Text: H.R.872 — 105th Congress (1997-1998)All Information (Except Text)

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Public Law No: 105-230 (08/13/1998)

 
[105th Congress Public Law 230]
[From the U.S. Government Printing Office]


<DOC>
[DOCID: f:publ230.105]


[[Page 112 STAT. 1519]]

Public Law 105-230
105th Congress

                                 An Act


 
   To establish rules governing product liability actions against raw 
materials and bulk component suppliers to medical device manufacturers, 
     and for other purposes. <<NOTE: Aug. 13, 1998 -  [H.R. 872]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Biomaterials Access 
Assistance Act of 1998.>> assembled,

SECTION 1. <<NOTE: 21 USC 1601 note.>> SHORT TITLE.

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

SEC. 2. <<NOTE: 21 USC 1601.>> 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;

[[Page 112 STAT. 1520]]

            (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 lifesaving 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 lifesaving medical 
        devices, although such protections do not protect negligent 
        suppliers.

SEC. 3. <<NOTE: 21 USC 1602.>> DEFINITIONS.

     As used in this Act:
            (1) Biomaterials supplier.--

[[Page 112 STAT. 1521]]

                    (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.

[[Page 112 STAT. 1522]]

                    (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,

[[Page 112 STAT. 1523]]

                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 in any case in which--
                                    (I) the sale or use of the 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; or
                          (iii) any person who acts in only a financial 
                      capacity with respect to the sale of an implant.

SEC. 4. <<NOTE: 21 USC 1603.>> 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, purchased for use 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

[[Page 112 STAT. 1524]]

        Code, that otherwise would not exist under applicable Federal or 
        State law.

SEC. 5. <<NOTE: 21 USC 1604.>> 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 is liable--
            (1) as a manufacturer of the implant, as provided in 
        subsection (b);
            (2) as a seller of the implant, as provided in subsection 
        (c); or
            (3) for furnishing 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) registered 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--

[[Page 112 STAT. 1525]]

                          (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. <<NOTE: Deadline.>> 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 files a petition with 
                the Secretary under this paragraph until such time as 
                either (i) the Secretary 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.

    (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;

[[Page 112 STAT. 1526]]

                          (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. <<NOTE: Courts. 21 USC 1605.>> 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.--In any civil 
action covered by this Act, 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 <<NOTE: Applicability.>> 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 with 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 it 
                did not furnish raw materials or component parts for the 
                implant that failed to meet applicable contractual 
                require

[[Page 112 STAT. 1527]]

                ments 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 treat 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,

[[Page 112 STAT. 1528]]

                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 the 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.--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.
    (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. <<NOTE: 21 USC 1606.>> 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

[[Page 112 STAT. 1529]]

                    (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 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 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 covered by 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. <<NOTE: Applicability. 21 USC 1601 note.>> 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.

    Approved August 13, 1998.

LEGISLATIVE HISTORY--H.R. 872:
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HOUSE REPORTS: No. 105-549, Pt. 1 (Comm. on the Judiciary) and Pt. 2 
(Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 144 (1998):
            July 29, considered and passed House.
            July 30, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 34 (1998):
            Aug. 13, Presidential statement.

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