II
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 Representa-
tives of the United States of America in Congress assembled,
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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 per-
manently 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) move in interstate commerce;
(B) are not designed or manufactured spe-
cifically 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 mate-
rials and component parts are used for medical de-
vices, sales of raw materials and component parts
for medical devices constitute an extremely small
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portion of the overall market for the raw materials
and component parts;
(6) under the Federal Food, Drug, and Cos-
metic 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 de-
signed 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 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 for a number of reasons, includ-
ing concerns about the costs of such litigation;
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(9) unless alternate sources of supply can be
found, the unavailability of raw materials and com-
ponent parts for medical devices will lead to unavail-
ability of lifesaving and life-enhancing medical de-
vices;
(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 de-
vices 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—
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(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 mate-
rials 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 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;
(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
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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 protec-
tions 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 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-
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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 of or through the estate of a deceased in-
dividual into whose body, or in contact with
whose blood or tissue the implant was placed,
such term includes the decedent that is the sub-
ject 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 in-
clude—
(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 profes-
sional health care services provided is
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the furnishing of judgment, skill, or
services;
(ii) a person acting in the capacity of
a manufacturer, seller, or biomaterials sup-
plier; or
(iii) a person alleging harm caused by
either the silicone gel or the silicone enve-
lope 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 proceed-
ing; and
(bb) except as necessary to
establish the applicability of this
Act, otherwise be presented in
any civil action or other proceed-
ing.
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(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 non-implant appli-
cations; 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.
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(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
surgically produced opening for a period of
less than 30 days; and
(B) suture materials used in implant pro-
cedures.
(6) MANUFACTURER.—The term ‘‘manufac-
turer’’ means any person who, with respect to an im-
plant—
(A) is engaged in the manufacture, prepa-
ration, 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—
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(i) to register with the Secretary pur-
suant to section 510 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360)
and the regulations issued under such sec-
tion; 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 de-
vice’’ 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.—
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(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 in-
clude—
(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 profes-
sional health care services provided is
the furnishing 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—
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(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 para-
graph (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 com-
mercial or contract law.
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(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.—Except as provided in section 7,
a biomaterials supplier shall not be liable for harm to a
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claimant caused by an implant unless such supplier is lia-
ble—
(1) as a manufacturer of the implant, as pro-
vided in subsection (b);
(2) as a seller of the implant, as provided in
subsection (c); or
(3) for furnishing raw materials or component
parts for the implant that failed to meet applicable
contractual requirements or specifications, as pro-
vided 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 biomate-
rials supplier may be considered the manufacturer of
the implant that allegedly caused harm to a claimant
only if the biomaterials supplier—
(A)(i) registered or was required to reg-
ister 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
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(ii) included or was required to include the
implant on a list of devices filed with the Sec-
retary pursuant to section 510(j) of such Act
(21 U.S.C. 360(j)) and the regulations issued
under such section;
(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
section 510 of such Act (21 U.S.C. 360),
and the regulations issued under such sec-
tion, but failed to do so; or
(ii) include the implant on a list of de-
vices 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; or
(C) is related by common ownership or
control to a person meeting all the requirements
described in subparagraph (A) or (B), if the
court deciding a motion to dismiss in accord-
ance with section 6(c)(3)(B)(i) finds, on the
basis of affidavits submitted in accordance with
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section 6, that it is necessary to impose liability
on the biomaterials supplier as a manufacturer
because the related manufacturer meeting the
requirements of subparagraph (A) or (B) lacks
sufficient financial resources to satisfy any
judgment that the court feels it is likely to
enter should the claimant prevail.
(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 120 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 from the time a
claimant files a petition with the Secretary
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under this paragraph until such time as either
(i) the Secretary issues a final decision on the
petition, or (ii) the petition is withdrawn.
(D) STAY PENDING PETITION FOR DEC-
LARATION.—If a claimant has filed a petition
for a declaration with respect to a defendant,
and the Secretary has not issued a final deci-
sion on the petition, the court shall stay all pro-
ceedings with respect to that defendant until
such time as the Secretary has issued a final
decision on the petition.
(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 only if—
(1) the biomaterials supplier—
(A) held title to the implant and then
acted as a seller of the implant after its initial
sale by the manufacturer; or
(B) acted under contract as a seller to ar-
range for the transfer of the implant directly to
the claimant after the initial sale by the manu-
facturer of the implant; or
(2) the biomaterials supplier is related by com-
mon ownership or control to a person meeting all the
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requirements described in paragraph (1), if a court
deciding a motion to dismiss in accordance with sec-
tion 6(c)(3)(B)(ii) finds, on the basis of affidavits
submitted in accordance with section 6, that it is
necessary to impose liability on the biomaterials sup-
plier as a seller because the related seller meeting
the requirements of paragraph (1) lacks sufficient fi-
nancial resources to satisfy any judgment that the
court feels it is likely to enter should the claimant
prevail.
