I 

111TH CONGRESS 

1ST SESSION H. R. 4039 

To improve the medical justice system by encouraging the prompt and fair 

resolution of disputes, enhancing the quality of care, ensuring patient 

access to health care services, fostering alternatives to litigation, and 

combating defensive medicine, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 6, 2009 

Mr. DENT (for himself, Mr. LEE of New York, and Mr. TIBERI) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To improve the medical justice system by encouraging the 

prompt and fair resolution of disputes, enhancing the 

quality of care, ensuring patient access to health care 

services, fostering alternatives to litigation, and combating defensive medicine, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ending Defensive Med5 icine and Encouraging Innovative Reforms Act of 2009’’. 


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1 SEC. 2. TABLE OF CONTENTS. 

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. 

3 TITLE I—NATIONWIDE REFORMS 

4 Subtitle A—In General 

5 SEC. 101. AUTHORIZATION OF PAYMENT OF FUTURE DAM6 AGES TO CLAIMANTS IN HEALTH CARE LAW7 SUITS. 

8 (a) COMPENSATING PATIENT INJURY.—In any 

9 health care lawsuit, if an award of future damages, with10 out reduction to present value, equaling or exceeding 

11 $50,000 is made against a party with sufficient insurance 

12 or other assets to fund a periodic payment of such a judgVerDate Nov 24 2008 04:00 Nov 08, 2009 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4039.IH H4039

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1 ment, the court shall, at the request of any party, enter 

2 a judgment ordering that the future damages be paid by 

3 periodic payments. In any health care lawsuit, the court 

4 may be guided by the Uniform Periodic Payment of Judg5 ments Act promulgated by the National Conference of 

6 Commissioners on Uniform State Laws. 

7 (b) APPLICABILITY.—This section applies to all ac8 tions which have not been first set for trial or retrial be9 fore the date of enactment of this Act. 

10 SEC. 102. FAIR SHARE RULE. 

11 In any health care lawsuit, each party shall be liable 

12 for that party’s several share of any damages only and 

13 not for the share of any other person. Each party shall 

14 be liable only for the amount of damages allocated to such 

15 party in direct proportion to such party’s percentage of 

16 responsibility. Whenever a judgment of liability is ren17 dered as to any party, a separate judgment shall be ren18 dered against each such party for the amount allocated 

19 to such party. For purposes of this section, the trier of 

20 fact shall determine the proportion of responsibility of 

21 each party for the claimant’s harm. 

22 SEC. 103. CERTIFICATE OF MERIT. 

23 (a) PRELIMINARY PROCEDURE.—Within 30 days of 

24 the filing of a health care lawsuit, the court shall appoint 

25 a qualified specialist whose appointment is agreed to by 


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1 one qualified specialist chosen by the claimant and one 

2 qualified specialist chosen by the defendant. If a qualified 

3 specialist is not agreed to by the qualified specialist chosen 

4 by the claimant and the qualified specialist chosen by the 

5 defendant within such 30 days, then the court shall ap6 point such qualified specialist at its discretion. The quali7 fied specialist appointed by the court shall, within 45 days 

8 of such appointment, submit to the court an affidavit that 

9 includes such specialist’s statement of opinion whether, 

10 based on a review of the available medical record and other 

11 relevant material, there is a reasonable and meritorious 

12 cause for the filing of the action against the defendant. 

13 If such specialist does not submit such affidavit to the 

14 court within 45 days of such appointment, the court shall 

15 dismiss such health care lawsuit. Such affidavit shall also 

16 contain a statement by the qualified specialist of specific 

17 breaches in the standard of care and the approximate neg18 ligence causation. Such affidavit shall not be admissible 

19 in any health care lawsuit or other court proceedings, or 

20 any arbitration proceeding. However, such affidavit, and 

21 information relevant to the determinations made by such 

22 specialist in such affidavit, shall be discoverable by the 

23 plaintiff and the defendant. In the case of multiple defend24 ants, a separate affidavit shall be required for each de25 fendant. The court shall set a reasonable fee that shall 


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1 be paid by the claimant for the preparation of such affi2 davit by such qualified specialist. The plaintiff’s attorney 

3 shall be given 90 days to obtain the certificate of merit 

4 affidavit in cases where the period to file the claim is due 

5 to expire because of the statute of limitations. If a case 

6 is filed without a certificate of merit affidavit, dismissal 

7 of the case is automatic without an extension permitted 

8 under the applicable statute of limitation exemption provi9 sion. 

10 (b) LOSER PAYS.—In a health care lawsuit, in the 

11 event the statement of opinion by a qualified specialist ap12 pointed by the court in an affidavit is that there is no 

13 reasonable and meritorious cause for the filing of the ac14 tion against the defendant, and the claimant does not sub15 stantially prevail by judgment, settlement, mediation, arbi16 tration, or any other form of alternative dispute resolu17 tion, the court shall order the claimant, or such claimant’s 

18 attorneys, to pay the costs and reasonable attorneys fees 

19 incurred by the defendant as a direct result of the health 

20 care lawsuit in which such qualified specialist’s opinion 

21 was filed. Claimants and their attorneys shall share liabil22 ity for such costs and reasonable attorneys fees incurred, 

23 as determined by the court in the interests of justice. 

24 (c) DEFINITION.—In this section, the term ‘‘qualified 

25 specialist’’ means, with respect to a health care lawsuit— 


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1 (1) a health care professional who— 

2 (A) is appropriately credentialed or li3 censed in one or more States to deliver health 

4 care services; 

5 (B) typically treats the diagnosis or condi6 tion or provides the type of treatment under re7 view; 

8 (C) can demonstrate by competent evi9 dence that, as a result of training, education, 

10 knowledge, and experience in the evaluation, di11 agnosis, and treatment of the disease or injury 

12 which is the subject matter of the lawsuit 

13 against the defendant, the health care profes14 sional is substantially familiar with applicable 

15 standards of care and practice on the date of 

16 the incident as they relate to the act or omis17 sion which is the subject of the lawsuit; and 

18 (D) has not been out of practice for more 

19 than 5 consecutive years; and 

20 (2) if the claim in the health care lawsuit in21 volved treatment that is recommended or provided 

22 by a physician (allopathic or osteopathic), with re23 spect to issues of negligence concerning such treat24 ment, a physician whose medical specialty or sub25 specialty is the same as the defendant’s or in addiVerDate Nov 24 2008 04:00 Nov 08, 2009 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4039.IH H4039

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1 tion to a showing of substantial familiarity in ac2 cordance with this section, there is a showing that 

3 the standards of care and practice in the two spe4 cialty or subspecialty fields are similar. 

5 SEC. 104. PRACTICE GUIDELINES. 

6 Notwithstanding any other provision of Federal, 

7 State, or local law the following shall apply: 

8 (1) In a health care lawsuit or proceeding 

9 brought against a health care provider, such pro10 vider shall not be liable for the care provided if, in 

11 delivering such care, such provider acted consistent 

12 with accepted clinical practice guidelines established 

13 by the specialty of which the defendant is board cer14 tified or if guidelines established by the specialty are 

15 not available, accepted clinical practice guideline list16 ed in the National Guideline Clearinghouse. Non17 compliance with accepted clinical practice guidelines 

18 established by the specialty of which the defendant 

19 is board certified, or if guidelines established by the 

20 specialty are not available, accepted clinical practice 

21 guidelines listed in the National Guideline Clearing22 house shall not, in a health care lawsuit or pro23 ceeding brought against a health care provider, con24 stitute a breach of the applicable medical standard 

25 of care, or be otherwise admissible to prove a breach 


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1 of the standard of care, negligence or other tortious 

2 conduct. 

3 (2) Compliance or non-compliance with regula4 tions, directives, or guidelines established by or on 

5 behalf of the Secretary of Health and Human Serv6 ices pursuant to authority set forth in title XVIII of 

7 the Social Security Act (42 U.S.C. 1395–1395ccc) 

8 shall not, in a health care lawsuit or proceeding 

9 brought against a health care provider, constitute a 

10 breach of the medical standard of care, or be other11 wise admissible to prove a breach of the medical 

12 standard of care, negligence or other tortious con13 duct. 

