[Congressional Record Volume 143, Number 92 (Thursday, June 26, 1997)]
[Senate]
[Pages S6499-S6502]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BREAUX:
  S. 966. A bill to provide legal standards and procedures for 
suppliers of raw materials and component parts for medical devices and 
for other purposes; to the Committee on Commerce, Science, and 
Transportation.


    the biomaterials access assurance and health safety act of 1997

  Mr. BREAUX. Mr. President, today I rise to introduce the Biomaterials 
Access Assurance and Health Safety act of 1997. While other legislation 
has been introduced that is intended to protect suppliers of raw 
materials used in the construction of important medical implants from 
liability, I believe that my legislation strikes the proper balance 
between the legitimate concerns of these suppliers and the health 
insurance and legal rights of patients.
  The legislation I am introducing today is similar to biomaterials 
legislation that has been introduced independently by Senator Lieberman 
and as a part of S. 5, the Product Liability Fairness Act. It does, 
however, differ on several important points. First, this bill would not 
immunize negligent suppliers or supplies who fail to warn of the 
harmful effects of their products. Second, this bill would be limited 
to the protection of suppliers of raw materials. Other biomaterials 
bills, while speaking only of the need to protect suppliers of raw 
materials, use overly broad language that immunizes a whole host of 
product manufacturers. Third, unlike the legislation sent to the 
President last year, this bill would not cover suppliers of materials 
used in breast implants.
  Mr. President, there are two other important differences between this 
legislation and other biomaterials liability legislation that has been 
introduced. I believe that this bill can be passed by Congress. I'm not 
sure that other biomaterials bills can. We know too well that the 
larger product liability bill will be controversial, and that its 
passage and enactment are uncertain at best. This biomaterials bill has 
been introduced as a stand-alone measure and can move independently of 
the product liability bill.
  I also believe that this legislation can be signed into law by 
President Clinton, and I'm not too sure that other biomaterials 
liability legislation can. When the President vetoed the product 
liability bill sent to him by the 104th Congress, H.R. 965, which 
included biomaterials language similar to that in Senator Lieberman's 
bill, he noted that he wanted to enact fair and balanced biomaterials 
liability legislation. However, he felt that the language before him 
went too far, particularly because it immunized negligent biomaterials 
suppliers. I believe the President will find the provisions of my bill 
acceptable.
  Mr. President, I think that this bill is the best hope we have of 
passing fair and meaningful biomaterials legislation, and I urge my 
colleagues to join me in support of its passage. I ask unanimous 
consent that the entire text of this bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 966

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This title may be cited as the ``Biomaterials Access 
     Assurance Act of 1997.''

