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104TH CONGRESS
1ST SESSION
H. R. 956
AN ACT
To establish legal standards and procedures for product
liability litigation, 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 AND TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Common Sense Product Liability and Legal Reform Act
of 1995’’.
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(b) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title and table of contents.
Sec. 2. Findings and purposes.
TITLE I—PRODUCT LIABILITY REFORM
Sec. 101. Applicability and preemption.
Sec. 102. Liability rules applicable to product sellers.
Sec. 103. Defense based on claimant’s use of intoxicating alcohol or drugs.
Sec. 104. Misuse or alteration.
Sec. 105. Frivolous pleadings.
Sec. 106. Statute of repose.
Sec. 107. Foreign products.
Sec. 108. Definitions.
TITLE II—LIMITATION ON SPECULATIVE AND ARBITRARY
DAMAGE AWARDS
Sec. 201. Treble damages as penalty in civil actions.
Sec. 202. Limitation on noneconomic damages in health care liability actions.
Sec. 203. Fair share rule for noneconomic damage awards.
Sec. 204. Definitions.
TITLE III—BIOMATERIALS SUPPLIERS
Sec. 301. Liability of biomaterials suppliers.
Sec. 302. Procedures for dismissal of civil actions against biomaterials suppli-
ers.
Sec. 303. Definitions.
TITLE IV—LIMITATIONS ON APPLICABILITY; EFFECTIVE DATE
Sec. 401. Application limited to interstate commerce.
Sec. 402. Effect on other law.
Sec. 403. Federal cause of action precluded.
Sec. 404. Effective date.
SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—The Congress finds that—
(1) the civil justice system, which is designed to
safeguard our most cherished rights, to remedy in-
justices, and to defend our liberty, is increasingly
being deployed to abridge our rights, create injus-
tice, and destroy our liberty;
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(2) our Nation is overly litigious, the civil jus-
tice system is overcrowded, sluggish, and excessively
costly, and the costs of lawsuits, both direct and in-
direct, are inflicting serious and unnecessary injury
on the national economy;
(3) excessive, unpredictable, and often arbitrary
damage awards and unfair allocations of liability
have a direct and undesirable effect on interstate
commerce by increasing the cost and decreasing the
availability of goods and services;
(4) the rules of law governing product liability
actions, damage awards, and allocations of liability
have evolved inconsistently within and among the
several States, resulting in a complex, contradictory,
and uncertain regime that is inequitable to both
plaintiffs and defendants and unduly burdens inter-
state commerce;
(5) as a result of excessive, unpredictable, and
often arbitrary damage awards and unfair alloca-
tions of liability, consumers have been adversely af-
fected through the withdrawal of products, produc-
ers, services, and service providers from the national
market, and from excessive liability costs passed on
to them through higher prices;
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(6) excessive, unpredictable, and often arbitrary
damage awards and unfair allocations of liability
jeopardize the financial well-being of many individ-
uals as well as entire industries, particularly the Na-
tion’s small businesses, and adversely affects govern-
ments, taxpayers, nonprofit entities and volunteer
organizations;
(7) the excessive costs of the civil justice system
undermine the ability of American companies to
compete internationally, and serve to decrease the
number of jobs and the amount of productive capital
in the national economy;
(8) the unpredictability of damage awards is in-
equitable to both plaintiffs and defendants and has
added considerably to the high cost of liability insur-
ance, making it difficult for producers, consumers,
and individuals to protect their liability with any de-
gree of confidence and at a reasonable cost;
(9) because of the national scope of the prob-
lems created by the defects in the civil justice sys-
tem, it is not possible for the several States to enact
laws that fully and effectively respond to those prob-
lems;
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(10) it is the constitutional role of the national
government to remove barriers to interstate com-
merce; and
(11) there is a need to restore rationality, cer-
tainty, and fairness to the civil justice system in
order to protect against excessive, arbitrary, and un-
certain damage awards and to reduce the volume,
costs, and delay of litigation.