14 (3) Compliance or non-compliance with regula15 tions, directives, or guidelines established by or on 

16 behalf of the Secretary of Health and Human Serv17 ices or any State official or entity administering 

18 Medicaid programs under title XIX of the Social Se19 curity Act (42 U.S.C. 1396–1396v) and Children’s 

20 Health Insurance Programs under title XXI of the 

21 Social Security Act (42 U.S.C. 1397aa–1397jj) shall 

22 not, in a health care lawsuit or proceeding brought 

23 against a health care provider, constitute a breach of 

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1 wise admissible to prove a breach of the standard of 

2 care, negligence or other tortious conduct. 

3 (4) Compliance or non-compliance with Com4 parative Effectiveness Research and any regulations, 

5 directives, or guidelines based in whole or in part 

6 upon such research shall not, in a health care law7 suit or proceeding brought against a health care pro8 vider, constitute a breach of the applicable medical 

9 standard of care, or be otherwise admissible to prove 

10 the medical standard of care, negligence or other 

11 tortious conduct. 

12 SEC. 105. PAYMENT DETERMINATION. 

13 Notwithstanding any other provision of Federal, 

14 State, or local law the following shall apply: 

15 (1) Evidence of payments and reimbursements 

16 made to health care providers pursuant to title 

17 XVIII of the Social Security Act (42 U.S.C. 1395– 

18 1395ccc) and evidence of payment rates, payment 

19 mechanisms, and payment policies established on or 

20 behalf of the Secretary of Health and Human Serv21 ices for services provided pursuant to the programs 

22 set forth in title XVIII of the Social Security Act 

23 (42 U.S.C. 1395–1395ccc) shall not, in a health care 

24 lawsuit or proceeding brought against a health care 

25 provider, constitute a determination that a health 


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1 care provider has or has not met the medical stand2 ard of care or be otherwise admissible to prove 

3 breach of the medical standard of care, negligence or 

4 other tortious conduct. 

5 (2) Compliance or non-compliance with pay6 ment rates, payment mechanisms, or payment poli7 cies established by or on behalf of the Secretary of 

8 Health and Human Services or any State official or 

9 entity administering Medicaid programs under title 

10 XIX of the Social Security Act (42 U.S.C. 1396– 

11 1396v) and Children’s Health Insurance Programs 

12 under title XXI of the Social Security Act (42 

13 U.S.C. 1397aa–1397jj) shall not, in a health care 

14 lawsuit or proceeding brought against a health care 

15 provider, constitute a determination that a health 

16 care provider has or has not met the applicable med17 ical standard of care or be otherwise admissible to 

18 prove a breach of the medical standard of care, neg19 ligence or other tortious conduct. 

20 SEC. 106. DEFINITIONS. 

21 In this subtitle: 

22 (1) HEALTH CARE LAWSUIT.—The term 

23 ‘‘health care lawsuit’’ means any health care liability 

24 claim concerning the provision of health care goods 

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1 state commerce, or any health care liability action 

2 concerning the provision of health care goods or 

3 services or any medical product affecting interstate 

4 commerce, brought in a State or Federal court or 

5 pursuant to an alternative dispute resolution system, 

6 against a health care provider, a health care organi7 zation, or the manufacturer, distributor, supplier, 

8 marketer, promoter, or seller of a medical product, 

9 regardless of the theory of liability on which the 

10 claim is based, or the number of claimants, plain11 tiffs, defendants, or other parties, or the number of 

12 claims or causes of action, in which the claimant al13 leges a health care liability claim. Such term does 

14 not include a claim or action which is based on 

15 criminal liability; which seeks civil fines or penalties 

16 paid to Federal, State, or local government; or which 

17 is grounded in antitrust. 

18 (2) CLAIMANT.—The term ‘‘claimant’’ means 

19 any person who brings a health care lawsuit, includ20 ing a person who asserts or claims a right to legal 

21 or equitable contribution, indemnity, or subrogation, 

22 arising out of a health care liability claim or action, 

23 and any person on whose behalf such a claim is as24 serted or such an action is brought, whether de25 ceased, incompetent, or a minor. 


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1 (3) HEALTH CARE PROVIDER.—The term 

2 ‘health care provider’ means any person or entity— 

3 (A) required by State or Federal law or 

4 regulations to be licensed, registered, or cer5 tified to provide health care services; and 

6 (B) being either so licensed, registered, or 

7 certified, or exempted from such requirement by 

8 other law or regulation. 

9 Subtitle B—Safety Net Providers 

10 SEC. 121. PROTECTION FOR EMERGENCY AND RELATED 

11 SERVICES FURNISHED PURSUANT TO 

12 EMTALA. 

13 Section 224(g) of the Public Health Service Act (42 

14 U.S.C. 233(g)) is amended— 

15 (1) in paragraph (4), by striking ‘‘An entity’’ 

16 and inserting ‘‘Subject to paragraph (6), an entity’’; 

17 and 

18 (2) by adding at the end the following: 

19 ‘‘(6)(A) For purposes of this section— 

20 ‘‘(i) an entity described in subparagraph 

21 (B) shall be considered to be an entity de22 scribed in paragraph (4); and 

23 ‘‘(ii) the provisions of this section shall 

24 apply to an entity described in subparagraph 

25 (B) in the same manner as such provisions 


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1 apply to an entity described in paragraph (4), 

2 except that— 

3 ‘‘(I) notwithstanding paragraph 

4 (1)(B), the deeming of any entity described 

5 in subparagraph (B), or of an officer, gov6 erning board member, employee, con7 tractor, or on-call provider of such an enti8 ty, to be an employee of the Public Health 

9 Service for purposes of this section shall 

10 apply only with respect to items and serv11 ices that are furnished to an individual 

12 pursuant to section 1867 of the Social Se13 curity Act and to post stabilization services 

14 (as defined in subparagraph (D)) furnished 

15 to such an individual; 

16 ‘‘(II) nothing in paragraph (1)(D) 

17 shall be construed as preventing a physi18 cian or physician group described in sub19 paragraph (B)(ii) from making the appli20 cation referred to in such paragraph or as 

21 conditioning the deeming of a physician or 

22 physician group that makes such an appli23 cation upon receipt by the Secretary of an 

24 application from the hospital or emergency 

25 department that employs or contracts with 


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1 the physician or group, or enlists the phy2 sician or physician group as an on-call pro3 vider; 

4 ‘‘(III) notwithstanding paragraph (3), 

5 this paragraph shall apply only with re6 spect to causes of action arising from acts 

7 or omissions that occur on or after Janu8 ary 1, 2010; 

9 ‘‘(IV) paragraph (5) shall not apply to 

10 a physician or physician group described in 

11 subparagraph (B)(ii); 

12 ‘‘(V) the Attorney General, in con13 sultation with the Secretary, shall make 

14 separate estimates under subsection (k)(1) 

15 with respect to entities described in sub16 paragraph (B) and entities described in 

17 paragraph (4) (other than those described 

18 in subparagraph (B)), and the Secretary 

19 shall establish separate funds under sub20 section (k)(2) with respect to such groups 

21 of entities, and any appropriations under 

22 this subsection for entities described in 

23 subparagraph (B) shall be separate from 

24 the amounts authorized by subsection 

25 (k)(2); 


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1 ‘‘(VI) notwithstanding subsection 

2 (k)(2), the amount of the fund established 

3 by the Secretary under such subsection 

4 with respect to entities described in sub5 paragraph (B) may exceed a total of 

6 $10,000,000 for a fiscal year; and 

7 ‘‘(VII) subsection (m) shall not apply 

8 to entities described in subparagraph (B). 

9 ‘‘(B) An entity described in this subparagraph 

10 is— 

11 ‘‘(i) a hospital or an emergency depart12 ment to which section 1867 of the Social Secu13 rity Act applies; and 

14 ‘‘(ii) a physician or physician group that is 

15 employed by, is under contract with, or is an 

16 on-call provider of such hospital or emergency 

17 department, to furnish items and services to in18 dividuals under such section. 

