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 within the jurisdiction of the committee concerned

A BILL

To establish legal standards and procedures for product

liability litigation, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Common Sense Product Liability and Legal Reform Act

6 of 1995’’.

7 (b) TABLE OF CONTENTS.—The table of contents is

8 as follows:

Sec. 1. Short title and table of contents.
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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 suppliers.

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.

1 TITLE I—PRODUCT LIABILITY

2 REFORM

3 SEC. 101. FINDINGS AND PURPOSES.

4 (a) FINDINGS.—The Congress finds that—

5 (1) the manufacture and distribution of goods

6 in interstate commerce is to a large extent a na7 tional activity which affects national interests in a

8 variety of important ways;

9 (2) in recent years, the free flow of products in

10 interstate commerce has been increasingly burdened

11 by product liability law;
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1 (3) as a result of this burden, consumers have

2 been adversely affected through the withdrawal of

3 products and producers from the national market,

4 and from excessive liability costs passed on to them

5 through higher prices;

6 (4) the rules of product liability law in recent

7 years have evolved rapidly and inconsistently within

8 and among the several States, such that the body of

9 product liability law prevailing in this nation today

10 is complex, contradictory, and uncertain;

11 (5) the unpredictability of product liability

12 awards and doctrines are inequitable to both plain13 tiffs and defendants and have added considerably to

14 the high cost of liability insurance, making it dif15 ficult for producers and insurers to protect their li16 ability with any degree of confidence;

17 (6) product liability actions and punitive dam18 age awards jeopardize the financial well-being of

19 many industries and are a particular threat to the

20 viability of the nation’s small businesses;

21 (7) the extraordinary costs of the product liabil22 ity system undermine the ability of American indus23 try to compete internationally, and is costing the

24 loss of jobs and productive capital; and
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1 (8) because of the national scope of the manu2 facture and distribution of most products, it is not

3 possible for the individual states to enact laws that

4 fully and effectively respond to these problems.

5 (b) PURPOSES.—Based upon the powers contained in

6 Article I, clause 3 of the United States Constitution, the

7 purposes of this title are to promote the free flow of goods

8 in interstate commerce—

9 (1) by establishing certain uniform legal prin10 ciples which provide a fair balance between the inter11 ests of product users, manufacturers, and product

12 sellers,

13 (2) by placing reasonable limits on product li14 ability law,

15 (3) by ensuring that product liability law oper16 ates to compensate persons injured by the wrong17 doing of others,

18 (4) by reducing the unacceptable transactions

19 costs and delays which harm both plaintiffs and de20 fendants,

21 (5) by allocating responsibility for harm to

22 those in the best position to prevent such harm, and

23 (6) by establishing greater predictability in

24 product liability actions.
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1 SEC. 102. APPLICABILITY AND PREEMPTION.

2 (a) PREEMPTION.—This title governs any product li3 ability action brought in any State or Federal court, on

4 any theory for harm caused by a product. A civil action

5 brought for commercial loss shall be governed only by ap6 plicable commercial or contract law.

7 (b) RELATIONSHIP TO STATE LAW.—This title su8 persedes State law only to the extent that State law ap9 plies to an issue covered by this title. Any issue that is

10 not governed by this title shall be governed by otherwise

11 applicable State or Federal law.

12 SEC. 103. LIABILITY RULES APPLICABLE TO PRODUCT

13 SELLERS.

14 (a) GENERAL RULE.—Except as provided in sub15 section (b), in any product liability action, a product seller

16 other than a manufacturer shall be liable to a claimant

17 for harm only if the claimant establishes that—

18 (1)(A) the product which allegedly caused the

19 harm complained of was sold by the product seller;

20 (B) the product seller failed to exercise reasonable

21 care with respect to the product; and (C) such fail22 ure to exercise reasonable care was a proximate

23 cause of the claimant’s harm; or

24 (2)(A) the product seller made an express war25 ranty applicable to the product which allegedly

26 caused the harm complained of, independent of any
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1 express warranty made by a manufacturer as to the

2 same product; (B) the product failed to conform to

3 the warranty; and (C) the failure of the product to

4 conform to the warranty caused the claimant’s

5 harm; or

6 (3) the product seller engaged in intentional

7 wrongdoing as determined under applicable State

8 law and such intentional wrongdoing was a proxi9 mate cause of the harm complained of by the claim10 ant.

