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that the court feels it is likely to enter should the
claimant prevail.
(3) ADMINISTRATIVE PROCEDURES.—
(A) IN GENERAL.—The Secretary may issue
a declaration described in paragraph (2)(B) on
the motion of the Secretary or on petition by
any person, after providing—
(i) notice to the affected persons; and
(ii) an opportunity for an informal
hearing.
(B) DOCKETING AND FINAL DECISION.—Im-
mediately upon receipt of a petition filed pursu-
ant to this paragraph, the Secretary shall docket
the petition. Not later than 180 days after the
petition is filed, the Secretary shall issue a final
decision on the petition.
(C) APPLICABILITY OF STATUTE OF LIMITA-
TIONS.—Any applicable statute of limitations
shall toll during the period during which a
claimant has filed a petition with the Secretary
under this paragraph.
(c) LIABILITY AS SELLER.—A biomaterials supplier
may, to the extent required and permitted by any other ap-
plicable law, be liable as a seller for harm to a claimant
caused by an implant if—
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(1) the biomaterials supplier—
(A) held title to the implant that allegedly
caused harm to the claimant as a result of pur-
chasing the implant after—
(i) the manufacture of the implant;
and
(ii) the entrance of the implant in the
stream of commerce; and
(B) subsequently resold the implant; or
(2) the biomaterials supplier is related by com-
mon ownership or control to a person meeting all the
requirements described in paragraph (1), if a court
deciding a motion to dismiss in accordance with sec-
tion 206(c)(3)(B)(i) finds, on the basis of affidavits
submitted in accordance with section 206, that it is
necessary to impose liability on the biomaterials sup-
plier as a seller because the related manufacturer
meeting the requirements of paragraph (1) lacks suffi-
cient financial resources to satisfy any judgment that
the court feels it is likely to enter should the claimant
prevail.
(d) LIABILITY
FOR VIOLATING CONTRACTUAL RE-
QUIREMENTS
OR SPECIFICATIONS.—A biomaterials sup-
plier may, to the extent required and permitted by any
other applicable law, be liable for harm to a claimant
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caused by an implant, if the claimant in an action shows,
by a preponderance of the evidence, that—
(1) the raw materials or component parts deliv-
ered by the biomaterials supplier either—
(A) did not constitute the product described
in the contract between the biomaterials supplier
and the person who contracted for delivery of the
product; or
(B) failed to meet any specifications that
were—
(i) provided to the biomaterials sup-
plier and not expressly repudiated by the
biomaterials supplier prior to acceptance of
delivery of the raw materials or component
parts;
(ii)(I) published by the biomaterials
supplier;
(II) provided to the manufacturer by
the biomaterials supplier; or
(III) contained in a master file that
was submitted by the biomaterials supplier
to the Secretary and that is currently main-
tained by the biomaterials supplier for pur-
poses of premarket approval of medical de-
vices; or
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(iii)(I) included in the submissions for
purposes of premarket approval or review
by the Secretary under section 510, 513,
515, or 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360, 360c, 360e, or
360j); and
(II) have received clearance from the
Secretary,
if such specifications were provided by the man-
ufacturer to the biomaterials supplier and were
not expressly repudiated by the biomaterials sup-
plier prior to the acceptance by the manufac-
turer of delivery of the raw materials or compo-
nent parts; and
(2) such conduct was an actual and proximate
cause of the harm to the claimant.
SEC. 206. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS
AGAINST BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—In any action that is sub-
ject to this title, a biomaterials supplier who is a defendant
in such action may, at any time during which a motion
to dismiss may be filed under an applicable law, move to
dismiss the action on the grounds that—
(1) the defendant is a biomaterials supplier; and
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(2)(A) the defendant should not, for the purposes
of—
(i) section 205(b), be considered to be a
manufacturer of the implant that is subject to
such section; or
(ii) section 205(c), be considered to be a
seller of the implant that allegedly caused harm
to the claimant; or
(B)(i) the claimant has failed to establish, pur-
suant to section 205(d), that the supplier furnished
raw materials or component parts in violation of con-
tractual requirements or specifications; or
(ii) the claimant has failed to comply with the
procedural requirements of subsection (b).
(b) MANUFACTURER OF IMPLANT SHALL BE NAMED
A PARTY.—The claimant shall be required to name the
manufacturer of the implant as a party to the action, un-
less—
(1) the manufacturer is subject to service of proc-
ess solely in a jurisdiction in which the biomaterials
supplier is not domiciled or subject to a service of
process; or
(2) an action against the manufacturer is barred
by applicable law.
