S5606 CONGRESSIONAL RECORD— SENATE April 24, 1995 

SIMON] and the Senator from California 

[Mrs. FEINSTEIN] were added as cosponsors of Senate Resolution 97, a resolution expressing the sense of the Senate 

with respect to peace and stability in 

the South China Sea. 

AMENDMENT NO. 568

At the request of Mr. WARNER the 

names of the Senator from North Carolina [Mr. HELMS] and the Senator from 

Michigan [Mr. ABRAHAM] were added as 

cosponsors of amendment No. 568 intended to be proposed to S. 383, a bill to 

provide for the establishment of policy 

on the deployment by the United 

States of an antiballistic missile system and of advanced theater missile 

defense systems. 

f 

SENATE RESOLUTION 110—CONDEMNING THE BOMBING IN 

OKLAHOMA CITY 

Mr. NICKLES (for himself, Mr. 

INHOFE, Mr. DOLE, Mr. DASCHLE, Mr. 

HELMS, Mr. BROWN, Mr. SMITH, Mrs. 

FEINSTEIN, Mr. DODD, Mr. BYRD, Mr. 

CONRAD, Mr. FORD, Mr. KOHL, Ms. 

MOSELEY-BRAUN, Mrs. MURRAY, Mr. 

ROBB, Mr. ROCKEFELLER, Mr. 

LIEBERMAN, Mr. ABRAHAM, Mr. 

ASHCROFT, Mr. BENNETT, Mr. BOND, Mr. 

BURNS, Mr. CAMPBELL, Mr. CHAFEE, Mr. 

COATS, Mr. COCHRAN, Mr. COHEN, Mr. 

COVERDELL, Mr. CRAIG, Mr. D’AMATO, 

Mr. DEWINE, Mr. DOMENICI, Mr. FAIRCLOTH, Mr. FRIST, Mr. GORTON, Mr. 

GRAMM, Mr. GRAMS, Mr. GRASSLEY, Mr. 

GREGG, Mrs. HUTCHISON, Mr. JEFFORDS, 

Mrs. KASSEBAUM, Mr. KEMPTHORNE, Mr. 

KYL, Mr. LOTT, Mr. LUGAR, Mr. MACK, 

Mr. MCCAIN, Mr. MCCONNELL, Mr. MURKOWSKI, Mr. PACKWOOD, Mr. PRESSLER, 

Mr. ROTH, Mr. SANTORUM, Mr. SHELBY, 

Mr. SIMPSON, Ms. SNOWE, Mr. SPECTER, 

Mr. STEVENS, Mr. THOMAS, Mr. THOMPSON, Mr. THURMOND, and Mr. WARNER) 

submitted the following resolution; 

which was considered: 

S. RES. 110 

Whereas, on Wednesday, April 19, 1995, a 

car bomb exploded outside the Alfred P. 

Murrah Federal Building in Oklahoma City, 

Oklahoma, collapsing the north face of this 

nine-story concrete building, killing and injuring innocent and defenseless children and 

adults; 

Whereas, authorities are calling this the 

deadliest terrorist attack ever on U.S. soil; 

Whereas, federal law authorizes the imposition of the death penalty for terrorist murder; and, 

Whereas, additional anti-terrorism measures are now pending for consideration in the 

United States Senate: Now, therefore, be it 

Resolved, That the Senate of the United 

States: 

(1) Condemns, in the strongest possible 

terms, the heinous bombing attack against 

innocent children and adults at the Alfred P. 

Murrah Federal Building in Oklahoma City; 

(2) Sends its heartfelt condolences to the 

families, friends, and loved ones of those 

whose lives were taken away by this abhorrent and cowardly act; and expresses its 

hopes for the rapid and complete recovery of 

those wounded in the bombing; 

(3) Applauds all those courageous rescue 

and volunteer workers who are giving unselfishly of themselves and commends all law 

enforcement officials who are working determinedly to bring the perpetrators to justice; 

(4) Supports the President’s and the United 

States Attorney General’s position that federal prosecutors will seek the maximum penalty allowed by law, including the death penalty, for those responsible; 

(5) Commends the rapid actions taken by 

the President to provide assistance to the 

victims of the explosion and for promptly beginning an investigation to find the perpetrators of this crime, and it urges the 

President to use all necessary means to continue this effort until the perpetrators and 

their accomplices are found and appropriately punished; 

(6) Will expeditiously approve legislation 

to strengthen the authority and resources of 

all federal agencies involved in combating 

such acts of terrorism. 

f 

AMENDMENTS SUBMITTED 

COMMONSENSE PRODUCT 

LIABILITY REFORM ACT 

GORTON (AND OTHERS) 

AMENDMENT NO. 596 

Mr. GORTON (for himself, Mr. 

ROCKEFELLER, Mr. MCCONNELL, Mr. 

LIEBERMAN, Mr. DODD, Mr. PRESSLER, 

Mr. HATCH, Mr. EXON, Mr. INHOFE, Mrs. 

HUTCHISON, Mr. CHAFEE, Mr. HATFIELD, 

Mr. LUGAR, and Mr. FRIST) proposed an 

amendment to the bill (H.R. 956) to establish legal standards and procedures 

for product liability litigation, and for 

other purposes; as follows: 

Strike all after the enacting clause and insert in lieu thereof, the following: 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Product Liability Fairness Act of 1995’’. 

TITLE I—PRODUCT LIABILITY 

SEC. 101. DEFINITIONS. 

For purposes of this Act, the following 

definitions shall apply: 

(1) CLAIMANT.—The term ‘‘claimant’’

means any person who brings a product liability action and any person on whose behalf such an action is brought. If an action is 

brought through or on behalf of—

(A) an estate, the term includes the decedent; or 

(B) a minor or incompetent, the term includes the legal guardian of the minor or incompetent. 

(2) CLAIMANT’S BENEFITS.—The term 

‘‘claimant’s benefits’’ means an amount 

equal to the sum of—

(A) the amount paid to an employee as 

workers’ compensation benefits; and 

(B) the present value of all workers’ compensation benefits to which the employee is 

or would be entitled at the time of the determination of the claimant’s benefits, as determined by the appropriate workers’ compensation authority for harm caused to an 

employee by a product. 

(3) CLEAR AND CONVINCING EVIDENCE.—

(A) IN GENERAL.—Subject to subparagraph 

(A), the term ‘‘clear and convincing evidence’’ is that measure of degree of proof 

that will produce in the mind of the trier of 

fact a firm belief or conviction as to the 

truth of the allegations sought to be established. 

