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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. 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
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.
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PACKARD, Mrs. ROUKEMA, Mr. DAN SCHAEFER of Colorado, Mr. SES-
SIONS, Mr. STENHOLM, Mr. TOWNS, Mr. BARTON of Texas, Mr. BOU-
CHER, 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. SOLO-
MON, 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 Or-
egon, Ms. LOFGREN, Mr. BOB SCHAFFER of Colorado, Ms. SLAUGHTER,
Mr. WHITE, Mr. CAMPBELL, Ms. HARMAN, Mrs. JOHNSON of Connecti-
cut, 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. STRICK-
LAND, 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE
This Act may be cited as the ‘‘Biomaterials Access As-
surance Act of 1998’’.
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(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 com-
merce;
(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 liabil-
ity for suppliers of raw materials and compo-
nent parts for medical devices; and
(B) to provide expeditious procedures to dis-
pose 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 in-
volving the national interest, address tort issues, and
a threatened shortage of raw materials and compo-
nent 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 suppli-
ers should not be protected.
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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, 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
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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 ac-
tion.
(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 transaction
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-
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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 find-
ing 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 es-
tablish 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 im-
plant.
(B) CERTAIN COMPONENTS.—Such term in-
cludes a manufactured piece of an implant
that—
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(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—
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(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 proce-
dures.
(6) MANUFACTURER.—The term ‘‘manufacturer’’
means any person who, with respect to an implant—
(A) is engaged in the manufacture, prepara-
tion, 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))
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and the regulations issued under such sec-
tion.
(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 con-
ducted 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;
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(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 furnish-
ing 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 de-
fense 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,
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against a manufacturer, seller, or biomaterials sup-
plier, on the basis of any legal theory, for harm alleg-
edly 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 commer-
cial or contract law.
(c) SCOPE OF PREEMPTION.—
(1) IN GENERAL.—This Act supersedes any State
law regarding recovery for harm caused by an im-
plant 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 applica-
ble 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 ap-
plicable Federal or State law.
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(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) or section 7, a biomate-
rials supplier shall not be liable for harm to a claim-
ant 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
harm to a claimant described in subsection (d).
(b) LIABILITY AS MANUFACTURER.—
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(1) IN GENERAL.—A biomaterials supplier may,
to the extent required and permitted by any other ap-
plicable 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 or should have 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 or should have included 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 im-
plant that allegedly caused harm to the claim-
ant, was required to—
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(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 sec-
tion, but failed to do so; or
(C) is related by common ownership or con-
trol to a person meeting all the requirements de-
scribed 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 affida-
vits submitted in accordance with section 6, that
it is necessary to impose liability on the bio-
materials supplier as a manufacturer because the
related manufacturer meeting the requirements
of subparagraph (A) or (B) lacks sufficient fi-
nancial 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
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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.—Im-
mediately upon receipt of a petition filed pursu-
ant 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 LIMITA-
TIONS.—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 ap-
plicable 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 that allegedly
caused harm to the claimant as a result of pur-
chasing the implant after—
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(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 nec-
essary to impose liability on the biomaterials supplier
as a seller because the related seller meeting the re-
quirements 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 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—
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(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) accepted, pursuant to applicable
law, by the biomaterials supplier;
(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 main-
tained by the biomaterials supplier for pur-
poses of premarket approval of medical de-
vices; 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 Sec-
retary if such specifications were accepted,
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pursuant to applicable law, by the biomate-
rials supplier; 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 purposes
of—
(i) section 5(b), be considered to be a manu-
facturer 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, pur-
suant to section 5(d), that the supplier furnished raw
materials or component parts in violation of contrac-
tual requirements or specifications; or
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(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 proc-
ess solely in a jurisdiction in which the biomaterials
supplier is not domiciled or subject to a service of
process; or
(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 under this section:
(1) AFFIDAVITS RELATING TO LISTING AND DEC-
LARATIONS.—
(A) IN GENERAL.—The defendant in the ac-
tion may submit an affidavit demonstrating that
defendant has not included the implant on a list,
if any, filed with Secretary pursuant to section
510(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(j)).
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(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 alleg-
edly 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 DISCOV-
ERY.—
(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 deter-
mine 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 sub-
mitted by the parties in accordance with this
section.
