[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 872 Enrolled Bill (ENR)]

        H.R.872

                       One Hundred Fifth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
the twenty-seventh day of January, one thousand nine hundred and ninety-
                                  eight


                                 An Act


 
   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; 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. 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 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. 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 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 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--
                (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 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;
                (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.--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 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 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 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, 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. 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 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. 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.