(b) PURPOSES.—Based upon the powers contained in
Article I, Section 8, Clause 3 of the United States Con-
stitution, the purposes of this Act are to promote the free
flow of goods and services and to lessen burdens on inter-
state commerce by—
(1) establishing certain uniform legal principles
of product liability which provide a fair balance
among the interests of product users, manufactur-
ers, and product sellers;
(2) placing reasonable limits on damages over
and above the actual damages suffered by a claim-
ant;
(3) ensuring the fair allocation of liability in
civil actions;
(4) reducing the unacceptable costs and delays
of our civil justice system caused by excessive litiga-
tion which harm both plaintiffs and defendants; and
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(5) establishing greater fairness, rationality,
and predictability in the civil justice system.
TITLE I—PRODUCT LIABILITY
REFORM
SEC. 101. APPLICABILITY AND PREEMPTION.
(a) PREEMPTION.—This title governs any product li-
ability action brought in any State or Federal court, on
any theory for harm caused by a product. A civil action
brought for commercial loss shall be governed only by ap-
plicable commercial or contract law.
(b) RELATIONSHIP TO STATE LAW.—This title su-
persedes State law only to the extent that State law ap-
plies to an issue covered by this title. Any issue that is
not governed by this title shall be governed by otherwise
applicable State or Federal law.
SEC. 102. LIABILITY RULES APPLICABLE TO PRODUCT
SELLERS.
(a) GENERAL RULE.—Except as provided in sub-
section (b), in any product liability action, a product seller
other than a manufacturer shall be liable to a claimant
for harm only if the claimant establishes that—
(1)(A) the product which allegedly caused the
harm complained of was sold by the product seller;
(B) the product seller failed to exercise reasonable
care with respect to the product; and (C) such fail-
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ure to exercise reasonable care was a proximate
cause of the claimant’s harm; or
(2)(A) the product seller made an express war-
ranty applicable to the product which allegedly
caused the harm complained of, independent of any
express warranty made by a manufacturer as to the
same product; (B) the product failed to conform to
the warranty; and (C) the failure of the product to
conform to the warranty caused the claimant’s
harm; or
(3) the product seller engaged in intentional
wrongdoing as determined under applicable State
law and such intentional wrongdoing was a proxi-
mate cause of the harm complained of by the claim-
ant.
For purposes of paragraph (1)(B), a product seller shall
not be considered to have failed to exercise reasonable care
with respect to the product based upon an alleged failure
to inspect a product where there was no reasonable oppor-
tunity to inspect the product in a manner which would,
in the exercise of reasonable care, have revealed the aspect
of the product which allegedly caused the claimant’s harm.
(b) EXCEPTION.—In a product liability action, a
product seller shall be liable for harm to the claimant
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caused by such product as if the product seller were the
manufacturer of such product if—
(1) the manufacturer is not subject to service of
process under the laws of any State in which the ac-
tion might have been brought; or
(2) the court determines that the claimant
would be unable to enforce a judgment against the
manufacturer.
(c) RENTAL
AND LEASES.—Notwithstanding any
other provision of law, any person, except a person ex-
cluded from the definition of product seller, engaged in
the business of renting or leasing a product shall be sub-
ject to liability pursuant to subsection (a) of this section,
but shall not be liable to a claimant for the tortious act
of another solely by reason of ownership of such product.
SEC. 103. DEFENSE BASED ON CLAIMANT’S USE OF INTOXI-
CATING ALCOHOL OR DRUGS.
(a) GENERAL RULE.—In any product liability action,
it shall be a complete defense to such action if—
(1) the claimant was intoxicated or was under
the influence of intoxicating alcohol or any drug
when the accident or other event which resulted in
such claimant’s harm occurred; and
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(2) the claimant, as a result of the influence of
the alcohol or drug, was more than 50 percent re-
sponsible for such accident or other event.
