[Congressional Record Volume 140, Number 78 (Monday, June 20, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: June 20, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. HEFLIN:
  S. 2212. A bill to provide guidelines for the membership of 
committees making recommendations on the rules of procedure appointed 
by the Judicial Conference, and for other purposes; to the Committee on 
the Judiciary.


                    amending the rules enabling act

  Mr. HEFLIN. Mr. President, sections 2071 through 2077 of title 28 of 
the United States Code are the cluster of statutory provisions 
authorizing the Supreme Court to issue the rules under which the 
various Federal courts function. While there have been many amendments 
to these sections over the years, the group is commonly referred to as 
the Rules Enabling Act. The original act, adopted in 1934, did not 
provide for committees to aid the Supreme Court in exercising this 
responsibility, but Chief Justice Hughes decided to appoint an advisory 
committee, whose original membership consisted of 13 members. Former 
Attorney General William Mitchell chaired the committee, which 
contained four law professors and very distinguished lawyers, including 
the president of the American Bar Association and the president of the 
American Law Institute. Between 1935 and the final promulgation of the 
rules in 1938, there were some changes in the personnel. Four 
practicing lawyers, two professors, and one district court judge became 
members of the committee. For the stupendous impact on the legal system 
of America, no subsequent rules have had the dynamic quality of those 
original rules.
  Over time, Congress has refined the system. The assistance of the 
committees is now regularized by statute--see 29 U.S.C. section 
2073(a)(2)--and this section of the statute provides that the various 
committees, like the early committee, ``shall consist of members of the 
bench and the professional bar and trial and appellate judges.'' The 
members are appointed by the Chief Justice of the United States.
  The rulemaking system, as spread over the various branches of court 
system with rules of civil, criminal, appeals, evidence, bankruptcy, et 
cetera, has on the whole worked fairly well. Suffice it to say that 
today the rules pass from advisory committees to a central standing 
committee, and from there go to the Judicial Conference of the United 
States, which does in fact exercise a meaningful supervisory function. 
For example, last year the Conference deleted a rule which had been 
recommended to it by the committee structure in the civil field. After 
the Conference approves a rule, it then passes to the Supreme Court of 
the United States, whose members have somewhat differing views as to 
what function they can be expected actually to perform; there is some 
sentiment for letting the process stop with the Judicial Conference. 
Next, the rules pass to Congress, and if it does not disapprove them 
within 180 days, they become effective.
  I turn now to the exact matter at issue. I can most easily do so by 
quoting from a statement by the American Bar Association, dated March 
28, 1994, to the relevant committee of the Judicial Conference:

       In 1935, when work was begun on the Federal rules, the 
     advisory committee that did the drafting was comprised of 
     nine lawyers and four academics; there were no judges 
     involved. In 1960, when the advisory committee was 
     reconstituted, a majority of its members were practicing 
     lawyers. As late as 1981, 40 percent of the advisory 
     committee were practitioners. Today, no more than four 
     members of the key panel of 13 civil rules drafters are trial 
     lawyers. While the inclusion of judges in the process has had 
     undoubted benefit, the near-total exclusion of practicing 
     trial lawyers has skewed the process and its product. We are 
     not confident, as a consequence, that the process has 
     produced rules that respond to the concerns of litigants and 
     the lawyers who represent them in court. This trend must be 
     reversed and lawyers restored to a position of real 
     responsibility in the rules drafting process. In order to do 
     this most effectively, and to benefit from the positive and 
     valuable contributions of practicing lawyers to the rules 
     process, the membership on all the advisory committees should 
     be expanded to include more bar representation.

  I believe this position is well taken. Clearly a gulf has arisen 
between the rulemakers and the bar which must live under those rules. 
In connection with the civil rules of last year, the Judiciary 
Subcommittee on Courts and Administrative Practice, which I chair, held 
hearings on the proposed rules changes, and we were overwhelmed by 
representatives of the bar strenuously objecting to several of the 
proposed rule changes. Both the House and Senate relevant committees 
concluded that the bar protests should be honored and that the rules 
should be changed; however, tangles in our own procedures prevented the 
more objectionable proposals from being deleted and all of the proposed 
changes went into effect on December 1, 1993.
  The bill I offer today would restore the composition of these 
committees which existed from the original rules in 1935 until 
approximately 1980 and which have been altered only in very recent 
times. This bill provides that a majority of all the Rules Committees 
shall be drawn from the practicing bar. It by no means diminishes the 
valuable role of academics and of judges, but it would restore to the 
bar a voice of responsibility.
  At the present time, under our statutes, the Rules Committees conduct 
extensive hearings. These become so crowded that individual 
presentations are necessarily brief, but they are balanced in the sense 
of giving broad scope to those who may participate. What is presented 
at those hearings, what is developed by the committee reporters and 
staff, and what is proposed by the various committee members 
themselves, are all put into a mix which must be finally shaped by the 
committee itself. In my judgment, those committees are seriously 
lacking in balance. Their work product goes to the Judicial Conference, 
by definition composed entirely of judges; and assuming that the 
Supreme Court stays in the process, then to that body which is of 
course composed entirely of judges. Somewhere in the process, making 
rules under which the courts shall function and the bar of the country 
shall do its business, there should be more room for the effective 
voice of the bar itself.

  My proposal does not limit the broad discretion of the Chief Justice 
of the United States, who will continue to select the membership of the 
various committees subject only to the restriction that a majority 
should be members of the bar. I comfortably leave it to his good 
judgment as to how to achieve balanced committees.
  I offer this bill, to provide that the majority of the various 
committees shall be composed of practicing lawyers, in order to restore 
that balance, and I urge its consideration by my colleagues in the 
Senate. Mr. President, I request unanimous consent that the text of the 
bill included in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S 2212

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

     SECTION 1. MEMBERSHIP OF COMMITTEES MAKING RECOMMENDATIONS ON 
                   RULES OF PROCEDURE.

