[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 886 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                 S. 886

  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

                             June 11, 1997

Mr. McConnell (for himself and Mr. Lieberman) 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.

    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 ``Health Care 
Liability Reform and Quality Assurance Act of 1997''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
                 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.
Sec. 127. Applicability.
                       Subtitle C--Applicability

Sec. 131. Applicability.
       TITLE II--PROTECTION OF THE HEALTH AND SAFETY OF PATIENTS

Sec. 201. Additional resources for State health care quality assurance 
                            and access activities.
Sec. 202. Quality assurance, patient safety, and consumer information.
                        TITLE III--SEVERABILITY

Sec. 301. Severability.

                 TITLE I--HEALTH CARE LIABILITY REFORM

                      Subtitle A--Liability Reform

SEC. 101. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds the following:
            (1) Effect on health care access and costs.--The civil 
        justice system of the United States is a costly and inefficient 
        mechanism for resolving claims of health care liability and 
        compensating injured patients and the problems associated with 
        the current system are having an adverse impact on the 
        availability of, and access to, health care services and the 
        cost of health care in the United States.
            (2) Effect on interstate commerce.--The health care and 
        insurance industries are industries affecting interstate 
        commerce and the health care liability litigation systems 
        existing throughout the United States affect interstate 
        commerce by contributing to the high cost of health care and 
        premiums for health care liability insurance purchased by 
        participants in the health care system.
            (3) Effect on federal spending.--The health care liability 
        litigation systems existing throughout the United States have a 
        significant effect on the amount, distribution, and use of 
        Federal funds because of--
                    (A) the large number of individuals who receive 
                health care benefits under programs operated or 
                financed by the Federal Government;
                    (B) the large number of individuals who benefit 
                because of the exclusion from Federal taxes of the 
                amounts spent to provide such individuals with health 
                insurance benefits; and
                    (C) the large number of health care providers who 
                provide items or services for which the Federal 
                Government makes payments.
    (b) Purpose.--It is the purpose of this Act to implement 
reasonable, comprehensive, and effective health care liability reform 
that is designed to--
            (1) ensure that individuals with meritorious health care 
        injury claims receive fair and adequate compensation;
            (2) improve the availability of health care service in 
        cases in which health care liability actions have been shown to 
        be a factor in the decreased availability of services; and
            (3) improve the fairness and cost-effectiveness of the 
        current health care liability system of the United States to 
        resolve disputes over, and provide compensation for, health 
        care liability by reducing uncertainty and unpredictability in 
        the amount of compensation provided to injured individuals.

SEC. 102. DEFINITIONS.

    As used in this subtitle:
            (1) Claimant.--The term ``claimant'' means any person who 
        commences a health care liability action, and any person on 
        whose behalf such an action is commenced, including the 
        decedent in the case of an action brought through or on behalf 
        of an estate.
            (2) Clear and convincing evidence.--The term ``clear and 
        convincing evidence'' means 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.
            (3) Collateral source rule.--The term ``collateral source 
        rule'' means a rule, either statutorily established or 
        established at common law, that prevents the introduction of 
        evidence regarding collateral source benefits or that prohibits 
        the deduction of collateral source benefits from an award of 
        damages in a health care liability action.
            (4) Contingency fee.--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.
            (5) Economic losses.--The term ``economic losses'' means 
        objectively verifiable monetary losses incurred as a result of 
        the provision of (or failure to provide or pay for) health care 
        services or the use of a medical product, including past and 
        future medical expenses, loss of past and future earnings, cost 
        of obtaining replacement services in the home (including child 
        care, transportation, food preparation, and household care), 
        cost of making reasonable accommodations to a personal 
        residence, loss of employment, and loss of business or 
        employment opportunities. Economic losses are neither 
        noneconomic losses nor punitive damages.
            (6) Health care liability action.--The term ``health care 
        liability action'' means a civil action against a health care 
        provider, health care professional, health plan, or other 
        defendant, including a right to legal or equitable 
        contribution, indemnity, subrogation, third-party claims, cross 
        claims, or counter-claims, in which the claimant alleges injury 
        related to the provision of, payment for, or the failure to 
        provide or pay for, health care services or medical products, 
        regardless of the theory of liability on which the action is 
        based. Such term does not include a product liability action, 
        except where such an action is brought as part of a broader 
        health care liability action.
            (7) Health plan.--The term ``health plan'' means any person 
        or entity which is obligated to provide or pay for health 
        benefits under any health insurance arrangement, including any 
        person or entity acting under a contract or arrangement to 
        provide, arrange for, or administer any health benefit.
            (8) Health care professional.--The term ``health care 
        professional'' means any individual who provides health care 
        services in a State and who is required by Federal or State 
        laws or regulations to be licensed, registered or certified to 
        provide such services or who is certified to provide health 
        care services pursuant to a program of education, training and 
        examination by an accredited institution, professional board, 
        or professional organization.
            (9) Health care provider.--The term ``health care 
        provider'' means any organization or institution that is 
        engaged in the delivery of health care items or services in a 
        State and that is required by Federal or State laws or 
        regulations to be licensed, registered or certified to engage 
        in the delivery of such items or services.
            (10) Health care services.--The term ``health care 
        services'' means any services provided by a health care 
        professional, health care provider, or health plan or any 
        individual working under the supervision of a health care 
        professional, that relate to the diagnosis, prevention, or 
        treatment of any disease or impairment, or the assessment of 
        the health of human beings.
            (11) Injury.--The term ``injury'' means any illness, 
        disease, or other harm that is the subject of a health care 
        liability action.
            (12) Medical product.--The term ``medical product'' means 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 such Act (21 U.S.C. 
        321(h)), including any component or raw material used therein, 
        but excluding health care services, as defined in paragraph 
        (9).
            (13) Noneconomic losses.--The term ``noneconomic losses'' 
        means losses for physical and emotional pain, suffering, 
        inconvenience, physical impairment, mental anguish, 
        disfigurement, loss of enjoyment of life, loss of consortium, 
        loss of society or companionship (other than loss of domestic 
        services), and other nonpecuniary losses incurred by an 
        individual with respect to which a health care liability action 
        is brought. Noneconomic losses are neither economic losses nor 
        punitive damages.
            (14) Punitive damages.--The term ``punitive damages'' means 
        damages awarded, for the purpose of punishment or deterrence, 
        and not for compensatory purposes, against a health care 
        professional, health care provider, or other defendant in a 
        health care liability action. Punitive damages are neither 
        economic nor noneconomic damages.
            (15) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (16) State.--The term ``State'' means each of the several 
        States of the United States, the District of Columbia, and the 
        Commonwealth of Puerto Rico.

SEC. 103. APPLICABILITY.

