[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 352 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 352

 To establish uniform national standards for the resolution of medical 
              malpractice claims, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 4, 1995

  Mr. Porter introduced the following bill; which was referred to the 
                       Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
 To establish uniform national standards for the resolution of medical 
              malpractice claims, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medical 
Malpractice Fairness Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; purpose.
           TITLE I--UNIFORM STANDARDS FOR MALPRACTICE CLAIMS

Sec. 101. Applicability.
Sec. 102. Requirement for initial resolution of action through 
                            alternative dispute resolution.
Sec. 103. Procedural requirements for filing of actions.
Sec. 104. Treatment of noneconomic and punitive damages.
Sec. 105. Periodic payments for future losses.
Sec. 106. Treatment of attorney's fees and other costs.
Sec. 107. Uniform statute of limitations.
Sec. 108. Special provision for certain obstetric services.
Sec. 109. Optional application of practice guidelines.
Sec. 110. Jurisdiction of Federal courts.
Sec. 111. Preemption.
TITLE II--REQUIREMENTS FOR STATE ALTERNATIVE DISPUTE RESOLUTION SYSTEMS 
                                 (ADR)

Sec. 201. Basic requirements.
Sec. 202. Certification of State systems; applicability of alternative 
                            Federal system.
Sec. 203. Reports on implementation and effectiveness of alternative 
                            dispute resolution systems.
                         TITLE III--DEFINITIONS

Sec. 301. Definitions.

SEC. 2. FINDINGS; PURPOSE.

    (a) Findings.--Congress finds that--
            (1) the costs of health care consume more than 14 percent 
        of the Gross Domestic Product of the United States, 
        significantly affecting interstate commerce and the budget of 
        the Federal Government;
            (2) claims for medical malpractice are a significant factor 
        in the cost of health care and cause physicians, hospitals, and 
        other health care providers to undertake diagnostic tests and 
        procedures partly as defensive measures against the possibility 
        of malpractice claims;
            (3) the health care and insurance industries are industries 
        affecting interstate commerce and the medical malpractice 
        litigation systems existing throughout the United States affect 
        interstate commerce by contributing to the high cost of health 
        care and premiums for malpractice insurance purchased by health 
        care providers; and
            (4) the Federal Government has a major interest in health 
        care as a direct provider of health care and as a source of 
        payment for health care, and has a demonstrated interest in 
        assessing the quality of care, access to care, and the costs of 
        care through the evaluative activities of several Federal 
        agencies.
    (b) Purpose.--It is the purpose of this Act to--
            (1) develop alternative dispute resolution procedures to 
        attain a more efficient, expeditious, and equitable resolution 
        of health care malpractice disputes;
            (2) enhance general knowledge concerning the benefits of 
        different forms of alternative dispute resolution mechanisms; 
        and
            (3) establish uniformity and curb excesses in the State-
        based medical liability systems through Federally mandated 
        reforms.

           TITLE I--UNIFORM STANDARDS FOR MALPRACTICE CLAIMS

SEC. 101. APPLICABILITY.

    Except as provided in section 111, this Act shall apply to any 
medical malpractice liability action brought in a Federal or State 
court, and to any medical malpractice claim subject to an alternative 
dispute resolution system, that is initiated on or after January 1, 
1997.

SEC. 102. REQUIREMENT FOR INITIAL RESOLUTION OF ACTION THROUGH 
              ALTERNATIVE DISPUTE RESOLUTION.