       Section 2073(a)(2) of title 28, United States Code, is 
     amended by striking out the second sentence and inserting in 
     lieu thereof ``Each such committee shall have a majority of 
     members of the practicing bar, and also shall have members of 
     the bench (including trial and appellate judges) and 
     academics.''.
                                 ______

      By Mr. BENNETT (for himself and Mr. Hatch):
  S. 2213. A bill to make applicable the provisions of the act commonly 
known as the Warren Act to the central Utah project, Utah, and for 
other purposes; to the Committee on Energy and Natural Resource.


   legislation making the warren act applicable to the central utah 
                                project

 Mr. BENNETT. Mr. President, today I am introducing legislation 
which will allow the Central Utah Water Conservancy District [CUWCD] to 
wheel Provo City water through the district's water delivery system.
  The legislation will assist the district in implementing its water 
conservation programs. As a water wholesaler, the Central Utah Water 
Conservancy District has been studying ways to work with local cities 
and counties to avoid duplication of water facilities and to increase 
the more efficient use of water treatment and delivery systems.
  This legislation clarifies that the Department of the Interior, or 
its agent, the Bureau of Reclamation, may enter into nonproject water 
storage and carriage agreements on a space available basis in the CUP 
project works, pursuant to the Warren Act.
  This legislation is not without precedent. This type of Warren Act 
authority already exists in California and Nevada and the identical 
authority was passed in the Reclamation States Emergency Drought Relief 
Act of 1991 (Pub. L. 102-250).
  Mr. HATCH. Mr. President, I rise to join my colleague from Utah, 
Senator Bennett, in sponsoring this legislation.
  The purpose of this legislation is to enhance the ability of the 
Central Utah project [CUP] to implement certain water conservation 
programs throughout the 13 counties that the project serves.
  My colleagues will remember that Congress passed legislation 
containing the CUP Completion Act, Public Law 102-575. This legislation 
authorized the completion of this critical water project for Utah. An 
important part of this law was a directive to the entity managing the 
completion of the CUP, the Central Utah Water Conservancy District, to 
study ways of achieving improved efficiencies in water management and 
delivery systems. Accomplishing this task through cooperative efforts 
with local water systems while conserving water, protecting instream 
flows, and avoiding duplication of facilities, has been the district's 
primary objective.
  In recent months, the question has been raised as to whether the 
district has the authority to move nonproject water through CUP 
facilities as part of the district's overall water conservation and 
management planning program.
  The legislation Senator Bennett and I are introducing today is 
necessary to clarify that the Secretary of the Interior, through the 
Commissioner of the Bureau of Reclamation, may enter into nonproject 
water storage and carriage agreements on a space available basis in 
project works. This authority would be granted pursuant to the Warren 
Act signed into law on February 21, 1911, which is found at 43 U.S.C. 
523, as amended. Additionally, the intent of our bill is that all 
appropriate costs associated with the movement on nonproject water 
would be recovered through the rates and charges included in each 
contract.
  My colleagues should note that the authority this bill would extend 
to the CUP now exists in several other Bureau of Reclamation projects. 
These include the Central Valley project, the Cachuma project, and the 
Ventura River project, all located in California, and the Truckee 
Storage and Washoe projects in Nevada.
  This legislation has the complete support of the primary sponsor of 
the Central Utah project, the Central Utah Water Conservancy District. 
I believe officials with the Bureau of Reclamation are also sympathetic 
to this problem and are willing to work toward a resolution of this 
matter.
  This is a noncontroversial measure that is necessary to make our 
project more versatile in achieving its ultimate objectives. I urge my 
colleagues to support this legislation.
                                 ______

      By Mr. RIEGLE (for himself and Mrs. Boxer):
  S. 2214. A bill to amend the Social Security Act to establish grants 
for States to carry out Children's Ombudsman programs, and for other 
purposes; to the Committee on Finance.


                        children's ombudsman act

  Mr. RIEGLE. Mr. President, today I am introducing a bill that 
I hope will lead to the creation of a children's ombudsman office in 
each State. This legislation will give the Department of Health and 
Human Services the power to establish demonstration projects in 10 
States. These demonstrations will create an ombudsman office 
responsible for overseeing the range of services that are in place to 
serve and protect the children in this country. These ombudsmen would 
serve as advocates for children--who both speak on behalf of children's 
interests and who understand the legislative and legal processes.
  Mr. President, it becomes increasingly important with each passing 
day that greater efforts be made to ensure the safety and health of our 
youngest citizens. During this session, Congress has addressed a number 
of key issues affecting children, including expanding family support 
efforts, improving the Head Start Program, establishing goals in our 
education system, increasing funding for a number of children's 
programs, and increasing our immunization efforts against childhood 
disease.
  I am hopeful that, in the coming weeks, Congress will take further 
actions to promote the well-being of our Nation's children. Key among 
these efforts will be enacting a national health plan. In addition, as 
we reform the current welfare system we must ensure that the system 
protects the rights and needs of affected children. An ombudsman could 
play a critical role in welfare reform and I think this bill can be an 
important component to what we finally enact.
  At the State level, an ombudsman would perform many important 
functions including assisting parents in their search for quality child 
care; overseeing the enforcement of the protective services laws and 
the operation of the foster care system; providing critical warning to 
appropriate officials whenever the health and welfare of a child is 
endangered. Finally a children's ombudsman would be a public advocate 
for children's programs and interests before the State and local 
leaders who are making critical funding decisions. No downsizing of 
government and no effort to win votes should come at the expense of 
children who cannot vote, do not organize, and will not protest.
  There is much that we still need to do for the children of the United 
States. Last year alone there were 1 million confirmed cases of child 
abuse and neglect, and 1,300 children died from child abuse. In 
addition, an estimated 460,000 children were in foster care--double the 
numbers of one decade ago. One in four children under the age of 3--
nearly 3 million--live in families that are in poverty. Over the last 
20 years the number of children under 6 has grown by less than 10 
percent but the number of poor children under 6 have grown by 60 
percent. It is painfully apparent that we are not doing enough to 
protect our children.
  Mr. President, we can, and we must, do a better job of protecting the 
welfare of our Nation's children. It is my hope this legislation will 
play one small part in reaching that goal.
  Mr. President I ask unanimous consent that the full text of the bill 
be printed in full at this point in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2214

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Children's Ombudsman Act''.