(B) DISCOVERY.—If a defendant files a mo-
tion to dismiss under subsection (a)(2)(B)(i) on
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the grounds that the biomaterials supplier did
not furnish raw materials or component parts in
violation of contractual requirements or speci-
fications, the court may permit discovery, as or-
dered by the court. The discovery conducted pur-
suant 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 TO STATUS OF DE-
FENDANT.—
(A) IN GENERAL.—Except as provided in
clauses (i) and (ii) of subparagraph (B), the
court shall consider a defendant to be a biomate-
rials 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 viola-
tion of contractual requirements or specifications
described in section 5(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 subject
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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 manufac-
turer, the defendant meets the applicable re-
quirements 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 sell-
er, the defendant meets the applicable re-
quirements 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 affi-
davits 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
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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 para-
graphs (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 mate-
rial fact to exist only if the evidence submitted
by claimant would be sufficient to allow a rea-
sonable 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 appli-
cable rules, the court permits discovery prior to a rul-
ing on a motion for summary judgment made pursu-
ant to this subsection, such discovery shall be limited
solely to establishing whether a genuine issue of mate-
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rial fact exists as to the applicable elements set forth
in paragraphs (1) and (2) of section 5(d).
(3) DISCOVERY WITH RESPECT TO A BIOMATE-
RIALS SUPPLIER.—A biomaterials supplier shall be
subject to discovery in connection with a motion seek-
ing dismissal or summary judgment on the basis of
the inapplicability of section 5(d) or the failure to es-
tablish 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 de-
fendant until such time as the Secretary has issued a final
decision on the petition. The Secretary shall complete re-
view of any such petition within 6 weeks of receipt of the
petition.
(f) DISMISSAL WITH PREJUDICE.—An order granting
a motion to dismiss or for summary judgment pursuant
to this section shall be entered with prejudice, except insofar
as the moving defendant may be rejoined to the action as
provided in section 7.
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(g) MANUFACTURER CONDUCT OF LITIGATION.—The
manufacturer of an implant that is the subject of an action
covered under this Act shall be permitted to conduct litiga-
tion on any motion for summary judgment or dismissal
filed by a biomaterials supplier who is a defendant under
this section on behalf of such supplier 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 litigation or
to conduct such litigation.
SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED DEFEND-
ANT.
(a) IMPLEADING
OF
DISMISSED
DEFENDANT.—A
court, upon motion by a manufacturer or a claimant with-
in 90 days after entry of a final judgment in an action
by the claimant against a manufacturer, and notwithstand-
ing any otherwise applicable statute of limitations, may
implead a biomaterials supplier who has been dismissed
from the action pursuant to this Act if—
(1) the manufacturer has made an assertion, ei-
ther in a motion or other pleading filed with the
court or in an opening or closing statement at trial,
or as part of a claim for contribution or indemnifica-
tion, and the court makes a finding based on the
court’s independent review of the evidence contained
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in the record of the action, that under applicable
law—
(A) the negligence or intentionally tortious
conduct of the dismissed supplier was an actual
and proximate cause of the harm to the claim-
ant; and
(B) the manufacturer’s liability for dam-
ages should be reduced in whole or in part be-
cause of such negligence or intentionally tortious
conduct; or
(2) the claimant has moved to implead the sup-
plier and the court makes a finding based on the
court’s independent review of the evidence contained
in the record of the action, that under applicable
law—
(A) the negligence or intentionally tortious
conduct of the dismissed supplier was an actual
and proximate cause of the harm to the claim-
ant; and
(B) the claimant is unlikely to be able to re-
cover the full amount of its damages from the re-
maining defendants.
(b) STANDARD OF LIABILITY.—Notwithstanding any
preliminary finding under subsection (a), a biomaterials
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supplier who has been impleaded into an action subject to
this Act, as provided for in this section—
(1) may, prior to entry of judgment on the claim
against it, supplement the record of the proceeding
that was developed prior to the grant of the motion
for impleader under subsection (a), and
(2) may be found liable to a manufacturer or a
claimant only to the extent required and permitted by
any applicable State or Federal law other than this
Act in an action alleging harm caused by an im-
plant.
