II

103D CONGRESS

2D SESSION S. 2215

To establish rules governing product liability actions against raw materials

and bulk component suppliers to medical device manufacturers, and

for other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 20 (legislative day, JUNE 7), 1994

Mr. BYRD (for Mr. LIEBERMAN) (for himself and Mr. DURENBERGER) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation

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 1994.’’

6 SEC. 2. FINDINGS.

7 Congress finds and declares the following:
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1 (1) Every year millions of Americans depend on

2 the availability of life-saving or life-enhancing per3 manently implantable medical devices;

4 (2) A continued supply of raw materials and

5 component parts is necessary to the invention, devel6 opment, improvement and maintenance of the supply

7 of such devices;

8 (3) Most of these devices are made with raw

9 materials and component parts that are not designed

10 or manufactured specifically for use in implantable

11 devices, but which have uses in a variety of

12 nonmedical products as well;

13 (4) Small quantities of these raw materials and

14 component parts are used, so that sales of raw ma15 terials and component parts for medical devices are

16 an extremely small portion of the overall market for

17 such raw materials and medical devices;

18 (5) Manufacturers of medical devices are re19 quired under the Federal Food Drug and Cosmetics

20 Act to demonstrate that their products are safe and

21 effective, including being properly designed and hav22 ing adequate warnings or instructions, and existing

23 tort law requires manufacturers of medical devices

24 to ensure they are properly designed and have ade25 quate warnings;
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1 (6) Notwithstanding the fact that raw materials

2 and component parts suppliers do not design,

3 produce, or test the final implant, they have been

4 sued in cases alleging inadequate design and testing

5 of, or warnings related to the use of, permanently

6 implanted medical devices;

7 (7) Even though raw materials and component

8 parts suppliers have almost never been held liable in

9 such suits, because the cost of litigating such suites

10 to a favorable judgment far exceeds the total poten11 tial sales of such raw materials and component parts

12 to the medical device industry, raw materials and

13 component parts suppliers have begun to cease sup14 plying such raw materials and component parts for

15 use in permanently implanted medical devices;

16 (8) The unavailability of raw materials and

17 component parts will, unless alternate sources of

18 supply can be found, lead to unavailability of life19 saving and life-enhancing medical devices;

20 (9) The prospects for development of new

21 sources of supply for the full range of threatened

22 raw materials and component parts are remote, as

23 other suppliers around the world are refusing to sell

24 raw materials or component parts for use in manu25 facturing permanently implantable medical devices
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1 in the United States, and it is unlikely that such a

2 small market could support the large investment

3 needed to develop new suppliers and attempts to do

4 so will raise the cost of medical devices;

5 (10) Courts that have considered the issue have

6 generally found that raw materials and component

7 part suppliers do not have a duty to evaluate the

8 safety and efficacy of the use of a raw material or

9 component part in a medical device, and also do not

10 have a duty to warn concerning the safety and effec11 tiveness of a medical device;

12 (11) Attempts to impose such duties will cause

13 more harm than good by driving raw materials and

14 component part suppliers to cease supplying manu15 facturers of permanently implantable medical de16 vices;

17 (12) In order to safeguard the availability of a

18 wide variety of life-saving and life-enhancing medical

19 devices, immediate action is needed to clarify the

20 permissible bases of liability for suppliers of raw ma21 terials and component parts used in the manufac22 ture of permanently implantable medical devices and

23 to provide expeditious procedures to dispose of un24 warranted suits against those suppliers so as to min25 imize litigation costs.
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1 SEC. 3. DEFINITIONS.

