I
105TH CONGRESS
1ST SESSION
H. R. 872
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. GREEN-
WOOD, 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. SENSEN-
BRENNER, 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 deter-
mined 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 1997’’.
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) 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 de-
vices, 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 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 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 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—
(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 medi-
cal 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 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.
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-
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 an individual
into whose body, or in contact with whose blood
or tissue the implant is placed, such term in-
cludes 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 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 the transaction; and
(II) the essence of the trans-
action is 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 be disclosed
to a jury in any civil action or other
proceeding and, except as necessary to
establish the applicability of this Act,
otherwise be presented in any civil ac-
tion or other proceeding.
(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.
(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—
(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.—
(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 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 fur-
nishing 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 raise any
defense set forth in section 5.
(2) PROCEDURES.—Notwithstanding any other
provision of law, the Federal or State court in which
a civil action covered by this Act is pending shall, in
connection with a motion for dismissal or judgment
based on a defense described in paragraph (1), use
the procedures set forth in section 6.
(b) APPLICABILITY.—
(1) IN GENERAL.—Except as provided in para-
graph (2), notwithstanding any other provision of
law, this Act applies to any civil action brought by
a claimant, whether in a Federal or State court,
against a manufacturer, seller, or biomaterials sup-
plier, on the basis of any legal theory, for harm al-
legedly caused by an implant.
(2) EXCLUSION.—A civil action brought by a
purchaser of a medical device for use in providing
professional services against a manufacturer, seller,
or biomaterials supplier for loss or damage to an im-
plant 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.
(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.—
(1) EXCLUSION
FROM
LIABILITY.—Except as
provided in paragraph (2), a biomaterials supplier
shall not be liable for harm to a claimant caused by
an implant.
(2) LIABILITY.—A biomaterials supplier that—
(A) is a manufacturer may be liable for
harm to a claimant described in subsection (b);
(B) is a seller may be liable for harm to
a claimant described in subsection (c); and
(C) furnishes raw materials or component
parts that fail to meet applicable contractual re-
quirements or specifications may be liable for a
harm to a claimant described 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) has registered 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) included the implant on a list of de-
vices filed with the Secretary pursuant to sec-
tion 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
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 180 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 during which a
claimant has filed a petition with the Secretary
under this paragraph.
(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 if—
(1) the biomaterials supplier—
(A) held title to the implant that allegedly
caused harm to the claimant as a result of pur-
chasing the implant after—
(i) the manufacture of the implant;
and
(ii) the entrance of the implant in the
stream of commerce; and
(B) subsequently resold the implant; or
(2) the biomaterials supplier is related by com-
mon ownership or control to a person meeting all the
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 VIOLATING CONTRACTUAL RE-
QUIREMENTS OR SPECIFICATIONS.—A biomaterials sup-
plier 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 claimant in an action shows,
by a preponderance of the evidence, that—
(1) the raw materials or component parts deliv-
ered by the biomaterials supplier either—
(A) did not constitute the product de-
scribed in the contract between the biomaterials
supplier and the person who contracted for de-
livery of the product; or
(B) failed to meet any specifications that
were—
(i) provided to the biomaterials sup-
plier and not expressly repudiated by the
biomaterials supplier prior to acceptance of
delivery of the raw materials or component
parts;
(ii)(I) published by the biomaterials
supplier;
(II) provided to the manufacturer by
the biomaterials supplier; or
(III) 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
(iii) 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 provided by the manufacturer to the
biomaterials supplier and were not ex-
pressly repudiated by the biomaterials sup-
plier prior to the acceptance by the manu-
facturer of delivery of the raw materials or
component parts; and
(2) such conduct was an actual and proximate
cause of the harm to the claimant.
SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS
AGAINST BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—In any action that is sub-
ject to this Act, a biomaterials supplier who is a defendant
in such action may, at any time during which a motion
to dismiss may be filed under an applicable law, move to
dismiss the action against it on the grounds that—
(1) the defendant is a biomaterials supplier;
and
(2)(A) the defendant should not, for the pur-
poses of—
(i) section 5(b), be considered to be a man-
ufacturer of the implant that is subject to such
section; or
(ii) section 5(c), be considered to be a sell-
er of the implant that allegedly caused harm to
the claimant; or
(B)(i) the claimant has failed to establish, pur-
suant to section 5(d), that the supplier furnished
raw materials or component parts in violation of
contractual requirements or specifications; or
(ii) the claimant has failed to comply with the
procedural requirements of subsection (b).
