II

105TH CONGRESS

2D SESSION H. R. 872

IN THE SENATE OF THE UNITED STATES

JULY 30, 1998

Received

AN ACT

To establish rules governing product liability actions against

raw materials and bulk component suppliers to medical

device manufacturers, 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,
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1 SECTION 1. SHORT TITLE

2 This Act may be cited as the ‘‘Biomaterials Access

3 Assurance Act of 1998’’.

4 SEC. 2. FINDINGS.

5 The Congress finds that—

6 (1) each year millions of citizens of the United

7 States depend on the availability of lifesaving or life8 enhancing medical devices, many of which are per9 manently implantable within the human body;

10 (2) a continued supply of raw materials and

11 component parts is necessary for the invention, de12 velopment, improvement, and maintenance of the

13 supply of the devices;

14 (3) most of the medical devices are made with

15 raw materials and component parts that—

16 (A) move in interstate commerce;

17 (B) are not designed or manufactured spe18 cifically for use in medical devices; and

19 (C) come in contact with internal human

20 tissue;

21 (4) the raw materials and component parts also

22 are used in a variety of nonmedical products;

23 (5) because small quantities of the raw mate24 rials and component parts are used for medical de25 vices, sales of raw materials and component parts

26 for medical devices constitute an extremely small
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1 portion of the overall market for the raw materials

2 and component parts;

3 (6) under the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 301 et seq.) manufacturers of

5 medical devices are required to demonstrate that the

6 medical devices are safe and effective, including

7 demonstrating that the products are properly de8 signed and have adequate warnings or instructions;

9 (7) notwithstanding the fact that raw materials

10 and component parts suppliers do not design,

11 produce, or test a final medical device, the suppliers

12 have been the subject of actions alleging inad13 equate—

14 (A) design and testing of medical devices

15 manufactured with materials or parts supplied

16 by the suppliers; or

17 (B) warnings related to the use of such

18 medical devices;

19 (8) even though suppliers of raw materials and

20 component parts have very rarely been held liable in

21 such actions, such suppliers have ceased supplying

22 certain raw materials and component parts for use

23 in medical devices for a number of reasons, includ24 ing concerns about the costs of such litigation;
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1 (9) unless alternate sources of supply can be

2 found, the unavailability of raw materials and com3 ponent parts for medical devices will lead to unavail4 ability of lifesaving and life-enhancing medical de5 vices;

6 (10) because other suppliers of the raw mate7 rials and component parts in foreign nations are re8 fusing to sell raw materials or component parts for

9 use in manufacturing certain medical devices in the

10 United States, the prospects for development of new

11 sources of supply for the full range of threatened

12 raw materials and component parts for medical de13 vices are remote;

14 (11) it is unlikely that the small market for

15 such raw materials and component parts in the

16 United States could support the large investment

17 needed to develop new suppliers of such raw mate18 rials and component parts;

19 (12) attempts to develop such new suppliers

20 would raise the cost of medical devices;

21 (13) courts that have considered the duties of

22 the suppliers of the raw materials and component

23 parts have generally found that the suppliers do not

24 have a duty—
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1 (A) to evaluate the safety and efficacy of

2 the use of a raw material or component part in

3 a medical device; or

4 (B) to warn consumers concerning the

5 safety and effectiveness of a medical device;

6 (14) because medical devices and the raw mate7 rials and component parts used in their manufacture

8 move in interstate commerce, a shortage of such raw

9 materials and component parts affects interstate

10 commerce;

11 (15) in order to safeguard the availability of a

12 wide variety of lifesaving and life-enhancing medical

13 devices, immediate action is needed—

14 (A) to clarify the permissible bases of li15 ability for suppliers of raw materials and com16 ponent parts for medical devices; and

17 (B) to provide expeditious procedures to

18 dispose of unwarranted suits against the suppli19 ers in such manner as to minimize litigation

20 costs;

21 (16) the several States and their courts are the

22 primary architects and regulators of our tort system;

23 Congress, however, must, in certain circumstances

24 involving the national interest, address tort issues,

25 and a threatened shortage of raw materials and
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1 component parts for life-saving medical devices is

2 one such circumstance; and

3 (17) the protections set forth in this Act are

4 needed to assure the continued supply of materials

5 for life-saving medical devices, although such protec6 tions do not protect negligent suppliers.