19 ‘‘(C) For purposes of this paragraph, the term 

20 ‘on-call provider’ means a physician or physician 

21 group that— 

22 ‘‘(i) has full, temporary, or locum tenens 

23 staff privileges at a hospital or emergency de24 partment to which section 1867 of the Social 

25 Security Act applies; and 


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1 ‘‘(ii) is not employed by or under contract 

2 with such hospital or emergency department, 

3 but agrees to be ready and available to provide 

4 services pursuant to section 1867 of the Social 

5 Security Act or post stabilization services to in6 dividuals being treated in the hospital or emer7 gency department with or without compensation 

8 from the hospital or emergency department. 

9 ‘‘(D) For purposes of this paragraph, the term 

10 ‘post stabilization services’ means, with respect to an 

11 individual who has been treated by an entity de12 scribed in subparagraph (B) for purposes of com13 plying with section 1867 of the Social Security Act, 

14 services that are— 

15 ‘‘(i) related to the condition that was so 

16 treated; and 

17 ‘‘(ii) provided after the individual is sta18 bilized in order to maintain the stabilized condi19 tion or to improve or resolve the condition of 

20 the individual. 

21 ‘‘(E)(i) Nothing in this paragraph (or in any 

22 other provision of this section as such provision ap23 plies to entities described in subparagraph (B) by 

24 operation of subparagraph (A)) shall be construed as 

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1 ments to such entities, the budget authority for 

2 which is not provided in advance by appropriation 

3 Acts. 

4 ‘‘(ii) The Secretary shall limit the total amount 

5 of payments under this paragraph for a fiscal year 

6 to the total amount appropriated in advance by ap7 propriation Acts for such purpose for such fiscal 

8 year. If the total amount of payments that would 

9 otherwise be made under this paragraph for a fiscal 

10 year exceeds such total amount appropriated, the 

11 Secretary shall take such steps as may be necessary 

12 to ensure that the total amount of payments under 

13 this paragraph for such fiscal year does not exceed 

14 such total amount appropriated.’’. 

15 Subtitle C—Community Health 

16 Center Volunteers 

17 SEC. 131. PROTECTION FOR HEALTH CENTER VOLUNTEER 

18 PRACTITIONERS. 

19 (a) IN GENERAL.—Section 224 of the Public Health 

20 Service Act (42 U.S.C. 233) is amended— 

21 (1) in subsection (g)(1)(A)— 

22 (A) in the first sentence, by striking ‘‘or 

23 employee’’ and inserting ‘‘employee, or (subject 

24 to subsection (k)(4)) volunteer practitioner’’; 

25 and 


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1 (B) in the second sentence, by inserting 

2 ‘‘and subsection (k)(4)’’ after ‘‘subject to para3 graph (5)’’; and 

4 (2) in each of subsections (g), (i), (j), (k), (l), 

5 and (m)— 

6 (A) by striking the term ‘‘employee, or 

7 contractor’’ each place such term appears and 

8 inserting ‘‘employee, volunteer practitioner, or 

9 contractor’’; 

10 (B) by striking the term ‘‘employee, and 

11 contractor’’ each place such term appears and 

12 inserting ‘‘employee, volunteer practitioner, and 

13 contractor’’; 

14 (C) by striking the term ‘‘employee, or any 

15 contractor’’ each place such term appears and 

16 inserting ‘‘employee, volunteer practitioner, or 

17 contractor’’; and 

18 (D) by striking the term ‘‘employees, or 

19 contractors’’ each place such term appears and 

20 inserting ‘‘employees, volunteer practitioners, or 

21 contractors’’. 

22 (b) APPLICABILITY; DEFINITION.—Section 224(k) of 

23 the Public Health Service Act (42 U.S.C. 233(k)) is 

24 amended by adding at the end the following paragraph: 


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1 ‘‘(4)(A) Subsections (g) through (m) apply with re2 spect to volunteer practitioners beginning with the first 

3 fiscal year for which an appropriations Act provides that 

4 amounts in the fund under paragraph (2) are available 

5 with respect to such practitioners. 

6 ‘‘(B) For purposes of subsections (g) through (m), 

7 the term ‘volunteer practitioner’ means a practitioner who, 

8 with respect to an entity described in subsection (g)(4), 

9 meets the following conditions: 

10 ‘‘(i) In the State involved, the practitioner is a 

11 licensed physician, a licensed clinical psychologist, or 

12 other licensed or certified health care practitioner. 

13 ‘‘(ii) At the request of such entity, the practi14 tioner provides services to patients of the entity, at 

15 a site at which the entity operates or at a site des16 ignated by the entity. The weekly number of hours 

17 of services provided to the patients by the practi18 tioner is not a factor with respect to meeting condi19 tions under this subparagraph. 

20 ‘‘(iii) The practitioner does not for the provision 

21 of such services receive any compensation from such 

22 patients, from the entity, or from third-party payers 

23 (including reimbursement under any insurance pol24 icy or health plan, or under any Federal or State 

25 health benefits program).’’. 


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1 Subtitle D—Disaster Relief 

2 Volunteers 

3 SEC. 141. PROTECTION FOR DISASTER RELIEF VOLUN4 TEERS. 

5 (a) LIABILITY OF DISASTER RELIEF VOLUN6 TEERS.—A disaster relief volunteer shall not be liable for 

7 any injury (including personal injury, property damage or 

8 loss, and death) caused by an act or omission of such vol9 unteer in connection with such volunteer’s providing or fa10 cilitating the provision of disaster relief services if— 

11 (1) the injury was not caused by willful, wan12 ton, or reckless misconduct by the volunteer; and 

13 (2) the injury was not caused by the volunteer’s 

14 operating a motor vehicle, vessel, aircraft, or other 

15 vehicle for which the state requires the operator or 

16 the owner of the vehicle, craft, or vessel to— 

17 (A) possess an operator’s license; or 

18 (B) maintain insurance. 

19 (b) LIABILITY OF EMPLOYER OR PARTNER OF DIS20 ASTER RELIEF VOLUNTEER.—An employer or business 

21 partner of a disaster relief volunteer shall not be liable 

22 for any act or omission of such volunteer in connection 

23 with such volunteer’s providing or facilitating the provi24 sion of disaster relief services. 


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1 (c) LIABILITY OF HOST OR ENABLING PERSON, EN2 TITY, OR ORGANIZATION.—A person or entity, including 

3 a governmental entity, that works with, accepts services 

4 from, or makes its facilities available to a disaster relief 

5 volunteer to enable such volunteer to provide disaster re6 lief services shall not be liable for any act or omission of 

7 such volunteer in connection with such volunteer’s pro8 viding such services. 

9 (d) LIABILITY OF NONPROFIT ORGANIZATIONS.—A 

10 nonprofit organization shall not be liable for any injury 

11 (including personal injury, property damage or loss, and 

12 death) caused by an act or omission in connection with 

13 such nonprofit organization’s providing or facilitating the 

14 provision of disaster relief services if the injury was not 

15 caused by willful, wanton, or reckless misconduct by the 

16 nonprofit organization. 

17 (e) LIABILITY OF GOVERNMENTAL AND INTERGOV18 ERNMENTAL ENTITIES FOR DONATIONS OF DISASTER

19 RELIEF GOODS.—A governmental or intergovernmental 

20 entity that donates to an agency or instrumentality of the 

21 United States disaster relief goods shall not be liable for 

22 any injury (including personal injury, property damage or 

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1 conduct by such governmental or intergovernmental enti2 ty. 

3 (f) LIMITATION ON PUNITIVE AND NONECONOMIC

4 DAMAGES BASED ON ACTIONS OF DISASTER RELIEF

5 VOLUNTEERS AND GOVERNMENTAL DONORS.— 

6 (1) PUNITIVE DAMAGES.—Unless the claimant 

7 establishes by clear and convincing evidence that its 

8 damages were proximately caused by willful, wanton, 

9 or reckless misconduct by either— 

10 (A) a disaster relief volunteer in any civil 

11 action brought for injury caused by the volun12 teer’s providing or facilitating the provision of 

13 disaster relief services; or 

14 (B) a governmental or intergovernmental 

15 entity in any civil action brought for injury 

16 caused by disaster relief goods donated by such 

17 governmental or intergovernmental entity; 

18 punitive damages may not be awarded in any civil 

19 action against such a volunteer or governmental en20 tity. 

