I

104TH CONGRESS

2D SESSION H. R. 3468

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

MAY 16, 1996

Mr. GEKAS (for himself, Mr. PASTOR, Mr. HASTERT, Mr. HAYWORTH, Mr.

UPTON, Mr. BERMAN, Mr. ROHRABACHER, Mr. CUNNINGHAM, Mr.

BREWSTER, Mr. GUTKNECHT, Mr. STUMP, Mr. BILBRAY, Mr. EHLERS,

Mr. HOBSON, Mrs. JOHNSON of Connecticut, Mr. SERRANO, Mr. BURR,

Mr. ROYCE, Mr. CELEMENT, Mr. BLUTE, Mr. SCHIFF, Mr. FORBES, Mr.

ZIMMER, Mr. BUYER, Mrs. KELLY, and Mr. STENHOLM) 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 1996’’.
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1 SEC. 2. FINDINGS.

2 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

6 permanently 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

21 devices, 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

26 Cosmetic Act (21 U.S.C. 301 et seq.), manufactur-
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1 ers of medical devices are required to demonstrate

2 that the medical devices are safe and effective, in3 cluding demonstrating that the products are prop4 erly designed and have adequate warnings or in5 structions;

6 (7) notwithstanding the fact that raw materials

7 and component parts suppliers do not design,

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

9 have been the subject of actions alleging inad10 equate—

11 (A) design and testing of medical devices

12 manufactured with materials or parts supplied

13 by the suppliers; or

14 (B) warnings related to the use of such

15 medical devices;

16 (8) even though suppliers of raw materials and

17 component parts have very rarely been held liable in

18 such actions, such suppliers have ceased supplying

19 certain raw materials and component parts for use

20 in medical devices because the costs associated with

21 litigation in order to ensure a favorable judgment for

22 the suppliers far exceeds the total potential sales

23 revenues from sales by such suppliers to the medical

24 device industry;
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1 (9) unless alternate sources of supply can be

2 found, the unavailability of raw materials and

3 component parts for medical devices will lead to

4 unavailability of lifesaving and life-enhancing medi5 cal devices;

6 (10) because other suppliers of the raw

7 materials and component parts in foreign nations

8 are refusing to sell raw materials or component

9 parts for use in manufacturing certain medical de10 vices in the United States, the prospects for develop11 ment of new sources of supply for the full range of

12 threatened raw materials and component parts for

13 medical devices 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

11 medical 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

16 liability for suppliers of raw materials and

17 component parts for medical devices; and

18 (B) to provide expeditious procedures to

19 dispose of unwarranted suits against the

20 suppliers in such manner as to minimize litiga21 tion 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

3 indirectly supplies a component part or raw

4 material for use in the manufacture of an im5 plant.

6 (B) PERSONS INCLUDED.—Such term

7 includes any person who—

8 (i) has submitted master files to the

9 Secretary for purposes of premarket

10 approval of a medical device; or

11 (ii) licenses a biomaterials supplier to

12 produce component parts or raw materials.

13 (2) CLAIMANT.—

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

15 means any person who brings a civil action, or

16 on whose behalf a civil action is brought,

17 arising from harm allegedly caused directly or

18 indirectly by an implant, including a person

19 other than the individual into whose body, or in

20 contact with whose blood or tissue, the implant

21 is placed, who claims to have suffered harm as

22 a result of the implant.

23 (B) ACTION BROUGHT ON BEHALF OF AN

24 ESTATE.—With respect to an action brought on

25 behalf of or through the estate of an individual
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1 into whose body, or in contact with whose blood

2 or tissue the implant is placed, such term

3 includes the decedent that is the subject of the

4 action.

5 (C) ACTION BROUGHT ON BEHALF OF A

6 MINOR OR INCOMPETENT.—With respect to an

7 action brought on behalf of or through a minor

8 or incompetent, such term includes the parent

9 or guardian of the minor or incompetent.

10 (D) EXCLUSIONS.—Such term does not

11 include—

12 (i) a provider of professional health

13 care services, in any case in which—

14 (I) the sale or use of an implant

15 is incidental to the transaction; and

16 (II) the essence of the

17 transaction is the furnishing of judg18 ment, skill, or services; or

19 (ii) a person acting in the capacity of

20 a manufacturer, seller, or biomaterials sup21 plier.