(b) CONSTRUCTION.—For purposes of subsection
(a)—
(1) the determination of whether a person was
intoxicated or was under the influence of intoxicat-
ing alcohol or any drug shall be made pursuant to
applicable State law; and
(2) the term ‘‘drug’’ means any controlled sub-
stance as defined in the Controlled Substances Act
(21 U.S.C. 802(6)) that has been taken by the
claimant other than in accordance with the terms of
a lawfully issued prescription.
SEC. 104. MISUSE OR ALTERATION.
(a) GENERAL RULE.—In a product liability action,
the damages for which a defendant is otherwise liable
under State law shall be reduced by the percentage of re-
sponsibility for the claimant’s harm attributable to misuse
or alteration of a product by any person if the defendant
establishes by a preponderance of the evidence that such
percentage of the claimant’s harm was proximately caused
by—
(1) a use or alteration of a product in violation
of, or contrary to, a defendant’s express warnings or
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instructions if the warnings or instructions are ade-
quate as determined pursuant to applicable State
law, or
(2) a use or alteration of a product involving a
risk of harm which was known or should have been
known by the ordinary person who uses or consumes
the product with the knowledge common to the class
of persons who used or would be reasonably antici-
pated to use the product.
(b) WORKPLACE
INJURY.—Notwithstanding sub-
section (a), the damage for which a defendant is otherwise
liable under State law shall not be reduced by the percent-
age of responsibility for the claimant’s harm attributable
to misuse or alteration of the product by the claimant’s
employer or any co-employee who is immune from suit by
the claimant pursuant to the State law applicable to work-
place injuries.
SEC. 105. FRIVOLOUS PLEADINGS.
(a) GENERAL RULE.—
(1) SIGNING
OF
PLEADING.—The signing or
verification of a pleading in a product liability action
in a State court subject to this title constitutes a
certificate that to the signatory’s or verifier’s best
knowledge, information, and belief, formed after rea-
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ing of the pleading, including costs, reasonable at-
torney’s fees, witness fees, fees of experts, and depo-
sition expenses.
(e) CONSTRUCTION.—For purposes of this section—
(1) a general denial does not constitute a frivo-
lous pleading; and
(2) the amount requested for damages does not
constitute a frivolous pleading.
SEC. 106. STATUTE OF REPOSE.
(a) GENERAL RULE.—A product liability action shall
be barred unless the complaint is served and filed within
15 years of the date of delivery of the product to its first
purchaser or lessee, who was not engaged in the business
of selling or leasing the product or of using the product
as a component in the manufacture of another product.
(b) EXCEPTION.—Subsection (a)—
(1) does not bar a product liability action
against a defendant who made an express warranty
in writing as to the safety of the specific product in-
volved which was longer than 15 years, but it will
apply at the expiration of such warranty,
(2) does not apply to a physical illness the evi-
dence of which does not ordinarily appear less than
15 years after the first exposure to the product, and
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(3) does not affect the limitations period estab-
lished by the General Aviation Revitalization Act of
1994.
SEC. 107. FOREIGN PRODUCTS.
(a) GENERAL RULE.—In any product liability action
for injury that was sustained in the United States and
that relates to the purchase or use of a product manufac-
tured outside the United States by a foreign manufac-
turer, the Federal court in which such action is brought
shall have jurisdiction over such manufacturer if the man-
ufacturer knew or reasonably should have known that the
product would be imported for sale or use in the United
States.
(b) ADMISSION.—If in any product liability action a
foreign manufacturer of the product involved in such ac-
tion fails to furnish any testimony, document, or other
thing upon a duly issued discovery order by the court in
such action, such failure shall be deemed an admission of
any fact with respect to which the discovery order relates.
(c) PROCESS.—Process in an action described in sub-
section (a) may be served wherever the foreign manufac-
turer is located, has an agent, or transacts business.
SEC. 108. DEFINITIONS.
As used in this title:
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(1) The term ‘‘claimant’’ means any person who
brings a product liability action and any person on
whose behalf such an action is brought. If such an
action is brought through or on behalf of an estate,
the term includes the claimant’s decedent. If such
action is brought through or on behalf of a minor
or incompetent, the term includes the claimant’s
legal guardian.