11 For purposes of paragraph (1)(B), a product seller shall

12 not be considered to have failed to exercise reasonable care

13 with respect to the product based upon an alleged failure

14 to inspect a product where there was no reasonable oppor15 tunity to inspect the product in a manner which would,

16 in the exercise of reasonable care, have revealed the aspect

17 of the product which allegedly caused the claimant’s harm.

18 (b) EXCEPTION.—In a product liability action, a

19 product seller shall be liable for harm to the claimant

20 caused by such product as if the product seller were the

21 manufacturer of such product if—

22 (1) the manufacturer is not subject to service of

23 process under the laws of any State in which the ac24 tion might have been brought; or
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1 (2) the court determines that the claimant

2 would be unable to enforce a judgment against the

3 manufacturer.

4 SEC. 104. DEFENSE BASED ON CLAIMANT’S USE OF INTOXI5 CATING ALCOHOL OR DRUGS.

6 (a) GENERAL RULE.—In any product liability action,

7 it shall be a complete defense to such action if—

8 (1) the claimant was intoxicated or was under

9 the influence of intoxicating alcohol or any drug

10 when the accident or other event which resulted in

11 such claimant’s harm occurred; and

12 (2) the claimant, as a result of the influence of

13 the alcohol or drug, was more than 50 percent re14 sponsible for such accident or other event.

15 (b) CONSTRUCTION.—For purposes of subsection

16 (a)—

17 (1) the determination of whether a person was

18 intoxicated or was under the influence of intoxicat19 ing alcohol or any drug shall be made pursuant to

20 applicable State law; and

21 (2) the term ‘‘drug’’ means any controlled sub22 stance as defined in the Controlled Substances Act

23 (21 U.S.C. 802(6)) that has been taken by the

24 claimant other than in accordance with the terms of

25 a lawfully issued prescription.
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1 SEC. 105. MISUSE OR ALTERATION.

2 (a) GENERAL RULE.—Except as provided in sub3 section (c), in a product liability action, the damages for

4 which a defendant is otherwise liable under State law shall

5 be reduced by the percentage of responsibility for the

6 claimant’s harm attributable to misuse or alteration of a

7 product by any person if the defendant establishes by a

8 preponderance of the evidence that such percentage of the

9 claimant’s harm was proximately caused by—

10 (1) a use or alteration of a product in violation

11 of, or contrary to, the defendant’s express warnings

12 or instructions if the warnings or instructions are

13 adequate as determined pursuant to applicable State

14 law, or

15 (2) a use or alteration of a product involving a

16 risk of harm which was known or should have been

17 known by the ordinary person who uses or consumes

18 the product with the knowledge common to the class

19 of persons who used or would be reasonably antici20 pated to use the product.

21 (b) WORKPLACE INJURY.—Notwithstanding sub22 section (a), the damage for which a defendant is otherwise

23 liable under State law shall not be reduced by the percent24 age of responsibility for the claimant’s harm attributable

25 to misuse or alteration of the product by the claimant’s

26 employer or any co-employee who is immune from suit by
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1 the claimant pursuant to the State law applicable to work2 place injuries.

3 SEC. 106. FRIVOLOUS PLEADINGS.

4 (a) GENERAL RULE.—

5 (1) SIGNING OF PLEADING.—The signing or

6 verification of a pleading in a product liability action

7 in a State court subject to this title constitutes a

8 certificate that to the signatory’s or verifier’s best

9 knowledge, information, and belief, formed after rea10 sonable inquiry, the pleading is not frivolous as de11 termined under paragraph (2).

12 (2) DEFINITIONS.—

13 (A) For purposes of this section, a plead14 ing is frivolous if the pleading is—

15 (i) groundless and brought in bad

16 faith;

17 (ii) groundless and brought for the

18 purpose of harassment; or

19 (iii) groundless and interposed for any

20 improper purpose, such as to cause unnec21 essary delay or needless increase in the

22 cost of litigation.

23 (B) For purposes of subparagraph (A), the

24 term ‘‘groundless’’ means—

25 (i) no basis in fact; or
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1 (ii) not warranted by existing law or

2 a good faith argument for the extension,

3 modification, or reversal of existing law.

4 (b) DETERMINATION THAT PLEADING FRIVO5 LOUS.—

6 (1) MOTION FOR DETERMINATION.—Not later

7 than 60 days after the date a pleading in a product

8 liability action in a State court is filed, a party to

9 the action may make a motion that the court deter10 mine if the pleading is frivolous.