22 (3) COMPONENT PART.—

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

24 part’’ means a manufactured piece of an im25 plant.
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1 (B) CERTAIN COMPONENTS.—Such term

2 includes a manufactured piece of an implant

3 that—

4 (i) has significant non-implant appli5 cations; and

6 (ii) alone, has no implant value or

7 purpose, but when combined with other

8 component parts and materials, constitutes

9 an implant.

10 (4) HARM.—

11 (A) IN GENERAL.—The term ‘‘harm’’

12 means—

13 (i) any injury to or damage suffered

14 by an individual;

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

16 that individual resulting from that injury

17 or damage; and

18 (iii) any loss to that individual or any

19 other individual resulting from that injury

20 or damage.

21 (B) EXCLUSION.—The term does not

22 include any commercial loss or loss of or dam23 age to an implant.

24 (5) IMPLANT.—The term ‘‘implant’’ means—
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1 (A) a medical device that is intended by

2 the manufacturer of the device—

3 (i) to be placed into a surgically or

4 naturally formed or existing cavity of the

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

6 (ii) to remain in contact with bodily

7 fluids or internal human tissue through a

8 surgically produced opening for a period of

9 less than 30 days; and

10 (B) suture materials used in implant

11 procedures.

12 (6) MANUFACTURER.—The term

13 ‘‘manufacturer’’ means any person who, with respect

14 to an implant—

15 (A) is engaged in the manufacture,

16 preparation, propagation, compounding, or

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

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

19 U.S.C. 360(a)(1)) of the implant; and

20 (B) is required—

21 (i) to register with the Secretary

22 pursuant to section 510 of the Federal

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

24 360) and the regulations issued under such

25 section; and
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1 (ii) to include the implant on a list of

2 devices filed with the Secretary pursuant

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

4 360(j)) and the regulations issued under

5 such section.

6 (7) MEDICAL DEVICE.—The term ‘‘medical

7 device’’ means a device, as defined in section 201(h)

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

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

10 of any combination product as that term is used in

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

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

13 means a substance or product that—

14 (A) has a generic use; and

15 (B) may be used in an application other

16 than an implant.

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

18 the Secretary of Health and Human Services.

19 (10) SELLER.—

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

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

22 conducted for that purpose, sells, distributes,

23 leases, packages, labels, or otherwise places an

24 implant in the stream of commerce.
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1 (B) EXCLUSIONS.—The term does not

2 include—

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

4 (ii) a provider of professional services,

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

6 implant is incidental to the transaction and

7 the essence of the transaction is the

8 furnishing of judgment, skill, or services;

9 or

10 (iii) any person who acts in only a

11 financial capacity with respect to the sale

12 of an implant.

13 SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PRE14 EMPTION.

15 (a) GENERAL REQUIREMENTS.—

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

17 by this Act, a biomaterials supplier may raise any

18 defense set forth in section 5.

19 (2) PROCEDURES.—Notwithstanding any other

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

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

22 connection with a motion for dismissal or judgment

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

24 the procedures set forth in section 6.

25 (b) APPLICABILITY.—
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1 (1) IN GENERAL.—Except as provided in

2 paragraph (2), notwithstanding any other provision

3 of law, this Act applies to any civil action brought

4 by a claimant, whether in a Federal or State court,

5 against a manufacturer, seller, or biomaterials

6 supplier, on the basis of any legal theory, for harm

7 allegedly caused by an implant.

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

9 purchaser of a medical device for use in providing

10 professional services against a manufacturer, seller,

11 or biomaterials supplier for loss or damage to an

12 implant or for commercial loss to the purchaser—

13 (A) shall not be considered an action that

14 is subject to this Act; and

15 (B) shall be governed by applicable

16 commercial or contract law.

17 (c) SCOPE OF PREEMPTION.—

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

19 State law regarding recovery for harm caused by an

20 implant and any rule of procedure applicable to a

21 civil action to recover damages for such harm only

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

23 applicable to the recovery of such damages.

24 (2) APPLICABILITY OF OTHER LAWS.—Any

25 issue that arises under this Act and that is not
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1 governed by a rule of law applicable to the recovery

2 of damages described in paragraph (1) shall be gov3 erned by applicable Federal or State law.

4 (d) STATUTORY CONSTRUCTION.—Nothing in this

5 Act may be construed—

6 (1) to affect any defense available to a de7 fendant under any other provisions of Federal or

8 State law in an action alleging harm caused by an

9 implant; or

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

11 jurisdiction pursuant to section 1331 or 1337 of title

12 28, United States Code, that otherwise would not

13 exist under applicable Federal or State law.

