Report text available as:

(PDF provides a complete and accurate display of this text.) Tip?


105th Congress                                            Rept. 105-549
                        HOUSE OF REPRESENTATIVES

 2d Session                                                      Part 1
_______________________________________________________________________


 
               BIOMATERIALS ACCESS ASSURANCE ACT OF 1998

_______________________________________________________________________


                  May 22, 1998.--Ordered to be printed

                                _______
                                

Mr. Gekas, from the Committee on the Judiciary, submitted the following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 872]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on the Judiciary, to whom was referred the bill 
(H.R. 872) to establish rules governing product liability 
actions against raw materials and bulk component suppliers to 
medical device manufacturers, and for other purposes, having 
considered the same, reports favorably thereon with an 
amendment and recommends that the bill as amended do pass.


                           TABLE OF CONTENTS

                                                                   Page
The Amendment..............................................           2
Purpose and Summary........................................           9
Background and Need for the Legislation....................           9
Hearings...................................................          12
Committee Consideration....................................          13
Committee Oversight Findings...............................          13
Committee on Government Reform and Oversight Findings......          13
New Budget Authority and Tax Expenditures..................          13
Congressional Budget Office Cost Estimate..................          13
Constitutional Authority Statement.........................          15
Section-by-Section Analysis and Discussion.................          15
Dissenting Views...........................................          21

  The amendment is as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

SECTION 1. SHORT TITLE

  This Act may be cited as the ``Biomaterials Access Assurance Act of 
1998''.

SEC. 2. FINDINGS.

  The 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) move in interstate commerce;
                  (B) are not designed or manufactured specifically for 
                use in medical devices; and
                  (C) 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 component parts;
          (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 for a number of 
        reasons, including concerns about the costs of such litigation;
          (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) because medical devices and the raw materials and 
        component parts used in their manufacture move in interstate 
        commerce, a shortage of such raw materials and component parts 
        affects interstate commerce;
          (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;
          (16) the several States and their courts are the primary 
        architects and regulators of our tort system; Congress, 
        however, must, in certain circumstances involving the national 
        interest, address tort issues, and a threatened shortage of raw 
        materials and component parts for life-saving medical devices 
        is one such circumstance; and
          (17) the protections set forth in this Act are needed to 
        assure the continued supply of materials for life-saving 
        medical devices; however, negligent suppliers should not be 
        protected.

SEC. 3. DEFINITIONS.

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

SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.

  (a) General Requirements.--
          (1) In general.--In any civil action covered by this Act, a 
        biomaterials supplier may raise any defense set forth in 
        section 5.
          (2) Procedures.--Notwithstanding any other provision of law, 
        the Federal or State court in which a civil action covered by 
        this Act 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 6.
  (b) Applicability.--
          (1) In general.--Except as provided in paragraph (2), 
        notwithstanding any other provision of law, this Act 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 Act; 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 Act establishes a rule 
        of law applicable to the recovery of such damages.
          (2) Applicability of other laws.--Any issue that arises under 
        this Act 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 Act 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. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

  (a) In General.--
          (1) Exclusion from liability.--Except as provided in 
        paragraph (2) or section 7, 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 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 or should have 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 or should have included the implant on 
                a list of devices filed with the Secretary pursuant to 
                section 510(j) of such Act (21 U.S.C. 360(j)) and the 
                regulations issued under such section;
                  (B) is the subject of a declaration issued by the 
                Secretary pursuant to paragraph (3) that states that 
                the supplier, with respect to the implant that 
                allegedly caused harm to the claimant, was required 
                to--
                          (i) register with the Secretary under section 
                        510 of such Act (21 U.S.C. 360), and the 
                        regulations issued under such section, but 
                        failed to do so; or
                          (ii) include the implant on a list of devices 
                        filed with the Secretary pursuant to section 
                        510(j) of such Act (21 U.S.C. 360(j)) and the 
                        regulations issued under such section, but 
                        failed to do so; or
                  (C) is related by common ownership or control to a 
                person meeting all the requirements described in 
                subparagraph (A) or (B), if the court deciding a motion 
                to dismiss in accordance with section 6(c)(3)(B)(i) 
                finds, on the basis of affidavits submitted in 
                accordance with section 6, that it is necessary to 
                impose liability on the biomaterials supplier as a 
                manufacturer because the related manufacturer meeting 
                the requirements of subparagraph (A) or (B) lacks 
                sufficient financial resources to satisfy any judgment 
                that the court feels it is likely to enter should the 
                claimant prevail.
          (3) Administrative procedures.--
                  (A) In general.--The Secretary may issue a 
                declaration described in paragraph (2)(B) on the motion 
                of the Secretary or on petition by any person, after 
                providing--
                          (i) notice to the affected persons; and
                          (ii) an opportunity for an informal hearing.
                  (B) Docketing and final decision.--Immediately upon 
                receipt of a petition filed pursuant to this paragraph, 
                the Secretary shall docket the petition. Not later than 
                180 days after the petition is filed, the Secretary 
                shall issue a final decision on the petition.
                  (C) Applicability of statute of limitations.--Any 
                applicable statute of limitations shall toll during the 
                period during which a claimant has filed a petition 
                with the Secretary under this paragraph.
  (c) Liability as Seller.--A biomaterials supplier may, to the extent 
required and permitted by any other applicable law, be liable as a 
seller for harm to a claimant caused by an implant only 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 6(c)(3)(B)(ii) finds, on the basis of 
        affidavits submitted in accordance with section 6, that it is 
        necessary to impose liability on the biomaterials supplier as a 
        seller because the related seller meeting the requirements of 
        paragraph (1) lacks sufficient financial resources to satisfy 
        any judgment that the court feels it is likely to enter should 
        the claimant prevail.
  (d) Liability for Violating Contractual Requirements or 
Specifications.--A biomaterials supplier may, to the extent required 
and permitted by any other applicable law, be liable for harm to a 
claimant caused by an implant if the claimant in an action shows, by a 
preponderance of the evidence, that--
          (1) the raw materials or component parts delivered by the 
        biomaterials supplier either--
                  (A) did not constitute the product described in the 
                contract between the biomaterials supplier and the 
                person who contracted for delivery of the product; or
                  (B) failed to meet any specifications that were--
                          (i) accepted, pursuant to applicable law, by 
                        the biomaterials supplier;
                          (ii)(I) published by the biomaterials 
                        supplier;
                          (II) provided to the manufacturer by the 
                        biomaterials supplier; or
                          (III) contained in a master file that was 
                        submitted by the biomaterials supplier to the 
                        Secretary and that is currently maintained by 
                        the biomaterials supplier for purposes of 
                        premarket approval of medical devices; or
                          (iii) included in the submissions for 
                        purposes of premarket approval or review by the 
                        Secretary under section 510, 513, 515, or 520 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360, 360c, 360e, or 360j), and received 
                        clearance from the Secretary if such 
                        specifications were accepted, pursuant to 
                        applicable law, by the biomaterials supplier; 
                        and
          (2) such conduct was an actual and proximate cause of the 
        harm to the claimant.

SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST BIOMATERIALS 
                    SUPPLIERS.