7 SEC. 3. DEFINITIONS.

8 As used in this Act:

9 (1) BIOMATERIALS SUPPLIER.—

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

11 supplier’’ means an entity that directly or indi12 rectly supplies a component part or raw mate13 rial for use in the manufacture of an implant.

14 (B) PERSONS INCLUDED.—Such term in15 cludes any person who—

16 (i) has submitted master files to the

17 Secretary for purposes of premarket ap18 proval of a medical device; or

19 (ii) licenses a biomaterials supplier to

20 produce component parts or raw materials.

21 (2) CLAIMANT.—

22 (A) IN GENERAL.—The term ‘‘claimant’’

23 means any person who brings a civil action, or

24 on whose behalf a civil action is brought, aris25 ing from harm allegedly caused directly or indi-
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1 rectly by an implant, including a person other

2 than the individual into whose body, or in con3 tact with whose blood or tissue, the implant is

4 placed, who claims to have suffered harm as a

5 result of the implant.

6 (B) ACTION BROUGHT ON BEHALF OF AN

7 ESTATE.—With respect to an action brought on

8 behalf of or through the estate of a deceased in9 dividual into whose body, or in contact with

10 whose blood or tissue the implant was placed,

11 such term includes the decedent that is the sub12 ject of the action.

13 (C) ACTION BROUGHT ON BEHALF OF A

14 MINOR OR INCOMPETENT.—With respect to an

15 action brought on behalf of or through a minor

16 or incompetent, such term includes the parent

17 or guardian of the minor or incompetent.

18 (D) EXCLUSIONS.—Such term does not in19 clude—

20 (i) a provider of professional health

21 care services in any case in which—

22 (I) the sale or use of an implant

23 is incidental to such services; and

24 (II) the essence of the profes25 sional health care services provided is
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1 the furnishing of judgment, skill, or

2 services;

3 (ii) a person acting in the capacity of

4 a manufacturer, seller, or biomaterials sup5 plier; or

6 (iii) a person alleging harm caused by

7 either the silicone gel or the silicone enve8 lope utilized in a breast implant containing

9 silicone gel, except that—

10 (I) neither the exclusion provided

11 by this clause nor any other provision

12 of this Act may be construed as a

13 finding that silicone gel (or any other

14 form of silicone) may or may not

15 cause harm; and

16 (II) the existence of the exclusion

17 under this clause may not—

18 (aa) be disclosed to a jury in

19 any civil action or other proceed20 ing; and

21 (bb) except as necessary to

22 establish the applicability of this

23 Act, otherwise be presented in

24 any civil action or other proceed25 ing.
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1 (3) COMPONENT PART.—

2 (A) IN GENERAL.—The term ‘‘component

3 part’’ means a manufactured piece of an im4 plant.

5 (B) CERTAIN COMPONENTS.—Such term

6 includes a manufactured piece of an implant

7 that—

8 (i) has significant non-implant appli9 cations; and

10 (ii) alone, has no implant value or

11 purpose, but when combined with other

12 component parts and materials, constitutes

13 an implant.

14 (4) HARM.—

15 (A) IN GENERAL.—The term ‘‘harm’’

16 means—

17 (i) any injury to or damage suffered

18 by an individual;

19 (ii) any illness, disease, or death of

20 that individual resulting from that injury

21 or damage; and

22 (iii) any loss to that individual or any

23 other individual resulting from that injury

24 or damage.
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1 (B) EXCLUSION.—The term does not in2 clude any commercial loss or loss of or damage

3 to an implant.

4 (5) IMPLANT.—The term ‘‘implant’’ means—

5 (A) a medical device that is intended by

6 the manufacturer of the device—

7 (i) to be placed into a surgically or

8 naturally formed or existing cavity of the

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

10 (ii) to remain in contact with bodily

11 fluids or internal human tissue through a

12 surgically produced opening for a period of

13 less than 30 days; and

14 (B) suture materials used in implant pro15 cedures.

