I 

109TH CONGRESS 

1ST SESSION H. R. 534

To improve patient access to health care services and provide improved 

medical care by reducing the excessive burden the liability system places 

on the health care delivery system. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 2, 2005

Mr. COX (for himself, Mr. MURTHA, Mr. KIRK, Mrs. BIGGERT, Ms. GINNY

BROWN-WAITE of Florida, Mr. FRELINGHUYSEN, Mr. BOEHLERT, Ms. 

GRANGER, Mr. GRAVES, Mr. HAYES, Mr. LEWIS of Kentucky, Mrs. 

JOHNSON of Connecticut, Mr. OTTER, Mr. PETERSON of Pennsylvania, 

Mr. KNOLLENBERG, Mr. SESSIONS, Mr. GILLMOR, Mr. ROGERS of Michigan, Mr. CHOCOLA, Mr. TIBERI, Mr. TAYLOR of Mississippi, Mr. SHUSTER, Mr. PETERSON of Minnesota, Mr. STEARNS, Mrs. NORTHUP, Mr. 

SOUDER, Mr. CANTOR, Mr. SHAYS, Mr. MCHUGH, Mr. BRADLEY of New 

Hampshire, Mr. KLINE, Mr. GINGREY, Mr. KING of Iowa, Mr. RADANOVICH, Mr. PITTS, Mr. WILSON of South Carolina, Mr. TURNER, Mr. 

MANZULLO, Mr. PLATTS, Mr. WELLER, Mr. KENNEDY of Minnesota, Mr. 

WAMP, Mr. KINGSTON, Mr. HOLDEN, Mr. BARTLETT of Maryland, Mr. 

SAXTON, Mr. SHAW, Mr. GALLEGLY, Mr. DENT, Mr. CUNNINGHAM, Mr. 

MCHENRY, Mr. WOLF, Mr. MCCAUL of Texas, Mr. SHIMKUS, Mr. AKIN, 

Mr. PENCE, Mr. HAYWORTH, Mr. FEENEY, Mr. HENSARLING, Mr. BASS, 

Mr. DREIER, Mr. WELDON of Florida, Mr. GERLACH, Mr. FORTUN ̃O, Mr. 

HASTINGS of Washington, Mr. PORTMAN, Mr. ROGERS of Alabama, Ms. 

HARRIS, Mrs. BLACKBURN, Mr. GARRETT of New Jersey, Mr. 

TANCREDO, Mr. PORTER, Mr. WALSH, Mr. WICKER, Mrs. CAPITO, Mr. 

PEARCE, Mr. COLE of Oklahoma, Mrs. JO ANN DAVIS of Virginia, Mrs. 

MUSGRAVE, Mr. LATOURETTE, Mr. BROWN of South Carolina, Mr. SIMPSON, Mr. SMITH of Texas, Mr. BEAUPREZ, Mr. ROYCE, Mr. SWEENEY, 

Mr. REGULA, Mr. ISSA, Mr. BRADY of Texas, Mr. EHLERS, Mr. CHABOT, 

Mr. GARY G. MILLER of California, Mr. SAM JOHNSON of Texas, Mr. 

FERGUSON, Mr. LAHOOD, Mr. FOSSELLA, Mr. KELLER, Mr. LEACH, Mr. 

JONES of North Carolina, Mr. WESTMORELAND, Mr. FORBES, Mr. 

THOMAS, Mr. MATHESON, Mr. MILLER of Florida, Mrs. CUBIN, Mr. POE, 

Mr. EVERETT, Mrs. MYRICK, Mr. CANNON, Mrs. KELLY, Mr. 

HOSTETTLER, Mr. CRENSHAW, Mr. TAYLOR of North Carolina, Mr. 

LOBIONDO, Mr. BISHOP of Utah, Mr. HERGER, Mr. ROHRABACHER, Mr. 

RENZI, Mr. SMITH of New Jersey, Ms. FOXX, Mr. NEUGEBAUER, Mr. 

NEY, Mr. LATHAM, Mr. NUNES, Ms. HART, and Mr. FOLEY) introduced 
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the following bill; which was referred to the Committee on the Judiciary, 

and in addition to the Committee on Energy and Commerce, 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 patient access to health care services and provide 

improved medical care by reducing the excessive burden 

the liability system places on the health care delivery 

system.