  (a) Motion to Dismiss.--In any action that is subject to this Act, a 
biomaterials supplier who is a defendant in such action may, at any 
time during which a motion to dismiss may be filed under an applicable 
law, move to dismiss the action against it on the grounds that--
          (1) the defendant is a biomaterials supplier; and
          (2)(A) the defendant should not, for the purposes of--
                  (i) section 5(b), be considered to be a manufacturer 
                of the implant that is subject to such section; or
                  (ii) section 5(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 5(d), that the supplier furnished raw materials or 
        component parts in violation of contractual requirements or 
        specifications; or
          (ii) the claimant has failed to comply with the procedural 
        requirements of subsection (b).
  (b) Manufacturer of Implant Shall be Named a Party.--The claimant 
shall be required to name the manufacturer of the implant as a party to 
the action, unless--
          (1) the manufacturer is subject to service of process solely 
        in a jurisdiction in which the biomaterials supplier is not 
        domiciled or subject to a service of process; or
          (2) a claim against the manufacturer is barred by applicable 
        law or rule of practice.
  (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 
                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 5(b)(2)(B); or
                          (ii) the defendant who filed the motion to 
                        dismiss is a seller of the implant who is 
                        liable under section 5(c).
          (2) Effect of motion to dismiss on discovery.--
                  (A) In general.--If a defendant files a motion to 
                dismiss under paragraph (1) or (2) of subsection (a), 
                no discovery shall be permitted in connection to the 
                action that is the subject of the motion, other than 
                discovery necessary to determine a motion to dismiss 
                for lack of jurisdiction, until such time as the court 
                rules on the motion to dismiss in accordance with the 
                affidavits submitted by the parties in accordance with 
                this section.
                  (B) Discovery.--If a defendant files a motion to 
                dismiss under subsection (a)(2)(B)(i) on the grounds 
                that the biomaterials supplier did not furnish raw 
                materials or component parts in violation of 
                contractual requirements or specifications, the court 
                may permit discovery, as ordered by the court. The 
                discovery conducted pursuant to this subparagraph shall 
                be limited to issues that are directly relevant to--
                          (i) the pending motion to dismiss; or
                          (ii) the jurisdiction of the court.
          (3) Affidavits relating to 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 section 5(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 5 on the grounds that the defendant is not a 
                manufacturer subject to such section 5(b) or seller 
                subject to section 5(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 
                        5(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 5(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 
                5(d).
                  (B) Issues of material fact.--With respect to a 
                finding made under subparagraph (A), the court shall 
                consider a genuine issue of material fact to exist only 
                if the evidence submitted by claimant would be 
                sufficient to allow a reasonable jury to reach a 
                verdict for the claimant if the jury found the evidence 
                to be credible.
          (2) Discovery made prior to a ruling on a motion for summary 
        judgment.--If, under applicable rules, the court permits 
        discovery prior to a ruling on a motion for summary judgment 
        made pursuant to this subsection, such discovery shall be 
        limited solely to establishing whether a genuine issue of 
        material fact exists as to the applicable elements set forth in 
        paragraphs (1) and (2) of section 5(d).
          (3) Discovery with respect to a biomaterials supplier.--A 
        biomaterials supplier shall be subject to discovery in 
        connection with a motion seeking dismissal or summary judgment 
        on the basis of the inapplicability of section 5(d) or the 
        failure to establish the applicable elements of section 5(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 5(b)(3)(A) with respect 
to a defendant, and the Secretary has not issued a final decision on 
the petition, the court shall stay all proceedings with respect to that 
defendant until such time as the Secretary has issued a final decision 
on the petition. The Secretary shall complete review of any such 
petition within 6 weeks of receipt of the petition.
  (f) Dismissal With Prejudice.--An order granting a motion to dismiss 
or for summary judgment pursuant to this section shall be entered with 
prejudice, except insofar as the moving defendant may be rejoined to 
the action as provided in section 7.
  (g) Manufacturer Conduct of Litigation.--The manufacturer of an 
implant that is the subject of an action covered under this Act shall 
be permitted to conduct litigation on any motion for summary judgment 
or dismissal filed by a biomaterials supplier who is a defendant under 
this section on behalf of such supplier 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 litigation or to conduct such litigation.

SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED DEFENDANT.

  (a) Impleading of Dismissed Defendant.--A court, upon motion by a 
manufacturer or a claimant within 90 days after entry of a final 
judgment in an action by the claimant against a manufacturer, and 
notwithstanding any otherwise applicable statute of limitations, may 
implead a biomaterials supplier who has been dismissed from the action 
pursuant to this Act if--
          (1) the manufacturer has made an assertion, either in a 
        motion or other pleading filed with the court or in an opening 
        or closing statement at trial, or as part of a claim for 
        contribution or indemnification, and the court makes a finding 
        based on the court's independent review of the evidence 
        contained in the record of the action, that under applicable 
        law--
                  (A) the negligence or intentionally tortious conduct 
                of the dismissed supplier was an actual and proximate 
                cause of the harm to the claimant; and
                  (B) the manufacturer's liability for damages should 
                be reduced in whole or in part because of such 
                negligence or intentionally tortious conduct; or
          (2) the claimant has moved to implead the supplier and the 
        court makes a finding based on the court's independent review 
        of the evidence contained in the record of the action, that 
        under applicable law--
                  (A) the negligence or intentionally tortious conduct 
                of the dismissed supplier was an actual and proximate 
                cause of the harm to the claimant; and
                  (B) the claimant is unlikely to be able to recover 
                the full amount of its damages from the remaining 
                defendants.
  (b) Standard of Liability.--Notwithstanding any preliminary finding 
under subsection (a), a biomaterials supplier who has been impleaded 
into an action subject to this Act, as provided for in this section--
          (1) may, prior to entry of judgment on the claim against it, 
        supplement the record of the proceeding that was developed 
        prior to the grant of the motion for impleader under subsection 
        (a), and
          (2) may be found liable to a manufacturer or a claimant only 
        to the extent required and permitted by any applicable State or 
        Federal law other than this Act in an action alleging harm 
        caused by an implant.
  (c) Discovery.--Nothing in this section shall give a claimant or any 
other party the right to obtain discovery from a biomaterials supplier 
defendant at any time prior to grant of a motion for impleader beyond 
that allowed under section 6.

SEC. 8. APPLICABILITY.

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

                          Purpose and Summary

    H.R. 872, the ``Biomaterials Access Assurance Act of 1998'' 
is designed to ensure American patients' access to medical 
implants and devices. To foster medical device access, the bill 
would protect the suppliers of raw materials and component 
parts for such devices from much of the costs of discovery and 
defense in lawsuits where those suppliers would not be held 
liable. Litigation costs currently drive biomaterials suppliers 
away from the medical market, with potentially disastrous 
effects for ill and injured Americans.
    H.R. 872 would essentially codify for biomaterials 
suppliers the ``bulk supplier'' and ``learned intermediary'' 
doctrines from the common law of torts. These doctrines 
generally provide that manufacturers--not suppliers of raw 
materials and component parts--are responsible for ensuring 
that products are safe.
    The bill would also establish expedited procedures for 
dismissal of actions from which biomaterials suppliers are 
protected. A biomaterials supplier could be re-joined to a suit 
from which it was dismissed if evidence admitted in a trial 
between a claimant and an implant manufacturer showed that the 
biomaterials supplier may be liable.

