court shall consider a defendant to be a
biomaterials supplier who is not subject to an
action for harm to a claimant caused by an im-
plant, other than an action relating to liability
for a violation of contractual requirements or
specifications described in subsection (d).
(B) RESPONSES TO MOTION TO DISMISS.—
The court shall grant a motion to dismiss any
action that asserts liability of the defendant
under subsection (b) or (c) of section 5 on the
grounds that the defendant is not a manufac-
turer subject to such subsection 5(b) or seller
subject to subsection 5(c), unless the claimant
submits a valid affidavit that demonstrates
that—
(i) with respect to a motion to dismiss con-
tending the defendant is not a manufacturer,
the defendant meets the applicable require-
ments for liability as a manufacturer under sec-
tion 5(b); or
(ii) with respect to a motion to dismiss
contending that the defendant is not a seller,
the defendant meets the applicable require-
ments for liability as a seller under section 5(c).
(4) BASIS
OF
RULING
ON
MOTION
TO
DIS-
MISS.—
(A) IN GENERAL.—The court shall rule on
a motion to dismiss filed under subsection (a)
solely on the basis of the pleadings of the par-
ties made pursuant to this section and any affi-
davits submitted by the parties pursuant to this
section.
(B) MOTION FOR SUMMARY JUDGMENT.—
Notwithstanding any other provision of law, if
the court determines that the pleadings and af-
fidavits made by parties pursuant to this sec-
tion raise genuine issues as concerning material
facts with respect to a motion concerning con-
tractual requirements and specifications, the
court may deem the motion to dismiss to be a
motion for summary judgment made pursuant
to subsection (d).
(d) SUMMARY JUDGMENT.—
(1) IN GENERAL.—
(A) BASIS FOR ENTRY OF JUDGMENT.—A
biomaterials supplier shall be entitled to entry
of judgment without trial if the court finds
there is no genuine issue as concerning any ma-
terial fact for each applicable element set forth
in paragraphs (1) and (2) of section 5(d).
(B) ISSUES OF MATERIAL FACT.—With re-
spect to a finding made under subparagraph
(A), the court shall consider a genuine issue of
material fact to exist only if the evidence sub-
mitted by 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 ap-
plicable rules, the court permits discovery prior to a
ruling on a motion for summary judgment made
pursuant to this subsection, such discovery shall be
limited solely to establishing whether a genuine issue
of material fact exists.
(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 5(d) or the
failure to establish the applicable elements of section
5(d) solely to the extent permitted by the applicable
Federal or State rules for discovery against
nonparties.
(e) STAY PENDING PETITION FOR DECLARATION.—
If a claimant has filed a petition for a declaration pursu-
ant to section 5(b) with respect to a defendant, and the
Secretary has not issued a final decision on the petition,
the court shall stay all proceedings with respect to that
defendant until such time as the Secretary has issued a
final decision on the petition.
(f) MANUFACTURER CONDUCT OF PROCEEDING.—
The manufacturer of an implant that is the subject of an
action covered under this Act shall be permitted to file
and conduct a proceeding on any motion for summary
judgment or dismissal filed by a biomaterials supplier who
is a defendant under this section if the manufacturer and
any other defendant in such action enter into a valid and
applicable contractual agreement under which the manu-
facturer agrees to bear the cost of such proceeding or to
conduct such proceeding.
(g) ATTORNEY FEES.—The court shall require the
claimant to compensate the biomaterials supplier (or a
manufacturer appearing in lieu of a supplier pursuant to
subsection (f)) for attorney fees and costs, if—
(1) 
the 
claimant 
named 
or 
joined 
the
biomaterials supplier; and
(2) the court found the claim against the
biomaterials supplier to be without merit and frivo-
lous.
SEC. 7. APPLICABILITY.
This Act shall apply to all civil actions covered under
this Act that are commenced on or after the date of enact-
ment of this Act, including any such action with respect
to which the harm asserted in the action or the conduct
that caused the harm occurred before the date of enact-
ment of this Act.
Æ
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