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H.R. 873 (ih) To amend the Comprehensive Environmental Response, Compensation, and ...

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                                                 Union Calendar No. 349
  2d Session
                                H. R. 872

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

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



                           February 27, 1997

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

                              May 22, 1998

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

                              May 22, 1998

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

                             July 14, 1998

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

                             July 14, 1998

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


                                 A BILL

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

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


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


    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 
            (8) even though suppliers of raw materials and component 
        parts have very rarely been held liable in such actions, such 
        suppliers have ceased supplying certain raw materials and 
        component parts for use in medical devices for a number of 
        reasons, including concerns about the costs of such litigation;
            (9) unless alternate sources of supply can be found, the 
        unavailability of raw materials and component parts for medical 
        devices will lead to unavailability of lifesaving and life-
        enhancing medical devices;
            (10) because other suppliers of the raw materials and 
        component parts in foreign nations are refusing to sell raw 
        materials or component parts for use in manufacturing certain 
        medical devices in the United States, the prospects for 
        development of new sources of supply for the full range of 
        threatened raw materials and component parts for medical 
        devices are remote;
            (11) it is unlikely that the small market for such raw 
        materials and component parts in the United States could 
        support the large investment needed to develop new suppliers of 
        such raw materials and component parts;
            (12) attempts to develop such new suppliers would raise the 
        cost of medical devices;
            (13) courts that have considered the duties of the 
        suppliers of the raw materials and component parts have 
        generally found that the suppliers do not have a duty--
                    (A) to evaluate the safety and efficacy of the use 
                of a raw material or component part in a medical 
                device; and
                    (B) to warn consumers concerning the safety and 
                effectiveness of a medical device;
            (14) because medical devices and the raw materials and 
        component parts used in their manufacture move in interstate 
        commerce, a shortage of such raw materials and component parts 
        affects interstate commerce;
            (15) in order to safeguard the availability of a wide 
        variety of lifesaving and life-enhancing medical devices, 
        immediate action is needed--
                    (A) to clarify the permissible bases of liability 
                for suppliers of raw materials and component parts for 
                medical devices; and
                    (B) to provide expeditious procedures to dispose of 
                unwarranted suits against the suppliers in such manner 
                as to minimize litigation costs;
            (16) the several States and their courts are the primary 
        architects and regulators of our tort system; Congress, 
        however, must, in certain circumstances involving the national 
        interest, address tort issues, and a threatened shortage of raw 
        materials and component parts for life-saving medical devices 
        is one such circumstance; and
            (17) the protections set forth in this Act are needed to 
        assure the continued supply of materials for life-saving 
        medical devices; however, negligent suppliers should not be 


     As used in this Act:
            (1) Biomaterials supplier.--
                    (A) In general.--The term ``biomaterials supplier'' 
                means an entity that directly or indirectly supplies a 
                component part or raw material for use in the 
                manufacture of an implant.
                    (B) Persons included.--Such term includes any 
                person who--
                            (i) has submitted master files to the 
                        Secretary for purposes of premarket approval of 
                        a medical device; or
                            (ii) licenses a biomaterials supplier to 
                        produce component parts or raw materials.
            (2) Claimant.--
                    (A) In general.--The term ``claimant'' means any 
                person who brings a civil action, or on whose behalf a 
                civil action is brought, arising from harm allegedly 
                caused directly or indirectly by an implant, including 
                a person other than the individual into whose body, or 
                in contact with whose blood or tissue, the implant is 
                placed, who claims to have suffered harm as a result of 
                the implant.
                    (B) Action brought on behalf of an estate.--With 
                respect to an action brought on behalf of or through 
                the estate of an individual into whose body, or in 
                contact with whose blood or tissue the implant is 
                placed, such term includes the decedent that is the 
                subject of the action.
                    (C) Action brought on behalf of a minor or 
                incompetent.--With respect to an action brought on 
                behalf of or through a minor or incompetent, such term 
                includes the parent or guardian of the minor or 
                    (D) Exclusions.--Such term does not include--
                            (i) a provider of professional health care 
                        services, in any case in which--
                                    (I) the sale or use of an implant 
                                is incidental to the transaction; and
                                    (II) the essence of the transaction 
                                is the furnishing of judgment, skill, 
                                or services;
                            (ii) a person acting in the capacity of a 
                        manufacturer, seller, or biomaterials supplier; 
                            (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 
                            (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 
                    (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

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