11 (2) COURT ACTION.—The court in a product li12 ability action in a State court shall on the motion

13 of a party or on its own motion determine if a plead14 ing is frivolous.

15 (c) CONSIDERATIONS.—In making its determination

16 of whether a pleading is frivolous, the court shall take into

17 account—

18 (1) the multiplicity of parties;

19 (2) the complexity of the claims and defenses;

20 (3) the length of time available to the party to

21 investigate and conduct discovery; and

22 (4) affidavits, depositions, and any other rel23 evant matter.

24 (d) SANCTION.—If the court determines that a plead25 ing is frivolous, the court shall impose an appropriate
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1 sanction on the signatory or verifier of the pleading. The

2 sanction may include one or more of the following:

3 (1) the striking of a pleading or the offending

4 portion thereof;

5 (2) the dismissal of a party; or

6 (3) an order to pay to a party who stands in

7 opposition to the offending pleading the amounts of

8 the reasonable expenses incurred because of the fil9 ing of the pleading, including costs, reasonable at10 torney’s fees, witness fees, fees of experts, and depo11 sition expenses.

12 (e) CONSTRUCTION.—For purposes of this section—

13 (1) a general denial does not constitute a frivo14 lous pleading; and

15 (2) the amount requested for damages does not

16 constitute a frivolous pleading.

17 SEC. 107. SEVERAL LIABILITY FOR NONECONOMIC LOSS.

18 In any product liability action, the liability of each

19 defendant for noneconomic loss shall be several only and

20 shall not be joint. Each defendant shall be liable only for

21 the amount of noneconomic loss attributable to such de22 fendant in direct proportion to such defendant’s propor23 tionate share of fault or responsibility for the claimant’s

24 harm, as determined by the trier of fact.
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1 SEC. 108. STATUTE OF REPOSE.

2 (a) GENERAL RULE.—A product liability action shall

3 be barred unless the complaint is served and filed within

4 15 years of the date of delivery of the product to its first

5 purchaser or lessee, who was not engaged in the business

6 of selling or leasing the product or of using the product

7 as a component in the manufacture of another product.

8 This subsection shall apply only if the court determines

9 that the claimant has received or would be eligible to re10 ceive full compensation from any source for medical ex11 pense losses.

12 (b) EXCEPTION.—Subsection (a)—

13 (1) does not bar a product liability action

14 against a defendant who made an express warranty

15 in writing as to the safety of the specific product in16 volved which was longer than 15 years, but it will

17 apply at the expiration of such warranty,

18 (2) does not apply to a physical illness the evi19 dence of which does not ordinarily appear less than

20 15 years after the first exposure to the product, and

21 (3) does not affect the limitations period estab22 lished by the General Aviation Revitalization Act of

23 1994.

24 SEC. 109. SERVICE OF PROCESS.

25 This title shall not apply to a product liability action

26 unless the manufacturer of the product or component part
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1 has appointed an agent in the United States for service

2 of process from anywhere in the United States.

3 SEC. 110. DEFINITIONS.

4 As used in this title:

5 (1) The term ‘‘claimant’’ means any person who

6 brings a product liability action and any person on

7 whose behalf such an action is brought. If such an

8 action is brought through or on behalf of an estate,

9 the term includes the claimant’s decedent. If such

10 action is brought through or on behalf of a minor

11 or incompetent, the term includes the claimant’s

12 legal guardian.

13 (2) The term ‘‘commercial loss’’ means any loss

14 of or damage to a product itself incurred in the

15 course of the ongoing business enterprise consisting

16 of providing goods or services for compensation.

17 (3) The term ‘‘economic loss’’ means any pecu18 niary loss resulting from harm (including the loss of

19 earnings, medical expense loss, replacement services

20 loss, loss due to death, and burial costs) to the ex21 tent recovery for such loss is allowed under applica22 ble State law.

23 (4) The term ‘‘harm’’ means any physical in24 jury, illness, disease, or death or damage to property

25 caused by a product. The term does not include
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1 commercial loss or loss or damage to a product it2 self.

