(b) Any petition filed pursuant to subsection (a) shall
be immediately docketed by the Secretary, and the Sec-
retary shall issue a final decision within 180 days of the
filing of the petition.
SEC. 
7. 
PROCEDURES 
FOR 
ACTIONS 
AGAINST 
A
BIOMATERIALS SUPPLIER.
(a) IN GENERAL.—The procedural requirements set
forth in subsection (b) shall apply to any action by a
claimant against a biomaterials supplier.
(b) PROCEDURAL REQUIREMENTS.—
(1) A claimant may not bring an action against
a biomaterials supplier unless the manufacturer of
the implant is named as a party, except if the manu-
facturer is subject to service of process in no juris-
diction in which the biomaterials supplier or is also
subject to service of process or unless litigation
against the manufacturer is barred by applicable
law.
(2) No action may be brought by any claimant
against a biomaterials supplier unless, at the time
the claimant brings the action, the claimant submits
an affidavit—
(A) declaring that the claimant has con-
sulted and reviewed the facts of the action with
qualified specialists, whose qualifications the
claimant shall disclose;
(B) including a written determination by a
qualified specialist that the raw materials or
component parts actually used in the manufac-
ture of claimant’s implant were raw materials
or component parts described in section 5(b)(1),
together with a statement of the basis for such
a determination;
(C) including 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 claimant’s implant was a cause
of claimant’s harm, together with a statement
of the basis for the determination; and
(D) on the basis of the qualified special-
ists’ review and consultation, that the claimant
(or the claimant’s attorney) has concluded that
there is a reasonable and meritorious cause for
the filing of the action against the biomaterials
supplier.
(c) DISMISSAL.—
(1) In any action subject to this Act, a defend-
ant may, at any time at which a motion to dismiss
may be filed under applicable law, move to dismiss
the action on the grounds that the defendant is a
biomaterials supplier and—
(A) claimant has failed to satisfy the con-
ditions in section 5(a) that would permit claim-
ant to bring an action against defendant;
(B) defendant was not a seller of the im-
plant which allegedly caused harm to the claim-
ant; or
(C) claimant has failed to comply with the
provisions of subsection (b).
(2) Defendant may submit affidavits dem-
onstrating that defendant has not included the im-
plant on a list, if any, filed with the Secretary pur-
suant to section 510(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360). Claimant may,
in response to such a motion, submit affidavits dem-
onstrating that the Secretary has, with respect to
the defendant and the implant that allegedly caused
claimant’s harm, issued a declaration pursuant to
section 6(a) of this Act, or that defendant was a
seller of the implant.
(3) No discovery shall be permitted against the
defendant who has filed a motion to dismiss under
subparagraph (1), other than discovery necessary to
determine a motion to dismiss for lack of jurisdic-
tion, until the court has ruled on the motion to dis-
miss filed pursuant to subsection (1).
(4) A defendant shall conclusively be deemed to
be a biomaterials supplier and not to be subject to
suit except pursuant to section 5(b) of this Act, and
a motion to dismiss under subsections (c)(1)(A) or
(c)(1)(B) shall be granted, unless the claimant sub-
mits valid affidavits demonstrating—
(A) with respect to a motion under sub-
section (c)(1)(A), that the Secretary has, with
respect to the defendant and the implant that
allegedly caused harm to the claimant, issued a
declaration pursuant to section 6(a) of this Act;
or
(B) with respect to a motion under sub-
section (c)(1)(B), that the biomaterials supplier
was a seller which held title to the implant as
a result or purchasing or selling the implant
after the implant was manufactured and en-
tered the stream of commerce.
(5) The court shall rule on the motion to dis-
miss filed under subsection (c) solely on the basis of
the pleadings and any affidavits, including affidavits
submitted under paragraph (2). If the pleadings and
affidavits raise genuine issues as to material facts
with respect to a motion under (c)(1)(C), the motion
may be treated as a motion for summary judgment
pursuant to subsection (d) of this section.
(d) SUMMARY JUDGMENT.—
(1) A biomaterials supplier shall be entitled to
entry of judgment without trial if there is no genu-
ine issue as to any material fact as to each element
set forth in section 5(b). A genuine issue of material
fact shall exist only if the evidence submitted by
claimant, if found by a jury to be credible, would be
sufficient to allow a reasonable jury to reach a ver-
dict for the claimant.
(2) In the event that the court, under applicable
rules, may permit discovery prior to ruling on a mo-
tion for summary judgment, such discovery shall be
limited solely to establishing whether a genuine issue
of material fact exists.
(e) A biomaterials supplier shall be subject to discov-
ery in connection with a motion under subsection (c) or
(d) solely to the extent permitted by the applicable State
or Federal rules for discovery against nonparties.
(f) In the event claimant has filed a petition for a
declaration pursuant to section 6(a) with respect to a de-
fendant, and the Secretary has not issued a final decision
thereon, the court shall stay all proceedings with respect
to that defendant until the Secretary has issued a final
decision.
(g) The manufacturer of the implant shall be per-
mitted to file and conduct the proceeding on any motion
filed pursuant to subsection (c) or (d) if the manufacturer
and the other defendant(s) have entered into a valid and
applicable contractual agreement in which the manufac-
turer agrees to bear the cost of or to conduct such pro-
ceeding.
(h) The court shall require the claimant to com-
pensate the biomaterials supplier (or a manufacturer ap-
pearing in lieu of a supplier pursuant to subsection (g))
for attorney fees and costs, if the claimant named or
joined the biomaterials supplier, but the court found the
claim against the biomaterials supplier to be without merit
and frivolous.
SEC. 8. EFFECTIVE DATE.
This Act shall take effect on the date of its enactment
and shall apply to all civil actions pursuant to this Act
commenced on or after such date, including any action in
which the harm or the conduct which caused the harm
occurred before the effective date of this Act.
SEC. 9. SEVERABILITY.
If any provision of this Act, or the application of such
provision to any person or circumstances is held to be un-
constitutional, the remainder of this Act and application
of the provisions of such to any person or circumstance
shall not be affected thereby.
Æ
HR 5092 IH——2