(B) DEGREE OF PROOF.—The degree of proof 

required to satisfy the standard of clear and 

convincing evidence shall be—

(i) greater than the degree of proof required to meet the standard of preponderance of the evidence; and 

(ii) less than the degree of proof required 

to meet the standard of proof beyond a reasonable doubt. 

(4) COMMERCIAL LOSS.—The term ‘‘commercial loss’’ means any loss or damage to a 

product itself, loss relating to a dispute over 

its value, or consequential economic loss the 

recovery of which is governed by the Uniform Commercial Code or analogous State 

commercial law, not including harm. 

(5) DURABLE GOOD.—The term ‘‘durable 

good’’ means any product, or any component 

of any such product, which has a normal life 

expectancy of 3 or more years or is of a character subject to allowance for depreciation 

under the Internal Revenue Code of 1986, and 

which is—

(A) used in a trade or business; 

(B) held for the production of income; or 

(C) sold or donated to a governmental or 

private entity for the production of goods, 

training, demonstration, or any other similar purpose. 

(6) ECONOMIC LOSS.—The term ‘‘economic 

loss’’ means any pecuniary loss resulting 

from harm (including any medical expense 

loss, work loss, replacement services loss, 

loss due to death, burial costs, and loss of 

business or employment opportunities), to 

the extent that recovery for the loss is permitted under applicable State law. 

(7) HARM.—The term ‘‘harm’’ means any 

physical injury, 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 itself. 

(8) INSURER.—The term ‘‘insurer’’ means 

the employer of a claimant, if the employer 

is self-insured, or the workers’ compensation 

insurer of an employer. 

(9) MANUFACTURER.—The term ‘‘manufacturer’’ means—

(A) any person who is engaged in a business to produce, create, make, or construct 

any product (or component part of a product), and who designs or formulates the product (or component part of the product), or 

has engaged another person to design or formulate the product (or component part of 

the product); 

(B) a product seller, but only with respect 

to those aspects of a product (or component 

part of a product) which are created or affected when, before placing the product in 

the stream of commerce, the product seller 

produces, creates, makes, constructs, designs, or formulates, or has engaged another 

person to design or formulate, an aspect of a 

product (or component part of a product) 

made by another person; or 

(C) any product seller that is not described 

in subparagraph (B) that holds itself out as a 

manufacturer to the user of the product. 

(10) NONECONOMIC LOSS.—The term ‘‘noneconomic loss’’—

(A) means subjective, nonmonetary loss resulting from harm, including pain, suffering, 

inconvenience, mental suffering, emotional 

distress, loss of society and companionship, 

loss of consortium, injury to reputation, and 

humiliation; and 

(B) does not include economic loss. 

(11) PERSON.—The term ‘‘person’’ means 

any individual, corporation, company, association, firm, partnership, society, joint 

stock company, or any other entity (including any governmental entity). 

(12) PRODUCT.—

(A) IN GENERAL.—The term ‘‘product’’

means any object, substance, mixture, or 

raw material in a gaseous, liquid, or solid 

state that—

(i) is capable of delivery itself or as an assembled whole, in a mixed or combined 

state, or as a component part or ingredient; 

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April 24, 1995 CONGRESSIONAL RECORD— SENATE S5607 

(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) EXCLUSION.—The term ‘‘product’’ does 

not include—

(i) tissue, organs, blood, and blood products 

used for therapeutic or medical purposes, except to the extent that such tissue, organs, 

blood, and blood products (or the provision 

thereof) are subject, under applicable State 

law, to a standard of liability other than 

negligence; and 

(ii) electricity, water delivered by a utility, natural gas, or steam. 

(13) PRODUCT LIABILITY ACTION.—The term 

‘‘product liability action’’ means a civil action brought on any theory for harm caused 

by a product. 

(14) PRODUCT SELLER.—

(A) IN GENERAL.—The term ‘‘product seller’’ means a person who—

(i) in the course of a business conducted for 

that purpose, sells, distributes, rents, leases, 

prepares, blends, packages, labels, or otherwise is involved in placing a product in the 

stream of commerce; or 

(ii) installs, repairs, refurbishes, reconditions, or maintains the harm-causing aspect 

of the product. 

(B) EXCLUSION.—The term ‘‘product seller’’

does not include—

(i) a seller or lessor of real property; 

(ii) a provider of professional services in 

any case in which the sale or use of a product is incidental to the transaction and the 

essence of the transaction is the furnishing 

of judgment, skill, or services; or 

(iii) 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 arrangement in which the lessor does not initially 

select the leased product and does not during 

the lease term ordinarily control the daily 

operations and maintenance of the product. 

(15) STATE.—The term ‘‘State’’ means each 

of the several States of the United States, 

the District of Columbia, the Commonwealth 

of Puerto Rico, the Virgin Islands, Guam, 

American Samoa, and the Commonwealth of 

the Northern Mariana Islands, and any other 

territory or possession of the United States, 

or any political subdivision thereof. 

(16) TIME OF DELIVERY.—The term ‘‘time of 

delivery’’ means the time when a product is 

delivered to the first purchaser or lessee of 

the product that was not involved in manufacturing or selling the product, or using the 

product as a component part of another 

product to be sold. 

SEC. 102. APPLICABILITY; PREEMPTION. 

(a) APPLICABILITY.—

(1) ACTIONS COVERED.—Subject to paragraph (2), this title applies to any product liability action commenced on or after the 

date of enactment of this Act, without regard to whether the harm that is the subject 

of the action or the conduct that caused the 

harm occurred before such date of enactment. 

(2) ACTIONS EXCLUDED.—

(A) ACTIONS FOR DAMAGE TO PRODUCT OR

COMMERCIAL LOSS.—A civil action brought for 

loss or damage to a product itself or for commercial loss, shall not be subject to the provisions of this title governing product liability actions, but shall be subject to any applicable commercial or contract law. 

(B) ACTIONS FOR NEGLIGENT ENTRUSTMENT.—A civil action for negligent entrustment shall not be subject to the provisions of 

this title governing product liability actions, 

but shall be subject to any applicable State 

law. 

(b) SCOPE OF PREEMPTION.—

(1) IN GENERAL.—This Act supersedes a 

State law only to the extent that State law 

applies to an issue covered under this title. 

(2) ISSUES NOT COVERED UNDER THIS ACT.—

Any issue that is not covered under this 

title, including any standard of liability applicable to a manufacturer, shall not be subject to this title, but shall be subject to applicable Federal or State law. 

