(B) CERTAIN
COMPONENTS.—Such term
includes a manufactured piece of an implant
that—
(i) has significant non-implant appli-
cations; and
(ii) alone, has no implant value or
purpose, but when combined with other
component parts and materials, constitutes
an implant.
(4) HARM.—
(A) IN
GENERAL.—The term ‘‘harm’’
means—
(i) any injury to or damage suffered
by an individual;
(ii) any illness, disease, or death of
that individual resulting from that injury
or damage; and
(iii) any loss to that individual or any
other individual resulting from that injury
or damage.
(B) EXCLUSION.—The term does not
include any commercial loss or loss of or dam-
age to an implant.
(5) IMPLANT.—The term ‘‘implant’’ means—
(A) a medical device that is intended by
the manufacturer of the device—
(i) to be placed into a surgically or
naturally formed or existing cavity of the
body for a period of at least 30 days; or
(ii) to remain in contact with bodily
fluids or internal human tissue through a
surgically produced opening for a period of
less than 30 days; and
(B) suture materials used in implant
procedures.
(6) 
MANUFACTURER.—The 
term
‘‘manufacturer’’ means any person who, with respect
to an implant—
(A) is engaged in the manufacture,
preparation, 
propagation, 
compounding, 
or
processing (as defined in section 510(a)(1)) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(a)(1)) of the implant; and
(B) is required—
(i) to register with the Secretary
pursuant to section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360) and the regulations issued under such
section; and
(ii) to include the implant on a list of
devices filed with the Secretary pursuant
to section 510(j) of such Act (21 U.S.C.
360(j)) and the regulations issued under
such section.
(7) MEDICAL
DEVICE.—The term ‘‘medical
device’’ means a device, as defined in section 201(h)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(h)) and includes any device component
of any combination product as that term is used in
section 503(g) of such Act (21 U.S.C. 353(g)).
(8) RAW MATERIAL.—The term ‘‘raw material’’
means a substance or product that—
(A) has a generic use; and
(B) may be used in an application other
than an implant.
(9) SECRETARY.—The term ‘‘Secretary’’ means
the Secretary of Health and Human Services.
(10) SELLER.—
(A) IN
GENERAL.—The term ‘‘seller’’
means a person who, in the course of a business
conducted for that purpose, sells, distributes,
leases, packages, labels, or otherwise places an
implant in the stream of commerce.
(B) EXCLUSIONS.—The term does not
include—
(i) a seller or lessor of real property;
(ii) a provider of professional services,
in any case in which the sale or use of an
implant is incidental to the transaction and
the essence of the transaction is the
furnishing of judgment, skill, or services;
or
(iii) any person who acts in only a
financial capacity with respect to the sale
of an implant.
SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PRE-
EMPTION.
(a) GENERAL REQUIREMENTS.—
(1) IN GENERAL.—In any civil action covered
by this Act, a biomaterials supplier may raise any
defense set forth in section 5.
(2) PROCEDURES.—Notwithstanding any other
provision of law, the Federal or State court in which
a civil action covered by this Act is pending shall, in
connection with a motion for dismissal or judgment
based on a defense described in paragraph (1), use
the procedures set forth in section 6.
(b) APPLICABILITY.—
(1) IN
GENERAL.—Except as provided in
paragraph (2), notwithstanding any other provision
of law, this Act applies to any civil action brought
by a claimant, whether in a Federal or State court,
against a manufacturer, seller, or biomaterials
supplier, on the basis of any legal theory, for harm
allegedly caused by an implant.
(2) EXCLUSION.—A civil action brought by a
purchaser of a medical device for use in providing
professional services against a manufacturer, seller,
or biomaterials supplier for loss or damage to an
implant or for commercial loss to the purchaser—
(A) shall not be considered an action that
is subject to this Act; and
(B) shall be governed by applicable
commercial or contract law.
(c) SCOPE OF PREEMPTION.—
(1) IN
GENERAL.—This Act supersedes any
State law regarding recovery for harm caused by an
implant and any rule of procedure applicable to a
civil action to recover damages for such harm only
to the extent that this Act establishes a rule of law
applicable to the recovery of such damages.
(2) APPLICABILITY
OF
OTHER
LAWS.—Any
issue that arises under this Act and that is not
governed by a rule of law applicable to the recovery
of damages described in paragraph (1) shall be gov-
erned by applicable Federal or State law.
(d) STATUTORY CONSTRUCTION.—Nothing in this
Act may be construed—
(1) to affect any defense available to a de-
fendant under any other provisions of Federal or
State law in an action alleging harm caused by an
implant; or
(2) to create a cause of action or Federal court
jurisdiction pursuant to section 1331 or 1337 of title
28, United States Code, that otherwise would not
exist under applicable Federal or State law.
SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.
(a) IN GENERAL.—
(1) EXCLUSION
FROM
LIABILITY.—Except as
provided in paragraph (2), a biomaterials supplier
shall not be liable for harm to a claimant caused by
an implant.
(2) LIABILITY.—A biomaterials supplier that—
(A) is a manufacturer may be liable for
harm to a claimant described in subsection (b);
(B) is a seller may be liable for harm to
a claimant described in subsection (c); and
that states that the supplier, with respect to the
implant that allegedly caused harm to the
claimant, was required to—
(i) register with the Secretary under
section 510 of such Act (21 U.S.C. 360),
and the regulations issued under such
section, but failed to do so; or
(ii) include the implant on a list of
devices filed with the Secretary pursuant
to section 510(j) of such Act (21 U.S.C.
360(j)) and the regulations issued under
such section, but failed to do so; or
(C) is related by common ownership or
control to a person meeting all the requirements
described in subparagraph (A) or (B), if the
court deciding a motion to dismiss in ac-
cordance with section 6(c)(3)(B)(i) finds, on
the basis of affidavits submitted in accordance
with section 6, that it is necessary to impose
liability on the biomaterials supplier as a
manufacturer because the related manufacturer
meeting the requirements of subparagraph (A)
or (B) lacks sufficient financial resources to
satisfy any judgment 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.—
Immediately upon receipt of a petition filed
pursuant 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 LIMI-
TATIONS.—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
applicable law, be liable as a seller for harm to a claimant
caused by an implant if—
(1) the biomaterials supplier—
(A) held title to the implant that allegedly
caused harm to the claimant as a result of
purchasing 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
common 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 section 6(c)(3)(B)(ii) finds, on the basis of affi-
davits submitted in accordance with section 6, that
it is necessary to impose liability on the biomaterials
supplier as a seller because the related seller meet-
ing 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
supplier may, to the extent required and permitted by any
other applicable law, be liable for harm to a claimant
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
delivered by the biomaterials supplier either—
(A) 
did 
not 
constitute 
the 
product
described in the contract between the biomate-
rials 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
supplier and not expressly repudiated by
the biomaterials supplier prior to accept-
ance 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
maintained by the biomaterials supplier for
purposes of premarket approval of medical
devices; or
(iii) 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 received clearance
from the Secretary if such specifications
were provided by the manufacturer to the
biomaterials supplier and were not ex-
pressly repudiated by the biomaterials sup-
plier 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
subject to this Act, a biomaterials supplier who is a de-
fendant 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 against it on the grounds
that—
(1) the defendant is a biomaterials supplier;
and
(2)(A) the defendant should not, for the
purposes 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,
pursuant 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) 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—
(1) the manufacturer is subject to service of
process solely in a jurisdiction in which the biomate-
rials supplier is not domiciled or subject to a service
of process; or
(2) an action against the manufacturer is
barred by applicable law.
(c) PROCEEDING
ON MOTION TO DISMISS.—The
following 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
allegedly caused harm to the claimant, is-
sued a declaration pursuant to section
5(b)(2)(B); or
(ii) the defendant who filed the
motion 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 (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
determine 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 submitted by the parties in accord-
ance with this section.
(B) DISCOVERY.—If a defendant files a
motion to dismiss under subsection (a)(2)(B)(i)
on the grounds that the biomaterials supplier
did not furnish raw materials or component
parts in violation of contractual requirements or
specifications, the court may permit discovery,
as ordered by the court. The discovery con-
ducted 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
court shall consider a defendant to be a bio-
materials supplier who is not subject to an ac-
tion for harm to a claimant caused by an
implant, other than an action relating to liabil-
ity 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
manufacturer subject to such section 5(b) or
seller subject to section 5(c), unless the claim-
ant submits a valid affidavit that demonstrates
that—
(i) with respect to a motion to dismiss
contending 
the 
defendant 
is 
not 
a
manufacturer, the defendant meets the
applicable requirements for liability as a
manufacturer under section 5(b); or
(ii) with respect to a motion to
dismiss contending that the defendant is
not a seller, the defendant meets the appli-
cable requirements 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
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 af-
fidavits made by parties pursuant to this
section raise genuine issues as concerning mate-
rial 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
ly 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 5(b)(3)(A) with respect to a defend-
ant, and the Secretary has not issued a final decision on
the petition, the court shall stay all proceedings with re-
spect 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
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 biomate-
rials supplier; and
(2) the court found the claim against the bio-
materials supplier to be without merit and frivolous.
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