HR 956 PP
States could support the large investment needed to
develop new suppliers of such raw materials and com-
ponent parts;
(12) attempts to develop such new suppliers
would raise the cost of medical devices;
(13) courts that have considered the duties of the
suppliers of the raw materials and component parts
have generally found that the suppliers do not have
a duty—
(A) to evaluate the safety and efficacy of the
use of a raw material or component part in a
medical device; and
(B) to warn consumers concerning the safe-
ty and effectiveness of a medical device;
(14) attempts to impose the duties referred to in
subparagraphs (A) and (B) of paragraph (13) on
suppliers of the raw materials and component parts
would cause more harm than good by driving the sup-
pliers to cease supplying manufacturers of medical
devices; and
(15) in order to safeguard the availability of a
wide variety of lifesaving and life-enhancing medical
devices, immediate action is needed—
HR 956 PP
(A) to clarify the permissible bases of liabil-
ity for suppliers of raw materials and compo-
nent parts for medical devices; and
(B) to provide expeditious procedures to dis-
pose of unwarranted suits against the suppliers
in such manner as to minimize litigation costs.
SEC. 203. DEFINITIONS.
As used in this title:
(1) BIOMATERIALS SUPPLIER.—
(A) IN GENERAL.—The term ‘‘biomaterials
supplier’’ means an entity that directly or indi-
rectly supplies a component part or raw mate-
rial for use in the manufacture of an implant.
(B) PERSONS
INCLUDED.—Such term in-
cludes any person who—
(i) has submitted master files to the
Secretary for purposes of premarket ap-
proval of a medical device; or
(ii) licenses a biomaterials supplier to
produce component parts or raw materials.
(2) CLAIMANT.—
(A) IN
GENERAL.—The term ‘‘claimant’’
means any person who brings a civil action, or
on whose behalf a civil action is brought, arising
from harm allegedly caused directly or indirectly
HR 956 PP
by an implant, including a person other than
the individual into whose body, or in contact
with whose blood or tissue, the implant is placed,
who claims to have suffered harm as a result of
the implant.
(B) ACTION BROUGHT ON BEHALF OF AN
ESTATE.—With respect to an action brought on
behalf or through the estate of an individual into
whose body, or in contact with whose blood or
tissue the implant is placed, such term includes
the decedent that is the subject of the action.
(C) ACTION
BROUGHT
ON
BEHALF
OF
A
MINOR.—With respect to an action brought on
behalf or through a minor, such term includes
the parent or guardian of the minor.
(D) EXCLUSIONS.—Such term does not in-
clude—
(i) a provider of professional services,
in any case in which—
(I) the sale or use of an implant
is incidental to the transaction; and
(II) the essence of the transaction
is the furnishing of judgment, skill, or
services; or
HR 956 PP
(ii) 
a 
manufacturer, 
seller, 
or
biomaterials supplier.
(3) COMPONENT PART.—
(A) IN
GENERAL.—The term ‘‘component
part’’ means a manufactured piece of an im-
plant.
(B) CERTAIN COMPONENTS.—Such term in-
cludes a manufactured piece of an implant
that—
(i) has significant nonimplant 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
HR 956 PP
(iii) any loss to that individual or any
other individual resulting from that injury
or damage.
(B) EXCLUSION.—The term does not in-
clude any commercial loss or loss of or damage
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 proce-
dures.
(6) MANUFACTURER.—The term ‘‘manufacturer’’
means any person who, with respect to an implant—
(A) is engaged in the manufacture, prepara-
tion, 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
HR 956 PP
(B) is required—
(i) to register with the Secretary pur-
suant to section 510 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360)
and the regulations issued under such sec-
tion; 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 sec-
tion.
(7) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ means a device, as defined in section 201(h) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h)).
(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 con-
HR 956 PP
ducted for that purpose, sells, distributes, leases,
packages, labels, or otherwise places an implant
in the stream of commerce.
(B) EXCLUSIONS.—The term does not in-
clude—
(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 furnish-
ing of judgment, skill, or services; or
(iii) any person who acts in only a fi-
nancial capacity with respect to the sale of
an implant.
SEC. 204. GENERAL REQUIREMENTS; APPLICABILITY; PRE-
EMPTION.
(a) GENERAL REQUIREMENTS.—
(1) IN GENERAL.—In any civil action covered by
this title, a biomaterials supplier may raise any de-
fense set forth in section 205.
(2) PROCEDURES.—Notwithstanding any other
provision of law, the Federal or State court in which
a civil action covered by this title is pending shall,
in connection with a motion for dismissal or judg-
HR 956 PP
ment based on a defense described in paragraph (1),
use the procedures set forth in section 206.
(b) APPLICABILITY.—
(1) IN GENERAL.—Except as provided in para-
graph (2), notwithstanding any other provision of
law, this title applies to any civil action brought by
a claimant, whether in a Federal or State court,
against a manufacturer, seller, or biomaterials sup-
plier, on the basis of any legal theory, for harm alleg-
edly 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 im-
plant or for commercial loss to the purchaser—
(A) shall not be considered an action that
is subject to this title; and
(B) shall be governed by applicable commer-
cial or contract law.
(c) SCOPE OF PREEMPTION.—
(1) IN
GENERAL.—This title 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
HR 956 PP
the extent that this title establishes a rule of law ap-
plicable to the recovery of such damages.
(2) APPLICABILITY OF OTHER LAWS.—Any issue
that arises under this title and that is not governed
by a rule of law applicable to the recovery of damages
described in paragraph (1) shall be governed by ap-
plicable Federal or State law.
(d) STATUTORY CONSTRUCTION.—Nothing in this title
may be construed—
(1) to affect any defense available to a defendant
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. 205. 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);
HR 956 PP
(B) is a seller may be liable for harm to a
claimant described in subsection (c); and
(C) furnishes raw materials or component
parts that fail to meet applicable contractual re-
quirements or specifications may be liable for a
harm to a claimant described in subsection (d).
(b) LIABILITY AS MANUFACTURER.—
(1) IN GENERAL.—A biomaterials supplier may,
to the extent required and permitted by any other ap-
plicable law, be liable for harm to a claimant caused
by an implant if the biomaterials supplier is the
manufacturer of the implant.
(2) GROUNDS FOR LIABILITY.—The biomaterials
supplier may be considered the manufacturer of the
implant that allegedly caused harm to a claimant
only if the biomaterials supplier—
(A)(i) has registered 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) included 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;
HR 956 PP
(B) is the subject of a declaration issued by
the Secretary pursuant to paragraph (3) that
states that the supplier, with respect to the im-
plant that allegedly caused harm to the claim-
ant, 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 sec-
tion, but failed to do so; or
(ii) include the implant on a list of de-
vices filed with the Secretary pursuant to
section 510(j) of such Act (21 U.S.C. 360(j))
and the regulations issued under such sec-
tion, but failed to do so; or
(C) is related by common ownership or con-
trol to a person meeting all the requirements de-
scribed in subparagraph (A) or (B), if the court
deciding a motion to dismiss in accordance with
section 206(c)(3)(B)(i) finds, on the basis of affi-
davits submitted in accordance with section 206,
that it is necessary to impose liability on the
biomaterials supplier as a manufacturer because
the related manufacturer meeting the require-
ments of subparagraph (A) or (B) lacks suffi-
cient financial resources to satisfy any judgment