    (a) In General.--
            (1) State cases.--A medical malpractice liability action 
        may not be brought in any State court during a calendar year 
        unless the medical malpractice claim that is the subject of the 
        action has been initially resolved under an alternative dispute 
        resolution system certified for the year by the Secretary under 
        section 202(a), or, in the case of a State in which such a 
        system is not in effect for the year, under the alternative 
        Federal system established under section 202(b).
            (2) Federal diversity actions.--A medical malpractice 
        liability action may not be brought in any Federal court under 
        section 1332 of title 28, United States Code, during a calendar 
        year unless the medical malpractice claim that is the subject 
        of the action has been initially resolved under the alternative 
        dispute resolution system referred to in paragraph (1) that 
        applied in the State whose law applies in such action.
            (3) Claims against united states.--
                    (A) Establishment of process for claims.--The 
                Attorney General shall establish an alternative dispute 
                resolution process for the resolution of tort claims 
                consisting of medical malpractice claims brought 
                against the United States under chapter 171 of title 
                28, United States Code. Under such process, the 
                resolution of a claim shall occur after the completion 
                of the administrative claim process applicable to the 
                claim under section 2675 of such title.
                    (B) Requirement for initial resolution under 
                process.--A medical malpractice liability action based 
                on a medical malpractice claim described in 
                subparagraph (A) may not be brought in any Federal 
                court unless the claim has been initially resolved 
                under the alternative dispute resolution process 
                established by the Attorney General under such 
                subparagraph.
    (b) Initial Resolution of Claims Under ADR.--For purposes of 
subsection (a), an action is ``initially resolved'' under an 
alternative dispute resolution system if--
            (1) the ADR reaches a decision on whether the defendant is 
        liable to the plaintiff for damages; and
            (2) if the ADR determines that the defendant is liable, the 
        ADR reaches a decision on the amount of damages assessed 
        against the defendant.
    (c) Legal Effect of Uncontested ADR Decision.--If no party files a 
notice of intent to contest a decision reached under an alternative 
dispute resolution system pursuant to section 103(a)(1), the decision 
shall be enforced by a court of competent jurisdiction in the same 
manner as the verdict of a medical malpractice liability action 
adjudicated in a State or Federal trial court.

SEC. 103. PROCEDURAL REQUIREMENTS FOR FILING OF ACTIONS.

    (a) Procedures for Filing Actions After Decision.--
            (1) Notice of intent to contest decision.--Not later than 
        60 days after a decision is issued with respect to a medical 
        malpractice claim under an alternative dispute resolution 
        system, each party affected by the decision shall submit a 
        sealed statement to a court of competent jurisdiction 
        indicating whether or not the party intends to contest the 
        decision.
            (2) Deadline for filing action.--A medical malpractice 
        liability action may not be brought by a party unless--
                    (A) the party has filed the notice of intent 
                required by paragraph (1); and
                    (B) the party files the action in a court of 
                competent jurisdiction not later than 90 days after the 
                decision resolving the medical malpractice claim that 
                is the subject of the action is issued under the 
                applicable alternative dispute resolution system.
            (3) Court of competent jurisdiction.--For purposes of this 
        subsection, the term ``court of competent jurisdiction'' 
        means--
                    (A) with respect to actions filed in a State court, 
                the appropriate State trial court; and
                    (B) with respect to actions filed in a Federal 
                court, the appropriate United States district court.
    (b) Certificate of Merit.--
            (1) In general.--Each individual who files a notice of 
        intent to contest a decision under the alternative dispute 
        resolution system pursuant to subsection (a)(1) shall, not 
        later than 90 days after the applicable medical malpractice 
        liability action is filed--
                    (A) submit a certificate of merit described in 
                subsection (b); or
                    (B) post a surety (or equivalent security) bond of 
                $4,000 (or, during the 45-day period that begins on the 
                date the action is filed, a cost bond of $2,000) with 
                the court.
            (2) Extension of deadline.--On the motion of any party to 
        the action or upon a written agreement of the parties filed 
        with the court, the court may extend the deadline specified in 
        paragraph (1) for a period not to exceed 30 days.
            (3) Waiver for good cause.--The court may waive the 
        application of paragraph (1) to a plaintiff if the plaintiff 
        shows good cause that such paragraph should not apply.
            (4) Certificate of merit described.--In this subsection, a 
        ``certificate of merit'' means--
                    (A) with respect to a plaintiff, an affidavit 
                declaring that the individual (or the individual's 
                attorney) has obtained a written opinion from a medical 
                expert who is knowledgeable of the relevant medical 
                issues involved in the action that the defendant was 
                negligent and the defendant's conduct was a proximate 
                cause of the alleged injury that is the subject of the 
                action; and
                    (B) with respect to a defendant, an affidavit 
                declaring that the individual (or the individual's 
                attorney) has obtained a written opinion from a medical 
                expert who is knowledgeable of the relevant medical 
                issues involved in the action that the defendant 
                followed the appropriate standards or procedures and 
                exercised due care, and that the defendant's conduct 
                was not the proximate cause of the alleged injury that 
                is the subject of the action.
    (c) Effect of Failure to Meet Requirement to File Certificate.--If 
an individual fails to file a certificate of merit with respect to a 
medical malpractice liability action under subsection (b)--
            (1) if the individual is a plaintiff, the court shall 
        dismiss the action without prejudice to the refiling of the 
        action by the individual;
            (2) if the individual is a defendant, the court shall award 
        judgment to the plaintiff based on the plaintiff's pleadings; 
        and
            (3) the court shall require the individual to pay any court 
        costs incurred by the opposing parties as a result of the 
        filing of the action.
    (d) Judicial Notice of Decision Under ADR System.--A medical 
malpractice liability action brought after a decision on the claim that 
is the subject of the action has been reached under an alternative 
dispute resolution system shall be tried de novo, except that the court 
shall take judicial notice of such decision and (in the case of an 
action tried by a jury) shall read the decision to the jury prior to 
any opening statements and make the decision available to the jury 
during the trial.

