II

104TH CONGRESS

1ST SESSION S. 454

To reform the health care liability system and improve health care quality

through the establishment of quality assurance programs, and for other

purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 16 (legislative day, JANUARY 30), 1995

Mr. MCCONNELL (for himself, Mr. LIEBERMAN, and Mrs. KASSEBAUM) introduced the following bill; which was read twice and referred to the Committee on Labor and Human Resources

A BILL

To reform the health care liability system and improve health

care quality through the establishment of quality assurance programs, 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; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Health Care Liability Reform and Quality Assurance Act

6 of 1995’’.

7 (b) TABLE OF CONTENTS.—The table of contents is

8 as follows:

Sec. 1. Short title; table of contents.
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TITLE I—HEALTH CARE LIABILITY REFORM

Subtitle A—Liability Reform

Sec. 101. Findings and purpose.

Sec. 102. Definitions.

Sec. 103. Applicability.

Sec. 104. Statute of limitations.

Sec. 105. Reform of punitive damages.

Sec. 106. Periodic payments.

Sec. 107. Scope of liability.

Sec. 108. Mandatory offsets for damages paid by a collateral source.

Sec. 109. Treatment of attorneys’ fees and other costs.

Sec. 110. Obstetric cases.

Sec. 111. State-based alternative dispute resolution mechanisms.

Sec. 112. Requirement of certificate of merit.

Subtitle B—Biomaterials Access Assurance

Sec. 121. Short title.

Sec. 122. Findings.

Sec. 123. Definitions.

Sec. 124. General requirements; applicability; preemption.

Sec. 125. Liability of biomaterials suppliers.

Sec. 126. Procedures for dismissal of civil actions against biomaterials suppliers.

Subtitle C—Applicability

Sec. 131. Applicability.

TITLE II—PROTECTION OF THE HEALTH AND SAFETY OF

PATIENTS

Sec. 201. Health care quality assurance program.

Sec. 202. Risk management programs.

Sec. 203. National practitioner data bank.

TITLE III—SEVERABILITY

Sec. 301. Severability.

1 TITLE I—HEALTH CARE

2 LIABILITY REFORM

3 Subtitle A—Liability Reform

4 SEC. 101. FINDINGS AND PURPOSE.

5 (a) FINDINGS.—Congress finds the following:

6 (1) EFFECT ON HEALTH CARE ACCESS AND

7 COSTS.—That the civil justice system of the United
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1 States is a costly and inefficient mechanism for re2 solving claims of health care liability and compensat3 ing injured patients and that the problems associ4 ated with the current system are having an adverse

5 impact on the availability of, and access to, health

6 care services and the cost of health care in this

7 country.

8 (2) EFFECT ON INTERSTATE COMMERCE.—

9 That the health care and insurance industries are

10 industries affecting interstate commerce and the

11 health care liability litigation systems existing

12 throughout the United States affect interstate com13 merce by contributing to the high cost of health care

14 and premiums for health care liability insurance pur15 chased by participants in the health care system.

16 (3) EFFECT ON FEDERAL SPENDING.—That

17 the health care liability litigation systems existing

18 throughout the United States have a significant ef19 fect on the amount, distribution, and use of Federal

20 funds because of—

21 (A) the large number of individuals who

22 receive health care benefits under programs op23 erated or financed by the Federal Government;

24 (B) the large number of individuals who

25 benefit because of the exclusion from Federal
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1 taxes of the amounts spent to provide them

2 with health insurance benefits; and

3 (C) the large number of health care provid4 ers who provide items or services for which the

5 Federal Government makes payments.

6 (b) PURPOSE.—It is the purpose of this Act to imple7 ment reasonable, comprehensive, and effective health care

8 liability reform that is designed to—

9 (1) ensure that individuals with meritorious

10 health care injury claims receive fair and adequate

11 compensation, including reasonable non-economic

12 damages;

13 (2) improve the availability of health care serv14 ice in cases in which health care liability actions

15 have been shown to be a factor in the decreased

16 availability of services; and

17 (3) improve the fairness and cost-effectiveness

18 of our current health care liability system to resolve

19 disputes over, and provide compensation for, health

20 care liability by reducing uncertainty and unpredict21 ability in the amount of compensation provided to

22 injured individuals.

23 SEC. 102. DEFINITIONS.

24 As used in this subtitle:
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1 (1) CLAIMANT.—The term ‘‘claimant’’ means

2 any person who commences a health care liability ac3 tion, and any person on whose behalf such an action

4 is commenced, including the decedent in the case of

5 an action brought through or on behalf of an estate.

6 (2) CLEAR AND CONVINCING EVIDENCE.—The

7 term ‘‘clear and convincing evidence’’ is that meas8 ure or degree of proof that will produce in the mind

9 of the trier of fact a firm belief or conviction as to

10 the truth of the allegations sought to be established,

11 except that such measure or degree of proof is more

12 than that required under preponderance of the evi13 dence, but less than that required for proof beyond

14 a reasonable doubt.

15 (3) HEALTH CARE LIABILITY ACTION.—The

16 term ‘‘health care liability action’’ means a civil ac17 tion in a State or Federal court—

18 (A) against a health care provider, health

19 care professional, or other defendant joined in

20 the action (regardless of the theory of liability

21 on which the action is based) in which the

22 claimant alleges injury related to the provision

23 of, or the failure to provide, health care serv24 ices; or
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1 (B) against a health care payor, a health

2 maintenance organization, insurance company,

3 or any other individual, organization, or entity

4 that provides payment for health care benefits

5 in which the claimant alleges that injury was

6 caused by the payment for, or the failure to

7 make payment for, health care benefits, except

8 to the extent such actions are subject to the

9 Employee Retirement Income Security Act of

10 1974.

11 (4) HEALTH CARE PROFESSIONAL.—The term

12 ‘‘health care professional’’ means any individual who

13 provides health care services in a State and who is

14 required by Federal or State laws or regulations to

15 be licensed, registered or certified to provide such

16 services or who is certified to provide health care

17 services pursuant to a program of education, train18 ing and examination by an accredited institution,

19 professional board, or professional organization.

20 (5) HEALTH CARE PROVIDER.—The term

21 ‘‘health care provider’’ means any organization or

22 institution that is engaged in the delivery of health

23 care items or services in a State and that is required

24 by Federal or State laws or regulations to be li-
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1 censed, registered or certified to engage in the deliv2 ery of such items or services.

3 (6) HEALTH CARE SERVICES.—The term

4 ‘‘health care services’’ means any services provided

5 by a health care professional or health care provider,

6 or any individual working under the supervision of

7 a health care professional, that relate to the diag8 nosis, prevention, or treatment of any disease or im9 pairment, or the assessment of the health of human

10 beings.

11 (7) INJURY.—The term ‘‘injury’’ means any ill12 ness, disease, or other harm that is the subject of

13 a health care liability action.

14 (8) NONECONOMIC LOSSES.—The term ‘‘non15 economic losses’’ means losses for physical and emo16 tional pain, suffering, inconvenience, physical im17 pairment, mental anguish, disfigurement, loss of en18 joyment of life, loss of consortium, and other

19 nonpecuniary losses incurred by an individual with

20 respect to which a health care liability action is

21 brought.

