| Home > 105th Congressional Bills > H.R. 873 (ih) To amend the Comprehensive Environmental Response, Compensation, and ...
H.R. 873 (ih) To amend the Comprehensive Environmental Response, Compensation, and ...
Union Calendar No. 349 105th CONGRESS 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. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES 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, 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; 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 protected. 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 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 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 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; 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
Other Popular 105th Congressional Bills Documents:
|GovRecords.org presents information on various agencies of the United States Government. Even though all information is believed to be credible and accurate, no guarantees are made on the complete accuracy of our government records archive. Care should be taken to verify the information presented by responsible parties. Please see our reference page for congressional, presidential, and judicial branch contact information. GovRecords.org values visitor privacy. Please see the privacy page for more information.|
Supreme Court Decisions
104th Congressional Documents
105th Congressional Documents
106th Congressional Documents
107th Congressional Documents
108th Congressional Documents
1994 Presidential Documents