><enum>(D)</enum><text>the number of
products sold or medical procedures rendered for compensation, as the case may
be, by such party, of the kind causing the harm complained of by the
claimant;</text>
</subparagraph><subparagraph id="HFF91246846254C3BA653328985E4AC4C"><enum>(E)</enum><text>any criminal
penalties imposed on such party, as a result of the conduct complained of by
the claimant; and</text>
</subparagraph><subparagraph id="H77646ECE4FB940BFA5BA94CB03C46A25"><enum>(F)</enum><text>the amount of any
civil fines assessed against such party as a result of the conduct complained
of by the claimant.</text>
</subparagraph></paragraph><paragraph id="H16042DA3A5654026AC928ED24A15B328"><enum>(2)</enum><header>Maximum
award</header><text>The amount of punitive damages, if awarded, in a health
care lawsuit may be as much as $250,000 or as much as two times the amount of
economic damages awarded, whichever is greater. The jury shall not be informed
of this limitation.</text>
</paragraph></subsection><subsection id="H46838B6254774AA288380504901F582A"><enum>(c)</enum><header>No Punitive
Damages for Products That Comply With FDA Standards</header>
<paragraph id="HE3ED19ACF9874CFC85181B89692A1764"><enum>(1)</enum><header>In
general</header>
<subparagraph id="H3C9ACA965E5D4575AEE4C2A08B5F545F"><enum>(A)</enum><text>No punitive
damages may be awarded against the manufacturer or distributor of a medical
product, or a supplier of any component or raw material of such medical
product, based on a claim that such product caused the claimant’s harm
where—</text>
<clause id="H9144E8FA96574CD8A71B35C1F632BAF0"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="H3B5956E84F754D0B9D0DEB5D803283DB"><enum>(I)</enum><text>such medical product was
subject to premarket approval, clearance, or licensure by the Food and Drug
Administration with respect to the safety of the formulation or performance of
the aspect of such medical product which caused the claimant’s harm or the
adequacy of the packaging or labeling of such medical product; and</text>
</subclause><subclause id="H0F9E949E841B45FC8D10A0665C8A6853" indent="up1"><enum>(II)</enum><text>such medical product was so approved,
cleared, or licensed; or</text>
</subclause></clause><clause id="H40D0E89BA9994C48A2849F358A124BA4"><enum>(ii)</enum><text>such medical
product is generally recognized among qualified experts as safe and effective
pursuant to conditions established by the Food and Drug Administration and
applicable Food and Drug Administration regulations, including without
limitation those related to packaging and labeling, unless the Food and Drug
Administration has determined that such medical product was not manufactured or
distributed in substantial compliance with applicable Food and Drug
Administration statutes and regulations.</text>
</clause></subparagraph><subparagraph id="HC5CFEE880571435AB5AC635104EF05E6"><enum>(B)</enum><header>Rule of
construction</header><text><internal-xref idref="H3C9ACA965E5D4575AEE4C2A08B5F545F" legis-path="7.(c)(1)(A)">Subparagraph
(A)</internal-xref> may not be construed as establishing the obligation of the
Food and Drug Administration to demonstrate affirmatively that a manufacturer,
distributor, or supplier referred to in such subparagraph meets any of the
conditions described in such subparagraph.</text>
</subparagraph></paragraph><paragraph id="H6939A005F2D74A1CB428F25C2525E38F"><enum>(2)</enum><header>Liability of
health care providers</header><text>A health care provider who prescribes, or
who dispenses pursuant to a prescription, a medical product approved, licensed,
or cleared by the Food and Drug Administration shall not be named as a party to
a product liability lawsuit involving such product and shall not be liable to a
claimant in a class action lawsuit against the manufacturer, distributor, or
seller of such product. Nothing in this paragraph prevents a court from
consolidating cases involving health care providers and cases involving
products liability claims against the manufacturer, distributor, or product
seller of such medical product.</text>
</paragraph><paragraph id="H001511E7B8B54C65AB94DD58C7ADA263"><enum>(3)</enum><header>Packaging</header><text>In
a health care lawsuit for harm which is alleged to relate to the adequacy of
