Biomaterials Access Assurance Act of 1998
PL 105-230 (H.R.872), enacted 08/13/1998

PUBLIC LAW 105-230—AUG. 13, 1998 
112 STAT. 1519 
Public Law 105-230 
105th Congress 
An Act 
To establish rules governing product liability actions against raw materials and 
Aug. 13, 1998 
bulk component suppliers to medical device manufacturers, and for other purposes. 
[H'.R. 872] 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
Biomaterials 
Access Assurance 
SECTION 1. SHORT TITLE. 
Act of 1998. 
21 use 1601 
This Act may be cited as the "Biomaterials Access Assurance note. 
Act of 1998". 
SEC. 2. FINDINGS. 
' 
21USC1601. 
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 Federsu 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; 
112 STAT. 1520 
PUBLIC LAW 105-230—AUG. 13, 1998 
(8) even though suppUers of raw materials and component 
parts have very rarely been held liable in such actions, such 
suppliers have ceased suppl3dng 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. 
21 use 1602. 
SEC. 3. DEFINITIONS. 
As used in this Act: 
(1) BlOMATERIALS SUPPLIER.— 
PUBLIC LAW 105-230—AUG. 13, 1998 
112 STAT. 1521 
(A) IN GENERAL.—The term "biomaterial$ supplier" 
means an entity that directly or indirectly isupplies 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. 
112 STAT. 1522 
PUBLIC LAW 105-230—AUG. 13, 1998 
(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. 
PUBLIC LAW 105-230—AUG. 13, 1998 
112 STAT. 1523 
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. 
21 USC 1603. 
(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 
112 STAT. 1524 
PUBLIC LAW 105-230—AUG. 13, 1998 
Code, that otherwise would not exist under apphcable Federal 
or State law. 
21 use 1604. 
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 onlyj£ithe 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— 
PUBLIC LAW 105-230—AUG. 13, 1998 
112 STAT. 1525 
(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 Deadline. 
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; 
59-194 O - 98 - 21: QL 3 Part 2 
112 STAT. 1526 
PUBLIC LAW 105-230—AUG. 13, 1998 
(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. 
Courts. 
SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST 
21 use 1605. 
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. 
Applicability. 
(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 
PUBLIC LAW 105-230—AUG. 13, 1998 
112 STAT. 1527 
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 
112 STAT. 1528 
PUBLIC LAW 105-230—AUG. 13, 1998 
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. 
21 use 1606. 
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 
PUBLIC LAW 105-230—AUG. 13, 1998 
112 STAT. 1529 
(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. 
Applicability. 
This Act shall apply to all civil actions covered under this note. 
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. 
Approved August 13, 1998. 
LEGISLATIVE HISTORY—H.R. 872: 
HOUSE REPORTS: No. 105-549, Pt. 1 (Comm. on the Judiciary) and Pt. 2 (Coram. 
on Commerce). 
CONGRESSIONAL RECORD, Vol. 144 (1998): 
July 29, considered and passed House. 
July 30, considered and passed Senate. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 34 (1998): 
Aug. 13, Presidential statement.