[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 872 Reported in House (RH)]






                                                 Union Calendar No. 349
105th CONGRESS
  2d Session
                                H. R. 872

                  [Report No. 105-549, Parts I and II]

  To establish rules governing product liability actions against raw 
materials and bulk component suppliers to medical device manufacturers, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 27, 1997

  Mr. Gekas (for himself, Mr. Bilbray, Mr. Bryant, Mr. Burr of North 
Carolina, Mr. Buyer, Mr. Cunningham, Ms. Dunn, Mr. Ehlers, Mr. English 
of Pennsylvania, Ms. Eshoo, Mr. Gallegly, Mr. Greenwood, Mr. Gutknecht, 
   Mr. Hastert, Mr. Hayworth, Mrs. Kelly, Mr. Kind, Mr. Luther, Mr. 
 McCollum, Mr. McIntosh, Mr. Pastor, Mr. Ramstad, Mr. Rohrabacher, Mr. 
    Sabo, Mr. Schiff, Mr. Sensenbrenner, Mr. Stump, and Mr. Vento) 
 introduced the following bill; which was referred to the Committee on 
  the Judiciary, and in addition to the Committee on Commerce, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

                              May 22, 1998

     Reported from the Committee on the Judiciary with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

                              May 22, 1998

Referral to the Committee on Commerce extended for a period ending not 
                        later than July 14, 1998

                             July 14, 1998

 Additional sponsors: Mr. Barcia, Mr. Clement, Mr. Coburn, Mr. Cox of 
 California, Mr. Crane, Mr. Horn, Mr. Norwood, Mr. Porter, Mr. Salmon, 
 Mr. Serrano, Mr. Shays, Mrs. Tauscher, Mrs. Emerson, Mr. Hutchinson, 
 Mr. Inglis of South Carolina, Mr. Pickering, Mr. Bunning, Mr. Condit, 
   Mrs. Cubin, Mr. Fox of Pennsylvania, Mr. Gillmor, Mr. Hefner, Mr. 
   McHugh, Mr. Moran of Virginia, Mr. Packard, Mrs. Roukema, Mr. Dan 
Schaefer of Colorado, Mr. Sessions, Mr. Stenholm, Mr. Towns, Mr. Barton 
of Texas, Mr. Boucher, Mr. Dooley of California, Mr. Faleomavaega, Mr. 
 Ganske, Mr. Goode, Mr. Kim, Mr. Largent, Mr. Minge, Mr. Pascrell, Mr. 
Spratt, Mr. Calvert, Mr. Cook, Mr. Dreier, Mr. Fazio of California, Mr. 
   Hoekstra, Mr. Oberstar, Mr. Pickett, Mr. Royce, Mr. Solomon, Mr. 
  Thornberry, Mr. Rothman, Mr. Torres, Mr. Ballenger, Mr. Coble, Ms. 
 Christian-Green, Mr. Cooksey, Mr. Graham, Mr. Hostettler, Mr. Lantos, 
    Mr. McKeon, Mr. Rogan, Ms. Sanchez, Mr. Shimkus, Mr. Capps, Mr. 
Goodling, Mr. Holden, Mr. Walsh, Mr. Young of Florida, Mr. Berman, Mr. 
    Edwards, Ms. Hooley of Oregon, Ms. Lofgren, Mr. Bob Schaffer of 
  Colorado, Ms. Slaughter, Mr. White, Mr. Campbell, Ms. Harman, Mrs. 
 Johnson of Connecticut, Mr. Sherman, Mr. Weldon of Pennsylvania, Mr. 
Davis of Florida, Mr. Franks of New Jersey, Mr. Matsui, Mr. Snyder, Mr. 
  Camp, Mr. Frelinghuysen, Mr. Lewis of California, Ms. Woolsey, Mr. 
 Pappas, Mrs. Northup, Ms. Pelosi, Mr. Quinn, Mr. Smith of New Jersey, 
Mr. Weldon of Florida, Mr. Farr of California, Mr. Saxton, Mr. Stearns, 
Mr. Andrews, Mr. LoBiondo, Mr. Menendez, Mr. Adam Smith of Washington, 
 Mr. Pallone, Mr. Redmond, Mr. Bilirakis, Mr. Strickland, Mr. Price of 
                     North Carolina, and Ms. Wilson