                Background and Need For the Legislation

    Biomaterials are the raw materials and component parts that 
go into medical implants and devices, which save and enhance 
the lives of millions of Americans. Under the bill's 
definition, biomaterials have generic or non-implant uses, and 
they are used in a variety of nonmedical products.
    The common law of torts generally gives an injured person a 
cause of action against manufacturers and sellers of products 
that cause injuries. This is based on the principle that such 
parties owe consumers a duty to make sure that their products 
are safe. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
Sec. 301 et seq.) requires manufacturers of medical devices to 
ensure and demonstrate that their products are safe and 
effective, are properly designed, and have adequate warnings or 
instructions.
    Suppliers of biomaterials do not design, test, or produce 
medical devices so they are not responsible, at common law or 
by statute, for ensuring the safety of medical devices. 
Nonetheless, when a medical device is alleged to have caused 
harm, biomaterials suppliers are often named along with 
manufacturers as defendants in lawsuits alleging inadequate 
design and testing or inadequate warning related to use of the 
device.
    Biomaterials suppliers are almost never held liable because 
of two common law doctrines, the ``bulk supplier'' and 
``learned intermediary'' doctrines. They hold, in general, that 
the manufacturer of a component (in this context, a 
biomaterials supplier) is not liable for injuries caused by the 
component when it is incorporated into a finished product by a 
third party (in this case, an implant manufacturer) where the 
component in and of itself was not unreasonably dangerous at 
the time it left the component manufacturer's control.\1\ In 
the same circumstances, a component manufacturer is generally 
not liable for failure to warn potential consumers of known or 
suspected finished product dangers.\2\
---------------------------------------------------------------------------
    \1\ See Restatement (Third) of Torts: Products Liability Sec. 5, 
cmt. a (1997) (``However expressed, these formulations recognize that 
component sellers who do not participate in the integration of the 
component into the design of the product should not be liable merely 
because the integration of the component causes the product to become 
dangerously defective.''); 1 Am. Law Prod. Liab. 3d (LCP BW) Sec. 8:8 
(May, 1996); In re TMJ Implants Prods. Liab. Litig., 872 F. Supp. 1019, 
1025-28 (D. Minn. 1995) (discussing raw material supplier and bulk 
supplier/learned intermediary rules).
    \2\ See 1 Am. Law Prod. Liab. 3d (LCP BW) Sec. 8:14 (May, 1996). 
Many courts have noted the inadvisability of extending the duty to 
warn, and thus liability, to component manufacturers. See, e.g., 
Apperson v. E.I. Du Pont de Nemours, 41 F.3d 1103 (7th Cir. 1994) 
(``[I]mposing such a duty forces the supplier to retain an expert in 
every finished product manufacturer's line of business.'').
---------------------------------------------------------------------------
    Because relatively small quantities and numbers of 
biomaterials are used for medical devices, sales of raw 
materials and component parts for medical devices often 
constitute an extremely small portion of the overall market for 
such products. For example, the quantity of polyester (PET) 
yarn consumed for permanent implants is about 0.002% of that 
consumed by other markets, the quantity of PTFE fiber consumed 
by the implant market is 0.3% of other markets, and the 
quantity of polyacetal resin consumed by the implant market is 
0.00025% of other markets.\3\
---------------------------------------------------------------------------
    \3\ Aronoff Associates, Market Study: Biomaterials Supply for 
Permanent Medical Implants 2 (March 1994).
---------------------------------------------------------------------------
    Many biomaterials suppliers have ceased supplying raw 
materials and component parts for use in medical devices and 
implants because the costs associated with litigation far 
exceed the benefits of sales to the medical market. For 
example, based on sales of less than $100 dollars-worth of 
Teflon, DuPont has been sued 651 times in 41 States over ten 
years, spending several million dollars successfully defending 
product liability suits related to another company's use of 
Teflon in jaw implants.\4\ In a recent study of biomaterials 
suppliers, all of them considered the risk of legal liability 
as a prominent factor in their decision whether or not to 
supply the medical market.\5\ Biomaterials that have been 
withdrawn or threatened with withdrawal from the market include 
fluorinated carbon, surgical stainless steel, fluorpolymers, 
resins and film products, silicone and silicone adhesives, 
polyethylene, nickel and titanium memory metals, and many 
others.
---------------------------------------------------------------------------
    \4\ Letter from Ross F. Schmucki, Senior Counsel, Du Pont, to 
Senator Joseph I. Lieberman (July 25, 1997).
    \5\ Aronoff Associates, Biomaterials Availability: A Vital Health 
Care Industry Hangs in the Balance 10 (April 1997).
---------------------------------------------------------------------------
    Continued abandonment of the medical market by biomaterials 
suppliers would have several probable effects. Some life-
enhancing and life-saving devices could disappear from the 
market altogether. Other devices could disappear from the 
market while implant manufacturers redesign, retest, and 
recertify them with the Food and Drug Administration using 
alternative biomaterials. Whether or not any device comes off 
the market, the prices of medical devices for patients would 
rise as manufacturers pass on added costs. Already, uncertain 
availability of biomaterials impedes the design, testing, and 
marketing of new life-enhancing and life-saving implants and 
devices.\6\ The medical device and implant industry could 
decline relative to countries where biomaterials continue to be 
available. American jobs in that now-vibrant industry could 
level off or decline. Most importantly, patients needing life-
saving and life-enhancing medical implants and devices could be 
forced to go without and, as a result, could needlessly suffer 
or die.
---------------------------------------------------------------------------
    \6\ See Biomaterials Access Assurance Act: Hearing on H.R. 872 
Before the Subcomm. on Commercial and Administrative Law of the House 
Comm. on the Judiciary, 105th Cong. 122 (1997) (testimony of Dr. James 
E. Brown).
---------------------------------------------------------------------------
    Article I, section 8 of the Constitution gives Congress the 
power ``To regulate Commerce with foreign Nations and among the 
several States.'' \7\ Modern consumers are less-and-less likely 
to reside in the State--or even the country--where products 
they purchase, and the components of those products, are 
manufactured. Biomaterials and the medical implants and devices 
made from them are a good example. They are bought, sold, and 
transported for purchase and sale throughout the United States 
and the world. Many medical devices and implants, moreover, go 
on to be transported among the States and throughout the world 
in the bodies of individuals whom they have restored to health 
and vitality.
---------------------------------------------------------------------------
    \7\ U.S. Const. art. I, Sec. 8, Cl. 3.
---------------------------------------------------------------------------
    Though the States and their courts are the primary 
architects and regulators of the tort system, biomaterials 
suppliers can not be protected, and their participation in the 
medical market fostered, by reform in any one State or group of 
States. The susceptibility of biomaterials suppliers to 
extensive litigation and discovery in any State could drive 
them from the medical market entirely, frustrating the purposes 
of the bill. The Committee has heard testimony empirically 
illustrating the incapacity of State tort law reform to 
effectively apply to products that move in interstate commerce 
because they are bought, sold, and used in numerous 
jurisdictions.\8\ Leaving biomaterials suppliers susceptible to 
high litigation costs in any State would harm all of the United 
States and their citizens because medical devices and implants 
would be more scarce and expensive, and because the now-
thriving biotechnology industry would be hobbled in its 
competition with firms in countries where biomaterials are more 
freely available.
---------------------------------------------------------------------------
    \8\ Hearing on Product Liability Reform Before the House Comm. on 
the Judiciary, 105th Cong. 93 (1997) (statement of Representative Tom 
Campbell).
---------------------------------------------------------------------------
    Congress can address civil liability issues when they 
directly and substantially affect commerce among the States and 
with foreign nations. A threatened or actual shortage of raw 
materials and component parts for life-saving and life-
enhancing medical devices, and a threatened or actual shortage 
of such devices, is a circumstance where the Constitution's 
Commerce Clause empowers Congress to act.
    The Biomaterials Access Assurance Act would generally 
codify for biomaterials suppliers the protections from 
liability found in the common law of torts. A limited 
protection from liability, coupled with three exceptions, cause 
the bill's protections to follow the contours of the common law 
in most States. A biomaterials supplier would not be protected 
by the bill if (a) it is the manufacturer of a medical device, 
(b) it is the seller of a medical device, or (c) it failed to 
meet contractual and other specifications.
    In addition, the bill would create expedited procedures for 
determining whether a biomaterials supplier defendant is 
protected by the bill. A defendant asserting such protection 
would file a motion to dismiss alleging that it is a 
biomaterials supplier not subject to any exception. The motion 
to dismiss in most cases would be decided on affidavits, and 
discovery would be limited during pendency of the motion.
    The bill contains a post-trial procedure designed to retain 
the protections of the bill while providing for the 
extraordinary situation in which a dismissed biomaterials 
supplier should be liable. Within 90 days of entry of final 
judgment in the action by the claimant against the implant 
manufacturer, a claimant could move to implead a dismissed 
biomaterials supplier. A court would be authorized to grant 
such a motion under limited circumstances. The rulings on these 
motions would be preliminary because, once brought back into 
the proceeding, a biomaterials supplier would be entitled to 
supplement the record with evidence relevant to the court's 
ultimate finding of liability.
    Some of the more prominent objections to the bill have 
decried cases where implant manufacturer defendants have sought 
bankruptcy protection, potentially denying recovery to 
deserving plaintiffs.\9\ Bankruptcy of an implant manufacturer 
creates no duty on the part of biomaterials suppliers to 
protect the users of implant manufacturers' products, and it 
does not extend liability on the part of biomaterials 
suppliers.\10\ The Biomaterials Access Assurance Act leaves in 
place the outcomes in cases where there is a bankrupt implant 
manufacturer. The bill would, however, allow actions against 
biomaterials suppliers related by common ownership and control 
to manufacturers or sellers found to lack sufficient resources 
to pay a likely judgment.
---------------------------------------------------------------------------
    \9\ Federal bankruptcy law generally protects debtors from 
proceedings and judgments against them. See 11 U.S.C. Sec. 362.
    \10\ See, e.g., In re TMJ Implants Prods. Liab. Litig., 872 F. 
Supp. 1019 (D. Minn. 1995).
---------------------------------------------------------------------------

