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U.S. Code as of:
01/19/04
Section 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.
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