SEC. 104. TREATMENT OF NONECONOMIC AND PUNITIVE DAMAGES.

    (a) Limitation on Noneconomic Damages.--The total amount of 
noneconomic damages that may be awarded to a claimant and the members 
of the claimant's family for losses resulting from the injury which is 
the subject of a medical malpractice liability action may not exceed 
$250,000, regardless of the number of parties against whom the action 
is brought or the number of actions brought with respect to the injury.
    (b) Treatment of Punitive Damages Awarded Against Manufacturer of 
Medical Product.--
            (1) Limitation on amount of award.--The total amount of 
        punitive or exemplary damages that may be awarded with respect 
        to an injury which is the subject of a medical malpractice 
        liability action may not exceed twice the total amount of other 
        damages awarded with respect to the injury.
            (2) Distribution of award.--Of the total amount of any 
        punitive damages awarded in a medical malpractice liability 
        action, 50 percent shall be paid to the claimant and 50 percent 
        shall be paid to the State in which the action is brought (or, 
        in a case brought in Federal court, in the State in which the 
        health care services that caused the injury that is the subject 
        of the action were provided) for the purposes of carrying out 
        the activities described in paragraph (3).
            (3) Activities described.--A State shall use amounts paid 
        pursuant to paragraph (2) to carry out activities to assure the 
        safety and quality of health care services provided in the 
        State, including (but not limited to)--
                    (A) implementing health care quality assurance 
                programs;
                    (B) carrying out programs to reduce malpractice-
                related costs for providers volunteering to provide 
                services in medically underserved areas; and
                    (C) implementing and operating a State alternative 
                dispute resolution system certified by the Secretary 
                under section 203.
            (4) Maintenance of effort.--A State shall use any amounts 
        paid pursuant to paragraph (2) to supplement and not to replace 
        amounts spent by the State for the activities described in 
        paragraph (3).
    (c) Several Liability for Noneconomic Damages.--The liability of 
each defendant for noneconomic damages shall be several only and shall 
not be joint, and each defendant shall be liable only for the amount of 
noneconomic damages allocated to the defendant in direct proportion to 
the defendant's percentage of responsibility (as determined by the 
trier of fact).

SEC. 105. PERIODIC PAYMENTS FOR FUTURE LOSSES.

    (a) Periodic Payments Permitted.--
            (1) In general.--In any medical malpractice liability 
        action in which the damages awarded for future economic loss 
        exceeds $100,000, a defendant may not be required to pay such 
        damages in a single, lump-sum payment, but may be permitted to 
        make such payments on a periodic basis if the court--
                    (A) determines that economic damages incurred 
                through the date of the award shall be paid;
                    (B) bases the periods for such payments upon 
                projections of when such expenses are likely to be 
                incurred; and
                    (C) determines that the periodic payments are 
                adequately secured.
    (b) Waiver.--A court may waive the application of subsection (a) 
with respect to a defendant if the court determines that it is not in 
the best interests of the plaintiff to receive payments for damages on 
such a periodic basis.

SEC. 106. TREATMENT OF ATTORNEY'S FEES AND OTHER COSTS.

