H. R. 956—13
was caused by the fault of the employer or a coemployee
of the claimant—
(i) the court shall reduce by the amount of the
claimant’s benefits—
(I) the damages awarded against the manufac-
turer or product seller; and
(II) any corresponding insurer’s subrogation
lien; and
(ii) the manufacturer or product seller shall have
no further right by way of contribution or otherwise
against the employer.
(D) CERTAIN RIGHTS OF SUBROGATION NOT AFFECTED.—
Notwithstanding a finding by the trier of fact described
in subparagraph (C), the insurer shall not lose any right
of subrogation related to any—
(i) intentional tort committed against the claimant
by a coemployee; or
(ii) act committed by a coemployee outside the
scope of normal work practices.
(b) ATTORNEY’S FEES.—If, in a product liability action that
is subject to this section, the court finds that harm to a claimant
was not caused by the fault of the employer or a coemployee
of the claimant, the manufacturer or product seller shall reimburse
the insurer for reasonable attorney’s fees and court costs incurred
by the insurer in the action, as determined by the court.
TITLE II—BIOMATERIALS ACCESS
ASSURANCE
SEC. 201. SHORT TITLE.
This title may be cited as the ‘‘Biomaterials Access Assurance
Act of 1996’’.
SEC. 202. FINDINGS.
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
H. R. 956—14
required to demonstrate that the medical devices are safe and
effective, including demonstrating that the products are prop-
erly designed and have adequate warnings or instructions;
(7) notwithstanding the fact that raw materials and compo-
nent 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 judg-
ment 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-enhanc-
ing 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 develop-
ment 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 subpara-
graphs (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.
H. R. 956—15
SEC. 203. DEFINITIONS.
As used in this title:
(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 per-
son 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 per-
son 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 INCOM-
PETENT.—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 fur-
nishing of judgment, skill, or services; or
(ii) a person acting in the capacity of a manufac-
turer, seller, or biomaterials supplier.
(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 mate-
rials, constitutes an implant.
(4) HARM.—
(A) IN GENERAL.—The term ‘‘harm’’ means—
(i) any injury to or damage suffered by an individ-
ual;
(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 individ-
ual resulting from that injury or damage.
H. R. 956—16
(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 manufac-
turer 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, propa-
gation, 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 sec-
tion 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 sub-
stance 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 capac-
ity with respect to the sale of an implant.
SEC. 204. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.
(a) GENERAL REQUIREMENTS.—
H. R. 956—17
(1) IN GENERAL.—In any civil action covered by this title,
a biomaterials supplier may raise any defense set forth in
section 205.
(2) PROCEDURES.—Notwithstanding any other provision of
law, the Federal or State court in which a civil action covered
by this title 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 206.
(b) APPLICABILITY.—
(1) IN GENERAL.—Except as provided in paragraph (2), not-
withstanding any other provision of law, this title 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 title; and
(B) shall be governed by applicable commercial or con-
tract law.
(c) SCOPE OF PREEMPTION.—
(1) IN
GENERAL.—This title 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 title establishes
a rule of law applicable to the recovery of such damages.
(2) APPLICABILITY OF OTHER LAWS.—Any issue that arises
under this title 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 title 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. 205. 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 speci-
H. R. 956—18
fications 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 alleg-
edly caused harm to a claimant only if the biomaterials sup-
plier—
(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 sec-
tion;
(B) is the subject of a declaration issued by the Sec-
retary pursuant to paragraph (3) that states that the sup-
plier, 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 subpara-
graph (A) or (B), if the court deciding a motion to dismiss
in accordance with section 206(c)(3)(B)(i) finds, on the basis
of affidavits submitted in accordance with section 206, that
it is necessary to impose liability on the biomaterials sup-
plier 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 declara-
tion 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.
H. R. 956—19
(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 owner-
ship 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 206(c)(3)(B)(ii) finds, on the
basis of affidavits submitted in accordance with section 206,
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 compo-
nent 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 manufac-
turer 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.
H. R. 956—20
SEC. 206. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST
BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—In any action that is subject to this
title, 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 205(b), be considered to be a manufacturer
of the implant that is subject to such section; or
(ii) section 205(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 205(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 domi-
ciled 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 Sec-
retary 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
205(b)(2)(B); or
(ii) the defendant who filed the motion to dismiss
is a seller of the implant who is liable under section
205(c).
(2) EFFECT OF MOTION TO DISMISS ON DISCOVERY.—
(A) IN GENERAL.—If a defendant files a motion to dis-
miss under paragraph (1) or (2) of subsection (a), no discov-
ery 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 dis-
miss under subsection (a)(2)(B)(i) on the grounds that the
H. R. 956—21
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
205 on the grounds that the defendant is not a manufac-
turer subject to such section 205(b) or seller subject to
section 205(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 205(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 205(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.—Notwithstand-
ing 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 concern-
ing any material fact for each applicable element set forth
in paragraphs (1) and (2) of section 205(d).
(B) ISSUES OF MATERIAL FACT.—With respect to a find-
ing 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 reason-
H. R. 956—22
able 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 205(d).
(3) DISCOVERY
WITH
RESPECT
TO
A
BIOMATERIALS
SUP-
PLIER.—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 205(d)
or the failure to establish the applicable elements of section
205(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 205(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 manufac-
turer of an implant that is the subject of an action covered under
this title 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 sup-
plier to be without merit and frivolous.
TITLE III—LIMITATIONS ON
APPLICABILITY; EFFECTIVE DATE
SEC. 301. EFFECT OF COURT OF APPEALS DECISIONS.
A decision by a Federal circuit court of appeals interpreting
a provision of this Act (except to the extent that the decision
is overruled or otherwise modified by the Supreme Court) shall
be considered a controlling precedent with respect to any subsequent
decision made concerning the interpretation of such provision by
any Federal or State court within the geographical boundaries
of the area under the jurisdiction of the circuit court of appeals.
SEC. 302. FEDERAL CAUSE OF ACTION PRECLUDED.
The district courts of the United States shall not have jurisdic-
tion pursuant to this Act based on section 1331 or 1337 of title
28, United States Code.