I

104TH CONGRESS

1ST SESSION H. R. 753

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

JANUARY 31, 1995

Mr. GEKAS (for himself, Mr. PASTOR, Mr. COBURN, Mr. RAMSTAD, Mr. COX

of California, and Mr. BILBRAY) 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 1995’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—
2

•HR 753 IH

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

2 States depend on the availability of lifesaving or life3 enhancing medical devices, many of which are per4 manently implantable within the human body;

5 (2) a continued supply of raw materials and

6 component parts is necessary for the invention, de7 velopment, improvement, and maintenance of the

8 supply of the devices;

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

10 raw materials and component parts that—

11 (A) are not designed or manufactured spe12 cifically for use in medical devices; and

13 (B) come in contact with internal human

14 tissue;

15 (4) the raw materials and component parts also

16 are used in a variety of nonmedical products;

17 (5) because small quantities of the raw mate18 rials and component parts are used for medical de19 vices, sales of raw materials and component parts

20 for medical devices constitute an extremely small

21 portion of the overall market for the raw materials

22 and medical devices;

23 (6) under the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 301 et seq.), manufacturers of

25 medical devices are required to demonstrate that the
3

•HR 753 IH

1 medical devices are safe and effective, including

2 demonstrating that the products are properly de3 signed and have adequate warnings or instructions;

4 (7) notwithstanding the fact that raw materials

5 and component parts suppliers do not design,

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

7 have been the subject of actions alleging inad8 equate—

9 (A) design and testing of medical devices

10 manufactured with materials or parts supplied

11 by the suppliers; or

12 (B) warnings related to the use of such

13 medical devices;

14 (8) even though suppliers of raw materials and

15 component parts have very rarely been held liable in

16 such actions, such suppliers have ceased supplying

17 certain raw materials and component parts for use

18 in medical devices because the costs associated with

19 litigation in order to ensure a favorable judgment for

20 the suppliers far exceeds the total potential sales

21 revenues from sales by such suppliers to the medical

22 device industry;

23 (9) unless alternate sources of supply can be

24 found, the unavailability of raw materials and com25 ponent parts for medical devices will lead to unavail-
4

•HR 753 IH

1 ability of lifesaving and life-enhancing medical

2 devices;

3 (10) because other suppliers of the raw mate4 rials and component parts in foreign nations are re5 fusing to sell raw materials or component parts for

6 use in manufacturing certain medical devices in the

7 United States, the prospects for development of new

8 sources of supply for the full range of threatened

9 raw materials and component parts for medical

10 devices are remote;

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

12 such raw materials and component parts in the

13 United States could support the large investment

14 needed to develop new suppliers of such raw mate15 rials and component parts;

16 (12) attempts to develop such new suppliers

17 would raise the cost of medical devices;

18 (13) courts that have considered the duties of

19 the suppliers of the raw materials and component

20 parts have generally found that the suppliers do not

21 have a duty—

22 (A) to evaluate the safety and efficacy of

23 the use of a raw material or component part in

24 a medical device; and
5

•HR 753 IH

1 (B) to warn consumers concerning the

2 safety and effectiveness of a medical device;

3 (14) attempts to impose the duties referred to

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

5 suppliers of the raw materials and component parts

6 would cause more harm than good by driving the

7 suppliers to cease supplying manufacturers of medi8 cal devices; and

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

10 wide variety of lifesaving and life-enhancing medical

11 devices, immediate action is needed—

12 (A) to clarify the permissible bases of li13 ability for suppliers of raw materials and com14 ponent parts for medical devices; and

15 (B) to provide expeditious procedures to

16 dispose of unwarranted suits against the suppli17 ers in such manner as to minimize litigation

18 costs.