(b) MANUFACTURER OF IMPLANT SHALL BE NAMED
A PARTY.—The claimant shall be required to name the
manufacturer of the implant as a party to the action, un-
less—
(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
(2) an action against the manufacturer is
barred by applicable law.
(c) PROCEEDING ON MOTION TO DISMISS.—The fol-
lowing rules shall apply to any proceeding on a motion
to dismiss filed under this section:
(1) AFFIDAVITS
RELATING
TO
LISTING
AND
DECLARATIONS.—
(A) IN GENERAL.—The defendant in the
action may submit an affidavit demonstrating
that 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) RESPONSE TO MOTION TO DISMISS.—
In response to the motion to dismiss, the claim-
ant may submit an affidavit 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 who filed the mo-
tion to dismiss is a seller of the implant
who is liable under section 5(c).
(2) EFFECT OF MOTION TO DISMISS ON DIS-
COVERY.—
(A) IN GENERAL.—If a defendant files a
motion to dismiss under paragraph (1) or (2) of
subsection (a), no discovery shall be permitted
in connection to the action that is the subject
of the motion, other than discovery necessary to
determine a motion to dismiss for lack of juris-
diction, until such time as the court rules on
the motion to dismiss in accordance with the af-
fidavits submitted by the parties in accordance
with this section.
(B) DISCOVERY.—If a defendant files a
motion to dismiss under subsection (a)(2)(B)(i)
on the grounds that the biomaterials supplier
did not furnish raw materials or component
parts in violation of contractual requirements or
specifications, the court may permit discovery,
as ordered by the court. The discovery con-
ducted pursuant to this subparagraph shall be
limited to issues that are directly relevant to—
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
(3) AFFIDAVITS RELATING STATUS OF DEFEND-
ANT.—
(A) IN GENERAL.—Except as provided in
clauses (i) and (ii) of subparagraph (B), the
court shall consider a defendant to be a bio-
materials supplier who is not subject to an ac-
tion for harm to a claimant caused by an im-
plant, other than an action relating to liability
for a violation of contractual requirements or
specifications described in subsection (d).
(B) RESPONSES TO MOTION TO DISMISS.—
The court shall grant a motion to dismiss any
action that asserts liability of the defendant
under subsection (b) or (c) of section 5 on the
grounds that the defendant is not a manufac-
turer subject to such section 5(b) or seller sub-
ject to section 5(c), unless the claimant submits
a valid affidavit that demonstrates that—
(i) with respect to a motion to dismiss
contending the defendant is not a manu-
facturer, the defendant meets the applica-
ble requirements for liability as a manufac-
turer under section 5(b); or
(ii) with respect to a motion to dis-
miss contending that the defendant is not
a seller, the defendant meets the applicable
requirements for liability as a seller under
section 5(c).
(4) BASIS
OF
RULING
ON
MOTION
TO
DIS-
MISS.—
(A) IN GENERAL.—The court shall rule on
a motion to dismiss filed under subsection (a)
solely on the basis of the pleadings of the par-
ties made pursuant to this section and any affi-
davits submitted by the parties pursuant to this
section.
(B) MOTION FOR SUMMARY JUDGMENT.—
Notwithstanding any other provision of law, if
the court determines that the pleadings and af-
fidavits made by parties pursuant to this sec-
tion raise genuine issues as concerning material
facts with respect to a motion concerning con-
tractual requirements and specifications, the
court may deem the motion to dismiss to be a
motion for summary judgment made pursuant
to subsection (d).
(d) SUMMARY JUDGMENT.—
(1) IN GENERAL.—
(A) BASIS FOR ENTRY OF JUDGMENT.—A
biomaterials supplier shall be entitled to entry
of judgment without trial if the court finds
there is no genuine issue as concerning any ma-
terial 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