Page:United States Statutes at Large Volume 112 Part 2.djvu/637

 PUBLIC LAW 105-230—AUG. 13, 1998 112 STAT. 1521 (A) IN GENERAL.— The term "biomaterial$ supplier" means an entity that directly or indirectly isupplies 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.

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