     SEC. 2. GRANTS FOR STATE CHILDREN'S OMBUDSMAN PROGRAMS.

       Title IV of the Social Security Act (42 U.S.C. 601 et seq.) 
     is amended by adding at the end the following:

             ``Part G--State Children's Ombudsman Programs


                            ``STATE PROGRAMS

       ``Sec. 491. (a) Definitions.--As used in this section:
       ``(1) Child.--The term `child' means an individual who is 
     younger than 18 years of age.
       ``(2) Children's services.--The term `children's services' 
     means child welfare services, as defined in section 425, 
     child protective services, including investigation and 
     intervention in response to cases of reported child abuse and 
     neglect, and services authorized to be provided under part E.
       ``(3) Facility.--The term `facility' means--
       ``(A) a child-care institution, or a foster family home, as 
     defined in section 472(c), or an entity eligible to carry out 
     activities under part E;
       ``(B) an entity eligible to carry out activities under part 
     B; and
       ``(C) an entity providing child protective services, 
     including investigation and intervention in response to cases 
     of reported child abuse and neglect.
       ``(4) Legal assistance.--The term ``legal assistance''--
       ``(A) means legal advice provided by an attorney to 
     children; and
       ``(B) includes--
       ``(i) to the extent feasible, counseling or other 
     appropriate assistance by a paralegal or law student under 
     the direct supervision of an attorney; and
       ``(ii) counseling by a nonlawyer where permitted by law.
       ``(5) Local ombudsman entity.--The term `local Ombudsman 
     entity' means an entity designated under subsection (c)(5)(A) 
     to carry out the duties described in subsection (c)(5)(B) 
     with respect to a service area described in subsection 
     (c)(1)(D)(iii) or other substate area.
       ``(6) Nonprofit.--The term `nonprofit', as applied to any 
     organization or entity, means an organization or entity that 
     is, or is owned and operated by, one or more corporations or 
     associations no part of the net earnings of which inures, or 
     may lawfully inure, to the benefit of any private shareholder 
     or individual.
       ``(7) Office.--The term `Office' means the office 
     established in subsection (c)(1)(D)(i).
       ``(8) Ombudsman.--The term `Ombudsman' means the individual 
     described in subsection (c)(2).
       ``(9) Program.--The term `program' means the State 
     Children's Ombudsman program established in subsection 
     (c)(1)(D)(ii).
       ``(10) Representative.--The term `representative' includes 
     an employee or volunteer who represents an entity designated 
     under subsection (c)(5)(A) and who is individually designated 
     by the Ombudsman.
       ``(11) Recipient.--The term `recipient' means a child who 
     receives, or who is eligible to receive, children's services.
       ``(12) State agency.--The term `State agency' means the 
     agency designated under subsection (c)(1)(A).
       ``(b) Grants.--
       ``(1) In general.--The Secretary shall award grants to not 
     more than 10 States to carry out Children's Ombudsman 
     programs.
       ``(2) Award of grants.--In awarding grants under paragraph 
     (1), the Secretary shall--
       ``(A) award the grants so as to support a variety of 
     approaches to carrying out the programs;
       ``(B) award at least one such grant to a State to carry out 
     a program by contract or other arrangement with a nonprofit 
     private organization; and
       ``(C) give preference in the award of grants to States that 
     have demonstrated the availability of non-Federal sources of 
     funds to carry out State Children's Ombudsman programs.
       ``(3) Period.--In awarding a grant under paragraph (1), the 
     Secretary shall award the grant for a period of 3 years.
       ``(4) Limitation.--A State that receives a grant under 
     paragraph (1) shall use not more than 10 percent of the 
     amounts made available through the grant to conduct the 
     evaluation described in subsection (c)(1)(C).
       ``(c) Establishment.--
       ``(1) In general.--
       ``(A) State agency.--In order for a State to be eligible to 
     receive a grant under subsection (b), the State shall, in 
     accordance with guidance provided by the Secretary, designate 
     a State agency as the sole State agency to carry out the 
     duties described in subparagraphs (B), (C), and (D). The 
     State may not designate a State agency that is responsible 
     for the licensing or regulation of a facility in the State.
       ``(B) State plan.--
       ``(i) In general.--In order for a State to be eligible to 
     receive such a grant, the State agency shall submit an 
     application to the Secretary at such time, in such manner, 
     and containing such information as the Secretary may require.
       ``(ii) Contents.--The application shall include, at a 
     minimum, a State plan that contains information indicating 
     the manner in which the State will carry out a program in 
     accordance with the requirements of this section.
       ``(C) Implementation.--The State agency shall administer 
     the State plan within such State, and be primarily 
     responsible for the planning, policy development, 
     administration, coordination, priority setting, and 
     evaluation of all State activities carried out under the 
     State plan.
       ``(D) Program.--The State agency shall, in accordance with 
     this section--
       ``(i) establish and operate an Office of the State 
     Children's Ombudsman;
       ``(ii) carry out through the Office a State Children's 
     Ombudsman program; and
       ``(iii) divide the State into distinct service areas, or 
     designate the entire State as a single service area, in 
     accordance with guidelines issued by the Secretary.
       ``(2) Ombudsman.--The Office shall be headed by an 
     individual, to be known as the State Children's Ombudsman, 
     who shall be selected from among individuals with expertise 
     and experience in the fields regarding care and advocacy for 
     children.
       ``(3) Functions.--The Ombudsman shall serve on a full-time 
     basis, and shall, personally or through representatives of 
     the Office--
       ``(A) identify, investigate, and resolve complaints that--
       ``(i) are made by, or on behalf of, recipients or the 
     parents or guardians of recipients; and
       ``(ii) relate to action, inaction, or decisions, that may 
     adversely affect the health, safety, welfare, or rights of 
     the recipients, of--

