
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: 21USC1605]

 
                        TITLE 21--FOOD AND DRUGS
 
                CHAPTER 21--BIOMATERIALS ACCESS ASSURANCE
 
Sec. 1605. Procedures for dismissal of civil actions against 
        biomaterials suppliers
        

(a) Motion to dismiss

    A defendant may, at any time during which a motion to dismiss may be 
filed under applicable law, move to dismiss an action against it on the 
grounds that the defendant is a biomaterials supplier and one or more of 
the following:
        (1) The defendant is not liable as a manufacturer, as provided 
    in section 1604(b) of this title.
        (2) The defendant is not liable as a seller, as provided in 
    section 1604(c) of this title.
        (3) The defendant is not liable for furnishing raw materials or 
    component parts for the implant that failed to meet applicable 
    contractual requirements or specifications, as provided in section 
    1604(d) of this title.
        (4) The claimant did not name the manufacturer as a party to the 
    action, as provided in subsection (b) of this section.

(b) Manufacturer of implant shall be named a party

    In any civil action covered by this chapter, the claimant shall be 
required to name the manufacturer of the implant as a party to the 
action, unless--
        (1) the manufacturer is subject to service of process solely in 
    a jurisdiction in which the biomaterials supplier is not domiciled 
    or subject to a service of process; or
        (2) a claim against the manufacturer is barred by applicable law 
    or rule of practice.

(c) Proceeding on motion to dismiss

    The following rules shall apply to any proceeding on a motion to 
dismiss filed by a defendant under this section:

            (1) Effect of motion to dismiss on discovery

        (A) In general

            Except as provided in subparagraph (B), if a defendant files 
        a motion to dismiss under subsection (a) of this section, no 
        discovery shall be permitted in connection with the action that 
        is the subject of the motion, other than discovery necessary to 
        determine a motion to dismiss for lack of jurisdiction, until 
        such time as the court rules on the motion to dismiss.

        (B) Discovery

            If a defendant files a motion to dismiss under subsection 
        (a)(3) of this section on the grounds that it did not furnish 
        raw materials or component parts for the implant that failed to 
        meet applicable contractual requirements or specifications, the 
        court may permit discovery limited to issues that are directly 
        relevant to--
                (i) the pending motion to dismiss; or
                (ii) the jurisdiction of the court.

                           (2) Affidavits

        (A) Defendant

            A defendant may submit affidavits supporting the grounds for 
        dismissal contained in its motion to dismiss under subsection 
        (a) of this section. If the motion is made under subsection 
        (a)(1) of this section, the defendant may submit an affidavit 
        demonstrating that the defendant has not included the implant on 
        a list, if any, filed with the Secretary pursuant to section 
        360(j) of this title.

        (B) Claimant

            In response to a motion to dismiss, the claimant may submit 
        affidavits demonstrating that--
                (i) the Secretary has, with respect to the defendant and 
            the implant that allegedly caused harm to the claimant, 
            issued a declaration pursuant to section 1604(b)(2)(B) of 
            this title; or
                (ii) the defendant is a seller of the implant who is 
            liable under section 1604(c) of this title.

              (3) Basis of ruling on motion to dismiss

        The court shall rule on a motion to dismiss filed under 
    subsection (a) of this section solely on the basis of the pleadings 
    and affidavits of the parties made pursuant to this subsection. The 
    court shall grant a motion to dismiss filed under subsection (a) of 
    this section--
            (A) unless the claimant submits a valid affidavit that 
        demonstrates that the defendant is not a biomaterials supplier;
            (B) unless the court determines, to the extent raised in the 
        pleadings and affidavits, that one or more of the following 
        apply:
                (i) the defendant may be liable as a manufacturer, as 
            provided in section 1604(b) of this title;
                (ii) the defendant may be liable as a seller, as 
            provided in section 1604(c) of this title; or
                (iii) the defendant may be liable for furnishing raw 
            materials or component parts for the implant that failed to 
            meet applicable contractual requirements or specifications, 
            as provided in section 1604(d) of this title; or

            (C) if the claimant did not name the manufacturer as a party 
        to the action, as provided in subsection (b) of this section.

       (4) Treatment of motion as motion for summary judgment

        The court may treat a motion to dismiss as a motion for summary 
    judgment subject to subsection (d) of this section in order to 
    determine whether the pleadings and affidavits, in connection with 
    such action, raise genuine issues of material fact concerning 
    whether the defendant furnished raw materials or component parts of 
    the implant that failed to meet applicable contractual requirements 
    or specifications as provided in section 1604(d) of this title.

(d) Summary judgment

                           (1) In general

        (A) Basis for entry of judgment

            If a motion to dismiss of a biomaterials supplier is to be 
        treated as a motion for summary judgment under subsection (c)(4) 
        of this section or if a biomaterials supplier moves for summary 
        judgment, the biomaterials supplier shall be entitled to entry 
        of judgment without trial if the court finds there is no genuine 
        issue of material fact for each applicable element set forth in 
        paragraphs (1) and (2) of section 1604(d) of this title.

        (B) Issues of material fact

            With respect to a finding made under subparagraph (A), the 
        court shall consider a genuine issue of material fact to exist 
        only if the evidence submitted by the claimant would be 
        sufficient to allow a reasonable jury to reach a verdict for the 
        claimant if the jury found the evidence to be credible.

    (2) Discovery made prior to a ruling on a motion for summary 
                                  judgment

        If, under applicable rules, the court permits discovery prior to 
    a ruling on a motion for summary judgment governed by section 
    1604(d) of this title, such discovery shall be limited solely to 
    establishing whether a genuine issue of material fact exists as to 
    the applicable elements set forth in paragraphs (1) and (2) of 
    section 1604(d) of this title.

        (3) Discovery with respect to a biomaterials supplier

        A biomaterials supplier shall be subject to discovery in 
    connection with a motion seeking dismissal or summary judgment on 
    the basis of the inapplicability of section 1604(d) of this title or 
    the failure to establish the applicable elements of section 1604(d) 
    of this title solely to the extent permitted by the applicable 
    Federal or State rules for discovery against nonparties.

(e) Dismissal with prejudice

    An order granting a motion to dismiss or for summary judgment 
pursuant to this section shall be entered with prejudice, except insofar 
as the moving defendant may be rejoined to the action as provided in 
section 1606 of this title.

(f) Manufacturer conduct of litigation

    The manufacturer of an implant that is the subject of an action 
covered under this chapter shall be permitted to conduct litigation on 
any motion for summary judgment or dismissal filed by a biomaterials 
supplier who is a defendant under this section on behalf of such 
supplier if the manufacturer and any other defendant in such action 
enter into a valid and applicable contractual agreement under which the 
manufacturer agrees to bear the cost of such litigation or to conduct 
such litigation.

(Pub. L. 105-230, Sec. 6, Aug. 13, 1998, 112 Stat. 1526.)

                  Section Referred to in Other Sections

    This section is referred to in sections 1603, 1604, 1606 of this 
title.