16 (6) MANUFACTURER.—The term ‘‘manufac17 turer’’ means any person who, with respect to an im18 plant—

19 (A) is engaged in the manufacture, prepa20 ration, propagation, compounding, or processing

21 (as defined in section 510(a)(1) of the Federal

22 Food, Drug, and Cosmetic Act (21 U.S.C.

23 360(a)(1)) of the implant; and

24 (B) is required—
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1 (i) to register with the Secretary pur2 suant to section 510 of the Federal Food,

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

4 and the regulations issued under such sec5 tion; and

6 (ii) to include the implant on a list of

7 devices filed with the Secretary pursuant

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

9 360(j)) and the regulations issued under

10 such section.

11 (7) MEDICAL DEVICE.—The term ‘‘medical de12 vice’’ means a device, as defined in section 201(h)

13 of the Federal Food, Drug, and Cosmetic Act (21

14 U.S.C. 321(h)), and includes any device component

15 of any combination product as that term is used in

16 section 503(g) of such Act (21 U.S.C. 353(g)).

17 (8) RAW MATERIAL.—The term ‘‘raw material’’

18 means a substance or product that—

19 (A) has a generic use; and

20 (B) may be used in an application other

21 than an implant.

22 (9) SECRETARY.—The term ‘‘Secretary’’ means

23 the Secretary of Health and Human Services.

24 (10) SELLER.—
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1 (A) IN GENERAL.—The term ‘‘seller’’

2 means a person who, in the course of a business

3 conducted for that purpose, sells, distributes,

4 leases, packages, labels, or otherwise places an

5 implant in the stream of commerce.

6 (B) EXCLUSIONS.—The term does not in7 clude—

8 (i) a seller or lessor of real property;

9 (ii) a provider of professional health

10 care services in any case in which—

11 (I) the sale or use of the implant

12 is incidental to such services; and

13 (II) the essence of the profes14 sional health care services provided is

15 the furnishing of judgment, skill, or

16 services; or

17 (iii) any person who acts in only a fi18 nancial capacity with respect to the sale of

19 an implant.

20 SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PRE21 EMPTION.

22 (a) GENERAL REQUIREMENTS.—

23 (1) IN GENERAL.—In any civil action covered

24 by this Act, a biomaterials supplier may—
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1 (A) raise any exclusion from liability set

2 forth in section 5; and

3 (B) make a motion for dismissal or for

4 summary judgment as set forth in section 6.

5 (2) PROCEDURES.—Notwithstanding any other

6 provision of law, a Federal or State court in which

7 an action covered by this Act is pending shall, in

8 connection with a motion under section 6 or 7, use

9 the procedures set forth in this Act.

10 (b) APPLICABILITY.—

11 (1) IN GENERAL.—Except as provided in para12 graph (2), this Act applies to any civil action

13 brought by a claimant, whether in a Federal or

14 State court, on the basis of any legal theory, for

15 harm allegedly caused, directly or indirectly, by an

16 implant.

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

18 purchaser of a medical device, purchased for use in

19 providing professional health care services, for loss

20 or damage to an implant or for commercial loss to

21 the purchaser—

22 (A) shall not be considered an action that

23 is subject to this Act; and

24 (B) shall be governed by applicable com25 mercial or contract law.
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1 (c) SCOPE OF PREEMPTION.—

2 (1) IN GENERAL.—This Act supersedes any

3 State law regarding recovery for harm caused by an

4 implant and any rule of procedure applicable to a

5 civil action to recover damages for such harm only

6 to the extent that this Act establishes a rule of law

7 applicable to the recovery of such damages.

8 (2) APPLICABILITY OF OTHER LAWS.—Any

9 issue that arises under this Act and that is not gov10 erned by a rule of law applicable to the recovery of

11 damages described in paragraph (1) shall be gov12 erned by applicable Federal or State law.

13 (d) STATUTORY CONSTRUCTION.—Nothing in this

14 Act may be construed—

15 (1) to affect any defense available to a defend16 ant under any other provisions of Federal or State

17 law in an action alleging harm caused by an im18 plant; or

19 (2) to create a cause of action or Federal court

20 jurisdiction pursuant to section 1331 or 1337 of title

21 28, United States Code, that otherwise would not

22 exist under applicable Federal or State law.