       ``(I) providers, or representatives of providers, of 
     children's services;
       ``(II) public agencies; or
       ``(III) health and social service agencies;

       ``(B) inform the parents or guardians of recipients about 
     means of obtaining children's services provided by providers 
     or agencies described in subparagraph (A)(ii);
       ``(C) provide administrative and technical assistance to 
     entities designated under paragraph (5) to assist the 
     entities in participating in the program;
       ``(D)(i) analyze, comment on, and monitor the development 
     and implementation of Federal, State, and local laws, 
     regulations, and other governmental policies and actions, 
     that pertain to the health, safety, welfare, and rights of 
     the recipients, with respect to the adequacy of facilities 
     and children's services for children in the State;
       ``(ii) recommend to the Governor of the State, the State 
     legislature, and appropriate State agencies, such changes in 
     State laws, regulations, policies, and actions as the Office 
     determines to be appropriate; and
       ``(iii) facilitate public comment on the Federal, State, 
     and local laws, regulations, policies, and actions;
       ``(E)(i) provide for recruiting and training 
     representatives of the Office; and
       ``(ii) promote the development of citizen organizations, to 
     participate in the program; and
       ``(F) carry out such other activities as the Secretary 
     determines to be appropriate.
       ``(4) Contracts and arrangements.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the State agency may establish and operate the Office, and 
     carry out the program, directly, or by contract or other 
     arrangement with any public agency or nonprofit private 
     organization.
       ``(B) Licensing or regulation entities; associations.--
     Except as provided in subparagraph (C), the State agency may 
     not enter into the contract or other arrangement described in 
     subparagraph (A) with--
       ``(i) an agency or organization that is responsible for the 
     licensing or regulation of a facility in the State; or
       ``(ii) an association (or an affiliate of such an 
     association) of facilities.
       ``(C) Waiver.--The Secretary may waive the requirements of 
     subparagraph (B) with respect to not more than 3 programs.
       ``(5) Designation of local ombudsman entities and 
     representatives.--
       ``(A) Designation.--In carrying out the duties of the 
     Office, the Ombudsman may designate an entity as a local 
     Ombudsman entity, and may designate a full-time employee or a 
     volunteer to represent the entity.
       ``(B) Duties.--An individual so designated shall, in 
     accordance with the policies and procedures established by 
     the Office and the State agency--
       ``(i) identify, investigate, and resolve complaints as 
     described in paragraph (3)(A);
       ``(ii)(I) review, and if necessary, comment on any existing 
     and proposed laws, regulations, and other government policies 
     and actions, that pertain to the rights and well-being of 
     recipients or of the parents or guardians of recipients; and
       ``(II) facilitate the ability of the public to comment on 
     the laws, regulations, policies, and actions; and
       ``(iii) carry out other activities that the Ombudsman 
     determines to be appropriate.
       ``(C) Eligibility for designation.--Entities eligible to be 
     designated as local Ombudsman entities, and individuals 
     eligible to be designated as representatives of such 
     entities, shall--
       ``(i) have demonstrated capability to carry out the 
     responsibilities of the Office;
       ``(ii) be free of conflicts of interest;
       ``(iii) in the case of the entities, be public or nonprofit 
     private entities; and
       ``(iv) meet such additional requirements as the Ombudsman 
     may specify.
       ``(D) Policies and procedures.--
       ``(i) In general.--The State agency shall establish, in 
     accordance with the Office, policies and procedures for 
     monitoring local Ombudsman entities designated to carry out 
     the duties of the Office.
       ``(ii) Confidentiality and disclosure.--The State agency 
     shall develop the policies and procedures in accordance with 
     all provisions of this part regarding confidentiality and 
     conflict of interest.
       ``(d) Procedures for Access.--
       ``(1) In general.--The State shall ensure that 
     representatives of the Office shall have--
       ``(A) access to facilities, recipients, and the parents or 
     guardians of recipients;
       ``(B) appropriate access to review the medical and social 
     records of a recipient;
       ``(C) access to the administrative records, policies, and 
     documents, of facilities, in any case in which the parents or 
     guardians of recipients have access, or the general public 
     has access, to such records, policies, and documents; and
       ``(D) access to and, on request, copies of all licensing or 
     oversight records maintained by the State with respect to 
     facilities.
       ``(2) Procedures.--The State agency shall establish 
     procedures to ensure the access described in paragraph (1).
       ``(e) Reporting System.--The State agency shall establish a 
     statewide uniform reporting system to--
       ``(1) collect and analyze data relating to complaints and 
     conditions in facilities, to recipients, and to the parents 
     or guardians of recipients, for the purpose of identifying 
     and resolving significant problems; and
       ``(2) submit the data, on a regular basis, to--
       ``(A) the agency of the State responsible for licensing, 
     regulation, or oversight of facilities in the State;
       ``(B) the Governor of the State, the State legislature, and 
     other State and Federal entities that the Ombudsman 
     determines to be appropriate; and
       ``(C) the Secretary.
       ``(f) Disclosure.--
       ``(1) In general.--The State agency shall establish 
     procedures for the disclosure by the Ombudsman or local 
     Ombudsman entities of files maintained by the program, 
     including records described in subsection (d)(1) or (e).
       ``(2) Identity of complainant or recipient.--The procedures 
     described in paragraph (1) shall--
       ``(A) provide that, subject to subparagraph (B), the files 
     and records described in paragraph (1) may be disclosed only 
     at the discretion of the Ombudsman (or the person designated 
     by the Ombudsman to disclose the files and records); and
       ``(B) prohibit the disclosure of the identity of any 
     complainant, recipient, or parent or guardian of a recipient, 
     with respect to whom the Office maintains such files or 
     records unless--
       ``(i) the complainant, the parent or guardian of the 
     recipient, or the legal representative of the complainant or 
     recipient, parent, or guardian, consents to the disclosure 
     and the consent is given in writing;
       ``(ii)(I) the complainant, or the parent or guardian of the 
     recipient gives consent orally; and
       ``(II) the consent is documented contemporaneously in a 
     writing made by a representative of the Office in accordance 
     with such requirements as the State agency shall establish; 
     or
       ``(iii) the disclosure is required by court order.
       ``(g) Consultation.--In planning and operating the program, 
     the State agency shall consider the views of--
       ``(1) agencies providing services for children;
       ``(2) children;
       ``(3) providers of care for children;
       ``(4) State child advocacy groups and local child advocacy 
     groups;
       ``(5) juvenile court judges and family court judges; and
       ``(6) persons representing programs that provide court-
     appointed representation for children.
       ``(h) Conflict of Interest.--The State agency shall--
       ``(1) ensure that no individual, or member of the immediate 
     family of an individual, involved in the designation of the 
     Ombudsman (whether by appointment or otherwise) or the 
     designation of an entity designated under subsection (c)(5), 
     is subject to a conflict of interest;
       ``(2) ensure that no officer or employee of the Office, 
     representative of a local Ombudsman entity, or member of the 
     immediate family of the officer, employee, or representative, 
     is subject to a conflict of interest;
       ``(3) ensure that the Ombudsman--
       ``(A) except in the case of an Ombudsman with a waiver 
     under subsection (c)(4)(C), does not have a direct 
     involvement in the licensing or regulation of a facility or 