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 ‘‘Help Efficient, Acces5 sible, Low-cost, Timely Healthcare (HEALTH) Act of 

6 2005’’. 

7 SEC. 2. FINDINGS AND PURPOSE. 

8 (a) FINDINGS.—

9 (1) EFFECT ON HEALTH CARE ACCESS AND

10 COSTS.—Congress finds that our current civil justice 

11 system is adversely affecting patient access to health 

12 care services, better patient care, and cost-efficient 

13 health care, in that the health care liability system 

14 is a costly and ineffective mechanism for resolving 

15 claims of health care liability and compensating in16 jured patients, and is a deterrent to the sharing of 
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1 information among health care professionals which 

2 impedes efforts to improve patient safety and quality 

3 of care. 

4 (2) EFFECT ON INTERSTATE COMMERCE.—

5 Congress finds that the health care and insurance 

6 industries are industries affecting interstate com7 merce and the health care liability litigation systems 

8 existing throughout the United States are activities 

9 that affect interstate commerce by contributing to 

10 the high costs of health care and premiums for 

11 health care liability insurance purchased by health 

12 care system providers. 

13 (3) EFFECT ON FEDERAL SPENDING.—Con14 gress finds that the health care liability litigation 

15 systems existing throughout the United States have 

16 a significant effect on the amount, distribution, and 

17 use of Federal funds because of—

18 (A) the large number of individuals who 

19 receive health care benefits under programs op20 erated or financed by the Federal Government; 

21 (B) the large number of individuals who 

22 benefit because of the exclusion from Federal 

23 taxes of the amounts spent to provide them 

24 with health insurance benefits; and 
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1 (C) the large number of health care pro2 viders who provide items or services for which 

3 the Federal Government makes payments. 

4 (b) PURPOSE.—It is the purpose of this Act to imple5 ment reasonable, comprehensive, and effective health care 

6 liability reforms designed to—

7 (1) improve the availability of health care serv8 ices in cases in which health care liability actions 

9 have been shown to be a factor in the decreased 

10 availability of services; 

11 (2) reduce the incidence of ‘‘defensive medi12 cine’’ and lower the cost of health care liability in13 surance, all of which contribute to the escalation of 

14 health care costs; 

15 (3) ensure that persons with meritorious health 

16 care injury claims receive fair and adequate com17 pensation, including reasonable noneconomic dam18 ages; 

19 (4) improve the fairness and cost-effectiveness 

20 of our current health care liability system to resolve 

21 disputes over, and provide compensation for, health 

22 care liability by reducing uncertainty in the amount 

23 of compensation provided to injured individuals; and 
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1 (5) provide an increased sharing of information 

2 in the health care system which will reduce unin3 tended injury and improve patient care. 

4 SEC. 3. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS. 

5 The time for the commencement of a health care law6 suit shall be 3 years after the date of manifestation of 

7 injury or 1 year after the claimant discovers, or through 

8 the use of reasonable diligence should have discovered, the 

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

10 for commencement of a health care lawsuit exceed 3 years 

11 after the date of manifestation of injury unless tolled for 

12 any of the following—

13 (1) upon proof of fraud; 

14 (2) intentional concealment; or 

15 (3) the presence of a foreign body, which has no 

16 therapeutic or diagnostic purpose or effect, in the 

17 person of the injured person. 

18 Actions by a minor shall be commenced within 3 years 

19 from the date of the alleged manifestation of injury except 

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

21 be commenced within 3 years of manifestation of injury 

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

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

24 minors for any period during which a parent or guardian 

25 and a health care provider or health care organization 
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1 have committed fraud or collusion in the failure to bring 

2 an action on behalf of the injured minor. 

3 SEC. 4. COMPENSATING PATIENT INJURY. 

4 (a) UNLIMITED AMOUNT OF DAMAGES FOR ACTUAL

5 ECONOMIC LOSSES IN HEALTH CARE LAWSUITS.—In any 

6 health care lawsuit, nothing in this Act shall limit a claim7 ant’s recovery of the full amount of the available economic 

8 damages, notwithstanding the limitation in subsection (b). 

9 (b) ADDITIONAL NONECONOMIC DAMAGES.—In any 

10 health care lawsuit, the amount of noneconomic damages, 

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

12 the number of parties against whom the action is brought 

13 or the number of separate claims or actions brought with 

14 respect to the same injury. 