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(c) PROCEEDING ON MOTION TO DISMISS.—The fol-
lowing rules shall apply to any proceeding on a motion to
dismiss filed under this section:
(1) AFFIDAVITS RELATING TO LISTING AND DEC-
LARATIONS.—
(A) IN GENERAL.—The defendant in the ac-
tion may submit an affidavit demonstrating that
defendant has not included the implant on a list,
if any, filed with the Secretary pursuant to sec-
tion 510(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360(j)).
(B) RESPONSE TO MOTION TO DISMISS.—In
response to the motion to dismiss, the claimant
may submit an affidavit demonstrating that—
(i) the Secretary has, with respect to
the defendant and the implant that alleg-
edly caused harm to the claimant, issued a
declaration 
pursuant 
to 
section
205(b)(2)(B); or
(ii) the defendant who filed the motion
to dismiss is a seller of the implant who is
liable under section 205(c).
(2) EFFECT OF MOTION TO DISMISS ON DISCOV-
ERY.—
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(A) IN GENERAL.—If a defendant files a
motion to dismiss under paragraph (1) or (2) of
subsection (a), no discovery shall be permitted in
connection to the action that is the subject of the
motion, other than discovery necessary to deter-
mine a motion to dismiss for lack of jurisdiction,
until such time as the court rules on the motion
to dismiss in accordance with the affidavits sub-
mitted by the parties in accordance with this
section.
(B) DISCOVERY.—If a defendant files a mo-
tion to dismiss under subsection (a)(2) on the
grounds that the biomaterials supplier did not
furnish raw materials or component parts in
violation of contractual requirements or speci-
fications, the court may permit discovery, as or-
dered by the court. The discovery conducted pur-
suant to this subparagraph shall be limited to is-
sues that are directly relevant to—
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
(3) AFFIDAVITS RELATING STATUS OF DEFEND-
ANT.—
(A) IN GENERAL.—Except as provided in
clauses (i) and (ii) of subparagraph (B), the
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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 205 on the
grounds that the defendant is not a manufac-
turer subject to such section 205(b) or seller sub-
ject to section 205(c), unless the claimant sub-
mits a valid affidavit that demonstrates that—
(i) with respect to a motion to dismiss
contending the defendant is not a manufac-
turer, the defendant meets the applicable re-
quirements for liability as a manufacturer
under section 205(b); or
(ii) with respect to a motion to dismiss
contending that the defendant is not a sell-
er, the defendant meets the applicable re-
quirements for liability as a seller under
section 205(c).
(4) BASIS OF RULING ON MOTION TO DISMISS.—
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(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 parties
made pursuant to this section and any affidavits
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 affi-
davits made by parties pursuant to this section
raise genuine issues as concerning material facts
with respect to a motion concerning contractual
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 material fact
for each applicable element set forth in para-
graphs (1) and (2) of section 205(d).
(B) ISSUES OF MATERIAL FACT.—With re-
spect to a finding made under subparagraph (A),
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the court shall consider a genuine issue of mate-
rial fact to exist only if the evidence submitted
by claimant would be sufficient to allow a rea-
sonable 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 appli-
cable rules, the court permits discovery prior to a rul-
ing on a motion for summary judgment made pursu-
ant to this subsection, such discovery shall be limited
solely to establishing whether a genuine issue of mate-
rial fact exists.
(3) 
DISCOVERY
WITH
RESPECT
TO
A
BIOMATERIALS
SUPPLIER.—A biomaterials supplier
shall be subject to discovery in connection with a mo-
tion seeking dismissal or summary judgment on the
basis of the inapplicability of section 205(d) or the
failure to establish the applicable elements of section
205(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 pursuant
to section 205(b) with respect to a defendant, and the Sec-
retary has not issued a final decision on the petition, the
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court shall stay all proceedings with respect to that defend-
ant until such time as the Secretary has issued a final deci-
sion on the petition.
(f) MANUFACTURER CONDUCT OF PROCEEDING.—The
manufacturer of an implant that is the subject of an action
covered under this title shall be permitted to file and con-
duct a proceeding on any motion for summary judgment
or dismissal filed by a biomaterials supplier who is a de-
fendant under this section if the manufacturer and any
other defendant in such action enter into a valid and appli-
cable contractual agreement under which the manufacturer
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. 207. APPLICABILITY.
This title shall apply to all civil actions covered under
this title that are commenced on or after the date of enact-
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104TH CONGRESS
1ST SESSION
H. R. 956
AMENDMENT
June 23 (legislative day, June 19), 1995
Ordered to be printed as passed