    (a) In General.--Except as provided in subsection (c), this 
subtitle shall apply with respect to any health care liability action 
brought in any Federal or State court, except that this subtitle shall 
not apply to an action for damages arising from a vaccine-related 
injury or death to the extent that title XXI of the Public Health 
Service Act (42 U.S.C. 300aa-1) applies to the action.
    (b) Preemption.--
            (1) In general.--The provisions of this subtitle shall 
        preempt any State law existing on, or enacted subsequent to, 
        the date of enactment of this Act, only to the extent that such 
        law is inconsistent with the limitations contained in such 
        provisions and shall not preempt State law to the extent that 
        such law--
                    (A) places greater restrictions on the amount of or 
                standards for awarding noneconomic or punitive damages;
                    (B) places greater limitations on the awarding of 
                attorneys fees for awards in excess of $150,000;
                    (C) permits a lower threshold for the periodic 
                payment of future damages;
                    (D) establishes a shorter period during which a 
                health care liability action may be initiated or a more 
                restrictive rule with respect to the time at which the 
                period of limitations begins to run; or
                    (E) implements collateral source rule reform that 
                either permits the introduction of evidence of 
                collateral source benefits or provides for the 
                mandatory offset of collateral source benefits from 
                damage awards.
            (2) Rules of construction.--The provisions of this subtitle 
        shall not be construed to preempt any State law that--
                    (A) permits State officials to commence health care 
                liability actions as a representative of an individual;
                    (B) permits provider-based dispute resolution;
                    (C) places a maximum limit on the total damages in 
                a health care liability action;
                    (D) places a maximum limit on the time in which a 
                health care liability action may be initiated; or
                    (E) provides for defenses in addition to those 
                contained in this Act.
    (c) Effect on Sovereign Immunity and Choice of Law or Venue.--
Nothing in this subtitle 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 
        actions brought by a foreign nation or a citizen of a foreign 
        nation;
            (5) affect the right of any court to transfer venue or to 
        apply the law of a foreign nation or to dismiss an action of a 
        foreign nation or of a citizen of a foreign nation on the 
        ground of inconvenient forum; or
            (6) supersede any provision of Federal law.
    (d) Federal Court Jurisdiction Not Established on Federal Question 
Grounds.--Nothing in this subtitle shall be construed to establish any 
jurisdiction in the district courts of the United States over health 
care liability actions on the basis of section 1331 or 1337 of title 
28, United States Code.

SEC. 104. STATUTE OF LIMITATIONS.

    A health care liability action that is subject to this Act may not 
be initiated unless a complaint with respect to such action is filed 
within the 2-year period beginning on the date on which the claimant 
discovered or, in the exercise of reasonable care, should have 
discovered the injury and its cause, except that such an action 
relating to a claimant under legal disability may be filed within 2 
years after the date on which the disability ceases. If the 
commencement of a health care liability action is stayed or enjoined, 
the running of the statute of limitations under this section shall be 
suspended for the period of the stay or injunction.

SEC. 105. REFORM OF PUNITIVE DAMAGES.

    (a) Limitation.--With respect to a health care liability action, an 
award for punitive damages may only be made, if otherwise permitted by 
applicable law, if it is proven by clear and convincing evidence that 
the defendant--
            (1) intended to injure the claimant for a reason unrelated 
        to the provision of health care services;
            (2) understood the claimant was substantially certain to 
        suffer unnecessary injury, and in providing or failing to 
        provide health care services, the defendant deliberately failed 
        to avoid such injury; or
            (3) acted with a conscious, flagrant disregard of a 
        substantial and unjustifiable risk of unnecessary injury which 
        the defendant failed to avoid in a manner which constitutes a 
        gross deviation from the normal standard of conduct in such 
        circumstances.
    (b) Punitive Damages Not Permitted.--Notwithstanding the provisions 
of subsection (a), punitive damages may not be awarded against a 
defendant with respect to any health care liability action if no 
judgment for compensatory damages, including nominal damages (under 
$500), is rendered against the defendant.
    (c) Procedure for Determining Punitive Damages.--
            (1) In general.--In any health care liability action 
        subject to this subtitle in which punitive damages are 
        recoverable, the trier of fact shall determine, concurrent with 
        all other issues presented in such action, whether such damages 
        shall be allowed. If the trier of fact determines that such 
        damages are allowed, a separate proceeding shall be conducted 
        by the court to determine the amount of such damages to be 
        awarded.
            (2) Separate proceeding.--At a separate proceeding to 
        determine the amount of punitive damages to be awarded under 
        paragraph (1), the court shall consider the following:
                    (A) The severity of the harm caused by the conduct 
                of the defendant.
                    (B) The duration of the conduct or any concealment 
                of such conduct by the defendant.
                    (C) The profitability of the conduct of the 
                defendant.
                    (D) The number of products sold or medical 
                procedures rendered for compensation, as the case may 
                be, by the defendant of the kind causing the harm 
                complained of by the claimant.
                    (E) The total deterrent effect of other damages and 
                punishment imposed upon the defendant as a result of 
                the misconduct, including compensatory, exemplary and 
                punitive damage awards to individuals in situations 
                similar to those of the claimant and the severity of 
                any criminal or administrative penalties, or civil 
                fines, to which the defendant has been or may be 
                subjected.
            (3) Determination.--At the conclusion of a separate 
        proceeding under paragraph (1), the court shall determine the 
        amount of punitive damages to be awarded with respect to the 
        health care liability action involved and shall enter judgment 
        for that amount. The court shall clearly state its reasons for 
        setting the amount of such award in findings of fact and 
        conclusions of law, demonstrating consideration of each of the 
        factors described in paragraph (2).
    (d) Limitation Amount.--The amount of damages that may be awarded 
as punitive damages in any health care liability action shall not 
exceed 3 times the amount awarded to the claimant for the economic 
injury on which such claim is based, or $250,000, whichever is greater. 
This subsection shall be applied by the court and shall not be 
disclosed to the jury.
    (e) Restrictions Permitted.--Nothing in this Act shall be construed 
to imply a right to seek punitive damages where none exists under 
Federal or State law.

SEC. 106. PERIODIC PAYMENTS.

    With respect to a health care liability action, if the award of 
future damages exceeds $100,000, the adjudicating body shall, at the 
request of either party, enter a judgment ordering that future damages 
be paid on a periodic basis in accordance with the guidelines contained 
in the Uniform Periodic Payments of Judgments Act, as promulgated by 
the National Conference of Commissioners on Uniform State Laws in July 
of 1990. The adjudicating body may waive the requirements of this 
section if such body determines that such a waiver is in the interests 
of justice.

SEC. 107. SCOPE OF LIABILITY.

