I

105TH CONGRESS

1ST SESSION H. R. 872

To establish rules governing product liability actions against raw materials

and bulk component suppliers to medical device manufacturers, and

for other purposes.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 27, 1997

Mr. GEKAS (for himself, Mr. BILBRAY, Mr. BRYANT, Mr. BURR of North

Carolina, Mr. BUYER, Mr. CUNNINGHAM, Ms. DUNN, Mr. EHLERS, Mr.

ENGLISH of Pennsylvania, Ms. ESHOO, Mr. GALLEGLY, Mr. GREENWOOD, Mr. GUTKNECHT, Mr. HASTERT, Mr. HAYWORTH, Mrs. KELLY,

Mr. KIND, Mr. LUTHER, Mr. MCCOLLUM, Mr. MCINTOSH, Mr. PASTOR,

Mr. RAMSTAD, Mr. ROHRABACHER, Mr. SABO, Mr. SCHIFF, Mr. SENSENBRENNER, Mr. STUMP, and Mr. VENTO) 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 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,

3 SECTION 1. SHORT TITLE.

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

5 Assurance Act of 1997’’.
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1 SEC. 2. FINDINGS.

2 The Congress finds that—

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

4 States depend on the availability of lifesaving or life

5 enhancing medical devices, many of which are per6 manently implantable within the human body;

7 (2) a continued supply of raw materials and

8 component parts is necessary for the invention, de9 velopment, improvement, and maintenance of the

10 supply of the devices;

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

12 raw materials and component parts that—

13 (A) are not designed or manufactured spe14 cifically for use in medical devices; and

15 (B) come in contact with internal human

16 tissue;

17 (4) the raw materials and component parts also

18 are used in a variety of nonmedical products;

19 (5) because small quantities of the raw mate20 rials and component parts are used for medical de21 vices, sales of raw materials and component parts

22 for medical devices constitute an extremely small

23 portion of the overall market for the raw materials

24 and medical devices;

25 (6) under the Federal Food, Drug, and Cos26 metic Act (21 U.S.C. 301 et seq.), manufacturers of
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1 medical devices are required to demonstrate that the

2 medical devices are safe and effective, including

3 demonstrating that the products are properly de4 signed and have adequate warnings or instructions;

5 (7) notwithstanding the fact that raw materials

6 and component parts suppliers do not design,

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

8 have been the subject of actions alleging inad9 equate—

10 (A) design and testing of medical devices

11 manufactured with materials or parts supplied

12 by the suppliers; or

13 (B) warnings related to the use of such

14 medical devices;

15 (8) even though suppliers of raw materials and

16 component parts have very rarely been held liable in

17 such actions, such suppliers have ceased supplying

18 certain raw materials and component parts for use

19 in medical devices because the costs associated with

20 litigation in order to ensure a favorable judgment for

21 the suppliers far exceeds the total potential sales

22 revenues from sales by such suppliers to the medical

23 device industry;
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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; and

4 (B) to warn consumers concerning the

5 safety and effectiveness of a medical device;

6 (14) attempts to impose the duties referred to

7 in subparagraphs (A) and (B) of paragraph (13) on

8 suppliers of the raw materials and component parts

9 would cause more harm than good by driving the

10 suppliers to cease supplying manufacturers of medi11 cal devices; and

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

13 wide variety of lifesaving and life-enhancing medical

14 devices, immediate action is needed—

15 (A) to clarify the permissible bases of li16 ability for suppliers of raw materials and com17 ponent parts for medical devices; and

18 (B) to provide expeditious procedures to

19 dispose of unwarranted suits against the suppli20 ers in such manner as to minimize litigation

21 costs.

22 SEC. 3. DEFINITIONS.

23 As used in this Act:

24 (1) BIOMATERIALS SUPPLIER.—
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1 (A) IN GENERAL.—The term ‘‘biomaterials

2 supplier’’ means an entity that directly or indi3 rectly supplies a component part or raw mate4 rial for use in the manufacture of an implant.