the packaging or labeling of a drug which is required to have tamper-resistant
packaging under regulations of the Secretary of Health and Human Services
(including labeling regulations related to such packaging), the manufacturer or
product seller of the drug shall not be held liable for punitive damages unless
such packaging or labeling is found by the trier of fact by clear and
convincing evidence to be substantially out of compliance with such
regulations.</text>
</paragraph><paragraph id="H2B2A1E464D6348FBA42CC3EFDB618A16"><enum>(4)</enum><header>Exception</header><text><internal-xref idref="HE3ED19ACF9874CFC85181B89692A1764" legis-path="7.(c)(1)">Paragraph
(1)</internal-xref> shall not apply in any health care lawsuit in which—</text>
<subparagraph id="HC5C15B6EBB6E4E7AAFF4A052D2120848"><enum>(A)</enum><text>a person, before
or after premarket approval, clearance, or licensure of such medical product,
knowingly misrepresented to or withheld from the Food and Drug Administration
information that is required to be submitted under the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 301 et seq.) or section 351 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C. 262) that
is material and is causally related to the harm which the claimant allegedly
suffered; or</text>
</subparagraph><subparagraph id="HA758D733636A49C9B68F557C12A8DF98"><enum>(B)</enum><text>a person made an
illegal payment to an official of the Food and Drug Administration for the
purpose of either securing or maintaining approval, clearance, or licensure of
such medical product.</text>
</subparagraph></paragraph></subsection></section><section id="HE2FC620D2F7F47ACBDB819DBBF046E65"><enum>3417.</enum><header>Definitions</header><text display-inline="no-display-inline">In this subtitle:</text>
<paragraph id="HB86B1591A12A4FCCA56695E8B476F792"><enum>(1)</enum><header>Alternative
dispute resolution system; ADR</header><text>The term <term>alternative dispute
resolution system</term> or <term>ADR</term> means a system that provides for
the resolution of health care lawsuits in a manner other than through a civil
action brought in a State or Federal court.</text>
</paragraph><paragraph id="H9B5D1A7CF0FD4D718865979184D22E59"><enum>(2)</enum><header>Claimant</header><text>The
term <term>claimant</term> means any person who brings a health care lawsuit,
including a person who asserts or claims a right to legal or equitable
contribution, indemnity, or subrogation, arising out of a health care liability
claim or action, and any person on whose behalf such a claim is asserted or
such an action is brought, whether deceased, incompetent, or a minor.</text>
</paragraph><paragraph id="H7B9B808547634001986F94C7043C4411"><enum>(3)</enum><header>Collateral
source benefits</header><text>The term <term>collateral source benefits</term>
means any amount paid or reasonably likely to be paid in the future to or on
behalf of the claimant, or any service, product, or other benefit provided or
reasonably likely to be provided in the future to or on behalf of the claimant,
as a result of the injury or wrongful death, pursuant to—</text>
<subparagraph id="HF3B2FE6872A64555AC154B0C8ABA65D0"><enum>(A)</enum><text>any State or
Federal health, sickness, income-disability, accident, or workers’ compensation
law;</text>
</subparagraph><subparagraph id="HF50C7C46DCAA4A9B8D4088D67B3CBEE2"><enum>(B)</enum><text>any health,
sickness, income-disability, or accident insurance that provides health
benefits or income-disability coverage;</text>
</subparagraph><subparagraph id="HFD163EDFCAF1445D9D990E70FDFBA971"><enum>(C)</enum><text>any contract or
agreement of any group, organization, partnership, or corporation to provide,
pay for, or reimburse the cost of medical, hospital, dental, or
income-disability benefits; and</text>
</subparagraph><subparagraph id="H05FC0D7599D14EA2BA57D5F5F497981B"><enum>(D)</enum><text>any other publicly
or privately funded program.</text>
</subparagraph></paragraph><paragraph id="HFC073E45870C443A8F8F6143E9EBDFF4"><enum>(4)</enum><header>Compensatory
damages</header><text>The term <term>compensatory damages</term> means
objectively verifiable monetary losses incurred as a result of the provision
of, use of, or payment for (or failure to provide, use, or pay for) health care