    (a) In General.--With respect to punitive and noneconomic damages, 
the liability of each defendant in a health care liability action shall 
be several only and may not be joint. Such a defendant shall be liable 
only for the amount of punitive or noneconomic damages allocated to the 
defendant in direct proportion to such defendant's percentage of fault 
or responsibility for the injury suffered by the claimant.
    (b) Determination of Percentage of Liability.--With respect to 
punitive or noneconomic damages, the trier of fact in a health care 
liability action shall determine the extent of each party's fault or 
responsibility for injury suffered by the claimant, and shall assign a 
percentage of responsibility for such injury to each such party.

SEC. 108. MANDATORY OFFSETS FOR DAMAGES PAID BY A COLLATERAL SOURCE.

    (a) In General.--With respect to a health care liability action, 
the total amount of damages received by an individual under such action 
shall be reduced, in accordance with subsection (b), by any other 
payment that has been, or will be, made to an individual to compensate 
such individual for the injury that was the subject of such action.
    (b) Amount of Reduction.--The amount by which an award of damages 
to an individual for an injury shall be reduced under subsection (a) 
shall be--
            (1) the total amount of any payments (other than such 
        award) that have been made or that will be made to such 
        individual to pay costs of or compensate such individual for 
        the injury that was the subject of the action; minus
            (2) the amount paid by such individual (or by the spouse, 
        parent, or legal guardian of such individual) to secure the 
        payments described in paragraph (1).
    (c) Determination of Amounts From Collateral Services.--The 
reductions required under subsection (b) shall be determined by the 
court in a pretrial proceeding. At the subsequent trial--
            (1) no evidence shall be admitted as to the amount of any 
        charge, payments, or damage for which a claimant--
                    (A) has received payment from a collateral source 
                or the obligation for which has been assured by a third 
                party; or
                    (B) is, or with reasonable certainty, will be 
                eligible to receive payment from a collateral source of 
                the obligation which will, with reasonable certainty be 
                assumed by a third party; and
            (2) the jury, if any, shall be advised that--
                    (A) except for damages as to which the court 
                permits the introduction of evidence, the claimant's 
                medical expenses and lost income have been or will be 
                paid by a collateral source or third party; and
                    (B) the claimant shall receive no award for any 
                damages that have been or will be paid by a collateral 
                source or third party.

SEC. 109. TREATMENT OF ATTORNEYS' FEES AND OTHER COSTS.

    (a) Limitation on Amount of Contingency Fees.--An attorney who 
represents, on a contingency fee basis, a claimant in a health care 
liability action may not charge, demand, receive, or collect for 
services rendered in connection with such action in excess of the 
following amount recovered by judgment or settlement under such action:
            (1) 33\1/3\ percent of the first $150,000 (or portion 
        thereof) recovered, based on after-tax recovery, plus
            (2) 25 percent of any amount in excess of $150,000 
        recovered, based on after-tax recovery.
    (b) Calculation of Periodic Payments.--In the event that a judgment 
or settlement includes periodic or future payments of damages, the 
amount recovered for purposes of computing the limitation on the 
contingency fee under subsection (a) shall be based on the cost of the 
annuity or trust established to make the payments. In any case in which 
an annuity or trust is not established to make such payments, such 
amount shall be based on the present value of the payments.

SEC. 110. OBSTETRIC CASES.

    With respect to a health care liability action relating to services 
provided during labor or the delivery of a baby, if the health care 
professional against whom the action is brought did not previously 
treat the pregnant woman for the pregnancy, the trier of fact may not 
find that the defendant committed malpractice and may not assess 
damages against the health care professional unless the malpractice is 
proven by clear and convincing evidence.

SEC. 111. STATE-BASED ALTERNATIVE DISPUTE RESOLUTION MECHANISMS.

    (a) Establishment by States.--Each State is encouraged to establish 
or maintain alternative dispute resolution mechanisms that promote the 
resolution of health care liability claims in a manner that--
            (1) is affordable for the parties involved in the claims;
            (2) provides for the timely resolution of claims; and
            (3) provides the parties with convenient access to the 
        dispute resolution process.
    (b) Guidelines.--The Attorney General, in consultation with the 
Secretary and the Administrative Conference of the United States, shall 
develop guidelines with respect to alternative dispute resolution 
mechanisms that may be established by States for the resolution of 
health care liability claims. Such guidelines shall include procedures 
with respect to the following methods of alternative dispute 
resolution:
            (1) Arbitration.--The use of arbitration, a nonjury 
        adversarial dispute resolution process which may, subject to 
        subsection (c), result in a final decision as to facts, law, 
        liability or damages. The parties may elect binding 
        arbitration.
            (2) Mediation.--The use of mediation, a settlement process 
        coordinated by a neutral third party without the ultimate 
        rendering of a formal opinion as to factual or legal findings.
            (3) Early neutral evaluation.--The use of early neutral 
        evaluation, in which the parties make a presentation to a 
        neutral attorney or other neutral evaluator for an assessment 
        of the merits, to encourage settlement. If the parties do not 
        settle as a result of assessment and proceed to trial, the 
        neutral evaluator's opinion shall be kept confidential.
            (4) Early offer and recovery mechanism.--The use of early 
        offer and recovery mechanisms under which a health care 
        provider, health care organization, or any other alleged 
        responsible defendant may offer to compensate a claimant for 
        his or her reasonable economic damages, including future 
        economic damages, less amounts available from collateral 
        sources.
            (5) No fault.--The use of a no-fault statute under which 
        certain health care liability actions are barred and claimants 
        are compensated for injuries through their health plans or 
        through other appropriate mechanisms.
    (c) Further Redress.--
            (1) In general.--The extent to which any party may seek 
        further redress (subsequent to a decision of an alternative 
        dispute resolution method) concerning a health care liability 
        claim in a Federal or State court shall be dependent upon the 
        methods of alternative dispute resolution adopted by the State.
            (2) Claimant.--With respect to further redress described in 
        paragraph (1), if the party initiating such court action is the 
        claimant and the claimant receives a level of damages that is 
        at least 25 percent less under the decision of the court than 
        under the State alternative dispute resolution method, such 
        party shall bear the reasonable costs, including legal fees, 
        incurred in the court action by the other party or parties to 
        such action.
            (3) Provider or other defendant.--With respect to further 
        redress described in paragraph (1), if the party initiating a 
        court action is the health care professional, health care 
        provider health plan, or other defendant in a health care 
        liability action and the health care professional, health care 
        provider, health plan or other defendant is found liable for a 
        level of damages that is at least 25 percent more under the 
        decision of the court than under the State alternative dispute 
        resolution method, such party shall bear the reasonable costs, 
        including legal fees, incurred in the court action by the other 
        party or parties to such action.
    (d) Technical Assistance and Evaluations.--
            (1) Technical assistance.--The Attorney General may provide 
        States with technical assistance in establishing or maintaining 
        alternative dispute resolution mechanisms under this section.
            (2) Evaluations.--The Attorney General, in consultation 
        with the Secretary and the Administrative Conference of the 
        United States, shall monitor and evaluate the effectiveness of 
        State alternative dispute resolution mechanisms established or 
        maintained under this section.