14 SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

15 (a) IN GENERAL.—

16 (1) EXCLUSION FROM LIABILITY.—Except as

17 provided in paragraph (2), a biomaterials supplier

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

19 an implant.

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

21 (A) is a manufacturer may be liable for

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

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

24 a claimant described in subsection (c); and
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1 (C) furnishes raw materials or component

2 parts that fail to meet applicable contractual

3 requirements or specifications may be liable for

4 a harm to a claimant described in subsection

5 (d).

6 (b) LIABILITY AS MANUFACTURER.—

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

8 to the extent required and permitted by any other

9 applicable law, be liable for harm to a claimant

10 caused by an implant if the biomaterials supplier is

11 the manufacturer of the implant.

12 (2) GROUNDS FOR LIABILITY.—The biomate13 rials supplier may be considered the manufacturer of

14 the implant that allegedly caused harm to a claimant

15 only if the biomaterials supplier—

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

17 pursuant to section 510 of the Federal Food,

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

19 the regulations issued under such section; and

20 (ii) included the implant on a list of

21 devices filed with the Secretary pursuant to

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

23 and the regulations issued under such section;

24 (B) is the subject of a declaration issued

25 by the Secretary pursuant to paragraph (3)
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1 that states that the supplier, with respect to the

2 implant that allegedly caused harm to the

3 claimant, was required to—

4 (i) register with the Secretary under

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

6 and the regulations issued under such

7 section, but failed to do so; or

8 (ii) include the implant on a list of

9 devices filed with the Secretary pursuant

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

11 360(j)) and the regulations issued under

12 such section, but failed to do so; or

13 (C) is related by common ownership or

14 control to a person meeting all the requirements

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

16 court deciding a motion to dismiss in ac17 cordance with section 6(c)(3)(B)(i) finds, on

18 the basis of affidavits submitted in accordance

19 with section 6, that it is necessary to impose

20 liability on the biomaterials supplier as a

21 manufacturer because the related manufacturer

22 meeting the requirements of subparagraph (A)

23 or (B) lacks sufficient financial resources to

24 satisfy any judgment that the court feels it is

25 likely to enter should the claimant prevail.
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1 (3) ADMINISTRATIVE PROCEDURES.—

2 (A) IN GENERAL.—The Secretary may

3 issue a declaration described in paragraph

4 (2)(B) on the motion of the Secretary or on

5 petition by any person, after providing—

6 (i) notice to the affected persons; and

7 (ii) an opportunity for an informal

8 hearing.

9 (B) DOCKETING AND FINAL DECISION.—

10 Immediately upon receipt of a petition filed

11 pursuant to this paragraph, the Secretary shall

12 docket the petition. Not later than 180 days

13 after the petition is filed, the Secretary shall

14 issue a final decision on the petition.

15 (C) APPLICABILITY OF STATUTE OF LIMI16 TATIONS.—Any applicable statute of limitations

17 shall toll during the period during which a

18 claimant has filed a petition with the Secretary

19 under this paragraph.

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

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

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

23 caused by an implant if—

24 (1) the biomaterials supplier—
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1 (A) held title to the implant that allegedly

2 caused harm to the claimant as a result of

3 purchasing the implant after—

4 (i) the manufacture of the implant;

5 and

6 (ii) the entrance of the implant in the

7 stream of commerce; and

8 (B) subsequently resold the implant; or

9 (2) the biomaterials supplier is related by

10 common ownership or control to a person meeting

11 all the requirements described in paragraph (1), if a

12 court deciding a motion to dismiss in accordance

13 with section 6(c)(3)(B)(ii) finds, on the basis of affi14 davits submitted in accordance with section 6, that

15 it is necessary to impose liability on the biomaterials

16 supplier as a seller because the related seller meet17 ing the requirements of paragraph (1) lacks suffi18 cient financial resources to satisfy any judgment

19 that the court feels it is likely to enter should the

20 claimant prevail.

