I
104TH CONGRESS
1ST SESSION
H. R. 1075
To establish legal standards and procedures for product liability litigation,
and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 28, 1995
Mr. HYDE (for himself and Mr. BLILEY) introduced the following bill; which
was referred to the Committee on the Judiciary and, in addition, to the
Committee on Commerce, for a period to be subsequently determined by
the Speaker, in each case for consideration of such provisions as fall with-
in the jurisdiction of the committee concerned
A BILL
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’’.
(b) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title and table of contents.
TITLE I—PRODUCT LIABILITY REFORM
Sec. 101. Findings and purposes.
Sec. 102. Applicability and preemption.
Sec. 103. Liability rules applicable to product sellers.
Sec. 104. Defense based on claimant’s use of intoxicating alcohol or drugs.
Sec. 105. Misuse or alteration.
Sec. 106. Frivolous pleadings.
Sec. 107. Several liability for noneconomic loss.
Sec. 108. Statute of repose.
Sec. 109. Service of process.
Sec. 110. Definitions.
TITLE II—PUNITIVE DAMAGES REFORM
Sec. 201. Punitive damages.
Sec. 202. 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—EFFECT ON OTHER LAW; EFFECTIVE DATE
Sec. 401. Effect on other law.
Sec. 402. Federal cause of action precluded.
Sec. 403. Effective date.
TITLE I—PRODUCT LIABILITY
REFORM
SEC. 101. FINDINGS AND PURPOSES.
(a) FINDINGS.—The Congress finds that—
(1) the manufacture and distribution of goods
in interstate commerce is to a large extent a na-
tional activity which affects national interests in a
variety of important ways;
(2) in recent years, the free flow of products in
interstate commerce has been increasingly burdened
by product liability law;
(3) as a result of this burden, consumers have
been adversely affected through the withdrawal of
products and producers from the national market,
and from excessive liability costs passed on to them
through higher prices;
(4) the rules of product liability law in recent
years have evolved rapidly and inconsistently within
and among the several States, such that the body of
product liability law prevailing in this nation today
is complex, contradictory, and uncertain;
(5) the unpredictability of product liability
awards and doctrines are inequitable to both plain-
tiffs and defendants and have added considerably to
the high cost of liability insurance, making it dif-
ficult for producers and insurers to protect their li-
ability with any degree of confidence;
(6) product liability actions and punitive dam-
age awards jeopardize the financial well-being of
many industries and are a particular threat to the
viability of the nation’s small businesses;
(7) the extraordinary costs of the product liabil-
ity system undermine the ability of American indus-
try to compete internationally, and is costing the
loss of jobs and productive capital; and
(8) because of the national scope of the manu-
facture and distribution of most products, it is not
possible for the individual states to enact laws that
fully and effectively respond to these problems.
(b) PURPOSES.—Based upon the powers contained in
Article I, clause 3 of the United States Constitution, the
purposes of this title are to promote the free flow of goods
in interstate commerce—
(1) by establishing certain uniform legal prin-
ciples which provide a fair balance between the inter-
ests of product users, manufacturers, and product
sellers,
(2) by placing reasonable limits on product li-
ability law,
(3) by ensuring that product liability law oper-
ates to compensate persons injured by the wrong-
doing of others,
(4) by reducing the unacceptable transactions
costs and delays which harm both plaintiffs and de-
fendants,
(5) by allocating responsibility for harm to
those in the best position to prevent such harm, and
(6) by establishing greater predictability in
product liability actions.
SEC. 102. 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. 103. 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-
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
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.
SEC. 104. 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
(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. 105. MISUSE OR ALTERATION.
(a) GENERAL RULE.—Except as provided in sub-
section (c), in a product liability action, the damages for
which a defendant is otherwise liable under State law shall
be reduced by the percentage of responsibility 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, the defendant’s express warnings
or instructions if the warnings or instructions are
adequate 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. 106. 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-
sonable inquiry, the pleading is not frivolous as de-
termined under paragraph (2).
(2) DEFINITIONS.—
(A) For purposes of this section, a plead-
ing is frivolous if the pleading is—
(i) groundless and brought in bad
faith;
(ii) groundless and brought for the
purpose of harassment; or
(iii) groundless and interposed for any
improper purpose, such as to cause unnec-
essary delay or needless increase in the
cost of litigation.