(c) DISCOVERY.—Nothing in this section shall give a
claimant or any other party the right to obtain discovery
from a biomaterials supplier defendant at any time prior
to grant of a motion for impleader beyond that allowed
under section 6.
SEC. 8. APPLICABILITY.
This Act shall apply to all civil actions covered under
this Act that are commenced on or after the date of enact-
ment of this Act, including any such action with respect
to which the harm asserted in the action or the conduct
that caused the harm occurred before the date of enactment
of this Act.
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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 avail-
ability of lifesaving or life-enhancing
medical devices, many of which are per-
manently implantable within the human
body;
(2) a continued supply of raw mate-
rials and component parts is necessary
for the invention, development, improve-
ment, 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 manufac-
tured specifically for use in medical
devices; and
(C) come in contact with internal
human tissue;
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(4) the raw materials and component
parts also are used in a variety of non-
medical products;
(5) because small quantities of the
raw materials and component parts are
used for medical devices, sales of raw ma-
terials 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.) manu-
facturers of medical devices are required
to demonstrate that the medical devices
are safe and effective, including dem-
onstrating 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 inad-
equate—
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(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 ma-
terials and component parts have very
rarely been held liable in such actions,
such suppliers have ceased supplying cer-
tain 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 medi-
cal devices will lead to unavailability of
lifesaving and life-enhancing medical de-
vices;
(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 de-
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velopment of new sources of supply for
the full range of threatened raw mate-
rials and component parts for medical de-
vices are remote;
(11) it is unlikely that the small mar-
ket for such raw materials and compo-
nent parts in the United States could sup-
port the large investment needed to de-
velop 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 mate-
rials and component parts have generally
found that the suppliers do not have a
duty—
(A) to evaluate the safety and effi-
cacy of the use of a raw material or
component part in a medical device;
or
(B) to warn consumers concern-
ing the safety and effectiveness of a
medical device;
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(14) because medical devices and the
raw materials and component parts used
in their manufacture move in interstate
commerce, a shortage of such raw mate-
rials and component parts affects inter-
state commerce;
(15) in order to safeguard the avail-
ability of a wide variety of lifesaving and
life-enhancing medical devices, imme-
diate 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 proce-
dures 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
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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 medi-
cal 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 ‘‘bio-
materials 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.—
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(A) IN GENERAL.—The term ‘‘claim-
ant’’ 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 re-
sult 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 dece-
dent that is the subject of the action.
(C) ACTION BROUGHT ON BEHALF OF
A
MINOR
OR
INCOMPETENT.—With re-
spect to an action brought on behalf
of or through a minor or incom-
petent, such term includes the parent
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or guardian of the minor or incom-
petent.
(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 pro-
fessional health care services
provided is the furnishing of
judgment, skill, or services;
(ii) a person acting in the ca-
pacity 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 sil-
icone gel, except that—
(I) neither the exclusion
provided by this clause nor
any other provision of this
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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 
nec-
essary to establish the ap-
plicability of this Act, oth-
erwise be presented in
any civil action or other
proceeding.
(3) COMPONENT PART.—
(A) IN GENERAL.—The term ‘‘com-
ponent part’’ means a manufactured
piece of an implant.
(B) CERTAIN
COMPONENTS.—Such
term includes a manufactured piece
of an implant that—
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(i) has significant non-implant
applications; and
(ii) alone, has no implant
value or purpose, but when com-
bined with other component parts
and materials, constitutes an im-
plant.
(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—
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(A) a medical device that is in-
tended by the manufacturer of the de-
vice—
(i) to be placed into a sur-
gically or naturally formed or ex-
isting cavity of the body for a pe-
riod of at least 30 days; or
(ii) to remain in contact with
bodily fluids or internal human
tissue through a surgically pro-
duced opening for a period of less
than 30 days; and
(B) suture materials used in im-
plant procedures.
