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Union Calendar No. 349

105TH CONGRESS

2D SESSION H. R. 872

[Report No. 105–549, Parts I and II]

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

MAY 22, 1998

Reported from the Committee on the Judiciary with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

MAY 22, 1998

Referral to the Committee on Commerce extended for a period ending not

later than July 14, 1998

JULY 14, 1998

Additional sponsors: Mr. BARCIA, Mr. CLEMENT, Mr. COBURN, Mr. COX of

California, Mr. CRANE, Mr. HORN, Mr. NORWOOD, Mr. PORTER, Mr.

SALMON, Mr. SERRANO, Mr. SHAYS, Mrs. TAUSCHER, Mrs. EMERSON,

Mr. HUTCHINSON, Mr. INGLIS of South Carolina, Mr. PICKERING, Mr.

BUNNING, Mr. CONDIT, Mrs. CUBIN, Mr. FOX of Pennsylvania, Mr.

GILLMOR, Mr. HEFNER, Mr. MCHUGH, Mr. MORAN of Virginia, Mr.
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PACKARD, Mrs. ROUKEMA, Mr. DAN SCHAEFER of Colorado, Mr. SESSIONS, Mr. STENHOLM, Mr. TOWNS, Mr. BARTON of Texas, Mr. BOUCHER, Mr. DOOLEY of California, Mr. FALEOMAVAEGA, Mr. GANSKE, Mr.

GOODE, Mr. KIM, Mr. LARGENT, Mr. MINGE, Mr. PASCRELL, Mr.

SPRATT, Mr. CALVERT, Mr. COOK, Mr. DREIER, Mr. FAZIO of California,

Mr. HOEKSTRA, Mr. OBERSTAR, Mr. PICKETT, Mr. ROYCE, Mr. SOLOMON, Mr. THORNBERRY, Mr. ROTHMAN, Mr. TORRES, Mr. BALLENGER,

Mr. COBLE, Ms. CHRISTIAN-GREEN, Mr. COOKSEY, Mr. GRAHAM, Mr.

HOSTETTLER, Mr. LANTOS, Mr. MCKEON, Mr. ROGAN, Ms. SANCHEZ,

Mr. SHIMKUS, Mr. CAPPS, Mr. GOODLING, Mr. HOLDEN, Mr. WALSH,

Mr. YOUNG of Florida, Mr. BERMAN, Mr. EDWARDS, Ms. HOOLEY of Oregon, Ms. LOFGREN, Mr. BOB SCHAFFER of Colorado, Ms. SLAUGHTER,

Mr. WHITE, Mr. CAMPBELL, Ms. HARMAN, Mrs. JOHNSON of Connecticut, Mr. SHERMAN, Mr. WELDON of Pennsylvania, Mr. DAVIS of Florida,

Mr. FRANKS of New Jersey, Mr. MATSUI, Mr. SNYDER, Mr. CAMP, Mr.

FRELINGHUYSEN, Mr. LEWIS of California, Ms. WOOLSEY, Mr. PAPPAS,

Mrs. NORTHUP, Ms. PELOSI, Mr. QUINN, Mr. SMITH of New Jersey, Mr.

WELDON of Florida, Mr. FARR of California, Mr. SAXTON, Mr. STEARNS,

Mr. ANDREWS, Mr. LOBIONDO, Mr. MENENDEZ, Mr. ADAM SMITH of

Washington, Mr. PALLONE, Mr. REDMOND, Mr. BILIRAKIS, Mr. STRICKLAND, Mr. PRICE of North Carolina, and Ms. WILSON

JULY 14, 1998

Reported from the Committee on Commerce with an amendment, committed

to the Committee of the Whole House on the State of the Union, and

ordered to be printed

[Strike out all after the enacting clause and insert the part printed in boldface roman]

[For text of introduced bill, see copy of bill as introduced on February 27, 1997]

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 As5 surance Act of 1998’’.
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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 life5 enhancing medical devices, many of which are perma6 nently implantable within the human body;

7 (2) a continued supply of raw materials and

8 component parts is necessary for the invention, devel9 opment, improvement, and maintenance of the supply

10 of the devices;

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

12 raw materials and component parts that—

13 (A) move in interstate commerce;

14 (B) are not designed or manufactured spe15 cifically for use in medical devices; and

16 (C) come in contact with internal human

17 tissue;

18 (4) the raw materials and component parts also

19 are used in a variety of nonmedical products;

20 (5) because small quantities of the raw materials

21 and component parts are used for medical devices,

22 sales of raw materials and component parts for medi23 cal devices constitute an extremely small portion of

24 the overall market for the raw materials and compo25 nent parts;
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1 (6) under the Federal Food, Drug, and Cosmetic

2 Act (21 U.S.C. 301 et seq.) manufacturers of medical

3 devices are required to demonstrate that the medical

4 devices are safe and effective, including demonstrating

5 that the products are properly designed and have ade6 quate warnings or instructions;

7 (7) notwithstanding the fact that raw materials

8 and component parts suppliers do not design,

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

10 have been the subject of actions alleging inadequate—

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 med15 ical 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 in

20 medical devices for a number of reasons, including

21 concerns about the costs of such litigation;

22 (9) unless alternate sources of supply can be

23 found, the unavailability of raw materials and com24 ponent parts for medical devices will lead to unavail-
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1 ability of lifesaving and life-enhancing medical de2 vices;

3 (10) because other suppliers of the raw materials

4 and component parts in foreign nations are refusing

5 to sell raw materials or component parts for use in

6 manufacturing certain medical devices in the United

7 States, the prospects for development of new sources of

8 supply for the full range of threatened raw materials

9 and component parts for medical devices are remote;

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

11 raw materials and component parts in the United

12 States could support the large investment needed to

13 develop new suppliers of such raw materials and com14 ponent parts;

15 (12) attempts to develop such new suppliers

16 would raise the cost of medical devices;

17 (13) courts that have considered the duties of the

18 suppliers of the raw materials and component parts

19 have generally found that the suppliers do not have

20 a duty—

21 (A) to evaluate the safety and efficacy of the

22 use of a raw material or component part in a

23 medical device; and

24 (B) to warn consumers concerning the safe25 ty and effectiveness of a medical device;
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1 (14) because medical devices and the raw mate2 rials and component parts used in their manufacture

3 move in interstate commerce, a shortage of such raw

4 materials and component parts affects interstate com5 merce;

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

7 wide variety of lifesaving and life-enhancing medical

8 devices, immediate action is needed—

9 (A) to clarify the permissible bases of liabil10 ity for suppliers of raw materials and compo11 nent parts for medical devices; and

12 (B) to provide expeditious procedures to dis13 pose of unwarranted suits against the suppliers

14 in such manner as to minimize litigation costs;

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

16 primary architects and regulators of our tort system;

17 Congress, however, must, in certain circumstances in18 volving the national interest, address tort issues, and

19 a threatened shortage of raw materials and compo20 nent parts for life-saving medical devices is one such

21 circumstance; and

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

23 needed to assure the continued supply of materials for

24 life-saving medical devices; however, negligent suppli25 ers should not be protected.
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1 SEC. 3. DEFINITIONS.

2 As used in this Act:

3 (1) BIOMATERIALS SUPPLIER.—

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

5 supplier’’ means an entity that directly or indi6 rectly supplies a component part or raw mate7 rial for use in the manufacture of an implant.