                                Hearings

    In the 105th Congress, the Committee's Subcommittee on 
Commercial and Administrative Law held a hearing dealing with 
H.R. 872 on June 12, 1997. Testimony was received from eleven 
witnesses, representing themselves and five organizations, with 
additional material submitted by two organizations. The 
witnesses were Neil Kahanovitz, M.D., Founder, Center for 
Patient Advocacy; Rita Bergmann of Clarksburg, Maryland; Randy 
Markey of Newton, Massachusetts; Stephen D. Kaiser of 
Baltimore, Maryland; Donald P. Doty of Minnetonka, Minnesota; 
Kenneth M. Kent, M.D., Director, Washington Cardiology Center; 
Ronald J. Greene, Esq., Wilmer, Cutler & Pickering, 
representing the Health Industry Manufacturers Association; Dr. 
James E. Brown, Vice President for Biopharmaceutical and 
Implant R&D;, Alza Corporation; Dane A. Miller, Ph.D., President 
and CEO, BioMet, Inc.; Jorge Ramirez, Ph.D., Sales and 
Marketing Manager, Hostalen GUR Americas, Hoechst Corporation; 
and Professor Mark McLaughlin Hager, Washington College of the 
Law, American University. The House Commerce Committee's 
Subcommittee on Telecommunications, Trade, and Consumer 
Protection also held a hearing on the subject of biomaterials 
access on April 8, 1997. A version of the bill has been 
reported by the Senate Committee on Commerce, Science, and 
Transportation as a title of S. 648. Several versions of 
biomaterials access legislation were introduced in the 104th 
Congress, including H.R. 753, introduced by Mr. Gekas, S. 303, 
and S. 565, the latter of which was reported by the Senate 
Committee on Commerce, Science, and Transportation. H.R. 753 
was the basis of the biomaterials access title in H.R. 956, the 
Common Sense Legal Standards Reform Act, which passed both the 
House and Senate. Mr. Gekas re-introduced biomaterials access 
legislation as H.R. 3468 after President Clinton vetoed H.R. 
956.

                        Committee Consideration

    On September 11, 1997, the Subcommittee on Commercial and 
Administrative Law met in open session and ordered reported the 
bill H.R. 872, as amended, by voice vote, a quorum being 
present. On April 1, 1998, the Committee met in open session 
and ordered reported favorably the bill H.R. 872 as amended by 
voice vote, a quorum being present.

                      Committee Oversight Findings

    In compliance with clause 2(l)(3)(A) of rule XI of the 
Rules of the House of Representatives, the Committee reports 
that the findings and recommendations of the Committee, based 
on oversight activities under clause 2(b)(1) of rule X of the 
Rules of the House of Representatives, are incorporated in the 
descriptive portions of this report.

         Committee on Government Reform and Oversight Findings

    No findings or recommendations of the Committee on 
Government Reform and Oversight were received as referred to in 
clause 2(l)(3)(D) of rule XI of the Rules of the House of 
Representatives.

               New Budget Authority and Tax Expenditures

    Clause 2(l)(3)(B) of House Rule XI is inapplicable because 
this legislation does not provide new budgetary authority or 
increased tax expenditures.

               Congressional Budget Office Cost Estimate

    In compliance with clause 2(l)(3)(C) of rule XI of the 
Rules of the House of Representatives, the Committee sets 
forth, with respect to the bill, H.R. 872, the following 
estimate and comparison prepared by the Director of the 
Congressional Budget Office under section 403 of the 
Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, April 13 1998.
Hon. Henry J. Hyde,
Chairman, Committee on the Judiciary,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 872, the 
Biomaterials Access Assurance Act of 1998.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Susanne S. 
Mehlman (for federal costs), who can be reached at 226-2860, 
and Pepper Santalucia (for the state and local impact), who can 
be reached at 225-3220.
            Sincerely,

                                           June E. O'Neill, Director.  
    Enclosure.

    cc: Hon. John Conyers, Jr.,
         Ranking Minority Member.

H.R. 872--Biomaterials Access Assurance Act of 1998
    CBO estimates that enacting this bill would have no 
significant impact on the federal budget. Because the bill 
would not affect direct spending or receipts, pay-as-you-go 
procedures would not apply.
    Under H.R. 872, suppliers of biomaterials (raw materials 
used to make medical implants and devices) would not be liable 
in federal or state courts for harm to a claimant caused by a 
medical implant or device unless the generic raw material used 
in the medical implant or device violated contract 
specifications or the biomaterials supplier could be classified 
as either a manufacturer or seller of the medical implant or 
device. In addition, implementing H.R. 872 would create 
expedited court procedures for determining whether a supplier 
of biomaterials is protected from liability.
    While some product liability cases are tried in federal 
court, the majority of such cases are handled in state courts. 
Based on information from the Administrative Office of the 
United States Courts, CBO estimates that enacting this bill 
would have no significant impact on the number of cases that 
would be referred to federal courts. Thus, we estimate that 
enacting H.R. 872 would have no significant impact on the 
federal budget.
    The bill contains intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act of 1995 (UMRA) because it 
would preempt state tort laws and would establish new court 
procedures for determining whether a supplier of biomaterials 
is protected from liability. States could initially incur some 
costs in adjusting to the new procedures. Based on information 
from the National Center for State Courts about the number of 
product liability cases heard in state courts, CBO estimates 
that those costs would be well below the threshold established 
in the law ($50 million in 1996, adjusted annually for 
inflation). In the longer run, states could realize net savings 
if this bill were to discourage potential plaintiffs from 
filing suits against suppliers of biomaterials. This bill would 
impose no new private-sector mandates as defined in UMRA.
    The CBO staff contacts for this estimate are Susanne S. 
Mehlman (for federal costs), who can be reached at 226-2860, 
and Pepper Santalucia (for the state and local impact), who can 
be reached at 225-3220. This estimate was approved by Robert A. 
Sunshine, Deputy Assistant Director for Budget Analysis.

                   Constitutional Authority Statement

    Pursuant to Rule XI, clause 2(l)(4) of the Rules of the 
House of Representatives, the Committee finds the authority for 
this legislation in Article I, section 8 of the Constitution.