3 (5) The term ‘‘manufacturer’’ means—

4 (A) any person who is engaged in a busi5 ness to produce, create, make, or construct any

6 product (or component part of a product) and

7 who (i) designs or formulates the product (or

8 component part of the product), (ii) has en9 gaged another person to design or formulate

10 the product (or component part of the product),

11 or (iii) uses the design or formulation of the

12 product developed by another person;

13 (B) a product seller of the product who,

14 before placing the product in the stream of

15 commerce—

16 (i) designs or formulates or has en17 gaged another person to design or formu18 late an aspect of the product after the

19 product was initially made by another, or

20 (ii) produces, creates, makes, or con21 structs such aspect of the product, or

22 (C) any product seller not described in

23 subparagraph (B) which holds itself out as a

24 manufacturer to the user of the product.
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1 (6) The term ‘‘noneconomic loss’’ means subjec2 tive, nonmonetary loss resulting from harm, includ3 ing pain, suffering, inconvenience, mental suffering,

4 emotional distress, loss of society and companion5 ship, loss of consortium, injury to reputation, and

6 humiliation.

7 (7) The term ‘‘person’’ means any individual,

8 corporation, company, association, firm, partnership,

9 society, joint stock company, or any other entity (in10 cluding any governmental entity).

11 (8)(A) The term ‘‘product’’ means any object,

12 substance, mixture, or raw material in a gaseous,

13 liquid, or solid state which—

14 (i) is capable of delivery itself or as an as15 sembled whole, in a mixed or combined state, or

16 as a component part or ingredient;

17 (ii) is produced for introduction into trade

18 or commerce;

19 (iii) has intrinsic economic value; and

20 (iv) is intended for sale or lease to persons

21 for commercial or personal use.

22 (B) The term does not include—

23 (i) human tissue, human organs, human

24 blood, and human blood products; or
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1 (ii) electricity, water delivered by a utility,

2 natural gas, or steam.

3 (9) The term ‘‘product liability action’’ means

4 a civil action brought on any theory for harm caused

5 by a product or product use.

6 (10) The term ‘‘product seller’’ means a person

7 who, in the course of a business conducted for that

8 purpose, sells, distributes, rents, leases, prepares,

9 blends, packages, labels a product, is otherwise in10 volved in placing a product in the stream of com11 merce, or installs, repairs, or maintains the harm12 causing aspect of a product. The term does not in13 clude—

14 (A) a seller or lessor of real property;

15 (B) a provider of professional services in

16 any case in which the sale or use of a product

17 is incidental to the transaction and the essence

18 of the transaction is the furnishing of judg19 ment, skill, or services; or

20 (C) any person who—

21 (i) acts in only a financial capacity

22 with respect to the sale of a product; or

23 (ii) leases a product under a lease ar24 rangement in which the selection, posses25 sion, maintenance, and operation of the
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1 product are controlled by a person other

2 than the lessor.

3 (11) The term ‘‘State’’ means any State of the

4 United States, the District of Columbia, Common5 wealth of Puerto Rico, the Northern Mariana Is6 lands, the Virgin Islands, Guam, American Samoa,

7 and any other territory or possession of the United

8 States, or any political subdivision of any of the

9 foregoing.

10 TITLE II—PUNITIVE DAMAGES

11 REFORM

12 SEC. 201. PUNITIVE DAMAGES.

13 (a) GENERAL RULE.—Punitive damages may, to the

14 extent permitted by applicable State law, be awarded in

15 any civil action for harm in any Federal or State court

16 against a defendant if the claimant establishes by clear

17 and convincing evidence that the harm suffered was result

18 of conduct—

19 (1) specifically intended to cause harm, or

20 (2) conduct manifesting a conscious, flagrant

21 indifference to the safety of others.

22 (b) PROPORTIONAL AWARDS.—The amount of puni23 tive damages that may be awarded in any civil action sub24 ject to this title shall not exceed 3 times the amount of

25 damages awarded to the claimant for the economic loss
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1 on which the claimant’s action is based, or $250,000,

2 whichever is greater.

3 (c) APPLICABILITY AND PREEMPTION.—Except as

4 provided in section 401, this title shall apply to any civil

5 action brought in any Federal or State court on any theory

6 where punitive damages are sought. This title does not

7 create a cause of action for punitive damages in any juris8 diction that does not authorize such actions.

9 (d) BIFURCATION.—At the request of any party, the

10 trier of fact shall consider in a separate proceeding wheth11 er punitive damages are to be awarded and the amount

12 of such award. If a separate proceeding is requested, evi13 dence relevant only to the claim of punitive damages, as

14 determined by applicable State law, shall be inadmissible

15 in any proceeding to determine whether compensatory

16 damages are to be awarded.

