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[Congressional Record Volume 141, Number 72 (Wednesday, May 3, 1995)]
[Senate]
[Pages S6109-S6125]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

                          AMENDMENTS SUBMITTED

                                 ______

   THE COMMON SENSE LEGAL STANDARDS REFORM ACT OF 1995 COMMON SENSE 
                  PRODUCT LIABILITY REFORM ACT OF 1995

                                 ______

                         DODD AMENDMENT NO. 624

  (Ordered to lie on the table.)
  Mr. DODD submitted an amendment intended to be proposed by him to the 
bill (H.R. 956) to establish legal standards and procedures for product 
liability litigation, and for other purposes; as follows:

       At the appropriate place insert the following:

     SEC.  . UNIFORM STANDARDS FOR AWARD OF PUNITIVE DAMAGES.

       (a) General Rule.--Notwithstanding any other provision of 
     this Act, punitive damages may, to the extent permitted by 
     applicable State law, be awarded against a defendant in an 
     action that is subject to this Act if the claimant 
     establishes by clear and convincing evidence that the harm 
     that is the subject of the action was the result of conduct 
     that was carried out by the defendant with a conscious, 
     flagrant indifference to the safety of others.
       (b) Bifurcation and Judicial Determination.--
       (1) In general.--Notwithstanding any other provision of 
     this Act, in an action that is subject to this Act in which 
     punitive damages are sought, the trier of fact shall 
     determine, concurrent with all other issues presented, 
     whether such damages shall be allowed. If such damages are 
     allowed, a separate proceeding shall be conducted by the 
     court to determine the amount of such damages to be awarded.
       (2) Admissible evidence.--
       (A) Inadmissibility of evidence relative only to a claim of 
     punitive damages in a bifurcated proceeding.--Notwithstanding 
     any other provision of this Act, in any proceeding to 
     determine whether the claimant in an action that is subject 
     to this Act may be awarded compensatory damages and punitive 
     damages, evidence of the defendant's financial condition and 
     other evidence bearing on the amount of punitive damages 
     shall not be admissible unless the evidence is admissible for 
     a purpose other than for determining the amount of punitive 
     damages.
       (B) Proceeding with respect to punitive damages.--Evidence 
     that is admissible in a separate proceeding conducted under 
     paragraph (1) shall include evidence that bears on the 
     factors listed in paragraph (3).
       (3) Factors.--Notwithstanding any other provision of this 
     Act, in determining the amount of punitive damages awarded in 
     an action that is subject to this Act, the court shall 
     consider the following factors:
       (A) The likelihood that serious harm would arise from the 
     misconduct of the defendant in question.
       (B) The degree of the awareness of the defendant in 
     question of that likelihood.
       (C) The profitability of the misconduct to the defendant in 
     question.
       (D) The duration of the misconduct and any concealment of 
     the conduct by the defendant in question.
       (E) The attitude and conduct of the defendant in question 
     upon the discovery of the misconduct and whether the 
     misconduct has terminated.
       (F) The financial condition of the defendant in question.
       (G) The total effect of other punishment imposed or likely 
     to be imposed upon the defendant in question as a result of 
     the misconduct, including any awards of punitive or exemplary 
     damages to persons similarly situated to the claimant and the 
     severity of criminal penalties to which the defendant in 
     question has been or is likely to be subjected.
       (H) Any other factor that the court determines to be 
     appropriate.
       (4) Reasons for setting award amount.--
       (A) In general.--Notwithstanding any other provision of 
     this Act, with respect to an award of punitive damages in an 
     action that is subject to this Act, in findings of fact and 
     conclusions of law issued by the court, the court shall 
     clearly state the reasons of the court for setting the amount 
     of the award. The statements referred to in the preceding 
     sentence shall demonstrate the consideration of the factors 
     listed in subparagraphs (A) through (G) of paragraph (3). If 
     the court considers a factor under subparagraph (H) of 
     paragraph (3), the court shall state the effect of the 
     consideration of the factor on setting the amount of the 
     award.
       (B) Review of determination of award amount.--The 
     determination of the amount of the award shall only be 
     reviewed by a court as a factual finding and shall not be set 
     aside by a court unless the court determines that the amount 
     of the award is clearly erroneous.
                                 ______

                         DODD AMENDMENT NO. 625

  (Ordered to lie on the table.)
  Mr. DODD submitted an amendment intended to be proposed by him to 
amendment No. 596 proposed by Mr. Gorton to the bill H.R. 956, supra; 
as follows:

       [[Page S6110]] Strike section 107 and insert the following 
     new section:

     SEC. 107. UNIFORM STANDARDS FOR AWARD OF PUNITIVE DAMAGES.

       (a) General Rule.--Notwithstanding any other provision of 
     this Act, punitive damages may, to the extent permitted by 
     applicable State law, be awarded against a defendant in an 
     action that is subject to this Act if the claimant 
     establishes by clear and convincing evidence that the harm 
     that is the subject of the action was the result of conduct 
     that was carried out by the defendant with a conscious, 
     flagrant indifference to the safety of others.
       (b) Bifurcation and Judicial Determination.--
       (1) In general.--Notwithstanding any other provision of 
     this Act, in an action that is subject to this Act in which 
     punitive damages are sought, the trier of fact shall 
     determine, concurrent with all other issues presented, 
     whether such damages shall be allowed. If such damages are 
     allowed, a separate proceeding shall be conducted by the 
     court to determine the amount of such damages to be awarded.
       (2) Admissible evidence.--
       (A) Inadmissibility of evidence relative only to a claim of 
     punitive damages in a bifurcated proceeding.--Notwithstanding 
     any other provision of this Act, in any proceeding to 
     determine whether the claimant in an action that is subject 
     to this Act may be awarded compensatory damages and punitive 
     damages, evidence of the defendant's financial condition and 
     other evidence bearing on the amount of punitive damages 
     shall not be admissible unless the evidence is admissible for 
     a purpose other than for determining the amount of punitive 
     damages.
       (B) Proceeding with respect to punitive damages.--Evidence 
     that is admissible in a separate proceeding conducted under 
     paragraph (1) shall include evidence that bears on the 
     factors listed in paragraph (3).
       (3) Factors.--Notwithstanding any other provision of this 
     Act, in determining the amount of punitive damages awarded in 
     an action that is subject to this Act, the court shall 
     consider the following factors:
       (A) The likelihood that serious harm would arise from the 
     misconduct of the defendant in question.
       (B) The degree of the awareness of the defendant in 
     question of that likelihood.
       (C) The profitability of the misconduct to the defendant in 
     question.
       (D) The duration of the misconduct and any concealment of 
     the conduct by the defendant in question.
       (E) The attitude and conduct of the defendant in question 
     upon the discovery of the misconduct and whether the 
     misconduct has terminated.
       (F) The financial condition of the defendant in question.
       (G) The total effect of other punishment imposed or likely 
     to be imposed upon the defendant in question as a result of 
     the misconduct, including any awards of punitive or exemplary 
     damages to persons similarly situated to the claimant and the 
     severity of criminal penalties to which the defendant in 
     question has been or is likely to be subjected.
       (H) Any other factor that the court determines to be 
     appropriate.
       (4) Reasons for setting award amount.--
       (A) In general.--Notwithstanding any other provision of 
     this Act, with respect to an award of punitive damages in an 
     action that is subject to this Act, in findings of fact and 
     conclusions of law issued by he court, the court shall 
     clearly state the reasons of the court for setting the amount 
     of the award. The statements referred to in the preceding 
     sentence shall demonstrate the consideration of the factors 
     listed in subparagraphs (A) through (G) of paragraph (3). If 
     the court considers a factor under subparagraph (H) of 
     paragraph (3), the court shall state the effect of the 
     consideration of the factor on setting the amount of the 
     award.
       (B) Review of determination of award amount.--The 
     determination of the amount of the award shall only be 
     reviewed by a court as a factual finding and shall not be set 
     aside by a court unless the court determines that the amount 
     of the award is clearly erroneous.
                                 ______

                     HEFLIN AMENDMENTS NOS. 626-627

  (Ordered to lie on the table.)
  Mr. HEFLIN submitted two amendments intended to be proposed by him to 
amendment No. 596 proposed by Mr. Gorton to the bill H.R. 956, supra; 
as follows:

                           Amendment No. 626

       At the appropriate place in amendment No. 596 insert the 
     following:

                    insurability of punitive damages

       (1) Insurance companies properly licensed under state law 
     shall be permitted to issue policies covering liability 
     giving rise to punitive or exemplary damages.
       (2) Nothing herein shall require insurers to offer such 
     insurance policies for punitive or exemplary damages.
       (3) Such policies shall be effective in all states of the 
     United States, notwithstanding state law to the contrary.
                                                                    ____

                           Amendment No. 627

       At the end of amendment No. 596, insert the following:

     SEC.  . TRULY UNIFORM STANDARDS FOR ALL STATES.

       (a) Punitive Damages.--Notwithstanding any other provision 
     of this Act or any limitation under State law, punitive 
     damages may be awarded to a claimant in a product liability 
     action subject to this title. The amount of punitive damages 
     that may be awarded may not exceed the greater of--
       (1) an amount equal to 3 times the amount awarded to the 
     claimant for the economic loss on which the claim is based, 
     or
       (2) $250,000.
       (b) Alteration or Misuse.--Notwithstanding any other 
     provision of this Act, the provisions of section 106(a) 
     supersede the law of any State concerning misuse or 
     alteration of a product.
       (c) Statute of Repose.--Notwithstanding any other provision 
     of this Act, no product liability action subject to this 
     title, other than a product liability action for toxic harm, 
     may be brought more than 20 years after the time of delivery 
     of the product. This subsection supersedes any State law that 
     requires a product liability action to be filed during a 
     period of time shorter than 20 years after the time of 
     delivery.
                                 ______

                 HEFLIN (AND SHELBY) AMENDMENT NO. 628

  (Ordered to lie on the table.)
  Mr. HEFLIN (for himself and Mr. Shelby) submitted an amendment 
intended to be proposed by them to amendment No. 596 proposed by Mr. 
Gorton to the bill H.R. 956, supra; as follows:

       At the appropriate place in amendment No. 596 insert the 
     following:

     SEC.   . LIABILITY FOR CERTAIN CLAIMS RELATING TO DEATH.

       In any civil action in which the alleged harm to the 
     claimant is death and, as of the effective date of this Act, 
     the applicable State law provides, or has been construed to 
     provide, for damages only punitive in nature, a defendant may 
     be liable for any such damages without regard to this 
     section, but only during such time as the State law so 
     provides.
                                 ______

                        DORGAN AMENDMENT NO. 629

  (Ordered to lie on the table.)
  Mr. DORGAN submitted an amendment intended to be proposed by him to 
amendment No. 596 proposed by Mr. Gorton to the bill H.R. 956, supra; 
as follows:

       Insert at the appropriate place: ``Notwithstanding any 
     other provision of this Act, nothing in this Act shall impose 
     limitations on punitive damage awards.''
                                 ______

                        McCAIN AMENDMENT NO. 630

  (Ordered to lie on the table.)
  Mr. McCAIN submitted an amendment intended to be proposed by him to 
amendment No. 596 proposed by Mr. Gorton to the bill H.R. 956, supra; 
as follows:

       At the appropriate place in title I in Amendment No. 596, 
     insert the following new section:

     SEC.  . ALLOCATION OF ATTORNEYS' FEES.

       (a) In General.--With respect to the consideration of any 
     award or offer of settlement presented to a court in any 
     civil action in Federal or State court, the court, in 
     determining the appropriate amount of attorneys' fees with 
     respect to an attorney who represents, on a contingency fee 
     basis, a class or claimant, shall take into account the best 
     interests of all claimants and seek to ensure that such award 
     or settlement does not disadvantage other litigants in the 
     action.
       (b) Consideration of Expenses.--
       (1) In general.--In determining an appropriate amount of 
     attorneys' fees in an action under subsection (a), the court 
     shall ensure that the recovery for the medical expenses 
     (present and foreseeable) of the class or claimants are given 
     priority over the attorneys' fee.
       (2) Minimal amount.--With respect to an action under 
     subsection (a) in which the medical expenses of the class or 
     claimants exceeds the amount of the award or settlement, the 
     court shall award the minimal amount of attorneys' fees 
     necessary to reimburse the attorney for competent counsel and 
     apply the remainder of the award or settlement amount to the 
     expenses of the class or claimants.
       (c) Payment of Fees.--The court, in an action described in 
     subsection (a), shall ensure that an attorney for the class 
     or claimant does not receive payment of fees until all 
     members of the class or all claimants entitled to a payment 
     under an award or settlement in such action receive such 
     payments, unless the court finds good cause for permitting 
     some other sequencing of payments.
       (d) Limitation.--After complying with the provisions of 
     subsections (a) and (b), the court shall ensure that the 
     attorneys' fees to be paid are reasonable. A court shall 
     determine that attorneys' fees are reasonable under this 
     section, if such fees are proportionate to the actual benefit 
     to the class or claimant under an award or settlement under 
     the action involved, and to the amount of time and effort 
     expended by the attorney with respect to such action.