22 (9) PUNITIVE DAMAGES.—The term ‘‘punitive

23 damages’’ means damages awarded, for the purpose

24 of punishment or deterrence, and not for compen25 satory purposes, against a health care provider,
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1 health care organization, or other defendant in a

2 health care liability action. Punitive damages are

3 neither economic nor noneconomic damages.

4 (10) SECRETARY.—The term ‘‘Secretary’’

5 means the Secretary of Health and Human Services.

6 SEC. 103. APPLICABILITY.

7 (a) IN GENERAL.—Except as provided in subsection

8 (c), this subtitle shall apply with respect to any health care

9 liability action brought in any Federal or State court, ex10 cept that this section shall not apply to an action for dam11 ages arising from a vaccine-related injury or death to the

12 extent that title XXI of the Public Health Service Act ap13 plies to the action.

14 (b) PREEMPTION.—The provisions of this subtitle

15 shall preempt any State law to the extent such law is in16 consistent with the limitations contained in such provi17 sions. The provisions of this subtitle shall not preempt any

18 State law that—

19 (1) provides for defenses in addition to those

20 contained in this subtitle, places greater limitations

21 on the amount of attorneys’ fees that can be col22 lected, or otherwise imposes greater restrictions on

23 non-economic or punitive damages than those pro24 vided in this subtitle;
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1 (2) permits State officials to commence health

2 care liability actions as a representative of an indi3 vidual; or

4 (3) permits provider-based dispute resolution.

5 (c) EFFECT ON SOVEREIGN IMMUNITY AND CHOICE

6 OF LAW OR VENUE.—Nothing in this subtitle shall be con7 strued to—

8 (1) waive or affect any defense of sovereign im9 munity asserted by any State under any provision of

10 law;

11 (2) waive or affect any defense of sovereign im12 munity asserted by the United States;

13 (3) affect the applicability of any provision of

14 the Foreign Sovereign Immunities Act of 1976;

15 (4) preempt State choice-of-law rules with re16 spect to actions brought by a foreign nation or a cit17 izen of a foreign nation; or

18 (5) affect the right of any court to transfer

19 venue or to apply the law of a foreign nation or to

20 dismiss an action of a foreign nation or of a citizen

21 of a foreign nation on the ground of inconvenient

22 forum.

23 (d) FEDERAL COURT JURISDICTION NOT ESTAB24 LISHED ON FEDERAL QUESTION GROUNDS.—Nothing in

25 this subtitle shall be construed to establish any jurisdiction
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1 in the district courts of the United States over health care

2 liability actions on the basis of sections 1331 or 1337 of

3 title 28, United States Code.

4 SEC. 104. STATUTE OF LIMITATIONS.

5 A health care liability action that is subject to this

6 Act may not be initiated unless a complaint with respect

7 to such action is filed within the 2-year period beginning

8 on the date on which the claimant discovered or, in the

9 exercise of reasonable care, should have discovered the

10 harm and its cause, except that such an action relating

11 to a claimant under legal disability may be filed within

12 2 years after the date on which the disability ceases. If

13 the commencement of a health care liability action is

14 stayed or enjoined, the running of the statute of limita15 tions under this section shall be suspended for the period

16 of the stay or injunction.

17 SEC. 105. REFORM OF PUNITIVE DAMAGES.

18 (a) LIMITATION.—With respect to a health care li19 ability action, an award for punitive damages may only

20 be made, if otherwise permitted by applicable law, if it

21 is proven by clear and convincing evidence that the defend22 ant—

23 (1) intended to injure the claimant for a reason

24 unrelated to the provision of health care services;
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1 (2) understood the claimant was substantially

2 certain to suffer unnecessary injury, and in provid3 ing or failing to provide health care services, the de4 fendant deliberately failed to avoid such injury; or

5 (3) acted with a conscious disregard of a sub6 stantial and unjustifiable risk of unnecessary injury

7 which the defendant failed to avoid in a manner

8 which constitutes a gross deviation from the normal

9 standard of conduct in such circumstances.

10 (b) PUNITIVE DAMAGES NOT PERMITTED.—Not11 withstanding the provisions of subsection (a), punitive

12 damages may not be awarded against a defendant with

13 respect to any health care liability action if no judgment

14 for compensatory damages, including nominal damages

15 (under $500), is rendered against the defendant.

16 (c) REQUIREMENTS FOR PLEADING OF PUNITIVE

17 DAMAGES.—

18 (1) IN GENERAL.—No demand for punitive

19 damages shall be included in a health care liability

20 action as initially filed.

21 (2) AMENDED PLEADING.—A court may allow a

22 claimant to file an amended complaint or pleading

23 for punitive damages in a health care liability action

24 if—
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1 (A) the claimant submits a motion to

2 amend the complaint or pleading within the

3 earlier of—

4 (i) 2 years after the complaint or ini5 tial pleading is filed, or

6 (ii) 9 months before the date the mat7 ter is first set for trial; and

8 (B) after a finding by a court upon review

9 of supporting and opposing affidavits or after a

10 hearing, that after weighing the evidence the

11 claimant has established by a substantial prob12 ability that the claimant will prevail on the

13 claim for punitive damages.

14 (d) SEPARATE PROCEEDING.—

15 (1) IN GENERAL.—At the request of any de16 fendant in a health care liability action, the trier of

17 fact shall consider in a separate proceeding—

18 (A) whether punitive damages are to be

19 awarded and the amount of such award, or

20 (B) the amount of punitive damages fol21 lowing a determination of punitive liability.

22 (2) ONLY RELEVANT EVIDENCE ADMISSIBLE.—

23 If a defendant requests a separate proceeding under

24 paragraph (1), evidence relevant only to the claim of

25 punitive damages in a health care liability action, as
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1 determined by applicable State law, shall be inadmis2 sible in any proceeding to determine whether com3 pensatory damages are to be awarded.

4 (e) DETERMINING AMOUNT OF PUNITIVE DAM5 AGES.—In determining the amount of punitive damages

6 in a health care liability action, the trier of fact shall con7 sider only the following:

8 (1) The severity of the harm caused by the con9 duct of the defendant.

10 (2) The duration of the conduct or any conceal11 ment of it by the defendant.

12 (3) The profitability of the conduct of the de13 fendant.

14 (4) The number of products sold or medical

15 procedures rendered for compensation, as the case

16 may be, by the defendant of the kind causing the

17 harm complained of by the claimant.

18 (5) Awards of punitive or exemplary damages

19 to persons similarly situated to the claimant, when

20 offered by the defendant.

21 (6) Prospective awards of compensatory dam22 ages to persons similarly situated to the claimant.

23 (7) Any criminal penalties imposed on the de24 fendant as a result of the conduct complained of by

25 the claimant, when offered by the defendant.
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1 (8) The amount of any civil fines assessed

2 against the defendant as a result of the conduct

3 complained of by the claimant, when offered by the

4 defendant.

5 (f) LIMITATION AMOUNT.—The amount of damages

6 that may be awarded as punitive damages in any health

7 care liability action shall not exceed 3 times the amount

8 awarded to the claimant for the economic injury on which

9 such claim is based, or $250,000, whichever is greater.

10 This subsection shall be applied by the court and shall

11 not be disclosed to the jury.

12 (g) RESTRICTIONS PERMITTED.—Nothing in this

13 section shall be construed to imply a right to seek punitive

14 damages where none exists under Federal or State law.