    (a) Requiring Party Contesting ADR Ruling To Pay Attorney's Fees 
and Other Costs.--
            (1) In general.--The court in a medical malpractice 
        liability action shall require the party that (pursuant to 
        section 103(a)(1)) contested the ruling of the alternative 
        dispute resolution system with respect to the medical 
        malpractice claim that is the subject of the action to pay to 
        the opposing party the costs incurred by the opposing party 
        under the action, including attorney's fees, fees paid to 
        expert witnesses, and other litigation expenses (but not 
        including court costs, filing fees, or other expenses paid 
        directly by the party to the court, or any fees or costs 
        associated with the resolution of the claim under the 
        alternative dispute resolution system), but only if--
                    (A) in the case of an action in which the party 
                that contested the ruling is the claimant, the amount 
                of damages awarded to the party under the action is 
                less than the amount of damages awarded to the party 
                under the ADR system; and
                    (B) in the case of an action in which the party 
                that contested the ruling is the defendant, the amount 
                of damages assessed against the party under the action 
                is greater than the amount of damages assessed under 
                the ADR system.
            (2) Exceptions.--Paragraph (1) shall not apply if--
                    (A) the party contesting the ruling made under the 
                previous alternative dispute resolution system shows 
                that--
                            (i) the ruling was procured by corruption, 
                        fraud, or undue means,
                            (ii) there was partiality or corruption 
                        under the system,
                            (iii) there was other misconduct under the 
                        system that materially prejudiced the party's 
                        rights, or
                            (iv) the ruling was based on an error of 
                        law;
                    (B) the party contesting the ruling made under the 
                alternative dispute resolution system presents new 
                evidence before the trier of fact that was not 
                available for presentation under the ADR system;
                    (C) the medical malpractice liability action raised 
                a novel issue of law; or
                    (D) the court finds that the application of such 
                paragraph to a party would constitute an undue 
                hardship, and issues an order waiving or modifying the 
                application of such paragraph that specifies the 
                grounds for the court's decision.
            (3) Limit on attorney's fees paid.--Attorneys' fees that 
        are required to be paid under paragraph (1) by the contesting 
        party shall not exceed the amount of the attorneys' fees 
        incurred by the contesting party in the action. If the 
        attorneys' fees of the contesting party are based on a 
        contingency fee agreement, the amount of attorneys' fees for 
        purposes of the preceding sentence shall not exceed the 
        reasonable value of those services.
            (4) Records.--In order to receive attorneys' fees under 
        paragraph (1), counsel of record in the medical malpractice 
        liability action involved shall maintain accurate, complete 
        records of hours worked on the action, regardless of the fee 
        arrangement with the client involved.
    (b) Contingency Fee Defined.--As used in this section, the term 
``contingency fee'' means any fee for professional legal services which 
is, in whole or in part, contingent upon the recovery of any amount of 
damages, whether through judgment or settlement.

SEC. 107. UNIFORM STATUTE OF LIMITATIONS.

    (a) In General.--Except as provided in subsection (b), no medical 
malpractice claim may be initiated after the expiration of the 2-year 
period that begins on the date on which the alleged injury that is the 
subject of such claim was discovered, but in no event may such a claim 
be initiated after the expiration of the 4-year period that begins on 
the date on which the alleged injury that is the subject of such claim 
occurred.
    (b) Exception for Minors.--In the case of an alleged injury 
suffered by a minor who has not attained 6 years of age, a medical 
malpractice claim may not be initiated after the expiration of the 2-
year period that begins on the date on which the alleged injury that is 
the subject of such claim was discovered or should reasonably have been 
discovered, but in no event may such a claim be initiated after the 
date on which the minor attains 12 years of age.

SEC. 108. SPECIAL PROVISION FOR CERTAIN OBSTETRIC SERVICES.

    (a) In General.--In the case of a medical malpractice claim 
relating to services provided during labor or the delivery of a baby, 
if the health care professional or health care provider against whom 
the claim is brought did not previously treat the claimant for the 
pregnancy, the trier of fact may not find that such professional or 
provider committed malpractice and may not assess damages against such 
professional or provider unless the malpractice is proven by clear and 
convincing evidence.
    (b) Applicability to Group Practices or Agreements Among 
Providers.--For purposes of subsection (a), a health care professional 
shall be considered to have previously treated an individual for a 
pregnancy if the professional is a member of a group practice whose 
members previously treated the individual for the pregnancy or is 
providing services to the individual during labor or the delivery of a 
baby pursuant to an agreement with another professional.