2 As used in this Act, the term—

3 (1) ‘‘biomaterials supplier’’ means an entity

4 that directly or indirectly supplies a component part

5 or raw material for use in the manufacture of an im6 plant, and includes persons that have submitted

7 master files to the Food and Drug Administration

8 for purposes of pre-market approval of medical de9 vices, but does not include a manufacturer or seller

10 of an implant;

11 (2) ‘‘claimant’’ means any person who brings a

12 civil action, or on whose behalf a civil action is

13 brought, arising from harm allegedly caused directly

14 or indirectly by an implant, and includes persons

15 other than the individual into whose body, or in con16 tact with whose blood or tissue, the implant is

17 placed, if such person claims to have suffered harm;

18 if such an action is brought through or on behalf of

19 an estate, the term includes the claimant’s decedent,

20 or if it is brought through or on behalf of a minor

21 or incompetent, the term includes the claimant’s

22 parent or guardian; the term does not include

23 (A) a provider of professional services in

24 any case in which the sale or use of an implant

25 is incidental to the transaction and the essence
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1 of the transaction is the furnishing of judg2 ment, skill, or services; or

3 (B) a manufacturer, seller, or biomaterials

4 supplier.

5 (3) ‘‘component part’’ means a manufactured

6 piece of an implant and includes a manufactured

7 piece that has significant nonimplant applications

8 and that by itself has no implant value or purpose,

9 but when combined with other component parts and

10 materials, constitutes an implant;

11 (4) ‘‘harm’’ means any injury to or damage suf12 fered by an individual, any illness, disease, or death

13 of that individual resulting from that injury or dam14 age, and any loss to that individual or any other in15 dividual resulting from that injury or damage; the

16 term does not include commercial loss or loss of or

17 damage to an implant itself;

18 (5) ‘‘implant’’ means a medical device that (A)

19 is placed into a surgically or naturally formed or ex20 isting cavity of the body or which contacts blood or

21 internal human tissue; and (B) which (i) is intended

22 by the manufacturer to remain in contact with the

23 body or internal tissue of the humans continuously

24 for a period of thirty days or more, or (ii) has label-
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1 ing which does not contraindicate implantation or

2 contact for thirty days or more;

3 (6) ‘‘manufacturer’’ means any person who,

4 with respect to any particular implant—

5 (A) is engaged in the manufacture, prepa6 ration, propagation, compounding, or process7 ing, as defined in Section 510(a)(1) of the Fed8 eral Food, Drug and Cosmetics Act (21 U.S.C.

9 360(a)(1)), of an implant; and

10 (B) is required under Section 510 of the

11 Federal Food, Drug, and Cosmetic Act (21

12 U.S.C. 360), and the regulations issued there13 under, to register with the Secretary of Health

14 and Human Services and to include the implant

15 on a list of devices filed with the Secretary pur16 suant to Section 510(j) of the Federal Food,

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

18 the regulations issued thereunder;

19 (7) ‘‘medical device’’ means a medical device as

20 defined in § 201(h) of the Federal Food, Drug and

21 Cosmetic Act (21 U.S.C. § 321(h));

22 (8) ‘‘qualified specialist’’ means a person who is

23 qualified by knowledge, skill, experience, training, or

24 education in the specialty areas that are the subject

25 of the action;
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1 (9) ‘‘raw material’’ means a substance or prod2 uct that has a generic use and that may be used in

3 applications other than implants;

4 (10) ‘‘seller’’ means a person who, in the course

5 of a business conducted for that purpose, sells, dis6 tributes, leases, packages, labels, or otherwise places

7 an implant in the stream of commerce; the term

8 does not include—

9 (A) a seller or lessor or real property;

10 (B) a provider of professional services in

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

12 is incidental to the transaction and the essence

13 of the transaction is the furnishing of judg14 ment, skill, or services; or

15 (C) any person who acts in only a financial

16 capacity with respect to the sale of an implant.

17 SEC. 4. APPLICABILITY; PREEMPTION.

18 (a) APPLICABILITY.—This Act applies to any civil ac19 tion brought by a claimant, whether in State or Federal

20 court, against a manufacturer, seller, or biomaterials sup21 plier, or against licensors of biomaterials suppliers, on any

22 theory, for harm caused by an implant. A civil action

23 brought by a purchaser of a medical device for use in pro24 viding professional services against a manufacturer, seller,

25 or biomaterials supplier for loss or damage to an implant
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1 itself or for commercial loss to the purchaser is not subject

2 to this Act and shall be governed by applicable commercial

3 or contract law.