21 (d) LIABILITY FOR VIOLATING CONTRACTUAL RE22 QUIREMENTS OR SPECIFICATIONS.—A biomaterials

23 supplier may, to the extent required and permitted by any

24 other applicable law, be liable for harm to a claimant
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1 caused by an implant, if the claimant in an action shows,

2 by a preponderance of the evidence, that—

3 (1) the raw materials or component parts

4 delivered by the biomaterials supplier either—

5 (A) did not constitute the product

6 described in the contract between the biomate7 rials supplier and the person who contracted for

8 delivery of the product; or

9 (B) failed to meet any specifications that

10 were—

11 (i) provided to the biomaterials

12 supplier and not expressly repudiated by

13 the biomaterials supplier prior to accept14 ance of delivery of the raw materials or

15 component parts;

16 (ii)(I) published by the biomaterials

17 supplier;

18 (II) provided to the manufacturer by

19 the biomaterials supplier; or

20 (III) contained in a master file that

21 was submitted by the biomaterials supplier

22 to the Secretary and that is currently

23 maintained by the biomaterials supplier for

24 purposes of premarket approval of medical

25 devices; or
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1 (iii) included in the submissions for

2 purposes of premarket approval or review

3 by the Secretary under section 510, 513,

4 515, or 520 of the Federal Food, Drug,

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

6 360e, or 360j), and received clearance

7 from the Secretary if such specifications

8 were provided by the manufacturer to the

9 biomaterials supplier and were not ex10 pressly repudiated by the biomaterials sup11 plier prior to the acceptance by the manu12 facturer of delivery of the raw materials or

13 component parts; and

14 (2) such conduct was an actual and proximate

15 cause of the harm to the claimant.

16 SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

17 AGAINST BIOMATERIALS SUPPLIERS.

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

19 subject to this Act, a biomaterials supplier who is a de20 fendant in such action may, at any time during which a

21 motion to dismiss may be filed under an applicable law,

22 move to dismiss the action against it on the grounds

23 that—

24 (1) the defendant is a biomaterials supplier;

25 and
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1 (2)(A) the defendant should not, for the

2 purposes of—

3 (i) section 5(b), be considered to be a man4 ufacturer of the implant that is subject to such

5 section; or

6 (ii) section 5(c), be considered to be a sell7 er of the implant that allegedly caused harm to

8 the claimant; or

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

10 pursuant to section 5(d), that the supplier furnished

11 raw materials or component parts in violation of

12 contractual requirements or specifications; or

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

14 procedural requirements of subsection (b).

15 (b) MANUFACTURER OF IMPLANT SHALL BE NAMED

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

17 manufacturer of the implant as a party to the action,

18 unless—

19 (1) the manufacturer is subject to service of

20 process solely in a jurisdiction in which the biomate21 rials supplier is not domiciled or subject to a service

22 of process; or

23 (2) an action against the manufacturer is

24 barred by applicable law.
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1 (c) PROCEEDING ON MOTION TO DISMISS.—The

2 following rules shall apply to any proceeding on a motion

3 to dismiss filed under this section:

4 (1) AFFIDAVITS RELATING TO LISTING AND

5 DECLARATIONS.—

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

7 action may submit an affidavit demonstrating

8 that defendant has not included the implant on

9 a list, if any, filed with the Secretary pursuant

10 to section 510(j) of the Federal Food, Drug,

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

12 (B) RESPONSE TO MOTION TO DISMISS.—

13 In response to the motion to dismiss, the claim14 ant may submit an affidavit demonstrating

15 that—

16 (i) the Secretary has, with respect to

17 the defendant and the implant that

18 allegedly caused harm to the claimant, is19 sued a declaration pursuant to section

20 5(b)(2)(B); or

21 (ii) the defendant who filed the

22 motion to dismiss is a seller of the implant

23 who is liable under section 5(c).

24 (2) EFFECT OF MOTION TO DISMISS ON DIS25 COVERY.—
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1 (A) IN GENERAL.—If a defendant files a

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

3 subsection (a), no discovery shall be permitted

4 in connection to the action that is the subject

5 of the motion, other than discovery necessary to

6 determine a motion to dismiss for lack of

7 jurisdiction, until such time as the court rules

8 on the motion to dismiss in accordance with the

9 affidavits submitted by the parties in accord10 ance with this section.

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

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

13 on the grounds that the biomaterials supplier

14 did not furnish raw materials or component

15 parts in violation of contractual requirements or

16 specifications, the court may permit discovery,

17 as ordered by the court. The discovery con18 ducted pursuant to this subparagraph shall be

19 limited to issues that are directly relevant to—

20 (i) the pending motion to dismiss; or

21 (ii) the jurisdiction of the court.

