I
103D CONGRESS
2D SESSION
H. R. 5092
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
SEPTEMBER 23, 1994
Mr. PASTOR (for himself, Mr. KYL, Mr. BOEHLERT, Mr. CANADY, Mrs.
MEEK, Mr. SERRANO, and Mr. MCCLOSKEY) introduced the following
bill; which was referred jointly to the Committees on the Judiciary and
Energy and Commerce
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 1994’’.
SEC. 2. FINDINGS.
Congress finds and declares the following:
(1) Every year millions of Americans depend on
the availability of life-saving or life-enhancing per-
manently implantable medical devices.
(2) A continued supply of raw materials and
component parts is necessary to the invention, devel-
opment, improvement and maintenance of the supply
of such devices.
(3) Most of these devices are made with raw
materials and component parts that are not designed
or manufactured specifically for use in implantable
devices, but which have uses in a variety of
nonmedical products as well.
(4) Small quantities of these raw materials and
component parts are used, so that sales of raw ma-
terials and component parts for medical devices are
an extremely small portion of the overall market for
such raw materials and medical devices.
(5) Manufacturers of medical devices are re-
quired under the Federal Food, Drug, and Cosmetic
Act to demonstrate that their products are safe and
effective, including being properly designed and hav-
ing adequate warnings or instructions, and existing
tort law requires manufacturers of medical devices
to ensure they are properly designed and have ade-
quate warnings.
(6) Notwithstanding the fact that raw materials
and component parts suppliers do not design,
produce, or test the final implant, they have been
sued in cases alleging inadequate design and testing
of, or warnings related to the use of, permanently
implanted medical devices.
(7) Even though raw materials and component
parts suppliers have almost never been held liable in
such suits, because the cost of litigating such suites
to a favorable judgment far exceeds the total poten-
tial sales of such raw materials and component parts
to the medical device industry, raw materials and
component parts suppliers have begun to cease sup-
plying such raw materials and component parts for
use in permanently implanted medical devices.
(8) The unavailability of raw materials and
component parts will, unless alternate sources of
supply can be found, lead to unavailability of life-
saving and life-enhancing medical devices.
(9) The prospects for development of new
sources of supply for the full range of threatened
raw materials and component parts are remote, as
other suppliers around the world are refusing to sell
raw materials or component parts for use in manu-
facturing permanently implantable medical devices
(9) ‘‘raw material’’ means a substance or prod-
uct that has a generic use and that may be used in
applications other than implants; and
(10) ‘‘seller’’ means a person who, in the course
of a business conducted for that purpose, sells, dis-
tributes, leases, packages, labels, or otherwise places
an implant in the stream of commerce; the term
does not include—
(A) a seller or lessor of real property;
(B) 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 judg-
ment, skill, or services; or
(C) any person who acts in only a financial
capacity with respect to the sale of an implant.
SEC. 4. APPLICABILITY; PREEMPTION.
(a) APPLICABILITY.—This Act applies to any civil ac-
tion brought by a claimant, whether in State or Federal
court, against a manufacturer, seller, or biomaterials sup-
plier, or against licensors of biomaterials suppliers, on any
theory, for harm caused by an implant. A civil action
brought by a purchaser of a medical device for use in pro-
viding professional services against a manufacturer, seller,
or biomaterials supplier for loss or damage to an implant
itself or for commercial loss to the purchaser is not subject
to this Act and shall be governed by applicable commercial
or contract law.
(b) SCOPE OF PREEMPTION.—This Act supersedes
any State law regarding recovery for harm caused by an
implant only to the extent that this Act establishes a rule
of law applicable to any such recovery. Any issue arising
under this Act that is not governed by any such rule of
law shall be governed by applicable State or Federal law.
(c) EFFECT ON OTHER LAWS.—Nothing in this Act
shall be construed to—
(1) affect any defense available under other
provisions of State or Federal law to a defendant in
an action alleging harm caused by an implant; or
(2) create a cause of action or Federal court ju-
risdiction pursuant to section 1331 or 1337 of title
28, United States Code, that otherwise would not
exist under applicable State or Federal law.
SEC. 5. ACTIONS AGAINST BIOMATERIALS SUPPLIERS.
(a)(1) Except as provided in subsection (b) of this
Act, no claimant may bring an action for harm caused
by an implant against a person, who has not registered
with the Secretary of Health and Human Services, pursu-
ant to section 510 of the Federal Food, Drug, and Cos-
metic Act, and the regulations issued thereunder, and in-
cluded the implant on a list of devices filed with the Sec-
retary pursuant to section 510(j) of the Federal Food,
Drug, and Cosmetic Act and the regulations issued there-
under.
(2) Notwithstanding subparagraph (1), a claimant
may bring an action, other than as provided in subsection
(b) of this Act, against a person who, with respect to
claimant’s implant, is the subject of a declaration issued
by the Secretary under section 6(a) of this Act, or is a
seller of the implant that allegedly caused harm to the
claimant.
(b) No claimant may bring an action for harm caused
by an implant against a biomaterials supplier, and no
biomaterials supplier shall be liable for harm to a claimant
caused by an implant, unless the claimant shows, by a pre-
ponderance of the evidence, that—
(1) the raw materials or component parts deliv-
ered by the biomaterials supplier either were not the
product described in the contract between the
biomaterials supplier and the person who contracted
for delivery of the product, or failed to meet any
specifications that were—
(A) provided to the biomaterials supplier
and 
not 
expressly 
repudiated 
by 
the
biomaterials supplier prior to acceptance of de-
livery of the raw materials or component parts;
(B) published by the biomaterials supplier,
provided 
to 
the 
manufacturer 
by 
the
biomaterials supplier, or contained in a master
file submitted by the biomaterials supplier to
the Food and Drug Administration, and cur-
rently maintained by the biomaterials supplier,
for purposes of pre-market approval of medical
devices; or
(C)(i) included in the manufacturer’s sub-
missions for purposes of pre-market approval or
review by the Food and Drug Administration
under sections 510, 513, 515, or 520 of the
Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360, 360c, 360e, or 360j) that have re-
ceived clearance from the Food and Drug Ad-
ministration;
(ii) that were provided by the manufac-
turer to the biomaterials supplier and not ex-
pressly repudiated by the biomaterials supplier
prior to the manufacturer’s acceptance of deliv-
ery of the raw materials or component parts;
and
(2) such conduct was an actual and proximate
cause of the claimant’s harm.
(c) No claimant may bring an action for harm caused
by an implant against a person who licenses a biomaterials
supplier to produce raw materials or component parts.
(d) The applicable statute of limitations shall be
tolled during any period in which claimant has filed a peti-
tion with the Secretary of Health and Human Services
under section 6 of this Act.
SEC. 6. REVIEW BY THE SECRETARY OF NON-REGISTRA-
TION.
(a) The Secretary may, on its own motion or upon
petition by any person, after notice to the affected persons
and affording an opportunity for an informal hearing,
issue a declaration that a person, with respect to the im-
plant that allegedly caused claimant’s harm—
(1) should have registered with the Secretary
under section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360), and the regulations
issued thereunder, but failed to do so, or
(2) should have included the implant on a list
of devices filed with the Secretary pursuant to sec-
tion 510(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(j)), but failed to do so.