Page:United States Statutes at Large Volume 112 Part 2.djvu/639

 PUBLIC LAW 105-230—AUG. 13, 1998 112 STAT. 1523 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. 21 USC 1603. (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.— T his 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

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