Title 21 — Food and Drugs
Chapter 21 — Biomaterials Access Assurance
§ 1603. General requirements; applicability; preemption
Statutory text
General requirements
In general
In any civil action covered by this chapter, a biomaterials supplier may—
raise any exclusion from liability set forth in section 1604 of this title; and
make a motion for dismissal or for summary judgment as set forth in section 1605 of this title.
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.
Applicability
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.
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—
shall not be considered an action that is subject to this chapter; and
shall be governed by applicable commercial or contract law.
Scope of preemption
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.
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.
Statutory construction
Nothing in this chapter may be construed—
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
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.
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Biomaterials Access Assurance Act of 1998
Pub. L. 105–230 § 4 · 112 Stat. 1519
Enacted · 21 U.S.C. § 1603
(Pub. L. 105–230, § 4, Aug. 13, 1998, 112 Stat. 1523.)
Source evidence
Code source credit
(Pub. L. 105–230, § 4, Aug. 13, 1998, 112 Stat. 1523.)Enacted provision · exact public law section
SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION. (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.— This 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 Code, that otherwise would not exist under applicable Federal or State law.
1 of 1 references resolved to an enrolled provision
Statutory Notes and Related Subsidiaries
Effective Date
Section applicable to all civil actions covered under this chapter commenced on or after , 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.