(B) in the second sentence, by inserting 
‘‘and subsection (k)(4)’’ after ‘‘subject to para-
graph (5)’’; and 
(2) in each of subsections (g), (i), (j), (k), (l), 
and (m)— 
(A) by striking the term ‘‘employee, or 
contractor’’ each place such term appears and 
inserting ‘‘employee, volunteer practitioner, or 
contractor’’; 
(B) by striking the term ‘‘employee, and 
contractor’’ each place such term appears and 
inserting ‘‘employee, volunteer practitioner, and 
contractor’’; 
(C) by striking the term ‘‘employee, or any 
contractor’’ each place such term appears and 
inserting ‘‘employee, volunteer practitioner, or 
contractor’’; and 
(D) by striking the term ‘‘employees, or 
contractors’’ each place such term appears and 
inserting ‘‘employees, volunteer practitioners, or 
contractors’’. 
(b) APPLICABILITY; DEFINITION.—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: 
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‘‘(4)(A) Subsections (g) through (m) apply with re-
spect 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. 
‘‘(B) For purposes of subsections (g) through (m), 
the term ‘volunteer practitioner’ means a practitioner who, 
with respect to an entity described in subsection (g)(4), 
meets the following conditions: 
‘‘(i) In the State involved, the practitioner is a 
licensed physician, a licensed clinical psychologist, or 
other licensed or certified health care practitioner. 
‘‘(ii) At the request of such entity, the practi-
tioner provides services to patients of the entity, at 
a site at which the entity operates or at a site des-
ignated by the entity. The weekly number of hours 
of services provided to the patients by the practi-
tioner is not a factor with respect to meeting condi-
tions under this subparagraph. 
‘‘(iii) 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 pol-
icy or health plan, or under any Federal or State 
health benefits program).’’. 
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Subtitle D—Disaster Relief 
Volunteers 
SEC. 141. PROTECTION FOR DISASTER RELIEF VOLUN-
TEERS. 
(a) LIABILITY
OF
DISASTER
RELIEF
VOLUN-
TEERS.—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 vol-
unteer in connection with such volunteer’s providing or fa-
cilitating the provision of disaster relief services if— 
(1) the injury was not caused by willful, wan-
ton, or reckless misconduct by the volunteer; and 
(2) 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— 
(A) possess an operator’s license; or 
(B) maintain insurance. 
(b) LIABILITY OF EMPLOYER OR PARTNER OF DIS-
ASTER RELIEF VOLUNTEER.—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 provi-
sion of disaster relief services. 
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(c) LIABILITY OF HOST OR ENABLING PERSON, EN-
TITY, OR ORGANIZATION.—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 re-
lief services shall not be liable for any act or omission of 
such volunteer in connection with such volunteer’s pro-
viding such services. 
(d) LIABILITY OF NONPROFIT ORGANIZATIONS.—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. 
(e) LIABILITY OF GOVERNMENTAL AND INTERGOV-
ERNMENTAL ENTITIES
FOR DONATIONS
OF DISASTER 
RELIEF GOODS.—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 in-
jury was not caused by willful, wanton, or reckless mis-
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conduct by such governmental or intergovernmental enti-
ty. 
(f) LIMITATION ON PUNITIVE AND NONECONOMIC 
DAMAGES BASED
ON ACTIONS
OF DISASTER RELIEF 
VOLUNTEERS AND GOVERNMENTAL DONORS.— 
(1) PUNITIVE DAMAGES.—Unless the claimant 
establishes by clear and convincing evidence that its 
damages were proximately caused by willful, wanton, 
or reckless misconduct by either— 
(A) a disaster relief volunteer in any civil 
action brought for injury caused by the volun-
teer’s providing or facilitating the provision of 
disaster relief services; or 
(B) a governmental or intergovernmental 
entity in any civil action brought for injury 
caused by disaster relief goods donated by such 
governmental or intergovernmental entity; 
punitive damages may not be awarded in any civil 
action against such a volunteer or governmental en-
tity. 
(2) NONECONOMIC DAMAGES.— 
(A) GENERAL RULE.—In any civil action 
brought against— 
(i) a disaster relief volunteer for in-
jury caused by such volunteer’s providing 
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or facilitating the provision of disaster re-
lief services; or 
(ii) a governmental or intergovern-
mental entity for injury caused by disaster 
relief goods donated by such governmental 
entity; 
liability for noneconomic loss, if permitted 
under subsection (a) or (e) of this section, shall 
be determined in accordance with this subpara-
graph. 