17 (e) CONSIDERATION.—In determining the amount of

18 punitive damages, the trier of fact shall consider all rel19 evant, admissible evidence, including—

20 (1) the severity of the harm caused by the con21 duct of the defendant,

22 (2) the duration of the conduct or any conceal23 ment of it by the defendant,

24 (3) the profitability of the specific conduct that

25 caused the harm to the defendant,
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1 (4) the number of products sold, the frequency

2 of services provided, or the type of activities con3 ducted by the defendant of the kind causing the

4 harm complained of by the claimant,

5 (5) awards of punitive damages to persons simi6 larly situated to the claimant,

7 (6) possibility of prospective awards of compen8 satory damages to persons similarly situated to the

9 claimant,

10 (7) any criminal penalties imposed on the de11 fendant as a result of the conduct complained of by

12 the claimant,

13 (8) the amount of any civil and administrative

14 fines and penalties assessed against the defendant as

15 a result of the conduct complained of by the claim16 ant, and

17 (9) whether the foregoing considerations have

18 been a factor in any prior proceeding involving the

19 defendant.

20 SEC. 202. DEFINITIONS.

21 As used in this title:

22 (1) The term ‘‘claimant’’ means any person who

23 brings a civil action and any person on whose behalf

24 such an action is brought. If such action is brought

25 through or on behalf of an estate, the term includes
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1 the claimant’s decedent. If such action is brought

2 through or on behalf of a minor or incompetent, the

3 term includes the claimant’s legal guardian.

4 (2) The term ‘‘clear and convincing evidence’’ is

5 that measure or degree of proof that will produce in

6 the mind of the trier of fact a firm belief or convic7 tion as to the truth of the allegations sought to be

8 established. The level of proof required to satisfy

9 such standard is more than that required under pre10 ponderance of the evidence, but less than that re11 quired for proof beyond a reasonable doubt.

12 (3) The term ‘‘economic loss’’ means any pecu13 niary loss resulting from harm (including the loss of

14 earnings, medical expense loss, replacement services

15 loss, loss due to death, and burial costs), to the ex16 tent recovery for such loss is allowed under applica17 ble State law.

18 (4) The term ‘‘harm’’ means any legally cog19 nizable wrong or injury for which punitive damages

20 may be imposed.

21 (5) The term ‘‘punitive damages’’ means dam22 ages awarded against any person or entity to punish

23 or deter such person or entity, or others, from en24 gaging in similar behavior in the future.
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1 (6) The term ‘‘State’’ means any State of the

2 United States, the District of Columbia, Common3 wealth of Puerto Rico, the Northern Mariana Is4 lands, the Virgin Islands, Guam, American Samoa,

5 and any other territory or possession of the United

6 States, or any political subdivision of any of the

7 foregoing.

8 TITLE III—BIOMATERIALS

9 SUPPLIERS

10 SEC. 301. LIABILITY OF BIOMATERIALS SUPPLIERS.

11 A biomaterials supplier may, to the extent required

12 and permitted by any other applicable law, be liable for

13 harm to a claimant caused by a medical device, only if

14 the claimant in a product liability action shows that the

15 conduct of the biomaterials supplier was an actual and

16 proximate cause of the harm to the claimant and—

17 (1) the raw materials or component parts deliv18 ered by the biomaterials supplier either—

19 (A) did not constitute the product de20 scribed in the contract between the biomaterials

21 supplier and the person who contracted for de22 livery of the product; or

23 (B) failed to meet any specifications that

24 were—
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1 (i) provided to the biomaterials sup2 plier and not expressly repudiated by the

3 biomaterials supplier prior to acceptance of

4 delivery of the raw materials or component

5 parts:

6 (ii)(I) provided to the biomaterials

7 supplier;

8 (II) provided to the manufacturer by

9 the biomaterials supplier; or

10 (III) contained in a master file that

11 was submitted by the biomaterials supplier

12 to the Secretary of Health and Human

13 Services and that is currently maintained

14 by the biomaterials supplier of purposes of

15 premarket approval of medical devices; or

16 (iii)(I) included in the submissions for

17 the purposes of premarket approval or re18 view by the Secretary of Health and

19 Human Services under section 510, 513,

20 515, or 520 of the Federal Food, Drug,

21 and Cosmetic Act (21 U.S.C. 360, 360c,

22 360e, or 360j); and

23 (II) have received clearance from the

24 Secretary of Health and Human Services,

25 if such specifications were provided by the
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1 manufacturer to the biomaterials supplier

2 and were not expressly repudiated by the

3 biomaterials supplier prior to the accept4 ance by the raw materials or component

5 parts;

6 (2) the biomaterials supplier intentionally and

7 wrongfully withheld or misrepresented information

8 that is material and relevant to the harm suffered

9 by the claimant; or

10 (3) the biomaterials supplier had actual knowl11 edge of prospective fraudulent or malicious activities

12 in the use of its supplies where such activities are

13 relevant to the harm suffered by the claimant.