     of a provider of children's services;
       ``(B) does not have an ownership or investment interest 
     (represented by equity, debt, or other financial 
     relationship) in a facility or in children's services;
       ``(C) is not employed by, or participating in the 
     management of, a facility; and
       ``(D) does not receive, or have the right to receive, 
     directly or indirectly, remuneration (in cash or in kind) 
     under a compensation arrangement with an owner or operator of 
     a facility; and
       ``(4) establish, and specify in writing, mechanisms to 
     identify and remove conflicts of interest referred to in 
     paragraphs (1) and (2), and to identify and eliminate the 
     relationships described in subparagraphs (A) through (D) of 
     paragraph (3), including such mechanisms as--
       ``(A) the methods by which the State agency will examine 
     individuals, and immediate family members, to identify the 
     conflicts; and
       ``(B) the actions that the State agency will require the 
     individuals and such family members to take to remove such 
     conflicts.
       ``(i) Legal Counsel.--The State agency shall ensure that--
       ``(1) adequate legal counsel is available, and is able, 
     without conflict of interest, to--
       ``(A) provide advice and consultation needed to protect the 
     health, safety, welfare, and rights of recipients; and
       ``(B) assist the Ombudsman and representatives of the 
     Office in the performance of the official duties of the 
     Ombudsman and representatives; and
       ``(2) legal representation is provided to any 
     representative of the Office against whom suit or other legal 
     action is brought or threatened to be brought in connection 
     with the performance of the official duties of the Ombudsman 
     or such a representative.
       ``(j) Administration.--The State agency shall require the 
     Office to--
       ``(1) prepare an annual report--
       ``(A) describing the activities carried out by the Office 
     in the year for which the report is prepared;
       ``(B) containing and analyzing the data collected under 
     subsection (e);
       ``(C) evaluating the problems experienced by, and the 
     complaints made by or on behalf of, recipients or parents or 
     guardians of recipients;
       ``(D) containing recommendations for--
       ``(i) improving quality of the care and life of the 
     recipients; and
       ``(ii) protecting the health, safety, welfare, and rights 
     of the recipients;
       ``(E)(i) analyzing the success of the activities of the 
     Office; and
       ``(ii) identifying barriers that prevent the optimal 
     operation of the Office; and
       ``(F) providing policy, regulatory, and legislative 
     recommendations to solve identified problems, to resolve the 
     complaints, to improve the quality of care and life of 
     recipients, to protect the health, safety, welfare, and 
     rights of recipients, and to remove the barriers;
       ``(2) analyze, comment on, and monitor the development and 
     implementation of Federal, State, and local laws, 
     regulations, and other government policies and actions that 
     pertain to facilities and children's services, and to the 
     health, safety, welfare, and rights of recipients, in the 
     State, and recommend any changes in such laws, regulations, 
     and policies as the Office determines to be appropriate;
       ``(3)(A) provide such information as the Office determines 
     to be necessary to public and private agencies, legislators, 
     and other persons, regarding--
       ``(i) the problems and concerns of recipients, and parents 
     or guardians of recipients; and
       ``(ii) recommendations related to the problems and 
     concerns; and
       ``(B) make available to the public, and submit to the 
     Secretary, the chief executive officer of the State, the 
     State legislature, the State agency responsible for 
     licensing, regulation, or oversight of facilities, and other 
     appropriate governmental entities, each report prepared under 
     paragraph (1);
       ``(4) disseminate information regarding the services 
     provided through the Office--
       ``(A) by providing a toll-free telephone number for 
     inquiries about the services;
       ``(B) through television, radio, and newspaper advertising; 
     and
       ``(C) through placement of notices in facilities and other 
     appropriate locations;
       ``(5)(A) not later than 1 year after the date of the 
     enactment of this section, establish procedures for the 
     training of the representatives of the Office, including 
     unpaid volunteers, based on model standards established by 
     the Secretary, in consultation with representatives of 
     citizen groups, providers of care for children, and the 
     Office, that--
       ``(i) specify a minimum number of hours of initial 
     training;
       ``(ii) specify the content of the training, including 
     training relating to--
       ``(I) Federal, State, and local laws, regulations, and 
     policies, with respect to facilities in the State;
       ``(II) investigative techniques;
       ``(III) alternative dispute resolution, including 
     mediation; and
       ``(IV) such other matters as the State determines to be 
     appropriate; and
       ``(iii) specify an annual number of hours of in-service 
     training for all designated representatives; and
       ``(B) require implementation of the procedures not later 
     than 21 months after the date of the enactment of this 
     section;
       ``(6) prohibit any representative of the Office (other than 
     the Ombudsman) from carrying out any activity described in 
     subparagraphs (A) through (D) of subsection (c)(3) unless the 
     representative--
       ``(A) has received the training required under paragraph 
     (5); and
       ``(B) has been approved by the Ombudsman as qualified to 
     carry out the activity on behalf of the Office; and
       ``(7) permit any local Ombudsman entity to carry out the 
     responsibilities described in paragraph (1), (2), (3), or 
     (4).
       ``(k) Liability.--The State shall ensure that no 
     representative of the Office will be liable under State law 
     for the good faith performance of official duties.
       ``(l) Noninterference.--The State shall--
       ``(1) ensure that willful interference with representatives 
     of the Office in the performance of the official duties of 
     the representatives (as defined by the Secretary) shall be 
     unlawful;
       ``(2) prohibit retaliation and reprisals by a facility or 
     other entity with respect to any recipient, employee, or 
     other person for filing a complaint with, providing 
     information to, or otherwise cooperating with any 
     representative of, the Office; and
       ``(3) provide for appropriate sanctions with respect to the 
     interference, retaliation, and reprisals.
       ``(m) Guidance.--The Secretary shall issue and periodically 
     update guidance respecting--
       ``(1) conflicts of interest by persons described in 
     paragraphs (1) and (2) of subsection (h); and
       ``(2) the relationships described in subparagraphs (A) 
     through (D) of subsection (h)(3).
       ``(n) Training, Technical Assistance, and Research.--The 
     Secretary shall reserve not more than 10 percent of the 
     amounts appropriated under subsection (p) to provide 
     technical assistance and training to Offices and local 
     Ombudsman entities, and to conduct research related to the 
     State and local operation of programs. The Secretary may 
     provide such technical assistance and training, and conduct 
     such research, directly or by awarding grants to appropriate 
     entities.
       ``(o) Coordination With Department of Justice.--To carry 
     out this Act and the State challenge activities under section 
     285 of the Juvenile Justice and Delinquency Prevention Act of 
     1974 (42 U.S.C. 5667c), in planning for, and awarding, grants 
     under this section, the Secretary shall coordinate the award 
     of such grants with--
       ``(1) the Coordinating Council on Juvenile Justice and 
     Delinquency Prevention, established under section 206 of 
     Juvenile Justice and Delinquency Prevention Act of 1974 (42 
     U.S.C. 5616); and
       ``(2) the Office of Justice and Delinquency Prevention of 
     the Department of Justice, created under section 201 of such 
     Act (42 U.S.C. 5611).
       ``(p) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $7,000,000 for fiscal year 1995 and such sums as may be 
     necessary for each subsequent fiscal year.''.
                                 ______