8 (B) PERSONS INCLUDED.—Such term in9 cludes any person who—

10 (i) has submitted master files to the

11 Secretary for purposes of premarket ap12 proval of a medical device; or

13 (ii) licenses a biomaterials supplier to

14 produce component parts or raw materials.

15 (2) CLAIMANT.—

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

17 means any person who brings a civil action, or

18 on whose behalf a civil action is brought, arising

19 from harm allegedly caused directly or indirectly

20 by an implant, including a person other than

21 the individual into whose body, or in contact

22 with whose blood or tissue, the implant is placed,

23 who claims to have suffered harm as a result of

24 the implant.

25 (B) ACTION BROUGHT ON BEHALF OF AN

26 ESTATE.—With respect to an action brought on
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1 behalf of or through the estate of an individual

2 into whose body, or in contact with whose blood

3 or tissue the implant is placed, such term in4 cludes the decedent that is the subject of the ac5 tion.

6 (C) ACTION BROUGHT ON BEHALF OF A

7 MINOR OR INCOMPETENT.—With respect to an

8 action brought on behalf of or through a minor

9 or incompetent, such term includes the parent or

10 guardian of the minor or incompetent.

11 (D) EXCLUSIONS.—Such term does not in12 clude—

13 (i) a provider of professional health

14 care services, in any case in which—

15 (I) the sale or use of an implant

16 is incidental to the transaction; and

17 (II) the essence of the transaction

18 is the furnishing of judgment, skill, or

19 services;

20 (ii) a person acting in the capacity of

21 a manufacturer, seller, or biomaterials sup22 plier; or

23 (iii) a person alleging harm caused by

24 either the silicone gel or the silicone enve-
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1 lope utilized in a breast implant containing

2 silicone gel, except that—

3 (I) neither the exclusion provided

4 by this clause nor any other provision

5 of this Act may be construed as a find6 ing that silicone gel (or any other form

7 of silicone) may or may not cause

8 harm; and

9 (II) the existence of the exclusion

10 under this clause may not—

11 (aa) be disclosed to a jury in

12 any civil action or other proceed13 ing, and

14 (bb) except as necessary to es15 tablish the applicability of this

16 Act, otherwise be presented in any

17 civil action or other proceeding.

18 (3) COMPONENT PART.—

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

20 part’’ means a manufactured piece of an im21 plant.

22 (B) CERTAIN COMPONENTS.—Such term in23 cludes a manufactured piece of an implant

24 that—
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1 (i) has significant non-implant appli2 cations; and

3 (ii) alone, has no implant value or

4 purpose, but when combined with other

5 component parts and materials, constitutes

6 an implant.

7 (4) HARM.—

8 (A) IN GENERAL.—The term ‘‘harm’’

9 means—

10 (i) any injury to or damage suffered

11 by an individual;

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

13 that individual resulting from that injury

14 or damage; and

15 (iii) any loss to that individual or any

16 other individual resulting from that injury

17 or damage.

18 (B) EXCLUSION.—The term does not in19 clude any commercial loss or loss of or damage

20 to an implant.

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

22 (A) a medical device that is intended by the

23 manufacturer of the device—
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1 (i) to be placed into a surgically or

2 naturally formed or existing cavity of the

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

4 (ii) to remain in contact with bodily

5 fluids or internal human tissue through a

6 surgically produced opening for a period of

7 less than 30 days; and

8 (B) suture materials used in implant proce9 dures.

10 (6) MANUFACTURER.—The term ‘‘manufacturer’’

11 means any person who, with respect to an implant—

12 (A) is engaged in the manufacture, prepara13 tion, propagation, compounding, or processing

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

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

16 360(a)(1)) of the implant; and

17 (B) is required—

18 (i) to register with the Secretary pur19 suant to section 510 of the Federal Food,

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

21 and the regulations issued under such sec22 tion; and

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

24 devices filed with the Secretary pursuant to

25 section 510(j) of such Act (21 U.S.C. 360(j))
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1 and the regulations issued under such sec2 tion.

3 (7) MEDICAL DEVICE.—The term ‘‘medical de4 vice’’ means a device, as defined in section 201(h) of

5 the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

6 321(h)), and includes any device component of any

7 combination product as that term is used in section

8 503(g) of such Act (21 U.S.C. 353(g)).

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

10 means a substance or product that—

11 (A) has a generic use; and

12 (B) may be used in an application other

13 than an implant.

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

15 the Secretary of Health and Human Services.

16 (10) SELLER.—

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

18 a person who, in the course of a business con19 ducted for that purpose, sells, distributes, leases,

20 packages, labels, or otherwise places an implant

21 in the stream of commerce.

22 (B) EXCLUSIONS.—The term does not in23 clude—

24 (i) a seller or lessor of real property;
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1 (ii) a provider of professional services,

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

3 implant is incidental to the transaction and

4 the essence of the transaction is the furnish5 ing of judgment, skill, or services; or

6 (iii) any person who acts in only a fi7 nancial capacity with respect to the sale of

8 an implant.

9 SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PRE10 EMPTION.

11 (a) GENERAL REQUIREMENTS.—

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

13 this Act, a biomaterials supplier may raise any de14 fense set forth in section 5.

15 (2) PROCEDURES.—Notwithstanding any other

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

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

18 connection with a motion for dismissal or judgment

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

20 procedures set forth in section 6.

21 (b) APPLICABILITY.—

22 (1) IN GENERAL.—Except as provided in para23 graph (2), notwithstanding any other provision of

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

25 a claimant, whether in a Federal or State court,
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1 against a manufacturer, seller, or biomaterials sup2 plier, on the basis of any legal theory, for harm alleg3 edly caused by an implant.

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

5 purchaser of a medical device for use in providing

6 professional services against a manufacturer, seller, or

7 biomaterials supplier for loss or damage to an im8 plant or for commercial loss to the purchaser—

9 (A) shall not be considered an action that

10 is subject to this Act; and

11 (B) shall be governed by applicable commer12 cial or contract law.

13 (c) SCOPE OF PREEMPTION.—

14 (1) IN GENERAL.—This Act supersedes any State

15 law regarding recovery for harm caused by an im16 plant and any rule of procedure applicable to a civil

17 action to recover damages for such harm only to the

18 extent that this Act establishes a rule of law applica19 ble to the recovery of such damages.

20 (2) APPLICABILITY OF OTHER LAWS.—Any issue

21 that arises under this Act and that is not governed

22 by a rule of law applicable to the recovery of damages

23 described in paragraph (1) shall be governed by ap24 plicable Federal or State law.
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1 (d) STATUTORY CONSTRUCTION.—Nothing in this Act

2 may be construed—

3 (1) to affect any defense available to a defendant

4 under any other provisions of Federal or State law in

5 an action alleging harm caused by an implant; or

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

7 jurisdiction pursuant to section 1331 or 1337 of title

8 28, United States Code, that otherwise would not exist

9 under applicable Federal or State law.

10 SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

11 (a) IN GENERAL.—

12 (1) EXCLUSION FROM LIABILITY.—Except as

13 provided in paragraph (2) or section 7, a biomate14 rials supplier shall not be liable for harm to a claim15 ant caused by an implant.

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

17 (A) is a manufacturer may be liable for

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

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

20 claimant described in subsection (c); and

21 (C) furnishes raw materials or component

22 parts that fail to meet applicable contractual re23 quirements or specifications may be liable for

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

25 (b) LIABILITY AS MANUFACTURER.—
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1 (1) IN GENERAL.—A biomaterials supplier may,

2 to the extent required and permitted by any other ap3 plicable law, be liable for harm to a claimant caused

4 by an implant if the biomaterials supplier is the

5 manufacturer of the implant.