SEC. 109. OPTIONAL APPLICATION OF PRACTICE GUIDELINES.

    (a) Development and Certification of Guidelines.--Each State may 
develop, for certification by the Secretary, a set of specialty 
clinical practice guidelines, based on recommended guidelines from 
national specialty societies, to be updated annually. In the absence of 
recommended guidelines from such societies, each State may develop such 
guidelines based on such criteria as the State considers appropriate 
(including based on recommended guidelines developed by the Agency for 
Health Care Policy and Research).
    (b) Provision of Health Care Under Guidelines.--Notwithstanding any 
other provision of law, in any medical malpractice liability action 
arising from the conduct of a health care provider or health care 
professional, if such conduct was in accordance with a guideline 
developed by the State in which the conduct occurred and certified by 
the Secretary under subsection (a), the guideline--
            (1) may be introduced by any party to the action (including 
        a health care provider, health care professional, or patient); 
        and
            (2) if introduced, shall establish a rebuttable presumption 
        that the conduct was in accordance with the appropriate 
        standard of medical care, which may only be overcome by the 
        presentation of clear and convincing evidence on behalf of the 
        party against whom the presumption operates.

SEC. 110. JURISDICTION OF FEDERAL COURTS.

    Nothing in this Act shall be construed to establish jurisdiction 
over any medical malpractice liability action in the district courts of 
the United States on the basis of sections 1331 or 1337 of title 28, 
United States Code.

SEC. 111. PREEMPTION.

    (a) In General.--This Act supersedes any State law only to the 
extent that the State law permits the recovery by a claimant or the 
assessment against a defendant of a greater amount of damages or 
establishes a less strict standard of proof for determining whether a 
defendant has committed malpractice, than the provisions of this Act.
    (b) Effect on Sovereign Immunity and Choice of Law or Venue.--
Nothing in this Act shall be construed to--
            (1) waive or affect any defense of sovereign immunity 
        asserted by any State under any provision of law;
            (2) waive or affect any defense of sovereign immunity 
        asserted by the United States;
            (3) affect the applicability of any provision of the 
        Foreign Sovereign Immunities Act of 1976;
            (4) preempt State choice-of-law rules with respect to 
        claims brought by a foreign nation or a citizen of a foreign 
        nation; or
            (5) affect the right of any court to transfer venue or to 
        apply the law of a foreign nation or to dismiss a claim of a 
        foreign nation or of a citizen of a foreign nation on the 
        ground in inconvenient forum.

TITLE II--REQUIREMENTS FOR STATE ALTERNATIVE DISPUTE RESOLUTION SYSTEMS 
                                 (ADR)

SEC. 201. BASIC REQUIREMENTS.

    (a) In General.--A State's alternative dispute resolution system 
meets the requirements of this section if the system--
            (1) applies to all medical malpractice claims under the 
        jurisdiction of the courts of that State;
            (2) requires that a written opinion resolving the dispute 
        be issued not later than 6 months after the date by which each 
        party against whom the claim is filed has received notice of 
        the claim (other than in exceptional cases for which a longer 
        period is required for the issuance of such an opinion), and 
        that the opinion contain--
                    (A) findings of fact relating to the dispute, and
                    (B) a description of the costs incurred in 
                resolving the dispute under the system (including any 
                fees paid to the individuals hearing and resolving the 
                claim), together with an appropriate assessment of the 
                costs against any of the parties;
            (3) requires individuals who hear and resolve claims under 
        the system to meet such qualifications as the State may require 
        (in accordance with regulations of the Secretary);
            (4) is approved by the State or by local governments in the 
        State;
            (5) with respect to a State system that consists of 
        multiple dispute resolution procedures--
                    (A) permits the parties to a dispute to select the 
                procedure to be used for the resolution of the dispute 
                under the system, and
                    (B) if the parties do not agree on the procedure to 
                be used for the resolution of the dispute, assigns a 
                particular procedure to the parties;
            (6) provides for the transmittal to the State agency 
        responsible for monitoring or disciplining health care 
        professionals and health care providers of any findings made 
        under the system that such a professional or provider committed 
        malpractice, unless, during the 90-day period beginning on the 
        date the system resolves the claim against the professional or 
        provider, the professional or provider brings an action 
        contesting the decision made under the system; and
            (7) provides for the regular transmittal to the 
        Administrator for Health Care Policy and Research of 
        information on disputes resolved under the system, in a manner 
        that assures that the identity of the parties to a dispute 
        shall not be revealed.
    (b) Application of Malpractice Liability Standards to Alternative 
Dispute Resolution.--The provisions of part 1 (other than section 102) 
shall apply with respect to claims brought under a State alternative 
dispute resolution system or the alternative Federal system in the same 
manner as such provisions apply with respect to medical malpractice 
liability actions brought in the State.