15 SEC. 106. PERIODIC PAYMENTS.

16 With respect to a health care liability action, no per17 son may be required to pay more than $100,000 for future

18 damages in a single payment of a damages award, but

19 a person shall be permitted to make such payments of the

20 award on a periodic basis. The periods for such payments

21 shall be determined by the adjudicating body, based upon

22 projections of future losses and shall be reduced to present

23 value. The adjudicating body may waive the requirements

24 of this section if such body determines that such a waiver

25 is in the interests of justice.
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1 SEC. 107. SCOPE OF LIABILITY.

2 (a) IN GENERAL.—With respect to punitive and non3 economic damages, the liability of each defendant in a

4 health care liability action shall be several only and may

5 not be joint. Such a defendant shall be liable only for the

6 amount of punitive or noneconomic damages allocated to

7 the defendant in direct proportion to such defendant’s per8 centage of fault or responsibility for the injury suffered

9 by the claimant.

10 (b) DETERMINATION OF PERCENTAGE OF LIABIL11 ITY.—The trier of fact in a health care liability action

12 shall determine the extent of each defendant’s fault or re13 sponsibility for injury suffered by the claimant, and shall

14 assign a percentage of responsibility for such injury to

15 each such defendant.

16 (c) PROHIBITION ON VICARIOUS LIABILITY.—A de17 fendant in a health care liability action may not be held

18 vicariously liable for the direct actions or omissions of

19 other individuals.

20 SEC. 108. MANDATORY OFFSETS FOR DAMAGES PAID BY A

21 COLLATERAL SOURCE.

22 (a) IN GENERAL.—With respect to a health care li23 ability action, the total amount of damages received by

24 an individual under such action shall be reduced, in ac25 cordance with subsection (b), by any other payment that

26 has been, or will be, made to an individual to compensate
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1 such individual for the injury that was the subject of such

2 action.

3 (b) AMOUNT OF REDUCTION.—The amount by which

4 an award of damages to an individual for an injury shall

5 be reduced under subsection (a) shall be—

6 (1) the total amount of any payments (other

7 than such award) that have been made or that will

8 be made to such individual to pay costs of or com9 pensate such individual for the injury that was the

10 subject of the action; minus

11 (2) the amount paid by such individual (or by

12 the spouse, parent, or legal guardian of such individ13 ual) to secure the payments described in paragraph

14 (1).

15 (c) PRETRIAL DETERMINATION OF AMOUNTS FROM

16 COLLATERAL SERVICES.—The reductions required under

17 subsection (b)(2) shall be determined by the court in a

18 pretrial proceeding. At such proceeding—

19 (1) no evidence shall be admitted as to the

20 amount of any charge, payments, or damage for

21 which a claimant—

22 (A) has received payment from a collateral

23 source or the obligation for which has been as24 sured by a third party; or
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1 (B) is, or with reasonable certainty, will be

2 eligible to receive payment from a collateral

3 source of the obligation which will, with reason4 able certainty be assumed by a third party; and

5 (2) the jury, if any, shall be advised that—

6 (A) except for damages as to which the

7 court permits the introduction of evidence, the

8 claimant’s medical expenses and lost income

9 have been or will be paid by a collateral source

10 or third party; and

11 (B) the claimant shall receive no award for

12 any damages that have been or will be paid by

13 a collateral source or third party.

14 SEC. 109. TREATMENT OF ATTORNEYS’ FEES AND OTHER

15 COSTS.

16 (a) LIMITATION ON AMOUNT OF CONTINGENCY

17 FEES.—

18 (1) IN GENERAL.—An attorney who represents,

19 on a contingency fee basis, a claimant in a health

20 care liability action may not charge, demand, re21 ceive, or collect for services rendered in connection

22 with such action in excess of the following amount

23 recovered by judgment or settlement under such ac24 tion:
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(A) 331 1 ⁄3 percent of the first $150,000 (or

2 portion thereof) recovered, based on after-tax

3 recovery, plus

4 (B) 25 percent of any amount in excess of

5 $150,000 recovered, based on after-tax recov6 ery.

7 (2) CALCULATION OF PERIODIC PAYMENTS.—In

8 the event that a judgment or settlement includes

9 periodic or future payments of damages, the amount

10 recovered for purposes of computing the limitation

11 on the contingency fee under paragraph (1) shall be

12 based on the cost of the annuity or trust established

13 to make the payments. In any case in which an an14 nuity or trust is not established to make such pay15 ments, such amount shall be based on the present

16 value of the payments.

17 (b) CONTINGENCY FEE DEFINED.—As used in this

18 section, the term ‘‘contingency fee’’ means any fee for pro19 fessional legal services which is, in whole or in part, con20 tingent upon the recovery of any amount of damages,

21 whether through judgment or settlement.

22 SEC. 110. OBSTETRIC CASES.

23 With respect to a health care liability action relating

24 to services provided during labor or the delivery of a baby,

25 if the health care professional against whom the action
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1 is brought did not previously treat the pregnant woman

2 for the pregnancy, the trier of fact may not find that the

3 defendant committed malpractice and may not assess

4 damages against the health care professional unless the

5 malpractice is proven by clear and convincing evidence.

6 SEC. 111. STATE-BASED ALTERNATIVE DISPUTE RESOLU7 TION MECHANISMS.

8 (a) APPLICATION TO HEALTH CARE LIABILITY

9 CLAIMS UNDER HEALTH PLANS.—Prior to or immediately

10 following the commencement of any health care liability

11 action, the parties shall participate in the alternative dis12 pute resolution system administered by the State under

13 subsection (b). Such participation shall be in lieu of any

14 other provision of Federal or State law applicable to the

15 parties prior to the commencement of the health care li16 ability action.

17 (b) ADOPTION OF MECHANISM BY STATE.—Each

18 State shall—

19 (1) maintain or adopt at least one of the alter20 native dispute resolution methods satisfying the re21 quirements specified under subsection (c) and (d) for

22 the resolution of health care liability claims arising

23 from the provision of (or failure to provide) health

24 care services to individuals enrolled in a health plan;

25 and
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1 (2) clearly disclose to enrollees in health plans

2 (and potential enrollees) the availability and proce3 dures for consumer grievances, including a descrip4 tion of the alternative dispute resolution method or

5 methods adopted under this subsection.

6 (c) SPECIFICATION OF PERMISSIBLE ALTERNATIVE

7 DISPUTE RESOLUTION METHODS.—

8 (1) IN GENERAL.—The Attorney General, in

9 consultation with the Secretary and the Administra10 tive Conference of the United States, shall, by regu11 lation, develop alternative dispute resolution methods

12 for the use by States in resolving health care liability

13 claims under subsection (a). Such methods shall in14 clude at least the following:

15 (A) ARBITRATION.—The use of arbitra16 tion, a nonjury adversarial dispute resolution

17 process which may, subject to subsection (d),

18 result in a final decision as to facts, law, liabil19 ity or damages. The parties may elect binding

20 arbitration.

21 (B) MEDIATION.—The use of mediation, a

22 settlement process coordinated by a neutral

23 third party without the ultimate rendering of a

24 formal opinion as to factual or legal findings.
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1 (C) EARLY NEUTRAL EVALUATION.—The

2 use of early neutral evaluation, in which the

3 parties make a presentation to a neutral attor4 ney or other neutral evaluator for an assess5 ment of the merits, to encourage settlement. If

6 the parties do not settle as a result of assess7 ment and proceed to trial, the neutral eval8 uator’s opinion shall be kept confidential.