22 (3) AFFIDAVITS RELATING STATUS OF DEFEND23 ANT.—

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

25 clauses (i) and (ii) of subparagraph (B), the
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1 court shall consider a defendant to be a bio2 materials supplier who is not subject to an ac3 tion for harm to a claimant caused by an

4 implant, other than an action relating to liabil5 ity for a violation of contractual requirements

6 or specifications described in subsection (d).

7 (B) RESPONSES TO MOTION TO DISMISS.—

8 The court shall grant a motion to dismiss any

9 action that asserts liability of the defendant

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

11 grounds that the defendant is not a

12 manufacturer subject to such section 5(b) or

13 seller subject to section 5(c), unless the claim14 ant submits a valid affidavit that demonstrates

15 that—

16 (i) with respect to a motion to dismiss

17 contending the defendant is not a

18 manufacturer, the defendant meets the

19 applicable requirements for liability as a

20 manufacturer under section 5(b); or

21 (ii) with respect to a motion to

22 dismiss contending that the defendant is

23 not a seller, the defendant meets the appli24 cable requirements for liability as a seller

25 under section 5(c).
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1 (4) BASIS OF RULING ON MOTION TO DIS2 MISS.—

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

4 a motion to dismiss filed under subsection (a)

5 solely on the basis of the pleadings of the par6 ties made pursuant to this section and any

7 affidavits submitted by the parties pursuant to

8 this section.

9 (B) MOTION FOR SUMMARY JUDGMENT.—

10 Notwithstanding any other provision of law, if

11 the court determines that the pleadings and af12 fidavits made by parties pursuant to this

13 section raise genuine issues as concerning mate14 rial facts with respect to a motion concerning

15 contractual requirements and specifications, the

16 court may deem the motion to dismiss to be a

17 motion for summary judgment made pursuant

18 to subsection (d).

19 (d) SUMMARY JUDGMENT.—

20 (1) IN GENERAL.—

21 (A) BASIS FOR ENTRY OF JUDGMENT.—A

22 biomaterials supplier shall be entitled to entry

23 of judgment without trial if the court finds

24 there is no genuine issue as concerning any
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1 material fact for each applicable element set

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

3 (B) ISSUES OF MATERIAL FACT.—With

4 respect to a finding made under subparagraph

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

6 material fact to exist only if the evidence

7 submitted by claimant would be sufficient to

8 allow a reasonable jury to reach a verdict for

9 the claimant if the jury found the evidence to

10 be credible.

11 (2) DISCOVERY MADE PRIOR TO A RULING ON

12 A MOTION FOR SUMMARY JUDGMENT.—If, under

13 applicable rules, the court permits discovery prior to

14 a ruling on a motion for summary judgment made

15 pursuant to this subsection, such discovery shall be

16 limited solely to establishing whether a genuine issue

17 of material fact exists as to the applicable elements

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

19 (3) DISCOVERY WITH RESPECT TO A BIOMATE20 RIALS SUPPLIER.—A biomaterials supplier shall be

21 subject to discovery in connection with a motion

22 seeking dismissal or summary judgment on the basis

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

24 establish the applicable elements of section 5(d) sole-
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1 ly to the extent permitted by the applicable Federal

2 or State rules for discovery against nonparties.

3 (e) STAY PENDING PETITION FOR DECLARATION.—

4 If a claimant has filed a petition for a declaration

5 pursuant to section 5(b)(3)(A) with respect to a defend6 ant, and the Secretary has not issued a final decision on

7 the petition, the court shall stay all proceedings with re8 spect to that defendant until such time as the Secretary

9 has issued a final decision on the petition.

10 (f) MANUFACTURER CONDUCT OF PROCEEDING.—

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

12 action covered under this Act shall be permitted to file

13 and conduct a proceeding on any motion for summary

14 judgment or dismissal filed by a biomaterials supplier who

15 is a defendant under this section if the manufacturer and

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

17 applicable contractual agreement under which the

18 manufacturer agrees to bear the cost of such proceeding

19 or to conduct such proceeding.

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

21 claimant to compensate the biomaterials supplier (or a

22 manufacturer appearing in lieu of a supplier pursuant to

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

24 (1) the claimant named or joined the biomate25 rials supplier; and
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1 (2) the court found the claim against the bio2 materials supplier to be without merit and frivolous.

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