services or medical products, such as past and future medical expenses, loss of
past and future earnings, cost of obtaining domestic services, loss of
employment, and loss of business or employment opportunities, damages for
physical and emotional pain, suffering, inconvenience, physical impairment,
mental anguish, disfigurement, loss of enjoyment of life, loss of society and
companionship, loss of consortium (other than loss of domestic service),
hedonic damages, injury to reputation, and all other nonpecuniary losses of any
kind or nature. The term <term>compensatory damages</term> includes economic
damages and noneconomic damages, as such terms are defined in this
section.</text>
</paragraph><paragraph id="H987ABE53A4264565B5E5412B751DEE44"><enum>(5)</enum><header>Contingent
fee</header><text>The term <term>contingent fee</term> includes all
compensation to any person or persons which is payable only if a recovery is
effected on behalf of one or more claimants.</text>
</paragraph><paragraph id="H97B5B8A84B0B4654A27DAA22FDFBF7F0"><enum>(6)</enum><header>Economic
damages</header><text>The term <term>economic damages</term> means objectively
verifiable monetary losses incurred as a result of the provision of, use of, or
payment for (or failure to provide, use, or pay for) health care services or
medical products, such as past and future medical expenses, loss of past and
future earnings, cost of obtaining domestic services, loss of employment, and
loss of business or employment opportunities.</text>
</paragraph><paragraph id="H7DCFD96D850E47E98A698734D767D04A"><enum>(7)</enum><header>Health care
lawsuit</header><text>The term <term>health care lawsuit</term> means any
health care liability claim concerning the provision of health care goods or
services or any medical product affecting interstate commerce, or any health
care liability action concerning the provision of health care goods or services
or any medical product affecting interstate commerce, brought in a State or
Federal court or pursuant to an alternative dispute resolution system, against
a health care provider, a health care organization, or the manufacturer,
distributor, supplier, marketer, promoter, or seller of a medical product,
regardless of the theory of liability on which the claim is based, or the
number of claimants, plaintiffs, defendants, or other parties, or the number of
claims or causes of action, in which the claimant alleges a health care
liability claim. Such term does not include a claim or action which is based on
criminal liability; which seeks civil fines or penalties paid to Federal,
State, or local government; or which is grounded in antitrust.</text>
</paragraph><paragraph id="H27474A0A223A41E2981103ACA8289C8D"><enum>(8)</enum><header>Health care
liability action</header><text>The term <term>health care liability
action</term> means a civil action brought in a State or Federal court or
pursuant to an alternative dispute resolution system, against a health care
provider, a health care organization, or the manufacturer, distributor,
supplier, marketer, promoter, or seller of a medical product, regardless of the
theory of liability on which the claim is based, or the number of plaintiffs,
defendants, or other parties, or the number of causes of action, in which the
claimant alleges a health care liability claim.</text>
</paragraph><paragraph id="HC8CB8F1DF2B64D52A0041F6F7BE1AF08"><enum>(9)</enum><header>Health care
liability claim</header><text>The term <term>health care liability claim</term>
means a demand by any person, whether or not pursuant to ADR, against a health
care provider, health care organization, or the manufacturer, distributor,
supplier, marketer, promoter, or seller of a medical product, including, but
not limited to, third-party claims, cross-claims, counter-claims, or
contribution claims, which are based upon the provision of, use of, or payment
for (or the failure to provide, use, or pay for) health care services or
medical products, regardless of the theory of liability on which the claim is
based, or the number of plaintiffs, defendants, or other parties, or the number
of causes of action.</text>
</paragraph><paragraph id="H801A0547DDA64B9080854CFDC3F87536"><enum>(10)</enum><header>Health care