6 (2) GROUNDS FOR LIABILITY.—The biomaterials

7 supplier may be considered the manufacturer of the

8 implant that allegedly caused harm to a claimant

9 only if the biomaterials supplier—

10 (A)(i) has or should have registered with the

11 Secretary pursuant to section 510 of the Federal

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

13 and the regulations issued under such section;

14 and

15 (ii) included or should have included the

16 implant on a list of devices filed with the Sec17 retary pursuant to section 510(j) of such Act (21

18 U.S.C. 360(j)) and the regulations issued under

19 such section;

20 (B) is the subject of a declaration issued by

21 the Secretary pursuant to paragraph (3) that

22 states that the supplier, with respect to the im23 plant that allegedly caused harm to the claim24 ant, was required to—
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1 (i) register with the Secretary under

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

3 and the regulations issued under such sec4 tion, but failed to do so; or

5 (ii) include the implant on a list of de6 vices filed with the Secretary pursuant to

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

8 and the regulations issued under such sec9 tion, but failed to do so; or

10 (C) is related by common ownership or con11 trol to a person meeting all the requirements de12 scribed in subparagraph (A) or (B), if the court

13 deciding a motion to dismiss in accordance with

14 section 6(c)(3)(B)(i) finds, on the basis of affida15 vits submitted in accordance with section 6, that

16 it is necessary to impose liability on the bio17 materials supplier as a manufacturer because the

18 related manufacturer meeting the requirements

19 of subparagraph (A) or (B) lacks sufficient fi20 nancial resources to satisfy any judgment that

21 the court feels it is likely to enter should the

22 claimant prevail.

23 (3) ADMINISTRATIVE PROCEDURES.—

24 (A) IN GENERAL.—The Secretary may issue

25 a declaration described in paragraph (2)(B) on
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1 the motion of the Secretary or on petition by

2 any person, after providing—

3 (i) notice to the affected persons; and

4 (ii) an opportunity for an informal

5 hearing.

6 (B) DOCKETING AND FINAL DECISION.—Im7 mediately upon receipt of a petition filed pursu8 ant to this paragraph, the Secretary shall docket

9 the petition. Not later than 180 days after the

10 petition is filed, the Secretary shall issue a final

11 decision on the petition.

12 (C) APPLICABILITY OF STATUTE OF LIMITA13 TIONS.—Any applicable statute of limitations

14 shall toll during the period during which a

15 claimant has filed a petition with the Secretary

16 under this paragraph.

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

18 may, to the extent required and permitted by any other ap19 plicable law, be liable as a seller for harm to a claimant

20 caused by an implant only if—

21 (1) the biomaterials supplier—

22 (A) held title to the implant that allegedly

23 caused harm to the claimant as a result of pur24 chasing the implant after—
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1 (i) the manufacture of the implant;

2 and

3 (ii) the entrance of the implant in the

4 stream of commerce; and

5 (B) subsequently resold the implant; or

6 (2) the biomaterials supplier is related by com7 mon ownership or control to a person meeting all the

8 requirements described in paragraph (1), if a court

9 deciding a motion to dismiss in accordance with sec10 tion 6(c)(3)(B)(ii) finds, on the basis of affidavits

11 submitted in accordance with section 6, that it is nec12 essary to impose liability on the biomaterials supplier

13 as a seller because the related seller meeting the re14 quirements of paragraph (1) lacks sufficient financial

15 resources to satisfy any judgment that the court feels

16 it is likely to enter should the claimant prevail.

17 (d) LIABILITY FOR VIOLATING CONTRACTUAL RE18 QUIREMENTS OR SPECIFICATIONS.—A biomaterials sup19 plier may, to the extent required and permitted by any

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

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

22 by a preponderance of the evidence, that—

23 (1) the raw materials or component parts deliv24 ered by the biomaterials supplier either—
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1 (A) did not constitute the product described

2 in the contract between the biomaterials supplier

3 and the person who contracted for delivery of the

4 product; or

5 (B) failed to meet any specifications that

6 were—

7 (i) accepted, pursuant to applicable

8 law, by the biomaterials supplier;

9 (ii)(I) published by the biomaterials

10 supplier;

11 (II) provided to the manufacturer by

12 the biomaterials supplier; or

13 (III) contained in a master file that

14 was submitted by the biomaterials supplier

15 to the Secretary and that is currently main16 tained by the biomaterials supplier for pur17 poses of premarket approval of medical de18 vices; or

19 (iii) included in the submissions for

20 purposes of premarket approval or review

21 by the Secretary under section 510, 513,

22 515, or 520 of the Federal Food, Drug, and

23 Cosmetic Act (21 U.S.C. 360, 360c, 360e, or

24 360j), and received clearance from the Sec25 retary if such specifications were accepted,
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1 pursuant to applicable law, by the biomate2 rials supplier; and

3 (2) such conduct was an actual and proximate

4 cause of the harm to the claimant.

5 SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

6 AGAINST BIOMATERIALS SUPPLIERS.

7 (a) MOTION TO DISMISS.—In any action that is sub8 ject to this Act, a biomaterials supplier who is a defendant

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

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

11 dismiss the action against it on the grounds that—

12 (1) the defendant is a biomaterials supplier; and

13 (2)(A) the defendant should not, for the purposes

14 of—

15 (i) section 5(b), be considered to be a manu16 facturer of the implant that is subject to such

17 section; or

18 (ii) section 5(c), be considered to be a seller

19 of the implant that allegedly caused harm to the

20 claimant; or

21 (B)(i) the claimant has failed to establish, pur22 suant to section 5(d), that the supplier furnished raw

23 materials or component parts in violation of contrac24 tual requirements or specifications; or
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1 (ii) the claimant has failed to comply with the

2 procedural requirements of subsection (b).

3 (b) MANUFACTURER OF IMPLANT SHALL BE NAMED

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

5 manufacturer of the implant as a party to the action, un6 less—

7 (1) the manufacturer is subject to service of proc8 ess solely in a jurisdiction in which the biomaterials

9 supplier is not domiciled or subject to a service of

10 process; or

11 (2) a claim against the manufacturer is barred

12 by applicable law or rule of practice.

13 (c) PROCEEDING ON MOTION TO DISMISS.—The fol14 lowing rules shall apply to any proceeding on a motion to

15 dismiss filed under this section:

16 (1) AFFIDAVITS RELATING TO LISTING AND DEC17 LARATIONS.—

18 (A) IN GENERAL.—The defendant in the ac19 tion may submit an affidavit demonstrating that

20 defendant has not included the implant on a list,

21 if any, filed with Secretary pursuant to section

22 510(j) of the Federal Food, Drug, and Cosmetic

23 Act (21 U.S.C. 360(j)).
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1 (B) RESPONSE TO MOTION TO DISMISS.—In

2 response to the motion to dismiss, the claimant

3 may submit an affidavit demonstrating that—

4 (i) the Secretary has, with respect to

5 the defendant and the implant that alleg6 edly caused harm to the claimant, issued a

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

8 or

9 (ii) the defendant who filed the motion

10 to dismiss is a seller of the implant who is

11 liable under section 5(c).