19 SEC. 3. DEFINITIONS.

20 As used in this Act:

21 (1) BIOMATERIALS SUPPLIER.—

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

23 supplier’’ means an entity that directly or indi24 rectly supplies a component part or raw mate25 rial for use in the manufacture of an implant.
6

•HR 753 IH

1 (B) PERSONS INCLUDED.—Such term in2 cludes any person who—

3 (i) has submitted master files to the

4 Secretary for purposes of premarket ap5 proval of a medical device; or

6 (ii) licenses a biomaterials supplier to

7 produce component parts or raw materials.

8 (2) CLAIMANT.—

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

10 means any person who brings a civil action, or

11 on whose behalf a civil action is brought, aris12 ing from harm allegedly caused directly or indi13 rectly by an implant, including a person other

14 than the individual into whose body, or in con15 tact with whose blood or tissue, the implant is

16 placed, who claims to have suffered harm as a

17 result of the implant.

18 (B) ACTION BROUGHT ON BEHALF OF AN

19 ESTATE.—With respect to an action brought on

20 behalf or through the estate of an individual

21 into whose body, or in contact with whose blood

22 or tissue the implant is placed, such term in23 cludes the decedent that is the subject of the

24 action.
7

•HR 753 IH

1 (C) ACTION BROUGHT ON BEHALF OF A

2 MINOR.—With respect to an action brought on

3 behalf or through a minor, such term includes

4 the parent or guardian of the minor.

5 (D) EXCLUSIONS.—Such term does not

6 include—

7 (i) a provider of professional services,

8 in any case in which—

9 (I) the sale or use of an implant

10 is incidental to the transaction; and

11 (II) the essence of the trans12 action is the furnishing of judgment,

13 skill, or services; or

14 (ii) a manufacturer, seller, or

15 biomaterials supplier.

16 (3) COMPONENT PART.—

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

18 part’’ means a manufactured piece of an im19 plant.

20 (B) CERTAIN COMPONENTS.—Such term

21 includes a manufactured piece of an implant

22 that—

23 (i) has significant nonimplant applications;

24 and
8

•HR 753 IH

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

2 but when combined with other component parts

3 and materials, constitutes an implant.

4 (4) HARM.—

5 (A) IN GENERAL.—The term ‘‘harm’’

6 means—

7 (i) any injury to or damage suffered

8 by an individual;

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

10 that individual resulting from that injury

11 or damage; and

12 (iii) any loss to that individual or any

13 other individual resulting from that injury

14 or damage.

15 (B) EXCLUSION.—The term does not in16 clude any commercial loss or loss of or damage

17 to an implant.

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

19 (A) a medical device that is intended by

20 the manufacturer of the device—

21 (i) to be placed into a surgically or

22 naturally formed or existing cavity of the

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

24 (ii) to remain in contact with bodily

25 fluids or internal human tissue through a
9

•HR 753 IH

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

7 implant—

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)
10

•HR 753 IH

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

2 U.S.C. 321(h)).

3 (8) QUALIFIED SPECIALIST.—With respect to

4 an action, the term ‘‘qualified specialist’’ means a

5 person who is qualified by knowledge, skill, experi6 ence, training, or education in the specialty area

7 that is the subject of the action.

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

9 means a substance or product that—

10 (A) has a generic use; and

11 (B) may be used in an application other

12 than an implant.

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

14 means the Secretary of Health and Human Services.

15 (11) SELLER.—

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

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

18 conducted for that purpose, sells, distributes,

19 leases, packages, labels, or otherwise places an

20 implant in the stream of commerce.

21 (B) EXCLUSIONS.—The term does not

22 include—

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

24 (ii) a provider of professional services,

25 in any case in which the sale or use of an
11

•HR 753 IH

1 implant is incidental to the transaction and

2 the essence of the transaction is the fur3 nishing of judgment, skill, or services; or

4 (iii) any person who acts in only a fi5 nancial capacity with respect to the sale of

6 an implant.

7 SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PRE8 EMPTION.

9 (a) GENERAL REQUIREMENTS.—

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

11 by this Act, a biomaterials supplier may raise any

12 defense set forth in section 5.