15 (c) NO DISCOUNT OF AWARD FOR NONECONOMIC

16 DAMAGES.—For purposes of applying the limitation in 

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

18 discounted to present value. The jury shall not be in19 formed about the maximum award for noneconomic dam20 ages. An award for noneconomic damages in excess of 

21 $250,000 shall be reduced either before the entry of judg22 ment, or by amendment of the judgment after entry of 

23 judgment, and such reduction shall be made before ac24 counting for any other reduction in damages required by 

25 law. If separate awards are rendered for past and future 
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1 noneconomic damages and the combined awards exceed 

2 $250,000, the future noneconomic damages shall be re3 duced first. 

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

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

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

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

8 damages allocated to such party in direct proportion to 

9 such party’s percentage of responsibility. Whenever a 

10 judgment of liability is rendered as to any party, a sepa11 rate judgment shall be rendered against each such party 

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

13 this section, the trier of fact shall determine the propor14 tion of responsibility of each party for the claimant’s 

15 harm. 

16 SEC. 5. MAXIMIZING PATIENT RECOVERY. 

17 (a) COURT SUPERVISION OF SHARE OF DAMAGES

18 ACTUALLY PAID TO CLAIMANTS.—In any health care law19 suit, the court shall supervise the arrangements for pay20 ment of damages to protect against conflicts of interest 

21 that may have the effect of reducing the amount of dam22 ages awarded that are actually paid to claimants. In par23 ticular, in any health care lawsuit in which the attorney 

24 for a party claims a financial stake in the outcome by vir25 tue of a contingent fee, the court shall have the power 
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1 to restrict the payment of a claimant’s damage recovery 

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

3 claimant based upon the interests of justice and principles 

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

5 for representing all claimants in a health care lawsuit ex6 ceed the following limits: 

7 (1) 40 percent of the first $50,000 recovered by 

8 the claimant(s). 

(2) 331 9 ⁄3 percent of the next $50,000 recovered 

10 by the claimant(s). 

11 (3) 25 percent of the next $500,000 recovered 

12 by the claimant(s). 

13 (4) 15 percent of any amount by which the re14 covery by the claimant(s) is in excess of $600,000. 

15 (b) APPLICABILITY.—The limitations in this section 

16 shall apply whether the recovery is by judgment, settle17 ment, mediation, arbitration, or any other form of alter18 native dispute resolution. In a health care lawsuit involv19 ing a minor or incompetent person, a court retains the 

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

21 the maximum permitted under this section. The require22 ment for court supervision in the first two sentences of 

23 subsection (a) applies only in civil actions. 
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1 SEC. 6. ADDITIONAL HEALTH BENEFITS. 

2 In any health care lawsuit involving injury or wrong3 ful death, any party may introduce evidence of collateral 

4 source benefits. If a party elects to introduce such evi5 dence, any opposing party may introduce evidence of any 

6 amount paid or contributed or reasonably likely to be paid 

7 or contributed in the future by or on behalf of the oppos8 ing party to secure the right to such collateral source bene9 fits. No provider of collateral source benefits shall recover 

10 any amount against the claimant or receive any lien or 

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

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

13 care lawsuit involving injury or wrongful death. This sec14 tion shall apply to any health care lawsuit that is settled 

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

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

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

18 1396a(a)(25)) of the Social Security Act. 

19 SEC. 7. PUNITIVE DAMAGES. 

20 (a) IN GENERAL.—Punitive damages may, if other21 wise permitted by applicable State or Federal law, be 

22 awarded against any person in a health care lawsuit only 

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

24 person acted with malicious intent to injure the claimant, 

25 or that such person deliberately failed to avoid unneces26 sary injury that such person knew the claimant was sub-
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1 stantially certain to suffer. In any health care lawsuit 

2 where no judgment for compensatory damages is rendered 

3 against such person, no punitive damages may be awarded 

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

5 punitive damages shall be included in a health care lawsuit 

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

7 amended pleading for punitive damages only upon a mo8 tion by the claimant and after a finding by the court, upon 

9 review of supporting and opposing affidavits or after a 

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

11 established by a substantial probability that the claimant 

12 will prevail on the claim for punitive damages. At the re13 quest of any party in a health care lawsuit, the trier of 

14 fact shall consider in a separate proceeding—

15 (1) whether punitive damages are to be award16 ed and the amount of such award; and 

17 (2) the amount of punitive damages following a 

18 determination of punitive liability. 

