if such specifications were provided by the man-
ufacturer to the biomaterials supplier and were
not expressly repudiated by the biomaterials
supplier prior to the acceptance by the manu-
facturer of delivery of the raw materials or
component parts; and
(2) such conduct was an actual and proximate
cause of the harm to the claimant.
SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS
AGAINST BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—In any action that is sub-
ject to this Act, 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
(2)(A) the defendant should not, for the pur-
poses of—
(i) section 5(b), be considered to be a man-
ufacturer of the implant that is subject to such
section; or
(ii) section 5(c), be considered to be a sell-
er of the implant that allegedly caused harm to
the claimant; or
(B)(i) the claimant has failed to establish, pur-
suant to section 5(d), that the supplier furnished
raw materials or component parts in violation of
contractual requirements or specifications; or
(ii) the claimant has failed to comply with the
procedural requirements of subsection (b).
(b) PROCEDURAL REQUIREMENTS.—
(1) IN GENERAL.—The procedural requirements
described in paragraphs (2) and (3) shall apply to
any action by a claimant against a biomaterials sup-
plier that is subject to this Act.
(2) 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, unless—
(A) 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
(B) an action against the manufacturer is
barred by applicable law.
(3) AFFIDAVIT.—At the time the claimant
brings an action against a biomaterials supplier the
claimant shall be required to submit an affidavit
that—
(A) declares that the claimant has con-
sulted and reviewed the facts of the action with
a qualified specialist, whose qualifications the
claimant shall disclose;
(B) includes a written determination by a
qualified specialist that the raw materials or
component parts actually used in the manufac-
ture of the implant of the claimant were raw
materials or component parts described in sec-
tion 5(d)(1), together with a statement of the
basis for such a determination;
(C) includes a written determination by a
qualified specialist that, after a review of the
medical record and other relevant material, the
raw material or component part supplied by the
biomaterials supplier and actually used in the
manufacture of the implant was a cause of the
harm alleged by claimant, together with a state-
ment of the basis for the determination; and
(D) states that, on the basis of review and
consultation of the qualified specialist, the
claimant (or the attorney of the claimant) has
concluded that there is a reasonable and meri-
torious cause for the filing of the action against
the biomaterials supplier.
(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
DECLARATIONS.—
(A) IN GENERAL.—The defendant in the
action may submit an affidavit demonstrating
that defendant has not included the implant on
a list, if any, filed with the Secretary pursuant
to section 510(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(j)).
(B) RESPONSE TO MOTION TO DISMISS.—
In response to the motion to dismiss, the claim-
ant 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 5(b)(2)(B);
or
(ii) the defendant who filed the mo-
tion to dismiss is a seller of the implant
who is liable under section 5(c).
(2) EFFECT OF MOTION TO DISMISS ON DIS-
COVERY.—
(A) IN GENERAL.—If a defendant files a
motion to dismiss under paragraph (1) or (3) 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
determine a motion to dismiss for lack of juris-
diction, until such time as the court rules on
the motion to dismiss in accordance with the af-
fidavits submitted by the parties in accordance
with this section.
(B) DISCOVERY.—If a defendant files a
motion 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 spec-
ifications, the court may permit discovery, as
ordered by the court. The discovery conducted
pursuant to this subparagraph shall be limited
to issues 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