SEC. 112. REQUIREMENT OF CERTIFICATE OF MERIT.

    (a) Requiring Submission with Complaint.--Except as provided in 
subsection (b) and subject to the penalties of subsection (d), no 
health care liability action may be brought by any individual unless, 
at the time the individual commences such action, the individual or the 
individual's attorney submits an affidavit declaring that--
            (1) the individual (or the individual's attorney) has 
        consulted and reviewed the facts of the claim with a qualified 
        specialist (as defined in subsection (c));
            (2) the individual or the individual's attorney has 
        obtained a written report by a qualified specialist that 
        clearly identifies the individual and that includes the 
        specialist's determination that, based upon a review of the 
        available medical record and other relevant material, a 
        reasonable medical interpretation of the facts supports a 
        finding that the claim against the defendant is meritorious and 
        based on good cause; and
            (3) on the basis of the qualified specialist's review and 
        consultation, the individual, and if represented, the 
        individual's attorney, have concluded that the claim is 
        meritorious and based on good cause.
    (b) Extension in Certain Instances.--
            (1) In general.--Subject to paragraph (2), subsection (a) 
        shall not apply with respect to an individual who brings a 
        health care liability action without submitting an affidavit 
        described in such subsection if--
                    (A) despite good faith efforts, the individual is 
                unable to obtain the written report before the 
                expiration of the applicable statute of limitations;
                    (B) despite good faith efforts, at the time the 
                individual commences the action, the individual has 
                been unable to obtain medical records or other 
                information necessary, pursuant to any applicable law, 
                to prepare the written report requested; or
                    (C) the court of competent jurisdiction determines 
                that the affidavit requirement shall be extended upon a 
                showing of good cause.
            (2) Deadline for submission where extension applies.--In 
        the case of an individual who brings an action to which 
        paragraph (1) applies, the action shall be dismissed unless the 
        individual submits the affidavit described in subsection (a) 
        not later than--
                    (A) in the case of an action to which subparagraph 
                (A) of paragraph (1) applies, 90 days after commencing 
                the action; or
                    (B) in the case of an action to which subparagraph 
                (B) of paragraph (1) applies, 90 days after obtaining 
                the information described in such subparagraph or when 
                good cause for an extension no longer exists.
    (c) Qualified Specialist Defined.--
            (1) In general.--As used in subsection (a), the term 
        ``qualified specialist'' means, with respect to a health care 
        liability action, a health care professional who has expertise 
        in the same or substantially similar area of practice to that 
        involved in the action.
            (2) Evidence of expertise.--For purposes of paragraph (1), 
        evidence of required expertise may include evidence that the 
        individual--
                    (A) practices (or has practiced) or teaches (or has 
                taught) in the same or substantially similar area of 
                health care or medicine to that involved in the action; 
                or
                    (B) is otherwise qualified by experience or 
                demonstrated competence in the relevant practice area.
    (d) Sanctions for Submitting False Affidavit.--Upon the motion of 
any party or on its own initiative, the court in a health care 
liability action may impose a sanction on a party, the party's 
attorney, or both, for--
            (1) any knowingly false statement made in an affidavit 
        described in subsection (a);
            (2) making any false representations in order to obtain a 
        qualified specialist's report; or
            (3) failing to have the qualified specialist's written 
        report in his or her custody and control;
and may require that the sanctioned party reimburse the other party to 
the action for costs and reasonable attorney's fees.

               Subtitle B--Biomaterials Access Assurance

SEC. 121. SHORT TITLE.

    This subtitle may be cited as the ``Biomaterials Access Assurance 
Act of 1997''.

SEC. 122. FINDINGS.

    Congress finds that--
            (1) each year millions of citizens of the United States 
        depend on the availability of lifesaving or life enhancing 
        medical devices, many of which are permanently implantable 
        within the human body;
            (2) a continued supply of raw materials and component parts 
        is necessary for the invention, development, improvement, and 
        maintenance of the supply of the devices;
            (3) most of the medical devices are made with raw materials 
        and component parts that--
                    (A) are not designed or manufactured specifically 
                for use in medical devices; and
                    (B) come in contact with internal human tissue;
            (4) the raw materials and component parts also are used in 
        a variety of nonmedical products;
            (5) because small quantities of the raw materials and 
        component parts are used for medical devices, sales of raw 
        materials and component parts for medical devices constitute an 
        extremely small portion of the overall market for the raw 
        materials and medical devices;
            (6) under the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 301 et seq.), manufacturers of medical devices are 
required to demonstrate that the medical devices are safe and 
effective, including demonstrating that the products are properly 
designed and have adequate warnings or instructions;
            (7) notwithstanding the fact that raw materials and 
        component parts suppliers do not design, produce, or test a 
        final medical device, the suppliers have been the subject of 
        actions alleging inadequate--
                    (A) design and testing of medical devices 
                manufactured with materials or parts supplied by the 
                suppliers; or
                    (B) warnings related to the use of such medical 
                devices;
            (8) even though suppliers of raw materials and component 
        parts have very rarely been held liable in such actions, such 
        suppliers have ceased supplying certain raw materials and 
        component parts for use in medical devices because the costs 
        associated with litigation in order to ensure a favorable 
        judgment for the suppliers far exceeds the total potential 
        sales revenues from sales by such suppliers to the medical 
        device industry;
            (9) unless alternate sources of supply can be found, the 
        unavailability of raw materials and component parts for medical 
        devices will lead to unavailability of lifesaving and life-
        enhancing medical devices;
            (10) because other suppliers of the raw materials and 
        component parts in foreign nations are refusing to sell raw 
        materials or component parts for use in manufacturing certain 
        medical devices in the United States, the prospects for 
        development of new sources of supply for the full range of 
        threatened raw materials and component parts for medical 
        devices are remote;
            (11) it is unlikely that the small market for such raw 
        materials and component parts in the United States could 
        support the large investment needed to develop new suppliers of 
        such raw materials and component parts;
            (12) attempts to develop such new suppliers would raise the 
        cost of medical devices;
            (13) courts that have considered the duties of the 
        suppliers of the raw materials and component parts have 
        generally found that the suppliers do not have a duty--
                    (A) to evaluate the safety and efficacy of the use 
                of a raw material or component part in a medical 
                device; and
                    (B) to warn consumers concerning the safety and 
                effectiveness of a medical device;
            (14) attempts to impose the duties referred to in 
        subparagraphs (A) and (B) of paragraph (13) on suppliers of the 
        raw materials and component parts would cause more harm than 
        good by driving the suppliers to cease supplying manufacturers 
        of medical devices; and
            (15) in order to safeguard the availability of a wide 
        variety of lifesaving and life-enhancing medical devices, 
        immediate action is needed--
                    (A) to clarify the permissible bases of liability 
                for suppliers of raw materials and component parts for 
                medical devices; and
                    (B) to provide expeditious procedures to dispose of 
                unwarranted suits against the suppliers in such manner 
                as to minimize litigation costs.