19 If a separate proceeding is requested, evidence relevant 

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

21 applicable State law, shall be inadmissible in any pro22 ceeding to determine whether compensatory damages are 

23 to be awarded. 

24 (b) DETERMINING AMOUNT OF PUNITIVE DAM25 AGES.—
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1 (1) FACTORS CONSIDERED.—In determining 

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

3 health care lawsuit, the trier of fact shall consider 

4 only the following—

5 (A) the severity of the harm caused by the 

6 conduct of such party; 

7 (B) the duration of the conduct or any 

8 concealment of it by such party; 

9 (C) the profitability of the conduct to such 

10 party; 

11 (D) the number of products sold or med12 ical procedures rendered for compensation, as 

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

14 causing the harm complained of by the claim15 ant; 

16 (E) any criminal penalties imposed on such 

17 party, as a result of the conduct complained of 

18 by the claimant; and 

19 (F) the amount of any civil fines assessed 

20 against such party as a result of the conduct 

21 complained of by the claimant. 

22 (2) MAXIMUM AWARD.—The amount of punitive 

23 damages, if awarded, in a health care lawsuit may 

24 be as much as $250,000 or as much as two times 

25 the amount of economic damages awarded, which-
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1 ever is greater. The jury shall not be informed of 

2 this limitation. 

3 (c) NO PUNITIVE DAMAGES FOR PRODUCTS THAT

4 COMPLY WITH FDA STANDARDS.—

5 (1) IN GENERAL.—

6 (A) No punitive damages may be awarded 

7 against the manufacturer or distributor of a 

8 medical product, or a supplier of any compo9 nent or raw material of such medical product, 

10 based on a claim that such product caused the 

11 claimant’s harm where—

12 (i)(I) such medical product was sub13 ject to premarket approval, clearance, or li14 censure by the Food and Drug Administra15 tion with respect to the safety of the for16 mulation or performance of the aspect of 

17 such medical product which caused the 

18 claimant’s harm or the adequacy of the 

19 packaging or labeling of such medical 

20 product; and 

21 (II) such medical product was so ap22 proved, cleared, or licensed; or 

23 (ii) such medical product is generally 

24 recognized among qualified experts as safe 

25 and effective pursuant to conditions estab-
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1 lished by the Food and Drug Administra2 tion and applicable Food and Drug Admin3 istration regulations, including without 

4 limitation those related to packaging and 

5 labeling, unless the Food and Drug Admin6 istration has determined that such medical 

7 product was not manufactured or distrib8 uted in substantial compliance with appli9 cable Food and Drug Administration stat10 utes and regulations. 

11 (B) RULE OF CONSTRUCTION.—Subpara12 graph (A) may not be construed as establishing 

13 the obligation of the Food and Drug Adminis14 tration to demonstrate affirmatively that a 

15 manufacturer, distributor, or supplier referred 

16 to in such subparagraph meets any of the con17 ditions described in such subparagraph. 

18 (2) LIABILITY OF HEALTH CARE PROVIDERS.—

19 A health care provider who prescribes, or who dis20 penses pursuant to a prescription, a medical product 

21 approved, licensed, or cleared by the Food and Drug 

22 Administration shall not be named as a party to a 

23 product liability lawsuit involving such product and 

24 shall not be liable to a claimant in a class action 

25 lawsuit against the manufacturer, distributor, or 
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1 seller of such product. Nothing in this paragraph 

2 prevents a court from consolidating cases involving 

3 health care providers and cases involving products li4 ability claims against the manufacturer, distributor, 

5 or product seller of such medical product. 

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

7 harm which is alleged to relate to the adequacy of 

8 the packaging or labeling of a drug which is required 

9 to have tamper-resistant packaging under regula10 tions of the Secretary of Health and Human Serv11 ices (including labeling regulations related to such 

12 packaging), the manufacturer or product seller of 

13 the drug shall not be held liable for punitive dam14 ages unless such packaging or labeling is found by 

15 the trier of fact by clear and convincing evidence to 

16 be substantially out of compliance with such regula17 tions. 