                      Section-By-Section Analysis

Sec. 1. Short Title.
    Section 1 entitles the Act the ``Biomaterials Access 
Assurance Act.''
Sec. 2. Findings.
     Section 2 contains findings upon which the Act is based.
Sec. 3. Definitions.
    Section 3 defines key terms used in the Act.
    A ``biomaterials supplier'' is a supplier of a component 
part or raw material used in the manufacture of an implant. 
This includes any person who has submitted master files \11\ to 
the Secretary of Health and Human Services for purposes of pre-
market approval of a medical device or who licenses a 
biomaterials supplier to produce component parts or raw 
materials.
---------------------------------------------------------------------------
    \11\ A ``master file'' is a reference source submitted to the Food 
and Drug Administration, which may contain detailed information on a 
specific manufacturing facility, process, methodology, or component 
used in the manufacture, processing, or packaging of a medical device. 
See 21 C.F.R. Sec. 814.3.
---------------------------------------------------------------------------
    A ``claimant'' is a person bringing a civil action, 
claiming to have suffered harm from an implant. The definition 
includes a decedent on whose behalf the estate brings an action 
and the parent or guardian bringing an action on behalf of a 
minor or incompetent. The definition excludes providers of 
professional health care services, persons acting in the 
capacity of a manufacturer, seller, or biomaterials supplier, 
and persons bringing such actions alleging harm caused by a 
silicone breast implant.
    The latter exclusion was not based on a determination that 
silicone gel or any other form of silicone causes or may cause 
adverse health effects. Because of the controversy surrounding 
the use of silicone breast implants, in 1992 the FDA placed 
certain restrictions on their use pending further study. Since 
the imposition of these restrictions, Congress has taken 
testimony which reveals results of several major studies that 
have found no significant connection between silicone gel 
breast implants and connective tissue disease. The FDA has 
acknowledged the value of these studies in congressional 
hearings, but the FDA's interpretation of the scientific 
evidence is not yet fully settled. Congress continues to 
encourage the FDA to pursue a sound scientific conclusion.
    The Act specifically prohibits the silicone-gel breast 
implant exclusion from being used to imply that Congress has 
made a finding regarding the health effects of silicone or 
silicone implants. Even the existence of this exclusion shall 
not be disclosed to a jury in a civil action or other 
proceeding. It shall not be presented in any type of proceeding 
except as necessary, if necessary, to establish the 
applicability of the Act. This would only happen in the 
unlikely event that a defendant in a breast implant case were 
to assert one of the defenses the Act provides.
    A ``component part'' is a manufactured piece of an implant. 
By definition, a component part has significant non-implant 
applications and has no implant value on its own.
    ``Harm'' is injury to or damage suffered by an individual; 
any illness, disease, or death of that individual resulting 
from that injury or damage; and any loss to that individual or 
any other individual resulting from that injury or damage. It 
is not commercial loss or damage to an implant.
    An ``implant'' is a medical device intended by its 
manufacturer to be placed into a surgically or naturally formed 
or existing cavity of the body for at least thirty days; or to 
remain in contact with bodily fluids or internal human tissue 
through a surgically produced opening for a period of less than 
thirty days; and suture materials used in implant procedures.
    A ``manufacturer'' is a person (a) engaged in manufacture, 
preparation, propagation, compounding, or processing, as 
defined in Sec. 510(a)(1) of the Federal Food, Drug, and 
Cosmetic Act, of an implant and (b) required to register with 
the Secretary pursuant to Sec. 510 of that Act and include the 
implant on a list of devices filed with the Secretary pursuant 
to Sec. 510(j) of that Act.
    A ``medical device'' is a device, as defined in Sec. 201 of 
the Federal Food, Drug, and Cosmetic Act, and includes any 
device component of any combination product as that term is 
used in Sec. 503(g) of that Act.
    A ``raw material'' is a substance or product that has 
generic and non-implant uses. While ``raw material'' and 
``component part'' are defined separately in this section of 
the Act, they are treated identically, just as they are at 
common law.\12\ When either a raw material or a component part 
is incorporated into a final product, the producer of that 
final product generally owes the product's users a duty of 
care. The supplier of the raw material or component part does 
not. Furthermore, there is no sound distinction between raw 
materials and component parts. For example, a substance that is 
highly manufactured to achieve specific molecular or chemical 
properties, though not formed into the shape it would take in a 
medical implant or device, straddles the divide between raw 
material and component part. Whether and when it moves from raw 
material to component part could fall at nearly any point in 
the manufacturing process. Advances in biotechnology may take 
advantage of both the chemical and mechanical properties of 
substances. A distinction between raw materials and component 
parts would confuse and confound the application of this Act to 
such innovations. As long as commerce follows the current model 
of purchase and sale among identifiable parties, however, 
suppliers of raw materials and component parts will be 
distinguishable from manufacturers and sellers of medical 
implants and devices.
---------------------------------------------------------------------------
    \12\ The Restatement treats raw materials as a subset of component 
parts. See Restatement (Third) of Torts: Products Liability Sec. 5, 
cmt. c (``Product components include raw materials.'').
---------------------------------------------------------------------------
    The ``Secretary'' is the Secretary of Health and Human 
Services.
    A ``seller'' is a person who sells, distributes, leases, 
packages, labels, or places an implant in the stream of 
commerce, but is not a seller of real property, a provider of 
professional services, or a person acting in a financial 
capacity with respect to the sale of an implant.
Sec. 4. General Requirements; Applicability; Preemption.
    This section makes the scope of the Act explicit. The Act 
provides a narrow, statutory defense to liability for 
biomaterials suppliers in actions brought by claimants alleging 
harm from a medical device or implant, and the means for 
asserting that defense. The Act applies to all civil actions in 
State or Federal court, brought against a manufacturer, seller, 
or biomaterials supplier for harm allegedly caused by an 
implant, as each of those terms are defined in the Act. It does 
not apply to loss of, or damage to, an implant, or to 
commercial loss to the purchaser. Nor is it intended to 
restrict any rights other persons may have to sue biomaterials 
suppliers under a variety of State law theories. The Act does 
not affect the scope of a biomaterials supplier's liability to 
such persons under existing State common law doctrines. As a 
result, an implant manufacturer may sue a supplier for breach 
of warranty or contract violations, if such claims exist under 
State law, without regard to the provisions of this Act.
    While the protections of the Act are intended to follow the 
contours of the common law in most states, they may not in 
every case, and the Act preempts State law to the extent it 
establishes a rule of law applicable to the recovery of 
damages. The Act does not affect any defense available under 
other provisions of law to a defendant in an action where harm 
caused by an implant is alleged. Other law, including, but not 
limited to, jurisdiction, rules of evidence, and jury trial 
rights, is unaffected by the Act.
    Note also that, following a successful impleader under 
section 7 of the Act, any preemption of the rule of law 
applicable to the recovery of damages would be nullified. If a 
party is re-joined to a case under section 7, other applicable 
law is fully reinstated as to that party.
Sec. 5. Liability of Biomaterials Suppliers.
    This section supplies the standard of liability for 
biomaterials suppliers, other than those re-joined to a case 
under section 7, and makes three exceptions that take a party 
otherwise fitting the definition of a biomaterials supplier out 
from under the protections of the Act.
    A biomaterials supplier is not liable for harm to a 
claimant caused by an implant unless it is (a) a manufacturer, 
(b) a seller, or (c) a furnisher of raw materials that fails to 
meet contractual requirements or specifications, as discussed 