(6) MANUFACTURER.—The term ‘‘manu-
facturer’’ means any person who, with re-
spect to an implant—
(A) is engaged in the manufac-
ture, 
preparation, 
propagation,
compounding, or processing (as de-
fined in section 510(a)(1) of the Fed-
eral 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 Sec-
retary pursuant to section 510 of
the Federal Food, Drug, and Cos-
metic 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 Sec-
retary 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 ‘‘medi-
cal 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
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(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 pur-
pose, sells, distributes, leases, pack-
ages, 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 where—
(I) the sale or use of the
implant is incidental to such
services; and
(II) the essence of the
health care services provided
is the furnishing of judgment,
skill, or services; or
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(iii) any person who acts in
only a financial capacity with re-
spect 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 sup-
plier may—
(A) raise any exclusion from li-
ability 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, wheth-
er in a Federal or State court, on the
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basis of any legal theory, for harm alleg-
edly caused, directly or indirectly, by an
implant.
(2) EXCLUSION.—A civil action brought
by a purchaser of a medical device,
where such purchaser intends to use the
device in providing professional health
care services, for loss or damage to an
implant or for commercial loss to the pur-
chaser—
(A) shall not be considered an ac-
tion that is subject to this Act; and
(B) shall be governed by applica-
ble 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
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that is not governed by a rule of law ap-
plicable to the recovery of damages de-
scribed 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
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 Fed-
eral court jurisdiction pursuant to sec-
tion 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 claimant caused by an im-
plant unless such supplier—
(1) is a manufacturer of the implant,
as provided in subsection (b);
(2) is a seller of the implant, as pro-
vided in subsection (c); or
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(3) furnished raw materials or compo-
nent parts for the implant that failed to
meet 
applicable 
contractual 
require-
ments or specifications, as provided in
subsection (d).
(b) LIABILITY AS MANUFACTURER.—
(1) IN GENERAL.—A biomaterials sup-
plier 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 biomaterials supplier is
the manufacturer of the implant.
(2) GROUNDS FOR LIABILITY.—The bio-
materials supplier may be considered the
manufacturer of the implant that alleg-
edly caused harm to a claimant only if
the biomaterials supplier—
(A)(i) has 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
(ii) included or was required to
include the implant on a list of de-
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vices filed with the Secretary pursu-
ant 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 Sec-
retary 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 owner-
ship or control to a person meeting
all the requirements described in sub-
paragraph (A) or (B), if the court de-
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ciding 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 manufac-
turer because the related manufac-
turer meeting the requirements of
subparagraph (A) or (B) lacks suffi-
cient 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 per-
son, after providing—
(i) notice to the affected per-
sons; and
(ii) an opportunity for an in-
formal hearing.
(B) DOCKETING
AND
FINAL
DECI-
SION.—Immediately upon receipt of a
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petition filed pursuant to this para-
graph, 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 pe-
tition.
(C) APPLICABILITY
OF
STATUTE
OF
LIMITATIONS.—Any applicable statute
of limitations shall toll during the pe-
riod from the time a claimant has
filed a petition with the Secretary
under this paragraph until such time
as the Secretary either (i) issues a
final decision on the petition, or (ii)
the petition is withdrawn.
(D) STAY
PENDING
PETITION
FOR
DECLARATION.—If a claimant has filed
a petition for a declaration with re-
spect to a defendant, and the Sec-
retary 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 Sec-
retary has issued a final decision on
the petition. The Secretary shall com-
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plete review of any such petition
within 120 days of receipt of the peti-
tion.
(c) LIABILITY AS SELLER.—A biomaterials
supplier may, to the extent required and per-
mitted 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 manufac-
turer; or
(B) acted under contract as a sell-
er to arrange for the transfer of the
implant directly to the claimant after
the initial sale by the manufacturer
of the implant; or
(2) the biomaterials supplier is relat-
ed by common ownership or control to a
person meeting all the requirements de-
scribed in paragraph (1), if a court decid-
ing a motion to dismiss in accordance
with section 6(c)(3)(B)(ii) finds, on the
basis of affidavits submitted in accord-
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ance 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 financial resources to
satisfy any judgment that the court feels
it is likely to enter should the claimant
prevail.