(2) The term ‘‘commercial loss’’ means any loss
of or damage to a product itself incurred in the
course of the ongoing business enterprise consisting
of providing goods or services for compensation.
(3) The term ‘‘economic loss’’ means any pecu-
niary loss resulting from harm (including the loss of
earnings, medical expense loss, replacement services
loss, loss due to death, and burial costs) to the ex-
tent recovery for such loss is allowed under applica-
ble State law.
(4) The term ‘‘harm’’ means any physical in-
jury, illness, disease, or death or damage to property
caused by a product. The term does not include
commercial loss or loss or damage to a product it-
self.
(5) The term ‘‘manufacturer’’ means—
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(A) any person who is engaged in a busi-
ness to produce, create, make, or construct any
product (or component part of a product) and
who (i) designs or formulates the product (or
component part of the product), (ii) has en-
gaged another person to design or formulate
the product (or component part of the product),
or (iii) uses the design or formulation of the
product developed by another person;
(B) a product seller of the product who,
before placing the product in the stream of
commerce—
(i) designs or formulates or has en-
gaged another person to design or formu-
late an aspect of the product after the
product was initially made by another, or
(ii) produces, creates, makes, or con-
structs such aspect of the product, or
(C) any product seller not described in
subparagraph (B) which holds itself out as a
manufacturer to the user of the product.
(6) The term ‘‘noneconomic loss’’ means subjec-
tive, nonmonetary loss resulting from harm, includ-
ing pain, suffering, inconvenience, mental suffering,
emotional distress, loss of society and companion-
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ship, loss of consortium, injury to reputation, and
humiliation.
(7) The term ‘‘person’’ means any individual,
corporation, company, association, firm, partnership,
society, joint stock company, or any other entity (in-
cluding any governmental entity).
(8)(A) The term ‘‘product’’ means any object,
substance, mixture, or raw material in a gaseous,
liquid, or solid state which—
(i) is capable of delivery itself or as an as-
sembled whole, in a mixed or combined state, or
as a component part or ingredient;
(ii) is produced for introduction into trade
or commerce;
(iii) has intrinsic economic value; and
(iv) is intended for sale or lease to persons
for commercial or personal use.
(B) The term does not include—
(i) human tissue, human organs, human
blood, and human blood products; or
(ii) electricity, water delivered by a utility,
natural gas, or steam.
(9) The term ‘‘product liability action’’ means
a civil action brought on any theory for harm caused
by a product or product use.
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(10) The term ‘‘product seller’’ means a person
who, in the course of a business conducted for that
purpose, sells, distributes, rents, leases, prepares,
blends, packages, labels a product, is otherwise in-
volved in placing a product in the stream of com-
merce, or installs, repairs, or maintains the harm-
causing aspect of a product. The term does not in-
clude—
(A) a seller or lessor of real property;
(B) a provider of professional services in
any case in which the sale or use of a product
is incidental to the transaction and the essence
of the transaction is the furnishing of judg-
ment, skill, or services; or
(C) any person who—
(i) acts in only a financial capacity
with respect to the sale of a product; or
(ii) leases a product under a lease ar-
rangement in which the selection, posses-
sion, maintenance, and operation of the
product are controlled by a person other
than the lessor.
(11) The term ‘‘State’’ means any State of the
United States, the District of Columbia, Common-
wealth of Puerto Rico, the Northern Mariana Is-
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lands, the Virgin Islands, Guam, American Samoa,
and any other territory or possession of the United
States, or any political subdivision of any of the
foregoing.
TITLE II—LIMITATION ON SPEC-
ULATIVE 
AND 
ARBITRARY
DAMAGE AWARDS
SEC. 201. PUNITIVE DAMAGES AS PENALTY IN CIVIL AC-
TIONS.
(a) GENERAL RULE.—Punitive damages may, to the
extent permitted by applicable State law, be awarded in
any civil action for harm in any Federal or State court
against a defendant if the claimant establishes by clear
and convincing evidence that the harm suffered was result
of conduct—
(1) specifically intended to cause harm, or
(2) conduct manifesting a conscious, flagrant
indifference to the rights or safety of others.