(c) STATUTORY CONSTRUCTION.—Nothing in 

this title may be construed to—

(1) waive or affect any defense of sovereign 

immunity asserted by any State under any 

law; 

(2) supersede any Federal law; 

(3) waive or affect any defense of sovereign 

immunity 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 

respect to claims brought by a foreign nation 

or a citizen of a foreign nation; 

(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; or 

(7) supersede or modify any statutory or 

common law, including any law providing for 

an action to abate a nuisance, that authorizes a person to institute an action for civil 

damages or civil penalties, cleanup costs, injunctions, restitution, cost recovery, punitive damages, or any other form of relief for 

remediation of the environment (as defined 

in section 101(8) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, 42 U.S.C. 9601(8)) or the 

threat of such remediation. 

(d) CONSTRUCTION.—To promote uniformity 

of law in the various jurisdictions, this title 

shall be construed and applied after consideration of its legislative history. 

(e) EFFECT OF COURT OF APPEALS DECISIONS.—Notwithstanding any other provision 

of law, any decision of a circuit court of appeals interpreting a provision of this title 

(except to the extent that the decision is 

overruled or otherwise modified by the Supreme Court) shall be considered a controlling precedent with respect to any subsequent decision made concerning the interpretation of such provision by any Federal or 

State court within the geographical boundaries of the area under the jurisdiction of the 

circuit court of appeals. 

SEC. 103. ALTERNATIVE DISPUTE RESOLUTION 

PROCEDURES. 

(a) IN GENERAL.—

(1) SERVICE OF OFFER.—A claimant or a defendant in a product liability action that is 

subject to this title may, not later than 60 

days after the service of the initial complaint of the claimant or the applicable 

deadline for a responsive pleading (whichever 

is later), serve upon an adverse party an 

offer to proceed pursuant to any voluntary, 

nonbinding alternative dispute resolution 

procedure established or recognized under 

the law of the State in which the product liability action is brought or under the rules 

of the court in which such action is maintained. 

(2) WRITTEN NOTICE OF ACCEPTANCE OR REJECTION.—Except as provided in paragraph 

(3), not later than 10 days after the service of 

an offer to proceed under paragraph (1), an 

offeree shall file a written notice of acceptance or rejection of the offer. 

(3) EXTENSION.—The court may, upon motion by an offeree made prior to the expiration of the 10-day period specified in paragraph (2), extend the period for filing a written notice under such paragraph for a period 

of not more than 60 days after the date of expiration of the period specified in paragraph 

(2). Discovery may be permitted during such 

period. 

(b) DEFENDANT’S PENALTY FOR UNREASONABLE REFUSAL.—

(1) IN GENERAL.—The court shall assess reasonable attorney’s fees (calculated in accordance with paragraph (2)) and costs against 

the offeree, incurred by the offeror during 

trial if—

(A) a defendant as an offeree refuses to proceed pursuant to the alternative dispute resolution procedure referred to subsection 

(a)(1); 

(B) final judgment is entered against the 

defendant for harm caused by the product 

that is the subject of the action; and 

(C) the refusal by the defendant to proceed 

pursuant to such alternative dispute resolution was unreasonable or not made in good 

faith. 

(2) REASONABLE ATTORNEY’S FEES.—For 

purposes of this subsection, a reasonable attorney’s fee shall be calculated on the basis 

of an hourly rate, which shall not exceed the 

hourly rate that is considered acceptable in 

the community in which the attorney practices law, taking into consideration the 

qualifications and experience of the attorney 

and the complexity of the case. 

(c) GOOD FAITH REFUSAL.—In determining 

whether the refusal of an offeree to proceed 

pursuant to the alternative dispute procedure referred to in subsection (a)(1) was unreasonable or not made in good faith, the 

court shall consider—

(1) whether the case involves potentially 

complicated questions of fact; 

(2) whether the case involves potentially 

dispositive issues of law; 

(3) the potential expense faced by the 

offeree in retaining counsel for both the alternative dispute resolution procedure and 

to litigate the matter for trial; 

(4) the professional capacity of available 

mediators within the applicable geographic 

area; and 

(5) such other factors as the court considers appropriate. 

SEC. 104. LIABILITY RULES APPLICABLE TO 

PRODUCT SELLERS. 

(a) GENERAL RULE.—

(1) IN GENERAL.—In any product liability 

action that is subject to this title filed by a 

claimant for harm caused by a product, a 

product seller other than a manufacturer 

shall be liable to a claimant, only if the 

claimant establishes—

(A) that—

(i) the product that allegedly caused the 

harm that is the subject of the complaint 

was sold, rented, or leased by the product 

seller; 

(ii) the product seller failed to exercise 

reasonable care with respect to the product; 

and 

(iii) the failure to exercise reasonable care 

was a proximate cause of harm to the claimant; or 

(B) that—

(i) the product seller made an express warranty applicable to the product that allegedly caused the harm that is the subject of 

the complaint, independent of any express 

warranty made by a manufacturer as to the 

same product; 

(ii) the product failed to conform to the 

warranty; and 

(iii) the failure of the product to conform 

to the warranty caused harm to the claimant; or 

(C) that—

(i) the product seller engaged in intentional wrongdoing, as determined under applicable State law; and 

(ii) such intentional wrongdoing was a 

proximate cause of the harm that is the subject of the complaint. 

(2) REASONABLE OPPORTUNITY FOR INSPECTION.—For purposes of paragraph (1)(A)(ii), a 

product seller shall not be considered to have 

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S5608 CONGRESSIONAL RECORD— SENATE April 24, 1995 

failed to exercise reasonable care with respect to a product based upon an alleged failure to inspect a product if the product seller 

had no reasonable opportunity to inspect the 

product that allegedly caused harm to the 

claimant. 

(b) SPECIAL RULE.—A product seller shall 

be deemed to be liable as a manufacturer of 

a product for harm caused by the product 

if—

(1) the manufacturer is not subject to service of process under the laws of any State in 

which the action may be brought; or 

(2) the court determines that the claimant 

would be unable to enforce a judgment 

against the manufacturer. 

(c) RENTED OR LEASED PRODUCTS.—

(1) Notwithstanding any other provision of 

law, any person engaged in the business of 

renting or leasing a product (other than a 

person excluded from the definition of product seller under section 101(14)(B)) shall be 

subject to liability in a product liability action under subsection (a), but shall not be 

liable to a claimant for the tortious act of 

another solely by reason of ownership of 

such product. 