5 (B) PERSONS INCLUDED.—Such term in6 cludes any person who—

7 (i) has submitted master files to the

8 Secretary for purposes of premarket ap9 proval of a medical device; or

10 (ii) licenses a biomaterials supplier to

11 produce component parts or raw materials.

12 (2) CLAIMANT.—

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

14 means any person who brings a civil action, or

15 on whose behalf a civil action is brought, aris16 ing from harm allegedly caused directly or indi17 rectly by an implant, including a person other

18 than the individual into whose body, or in con19 tact with whose blood or tissue, the implant is

20 placed, who claims to have suffered harm as a

21 result of the implant.

22 (B) ACTION BROUGHT ON BEHALF OF AN

23 ESTATE.—With respect to an action brought on

24 behalf of or through the estate of an individual

25 into whose body, or in contact with whose blood
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1 or tissue the implant is placed, such term in2 cludes the decedent that is the subject of the

3 action.

4 (C) ACTION BROUGHT ON BEHALF OF A

5 MINOR OR INCOMPETENT.—With respect to an

6 action brought on behalf of or through a minor

7 or incompetent, such term includes the parent

8 or guardian of the minor or incompetent.

9 (D) EXCLUSIONS.—Such term does not in10 clude—

11 (i) a provider of professional health

12 care services, in any case in which—

13 (I) the sale or use of an implant

14 is incidental to the transaction; and

15 (II) the essence of the trans16 action is the furnishing of judgment,

17 skill, or services;

18 (ii) a person acting in the capacity of

19 a manufacturer, seller, or biomaterials sup20 plier; or

21 (iii) a person alleging harm caused by

22 either the silicone gel or the silicone enve23 lope utilized in a breast implant containing

24 silicone gel, except that—
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1 (I) neither the exclusion provided

2 by this clause nor any other provision

3 of this Act may be construed as a

4 finding that silicone gel (or any other

5 form of silicone) may or may not

6 cause harm; and

7 (II) the existence of the exclusion

8 under this clause may not be disclosed

9 to a jury in any civil action or other

10 proceeding and, except as necessary to

11 establish the applicability of this Act,

12 otherwise be presented in any civil ac13 tion or other proceeding.

14 (3) COMPONENT PART.—

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

16 part’’ means a manufactured piece of an im17 plant.

18 (B) CERTAIN COMPONENTS.—Such term

19 includes a manufactured piece of an implant

20 that—

21 (i) has significant non-implant appli22 cations; and

23 (ii) alone, has no implant value or

24 purpose, but when combined with other
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1 component parts and materials, constitutes

2 an implant.

3 (4) HARM.—

4 (A) IN GENERAL.—The term ‘‘harm’’

5 means—

6 (i) any injury to or damage suffered

7 by an individual;

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

9 that individual resulting from that injury

10 or damage; and

11 (iii) any loss to that individual or any

12 other individual resulting from that injury

13 or damage.

14 (B) EXCLUSION.—The term does not in15 clude any commercial loss or loss of or damage

16 to an implant.

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

18 (A) a medical device that is intended by

19 the manufacturer of the device—

20 (i) to be placed into a surgically or

21 naturally formed or existing cavity of the

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

23 (ii) to remain in contact with bodily

24 fluids or internal human tissue through a
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1 surgically produced opening for a period of

2 less than 30 days; and

3 (B) suture materials used in implant pro4 cedures.

5 (6) MANUFACTURER.—The term ‘‘manufac6 turer’’ means any person who, with respect to an im7 plant—

8 (A) is engaged in the manufacture, prepa9 ration, propagation, compounding, or processing

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

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

12 360(a)(1)) of the implant; and

13 (B) is required—

14 (i) to register with the Secretary pur15 suant to section 510 of the Federal Food,

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

17 and the regulations issued under such sec18 tion; and

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

20 devices filed with the Secretary pursuant

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

22 360(j)) and the regulations issued under

23 such section.

24 (7) MEDICAL DEVICE.—The term ‘‘medical de25 vice’’ means a device, as defined in section 201(h)
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1 of the Federal Food, Drug, and Cosmetic Act (21

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

3 of any combination product as that term is used in

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

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

6 means a substance or product that—

7 (A) has a generic use; and

8 (B) may be used in an application other

9 than an implant.