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) each year millions of citizens of the United States 
     depend on the availability of lifesaving or life enhancing 
     medical devices, many of which are permanently implantable 
     within the human body;
       (2) a continued supply of raw materials and component parts 
     is necessary for the invention, development, improvement, and 
     maintenance of the supply of the devices;
       (3) most of the medical devices are made with raw materials 
     and component parts that--
       (A) are not designed or manufactured specifically for use 
     in medical devices; and
       (B) come in contact with internal human tissue;
       (4) the raw materials and component parts also are used in 
     a variety of nonmedical products;
       (5) because small quantities of the raw materials and 
     component parts are used for medical devices, sales of raw 
     materials and component parts for medical devices constitute 
     an extremely small portion of the overall market for the raw 
     materials and medical devices;
       (6) under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.), manufacturers of medical devices are 
     required to demonstrate that the medical devices are safe and 
     effective, including demonstrating that the products are 
     properly designed and have adequate warnings or instructions;
       (7) notwithstanding the fact that raw materials and 
     component parts suppliers do not design, produce, or test a 
     final medical device, the suppliers have been the subject of 
     actions alleging adequate--
       (A) design and testing of medical devices manufactured with 
     materials or parts supplied by the suppliers; or
       (B) warnings related to the use of such medical devices;
       (8) even though suppliers of raw materials and component 
     parts have very rarely been held liable in such actions, such 
     suppliers have ceased supplying certain raw materials and 
     component parts for use in medical devices because the costs 
     associated with litigation in order to ensure a favorable 
     judgment for the suppliers far exceeds the total potential 
     sales revenues from sales by such suppliers to the medical 
     device industry;
       (9) unless alternate sources of supply can be found, the 
     unavailability of raw materials and component parts for 
     medical devices will lead to unavailability of lifesaving and 
     life-enhancing medical devices;
       (10) because other suppliers of the raw materials and 
     component parts in foreign nations are refusing to sell raw 
     materials or component parts for use in manufacturing certain 
     medical devices in the United States, the prospects for 
     development of new sources of supply for the full range of 
     threatened raw materials and component parts for medical 
     devices are remote;
       (11) it is unlikely that the small market for such raw 
     materials and component parts in the United States could 
     support the large investment needed to develop new suppliers 
     of such raw materials and component parts;
       (12) attempts to develop such new suppliers would raise the 
     cost of medical devices;
       (13) courts that have considered the duties of the 
     suppliers of the raw materials and component parts have 
     generally found that the suppliers do not have a duty--
       (A) to evaluate the safety and efficacy of the use of a raw 
     material or component part in a medical device; and
       (B) to warn consumers concerning the safety and 
     effectiveness of a medical device;
       (14) attempts to impose the duties referred to in 
     subparagraphs (A) and (B) of paragraph (13) on suppliers of 
     the raw materials and component parts would cause more harm 
     than good by driving the suppliers to cease supplying 
     manufacturers of medical devices; and
       (15) in order to safeguard the availability of a wide 
     variety of lifesaving and life-enhancing medical devices, 
     immediate action is needed--
       (A) to clarify the permissible bases of liability for 
     suppliers of raw materials and component parts for medical 
     devices; and
       (B) to provide expeditious procedures to dispose of 
     unwarranted suits against the suppliers in such manner as to 
     minimize litigation costs.

     SEC. 3. DEFINITIONS.

       As use in this Act:
       (1) Biomaterials supplier.--
       (A) In general.--The term ``biomaterials supplier'' means 
     an entity that directly or indirectly supplies raw material 
     for use in the manufacture of an implant.
       (B) Persons included.--Such term includes any person who--
       (i) has submitted master files to the Secretary for 
     purposes of premarket approval of a medical device; or

[[Page S6500]]

       (ii) licenses a biomaterials supplier to produce raw 
     materials.
       (2) Claimant.--
       (A) In general.--The term ``claimant'' means any person who 
     brings a civil action, or on whose behalf a civil action is 
     brought, arising from harm allegedly caused directly or 
     indirectly by an implant, including a person other than the 
     individual into whose body, or in contact with whose blood or 
     tissue, the implant is placed, who claims to have suffered 
     harm as a result of the implant.
       (B) Action brought on behalf of an estate.--With respect to 
     an action brought on behalf of or through the estate of an 
     individual into whose body, or in contact with whose blood or 
     tissue the implant is placed, such term includes the decedent 
     that is the subject of the action.
       (C) Action brought on behalf of a minor or incompetent.--
     With respect to an action brought on behalf of or through a 
     minor or incompetent, such term includes the parent or 
     guardian of the minor or incompetent.
       (D) Exclusions.--Such term does not include--
       (i) a provider of professional health care services, in any 
     case in which--
       (I) the sale or use of an implant is incidental to the 
     transaction; and
       (II) the essence of the transaction is the furnishing of 
     judgment, skill, or services;
       (ii) a person acting in the capacity of a manufacturer, 
     seller, or biomaterials supplier; or
       (iii) a person alleging harm caused by a breast implant.
       (3) Harm.--
       (A) In general.--The term ``harm'' means--
       (i) any injury to or damage suffered by an individual;
       (ii) any illness, disease, or death of that individual 
     resulting from that injury or damage; and
       (iii) any loss to that individual or any other individual 
     resulting from that injury or damage;
       (B) Commercial loss.--The term includes any commercial loss 
     or loss of or damage to an implant.
       (4) Implant.--The term ``implant'' means--
       (A) a medical device that is intended by the manufacturer 
     of the device--
       (i) to be placed into a surgically or naturally formed or 
     existing cavity of the body for a period of at least 30 days; 
     or
       (ii) to remain in contact with bodily fluids or internal 
     human tissue through a surgically produced opening for a 
     period of less than 30 days; and
       (A) suture materials used in implant procedures.
       (5) Manufacturer.--The term ``manufacturer'' means any 
     person who, with respect to an implant--
       (A) is engaged in the manufacture, preparation, 
     propagation, compounding, or processing (as defined in 
     section 510(a)(1)) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360)(a)(1)) of the implant; and
       (B) is required--
       (i) to register with the Secretary pursuant to section 510 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) 
     and the regulations issued under such section; and
       (ii) to include the implant on a list of devices filed with 
     the Secretary pursuant to section 510(j) of such Act (21 
     U.S.C. 360(j) and the regulations issued under such section.
       (6) Medical device.--The term ``medical device'' means a 
     device, as defined in section 1(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321(h)) and includes any device 
     component of any combination product as that term is used in 
     section 503(g) of such Act (21 U.S.C. 353(g))
       (7) Raw material.--The term ``raw material'' means a 
     substance or product that--
       (A) has a generic use; and
       (B) may be used in an application other than an implant.
       (8) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (9) Seller.--
       (A) In General.--The term ``seller'' means a person who, in 
     the course of a business conducted for that purpose, sells, 
     distributes, leases, packages, labels, or otherwise places an 
     implant in the stream of commerce.
       (B) Exclusions.--the term does not include--
       (i) a seller or lessor of real property;
       (ii) a provider of professional services, in any case in 
     which the sale or use of an implant is incidental to the 
     transaction and the essence of the transaction is the 
     furnishing of judgment, skill, or services; or
       (iii) any person who acts in only a financial capacity with 
     respect to the sale of an implant.