12 (2) EFFECT OF MOTION TO DISMISS ON DISCOV13 ERY.—

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

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

16 subsection (a), no discovery shall be permitted in

17 connection to the action that is the subject of the

18 motion, other than discovery necessary to deter19 mine a motion to dismiss for lack of jurisdiction,

20 until such time as the court rules on the motion

21 to dismiss in accordance with the affidavits sub22 mitted by the parties in accordance with this

23 section.

24 (B) DISCOVERY.—If a defendant files a mo25 tion to dismiss under subsection (a)(2)(B)(i) on
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1 the grounds that the biomaterials supplier did

2 not furnish raw materials or component parts in

3 violation of contractual requirements or speci4 fications, the court may permit discovery, as or5 dered by the court. The discovery conducted pur6 suant to this subparagraph shall be limited to

7 issues that are directly relevant to—

8 (i) the pending motion to dismiss; or

9 (ii) the jurisdiction of the court.

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

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

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

14 court shall consider a defendant to be a biomate15 rials supplier who is not subject to an action for

16 harm to a claimant caused by an implant, other

17 than an action relating to liability for a viola18 tion of contractual requirements or specifications

19 described in section 5(d).

20 (B) RESPONSES TO MOTION TO DISMISS.—

21 The court shall grant a motion to dismiss any

22 action that asserts liability of the defendant

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

24 grounds that the defendant is not a manufac25 turer subject to such section 5(b) or seller subject
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1 to section 5(c), unless the claimant submits a

2 valid affidavit that demonstrates that—

3 (i) with respect to a motion to dismiss

4 contending the defendant is not a manufac5 turer, the defendant meets the applicable re6 quirements for liability as a manufacturer

7 under section 5(b); or

8 (ii) with respect to a motion to dismiss

9 contending that the defendant is not a sell10 er, the defendant meets the applicable re11 quirements for liability as a seller under

12 section 5(c).

13 (4) BASIS OF RULING ON MOTION TO DISMISS.—

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

15 a motion to dismiss filed under subsection (a)

16 solely on the basis of the pleadings of the parties

17 made pursuant to this section and any affidavits

18 submitted by the parties pursuant to this section.

19 (B) MOTION FOR SUMMARY JUDGMENT.—

20 Notwithstanding any other provision of law, if

21 the court determines that the pleadings and affi22 davits made by parties pursuant to this section

23 raise genuine issues as concerning material facts

24 with respect to a motion concerning contractual

25 requirements and specifications, the court may
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1 deem the motion to dismiss to be a motion for

2 summary judgment made pursuant to subsection

3 (d).

4 (d) SUMMARY JUDGMENT.—

5 (1) IN GENERAL.—

6 (A) BASIS FOR ENTRY OF JUDGMENT.—A

7 biomaterials supplier shall be entitled to entry of

8 judgment without trial if the court finds there is

9 no genuine issue as concerning any material fact

10 for each applicable element set forth in para11 graphs (1) and (2) of section 5(d).

12 (B) ISSUES OF MATERIAL FACT.—With re13 spect to a finding made under subparagraph (A),

14 the court shall consider a genuine issue of mate15 rial fact to exist only if the evidence submitted

16 by claimant would be sufficient to allow a rea17 sonable jury to reach a verdict for the claimant

18 if the jury found the evidence to be credible.

19 (2) DISCOVERY MADE PRIOR TO A RULING ON A

20 MOTION FOR SUMMARY JUDGMENT.—If, under appli21 cable rules, the court permits discovery prior to a rul22 ing on a motion for summary judgment made pursu23 ant to this subsection, such discovery shall be limited

24 solely to establishing whether a genuine issue of mate-
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1 rial fact exists as to the applicable elements set forth

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

3 (3) DISCOVERY WITH RESPECT TO A BIOMATE4 RIALS SUPPLIER.—A biomaterials supplier shall be

5 subject to discovery in connection with a motion seek6 ing dismissal or summary judgment on the basis of

7 the inapplicability of section 5(d) or the failure to es8 tablish the applicable elements of section 5(d) solely

9 to the extent permitted by the applicable Federal or

10 State rules for discovery against nonparties.

11 (e) STAY PENDING PETITION FOR DECLARATION.—If

12 a claimant has filed a petition for a declaration pursuant

13 to section 5(b)(3)(A) with respect to a defendant, and the

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

15 the court shall stay all proceedings with respect to that de16 fendant until such time as the Secretary has issued a final

17 decision on the petition. The Secretary shall complete re18 view of any such petition within 6 weeks of receipt of the

19 petition.

20 (f) DISMISSAL WITH PREJUDICE.—An order granting

21 a motion to dismiss or for summary judgment pursuant

22 to this section shall be entered with prejudice, except insofar

23 as the moving defendant may be rejoined to the action as

24 provided in section 7.
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1 (g) MANUFACTURER CONDUCT OF LITIGATION.—The

2 manufacturer of an implant that is the subject of an action

3 covered under this Act shall be permitted to conduct litiga4 tion on any motion for summary judgment or dismissal

5 filed by a biomaterials supplier who is a defendant under

6 this section on behalf of such supplier if the manufacturer

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

8 and applicable contractual agreement under which the

9 manufacturer agrees to bear the cost of such litigation or

10 to conduct such litigation.

11 SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED DEFEND12 ANT.

13 (a) IMPLEADING OF DISMISSED DEFENDANT.—A

14 court, upon motion by a manufacturer or a claimant with15 in 90 days after entry of a final judgment in an action

16 by the claimant against a manufacturer, and notwithstand17 ing any otherwise applicable statute of limitations, may

18 implead a biomaterials supplier who has been dismissed

19 from the action pursuant to this Act if—

20 (1) the manufacturer has made an assertion, ei21 ther in a motion or other pleading filed with the

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

23 or as part of a claim for contribution or indemnifica24 tion, and the court makes a finding based on the

25 court’s independent review of the evidence contained
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1 in the record of the action, that under applicable

2 law—

3 (A) the negligence or intentionally tortious

4 conduct of the dismissed supplier was an actual

5 and proximate cause of the harm to the claim6 ant; and

7 (B) the manufacturer’s liability for dam8 ages should be reduced in whole or in part be9 cause of such negligence or intentionally tortious

10 conduct; or

11 (2) the claimant has moved to implead the sup12 plier and the court makes a finding based on the

13 court’s independent review of the evidence contained

14 in the record of the action, that under applicable

15 law—

16 (A) the negligence or intentionally tortious

17 conduct of the dismissed supplier was an actual

18 and proximate cause of the harm to the claim19 ant; and

20 (B) the claimant is unlikely to be able to re21 cover the full amount of its damages from the re22 maining defendants.

23 (b) STANDARD OF LIABILITY.—Notwithstanding any

24 preliminary finding under subsection (a), a biomaterials
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1 supplier who has been impleaded into an action subject to

2 this Act, as provided for in this section—

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

4 against it, supplement the record of the proceeding

5 that was developed prior to the grant of the motion

6 for impleader under subsection (a), and

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

8 claimant only to the extent required and permitted by

9 any applicable State or Federal law other than this

10 Act in an action alleging harm caused by an im11 plant.

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

13 claimant or any other party the right to obtain discovery

14 from a biomaterials supplier defendant at any time prior

15 to grant of a motion for impleader beyond that allowed

16 under section 6.