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

11 the Secretary of Health and Human Services.

12 (10) SELLER.—

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

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

15 conducted for that purpose, sells, distributes,

16 leases, packages, labels, or otherwise places an

17 implant in the stream of commerce.

18 (B) EXCLUSIONS.—The term does not in19 clude—

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

21 (ii) a provider of professional services,

22 in any case in which the sale or use of an

23 implant is incidental to the transaction and

24 the essence of the transaction is the fur25 nishing of judgment, skill, or services; or
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1 (iii) any person who acts in only a fi2 nancial capacity with respect to the sale of

3 an implant.

4 SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PRE5 EMPTION.

6 (a) GENERAL REQUIREMENTS.—

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

8 by this Act, a biomaterials supplier may raise any

9 defense set forth in section 5.

10 (2) PROCEDURES.—Notwithstanding any other

11 provision of law, the Federal or State court in which

12 a civil action covered by this Act is pending shall, in

13 connection with a motion for dismissal or judgment

14 based on a defense described in paragraph (1), use

15 the procedures set forth in section 6.

16 (b) APPLICABILITY.—

17 (1) IN GENERAL.—Except as provided in para18 graph (2), notwithstanding any other provision of

19 law, this Act applies to any civil action brought by

20 a claimant, whether in a Federal or State court,

21 against a manufacturer, seller, or biomaterials sup22 plier, on the basis of any legal theory, for harm al23 legedly caused by an implant.

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

25 purchaser of a medical device for use in providing
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1 professional services against a manufacturer, seller,

2 or biomaterials supplier for loss or damage to an im3 plant or for commercial loss to the purchaser—

4 (A) shall not be considered an action that

5 is subject to this Act; and

6 (B) shall be governed by applicable com7 mercial or contract law.

8 (c) SCOPE OF PREEMPTION.—

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

10 State law regarding recovery for harm caused by an

11 implant and any rule of procedure applicable to a

12 civil action to recover damages for such harm only

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

14 applicable to the recovery of such damages.

15 (2) APPLICABILITY OF OTHER LAWS.—Any

16 issue that arises under this Act and that is not gov17 erned by a rule of law applicable to the recovery of

18 damages described in paragraph (1) shall be gov19 erned by applicable Federal or State law.

20 (d) STATUTORY CONSTRUCTION.—Nothing in this

21 Act may be construed—

22 (1) to affect any defense available to a defend23 ant under any other provisions of Federal or State

24 law in an action alleging harm caused by an im25 plant; or
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1 (2) to create a cause of action or Federal court

2 jurisdiction pursuant to section 1331 or 1337 of title

3 28, United States Code, that otherwise would not

4 exist under applicable Federal or State law.

5 SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

6 (a) IN GENERAL.—

7 (1) EXCLUSION FROM LIABILITY.—Except as

8 provided in paragraph (2), a biomaterials supplier

9 shall not be liable for harm to a claimant caused by

10 an implant.

11 (2) LIABILITY.—A biomaterials supplier that—

12 (A) is a manufacturer may be liable for

13 harm to a claimant described in subsection (b);

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

15 a claimant described in subsection (c); and

16 (C) furnishes raw materials or component

17 parts that fail to meet applicable contractual re18 quirements or specifications may be liable for a

19 harm to a claimant described in subsection (d).

