Page:United States Statutes at Large Volume 112 Part 2.djvu/636

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112 STAT. 1520 PUBLIC LAW 105-230—AUG. 13, 1998 (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. 21 USC 1602. SEC. 3. DEFINITIONS. As used in this Act: (1) BlOMATERIALS SUPPLIER.—