below.
    A biomaterials supplier may be liable as a manufacturer if 
it registered, or if it should have registered, as such with 
the Secretary under the Federal Food, Drug and Cosmetic Act. It 
also may be liable if it listed, or if it should have listed, 
the implant with the Secretary pursuant to that Act. It may be 
liable if the Secretary declares that it was required either to 
register or to list the implant under federal law, but failed 
to do so. A biomaterials supplier may also be liable if it is 
related by common ownership or control to a person, meeting 
either requirement above, that is found by a court to lack 
sufficient resources to pay a likely judgment.
    A biomaterials supplier may be liable as a seller if it 
held title to the implant after the implant's manufacture and 
entry into the stream of commerce and if it subsequently resold 
the implant. It may also be liable if it is related by common 
ownership or control to a person meeting the above requirement 
if that person is found by a court to lack sufficient resources 
to pay a likely judgment.
    A biomaterials supplier may be liable, having violated 
contractual requirements or specifications, if that violation 
was an actual and proximate cause of harm. A violation of 
contractual requirements or specifications occurs if the raw 
material or component parts did not constitute the product 
described in the contract, or if the biomaterials supplier 
failed to meet specifications that were (a) accepted by it 
under applicable law, (b) published by the biomaterials 
supplier, (c) provided to the manufacturer by the supplier, or 
(d) submitted by the supplier to the Secretary pursuant to the 
pre-market approval process. While making clear that a 
biomaterials supplier may be liable if it failed to meet the 
terms of a contract or certain administrative filings, these 
provisions do not place any requirement on a biomaterials 
supplier to ensure that its products meet the specialized 
requirements of medical applications; this must be done by 
implant manufacturers and sellers.
    The Act allows claimants to petition the Secretary and, if 
warranted, receive a declaration that a biomaterials supplier 
should have registered with the Secretary or listed an implant 
under the Federal Food, Drug and Cosmetic Act. The Act sets 
forth the procedures the Secretary must follow in deciding 
whether to issue a declaration. In light of the Secretary's 
expertise and in the interest of consistent interpretations of 
law and regulation, the Committee encourages courts to defer to 
a declaration issued by the Secretary regarding registration or 
listing requirements. In passing these provisions, the 
Committee contemplated currently issued registration and 
listing requirements. Changes to the registration and listing 
requirements after the Act is passed should not make otherwise 
bona fide biomaterials suppliers susceptible to suit as 
manufacturers.
    The Act allows 180 days for the Secretary to decide on the 
petition. So that claims can be promptly adjudicated, this time 
is shortened elsewhere in the Act if an action is stayed due to 
pendency of a petition. Any statute of limitations is tolled 
while the Secretary considers whether to issue a declaration. 
This is intended to eliminate the incentive to file suit 
against a biomaterials supplier while a petition is pending. 
The Committee encourages potential claimants to refrain from 
filing an action against a biomaterials supplier on the theory 
that the supplier may be liable as a manufacturer until a 
declaration that the biomaterials supplier should have 
registered has been issued by the Secretary.
Sec. 6. Procedures for Dismissal of Civil Actions Against Biomaterials 
        Suppliers.
    This section lays out the procedure to be used for ruling 
on a motion to dismiss under the Act. It narrowly circumscribes 
discovery during pendency of such a motion so that a 
presumptively protected biomaterials supplier is subject to 
discovery only on issues salient to the motion until the court 
rules.
    A supplier may file a motion to dismiss on the grounds that 
it is a biomaterials supplier and that it is not considered to 
be a manufacturer; that it is not a seller; and that it has not 
failed to meet specifications. The claimant must name the 
manufacturer of the implant as a party unless jurisdiction over 
the manufacturer is not available or the claimant can not 
proceed against the manufacturer because of applicable law or 
rules of practice. A biomaterials supplier may file a motion to 
dismiss on the ground that the claimant has failed to name the 
manufacturer of the implant as a party.
    The defendant and claimant may file affidavits regarding 
certain issues in the dismissal motion. If the court permits 
discovery while the motion to dismiss is pending, it is limited 
to the issues salient to the motion, and to jurisdiction of the 
court.
    In an action other than one based on failure to meet 
specifications, the court shall grant the motion to dismiss 
unless the claimant demonstrates by affidavit that the supplier 
is a manufacturer or seller. The court shall make its 
determination based solely on the pleadings and affidavits, and 
may treat the motion as a motion for summary judgment.
    If the claimant has petitioned the Secretary for a 
declaration, and if the Secretary's decision on the petition 
has not been issued, the court shall stay proceedings for which 
the declaration is needed until the Secretary has issued a 
final decision on the petition. When a proceeding is stayed, 
the Secretary must issue a decision on the petition within six 
weeks of the date the petition was received.
    A dismissal under the Act shall be entered with prejudice, 
except insofar as a biomaterials supplier may be re-joined to 
the action under section 7.
    The Act permits a manufacturer to file and conduct any 
proceeding on behalf of a supplier if both parties have entered 
into a binding indemnification agreement allowing the 
manufacturer to do so.
Sec. 7 Subsequent Impleader of Dismissed Defendant.
    Section 7 provides for the extraordinary situation where 
evidence admitted at the trial between the claimant and the 
implant manufacturer clearly shows that the dismissed 
biomaterials supplier may be liable under other law. The 
purpose of this section is to leave open the possibility of 
litigation against a biomaterials supplier in an extreme case 
so egregious as to overcome the common law limitations on 
supplier liability. The Committee has not found a single case 
that has gone to final judgment where a biomaterials supplier 
has been held liable. While this procedure may identify such a 
case, if one ever arises, courts should police its use to 
ensure that it does not become a routine post-trial motion. It 
is for extreme, unusual cases.
    Upon motion, made within ninety days after entry of a final 
judgment in an action by the claimant against a manufacturer, a 
court may implead a biomaterials supplier who was dismissed 
pursuant to the Act. The court may do so if the manufacturer 
asserts in motions or arguments at trial, and the court finds 
preliminarily, based on its independent review of the evidence 
contained in the record of the action, that, under applicable 
law, the biomaterials supplier's negligence or intentional 
tortious conduct caused the claimant's injury. Additional or 
novel theories of liability should not form the basis for 
granting the motion.
    The court's review should be independent and substantive. A 
court should grant the impleader motion only if it finds by a 
preponderance of the evidence that a biomaterials supplier may 
be liable--not if it finds, for example, that a ``reasonable 
jury'' might view the evidence that is part of the record as 
sufficient to support liability. Because the biomaterials 
supplier will not have been represented in the trial, no 
finding by a jury, by general or special verdict, can dispose 
of any issue for purposes of the court's review.
    If a court grants the motion, its finding that a 
biomaterials supplier may be liable is preliminary. Because it 
is based on evidence adduced at a trial where the biomaterials 
supplier will not have been represented, the court's 
preliminary finding may not become the law of the case, or a 
basis for issue preclusion or collateral estoppel. The Act 
gives a re-joined biomaterials supplier an opportunity to fully 
supplement the record. This is intended to ensure that the 
claimant and the biomaterials supplier reach equipoise in terms 
of evidence admitted, opportunity to have facts found, and 
arguments and motions made. A court must make every effort to 
see that they do.
    If the court allows impleader of the biomaterials supplier, 
the standard of liability and legal rule determining all issues 
are provided by other applicable law.
Sec. 8. Applicability.
    The Act does not apply to actions commenced before the date 
of enactment of the Act.