23 SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

24 (a) IN GENERAL.—Except as provided in section 7,

25 a biomaterials supplier shall not be liable for harm to a
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1 claimant caused by an implant unless such supplier is lia2 ble—

3 (1) as a manufacturer of the implant, as pro4 vided in subsection (b);

5 (2) as a seller of the implant, as provided in

6 subsection (c); or

7 (3) for furnishing raw materials or component

8 parts for the implant that failed to meet applicable

9 contractual requirements or specifications, as pro10 vided in subsection (d).

11 (b) LIABILITY AS MANUFACTURER.—

12 (1) IN GENERAL.—A biomaterials supplier may,

13 to the extent required and permitted by any other

14 applicable law, be liable for harm to a claimant

15 caused by an implant if the biomaterials supplier is

16 the manufacturer of the implant.

17 (2) GROUNDS FOR LIABILITY.—The biomate18 rials supplier may be considered the manufacturer of

19 the implant that allegedly caused harm to a claimant

20 only if the biomaterials supplier—

21 (A)(i) registered or was required to reg22 ister with the Secretary pursuant to section 510

23 of the Federal Food, Drug, and Cosmetic Act

24 (21 U.S.C. 360) and the regulations issued

25 under such section; and
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1 (ii) included or was required to include the

2 implant on a list of devices filed with the Sec3 retary pursuant to section 510(j) of such Act

4 (21 U.S.C. 360(j)) and the regulations issued

5 under such section;

6 (B) is the subject of a declaration issued

7 by the Secretary pursuant to paragraph (3)

8 that states that the supplier, with respect to the

9 implant that allegedly caused harm to the

10 claimant, was required to—

11 (i) register with the Secretary under

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

13 and the regulations issued under such sec14 tion, but failed to do so; or

15 (ii) include the implant on a list of de16 vices filed with the Secretary pursuant to

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

18 360(j)) and the regulations issued under

19 such section, but failed to do so; or

20 (C) is related by common ownership or

21 control to a person meeting all the requirements

22 described in subparagraph (A) or (B), if the

23 court deciding a motion to dismiss in accord24 ance with section 6(c)(3)(B)(i) finds, on the

25 basis of affidavits submitted in accordance with
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1 section 6, that it is necessary to impose liability

2 on the biomaterials supplier as a manufacturer

3 because the related manufacturer meeting the

4 requirements of subparagraph (A) or (B) lacks

5 sufficient financial resources to satisfy any

6 judgment that the court feels it is likely to

7 enter should the claimant prevail.

8 (3) ADMINISTRATIVE PROCEDURES.—

9 (A) IN GENERAL.—The Secretary may

10 issue a declaration described in paragraph

11 (2)(B) on the motion of the Secretary or on pe12 tition by any person, after providing—

13 (i) notice to the affected persons; and

14 (ii) an opportunity for an informal

15 hearing.

16 (B) DOCKETING AND FINAL DECISION.—

17 Immediately upon receipt of a petition filed

18 pursuant to this paragraph, the Secretary shall

19 docket the petition. Not later than 120 days

20 after the petition is filed, the Secretary shall

21 issue a final decision on the petition.

22 (C) APPLICABILITY OF STATUTE OF LIMI23 TATIONS.—Any applicable statute of limitations

24 shall toll during the period from the time a

25 claimant files a petition with the Secretary
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1 under this paragraph until such time as either

2 (i) the Secretary issues a final decision on the

3 petition, or (ii) the petition is withdrawn.

4 (D) STAY PENDING PETITION FOR DEC5 LARATION.—If a claimant has filed a petition

6 for a declaration with respect to a defendant,

7 and the Secretary has not issued a final deci8 sion on the petition, the court shall stay all pro9 ceedings with respect to that defendant until

10 such time as the Secretary has issued a final

11 decision on the petition.