     SEC. 4. GENERAL REQUIREMENTS: APPLICABILITY; PREEMPTION.

       (a) General Requirements.--
       (1) In General.--In any civil action covered by this Act, a 
     biomaterials supplier may raise any defense set forth in 
     section 5.
       (A) Procedures.--Notwithstanding any other provision of 
     law, the Federal or State court in which a civil action 
     covered by this Act is pending shall, in connection with a 
     motion for dismissal or judgment based on a defense described 
     in paragraph (1), use the procedures set forth in section 6.
       (b) Applicability.--
       (1) In General.--Except as provided in paragraph (2), 
     notwithstanding any other provision of law, this Act applies 
     to any civil action brought by a claimant, whether in a 
     Federal or State court, against a manufacturer, seller, or 
     biomaterials supplier, on the basis of any legal theory, for 
     harm allegedly caused by an implant.
       (2) Exclusion.--A civil action brought by a purchaser of a 
     medical device for use in providing professional services 
     against a manufacturer, seller, or biomaterials supplier for 
     loss or damage to an implant or for commercial loss to the 
     purchaser--
       (A) shall not be considered an action that is subject to 
     this Act; and
       (B) shall be governed by applicable commercial or contract 
     law.
       (c) Scope of Preemption.--
       (1) In general.--This title supersedes any State law 
     regarding recovery for harm caused by an implant and any rule 
     of procedure applicable to a civil action to recover damages 
     for such harm only to the extent that this Act establishes a 
     rule of law applicable to the recovery of such damages.
       (2) Applicability of other laws.--Any issue that arises 
     under this Act and that is not governed by a rule of law 
     applicable to the recovery of damages described in paragraph 
     (1) shall be governed by applicable Federal or State law.
       (d) Statutory Construction.--Nothing in this Act may be 
     construed to create a cause of action or Federal court 
     jurisdiction pursuant to section 1331 or 1337 of title 28, 
     United States Code, that otherwise would not exist under 
     applicable Federal or State law.

     SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

       (a) In General.--
       (1) Exclusion from liability.--Except as provided in 
     paragraph (2), a biomaterials supplier shall not be liable 
     for harm to a claimant caused by an implant.
       (2) Liability.--A biomaterials suppler that--
       (A) is a manufacturer may be liable for harm to a claimant 
     described in subsection (b);
       (B) is a seller may be liable for harm to a claimant 
     described in subsection (c);
       (C) furnishes raw materials that fail to meet applicable 
     contractual requirements or specifications may be liable for 
     a harm to a claimant described in subsection (d).
       (D) knows, or through reasonable inquiry could have known:
       (i) of the application to which the raw material is to be 
     put;
       (ii) of the risks attendant to such use; and
       (iii) that the buyer or user of the raw material is 
     ignorant of such risks, but failed to warn such buyer or user 
     of such risks, may be liable for harm to a claimant described 
     in subsection (e); and
       (E) furnishes raw materials that are defective may be 
     liable for harm to a claimant as described in subsection (f).
       (b) Liability Manufacturer.--
       (1) In general.--A biomaterials supplier may, to the extent 
     required and permitted by any other applicable law, be liable 
     for harm to a claimant caused by an implant if the 
     biomaterials supplier is the manufacturer of the implant.
       (2) Grounds for liability.--
       (A) The biomaterials supplier may be considered the 
     manufacturer of the implant that allegedly caused harm to a 
     claimant only if the biomaterials supplier--
       (i) has registered with the Secretary pursuant to section 
     510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360) and the regulations issued under such section; and
       (ii) included the implant on a list of devices filed with 
     the Secretary pursuant to section 510(f) of such Act (21 
     U.S.C. 360(f)) and the regulations issued under such section;
       (B) is the subject of a declaration issued by the Secretary 
     pursuant to paragraph (3) that states that the supplier, with 
     respect to the implant that allegedly caused harm to the 
     claimant, was required to--
       (i) register with the Secretary under section 510 of such 
     Act (21 U.S.C. 360), and the regulations issued under such 
     section, but failed to do so; or
       (ii) include the implant on a list of devices filed with 
     the Secretary pursuant to section 510(j) of such Act (21 
     U.S.C. 360(j)) and the regulations issued under such section, 
     but failed to do so; or
       (C) is related by common ownership or control to a person 
     meeting all the requirements described in subparagraph (A) or 
     (B), if the court deciding a motion to dismiss in accordance 
     with section 6(c)(3)(B)(i) finds, on the basis of affidavits 
     submitted in accordance with section 6, that it is necessary 
     to impose liability on the biomaterials supplier as a 
     manufacturer because the related manufacturer meeting the 
     requirements of a subparagraph (A) or (B) lacks sufficient 
     financial resources to satisfy any judgment that the court 
     feels it is likely to enter should the claimant prevail.
       (3) Administrative procedures.--
       (A) In general.--The Secretary may issue a declaration 
     described in paragraph (2)(B) on the motion of the Secretary 
     or on petition by any person, after providing--
       (i) notice to the affected persons; and
       (ii) an opportunity for an informal hearing.
       (B) Docketing and final decision.--Immediately upon receipt 
     of a petition filed pursuant to this paragraph, the Secretary 
     shall docket the petition. Not later than 180 days after the 
     petition is filed, the Secretary shall issue a final decision 
     on the petition.
       (C) Applicability of statute of limitations.--Any 
     applicable statute of limitations shall toll during the 
     period during which a claimant has filed a petition with the 
     Secretary under this paragraph.
       (c) Liability as Seller.--A biomaterials supplier may, to 
     the extent required and permitted by any other applicable law 
     be liable

[[Page S6501]]