4 (b) SCOPE OF PREEMPTION.—This Act supersedes

5 any State law regarding recovery for harm caused by an

6 implant only to the extent that this Act establishes a rule

7 of law applicable to any such recovery. Any issue arising

8 under this Act that is not governed by any such rule of

9 law shall be governed by applicable State or Federal law.

10 (c) EFFECT ON OTHER LAWS.—Nothing in this Act

11 shall be construed to—

12 (1) affect any defense available under other

13 provisions of State or Federal law to a defendant in

14 an action alleging harm caused by an implant; or

15 (2) create a cause of action or Federal court ju16 risdiction pursuant to 28 U.S.C. 1331 or 1337 that

17 otherwise would not exist under applicable State or

18 Federal law.

19 SEC. 5. ACTIONS AGAINST BIOMATERIALS SUPPLIERS.

20 (a)(1) Except as provided in subsection (b) of this

21 Act, no claimant may bring an action for harm caused

22 by an implant against a person, who has not registered

23 with the Secretary of Health and Human Services, pursu24 ant to section 510 of the Federal Food, Drug and Cosmet25 ics Act, and the regulations issued thereunder, and in-
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1 cluded the implant on a list of devices filed with the Sec2 retary pursuant to Section 510(j) of the Federal Food,

3 Drug and Cosmetics Act and the regulations issued there4 under.

5 (2) Notwithstanding subparagraph (1), a claimant

6 may bring an action, other than as provided in subsection

7 (b) of this Act, against a person who, with respect to

8 claimant’s implant, is the subject of a declaration issued

9 by the Secretary under section 6(a) of this Act, or is a

10 seller of the implant that allegedly caused harm to the

11 claimant.

12 (b) No claimant may bring an action for harm caused

13 by an implant against a biomaterials supplier, and no

14 biomaterials supplier shall be liable for harm to a claimant

15 caused by an implant, unless the claimant shows, by a pre16 ponderance of the evidence, that—

17 (1) the raw materials or component parts deliv18 ered by the biomaterials supplier either were not the

19 product described in the contract between the

20 biomaterials supplier and the person who contracted

21 for delivery of the product, or failed to meet any

22 specifications that were—

23 (A) provided to the biomaterials supplier

24 and not expressly repudiated by the
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1 biomaterials supplier prior to acceptance of de2 livery of the raw materials or component parts;

3 (B) published by the biomaterials supplier,

4 provided to the manufacturer by the

5 biomaterials supplier, or contained in a master

6 file submitted by the biomaterials supplier to

7 the Food and Drug Administration, and cur8 rently maintained by the biomaterials supplier,

9 for purposes of pre-market approval of medical

10 devices; or

11 (C)(i) included in the manufacturer’s sub12 missions for purposes of pre-market approval or

13 review by the Food and Drug Administration

14 under section 510, 513, 515, or 520 of the Fed15 eral Food, Drug and Cosmetic Act (21 U.S.

16 Code §§ 360, 360c, 360e, or 360j) that have re17 ceived clearance from the Food and Drug Ad18 ministration, (ii) that were provided by the

19 manufacturer to the biomaterials supplier and

20 not expressly repudiated by the biomaterials

21 supplier prior to the manufacturer’s acceptance

22 of delivery of the raw materials or component

23 parts; and

24 (2) such conduct was an actual and proximate

25 cause of the claimant’s harm.
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1 (c) No claimant may bring an action for harm caused

2 by an implant against a person who licenses a biomaterials

3 supplier to produce raw materials or component parts.

4 (d) The applicable statute of limitations shall be

5 tolled during any period in which claimant has filed a peti6 tion with the Secretary of Health and Human Services

7 under section 6 of this Act.