20 (b) LIABILITY AS MANUFACTURER.—

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

22 to the extent required and permitted by any other

23 applicable law, be liable for harm to a claimant

24 caused by an implant if the biomaterials supplier is

25 the manufacturer of the implant.
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1 (2) GROUNDS FOR LIABILITY.—The biomate2 rials supplier may be considered the manufacturer of

3 the implant that allegedly caused harm to a claimant

4 only if the biomaterials supplier—

5 (A)(i) has registered with the Secretary

6 pursuant to section 510 of the Federal Food,

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

8 the regulations issued under such section; and

9 (ii) included the implant on a list of de10 vices filed with the Secretary pursuant to sec11 tion 510(j) of such Act (21 U.S.C. 360(j)) and

12 the regulations issued under such section;

13 (B) is the subject of a declaration issued

14 by the Secretary pursuant to paragraph (3)

15 that states that the supplier, with respect to the

16 implant that allegedly caused harm to the

17 claimant, was required to—

18 (i) register with the Secretary under

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

20 and the regulations issued under such sec21 tion, but failed to do so; or

22 (ii) include the implant on a list of de23 vices filed with the Secretary pursuant to

24 section 510(j) of such Act (21 U.S.C.
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1 360(j)) and the regulations issued under

2 such section, but failed to do so; or

3 (C) is related by common ownership or

4 control to a person meeting all the requirements

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

6 court deciding a motion to dismiss in accord7 ance with section 6(c)(3)(B)(i) finds, on the

8 basis of affidavits submitted in accordance with

9 section 6, that it is necessary to impose liability

10 on the biomaterials supplier as a manufacturer

11 because the related manufacturer meeting the

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

13 sufficient financial resources to satisfy any

14 judgment that the court feels it is likely to

15 enter should the claimant prevail.

16 (3) ADMINISTRATIVE PROCEDURES.—

17 (A) IN GENERAL.—The Secretary may

18 issue a declaration described in paragraph

19 (2)(B) on the motion of the Secretary or on pe20 tition by any person, after providing—

21 (i) notice to the affected persons; and

22 (ii) an opportunity for an informal

23 hearing.

24 (B) DOCKETING AND FINAL DECISION.—

25 Immediately upon receipt of a petition filed
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1 pursuant to this paragraph, the Secretary shall

2 docket the petition. Not later than 180 days

3 after the petition is filed, the Secretary shall

4 issue a final decision on the petition.

5 (C) APPLICABILITY OF STATUTE OF LIMI6 TATIONS.—Any applicable statute of limitations

7 shall toll during the period during which a

8 claimant has filed a petition with the Secretary

9 under this paragraph.

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

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

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

13 caused by an implant if—

14 (1) the biomaterials supplier—

15 (A) held title to the implant that allegedly

16 caused harm to the claimant as a result of pur17 chasing the implant after—

18 (i) the manufacture of the implant;

19 and

20 (ii) the entrance of the implant in the

21 stream of commerce; and

22 (B) subsequently resold the implant; or

23 (2) the biomaterials supplier is related by com24 mon ownership or control to a person meeting all the

25 requirements described in paragraph (1), if a court
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1 deciding a motion to dismiss in accordance with sec2 tion 6(c)(3)(B)(ii) finds, on the basis of affidavits

3 submitted in accordance with section 6, that it is

4 necessary to impose liability on the biomaterials sup5 plier as a seller because the related seller meeting

6 the requirements of paragraph (1) lacks sufficient fi7 nancial resources to satisfy any judgment that the

8 court feels it is likely to enter should the claimant

9 prevail.

10 (d) LIABILITY FOR VIOLATING CONTRACTUAL RE11 QUIREMENTS OR SPECIFICATIONS.—A biomaterials sup12 plier may, to the extent required and permitted by any

13 other applicable law, be liable for harm to a claimant

14 caused by an implant, if the claimant in an action shows,

15 by a preponderance of the evidence, that—

16 (1) the raw materials or component parts deliv17 ered by the biomaterials supplier either—

18 (A) did not constitute the product de19 scribed in the contract between the biomaterials

20 supplier and the person who contracted for de21 livery of the product; or

22 (B) failed to meet any specifications that

23 were—

24 (i) provided to the biomaterials sup25 plier and not expressly repudiated by the
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1 biomaterials supplier prior to acceptance of

2 delivery of the raw materials or component

3 parts;

4 (ii)(I) published by the biomaterials

5 supplier;

6 (II) provided to the manufacturer by

7 the biomaterials supplier; or

8 (III) 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 (iii) 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 provided by the manufacturer to the
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1 biomaterials supplier and were not ex2 pressly repudiated by the biomaterials sup3 plier prior to the acceptance by the manu4 facturer of delivery of the raw materials or

5 component parts; and

6 (2) such conduct was an actual and proximate

7 cause of the harm to the claimant.