(B) AMOUNT
OF
LIABILITY.—(i) 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 responsi-
bility of that defendant (determined in accord-
ance with clause (ii)) for the harm to the claim-
ant with respect to which that defendant is lia-
ble. The court shall render a separate judgment 
against each defendant in an amount deter-
mined pursuant to this section. 
(ii) For purposes of determining the 
amount of noneconomic loss allocated to a de-
fendant, the trier of fact shall determine the 
percentage of responsibility of each person or 
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entity responsible for the claimant’s harm, 
whether or not such person or entity is a party 
to the action. 
(g) CONSTRUCTION.—Nothing in this section shall be 
construed to abrogate or limit any protection that a volun-
teer, 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 inter-
governmental entity may be entitled to under any other 
provision of law. 
(h) SUPPLEMENTAL DECLARATION.—If a Disaster 
Declaration is issued, the President, the Secretary of 
Health and Human Services, or the Secretary of Home-
land Security may issue a Supplemental Declaration under 
this section. 
(1) TEMPORAL
EFFECT.—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 Dis-
aster Declaration shall have an effective date earlier 
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than the date of the declaration or determination of 
such Disaster Declaration. 
(2) GEOGRAPHIC
AND
OTHER
CONDITIONS.— 
Such Supplemental Declaration may provide that, 
for purposes of this section, such Disaster Declara-
tion shall have such geographic or other conditions 
as the President or the Secretary may deem nec-
essary or appropriate to further the public interest. 
(i) LICENSING, CERTIFICATION, AND AUTHORIZA-
TION.—This section shall not apply to a disaster relief vol-
unteer where the disaster relief service such volunteer pro-
vides is of a type that generally requires a license, certifi-
cate, or authorization, and the disaster relief volunteer 
lacks such license, certificate, or authorization, unless— 
(1) such volunteer is licensed, certified, or au-
thorized to provide such services in any State to the 
extent required, if any, by the appropriate authori-
ties of that State, even if such State is not the State 
in which the disaster relief volunteer provides dis-
aster relief services; or 
(2) otherwise specified in a Disaster Declara-
tion or Supplemental Declaration under this section. 
(j) DEFINITIONS.—For purposes of this section: 
(1) The term ‘‘Disaster Declaration’’ means— 
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(A) 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); 
(B) a declaration of a public health emer-
gency or a risk of such emergency as deter-
mined 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 
(C) an emergency or major disaster dec-
laration 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). 
(2) The term ‘‘disaster relief volunteer’’ means 
an individual who provides disaster relief services in 
connection with a Disaster Declaration without ex-
pectation or receipt of compensation in exchange for 
providing such services. 
(3) The term ‘‘disaster relief services’’ means 
services or assistance provided in preparation for, re-
sponse to, or recovery from any event that is the 
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subject of a Disaster Declaration, including but not 
limited to health, medical, fire fighting, rescue, re-
construction, and any other services or assistance 
specified by a Supplemental Declaration under this 
section as necessary or desirable to prepare for, re-
spond to, or recover from an event that is the sub-
ject of a Disaster Declaration. 
(4) The term ‘‘disaster relief good’’ means ei-
ther— 
(A) 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 
(B) those goods defined by a Disaster Dec-
laration or Supplemental Declaration under this 
section. 
(5) The term ‘‘noneconomic loss’’ means losses 
for physical and emotional pain, suffering, inconven-
ience, physical impairment, mental anguish, dis-
figurement, 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. 
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(6) The term ‘‘State’’ 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. 
(7) The term ‘‘compensation’’ means monetary 
or other compensation of any kind provided in ex-
change for an individual’s services, but does not in-
clude— 
(A) reasonable reimbursement or allowance 
for expenses actually incurred by such an indi-
vidual; 
(B) provision of reasonable supplies, lodg-
ing, or transportation to such an individual; or 
(C) such an individual’s ordinary salary or 
compensation paid by his or her employer while 
such individual is on leave from his or her ordi-
nary duties with such employer in order to pro-
vide disaster relief services. 
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TITLE II—STATE REFORM 
INCENTIVES 
SEC. 201. PUBLIC HEALTH SERVICE ACT AMENDMENT. 
The Public Health Service Act is amended by adding 
at the end the following: 
‘‘TITLE XXXIV—MEDICAL 
LIABILITY ALTERNATIVES 
‘‘Subtitle A—Incentive Payments 
‘‘SEC. 3401. INCENTIVE PAYMENTS FOR MEDICAL LIABILITY 
REFORM. 