12 (c) LIABILITY AS SELLER.—A biomaterials supplier

13 may, to the extent required and permitted by any other

14 applicable law, be liable as a seller for harm to a claimant

15 caused by an implant only if—

16 (1) the biomaterials supplier—

17 (A) held title to the implant and then

18 acted as a seller of the implant after its initial

19 sale by the manufacturer; or

20 (B) acted under contract as a seller to ar21 range for the transfer of the implant directly to

22 the claimant after the initial sale by the manu23 facturer of the implant; or

24 (2) the biomaterials supplier is related by com25 mon ownership or control to a person meeting all the
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1 requirements described in paragraph (1), if a court

2 deciding a motion to dismiss in accordance with sec3 tion 6(c)(3)(B)(ii) finds, on the basis of affidavits

4 submitted in accordance with section 6, that it is

5 necessary to impose liability on the biomaterials sup6 plier as a seller because the related seller meeting

7 the requirements of paragraph (1) lacks sufficient fi8 nancial resources to satisfy any judgment that the

9 court feels it is likely to enter should the claimant

10 prevail.

11 (d) LIABILITY FOR FAILURE TO MEET APPLICABLE

12 CONTRACTUAL REQUIREMENTS OR SPECIFICATIONS.—A

13 biomaterials supplier may, to the extent required and per14 mitted by any other applicable law, be liable for harm to

15 a claimant caused by an implant if the claimant in an ac16 tion shows, by a preponderance of the evidence, that—

17 (1) the biomaterials supplier supplied raw mate18 rials or component parts for use in the implant that

19 either—

20 (A) did not constitute the product de21 scribed in the contract between the biomaterials

22 supplier and the person who contracted for the

23 supplying of the product; or

24 (B) failed to meet any specifications that

25 were—
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1 (i) accepted, pursuant to applicable

2 law, by the biomaterials supplier;

3 (ii) published by the biomaterials sup4 plier;

5 (iii) provided by the biomaterials sup6 plier to the person who contracted for such

7 product;

8 (iv) contained in a master file that

9 was submitted by the biomaterials supplier

10 to the Secretary and that is currently

11 maintained by the biomaterials supplier for

12 purposes of premarket approval of medical

13 devices; or

14 (v) included in the submissions for

15 purposes of premarket approval or review

16 by the Secretary under section 510, 513,

17 515, or 520 of the Federal Food, Drug,

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

19 360e, or 360j), and received clearance

20 from the Secretary if such specifications

21 were accepted, pursuant to applicable law,

22 by the biomaterials supplier; and

23 (2) such failure to meet applicable contractual

24 requirements or specifications was an actual and

25 proximate cause of the harm to the claimant.
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1 SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

2 AGAINST BIOMATERIALS SUPPLIERS.

3 (a) MOTION TO DISMISS.—A defendant may, at any

4 time during which a motion to dismiss may be filed under

5 applicable law, move to dismiss an action against it on

6 the grounds that the defendant is a biomaterials supplier

7 and one or more of the following:

8 (1) The defendant is not liable as a manufac9 turer, as provided in section 5(b).

10 (2) The defendant is not liable as a seller, as

11 provided in section 5(c).

12 (3) The defendant is not liable for furnishing

13 raw materials or component parts for the implant

14 that failed to meet applicable contractual require15 ments or specifications, as provided in section 5(d).

16 (4) The claimant did not name the manufac17 turer as a party to the action, as provided in sub18 section (b).

19 (b) MANUFACTURER OF IMPLANT SHALL BE NAMED

20 A PARTY.—In any civil action covered by this Act, the

21 claimant shall be required to name the manufacturer of

22 the implant as a party to the action, unless—

23 (1) the manufacturer is subject to service of

24 process solely in a jurisdiction in which the biomate25 rials supplier is not domiciled or subject to a service

26 of process; or
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1 (2) a claim against the manufacturer is barred

2 by applicable law or rule of practice.

3 (c) PROCEEDING ON MOTION TO DISMISS.—The fol4 lowing rules shall apply to any proceeding on a motion

5 to dismiss filed by a defendant under this section:

6 (1) EFFECT OF MOTION TO DISMISS ON DIS7 COVERY.—

8 (A) IN GENERAL.—Except as provided in

9 subparagraph (B), if a defendant files a motion

10 to dismiss under subsection (a), no discovery

11 shall be permitted in connection with the action

12 that is the subject of the motion, other than

13 discovery necessary to determine a motion to

14 dismiss for lack of jurisdiction, until such time

15 as the court rules on the motion to dismiss.