(b) PROPORTIONAL AWARDS.—The amount of puni-
tive damages that may be awarded in any civil action sub-
ject to this title shall not exceed 3 times the amount of
damages awarded to the claimant for economic loss, or
$250,000, whichever is greater. This section shall be ap-
plied by the court and shall not be disclosed to the jury.
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(c) APPLICABILITY.—Except as provided in section
401, this section shall apply to any civil action brought
in any Federal or State court on any theory where punitive
damages are sought. This section does not create a cause
of action for punitive damages. This section does not pre-
empt or supersede any State or Federal law to the extent
that such law would further limit the award of punitive
damages.
(d) BIFURCATION.—At the request of any party, the
trier of fact shall consider in a separate proceeding wheth-
er punitive damages are to be awarded and the amount
of such award. If a separate proceeding is requested, evi-
dence relevant only to the claim of punitive damages, as
determined by applicable State law, shall be inadmissible
in any proceeding to determine whether compensatory
damages are to be awarded.
(e) CONSIDERATIONS.—In determining the amount
of punitive damages, the trier of fact shall consider all rel-
evant, admissible evidence, including—
(1) the severity of the harm caused by the con-
duct of the defendant,
(2) the duration of the conduct or any conceal-
ment of it by the defendant,
(3) the profitability of the specific conduct that
caused the harm to the defendant,
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(4) the number of products sold, the frequency
of services provided, or the type of activities con-
ducted by the defendant of the kind causing the
harm complained of by the claimant,
(5) awards of punitive damages to persons simi-
larly situated to the claimant,
(6) possibility of prospective awards of compen-
satory damages to persons similarly situated to the
claimant,
(7) any criminal penalties imposed on the de-
fendant as a result of the conduct complained of by
the claimant,
(8) the amount of any civil and administrative
fines and penalties assessed against the defendant as
a result of the conduct complained of by the claim-
ant, and
(9) whether the foregoing considerations have
been a factor in any prior proceeding involving the
defendant.
(f) DRUGS AND DEVICES.—
(1)(A) Punitive damages shall not be awarded
against a manufacturer or product seller of a drug
(as defined in section 201(g)(1) of the Federal
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C.
321(g)(1)) or medical device (as defined in section
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201(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)) which caused the claimant’s
harm where—
(i) such drug or device was subject to pre-
market approval by the Food and Drug Admin-
istration with respect to the safety of the for-
mulation or performance of the aspect of such
drug or device which caused the claimant’s
harm or the adequacy of the packaging or label-
ing of such drug or device, and such drug was
approved by the Food and Drug Administra-
tion; or
(ii) the drug is generally recognized as safe
and effective pursuant to conditions established
by the Food and Drug Administration and ap-
plicable regulations, including packaging and la-
beling regulations.
(B) Subparagraph (A) shall not apply in any
case in which the defendant, before or after pre-
market approval of a drug or device—
(i) intentionally and wrongfully withheld
from or misrepresented to the Food and Drug
Administration information concerning such
drug or device required to be submitted under
the Federal Food, Drug, and Cosmetic Act (21
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U.S.C. 301 et seq.) or section 351 of the Public
Health Service Act (42 U.S.C. 262) that is ma-
terial and relevant to the harm suffered by the
claimant, or
(ii) made an illegal payment to an official
or employee of the Food and Drug Administra-
tion for the purpose of securing or maintaining
approval of such drug or device.
(2) PACKAGING.—In a product liability action
for harm which is alleged to relate to the adequacy
of the packaging (or labeling relating to such pack-
aging) of a drug which is required to have tamper-
resistant packaging under regulations of the Sec-
retary of Health and Human Services (including la-
beling regulations related to such packaging), the
manufacturer of the drug shall not be held liable for
punitive damages unless the drug is found by the
court by clear and convincing evidence to be sub-
stantially out of compliance with such regulations.