‘‘(a) ELIGIBILITY.—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 appropria-
tions for that purpose. 
‘‘(b) CONTENTS OF ALTERNATIVE MEDICAL LIABIL-
ITY LAW.—An alternative medical liability law shall con-
tain any one or a combination of the following litigation 
alternatives: 
‘‘(1) EARLY OFFER.—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. Notifi-
cation would not constitute an admission of liability. 
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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. 
‘‘(2) HEALTHCARE
COURT.—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. 
‘‘(3) I’M SORRY PROVISION.—In any medical li-
ability 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. 
‘‘(4) VOLUNTARY ALTERNATIVE DISPUTE RESO-
LUTION.—Alternatives to medical liability trials 
would be pursued through binding and nonbinding 
dispute processes and techniques, including but not 
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limited to mediation and arbitration. Mediation is a 
private, facilitated negotiation in which parties dis-
cuss 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 settle-
ment. Arbitration is different from mediation in that 
the neutral arbitrator actually has the authority to 
make a decision about the dispute. 
‘‘(5) EXPERT
WITNESS
QUALIFICATIONS.— 
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. 
‘‘(6) OTHER ALTERNATIVES APPROVED BY THE 
SECRETARY.—Any other alternative the Secretary 
approves by rule as carrying out the purposes of this 
subtitle. 
‘‘(c) USE
OF INCENTIVE PAYMENTS.—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. 
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‘‘SEC. 3402. STATE REPORTS. 
‘‘(a) DUTY TO REPORT.—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 alter-
native medical liability law. 
‘‘(b) REQUIRED CONTENTS
OF REPORTS.—Each 
such report shall contain, for the period covered by the 
report— 
‘‘(1) the number of health care lawsuits initi-
ated in the State; 
‘‘(2) the average amount of time taken to re-
solve each lawsuit that is resolved in the State; and 
‘‘(3) the average cost of malpractice insurance 
in the State. 
‘‘SEC. 3403. REPORTS BY SECRETARY TO CONGRESS. 
‘‘(a) ANNUAL REPORTS BY SECRETARY.—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 re-
storing reliability to that State’s medical justice system. 
Such report shall include any determination made by the 
Secretary under subsection (b). 
‘‘(b) DETERMINATION
OF
EFFECTIVENESS
OF 
LAWS.— 
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‘‘(1) GENERAL RULE.—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— 
‘‘(A) a reduction in the number of health 
care lawsuits initiated in the State; 
‘‘(B) a reduction in the amount of time re-
quired to resolve lawsuits in the State; and 
‘‘(C) a reduction in the cost of malpractice 
insurance in the State. 
‘‘(2) EXCEPTION.—If the Secretary finds that 
litigation about the implementation of a State’s al-
ternative medical liability laws has prevented those 
laws from having their expected effect, the Secretary 
may defer making the determination under para-
graph (a) until the Secretary finds that 3 years have 
passed since that litigation ceased preventing those 
laws from having their expected effect. 
‘‘SEC. 3404. APPLICATION OF SUBTITLE B TO STATES WITH 
INEFFECTIVE LAWS. 
‘‘(a) GENERAL RULE.—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 sec-
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tion, 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. 
‘‘(b) STATUTE
OF
LIMITATION
FOR
CERTAIN 
CASES.—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. 
‘‘SEC. 3405. APPLICATION REQUIRED FOR PAYMENT. 
‘‘(a) APPLICATION REQUIRED.—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 re-
quire. 
‘‘(b) TIME LIMIT
FOR SUBMISSION
OF APPLICA-
TIONS.—The Secretary may not accept any application 
under this subtitle later than 5 years after the date of 
the enactment of this Act. 
‘‘SEC. 3406. TECHNICAL ASSISTANCE. 
‘‘The Secretary may provide technical assistance to 
the States applying for or awarded an incentive payment 
under this title. 
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‘‘SEC. 3407. RULEMAKING. 
‘‘The Secretary may make rules to carry out this 
title. 
‘‘SEC. 3408. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated to carry out 
this title such sums as may be necessary, to remain avail-
able until expended. 
‘‘SEC. 3409. DEFINITIONS. 
‘‘In this title— 
‘‘(1) the term ‘Secretary’ means the Secretary 
of Health and Human Services; and 
‘‘(2) the term ‘State’ includes the District of 
Columbia, Puerto Rico, and each other territory or 
possession of the United States. 
‘‘Subtitle B—Liability Limits for 
States With Ineffective Laws 
‘‘SEC. 3411. APPLICATION. 