[[Page S6111]]

                      EXON AMENDMENTS NOS. 631-634

  (Ordered to lie on the table.)
  Mr. EXON submitted four amendments intended to be proposed by him to 
amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 956, supra; 
as follows:

                           Amendment No. 631

       On page 42, line 7, delete ``so.'' and insert in lieu 
     thereof: ``so; or''.
       On page 42, between lines 7 and 8 add the following new 
     section:
       ``(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 206(c)(3)(B)(i) finds, on the basis of 
     affidavits submitted in accordance with section 206, 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 judgement that the court 
     feels it is likely to enter should the claimant prevail.''.
       On page 43, line 6, insert ``(1)'' before ``if''.
       On page 43, line 7, delete ``(1)'' and insert in lieu 
     thereof: ``(A)''.
       On page 43, line 10, delete ``(A)'' and insert in lieu 
     thereof: ``(i)''.
       On page 43, line 11, delete ``(B)'' and insert in lieu 
     thereof: ``(ii)''.
       On page 43, line 13, delete ``(2)'' and insert in lieu 
     thereof: ``(B)''.
       On page 43, line 13, delete ``implant.'' and insert in lieu 
     thereof: ``implant; or''.
       On page 43, between lines 13 and 14 insert the following 
     new section:
       ``(2) if the biomaterials supplier is related by common 
     ownership or control to a person meeting all of the 
     requirements described in paragraph (1), if the court 
     deciding a motion to dismiss in accordance with section 
     206(c)(3)(B)(i) finds, on the basis of affidavits submitted 
     in accordance with section 206, 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 judgement that the court feels it is likely to enter 
     should the claimant prevail.''.
                                                                    ____

                            Amendment No 632
       On page 23, line 17, strike ``Each' and insert in lieu 
     thereof: ``Except as provided in (3), each''.
       On page 24, line 1, strike ``For'' and insert in lieu 
     thereof: ``Except as provided in (3), for''.
       On page 24 between lines 6 and 7, insert the following:
       (3) Cases affected by Title II.
       For cases involving manufacturers or biomaterials suppliers 
     covered by Title II of this Act (the Biomaterials Access 
     Assurance Act of 1995), the trier of fact shall allocate to 
     such manufacturer (or manufacturers) the amount of 
     noneconomic loss (if any) which is determined to be the 
     responsibility of a biomaterials supplier (or biomaterials 
     suppliers) where such biomaterials supplier (or suppliers) is 
     (or are) protected from liability to a claimant by Title II 
     of this Act.
                                                                    ____

                           Amendment no. 633

       On page 14, line 16 strike ``claimant,'' and insert in lieu 
     thereof ``claimant to the extent permitted by applicable 
     State law,''.
                                                                    ____

                           Amendment no. 634

       On page 38, line 24, after the phrase ``any civil action'' 
     add ``except for an action based on an intentional wrongful 
     act''.
       On page 39, on line 2 after the phrase ``any legal 
     theory,'' add ``except on the basis of an intentional 
     wrongful act''.
                                 ______

                     BOXER AMENDMENTS NOS. 635-640

  (Ordered to lie on the table.)
  Mrs. BOXER submitted six amendments intended to be proposed by her to 
amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 956, supra; 
as follows:

                           Amendment No. 635

       Strike page 29 through page 54, line 4.
                                                                    ____

                           Amendment No. 636

       At the appropriate place in amendment 596, insert the 
     following: ``Notwithstanding Section 107 with regard to 
     Uniform Standards for Award of Punitive Damages, the 
     limitation of amount for punitive damages shall not apply to 
     the loss of human reproductive function.''
                                                                    ____

                           Amendment No. 637

       At the appropriate place in amendment 596, insert the 
     following: ``Notwithstanding Section 107 with regard to 
     Uniform Standards for Award of Punitive Damages, the 
     limitation of amount for punitive damages shall not apply to 
     brain damage.''
                                                                    ____

                           Amendment No. 638

       At the appropriate place in amendment 596, insert the 
     following: ``Notwithstanding Section 107 with regard to 
     Uniform Standards for Award of Punitive Damages, the 
     limitation of amount for punitive damages shall not apply to 
     the loss of a limb.''
                                                                    ____

                           Amendment No. 639

       At the appropriate place in amendment 596, insert the 
     following: ``Notwithstanding Section 107 with regard to 
     Uniform Standards for Award of Punitive Damages, the 
     limitation of amount for punitive damages shall not apply to 
     facial disfigurement.''
                                                                    ____

                           Amendment No. 640

       In section 104, of amendment 596, strike subsection (a) and 
     insert the following new subsection:
       (a) General Rule.--Except as otherwise provided under 
     applicable State law, in any product liability action that is 
     subject to this title filed by a claimant for harm caused by 
     a product, a product seller other than a manufacturer shall 
     be liable to a claimant only if the claimant establishes that 
     the product that allegedly caused the harm that is the 
     subject of the complaint was sold, rented, or leased by the 
     product seller.
                                 ______

                  ROCKEFELLER AMENDMENTS NOS. 641-651

  (Ordered to lie on the table.)
  Mr. ROCKEFELLER submitted 11 amendments intended to be proposed by 
him to amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, 
supra; as follows:

                           Amendment No. 641
       In lieu of the matter proposed to be inserted by Gorton 
     amendment 596, insert the following:
     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Product Liability Fairness 
     Act of 1995''.

                       TITLE I--PRODUCT LIABILITY

     SEC. 101. DEFINITIONS.

       For purposes of this Act, the following definitions shall 
     apply:
       (1) Claimant.--The term ``claimant'' means any person who 
     brings a product liability action and any person on whose 
     behalf such an action is brought. If an action is brought 
     through or on behalf of--
       (A) an estate, the term includes the decedent; or
       (B) a minor or incompetent, the term includes the legal 
     guardian of the minor or incompetent.
       (2) Claimant's benefits.--The term ``claimant's benefits'' 
     means an amount equal to the sum of--
       (A) the amount paid to an employee as workers' compensation 
     benefits; and
       (B) the present value of all workers' compensation benefits 
     to which the employee is or would be entitled at the time of 
     the determination of the claimant's benefits, as determined 
     by the appropriate workers' compensation authority for harm 
     caused to an employee by a product.
       (3) Clear and convincing evidence.--
       (A) In general.--Subject to subparagraph (A), the term 
     ``clear and convincing evidence'' is that measure of 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.
       (B) Degree of proof.--The degree of proof required to 
     satisfy the standard of clear and convincing evidence shall 
     be--
       (i) greater than the degree of proof required to meet the 
     standard of preponderance of the evidence; and
       (ii) less than the degree of proof required to meet the 
     standard of proof beyond a reasonable doubt.
       (4) Commercial loss.--The term ``commercial loss'' means 
     any loss or damage to a product itself, loss relating to a 
     dispute over its value, or consequential economic loss the 
     recovery of which is governed by the Uniform Commercial Code 
     or analogous State commercial law, not including harm.
       (5) Durable good.--The term ``durable good'' means any 
     product, or any component of any such product, which has a 
     normal life expectancy of 3 or more years or is of a 
     character subject to allowance for depreciation under the 
     Internal Revenue Code of 1986, and which is--
       (A) used in a trade or business;
       (B) held for the production of income; or
       (C) sold or donated to a governmental or private entity for 
     the production of goods, training, demonstration, or any 
     other similar purpose.
       (6) Economic loss.--The term ``economic loss'' means any 
     pecuniary loss resulting from harm (including any medical 
     expense loss, work loss, replacement services loss, loss due 
     to death, burial costs, and loss of business or employment 
     opportunities), to the extent that recovery for the loss is 
     permitted under applicable State law.
       (7) Harm.--The term ``harm'' means any physical injury, 
     illness, disease, or death, or damage to property, caused by 
     a product. The term does not include commercial loss or loss 
     or damage to a product itself.
       (8) Insurer.--The term ``insurer'' means the employer of a 
     claimant, if the employer is self-insured, or the workers' 
     compensation insurer of an employer.
       (9) Manufacturer.--The term ``manufacturer'' means--
       (A) any person who is engaged in a business to produce, 
     create, make, or construct any product (or component part of 
     a product), and who designs or formulates the product (or 
     component part of the product), or has engaged another person 
     to design or formulate the product (or component part of the 
     product);
       (B) a product seller, but only with respect to those 
     aspects of a product (or component 
     [[Page S6112]] part of a product) which are created or 
     affected when,
      before placing the product in the stream of commerce, the 
     product seller produces, creates, makes, constructs, 
     designs, or formulates, or has engaged another person to 
     design or formulate, an aspect of a product (or component 
     part of a product) made by another person; or
       (C) any product seller that is not described in 
     subparagraph (B) that holds itself out as a manufacturer to 
     the user of the product.
       (10) Noneconomic loss.--The term ``noneconomic loss''--
       (A) means subjective, nonmonetary loss resulting from harm, 
     including pain, suffering, inconvenience, mental suffering, 
     emotional distress, loss of society and companionship, loss 
     of consortium, injury to reputation, and humiliation; and
       (B) does not include economic loss.
       (11) Person.--The term ``person'' means any individual, 
     corporation, company, association, firm, partnership, 
     society, joint stock company, or any other entity (including 
     any governmental entity).
       (12) Product.--
       (A) In general.--The term ``product'' means any object, 
     substance, mixture, or raw material in a gaseous, liquid, or 
     solid state that--
       (i) is capable of delivery itself or as an assembled whole, 
     in a mixed or combined state, or as a component part or 
     ingredient;
       (ii) is produced for introduction into trade or commerce;
       (iii) has intrinsic economic value; and
       (iv) is intended for sale or lease to persons for 
     commercial or personal use.
       (B) Exclusion.--The term ``product'' does not include--
       (i) tissue, organs, blood, and blood products used for 
     therapeutic or medical purposes, except to the extent that 
     such tissue, organs, blood, and blood products (or the 
     provision thereof) are subject, under applicable State law, 
     to a standard of liability other than negligence; and
       (ii) electricity, water delivered by a utility, natural 
     gas, or steam.
       (13) Product liability action.--The term ``product 
     liability action'' means a civil action brought on any theory 
     for harm caused by a product.
       (14) Product seller.--
       (A) In general.--The term ``product seller'' means a person 
     who--
       (i) in the course of a business conducted for that purpose, 
     sells, distributes, rents, leases, prepares, blends, 
     packages, labels, or otherwise is involved in placing a 
     product in the stream of commerce; or
       (ii) installs, repairs, refurbishes, reconditions, or 
     maintains the harm-causing aspect of the product.
       (B) Exclusion.--The term ``product seller'' 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 a product is incidental to the 
     transaction and the essence of the transaction is the 
     furnishing of judgment, skill, or services; or
       (iii) any person who--

       (I) acts in only a financial capacity with respect to the 
     sale of a product; or
       (II) leases a product under a lease arrangement in which 
     the lessor does not initially select the leased product and 
     does not during the lease term ordinarily control the daily 
     operations and maintenance of the product.

       (15) State.--The term ``State'' means each of the several 
     States of the United States, the District of Columbia, the 
     Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
     American Samoa, and the Commonwealth of the Northern Mariana 
     Islands, and any other territory or possession of the United 
     States, or any political subdivision thereof.
       (16) Time of delivery.--The term ``time of delivery'' means 
     the time when a product is delivered to the first purchaser 
     or lessee of the product that was not involved in 
     manufacturing or selling the product, or using the product as 
     a component part of another product to be sold.

     SEC. 102. APPLICABILITY; PREEMPTION.

       (a) Applicability.--
       (1) Actions covered.--Subject to paragraph (2), this title 
     applies to any product liability action commenced on or after 
     the date of enactment of this Act, without regard to whether 
     the harm that is the subject of the action or the conduct 
     that caused the harm occurred before such date of enactment.
       (2) Actions excluded.--
       (A) Actions for damage to product or commercial loss.--A 
     civil action brought for loss or damage to a product itself 
     or for commercial loss, shall not be subject to the 
     provisions of this title governing product liability actions, 
     but shall be subject to any applicable commercial or contract 
     law.
       (B) Actions for negligent entrustment.--A civil action for 
     negligent entrustment shall not be subject to the provisions 
     of this title governing product liability actions, but shall 
     be subject to any applicable State law.
       (b) Scope of Preemption.--
       (1) In general.--This Act supersedes a State law only to 
     the extent that State law applies to an issue covered under 
     this title.
       (2) Issues not covered under this act.--Any issue that is 
     not covered under this title, including any standard of 
     liability applicable to a manufacturer, shall not be subject 
     to this title, but shall be subject to applicable Federal or 
     State law.
       (c) Statutory Construction.--Nothing in this title may be 
     construed to--
       (1) waive or affect any defense of sovereign immunity 
     asserted by any State under any law;
       (2) supersede any Federal law;
       (3) waive or affect any defense of sovereign immunity 
     asserted by the United States;
       (4) affect the applicability of any provision of chapter 97 
     of title 28, United States Code;
       (5) preempt State choice-of-law rules with respect to 
     claims brought by a foreign nation or a citizen of a foreign 
     nation;
       (6) 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 of inconvenient forum; or
       (7) supersede or modify any statutory or common law, 
     including any law providing for an action to abate a 
     nuisance, that authorizes a person to institute an action for 
     civil damages or civil penalties, cleanup costs, injunctions, 
     restitution, cost recovery, punitive damages, or any other 
     form of relief for remediation of the environment (as defined 
     in section 101(8) of the Comprehensive Environmental 
     Response, Compensation, and Liability Act of 1980, 42 U.S.C. 
     9601(8)) or the threat of such remediation.
       (d) Construction.--To promote uniformity of law in the 
     various jurisdictions, this title shall be construed and 
     applied after consideration of its legislative history.
       (e) Effect of Court of Appeals Decisions.--Notwithstanding 
     any other provision of law, any decision of a circuit court 
     of appeals interpreting a provision of this title (except to 
     the extent that the decision is overruled or otherwise 
     modified by the Supreme Court) shall be considered a 
     controlling precedent with respect to any subsequent decision 
     made concerning the interpretation of such provision by any 
     Federal or State court within the geographical boundaries of 
     the area under the jurisdiction of the circuit court of 
     appeals.