18 (4) EXCEPTION.—Paragraph (1) shall not 

19 apply in any health care lawsuit in which—

20 (A) a person, before or after premarket ap21 proval, clearance, or licensure of such medical 

22 product, knowingly misrepresented to or with23 held from the Food and Drug Administration 

24 information that is required to be submitted 

25 under the Federal Food, Drug, and Cosmetic 
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1 Act (21 U.S.C. 301 et seq.) or section 351 of 

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

3 that is material and is causally related to the 

4 harm which the claimant allegedly suffered; or 

5 (B) a person made an illegal payment to 

6 an official of the Food and Drug Administra7 tion for the purpose of either securing or main8 taining approval, clearance, or licensure of such 

9 medical product. 

10 SEC. 8. AUTHORIZATION OF PAYMENT OF FUTURE DAM11 AGES TO CLAIMANTS IN HEALTH CARE LAW12 SUITS. 

13 (a) IN GENERAL.—In any health care lawsuit, if an 

14 award of future damages, without reduction to present 

15 value, equaling or exceeding $50,000 is made against a 

16 party with sufficient insurance or other assets to fund a 

17 periodic payment of such a judgment, the court shall, at 

18 the request of any party, enter a judgment ordering that 

19 the future damages be paid by periodic payments. In any 

20 health care lawsuit, the court may be guided by the Uni21 form Periodic Payment of Judgments Act promulgated by 

22 the National Conference of Commissioners on Uniform 

23 State Laws. 
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1 (b) APPLICABILITY.—This section applies to all ac2 tions which have not been first set for trial or retrial be3 fore the effective date of this Act. 

4 SEC. 9. DEFINITIONS. 

5 In this Act: 

6 (1) ALTERNATIVE DISPUTE RESOLUTION SYS7 TEM; ADR.—The term ‘‘alternative dispute resolution 

8 system’’ or ‘‘ADR’’ means a system that provides 

9 for the resolution of health care lawsuits in a man10 ner other than through a civil action brought in a 

11 State or Federal court. 

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

13 any person who brings a health care lawsuit, includ14 ing a person who asserts or claims a right to legal 

15 or equitable contribution, indemnity or subrogation, 

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

17 and any person on whose behalf such a claim is as18 serted or such an action is brought, whether de19 ceased, incompetent, or a minor. 

20 (3) COLLATERAL SOURCE BENEFITS.—The 

21 term ‘‘collateral source benefits’’ means any amount 

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

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

24 or other benefit provided or reasonably likely to be 

25 provided in the future to or on behalf of the claim-
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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-disability, 

7 or accident insurance that provides health bene8 fits 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 

18 verifiable monetary losses incurred as a result of the 

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

20 provide, use, or pay for) health care services or med21 ical products, such as past and future medical ex22 penses, loss of past and future earnings, cost of ob23 taining domestic services, loss of employment, and 

24 loss of business or employment opportunities, dam25 ages for physical and emotional pain, suffering, in-
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1 convenience, physical impairment, mental anguish, 

2 disfigurement, loss of enjoyment of life, loss of soci3 ety and companionship, loss of consortium (other 

4 than loss of domestic service), hedonic damages, in5 jury to reputation, and all other nonpecuniary losses 

6 of any kind or nature. The term ‘‘compensatory 

7 damages’’ includes economic damages and non8 economic damages, as such terms are defined in this 

9 section. 

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

11 fee’’ includes all compensation to any person or per12 sons which is payable only if a recovery is effected 

13 on behalf of one or more claimants. 

14 (6) ECONOMIC DAMAGES.—The term ‘‘economic 

15 damages’’ means objectively verifiable monetary 

16 losses incurred as a result of the provision of, use 

17 of, or payment for (or failure to provide, use, or pay 

18 for) health care services or medical products, such as 

19 past and future medical expenses, loss of past and 

20 future earnings, cost of obtaining domestic services, 

21 loss of employment, and loss of business or employ22 ment opportunities. 