SEC. 202. CERTIFICATION OF STATE SYSTEMS; APPLICABILITY OF ALTERNATIVE 
              FEDERAL SYSTEM.

    (a) Certification.--
            (1) In general.--Not later than October 1 of each year 
        (beginning with 1996), the Secretary, in consultation with the 
        Attorney General, shall determine whether a State's alternative 
        dispute resolution system meets the requirements of this title 
        for the following calendar year.
            (2) Basis for certification.--The Secretary shall certify a 
        State's alternative dispute resolution system under this 
        subsection for a calendar year if the Secretary determines 
        under paragraph (1) that the system meets the requirements of 
        section 201, including the requirement described in section 104 
        that punitive damages awarded under the system are paid to the 
        State for the uses described in such section.
    (b) Applicability of Alternative Federal System.--
            (1) Establishment and applicability.--Not later than 
        October 1, 1996, the Secretary, in consultation with the 
        Attorney General, shall establish by rule an alternative 
        Federal ADR system for the resolution of medical malpractice 
        claims during a calendar year in States that do not have in 
        effect an alternative dispute resolution system certified under 
        subsection (a) for the year.
            (2) Requirements for system.--Under the alternative Federal 
        ADR system established under paragraph (1)--
                    (A) paragraphs (1), (2), (6), and (7) of section 
                201(a) shall apply to claims brought under the system;
                    (B) if the system provides for the resolution of 
                claims through arbitration, the claims brought under 
                the system shall be heard and resolved by arbitrators 
                appointed by the Secretary in consultation with the 
                Attorney General; and
                    (C) with respect to a State in which the system is 
                in effect, the Secretary may (at the State's request) 
                modify the system to take into account the existence of 
                dispute resolution procedures in the State that affect 
                the resolution of medical malpractice claims.
            (3) Treatment of States with alternative system in 
        effect.--If the alternative Federal ADR system established 
        under this subsection is applied with respect to a State for a 
        calendar year, the State shall make a payment to the United 
        States (at such time and in such manner as the Secretary may 
        require) in an amount equal to 110 percent of the costs 
        incurred by the United States during the year as a result of 
        the application of the system with respect to the State.

SEC. 203. REPORTS ON IMPLEMENTATION AND EFFECTIVENESS OF ALTERNATIVE 
              DISPUTE RESOLUTION SYSTEMS.

    (a) In General.--Not later than 5 years after the date of the 
enactment of this Act, the Secretary shall prepare and submit to the 
Congress a report describing and evaluating State alternative dispute 
resolution systems operated pursuant to this title and the alternative 
Federal system established under section 202(b).
    (b) Contents of Report.--The Secretary shall include in the report 
prepared and submitted under subsection (a)--
            (1) information on--
                    (A) the effect of the alternative dispute 
                resolution systems on the cost of health care within 
                each State,
                    (B) the impact of such systems on the access of 
                individuals to health care within the State, and
                    (C) the effect of such systems on the quality of 
                health care provided within the State; and
            (2) to the extent that such report does not provide 
        information on no-fault systems operated by States as 
        alternative dispute resolution systems pursuant to this title, 
        an analysis of the feasibility and desirability of establishing 
        a system under which medical malpractice claims shall be 
        resolved on a no-fault basis.

                         TITLE III--DEFINITIONS

SEC. 301. DEFINITIONS.