8 SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

9 AGAINST BIOMATERIALS SUPPLIERS.

10 (a) MOTION TO DISMISS.—In any action that is sub11 ject to this Act, a biomaterials supplier who is a defendant

12 in such action may, at any time during which a motion

13 to dismiss may be filed under an applicable law, move to

14 dismiss the action against it on the grounds that—

15 (1) the defendant is a biomaterials supplier;

16 and

17 (2)(A) the defendant should not, for the pur18 poses of—

19 (i) section 5(b), be considered to be a man20 ufacturer of the implant that is subject to such

21 section; or

22 (ii) section 5(c), be considered to be a sell23 er of the implant that allegedly caused harm to

24 the claimant; or
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1 (B)(i) the claimant has failed to establish, pur2 suant to section 5(d), that the supplier furnished

3 raw materials or component parts in violation of

4 contractual requirements or specifications; or

5 (ii) the claimant has failed to comply with the

6 procedural requirements of subsection (b).

7 (b) MANUFACTURER OF IMPLANT SHALL BE NAMED

8 A PARTY.—The claimant shall be required to name the

9 manufacturer of the implant as a party to the action, un10 less—

11 (1) the manufacturer is subject to service of

12 process solely in a jurisdiction in which the biomate13 rials supplier is not domiciled or subject to a service

14 of process; or

15 (2) an action against the manufacturer is

16 barred by applicable law.

17 (c) PROCEEDING ON MOTION TO DISMISS.—The fol18 lowing rules shall apply to any proceeding on a motion

19 to dismiss filed under this section:

20 (1) AFFIDAVITS RELATING TO LISTING AND

21 DECLARATIONS.—

22 (A) IN GENERAL.—The defendant in the

23 action may submit an affidavit demonstrating

24 that defendant has not included the implant on

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

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

3 (B) RESPONSE TO MOTION TO DISMISS.—

4 In response to the motion to dismiss, the claim5 ant may submit an affidavit demonstrating

6 that—

7 (i) the Secretary has, with respect to

8 the defendant and the implant that alleg9 edly caused harm to the claimant, issued a

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

11 or

12 (ii) the defendant who filed the mo13 tion to dismiss is a seller of the implant

14 who is liable under section 5(c).

15 (2) EFFECT OF MOTION TO DISMISS ON DIS16 COVERY.—

17 (A) IN GENERAL.—If a defendant files a

18 motion to dismiss under paragraph (1) or (2) of

19 subsection (a), no discovery shall be permitted

20 in connection to the action that is the subject

21 of the motion, other than discovery necessary to

22 determine a motion to dismiss for lack of juris23 diction, until such time as the court rules on
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1 the motion to dismiss in accordance with the af2 fidavits submitted by the parties in accordance

3 with this section.

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

5 motion to dismiss under subsection (a)(2)(B)(i)

6 on the grounds that the biomaterials supplier

7 did not furnish raw materials or component

8 parts in violation of contractual requirements or

9 specifications, the court may permit discovery,

10 as ordered by the court. The discovery con11 ducted pursuant to this subparagraph shall be

12 limited to issues that are directly relevant to—

13 (i) the pending motion to dismiss; or

14 (ii) the jurisdiction of the court.

15 (3) AFFIDAVITS RELATING STATUS OF DEFEND16 ANT.—

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

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

19 court shall consider a defendant to be a bio20 materials supplier who is not subject to an ac21 tion for harm to a claimant caused by an im22 plant, other than an action relating to liability

23 for a violation of contractual requirements or

24 specifications described in subsection (d).
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1 (B) RESPONSES TO MOTION TO DISMISS.—

2 The court shall grant a motion to dismiss any

3 action that asserts liability of the defendant

4 under subsection (b) or (c) of section 5 on the

5 grounds that the defendant is not a manufac6 turer subject to such section 5(b) or seller sub7 ject to section 5(c), unless the claimant submits

8 a valid affidavit that demonstrates that—

9 (i) with respect to a motion to dismiss

10 contending the defendant is not a manu11 facturer, the defendant meets the applica12 ble requirements for liability as a manufac13 turer under section 5(b); or

14 (ii) with respect to a motion to dis15 miss contending that the defendant is not

16 a seller, the defendant meets the applicable

17 requirements for liability as a seller under

18 section 5(c).