     SEC. 103. ALTERNATIVE DISPUTE RESOLUTION PROCEDURES.

       (a) In General.--
       (1) Service of offer.--A claimant or a defendant in a 
     product liability action that is subject to this title may, 
     not later than 60 days after the service of the initial 
     complaint of the claimant or the applicable deadline for a 
     responsive pleading (whichever is later), serve upon an 
     adverse party an offer to proceed pursuant to any voluntary, 
     nonbinding alternative dispute resolution procedure 
     established or recognized under the law of the State in which 
     the product liability action is brought or under the rules of 
     the court in which such action is maintained.
       (2) Written notice of acceptance or rejection.--Except as 
     provided in paragraph (3), not later than 10 days after the 
     service of an offer to proceed under paragraph (1), an 
     offeree shall file a written notice of acceptance or 
     rejection of the offer.
       (3) Extension.--The court may, upon motion by an offeree 
     made prior to the expiration of the 10-day period specified 
     in paragraph (2), extend the period for filing a written 
     notice under such paragraph for a period of not more than 60 
     days after the date of expiration of the period specified in 
     paragraph (2). Discovery may be permitted during such period.
       (b) Defendant's Penalty for Unreasonable Refusal.--
       (1) In general.--The court shall assess reasonable 
     attorney's fees (calculated in accordance with paragraph (2)) 
     and costs against the offeree, incurred by the offeror during 
     trial if--
       (A) a defendant as an offeree refuses to proceed pursuant 
     to the alternative dispute resolution procedure referred to 
     subsection (a)(1);
       (B) final judgment is entered against the defendant for 
     harm caused by the product that is the subject of the action; 
     and
       (C) the refusal by the defendant to proceed pursuant to 
     such alternative dispute resolution was unreasonable or not 
     made in good faith.
       (2) Reasonable attorney's fees.--For purposes of this 
     subsection, a reasonable attorney's fee shall be calculated 
     on the basis of an hourly rate, which shall not exceed the 
     hourly rate that is considered acceptable in the community in 
     which the attorney practices law, taking into consideration 
     the qualifications and experience of the attorney and the 
     complexity of the case.
       (c) Good Faith Refusal.--In determining whether the refusal 
     of an offeree to proceed pursuant to the alternative dispute 
     procedure referred to in subsection (a)(1) was unreasonable 
     or not made in good faith, the court shall consider--
       (1) whether the case involves potentially complicated 
     questions of fact;
       (2) whether the case involves potentially dispositive 
     issues of law;
       (3) the potential expense faced by the offeree in retaining 
     counsel for both the alternative dispute resolution procedure 
     and to litigate the matter for trial;
       (4) the professional capacity of available mediators within 
     the applicable geographic area; and
       (5) such other factors as the court considers appropriate.

     SEC. 104. LIABILITY RULES APPLICABLE TO PRODUCT SELLERS.

       (a) General Rule.--
       (1) In general.--In any product liability action that is 
     subject to this title filed by a claimant for harm caused by 
     a product, a product seller other than a manufacturer shall 
     be liable to a claimant, only if the claimant establishes--
       (A) that--
     [[Page S6113]]   (i) the product that allegedly caused the 
     harm that is the subject of the complaint was sold, rented, 
     or leased by the product seller;
       (ii) the product seller failed to exercise reasonable care 
     with respect to the product; and
       (iii) the failure to exercise reasonable care was a 
     proximate cause of harm to the claimant; or
       (B) that--
       (i) the product seller made an express warranty applicable 
     to the product that allegedly caused the harm that is the 
     subject of the complaint, independent of any express warranty 
     made by a manufacturer as to the same product;
       (ii) the product failed to conform to the warranty; and
       (iii) the failure of the product to conform to the warranty 
     caused harm to the claimant; or
       (C) that--
       (i) the product seller engaged in intentional wrongdoing, 
     as determined under applicable State law; and
       (ii) such intentional wrongdoing was a proximate cause of 
     the harm that is the subject of the complaint.
       (2) Reasonable opportunity for inspection.--For purposes of 
     paragraph (1)(A)(ii), a product seller shall not be 
     considered to have failed to exercise reasonable care with 
     respect to a product based upon an alleged failure to inspect 
     a product if the product seller had no reasonable opportunity 
     to inspect the product that allegedly caused harm to the 
     claimant.
       (b) Special Rule.--A product seller shall be deemed to be 
     liable as a manufacturer of a product for harm caused by the 
     product if--
       (1) the manufacturer is not subject to service of process 
     under the laws of any State in which the action may be 
     brought; or
       (2) the court determines that the claimant would be unable 
     to enforce a judgment against the manufacturer.
       (c) Rented or Leased Products.--
       (1) Notwithstanding any other provision of law, any person 
     engaged in the business of renting or leasing a product 
     (other than a person excluded from the definition of product 
     seller under section 101(14)(B)) shall be subject to 
     liability in a product liability action under subsection (a), 
     but shall not be liable to a claimant for the tortious act of 
     another solely by reason of ownership of such product.
       (2) For purposes of paragraph (1), and for determining the 
     applicability of this title to any person subject to 
     paragraph (1), the term ``product liability
      action'' means a civil action brought on any theory for harm 
     caused by a product or product use.

     SEC. 105. DEFENSES INVOLVING INTOXICATING ALCOHOL OR DRUGS.

       (a) General Rule.--Notwithstanding any other provision of 
     law, a defendant in a product liability action that is 
     subject to this title shall have a complete defense in the 
     action if the defendant proves that--
       (1) the claimant was under the influence of intoxicating 
     alcohol or any drug that may not lawfully be sold over-the-
     counter without a prescription, and was not prescribed by a 
     physician for use by the claimant; and
       (2) the claimant, as a result of the influence of the 
     alcohol or drug, was more than 50 percent responsible for the 
     accident or event which resulted in the harm to the claimant.
       (b) Construction.--For purposes of this section, the 
     determination of whether a person was intoxicated or was 
     under the influence of intoxicating alcohol or any drug shall 
     be made pursuant to applicable State law.

     SEC. 106. REDUCTION FOR MISUSE OR ALTERATION OF PRODUCT.

       (a) General Rule.--
       (1) In general.--Except as provided in subsection (c), in a 
     product liability action that is subject to this title, the 
     damages for which a defendant is otherwise liable under 
     applicable State law shall be reduced by the percentage of 
     responsibility for the harm to the claimant attributable to 
     misuse or alteration of a product by any person if the 
     defendant establishes that such percentage of the harm was 
     proximately caused by a use or alteration of a product--
       (A) in violation of, or contrary to, the express warnings 
     or instructions of the defendant if the warnings or 
     instructions are determined to be adequate pursuant to 
     applicable State law; or
       (B) involving a risk of harm which was known or should have 
     been known by the ordinary person who uses or consumes the 
     product with the knowledge common to the class of persons who 
     used or would be reasonably anticipated to use the product.
       (2) Use intended by a manufacturer is not misuse or 
     alteration.--For the purposes of this title, a use of a 
     product that is intended by the manufacturer of the product 
     does not constitute a misuse or alteration of the product.
       (b) State Law.--Notwithstanding section 3(b), subsection 
     (a) of this section shall supersede State law concerning 
     misuse or alteration of a product only to the extent that 
     State law is inconsistent with such subsection.
       (c) Workplace Injury.--Notwithstanding subsection (a), the 
     amount of damages for which a defendant is otherwise liable 
     under State law shall not be reduced by the application of 
     this section with respect to the conduct of any employer or 
     coemployee of the plaintiff who is, under applicable State 
     law concerning workplace injuries, immune from being subject 
     to an action by the claimant.

     SEC. 107. UNIFORM STANDARDS FOR AWARD OF PUNITIVE DAMAGES.

       (a) General Rule.--Punitive damages may, to the extent 
     permitted by applicable State law, be awarded against a 
     defendant in a product liability action that is subject to 
     this title if the claimant establishes by clear and 
     convincing evidence that the harm that is the subject of the 
     action was the result of conduct that was carried out by the 
     defendant with a conscious, flagrant indifference to the 
     safety of others.
       (b) Limitation on Amount.--The amount of punitive damages 
     that may be awarded to a claimant in any product liability 
     action that is subject to this title shall not exceed 3 times 
     the amount awarded to the claimant for the economic loss on 
     which the claim is based, or $250,000, whichever is greater. 
     This subsection shall be applied by the court and the 
     application of this subsection shall not be disclosed to the 
     jury.
       (c) Bifurcation at Request of Either Party.--
       (1) In general.--At the request of either party, the trier 
     of fact in a product liability action that is subject to this 
     title shall consider in a separate proceeding whether 
     punitive damages are to be awarded for the harm that is the 
     subject of the action and the amount of the award.
       (2) Admissible evidence.--
       (A) Inadmissibility of evidence relative only to a claim of 
     punitive damages in a proceeding concerning compensatory 
     damages.--If either party requests a separate proceeding 
     under paragraph (1), in any proceeding to determine whether 
     the claimant may be awarded compensatory damages, any 
     evidence that is relevant only to the claim of punitive 
     damages, as determined by applicable State law, shall be 
     inadmissible.
       (B) Proceeding with respect to punitive damages.--Evidence 
     that is admissible in the separate proceeding under paragraph 
     (1)--
       (i) may include evidence of the profits of the defendant, 
     if any, from the alleged wrongdoing; and
       (ii) shall not include evidence of the overall assets of 
     the defendant.

      SEC. 108. UNIFORM TIME LIMITATIONS ON LIABILITY.

       (a) Statute of Limitations.--
       (1) In general.--Except as provided in paragraph (2) and 
     subsection (b), a product liability action that is subject to 
     this title may be filed not later than 2 years after the date 
     on which the claimant discovered or, in the exercise of 
     reasonable care, should have discovered, the harm that is the 
     subject of the action and the cause of the harm.
       (2) Exceptions.--
       (A) Person with a legal disability.--A person with a legal 
     disability (as determined under applicable law) may file a 
     product liability action that is subject to this title not 
     later than 2 years after the date on which the person ceases 
     to have the legal disability.
       (B) Effect of stay or injunction.--If the commencement of a 
     civil action that is subject to this title is stayed or 
     enjoined, the running of the statute of limitations under 
     this section shall be suspended until the end of the period 
     that the stay or injunction is in effect.
       (b) Statute of Repose.--
       (1) In general.--Subject to paragraphs (2) and (3), no 
     product liability action that is subject to this title 
     concerning a product that is a durable good alleged to have 
     caused harm (other than toxic harm) may be filed after the 
     20-year period beginning at the time of delivery of the 
     product.
       (2) State law.--Notwithstanding paragraph (1), if pursuant 
     to an applicable State law, an action described in such 
     paragraph is required to be filed during a period that is 
     shorter than the 20-year period specified in such paragraph, 
     the State law shall apply with respect to such period.
       (3) Exceptions.--
       (A) A motor vehicle, vessel, aircraft, or train that is 
     used primarily to transport passengers for hire shall not be 
     subject to this subsection.
       (B) Paragraph (1) does not bar a product liability action 
     against a defendant who made an express warranty in writing 
     as to the safety of the specific product involved which was 
     longer than 20 years, but it will apply at the expiration of 
     that warranty.
       (c) Transitional Provision Relating to Extension of Period 
     for Bringing Certain Actions.--If any provision of subsection 
     (a) or (b) shortens the period during which a product 
     liability action that could be otherwise brought pursuant to 
     another provision of law, the claimant may, notwithstanding 
     subsections (a) and (b), bring the product liability action 
     pursuant to this title not later than 1 year after the date 
     of enactment of this Act.

     SEC. 109. SEVERAL LIABILITY FOR NONECONOMIC LOSS.