‘‘This subtitle applies only in those States to which 
it is made applicable by subtitle A. 
‘‘SEC. 
3412. 
ENCOURAGING 
SPEEDY 
RESOLUTION 
OF 
CLAIMS. 
‘‘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 
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for commencement of a health care lawsuit exceed 3 years 
after the date of manifestation of injury unless tolled for 
any of the following— 
‘‘(1) upon proof of fraud; 
‘‘(2) intentional concealment; or 
‘‘(3) the presence of a foreign body, which has 
no therapeutic or diagnostic purpose or effect, in the 
person of the injured person. 
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. 
‘‘SEC. 3413. COMPENSATING PATIENT INJURY. 
‘‘(a) UNLIMITED AMOUNT OF DAMAGES FOR ACTUAL 
ECONOMIC LOSSES IN HEALTH CARE LAWSUITS.—In any 
health care lawsuit, nothing in this subtitle shall limit a 
claimant’s recovery of the full amount of the available eco-
nomic damages, notwithstanding the limitation in sub-
section (b). 
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‘‘(b) ADDITIONAL NONECONOMIC DAMAGES.—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. 
‘‘(c) NO DISCOUNT OF AWARD FOR NONECONOMIC 
DAMAGES.—For purposes of applying the limitation in 
subsection (b), future noneconomic damages shall not be 
discounted to present value. The jury shall not be in-
formed about the maximum award for noneconomic dam-
ages. An award for noneconomic damages in excess of 
$250,000 shall be reduced either before the entry of judg-
ment, or by amendment of the judgment after entry of 
judgment, and such reduction shall be made before ac-
counting 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 re-
duced first. 
‘‘(d) FAIR SHARE RULE.—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 
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such party’s percentage of responsibility. Whenever a 
judgment of liability is rendered as to any party, a sepa-
rate 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 propor-
tion of responsibility of each party for the claimant’s 
harm. 
‘‘SEC. 3414. MAXIMIZING PATIENT RECOVERY. 
‘‘(a) COURT SUPERVISION OF SHARE OF DAMAGES 
ACTUALLY PAID TO CLAIMANTS.—In any health care law-
suit, the court shall supervise the arrangements for pay-
ment of damages to protect against conflicts of interest 
that may have the effect of reducing the amount of dam-
ages awarded that are actually paid to claimants. In par-
ticular, in any health care lawsuit in which the attorney 
for a party claims a financial stake in the outcome by vir-
tue 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 ex-
ceed the following limits: 
‘‘(1) Forty percent of the first $50,000 recov-
ered by the claimant(s). 
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‘‘(2) Thirty-three and one-third percent of the 
next $50,000 recovered by the claimant(s). 
‘‘(3) Twenty-five percent of the next $500,000 
recovered by the claimant(s). 
‘‘(4) Fifteen percent of any amount by which 
the recovery by the claimant(s) is in excess of 
$600,000. 
‘‘(b) APPLICABILITY.—The limitations in this section 
shall apply whether the recovery is by judgment, settle-
ment, mediation, arbitration, or any other form of alter-
native dispute resolution. In a health care lawsuit involv-
ing 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 require-
ment for court supervision in the first two sentences of 
subsection (a) applies only in civil actions. 
‘‘SEC. 3415. ADDITIONAL HEALTH BENEFITS. 
‘‘In any health care lawsuit involving injury or wrong-
ful death, any party may introduce evidence of collateral 
source benefits. If a party elects to introduce such evi-
dence, 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 oppos-
ing party to secure the right to such collateral source bene-
fits. No provider of collateral source benefits shall recover 
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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 sec-
tion 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 Social Security Act. 
‘‘SEC. 3416. PUNITIVE DAMAGES. 
‘‘(a) IN GENERAL.—Punitive damages may, if other-
wise 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 unneces-
sary injury that such person knew the claimant was sub-
stantially 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 mo-
tion by the claimant and after a finding by the court, upon 
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‘‘(C) the profitability of the conduct to 
such party; 
‘‘(D) the number of products sold or med-
ical procedures rendered for compensation, as 
the case may be, by such party, of the kind 
causing the harm complained of by the claim-
ant; 
‘‘(E) any criminal penalties imposed on 
such party, as a result of the conduct com-
plained of by the claimant; and 
‘‘(F) the amount of any civil fines assessed 
against such party as a result of the conduct 
complained of by the claimant. 
‘‘(2) MAXIMUM AWARD.—The amount of puni-
tive 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. 