                             July 14, 1998

Reported from the Committee on Commerce with an amendment, committed to 
the Committee of the Whole House on the State of the Union, and ordered 
                             to be printed
 [Strike out all after the enacting clause and insert the part printed 
                           in boldface roman]
    [For text of introduced bill, see copy of bill as introduced on 
                           February 27, 1997]

_______________________________________________________________________

                                 A BILL


 
  To establish rules governing product liability actions against raw 
materials and bulk component suppliers to medical device manufacturers, 
                        and for other purposes.

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

SECTION 1. SHORT TITLE

    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.

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; or
                    (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, although such protections do not protect 
        negligent suppliers.

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 a deceased individual into whose body, or 
                in contact with whose blood or tissue the implant was 
                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 such services; and
                                    (II) the essence of the 
                                professional health care services 
                                provided 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 health care 
                        services where--
                                    (I) the sale or use of the implant 
                                is incidental to such services; and
                                    (II) the essence of the health care 
                                services provided 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--
                    (A) raise any exclusion from liability set forth in 
                section 5; and
                    (B) make a motion for dismissal or for summary 
                judgment as set forth in section 6.
            (2) Procedures.--Notwithstanding any other provision of 
        law, a Federal or State court in which an action covered by 
        this Act is pending shall, in connection with a motion under 
        section 6 or 7, use the procedures set forth in this Act.
    (b) Applicability.--
            (1) In general.--Except as provided in paragraph (2), this 
        Act applies to any civil action brought by a claimant, whether 
        in a Federal or State court, on the basis of any legal theory, 
        for harm allegedly caused, directly or indirectly, by an 
        implant.
            (2) Exclusion.--A civil action brought by a purchaser of a 
        medical device, where such purchaser intends to use the device 
        in providing professional health care services, 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.--Except as provided in section 7, a biomaterials 
supplier shall not be liable for harm to a claimant caused by an 
implant unless such supplier--
            (1) is a manufacturer of the implant, as provided in 
        subsection (b);
            (2) is a seller of the implant, as provided in subsection 
        (c); or
            (3) furnished raw materials or component parts for the 
        implant that failed to meet applicable contractual requirements 
        or specifications, as provided 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 was required 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) included or was required 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;
                    (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 120 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 from the time a claimant has filed a petition 
                with the Secretary under this paragraph until such time 
                as the Secretary either (i) issues a final decision on 
                the petition, or (ii) the petition is withdrawn.
                    (D) Stay pending petition for declaration.--If a 
                claimant has filed a petition for a declaration 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 120 days of 
                receipt of the petition.
    (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 and then acted as a 
                seller of the implant after its initial sale by the 
                manufacturer; or
                    (B) acted under contract as a seller to arrange for 
                the transfer of the implant directly to the claimant 
                after the initial sale by the manufacturer of 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 Failure To Meet Applicable 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 biomaterials supplier supplied raw materials or 
        component parts for use in the implant that either--
                    (A) did not constitute the product described in the 
                contract between the biomaterials supplier and the 
                person who contracted for the supplying of the product; 
                or
                    (B) failed to meet any specifications that were--
                            (i) accepted, pursuant to applicable law, 
                        by the biomaterials supplier;
                            (ii) published by the biomaterials 
                        supplier;
                            (iii) provided by the biomaterials supplier 
                        to the person who contracted for such product;
                            (iv) 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
                            (v) 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 failure to meet applicable contractual 
        requirements or specifications 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.--A defendant may, at any time during which a 
motion to dismiss may be filed under applicable law, move to dismiss an 
action against it on the grounds that the defendant is a biomaterials 
supplier and one or more of the following:
            (1) The defendant is not liable as a manufacturer, as 
        provided in section 5(b).
            (2) The defendant is not liable as a seller, as provided in 
        section 5(c).