       (a) General Rule.--In a product liability action that is 
     subject to this title, the liability of each defendant for 
     noneconomic loss shall be several only and shall not be 
     joint.
       (b) Amount of Liability.--
       (1) In general.--Each defendant shall be liable only for 
     the amount of noneconomic loss allocated to the defendant in 
     direct proportion to the percentage of responsibility of the 
     defendant (determined in accordance with paragraph (2)) for 
     the harm to the 
     [[Page S6114]] claimant with respect to which the defendant 
     is liable. The court shall render a separate judgment against 
     each defendant in an amount determined pursuant to the 
     preceding sentence.
       (2) Percentage of responsibility.--For purposes of 
     determining the amount of noneconomic loss allocated to a 
     defendant under this section, the trier of fact shall 
     determine the percentage of responsibility of each person 
     responsible for the claimant's harm, whether or not such 
     person is a party to the action.

      SEC. 110. WORKERS' COMPENSATION SUBROGATION STANDARDS.

       (a) General Rule.--
       (1) Right of subrogation.--
       (A) In general.--An insurer shall have a right of 
     subrogation against a manufacturer or product seller to 
     recover any claimant's benefits relating to harm that is the 
     subject of a product liability action that is subject to this 
     title.
       (B) Written notification.--To assert a right of subrogation 
     under subparagraph (A), the insurer shall provide written 
     notice to the court in which the product liability action is 
     brought.
       (C) Insurer not required to be a party.--An insurer shall 
     not be required to be a necessary and proper party in a 
     product liability action covered under subparagraph (A).
       (2) Settlements and other legal proceedings.--
       (A) In general.--In any proceeding relating to harm or 
     settlement with the manufacturer or product seller by a 
     claimant who files a product liability action that is subject 
     to this title, an insurer may participate to assert a right 
     of subrogation for claimant's benefits with respect to any 
     payment made by the manufacturer or product seller by reason 
     of such harm, without regard to whether the payment is made--
       (i) as part of a settlement;
       (ii) in satisfaction of judgment;
       (iii) as consideration for a covenant not to sue; or
       (iv) in another manner.
       (B) Written consent.--Except as provided in subparagraph 
     (C)--
       (i) an employee shall not make any settlement with or 
     accept any payment from the manufacturer or product seller 
     without the written consent of the insurer; and
       (ii) no release to or agreement with the manufacturer or 
     product seller described in clauses (i) through (iv) of 
     subparagraph (A) shall be valid or enforceable for any 
     purpose without the consent of the insurer.
       (C) Exemption.--Subparagraph (B) shall not apply in any 
     case in which the insurer has been compensated for the full 
     amount of the claimant's benefits.
       (3) Harm resulting from action of employer or coemployee.--
       (A) In general.--If, with respect to a product liability 
     action that is subject to this title, the manufacturer or 
     product seller attempts to persuade the trier of fact that 
     the harm to the claimant was caused by the fault of the 
     employer of the claimant or any coemployee of the claimant, 
     the issue of that fault shall be submitted to the trier of 
     fact, but only after the manufacturer or product seller has 
     provided timely written notice to the employer.
       (B) Rights of employer.--
       (i) In general.--Notwithstanding any other provision of 
     law, with respect to an issue of fault submitted to a trier 
     of fact pursuant to subparagraph (A), an employer shall, in 
     the same manner as any party in the action (even if the 
     employer is not a named party in the action), have the right 
     to--

       (I) appear;
       (II) be represented;
       (III) introduce evidence;
       (IV) cross-examine adverse witnesses; and
       (V) present arguments to the trier of fact.

       (ii) Last issue.--The issue of harm resulting from an 
     action of an employer or coemployee shall be the last issue 
     that is presented to the trier of fact.
       (C) Reduction of damages.--If the trier of fact finds by 
     clear and convincing evidence that the harm to the claimant 
     that is the subject of the product liability action was 
     caused by the fault of the employer or a coemployee of the 
     claimant--
       (i) the court shall reduce by the amount of the claimant's 
     benefits--

       (I) the damages awarded against the manufacturer or product 
     seller; and
       (II) any corresponding insurer's subrogation lien; and

       (ii) the manufacturer or product seller shall have no 
     further right by way of contribution or otherwise against the 
     employer.
       (D) Certain rights of subrogation not affected.--
     Notwithstanding a finding by the trier of fact described in 
     subparagraph (C), the insurer shall not lose any right of 
     subrogation related to any--
       (i) intentional tort committed against the claimant by a 
     coemployee; or
       (ii) act committed by a coemployee outside the scope of 
     normal work practices.
       (b) Attorney's Fees.--If, in a product liability action 
     that is subject to this section, the court finds that harm to 
     a claimant was not caused by the fault of the employer or a 
     coemployee of the claimant, the manufacturer or product 
     seller shall reimburse the insurer for reasonable attorney's 
     fees and court costs incurred by the insurer in the action, 
     as determined by the court.

     SEC. 111. FEDERAL CAUSE OF ACTION PRECLUDED.

       The district courts of the United States shall not have 
     jurisdiction under section 1331 or 1337 of title 28, United 
     States Code, over any product liability action covered under 
     this title.
                TITLE II--BIOMATERIALS ACCESS ASSURANCE

     SEC. 201. SHORT TITLE.

       This title may be cited as the ``Biomaterials Access 
     Assurance Act of 1995''.

     SEC. 202. 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. 203. DEFINITIONS.

       As used in this title:
       (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, 
     [[Page S6115]] 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 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.--With respect to 
     an action brought on behalf or through a minor, such term 
     includes the parent or guardian of the minor.
       (D) Exclusions.--Such term does not include--
       (i) a provider of professional 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; or

       (ii) a manufacturer, seller, or biomaterials supplier.
       (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 nonimplant 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)).
       (8) Qualified specialist.--With respect to an action, the 
     term ``qualified specialist'' means a person who is qualified 
     by knowledge, skill, experience, training, or education in 
     the specialty area that is the subject of the action.
       (9) 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.
       (10) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (11) 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. 204. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.

       (a) General Requirements.--
       (1) In general.--In any civil action covered by this title, 
     a biomaterials supplier may raise any defense set forth in 
     section 205.
       (2) Procedures.--Notwithstanding any other provision of 
     law, the Federal or State court in which a civil action 
     covered by this title 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 
     206.
       (b) Applicability.--
       (1) In general.--Except as provided in paragraph (2), 
     notwithstanding any other provision of law, this title 
     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 title; and
       (B) shall be governed by applicable commercial or contract 
     law.
       (c) Scope of Preemption.--
       (1) In general.--This Act 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 title establishes 
     a rule of law applicable to the recovery of such damages.
       (2) Applicability of other laws.--Any issue that arises 
     under this title 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 title 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. 205. 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; 
     or
       (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.
       (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 the biomaterials supplier--
       (1) held title to the implant that allegedly caused harm to 
     the claimant as a result of purchasing the implant after--
       (A) the manufacture of the implant; and
       (B) the entrance of the implant in the stream of commerce; 
     and
       (2) subsequently resold the implant.
     [[Page S6116]]   (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)(I) 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
       (II) have 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. 206. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST 
                   BIOMATERIALS SUPPLIERS.

       (a) Motion To Dismiss.--In any action that is subject to 
     this title, 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 on the grounds that--
       (1) the defendant is a biomaterials supplier; and
       (2)(A) the defendant should not, for the purposes of--
       (i) section 205(b), be considered to be a manufacturer of 
     the implant that is subject to such section; or
       (ii) section 205(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 205(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) Procedural Requirements.--
       (1) In general.--The procedural requirements described in 
     paragraphs (2) and (3) shall apply to any action by a 
     claimant against a biomaterials supplier that is subject to 
     this title.
       (2) 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--
       (A) 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
       (B) an action against the manufacturer is barred by 
     applicable law.
       (3) Affidavit.--At the time the claimant brings an action 
     against a biomaterials supplier the claimant shall be 
     required to submit an affidavit that--
       (A) declares that the claimant has consulted and reviewed 
     the facts of the action with a qualified specialist, whose 
     qualifications the claimant shall disclose;
       (B) includes a written determination by a qualified 
     specialist that the raw materials or component parts actually 
     used in the manufacture of the implant of the claimant were 
     raw materials or component parts described in section 
     205(d)(1), together with a statement of the basis for such a 
     determination;
       (C) includes a written determination by a qualified 
     specialist that, after a review of the medical record and 
     other relevant material, the raw material or component part 
     supplied by the biomaterials supplier and actually used in 
     the manufacture of the implant was a cause of the harm 
     alleged by claimant, together with a statement of the basis 
     for the determination; and
       (D) states that, on the basis of review and consultation of 
     the qualified specialist, the claimant (or the attorney of 
     the claimant) has concluded that there is a reasonable and 
     meritorious cause for the filing of the action against the 
     biomaterials supplier.
       (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 205(b)(2)(B); or
       (ii) the defendant who filed the motion to dismiss is a 
     seller of the implant who is liable under section 205(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) 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 205 on the 
     grounds that the defendant is not a manufacturer subject to 
     such section 205(b) or seller subject to section 205(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 205(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 205(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 205(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.
       (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 
     205(d) or the failure to establish the applicable elements of 
     section 205(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 
     205(b) 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 
     [[Page S6117]] title 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. 207. APPLICABILITY.

       This Act shall apply to all civil actions covered under 
     this title that are commenced on or after the date of 
     enactment of this title, 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 title.
                                                                    ____

                           Amendment No. 642

       Strike all after the first word of amendment 596 and insert 
     the following:
     1. SHORT TITLE.

       This Act may be cited as the ``Product Liability Fairness 
     Act of 1995''.

                       TITLE I--PRODUCT LIABILITY

     SEC. 101. DEFINITIONS.

       For purposes of this Act, the following definitions shall 
     apply:
       (1) Claimant.--The term ``claimant'' means any person who 
     brings a product liability action and any person on whose 
     behalf such an action is brought. If an action is brought 
     through or on behalf of--
       (A) an estate, the term includes the decedent; or
       (B) a minor or incompetent, the term includes the legal 
     guardian of the minor or incompetent.
       (2) Claimant's benefits.--The term ``claimant's benefits'' 
     means an amount equal to the sum of--
       (A) the amount paid to an employee as workers' compensation 
     benefits; and
       (B) the present value of all workers' compensation benefits 
     to which the employee is or would be entitled at the time of 
     the determination of the claimant's benefits, as determined 
     by the appropriate workers' compensation authority for harm 
     caused to an employee by a product.
       (3) Clear and convincing evidence.--
       (A) In general.--Subject to subparagraph (A), the term 
     ``clear and convincing evidence'' is that measure of 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.
       (B) Degree of proof.--The degree of proof required to 
     satisfy the standard of clear and convincing evidence shall 
     be--
       (i) greater than the degree of proof required to meet the 
     standard of preponderance of the evidence; and
       (ii) less than the degree of proof required to meet the 
     standard of proof beyond a reasonable doubt.
       (4) Commercial loss.--The term ``commercial loss'' means 
     any loss or damage to a product itself, loss relating to a 
     dispute over its value, or consequential economic loss the 
     recovery of which is governed by the Uniform Commercial Code 
     or analogous State commercial law, not including harm.
       (5) Durable good.--The term ``durable good'' means any 
     product, or any component of any such product, which has a 
     normal life expectancy of 3 or more years or is of a 
     character subject to allowance for depreciation under the 
     Internal Revenue Code of 1986, and which is--
       (A) used in a trade or business;
       (B) held for the production of income; or
       (C) sold or donated to a governmental or private entity for 
     the production of goods, training, demonstration, or any 
     other similar purpose.
       (6) Economic loss.--The term ``economic loss'' means any 
     pecuniary loss resulting from harm (including any medical 
     expense loss, work loss, replacement services loss, loss due 
     to death, burial costs, and loss of business or employment 
     opportunities), to the extent that recovery for the loss is 
     permitted under applicable State law.
       (7) Harm.--The term ``harm'' means any physical injury, 
     illness, disease, or death, or damage to property, caused by 
     a product. The term does not include commercial loss or loss 
     or damage to a product itself.
       (8) Insurer.--The term ``insurer'' means the employer of a 
     claimant, if the employer is self-insured, or the workers' 
     compensation insurer of an employer.
       (9) Manufacturer.--The term ``manufacturer'' means--
       (A) any person who is engaged in a business to produce, 
     create, make, or construct any product (or component part of 
     a product), and who designs or formulates the product (or 
     component part of the product), or has engaged another person 
     to design or formulate the product (or component part of the 
     product);
       (B) a product seller, but only with respect to those 
     aspects of a product (or component part of a product) which 
     are created or affected when,
      before placing the product in the stream of commerce, the 
     product seller produces, creates, makes, constructs, 
     designs, or formulates, or has engaged another person to 
     design or formulate, an aspect of a product (or component 
     part of a product) made by another person; or
       (C) any product seller that is not described in 
     subparagraph (B) that holds itself out as a manufacturer to 
     the user of the product.
       (10) Noneconomic loss.--The term ``noneconomic loss''--
       (A) means subjective, nonmonetary loss resulting from harm, 
     including pain, suffering, inconvenience, mental suffering, 
     emotional distress, loss of society and companionship, loss 
     of consortium, injury to reputation, and humiliation; and
       (B) does not include economic loss.
       (11) Person.--The term ``person'' means any individual, 
     corporation, company, association, firm, partnership, 
     society, joint stock company, or any other entity (including 
     any governmental entity).
       (12) Product.--
       (A) In general.--The term ``product'' means any object, 
     substance, mixture, or raw material in a gaseous, liquid, or 
     solid state that--
       (i) is capable of delivery itself or as an assembled whole, 
     in a mixed or combined state, or as a component part or 
     ingredient;
       (ii) is produced for introduction into trade or commerce;
       (iii) has intrinsic economic value; and
       (iv) is intended for sale or lease to persons for 
     commercial or personal use.
       (B) Exclusion.--The term ``product'' does not include--
       (i) tissue, organs, blood, and blood products used for 
     therapeutic or medical purposes, except to the extent that 
     such tissue, organs, blood, and blood products (or the 
     provision thereof) are subject, under applicable State law, 
     to a standard of liability other than negligence; and
       (ii) electricity, water delivered by a utility, natural 
     gas, or steam.
       (13) Product liability action.--The term ``product 
     liability action'' means a civil action brought on any theory 
     for harm caused by a product.
       (14) Product seller.--
       (A) In general.--The term ``product seller'' means a person 
     who--
       (i) in the course of a business conducted for that purpose, 
     sells, distributes, rents, leases, prepares, blends, 
     packages, labels, or otherwise is involved in placing a 
     product in the stream of commerce; or
       (ii) installs, repairs, refurbishes, reconditions, or 
     maintains the harm-causing aspect of the product.
       (B) Exclusion.--The term ``product seller'' 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 a product is incidental to the 
     transaction and the essence of the transaction is the 
     furnishing of judgment, skill, or services; or
       (iii) any person who--

       (I) acts in only a financial capacity with respect to the 
     sale of a product; or
       (II) leases a product under a lease arrangement in which 
     the lessor does not initially select the leased product and 
     does not during the lease term ordinarily control the daily 
     operations and maintenance of the product.