13 (2) PROCEDURES.—Notwithstanding any other

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

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

16 connection with a motion for dismissal or judgment

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

18 the procedures set forth in section 6.

19 (b) APPLICABILITY.—

20 (1) IN GENERAL.—Except as provided in para21 graph (2), notwithstanding any other provision of

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

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

24 against a manufacturer, seller, or biomaterials sup-
12

•HR 753 IH

1 plier, on the basis of any legal theory, for harm al2 legedly caused by an implant.

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

4 purchaser of a medical device for use in providing

5 professional services against a manufacturer, seller,

6 or biomaterials supplier for loss or damage to an im7 plant or for commercial loss to the purchaser—

8 (A) shall not be considered an action that

9 is subject to this Act; and

10 (B) shall be governed by applicable com11 mercial or contract law.

12 (c) SCOPE OF PREEMPTION.—

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

14 State law regarding recovery for harm caused by an

15 implant and any rule of procedure applicable to a

16 civil action to recover damages for such harm only

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

18 applicable to the recovery of such damages.

19 (2) APPLICABILITY OF OTHER LAWS.—Any

20 issue that arises under this Act and that is not gov21 erned by a rule of law applicable to the recovery of

22 damages described in paragraph (1) shall be gov23 erned by applicable Federal or State law.

24 (d) STATUTORY CONSTRUCTION.—Nothing in this

25 Act may be construed—
13

•HR 753 IH

1 (1) to affect any defense available to a defend2 ant under any other provisions of Federal or State

3 law in an action alleging harm caused by an im4 plant; or

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

6 jurisdiction pursuant to section 1331 or 1337 of title

7 28, United States Code, that otherwise would not

8 exist under applicable Federal or State law.

9 SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

10 (a) IN GENERAL.—

11 (1) EXCLUSION FROM LIABILITY.—Except as

12 provided in paragraph (2), a biomaterials supplier

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

14 an implant.

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

16 (A) is a manufacturer may be liable for

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

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

19 a claimant described in subsection (c); and

20 (C) furnishes raw materials or component

21 parts that fail to meet applicable contractual re22 quirements or specifications may be liable for a

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

24 (b) LIABILITY AS MANUFACTURER.—
14

•HR 753 IH

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

2 to the extent required and permitted by any other

3 applicable law, be liable for harm to a claimant

4 caused by an implant if the biomaterials supplier is

5 the manufacturer of the implant.

6 (2) GROUNDS FOR LIABILITY.—The

7 biomaterials supplier may be considered the manu8 facturer of the implant that allegedly caused harm

9 to a claimant only if the biomaterials supplier—

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

11 pursuant to section 510 of the Federal Food,

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

13 the regulations issued under such section; and

14 (ii) included the implant on a list of de15 vices filed with the Secretary pursuant to sec16 tion 510(j) of such Act (21 U.S.C. 360(j)) and

17 the regulations issued under such section; or

18 (B) is the subject of a declaration issued

19 by the Secretary pursuant to paragraph (3)

20 that states that the supplier, with respect to the

21 implant that allegedly caused harm to the

22 claimant, was required to—

23 (i) register with the Secretary under sec24 tion 510 of such Act (21 U.S.C. 360), and the
15

•HR 753 IH

1 regulations issued under such section, but failed

2 to do so; or

3 (ii) include the implant on a list of devices

4 filed with the Secretary pursuant to section

5 510(j) of such Act (21 U.S.C. 360(j)) and the

6 regulations issued under such section, but failed

7 to do so.

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 180 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 during which a
16

•HR 753 IH

1 claimant has filed a petition with the Secretary

2 under this paragraph.

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

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

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

6 caused by an implant if the biomaterials supplier—

7 (1) held title to the implant that allegedly

8 caused harm to the claimant as a result of purchas9 ing the implant after—

10 (A) the manufacture of the implant; and

11 (B) the entrance of the implant in the

12 stream of commerce; and

13 (2) subsequently resold the implant.