organization</header><text>The term <term>health care organization</term> means
any person or entity which is obligated to provide or pay for health benefits
under any health plan, including any person or entity acting under a contract
or arrangement with a health care organization to provide or administer any
health benefit.</text>
</paragraph><paragraph id="HC1818FCA9EE44A50B33682B15AE5C4BC"><enum>(11)</enum><header>Health care
provider</header><text>The term <term>health care provider</term> means any
person or entity required by State or Federal laws or regulations to be
licensed, registered, or certified to provide health care services, and being
either so licensed, registered, or certified, or exempted from such requirement
by other statute or regulation.</text>
</paragraph><paragraph id="H427119D302E645BA9039D02049227184"><enum>(12)</enum><header>Health care
goods or services</header><text>The term <term>health care goods or
services</term> means any goods or services provided by a health care
organization, provider, or by any individual working under the supervision of a
health care provider, that relates to the diagnosis, prevention, or treatment
of any human disease or impairment, or the assessment or care of the health of
human beings.</text>
</paragraph><paragraph id="H37827C1DA44B4F43A613877FD30820E3"><enum>(13)</enum><header>Malicious
intent to injure</header><text>The term <term>malicious intent to injure</term>
means intentionally causing or attempting to cause physical injury other than
providing health care goods or services.</text>
</paragraph><paragraph id="HF6CCF02BFAE744ED89C04B3A2BC5599C"><enum>(14)</enum><header>Medical
product</header><text>The term <term>medical product</term> means a drug,
device, or biological product intended for humans, and the terms
<term>drug</term>, <term>device</term>, and <term>biological product</term>
have the meanings given such terms in sections 201(g)(1) and 201(h) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(g)(1) and (h)) and section
351(i) of the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name> (42 U.S.C. 262(a)), respectively, including any component or raw
material used therein, but excluding health care services.</text>
</paragraph><paragraph id="H662B8F42B2B544F881A18FC5144A4BD9"><enum>(15)</enum><header>Noneconomic
damages</header><text>The term <term>noneconomic damages</term> means damages
for physical and emotional pain, suffering, inconvenience, physical impairment,
mental anguish, disfigurement, loss of enjoyment of life, loss of society and
companionship, loss of consortium (other than loss of domestic service),
hedonic damages, injury to reputation, and all other nonpecuniary losses of any
kind or nature.</text>
</paragraph><paragraph id="H6339CC53C58E4FEBA493981BEE22EF83"><enum>(16)</enum><header>Punitive
damages</header><text>The term <term>punitive damages</term> means damages
awarded, for the purpose of punishment or deterrence, and not solely for
compensatory purposes, against a health care provider, health care
organization, or a manufacturer, distributor, or supplier of a medical product.
Punitive damages are neither economic nor noneconomic damages.</text>
</paragraph><paragraph id="H9CCA2372C9BB4D5987871CFFE50EE74F"><enum>(17)</enum><header>Recovery</header><text>The
term <term>recovery</term> means the net sum recovered after deducting any
disbursements or costs incurred in connection with prosecution or settlement of
the claim, including all costs paid or advanced by any person. Costs of health
care incurred by the plaintiff and the attorneys’ office overhead costs or
charges for legal services are not deductible disbursements or costs for such
purpose.</text>
</paragraph><paragraph id="H5904DDAB7B88433B9CE3037FB3E9E09A"><enum>(18)</enum><header>State</header><text>The
term <term>State</term> has the same meaning as that term has for the purposes
of subtitle A.</text>
</paragraph></section><section id="HBA75F1CBFC3E44538486550017209AA3"><enum>3418.</enum><header>Effect on
other laws</header>
<subsection id="H30E6EA7D34324519A4D1F98E868758FB"><enum>(a)</enum><header>Vaccine
Injury</header>
<paragraph id="H2CDA47674FB6433F8FEFBF097D043249"><enum>(1)</enum><text>To the extent that
title XXI establishes a Federal rule of law applicable to a civil action