                      DISSENTING VIEWS ON H.R. 872

            H.R. 872 ``Biomaterials Access Assurance Act of 1998''

                              introduction

    We oppose the Biomaterials Access Assurance Act of 1998. 
While we recognize that H.R. 872 represents an improvement over 
predecessor versions of the legislation, we believe the 
legislation represents yet another misguided effort to 
federalize state tort law at the expense of victims.
    H.R. 872 would shield the liability of biomaterials 
suppliers under state law to those who fail to meet contractual 
and other specifications where such failure is an actual and 
proximate cause of the harm to the claimant. The immunity is so 
broad that even a supplier that knew or should have known that 
its product would cause injury or death would be immune from 
suit if it can meet the foregoing requirement. The legislation 
also prescribes very detailed procedural mandates on state 
courts for the dismissal of actions against biomaterials 
suppliers, at the beginning stage of a suit. It provides for 
post-trial procedures permitting a dismissed supplier to be 
brought back into the action only if it can be shown that its 
negligence was an actual and proximate cause of harm to the 
claimant.
    We oppose H.R. 872 because in our view there is no evidence 
of a shortage of life-saving medical devices, and there is no 
compelling reason to abrogate traditional respect for state 
tort law in this area. For these and the other reasons set 
forth herein, we dissent from H.R. 872.
1. There is no evidence of a shortage of medical devices and current 
        law provides appropriate safeguards for the dismissal of 
        frivolous litigation.
    Although the purported justification to H.R. 872 is that 
there is an imminent shortage of life-saving medical devices 
and that manufacturers will soon run out of their raw materials 
stock piles, a comprehensive review of the 1997 Medical Device 
Register (published by Medical Economics) which lists every 
medical device registered with the FDA, indicates to the 
contrary. Among other things, the most recent Register reports 
that there continue to be several, and often numerous, 
manufacturers of almost every permanent implant that are 
alleged to be in short supply.\1\
---------------------------------------------------------------------------
    \1\ U.S. Public Interest Research Group, The ``Biomaterials 
Shortage'' Where's the Evidence at 1.
---------------------------------------------------------------------------
    Notwithstanding proponents' arguments that costly lawsuits 
and the fear of litigation remove incentives for suppliers to 
make their life-saving compounds available to implant 
manufacturers, the record indicates that biomaterials suppliers 
have been sued infrequently, and when they are, blameless 
suppliers are routinely found not liable for injuries and 
illnesses caused by defective medical implants.\2\
---------------------------------------------------------------------------
    \2\ For example, while complaints frequently cite that children 
suffering from hydrocephalus (water on the brain) will be unable to 
obtain life-saving silastic shunts because of costly litigation, a 
review of case filings reveals only two lawsuits involving defective 
shunts. Both cases were brought against physicians whose failure to 
diagnose shunt malfunction resulted in serious mental incapacity for 
the patients. See U.S. Public Interest Research Group, The 
``Biomaterials Shortage'' Where's the Evidence? at 2.
---------------------------------------------------------------------------
    Professor Mark Hager has also observed that a number of 
legal doctrines have evolved which provide protection to 
biomaterials suppliers from supposedly frivolous lawsuits:
          A fabric of common law doctrines has effectively 
        protected upstream suppliers from such suits. These 
        doctrines--the bulk supplier doctrine, the 
        sophisticated user doctrine, the component parts 
        doctrine, and others--have been constructed by courts 
        to protect upstream suppliers in the medical device 
        industry and elsewhere from liability. Courts have 
        determined that upstream liability could saddle 
        suppliers with burdensome duties to monitor the safety 
        of parts and materials they sell in a thousand and one 
        different applications.\3\
---------------------------------------------------------------------------
    \3\ H.R. 872, The Biomaterials Access Assurance Act of 1997: 
Hearing before the House Judiciary Sub-Committee on Administrative and 
Commercial Law, 105th Cong., 1st Sess. (June 12, 1997) (Statement of 
Mark Hager at 1-2).
---------------------------------------------------------------------------
The bulk supplier/sophisticated user doctrine, for example, 
provides a supplier with immunity if the supplier sold bulk 
quantities of an inherently nondefective raw material to a 
manufacturer, who combined the material with other ingredients 
to produce a defective implant, and the supplier did not know 
that the raw material would be put to a dangerous use.\4\
---------------------------------------------------------------------------
    \4\ The rationale supporting this doctrine is that downstream 
producers (finished product manufacturers) are in a better position 
than upstream suppliers (raw materials and component parts 
manufacturers) to convey product warnings to consumers. This is 
especially true when the raw materials suppliers supply in ``bulk'' to 
a host of manufacturers or where product manufacturers are so 
``sophisticated,'' such as medical device manufacturers, that they can 
assess the dangers of the product and properly advise the public.
---------------------------------------------------------------------------
    The fact that the few possible negligent manufacturers are 
subject to potential liability through the tort system helps 
ensure the safety of biomaterials supplies. As Professor Andrew 
Popper testified at the House Commerce Subcommittee on 
Telecommunications, Trade and Consumer Protections Hearing on 
access to biomaterials:
          Suppliers currently have an incentive to develop 
        means to inspect and test products or create such 
        opportunities in part because they are subject to 
        liability in tort . . . Their exposure compels a 
        critical level of caution regarding their products, a 
        pressure that would be lost were they to be granted 
        immunity from liability.\5\
---------------------------------------------------------------------------
    \5\ Product Liability and Consumer Access to Biomaterial Products: 
Hearing before the House Commerce Sub-Committee on Telecommunications, 
Trade, and Consumer Protection, 105th Cong., 1st Sess. (April 8, 1997) 
(Statement of Professor Andrew F. Popper at 17).
---------------------------------------------------------------------------
While the FDA regulates the design of medical devices, it only 
regulates the raw materials and component parts on rare 
occasions. It is therefore important that safety standards be 
imposed by the suppliers on themselves and by the manufacturers 
on the suppliers. The current state tort system fills these 
regulatory gaps.
2. H.R. 872 prevents adequate discovery from taking place in cases 
        involving defective medical devices
    In a misguided and unnecessary effort to protect 
biomaterials suppliers from defending against most lawsuits, 
H.R. 872 inappropriately dismisses biomaterials suppliers at 
the outset of litigation, rather than after the discovery 
period. Although the legislation nominally allows for 
interpleader of negligent suppliers at the end of the case, the 
proposed standards provided in H.R. 872 are extremely 
burdensome. The supplier can be made a party to the action 
subsequent to dismissal, but only after a final judgment has 
been ordered. Thus, the case must by tried twice. Even then, 
the motion to implead will only be granted if the court finds 
that evidence contained in the record exists that the supplier 
was the actual and proximate cause of harm. Finally, there are 
many reasons why evidence may not make it into the record--for 
example, the court may determine certain evidence offered by 
the plaintiff in the initial trial to be irrelevant--and once a 
court renders a final decision, it is generally reluctant to 
reopen the case.
    The net effect of these restrictive impleader rules will be 
to prevent victims from obtaining information leading to the 
determination of the biomaterials supplier's liability and to 
prevent victims from gathering valuable information that would 
strengthen the case against the device manufacturer. As a 
result, plaintiffs may never learn who is responsible for their 
injuries, and neither the public nor regulators may be alerted 
to product dangers.
3. H.R. 872 abrogates our traditional respect for State tort law
    States are fully capable of enacting product liability 
reforms when they feel it necessary to balance the competing 
needs of business and consumers within their borders. Indeed 
over the last twenty years all states have enacted some form or 
another of product liability or tort law protection to benefit 
defendants.\6\
---------------------------------------------------------------------------
    \6\ See Henry Cohen, Fifty-State Surveys of Selected Products 
Liability Issues, CRS Report for Congress (June 20, 1995).
---------------------------------------------------------------------------
    Unfortunately, federalizing this issue will inevitably lead 
to greater confusion than certainty because the federal 
standard will be applied and interpreted in many different 
contexts in federal and state courts. The Conference of Chief 
Justices has testified that the search for uniformity of 
product liability laws (through laws such as H.R. 872) will 
ultimately prove counterproductive:

          It follows that Federal standards, however well 
        articulated, will be applied in many different contexts 
        and inevitably will be interpreted and implemented 
        differently, not only by the State courts but also by 
        the Federal courts . . . Moreover, State Supreme Courts 
        will no longer be, as they are today, the final 
        arbiters of their tort law . . . a legal thicket is 
        inevitable and the burden of untangling it, if it can 
        be untangled at all, will lie only with the Supreme 
        Court of the United States, a court which many experts 
        feel is not only overburdened but also incapable of 
        maintaining adequate uniformity in existing Federal 
        law.\7\
---------------------------------------------------------------------------
    \7\ Product Liability and Civil Justice Reform: Hearings before the 
House Comm. On the Judiciary, 104th Cong., 1st Sess. (February 13, 
1995) (Statement of the Conference of Chief Justices at 6-7).