(2) For purposes of paragraph (1), and for 

determining the applicability of this title to 

any person subject to paragraph (1), the term 

‘‘product liability action’’ means a civil action brought on any theory for harm caused 

by a product or product use. 

SEC. 105. DEFENSES INVOLVING INTOXICATING 

ALCOHOL OR DRUGS. 

(a) GENERAL RULE.—Notwithstanding any 

other provision of law, a defendant in a product liability action that is subject to this 

title shall have a complete defense in the action if the defendant proves that—

(1) the claimant was under the influence of 

intoxicating alcohol or any drug that may 

not lawfully be sold over-the-counter without a prescription, and was not prescribed by 

a physician for use by the claimant; and 

(2) the claimant, as a result of the influence of the alcohol or drug, was more than 50 

percent responsible for the accident or event 

which resulted in the harm to the claimant. 

(b) CONSTRUCTION.—For purposes of this 

section, the determination of whether a person was intoxicated or was under the influence of intoxicating alcohol or any drug 

shall be made pursuant to applicable State 

law. 

SEC. 106. REDUCTION FOR MISUSE OR ALTERATION OF PRODUCT. 

(a) GENERAL RULE.—

(1) IN GENERAL.—Except as provided in subsection (c), in a product liability action that 

is subject to this title, the damages for 

which a defendant is otherwise liable under 

applicable State law shall be reduced by the 

percentage of responsibility for the harm to 

the claimant attributable to misuse or alteration of a product by any person if the defendant establishes that such percentage of 

the harm was proximately caused by a use or 

alteration of a product—

(A) in violation of, or contrary to, the express warnings or instructions of the defendant if the warnings or instructions are determined to be adequate pursuant to applicable 

State law; or 

(B) 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 anticipated to use the product. 

(2) USE INTENDED BY A MANUFACTURER IS

NOT MISUSE OR ALTERATION.—For the purposes of this title, a use of a product that is 

intended by the manufacturer of the product 

does not constitute a misuse or alteration of 

the product. 

(b) STATE LAW.—Notwithstanding section 

3(b), subsection (a) of this section shall supersede State law concerning misuse or alteration of a product only to the extent that 

State law is inconsistent with such subsection. 

(c) WORKPLACE INJURY.—Notwithstanding 

subsection (a), the amount of damages for 

which a defendant is otherwise liable under 

State law shall not be reduced by the application of this section with respect to the 

conduct of any employer or coemployee of 

the plaintiff who is, under applicable State 

law concerning workplace injuries, immune 

from being subject to an action by the claimant. 

SEC. 107. UNIFORM STANDARDS FOR AWARD OF 

PUNITIVE DAMAGES. 

(a) GENERAL RULE.—Punitive damages 

may, to the extent permitted by applicable 

State law, be awarded against a defendant in 

a product liability action that is subject to 

this title if the claimant establishes by clear 

and convincing evidence that the harm that 

is the subject of the action was the result of 

conduct that was carried out by the defendant with a conscious, flagrant indifference to 

the safety of others. 

(b) LIMITATION ON AMOUNT.—The amount of 

punitive damages that may be awarded to a 

claimant in any product liability action that 

is subject to this title shall not exceed 3 

times the amount awarded to the claimant 

for the economic loss on which the claim is 

based, or $250,000, whichever is greater. This 

subsection shall be applied by the court and 

the application of this subsection shall not 

be disclosed to the jury. 

(c) BIFURCATION AT REQUEST OF EITHER

PARTY.—

(1) IN GENERAL.—At the request of either 

party, the trier of fact in a product liability 

action that is subject to this title shall consider in a separate proceeding whether punitive damages are to be awarded for the harm 

that is the subject of the action and the 

amount of the award. 

(2) ADMISSIBLE EVIDENCE.—

(A) INADMISSIBILITY OF EVIDENCE RELATIVE

ONLY TO A CLAIM OF PUNITIVE DAMAGES IN A

PROCEEDING CONCERNING COMPENSATORY DAMAGES.—If either party requests a separate 

proceeding under paragraph (1), in any proceeding to determine whether the claimant 

may be awarded compensatory damages, any 

evidence that is relevant only to the claim of 

punitive damages, as determined by applicable State law, shall be inadmissible. 

(B) PROCEEDING WITH RESPECT TO PUNITIVE

DAMAGES.—Evidence that is admissible in the 

separate proceeding under paragraph (1)—

(i) may include evidence of the profits of 

the defendant, if any, from the alleged 

wrongdoing; and 

(ii) shall not include evidence of the overall assets of the defendant. 

SEC. 108. UNIFORM TIME LIMITATIONS ON LIABILITY. 

(a) STATUTE OF LIMITATIONS.—

(1) IN GENERAL.—Except as provided in 

paragraph (2) and subsection (b), a product 

liability action that is subject to this title 

may be filed not later than 2 years after the 

date on which the claimant discovered or, in 

the exercise of reasonable care, should have 

discovered, the harm that is the subject of 

the action and the cause of the harm. 

(2) EXCEPTIONS.—

(A) PERSON WITH A LEGAL DISABILITY.—A 

person with a legal disability (as determined 

under applicable law) may file a product liability action that is subject to this title not 

later than 2 years after the date on which 

the person ceases to have the legal disability. 

(B) EFFECT OF STAY OR INJUNCTION.—If the 

commencement of a civil action that is subject to this title is stayed or enjoined, the 

running of the statute of limitations under 

this section shall be suspended until the end 

of the period that the stay or injunction is in 

effect. 

(b) STATUTE OF REPOSE.—

(1) IN GENERAL.—Subject to paragraphs (2) 

and (3), no product liability action that is 

subject to this title concerning a product 

that is a durable good alleged to have caused 

harm (other than toxic harm) may be filed 

after the 20-year period beginning at the 

time of delivery of the product. 

(2) STATE LAW.—Notwithstanding paragraph (1), if pursuant to an applicable State 

law, an action described in such paragraph is 

required to be filed during a period that is 

shorter than the 20-year period specified in 

such paragraph, the State law shall apply 

with respect to such period. 

(3) EXCEPTIONS.—

(A) A motor vehicle, vessel, aircraft, or 

train that is used primarily to transport passengers for hire shall not be subject to this 

subsection. 

(B) Paragraph (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 involved which 

was longer than 20 years, but it will apply at 

the expiration of that warranty. 

