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U.S. Code as of:
01/19/04
Section 1603. General requirements; applicability; preemption
(a) General requirements
(1) In general
In any civil action covered by this chapter, a biomaterials
supplier may -
(A) raise any exclusion from liability set forth in section
1604 of this title; and
(B) make a motion for dismissal or for summary judgment as
set forth in section 1605 of this title.
(2) Procedures
Notwithstanding any other provision of law, a Federal or State
court in which an action covered by this chapter is pending
shall, in connection with a motion under section 1605 or 1606 of
this title, use the procedures set forth in this chapter.
(b) Applicability
(1) In general
Except as provided in paragraph (2), this chapter 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
chapter; and
(B) shall be governed by applicable commercial or contract
law.
(c) Scope of preemption
(1) In general
This chapter 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 chapter establishes a rule of law applicable to
the recovery of such damages.
(2) Applicability of other laws
Any issue that arises under this chapter 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 chapter 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 that otherwise would
not exist under applicable Federal or State law.
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