Home > 105th Congressional Bills > H.R. 872 (rh) To establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. ...H.R. 872 (rh) To establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes. ...
105th CONGRESS
2d Session
H. R. 872
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 30, 1998
Received
_______________________________________________________________________
AN ACT
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 Representatives 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
1998''.
SEC. 2. FINDINGS.
The 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, development, 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) move in interstate commerce;
(B) are not designed or manufactured specifically
for use in medical devices; and
(C) 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 materials 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 component parts;
(6) under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) manufacturers of medical devices are
required to demonstrate that the medical devices are safe and
effective, including demonstrating that the products are
properly designed and have adequate warnings or instructions;
(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 inadequate--
(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 for a number of
reasons, including concerns about the costs of such litigation;
(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 medical 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 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 materials 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; or
(B) to warn consumers concerning the safety and
effectiveness of a medical device;
(14) because medical devices and the raw materials and
component parts used in their manufacture move in interstate
commerce, a shortage of such raw materials and component parts
affects interstate commerce;
(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 litigation costs;
(16) the several States and their courts are the primary
architects and regulators of our tort system; Congress,
however, must, in certain circumstances involving the national
interest, address tort issues, and a threatened shortage of raw
materials and component parts for life-saving medical devices
is one such circumstance; and
(17) the protections set forth in this Act are needed to
assure the continued supply of materials for life-saving
medical devices, although such protections do not protect
negligent suppliers.
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 implant.
(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 a deceased individual into whose body, or
in contact with whose blood or tissue the implant was
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 such services; and
(II) the essence of the
professional health care services
provided is the furnishing of judgment,
skill, or services;
(ii) a person acting in the capacity of a
manufacturer, seller, or biomaterials supplier;
or
(iii) a person alleging harm caused by
either the silicone gel or the silicone
envelope utilized in a breast implant
containing silicone gel, except that--
(I) neither the exclusion provided
by this clause nor any other provision
of this Act may be construed as a
finding that silicone gel (or any other
form of silicone) may or may not cause
harm; and
(II) the existence of the exclusion
under this clause may not--
(aa) be disclosed to a jury
in any civil action or other
proceeding; and
(bb) except as necessary to
establish the applicability of
this Act, otherwise be
presented in any civil action
or other proceeding.
(3) Component part.--
(A) In general.--The term ``component part'' means
a manufactured piece of an implant.
(B) Certain components.--Such term includes a
manufactured piece of an implant that--
(i) has significant non-implant
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 include 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 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 health care
services in any case in which--
(I) the sale or use of the implant
is incidental to such services; and
(II) the essence of the
professional health care services
provided 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; PREEMPTION.
(a) General Requirements.--
(1) In general.--In any civil action covered by this Act, a
biomaterials supplier may--
(A) raise any exclusion from liability set forth in
section 5; and
(B) make a motion for dismissal or for summary
judgment as set forth in section 6.
(2) Procedures.--Notwithstanding any other provision of
law, a Federal or State court in which an action covered by
this Act is pending shall, in connection with a motion under
section 6 or 7, use the procedures set forth in this Act.
(b) Applicability.--
(1) In general.--Except as provided in paragraph (2), this
Act applies to any civil action brought by a claimant, whether
in a Federal or State court, on the basis of any legal theory,
for harm allegedly caused, directly or indirectly, by an
implant.
(2) Exclusion.--A civil action brought by a purchaser of a
medical device, purchased for use in providing professional
health care services, 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
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