            (3) The defendant is not liable for furnishing raw 
        materials or component parts for the implant that failed to 
        meet applicable contractual requirements or specifications, as 
        provided in section 5(d).
            (4) The claimant did not name the manufacturer as a party 
        to the action, as provided in subsection (b).
    (b) Manufacturer of Implant Shall Be Named a Party.--The claimant 
in an action brought for harm caused by an implant 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 by a defendant 
under this section:
            (1) Effect of motion to dismiss on discovery.--
                    (A) In general.--Except as provided in subparagraph 
                (B), if a defendant files a motion to dismiss under 
                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.
                    (B) Discovery.--If a defendant files a motion to 
                dismiss under subsection (a)(3) on the grounds that the 
                biomaterials supplier did not furnish raw materials or 
                component parts for the implant that failed to meet 
                applicable contractual requirements or specifications, 
                the court may permit discovery limited to issues that 
                are directly relevant to--
                            (i) the pending motion to dismiss; or
                            (ii) the jurisdiction of the court.
            (2) Affidavits.--
                    (A) Defendant.--A defendant may submit affidavits 
                supporting the grounds for dismissal contained in its 
                motion to dismiss under subsection (a). If the motion 
                is made under subsection (a)(1), the defendant may 
                submit an affidavit demonstrating that the defendant 
                has not included the implant on a list, if any, filed 
                with the Secretary pursuant to section 510(j) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                360(j)).
                    (B) Claimant.--In response to a motion to dismiss, 
                the claimant may submit affidavits 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 is a seller of the 
                        implant who is liable under section 5(c).
            (3) Basis of ruling on motion to dismiss.--The court shall 
        rule on a motion to dismiss filed under subsection (a) solely 
on the basis of the pleadings and affidavits of the parties made 
pursuant to this subsection. The court shall grant a motion to dismiss 
filed under subsection (a)--
                    (A) unless the claimant submits a valid affidavit 
                that demonstrates that the defendant is not a 
                biomaterials supplier;
                    (B) unless the court determines, to the extent 
                raised in the pleadings and affidavits, that one or 
                more of the following apply:
                            (i) the defendant may be liable as a 
                        manufacturer, as provided in section 5(b);
                            (ii) the defendant may be liable as a 
                        seller, as provided in section 5(c); or
                            (iii) the defendant may be liable for 
                        furnishing raw materials or component parts for 
                        the implant that failed to meet applicable 
                        contractual requirements or specifications, as 
                        provided in section 5(d); or
                    (C) if the claimant did not name the manufacturer 
                as a party to the action, as provided in subsection 
                (b).
            (4) Treatment of motion as motion for summary judgment.--
        The court may deem a motion to dismiss as a motion for summary 
        judgment subject to subsection (d) in order to determine 
        whether the pleadings and affidavits, in connection with such 
        action, raise genuine issues of material fact concerning 
        whether the defendant furnished raw materials or component 
        parts of the implant that failed to meet applicable contractual 
        requirements or specifications as provided in section 5(d).
    (d) Summary Judgment.--
            (1) In general.--
                    (A) Basis for entry of judgment.--If a motion to 
                dismiss of a biomaterials supplier is to be treated as 
                a motion for summary judgment under subsection (c)(4) 
                or if a biomaterials supplier moves for summary 
                judgment, the biomaterials supplier shall be entitled 
                to entry of judgment without trial if the court finds 
                there is no genuine issue of 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 governed by section 5(d), 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) Dismissal With Prejudice.--Except as provided in section 7, an 
order granting a motion to dismiss or for summary judgment pursuant to 
this section shall be entered with prejudice.
    (f) 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 BIOMATERIALS SUPPLIER.

    (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 finds 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.
    (c) Discovery.--Nothing in this section shall give a claimant or 
any other party the right to obtain discovery from a biomaterials 
supplier at any time prior to grant of a motion for impleader beyond 
that allowed under section 6.

SEC. 8. EFFECTIVE DATE.

    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.




                                                 Union Calendar No. 349

105th CONGRESS

  2d Session

                               H. R. 872

                  [Report No. 105-549, Parts I and II]

_______________________________________________________________________

                                 A BILL

  To establish rules governing product liability actions against raw 
materials and bulk component suppliers to medical device manufacturers, 
                        and for other purposes.

_______________________________________________________________________



Reported from the Committee on Commerce with an amendment, committed to 
the Committee of the Whole House on the State of the Union, and ordered 
                             to be printed