      By Mr. BYRD (for Mr. Lieberman (for himself and Mr. 
        Durenberger)):
  S. 2215. A bill to establish rules governing product liability 
actions against raw materials and bulk component suppliers to medical 
device manufacturers, and for other purposes; to the Committee on 
Commerce, Science, and Transportation.


                 biomaterials availability act of 1994

 Mr. LIEBERMAN. Mr. President, I am introducing today, together 
with Senator Durenberger, the Biomaterial Availability Act 
of 1994. This bill is an attempt to address what could be a major 
threat to many of the miracles of modern medicine. Over the next 2 
years, health care as we know it could be radically transformed, not by 
health care reform legislation, but because the makers of many of the 
life-saving medical devices that we take for granted today may no 
longer be able to buy the raw materials and components necessary to 
produce their products. This is a public health time bomb--and it is 
ticking--and the lives of real people are going to be lost if it 
explodes.
  What could cause this public health catastrophe? The Subcommittee on 
Regulation and Government Information, which I chair, examined this 
question at a hearing on May 20, 1994. The answer appears to be an out-
of-control product liability system which makes it too easy to bring 
lawsuits against raw materials suppliers, and too costly for those 
suppliers to defend themselves even when they ultimately win. Those 
suppliers have begun to decide that the costs of defending lawsuits 
involving medical products is too high to justify selling raw materials 
to the makers of implantable medical devices. For those suppliers, it 
just isn't worth it.
  How could this be? A recent study by Aronoff Associates paints a 
clear, but dismal, picture. That study surveyed the markets for 
polyester yarn, resins such as DuPont's Teflon, and polyacetal resin 
such as Dupont's Delrin. Aronoff found that sales of these raw 
materials for use in manufacturing implantable medical devices was just 
a tiny percentage (0.006 percent) of the overall market, $606,000 out 
of total sales of over $11 billion.
  In return for that extra $606,000 in total annual sales, however, raw 
materials suppliers face potentially huge liability-related costs, even 
if they never lose a lawsuit. To take one example, a company named 
Vitek manufactured an estimated 26,000 jaw implants using about 5 cents 
worth of DuPont Teflon in each device. The device was developed, 
designed and marketed by Vitek, which was not related to DuPont. When 
those implants failed, Vitek declared bankruptcy, its founder fled to 
Switzerland, and the patients sued DuPont. DuPont's record in court on 
Vitek-related claims so far has been enviable--258 wins and one loss--
but the cost has been staggering. Aronoff estimated that DuPont alone 
was spending at least $8 million per year over the past 5 to 6 years to 
defend these suits. To put this in perspective, DuPont's estimated 
legal expenses in these cases for just 1 year would buy over a 13 year 
supply of DuPont's Dacron polyester, Teflon and Delrin for all U.S. 
makers of implantable medical devices, not just makers of jaw implants.
  Faced with this cost/benefit picture, DuPont decided, in January 
1993, to stop selling its products to manufacturers of permanently 
implanted medical devices. At that time, DuPont said it would only 
permit manufacturers to purchase a year's supply, based on historical 
buying patters. DuPont has subsequently allowed manufacturers to 
purchase up to 3 more years' worth of raw materials.