21 (2) NONECONOMIC DAMAGES.— 

22 (A) GENERAL RULE.—In any civil action 

23 brought against— 

24 (i) a disaster relief volunteer for in25 jury caused by such volunteer’s providing 


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1 or facilitating the provision of disaster re2 lief services; or 

3 (ii) a governmental or intergovern4 mental entity for injury caused by disaster 

5 relief goods donated by such governmental 

6 entity; 

7 liability for noneconomic loss, if permitted 

8 under subsection (a) or (e) of this section, shall 

9 be determined in accordance with this subpara10 graph. 

11 (B) AMOUNT OF LIABILITY.—(i) The 

12 amount of noneconomic loss allocated to the 

13 disaster relief volunteer or governmental or 

14 intergovernmental entity defendant shall be in 

15 direct proportion to the percentage of responsi16 bility of that defendant (determined in accord17 ance with clause (ii)) for the harm to the claim18 ant with respect to which that defendant is lia19 ble. The court shall render a separate judgment 

20 against each defendant in an amount deter21 mined pursuant to this section. 

22 (ii) For purposes of determining the 

23 amount of noneconomic loss allocated to a 

24 defendant, the trier of fact shall determine 

25 the percentage of responsibility of each 


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1 person or entity responsible for the claim2 ant’s harm, whether or not such person or 

3 entity is a party to the action. 

4 (g) CONSTRUCTION.—Nothing in this section shall be 

5 construed to abrogate or limit any protection that a volun6 teer, as defined in the Volunteer Protection Act of 1997 

7 (42 U.S.C. 14501 et seq.), may be entitled to under that 

8 Act. Neither shall anything in this section be construed 

9 to confer any private right of action or to abrogate or limit 

10 any protection with respect to either liability or damages 

11 that any disaster relief volunteer or governmental or inter12 governmental entity may be entitled to under any other 

13 provision of law. 

14 (h) SUPPLEMENTAL DECLARATION.—If a Disaster 

15 Declaration is issued, the President, the Secretary of 

16 Health and Human Services, or the Secretary of Home17 land Security may issue a Supplemental Declaration under 

18 this section. 

19 (1) TEMPORAL EFFECT.—Such Supplemental 

20 Declaration may provide that, for purposes of this 

21 section, such Disaster Declaration shall have such 

22 temporal effect as the President or the Secretary 

23 may deem necessary or appropriate to further the 

24 public interest, including providing that such Dis25 aster Declaration shall have an effective date earlier 


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1 than the date of the declaration or determination of 

2 such Disaster Declaration. 

3 (2) GEOGRAPHIC AND OTHER CONDITIONS.— 

4 Such Supplemental Declaration may provide that, 

5 for purposes of this section, such Disaster Declara6 tion shall have such geographic or other conditions 

7 as the President or the Secretary may deem nec8 essary or appropriate to further the public interest. 

9 (i) LICENSING, CERTIFICATION, AND AUTHORIZA10 TION.—This section shall not apply to a disaster relief vol11 unteer where the disaster relief service such volunteer pro12 vides is of a type that generally requires a license, certifi13 cate, or authorization, and the disaster relief volunteer 

14 lacks such license, certificate, or authorization, unless— 

15 (1) such volunteer is licensed, certified, or au16 thorized to provide such services in any State to the 

17 extent required, if any, by the appropriate authori18 ties of that State, even if such State is not the State 

19 in which the disaster relief volunteer provides dis20 aster relief services; or 

21 (2) otherwise specified in a Disaster Declara22 tion or Supplemental Declaration under this section. 

23 (j) DEFINITIONS.—For purposes of this section: 

24 (1) The term ‘‘Disaster Declaration’’ means— 


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1 (A) a public health emergency declaration 

2 by the Secretary of Health and Human Services 

3 under section 319 of the Public Health Service 

4 Act (42 U.S.C. 247d); 

5 (B) a declaration of a public health emer6 gency or a risk of such emergency as deter7 mined by the Secretary of Homeland Security 

8 in accordance with clause (i) or clause (ii) of 

9 section 2811(b)(3)(A) of such Act (42 U.S.C. 

10 300hh–11(b)(3)(A)) and section 503(5) of the 

11 Homeland Security Act of 2002 (6 U.S.C. 

12 313(5)); or 

13 (C) an emergency or major disaster dec14 laration by the President under section 401 or 

15 501 of the Robert T. Stafford Disaster Relief 

16 and Emergency Assistance Act (42 U.S.C. 5170 

17 or 5191). 

18 (2) The term ‘‘disaster relief volunteer’’ means 

19 an individual who provides disaster relief services in 

20 connection with a Disaster Declaration without ex21 pectation or receipt of compensation in exchange for 

22 providing such services. 

23 (3) The term ‘‘disaster relief services’’ means 

24 services or assistance provided in preparation for, re25 sponse to, or recovery from any event that is the 


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1 subject of a Disaster Declaration, including but not 

2 limited to health, medical, fire fighting, rescue, re3 construction, and any other services or assistance 

4 specified by a Supplemental Declaration under this 

5 section as necessary or desirable to prepare for, re6 spond to, or recover from an event that is the sub7 ject of a Disaster Declaration. 

8 (4) The term ‘‘disaster relief good’’ means ei9 ther— 

10 (A) those goods provided in preparation 

11 for, response to, or recovery from any event 

12 that is the subject of a Disaster Declaration 

13 and reasonably necessary to such preparation, 

14 response, or recovery; or 

15 (B) those goods defined by a Disaster Dec16 laration or Supplemental Declaration under this 

17 section. 

18 (5) The term ‘‘noneconomic loss’’ means losses 

19 for physical and emotional pain, suffering, inconven20 ience, physical impairment, mental anguish, dis21 figurement, loss of enjoyment of life, loss of society 

22 and companionship, loss of consortium (other than 

23 loss of domestic service), hedonic damages, injury to 

24 reputation, and all other nonpecuniary losses of any 

25 kind or nature. 


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1 (6) The term ‘‘State’’ means each of the several 

2 States, the District of Columbia, the Commonwealth 

3 of Puerto Rico, the Virgin Islands, Guam, American 

4 Samoa, the Northern Mariana Islands, any other 

5 territory or possession of the United States, or any 

6 political subdivision of any such State, territory, or 

7 possession, and (for purposes of subsection (h)) any 

8 foreign country. 

9 (7) The term ‘‘compensation’’ means monetary 

10 or other compensation of any kind provided in ex11 change for an individual’s services, but does not in12 clude— 

13 (A) reasonable reimbursement or allowance 

14 for expenses actually incurred by such an indi15 vidual; 

16 (B) provision of reasonable supplies, lodg17 ing, or transportation to such an individual; or 

18 (C) such an individual’s ordinary salary or 

19 compensation paid by his or her employer while 

20 such individual is on leave from his or her ordi21 nary duties with such employer in order to pro22 vide disaster relief services. 


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1 TITLE II—STATE REFORM 

2 INCENTIVES 

3 SEC. 201. PUBLIC HEALTH SERVICE ACT AMENDMENT. 

4 The Public Health Service Act is amended by adding 

5 at the end the following: 

6 ‘‘TITLE XXXI—MEDICAL 

7 LIABILITY ALTERNATIVES 

8 ‘‘Subtitle A—Incentive Payments 

9 ‘‘SEC. 3101. INCENTIVE PAYMENTS FOR MEDICAL LIABILITY 

10 REFORM. 

11 ‘‘(a) ELIGIBILITY.—A State that has enacted and is 

12 implementing an alternative medical liability law is eligible 

13 to receive an incentive payment in an amount determined 

14 by the Secretary, subject to the availability of appropria15 tions for that purpose. 

