I
104TH CONGRESS
1ST SESSION
H. R. 753
To establish rules governing product liability actions against raw materials
and bulk component suppliers to medical device manufacturers, and
for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 31, 1995
Mr. GEKAS (for himself, Mr. PASTOR, Mr. COBURN, Mr. RAMSTAD, Mr. COX
of California, and Mr. BILBRAY) introduced the following bill; which was
referred to the Committee on the Judiciary and, in addition, to the Com-
mittee on Commerce, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall within
the jurisdiction of the committee concerned
A BILL
To establish rules governing product liability actions against
raw materials and bulk component suppliers to medical
device manufacturers, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Biomaterials Access
Assurance Act of 1995’’.
SEC. 2. FINDINGS.
Congress finds that—
ability of lifesaving and life-enhancing medical
devices;
(10) because other suppliers of the raw mate-
rials and component parts in foreign nations are re-
fusing to sell raw materials or component parts for
use in manufacturing certain medical devices in the
United States, the prospects for development of new
sources of supply for the full range of threatened
raw materials and component parts for medical
devices are remote;
(11) it is unlikely that the small market for
such raw materials and component parts in the
United States could support the large investment
needed to develop new suppliers of such raw mate-
rials and component 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
safety 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
suppliers to cease supplying manufacturers of medi-
cal devices; and
(15) in order to safeguard the availability of a
wide variety of lifesaving and life-enhancing medical
devices, immediate action is needed—
(A) to clarify the permissible bases of li-
ability for suppliers of raw materials and com-
ponent parts for medical devices; and
(B) to provide expeditious procedures to
dispose of unwarranted suits against the suppli-
ers in such manner as to minimize litigation
costs.
SEC. 3. DEFINITIONS.
As used in this Act:
(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, aris-
ing from harm allegedly caused directly or indi-
rectly by an implant, including a person other
than the individual into whose body, or in con-
tact 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 in-
cludes 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
include—
(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 trans-
action is the furnishing of judgment,
skill, or services; or
(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
includes a manufactured piece of an implant
that—
(i) has significant nonimplant applications;
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 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
implant is incidental to the transaction and
the essence of the transaction is the fur-
nishing 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. 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 para-
graph (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 sup-
plier, on the basis of any legal theory, for harm al-
legedly 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 Act; and
(B) shall be governed by applicable com-
mercial 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 gov-
erned 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 defend-
ant under any other provisions of Federal or State
law in an action alleging harm caused by an im-
plant; 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
(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
applicable 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 manu-
facturer 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 de-
vices filed with the Secretary pursuant to sec-
tion 510(j) of such Act (21 U.S.C. 360(j)) and
the regulations issued under such section; or
(B) is the subject of a declaration issued
by the Secretary pursuant to paragraph (3)
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 sec-
tion 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.
(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 pe-
tition 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 the biomaterials supplier—
(1) held title to the implant that allegedly
caused harm to the claimant as a result of purchas-
ing the implant after—
(A) the manufacture of the implant; and
(B) the entrance of the implant in the
stream of commerce; and
(2) subsequently resold the implant.
(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
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 de-
scribed in the contract between the biomaterials
supplier and the person who contracted for de-
livery 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
maintained by the biomaterials supplier for
purposes of premarket approval of medical
devices; or
(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,