(c) TRANSITIONAL PROVISION RELATING TO

EXTENSION OF PERIOD FOR BRINGING CERTAIN

ACTIONS.—If any provision of subsection (a) 

or (b) shortens the period during which a 

product liability action that could be otherwise brought pursuant to another provision 

of law, the claimant may, notwithstanding 

subsections (a) and (b), bring the product liability action pursuant to this title not later 

than 1 year after the date of enactment of 

this Act. 

SEC. 109. SEVERAL LIABILITY FOR NONECONOMIC LOSS. 

(a) GENERAL RULE.—In a product liability 

action that is subject to this title, the liability of each defendant for noneconomic loss 

shall be several only and shall not be joint. 

(b) AMOUNT OF LIABILITY.—

(1) IN GENERAL.—Each defendant shall be 

liable only for the amount of noneconomic 

loss allocated to the defendant in direct proportion to the percentage of responsibility of 

the defendant (determined in accordance 

with paragraph (2)) for the harm to the 

claimant with respect to which the defendant is liable. The court shall render a separate judgment against each defendant in an 

amount determined pursuant to the preceding sentence. 

(2) PERCENTAGE OF RESPONSIBILITY.—For 

purposes of determining the amount of noneconomic loss allocated to a defendant under 

this section, the trier of fact shall determine 

the percentage of responsibility of each person responsible for the claimant’s harm, 

whether or not such person is a party to the 

action. 

SEC. 110. WORKERS’ COMPENSATION SUBROGATION STANDARDS. 

(a) GENERAL RULE.—

(1) RIGHT OF SUBROGATION.—

(A) IN GENERAL.—An insurer shall have a 

right of subrogation against a manufacturer 

or product seller to recover any claimant’s 

benefits relating to harm that is the subject 

of a product liability action that is subject 

to this title. 

(B) WRITTEN NOTIFICATION.—To assert a 

right of subrogation under subparagraph (A), 

the insurer shall provide written notice to 

the court in which the product liability action is brought. 

(C) INSURER NOT REQUIRED TO BE A PARTY.—

An insurer shall not be required to be a necessary and proper party in a product liability 

action covered under subparagraph (A). 

(2) SETTLEMENTS AND OTHER LEGAL PROCEEDINGS.—

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(A) IN GENERAL.—In any proceeding relating to harm or settlement with the manufacturer or product seller by a claimant who 

files a product liability action that is subject 

to this title, an insurer may participate to 

assert a right of subrogation for claimant’s 

benefits with respect to any payment made 

by the manufacturer or product seller by 

reason of such harm, without regard to 

whether the payment is made—

(i) as part of a settlement; 

(ii) in satisfaction of judgment; 

(iii) as consideration for a covenant not to 

sue; or 

(iv) in another manner. 

(B) WRITTEN CONSENT.—Except as provided 

in subparagraph (C)—

(i) an employee shall not make any settlement with or accept any payment from the 

manufacturer or product seller without the 

written consent of the insurer; and 

(ii) no release to or agreement with the 

manufacturer or product seller described in 

clauses (i) through (iv) of subparagraph (A) 

shall be valid or enforceable for any purpose 

without the consent of the insurer. 

(C) EXEMPTION.—Subparagraph (B) shall 

not apply in any case in which the insurer 

has been compensated for the full amount of 

the claimant’s benefits. 

(3) HARM RESULTING FROM ACTION OF EMPLOYER OR COEMPLOYEE.—

(A) IN GENERAL.—If, with respect to a product liability action that is subject to this 

title, the manufacturer or product seller attempts to persuade the trier of fact that the 

harm to the claimant was caused by the 

fault of the employer of the claimant or any 

coemployee of the claimant, the issue of that 

fault shall be submitted to the trier of fact, 

but only after the manufacturer or product 

seller has provided timely written notice to 

the employer. 

(B) RIGHTS OF EMPLOYER.—

(i) IN GENERAL.—Notwithstanding any 

other provision of law, with respect to an 

issue of fault submitted to a trier of fact pursuant to subparagraph (A), an employer 

shall, in the same manner as any party in 

the action (even if the employer is not a 

named party in the action), have the right 

to—

(I) appear; 

(II) be represented; 

(III) introduce evidence; 

(IV) cross-examine adverse witnesses; and 

(V) present arguments to the trier of fact. 

(ii) LAST ISSUE.—The issue of harm resulting from an action of an employer or coemployee shall be the last issue that is presented to the trier of fact. 

(C) REDUCTION OF DAMAGES.—If the trier of 

fact finds by clear and convincing evidence 

that the harm to the claimant that is the 

subject of the product liability action was 

caused by the fault of the employer or a coemployee of the claimant—

(i) the court shall reduce by the amount of 

the claimant’s benefits—

(I) the damages awarded against the manufacturer or product seller; and 

(II) any corresponding insurer’s subrogation lien; and 

(ii) the manufacturer or product seller 

shall have no further right by way of contribution or otherwise against the employer. 

(D) CERTAIN RIGHTS OF SUBROGATION NOT

AFFECTED.—Notwithstanding a finding by the 

trier of fact described in subparagraph (C), 

the insurer shall not lose any right of subrogation related to any—

(i) intentional tort committed against the 

claimant by a coemployee; or 

(ii) act committed by a coemployee outside 

the scope of normal work practices. 

(b) ATTORNEY’S FEES.—If, in a product liability action that is subject to this section, 

the court finds that harm to a claimant was 

not caused by the fault of the employer or a 

coemployee of the claimant, the manufacturer or product seller shall reimburse the 

insurer for reasonable attorney’s fees and 

court costs incurred by the insurer in the action, as determined by the court. 

SEC. 111. FEDERAL CAUSE OF ACTION PRECLUDED. 

The district courts of the United States 

shall not have jurisdiction under section 1331 

or 1337 of title 28, United States Code, over 

any product liability action covered under 

this title. 

TITLE II—BIOMATERIALS ACCESS 

ASSURANCE 

SEC. 201. SHORT TITLE. 

This title may be cited as the ‘‘Biomaterials Access Assurance Act of 1995’’. 

SEC. 202. FINDINGS. 

