H. R. 872
One Hundred Fifth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twenty-seventh day of January, one thousand nine hundred and ninety-eight
An Act
To establish rules governing product liability actions against raw materials and
bulk component suppliers to medical device manufacturers, and for other purposes.
Be it enacted by the Senate and House of 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 1998’’.
SEC. 2. FINDINGS.
The Congress finds that—
(1) each year millions of citizens of the United States
depend on the availability of lifesaving or life-enhancing medi-
cal 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) move in interstate commerce;
(B) are not designed or manufactured specifically for
use in medical devices; and
(C) come in contact with internal human tissue;
(4) the raw materials and component parts also are used
in a variety of nonmedical products;
(5) because small quantities of the raw 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 component parts;
(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 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;
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(8) even though suppliers of raw materials and component
parts have very rarely been held liable in such actions, such
suppliers have ceased supplying certain raw materials and
component parts for use in medical devices for a number of
reasons, 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 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;
or
(B) to warn consumers concerning the safety and
effectiveness of a medical device;
(14) because medical devices and the raw materials and
component parts used in their manufacture move in interstate
commerce, a shortage of such raw materials and component
parts affects interstate commerce;
(15) in order to safeguard the availability of a wide variety
of lifesaving and life-enhancing medical devices, immediate
action is needed—
(A) to clarify the permissible bases of 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;
(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 lifesaving 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 lifesaving medical
devices, although such protections do not protect negligent
suppliers.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) BIOMATERIALS SUPPLIER.—
H. R. 872—3
(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 a deceased individual into whose body, or in
contact with whose blood or tissue the implant was 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 such services; and
(II) the essence of the professional health care
services provided is the furnishing of judgment,
skill, or services;
(ii) a person acting in the capacity of a manufac-
turer, 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—
(aa) be disclosed to a jury in any civil
action or other proceeding; and
(bb) except as necessary to establish the
applicability of this Act, otherwise be pre-
sented in any civil action or other proceeding.
(3) COMPONENT PART.—
(A) IN GENERAL.—The term ‘‘component part’’ means
a manufactured piece of an implant.
H. R. 872—4
(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
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 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
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,
H. R. 872—5
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 health care services
in any case in which—
(I) the sale or use of the implant is incidental
to such services; and
(II) the essence of the professional health care
services provided 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. 4. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.
(a) GENERAL REQUIREMENTS.—
(1) IN GENERAL.—In any civil action covered by this Act,
a biomaterials supplier may—
(A) raise any exclusion from liability set forth in section
5; and
(B) make a motion for dismissal or for summary judg-
ment 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, whether
in a Federal or State court, on the basis of any legal theory,
for harm allegedly caused, directly or indirectly, by an implant.
(2) EXCLUSION.—A civil action brought by a purchaser of
a medical device, purchased for use in providing professional
health care services, for loss or damage to an implant or for
commercial loss to the purchaser—
(A) shall not be considered an action that is subject
to this Act; and
(B) shall be governed by applicable commercial or
contract law.
(c) SCOPE OF PREEMPTION.—
(1) IN GENERAL.—This Act supersedes any State law regard-
ing 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
H. R. 872—6
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 biomate-
rials supplier shall not be liable for harm to a claimant caused
by an implant unless such supplier is liable—
(1) as a manufacturer of the implant, as provided in
subsection (b);
(2) as a seller of the implant, as provided in subsection
(c); or
(3) for furnishing raw materials or component parts for
the implant that failed to meet applicable contractual require-
ments or specifications, as provided 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) registered or was required 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) included or was required 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 regula-
tions 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 subpara-
graph (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 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—
H. R. 872—7
(i) notice to the affected persons; and
(ii) an opportunity for an informal hearing.
(B) DOCKETING
AND
FINAL
DECISION.—Immediately
upon receipt of a petition filed pursuant to this paragraph,
the Secretary shall docket the petition. Not later than
120 days after the petition is filed, the Secretary shall
issue a final decision on the petition.
(C) APPLICABILITY OF STATUTE OF LIMITATIONS.—Any
applicable statute of limitations shall toll during the period
from the time a claimant files a petition with the Secretary
under this paragraph until such time as either (i) the
Secretary issues a final decision on the petition, or (ii)
the petition is withdrawn.
(D) STAY PENDING PETITION FOR DECLARATION.—If a
claimant has filed a petition for a declaration 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.