       (15) State.--The term ``State'' means each of the several 
     States of the United States, the District of Columbia, the 
     Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
     American Samoa, and the Commonwealth of the Northern Mariana 
     Islands, and any other territory or possession of the United 
     States, or any political subdivision thereof.
       (16) Time of delivery.--The term ``time of delivery'' means 
     the time when a product is delivered to the first purchaser 
     or lessee of the product that was not involved in 
     manufacturing or selling the product, or using the product as 
     a component part of another product to be sold.

     SEC. 102. APPLICABILITY; PREEMPTION.

       (a) Applicability.--
       (1) Actions covered.--Subject to paragraph (2), this title 
     applies to any product liability action commenced on or after 
     the date of enactment of this Act, without regard to whether 
     the harm that is the subject of the action or the conduct 
     that caused the harm occurred before such date of enactment.
       (2) Actions excluded.--
       (A) Actions for damage to product or commercial loss.--A 
     civil action brought for loss or damage to a product itself 
     or for commercial loss, shall not be subject to the 
     provisions of this title governing product liability actions, 
     but shall be subject to any applicable commercial or contract 
     law.
       (B) Actions for negligent entrustment.--A civil action for 
     negligent entrustment shall not be subject to the provisions 
     of this title governing product liability actions, but shall 
     be subject to any applicable State law.
       (b) Scope of Preemption.--
       (1) In general.--This Act supersedes a State law only to 
     the extent that State law applies to an issue covered under 
     this title.
       (2) Issues not covered under this act.--Any issue that is 
     not covered under this title, including any standard of 
     liability applicable to a manufacturer, shall not be subject 
     to this title, but shall be subject to applicable Federal or 
     State law.
       (c) Statutory Construction.--Nothing in this title may be 
     construed to--
       (1) waive or affect any defense of sovereign immunity 
     asserted by any State under any law;
     [[Page S6118]]   (2) supersede any Federal law;
       (3) waive or affect any defense of sovereign immunity 
     asserted by the United States;
       (4) affect the applicability of any provision of chapter 97 
     of title 28, United States Code;
       (5) preempt State choice-of-law rules with respect to 
     claims brought by a foreign nation or a citizen of a foreign 
     nation;
       (6) 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 of inconvenient forum; or
       (7) supersede or modify any statutory or common law, 
     including any law providing for an action to abate a 
     nuisance, that authorizes a person to institute an action for 
     civil damages or civil penalties, cleanup costs, injunctions, 
     restitution, cost recovery, punitive damages, or any other 
     form of relief for remediation of the environment (as defined 
     in section 101(8) of the Comprehensive Environmental 
     Response, Compensation, and Liability Act of 1980, 42 U.S.C. 
     9601(8)) or the threat of such remediation.
       (d) Construction.--To promote uniformity of law in the 
     various jurisdictions, this title shall be construed and 
     applied after consideration of its legislative history.
       (e) Effect of Court of Appeals Decisions.--Notwithstanding 
     any other provision of law, any decision of a circuit court 
     of appeals interpreting a provision of this title (except to 
     the extent that the decision is overruled or otherwise 
     modified by the Supreme Court) shall be considered a 
     controlling precedent with respect to any subsequent decision 
     made concerning the interpretation of such provision by any 
     Federal or State court within the geographical boundaries of 
     the area under the jurisdiction of the circuit court of 
     appeals.

     SEC. 103. ALTERNATIVE DISPUTE RESOLUTION PROCEDURES.

       (a) In General.--
       (1) Service of offer.--A claimant or a defendant in a 
     product liability action that is subject to this title may, 
     not later than 60 days after the service of the initial 
     complaint of the claimant or the applicable deadline for a 
     responsive pleading (whichever is later), serve upon an 
     adverse party an offer to proceed pursuant to any voluntary, 
     nonbinding alternative dispute resolution procedure 
     established or recognized under the law of the State in which 
     the product liability action is brought or under the rules of 
     the court in which such action is maintained.
       (2) Written notice of acceptance or rejection.--Except as 
     provided in paragraph (3), not later than 10 days after the 
     service of an offer to proceed under paragraph (1), an 
     offeree shall file a written notice of acceptance or 
     rejection of the offer.
       (3) Extension.--The court may, upon motion by an offeree 
     made prior to the expiration of the 10-day period specified 
     in paragraph (2), extend the period for filing a written 
     notice under such paragraph for a period of not more than 60 
     days after the date of expiration of the period specified in 
     paragraph (2). Discovery may be permitted during such period.
       (b) Defendant's Penalty for Unreasonable Refusal.--
       (1) In general.--The court shall assess reasonable 
     attorney's fees (calculated in accordance with paragraph (2)) 
     and costs against the offeree, incurred by the offeror during 
     trial if--
       (A) a defendant as an offeree refuses to proceed pursuant 
     to the alternative dispute resolution procedure referred to 
     subsection (a)(1);
       (B) final judgment is entered against the defendant for 
     harm caused by the product that is the subject of the action; 
     and
       (C) the refusal by the defendant to proceed pursuant to 
     such alternative dispute resolution was unreasonable or not 
     made in good faith.
       (2) Reasonable attorney's fees.--For purposes of this 
     subsection, a reasonable attorney's fee shall be calculated 
     on the basis of an hourly rate, which shall not exceed the 
     hourly rate that is considered acceptable in the community in 
     which the attorney practices law, taking into consideration 
     the qualifications and experience of the attorney and the 
     complexity of the case.
       (c) Good Faith Refusal.--In determining whether the refusal 
     of an offeree to proceed pursuant to the alternative dispute 
     procedure referred to in subsection (a)(1) was unreasonable 
     or not made in good faith, the court shall consider--
       (1) whether the case involves potentially complicated 
     questions of fact;
       (2) whether the case involves potentially dispositive 
     issues of law;
       (3) the potential expense faced by the offeree in retaining 
     counsel for both the alternative dispute resolution procedure 
     and to litigate the matter for trial;
       (4) the professional capacity of available mediators within 
     the applicable geographic area; and
       (5) such other factors as the court considers appropriate.

     SEC. 104. LIABILITY RULES APPLICABLE TO PRODUCT SELLERS.

       (a) General Rule.--
       (1) In general.--In any product liability action that is 
     subject to this title filed by a claimant for harm caused by 
     a product, a product seller other than a manufacturer shall 
     be liable to a claimant, only if the claimant establishes--
       (A) that--
       (i) the product that allegedly caused the harm that is the 
     subject of the complaint was sold, rented, or leased by the 
     product seller;
       (ii) the product seller failed to exercise reasonable care 
     with respect to the product; and
       (iii) the failure to exercise reasonable care was a 
     proximate cause of harm to the claimant; or
       (B) that--
       (i) the product seller made an express warranty applicable 
     to the product that allegedly caused the harm that is the 
     subject of the complaint, independent of any express warranty 
     made by a manufacturer as to the same product;
       (ii) the product failed to conform to the warranty; and
       (iii) the failure of the product to conform to the warranty 
     caused harm to the claimant; or
       (C) that--
       (i) the product seller engaged in intentional wrongdoing, 
     as determined under applicable State law; and
       (ii) such intentional wrongdoing was a proximate cause of 
     the harm that is the subject of the complaint.
       (2) Reasonable opportunity for inspection.--For purposes of 
     paragraph (1)(A)(ii), a product seller shall not be 
     considered to have failed to exercise reasonable care with 
     respect to a product based upon an alleged failure to inspect 
     a product if the product seller had no reasonable opportunity 
     to inspect the product that allegedly caused harm to the 
     claimant.
       (b) Special Rule.--A product seller shall be deemed to be 
     liable as a manufacturer of a product for harm caused by the 
     product if--
       (1) the manufacturer is not subject to service of process 
     under the laws of any State in which the action may be 
     brought; or
       (2) the court determines that the claimant would be unable 
     to enforce a judgment against the manufacturer.
       (c) Rented or Leased Products.--
       (1) Notwithstanding any other provision of law, any person 
     engaged in the business of renting or leasing a product 
     (other than a person excluded from the definition of product 
     seller under section 101(14)(B)) shall be subject to 
     liability in a product liability action under subsection (a), 
     but shall not be liable to a claimant for the tortious act of 
     another solely by reason of ownership of such product.
       (2) For purposes of paragraph (1), and for determining the 
     applicability of this title to any person subject to 
     paragraph (1), the term ``product liability
      action'' means a civil action brought on any theory for harm 
     caused by a product or product use.

     SEC. 105. DEFENSES INVOLVING INTOXICATING ALCOHOL OR DRUGS.

       (a) General Rule.--Notwithstanding any other provision of 
     law, a defendant in a product liability action that is 
     subject to this title shall have a complete defense in the 
     action if the defendant proves that--
       (1) the claimant was under the influence of intoxicating 
     alcohol or any drug that may not lawfully be sold over-the-
     counter without a prescription, and was not prescribed by a 
     physician for use by the claimant; and
       (2) the claimant, as a result of the influence of the 
     alcohol or drug, was more than 50 percent responsible for the 
     accident or event which resulted in the harm to the claimant.
       (b) Construction.--For purposes of this section, the 
     determination of whether a person was intoxicated or was 
     under the influence of intoxicating alcohol or any drug shall 
     be made pursuant to applicable State law.

     SEC. 106. REDUCTION FOR MISUSE OR ALTERATION OF PRODUCT.

       (a) General Rule.--
       (1) In general.--Except as provided in subsection (c), in a 
     product liability action that is subject to this title, the 
     damages for which a defendant is otherwise liable under 
     applicable State law shall be reduced by the percentage of 
     responsibility for the harm to the claimant attributable to 
     misuse or alteration of a product by any person if the 
     defendant establishes that such percentage of the harm was 
     proximately caused by a use or alteration of a product--
       (A) in violation of, or contrary to, the express warnings 
     or instructions of the defendant if the warnings or 
     instructions are determined to be adequate pursuant to 
     applicable State law; or
       (B) involving a risk of harm which was known or should have 
     been known by the ordinary person who uses or consumes the 
     product with the knowledge common to the class of persons who 
     used or would be reasonably anticipated to use the product.
       (2) Use intended by a manufacturer is not misuse or 
     alteration.--For the purposes of this title, a use of a 
     product that is intended by the manufacturer of the product 
     does not constitute a misuse or alteration of the product.
       (b) State Law.--Notwithstanding section 3(b), subsection 
     (a) of this section shall supersede State law concerning 
     misuse or alteration of a product only to the extent that 
     State law is inconsistent with such subsection.
       (c) Workplace Injury.--Notwithstanding subsection (a), the 
     amount of damages for which a defendant is otherwise liable 
     under State law shall not be reduced by the application of 
     this section with respect to the conduct of any employer or 
     coemployee of the plaintiff who is, under applicable State 
     law concerning workplace injuries, immune 
     [[Page S6119]] from being subject to an action by the 
     claimant.

     SEC. 107. UNIFORM STANDARDS FOR AWARD OF PUNITIVE DAMAGES.