Congress finds that—

(1) each year millions of citizens of the 

United States depend on the availability of 

lifesaving or life-enhancing medical devices, 

many of which are permanently implantable 

within the human body; 

(2) a continued supply of raw materials and 

component parts is necessary for the invention, development, improvement, and maintenance of the supply of the devices; 

(3) most of the medical devices are made 

with raw materials and component parts 

that—

(A) are not designed or manufactured specifically for use in medical devices; and 

(B) come in contact with internal human 

tissue; 

(4) the raw materials and component parts 

also are used in a variety of nonmedical 

products; 

(5) because small quantities of the raw materials and component parts are used for 

medical devices, sales of raw materials and 

component parts for medical devices constitute an extremely small portion of the 

overall market for the raw materials and 

medical devices; 

(6) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), manufacturers of medical devices are required to demonstrate that the medical devices are safe 

and effective, including demonstrating that 

the products are properly designed and have 

adequate warnings or instructions; 

(7) notwithstanding the fact that raw materials and component parts suppliers do not 

design, produce, or test a final medical device, the suppliers have been the subject of 

actions alleging inadequate—

(A) design and testing of medical devices 

manufactured with materials or parts supplied by the suppliers; or 

(B) warnings related to the use of such 

medical devices; 

(8) even though suppliers of raw materials 

and component parts have very rarely been 

held liable in such actions, such suppliers 

have ceased supplying certain raw materials 

and component parts for use in medical devices because the costs associated with litigation in order to ensure a favorable judgment for the suppliers far exceeds the total 

potential sales revenues from sales by such 

suppliers to the medical device industry; 

(9) unless alternate sources of supply can 

be found, the unavailability of raw materials 

and component parts for medical devices will 

lead to unavailability of lifesaving and lifeenhancing 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 development of new sources 

of supply for the full range of threatened raw 

materials and component parts for medical 

devices are remote; 

(11) it is unlikely that the small market 

for such raw materials and component parts 

in the United States could support the large 

investment needed to develop new suppliers 

of such raw materials and component parts; 

(12) attempts to develop such new suppliers 

would raise the cost of medical devices; 

(13) courts that have considered the duties 

of the suppliers of the raw materials and 

component parts have generally found that 

the suppliers do not have a duty—

(A) to evaluate the safety and efficacy of 

the use of a raw material or component part 

in a medical device; and 

(B) to warn consumers concerning the safety and effectiveness of a medical device; 

(14) attempts to impose the duties referred 

to in subparagraphs (A) and (B) of paragraph 

(13) on suppliers of the raw materials and 

component parts would cause more harm 

than good by driving the suppliers to cease 

supplying manufacturers of medical devices; 

and 

(15) in order to safeguard the availability 

of a wide variety of lifesaving and life-enhancing medical devices, immediate action 

is needed—

(A) to clarify the permissible bases of liability for suppliers of raw materials and 

component parts for medical devices; and 

(B) to provide expeditious procedures to 

dispose of unwarranted suits against the suppliers in such manner as to minimize litigation costs. 

SEC. 203. DEFINITIONS. 

As used in this title: 

(1) BIOMATERIALS SUPPLIER.—

(A) IN GENERAL.—The term ‘‘biomaterials 

supplier’’ means an entity that directly or 

indirectly supplies a component part or raw 

material for use in the manufacture of an 

implant. 

(B) PERSONS INCLUDED.—Such term includes any 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 or through the estate of an individual 

into whose body, or in contact with whose 

blood or tissue the implant is placed, such 

term includes the decedent that is the subject of the action. 

(C) ACTION BROUGHT ON BEHALF OF A

MINOR.—With respect to an action brought 

on behalf or through a minor, such term includes the parent or guardian of the minor. 

(D) EXCLUSIONS.—Such term does not include—

(i) a provider of professional services, in 

any case in which—

(I) the sale or use of an implant is incidental to the transaction; and 

(II) the essence of the transaction is the 

furnishing of judgment, skill, or services; or 

(ii) a manufacturer, seller, or biomaterials 

supplier. 

(3) COMPONENT PART.—

(A) IN GENERAL.—The term ‘‘component 

part’’ means a manufactured piece of an implant. 

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S5610 CONGRESSIONAL RECORD— SENATE April 24, 1995 

(B) CERTAIN COMPONENTS.—Such term includes a manufactured piece of an implant 

that—

(i) has significant nonimplant applications; 

and 

(ii) alone, has no implant value or purpose, 

but when combined with other component 

parts and materials, 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 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 

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, 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 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)). 

(8) QUALIFIED SPECIALIST.—With respect to 

an action, the term ‘‘qualified specialist’’

means a person who is qualified by knowledge, skill, experience, training, or education in the specialty area that is the subject of the action. 

(9) 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. 

(10) SECRETARY.—The term ‘‘Secretary’’

means the Secretary of Health and Human 

Services. 

(11) SELLER.—

(A) IN GENERAL.—The term ‘‘seller’’ means 

a person who, in the course of a business conducted for that purpose, sells, distributes, 

leases, packages, labels, or otherwise places 

an implant in the stream of commerce. 

(B) EXCLUSIONS.—The term does not include—

(i) a seller or lessor of real property; 

(ii) a provider of professional services, in 

any case in which the sale or use of an implant is incidental to the transaction and the 

essence of the transaction is the furnishing 

of judgment, skill, or services; or 

(iii) any person who acts in only a financial capacity with respect to the sale of an 

implant. 

SEC. 204. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION. 

(a) GENERAL REQUIREMENTS.—

(1) IN GENERAL.—In any civil action covered by this title, a biomaterials supplier 

may raise any defense set forth in section 

205. 

(2) PROCEDURES.—Notwithstanding any 

other provision of law, the Federal or State 

court in which a civil action covered by this 

title is pending shall, in connection with a 

motion for dismissal or judgment based on a 

defense described in paragraph (1), use the 

procedures set forth in section 206. 

(b) APPLICABILITY.—

(1) IN GENERAL.—Except as provided in 

paragraph (2), notwithstanding any other 

provision of law, this title applies to any 

civil action brought by a claimant, whether 

in a Federal or State court, against a manufacturer, seller, or biomaterials supplier, on 

the basis of any legal theory, for harm allegedly caused by an implant. 

(2) EXCLUSION.—A civil action brought by a 

purchaser of a medical device for use in providing professional services against a manufacturer, seller, or biomaterials supplier for 

loss or damage to an implant or for commercial loss to the purchaser—

(A) shall not be considered an action that 

is subject to this title; and 

(B) shall be governed by applicable commercial or contract law. 

(c) SCOPE OF PREEMPTION.—

(1) IN GENERAL.—This Act supersedes any 

State law regarding recovery for harm 

caused by an implant and any rule of procedure applicable to a civil action to recover 

damages for such harm only to the extent 

that this title establishes a rule of law applicable to the recovery of such damages. 

(2) APPLICABILITY OF OTHER LAWS.—Any 

issue that arises under this title and that is 

not governed by a rule of law applicable to 

the recovery of damages described in paragraph (1) shall be governed by applicable 

Federal or State law. 