19 (4) BASIS OF RULING ON MOTION TO DIS20 MISS.—

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

22 a motion to dismiss filed under subsection (a)
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1 solely on the basis of the pleadings of the par2 ties made pursuant to this section and any affi3 davits submitted by the parties pursuant to this

4 section.

5 (B) MOTION FOR SUMMARY JUDGMENT.—

6 Notwithstanding any other provision of law, if

7 the court determines that the pleadings and af8 fidavits made by parties pursuant to this sec9 tion raise genuine issues as concerning material

10 facts with respect to a motion concerning con11 tractual requirements and specifications, the

12 court may deem the motion to dismiss to be a

13 motion for summary judgment made pursuant

14 to subsection (d).

15 (d) SUMMARY JUDGMENT.—

16 (1) IN GENERAL.—

17 (A) BASIS FOR ENTRY OF JUDGMENT.—A

18 biomaterials supplier shall be entitled to entry

19 of judgment without trial if the court finds

20 there is no genuine issue as concerning any ma21 terial fact for each applicable element set forth

22 in paragraphs (1) and (2) of section 5(d).

23 (B) ISSUES OF MATERIAL FACT.—With re24 spect to a finding made under subparagraph

25 (A), the court shall consider a genuine issue of
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1 material fact to exist only if the evidence sub2 mitted by claimant would be sufficient to allow

3 a reasonable jury to reach a verdict for the

4 claimant if the jury found the evidence to be

5 credible.

6 (2) DISCOVERY MADE PRIOR TO A RULING ON

7 A MOTION FOR SUMMARY JUDGMENT.—If, under ap8 plicable rules, the court permits discovery prior to a

9 ruling on a motion for summary judgment made

10 pursuant to this subsection, such discovery shall be

11 limited solely to establishing whether a genuine issue

12 of material fact exists as to the applicable elements

13 set forth in paragraphs (1) and (2) of section 5(d).

14 (3) DISCOVERY WITH RESPECT TO A BIOMATE15 RIALS SUPPLIER.—A biomaterials supplier shall be

16 subject to discovery in connection with a motion

17 seeking dismissal or summary judgment on the basis

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

19 establish the applicable elements of section 5(d) sole20 ly to the extent permitted by the applicable Federal

21 or State rules for discovery against nonparties.

22 (e) STAY PENDING PETITION FOR DECLARATION.—

23 If a claimant has filed a petition for a declaration pursu24 ant to section 5(b)(3)(A) with respect to a defendant, and
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1 the Secretary has not issued a final decision on the peti2 tion, the court shall stay all proceedings with respect to

3 that defendant until such time as the Secretary has issued

4 a final decision on the petition.

5 (f) MANUFACTURER CONDUCT OF PROCEEDING.—

6 The manufacturer of an implant that is the subject of an

7 action covered under this Act shall be permitted to file

8 and conduct a proceeding on any motion for summary

9 judgment or dismissal filed by a biomaterials supplier who

10 is a defendant under this section if the manufacturer and

11 any other defendant in such action enter into a valid and

12 applicable contractual agreement under which the manu13 facturer agrees to bear the cost of such proceeding or to

14 conduct such proceeding.

15 (g) ATTORNEY FEES.—The court shall require the

16 claimant to compensate the biomaterials supplier (or a

17 manufacturer appearing in lieu of a supplier pursuant to

18 subsection (f)) for attorney fees and costs, if—

19 (1) the claimant named or joined the biomate20 rials supplier; and

21 (2) the court found the claim against the bio22 materials supplier to be without merit and frivolous.

Æ