    We would also note that H.R. 872 sets forth elaborate rules 
of civil procedure with regard to motions to dismiss, 
discovery, summary judgment and impleader for the states to 
follow, disregarding state rules of civil procedure.\8\ This 
unprecedented intervention into state procedural rules may well 
violate the Tenth Amendment under the New York v. United 
States.\9\ In that 1992 case, the Supreme Court held that the 
federal government cannot commandeer state regulatory processes 
for federal purposes in a way that unduly burdens or takes away 
political accountability. In H.R. 872 as well, we are concerned 
that dictating state rules of civil procedure will unduly 
burden state courts and will remove the political 
accountability of the state legislatures.
---------------------------------------------------------------------------
    \8\ For example, in order to obtain a pre-trial dismissal, the bill 
specifies that a defendant may file a motion alleging that it has met 
the various legal requirements for dismissal, including the contractual 
and other product specifications. While the motion is pending, H.R. 872 
limits discovery and requires that State courts rule on the motion 
based on the pleadings and affidavits before it. It also sets forth 
rules for the issuance of summary judgments and stays. Post-trial 
motions to implead are also subject to limited discovery and the bill 
provides further opportunity for the supplier to supplement the record 
before any trial on the merits may proceed.
    \9\ 505 U.S. 144 (1992). See also Printz v. United States, 117 
S.Ct. 2365 (1997) (holding unconstitutional, under the Tenth Amendment, 
the requirement in the Brady Handgun Violence Protection Act that local 
law enforcement officials conduct background checks on prospective gun 
purchasers).
---------------------------------------------------------------------------
4. There is no evidence of a competitive threat from foreign 
        biomaterials providers
    One of the principal rationales stated for the bill is 
American competitiveness--the need to ensure that we are not at 
a competitive disadvantage in our biomaterials industry as 
compared to other countries, as suppliers supposedly withdraw 
from the medical device market.\10\ But, the medical device 
industry is a thriving domestic market and as Professor Popper 
has testified, ``a system that condemns defective products and 
services produced in a negligent or grossly negligent manner 
cannot possibly be considered destructive of our competitive 
posture.'' \11\
---------------------------------------------------------------------------
    \10\ Sec. 2(10).
    \11\ Product Liability and Consumer Access to Biomaterial Products: 
Hearing before the House Commerce Sub-Committee on Telecommunications, 
Trade, and Consumer Protection, 105th Cong., 1st Sess. (April 8, 1997) 
(Statement of Professor Andrew F. Popper at 14).
---------------------------------------------------------------------------
    If increased foreign competitiveness was being sought by 
the bill's proponents, they would have accepted an amendment 
offered by Representative Conyers providing that the 
protections under H.R. 872 do not apply to a biomaterials 
supplier which is a foreign corporation unless it was located 
in the United States or was headquartered in a country whose 
law accords protections comparable to those that will apply in 
the United States with respect to biomaterials suppliers. This 
would have ensured that our own suppliers would be placed on at 
least an equal footing with foreign firms. However, the 
amendment was defeated by the majority.
5. Other substantive concerns
    In addition to the above problems we have with the 
legislation, there are a number of other substantive concerns 
with H.R. 872. For example, immunity is so broadly written \12\ 
that it extends to biomaterials suppliers who knew or should 
have known that their product would cause injury or death. 
President Clinton specifically addressed this issue in his veto 
statement of last Congress' products liability bill where he 
stated that ``such suppliers should not receive any protection 
from suit.'' \13\ Because suppliers usually know the potential 
misuses of their products and are aware of the dangerous 
consequences associated with improper uses, they must be relied 
upon to take remedial action when appropriate.
---------------------------------------------------------------------------
    \12\ Sec. 5.
    \13\ Message on Returning Without Approval to the House of 
Representatives the Common Sense Product Liability Legal Reform Act of 
1996, 32 Weekly Comp. Pres. Doc. 780 (May 2, 1996).
---------------------------------------------------------------------------
    H.R. 872 also improperly shields components that are 
intricate products themselves. While the legislation's 
proponents claim their motivation is to protect the 
availability of raw materials used in medical implants, the 
definition of ``biomaterials'' includes ``components'' and 
thus, extends the legislation's protections to manufacturers of 
component parts contained in implantable medical devices. Raw 
materials and component parts are not one and the same and 
should not be treated as such. No showing has been made during 
the hearings of any need to immunize component parts 
manufacturers.
    It is also informative to note that H.R. 872 exempts breast 
implant litigants from its coverage. However, the exclusion 
does not take into account the thousands of medical device 
patients, who may suffer from a silicone induced disease, 
caused by such products as penile implants, hip or joint 
implants, and jaw implants. In our view, there is simply no 
policy rationale for distinguishing between these cases. While 
this exclusion reflects the sponsors' awareness that 
biomaterials may, in certain limited circumstances, cause 
substantial physical injury, it also indicates that the 
sponsors of this bill are, in essence, betting the lives and 
health of future generations of Americans that the silicone gel 
tragedy will never occur with some other biomaterial.
    H.R. 872 also carves out a number of possible non-
individual claimants from the liability restrictions in the 
bill. For example, providers of professional health care 
services, manufacturers, sellers and biomaterials suppliers are 
specifically excluded from the definition of ``claimant.'' \14\ 
H.R. 872 further provides a ``commercial loss'' exception which 
allows doctors and others who use implants to provide 
professional services to sue the biomaterials supplier for 
commercial loss (damage to goods). Collectively, these 
provisions discriminate against implant recipients, the persons 
whose lives have been drastically affected \15\ by taking away 
their right to sue suppliers, while retaining every other 
possible corporate plaintiff's right to sue.
---------------------------------------------------------------------------
    \14\ Sec. (3)(2)(D)(I) and (2).
    \15\ Sec. 4(B)(2).
---------------------------------------------------------------------------
    Finally, we would note there are possible market solutions 
to the liability concerns of biomaterials suppliers that do not 
require federal preemption of state liability law. For example, 
medical device manufacturers could indemnify suppliers against 
liability or could name suppliers as co-insureds on liability 
policies that they maintain.

                               conclusion

    While we support appropriate safeguards to protect 
biomaterials suppliers from frivolous litigation, we cannot 
support this legislation. State common law provides numerous 
special defenses to suppliers. To the extent such defenses are 
found to be in any way to be insufficient, the remedy lies with 
the states, rather than with a one-size-fits-all federal fix.
    H.R. 872, though improved from prior versions, continues to 
include numerous flaws. These include offering immunity to 
potentially negligent raw material and component parts 
suppliers; restrictive discovery and interpleader rules; 
burdensome procedural mandates on the states; and exclusions 
for potential corporate victims which discriminate against 
individual victims.
                                   John Conyers, Jr.
                                   Jerrold Nadler.
                                   Robert C. Scott.
                                   Sheila Jackson Lee.
                                   Maxine Waters.