SEC. 202. FAIR SHARE RULE FOR NONECONOMIC DAMAGE
AWARDS.
(a) FAIR SHARE OF LIABILITY IMPOSED ACCORDING
TO SHARE OF FAULT.—In any product liability or other
civil action brought in State or Federal court, a defendant
shall be liable only for the amount of noneconomic dam-
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ages attributable to such defendant in direct proportion
to such defendant’s share of fault or responsibility for the
claimant’s actual damages, as determined by the trier of
fact. In all such cases, the liability of a defendant for non-
economic damages shall be several and not joint.
(b) APPLICABILITY.—Except as provided in section
402, this section shall apply to any product liability or
other civil action brought in any Federal or State court
on any theory where noneconomic damages are sought.
This section does not preempt or supersede any State or
Federal law to the extent that such law would further limit
the application of the theory of joint liability to any kind
of damages.
SEC. 203. LIMITATION ON NONECONOMIC DAMAGES IN
HEALTH CARE LIABILITY ACTIONS.
(a) MAXIMUM
AWARD
OF
NONECONOMIC
DAM-
AGES.—In any health care liability action, in addition to
actual damages or punitive damages, or both, a claimant
may also be awarded noneconomic damages, including
damages awarded to compensate injured feelings, such as
pain and suffering and emotional distress. The maximum
amount of such damages that may be awarded to a claim-
ant shall be $250,000. Such maximum amount shall apply
regardless of the number of parties against whom the ac-
tion is brought, and regardless of the number of claims
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or actions brought with respect to the health care injury.
An award for future noneconomic damages shall not be
discounted to present value. The jury shall not be in-
formed about the limitation on noneconomic damages, but
an award for noneconomic damages in excess of $250,000
shall be reduced either before the entry of judgment or
by amendment of the judgment after entry. An award of
damages for noneconomic losses in excess of $250,000
shall be reduced to $250,000 before accounting for any
other reduction in damages required by law. If separate
awards of damages for past and future noneconomic dam-
ages are rendered and the combined award exceeds
$250,000, the award of damages for future noneconomic
losses shall be reduced first.
(b) APPLICABILITY.—Except as provided in section
401, this section shall apply to any health care liability
action brought in any Federal or State court on any theory
or pursuant to any alternative dispute resolution process
where noneconomic damages are sought. This section does
not create a cause of action for noneconomic damages.
This section does not preempt or supersede any State or
Federal law to the extent that such law would further limit
the award of noneconomic damages. This section does not
preempt any State law enacted before the date of the en-
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actment of this Act that places a cap on the total liability
in a health care liability action.
(c) DEFINITIONS.—As used in this section:
(1) The term ‘‘claimant’’ means any person who
asserts a health care liability claim or brings a
health care liability action, including a person who
asserts or claims a right to legal or equitable con-
tribution, indemnity or subrogation, arising out of a
health care liability claim or action, and any person
on whose behalf such a claim is asserted or such an
action is brought, whether deceased, incompetent or
a minor.
(2) The term ‘‘economic loss’’ has the same
meaning as defined at section 203(3).
(3) The term ‘‘health care liability action’’
means a civil action brought in a State or Federal
court or pursuant to any alternative dispute resolu-
tion process, against a health care provider, an en-
tity which is obligated to provide or pay for health
benefits under any health plan (including any person
or entity acting under a contract or arrangement to
provide or administer any health benefit), or the
manufacturer, distributor, supplier, marketer, pro-
moter, or seller of a medical product, in which the
claimant alleges a claim (including third party
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claims, cross claims, counter claims, or distribution
claims) based upon the provision of (or the failure
to provide or pay for) health care services or the use
of a medical product, regardless of the theory of li-
ability on which the claim is based, or the number
of plaintiffs, or defendants or causes of action.
SEC. 204. DEFINITIONS.
As used in this title:
(1) The term ‘‘actual damages’’ means damages
awarded to pay for economic loss.