9 (D) EARLY OFFER AND RECOVERY MECHA10 NISM.—

11 (i) IN GENERAL.—The use of early

12 offer and recovery mechanisms under

13 which a health care provider, health care

14 organization, or any other alleged respon15 sible defendant may offer to compensate a

16 claimant for his or her reasonable eco17 nomic damages, including future economic

18 damages, less amounts available from col19 lateral sources.

20 (ii) BINDING ARBITRATION.—If, after

21 an offer is made under clause (i), the

22 claimant alleges that payment of economic

23 damages under the offer has not been rea24 sonably made, or the participants in the

25 offer dispute their relative contributions to
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1 the payments to be made to the claimant,

2 such disputes shall be resolved through

3 binding arbitration in accordance with ap4 plicable rules and procedures established

5 by the State involved.

6 (2) STANDARDS FOR ESTABLISHING METH7 ODS.—In developing alternative dispute resolution

8 methods under paragraph (1), the Attorney General

9 shall assure that the methods promote the resolution

10 of health care liability claims in a manner that—

11 (A) is affordable for the parties involved;

12 (B) provides for timely resolution of

13 claims;

14 (C) provides for the consistent and fair

15 resolution of claims; and

16 (D) provides for reasonably convenient ac17 cess to dispute resolution for individuals en18 rolled in plans.

19 (3) WAIVER AUTHORITY.—Upon application of

20 a State, the Attorney General, in consultation with

21 the Secretary, may grant the State the authority to

22 fulfill the requirement of subsection (b) by adopting

23 a mechanism other than a mechanism established by

24 the Attorney General pursuant to this subsection,
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1 except that such mechanism must meet the stand2 ards set forth in paragraph (2).

3 (d) FURTHER REDRESS.—Except with respect to the

4 claimant-requested binding arbitration method set forth in

5 subsection (c)(1)(A), a claimant who is dissatisfied with

6 the determination reached as a result of an alternative dis7 pute resolution method applied under this section may,

8 after the final resolution of the claimant’s claim under the

9 method, initiate or resume a cause of action to seek dam10 ages or other redress with respect to the claim to the ex11 tent otherwise permitted under State law. State law shall

12 govern the admissibility of results of any alternative dis13 pute resolution procedure and all statements, offers, and

14 other communications made during such procedures, at

15 any subsequent trial. An individual who initiates or re16 sumes a health care liability action shall only prevail if

17 such individual proves each element of the action beyond

18 a reasonable doubt, including proving that the defendant

19 was grossly negligent or intentionally caused injury.

20 SEC. 112. REQUIREMENT OF CERTIFICATE OF MERIT.

21 (a) REQUIRING SUBMISSION WITH COMPLAINT.—Ex22 cept as provided in subsection (b) and subject to the pen23 alties of subsection (d), no health care liability action may

24 be brought by any individual unless, at the time the indi-
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1 vidual commences such action, the individual or the indi2 vidual’s attorney submits an affidavit declaring that—

3 (1) the individual (or the individual’s attorney)

4 has consulted and reviewed the facts of the claim

5 with a qualified specialist (as defined in subsection

6 (c));

7 (2) the individual or the individual’s attorney

8 has obtained a written report by a qualified special9 ist that clearly identifies the individual and that in10 cludes the specialist’s determination that, based

11 upon a review of the available medical record and

12 other relevant material, a reasonable medical inter13 pretation of the facts supports a finding that the

14 claim against the defendant is meritorious and based

15 on good cause; and

16 (3) on the basis of the qualified specialist’s re17 view and consultation, the individual, and if rep18 resented, the individual’s attorney, have concluded

19 that the claim is meritorious and based on good

20 cause.

21 (b) EXTENSION IN CERTAIN INSTANCES.—

22 (1) IN GENERAL.—Subject to paragraph (2),

23 subsection (a) shall not apply with respect to an in24 dividual who brings a health care liability action
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1 without submitting an affidavit described in such

2 subsection if—

3 (A) despite good faith efforts, the individ4 ual is unable to obtain the written report before

5 the expiration of the applicable statute of limi6 tations;

7 (B) despite good faith efforts, at the time

8 the individual commences the action, the indi9 vidual has been unable to obtain medical

10 records or other information necessary, pursu11 ant to any applicable law, to prepare the writ12 ten report requested; or

13 (C) the court of competent jurisdiction de14 termines that the affidavit requirement shall be

15 extended upon a showing of good cause.

16 (2) DEADLINE FOR SUBMISSION WHERE EX17 TENSION APPLIES.—In the case of an individual who

18 brings an action to which paragraph (1) applies, the

19 action shall be dismissed unless the individual sub20 mits the affidavit described in subsection (a) not

21 later than—

22 (A) in the case of an action to which sub23 paragraph (A) of paragraph (1) applies, 90

24 days after commencing the action; or
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1 (B) in the case of an action to which sub2 paragraph (B) of paragraph (1) applies, 90

3 days after obtaining the information described

4 in such subparagraph or when good cause for

5 an extension no longer exists.

6 (c) QUALIFIED SPECIALIST DEFINED.—

7 (1) IN GENERAL.—As used in subsection (a),

8 the term ‘‘qualified specialist’’ means, with respect

9 to a health care liability action, a health care profes10 sional who has expertise in the same or substantially

11 similar area of practice to that involved in the

12 action.

13 (2) EVIDENCE OF EXPERTISE.—For purposes

14 of paragraph (1), evidence of required expertise may

15 include evidence that the individual—

16 (A) practices (or has practiced) or teaches

17 (or has taught) in the same or substantially

18 similar area of health care or medicine to that

19 involved in the action; or

20 (B) is otherwise qualified by experience or

21 demonstrated competence in the relevant prac22 tice area.

23 (d) SANCTIONS FOR SUBMITTING FALSE AFFIDA24 VIT.—Upon the motion of any party or on its own initia-
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1 tive, the court in a health care liability action may impose

2 a sanction on a party, the party’s attorney, or both, for—

3 (1) any knowingly false statement made in an

4 affidavit described in subsection (a);

5 (2) making any false representations in order to

6 obtain a qualified specialist’s report; or

7 (3) failing to have the qualified specialist’s writ8 ten report in his or her custody and control;

9 and may require that the sanctioned party reimburse the

10 other party to the action for costs and reasonable attor11 ney’s fees.