16 (B) DISCOVERY.—If a defendant files a

17 motion to dismiss under subsection (a)(3) on

18 the grounds that it did not furnish raw mate19 rials or component parts for the implant that

20 failed to meet applicable contractual require21 ments or specifications, the court may permit

22 discovery limited to issues that are directly rel23 evant to—

24 (i) the pending motion to dismiss; or

25 (ii) the jurisdiction of the court.
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1 (2) AFFIDAVITS.—

2 (A) DEFENDANT.—A defendant may sub3 mit affidavits supporting the grounds for dis4 missal contained in its motion to dismiss under

5 subsection (a). If the motion is made under

6 subsection (a)(1), the defendant may submit an

7 affidavit demonstrating that the defendant has

8 not included the implant on a list, if any, filed

9 with the Secretary pursuant to section 510(j) of

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

11 U.S.C. 360(j)).

12 (B) CLAIMANT.—In response to a motion

13 to dismiss, the claimant may submit affidavits

14 demonstrating that—

15 (i) the Secretary has, with respect to

16 the defendant and the implant that alleg17 edly caused harm to the claimant, issued a

18 declaration pursuant to section 5(b)(2)(B);

19 or

20 (ii) the defendant is a seller of the im21 plant who is liable under section 5(c).

22 (3) BASIS OF RULING ON MOTION TO DIS23 MISS.—The court shall rule on a motion to dismiss

24 filed under subsection (a) solely on the basis of the

25 pleadings and affidavits of the parties made pursu-
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1 ant to this subsection. The court shall grant a mo2 tion to dismiss filed under subsection (a)—

3 (A) unless the claimant submits a valid af4 fidavit that demonstrates that the defendant is

5 not a biomaterials supplier;

6 (B) unless the court determines, to the ex7 tent raised in the pleadings and affidavits, that

8 one or more of the following apply:

9 (i) the defendant may be liable as a

10 manufacturer, as provided in section 5(b);

11 (ii) the defendant may be liable as a

12 seller, as provided in section 5(c); or

13 (iii) the defendant may be liable for

14 furnishing raw materials or component

15 parts for the implant that failed to meet

16 applicable contractual requirements or

17 specifications, as provided in section 5(d);

18 or

19 (C) if the claimant did not name the man20 ufacturer as a party to the action, as provided

21 in subsection (b).

22 (4) TREATMENT OF MOTION AS MOTION FOR

23 SUMMARY JUDGMENT.—The court may treat a mo24 tion to dismiss as a motion for summary judgment

25 subject to subsection (d) in order to determine
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1 whether the pleadings and affidavits, in connection

2 with such action, raise genuine issues of material

3 fact concerning whether the defendant furnished raw

4 materials or component parts of the implant that

5 failed to meet applicable contractual requirements or

6 specifications as provided in section 5(d).

7 (d) SUMMARY JUDGMENT.—

8 (1) IN GENERAL.—

9 (A) BASIS FOR ENTRY OF JUDGMENT.—If

10 a motion to dismiss of a biomaterials supplier

11 is to be treated as a motion for summary judg12 ment under subsection (c)(4) or if a biomate13 rials supplier moves for summary judgment, the

14 biomaterials supplier shall be entitled to entry

15 of judgment without trial if the court finds

16 there is no genuine issue of material fact for

17 each applicable element set forth in paragraphs

18 (1) and (2) of section 5(d).

19 (B) ISSUES OF MATERIAL FACT.—With re20 spect to a finding made under subparagraph

21 (A), the court shall consider a genuine issue of

22 material fact to exist only if the evidence sub23 mitted by the claimant would be sufficient to

24 allow a reasonable jury to reach a verdict for
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1 the claimant if the jury found the evidence to

2 be credible.

3 (2) DISCOVERY MADE PRIOR TO A RULING ON

4 A MOTION FOR SUMMARY JUDGMENT.—If, under ap5 plicable rules, the court permits discovery prior to a

6 ruling on a motion for summary judgment governed

7 by section 5(d), such discovery shall be limited solely

8 to establishing whether a genuine issue of material

9 fact exists as to the applicable elements set forth in

10 paragraphs (1) and (2) of section 5(d).