16 ‘‘(b) CONTENTS OF ALTERNATIVE MEDICAL LIABIL17 ITY LAW.—An alternative medical liability law shall con18 tain any one or a combination of the following litigation 

19 alternatives: 

20 ‘‘(1) EARLY OFFER.—Within a time period to 

21 be determined by the State, a health care provider 

22 may offer to pay economic damages to an injured 

23 party. The injured party must be provided an equal 

24 amount of time to accept or reject the offer. Notifi25 cation would not constitute an admission of liability. 


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1 Evidence of an offer would be inadmissible in a 

2 health care lawsuit. Providers should be incentivized 

3 to make good faith offers as early as possible and 

4 patients should be incentivized to accept legitimate 

5 offers of compensation. 

6 ‘‘(2) HEALTHCARE COURT.—Health Courts 

7 would provide a forum, either a bench or jury trial, 

8 where medical liability actions could be heard by 

9 judges specially trained in medical liability matters 

10 and who hear only medical liability cases. 

11 ‘‘(3) I’M SORRY PROVISION.—In any medical li12 ability action, any and all statements, affirmations, 

13 gestures, or conduct expressing apology, sympathy, 

14 commiseration, condolence, compassion, fault, or a 

15 general sense of benevolence which are made by a 

16 healthcare provider to the plaintiff or a relative of 

17 the plaintiff which relate solely to the discomfort, 

18 pain, suffering, injury, or death as the result of the 

19 unanticipated outcome of the medical care shall be 

20 inadmissible as evidence of an admission of liability 

21 or as evidence of an admission against interest. 

22 ‘‘(4) VOLUNTARY ALTERNATIVE DISPUTE RESO23 LUTION.—Alternatives to medical liability trials 

24 would be pursued through binding and nonbinding 

25 dispute processes and techniques, including but not 


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1 limited to mediation and arbitration. Mediation is a 

2 private, facilitated negotiation in which parties dis3 cuss their dispute with the help of a neutral third 

4 party, whose role is to help the parties communicate 

5 with one another to reach an agreement or settle6 ment. Arbitration is different from mediation in that 

7 the neutral arbitrator actually has the authority to 

8 make a decision about the dispute. 

9 ‘‘(5) EXPERT WITNESS QUALIFICATIONS.— 

10 Amendments to State statutory qualifications for 

11 those who may serve as medical expert witnesses at 

12 trial, including the creation of additional standards 

13 that medical expert witnesses must meet in order to 

14 ensure the testimony juries receive is presented by 

15 an individual with particularized expertise in the 

16 matter in question. 

17 ‘‘(6) OTHER ALTERNATIVES APPROVED BY THE

18 SECRETARY.—Any other alternative the Secretary 

19 approves by rule as carrying out the purposes of this 

20 subtitle. 

21 ‘‘(c) USE OF INCENTIVE PAYMENTS.—The State 

22 shall, not later than 3 years after receipt of an incentive 

23 payment under this title, use that incentive payment to 

24 improve health care in that State. 


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1 ‘‘SEC. 3102. STATE REPORTS. 

2 ‘‘(a) DUTY TO REPORT.—Each State that accepts an 

3 incentive payment under this title shall thereafter submit 

4 annual reports to the Secretary describing the progress 

5 of that State in the implementation of that State’s alter6 native medical liability law. 

7 ‘‘(b) REQUIRED CONTENTS OF REPORTS.—Each 

8 such report shall contain, for the period covered by the 

9 report— 

10 ‘‘(1) the number of health care lawsuits initi11 ated in the State; 

12 ‘‘(2) the average amount of time taken to re13 solve each lawsuit that is resolved in the State; and 

14 ‘‘(3) the average cost of malpractice insurance 

15 in the State. 

16 ‘‘SEC. 3103. REPORTS BY SECRETARY TO CONGRESS. 

17 ‘‘(a) ANNUAL REPORTS BY SECRETARY.—Beginning 

18 not later than one year after the date of the enactment 

19 of this title, the Secretary shall submit to Congress an 

20 annual report on the effect of the laws of each State that 

21 has received an incentive payment under this title in re22 storing reliability to that State’s medical justice system. 

23 Such report shall include any determination made by the 

24 Secretary under subsection (b). 

25 ‘‘(b) DETERMINATION OF EFFECTIVENESS OF

26 LAWS.— 


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1 ‘‘(1) GENERAL RULE.—Except as provided in 

2 paragraph (2), after a State makes 3 reports under 

3 section 3102, the Secretary shall determine whether, 

4 during the period covered by such reports, those 

5 laws have brought about— 

6 ‘‘(A) a reduction in the number of health 

7 care lawsuits initiated in the State; 

8 ‘‘(B) a reduction in the amount of time re9 quired to resolve lawsuits in the State; and 

10 ‘‘(C) a reduction in the cost of malpractice 

11 insurance in the State. 

12 ‘‘(2) EXCEPTION.—If the Secretary finds that 

13 litigation about the implementation of a State’s al14 ternative medical liability laws has prevented those 

15 laws from having their expected effect, the Secretary 

16 may defer making the determination under para17 graph (a) until the Secretary finds that 3 years have 

18 passed since that litigation ceased preventing those 

19 laws from having their expected effect. 

20 ‘‘SEC. 3104. APPLICATION OF SUBTITLE B TO STATES WITH 

21 INEFFECTIVE LAWS. 

22 ‘‘(a) GENERAL RULE.—Except as otherwise provided 

23 in this section, if the Secretary determines under section 

24 3103(b) that a State’s alternative medical liability laws 

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1 tion, beginning on the first day of the next succeeding year 

2 after that determination, that State, and any health care 

3 lawsuit commenced under the law of that State on or after 

4 that day, shall be subject to the provisions of subtitle B. 

5 ‘‘(b) STATUTE OF LIMITATION FOR CERTAIN

6 CASES.—Any health care lawsuit commenced in a State 

7 while that State is subject to subtitle B, but arising from 

8 an injury that occurred before subtitle B began to apply 

9 in that State, shall continue to be governed by the statute 

10 of limitations in effect at the time the injury occurred. 

11 ‘‘SEC. 3105. APPLICATION REQUIRED FOR PAYMENT. 

12 ‘‘(a) APPLICATION REQUIRED.—Each State seeking 

13 an incentive payment under this title shall submit to the 

14 Secretary an application, at such time, in such manner, 

15 and containing such information as the Secretary may re16 quire. 

17 ‘‘(b) TIME LIMIT FOR SUBMISSION OF APPLICA18 TIONS.—The Secretary may not accept any application 

19 under this subtitle later than 5 years after the date of 

20 the enactment of this Act. 

21 ‘‘SEC. 3106. TECHNICAL ASSISTANCE. 

22 ‘‘The Secretary may provide technical assistance to 

23 the States applying for or awarded an incentive payment 

24 under this title. 


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1 ‘‘SEC. 3107. RULEMAKING. 

2 ‘‘The Secretary may make rules to carry out this 

3 title. 

4 ‘‘SEC. 3108. AUTHORIZATION OF APPROPRIATIONS. 

5 ‘‘There are authorized to be appropriated to carry out 

6 this title such sums as may be necessary, to remain avail7 able until expended. 

8 ‘‘SEC. 3109. DEFINITIONS. 

9 ‘‘In this title— 

10 ‘‘(1) the term ‘Secretary’ means the Secretary 

11 of Health and Human Services; and 

12 ‘‘(2) the term ‘State’ includes the District of 

13 Columbia, Puerto Rico, and each other territory or 

14 possession of the United States. 

15 ‘‘Subtitle B—Liability Limits for 

16 States With Ineffective Laws 

17 ‘‘SEC. 3111. APPLICATION. 

18 ‘‘This subtitle applies only in those States to which 

19 it is made applicable by subtitle A. 