12 Subtitle B—Biomaterials Access

13 Assurance

14 SEC. 121. SHORT TITLE.

15 This subtitle may be cited as the ‘‘Biomaterials Ac16 cess Assurance Act of 1995’’.

17 SEC. 122. FINDINGS.

18 Congress finds that—

19 (1) each year millions of citizens of the United

20 States depend on the availability of lifesaving or life21 enhancing medical devices, many of which are per22 manently implantable within the human body;

23 (2) a continued supply of raw materials and

24 component parts is necessary for the invention, de-
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•S 454 IS

1 velopment, improvement, and maintenance of the

2 supply of the devices;

3 (3) most of the medical devices are made with

4 raw materials and component parts that—

5 (A) are not designed or manufactured spe6 cifically for use in medical devices; and

7 (B) come in contact with internal human

8 tissue;

9 (4) the raw materials and component parts also

10 are used in a variety of nonmedical products;

11 (5) because small quantities of the raw mate12 rials and component parts are used for medical de13 vices, sales of raw materials and component parts

14 for medical devices constitute an extremely small

15 portion of the overall market for the raw materials

16 and medical devices;

17 (6) under the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 301 et seq.), manufacturers of

19 medical devices are required to demonstrate that the

20 medical devices are safe and effective, including

21 demonstrating that the products are properly de22 signed and have adequate warnings or instructions;

23 (7) notwithstanding the fact that raw materials

24 and component parts suppliers do not design,

25 produce, or test a final medical device, the suppliers
29

•S 454 IS

1 have been the subject of actions alleging inad2 equate—

3 (A) design and testing of medical devices

4 manufactured with materials or parts supplied

5 by the suppliers; or

6 (B) warnings related to the use of such

7 medical devices;

8 (8) even though suppliers of raw materials and

9 component parts have very rarely been held liable in

10 such actions, such suppliers have ceased supplying

11 certain raw materials and component parts for use

12 in medical devices because the costs associated with

13 litigation in order to ensure a favorable judgment for

14 the suppliers far exceeds the total potential sales

15 revenues from sales by such suppliers to the medical

16 device industry;

17 (9) unless alternate sources of supply can be

18 found, the unavailability of raw materials and com19 ponent parts for medical devices will lead to unavail20 ability of lifesaving and life-enhancing medical de21 vices;

22 (10) because other suppliers of the raw mate23 rials and component parts in foreign nations are re24 fusing to sell raw materials or component parts for

25 use in manufacturing certain medical devices in the
30

•S 454 IS

1 United States, the prospects for development of new

2 sources of supply for the full range of threatened

3 raw materials and component parts for medical de4 vices are remote;

5 (11) it is unlikely that the small market for

6 such raw materials and component parts in the

7 United States could support the large investment

8 needed to develop new suppliers of such raw mate9 rials and component parts;

10 (12) attempts to develop such new suppliers

11 would raise the cost of medical devices;

12 (13) courts that have considered the duties of

13 the suppliers of the raw materials and component

14 parts have generally found that the suppliers do not

15 have a duty—

16 (A) to evaluate the safety and efficacy of

17 the use of a raw material or component part in

18 a medical device; and

19 (B) to warn consumers concerning the

20 safety and effectiveness of a medical device;

21 (14) attempts to impose the duties referred to

22 in subparagraphs (A) and (B) of paragraph (13) on

23 suppliers of the raw materials and component parts

24 would cause more harm than good by driving the
31

•S 454 IS

1 suppliers to cease supplying manufacturers of medi2 cal devices; and

3 (15) in order to safeguard the availability of a

4 wide variety of lifesaving and life-enhancing medical

5 devices, immediate action is needed—

6 (A) to clarify the permissible bases of li7 ability for suppliers of raw materials and com8 ponent parts for medical devices; and

9 (B) to provide expeditious procedures to

10 dispose of unwarranted suits against the suppli11 ers in such manner as to minimize litigation

12 costs.

13 SEC. 123. DEFINITIONS.

14 As used in this subtitle:

15 (1) BIOMATERIALS SUPPLIER.—

16 (A) IN GENERAL.—The term ‘‘biomaterials

17 supplier’’ means an entity that directly or indi18 rectly supplies a component part or raw mate19 rial for use in the manufacture of an implant.

20 (B) PERSONS INCLUDED.—Such term in21 cludes any person who—

22 (i) has submitted master files to the

23 Secretary for purposes of premarket ap24 proval of a medical device; or
32

•S 454 IS

1 (ii) licenses a biomaterials supplier to

2 produce component parts or raw materials.

3 (2) CLAIMANT.—

4 (A) IN GENERAL.—The term ‘‘claimant’’

5 means any person who brings a civil action, or

6 on whose behalf a civil action is brought, aris7 ing from harm allegedly caused directly or indi8 rectly by an implant, including a person other

9 than the individual into whose body, or in con10 tact with whose blood or tissue, the implant is

11 placed, who claims to have suffered harm as a

12 result of the implant.

13 (B) ACTION BROUGHT ON BEHALF OF AN

14 ESTATE.—With respect to an action brought on

15 behalf or through the estate of an individual

16 into whose body, or in contact with whose blood

17 or tissue the implant is placed, such term in18 cludes the decedent that is the subject of the

19 action.

20 (C) ACTION BROUGHT ON BEHALF OF A

21 MINOR.—With respect to an action brought on

22 behalf or through a minor, such term includes

23 the parent or guardian of the minor.

24 (D) EXCLUSIONS.—Such term does not in25 clude—
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•S 454 IS

1 (i) a provider of professional services,

2 in any case in which—

3 (I) the sale or use of an implant

4 is incidental to the transaction; and

5 (II) the essence of the trans6 action is the furnishing of judgment,

7 skill, or services; or

8 (ii) a manufacturer, seller, or

9 biomaterials supplier.

10 (3) COMPONENT PART.—

11 (A) IN GENERAL.—The term ‘‘component

12 part’’ means a manufactured piece of an im13 plant.

14 (B) CERTAIN COMPONENTS.—Such term

15 includes a manufactured piece of an implant

16 that—

17 (i) has significant nonimplant applica18 tions; and

19 (ii) alone, has no implant value or

20 purpose, but when combined with other

21 component parts and materials, constitutes

22 an implant.

23 (4) HARM.—

24 (A) IN GENERAL.—The term ‘‘harm’’

25 means—
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•S 454 IS

1 (i) any injury to or damage suffered

2 by an individual;

3 (ii) any illness, disease, or death of

4 that individual resulting from that injury

5 or damage; and

6 (iii) any loss to that individual or any

7 other individual resulting from that injury

8 or damage.

9 (B) EXCLUSION.—The term does not in10 clude any commercial loss or loss of or damage

11 to an implant.

12 (5) IMPLANT.—The term ‘‘implant’’ means—

13 (A) a medical device that is intended by

14 the manufacturer of the device—

15 (i) to be placed into a surgically or

16 naturally formed or existing cavity of the

17 body for a period of at least 30 days; or

18 (ii) to remain in contact with bodily

19 fluids or internal human tissue through a

20 surgically produced opening for a period of

21 less than 30 days; and

22 (B) suture materials used in implant pro23 cedures.
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1 (6) MANUFACTURER.—The term ‘‘manufac2 turer’’ means any person who, with respect to an im3 plant—

4 (A) is engaged in the manufacture, prepa5 ration, propagation, compounding, or processing

6 (as defined in section 510(a)(1) of the Federal

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

8 360(a)(1)) of the implant; and

9 (B) is required—

10 (i) to register with the Secretary pur11 suant to section 510 of the Federal Food,

12 Drug, and Cosmetic Act (21 U.S.C. 360)

13 and the regulations issued under such sec14 tion; and

15 (ii) to include the implant on a list of

16 devices filed with the Secretary pursuant

17 to section 510(j) of such Act (21 U.S.C.

18 360(j)) and the regulations issued under

19 such section.

20 (7) MEDICAL DEVICE.—The term ‘‘medical de21 vice’’ means a device, as defined in section 201(h)

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

23 U.S.C. 321(h)).

24 (8) QUALIFIED SPECIALIST.—With respect to

25 an action, the term ‘‘qualified specialist’’ means a
36

•S 454 IS

1 person who is qualified by knowledge, skill, experi2 ence, training, or education in the specialty area

3 that is the subject of the action.

