[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 2215 Introduced in Senate (IS)]

103d CONGRESS
  2d Session
                                S. 2215

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                June 20 (legislative day, June 7), 1994

    Mr. Byrd (for Mr. Lieberman) (for himself and Mr. Durenberger) 
introduced the following bill; which was read twice and referred to the 
           Committee on Commerce, Science, and Transportation

_______________________________________________________________________

                                 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 
1994.''

SEC. 2. FINDINGS.

    Congress finds and declares the following:
            (1) Every year millions of Americans depend on the 
        availability of life-saving or life-enhancing permanently 
        implantable medical devices;
            (2) A continued supply of raw materials and component parts 
        is necessary to the invention, development, improvement and 
        maintenance of the supply of such devices;
            (3) Most of these devices are made with raw materials and 
        component parts that are not designed or manufactured 
        specifically for use in implantable devices, but which have 
        uses in a variety of nonmedical products as well;
            (4) Small quantities of these raw materials and component 
        parts are used, so that sales of raw materials and component 
        parts for medical devices are an extremely small portion of the 
        overall market for such raw materials and medical devices;
            (5) Manufacturers of medical devices are required under the 
        Federal Food Drug and Cosmetics Act to demonstrate that their 
        products are safe and effective, including being properly 
        designed and having adequate warnings or instructions, and 
        existing tort law requires manufacturers of medical devices to 
        ensure they are properly designed and have adequate warnings;
            (6) Notwithstanding the fact that raw materials and 
        component parts suppliers do not design, produce, or test the 
        final implant, they have been sued in cases alleging inadequate 
        design and testing of, or warnings related to the use of, 
        permanently implanted medical devices;
            (7) Even though raw materials and component parts suppliers 
        have almost never been held liable in such suits, because the 
        cost of litigating such suites to a favorable judgment far 
        exceeds the total potential sales of such raw materials and 
        component parts to the medical device industry, raw materials 
        and component parts suppliers have begun to cease supplying 
        such raw materials and component parts for use in permanently 
        implanted medical devices;
            (8) The unavailability of raw materials and component parts 
        will, unless alternate sources of supply can be found, lead to 
        unavailability of life-saving and life-enhancing medical 
        devices;
            (9) The prospects for development of new sources of supply 
        for the full range of threatened raw materials and component 
        parts are remote, as other suppliers around the world are 
        refusing to sell raw materials or component parts for use in 
        manufacturing permanently implantable medical devices in the 
        United States, and it is unlikely that such a small market 
        could support the large investment needed to develop new 
        suppliers and attempts to do so will raise the cost of medical 
        devices;
            (10) Courts that have considered the issue have generally 
        found that raw materials and component part suppliers do not 
        have a duty to evaluate the safety and efficacy of the use of a 
        raw material or component part in a medical device, and also do 
        not have a duty to warn concerning the safety and effectiveness 
        of a medical device;
            (11) Attempts to impose such duties will cause more harm 
        than good by driving raw materials and component part suppliers 
        to cease supplying manufacturers of permanently implantable 
        medical devices;
            (12) In order to safeguard the availability of a wide 
        variety of life-saving and life-enhancing medical devices, 
        immediate action is needed to clarify the permissible bases of 
        liability for suppliers of raw materials and component parts 
        used in the manufacture of permanently implantable medical 
        devices and to provide expeditious procedures to dispose of 
        unwarranted suits against those suppliers so as to minimize 
        litigation costs.

SEC. 3. DEFINITIONS.