    As used in this Act:
            (1) Alternative dispute resolution system.--The term 
        ``alternative dispute resolution system'' means a system that 
        is enacted or adopted by a State to resolve medical malpractice 
        claims other than through a medical malpractice liability 
        action.
            (2) Claimant.--The term ``claimant'' means any person who 
        brings a health care liability action and, in the case of an 
        individual who is deceased, incompetent, or a minor, the person 
        on whose behalf such an action is brought.
            (3) Clear and convincing evidence.--The term ``clear and 
        convincing evidence'' is that measure or degree of proof that 
        will produce in the mind of the trier of fact a firm belief or 
        conviction as to the truth of the allegations sought to be 
        established, except that such measure or degree of proof is 
        more than that required under preponderance of the evidence, 
        but less than that required for proof beyond a reasonable 
        doubt.
            (4) Economic damages.--The term ``economic damages'' means 
        damages paid to compensate an individual for losses for 
        hospital and other medical expenses, lost wages, lost 
        employment, and other pecuniary losses.
            (5) Health care professional.--The term ``health care 
        professional'' means any individual who provides health care 
        services in a State and who is required by State law or 
        regulation to be licensed or certified by the State to provide 
        such services in the State.
            (6) Health care provider.--The term ``health care 
        provider'' means any organization or institution that is 
        engaged in the delivery of health care services in a State that 
        is required by State law or regulation to be licensed or 
        certified by the State to engage in the delivery of such 
        services in the State.
            (7) Injury.--The term ``injury'' means any illness, 
        disease, or other harm that is the subject of a medical 
        malpractice claim.
            (8) Medical malpractice liability action.--The term 
        ``medical malpractice liability action'' means any civil action 
        brought pursuant to State law in which a plaintiff alleges a 
        medical malpractice claim against a health care provider or 
        health care professional, but does not include any action in 
        which the plaintiff's sole allegation is an allegation of an 
        intentional tort.
            (9) Medical malpractice claim.--The term ``medical 
        malpractice claim'' means any claim relating to the provision 
        of (or the failure to provide) health care services or the use 
        of a medical product, without regard to the theory of liability 
        asserted, and includes any third-party claim, cross-claim, 
        counterclaim, or contribution claim in a medical malpractice 
        liability action.
            (10) Medical product.--
                    (A) In general.--The term ``medical product'' 
                means, with respect to the allegation of a claimant, a 
                drug (as defined in section 201(g)(1) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)) or a 
                medical device (as defined in section 201(h) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) 
                if--
                            (i) such drug or device was subject to 
                        premarket approval under section 505, 507, or 
                        515 of the Federal Food, Drug, and Cosmetic Act 
                        (21 U.S.C. 355, 357, or 360e) or section 351 of 
                        the Public Health Service Act (42 U.S.C. 262) 
                        with respect to the safety of the formulation 
                        or performance of the aspect of such drug or 
                        device which is the subject of the claimant's 
                        allegation or the adequacy of the packaging or 
                        labeling of such drug or device, and such drug 
                        or device is approved by the Food and Drug 
                        Administration; or
                            (ii) the drug or device is generally 
                        recognized as safe and effective under 
                        regulations issued by the Secretary of Health 
                        and Human Services under section 201(p) of the 
                        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                        321(p)).
                    (B) Exception in case of misrepresentation or 
                fraud.--Notwithstanding subparagraph (A), the term 
                ``medical product'' shall not include any product 
                described in such subparagraph if the claimant shows 
                that the product is approved by the Food and Drug 
                Administration for marketing as a result of withheld 
                information, misrepresentation, or an illegal payment 
                by manufacturer of the product.
            (11) Noneconomic damages.--The term ``noneconomic damages'' 
        means damages paid to compensate an individual for losses for 
        physical and emotional pain, suffering, inconvenience, physical 
        impairment, mental anguish, disfigurement, loss of enjoyment of 
        life, loss of consortium, and other nonpecuniary losses, but 
        does not include punitive damages.
            (12) Punitive damages.--The term ``punitive damages'' means 
        compensation, in addition to compensation for actual harm 
        suffered, that is awarded for the purpose of punishing a person 
        for conduct deemed to be malicious, wanton, willful, or 
        excessively reckless.
                                 <all>
HR 352 IH----2
HR 352 IH----3