‘‘(c) NO PUNITIVE DAMAGES FOR PRODUCTS THAT 
COMPLY WITH FDA STANDARDS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) No punitive damages may be awarded 
against the manufacturer or distributor of a 
medical product, or a supplier of any compo-
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nent or raw material of such medical product, 
based on a claim that such product caused the 
claimant’s harm where— 
‘‘(i)(I) such medical product was sub-
ject to premarket approval, clearance, or li-
censure by the Food and Drug Administra-
tion with respect to the safety of the for-
mulation 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 
‘‘(II) such medical product was so ap-
proved, cleared, or licensed; or 
‘‘(ii) such medical product is generally 
recognized among qualified experts as safe 
and effective pursuant to conditions estab-
lished by the Food and Drug Administra-
tion and applicable Food and Drug Admin-
istration regulations, including without 
limitation those related to packaging and 
labeling, unless the Food and Drug Admin-
istration has determined that such medical 
product was not manufactured or distrib-
uted in substantial compliance with appli-
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cable Food and Drug Administration stat-
utes and regulations. 
‘‘(B) RULE OF CONSTRUCTION.—Subpara-
graph (A) may not be construed as establishing 
the obligation of the Food and Drug Adminis-
tration to demonstrate affirmatively that a 
manufacturer, distributor, or supplier referred 
to in such subparagraph meets any of the con-
ditions described in such subparagraph. 
‘‘(2) 
LIABILITY
OF
HEALTH
CARE
PRO-
VIDERS.—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, dis-
tributor, 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 prod-
uct. 
‘‘(3) PACKAGING.—In a health care lawsuit for 
harm which is alleged to relate to the adequacy of 
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the packaging or labeling of a drug which is required 
to have tamper-resistant packaging under regula-
tions of the Secretary of Health and Human Serv-
ices (including labeling regulations related to such 
packaging), the manufacturer or product seller of 
the drug shall not be held liable for punitive dam-
ages 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 regula-
tions. 
‘‘(4) EXCEPTION.—Paragraph (1) shall not 
apply in any health care lawsuit in which— 
‘‘(A) a person, before or after premarket 
approval, clearance, or licensure of such medical 
product, knowingly misrepresented to or with-
held from the Food and Drug Administration 
information that is required to be submitted 
under the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) 
that is material and is causally related to the 
harm which the claimant allegedly suffered; or 
‘‘(B) a person made an illegal payment to 
an official of the Food and Drug Administra-
tion for the purpose of either securing or main-
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taining approval, clearance, or licensure of such 
medical product. 
‘‘SEC. 3417. DEFINITIONS. 
‘‘In this subtitle: 
‘‘(1) ALTERNATIVE DISPUTE RESOLUTION SYS-
TEM; ADR.—The term ‘alternative dispute resolution 
system’ or ‘ADR’ 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. 
‘‘(2) CLAIMANT.—The term ‘claimant’ means 
any person who brings a health care lawsuit, includ-
ing 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 as-
serted or such an action is brought, whether de-
ceased, incompetent, or a minor. 
‘‘(3) COLLATERAL
SOURCE
BENEFITS.—The 
term ‘collateral source benefits’ 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 claim-
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ant, as a result of the injury or wrongful death, pur-
suant to— 
‘‘(A) any State or Federal health, sickness, 
income-disability, accident, or workers’ com-
pensation law; 
‘‘(B) any health, sickness, income-dis-
ability, or accident insurance that provides 
health benefits or income-disability coverage; 
‘‘(C) 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 
‘‘(D) any other publicly or privately funded 
program. 
‘‘(4) COMPENSATORY
DAMAGES.—The term 
‘compensatory damages’ 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 
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impairment, mental anguish, disfigurement, loss of 
enjoyment of life, loss of society and companionship, 
loss of consortium (other than loss of domestic serv-
ice), hedonic damages, injury to reputation, and all 
other nonpecuniary losses of any kind or nature. 
The term ‘compensatory damages’ includes economic 
damages and noneconomic damages, as such terms 
are defined in this section. 
‘‘(5) CONTINGENT FEE.—The term ‘contingent 
fee’ includes all compensation to any person or per-
sons which is payable only if a recovery is effected 
on behalf of one or more claimants. 
‘‘(6) ECONOMIC
DAMAGES.—The term ‘eco-
nomic damages’ means objectively verifiable mone-
tary 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. 