23 (7) HEALTH CARE LAWSUIT.—The term 

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

25 claim concerning the provision of health care goods 
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1 or services or any medical product affecting inter2 state commerce, or any health care liability action 

3 concerning the provision of health care goods or 

4 services or any medical product affecting interstate 

5 commerce, brought in a State or Federal court or 

6 pursuant to an alternative dispute resolution system, 

7 against a health care provider, a health care organi8 zation, or the manufacturer, distributor, supplier, 

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

10 regardless of the theory of liability on which the 

11 claim is based, or the number of claimants, plain12 tiffs, defendants, or other parties, or the number of 

13 claims or causes of action, in which the claimant al14 leges a health care liability claim. Such term does 

15 not include a claim or action which is based on 

16 criminal liability; which seeks civil fines or penalties 

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

18 is grounded in antitrust. 

19 (8) HEALTH CARE LIABILITY ACTION.—The 

20 term ‘‘health care liability action’’ means a civil ac21 tion brought in a State or Federal Court or pursu22 ant to an alternative dispute resolution system, 

23 against a health care provider, a health care organi24 zation, or the manufacturer, distributor, supplier, 

25 marketer, promoter, or seller of a medical product, 
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1 regardless of the theory of liability on which the 

2 claim is based, or the number of plaintiffs, defend3 ants, or other parties, or the number of causes of ac4 tion, in which the claimant alleges a health care li5 ability claim. 

6 (9) HEALTH CARE LIABILITY CLAIM.—The 

7 term ‘‘health care liability claim’’ means a demand 

8 by any person, whether or not pursuant to ADR, 

9 against a health care provider, health care organiza10 tion, or the manufacturer, distributor, supplier, mar11 keter, promoter, or seller of a medical product, in12 cluding, but not limited to, third-party claims, cross13 claims, counter-claims, or contribution claims, which 

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

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

16 care services or medical products, regardless of the 

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

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

19 the number of causes of action. 

20 (10) HEALTH CARE ORGANIZATION.—The term 

21 ‘‘health care organization’’ means any person or en22 tity which is obligated to provide or pay for health 

23 benefits under any health plan, including any person 

24 or entity acting under a contract or arrangement 
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1 with a health care organization to provide or admin2 ister any health benefit. 

3 (11) HEALTH CARE PROVIDER.—The term 

4 ‘‘health care provider’’ means any person or entity 

5 required by State or Federal laws or regulations to 

6 be licensed, registered, or certified to provide health 

7 care services, and being either so licensed, reg8 istered, or certified, or exempted from such require9 ment by other statute or regulation. 

10 (12) HEALTH CARE GOODS OR SERVICES.—The 

11 term ‘‘health care goods or services’’ means any 

12 goods or services provided by a health care organiza13 tion, provider, or by any individual working under 

14 the supervision of a health care provider, that relates 

15 to the diagnosis, prevention, or treatment of any 

16 human disease or impairment, or the assessment or 

17 care of the health of human beings. 

18 (13) MALICIOUS INTENT TO INJURE.—The 

19 term ‘‘malicious intent to injure’’ means inten20 tionally causing or attempting to cause physical in21 jury other than providing health care goods or serv22 ices. 

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

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

25 intended for humans, and the terms ‘‘drug’’, ‘‘de-
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1 vice’’, and ‘‘biological product’’ have the meanings 

2 given such terms in sections 201(g)(1) and 201(h) 

3 of the Federal Food, Drug and Cosmetic Act (21 

4 U.S.C. 321) and section 351(a) of the Public Health 

5 Service Act (42 U.S.C. 262(a)), respectively, includ6 ing any component or raw material used therein, but 

7 excluding health care services. 

8 (15) NONECONOMIC DAMAGES.—The term 

9 ‘‘noneconomic damages’’ means damages for phys10 ical and emotional pain, suffering, inconvenience, 

11 physical impairment, mental anguish, disfigurement, 

12 loss of enjoyment of life, loss of society and compan13 ionship, loss of consortium (other than loss of do14 mestic service), hedonic damages, injury to reputa15 tion, and all other nonpecuniary losses of any kind 

16 or nature. 

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

18 damages’’ means damages awarded, for the purpose 

19 of punishment or deterrence, and not solely for com20 pensatory purposes, against a health care provider, 

21 health care organization, or a manufacturer, dis22 tributor, or supplier of a medical product. Punitive 

23 damages are neither economic nor noneconomic 

24 damages. 
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1 (17) RECOVERY.—The term ‘‘recovery’’ means 

2 the net sum recovered after deducting any disburse3 ments or costs incurred in connection with prosecu4 tion or settlement of the claim, including all costs 

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

6 incurred by the plaintiff and the attorneys’ office 

7 overhead costs or charges for legal services are not 

8 deductible disbursements or costs for such purpose. 