4 (9) RAW MATERIAL.—The term ‘‘raw material’’

5 means a substance or product that—

6 (A) has a generic use; and

7 (B) may be used in an application other

8 than an implant.

9 (10) SECRETARY.—The term ‘‘Secretary’’

10 means the Secretary of Health and Human Services.

11 (11) SELLER.—

12 (A) IN GENERAL.—The term ‘‘seller’’

13 means a person who, in the course of a business

14 conducted for that purpose, sells, distributes,

15 leases, packages, labels, or otherwise places an

16 implant in the stream of commerce.

17 (B) EXCLUSIONS.—The term does not in18 clude—

19 (i) a seller or lessor of real property;

20 (ii) a provider of professional services,

21 in any case in which the sale or use of an

22 implant is incidental to the transaction and

23 the essence of the transaction is the fur24 nishing of judgment, skill, or services; or
37

•S 454 IS

1 (iii) any person who acts in only a fi2 nancial capacity with respect to the sale of

3 an implant.

4 SEC. 124. GENERAL REQUIREMENTS; APPLICABILITY; PRE5 EMPTION.

6 (a) GENERAL REQUIREMENTS.—

7 (1) IN GENERAL.—In any civil action covered

8 by this subtitle, a biomaterials supplier may raise

9 any defense set forth in section 125.

10 (2) PROCEDURES.—Notwithstanding any other

11 provision of law, the Federal or State court in which

12 a civil action covered by this subtitle is pending

13 shall, in connection with a motion for dismissal or

14 judgment based on a defense described in paragraph

15 (1), use the procedures set forth in section 126.

16 (b) APPLICABILITY.—

17 (1) IN GENERAL.—Except as provided in para18 graph (2), notwithstanding any other provision of

19 law, this subtitle applies to any civil action brought

20 by a claimant, whether in a Federal or State court,

21 against a manufacturer, seller, or biomaterials sup22 plier, on the basis of any legal theory, for harm al23 legedly caused by an implant.

24 (2) EXCLUSION.—A civil action brought by a

25 purchaser of a medical device for use in providing
38

•S 454 IS

1 professional services against a manufacturer, seller,

2 or biomaterials supplier for loss or damage to an im3 plant or for commercial loss to the purchaser—

4 (A) shall not be considered an action that

5 is subject to this subtitle; and

6 (B) shall be governed by applicable com7 mercial or contract law.

8 (c) SCOPE OF PREEMPTION.—

9 (1) IN GENERAL.—This subtitle supersedes any

10 State law regarding recovery for harm caused by an

11 implant and any rule of procedure applicable to a

12 civil action to recover damages for such harm only

13 to the extent that this subtitle establishes a rule of

14 law applicable to the recovery of such damages.

15 (2) APPLICABILITY OF OTHER LAWS.—Any

16 issue that arises under this subtitle and that is not

17 governed by a rule of law applicable to the recovery

18 of damages described in paragraph (1) shall be gov19 erned by applicable Federal or State law.

20 (d) STATUTORY CONSTRUCTION.—Nothing in this

21 subtitle may be construed—

22 (1) to affect any defense available to a defend23 ant under any other provisions of Federal or State

24 law in an action alleging harm caused by an im25 plant; or
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•S 454 IS

1 (2) to create a cause of action or Federal court

2 jurisdiction pursuant to section 1331 or 1337 of title

3 28, United States Code, that otherwise would not

4 exist under applicable Federal or State law.

5 SEC. 125. LIABILITY OF BIOMATERIALS SUPPLIERS.

6 (a) IN GENERAL.—

7 (1) EXCLUSION FROM LIABILITY.—Except as

8 provided in paragraph (2), a biomaterials supplier

9 shall not be liable for harm to a claimant caused by

10 an implant.

11 (2) LIABILITY.—A biomaterials supplier that—

12 (A) is a manufacturer may be liable for

13 harm to a claimant described in subsection (b);

14 (B) is a seller may be liable for harm to

15 a claimant described in subsection (c); and

16 (C) furnishes raw materials or component

17 parts that fail to meet applicable contractual re18 quirements or specifications may be liable for a

19 harm to a claimant described in subsection (d).

20 (b) LIABILITY AS MANUFACTURER.—

21 (1) IN GENERAL.—A biomaterials supplier may,

22 to the extent required and permitted by any other

23 applicable law, be liable for harm to a claimant

24 caused by an implant if the biomaterials supplier is

25 the manufacturer of the implant.
40

•S 454 IS

1 (2) GROUNDS FOR LIABILITY.—The

2 biomaterials supplier may be considered the manu3 facturer of the implant that allegedly caused harm

4 to a claimant only if the biomaterials supplier—

5 (A)(i) has registered with the Secretary

6 pursuant to section 510 of the Federal Food,

7 Drug, and Cosmetic Act (21 U.S.C. 360) and

8 the regulations issued under such section; and

9 (ii) included the implant on a list of de10 vices filed with the Secretary pursuant to sec11 tion 510(j) of such Act (21 U.S.C. 360(j)) and

12 the regulations issued under such section; or

13 (B) is the subject of a declaration issued

14 by the Secretary pursuant to paragraph (3)

15 that states that the supplier, with respect to the

16 implant that allegedly caused harm to the

17 claimant, was required to—

18 (i) register with the Secretary under

19 section 510 of such Act (21 U.S.C. 360),

20 and the regulations issued under such sec21 tion, but failed to do so; or

22 (ii) include the implant on a list of de23 vices filed with the Secretary pursuant to

24 section 510(j) of such Act (21 U.S.C.
41

•S 454 IS

1 360(j)) and the regulations issued under

2 such section, but failed to do so.

3 (3) ADMINISTRATIVE PROCEDURES.—

4 (A) IN GENERAL.—The Secretary may

5 issue a declaration described in paragraph

6 (2)(B) on the motion of the Secretary or on pe7 tition by any person, after providing—

8 (i) notice to the affected persons; and

9 (ii) an opportunity for an informal

10 hearing.

11 (B) DOCKETING AND FINAL DECISION.—

12 Immediately upon receipt of a petition filed

13 pursuant to this paragraph, the Secretary shall

14 docket the petition. Not later than 180 days

15 after the petition is filed, the Secretary shall

16 issue a final decision on the petition.

17 (C) APPLICABILITY OF STATUTE OF LIMI18 TATIONS.—Any applicable statute of limitations

19 shall toll during the period during which a

20 claimant has filed a petition with the Secretary

21 under this paragraph.

22 (c) LIABILITY AS SELLER.—A biomaterials supplier

23 may, to the extent required and permitted by any other

24 applicable law, be liable as a seller for harm to a claimant

25 caused by an implant if the biomaterials supplier—
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•S 454 IS

1 (1) held title to the implant that allegedly

2 caused harm to the claimant as a result of purchas3 ing the implant after—

4 (A) the manufacture of the implant; and

5 (B) the entrance of the implant in the

6 stream of commerce; and

7 (2) subsequently resold the implant.