     as seller for harm to a claimant caused by an implant if--
       (1) the biomaterials supplier--
       (A) held little to the implant that allegedly caused harm 
     to the claimant as a result of purchasing the implant after--
       (i) the manufacture of the implant and
       (ii) the entrance of the implant in the stream of commerce; 
     and
       (B) subsequently resold the implant; or
       (2) the biomaterials supplier is related by common 
     ownership or control to a person meeting all the requirements 
     described in paragraph (1), if a court deciding a motion to 
     dismiss in accordance with section 6(c)(3)(B)(ii) finds on 
     the basis of affidavits submitted in accordance with section 
     6 that is necessary to impose liability on the biomaterials 
     supplier as a seller because the related seller meeting the 
     requirements of paragraph (1) lacks sufficient financial 
     resources to satisfy any judgment that the court feels it is 
     likely to enter should the claimant prevail.
       (d) Liability for Violating Contractual Requirements or 
     Specifications.--A biomaterials supplier may, to the extent 
     required and permitted by any other applicable law, be liable 
     for harm to a claimant caused by an implant, if the claimant 
     in an action shows, by a preponderance of the evidence, 
     that--
       (1) the raw materials or component parts delivered by the 
     biomaterials supplier either--
       (A) did not constitute the product described in the 
     contract between the biomaterials supplier and the person who 
     contracted for delivery of the product; or
       (B) failed to meet any specifications that were--
       (i) provided to the biomaterials supplier and not expressly 
     repudiated by the biomaterials supplier prior to acceptance 
     of delivery of the raw materials or component parts;
       (I) published by the biomaterials supplier;
       (II) provided to the manufacturer by the biomaterials 
     supplier; or
       (III) contained in a master file that was submitted by the 
     biomaterials supplier to the Secretary and that is currently 
     maintained by the biomaterials supplier for purposes of 
     premarket approval of medical devices; or
       (ii) included in the submissions for purposes of premarket 
     approval or review by the Secretary under section 510, 513, 
     515, or 520 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360, 360c, 360e, or 360j), and received clearance from 
     the Secretary if such specifications were provided by the 
     manufacturer to the biomaterials supplier and were not 
     expressly repudiated by the biomaterials supplier prior to 
     the acceptance by the manufacturer of delivery of the raw 
     materials or component parts; and
       (2) such conduct was an actual and proximate cause of the 
     harm to the claimant.
       (e) Liability for Failure to Warn.--A biomaterials supplier 
     may, to the extent required or permitted by any other 
     applicable law, be liable for harm caused by an implant if 
     the biomaterials supplier--
       (1) knew, or through reasonable inquiry could have known;
       (A) of the application to which the raw material was to be 
     put;
       (B) of the risks attendant to such use;
       (C) that the buyer or user of the raw material was ignorant 
     of such risks; and
       (2) failed to warn such buyer or user of such risks.
       (f) Liability for Defective Material.--A biomaterials 
     supplier may, to the extent permitted by any other applicable 
     law, be liable for harm caused by an implant if the harm was 
     in whole or in part caused by a defect in the raw material 
     supplied by the biomaterials supplier.

     SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST 
                   BIOMATERIALS SUPPLIERS.