17 SEC. 8. APPLICABILITY.

18 This Act shall apply to all civil actions covered under

19 this Act that are commenced on or after the date of enact20 ment of this Act, including any such action with respect

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

22 that caused the harm occurred before the date of enactment

23 of this Act.
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Biomaterials

3 Access Assurance Act of 1998’’.

4 SEC. 2. FINDINGS.

5 The Congress finds that—

6 (1) each year millions of citizens of

7 the United States depend on the avail8 ability of lifesaving or life-enhancing

9 medical devices, many of which are per10 manently implantable within the human

11 body;

12 (2) a continued supply of raw mate13 rials and component parts is necessary

14 for the invention, development, improve15 ment, and maintenance of the supply of

16 the devices;

17 (3) most of the medical devices are

18 made with raw materials and component

19 parts that—

20 (A) move in interstate commerce;

21 (B) are not designed or manufac22 tured specifically for use in medical

23 devices; and

24 (C) come in contact with internal

25 human tissue;
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1 (4) the raw materials and component

2 parts also are used in a variety of non3 medical products;

4 (5) because small quantities of the

5 raw materials and component parts are

6 used for medical devices, sales of raw ma7 terials and component parts for medical

8 devices constitute an extremely small

9 portion of the overall market for the raw

10 materials and component parts;

11 (6) under the Federal Food, Drug, and

12 Cosmetic Act (21 U.S.C. 301 et seq.) manu13 facturers of medical devices are required

14 to demonstrate that the medical devices

15 are safe and effective, including dem16 onstrating that the products are properly

17 designed and have adequate warnings or

18 instructions;

19 (7) notwithstanding the fact that raw

20 materials and component parts suppliers

21 do not design, produce, or test a final

22 medical device, the suppliers have been

23 the subject of actions alleging inad24 equate—
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1 (A) design and testing of medical

2 devices manufactured with materials

3 or parts supplied by the suppliers; or

4 (B) warnings related to the use of

5 such medical devices;

6 (8) even though suppliers of raw ma7 terials and component parts have very

8 rarely been held liable in such actions,

9 such suppliers have ceased supplying cer10 tain raw materials and component parts

11 for use in medical devices for a number

12 of reasons, including concerns about the

13 costs of such litigation;

14 (9) unless alternate sources of supply

15 can be found, the unavailability of raw

16 materials and component parts for medi17 cal devices will lead to unavailability of

18 lifesaving and life-enhancing medical de19 vices;

20 (10) because other suppliers of the

21 raw materials and component parts in

22 foreign nations are refusing to sell raw

23 materials or component parts for use in

24 manufacturing certain medical devices in

25 the United States, the prospects for de-
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1 velopment of new sources of supply for

2 the full range of threatened raw mate3 rials and component parts for medical de4 vices are remote;

5 (11) it is unlikely that the small mar6 ket for such raw materials and compo7 nent parts in the United States could sup8 port the large investment needed to de9 velop new suppliers of such raw mate10 rials and component parts;

11 (12) attempts to develop such new

12 suppliers would raise the cost of medical

13 devices;

14 (13) courts that have considered the

15 duties of the suppliers of the raw mate16 rials and component parts have generally

17 found that the suppliers do not have a

18 duty—

19 (A) to evaluate the safety and effi20 cacy of the use of a raw material or

21 component part in a medical device;

22 or

23 (B) to warn consumers concern24 ing the safety and effectiveness of a

25 medical device;
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1 (14) because medical devices and the

2 raw materials and component parts used

3 in their manufacture move in interstate

4 commerce, a shortage of such raw mate5 rials and component parts affects inter6 state commerce;

7 (15) in order to safeguard the avail8 ability of a wide variety of lifesaving and

9 life-enhancing medical devices, imme10 diate action is needed—

11 (A) to clarify the permissible

12 bases of liability for suppliers of raw

13 materials and component parts for

14 medical devices; and

15 (B) to provide expeditious proce16 dures to dispose of unwarranted suits

17 against the suppliers in such manner

18 as to minimize litigation costs;

19 (16) the several States and their

20 courts are the primary architects and

21 regulators of our tort system; Congress,

22 however, must, in certain circumstances

23 involving the national interest, address

24 tort issues, and a threatened shortage of

25 raw materials and component parts for
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1 life-saving medical devices is one such

2 circumstance; and

3 (17) the protections set forth in this

4 Act are needed to assure the continued

5 supply of materials for life-saving medi6 cal devices, although such protections do

7 not protect negligent suppliers.

8 SEC. 3. DEFINITIONS.

9 As used in this Act:

10 (1) BIOMATERIALS SUPPLIER.—

11 (A) IN GENERAL.—The term ‘‘bio12 materials supplier’’ means an entity

13 that directly or indirectly supplies a

14 component part or raw material for

15 use in the manufacture of an implant

16 (B) PERSONS INCLUDED.—Such

17 term includes any person who—

18 (i) has submitted master files

19 to the Secretary for purposes of

20 premarket approval of a medical

21 device; or

22 (ii) licenses a biomaterials

23 supplier to produce component

24 parts or raw materials.

25 (2) CLAIMANT.—
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1 (A) IN GENERAL.—The term ‘‘claim2 ant’’ means any person who brings a

3 civil action, or on whose behalf a civil

4 action is brought, arising from harm

5 allegedly caused directly or indirectly

6 by an implant, including a person

7 other than the individual into whose

8 body, or in contact with whose blood

9 or tissue, the implant is placed, who

10 claims to have suffered harm as a re11 sult of the implant.

12 (B) ACTION BROUGHT ON BEHALF OF

13 AN ESTATE.—With respect to an action

14 brought on behalf of or through the

15 estate of a deceased individual into

16 whose body, or in contact with whose

17 blood or tissue the implant was

18 placed, such term includes the dece19 dent that is the subject of the action.

20 (C) ACTION BROUGHT ON BEHALF OF

21 A MINOR OR INCOMPETENT.—With re22 spect to an action brought on behalf

23 of or through a minor or incom24 petent, such term includes the parent
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1 or guardian of the minor or incom2 petent.

3 (D) EXCLUSIONS.—Such term does

4 not include—

5 (i) a provider of professional

6 health care services in any case

7 in which—

8 (I) the sale or use of an

9 implant is incidental to such

10 services; and

11 (II) the essence of the pro12 fessional health care services

13 provided is the furnishing of

14 judgment, skill, or services;

15 (ii) a person acting in the ca16 pacity of a manufacturer, seller,

17 or biomaterials supplier; or

18 (iii) a person alleging harm

19 caused by either the silicone gel,

20 or the silicone envelope, utilized

21 in a breast implant containing sil22 icone gel, except that—

23 (I) neither the exclusion

24 provided by this clause nor

25 any other provision of this
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1 Act may be construed as a

2 finding that silicone gel (or

3 any other form of silicone)

4 may or may not cause harm;

5 and

6 (II) the existence of the

7 exclusion under this clause

8 may not—

9 (aa) be disclosed to a

10 jury in any civil action or

11 other proceeding, and

12 (bb) except as nec13 essary to establish the ap14 plicability of this Act, oth15 erwise be presented in

16 any civil action or other

17 proceeding.

18 (3) COMPONENT PART.—

19 (A) IN GENERAL.—The term ‘‘com20 ponent part’’ means a manufactured

21 piece of an implant.

22 (B) CERTAIN COMPONENTS.—Such

23 term includes a manufactured piece

24 of an implant that—
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1 (i) has significant non-implant

2 applications; and

3 (ii) alone, has no implant

4 value or purpose, but when com5 bined with other component parts

6 and materials, constitutes an im7 plant.