(d) LIABILITY FOR FAILURE TO MEET APPLI-
CABLE CONTRACTUAL REQUIREMENTS OR SPECI-
FICATIONS.—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 biomaterials supplier supplied
raw materials or component parts for use
in the implant that either—
(A) did not constitute the product
described in the contract between the
biomaterials supplier and the person
who contracted for the supplying of
the product; or
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(B) failed to meet any specifica-
tions that were—
(i) accepted, pursuant to ap-
plicable law, by the biomaterials
supplier;
(ii) published by the biomate-
rials supplier;
(iii) provided by the biomate-
rials supplier to the person who
contracted for such product;
(iv) contained in a master file
that was submitted by the bio-
materials supplier to the Sec-
retary and that is currently main-
tained by the biomaterials sup-
plier for purposes of premarket
approval of medical devices; or
(v) included in the submis-
sions for purposes of premarket
approval or review by the Sec-
retary 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
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such specifications were accept-
ed, pursuant to applicable law, by
the biomaterials supplier; and
(2) such failure to meet applicable
contractual requirements or specifica-
tions 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.—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
manufacturer, 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 fur-
nishing raw materials or component
parts for the implant that failed to meet
applicable contractual requirements or
specifications, as provided in section 5(d).
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(4) The claimant did not name the
manufacturer as a party to the action, as
provided in subsection (b).
(b) MANUFACTURER OF IMPLANT SHALL BE
NAMED A PARTY.—The claimant in an action
brought for harm caused by an implant 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 proc-
ess; or
(2) a claim against the manufacturer
is barred by applicable law or rule of
practice.
(c) PROCEEDING ON MOTION TO DISMISS.—
The following rules shall apply to any pro-
ceeding on a motion to dismiss filed by a de-
fendant under this section:
(1) EFFECT OF MOTION TO DISMISS ON
DISCOVERY.—
(A) IN
GENERAL.—Except as pro-
vided in subparagraph (B), if a de-
fendant files a motion to dismiss
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under subsection (a), no discovery
shall be permitted in connection to
the action that is the subject of the
motion, other than discovery nec-
essary to determine a motion to dis-
miss 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 sub-
section (a)(3) on the grounds that the
biomaterials supplier did not furnish
raw materials or component parts for
the implant that failed to meet appli-
cable contractual requirements or
specifications, the court may permit
discovery limited to issues that are
directly relevant to—
(i) the pending motion to dis-
miss; or
(ii) the jurisdiction of the
court.
(2) AFFIDAVITS.—
(A) DEFENDANT.—A defendant may
submit 
affidavits 
supporting 
the
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grounds for dismissal contained in its
motion to dismiss under subsection
(a). If the motion is made under sub-
section (a)(1), the defendant may sub-
mit 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 Cos-
metic 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 re-
spect 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 is a seller of
the implant who is liable under
section 5(c).
(3) BASIS OF RULING ON MOTION TO DIS-
MISS.—The court shall rule on a motion to
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dismiss filed under subsection (a) solely
on the basis of the pleadings and affida-
vits of the parties made pursuant to this
subsection. The court shall grant a mo-
tion to dismiss filed under subsection
(a)—
(A) unless the claimant submits a
valid affidavit that demonstrates that
the defendant is not a biomaterials
supplier;
(B) unless the court determines,
to the extent raised in the pleadings
and affidavits, that one or more of the
following apply:
(i) the defendant may be lia-
ble as a manufacturer, as pro-
vided in section 5(b);
(ii) the defendant may be lia-
ble as a seller, as provided in sec-
tion 5(c); or
(iii) the defendant may be lia-
ble for furnishing raw materials
or component parts for the im-
plant that failed to meet applica-
ble contractual requirements or
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specifications, as provided in sec-
tion 5(d); or
(C) if the claimant did not name
the manufacturer as a party to the ac-
tion, as provided in subsection (b).
(4) TREATMENT OF MOTION AS MOTION
FOR SUMMARY JUDGMENT.—The court may
deem a motion to dismiss as a motion for
summary judgment subject to subsection
(d) in order to determine whether the
pleadings and affidavits, in connection
with such action, raise genuine issues of
material fact concerning whether the de-
fendant furnished raw materials or com-
ponent parts of the implant that failed to
meet 
applicable 
contractual 
require-
ments or specifications as provided in
section 5(d).
(d) SUMMARY JUDGMENT.—
(1) IN GENERAL.—
(A) BASIS
FOR
ENTRY
OF
JUDG-
MENT.—If a motion to dismiss of a bio-
materials supplier is to be treated as
a 
motion 
for 
summary 
judgment
under subsection (c)(4) or if a bio-
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materials supplier moves for sum-
mary judgment, the biomaterials sup-
plier shall be entitled to entry of
judgment without trial if the court
finds there is no genuine issue of ma-
terial 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 con-
sider a genuine issue of material fact
to exist only if the evidence submit-
ted 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 governed by sec-
tion 5(d), such discovery shall be limited
solely to establishing whether a genuine
issue of material fact exists as to the ap-
HR 872 RH1S
plicable elements set forth in paragraphs
(1) and (2) of section 5(d).