brought for a vaccine-related injury or death—</text>
<subparagraph id="HB8A1EC2A0F35430380A7B4C489C3E5DD"><enum>(A)</enum><text>this subtitle does
not affect the application of the rule of law to such an action; and</text>
</subparagraph><subparagraph id="HCCFDC7667C2C47DE8B6F8FBC03D02BFA"><enum>(B)</enum><text>any rule of law
prescribed by this subtitle in conflict with a rule of law of title XXI shall
not apply to such action.</text>
</subparagraph></paragraph><paragraph id="H83AC61FD7307413A8C446248EF2A66C6"><enum>(2)</enum><text>If there is an
aspect of a civil action brought for a vaccine-related injury or death to which
a Federal rule of law under title XXI of this Act does not apply, then this
subtitle or otherwise applicable law (as determined under this subtitle) will
apply to such aspect of such action.</text>
</paragraph></subsection><subsection id="HF8C852C14E154A2F8A3984AAAE4C2571"><enum>(b)</enum><header>Other Federal
Law</header><text>Except as provided in this section, nothing in this subtitle
shall be deemed to affect any defense available to a defendant in a health care
lawsuit or action under any other provision of Federal law.</text>
</subsection></section><section id="H81DF334F560F40509E1A0E160B8F9E34"><enum>3419.</enum><header>State
flexibility and protection of states’ rights</header>
<subsection id="HECD702D0A8784BE5A42E56416067095E"><enum>(a)</enum><header>Health Care
Lawsuits</header><text>The provisions governing health care lawsuits set forth
in this subtitle preempt, subject to subsections (b) and (c), State law to the
extent that State law prevents the application of any provisions of law
established by or under this subtitle. The provisions governing health care
lawsuits set forth in this subtitle supersede chapter 171 of title 28, United
States Code, to the extent that such chapter—</text>
<paragraph id="H007E3135FC404B8C8DBAD106F8ED9785"><enum>(1)</enum><text>provides for a
greater amount of damages or contingent fees, a longer period in which a health
care lawsuit may be commenced, or a reduced applicability or scope of periodic
payment of future damages, than provided in this subtitle; or</text>
</paragraph><paragraph id="H28C67C5ABEDE46A5A64465D68D9D8735"><enum>(2)</enum><text>prohibits the
introduction of evidence regarding collateral source benefits, or mandates or
permits subrogation or a lien on collateral source benefits.</text>
</paragraph></subsection><subsection id="HB08AE67C8FCC421C9001782C2A5FB4A5"><enum>(b)</enum><header>Protection of
States’ Rights and Other Laws</header><paragraph commented="no" display-inline="yes-display-inline" id="H546801F88FCF45108FCCD8E6C3BC3405"><enum>(1)</enum><text>Any issue that is not
governed by any provision of law established by or under this subtitle
(including State standards of negligence) shall be governed by otherwise
applicable State or Federal law.</text>
</paragraph><paragraph id="HB8E27140D4A44C988D4567B2469F94B6" indent="up1"><enum>(2)</enum><text>This subtitle shall not preempt or
supersede any State or Federal law that imposes greater procedural or
substantive protections for health care providers and health care organizations
from liability, loss, or damages than those provided by this subtitle or create
a cause of action.</text>
</paragraph></subsection><subsection id="H3AC0170258314141B9893667BCBA6553"><enum>(c)</enum><header>State
Flexibility</header><text>No provision of this subtitle shall be construed to
preempt—</text>
<paragraph id="H1BDC859262F24CE39A71A1B350344DF3"><enum>(1)</enum><text>any State law
(whether effective before, on, or after the date of the enactment of this Act)
that specifies a particular monetary amount of compensatory or punitive damages
(or the total amount of damages) that may be awarded in a health care lawsuit,
regardless of whether such monetary amount is greater or lesser than is
provided for under this subtitle, notwithstanding
<internal-xref idref="H8D7B25BAB2794A458D2AFD08504A3CB2" legis-path="4.(a)">section 4(a)</internal-xref>; or</text>
</paragraph><paragraph id="H156D7E5510884628812E361E75D471AF"><enum>(2)</enum><text>any defense
available to a party in a health care lawsuit under any other provision of
State or Federal
law.</text>
</paragraph></subsection></section></subtitle>.