20 ‘‘SEC. 3112. ENCOURAGING SPEEDY RESOLUTION OF 

21 CLAIMS. 

22 ‘‘The time for the commencement of a health care 

23 lawsuit shall be 3 years after the date of manifestation 

24 of injury or 1 year after the claimant discovers, or through 

25 the use of reasonable diligence should have discovered, the 

26 injury, whichever occurs first. In no event shall the time 


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1 for commencement of a health care lawsuit exceed 3 years 

2 after the date of manifestation of injury unless tolled for 

3 any of the following— 

4 ‘‘(1) upon proof of fraud; 

5 ‘‘(2) intentional concealment; or 

6 ‘‘(3) the presence of a foreign body, which has 

7 no therapeutic or diagnostic purpose or effect, in the 

8 person of the injured person. 

9 Actions by a minor shall be commenced within 3 years 

10 from the date of the alleged manifestation of injury except 

11 that actions by a minor under the full age of 6 years shall 

12 be commenced within 3 years of manifestation of injury 

13 or prior to the minor’s 8th birthday, whichever provides 

14 a longer period. Such time limitation shall be tolled for 

15 minors for any period during which a parent or guardian 

16 and a health care provider or health care organization 

17 have committed fraud or collusion in the failure to bring 

18 an action on behalf of the injured minor. 

19 ‘‘SEC. 3113. COMPENSATING PATIENT INJURY. 

20 ‘‘(a) UNLIMITED AMOUNT OF DAMAGES FOR ACTUAL

21 ECONOMIC LOSSES IN HEALTH CARE LAWSUITS.—In any 

22 health care lawsuit, nothing in this subtitle shall limit a 

23 claimant’s recovery of the full amount of the available eco24 nomic damages, notwithstanding the limitation in sub25 section (b). 


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1 ‘‘(b) ADDITIONAL NONECONOMIC DAMAGES.—In any 

2 health care lawsuit, the amount of noneconomic damages, 

3 if available, may be as much as $250,000, regardless of 

4 the number of parties against whom the action is brought 

5 or the number of separate claims or actions brought with 

6 respect to the same injury. 

7 ‘‘(c) NO DISCOUNT OF AWARD FOR NONECONOMIC

8 DAMAGES.—For purposes of applying the limitation in 

9 subsection (b), future noneconomic damages shall not be 

10 discounted to present value. The jury shall not be in11 formed about the maximum award for noneconomic dam12 ages. An award for noneconomic damages in excess of 

13 $250,000 shall be reduced either before the entry of judg14 ment, or by amendment of the judgment after entry of 

15 judgment, and such reduction shall be made before ac16 counting for any other reduction in damages required by 

17 law. If separate awards are rendered for past and future 

18 noneconomic damages and the combined awards exceed 

19 $250,000, the future noneconomic damages shall be re20 duced first. 

21 ‘‘(d) FAIR SHARE RULE.—In any health care lawsuit, 

22 each party shall be liable for that party’s several share 

23 of any damages only and not for the share of any other 

24 person. Each party shall be liable only for the amount of 

25 damages allocated to such party in direct proportion to 


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1 such party’s percentage of responsibility. Whenever a 

2 judgment of liability is rendered as to any party, a sepa3 rate judgment shall be rendered against each such party 

4 for the amount allocated to such party. For purposes of 

5 this section, the trier of fact shall determine the propor6 tion of responsibility of each party for the claimant’s 

7 harm. 

8 ‘‘SEC. 3114. MAXIMIZING PATIENT RECOVERY. 

9 ‘‘(a) COURT SUPERVISION OF SHARE OF DAMAGES

10 ACTUALLY PAID TO CLAIMANTS.—In any health care law11 suit, the court shall supervise the arrangements for pay12 ment of damages to protect against conflicts of interest 

13 that may have the effect of reducing the amount of dam14 ages awarded that are actually paid to claimants. In par15 ticular, in any health care lawsuit in which the attorney 

16 for a party claims a financial stake in the outcome by vir17 tue of a contingent fee, the court shall have the power 

18 to restrict the payment of a claimant’s damage recovery 

19 to such attorney, and to redirect such damages to the 

20 claimant based upon the interests of justice and principles 

21 of equity. In no event shall the total of all contingent fees 

22 for representing all claimants in a health care lawsuit ex23 ceed the following limits: 

24 ‘‘(1) 40 percent of the first $50,000 recovered 

25 by the claimant(s). 


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‘‘(2) 331 1 ⁄3 percent of the next $50,000 recov2 ered by the claimant(s). 

3 ‘‘(3) 25 percent of the next $500,000 recovered 

4 by the claimant(s). 

5 ‘‘(4) 15 percent of any amount by which the re6 covery by the claimant(s) is in excess of $600,000. 

7 ‘‘(b) APPLICABILITY.—The limitations in this section 

8 shall apply whether the recovery is by judgment, settle9 ment, mediation, arbitration, or any other form of alter10 native dispute resolution. In a health care lawsuit involv11 ing a minor or incompetent person, a court retains the 

12 authority to authorize or approve a fee that is less than 

13 the maximum permitted under this section. The require14 ment for court supervision in the first two sentences of 

15 subsection (a) applies only in civil actions. 

16 ‘‘SEC. 3115. ADDITIONAL HEALTH BENEFITS. 

17 ‘‘In any health care lawsuit involving injury or wrong18 ful death, any party may introduce evidence of collateral 

19 source benefits. If a party elects to introduce such evi20 dence, any opposing party may introduce evidence of any 

21 amount paid or contributed or reasonably likely to be paid 

22 or contributed in the future by or on behalf of the oppos23 ing party to secure the right to such collateral source bene24 fits. No provider of collateral source benefits shall recover 

25 any amount against the claimant or receive any lien or 


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1 credit against the claimant’s recovery or be equitably or 

2 legally subrogated to the right of the claimant in a health 

3 care lawsuit involving injury or wrongful death. This sec4 tion shall apply to any health care lawsuit that is settled 

5 as well as a health care lawsuit that is resolved by a fact 

6 finder. This section shall not apply to section 1862(b) (42 

7 U.S.C. 1395y(b)) or section 1902(a)(25) (42 U.S.C. 

8 1396a(a)(25)) of the Social Security Act. 

9 ‘‘SEC. 3116. PUNITIVE DAMAGES. 

10 ‘‘(a) IN GENERAL.—Punitive damages may, if other11 wise permitted by applicable State or Federal law, be 

12 awarded against any person in a health care lawsuit only 

13 if it is proven by clear and convincing evidence that such 

14 person acted with malicious intent to injure the claimant, 

15 or that such person deliberately failed to avoid unneces16 sary injury that such person knew the claimant was sub17 stantially certain to suffer. In any health care lawsuit 

18 where no judgment for compensatory damages is rendered 

19 against such person, no punitive damages may be awarded 

20 with respect to the claim in such lawsuit. No demand for 

21 punitive damages shall be included in a health care lawsuit 

22 as initially filed. A court may allow a claimant to file an 

23 amended pleading for punitive damages only upon a mo24 tion by the claimant and after a finding by the court, upon 

25 review of supporting and opposing affidavits or after a 


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1 hearing, after weighing the evidence, that the claimant has 

2 established by a substantial probability that the claimant 

3 will prevail on the claim for punitive damages. At the re4 quest of any party in a health care lawsuit, the trier of 

5 fact shall consider in a separate proceeding— 

6 ‘‘(1) whether punitive damages are to be award7 ed and the amount of such award; and 

8 ‘‘(2) the amount of punitive damages following 

9 a determination of punitive liability. 

10 If a separate proceeding is requested, evidence relevant 

11 only to the claim for punitive damages, as determined by 

12 applicable State law, shall be inadmissible in any pro13 ceeding to determine whether compensatory damages are 

14 to be awarded. 

15 ‘‘(b) DETERMINING AMOUNT OF PUNITIVE DAM16 AGES.— 

17 ‘‘(1) FACTORS CONSIDERED.—In determining 

18 the amount of punitive damages, if awarded, in a 

19 health care lawsuit, the trier of fact shall consider 

20 only the following— 

21 ‘‘(A) the severity of the harm caused by 

22 the conduct of such party; 

23 ‘‘(B) the duration of the conduct or any 

24 concealment of it by such party; 


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1 ‘‘(C) the profitability of the conduct to 

2 such party; 

3 ‘‘(D) the number of products sold or med4 ical procedures rendered for compensation, as 

5 the case may be, by such party, of the kind 

6 causing the harm complained of by the claim7 ant; 

8 ‘‘(E) any criminal penalties imposed on 

9 such party, as a result of the conduct com10 plained of by the claimant; and 

11 ‘‘(F) the amount of any civil fines assessed 

12 against such party as a result of the conduct 

13 complained of by the claimant. 