  One supplier's decision alone might not be troublesome except that 
there is no reason to believe that the economics will be different for 
other suppliers around the world. One of the witnesses at our 
subcommittee hearing testified that she had already contacted 15 
alternate suppliers of polyester yarn worldwide. All were interested in 
selling her raw materials--except for use in products made and used in 
the United States. By itself this is a powerful statement about the 
nature of our product liability laws, and makes a powerful case for 
reform.
  What is at stake here? Without raw materials, you cannot make a final 
product. Take a heart valve, for example. Around the edge of a heart 
valve is a sleeve of polyester fabric. This fabric is what the surgeon 
sews through when he or she installs this valve. Without the sleeve, it 
would be difficult, if not impossible, to install the valve. Without 
that valve, the patient will die prematurely.
  Take another example, a pacemaker. Pacemakers are installed in 
patients whose hearts no longer generate enough of an electrical pulse 
to get the heart to beat. To keep the heart beating, a pacemaker is 
connected to the heart with wires. These wires have silicone rubber 
insulation. Unfortunately, the suppliers of the rubber have begun to 
withdraw from the market. Without this pacemaker and its leads, the 
patient will die prematurely. With that pacemaker, the patient can live 
for decades.
  Take still a third example. At our hearing, we had in attendance 
Thomas Reilly, a 9-year-old boy from Houston, TX, who suffers from 
hydrocephalus, a condition in which fluid accumulates around the brain. 
A special shunt enables him to survive. But continued production of 
that shunt is in doubt because of the raw materials suppliers are 
concerned about the potential cost of product liability lawsuits. 
Thomas' father, Mark Reilly, pleaded for the Congress to move forward 
quickly to assure that hydrocephalic shunts will continue to be 
available.
  We also heard from Peggy Phillips of Falls Church, VA, whose heart 
had twice stopped beating because of fibrillation. Today, she lives an 
active, normal life because she has an implanted automatic 
defibrillator. Again, critical components of the defibrillator may no 
longer be available because of potential product liability costs. Ms. 
Phillips, like Mr. Reilly, urge the Congress to move swiftly to enact 
legislation protecting raw materials and component part suppliers from 
product liability suits.
  These people are all grateful beneficiaries of our modern medical 
system. But we cannot allow the 7.4 million people who owe the quality 
of their lives to medical devices to become casualties of an outmoded 
legal liability system. Because product liability litigation costs make 
the economics of supplying raw materials to the implantable medical 
device makers very unfavorable, it is imperative that we act now. We 
cannot expect raw materials suppliers to continue to serve the medical 
device market out of the goodness of their hearts, notwithstanding the 
liability-related costs. We need to reform our product liability laws, 
to give raw material suppliers some assurance that unless there is real 
evidence that they were responsible for putting a defective device on 
the market, they cannot be sued simply in the hope that their deep 
pockets will fund legal settlements.
  I have long believed that liability reform could be both proconsumer 
and probusiness. I believe that the testimony we heard at our hearing 
on May 20, 1994, proved this once again. When fear of liability suits 
and litigation costs drives valuable, life-saving products off the 
market because their makers cannot get raw materials, consumers cannot 
possibly come out ahead.
  When companies must divert money from developing new life-saving 
products to replacing old sources of raw materials supply, consumers 
cannot possibly be coming out ahead. When one company must spend 
millions just to defend itself in lawsuits over a product it did not 
design or make--for which it simply provided a raw material 
ingredient--consumers are the ones who suffer. Our hearing dramatically 
illustrated that efforts to increase compensation for the injured can 
sometimes come at an unacceptably high cost.
  Based on the testimony we heard, I am committed to forging a solution 
that will head off this threat to our national public health. Today, I 
am introducing the Biomaterials Availability Act of 1994, which will 
establish clear national rules to govern suits against suppliers of raw 
materials and component parts for permanently implantable medical 
devices. Under this bill, a supplier of raw materials or component 
parts can only be sued if the materials they supplied do not meet 
contractual specifications, or if they simply delivered the wrong 
product. They cannot, however, be sued for deficiencies in the design 
of the final device, the testing of that device, or for inadequate 
warnings with respect to that device.
  I believe that enactment of this bill would help ensure that 
America's patients continue to have access to high-quality life saving 
and life enhancing medical implants, made with the best materials 
science and technology can produce. We must, however, act quickly. The 
patient is in critical condition, and we need to perform emergency 
surgery. Delay could, quite literally, be deadly.
  I ask unanimous consent that a copy of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2215

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Biomaterials Access 
     Assurance Act of 1994''.

     SEC. 2. FINDINGS.

