
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC1603]

 
                        TITLE 21--FOOD AND DRUGS
 
                CHAPTER 21--BIOMATERIALS ACCESS ASSURANCE
 
Sec. 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.

(Pub. L. 105-230, Sec. 4, Aug. 13, 1998, 112 Stat. 1523.)