14 ‘‘(2) MAXIMUM AWARD.—The amount of puni15 tive damages, if awarded, in a health care lawsuit 

16 may be as much as $250,000 or as much as two 

17 times the amount of economic damages awarded, 

18 whichever is greater. The jury shall not be informed 

19 of this limitation. 

20 ‘‘(c) NO PUNITIVE DAMAGES FOR PRODUCTS THAT

21 COMPLY WITH FDA STANDARDS.— 

22 ‘‘(1) IN GENERAL.— 

23 ‘‘(A) No punitive damages may be awarded 

24 against the manufacturer or distributor of a 

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1 nent or raw material of such medical product, 

2 based on a claim that such product caused the 

3 claimant’s harm where— 

4 ‘‘(i)(I) such medical product was sub5 ject to premarket approval, clearance, or li6 censure by the Food and Drug Administra7 tion with respect to the safety of the for8 mulation or performance of the aspect of 

9 such medical product which caused the 

10 claimant’s harm or the adequacy of the 

11 packaging or labeling of such medical 

12 product; and 

13 ‘‘(II) such medical product was so ap14 proved, cleared, or licensed; or 

15 ‘‘(ii) such medical product is generally 

16 recognized among qualified experts as safe 

17 and effective pursuant to conditions estab18 lished by the Food and Drug Administra19 tion and applicable Food and Drug Admin20 istration regulations, including without 

21 limitation those related to packaging and 

22 labeling, unless the Food and Drug Admin23 istration has determined that such medical 

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1 cable Food and Drug Administration stat2 utes and regulations. 

3 ‘‘(B) RULE OF CONSTRUCTION.—Subpara4 graph (A) may not be construed as establishing 

5 the obligation of the Food and Drug Adminis6 tration to demonstrate affirmatively that a 

7 manufacturer, distributor, or supplier referred 

8 to in such subparagraph meets any of the con9 ditions described in such subparagraph. 

10 ‘‘(2) LIABILITY OF HEALTH CARE PRO11 VIDERS.—A health care provider who prescribes, or 

12 who dispenses pursuant to a prescription, a medical 

13 product approved, licensed, or cleared by the Food 

14 and Drug Administration shall not be named as a 

15 party to a product liability lawsuit involving such 

16 product and shall not be liable to a claimant in a 

17 class action lawsuit against the manufacturer, dis18 tributor, or seller of such product. Nothing in this 

19 paragraph prevents a court from consolidating cases 

20 involving health care providers and cases involving 

21 products liability claims against the manufacturer, 

22 distributor, or product seller of such medical prod23 uct. 

24 ‘‘(3) PACKAGING.—In a health care lawsuit for 

25 harm which is alleged to relate to the adequacy of 


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1 the packaging or labeling of a drug which is required 

2 to have tamper-resistant packaging under regula3 tions of the Secretary of Health and Human Serv4 ices (including labeling regulations related to such 

5 packaging), the manufacturer or product seller of 

6 the drug shall not be held liable for punitive dam7 ages unless such packaging or labeling is found by 

8 the trier of fact by clear and convincing evidence to 

9 be substantially out of compliance with such regula10 tions. 

11 ‘‘(4) EXCEPTION.—Paragraph (1) shall not 

12 apply in any health care lawsuit in which— 

13 ‘‘(A) a person, before or after premarket 

14 approval, clearance, or licensure of such medical 

15 product, knowingly misrepresented to or with16 held from the Food and Drug Administration 

17 information that is required to be submitted 

18 under the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 301 et seq.) or section 351 of 

20 the Public Health Service Act (42 U.S.C. 262) 

21 that is material and is causally related to the 

22 harm which the claimant allegedly suffered; or 

23 ‘‘(B) a person made an illegal payment to 

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1 taining approval, clearance, or licensure of such 

2 medical product. 

3 ‘‘SEC. 3117. DEFINITIONS. 

4 ‘‘In this subtitle: 

5 ‘‘(1) ALTERNATIVE DISPUTE RESOLUTION SYS6 TEM; ADR.—The term ‘alternative dispute resolution 

7 system’ or ‘ADR’ means a system that provides for 

8 the resolution of health care lawsuits in a manner 

9 other than through a civil action brought in a State 

10 or Federal court. 

11 ‘‘(2) CLAIMANT.—The term ‘claimant’ means 

12 any person who brings a health care lawsuit, includ13 ing a person who asserts or claims a right to legal 

14 or equitable contribution, indemnity, or subrogation, 

15 arising out of a health care liability claim or action, 

16 and any person on whose behalf such a claim is as17 serted or such an action is brought, whether de18 ceased, incompetent, or a minor. 

19 ‘‘(3) COLLATERAL SOURCE BENEFITS.—The 

20 term ‘collateral source benefits’ means any amount 

21 paid or reasonably likely to be paid in the future to 

22 or on behalf of the claimant, or any service, product, 

23 or other benefit provided or reasonably likely to be 

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1 ant, as a result of the injury or wrongful death, pur2 suant to— 

3 ‘‘(A) any State or Federal health, sickness, 

4 income-disability, accident, or workers’ com5 pensation law; 

6 ‘‘(B) any health, sickness, income-dis7 ability, or accident insurance that provides 

8 health benefits or income-disability coverage; 

9 ‘‘(C) any contract or agreement of any 

10 group, organization, partnership, or corporation 

11 to provide, pay for, or reimburse the cost of 

12 medical, hospital, dental, or income-disability 

13 benefits; and 

14 ‘‘(D) any other publicly or privately funded 

15 program. 

16 ‘‘(4) COMPENSATORY DAMAGES.—The term 

17 ‘compensatory damages’ means objectively verifiable 

18 monetary losses incurred as a result of the provision 

19 of, use of, or payment for (or failure to provide, use, 

20 or pay for) health care services or medical products, 

21 such as past and future medical expenses, loss of 

22 past and future earnings, cost of obtaining domestic 

23 services, loss of employment, and loss of business or 

24 employment opportunities, damages for physical and 

25 emotional pain, suffering, inconvenience, physical 


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1 impairment, mental anguish, disfigurement, loss of 

2 enjoyment of life, loss of society and companionship, 

3 loss of consortium (other than loss of domestic serv4 ice), hedonic damages, injury to reputation, and all 

5 other nonpecuniary losses of any kind or nature. 

6 The term ‘compensatory damages’ includes economic 

7 damages and noneconomic damages, as such terms 

8 are defined in this section. 

9 ‘‘(5) CONTINGENT FEE.—The term ‘contingent 

10 fee’ includes all compensation to any person or per11 sons which is payable only if a recovery is effected 

12 on behalf of one or more claimants. 

13 ‘‘(6) ECONOMIC DAMAGES.—The term ‘eco14 nomic damages’ means objectively verifiable mone15 tary losses incurred as a result of the provision of, 

16 use of, or payment for (or failure to provide, use, or 

17 pay for) health care services or medical products, 

18 such as past and future medical expenses, loss of 

19 past and future earnings, cost of obtaining domestic 

20 services, loss of employment, and loss of business or 

21 employment opportunities. 

22 ‘‘(7) HEALTH CARE LAWSUIT.—The term 

23 ‘health care lawsuit’ means any health care liability 

24 claim concerning the provision of health care goods 

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1 state commerce, or any health care liability action 

2 concerning the provision of health care goods or 

3 services or any medical product affecting interstate 

4 commerce, brought in a State or Federal court or 

5 pursuant to an alternative dispute resolution system, 

6 against a health care provider, a health care organi7 zation, or the manufacturer, distributor, supplier, 

8 marketer, promoter, or seller of a medical product, 

9 regardless of the theory of liability on which the 

10 claim is based, or the number of claimants, plain11 tiffs, defendants, or other parties, or the number of 

12 claims or causes of action, in which the claimant al13 leges a health care liability claim. Such term does 

14 not include a claim or action which is based on 

15 criminal liability; which seeks civil fines or penalties 

16 paid to Federal, State, or local government; or which 

17 is grounded in antitrust. 