       (a) General Rule.--Punitive damages may, to the extent 
     permitted by applicable State law, be awarded against a 
     defendant in a product liability action that is subject to 
     this title if the claimant establishes by clear and 
     convincing evidence that the harm that is the subject of the 
     action was the result of conduct that was carried out by the 
     defendant with a conscious, flagrant indifference to the 
     safety of others.
       (b) Limitation on Amount.--The amount of punitive damages 
     that may be awarded to a claimant in any product liability 
     action that is subject to this title shall not exceed 3 times 
     the amount awarded to the claimant for the economic loss on 
     which the claim is based, or $250,000, whichever is greater. 
     This subsection shall be applied by the court and the 
     application of this subsection shall not be disclosed to the 
     jury.
       (c) Bifurcation at Request of Either Party.--
       (1) In general.--At the request of either party, the trier 
     of fact in a product liability action that is subject to this 
     title shall consider in a separate proceeding whether 
     punitive damages are to be awarded for the harm that is the 
     subject of the action and the amount of the award.
       (2) Admissible evidence.--
       (A) Inadmissibility of evidence relative only to a claim of 
     punitive damages in a proceeding concerning compensatory 
     damages.--If either party requests a separate proceeding 
     under paragraph (1), in any proceeding to determine whether 
     the claimant may be awarded compensatory damages, any 
     evidence that is relevant only to the claim of punitive 
     damages, as determined by applicable State law, shall be 
     inadmissible.
       (B) Proceeding with respect to punitive damages.--Evidence 
     that is admissible in the separate proceeding under paragraph 
     (1)--
       (i) may include evidence of the profits of the defendant, 
     if any, from the alleged wrongdoing; and
       (ii) shall not include evidence of the overall assets of 
     the defendant.

      SEC. 108. UNIFORM TIME LIMITATIONS ON LIABILITY.

       (a) Statute of Limitations.--
       (1) In general.--Except as provided in paragraph (2) and 
     subsection (b), a product liability action that is subject to 
     this title may be filed not later than 2 years after the date 
     on which the claimant discovered or, in the exercise of 
     reasonable care, should have discovered, the harm that is the 
     subject of the action and the cause of the harm.
       (2) Exceptions.--
       (A) Person with a legal disability.--A person with a legal 
     disability (as determined under applicable law) may file a 
     product liability action that is subject to this title not 
     later than 2 years after the date on which the person ceases 
     to have the legal disability.
       (B) Effect of stay or injunction.--If the commencement of a 
     civil action that is subject to this title is stayed or 
     enjoined, the running of the statute of limitations under 
     this section shall be suspended until the end of the period 
     that the stay or injunction is in effect.
       (b) Statute of Repose.--
       (1) In general.--Subject to paragraphs (2) and (3), no 
     product liability action that is subject to this title 
     concerning a product that is a durable good alleged to have 
     caused harm (other than toxic harm) may be filed after the 
     20-year period beginning at the time of delivery of the 
     product.
       (2) State law.--Notwithstanding paragraph (1), if pursuant 
     to an applicable State law, an action described in such 
     paragraph is required to be filed during a period that is 
     shorter than the 20-year period specified in such paragraph, 
     the State law shall apply with respect to such period.
       (3) Exceptions.--
       (A) A motor vehicle, vessel, aircraft, or train that is 
     used primarily to transport passengers for hire shall not be 
     subject to this subsection.
       (B) Paragraph (1) does not bar a product liability action 
     against a defendant who made an express warranty in writing 
     as to the safety of the specific product involved which was 
     longer than 20 years, but it will apply at the expiration of 
     that warranty.
       (c) Transitional Provision Relating to Extension of Period 
     for Bringing Certain Actions.--If any provision of subsection 
     (a) or (b) shortens the period during which a product 
     liability action that could be otherwise brought pursuant to 
     another provision of law, the claimant may, notwithstanding 
     subsections (a) and (b), bring the product liability action 
     pursuant to this title not later than 1 year after the date 
     of enactment of this Act.

     SEC. 109. SEVERAL LIABILITY FOR NONECONOMIC LOSS.

       (a) General Rule.--In a product liability action that is 
     subject to this title, the liability of each defendant for 
     noneconomic loss shall be several only and shall not be 
     joint.
       (b) Amount of Liability.--
       (1) In general.--Each defendant shall be liable only for 
     the amount of noneconomic loss allocated to the defendant in 
     direct proportion to the percentage of responsibility of the 
     defendant (determined in accordance with paragraph (2)) for 
     the harm to the claimant with respect to which the defendant 
     is liable. The court shall render a separate judgment against 
     each defendant in an amount determined pursuant to the 
     preceding sentence.
       (2) Percentage of responsibility.--For purposes of 
     determining the amount of noneconomic loss allocated to a 
     defendant under this section, the trier of fact shall 
     determine the percentage of responsibility of each person 
     responsible for the claimant's harm, whether or not such 
     person is a party to the action.

      SEC. 110. WORKERS' COMPENSATION SUBROGATION STANDARDS.

       (a) General Rule.--
       (1) Right of subrogation.--
       (A) In general.--An insurer shall have a right of 
     subrogation against a manufacturer or product seller to 
     recover any claimant's benefits relating to harm that is the 
     subject of a product liability action that is subject to this 
     title.
       (B) Written notification.--To assert a right of subrogation 
     under subparagraph (A), the insurer shall provide written 
     notice to the court in which the product liability action is 
     brought.
       (C) Insurer not required to be a party.--An insurer shall 
     not be required to be a necessary and proper party in a 
     product liability action covered under subparagraph (A).
       (2) Settlements and other legal proceedings.--
       (A) In general.--In any proceeding relating to harm or 
     settlement with the manufacturer or product seller by a 
     claimant who files a product liability action that is subject 
     to this title, an insurer may participate to assert a right 
     of subrogation for claimant's benefits with respect to any 
     payment made by the manufacturer or product seller by reason 
     of such harm, without regard to whether the payment is made--
       (i) as part of a settlement;
       (ii) in satisfaction of judgment;
       (iii) as consideration for a covenant not to sue; or
       (iv) in another manner.
       (B) Written consent.--Except as provided in subparagraph 
     (C)--
       (i) an employee shall not make any settlement with or 
     accept any payment from the manufacturer or product seller 
     without the written consent of the insurer; and
       (ii) no release to or agreement with the manufacturer or 
     product seller described in clauses (i) through (iv) of 
     subparagraph (A) shall be valid or enforceable for any 
     purpose without the consent of the insurer.
       (C) Exemption.--Subparagraph (B) shall not apply in any 
     case in which the insurer has been compensated for the full 
     amount of the claimant's benefits.
       (3) Harm resulting from action of employer or coemployee.--
       (A) In general.--If, with respect to a product liability 
     action that is subject to this title, the manufacturer or 
     product seller attempts to persuade the trier of fact that 
     the harm to the claimant was caused by the fault of the 
     employer of the claimant or any coemployee of the claimant, 
     the issue of that fault shall be submitted to the trier of 
     fact, but only after the manufacturer or product seller has 
     provided timely written notice to the employer.
       (B) Rights of employer.--
       (i) In general.--Notwithstanding any other provision of 
     law, with respect to an issue of fault submitted to a trier 
     of fact pursuant to subparagraph (A), an employer shall, in 
     the same manner as any party in the action (even if the 
     employer is not a named party in the action), have the right 
     to--

       (I) appear;
       (II) be represented;
       (III) introduce evidence;
       (IV) cross-examine adverse witnesses; and
       (V) present arguments to the trier of fact.

       (ii) Last issue.--The issue of harm resulting from an 
     action of an employer or coemployee shall be the last issue 
     that is presented to the trier of fact.
       (C) Reduction of damages.--If the trier of fact finds by 
     clear and convincing evidence that the harm to the claimant 
     that is the subject of the product liability action was 
     caused by the fault of the employer or a coemployee of the 
     claimant--
       (i) the court shall reduce by the amount of the claimant's 
     benefits--

       (I) the damages awarded against the manufacturer or product 
     seller; and
       (II) any corresponding insurer's subrogation lien; and

       (ii) the manufacturer or product seller shall have no 
     further right by way of contribution or otherwise against the 
     employer.
       (D) Certain rights of subrogation not affected.--
     Notwithstanding a finding by the trier of fact described in 
     subparagraph (C), the insurer shall not lose any right of 
     subrogation related to any--
       (i) intentional tort committed against the claimant by a 
     coemployee; or
       (ii) act committed by a coemployee outside the scope of 
     normal work practices.
       (b) Attorney's Fees.--If, in a product liability action 
     that is subject to this section, the court finds that harm to 
     a claimant was not caused by the fault of the employer or a 
     coemployee of the claimant, the manufacturer or product 
     seller shall reimburse the insurer for reasonable attorney's 
     fees and court costs incurred by the insurer in the action, 
     as determined by the court.

     SEC. 111. FEDERAL CAUSE OF ACTION PRECLUDED.

       The district courts of the United States shall not have 
     jurisdiction under section 1331 or 1337 of title 28, United 
     States Code, over any product liability action covered under 
     this title.

[[Page S6120]]

                TITLE II--BIOMATERIALS ACCESS ASSURANCE

     SEC. 201. SHORT TITLE.

       This title may be cited as the ``Biomaterials Access 
     Assurance Act of 1995''.

     SEC. 202. 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. 203. DEFINITIONS.

       As used in this title:
       (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 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.--With respect to 
     an action brought on behalf or through a minor, such term 
     includes the parent or guardian of the minor.
       (D) Exclusions.--Such term does not include--
       (i) a provider of professional 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; or

       (ii) a manufacturer, seller, or biomaterials supplier.
       (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 nonimplant 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)).
       (8) Qualified specialist.--With respect to an action, the 
     term ``qualified specialist'' means a person who is qualified 
     by knowledge, skill, experience, training, or education in 
     the specialty area that is the subject of the action.
       (9) 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.
       (10) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (11) 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. 204. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.

       (a) General Requirements.--
       (1) In general.--In any civil action covered by this title, 
     a biomaterials supplier may raise any defense set forth in 
     section 205.
       (2) Procedures.--Notwithstanding any other provision of 
     law, the Federal or State court in which a civil action 
     covered by this title 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 
     206.
     [[Page S6121]]   (b) Applicability.--
       (1) In general.--Except as provided in paragraph (2), 
     notwithstanding any other provision of law, this title 
     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 title; and
       (B) shall be governed by applicable commercial or contract 
     law.
       (c) Scope of Preemption.--
       (1) In general.--This Act 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 title establishes 
     a rule of law applicable to the recovery of such damages.
       (2) Applicability of other laws.--Any issue that arises 
     under this title 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 title 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. 205. 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; 
     or
       (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.
       (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 the biomaterials supplier--
       (1) held title to the implant that allegedly caused harm to 
     the claimant as a result of purchasing the implant after--
       (A) the manufacture of the implant; and
       (B) the entrance of the implant in the stream of commerce; 
     and
       (2) subsequently resold the implant.
       (d) Liability for Violating Contractual Requirements or 
     Specifications.--A bio- materials 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)(I) 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
       (II) have 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. 206. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST 
                   BIOMATERIALS SUPPLIERS.

       (a) Motion To Dismiss.--In any action that is subject to 
     this title, 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 on the grounds that--
       (1) the defendant is a biomaterials supplier; and
       (2)(A) the defendant should not, for the purposes of--
       (i) section 205(b), be considered to be a manufacturer of 
     the implant that is subject to such section; or
       (ii) section 205(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 205(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) Procedural Requirements.--
       (1) In general.--The procedural requirements described in 
     paragraphs (2) and (3) shall apply to any action by a 
     claimant against a biomaterials supplier that is subject to 
     this title.
       (2) 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--
       (A) 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
       (B) an action against the manufacturer is barred by 
     applicable law.
       (3) Affidavit.--At the time the claimant brings an action 
     against a biomaterials supplier the claimant shall be 
     required to submit an affidavit that--
       (A) declares that the claimant has consulted and reviewed 
     the facts of the action with a qualified specialist, whose 
     qualifications the claimant shall disclose;
       (B) includes a written determination by a qualified 
     specialist that the raw materials or component parts actually 
     used in the manufacture of the implant of the claimant were 
     raw materials or component parts described in section 
     205(d)(1), together with a statement of the basis for such a 
     determination;
       (C) includes a written determination by a qualified 
     specialist that, after a review of the medical record and 
     other relevant material, the raw material or component part 
     supplied by the biomaterials supplier and actually used in 
     the manufacture of the implant was a cause of the harm 
     alleged by claimant, together with a statement of the basis 
     for the determination; and
       (D) states that, on the basis of review and consultation of 
     the qualified specialist, the claimant (or the attorney of 
     the claimant) has concluded that there is a reasonable and 
     meritorious cause for the filing of the action against the 
     biomaterials supplier.
       (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)).
     [[Page S6122]]   (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 205(b)(2)(B); or
       (ii) the defendant who filed the motion to dismiss is a 
     seller of the implant who is liable under section 205(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) 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 205 on the 
     grounds that the defendant is not a manufacturer subject to 
     such section 205(b) or seller subject to section 205(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 205(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 205(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 205(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.
       (3) Discovery with respect to a biomaterials supplier.--A 
     bio- materials supplier shall be subject to 
     discovery in connection with a motion seeking dismissal or 
     summary judgment on the basis of the inapplicability of 
     section 205(d) or the failure to establish the applicable 
     elements of section 205(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 
     205(b) 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 title 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. 207. APPLICABILITY.