8 SEC. 6. REVIEW BY THE SECRETARY OF NON-REGISTRA9 TION.

10 (a) The Secretary may, on its own motion or upon

11 petition by any person, after notice to the affected persons

12 and affording an opportunity for an informal hearing,

13 issue a declaration that a person, with respect to the im14 plant that allegedly caused claimant’s harm,

15 (1) should have registered with the Secretary

16 under Section 510 of the Federal Food, Drug and

17 Cosmetics Act (21 U.S.C. 360), and the regulations

18 issued thereunder, but failed to do so, or

19 (2) should have included the implant on a list

20 of devices filed with the Secretary pursuant to Sec21 tion 510(j) of the Federal Food, Drug and Cosmetic

22 Act (21 U.S.C. 360(j)), but failed to do so.

23 (b) Any petition filed pursuant to subsection (a) shall

24 be immediately docketed by the Secretary, and the Sec-
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1 retary shall issue a final decision within 180 days of the

2 filing of the petition.

3 SEC. 7. PROCEDURES FOR ACTIONS AGAINST A

4 BIOMATERIALS SUPPLIER.

5 (a) IN GENERAL.—The procedural requirements set

6 forth in subsection (b) shall apply to any action by a

7 claimant against a biomaterials supplier.

8 (b) PROCEDURAL REQUIREMENTS.—

9 (1) A claimant may not bring an action against

10 a biomaterials supplier unless the manufacturer of

11 the implant is named as a party, except if the manu12 facturer is subject to service of process in no juris13 diction in which the biomaterials supplier or is also

14 subject to service of process or unless litigation

15 against the manufacturer is barred by applicable

16 law.

17 (2) No action may be brought by any claimant

18 against a biomaterials supplier unless, at the time

19 the claimant brings the action, the claimant submits

20 an affidavit—

21 (A) declaring that the claimant has con22 sulted and reviewed the facts of the action with

23 qualified specialists, whose qualifications the

24 claimant shall disclose;
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1 (B) including a written determination by a

2 qualified specialist that the raw materials or

3 component parts actually used in the manufac4 ture of claimant’s implant were raw materials

5 or component parts described in section 5(b)(1),

6 together with a statement of the basis for such

7 a determination;

8 (C) including a written determination by a

9 qualified specialist that, after a review of the

10 medical record and other relevant material, the

11 raw material or component part supplied by the

12 biomaterials supplier and actually used in the

13 manufacture of claimant’s implant was a cause

14 of claimant’s harm, together with a statement

15 of the basis for the determination;

16 (D) on the basis of the qualified special17 ists’ review and consultation, that the claimant

18 (or the claimant’s attorney) has concluded that

19 there is a reasonable and meritorious cause for

20 the filing of the action against the biomaterials

21 supplier.

22 (c) DISMISSAL.—

23 (1) In any action subject to this Act, a defend24 ant may, at any time at which a motion to dismiss

25 may be filed under applicable law, move to dismiss
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1 the action on the grounds that the defendant is a

2 biomaterials supplier and—

3 (A) claimant has failed to satisfy the con4 ditions in section 5(a) that would permit claim5 ant to bring an action against defendant;

6 (B) defendant was not a seller of the im7 plant which allegedly caused harm to the claim8 ant; or

9 (C) claimant has failed to comply with the

10 provisions of subsection (b).

11 (2) Defendant may submit affidavits dem12 onstrating that defendant has not included the im13 plant on a list, if any, filed with the Secretary pur14 suant to section 510(j) of the Federal Food, Drug

15 and Cosmetic Act (21 U.S.C. 360). Claimant may,

16 in response to such a motion, submit affidavits dem17 onstrating that the Secretary has, with respect to

18 the defendant and the implant that allegedly caused

19 claimant’s harm, issued a declaration pursuant to

20 section 6(a) of this Act, or that defendant was a

21 seller of the implant.

