21 U.S.C. § 1603

Current through P.L. 118-107 (published on www.congress.gov on 11/21/2024)

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.

21 U.S.C. § 1603

Pub. L. 105-230, §4, Aug. 13, 1998, 112 Stat. 1523.

STATUTORY NOTES AND RELATED SUBSIDIARIES

EFFECTIVE DATESection applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105-230 set out as a note under section 1601 of this title.

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.

medical device

The term "medical device" means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.