8 (4) HARM.—

9 (A) IN GENERAL.—The term ‘‘harm’’

10 means—

11 (i) any injury to or damage

12 suffered by an individual;

13 (ii) any illness, disease, or

14 death of that individual resulting

15 from that injury or damage; and

16 (iii) any loss to that individual

17 or any other individual resulting

18 from that injury or damage.

19 (B) EXCLUSION.—The term does

20 not include any commercial loss or

21 loss of or damage to an implant.

22 (5) IMPLANT.—The term ‘‘implant’’

23 means—
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1 (A) a medical device that is in2 tended by the manufacturer of the de3 vice—

4 (i) to be placed into a sur5 gically or naturally formed or ex6 isting cavity of the body for a pe7 riod of at least 30 days; or

8 (ii) to remain in contact with

9 bodily fluids or internal human

10 tissue through a surgically pro11 duced opening for a period of less

12 than 30 days; and

13 (B) suture materials used in im14 plant procedures.

15 (6) MANUFACTURER.—The term ‘‘manu16 facturer’’ means any person who, with re17 spect to an implant—

18 (A) is engaged in the manufac19 ture, preparation, propagation,

20 compounding, or processing (as de21 fined in section 510(a)(1) of the Fed22 eral Food, Drug, and Cosmetic Act (21

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

24 (B) is required—
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1 (i) to register with the Sec2 retary pursuant to section 510 of

3 the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 360) and the

5 regulations issued under such

6 section; and

7 (ii) to include the implant on

8 a list of devices filed with the Sec9 retary pursuant to section 510(j)

10 of such Act (21 U.S.C. 360(j)) and

11 the regulations issued under such

12 section.

13 (7) MEDICAL DEVICE.—The term ‘‘medi14 cal device’’ means a device, as defined in

15 section 201(h) of the Federal Food, Drug,

16 and Cosmetic Act (21 U.S.C. 321(h)), and

17 includes any device component of any

18 combination product as that term is used

19 in section 503(g) of such Act (21 U.S.C.

20 353(g)).

21 (8) RAW MATERIAL.—The term ‘‘raw

22 material’’ means a substance or product

23 that—

24 (A) has a generic use; and
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1 (B) may be used in an application

2 other than an implant.

3 (9) SECRETARY.—The term ‘‘Secretary’’

4 means the Secretary of Health and

5 Human Services.

6 (10) SELLER.—

7 (A) IN GENERAL.—The term ‘‘seller’’

8 means a person who, in the course of

9 a business conducted for that pur10 pose, sells, distributes, leases, pack11 ages, labels, or otherwise places an

12 implant in the stream of commerce.

13 (B) EXCLUSIONS.—The term does

14 not include—

15 (i) a seller or lessor of real

16 property;

17 (ii) a provider of professional

18 health care services where—

19 (I) the sale or use of the

20 implant is incidental to such

21 services; and

22 (II) the essence of the

23 health care services provided

24 is the furnishing of judgment,

25 skill, or services; or
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1 (iii) any person who acts in

2 only a financial capacity with re3 spect to the sale of an implant.

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

6 (a) GENERAL REQUIREMENTS.—

7 (1) IN GENERAL.—In any civil action

8 covered by this Act, a biomaterials sup9 plier may—

10 (A) raise any exclusion from li11 ability set forth in section 5; and

12 (B) make a motion for dismissal

13 or for summary judgment as set forth

14 in section 6.

15 (2) PROCEDURES.—Notwithstanding

16 any other provision of law, a Federal or

17 State court in which an action covered by

18 this Act is pending shall, in connection

19 with a motion under section 6 or 7, use

20 the procedures set forth in this Act.

21 (b) APPLICABILITY.—

22 (1) IN GENERAL.—Except as provided

23 in paragraph (2), this Act applies to any

24 civil action brought by a claimant, wheth25 er in a Federal or State court, on the
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1 basis of any legal theory, for harm alleg2 edly caused, directly or indirectly, by an

3 implant.

4 (2) EXCLUSION.—A civil action brought

5 by a purchaser of a medical device,

6 where such purchaser intends to use the

7 device in providing professional health

8 care services, for loss or damage to an

9 implant or for commercial loss to the pur10 chaser—

11 (A) shall not be considered an ac12 tion that is subject to this Act; and

13 (B) shall be governed by applica14 ble commercial or contract law.

15 (c) SCOPE OF PREEMPTION.—

16 (1) IN GENERAL.—This Act supersedes

17 any State law regarding recovery for

18 harm caused by an implant and any rule

19 of procedure applicable to a civil action

20 to recover damages for such harm only to

21 the extent that this Act establishes a rule

22 of law applicable to the recovery of such

23 damages.

24 (2) APPLICABILITY OF OTHER LAWS.—

25 Any issue that arises under this Act and
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1 that is not governed by a rule of law ap2 plicable to the recovery of damages de3 scribed in paragraph (1) shall be gov4 erned by applicable Federal or State law.

5 (d) STATUTORY CONSTRUCTION.—Nothing in

6 this Act may be construed—

7 (1) to affect any defense available to a

8 defendant under any other provisions of

9 Federal or State law in an action alleging

10 harm caused by an implant; or

11 (2) to create a cause of action or Fed12 eral court jurisdiction pursuant to sec13 tion 1331 or 1337 of title 28, United States

14 Code, that otherwise would not exist

15 under applicable Federal or State law.

16 SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

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

18 section 7, a biomaterials supplier shall not be

19 liable for harm to a claimant caused by an im20 plant unless such supplier—

21 (1) is a manufacturer of the implant,

22 as provided in subsection (b);

23 (2) is a seller of the implant, as pro24 vided in subsection (c); or
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1 (3) furnished raw materials or compo2 nent parts for the implant that failed to

3 meet applicable contractual require4 ments or specifications, as provided in

5 subsection (d).

6 (b) LIABILITY AS MANUFACTURER.—

7 (1) IN GENERAL.—A biomaterials sup8 plier may, to the extent required and per9 mitted by any other applicable law, be

10 liable for harm to a claimant caused by

11 an implant if the biomaterials supplier is

12 the manufacturer of the implant.

13 (2) GROUNDS FOR LIABILITY.—The bio14 materials supplier may be considered the

15 manufacturer of the implant that alleg16 edly caused harm to a claimant only if

17 the biomaterials supplier—

18 (A)(i) has or was required to reg19 ister with the Secretary pursuant to

20 section 510 of the Federal Food, Drug,

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

22 the regulations issued under such

23 section; and

24 (ii) included or was required to

25 include the implant on a list of de-
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1 vices filed with the Secretary pursu2 ant to section 510(j) of such Act (21

3 U.S.C. 360(j)) and the regulations

4 issued under such section;

5 (B) is the subject of a declaration

6 issued by the Secretary pursuant to

7 paragraph (3) that states that the

8 supplier, with respect to the implant

9 that allegedly caused harm to the

10 claimant, was required to—

11 (i) register with the Secretary

12 under section 510 of such Act (21

13 U.S.C. 360), and the regulations

14 issued under such section, but

15 failed to do so; or

16 (ii) include the implant on a

17 list of devices filed with the Sec18 retary pursuant to section 510(j)

19 of such Act (21 U.S.C. 360(j)) and

20 the regulations issued under such

21 section, but failed to do so; or

22 (C) is related by common owner23 ship or control to a person meeting

24 all the requirements described in sub25 paragraph (A) or (B), if the court de-
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1 ciding a motion to dismiss in accord2 ance with section 6(c)(3)(B)(i) finds,

3 on the basis of affidavits submitted in

4 accordance with section 6, that it is

5 necessary to impose liability on the

6 biomaterials supplier as a manufac7 turer because the related manufac8 turer meeting the requirements of

9 subparagraph (A) or (B) lacks suffi10 cient financial resources to satisfy

11 any judgment that the court feels it is

12 likely to enter should the claimant

13 prevail.