22 (3) No discovery shall be permitted against the

23 defendant who has filed a motion to dismiss under

24 subparagraph (1), other than discovery necessary to

25 determine a motion to dismiss for lack of jurisdic-
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1 tion, until the court has ruled on the motion to dis2 miss filed pursuant to subsection (1).

3 (4) A defendant shall conclusively be deemed to

4 be a biomaterials supplier and not to be subject to

5 suit except pursuant to section 5(b) of this Act, and

6 a motion to dismiss under subsections (c)(1)(A) or

7 (c)(1)(B) shall be granted, unless the claimant sub8 mits valid affidavits demonstrating—

9 (A) with respect to a motion under sub10 section (c)(1)(A), that the Secretary has, with

11 respect to the defendant and the implant that

12 allegedly caused harm to the claimant, issued a

13 declaration pursuant to section 6(a) of this Act;

14 or

15 (B) with respect to a motion under sub16 section (c)(1)(B), that the biomaterials supplier

17 was a seller which held title to the implant as

18 a result or purchasing or selling the implant

19 after the implant was manufactured and en20 tered the stream of commerce.

21 (5) The court shall rule on the motion to dis22 miss filed under subsection (c) solely on the basis of

23 the pleadings and any affidavits, including affidavits

24 submitted under paragraph (2). If the pleadings and

25 affidavits raise genuine issues as to material facts
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1 with respect to a motion under (c)(1)(C), the motion

2 may be treated as a motion for summary judgment

3 pursuant to subsection (d) of this section.

4 (d) SUMMARY JUDGMENT.—

5 (1) A biomaterials supplier shall be entitled to

6 entry of judgment without trial if there is no genu7 ine issue as to any material fact as to each element

8 set forth in section 5(b). A genuine issue of material

9 fact shall exist only if the evidence submitted by

10 claimant, if found by a jury to be credible, would be

11 sufficient to allow a reasonable jury to reach a ver12 dict for the claimant.

13 (2) In the event that the court, under applicable

14 rules, may permit discovery prior to ruling on a mo15 tion for summary judgment, such discovery shall be

16 limited solely to establishing whether a genuine issue

17 of material fact exists.

18 (e) A biomaterials supplier shall be subject to discov19 ery in connection with a motion under subsection (c) or

20 (d) solely to the extent permitted by the applicable State

21 or Federal rules for discovery against nonparties.

22 (f) In the event claimant has filed a petition for a

23 declaration pursuant to section 6(a) with respect to a de24 fendant, and the Secretary has not issued a final decision

25 thereon, the court shall stay all proceedings with respect
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1 to that defendant until the Secretary has issued a final

2 decision.

3 (g) The manufacturer of the implant shall be per4 mitted to file and conduct the proceeding on any motion

5 filed pursuant to subsection (c) or (d) if the manufacturer

6 and the other defendant(s) have entered into a valid and

7 applicable contractual agreement in which the manufac8 turer agrees to bear the cost of or to conduct such pro9 ceeding.

10 (h) The court shall require the claimant to com11 pensate the biomaterials supplier (or a manufacturer ap12 pearing in lieu of a supplier pursuant to subsection (g))

13 for attorney fees and costs, if the claimant named or

14 joined the biomaterials supplier, but the court found the

15 claim against the biomaterials supplier to be without merit

16 and frivolous.

17 SEC. 9. EFFECTIVE DATE.

18 This act shall take effect on the date of its enactment

19 and shall apply to all civil actions pursuant to this act

20 commenced on or after such date, including any action in

21 which the harm or the conduct which caused the harm

22 occurred before the effective date of this act.

23 SEC. 10. SEVERABILITY.

24 If any provision of this act, or the application of such

25 provision to any person or circumstances is held to be un-
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1 constitutional, the remainder of this act and application

2 of the provisions of such to any person or circumstance

3 shall not be affected thereby.

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