    As used in this Act, the term--
            (1) ``biomaterials supplier'' means an entity that directly 
        or indirectly supplies a component part or raw material for use 
        in the manufacture of an implant, and includes persons that 
        have submitted master files to the Food and Drug Administration 
        for purposes of pre-market approval of medical devices, but 
        does not include a manufacturer or seller of an implant;
            (2) ``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, and includes persons other than the individual into 
        whose body, or in contact with whose blood or tissue, the 
        implant is placed, if such person claims to have suffered harm; 
        if such an action is brought through or on behalf of an estate, 
        the term includes the claimant's decedent, or if it is brought 
        through or on behalf of a minor or incompetent, the term 
        includes the claimant's parent or guardian; the term does not 
        include
                    (A) 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
                    (B) a manufacturer, seller, or biomaterials 
                supplier.
            (3) ``component part'' means a manufactured piece of an 
        implant and includes a manufactured piece that has significant 
        nonimplant applications and that by itself has no implant value 
        or purpose, but when combined with other component parts and 
        materials, constitutes an implant;
            (4) ``harm'' means any injury to or damage suffered by an 
        individual, any illness, disease, or death of that individual 
        resulting from that injury or damage, and any loss to that 
        individual or any other individual resulting from that injury 
        or damage; the term does not include commercial loss or loss of 
        or damage to an implant itself;
            (5) ``implant'' means a medical device that (A) is placed 
        into a surgically or naturally formed or existing cavity of the 
        body or which contacts blood or internal human tissue; and (B) 
        which (i) is intended by the manufacturer to remain in contact 
        with the body or internal tissue of the humans continuously for 
        a period of thirty days or more, or (ii) has labeling which 
        does not contraindicate implantation or contact for thirty days 
        or more;
            (6) ``manufacturer'' means any person who, with respect to 
        any particular 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 
                Cosmetics Act (21 U.S.C. 360(a)(1)), of an implant; and
                    (B) is required under Section 510 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360), and the 
                regulations issued thereunder, to register with the 
                Secretary of Health and Human Services and to include 
                the implant on a list of devices filed with the 
                Secretary pursuant to Section 510(j) of the Federal 
                Food, Drug and Cosmetic Act (21 U.S.C. 360(j)), and the 
                regulations issued thereunder;
            (7) ``medical device'' means a medical device as defined in 
        Sec. 201(h) of the Federal Food, Drug and Cosmetic Act (21 
        U.S.C. Sec. 321(h));
            (8) ``qualified specialist'' means a person who is 
        qualified by knowledge, skill, experience, training, or 
        education in the specialty areas that are the subject of the 
        action;
            (9) ``raw material'' means a substance or product that has 
        a generic use and that may be used in applications other than 
        implants;
            (10) ``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; the term does not include--
                    (A) a seller or lessor or real property;
                    (B) 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
                    (C) any person who acts in only a financial 
                capacity with respect to the sale of an implant.

SEC. 4. APPLICABILITY; PREEMPTION.

    (a) Applicability.--This Act applies to any civil action brought by 
a claimant, whether in State or Federal court, against a manufacturer, 
seller, or biomaterials supplier, or against licensors of biomaterials 
suppliers, on any theory, for harm caused by an implant. 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 itself or for commercial loss 
to the purchaser is not subject to this Act and shall be governed by 
applicable commercial or contract law.
    (b) Scope of Preemption.--This Act supersedes any State law 
regarding recovery for harm caused by an implant only to the extent 
that this Act establishes a rule of law applicable to any such 
recovery. Any issue arising under this Act that is not governed by any 
such rule of law shall be governed by applicable State or Federal law.
    (c) Effect on Other Laws.--Nothing in this Act shall be construed 
to--
            (1) affect any defense available under other provisions of 
        State or Federal law to a defendant in an action alleging harm 
        caused by an implant; or
            (2) create a cause of action or Federal court jurisdiction 
        pursuant to 28 U.S.C. 1331 or 1337 that otherwise would not 
        exist under applicable State or Federal law.

SEC. 5. ACTIONS AGAINST BIOMATERIALS SUPPLIERS.