(c) LIABILITY AS SELLER.—A biomaterials supplier may, to the
extent required and permitted by any other applicable law, be
liable as a seller for harm to a claimant caused by an implant
only if—
(1) the biomaterials supplier—
(A) held title to the implant and then acted as a
seller of the implant after its initial sale by the manufac-
turer; or
(B) acted under contract as a seller 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 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 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 FAILURE TO MEET APPLICABLE 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 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
(B) failed to meet any specifications that were—
(i) accepted, pursuant to applicable law, by the
biomaterials supplier;
(ii) published by the biomaterials supplier;
(iii) provided by the biomaterials supplier to the
person who contracted for such product;
H. R. 872—8
(iv) contained in a master file that was submitted
by the biomaterials supplier to the Secretary and that
is currently maintained by the biomaterials supplier
for purposes of premarket approval of medical devices;
or
(v) included in the submissions for purposes of
premarket approval or review by the Secretary under
section 510, 513, 515, or 520 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360, 360c, 360e,
or 360j), and received clearance from the Secretary
if such specifications were accepted, pursuant to
applicable law, by the biomaterials supplier; and
(2) such failure to meet applicable contractual requirements
or specifications was an actual and proximate cause of the
harm to the claimant.
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 furnishing raw materials
or component parts for the implant that failed to meet
applicable contractual requirements or specifications, as pro-
vided in section 5(d).
(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.—
In any civil action covered by this Act, the claimant shall be
required to name the manufacturer of the implant as a party
to the action, unless—
(1) the manufacturer is subject to service of process solely
in a jurisdiction in which the biomaterials supplier is not domi-
ciled 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 following rules
shall apply to any proceeding on a motion to dismiss filed by
a defendant under this section:
(1) EFFECT OF MOTION TO DISMISS ON DISCOVERY.—
(A) IN GENERAL.—Except as provided in subparagraph
(B), if a defendant files a motion to dismiss under sub-
section (a), no discovery shall be permitted in connection
with the action that is the subject of the motion, other
than discovery necessary to determine a motion to dismiss
for lack of jurisdiction, until such time as the court rules
on the motion to dismiss.
(B) DISCOVERY.—If a defendant files a motion to dis-
miss under subsection (a)(3) on the grounds that it did
not furnish raw materials or component parts for the
H. R. 872—9
implant that failed to meet applicable contractual require-
ments or specifications, the court may permit discovery
limited to issues that are directly relevant to—
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
(2) AFFIDAVITS.—
(A) DEFENDANT.—A defendant may submit affidavits
supporting the grounds for dismissal contained in its
motion to dismiss under subsection (a). If the motion is
made under subsection (a)(1), the defendant may submit
an affidavit demonstrating that the defendant has not
included the implant on a list, if any, filed with the Sec-
retary pursuant to section 510( j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360( j)).
(B) CLAIMANT.—In response to a motion to dismiss,
the claimant may submit affidavits demonstrating that—
(i) the Secretary has, with respect to the defendant
and the implant that 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 DISMISS.—The court
shall rule on a motion to dismiss filed under subsection (a)
solely on the basis of the pleadings and affidavits of the parties
made pursuant to this subsection. The court shall grant a
motion to dismiss filed under subsection (a)—
(A) unless the claimant submits a valid affidavit that
demonstrates that the defendant is not a biomaterials sup-
plier;
(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 liable as a manufacturer,
as provided in section 5(b);
(ii) the defendant may be liable as a seller, as
provided in section 5(c); or
(iii) the defendant may be liable for furnishing
raw materials or component parts for the implant that
failed to meet applicable contractual requirements or
specifications, as provided in section 5(d); or
(C) if the claimant did not name the manufacturer
as a party to the action, as provided in subsection (b).
(4) TREATMENT OF MOTION AS MOTION FOR SUMMARY JUDG-
MENT.—The court may treat 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 defendant furnished raw materials or
component parts of the implant that failed to meet applicable
contractual requirements or specifications as provided in section
5(d).
(d) SUMMARY JUDGMENT.—
(1) IN GENERAL.—
(A) BASIS FOR ENTRY OF JUDGMENT.—If a motion to
dismiss of a biomaterials supplier is to be treated as a
motion for summary judgment under subsection (c)(4) or
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if a biomaterials supplier moves for summary judgment,
the biomaterials supplier shall be entitled to entry of judg-
ment without trial if the court finds there is no genuine
issue of material fact for each applicable element set forth
in paragraphs (1) and (2) of section 5(d).
(B) ISSUES OF MATERIAL FACT.—With 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 the 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 section 5(d), such discovery shall be
limited solely to establishing whether a genuine issue of mate-
rial fact exists as to the applicable elements set forth in para-
graphs (1) and (2) of section 5(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 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) 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.
(f ) MANUFACTURER CONDUCT OF LITIGATION.—The manufac-
turer 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 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 BIOMATERIALS
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 stat-
ute 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, either 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 contribu-
tion or indemnification, and the court finds 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 claimant; and
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(B) the manufacturer’s liability for damages should
be reduced in whole or in part because of such negligence
or intentionally tortious conduct; or
(2) the claimant has moved to implead the supplier and
the court finds, 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 claimant; and
(B) the claimant is unlikely to be able to recover the
full amount of its damages from the remaining defendants.
(b) STANDARD OF LIABILITY.—Notwithstanding any preliminary
finding under subsection (a), a biomaterials supplier who has been
impleaded into an action covered by 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.
(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 section 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 which the harm
asserted in the action or the conduct that caused the harm occurred
before the date of enactment of this Act.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.