I
104TH CONGRESS
2D SESSION
H. R. 3468
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
MAY 16, 1996
Mr. GEKAS (for himself, Mr. PASTOR, Mr. HASTERT, Mr. HAYWORTH, Mr.
UPTON, Mr. BERMAN, Mr. ROHRABACHER, Mr. CUNNINGHAM, Mr.
BREWSTER, Mr. GUTKNECHT, Mr. STUMP, Mr. BILBRAY, Mr. EHLERS,
Mr. HOBSON, Mrs. JOHNSON of Connecticut, Mr. SERRANO, Mr. BURR,
Mr. ROYCE, Mr. CELEMENT, Mr. BLUTE, Mr. SCHIFF, Mr. FORBES, Mr.
ZIMMER, Mr. BUYER, Mrs. KELLY, and Mr. STENHOLM) introduced the
following bill; which was referred to the Committee on the Judiciary, and
in addition to the Committee on Commerce, for a period to be subse-
quently 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 1996’’.
SEC. 2. FINDINGS.
Congress finds that—
(1) each year millions of citizens of the United
States depend on the availability of lifesaving or life
enhancing medical devices, many of which are
permanently implantable within the human body;
(2) a continued supply of raw materials and
component parts is necessary for the invention, de-
velopment, improvement, and maintenance of the
supply of the devices;
(3) most of the medical devices are made with
raw materials and component parts that—
(A) are not designed or manufactured spe-
cifically for use in medical devices; and
(B) come in contact with internal human
tissue;
(4) the raw materials and component parts also
are used in a variety of nonmedical products;
(5) because small quantities of the raw mate-
rials and component parts are used for medical
devices, sales of raw materials and component parts
for medical devices constitute an extremely small
portion of the overall market for the raw materials
and medical devices;
(6) under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), manufactur-
ers of medical devices are required to demonstrate
that the medical devices are safe and effective, in-
cluding demonstrating that the products are prop-
erly designed and have adequate warnings or in-
structions;
(7) notwithstanding the fact that raw materials
and component parts suppliers do not design,
produce, or test a final medical device, the suppliers
have been the subject of actions alleging inad-
equate—
(A) design and testing of medical devices
manufactured with materials or parts supplied
by the suppliers; or
(B) warnings related to the use of such
medical devices;
(8) even though suppliers of raw materials and
component parts have very rarely been held liable in
such actions, such suppliers have ceased supplying
certain raw materials and component parts for use
in medical devices because the costs associated with
litigation in order to ensure a favorable judgment for
the suppliers far exceeds the total potential sales
revenues from sales by such suppliers to the medical
device industry;
(9) unless alternate sources of supply can be
found, the unavailability of raw materials and
component parts for medical devices will lead to
unavailability of lifesaving and life-enhancing medi-
cal devices;
(10) because other suppliers of the raw
materials and component parts in foreign nations
are refusing to sell raw materials or component
parts for use in manufacturing certain medical de-
vices in the United States, the prospects for develop-
ment 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
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—
(A) to clarify the permissible bases of
liability for suppliers of raw materials and
component parts for medical devices; and
(B) to provide expeditious procedures to
dispose of unwarranted suits against the
suppliers in such manner as to minimize litiga-
tion 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
indirectly supplies a component part or raw
material for use in the manufacture of an im-
plant.
(B) 
PERSONS
INCLUDED.—Such 
term
includes any person who—
(i) has submitted master files to the
Secretary 
for 
purposes 
of 
premarket
approval 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 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 of 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 OR INCOMPETENT.—With respect to an
action brought on behalf of or through a minor
or incompetent, such term includes the parent
or guardian of the minor or incompetent.
(D) EXCLUSIONS.—Such term does not
include—
(i) a provider of professional health
care 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 judg-
ment, skill, or services; or
(ii) a person acting in the capacity of
a manufacturer, seller, or biomaterials sup-
plier.
(3) COMPONENT PART.—
(A) IN GENERAL.—The term ‘‘component
part’’ means a manufactured piece of an im-
plant.
material fact for each applicable element set
forth in paragraphs (1) and (2) of section 5(d).
(B) ISSUES
OF
MATERIAL
FACT.—With
respect to a finding made under subparagraph
(A), the court shall consider a genuine issue of
material fact to exist only if the evidence
submitted by claimant would be sufficient to
allow a reasonable jury to reach a verdict for
the claimant if the jury found the evidence to
be credible.
(2) DISCOVERY MADE PRIOR TO A RULING ON
A
MOTION
FOR
SUMMARY
JUDGMENT.—If, under
applicable rules, the court permits discovery prior to
a ruling on a motion for summary judgment made
pursuant to this subsection, such discovery shall be
limited solely to establishing whether a genuine issue
of material fact exists as to the applicable elements
set forth in paragraphs (1) and (2) of section 5(d).
(3) DISCOVERY WITH RESPECT TO A BIOMATE-
RIALS SUPPLIER.—A biomaterials supplier shall be
subject to discovery in connection with a motion
seeking dismissal or summary judgment on the basis
of the inapplicability of section 5(d) or the failure to
establish the applicable elements of section 5(d) sole-