(3) DISCOVERY WITH RESPECT TO A BIO-
MATERIALS SUPPLIER.—A biomaterials sup-
plier shall be subject to discovery in con-
nection with a motion seeking dismissal
or summary judgment on the basis of the
inapplicability of section 5(d) or the fail-
ure to establish the applicable elements
of section 5(d) solely to the extent per-
mitted by the applicable Federal or State
rules for discovery against nonparties.
(e) DISMISSAL WITH PREJUDICE.—Except as
provided in section 7, an order granting a mo-
tion to dismiss or for summary judgment pur-
suant to this section shall be entered with
prejudice.
(f) MANUFACTURER
CONDUCT
OF
LITIGA-
TION.—The manufacturer of an implant that is
the subject of an action covered under this
Act shall be permitted to conduct litigation on
any motion for summary judgment or dismis-
sal filed by a biomaterials supplier who is a
defendant under this section on behalf of
such supplier if the manufacturer and any
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other defendant in such action enter into a
valid and applicable contractual agreement
under which the manufacturer agrees to bear
the cost of such litigation or to conduct such
litigation.
SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED BIOMATE-
RIALS SUPPLIER.
(a) IMPLEADING OF DISMISSED DEFENDANT.—
A court, upon motion by a manufacturer or a
claimant within 90 days after entry of a final
judgment in an action by the claimant against
a manufacturer, and notwithstanding any
otherwise applicable statute of limitations,
may implead a biomaterials supplier who has
been dismissed from the action pursuant to
this Act if—
(1) the manufacturer has made an as-
sertion, either in a motion or other plead-
ing filed with the court or in an opening
or closing statement at trial, or as part of
a claim for contribution or indemnifica-
tion, and the court finds based on the
court’s independent review of the evi-
dence contained in the record of the ac-
tion, that under applicable law—
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(A) 
the 
negligence 
or 
inten-
tionally tortious conduct of the dis-
missed supplier was an actual and
proximate cause of the harm to the
claimant; and
(B) the manufacturer’s liability
for damages should be reduced in
whole or in part because of such neg-
ligence or intentionally tortious con-
duct; or
(2) the claimant has moved to im-
plead the supplier and the court makes a
finding based on the court’s independent
review of the evidence contained in the
record of the action, that under applica-
ble law—
(A) 
the 
negligence 
or 
inten-
tionally tortious conduct of the dis-
missed supplier was an actual and
proximate cause of the harm to the
claimant; and
(B) the claimant is unlikely to be
able to recover the full amount of its
damages from the remaining defend-
ants.
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(b) 
STANDARD
OF
LIABILITY.—Notwith-
standing any preliminary finding under sub-
section (a), a biomaterials supplier who has
been impleaded into an action subject to this
Act, as provided for in this section—
(1) may, prior to entry of judgment on
the claim against it, supplement the
record of the proceeding that was devel-
oped prior to the grant of the motion for
impleader under subsection (a), and
(2) may be found liable to a manufac-
turer or a claimant only to the extent re-
quired and permitted by any applicable
State or Federal law other than this Act.
(c) DISCOVERY.—Nothing in this section
shall give a claimant or any other party the
right to obtain discovery from a biomaterials
supplier at any time prior to grant of a motion
for impleader beyond that allowed under sec-
tion 6.
SEC. 8. EFFECTIVE DATE.
This Act shall apply to all civil actions
covered under this Act that are commenced
on or after the date of enactment of this Act,
including any such action with respect to
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which the harm asserted in the action or the
conduct that caused the harm occurred be-
fore the date of enactment of this Act.
Union Calendar No. 349
105TH CONGRESS
2D SESSION
H. R. 872
[Report No. 105–549, Parts I and II]
A BILL
To establish rules governing product liability ac-
tions against raw materials and bulk component
suppliers to medical device manufacturers, and
for other purposes.
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