14 (d) LIABILITY FOR VIOLATING CONTRACTUAL RE15 QUIREMENTS OR SPECIFICATIONS.—A biomaterials sup16 plier may, to the extent required and permitted by any

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

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

19 by a preponderance of the evidence, that—

20 (1) the raw materials or component parts deliv21 ered by the biomaterials supplier either—

22 (A) did not constitute the product de23 scribed in the contract between the biomaterials

24 supplier and the person who contracted for de25 livery of the product; or
17

•HR 753 IH

1 (B) failed to meet any specifications that

2 were—

3 (i) provided to the biomaterials sup4 plier and not expressly repudiated by the

5 biomaterials supplier prior to acceptance of

6 delivery of the raw materials or component

7 parts;

8 (ii)(I) published by the biomaterials

9 supplier;

10 (II) provided to the manufacturer by

11 the biomaterials supplier; or

12 (III) contained in a master file that

13 was submitted by the biomaterials supplier

14 to the Secretary and that is currently

15 maintained by the biomaterials supplier for

16 purposes of premarket approval of medical

17 devices; or

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

19 purposes of premarket approval or review

20 by the Secretary under section 510, 513,

21 515, or 520 of the Federal Food, Drug,

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

23 360e, or 360j); and

24 (II) have received clearance from the

25 Secretary,
18

•HR 753 IH

1 if such specifications were provided by the man2 ufacturer to the biomaterials supplier and were

3 not expressly repudiated by the biomaterials

4 supplier prior to the acceptance by the manu5 facturer of delivery of the raw materials or

6 component parts; and

7 (2) such conduct was an actual and proximate

8 cause of the harm to the claimant.

9 SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

10 AGAINST BIOMATERIALS SUPPLIERS.

11 (a) MOTION TO DISMISS.—In any action that is sub12 ject to this Act, a biomaterials supplier who is a defendant

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

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

15 dismiss the action on the grounds that—

16 (1) the defendant is a biomaterials supplier;

17 and

18 (2)(A) the defendant should not, for the pur19 poses of—

20 (i) section 5(b), be considered to be a man21 ufacturer of the implant that is subject to such

22 section; or

23 (ii) section 5(c), be considered to be a sell24 er of the implant that allegedly caused harm to

25 the claimant; or
19

•HR 753 IH

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) PROCEDURAL REQUIREMENTS.—

8 (1) IN GENERAL.—The procedural requirements

9 described in paragraphs (2) and (3) shall apply to

10 any action by a claimant against a biomaterials sup11 plier that is subject to this Act.

12 (2) MANUFACTURER OF IMPLANT SHALL BE

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

14 name the manufacturer of the implant as a party to

15 the action, unless—

16 (A) the manufacturer is subject to service

17 of process solely in a jurisdiction in which the

18 biomaterials supplier is not domiciled or subject

19 to a service of process; or

20 (B) an action against the manufacturer is

21 barred by applicable law.

22 (3) AFFIDAVIT.—At the time the claimant

23 brings an action against a biomaterials supplier the

24 claimant shall be required to submit an affidavit

25 that—
20

•HR 753 IH

1 (A) declares that the claimant has con2 sulted and reviewed the facts of the action with

3 a qualified specialist, whose qualifications the

4 claimant shall disclose;

5 (B) includes a written determination by a

6 qualified specialist that the raw materials or

7 component parts actually used in the manufac8 ture of the implant of the claimant were raw

9 materials or component parts described in sec10 tion 5(d)(1), together with a statement of the

11 basis for such a determination;

12 (C) includes a written determination by a

13 qualified specialist that, after a review of the

14 medical record and other relevant material, the

15 raw material or component part supplied by the

16 biomaterials supplier and actually used in the

17 manufacture of the implant was a cause of the

18 harm alleged by claimant, together with a state19 ment of the basis for the determination; and