       This Act shall apply to all civil actions covered under 
     this title that are commenced on or after the date of 
     enactment of this title, 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 title.
                                                                    ____

                           Amendment No. 643

       Strike title II of amendment 596.
                                                                    ____

                           Amendment No. 644

       In section 107 of amendment 596, strike subsection (b) and 
     insert the following:
       (b) Limitation on Amount.--
       (1) In general.--Except as provided in paragraph (2), the 
     amount of punitive damages that may be awarded to a claimant 
     in a product liability action that is subject to this title 
     shall not exceed the greater of--
       (A) 3 times the sum of--
       (i) the amount awarded to the claimant for the economic 
     loss on which the claim is based; and
       (ii) the amount awarded to the claimant for the noneconomic 
     loss on which the claim is based; or
       (B) $250,000.
       (2) Exception.--
       (A) Determination by court.--Notwithstanding subsection 
     (c), in a product liability action that is subject to this 
     title, if the court makes a determination that the 
     application of paragraph (1) would result in an award of 
     punitive damages that is insufficient to punish the egregious 
     conduct of the defendant against whom the punitive damages 
     are to be awarded or to deter such conduct in the future, the 
     court shall determine the amount of punitive damages to be 
     awarded to the claimant in a separate proceeding in 
     accordance with this paragraph.
       (B) Factors for consideration.--In any proceeding under 
     subparagraph (A), the court shall consider each of the 
     following:
       (i) The likelihood that serious harm would arise from the 
     misconduct of the defendant.
       (ii) The degree of the awareness of the defendant of that 
     likelihood.
       (iii) The profitability of the misconduct to the defendant.
       (iv) The duration of the misconduct and any concealment of 
     the conduct by the defendant.
       (v) The attitude and conduct of the defendant upon the 
     discovery of the misconduct and whether the misconduct has 
     terminated.
       (vi) The financial condition of the defendant.
       (vii) The total effect of other punishment imposed or 
     likely to be imposed upon the defendant as a result of the 
     misconduct, including any awards of punitive or exemplary 
     damages to persons similarly situated to the claimant and the 
     severity of criminal penalties to which the defendant has 
     been or is likely to be subjected.
       (viii) Any other factor that the court determines to be 
     appropriate.
       (C) Final procedures.--
       (i) Entry of judgment.--At the conclusion of any proceeding 
     under subparagraph (A), the court shall determine the amount 
     of punitive damages to be awarded and shall enter judgment 
     for that amount.
       (ii) Findings of fact and conclusions of law.--Any judgment 
     entered under this subparagraph shall be accompanied by 
     findings of fact and conclusions of law demonstrating 
     consideration of each of the factors set forth in clauses (i) 
     through (v) of subparagraph (B).
                                                                    ____

                           Amendment No. 645

       At the appropriate place in amendment 596, insert the 
     following new section:

     SEC.   . CAP ON PUNITIVE DAMAGES IN CERTAIN ACTIONS.

       Notwithstanding section    15(e)(1), the amount of punitive 
     damages that may be awarded to a claimant in a product 
     liability action that is subject to this Act shall be 
     determined under such section but shall not exceed the amount 
     determined under such section or $250,000, whichever is 
     greater.
                                                                    ____

                           Amendment No. 646

       At the appropriate place in amendment 596, insert the 
     following new section:

     SEC.   . CAP ON PUNITIVE DAMAGES IN CERTAIN ACTIONS.

       Notwithstanding section    15(e), the amount of punitive 
     damages that may be awarded to a claimant in a product 
     liability action that is subject to this Act shall not exceed 
     $500,000.
                                                                    ____

                           Amendment No. 647

       At the appropriate place in amendment 596, insert the 
     following new section:
     [[Page S6123]] SEC.   . CAP ON PUNITIVE DAMAGES IN CERTAIN 
                   ACTIONS.

       Notwithstanding section    15(e)(1), the amount of punitive 
     damages that may be awarded to a claimant in a product 
     liability action that is subject to this Act shall not exceed 
     the greater of 3 times the sum of the amounts described in 
     subparagraphs (A) and (B) of such section.
                                                                    ____

                           Amendment No. 648

       In section 107 of amendment 596, strike subsection (b) and 
     insert the following:
       (b) Limitation on Amount.--
       (1) In general.--Except as provided in paragraph (2), the 
     amount of punitive damages that may be awarded to a claimant 
     in a product liability action that is subject to this title 
     shall not exceed the greater of--
       (A) 2 times the sum of--
       (i) the amount awarded to the claimant for the economic 
     loss on which the claim is based; and
       (ii) the amount awarded to the claimant for the noneconomic 
     loss on which the claim is based; or
       (B) $250,000.
       (2) Exception.--In a product liability action that is 
     subject to this title, if the trier of fact determines that, 
     at the time the action is filed, the annual revenues of the 
     defendant are greater than or equal to $10,000,000, the 
     amount of punitive damages that may be awarded to the 
     claimant shall not exceed the greater of--
       (A) 2 times the sum of--
       (i) the amount awarded to the claimant for the economic 
     loss on which the claim is based; and
       (ii) the amount awarded to the claimant for the noneconomic 
     loss on which the claim is based; or
       (B) $1,000,000.
       (3) Application.--This subsection shall be applied by the 
     court and the application of this subsection shall not be 
     disclosed to the jury.
                                                                    ____

                           Amendment No. 649

       At the end of section 109 of amendment 596, add the 
     following new subsection:
       (c) Special Rule.--Notwithstanding subsections (a) and (b), 
     if a defendant that is liable for noneconomic loss is unable 
     to pay for the damages because the defendant is insolvent or 
     bankrupt (as determined pursuant to applicable Federal or 
     State law), the amount of liability of each other defendant 
     in the action that is found to be liable for noneconomic loss 
     shall be increased by a share, determined in accordance with 
     the percentage of responsibility of the defendant, to cover 
     the amount of liability for noneconomic loss of insolvent or 
     bankrupt defendant.
                                                                    ____

                           Amendment No. 650

       At the end of section 109 of amendment 596, add the 
     following new subsection:
       (C) Exception.--
       (1) In general.--Notwithstanding subsections (a) and (b), 
     in a product liability action that is subject to this title, 
     the liability of the defendant for noneconomic loss shall be 
     joint and several if--
       (A) the percentage of responsibility of the defendant is 
     determined to be greater than or equal to 30 percent of the 
     harm to the claimant; and
       (B) other defendants who are found to be liable for 
     noneconomic loss become insolvent or bankrupt pursuant to 
     applicable Federal or State laws.
       (2) Determination of percentage of responsibility.--For 
     purposes of paragraph (1), in a product liability action that 
     is subject to this title, the trier of fact shall determine 
     the percentage of responsibility of each defendant for the 
     harm to the claimant.
                                                                    ____

                           Amendment No. 651

       At the end of section 107 of amendment 596, add the 
     following new subsections:
       (d) Punitive Damage Revolving Funds.--
       (1) State revolving funds.--
       (A) In general.--Notwithstanding any other provision of 
     law, as soon as practicable after the date of enactment of 
     this Act, each State in which punitive damages may be awarded 
     in connection with product liability actions that are subject 
     to this title shall establish a punitive damage revolving 
     fund into which one-third of the amount of punitive damages 
     awarded in such State in product liability actions that are 
     subject to this title shall be deposited.
       (B) Use of amounts deposited in revolving fund.--Subject to 
     subsection (e), the amounts deposited in the revolving fund 
     shall be used to pay the proportional share of the punitive 
     damages that a defendant in such a product liability action 
     that becomes insolvent or bankrupt pursuant to applicable 
     Federal or State laws is unable to pay.
       (2) Federal revolving fund.--
       (A) In general.--Notwithstanding any other provision of 
     law, as soon as practicable after the date of enactment of 
     this Act, the Secretary of the Treasury shall establish a 
     punitive damage revolving fund that shall be administered by 
     the Director of the Administrative Conference of the United 
     States Courts, into which one-third of the amounts awarded by 
     Federal courts as punitive damages in product liability 
     actions that are subject to this title shall be deposited.
       (B) Use of amounts deposited revolving fund.--Subject to 
     subsection (e), the amounts deposited in the revolving fund 
     shall be used to pay the proportional share of the punitive 
     damages that a defendant in such a product liability action 
     that becomes insolvent or bankrupt pursuant to applicable 
     Federal or State laws is unable to pay.
       (e) Limitation on Payment to Claimant.--With respect to a 
     product liability action that is subject to this title, no 
     claimant may receive a total payment of punitive damages in 
     an amount greater than two-thirds of the amount of the 
     punitive damages awarded by the court.
       (f) Conforming Amendment.--Section 604(a) of title 28, 
     United States Code, is amended by adding at the end the 
     following new paragraph:
       ``(26) Administer the punitive damage revolving fund 
     established under section 107(d)(2) of the Product Liability 
     Fairness Act of 1995.''.
                                 ______

                    FEINGOLD AMENDMENTS NOS. 652-653

  (Ordered to lie on the table.)
  Mr. FEINGOLD submitted two amendments intended to be proposed by him 
to amendment no. 596, proposed by Mr. Gorton to the bill, H.R. 965, 
supra; as follows:

                           Amendment No. 652

       On page 6, line 22, in section 101(12)(B)(i) of title I, 
     insert before the semicolon: ``or any product designed or 
     marketed primarily for the use of children''.
                                                                    ____

                           Amendment No. 653

       On page 6, line 22, in section 101(12)(B)(i) of title I, 
     insert before the semicolon: ``or any product designed or 
     marketed primarily for the use of children''.
                                 ______

                        HATCH AMENDMENT NO. 654

  (Ordered to lie on the table.)
  Mr. HATCH submitted an amendment intended to be proposed by him to 
amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, supra; 
as follows:

       At the appropriate place in amendment No. 596, insert the 
     following new section:

     SEC.   . REPRESENTATIONS AND SANCTIONS UNDER RULE 11 FEDERAL 
                   RULES OF CIVIL PROCEDURE.

       (a) In General.--Notwithstanding anything in this Act, Rule 
     11 of the Federal Rules of Civil Procedure is amendment--
       (1) in subsection (b)(3) by striking out ``or, if 
     specifically so identified, are likely to have evidentiary 
     support after a reasonable opportunity for further 
     investigation or discovery'' and inserting in lieu thereof 
     ``or are well grounded in fact''; and
       (2) in subsection (c)--
       (A) in the first sentence by striking out ``may, subject to 
     the conditions stated below,'' and inserting in lieu thereof 
     ``may'';
       (B) in paragraph (2) by striking out the first and second 
     sentences and inserting in lieu thereof the following: ``A 
     sanction imposed for violation of this rule may consist of 
     reasonable attorneys' fees and other expenses incurred as a 
     result of the violation, directives of a nonmonetary nature, 
     or an order to pay penalty into court or to a party.''; and
       (C) in paragraph (2)(A) by inserting before the period ``, 
     although such sanctions may be awarded against a party's 
     attorneys''.
       (b) Effective Date.--The provisions of this section shall 
     take effect 30 days after the date of the enactment of this 
     Act.
                                 ______

                    SPECTER AMENDMENTS NOS. 655-657

  (Ordered to lie on the table.)
  Mr. SPECTER submitted three amendments intended to be proposed by him 
to amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, 
supra; as follows:

                           Amendment No. 655

       At the appropriate place in title I of the substitute 
     amendment No. 596, insert the following:

     SEC.   . FOREIGN PRODUCTS.

       (a) General Rule.--
       (1) In general.--Notwithstanding any other provisions of 
     law, in any product liability action that is subject to this 
     title for any harm sustained in the United States that 
     relates to the purchase or use of a product manufactured 
     outside the United States by a foreign manufacturer, the 
     Federal district court in which the action is filed shall 
     have personal jurisdiction over such manufacturer if the 
     court determines that the manufacturer knew or reasonably 
     should have known that the product would be imported for sale 
     or use in the United States.
       (2) Service of process.--Process in any action described in 
     paragraph (1) may be served at any location at which the 
     foreign manufacturer is located, has an agent, or regularly 
     transacts business.
       (b) Admission.--In any product liability action that is 
     subject to this title, if a foreign manufacturer of the 
     product fails to furnish any testimony, document, or other 
     thing upon a duly issued discovery order by the court in such 
     action, that failure shall be deemed to be an admission by 
     such manufacturer of any and all facts to which the discovery 
     order relates.
                                                                    ____

                           Amendment No. 656

       In the appropriate place in amendment No. 596, substitute 
     in lieu of section 107(c) the 
     [[Page S6124]] following: ``The amount of punitive damages 
     that may be awarded to a claimant in any civil action subject 
     to this section shall not exceed ten (10) percent of the net 
     worth of the defendant against whom they are imposed.''
                                                                    ____

                           Amendment No. 657

       Strike section 109 of amendment No. 596, and insert the 
     following section:

     SEC. 109. JOINT AND SEVERAL LIABILITY.