SEC. 123. DEFINITIONS.

    As used in this subtitle:
            (1) Biomaterials supplier.--
                    (A) In general.--The term ``biomaterials supplier'' 
                means an entity that directly or indirectly supplies a 
                component part or raw material for use in the 
                manufacture of an implant.
                    (B) Persons included.--Such term includes any 
                person who--
                            (i) has submitted master files to the 
                        Secretary for purposes of premarket approval of 
                        a medical device; or
                            (ii) licenses a biomaterials supplier to 
                        produce component parts or raw materials.
            (2) Claimant.--
                    (A) In general.--The term ``claimant'' means any 
                person who brings a civil action, or on whose behalf a 
                civil action is brought, arising from harm allegedly 
                caused directly or indirectly by an implant, including 
                a person other than the individual into whose body, or 
                in contact with whose blood or tissue, the implant is 
                placed, who claims to have suffered harm as a result of 
                the implant.
                    (B) Action brought on behalf of an estate.--With 
                respect to an action brought on behalf of or through 
                the estate of an individual into whose body, or in 
                contact with whose blood or tissue the implant is 
                placed, such term includes the decedent that is the 
                subject of the action.
                    (C) Action brought on behalf of a minor or 
                incompetent.--With respect to an action brought on 
                behalf of or through a minor or incompetent, such term 
                includes the parent or guardian of the minor or 
                incompetent.
                    (D) Exclusions.--Such term does not include--
                            (i) a provider of professional health care 
                        services, in any case in which--
                                    (I) the sale or use of an implant 
                                is incidental to the transaction; and
                                    (II) the essence of the transaction 
                                is the furnishing of judgment, skill, 
                                or services;
                            (ii) a person acting in the capacity of a 
                        manufacturer, seller, or biomaterials supplier; 
                        or
                            (iii) a person alleging harm caused by 
                        either the silicone gel or the silicone 
                        envelope utilized in a breast implant 
                        containing silicone gel, except that--
                                    (I) neither the exclusion provided 
                                by this clause nor any other provision 
                                of this subtitle may be construed as a 
                                finding that silicone gel (or any other 
                                form of silicone) may or may not cause 
                                harm; and
                                    (II) the existence of the exclusion 
                                under this clause may not--
                                            (aa) be disclosed to a jury 
                                        in any civil action or other 
                                        proceeding; and
                                            (bb) except as necessary to 
                                        establish the applicability of 
                                        this subtitle, otherwise be 
                                        presented in any civil action 
                                        or other proceeding.
            (3) Component part.--
                    (A) In general.--The term ``component part'' means 
                a manufactured piece of an implant.
                    (B) Certain components.--Such term includes a 
                manufactured piece of an implant that--
                            (i) has significant non-implant 
                        applications; and
                            (ii) alone, has no implant value or 
                        purpose, but when combined with other component 
                        parts and materials, constitutes an implant.
            (4) Harm.--
                    (A) In general.--The term ``harm'' means--
                            (i) any injury to or damage suffered by an 
                        individual;
                            (ii) any illness, disease, or death of that 
                        individual resulting from that injury or 
                        damage; and
                            (iii) any loss to that individual or any 
                        other individual resulting from that injury or 
                        damage.
                    (B) Exclusion.--The term does not include any 
                commercial loss or loss of or damage to an implant.
            (5) Implant.--The term ``implant'' means--
                    (A) a medical device that is intended by the 
                manufacturer of the device--
                            (i) to be placed into a surgically or 
                        naturally formed or existing cavity of the body 
                        for a period of at least 30 days; or
                            (ii) to remain in contact with bodily 
                        fluids or internal human tissue through a 
                        surgically produced opening for a period of 
                        less than 30 days; and
                    (B) suture materials used in implant procedures.
            (6) Manufacturer.--The term ``manufacturer'' means any 
        person who, with respect to an implant--
                    (A) is engaged in the manufacture, preparation, 
                propagation, compounding, or processing (as defined in 
                section 510(a)(1)) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360(a)(1)) of the implant; and
                    (B) is required--
                            (i) to register with the Secretary pursuant 
                        to section 510 of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 360) and the 
                        regulations issued under such section; and
                            (ii) to include the implant on a list of 
                        devices filed with the Secretary pursuant to 
                        section 510(j) of such Act (21 U.S.C. 360(j)) 
                        and the regulations issued under such section.
            (7) Medical device.--The term ``medical device'' means a 
        device, as defined in section 201(h) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321(h)) and includes any device 
        component of any combination product as that term is used in 
        section 503(g) of such Act (21 U.S.C. 353(g)).
            (8) Raw material.--The term ``raw material'' means a 
        substance or product that--
                    (A) has a generic use; and
                    (B) may be used in an application other than an 
                implant.
            (9) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (10) Seller.--
                    (A) In general.--The term ``seller'' means a person 
                who, in the course of a business conducted for that 
                purpose, sells, distributes, leases, packages, labels, 
                or otherwise places an implant in the stream of 
                commerce.
                    (B) Exclusions.--The term does not include--
                            (i) a seller or lessor of real property;
                            (ii) a provider of professional services, 
                        in any case in which the sale or use of an 
                        implant is incidental to the transaction and 
                        the essence of the transaction is the 
                        furnishing of judgment, skill, or services; or
                            (iii) any person who acts in only a 
                        financial capacity with respect to the sale of 
                        an implant.

SEC. 124. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.

    (a) General Requirements.--
            (1) In general.--In any civil action covered by this 
        subtitle, a biomaterials supplier may raise any defense set 
        forth in section 125.
            (2) Procedures.--Notwithstanding any other provision of 
        law, the Federal or State court in which a civil action covered 
        by this subtitle is pending shall, in connection with a motion 
        for dismissal or judgment based on a defense described in 
        paragraph (1), use the procedures set forth in section 126.
    (b) Applicability.--
            (1) In general.--Except as provided in paragraph (2), 
        notwithstanding any other provision of law, this subtitle 
        applies to any civil action brought by a claimant, whether in a 
        Federal or State court, against a manufacturer, seller, or 
        biomaterials supplier, on the basis of any legal theory, for 
        harm allegedly caused by an implant.
            (2) Exclusion.--A civil action brought by a purchaser of a 
        medical device for use in providing professional services 
        against a manufacturer, seller, or biomaterials supplier for 
        loss or damage to an implant or for commercial loss to the 
        purchaser--
                    (A) shall not be considered an action that is 
                subject to this subtitle; and
                    (B) shall be governed by applicable commercial or 
                contract law.
    (c) Scope of Preemption.--
            (1) In general.--This subtitle supersedes any State law 
        regarding recovery for harm caused by an implant and any rule 
        of procedure applicable to a civil action to recover damages 
        for such harm only to the extent that this subtitle establishes 
        a rule of law applicable to the recovery of such damages.
            (2) Applicability of other laws.--Any issue that arises 
        under this subtitle and that is not governed by a rule of law 
        applicable to the recovery of damages described in paragraph 
        (1) shall be governed by applicable Federal or State law.
    (d) Statutory Construction.--Nothing in this subtitle may be 
construed--
            (1) to affect any defense available to a defendant under 
        any other provisions of Federal or State law in an action 
        alleging harm caused by an implant; or
            (2) to create a cause of action or Federal court 
        jurisdiction pursuant to section 1331 or 1337 of title 28, 
        United States Code, that otherwise would not exist under 
        applicable Federal or State law.