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

21 consultation of the qualified specialist, the

22 claimant (or the attorney of the claimant) has

23 concluded that there is a reasonable and meri24 torious cause for the filing of the action against

25 the biomaterials supplier.
21

•HR 753 IH

1 (c) PROCEEDING ON MOTION TO DISMISS.—The fol2 lowing 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 alleg18 edly caused harm to the claimant, issued a

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

20 or

21 (ii) the defendant who filed the mo22 tion 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.—
22

•HR 753 IH

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

2 motion to dismiss under paragraph (1) or (3) 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 juris7 diction, until such time as the court rules on

8 the motion to dismiss in accordance with the af9 fidavits submitted by the parties in accordance

10 with this section.

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

12 motion to dismiss under subsection (a)(2) on

13 the grounds that the biomaterials supplier did

14 not furnish raw materials or component parts

15 in violation of contractual requirements or spec16 ifications, the court may permit discovery, as

17 ordered by the court. The discovery conducted

18 pursuant to this subparagraph shall be limited

19 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
23

•HR 753 IH

1 court shall consider a defendant to be a

2 biomaterials supplier who is not subject to an

3 action for harm to a claimant caused by an im4 plant, other than an action relating to liability

5 for a violation of contractual requirements or

6 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 manufac12 turer subject to such subsection 5(b) or seller

13 subject to subsection 5(c), unless the claimant

14 submits a valid affidavit that demonstrates

15 that—

16 (i) with respect to a motion to dismiss con17 tending the defendant is not a manufacturer,

18 the defendant meets the applicable require19 ments for liability as a manufacturer under sec20 tion 5(b); or

21 (ii) with respect to a motion to dismiss

22 contending that the defendant is not a seller,

23 the defendant meets the applicable require24 ments for liability as a seller under section 5(c).
24

•HR 753 IH

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 affi7 davits submitted by the parties pursuant to this

8 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 sec13 tion raise genuine issues as concerning material

14 facts with respect to a motion concerning con15 tractual 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 ma-
25

•HR 753 IH

1 terial fact for each applicable element set forth

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

3 (B) ISSUES OF MATERIAL FACT.—With re4 spect 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 sub7 mitted by claimant would be sufficient to allow

8 a reasonable jury to reach a verdict for the

9 claimant if the jury found the evidence to be

10 credible.

11 (2) DISCOVERY MADE PRIOR TO A RULING ON

12 A MOTION FOR SUMMARY JUDGMENT.—If, under ap13 plicable rules, the court permits discovery prior to a

14 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.

18 (3) DISCOVERY WITH RESPECT TO A

19 BIOMATERIALS SUPPLIER.—A biomaterials supplier

20 shall be subject to discovery in connection with a

21 motion seeking dismissal or summary judgment on

22 the basis of the inapplicability of section 5(d) or the

23 failure to establish the applicable elements of section

24 5(d) solely to the extent permitted by the applicable
26

•HR 753 IH

1 Federal or State rules for discovery against

2 nonparties.

3 (e) STAY PENDING PETITION FOR DECLARATION.—

4 If a claimant has filed a petition for a declaration pursu5 ant to section 5(b) with respect to a defendant, and the

6 Secretary has not issued a final decision on the petition,

7 the court shall stay all proceedings with respect to that

8 defendant until such time as the Secretary has issued a

9 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 manu18 facturer agrees to bear the cost of such proceeding or to

19 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

25 biomaterials supplier; and
27

•HR 753 IH

1 (2) the court found the claim against the

2 biomaterials supplier to be without merit and frivo3 lous.

4 SEC. 7. APPLICABILITY.

5 This Act shall apply to all civil actions covered under

6 this Act that are commenced on or after the date of enact7 ment of this Act, including any such action with respect

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

9 that caused the harm occurred before the date of enact10 ment of this Act.

Æ

HR 753 IH——2

HR 753 IH——3