    (a)(1) Except as provided in subsection (b) of this Act, no 
claimant may bring an action for harm caused by an implant against a 
person, who has not registered with the Secretary of Health and Human 
Services, pursuant to section 510 of the Federal Food, Drug and 
Cosmetics Act, and the regulations issued thereunder, and included the 
implant on a list of devices filed with the Secretary pursuant to 
Section 510(j) of the Federal Food, Drug and Cosmetics Act and the 
regulations issued thereunder.
    (2) Notwithstanding subparagraph (1), a claimant may bring an 
action, other than as provided in subsection (b) of this Act, against a 
person who, with respect to claimant's implant, is the subject of a 
declaration issued by the Secretary under section 6(a) of this Act, or 
is a seller of the implant that allegedly caused harm to the claimant.
    (b) No claimant may bring an action for harm caused by an implant 
against a biomaterials supplier, and no biomaterials supplier shall be 
liable for harm to a claimant caused by an implant, unless the claimant 
shows, by a preponderance of the evidence, that--
            (1) the raw materials or component parts delivered by the 
        biomaterials supplier either were not the product described in 
        the contract between the biomaterials supplier and the person 
        who contracted for delivery of the product, or failed to meet 
        any specifications that were--
                    (A) provided to the biomaterials supplier and not 
                expressly repudiated by the biomaterials supplier prior 
                to acceptance of delivery of the raw materials or 
                component parts;
                    (B) published by the biomaterials supplier, 
                provided to the manufacturer by the biomaterials 
                supplier, or contained in a master file submitted by 
                the biomaterials supplier to the Food and Drug 
                Administration, and currently maintained by the 
                biomaterials supplier, for purposes of pre-market 
                approval of medical devices; or
                    (C)(i) included in the manufacturer's submissions 
                for purposes of pre-market approval or review by the 
                Food and Drug Administration under section 510, 513, 
                515, or 520 of the Federal Food, Drug and Cosmetic Act 
                (21 U.S. Code Sec. Sec. 360, 360c, 360e, or 360j) that 
                have received clearance from the Food and Drug 
                Administration, (ii) that were provided by the 
                manufacturer to the biomaterials supplier and not 
                expressly repudiated by the biomaterials supplier prior 
                to the manufacturer's acceptance of delivery of the raw 
                materials or component parts; and
            (2) such conduct was an actual and proximate cause of the 
        claimant's harm.
    (c) No claimant may bring an action for harm caused by an implant 
against a person who licenses a biomaterials supplier to produce raw 
materials or component parts.
    (d) The applicable statute of limitations shall be tolled during 
any period in which claimant has filed a petition with the Secretary of 
Health and Human Services under section 6 of this Act.

SEC. 6. REVIEW BY THE SECRETARY OF NON-REGISTRATION.

    (a) The Secretary may, on its own motion or upon petition by any 
person, after notice to the affected persons and affording an 
opportunity for an informal hearing, issue a declaration that a person, 
with respect to the implant that allegedly caused claimant's harm,
            (1) should have registered with the Secretary under Section 
        510 of the Federal Food, Drug and Cosmetics Act (21 U.S.C. 
        360), and the regulations issued thereunder, but failed to do 
        so, or
            (2) should have included the implant on a list of devices 
        filed with the Secretary pursuant to Section 510(j) of the 
        Federal Food, Drug and Cosmetic Act (21 U.S.C. 360(j)), but 
        failed to do so.
    (b) Any petition filed pursuant to subsection (a) shall be 
immediately docketed by the Secretary, and the Secretary shall issue a 
final decision within 180 days of the filing of the petition.

SEC. 7. PROCEDURES FOR ACTIONS AGAINST A BIOMATERIALS SUPPLIER.