‘‘(7) HEALTH
CARE
LAWSUIT.—The term 
‘health care lawsuit’ means any health care liability 
claim concerning the provision of health care goods 
or services or any medical product affecting inter-
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state 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 organi-
zation, 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, plain-
tiffs, defendants, or other parties, or the number of 
claims or causes of action, in which the claimant al-
leges 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. 
‘‘(8) HEALTH
CARE
LIABILITY
ACTION.—The 
term ‘health care liability action’ means a civil ac-
tion 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, 
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or the number of plaintiffs, defendants, or other par-
ties, or the number of causes of action, in which the 
claimant alleges a health care liability claim. 
‘‘(9) HEALTH
CARE
LIABILITY
CLAIM.—The 
term ‘health care liability claim’ means a demand by 
any person, whether or not pursuant to ADR, 
against a health care provider, health care organiza-
tion, or the manufacturer, distributor, supplier, mar-
keter, promoter, or seller of a medical product, in-
cluding, 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. 
‘‘(10) HEALTH
CARE
ORGANIZATION.—The 
term ‘health care organization’ 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 admin-
ister any health benefit. 
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‘‘(11) HEALTH
CARE
PROVIDER.—The term 
‘health care provider’ means any person or entity re-
quired by State or Federal laws or regulations to be 
licensed, registered, or certified to provide health 
care services, and being either so licensed, reg-
istered, or certified, or exempted from such require-
ment by other statute or regulation. 
‘‘(12) HEALTH CARE GOODS OR SERVICES.— 
The term ‘health care goods or services’ means any 
goods or services provided by a health care organiza-
tion, 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. 
‘‘(13) MALICIOUS
INTENT
TO
INJURE.—The 
term ‘malicious intent to injure’ means intentionally 
causing or attempting to cause physical injury other 
than providing health care goods or services. 
‘‘(14) MEDICAL PRODUCT.—The term ‘medical 
product’ means a drug, device, or biological product 
intended for humans, and the terms ‘drug’, ‘device’, 
and ‘biological product’ 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. 
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321(g)(1) and (h)) and section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(a)), respectively, 
including any component or raw material used there-
in, but excluding health care services. 
‘‘(15) NONECONOMIC
DAMAGES.—The term 
‘noneconomic damages’ means damages for physical 
and emotional pain, suffering, inconvenience, phys-
ical impairment, mental anguish, disfigurement, loss 
of enjoyment of life, loss of society and companion-
ship, loss of consortium (other than loss of domestic 
service), hedonic damages, injury to reputation, and 
all other nonpecuniary losses of any kind or nature. 
‘‘(16) PUNITIVE DAMAGES.—The term ‘punitive 
damages’ means damages awarded, for the purpose 
of punishment or deterrence, and not solely for com-
pensatory purposes, against a health care provider, 
health care organization, or a manufacturer, dis-
tributor, or supplier of a medical product. Punitive 
damages are neither economic nor noneconomic 
damages. 
‘‘(17) RECOVERY.—The term ‘recovery’ means 
the net sum recovered after deducting any disburse-
ments or costs incurred in connection with prosecu-
tion or settlement of the claim, including all costs 
paid or advanced by any person. Costs of health care 
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affect any defense available to a defendant in a health care 
lawsuit or action under any other provision of Federal law. 
‘‘SEC. 3419. STATE FLEXIBILITY AND PROTECTION OF 
STATES’ RIGHTS. 
‘‘(a) HEALTH CARE LAWSUITS.—The provisions gov-
erning health care lawsuits set forth in this subtitle pre-
empt, subject to subsections (b) and (c), State law to the 
extent that State law prevents the application of any pro-
visions 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— 
‘‘(1) 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 appli-
cability or scope of periodic payment of future dam-
ages, than provided in this subtitle; or 
‘‘(2) prohibits the introduction of evidence re-
garding collateral source benefits, or mandates or 
permits subrogation or a lien on collateral source 
benefits. 
‘‘(b) PROTECTION OF STATES’ RIGHTS AND OTHER 
LAWS.—(1) Any issue that is not governed by any provi-
sion of law established by or under this subtitle (including 
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State standards of negligence) shall be governed by other-
wise applicable State or Federal law. 
‘‘(2) 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. 
‘‘(c) STATE FLEXIBILITY.—No provision of this sub-
title shall be construed to preempt— 
‘‘(1) any State law (whether effective before, 
on, or after the date of the enactment of this Act) 
that specifies a particular monetary amount of com-
pensatory 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 section 4(a); or 
‘‘(2) any defense available to a party in a health 
care lawsuit under any other provision of State or 
Federal law.’’. 
Æ 
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