14 SEC. 302. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

15 AGAINST BIOMATERIALS SUPPLIERS.

16 (a) MOTION TO DISMISS.—

17 (1) GENERAL RULE.—Any biomaterials supplier

18 who is a defendant in any product liability action in19 volving a medical device which allegedly caused the

20 harm for which the action is brought and who did

21 not take part in the design, manufacture, or sale of

22 such medical device may, at any time during which

23 a motion to dismiss may be filed under an applicable

24 law, move to dismiss the action on the grounds

25 that—
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1 (A) the claimant has failed to establish

2 that the supplier furnished raw materials or

3 component parts in violation of applicable con4 tractual requirements or specifications agreed

5 to by the biomaterials supplier; or

6 (B) the claimant has failed to comply with

7 the requirements of subsection (b).

8 (2) EXCEPTION.—The biomaterials supplier

9 may not move to dismiss the action if—

10 (A) the biomaterials supplier intentionally

11 and wrongfully withheld or misrepresented in12 formation that is material and relevant to the

13 harm suffered by the claimant; or

14 (B) the biomaterials supplier had actual

15 knowledge of prospective fraudulent or mali16 cious activities in the use of its supplies where

17 such activities are relevant to the harm suffered

18 by the claimant.

19 (b) MANUFACTURER OF MEDICAL DEVICE SHALL BE

20 NAMED A PARTY.—The claimant shall be required to

21 name the manufacturer of the medical device to which the

22 biomaterials supplier furnished raw materials or compo23 nent parts as a party to the product liability action, un24 less—
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1 (1) the manufacturer is subject to service of

2 process solely in a jurisdiction in which the

3 biomaterials supplier is not domiciled or subject to

4 a service of process; or

5 (2) an action against the manufacturer is

6 barred by applicable law.

7 (c) PROCEEDINGS ON MOTION TO DISMISS.—The fol8 lowing rules shall apply to any proceeding on a motion

9 to dismiss filed under this section:

10 (1) AFFIDAVITS RELATING TO STATUS OF DE11 FENDANT.—

12 (A) DEFENDANT AFFIDAVIT.—The defend13 ant in the action may support a motion to dis14 miss by filing an affidavit demonstrating that

15 defendant is a biomaterials supplier and that it

16 is neither the manufacturer nor the product

17 seller of the medical device which caused the

18 harm alleged by the claimant.

19 (B) RESPONSE TO MOTION TO DISMISS.—

20 In response to a motion to dismiss described in

21 this section, the claimant may submit an affida22 vit demonstrating why it asserts that—

23 (i) the defendant who filed the motion

24 to dismiss is not a biomaterials supplier
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1 with respect to the medical device which

2 caused the harm alleged by the claimant;

3 (ii) on what basis it asserts that the

4 supplier furnished raw materials or compo5 nent parts in violation of applicable con6 tractual requirements or specifications

7 agreed to by the biomaterials supplier;

8 (iii) the biomaterials supplier inten9 tionally and wrongfully withheld or mis10 represented information that is material

11 and relevant to the harm suffered by the

12 claimant; or

13 (iv) the biomaterials supplier had ac14 tual knowledge of prospective fraudulent or

15 malicious activities in the use of its sup16 plies where such activities are relevant to

17 the harm suffered by the claimant.

18 (2) EFFECT OF MOTION TO DISMISS ON DIS19 COVERY.—If a defendant files a motion to dismiss,

20 no discovery shall be permitted in connection with

21 the action that is the subject of the motion, unless

22 the affidavits submitted in accordance with this

23 section raise material issues of fact concerning

24 whether—
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1 (A) the supplier furnished raw materials or

2 component parts in violation of applicable con3 tractual requirements or specifications agreed

4 to by the biomaterials supplier;

5 (B) the biomaterials supplier intentionally

6 and wrongfully withheld or misrepresented in7 formation that is material and relevant to the

8 harm suffered by the claimant; or

9 (C) the biomaterials supplier had actual

10 knowledge of prospective fraudulent or mali11 cious activities in the use of its supplies where

12 such activities are relevant to the harm suffered

13 by the claimant.