    (a) In General.--The procedural requirements set forth in 
subsection (b) shall apply to any action by a claimant against a 
biomaterials supplier.
    (b) Procedural Requirements.--
            (1) A claimant may not bring an action against a 
        biomaterials supplier unless the manufacturer of the implant is 
        named as a party, except if the manufacturer is subject to 
        service of process in no jurisdiction in which the biomaterials 
        supplier or is also subject to service of process or unless 
        litigation against the manufacturer is barred by applicable 
        law.
            (2) No action may be brought by any claimant against a 
        biomaterials supplier unless, at the time the claimant brings 
        the action, the claimant submits an affidavit--
                    (A) declaring that the claimant has consulted and 
                reviewed the facts of the action with qualified 
                specialists, whose qualifications the claimant shall 
                disclose;
                    (B) including a written determination by a 
                qualified specialist that the raw materials or 
                component parts actually used in the manufacture of 
                claimant's implant were raw materials or component 
                parts described in section 5(b)(1), together with a 
                statement of the basis for such a determination;
                    (C) including a written determination by a 
                qualified specialist that, after a review of the 
                medical record and other relevant material, the raw 
                material or component part supplied by the biomaterials 
                supplier and actually used in the manufacture of 
                claimant's implant was a cause of claimant's harm, 
                together with a statement of the basis for the 
                determination;
                    (D) on the basis of the qualified specialists' 
                review and consultation, that the claimant (or the 
                claimant's attorney) has concluded that there is a 
                reasonable and meritorious cause for the filing of the 
                action against the biomaterials supplier.
    (c) Dismissal.--
            (1) In any action subject to this Act, a defendant may, at 
        any time at which a motion to dismiss may be filed under 
        applicable law, move to dismiss the action on the grounds that 
        the defendant is a biomaterials supplier and--
                    (A) claimant has failed to satisfy the conditions 
                in section 5(a) that would permit claimant to bring an 
                action against defendant;
                    (B) defendant was not a seller of the implant which 
                allegedly caused harm to the claimant; or
                    (C) claimant has failed to comply with the 
                provisions of subsection (b).
            (2) Defendant may submit affidavits demonstrating that 
        defendant has not included the implant on a list, if any, filed 
        with the Secretary pursuant to section 510(j) of the Federal 
        Food, Drug and Cosmetic Act (21 U.S.C. 360). Claimant may, in 
        response to such a motion, submit affidavits demonstrating that 
        the Secretary has, with respect to the defendant and the 
        implant that allegedly caused claimant's harm, issued a 
        declaration pursuant to section 6(a) of this Act, or that 
        defendant was a seller of the implant.
            (3) No discovery shall be permitted against the defendant 
        who has filed a motion to dismiss under subparagraph (1), other 
        than discovery necessary to determine a motion to dismiss for 
        lack of jurisdiction, until the court has ruled on the motion 
        to dismiss filed pursuant to subsection (1).
            (4) A defendant shall conclusively be deemed to be a 
        biomaterials supplier and not to be subject to suit except 
        pursuant to section 5(b) of this Act, and a motion to dismiss 
        under subsections (c)(1)(A) or (c)(1)(B) shall be granted, 
        unless the claimant submits valid affidavits demonstrating--
                    (A) with respect to a motion under subsection 
                (c)(1)(A), that the Secretary has, with respect to the 
                defendant and the implant that allegedly caused harm to 
                the claimant, issued a declaration pursuant to section 
                6(a) of this Act; or
                    (B) with respect to a motion under subsection 
                (c)(1)(B), that the biomaterials supplier was a seller 
                which held title to the implant as a result or 
                purchasing or selling the implant after the implant was 
                manufactured and entered the stream of commerce.
            (5) The court shall rule on the motion to dismiss filed 
        under subsection (c) solely on the basis of the pleadings and 
        any affidavits, including affidavits submitted under paragraph 
        (2). If the pleadings and affidavits raise genuine issues as to 
        material facts with respect to a motion under (c)(1)(C), the 
        motion may be treated as a motion for summary judgment pursuant 
        to subsection (d) of this section.
    (d) Summary Judgment.--
            (1) A biomaterials supplier shall be entitled to entry of 
        judgment without trial if there is no genuine issue as to any 
        material fact as to each element set forth in section 5(b). A 
        genuine issue of material fact shall exist only if the evidence 
        submitted by claimant, if found by a jury to be credible, would 
        be sufficient to allow a reasonable jury to reach a verdict for 
        the claimant.
            (2) In the event that the court, under applicable rules, 
        may permit discovery prior to ruling on a motion for summary 
        judgment, such discovery shall be limited solely to 
        establishing whether a genuine issue of material fact exists.
    (e) A biomaterials supplier shall be subject to discovery in 
connection with a motion under subsection (c) or (d) solely to the 
extent permitted by the applicable State or Federal rules for discovery 
against nonparties.
    (f) In the event claimant has filed a petition for a declaration 
pursuant to section 6(a) with respect to a defendant, and the Secretary 
has not issued a final decision thereon, the court shall stay all 
proceedings with respect to that defendant until the Secretary has 
issued a final decision.
    (g) The manufacturer of the implant shall be permitted to file and 
conduct the proceeding on any motion filed pursuant to subsection (c) 
or (d) if the manufacturer and the other defendant(s) have entered into 
a valid and applicable contractual agreement in which the manufacturer 
agrees to bear the cost of or to conduct such proceeding.
    (h) The court shall require the claimant to compensate the 
biomaterials supplier (or a manufacturer appearing in lieu of a 
supplier pursuant to subsection (g)) for attorney fees and costs, if 
the claimant named or joined the biomaterials supplier, but the court 
found the claim against the biomaterials supplier to be without merit 
and frivolous.

SEC. 9. EFFECTIVE DATE.

    This act shall take effect on the date of its enactment and shall 
apply to all civil actions pursuant to this act commenced on or after 
such date, including any action in which the harm or the conduct which 
caused the harm occurred before the effective date of this act.

SEC. 10. SEVERABILITY.

    If any provision of this act, or the application of such provision 
to any person or circumstances is held to be unconstitutional, the 
remainder of this act and application of the provisions of such to any 
person or circumstance shall not be affected thereby.

                                 <all>

S 2215 IS----2
S 2215 IS----3