(d) STATUTORY CONSTRUCTION.—Nothing in 

this title may be construed—

(1) to affect any defense available to a defendant under any other provisions of Federal or State law in an action alleging harm 

caused by an implant; or 

(2) to create a cause of action or Federal 

court jurisdiction pursuant to section 1331 or 

1337 of title 28, United States Code, that otherwise would not exist under applicable Federal or State law. 

SEC. 205. LIABILITY OF BIOMATERIALS SUPPLIERS. 

(a) IN GENERAL.—

(1) EXCLUSION FROM LIABILITY.—Except as 

provided in paragraph (2), a biomaterials 

supplier shall not be liable for harm to a 

claimant caused by an implant. 

(2) LIABILITY.—A biomaterials supplier 

that—

(A) is a manufacturer may be liable for 

harm to a claimant described in subsection 

(b); 

(B) is a seller may be liable for harm to a 

claimant described in subsection (c); and 

(C) furnishes raw materials or component 

parts that fail to meet applicable contractual requirements or specifications may be 

liable for a harm to a claimant described in 

subsection (d). 

(b) LIABILITY AS MANUFACTURER.—

(1) IN GENERAL.—A biomaterials supplier 

may, to the extent required and permitted 

by any other applicable law, be liable for 

harm to a claimant caused by an implant if 

the biomaterials supplier is the manufacturer of the implant. 

(2) GROUNDS FOR LIABILITY.—The biomaterials supplier may be considered the manufacturer of the implant that allegedly caused 

harm to a claimant only if the biomaterials 

supplier—

(A)(i) has registered with the Secretary 

pursuant to section 510 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360) and 

the regulations issued under such section; 

and 

(ii) included the implant on a list of devices filed with the Secretary pursuant to 

section 510(j) of such Act (21 U.S.C. 360(j)) 

and the regulations issued under such section; or 

(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. 

(3) ADMINISTRATIVE PROCEDURES.—

(A) IN GENERAL.—The Secretary may issue 

a declaration described in paragraph (2)(B) 

on the motion of the Secretary or on petition by any person, after providing—

(i) notice to the affected persons; and 

(ii) an opportunity for an informal hearing. 

(B) DOCKETING AND FINAL DECISION.—Immediately upon receipt of a petition filed pursuant to this paragraph, the Secretary shall 

docket the petition. Not later than 180 days 

after the petition is filed, the Secretary shall 

issue a final decision on the petition. 

(C) APPLICABILITY OF STATUTE OF LIMITATIONS.—Any applicable statute of limitations 

shall toll during the period during which a 

claimant has filed a petition with the Secretary under this paragraph. 

(c) LIABILITY AS SELLER.—A biomaterials 

supplier may, to the extent required and permitted by any other applicable law, be liable 

as a seller for harm to a claimant caused by 

an implant if the biomaterials supplier—

(1) held title to the implant that allegedly 

caused harm to the claimant as a result of 

purchasing the implant after—

(A) the manufacture of the implant; and 

(B) the entrance of the implant in the 

stream of commerce; and 

(2) subsequently resold the implant. 

(d) LIABILITY FOR VIOLATING CONTRACTUAL

REQUIREMENTS OR SPECIFICATIONS.—A biomaterials supplier may, to the extent required and permitted by any other applicable 

law, be liable for harm to a claimant caused 

by an implant, if the claimant in an action 

shows, by a preponderance of the evidence, 

that—

(1) the raw materials or component parts 

delivered by the biomaterials supplier either—

(A) did not constitute the product described in the contract between the biomaterials supplier and the person who contracted 

for delivery of the product; or 

(B) failed to meet any specifications that 

were—

(i) provided to the biomaterials supplier 

and not expressly repudiated by the biomaterials supplier prior to acceptance of delivery 

of the raw materials or component parts; 

(ii)(I) published by the biomaterials supplier; 

(II) provided to the manufacturer by the 

biomaterials supplier; or 

(III) contained in a master file that was 

submitted by the biomaterials supplier to 

the Secretary and that is currently maintained by the biomaterials supplier for purposes of premarket approval of medical devices; or 

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April 24, 1995 CONGRESSIONAL RECORD— SENATE S5611 

(iii)(I) 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 

(II) have received clearance from the Secretary, 

if such specifications were provided by the 

manufacturer to the biomaterials supplier 

and were not expressly repudiated by the 

biomaterials supplier prior to the acceptance 

by the manufacturer of delivery of the raw 

materials or component parts; and 

(2) such conduct was an actual and proximate cause of the harm to the claimant. 

SEC. 206. PROCEDURES FOR DISMISSAL OF CIVIL 

ACTIONS AGAINST BIOMATERIALS 

SUPPLIERS. 

(a) MOTION TO DISMISS.—In any action that 

is subject to this title, a biomaterials supplier who is a defendant in such action may, 

at any time during which a motion to dismiss may be filed under an applicable law, 

move to dismiss the action on the grounds 

that—

(1) the defendant is a biomaterials supplier; and 

(2)(A) the defendant should not, for the 

purposes of—

(i) section 205(b), be considered to be a 

manufacturer of the implant that is subject 

to such section; or 

(ii) section 205(c), be considered to be a 

seller of the implant that allegedly caused 

harm to the claimant; or 

(B)(i) the claimant has failed to establish, 

pursuant to section 205(d), that the supplier 

furnished raw materials or component parts 

in violation of contractual requirements or 

specifications; or 

(ii) the claimant has failed to comply with 

the procedural requirements of subsection 

(b). 

(b) PROCEDURAL REQUIREMENTS.—

(1) IN GENERAL.—The procedural requirements described in paragraphs (2) and (3) 

shall apply to any action by a claimant 

against a biomaterials supplier that is subject to this title. 

(2) MANUFACTURER OF IMPLANT SHALL BE

NAMED A PARTY.—The claimant shall be required to name the manufacturer of the implant as a party to the action, unless—

(A) 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 

(B) an action against the manufacturer is 

barred by applicable law. 