(d) LIABILITY FOR FAILURE TO MEET APPLICABLE
CONTRACTUAL REQUIREMENTS OR SPECIFICATIONS.—A
biomaterials supplier may, to the extent required and per-
mitted by any other applicable law, be liable for harm to
a claimant caused by an implant if the claimant in an ac-
tion shows, by a preponderance of the evidence, that—
(1) the biomaterials supplier supplied raw mate-
rials or component parts for use in the implant that
either—
(A) did not constitute the product de-
scribed in the contract between the biomaterials
supplier and the person who contracted for the
supplying of the product; or
(B) failed to meet any specifications that
were—
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(i) accepted, pursuant to applicable
law, by the biomaterials supplier;
(ii) published by the biomaterials sup-
plier;
(iii) provided by the biomaterials sup-
plier to the person who contracted for such
product;
(iv) 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
(v) 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 received clearance
from the Secretary if such specifications
were accepted, pursuant to applicable law,
by the biomaterials supplier; and
(2) such failure to meet applicable contractual
requirements or specifications was an actual and
proximate cause of the harm to the claimant.
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SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS
AGAINST BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—A defendant may, at any
time during which a motion to dismiss may be filed under
applicable law, move to dismiss an action against it on
the grounds that the defendant is a biomaterials supplier
and one or more of the following:
(1) The defendant is not liable as a manufac-
turer, as provided in section 5(b).
(2) The defendant is not liable as a seller, as
provided in section 5(c).
(3) The defendant is not liable for furnishing
raw materials or component parts for the implant
that failed to meet applicable contractual require-
ments or specifications, as provided in section 5(d).
(4) The claimant did not name the manufac-
turer as a party to the action, as provided in sub-
section (b).
(b) MANUFACTURER OF IMPLANT SHALL BE NAMED
A PARTY.—In any civil action covered by this Act, the
claimant shall be required to name the manufacturer of
the implant as a party to the action, unless—
(1) the manufacturer is subject to service of
process solely in a jurisdiction in which the biomate-
rials supplier is not domiciled or subject to a service
of process; or
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(2) a claim against the manufacturer is barred
by applicable law or rule of practice.
(c) PROCEEDING ON MOTION TO DISMISS.—The fol-
lowing rules shall apply to any proceeding on a motion
to dismiss filed by a defendant under this section:
(1) EFFECT OF MOTION TO DISMISS ON DIS-
COVERY.—
(A) IN GENERAL.—Except as provided in
subparagraph (B), if a defendant files a motion
to dismiss under subsection (a), no discovery
shall be permitted in connection with the action
that is the subject of the motion, other than
discovery necessary to determine a motion to
dismiss for lack of jurisdiction, until such time
as the court rules on the motion to dismiss.
(B) DISCOVERY.—If a defendant files a
motion to dismiss under subsection (a)(3) on
the grounds that it did not furnish raw mate-
rials or component parts for the implant that
failed to meet applicable contractual require-
ments or specifications, the court may permit
discovery limited to issues that are directly rel-
evant to—
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
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(2) AFFIDAVITS.—
(A) DEFENDANT.—A defendant may sub-
mit affidavits supporting the grounds for dis-
missal contained in its motion to dismiss under
subsection (a). If the motion is made under
subsection (a)(1), the defendant may submit an
affidavit demonstrating that the defendant has
not included the implant on a list, if any, filed
with the Secretary pursuant to section 510(j) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(j)).
(B) CLAIMANT.—In response to a motion
to dismiss, the claimant may submit affidavits
demonstrating that—
(i) the Secretary has, with respect to
the defendant and the implant that alleg-
edly caused harm to the claimant, issued a
declaration pursuant to section 5(b)(2)(B);
or
(ii) the defendant is a seller of the im-
plant who is liable under section 5(c).
(3) BASIS
OF
RULING
ON
MOTION
TO
DIS-
MISS.—The court shall rule on a motion to dismiss
filed under subsection (a) solely on the basis of the
pleadings and affidavits of the parties made pursu-
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ant to this subsection. The court shall grant a mo-
tion to dismiss filed under subsection (a)—
(A) unless the claimant submits a valid af-
fidavit that demonstrates that the defendant is
not a biomaterials supplier;
(B) unless the court determines, to the ex-
tent raised in the pleadings and affidavits, that
one or more of the following apply:
(i) the defendant may be liable as a
manufacturer, as provided in section 5(b);
(ii) the defendant may be liable as a
seller, as provided in section 5(c); or
(iii) the defendant may be liable for
furnishing raw materials or component
parts for the implant that failed to meet
applicable contractual requirements or
specifications, as provided in section 5(d);
or
(C) if the claimant did not name the man-
ufacturer as a party to the action, as provided
in subsection (b).
(4) TREATMENT OF MOTION AS MOTION FOR
SUMMARY JUDGMENT.—The court may treat a mo-
tion to dismiss as a motion for summary judgment
subject to subsection (d) in order to determine
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whether the pleadings and affidavits, in connection
with such action, raise genuine issues of material
fact concerning whether the defendant furnished raw
materials or component parts of the implant that
failed to meet applicable contractual requirements or
specifications as provided in section 5(d).
(d) SUMMARY JUDGMENT.—
(1) IN GENERAL.—
(A) BASIS FOR ENTRY OF JUDGMENT.—If
a motion to dismiss of a biomaterials supplier
is to be treated as a motion for summary judg-
ment under subsection (c)(4) or if a biomate-
rials supplier moves for summary judgment, the
biomaterials supplier shall be entitled to entry
of judgment without trial if the court finds
there is no genuine issue of material fact for
each applicable element set forth in paragraphs
(1) and (2) of section 5(d).
(B) ISSUES OF MATERIAL FACT.—With re-
spect to a finding made under subparagraph
(A), the court shall consider a genuine issue of
material fact to exist only if the evidence sub-
mitted by the claimant would be sufficient to
allow a reasonable jury to reach a verdict for