[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 872 Introduced in House (IH)]
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. 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
_______________________________________________________________________
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
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 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) are not designed or manufactured specifically
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 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 medical devices;
(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 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 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) 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 medical 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 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.
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 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 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 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 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 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 paragraph (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
supplier, on the basis of any legal theory, for harm allegedly
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 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
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 governed by a rule of law
applicable to the recovery of damages described in paragraph
(1) shall be governed by applicable Federal or State law.
(d) Statutory Construction.--Nothing in this Act may be construed--
(1) to affect any defense available to a defendant under
any other provisions of Federal or State law in an action
alleging harm caused by an implant; 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 requirements 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 biomaterials 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 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;
(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 section, but
failed to do so; or
(ii) 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,
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 accordance 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 petition 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 limitations.--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 purchasing 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 common
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 section 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
supplier as a seller because the related seller meeting the
requirements of paragraph (1) lacks sufficient financial
resources to satisfy any judgment that the court feels it is
likely to enter should the claimant prevail.
(d) Liability for Violating Contractual Requirements or
Specifications.--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 claimant in an action shows, by a
preponderance of the evidence, that--
(1) the raw materials or component parts delivered by the
biomaterials supplier either--
(A) did not constitute the product described in the
contract between the biomaterials supplier and the
person who contracted for delivery of the product; or
(B) failed to meet any specifications that were--
(i) provided to the biomaterials supplier
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 expressly repudiated by the
biomaterials supplier prior to the acceptance
by the manufacturer 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 subject 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 purposes of--
(i) section 5(b), be considered to be a
manufacturer of the implant that is subject to such
section; or
(ii) section 5(c), be considered to be a seller of
the implant that allegedly caused harm to the claimant;
or
(B)(i) the claimant has failed to establish, pursuant 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, unless--
(1) the manufacturer is subject to service of process
solely in a jurisdiction in which the biomaterials 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 following 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 claimant may submit an
affidavit demonstrating that--
(i) the Secretary has, with respect to the
defendant and the implant that allegedly caused
harm to the claimant, issued a declaration
pursuant to section 5(b)(2)(B); or
(ii) the defendant who filed the motion to
dismiss is a seller of the implant who is
liable under section 5(c).
(2) Effect of motion to dismiss on discovery.--
(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 jurisdiction, until such time as the court
rules on the motion to dismiss in accordance with the
affidavits 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 conducted 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 defendant.--
(A) In general.--Except as provided in clauses (i)
and (ii) of subparagraph (B), the court shall consider
a defendant to be a biomaterials supplier who is not
subject to an action for harm to a claimant caused by
an implant, 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
manufacturer subject to such section 5(b) or seller
subject 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 manufacturer,
the defendant meets the applicable requirements
for liability as a manufacturer under section
5(b); or
(ii) with respect to a motion to dismiss
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 dismiss.--
(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 parties made pursuant to
this section and any affidavits 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 affidavits made by parties
pursuant to this section raise genuine issues as
concerning material facts with respect to a motion
concerning contractual 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 material fact for each applicable
element set forth in paragraphs (1) and (2) of section
5(d).
(B) Issues of material fact.--With respect to a
finding made under subparagraph (A), the court shall
consider a genuine issue of material fact to exist only
if the evidence submitted by claimant would be
sufficient to allow a reasonable jury to reach a
verdict for the claimant if the jury found the evidence
to be credible.
(2) Discovery made prior to a ruling on a motion for
summary judgment.--If, under applicable rules, the court
permits discovery prior to a ruling on a motion for summary
judgment made pursuant to this subsection, such discovery shall
be limited solely to establishing whether a genuine issue of
material fact exists as to the applicable elements set forth in
paragraphs (1) and (2) of section 5(d).
(3) Discovery with respect to a biomaterials supplier.--A
biomaterials supplier shall be subject to discovery in
connection with a motion seeking dismissal or summary judgment
on the basis of the inapplicability of section 5(d) or the
failure to establish the applicable elements of section 5(d)
solely to the extent permitted by the applicable Federal or
State rules for discovery against nonparties.
(e) Stay Pending Petition for Declaration.--If a claimant has filed
a petition for a declaration pursuant to section 5(b)(3)(A) with
respect to a defendant, and the Secretary has not issued a final
decision on the petition, the court shall stay all proceedings with
respect to that defendant until such time as the Secretary has issued a
final decision on the petition.
(f) Manufacturer Conduct of Proceeding.--The manufacturer of an
implant that is the subject of an action covered under this Act shall
be permitted to file and conduct a proceeding on any motion for summary
judgment or dismissal filed by a biomaterials supplier who is a
defendant under this section if the manufacturer and any other
defendant in such action enter into a valid and applicable contractual
agreement under which the manufacturer agrees to bear the cost of such
proceeding or to conduct such proceeding.
(g) Attorney Fees.--The court shall require the claimant to
compensate the biomaterials supplier (or a manufacturer appearing in
lieu of a supplier pursuant to subsection (f)) for attorney fees and
costs, if--
(1) the claimant named or joined the biomaterials supplier;
and
(2) the court found the claim against the biomaterials
supplier to be without merit and frivolous.
<all>