H.R. 872 (ih) To establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. ...

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        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);

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