(B) For purposes of subparagraph (A), the
term ‘‘groundless’’ means—
(i) no basis in fact; or
sanction on the signatory or verifier of the pleading. The
sanction may include one or more of the following:
(1) the striking of a pleading or the offending
portion thereof;
(2) the dismissal of a party; or
(3) an order to pay to a party who stands in
opposition to the offending pleading the amounts of
the reasonable expenses incurred because of the fil-
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. 107. SEVERAL LIABILITY FOR NONECONOMIC LOSS.
In any product liability action, the liability of each
defendant for noneconomic loss shall be several only and
shall not be joint. Each defendant shall be liable only for
the amount of noneconomic loss attributable to such de-
fendant in direct proportion to such defendant’s propor-
tionate share of fault or responsibility for the claimant’s
harm, as determined by the trier of fact.
SEC. 108. 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.
This subsection shall apply only if the court determines
that the claimant has received or would be eligible to re-
ceive full compensation from any source for medical ex-
pense losses.
(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
(3) does not affect the limitations period estab-
lished by the General Aviation Revitalization Act of
1994.
SEC. 109. SERVICE OF PROCESS.
This title shall not apply to a product liability action
unless the manufacturer of the product or component part
has appointed an agent in the United States for service
of process from anywhere in the United States.
SEC. 110. DEFINITIONS.
As used in this title:
(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—
(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-
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.
(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-
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—PUNITIVE DAMAGES
REFORM
SEC. 201. PUNITIVE DAMAGES.
(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 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 the economic loss
on which the claimant’s action is based, or $250,000,
whichever is greater.
(c) APPLICABILITY AND PREEMPTION.—Except as
provided in section 401, this title shall apply to any civil
action brought in any Federal or State court on any theory
where punitive damages are sought. This title does not
create a cause of action for punitive damages in any juris-
diction that does not authorize such actions.
(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) CONSIDERATION.—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,
(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.
SEC. 202. DEFINITIONS.
As used in this title:
(1) 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.
(2) 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.
(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 legally cog-
nizable wrong or injury for which punitive damages
may be imposed.
(5) 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.
(6) 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.
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;
(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
that is material and relevant to the harm suffered
by the claimant; or
(3) the biomaterials supplier had actual knowl-
edge of prospective fraudulent or malicious activities
in the use of its supplies where such activities are
relevant to the harm suffered by the claimant.
SEC. 302. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS
AGAINST BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—
(1) GENERAL RULE.—Any biomaterials supplier
who is a defendant in any product liability action in-
volving a medical device which allegedly caused the
harm for which the action is brought and who did
not take part in the design, manufacture, or sale of
such medical device may, at any time during which
a motion to dismiss may be filed under an applicable
law, move to dismiss the action on the grounds
that—
(A) the claimant has failed to establish
that the supplier furnished raw materials or
component parts in violation of applicable con-
tractual requirements or specifications agreed
to by the biomaterials supplier; or
(B) the claimant has failed to comply with
the requirements of subsection (b).
(2) EXCEPTION.—The biomaterials supplier
may not move to dismiss the action if—
(A) the biomaterials supplier intentionally
and wrongfully withheld or misrepresented in-
formation that is material and relevant to the
harm suffered by the claimant; or
(B) the biomaterials supplier had actual
knowledge of prospective fraudulent or mali-
cious activities in the use of its supplies where
such activities are relevant to the harm suffered
by the claimant.
(b) MANUFACTURER OF MEDICAL DEVICE SHALL BE
NAMED A PARTY.—The claimant shall be required to
name the manufacturer of the medical device to which the
biomaterials supplier furnished raw materials or compo-
nent parts as a party to the product liability action, un-
less—
(1) the manufacturer is subject to service of
process solely in a jurisdiction in which the
biomaterials supplier is not domiciled or subject to
a service of process; or
(2) an action against the manufacturer is
barred by applicable law.
(c) PROCEEDINGS ON MOTION TO DISMISS.—The fol-
lowing rules shall apply to any proceeding on a motion
to dismiss filed under this section:
(1) AFFIDAVITS RELATING TO STATUS OF DE-
FENDANT.—
(A) DEFENDANT AFFIDAVIT.—The defend-
ant in the action may support a motion to dis-
miss by filing an affidavit demonstrating that
defendant is a biomaterials supplier and that it
is neither the manufacturer nor the product
seller of the medical device which caused the
harm alleged by the claimant.