8 (d) LIABILITY FOR VIOLATING CONTRACTUAL RE9 QUIREMENTS OR SPECIFICATIONS.—A biomaterials sup10 plier may, to the extent required and permitted by any

11 other applicable law, be liable for harm to a claimant

12 caused by an implant, if the claimant in an action shows,

13 by a preponderance of the evidence, that—

14 (1) the raw materials or component parts deliv15 ered by the biomaterials supplier either—

16 (A) did not constitute the product de17 scribed in the contract between the biomaterials

18 supplier and the person who contracted for de19 livery of the product; or

20 (B) failed to meet any specifications that

21 were—

22 (i) provided to the biomaterials sup23 plier and not expressly repudiated by the

24 biomaterials supplier prior to acceptance of
43

•S 454 IS

1 delivery of the raw materials or component

2 parts;

3 (ii)(I) published by the biomaterials

4 supplier;

5 (II) provided to the manufacturer by

6 the biomaterials supplier; or

7 (III) contained in a master file that

8 was submitted by the biomaterials supplier

9 to the Secretary and that is currently

10 maintained by the biomaterials supplier for

11 purposes of premarket approval of medical

12 devices; or

13 (iii)(I) included in the submissions for

14 purposes of premarket approval or review

15 by the Secretary under section 510, 513,

16 515, or 520 of the Federal Food, Drug,

17 and Cosmetic Act (21 U.S.C. 360, 360c,

18 360e, or 360j); and

19 (II) have received clearance from the

20 Secretary,

21 if such specifications were provided by the man22 ufacturer to the biomaterials supplier and were

23 not expressly repudiated by the biomaterials

24 supplier prior to the acceptance by the manu-
44

•S 454 IS

1 facturer of delivery of the raw materials or

2 component parts; and

3 (2) such conduct was an actual and proximate

4 cause of the harm to the claimant.

5 SEC. 126. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

6 AGAINST BIOMATERIALS SUPPLIERS.

7 (a) MOTION TO DISMISS.—In any action that is sub8 ject to this subtitle, a biomaterials supplier who is a de9 fendant in such action may, at any time during which a

10 motion to dismiss may be filed under an applicable law,

11 move to dismiss the action on the grounds that—

12 (1) the defendant is a biomaterials supplier;

13 and

14 (2)(A) the defendant should not, for the pur15 poses of—

16 (i) section 125(b), be considered to be a

17 manufacturer of the implant that is subject to

18 such section; or

19 (ii) section 125(c), be considered to be a

20 seller of the implant that allegedly caused harm

21 to the claimant; or

22 (B)(i) the claimant has failed to establish, pur23 suant to section 125(d), that the supplier furnished

24 raw materials or component parts in violation of

25 contractual requirements or specifications; or
45

•S 454 IS

1 (ii) the claimant has failed to comply with the

2 procedural requirements of subsection (b).

3 (b) PROCEDURAL REQUIREMENTS.—

4 (1) IN GENERAL.—The procedural requirements

5 described in paragraphs (2) and (3) shall apply to

6 any action by a claimant against a biomaterials sup7 plier that is subject to this subtitle.

8 (2) MANUFACTURER OF IMPLANT SHALL BE

9 NAMED A PARTY.—The claimant shall be required to

10 name the manufacturer of the implant as a party to

11 the action, unless—

12 (A) the manufacturer is subject to service

13 of process solely in a jurisdiction in which the

14 biomaterials supplier is not domiciled or subject

15 to a service of process; or

16 (B) an action against the manufacturer is

17 barred by applicable law.

18 (3) AFFIDAVIT.—At the time the claimant

19 brings an action against a biomaterials supplier the

20 claimant shall be required to submit an affidavit

21 that—

22 (A) declares that the claimant has con23 sulted and reviewed the facts of the action with

24 a qualified specialist, whose qualifications the

25 claimant shall disclose;
46

•S 454 IS

1 (B) includes a written determination by a

2 qualified specialist that the raw materials or

3 component parts actually used in the manufac4 ture of the implant of the claimant were raw

5 materials or component parts described in sec6 tion 125(d)(1), together with a statement of the

7 basis for such a determination;

8 (C) includes a written determination by a

9 qualified specialist that, after a review of the

10 medical record and other relevant material, the

11 raw material or component part supplied by the

12 biomaterials supplier and actually used in the

13 manufacture of the implant was a cause of the

14 harm alleged by claimant, together with a state15 ment of the basis for the determination; and

16 (D) states that, on the basis of review and

17 consultation of the qualified specialist, the

18 claimant (or the attorney of the claimant) has

19 concluded that there is a reasonable and meri20 torious cause for the filing of the action against

21 the biomaterials supplier.

22 (c) PROCEEDING ON MOTION TO DISMISS.—The fol23 lowing rules shall apply to any proceeding on a motion

24 to dismiss filed under this section:
47

•S 454 IS

1 (1) AFFIDAVITS RELATING TO LISTING AND

2 DECLARATIONS.—

3 (A) IN GENERAL.—The defendant in the

4 action may submit an affidavit demonstrating

5 that defendant has not included the implant on

6 a list, if any, filed with the Secretary pursuant

7 to section 510(j) of the Federal Food, Drug,

8 and Cosmetic Act (21 U.S.C. 360(j)).

9 (B) RESPONSE TO MOTION TO DISMISS.—

10 In response to the motion to dismiss, the claim11 ant may submit an affidavit demonstrating

12 that—

13 (i) the Secretary has, with respect to

14 the defendant and the implant that alleg15 edly caused harm to the claimant, issued a

16 declaration pursuant to section

17 125(b)(2)(B); or

18 (ii) the defendant who filed the mo19 tion to dismiss is a seller of the implant

20 who is liable under section 125(c).

21 (2) EFFECT OF MOTION TO DISMISS ON DIS22 COVERY.—

23 (A) IN GENERAL.—If a defendant files a

24 motion to dismiss under paragraph (1) or (3) of

25 subsection (a), no discovery shall be permitted
48

•S 454 IS

1 in connection to the action that is the subject

2 of the motion, other than discovery necessary

3 to determine a motion to dismiss for lack of ju4 risdiction, until such time as the court rules on

5 the motion to dismiss in accordance with the

6 affidavits submitted by the parties in accord7 ance with this section.

8 (B) DISCOVERY.—If a defendant files a

9 motion to dismiss under subsection (a)(2) on

10 the grounds that the biomaterials supplier did

11 not furnish raw materials or component parts

12 in violation of contractual requirements or spec13 ifications, the court may permit discovery, as

14 ordered by the court. The discovery conducted

15 pursuant to this subparagraph shall be limited

16 to issues that are directly relevant to—

17 (i) the pending motion to dismiss; or

18 (ii) the jurisdiction of the court.

19 (3) AFFIDAVITS RELATING STATUS OF DEFEND20 ANT.—

21 (A) IN GENERAL.—Except as provided in

22 clauses (i) and (ii) of subparagraph (B), the

23 court shall consider a defendant to be a

24 biomaterials supplier who is not subject to an

25 action for harm to a claimant caused by an im-
49

•S 454 IS

1 plant, other than an action relating to liability

2 for a violation of contractual requirements or

3 specifications described in subsection (d).

4 (B) RESPONSES TO MOTION TO DISMISS.—

5 The court shall grant a motion to dismiss any

6 action that asserts liability of the defendant

7 under subsection (b) or (c) of section 125 on

8 the grounds that the defendant is not a manu9 facturer subject to such subsection 125(b) or

10 seller subject to subsection 125(c), unless the

11 claimant submits a valid affidavit that dem12 onstrates that—

13 (i) with respect to a motion to dismiss

14 contending the defendant is not a manu15 facturer, the defendant meets the applica16 ble requirements for liability as a manufac17 turer under section 125(b); or

18 (ii) with respect to a motion to dis19 miss contending that the defendant is not

20 a seller, the defendant meets the applicable

21 requirements for liability as a seller under

22 section 125(c).