(2) The term ‘‘claimant’’ means any person who
brings a civil action and any person on whose behalf
such an action is brought. If such action is brought
through or on behalf of an estate, the term includes
the claimant’s decedent. If such action is brought
through or on behalf of a minor or incompetent, the
term includes the claimant’s legal guardian.
(3) The term ‘‘clear and convincing evidence’’ is
that measure or degree of proof that will produce in
the mind of the trier of fact a firm belief or convic-
tion as to the truth of the allegations sought to be
established. The level of proof required to satisfy
such standard is more than that required under pre-
ponderance of the evidence, but less than that re-
quired for proof beyond a reasonable doubt.
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(4) The term ‘‘economic loss’’ means any pecu-
niary loss resulting from harm (including the loss of
earnings, medical expense loss, replacement services
loss, loss due to death, and burial costs), to the ex-
tent recovery for such loss is allowed under applica-
ble State law.
(5) The term ‘‘harm’’ means any legally cog-
nizable wrong or injury for which punitive damages
may be imposed.
(6) The term ‘‘noneconomic damages’’ means
damages other than punitive damages or actual
damages.
(7) The term ‘‘punitive damages’’ means dam-
ages awarded against any person or entity to punish
or deter such person or entity, or others, from en-
gaging in similar behavior in the future.
(8) The term ‘‘State’’ means any State of the
United States, the District of Columbia, Common-
wealth of Puerto Rico, the Northern Mariana Is-
lands, the Virgin Islands, Guam, American Samoa,
and any other territory or possession of the United
States, or any political subdivision of any of the
foregoing.
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TITLE III—BIOMATERIALS
SUPPLIERS
SEC. 301. LIABILITY OF BIOMATERIALS SUPPLIERS.
A biomaterials supplier may, to the extent required
and permitted by any other applicable law, be liable for
harm to a claimant caused by a medical device, only if
the claimant in a product liability action shows that the
conduct of the biomaterials supplier was an actual and
proximate cause of the harm to the claimant and—
(1) the raw materials or component parts deliv-
ered by the biomaterials supplier either—
(A) did not constitute the product de-
scribed in the contract between the biomaterials
supplier and the person who contracted for de-
livery of the product; or
(B) failed to meet any specifications that
were—
(i) provided to the biomaterials sup-
plier and not expressly repudiated by the
biomaterials supplier prior to acceptance of
delivery of the raw materials or component
parts;
(ii)(I) provided to the biomaterials
supplier;
HR 956 EH1S
(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 of Health and Human
Services and that is currently maintained
by the biomaterials supplier of purposes of
premarket approval of medical devices; or
(iii)(I) included in the submissions for
the purposes of premarket approval or re-
view by the Secretary of Health and
Human Services 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
(II) have received clearance from the
Secretary of Health and Human Services,
if such specifications were provided by the
manufacturer to the biomaterials supplier
and were not expressly repudiated by the
biomaterials supplier prior to the accept-
ance by the raw materials or component
parts;
(2) the biomaterials supplier intentionally and
wrongfully withheld or misrepresented information
HR 956 EH1S
TITLE IV—LIMITATIONS ON AP-
PLICABILITY; 
EFFECTIVE
DATE
SEC. 401. APPLICATION LIMITED TO INTERSTATE COM-
MERCE.
Titles I, II, and III shall apply only to product liabil-
ity or other civil actions affecting interstate commerce.
For purposes of the preceding sentence, the term ‘‘inter-
state commerce’’ means commerce among the several
States or with foreign nations, or in any territory of the
United States or in the District of Columbia, or between
any such territory and another, or between any such terri-
tory and any State or foreign nation, or between the Dis-
trict of Columbia and any State or territory or foreign
nation.
SEC. 402. EFFECT ON OTHER LAW.
Nothing in title I, II, or III shall be construed to—
(1) waive or affect any defense of sovereign im-
munity asserted by any State under any law;
(2) supersede any Federal law;
(3) waive or affect any defense of sovereign im-
munity asserted by the United States;
(4) affect the applicability of any provision of
chapter 97 of title 28, United States Code;