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Union Calendar No. 349
105th CONGRESS
2d Session
H. R. 872
[Report No. 105-549, Parts I and II]
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
February 27, 1997
Mr. Gekas (for himself, Mr. Bilbray, Mr. Bryant, Mr. Burr of North
Carolina, Mr. Buyer, Mr. Cunningham, Ms. Dunn, Mr. Ehlers, Mr. English
of Pennsylvania, Ms. Eshoo, Mr. Gallegly, Mr. Greenwood, Mr. Gutknecht,
Mr. Hastert, Mr. Hayworth, Mrs. Kelly, Mr. Kind, Mr. Luther, Mr.
McCollum, Mr. McIntosh, Mr. Pastor, Mr. Ramstad, Mr. Rohrabacher, Mr.
Sabo, Mr. Schiff, Mr. Sensenbrenner, Mr. Stump, and Mr. Vento)
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 subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
May 22, 1998
Reported from the Committee on the Judiciary with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
May 22, 1998
Referral to the Committee on Commerce extended for a period ending not
later than July 14, 1998
July 14, 1998
Additional sponsors: Mr. Barcia, Mr. Clement, Mr. Coburn, Mr. Cox of
California, Mr. Crane, Mr. Horn, Mr. Norwood, Mr. Porter, Mr. Salmon,
Mr. Serrano, Mr. Shays, Mrs. Tauscher, Mrs. Emerson, Mr. Hutchinson,
Mr. Inglis of South Carolina, Mr. Pickering, Mr. Bunning, Mr. Condit,
Mrs. Cubin, Mr. Fox of Pennsylvania, Mr. Gillmor, Mr. Hefner, Mr.
McHugh, Mr. Moran of Virginia, Mr. Packard, Mrs. Roukema, Mr. Dan
Schaefer of Colorado, Mr. Sessions, Mr. Stenholm, Mr. Towns, Mr. Barton
of Texas, Mr. Boucher, Mr. Dooley of California, Mr. Faleomavaega, Mr.
Ganske, Mr. Goode, Mr. Kim, Mr. Largent, Mr. Minge, Mr. Pascrell, Mr.
Spratt, Mr. Calvert, Mr. Cook, Mr. Dreier, Mr. Fazio of California, Mr.
Hoekstra, Mr. Oberstar, Mr. Pickett, Mr. Royce, Mr. Solomon, Mr.
Thornberry, Mr. Rothman, Mr. Torres, Mr. Ballenger, Mr. Coble, Ms.
Christian-Green, Mr. Cooksey, Mr. Graham, Mr. Hostettler, Mr. Lantos,
Mr. McKeon, Mr. Rogan, Ms. Sanchez, Mr. Shimkus, Mr. Capps, Mr.
Goodling, Mr. Holden, Mr. Walsh, Mr. Young of Florida, Mr. Berman, Mr.
Edwards, Ms. Hooley of Oregon, Ms. Lofgren, Mr. Bob Schaffer of
Colorado, Ms. Slaughter, Mr. White, Mr. Campbell, Ms. Harman, Mrs.
Johnson of Connecticut, Mr. Sherman, Mr. Weldon of Pennsylvania, Mr.
Davis of Florida, Mr. Franks of New Jersey, Mr. Matsui, Mr. Snyder, Mr.
Camp, Mr. Frelinghuysen, Mr. Lewis of California, Ms. Woolsey, Mr.
Pappas, Mrs. Northup, Ms. Pelosi, Mr. Quinn, Mr. Smith of New Jersey,
Mr. Weldon of Florida, Mr. Farr of California, Mr. Saxton, Mr. Stearns,
Mr. Andrews, Mr. LoBiondo, Mr. Menendez, Mr. Adam Smith of Washington,
Mr. Pallone, Mr. Redmond, Mr. Bilirakis, Mr. Strickland, Mr. Price of
North Carolina, and Ms. Wilson
July 14, 1998
Reported from the Committee on Commerce with an amendment, committed to
the Committee of the Whole House on the State of the Union, and ordered
to be printed
[Strike out all after the enacting clause and insert the part printed
in boldface roman]
[For text of introduced bill, see copy of bill as introduced on
February 27, 1997]
_______________________________________________________________________
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 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; and
(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; however, negligent suppliers should not be
protected.
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 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 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
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