11 (3) DISCOVERY WITH RESPECT TO A BIOMATE12 RIALS SUPPLIER.—A biomaterials supplier shall be

13 subject to discovery in connection with a motion

14 seeking dismissal or summary judgment on the basis

15 of the inapplicability of section 5(d) or the failure to

16 establish the applicable elements of section 5(d) sole17 ly to the extent permitted by the applicable Federal

18 or State rules for discovery against nonparties.

19 (e) DISMISSAL WITH PREJUDICE.—An order grant20 ing a motion to dismiss or for summary judgment pursu21 ant to this section shall be entered with prejudice, except

22 insofar as the moving defendant may be rejoined to the

23 action as provided in section 7.

24 (f) MANUFACTURER CONDUCT OF LITIGATION.—The

25 manufacturer of an implant that is the subject of an ac-
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1 tion covered under this Act shall be permitted to conduct

2 litigation on any motion for summary judgment or dismis3 sal filed by a biomaterials supplier who is a defendant

4 under this section on behalf of such supplier if the manu5 facturer and any other defendant in such action enter into

6 a valid and applicable contractual agreement under which

7 the manufacturer agrees to bear the cost of such litigation

8 or to conduct such litigation.

9 SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED BIOMATE10 RIALS SUPPLIER.

11 (a) IMPLEADING OF DISMISSED DEFENDANT.—A

12 court, upon motion by a manufacturer or a claimant with13 in 90 days after entry of a final judgment in an action

14 by the claimant against a manufacturer, and notwith15 standing any otherwise applicable statute of limitations,

16 may implead a biomaterials supplier who has been dis17 missed from the action pursuant to this Act if—

18 (1) the manufacturer has made an assertion, ei19 ther in a motion or other pleading filed with the

20 court or in an opening or closing statement at trial,

21 or as part of a claim for contribution or indemnifica22 tion, and the court finds based on the court’s inde23 pendent review of the evidence contained in the

24 record of the action, that under applicable law—
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1 (A) the negligence or intentionally tortious

2 conduct of the dismissed supplier was an actual

3 and proximate cause of the harm to the claim4 ant; and

5 (B) the manufacturer’s liability for dam6 ages should be reduced in whole or in part be7 cause of such negligence or intentionally

8 tortious conduct; or

9 (2) the claimant has moved to implead the sup10 plier and the court finds, based on the court’s inde11 pendent review of the evidence contained in the

12 record of the action, that under applicable law—

13 (A) the negligence or intentionally tortious

14 conduct of the dismissed supplier was an actual

15 and proximate cause of the harm to the claim16 ant; and

17 (B) the claimant is unlikely to be able to

18 recover the full amount of its damages from the

19 remaining defendants.

20 (b) STANDARD OF LIABILITY.—Notwithstanding any

21 preliminary finding under subsection (a), a biomaterials

22 supplier who has been impleaded into an action covered

23 by this Act, as provided for in this section—

24 (1) may, prior to entry of judgment on the

25 claim against it, supplement the record of the pro-
29

HR 872 RDS

1 ceeding that was developed prior to the grant of the

2 motion for impleader under subsection (a); and

3 (2) may be found liable to a manufacturer or

4 a claimant only to the extent required and permitted

5 by any applicable State or Federal law other than

6 this Act.

7 (c) DISCOVERY.—Nothing in this section shall give

8 a claimant or any other party the right to obtain discovery

9 from a biomaterials supplier at any time prior to grant

10 of a motion for impleader beyond that allowed under sec11 tion 6.

12 SEC. 8. EFFECTIVE DATE.

13 This Act shall apply to all civil actions covered under

14 this Act that are commenced on or after the date of enact15 ment of this Act, including any such action with respect

16 to which the harm asserted in the action or the conduct

17 that caused the harm occurred before the date of enact18 ment of this Act.

Passed the House of Representatives July 30 (legislative day, July 29), 1998.

Attest: ROBIN H. CARLE,

Clerk.