14 Any such discovery shall be limited solely to such

15 material facts.

16 (3) RESPONSE TO MOTION TO DISMISS.—The

17 court shall rule on the motion to dismiss solely on

18 the basis of the affidavits filed under this section

19 and on the basis of any evidence developed in the

20 course of discovery under paragraph (2) and subse21 quently submitted to the court in accordance with

22 applicable rules of evidence.

23 (d) ATTORNEY FEES.—The court shall require the

24 claimant to compensate the biomaterials supplier for at25 torney fees and costs, if—
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1 (1) the claimant named or joined the

2 biomaterials supplier; and

3 (2) the court found the claim against the

4 biomaterials supplier to be without merit and frivo5 lous.

6 SEC. 303. DEFINITIONS.

7 For purposes of this title:

8 (1) The term ‘‘biomaterials supplier’’ means an

9 entity that directly or indirectly supplies, or licenses

10 another person to supply, a component part or raw

11 material for use in the manufacture of a medical de12 vice—

13 (A) that is intended by the manufacturer

14 of the device—

15 (i) to be placed into a surgically or

16 naturally formed or existing cavity of the

17 body for a period of at least 30 days; or

18 (ii) to remain in contact with bodily

19 fluids of internal human tissue through a

20 surgically produced opening for a period of

21 less than 30 days; and

22 (B) suture materials used in implant pro23 cedures.

24 (2) Notwithstanding paragraph (1), the term

25 ‘‘biomaterials supplier’’ excludes any person, with re-
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1 spect to a medical device which is the subject of a

2 product liability action—

3 (A) who is engaged in the manufacture,

4 preparation, propagation, compounding, or

5 processing (as defined in section 510(a)(1) of

6 the Federal Food, Drug, and Cosmetic Act (21

7 U.S.C. 360(a)(1)) of the medical device, and

8 has registered with the Secretary of Health and

9 Human Services pursuant to section 510 of the

10 Federal Food, Drug, and Cosmetic Act (21

11 U.S.C. 360) and the regulations issued under

12 such section, and has included the medical de13 vice on a list of devices filed with the Secretary

14 of Health and Human Services pursuant to sec15 tion 510(j) of such Act (21 U.S.C. 360(j)) and

16 the regulations issued under such section; or

17 (B) who, in the course of a business con18 ducted for that purpose, has sold, distributed,

19 leased, packaged, labeled, or otherwise placed

20 the implant in the stream of commerce after it

21 was manufactured.

22 (3) The term ‘‘harm’’ means any physical in23 jury, illness, disease, or death or damage to property

24 caused by a product. The term does not include
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1 commercial loss or loss or damage to a product it2 self.

3 (4) The term ‘‘product liability action’’ means

4 a civil action brought on any theory for harm caused

5 by a product or product use.

6 TITLE IV—EFFECT ON OTHER

7 LAW; EFFECTIVE DATE

8 SEC. 401. EFFECT ON OTHER LAW.

9 Nothing in title I, II, or III shall be construed to—

10 (1) waive or affect any defense of sovereign im11 munity asserted by any State under any law;

12 (2) supersede any Federal law;

13 (3) waive or affect any defense of sovereign im14 munity asserted by the United States;

15 (4) affect the applicability of any provision of

16 chapter 97 of title 28, United States Code;

17 (5) preempt State choice-of-law rules with re18 spect to claims brought by a foreign nation or a citi19 zen of a foreign nation; or

20 (6) affect the right of any court to transfer

21 venue or to apply the law of a foreign nation or to

22 dismiss a claim of a foreign nation or of a citizen

23 of a foreign nation on the ground of inconvenient

24 forum.
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1 SEC. 402. FEDERAL CAUSE OF ACTION PRECLUDED.

2 The district courts of the United States shall not

3 have jurisdiction pursuant to this Act based on section

4 1331 or 1337 of title 28, United States Code.

5 SEC. 403. EFFECTIVE DATE.

6 Titles I, II, and III shall apply with respect to actions

7 which are commenced after the date of the enactment of

8 this Act.

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