23 (4) BASIS OF RULING ON MOTION TO DIS24 MISS.—
50

•S 454 IS

1 (A) IN GENERAL.—The court shall rule on

2 a motion to dismiss filed under subsection (a)

3 solely on the basis of the pleadings of the par4 ties made pursuant to this section and any affi5 davits submitted by the parties pursuant to this

6 section.

7 (B) MOTION FOR SUMMARY JUDGMENT.—

8 Notwithstanding any other provision of law, if

9 the court determines that the pleadings and af10 fidavits made by parties pursuant to this sec11 tion raise genuine issues as concerning material

12 facts with respect to a motion concerning con13 tractual requirements and specifications, the

14 court may deem the motion to dismiss to be a

15 motion for summary judgment made pursuant

16 to subsection (d).

17 (d) SUMMARY JUDGMENT.—

18 (1) IN GENERAL.—

19 (A) BASIS FOR ENTRY OF JUDGMENT.—A

20 biomaterials supplier shall be entitled to entry

21 of judgment without trial if the court finds

22 there is no genuine issue as concerning any ma23 terial fact for each applicable element set forth

24 in paragraphs (1) and (2) of section 125(d).
51

•S 454 IS

1 (B) ISSUES OF MATERIAL FACT.—With re2 spect to a finding made under subparagraph

3 (A), the court shall consider a genuine issue of

4 material fact to exist only if the evidence sub5 mitted by claimant would be sufficient to allow

6 a reasonable jury to reach a verdict for the

7 claimant if the jury found the evidence to be

8 credible.

9 (2) DISCOVERY MADE PRIOR TO A RULING ON

10 A MOTION FOR SUMMARY JUDGMENT.—If, under ap11 plicable rules, the court permits discovery prior to a

12 ruling on a motion for summary judgment made

13 pursuant to this subsection, such discovery shall be

14 limited solely to establishing whether a genuine issue

15 of material fact exists.

16 (3) DISCOVERY WITH RESPECT TO A

17 BIOMATERIALS SUPPLIER.—A biomaterials supplier

18 shall be subject to discovery in connection with a

19 motion seeking dismissal or summary judgment on

20 the basis of the inapplicability of section 125(d) or

21 the failure to establish the applicable elements of

22 section 125(d) solely to the extent permitted by the

23 applicable Federal or State rules for discovery

24 against nonparties.
52

•S 454 IS

1 (e) STAY PENDING PETITION FOR DECLARATION.—

2 If a claimant has filed a petition for a declaration pursu3 ant to section 125(b) with respect to a defendant, and the

4 Secretary has not issued a final decision on the petition,

5 the court shall stay all proceedings with respect to that

6 defendant until such time as the Secretary has issued a

7 final decision on the petition.

8 (f) MANUFACTURER CONDUCT OF PROCEEDING.—

9 The manufacturer of an implant that is the subject of an

10 action covered under this subtitle shall be permitted to file

11 and conduct a proceeding on any motion for summary

12 judgment or dismissal filed by a biomaterials supplier who

13 is a defendant under this section if the manufacturer and

14 any other defendant in such action enter into a valid and

15 applicable contractual agreement under which the manu16 facturer agrees to bear the cost of such proceeding or to

17 conduct such proceeding.

18 (g) ATTORNEY FEES.—The court shall require the

19 claimant to compensate the biomaterials supplier (or a

20 manufacturer appearing in lieu of a supplier pursuant to

21 subsection (f)) for attorney fees and costs, if—

22 (1) the claimant named or joined the

23 biomaterials supplier; and
53

•S 454 IS

1 (2) the court found the claim against the

2 biomaterials supplier to be without merit and frivo3 lous.

4 Subtitle C—Applicability

5 SEC. 131. APPLICABILITY.

6 This title shall apply to all civil actions covered under

7 this title that are commenced on or after the date of enact8 ment of this Act, including any such action with respect

9 to which the harm asserted in the action or the conduct

10 that caused the harm occurred before the date of enact11 ment of this Act.

12 TITLE II—PROTECTION OF THE

13 HEALTH AND SAFETY OF PA14 TIENTS

15 SEC. 201. HEALTH CARE QUALITY ASSURANCE PROGRAM.

16 (a) FUND.—Each State shall establish a health care

17 quality assurance program, to be approved by the Sec18 retary, and a fund consisting of such amounts as are

19 transferred to the fund under subsection (b).

20 (b) TRANSFER OF AMOUNTS.—Each State shall re21 quire that 50 percent of all awards of punitive damages

22 resulting from all health care liability actions in that State

23 be transferred to the fund established under subsection

24 (a) in the State.
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•S 454 IS

1 (c) OBLIGATIONS FROM FUND.—The chief executive

2 officer of a State shall obligate such sums as are available

3 in the fund established in that State under subsection (a)

4 to—

5 (1) license and certify health care professionals

6 in the State;

7 (2) implement health care quality assurance

8 programs; and

9 (3) carry out programs to reduce malpractice10 related costs for health care providers volunteering

11 to provide health care services in medically under12 served areas.

13 SEC. 202. RISK MANAGEMENT PROGRAMS.

14 (a) REQUIREMENTS FOR PROVIDERS.—Each State

15 shall require each health care professional and health care

16 provider providing services in the State to participate in

17 a risk management program to prevent and provide early

18 warning of practices which may result in injuries to pa19 tients or which otherwise may endanger patient safety.

20 (b) REQUIREMENTS FOR INSURERS.—Each State

21 shall require each entity which provides health care profes22 sional or provider liability insurance to health care profes23 sionals and health care providers in the State to—

24 (1) establish risk management programs based

25 on data available to such entity or sanction pro-
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1 grams of risk management for health care profes2 sionals and health care providers provided by other

3 entities; and

4 (2) require each such professional or provider,

5 as a condition of maintaining insurance, to partici6 pate in one program described in paragraph (1) at

7 least once in each 3-year period.

8 SEC. 203. NATIONAL PRACTITIONER DATA BANK.

9 Section 427 of the Health Care Quality Improvement

10 Act of 1986 (42 U.S.C. 11137) is amended—

11 (1) by redesignating subsections (b) through (d)

12 as subsections (c) through (e), respectively;

13 (2) by inserting after subsection (a), the follow14 ing new subsection:

15 ‘‘(b) DISCLOSURE OF INFORMATION.—The Secretary

16 shall promulgate regulations providing for the disclosure

17 of information reported to the Secretary under sections

18 422 and 423, upon request, to any individual.’’; and

19 (3) in subsection (c) (as so redesignated)—

20 (A) in the first sentence of paragraph (1),

21 by striking ‘‘under this part’’ and inserting

22 ‘‘under section 421’’; and

23 (B) in paragraph (3), by striking ‘‘sub24 section (a)’’ and inserting ‘‘subsections (a) and

25 (b)’’.
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1 TITLE III—SEVERABILITY

2 SEC. 301. SEVERABILITY.

3 If any provision of this Act, an amendment made by

4 this Act, or the application of such provision or amend5 ment to any person or circumstance is held to be unconsti6 tutional, the remainder of this Act, the amendments made

7 by this Act, and the application of the provisions of such

8 to any person or circumstance shall not be affected

9 thereby.

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