SEC. 125. LIABILITY OF BIOMATERIALS SUPPLIERS.

    (a) In General.--
            (1) Exclusion from liability.--Except as provided in 
        paragraph (2), a biomaterials supplier shall not be liable for 
        harm to a claimant caused by an implant.
            (2) Liability.--A biomaterials supplier that--
                    (A) is a manufacturer may be liable for harm to a 
                claimant described in subsection (b);
                    (B) is a seller may be liable for harm to a 
                claimant described in subsection (c); and
                    (C) furnishes raw materials or component parts that 
                fail to meet applicable contractual requirements or 
                specifications may be liable for a harm to a claimant 
                described in subsection (d).
    (b) Liability as Manufacturer.--
            (1) In general.--A biomaterials supplier may, to the extent 
        required and permitted by any other applicable law, be liable 
        for harm to a claimant caused by an implant if the biomaterials 
        supplier is the manufacturer of the implant.
            (2) Grounds for liability.--The biomaterials supplier may 
        be considered the manufacturer of the implant that allegedly 
        caused harm to a claimant only if the biomaterials supplier--
                    (A)(i) has registered with the Secretary pursuant 
                to section 510 of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360) and the regulations issued under 
                such section; and
                    (ii) included the implant on a list of devices 
                filed with the Secretary pursuant to section 510(j) of 
                such Act (21 U.S.C. 360(j)) and the regulations issued 
                under such section;
                    (B) is the subject of a declaration issued by the 
                Secretary pursuant to paragraph (3) that states that 
                the supplier, with respect to the implant that 
                allegedly caused harm to the claimant, was required 
                to--
                            (i) register with the Secretary under 
                        section 510 of such Act (21 U.S.C. 360), and 
                        the regulations issued under such section, but 
                        failed to do so; or
                            (ii) include the implant on a list of 
                        devices filed with the Secretary pursuant to 
                        section 510(j) of such Act (21 U.S.C. 360(j)) 
                        and the regulations issued under such section, 
                        but failed to do so; or
                    (C) is related by common ownership or control to a 
                person meeting all the requirements described in 
                subparagraph (A) or (B), if the court deciding a motion 
                to dismiss in accordance with section 126(c)(3)(B)(i) 
                finds, on the basis of affidavits submitted in 
                accordance with section 126, that it is necessary to 
                impose liability on the biomaterials supplier as a 
                manufacturer because the related manufacturer meeting 
                the requirements of subparagraph (A) or (B) lacks 
                sufficient financial resources to satisfy any judgment 
                that the court feels it is likely to enter should the 
                claimant prevail.
            (3) Administrative procedures.--
                    (A) In general.--The Secretary may issue a 
                declaration described in paragraph (2)(B) on the motion 
                of the Secretary or on petition by any person, after 
                providing--
                            (i) notice to the affected persons; and
                            (ii) an opportunity for an informal 
                        hearing.
                    (B) Docketing and final decision.--Immediately upon 
                receipt of a petition filed pursuant to this paragraph, 
the Secretary shall docket the petition. Not later than 180 days after 
the petition is filed, the Secretary shall issue a final decision on 
the petition.
                    (C) Applicability of statute of limitations.--Any 
                applicable statute of limitations shall toll during the 
                period during which a claimant has filed a petition 
                with the Secretary under this paragraph.
    (c) Liability as Seller.--A biomaterials supplier may, to the 
extent required and permitted by any other applicable law, be liable as 
a seller for harm to a claimant caused by an implant if--
            (1) the biomaterials supplier--
                    (A) held title to the implant that allegedly caused 
                harm to the claimant as a result of purchasing the 
                implant after--
                            (i) the manufacture of the implant; and
                            (ii) the entrance of the implant in the 
                        stream of commerce; and
                    (B) subsequently resold the implant; or
            (2) the biomaterials supplier is related by common 
        ownership or control to a person meeting all the requirements 
        described in paragraph (1), if a court deciding a motion to 
        dismiss in accordance with section 126(c)(3)(B)(ii) finds, on 
        the basis of affidavits submitted in accordance with section 
        126, that it is necessary to impose liability on the 
        biomaterials supplier as a seller because the related seller 
        meeting the requirements of paragraph (1) lacks sufficient 
        financial resources to satisfy any judgment that the court 
        feels it is likely to enter should the claimant prevail.
    (d) Liability for Violating Contractual Requirements or 
Specifications.--A biomaterials supplier may, to the extent required 
and permitted by any other applicable law, be liable for harm to a 
claimant caused by an implant, if the claimant in an action shows, by a 
preponderance of the evidence, that--
            (1) the raw materials or component parts delivered by the 
        biomaterials supplier either--
                    (A) did not constitute the product described in the 
                contract between the biomaterials supplier and the 
                person who contracted for delivery of the product; or
                    (B) failed to meet any specifications that were--
                            (i) provided to the biomaterials supplier 
                        and not expressly repudiated by the 
                        biomaterials supplier prior to acceptance of 
                        delivery of the raw materials or component 
                        parts;
                            (ii)(I) published by the biomaterials 
                        supplier;
                            (II) provided to the manufacturer by the 
                        biomaterials supplier; or
                            (III) contained in a master file that was 
                        submitted by the biomaterials supplier to the 
                        Secretary and that is currently maintained by 
                        the biomaterials supplier for purposes of 
                        premarket approval of medical devices; or
                            (iii) included in the submissions for 
                        purposes of premarket approval or review by the 
                        Secretary under section 510, 513, 515, or 520 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360, 360c, 360e, or 360j), and received 
                        clearance from the Secretary if such 
                        specifications were provided by the 
                        manufacturer to the biomaterials supplier and 
                        were not expressly repudiated by the 
                        biomaterials supplier prior to the acceptance 
                        by the manufacturer of delivery of the raw 
                        materials or component parts; and
            (2) such conduct was an actual and proximate cause of the 
        harm to the claimant.

SEC. 126. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST 
              BIOMATERIALS SUPPLIERS.