       (a) In General.--
       (1) Joint and several liability for all harm.--Except as 
     provided in paragraph (2), in a product liability action that 
     is subject to this title, the liability of each defendant 
     shall be joint and several.
       (2) Exception.--In a product liability action that is 
     subject to this title, the liability of a defendant for 
     noneconomic loss shall be several only if such defendant is 
     determined under subsection (b) to be responsible for a 
     percentage of responsibility for the harm to the claimant 
     that is less than 15 percent.
       (b) Percentage of Responsibility.--In a product liability 
     action that is subject to this title, the trier of fact shall 
     determine the percentage of responsibility of each defendant 
     for the harm to the claimant, including any noneconomic loss.
                                 ______

                     GRAHAM AMENDMENTS NOS. 658-659

  (Ordered to lie on the table.)
  Mr. GRAHAM submitted two amendments intended to be proposed by him to 
amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, supra; 
as follows:

                           Amendment No. 658

       On page 16 of amendment 596, between lines 14 and 15, 
     insert the following:
       (c) Special Rule Relating to Drugs.--
       (1) In general.--Notwithstanding any other provision of 
     law, in any product liability action that is subject to this 
     Act, the amount of liability of a product seller that is 
     found liable to a claimant under subsection (a) for harm 
     caused by a drug that may be lawfully sold, shall be 
     determined on the basis of the market share of sales of the 
     drug by the product seller (as defined and determined by the 
     court).
       (2) Drug defined.--As used in this subsection, the term 
     ``drug'' has the meaning given in section 201(g)(1) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
                                                                    ____

                           Amendment No. 659

       On page 6 of amendment 596, strike out lines 16 through 
     ``subject'' on line 20, and insert the following:
       ``(i) tissue, organs, and blood used for therapeutic or 
     medical purposes, except to the extent that such tissue, 
     organs, and blood (or the provision thereof) are subject,''.
                                 ______

                   WELLSTONE AMENDMENTS NOS. 660-661

  (Ordered to lie on the table.)
  Mr. WELLSTONE submitted two amendments intended to be proposed by him 
to amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, 
supra; as follows:

                           Amendment No. 660

       At an appropriate place, insert the following:
       ``Section   . Notwithstanding any other provision of this 
     Act, with regard to any separate proceeding under this Act to 
     determine the amount of punitive damages, nothing in this Act 
     shall be construed to limit the evidence admissible in such a 
     proceeding beyond the restriction that evidence be relevant 
     to the issue of the amount of punitive damages.''
                                                                    ____

                           Amendment No. 661

       At an appropriate place, insert the following:
       ``Section   . Any limitation contained in this Act on the 
     application of joint liability to the recovery of damages 
     shall apply unless the court determines that its operation 
     will prevent the recovery of ``fair and adequate 
     compensation'' as described in the ``Purposes'' sub-section 
     of the ``Health Care Liability Reform'' title of this Act.''
                                 ______

                         KYL AMENDMENT NO. 681

  Mr. KYL proposed an amendment to amendment No. 596 proposed by Mr. 
Gorton to the bill H.R. 956, supra; as follows:

       In section 103, strike all after subsection (a) through the 
     end of the section.
                                 ______

                       HOLLINGS AMENDMENT NO. 682

  Mr. HOLLINGS proposed an amendment to amendment No. 596 proposed by 
Mr. Gorton to the bill H.R. 956, supra; as follows:

       At the appropriate place in title I, insert the following 
     new section:

     SEC.   . PRODUCT LIABILITY INSURANCE REPORTING.

       (a) Report to Congress.--The Secretary of Commerce 
     (hereafter in this section referred to as the ``Secretary'') 
     shall provide to the Congress before June 30 of each year 
     after the date of enactment of this Act a report analyzing 
     the impact of this Act on insurers which issue product 
     liability insurance either separately or in conjunction with 
     other insurance; and on self-insurers, captive insurers, and 
     risk retention groups.
       (b) Collection of Data.--To carry out the purposes of this 
     section, the Secretary shall collect from each insurer all 
     data considered necessary by the Secretary to present and 
     analyze fully the impact of this Act on such insurers.
       (c) Regulations.--Within 120 days after the date of 
     enactment of this Act, the Secretary shall issue such 
     regulations as may be necessary to implement the purposes, 
     and carry out the provisions, of this section. Such 
     regulations shall be promulgated in accordance with section 
     553 of title 5, United States Code. Such regulations shall--
       (1) require the reporting of information sufficiently 
     comprehensive to make possible a full evaluation of the 
     impact of this Act on such insurers;
       (2) specify the information to be provided by such insurers 
     and the format of such information, taking into account 
     methods to minimize the paper-work and cost burdens on such 
     insurers and the Federal Government; and
       (3) provide, to the maximum extent practicable, that such 
     information is obtained from existing sources, including, but 
     not limited to, State insurance commissioners, recognized 
     insurance statistical agencies, the Administrative Office of 
     the United States Courts, and the National Center for State 
     Courts.
       (d) Subpoena.--The Secretary may subpoena witnesses and 
     records related to the report required under this section 
     from any place in the United States. If a witness disobeys 
     such a subpoena, the Secretary may petition any district 
     court of the United States to enforce such subpoena. The 
     court may punish a refusal to obey an order of the court to 
     comply with such a subpoena as a contempt of court.
                                 ______

                     GORTON AMENDMENTS NOS. 683-685

  Mr. GORTON proposed three amendments to amendment No. 596 proposed by 
Mr. Gorton to the bill H.R. 956, supra; as follows:

                           Amendment No. 683

       On page 2, strike lines 4 through 14 and insert the 
     following:
       (2) Claimant's benefits.--The term ``claimant's benefits'' 
     means the amount paid to an employee as workers' compensation 
     benefits.
       On page 25, line 15, strike ``consent'' and insert 
     ``notification''.
       On page 25, beginning with ``subparagraph'' on line 16 
     strike through line 25 and insert ``Subparagraph (C), an 
     employee shall not make any settlement with or accept any 
     payment from the manufacturer or product seller without 
     written notification to the employer.''.
                                                                    ____

                           Amendment No. 684

       On page 16, line 21, after ``but'' insert ``any person 
     engaged in the business of renting or leasing a product''.
                                                                    ____

                           Amendment No. 685

       On page 16, between lines 14 and 15, insert the following: 
     ``For purposes of this subsection only, the statute of 
     limitations applicable to claims asserting liability of a 
     product seller as a manufacturer shall be tolled from the 
     date of the filing of a complaint against the manufacturer to 
     the date that judgment is entered against the manufacturer.''
                                 ______

                    HOLLINGS AMENDMENTS NOS. 662-674

  (Ordered to lie on the table.)
  Mr. HOLLINGS submitted 13 amendments intended to be proposed by him 
to amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, 
supra; as follows:

                           Amendment No. 662

       Strike lines 8 through 14 on page 9.
                                                                    ____

                           Amendment No. 663

       On page 4, beginning with ``The'' on line 10, strike 
     through line 12.
                                                                    ____

                           Amendment No. 664

       Strike lines 10 through 15 on page 22.
                                                                    ____

                           Amendment No. 665

       On page 11, strike lines 8 through 17.
                                                                    ____

                           Amendment No. 666

       Strike lines 20 through 24 on page 28.
                                                                    ____

                           Amendment No. 667
       At the appropriate place, insert the following:
       Sec.   . Notwithstanding any other provision of this Act, 
     the provision of section 107 that pertains to bifurcated 
     proceedings shall not apply to any civil action.
                                                                    ____

                           Amendment No. 668

       At the appropriate place, insert the following:
       Sec.   . Notwithstanding any other provision of this Act, 
     there shall be no limit because of this Act on the amount of 
     punitive damages that may be awarded to a claimant in any 
     civil action subject to this Act.
                                                                    ____

                    [[Page S6125]] Amendment No. 669

       At the appropriate place, insert the following:
       Sec.   . Notwithstanding any other provision of this Act, 
     no civil action shall be subject to section 107 of this Act.
                                                                    ____

                           Amendment No. 670

       On page 28, between lines 12 and 13, insert the following:

     SEC. 2. APPLICATION OF ACT LIMITED TO DOMESTIC PRODUCTS.

       Notwithstanding any other provision of this Act, this Act 
     shall not apply to any product, component part, implant, or 
     medical device that is not manufactured in the United States 
     within the meaning of the Buy American Act (41 U.S.C. 10a) 
     and the regulations issued thereunder, or to any raw material 
     derived from sources outside the United States.
                                                                    ____

                           Amendment No. 671
       At the appropriate place, insert the following:

     SEC.   . NO PREEMPTION OF RECENT TORT REFORM LAWS.

       Notwithstanding any other provision of this Act to the 
     contrary, nothing in this Act preempts any provision of State 
     law inconsistent with this Act if the legislature of that 
     State considered a legislative proposal dealing with that 
     provision in connection with reforming the tort laws of that 
     State during the period beginning on January 1, 1980, and 
     ending on the date of enactment of this Act, without regard 
     to whether such proposal was adopted, modified and adopted, 
     or rejected.
                                                                    ____

                           Amendment No. 672

       At the appropriate place, insert the following:

     SEC.   . NO PREEMPTION OF RECENT TORT REFORM LAWS.

       Notwithstanding any other provision of this Act to the 
     contrary, nothing in this Act preempts any provision of State 
     law adopted after the date of enactment of this Act.
                                                                    ____

                           Amendment No. 673

       On page 1, between lines 15 and 16, insert the following:

     SEC. 2. STATE IMPLEMENTATION REQUIRED.

       Notwithstanding any provision of this Act to the contrary, 
     nothing in this Act shall supersede any provision of State 
     law or rule of civil procedure unless that State has enacted 
     a law providing for the application of this Act in that 
     State.
                                                                    ____

                           Amendment No. 674
       At the appropriate place in the bill, insert the following:

     SEC. ----. NO PREEMPTION OF RECENT TORT REFORM LAWS.

       Notwithstanding any other provision of this Act to the 
     contrary, nothing in this Act preempts any provision of State 
     law--
       (1) if the legislature of that State considered a 
     legislative proposal dealing with that provision in 
     connection with reforming the tort laws of that State during 
     the period beginning on January 1, 1980, and ending on the 
     date of enactment of this Act, without regard to whether such 
     proposal was adopted, modified and adopted, or rejected; or
       (2) adopted after the date of enactment of this Act.
                                 ______

                     GORTON AMENDMENTS NOS. 675-680

  (Ordered to lie on the table.)
  Mr. GORTON submitted six amendments intended to be proposed by him to 
amendment No. 596, proposed by Mr. Gorton to the bill, H.R. 965, supra; 
as follows:

                           Amendment No. 675

       On page 41, line 17, strike ``or''.
       On page 42, line 2, strike ``or''.
       On page 42, line 7, strike ``so.'' and insert ``so; or''.
       On page 42, between lines 7 and 8, insert the following:
       ``(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 206(c)(3)(B)(i) finds, on the basis of 
     affidavits submitted in accordance with section 206, 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.
       On page 43, strike lines 3 through 13 and insert the 
     following:
       (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 206(c)(3)(B)(i) finds, on 
     the basis of affidavits submitted in accordance with section 
     206, that it is necessary to impose liability on the 
     biomaterials supplier as a seller because the related 
     manufacturer 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.
                                                                    ____

                           Amendment No. 676
       On page 16, line 21, after ``but'' insert ``any person 
     engaged in the business of renting or leasing a product''.
                                                                    ____

                           Amendment No. 677

       On page 2, strike lines 4 through 14 and insert the 
     following:
       (2) Claimant's benefits.--The term ``claimant's benefits'' 
     means the amount paid to an employee as workers' compensation 
     benefits.
       On page 25, line 15, strike ``consent'' and insert 
     ``notification''.
       On page 25, beginning with ``subparagraph'' on line 16 
     strike through line 25 and insert ``subparagraph (C), an 
     employee shall not make any settlement with or accept any 
     payment from the manufacturer or product seller without 
     written notification to the employer.''.
                                                                    ____

                           Amendment No. 678

       On page 16, between lines 14 and 15, insert the following:
       For purposes of this subsection only, the statute of 
     limitations applicable to claims asserting liability of a 
     product seller as a manufacturer shall be tolled from the 
     date of the filing of a complaint against the manufacturer to 
     the date that judgment is entered against the manufacturer.
                                                                    ____

                           Amendment No. 679
       On page 37, strike lines 5 through 9.
       On page 37, line 10, strike ``(9)'' and insert ``(8)''.
       On page 37, line 15, strike ``(10)'' and insert ``(9)''.
       On page 37, line 17, strike ``(11)'' and insert ``(10)''.
       On page 46, beginning with line 7, strike through line 25 
     on page 74 and insert the following:
       (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.
                                                                    ____

                           Amendment No. 680

       On page 7, lines 1 through 3, strike all and insert in lieu 
     thereof the following:
       (13) Product liability action.--The term ``product 
     liability action'' means a civil action, brought against a 
     manufacturer, seller, or any other person responsible for the 
     distribution of a product in the stream of commerce, 
     involving a defect or design of the product or anything for 
     harm caused by the product.
     

                          ____________________
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