18 ‘‘(8) HEALTH CARE LIABILITY ACTION.—The 

19 term ‘health care liability action’ means a civil ac20 tion brought in a State or Federal court or pursuant 

21 to an alternative dispute resolution system, against 

22 a health care provider, a health care organization, or 

23 the manufacturer, distributor, supplier, marketer, 

24 promoter, or seller of a medical product, regardless 

25 of the theory of liability on which the claim is based, 


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1 or the number of plaintiffs, defendants, or other par2 ties, or the number of causes of action, in which the 

3 claimant alleges a health care liability claim. 

4 ‘‘(9) HEALTH CARE LIABILITY CLAIM.—The 

5 term ‘health care liability claim’ means a demand by 

6 any person, whether or not pursuant to ADR, 

7 against a health care provider, health care organiza8 tion, or the manufacturer, distributor, supplier, mar9 keter, promoter, or seller of a medical product, in10 cluding, but not limited to, third-party claims, cross11 claims, counter-claims, or contribution claims, which 

12 are based upon the provision of, use of, or payment 

13 for (or the failure to provide, use, or pay for) health 

14 care services or medical products, regardless of the 

15 theory of liability on which the claim is based, or the 

16 number of plaintiffs, defendants, or other parties, or 

17 the number of causes of action. 

18 ‘‘(10) HEALTH CARE ORGANIZATION.—The 

19 term ‘health care organization’ means any person or 

20 entity which is obligated to provide or pay for health 

21 benefits under any health plan, including any person 

22 or entity acting under a contract or arrangement 

23 with a health care organization to provide or admin24 ister any health benefit. 


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1 ‘‘(11) HEALTH CARE PROVIDER.—The term 

2 ‘health care provider’ means any person or entity re3 quired by State or Federal laws or regulations to be 

4 licensed, registered, or certified to provide health 

5 care services, and being either so licensed, reg6 istered, or certified, or exempted from such require7 ment by other statute or regulation. 

8 ‘‘(12) HEALTH CARE GOODS OR SERVICES.— 

9 The term ‘health care goods or services’ means any 

10 goods or services provided by a health care organiza11 tion, provider, or by any individual working under 

12 the supervision of a health care provider, that relates 

13 to the diagnosis, prevention, or treatment of any 

14 human disease or impairment, or the assessment or 

15 care of the health of human beings. 

16 ‘‘(13) MALICIOUS INTENT TO INJURE.—The 

17 term ‘malicious intent to injure’ means intentionally 

18 causing or attempting to cause physical injury other 

19 than providing health care goods or services. 

20 ‘‘(14) MEDICAL PRODUCT.—The term ‘medical 

21 product’ means a drug, device, or biological product 

22 intended for humans, and the terms ‘drug’, ‘device’, 

23 and ‘biological product’ have the meanings given 

24 such terms in sections 201(g)(1) and 201(h) of the 

25 Federal Food, Drug and Cosmetic Act (21 U.S.C. 


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1 321(g)(1) and (h)) and section 351(a) of the Public 

2 Health Service Act (42 U.S.C. 262(a)), respectively, 

3 including any component or raw material used there4 in, but excluding health care services. 

5 ‘‘(15) NONECONOMIC DAMAGES.—The term 

6 ‘noneconomic damages’ means damages for physical 

7 and emotional pain, suffering, inconvenience, phys8 ical impairment, mental anguish, disfigurement, loss 

9 of enjoyment of life, loss of society and companion10 ship, loss of consortium (other than loss of domestic 

11 service), hedonic damages, injury to reputation, and 

12 all other nonpecuniary losses of any kind or nature. 

13 ‘‘(16) PUNITIVE DAMAGES.—The term ‘punitive 

14 damages’ means damages awarded, for the purpose 

15 of punishment or deterrence, and not solely for com16 pensatory purposes, against a health care provider, 

17 health care organization, or a manufacturer, dis18 tributor, or supplier of a medical product. Punitive 

19 damages are neither economic nor noneconomic 

20 damages. 

21 ‘‘(17) RECOVERY.—The term ‘recovery’ means 

22 the net sum recovered after deducting any disburse23 ments or costs incurred in connection with prosecu24 tion or settlement of the claim, including all costs 

25 paid or advanced by any person. Costs of health care 


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1 incurred by the plaintiff and the attorneys’ office 

2 overhead costs or charges for legal services are not 

3 deductible disbursements or costs for such purpose. 

4 ‘‘(18) STATE.—The term ‘State’ has the same 

5 meaning as that term has for the purposes of sub6 title A. 

7 ‘‘SEC. 3118. EFFECT ON OTHER LAWS. 

8 ‘‘(a) VACCINE INJURY.— 

9 ‘‘(1) To the extent that title XXI establishes a 

10 Federal rule of law applicable to a civil action 

11 brought for a vaccine-related injury or death— 

12 ‘‘(A) this subtitle does not affect the appli13 cation of the rule of law to such an action; and 

14 ‘‘(B) any rule of law prescribed by this 

15 subtitle in conflict with a rule of law of title 

16 XXI shall not apply to such action. 

17 ‘‘(2) If there is an aspect of a civil action 

18 brought for a vaccine-related injury or death to 

19 which a Federal rule of law under title XXI of this 

20 Act does not apply, then this subtitle or otherwise 

21 applicable law (as determined under this subtitle) 

22 will apply to such aspect of such action. 

23 ‘‘(b) OTHER FEDERAL LAW.—Except as provided in 

24 this section, nothing in this subtitle shall be deemed to 


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1 affect any defense available to a defendant in a health care 

2 lawsuit or action under any other provision of Federal law. 

3 ‘‘SEC. 3119. STATE FLEXIBILITY AND PROTECTION OF 

4 STATES’ RIGHTS. 

5 ‘‘(a) HEALTH CARE LAWSUITS.—The provisions gov6 erning health care lawsuits set forth in this subtitle pre7 empt, subject to subsections (b) and (c), State law to the 

8 extent that State law prevents the application of any pro9 visions of law established by or under this subtitle. The 

10 provisions governing health care lawsuits set forth in this 

11 subtitle supersede chapter 171 of title 28, United States 

12 Code, to the extent that such chapter— 

13 ‘‘(1) provides for a greater amount of damages 

14 or contingent fees, a longer period in which a health 

15 care lawsuit may be commenced, or a reduced appli16 cability or scope of periodic payment of future dam17 ages, than provided in this subtitle; or 

18 ‘‘(2) prohibits the introduction of evidence re19 garding collateral source benefits, or mandates or 

20 permits subrogation or a lien on collateral source 

21 benefits. 

22 ‘‘(b) PROTECTION OF STATES’ RIGHTS AND OTHER

23 LAWS.—(1) Any issue that is not governed by any provi24 sion of law established by or under this subtitle (including 


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1 State standards of negligence) shall be governed by other2 wise applicable State or Federal law. 

3 ‘‘(2) This subtitle shall not preempt or supersede any 

4 State or Federal law that imposes greater procedural or 

5 substantive protections for health care providers and 

6 health care organizations from liability, loss, or damages 

7 than those provided by this subtitle or create a cause of 

8 action. 

9 ‘‘(c) STATE FLEXIBILITY.—No provision of this sub10 title shall be construed to preempt— 

11 ‘‘(1) any State law (whether effective before, 

12 on, or after the date of the enactment of this Act) 

13 that specifies a particular monetary amount of com14 pensatory or punitive damages (or the total amount 

15 of damages) that may be awarded in a health care 

16 lawsuit, regardless of whether such monetary 

17 amount is greater or lesser than is provided for 

18 under this subtitle, notwithstanding section 4(a); or 

19 ‘‘(2) any defense available to a party in a health 

20 care lawsuit under any other provision of State or 

21 Federal law.’’. 

Æ 


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