(3) AFFIDAVIT.—At the time the claimant 

brings an action against a biomaterials supplier the claimant shall be required to submit an affidavit that—

(A) declares that the claimant has consulted and reviewed the facts of the action 

with a qualified specialist, whose qualifications the claimant shall disclose; 

(B) includes a written determination by a 

qualified specialist that the raw materials or 

component parts actually used in the manufacture of the implant of the claimant were 

raw materials or component parts described 

in section 205(d)(1), together with a statement of the basis for such a determination; 

(C) includes a written determination by a 

qualified specialist that, after a review of 

the medical record and other relevant material, the raw material or component part 

supplied by the biomaterials supplier and actually used in the manufacture of the implant was a cause of the harm alleged by 

claimant, together with a statement of the 

basis for the determination; and 

(D) states that, on the basis of review and 

consultation of the qualified specialist, the 

claimant (or the attorney of the claimant) 

has concluded that there is a reasonable and 

meritorious cause for the filing of the action 

against the biomaterials supplier. 

(c) PROCEEDING ON MOTION TO DISMISS.—

The following rules shall apply to any proceeding on a motion to dismiss filed under 

this section: 

(1) AFFIDAVITS RELATING TO LISTING AND

DECLARATIONS.—

(A) IN GENERAL.—The defendant in the action may submit an affidavit demonstrating 

that defendant has not included the implant 

on a list, if any, filed with the Secretary pursuant to section 510(j) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360(j)). 

(B) RESPONSE TO MOTION TO DISMISS.—In response to the motion to dismiss, the claimant may submit an affidavit demonstrating 

that—

(i) the Secretary has, with respect to the 

defendant and the implant that allegedly 

caused harm to the claimant, issued a declaration pursuant to section 205(b)(2)(B); or 

(ii) the defendant who filed the motion to 

dismiss is a seller of the implant who is liable under section 205(c). 

(2) EFFECT OF MOTION TO DISMISS ON DISCOVERY.—

(A) IN GENERAL.—If a defendant files a motion to dismiss under paragraph (1) or (2) of 

subsection (a), no discovery shall be permitted in connection to the action that is 

the subject of the motion, other than discovery necessary to determine a motion to 

dismiss for lack of jurisdiction, until such 

time as the court rules on the motion to dismiss in accordance with the affidavits submitted by the parties in accordance with this 

section. 

(B) DISCOVERY.—If a defendant files a motion to dismiss under subsection (a)(2) on the 

grounds that the biomaterials supplier did 

not furnish raw materials or component 

parts in violation of contractual requirements or specifications, the court may permit discovery, as ordered by the court. The 

discovery conducted pursuant to this subparagraph shall be limited to issues that are 

directly relevant to—

(i) the pending motion to dismiss; or 

(ii) the jurisdiction of the court. 

(3) AFFIDAVITS RELATING STATUS OF DEFENDANT.—

(A) IN GENERAL.—Except as provided in 

clauses (i) and (ii) of subparagraph (B), the 

court shall consider a defendant to be a biomaterials supplier who is not subject to an 

action for harm to a claimant caused by an 

implant, other than an action relating to liability for a violation of contractual requirements or specifications described in subsection (d). 

(B) RESPONSES TO MOTION TO DISMISS.—The 

court shall grant a motion to dismiss any action that asserts liability of the defendant 

under subsection (b) or (c) of section 205 on 

the grounds that the defendant is not a manufacturer subject to such section 205(b) or 

seller subject to section 205(c), unless the 

claimant submits a valid affidavit that demonstrates that—

(i) with respect to a motion to dismiss contending the defendant is not a manufacturer, 

the defendant meets the applicable requirements for liability as a manufacturer under 

section 205(b); or 

(ii) with respect to a motion to dismiss 

contending that the defendant is not a seller, 

the defendant meets the applicable requirements for liability as a seller under section 

205(c). 

(4) BASIS OF RULING ON MOTION TO DISMISS.—

(A) IN GENERAL.—The court shall rule on a 

motion to dismiss filed under subsection (a) 

solely on the basis of the pleadings of the 

parties made pursuant to this section and 

any affidavits submitted by the parties pursuant to this section. 

(B) MOTION FOR SUMMARY JUDGMENT.—Notwithstanding any other provision of law, if 

the court determines that the pleadings and 

affidavits made by parties pursuant to this 

section raise genuine issues as concerning 

material facts with respect to a motion concerning contractual requirements and specifications, the court may deem the motion to 

dismiss to be a motion for summary judgment made pursuant to subsection (d). 

(d) SUMMARY JUDGMENT.—

(1) IN GENERAL.—

(A) BASIS FOR ENTRY OF JUDGMENT.—A biomaterials supplier shall be entitled to entry 

of judgment without trial if the court finds 

there is no genuine issue as concerning any 

material fact for each applicable element set 

forth in paragraphs (1) and (2) of section 

205(d). 

(B) ISSUES OF MATERIAL FACT.—With respect to a finding made under subparagraph 

(A), the court shall consider a genuine issue 

of material fact to exist only if the evidence 

submitted by claimant would be sufficient to 

allow a 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 made pursuant to this subsection, 

such discovery shall be limited solely to establishing whether a genuine issue of material fact exists. 

(3) DISCOVERY WITH RESPECT TO A BIOMATERIALS SUPPLIER.—A biomaterials supplier 

shall be subject to discovery in connection 

with a motion seeking dismissal or summary 

judgment on the basis of the inapplicability 

of section 205(d) or the failure to establish 

the applicable elements of section 205(d) 

solely to the extent permitted by the applicable Federal or State rules for discovery 

against nonparties. 

(e) STAY PENDING PETITION FOR DECLARATION.—If a claimant has filed a petition for a 

declaration pursuant to section 205(b) with 

respect to a defendant, and the Secretary has 

not issued a final decision on the petition, 

the court shall stay all proceedings with respect to that defendant until such time as 

the Secretary has issued a final decision on 

the petition. 

(f) MANUFACTURER CONDUCT OF PROCEEDING.—The manufacturer of an implant 

that is the subject of an action covered 

under this title shall be permitted to file and 

conduct a proceeding on any motion for summary judgment or dismissal filed by a biomaterials supplier who is a defendant under 

this section if the manufacturer and any 

other defendant in such action enter into a 

valid and applicable contractual agreement 

under which the manufacturer agrees to bear 

the cost of such proceeding or to conduct 

such proceeding. 

(g) ATTORNEY FEES.—The court shall require the claimant to compensate the biomaterials supplier (or a manufacturer appearing in lieu of a supplier pursuant to subsection (f)) for attorney fees and costs, if—

(1) the claimant named or joined the biomaterials supplier; and 

(2) the court found the claim against the 

biomaterials supplier to be without merit 

and frivolous. 

SEC. 207. APPLICABILITY. 

This Act shall apply to all civil actions 

covered under this title that are commenced 

on or after the date of enactment of this 

title, 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 title. 

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