(B) RESPONSE TO MOTION TO DISMISS.—
In response to a motion to dismiss described in
this section, the claimant may submit an affida-
vit demonstrating why it asserts that—
(i) the defendant who filed the motion
to dismiss is not a biomaterials supplier
with respect to the medical device which
caused the harm alleged by the claimant;
(ii) on what basis it asserts that the
supplier furnished raw materials or compo-
nent parts in violation of applicable con-
tractual requirements or specifications
agreed to by the biomaterials supplier;
(iii) the biomaterials supplier inten-
tionally and wrongfully withheld or mis-
represented information that is material
and relevant to the harm suffered by the
claimant; or
(iv) the biomaterials supplier had ac-
tual knowledge of prospective fraudulent or
malicious activities in the use of its sup-
plies where such activities are relevant to
the harm suffered by the claimant.
(2) EFFECT OF MOTION TO DISMISS ON DIS-
COVERY.—If a defendant files a motion to dismiss,
no discovery shall be permitted in connection with
the action that is the subject of the motion, unless
the affidavits submitted in accordance with this
section raise material issues of fact concerning
whether—
(A) the supplier furnished raw materials or
component parts in violation of applicable con-
tractual requirements or specifications agreed
to by the biomaterials supplier;
(B) the biomaterials supplier intentionally
and wrongfully withheld or misrepresented in-
formation that is material and relevant to the
harm suffered by the claimant; or
(C) the biomaterials supplier had actual
knowledge of prospective fraudulent or mali-
cious activities in the use of its supplies where
such activities are relevant to the harm suffered
by the claimant.
Any such discovery shall be limited solely to such
material facts.
(3) RESPONSE TO MOTION TO DISMISS.—The
court shall rule on the motion to dismiss solely on
the basis of the affidavits filed under this section
and on the basis of any evidence developed in the
course of discovery under paragraph (2) and subse-
quently submitted to the court in accordance with
applicable rules of evidence.
(d) ATTORNEY FEES.—The court shall require the
claimant to compensate the biomaterials supplier for at-
torney fees and costs, if—
(1) 
the 
claimant 
named 
or 
joined 
the
biomaterials supplier; and
(2) the court found the claim against the
biomaterials supplier to be without merit and frivo-
lous.
SEC. 303. DEFINITIONS.
For purposes of this title:
(1) The term ‘‘biomaterials supplier’’ means an
entity that directly or indirectly supplies, or licenses
another person to supply, a component part or raw
material for use in the manufacture of a medical de-
vice—
(A) that is intended by the manufacturer
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 of internal human tissue through a
surgically produced opening for a period of
less than 30 days; and
(B) suture materials used in implant pro-
cedures.
(2) Notwithstanding paragraph (1), the term
‘‘biomaterials supplier’’ excludes any person, with re-
spect to a medical device which is the subject of a
product liability action—
(A) who is engaged in the manufacture,
preparation, 
propagation, 
compounding, 
or
processing (as defined in section 510(a)(1) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(a)(1)) of the medical device, and
has registered with the Secretary of Health and
Human Services 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 has included the medical de-
vice on a list of devices filed with the Secretary
of Health and Human Services pursuant to sec-
tion 510(j) of such Act (21 U.S.C. 360(j)) and
the regulations issued under such section; or
(B) who, in the course of a business con-
ducted for that purpose, has sold, distributed,
leased, packaged, labeled, or otherwise placed
the implant in the stream of commerce after it
was manufactured.
(3) 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.
(4) The term ‘‘product liability action’’ means
a civil action brought on any theory for harm caused
by a product or product use.
TITLE IV—EFFECT ON OTHER
LAW; EFFECTIVE DATE
SEC. 401. 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;
(5) preempt State choice-of-law rules with re-
spect to claims brought by a foreign nation or a citi-
zen of a foreign nation; or
(6) affect the right of any court to transfer
venue or to apply the law of a foreign nation or to
dismiss a claim of a foreign nation or of a citizen
of a foreign nation on the ground of inconvenient
forum.
SEC. 402. FEDERAL CAUSE OF ACTION PRECLUDED.
The district courts of the United States shall not
have jurisdiction pursuant to this Act based on section
1331 or 1337 of title 28, United States Code.
SEC. 403. EFFECTIVE DATE.
Titles I, II, and III shall apply with respect to actions
which are commenced after the date of the enactment of
this Act.
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HR 1075 IH——2