14 (3) ADMINISTRATIVE PROCEDURES.—

15 (A) IN GENERAL.—The Secretary

16 may issue a declaration described in

17 paragraph (2)(B) on the motion of the

18 Secretary or on petition by any per19 son, after providing—

20 (i) notice to the affected per21 sons; and

22 (ii) an opportunity for an in23 formal hearing.

24 (B) DOCKETING AND FINAL DECI25 SION.—Immediately upon receipt of a
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1 petition filed pursuant to this para2 graph, the Secretary shall docket the

3 petition. Not later than 120 days after

4 the petition is filed, the Secretary

5 shall issue a final decision on the pe6 tition.

7 (C) APPLICABILITY OF STATUTE OF

8 LIMITATIONS.—Any applicable statute

9 of limitations shall toll during the pe10 riod from the time a claimant has

11 filed a petition with the Secretary

12 under this paragraph until such time

13 as the Secretary either (i) issues a

14 final decision on the petition, or (ii)

15 the petition is withdrawn.

16 (D) STAY PENDING PETITION FOR

17 DECLARATION.—If a claimant has filed

18 a petition for a declaration with re19 spect to a defendant, and the Sec20 retary has not issued a final decision

21 on the petition, the court shall stay

22 all proceedings with respect to that

23 defendant until such time as the Sec24 retary has issued a final decision on

25 the petition. The Secretary shall com-
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1 plete review of any such petition

2 within 120 days of receipt of the peti3 tion.

4 (c) LIABILITY AS SELLER.—A biomaterials

5 supplier may, to the extent required and per6 mitted by any other applicable law, be liable

7 as a seller for harm to a claimant caused by

8 an implant only if—

9 (1) the biomaterials supplier—

10 (A) held title to the implant and

11 then acted as a seller of the implant

12 after its initial sale by the manufac13 turer; or

14 (B) acted under contract as a sell15 er to arrange for the transfer of the

16 implant directly to the claimant after

17 the initial sale by the manufacturer

18 of the implant; or

19 (2) the biomaterials supplier is relat20 ed by common ownership or control to a

21 person meeting all the requirements de22 scribed in paragraph (1), if a court decid23 ing a motion to dismiss in accordance

24 with section 6(c)(3)(B)(ii) finds, on the

25 basis of affidavits submitted in accord-
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1 ance with section 6, that it is necessary to

2 impose liability on the biomaterials sup3 plier as a seller because the related seller

4 meeting the requirements of paragraph

5 (1) lacks sufficient financial resources to

6 satisfy any judgment that the court feels

7 it is likely to enter should the claimant

8 prevail.

9 (d) LIABILITY FOR FAILURE TO MEET APPLI10 CABLE CONTRACTUAL REQUIREMENTS OR SPECI11 FICATIONS.—A biomaterials supplier may, to

12 the extent required and permitted by any

13 other applicable law, be liable for harm to a

14 claimant caused by an implant if the claimant

15 in an action shows, by a preponderance of the

16 evidence, that—

17 (1) the biomaterials supplier supplied

18 raw materials or component parts for use

19 in the implant that either—

20 (A) did not constitute the product

21 described in the contract between the

22 biomaterials supplier and the person

23 who contracted for the supplying of

24 the product; or
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1 (B) failed to meet any specifica2 tions that were—

3 (i) accepted, pursuant to ap4 plicable law, by the biomaterials

5 supplier;

6 (ii) published by the biomate7 rials supplier;

8 (iii) provided by the biomate9 rials supplier to the person who

10 contracted for such product;

11 (iv) contained in a master file

12 that was submitted by the bio13 materials supplier to the Sec14 retary and that is currently main15 tained by the biomaterials sup16 plier for purposes of premarket

17 approval of medical devices; or

18 (v) included in the submis19 sions for purposes of premarket

20 approval or review by the Sec21 retary under section 510, 513, 515,

22 or 520 of the Federal Food, Drug,

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

24 360c, 360e, or 360j), and received

25 clearance from the Secretary if
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1 such specifications were accept2 ed, pursuant to applicable law, by

3 the biomaterials supplier; and

4 (2) such failure to meet applicable

5 contractual requirements or specifica6 tions was an actual and proximate cause

7 of the harm to the claimant.

8 SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS

9 AGAINST BIOMATERIALS SUPPLIERS.

10 (a) MOTION TO DISMISS.—A defendant may,

11 at any time during which a motion to dismiss

12 may be filed under applicable law, move to

13 dismiss an action against it on the grounds

14 that the defendant is a biomaterials supplier

15 and one or more of the following:

16 (1) The defendant is not liable as a

17 manufacturer, as provided in section 5(b).

18 (2) The defendant is not liable as a

19 seller, as provided in section 5(c).

20 (3) The defendant is not liable for fur21 nishing raw materials or component

22 parts for the implant that failed to meet

23 applicable contractual requirements or

24 specifications, as provided in section 5(d).
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1 (4) The claimant did not name the

2 manufacturer as a party to the action, as

3 provided in subsection (b).

4 (b) MANUFACTURER OF IMPLANT SHALL BE

5 NAMED A PARTY.—The claimant in an action

6 brought for harm caused by an implant shall

7 be required to name the manufacturer of the

8 implant as a party to the action, unless—

9 (1) the manufacturer is subject to

10 service of process solely in a jurisdiction

11 in which the biomaterials supplier is not

12 domiciled or subject to a service of proc13 ess; or

14 (2) a claim against the manufacturer

15 is barred by applicable law or rule of

16 practice.

17 (c) PROCEEDING ON MOTION TO DISMISS.—

18 The following rules shall apply to any pro19 ceeding on a motion to dismiss filed by a de20 fendant under this section:

21 (1) EFFECT OF MOTION TO DISMISS ON

22 DISCOVERY.—

23 (A) IN GENERAL.—Except as pro24 vided in subparagraph (B), if a de25 fendant files a motion to dismiss
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1 under subsection (a), no discovery

2 shall be permitted in connection to

3 the action that is the subject of the

4 motion, other than discovery nec5 essary to determine a motion to dis6 miss for lack of jurisdiction, until

7 such time as the court rules on the

8 motion to dismiss.

9 (B) DISCOVERY.—If a defendant

10 files a motion to dismiss under sub11 section (a)(3) on the grounds that the

12 biomaterials supplier did not furnish

13 raw materials or component parts for

14 the implant that failed to meet appli15 cable contractual requirements or

16 specifications, the court may permit

17 discovery limited to issues that are

18 directly relevant to—

19 (i) the pending motion to dis20 miss; or

21 (ii) the jurisdiction of the

22 court.

23 (2) AFFIDAVITS.—

24 (A) DEFENDANT.—A defendant may

25 submit affidavits supporting the
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1 grounds for dismissal contained in its

2 motion to dismiss under subsection

3 (a). If the motion is made under sub4 section (a)(1), the defendant may sub5 mit an affidavit demonstrating that

6 the defendant has not included the

7 implant on a list, if any, filed with the

8 Secretary pursuant to section 510(j)

9 of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360(j)).