    (a) Motion To Dismiss.--In any action that is subject to this 
subtitle, a biomaterials supplier who is a defendant in such action 
may, at any time during which a motion to dismiss may be filed under an 
applicable law, move to dismiss the action against it on the grounds 
that--
            (1) the defendant is a biomaterials supplier; and
            (2)(A) the defendant should not, for the purposes of--
                    (i) section 125(b), be considered to be a 
                manufacturer of the implant that is subject to such 
                section; or
                    (ii) section 125(c), be considered to be a seller 
                of the implant that allegedly caused harm to the 
                claimant; or
            (B)(i) the claimant has failed to establish, pursuant to 
        section 125(d), that the supplier furnished raw materials or 
        component parts in violation of contractual requirements or 
        specifications; or
            (ii) the claimant has failed to comply with the procedural 
        requirements of subsection (b).
    (b) Manufacturer of Implant Shall Be Named a Party.--The claimant 
shall be required to name the manufacturer of the implant as a party to 
the action, unless--
            (1) the manufacturer is subject to service of process 
        solely in a jurisdiction in which the biomaterials supplier is 
        not domiciled or subject to a service of process; or
            (2) an action against the manufacturer is barred by 
        applicable law.
    (c) Proceeding on Motion To Dismiss.--The following rules shall 
apply to any proceeding on a motion to dismiss filed under this 
section:
            (1) Affidavits relating to listing and declarations.--
                    (A) In general.--The defendant in the action may 
                submit an affidavit demonstrating that defendant has 
                not included the implant on a list, if any, filed with 
                the Secretary pursuant to section 510(j) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)).
                    (B) Response to motion to dismiss.--In response to 
                the motion to dismiss, the claimant may submit an 
                affidavit demonstrating that--
                            (i) the Secretary has, with respect to the 
                        defendant and the implant that allegedly caused 
                        harm to the claimant, issued a declaration 
                        pursuant to section 125(b)(2)(B); or
                            (ii) the defendant who filed the motion to 
                        dismiss is a seller of the implant who is 
                        liable under section 125(c).
            (2) Effect of motion to dismiss on discovery.--
                    (A) In general.--If a defendant files a motion to 
                dismiss under paragraph (1) or (2) of subsection (a), 
                no discovery shall be permitted in connection to the 
                action that is the subject of the motion, other than 
                discovery necessary to determine a motion to dismiss 
                for lack of jurisdiction, until such time as the court 
                rules on the motion to dismiss in accordance with the 
                affidavits submitted by the parties in accordance with 
                this section.
                    (B) Discovery.--If a defendant files a motion to 
                dismiss under subsection (a)(2)(B)(i) on the grounds 
                that the biomaterials supplier did not furnish raw 
                materials or component parts in violation of 
                contractual requirements or specifications, the court 
                may permit discovery, as ordered by the court. The 
                discovery conducted pursuant to this subparagraph shall 
                be limited to issues that are directly relevant to--
                            (i) the pending motion to dismiss; or
                            (ii) the jurisdiction of the court.
            (3) Affidavits relating status of defendant.--
                    (A) In general.--Except as provided in clauses (i) 
                and (ii) of subparagraph (B), the court shall consider 
                a defendant to be a biomaterials supplier who is not 
                subject to an action for harm to a claimant caused by 
                an implant, other than an action relating to liability 
                for a violation of contractual requirements or 
                specifications described in subsection (d).
                    (B) Responses to motion to dismiss.--The court 
                shall grant a motion to dismiss any action that asserts 
                liability of the defendant under subsection (b) or (c) 
                of section 125 on the grounds that the defendant is not 
                a manufacturer subject to such section 125(b) or seller 
                subject to section 125(c), unless the claimant submits 
                a valid affidavit that demonstrates that--
                            (i) with respect to a motion to dismiss 
                        contending the defendant is not a manufacturer, 
                        the defendant meets the applicable requirements 
                        for liability as a manufacturer under section 
                        125(b); or
                            (ii) with respect to a motion to dismiss 
                        contending that the defendant is not a seller, 
                        the defendant meets the applicable requirements 
                        for liability as a seller under section 125(c).
            (4) Basis of ruling on motion to dismiss.--
                    (A) In general.--The court shall rule on a motion 
                to dismiss filed under subsection (a) solely on the 
                basis of the pleadings of the parties made pursuant to 
                this section and any affidavits submitted by the 
                parties pursuant to this section.
                    (B) Motion for summary judgment.--Notwithstanding 
                any other provision of law, if the court determines 
                that the pleadings and affidavits made by parties 
                pursuant to this section raise genuine issues as 
                concerning material facts with respect to a motion 
                concerning contractual requirements and specifications, 
                the court may deem the motion to dismiss to be a motion 
                for summary judgment made pursuant to subsection (d).
    (d) Summary Judgment.--
            (1) In general.--
                    (A) Basis for entry of judgment.--A biomaterials 
                supplier shall be entitled to entry of judgment without 
                trial if the court finds there is no genuine issue as 
                concerning any material fact for each applicable 
                element set forth in paragraphs (1) and (2) of section 
                125(d).
                    (B) Issues of material fact.--With respect to a 
                finding made under subparagraph (A), the court shall 
                consider a genuine issue of material fact to exist only 
                if the evidence submitted by claimant would be 
                sufficient to allow a reasonable jury to reach a 
                verdict for the claimant if the jury found the evidence 
                to be credible.
            (2) Discovery made prior to a ruling on a motion for 
        summary judgment.--If, under applicable rules, the court 
        permits discovery prior to a ruling on a motion for summary 
        judgment made pursuant to this subsection, such discovery shall 
        be limited solely to establishing whether a genuine issue of 
        material fact exists as to the applicable elements set forth in 
        paragraphs (1) and (2) of section 125(d).
            (3) Discovery with respect to a biomaterials supplier.--A 
        biomaterials supplier shall be subject to discovery in 
        connection with a motion seeking dismissal or summary judgment 
        on the basis of the inapplicability of section 125(d) or the 
        failure to establish the applicable elements of section 125(d) 
        solely to the extent permitted by the applicable Federal or 
        State rules for discovery against nonparties.
    (e) Stay Pending Petition for Declaration.--If a claimant has filed 
a petition for a declaration pursuant to section 125(b)(3)(A) with 
respect to a defendant, and the Secretary has not issued a final 
decision on the petition, the court shall stay all proceedings with 
respect to that defendant until such time as the Secretary has issued a 
final decision on the petition.
    (f) Manufacturer Conduct of Proceeding.--The manufacturer of an 
implant that is the subject of an action covered under this subtitle 
shall be permitted to file and conduct a proceeding on any motion for 
summary judgment or dismissal filed by a biomaterials supplier who is a 
defendant under this section if the manufacturer and any other 
defendant in such action enter into a valid and applicable contractual 
agreement under which the manufacturer agrees to bear the cost of such 
proceeding or to conduct such proceeding.
    (g) Attorney Fees.--The court shall require the claimant to 
compensate the biomaterials supplier (or a manufacturer appearing in 
lieu of a supplier pursuant to subsection (f)) for attorney fees and 
costs, if--
            (1) the claimant named or joined the biomaterials supplier; 
        and
            (2) the court found the claim against the biomaterials 
        supplier to be without merit and frivolous.