       (a) Motion to Dismiss.--In any action that is subject to 
     this Act, a biomaterials supplier who is a defendant in such 
     action may, at any time during which a motion to dismiss may 
     be filed under an applicable law, move to dismiss the action 
     against it on the grounds that--
       (1) the defendant is a biomaterials supplier; and
       (2)(A) the defendant should not, for the purposes of--
       (i) section 5(b), be considered to be a manufacturer of the 
     implant that is subject to such section; or
       (ii) section 5(c), be considered to be a seller of the 
     implant that allegedly caused harm to the claimant;
       (iii) section 5(e), be found to have failed to warn the 
     buyer or user of the raw material of its known risks;
       (iv) section 5(f), be found to have supplied defective 
     material; or
       (B)(i) the claimant has failed to establish pursuant to 
     section 5(d), that the supplier furnished raw materials or 
     component parts in violation of contractual requirements or 
     specifications; or
       (ii) the claimant has failed to comply with the procedural 
     requirements of subsection (b).
       (b) Proceeding on Motion To Dismiss.--The following rules 
     shall apply to any proceeding on a motion to dismiss filed 
     under this section:
       (1) Affidavits relating to listing and declarations.--
       (A) In general.--The defendant in the action may submit an 
     affidavit demonstrating that defendant has not included the 
     implant on a list, if any, filed with Secretary pursuant to 
     section 510(j) of the Federal Food, Drug and Cosmetic Act (21 
     U.S.C. 360(j)).
       (B) Response to motion to dismiss.--In response to the 
     motion to dismiss, the claimant may submit an affidavit 
     demonstrating that--
       (i) the Secretary has, with respect to the defendant and 
     the implant that allegedly caused harm to the claimant, 
     issued a declaration pursuant to section 5(b)(2)(B); or
       (ii) the defendant who filed the motion to dismiss is a 
     seller of the implant who is liable under section 5(c).
       (2) Effect of motion to dismiss on discovery.--
       (A) In general.--If a defendant files a motion to dismiss 
     under paragraph (1) or (2) of subsection (a), no discovery 
     shall be permitted connection to the action that is subject 
     of the motion, other than discovery necessary to determine a 
     motion to dismiss for lack of jurisdiction, until such time 
     as the court rules on the motion to dismiss in accordance 
     with the affidavits submitted the parties in accordance with 
     section.
       (B) Discovery.--If a defendant files a motion to dismiss 
     under subsection (a)(2)(B)(i) on the grounds that the 
     biomaterials supplier did not furnish raw materials or 
     component parts in violation of contractual requirements or 
     specifications, the court may permit discovery, as ordered by 
     the court. The discovery conducted pursuant to this 
     subparagraph shall be limited to issues that are directly 
     relevant to--
       (i) the pending motion to dismiss; or
       (ii) the jurisdiction of the court.
       (3) Affidavits relating states of defendant.--
       (A) In general.--Except as provided in clauses (i) and (ii) 
     of subparagraph (B), the court shall consider a defendant to 
     be a biomaterials supplier who is not subject to an action 
     for harm to a claimant caused by an implant, other than an 
     action relating to liability for a violation of contractual 
     requirements or specifications described in subsection (d).
       (B) Responses to motion to dismiss.--The court shall grant 
     a motion to dismiss any action that asserts liability of the 
     defendant under subsection (b) or (c) of section 5 on the 
     grounds that the defendant is not a manufacturer subject to 
     such section 5(b) or seller subject to section 5(c), unless 
     the claimant submits a valid affidavit that demonstrates 
     that--
       (i) with respect to a motion to dismiss contending the 
     defendant is not a manufacturer, the defendant meets the 
     applicable requirements for liability as a manufacturer under 
     section 5(b); or
       (ii) with respect to a motion to dismiss contending that 
     the defendant is not a seller, the defendant meets the 
     applicable requirements for liability as a seller under 
     section 5(c).
       (4) Basis of ruling on motion to dismiss.--
       (A) In general.--The court shall rule on a motion to 
     dismiss filed under subsection (a) solely on the basis of the 
     pleadings of the parties made pursuant to this section and 
     any affidavits submitted by the parties pursuant to this 
     section.
       (B) Motion for summary judgement.--Notwithstanding any 
     other provision of law, if the court determines that the 
     pleadings and affidavits made by parties pursuant to this 
     section raise genuine issues as concerning material facts 
     with respect to a motion to dismiss to be a motion for 
     summary judgment made pursuant to subsection (c).
       (c) Summary Judgment.--
       (1) In general.--
       (A) Basis for entry of judgment.--A biomaterials supplier 
     shall be entitled to entry of judgment without trial if the 
     court finds there is a no genuine issue as concerning any 
     material fact for each applicable element set forth in 
     paragraphs (1) and (2) of section 5(d).
       (B) Issues of material fact.--With respect to a finding 
     made under subparagraph (A), the court shall consider a 
     genuine issue of material fact to exist only if the evidence 
     submitted by claimant would be sufficient to allow a 
     reasonable jury to reach a verdict for the claimant if the 
     jury found the evidence to be credible.
       (2) Discovery made prior to a ruling on a motion for 
     summary judgment.--If, under applicable rules, the court 
     permits discovery prior to a ruling on a motion for summary 
     judgment made pursuant to this subsection, such discovery 
     shall be limited solely to establishing whether a genuine 
     issue of material fact exists as to the applicable elements 
     set forth in paragraphs (1) and (92) of section 5(9)(d).
       (3) Discovery with respect to a biomaterials supplier.--A 
     biomaterials supplier shall be subject to discovery in 
     connection with a motion seeking dismissal or summary 
     judgment on the basis of the inapplicability of section 5(d) 
     or the failure to establish the applicable elements of 
     section 5(d) solely to the extent permitted by the applicable 
     Federal or State rules for discovery against nonparties.
       (d) Stay Pending Petition for Declaration.--If a claimant 
     has filed a petition for a declaration pursuant to section 
     5(b)(3)(A) with respect to a defendant, and the Secretary has 
     not issued a final decision on the petition, the court shall 
     stay all proceedings with respect to that defendant until 
     such time as the Secretary has issued a final decision on the 
     petition.
       (a) Attorney Fees.--The court shall require the claimant to 
     compensate the biomaterials supplier for a manufacturer 
     appearing in lieu of a supplier pursuant to subsection (f) 
     for attorney fees and costs, if
       (1) the claimant named or joined the biomaterials supplier; 
     and

[[Page S6502]]

       (2) the court found the claim against the biolmaterials 
     supplier was clearly without merit and frivolous at the time 
     the claim was brought.
                                 ______