11 (B) CLAIMANT.—In response to a

12 motion to dismiss, the claimant may

13 submit affidavits demonstrating

14 that—

15 (i) the Secretary has, with re16 spect to the defendant and the

17 implant that allegedly caused

18 harm to the claimant, issued a

19 declaration pursuant to section

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

21 (ii) the defendant is a seller of

22 the implant who is liable under

23 section 5(c).

24 (3) BASIS OF RULING ON MOTION TO DIS25 MISS.—The court shall rule on a motion to
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1 dismiss filed under subsection (a) solely

2 on the basis of the pleadings and affida3 vits of the parties made pursuant to this

4 subsection. The court shall grant a mo5 tion to dismiss filed under subsection

6 (a)—

7 (A) unless the claimant submits a

8 valid affidavit that demonstrates that

9 the defendant is not a biomaterials

10 supplier;

11 (B) unless the court determines,

12 to the extent raised in the pleadings

13 and affidavits, that one or more of the

14 following apply:

15 (i) the defendant may be lia16 ble as a manufacturer, as pro17 vided in section 5(b);

18 (ii) the defendant may be lia19 ble as a seller, as provided in sec20 tion 5(c); or

21 (iii) the defendant may be lia22 ble for furnishing raw materials

23 or component parts for the im24 plant that failed to meet applica25 ble contractual requirements or
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1 specifications, as provided in sec2 tion 5(d); or

3 (C) if the claimant did not name

4 the manufacturer as a party to the ac5 tion, as provided in subsection (b).

6 (4) TREATMENT OF MOTION AS MOTION

7 FOR SUMMARY JUDGMENT.—The court may

8 deem a motion to dismiss as a motion for

9 summary judgment subject to subsection

10 (d) in order to determine whether the

11 pleadings and affidavits, in connection

12 with such action, raise genuine issues of

13 material fact concerning whether the de14 fendant furnished raw materials or com15 ponent parts of the implant that failed to

16 meet applicable contractual require17 ments or specifications as provided in

18 section 5(d).

19 (d) SUMMARY JUDGMENT.—

20 (1) IN GENERAL.—

21 (A) BASIS FOR ENTRY OF JUDG22 MENT.—If a motion to dismiss of a bio23 materials supplier is to be treated as

24 a motion for summary judgment

25 under subsection (c)(4) or if a bio-
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1 materials supplier moves for sum2 mary judgment, the biomaterials sup3 plier shall be entitled to entry of

4 judgment without trial if the court

5 finds there is no genuine issue of ma6 terial fact for each applicable element

7 set forth in paragraphs (1) and (2) of

8 section 5(d).

9 (B) ISSUES OF MATERIAL FACT.—

10 With respect to a finding made under

11 subparagraph (A), the court shall con12 sider a genuine issue of material fact

13 to exist only if the evidence submit14 ted by claimant would be sufficient to

15 allow a reasonable jury to reach a

16 verdict for the claimant if the jury

17 found the evidence to be credible.

18 (2) DISCOVERY MADE PRIOR TO A RULING

19 ON A MOTION FOR SUMMARY JUDGMENT.—If,

20 under applicable rules, the court permits

21 discovery prior to a ruling on a motion

22 for summary judgment governed by sec23 tion 5(d), such discovery shall be limited

24 solely to establishing whether a genuine

25 issue of material fact exists as to the ap-
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1 plicable elements set forth in paragraphs

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

3 (3) DISCOVERY WITH RESPECT TO A BIO4 MATERIALS SUPPLIER.—A biomaterials sup5 plier shall be subject to discovery in con6 nection with a motion seeking dismissal

7 or summary judgment on the basis of the

8 inapplicability of section 5(d) or the fail9 ure to establish the applicable elements

10 of section 5(d) solely to the extent per11 mitted by the applicable Federal or State

12 rules for discovery against nonparties.

13 (e) DISMISSAL WITH PREJUDICE.—Except as

14 provided in section 7, an order granting a mo15 tion to dismiss or for summary judgment pur16 suant to this section shall be entered with

17 prejudice.

18 (f) MANUFACTURER CONDUCT OF LITIGA19 TION.—The manufacturer of an implant that is

20 the subject of an action covered under this

21 Act shall be permitted to conduct litigation on

22 any motion for summary judgment or dismis23 sal filed by a biomaterials supplier who is a

24 defendant under this section on behalf of

25 such supplier if the manufacturer and any
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1 other defendant in such action enter into a

2 valid and applicable contractual agreement

3 under which the manufacturer agrees to bear

4 the cost of such litigation or to conduct such

5 litigation.

6 SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED BIOMATE7 RIALS SUPPLIER.

8 (a) IMPLEADING OF DISMISSED DEFENDANT.—

9 A court, upon motion by a manufacturer or a

10 claimant within 90 days after entry of a final

11 judgment in an action by the claimant against

12 a manufacturer, and notwithstanding any

13 otherwise applicable statute of limitations,

14 may implead a biomaterials supplier who has

15 been dismissed from the action pursuant to

16 this Act if—

17 (1) the manufacturer has made an as18 sertion, either in a motion or other plead19 ing filed with the court or in an opening

20 or closing statement at trial, or as part of

21 a claim for contribution or indemnifica22 tion, and the court finds based on the

23 court’s independent review of the evi24 dence contained in the record of the ac25 tion, that under applicable law—
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1 (A) the negligence or inten2 tionally tortious conduct of the dis3 missed supplier was an actual and

4 proximate cause of the harm to the

5 claimant; and

6 (B) the manufacturer’s liability

7 for damages should be reduced in

8 whole or in part because of such neg9 ligence or intentionally tortious con10 duct; or

11 (2) the claimant has moved to im12 plead the supplier and the court makes a

13 finding based on the court’s independent

14 review of the evidence contained in the

15 record of the action, that under applica16 ble law—

17 (A) the negligence or inten18 tionally tortious conduct of the dis19 missed supplier was an actual and

20 proximate cause of the harm to the

21 claimant; and

22 (B) the claimant is unlikely to be

23 able to recover the full amount of its

24 damages from the remaining defend25 ants.
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1 (b) STANDARD OF LIABILITY.—Notwith2 standing any preliminary finding under sub3 section (a), a biomaterials supplier who has

4 been impleaded into an action subject to this

5 Act, as provided for in this section—

6 (1) may, prior to entry of judgment on

7 the claim against it, supplement the

8 record of the proceeding that was devel9 oped prior to the grant of the motion for

10 impleader under subsection (a), and

11 (2) may be found liable to a manufac12 turer or a claimant only to the extent re13 quired and permitted by any applicable

14 State or Federal law other than this Act.

15 (c) DISCOVERY.—Nothing in this section

16 shall give a claimant or any other party the

17 right to obtain discovery from a biomaterials

18 supplier at any time prior to grant of a motion

19 for impleader beyond that allowed under sec20 tion 6.

21 SEC. 8. EFFECTIVE DATE.

22 This Act shall apply to all civil actions

23 covered under this Act that are commenced

24 on or after the date of enactment of this Act,

25 including any such action with respect to
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1 which the harm asserted in the action or the

2 conduct that caused the harm occurred be3 fore the date of enactment of this Act.
Union Calendar No. 349

105TH CONGRESS

2D SESSION H. R. 872

[Report No. 105–549, Parts I and II]

A BILL

To establish rules governing product liability acfor other purposes. suppliers to medical device manufacturers, and tions against raw materials and bulk componentReported from the Committee on Commerce with an

printedHouse on the State of the Union, and ordered to beamendment, committed to the Committee of the Whole