SEC. 127. APPLICABILITY.

    This subtitle shall apply to all civil actions covered under this 
subtitle that are commenced on or after the date of enactment of this 
Act, including any such action with respect to which the harm asserted 
in the action or the conduct that caused the harm occurred before the 
date of enactment of this Act.

                       Subtitle C--Applicability

SEC. 131. APPLICABILITY.

    This title shall apply to all civil actions covered under this 
title that are commenced on or after the date of enactment of this Act, 
including any such action with respect to which the harm asserted in 
the action or the conduct that caused the injury occurred before the 
date of enactment of this Act.

       TITLE II--PROTECTION OF THE HEALTH AND SAFETY OF PATIENTS

SEC. 201. ADDITIONAL RESOURCES FOR STATE HEALTH CARE QUALITY ASSURANCE 
              AND ACCESS ACTIVITIES.

    Each State shall require that not less than 50 percent of all 
awards of punitive damages resulting from all health care liability 
actions in that State, if punitive damages are otherwise permitted by 
applicable law, be used for activities relating to--
            (1) the licensing, investigating, disciplining, and 
        certification of health care professionals in the State; and
            (2) the reduction of malpractice-related costs for health 
        care providers volunteering to provide health care services in 
        medically underserved areas.

SEC. 202. QUALITY ASSURANCE, PATIENT SAFETY, AND CONSUMER INFORMATION.

    (a) Advisory Panel.--
            (1) In general.--Not later than 90 days after the date of 
        enactment of this Act, the Administrator of the Agency for 
        Health Care Policy and Research (hereafter referred to in this 
        section as the ``Administrator'') shall establish an advisory 
        panel to coordinate and evaluate, methods, procedures, and data 
        to enhance the quality, safety, and effectiveness of health 
        care services provided to patients.
            (2) Participation.--In establishing the advisory panel 
        under paragraph (1), the Administrator shall ensure that 
        members of the panel include representatives of public and 
        private sector entities having expertise in quality assurance, 
        risk assessment, risk management, patient safety, and patient 
        satisfaction.
            (3) Objectives.--In carrying out the duties described in 
        this section, the Administrator, acting through the advisory 
        panel established under paragraph (1), shall conduct a survey 
        of public and private entities involved in quality assurance, 
        risk assessment, patient safety, patient satisfaction, and 
        practitioner licensing. Such survey shall include the gathering 
        of data with respect to--
                    (A) performance measures of quality for health care 
                providers and health plans;
                    (B) developments in survey methodology, sampling, 
                and audit methods;
                    (C) methods of medical practice and patterns, and 
                patient outcomes; and
                    (D) methods of disseminating information concerning 
                successful health care quality improvement programs, 
                risk management and patient safety programs, practice 
                guidelines, patient satisfaction, and practitioner 
                licensing.
    (b) Guidelines.--Not later than 2 years after the date of enactment 
of this Act, the Administrator shall, in accordance with chapter 5 of 
title 5, United States Code, establish health care quality assurance, 
patient safety and consumer information guidelines. Such guidelines 
shall be modified periodically when determined appropriate by the 
Administrator. Such guidelines shall be advisory in nature and not 
binding.
    (c) Reports.--
            (1) Initial report.--Not later than 6 months after the date 
        of enactment of this Act, the Administrator shall prepare and 
        submit to the Committee on Labor and Human Resources of the 
        Senate and the Committee on Commerce of the House of 
Representatives, a report that contains--
                    (A) data concerning the availability of information 
                relating to risk management, quality assessment, 
                patient safety, and patient satisfaction;
                    (B) an estimation of the degree of consensus 
                concerning the accuracy and content of the information 
                available under subparagraph (A);
                    (C) a summary of the best practices used in the 
                public and private sectors for disseminating 
                information to consumers; and
                    (D) an evaluation of the National Practitioner Data 
                Bank (as established under the Health Quality 
                Improvement Act of 1986), for reliability and validity 
                of the data and the effectiveness of the Data Bank in 
                assisting hospitals and medical groups in overseeing 
                the quality of practitioners.
            (2) Interim report.--Not later than 1 year after the date 
        of enactment of this Act, the Administrator shall prepare and 
        submit to the Committees referred to in paragraph (1) a report, 
        based on the results of the advisory panel survey conducted 
        under subsection (a)(3), concerning--
                    (A) the consensus of indicators of patient safety 
                and risk;
                    (B) an assessment of the consumer perspective on 
                health care quality that includes an examination of--
                            (i) the information most often requested by 
                        consumers;
                            (ii) the types of technical quality 
                        information that consumers find compelling;
                            (iii) the amount of information that 
                        consumers consider to be sufficient and the 
                        amount of such information considered 
                        overwhelming; and
                            (iv) the manner in which such information 
                        should be presented;
                and recommendations for increasing the awareness of 
                consumers concerning such information;
                    (C) proposed methods, building on existing data 
                gathering and dissemination systems, for ensuring that 
                such data is available and accessible to consumers, 
                employers, hospitals, and patients;
                    (D) the existence of legal, regulatory, and 
                practical obstacles to making such data available and 
                accessible to consumers;
                    (E) privacy or proprietary issues involving the 
                dissemination of such data;
                    (F) an assessment of the appropriateness of 
                collecting such data at the Federal or State level;
                    (G) an evaluation of the value of permitting 
                consumers to have access to information contained in 
                the National Practitioner Data Bank and recommendations 
                to improve the reliability and validity of the 
                information; and
                    (H) the reliability and validity of data collected 
                by the State medical boards and recommendations for 
                developing investigation protocols.
            (3) Annual report.--Not later than 1 year after the date of 
        the submission of the report under paragraph (2), and each year 
        thereafter, the Administrator shall prepare and submit to the 
        Committees referred to in paragraph (1) a report concerning the 
        progress of the advisory panel in the development of a 
        consensus with respect to the findings of the panel and in the 
        development and modification of the guidelines required under 
        subsection (b).
            (4) Termination.--The advisory panel shall terminate on the 
        date that is 3 years after the date of enactment of this Act.

                        TITLE III--SEVERABILITY

SEC. 301. SEVERABILITY.

    If any provision of this Act, an amendment made by this Act, or the 
application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this Act, 
the amendments made by this Act, and the application of the provisions 
of such to any person or circumstance shall not be affected thereby.
                                 <all>