9 (18) STATE.—The term ‘‘State’’ means each of 

10 the several States, the District of Columbia, the 

11 Commonwealth of Puerto Rico, the Virgin Islands, 

12 Guam, American Samoa, the Northern Mariana Is13 lands, the Trust Territory of the Pacific Islands, and 

14 any other territory or possession of the United 

15 States, or any political subdivision thereof. 

16 SEC. 10. EFFECT ON OTHER LAWS. 

17 (a) VACCINE INJURY.—

18 (1) To the extent that title XXI of the Public 

19 Health Service Act establishes a Federal rule of law 

20 applicable to a civil action brought for a vaccine-re21 lated injury or death—

22 (A) this Act does not affect the application 

23 of the rule of law to such an action; and 
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1 (B) any rule of law prescribed by this Act 

2 in conflict with a rule of law of such title XXI 

3 shall not apply to such action. 

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

5 brought for a vaccine-related injury or death to 

6 which a Federal rule of law under title XXI of the 

7 Public Health Service Act does not apply, then this 

8 Act or otherwise applicable law (as determined 

9 under this Act) will apply to such aspect of such ac10 tion. 

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

12 this section, nothing in this Act shall be deemed to affect 

13 any defense available to a defendant in a health care law14 suit or action under any other provision of Federal law. 

15 SEC. 11. STATE FLEXIBILITY AND PROTECTION OF STATES’ 

16 RIGHTS. 

17 (a) HEALTH CARE LAWSUITS.—The provisions gov18 erning health care lawsuits set forth in this Act preempt, 

19 subject to subsections (b) and (c), State law to the extent 

20 that State law prevents the application of any provisions 

21 of law established by or under this Act. The provisions 

22 governing health care lawsuits set forth in this Act super23 sede chapter 171 of title 28, United States Code, to the 

24 extent that such chapter—
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1 (1) provides for a greater amount of damages 

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

3 care lawsuit may be commenced, or a reduced appli4 cability or scope of periodic payment of future dam5 ages, than provided in this Act; or 

6 (2) prohibits the introduction of evidence re7 garding collateral source benefits, or mandates or 

8 permits subrogation or a lien on collateral source 

9 benefits. 

10 (b) PROTECTION OF STATES’ RIGHTS AND OTHER

11 LAWS.—(1) Any issue that is not governed by any provi12 sion of law established by or under this Act (including 

13 State standards of negligence) shall be governed by other14 wise applicable State or Federal law. 

15 (2) This Act shall not preempt or supersede any State 

16 or Federal law that imposes greater procedural or sub17 stantive protections for health care providers and health 

18 care organizations from liability, loss, or damages than 

19 those provided by this Act or create a cause of action. 

20 (c) STATE FLEXIBILITY.—No provision of this Act 

21 shall be construed to preempt—

22 (1) any State law (whether effective before, on, 

23 or after the date of the enactment of this Act) that 

24 specifies a particular monetary amount of compen25 satory or punitive damages (or the total amount of 
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1 damages) that may be awarded in a health care law2 suit, regardless of whether such monetary amount is 

3 greater or lesser than is provided for under this Act, 

4 notwithstanding section 4(a); or 

5 (2) any defense available to a party in a health 

6 care lawsuit under any other provision of State or 

7 Federal law. 

8 SEC. 12. APPLICABILITY; EFFECTIVE DATE. 

9 This Act shall apply to any health care lawsuit 

10 brought in a Federal or State court, or subject to an alter11 native dispute resolution system, that is initiated on or 

12 after the date of the enactment of this Act, except that 

13 any health care lawsuit arising from an injury occurring 

14 prior to the date of the enactment of this Act shall be 

15 governed by the applicable statute of limitations provisions 

16 in effect at the time the injury occurred. 

17 SEC. 13. SENSE OF CONGRESS. 

18 It is the sense of Congress that a health insurer 

19 should be liable for damages for harm caused when it 

20 makes a decision as to what care is medically necessary 

21 and appropriate.

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