       Congress finds and declares the following:
       (1) Every year millions of Americans depend on the 
     availability of life-saving or life enhancing permanently 
     implantable medical devices;
       (2) A continued supply of raw materials and component parts 
     is necessary to the invention, development, improvement and 
     maintenance of the supply of such devices;
       (3) Most of these devices are made with raw materials and 
     component parts that are not designed or manufactured 
     specifically for use in implantable devices, but which have 
     uses in a variety of non-medical products as well;
       (4) Small quantities of these raw materials and component 
     parts are used, so that sales of raw materials and component 
     parts for medical devices are an extremely small portion of 
     the overall market for such raw materials and medical 
     devices;
       (4) Manufacturers of medical devices are required under the 
     Federal Food Drug and Cosmetic Act to demonstrate that their 
     products are safe and effective, including being properly 
     designed and having adequate warnings or instructions, and 
     existing tort law requires manufacturers of medical devices 
     to ensure they are properly designed and have adequate 
     warnings;
       (6) Notwithstanding the fact that raw materials and 
     component parts suppliers do not design, produce or test the 
     final implant, they have been sued in cases alleging 
     inadequate design and testing of, or warnings related to use 
     of, permanently implanted medical devices;
       (7) Even though raw materials and component parts suppliers 
     have almost never been held liable in such suits, because the 
     cost of litigating such suits to a favorable judgment far 
     exceeds the total potential sales of such raw materials and 
     component parts to the medical device industry, raw materials 
     and component parts suppliers have begun to cease supplying 
     such raw materials and component parts for use in permanently 
     implanted medical devices;
       (8) The unavailability of raw materials and component parts 
     will, unless alternate sources of supply can be found, lead 
     to unavailability of life saving and life enhancing medical 
     devices;
       (9) The prospects for developing of new sources of supply 
     for the full range of threatened raw materials and component 
     parts are remote, as other suppliers around the world are 
     refusing to sell raw materials or component parts for use in 
     manufacturing permanently implantable medical devices in the 
     United States, and it is unlikely that such a small market 
     could support the large investment needed to develop new 
     suppliers and attempts to do so will raise the cost of 
     medical devices;
       (10) Courts that have considered the issue have generally 
     found that raw materials and component part suppliers do not 
     have a duty to evaluate the safety and efficacy of the use of 
     a raw material or component part in a medical device, and 
     also do not have a duty to warn concerning the safety and 
     effectiveness of a medical device;
       (11) Attempts to impose such duties will cause more harm 
     than good by driving raw materials and component part 
     suppliers to cease supplying manufacturers of permanently 
     implantable medical devices;
       (12) In order to safeguard the availability of a wide 
     variety of life savings and life enhancing medical devices, 
     immediate action is needed to clarify the permissible bases 
     of liability for suppliers of raw materials and component 
     parts used in the manufacture of permanently implantable 
     medical devices and to provide expeditious procedures to 
     dispose of unwarranted suits against those suppliers so as to 
     minimize litigation costs.

     SEC. 3. DEFINITIONS.

       As used in this Act, the term--
       (1) ``biomaterials supplier'' means an entity that directly 
     or indirectly supplies a component part or raw material for 
     use in the manufacture of an implant, and includes persons 
     that have submitted master files to the Food and Drug 
     Administration for purposes of pre-market approval of medical 
     devices, but does not include a manufacturer or seller of an 
     implant;
       (2) ``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, and includes persons other than the individual into 
     whose body, or in contact with whose blood or tissue, the 
     implant is placed, if such person claims to have suffered 
     harm; if such an action is brought through or on behalf of an 
     estate, the term includes the claimant's decedent, or if it 
     is brought through or on behalf of a minor or incompetent, 
     the term includes the claimant's parent or guardian; the term 
     does not include
       (A) 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
       (B) a manufacturer, seller or biomaterials supplier.
       (3) ``component part'' means a manufactured piece of an 
     implant and includes a manufactured piece that has 
     significant non-implant applications and that by itself has 
     no implant value or purpose, but when combined with other 
     component parts and materials, constitutes an implant;
       (4) ``harm'' means any injury to or damage suffered by an 
     individual, any illness, disease, or death of that individual 
     resulting from that injury or damage, and any loss to that 
     individual or any other individual resulting from that injury 
     or damage; the term does not include commercial loss or loss 
     of or damage to an implant itself;
       (5) ``implant'' means a medical device that (A) is placed 
     into a surgically or naturally formed or existing cavity of 
     the body or which contacts blood or internal human tissue and 
     (B) which (i) is intended by the manufacturer to remain in 
     contact with the body or internal tissue of the humans 
     continuously for a period of thirty days or more, or (ii) has 
     labeling which does not contraindicate implantation or 
     contact for thirty days or more;
       (6) ``manufacturer'' means any person who, with respect to 
     any particular 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 Cosmetics Act (21 
     U.S.C. 360(a)(1)), of an implant; and
       (B) is required under Section 510 of the Federal Food, Drug 
     and Cosmetic Act (21 U.S.C. 360), and the regulations issued 
     thereunder, to register with the Secretary of Health and 
     Human Services and to include the implant on a list of 
     devices filed with the Secretary pursuant to Section 510(j) 
     of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
     360(j)), and the regulations issued thereunder.
       (7) ``medical device'' means a medical device as defined in 
     Sec. 201(h) of the Federal Food, Drug and Cosmetic Act (21 
     U.S.C. Sec. 321(h));
       (8) ``qualified specialist'' means a person who is 
     qualified by knowledge, skill, experience, training or 
     education in the specialty areas that are the subject of the 
     action;
       (9) ``raw material'' means a substance or product that has 
     a generic use and that may be used in applications other than 
     implants;
       (10) ``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; the term does not include--
       (A) a seller or lessor of real property;
       (B) 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
       (C) any person who acts in only a financial capacity with 
     respect to the sale of an implant.

     SEC. 4. APPLICABILITY; PREEMPTION.

       (a) Applicability.--This Act applies to any civil action 
     brought by a claimant, whether in state or federal court, 
     against a manufacturer, seller or biomaterials supplier, or 
     against licensors of biomaterials suppliers, on any theory, 
     for harm caused by an implant. 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 itself 
     or for commercial loss to the purchaser is not subject to 
     this Act and shall be governed by applicable commercial or 
     contract law.
       (b) Scope of Preemption.--This Act supersedes any State law 
     regarding recovery for harm caused by an implant only to the 
     extent that this Act establishes a rule of law applicable to 
     any such recovery. Any issue arising under this Act that is 
     not governed by any such rule of law shall be governed by 
     applicable State or Federal law.
       (c) Effect on Other Laws.--Nothing in this Act shall be 
     construed to--
       (1) affect any defense available under other provisions of 
     state or federal law to a defendant in an action alleging 
     harm caused by an implant; or
       (2) create a cause of action or federal court jurisdiction 
     pursuant to 28 U.S.C. 1331 or 1337 that otherwise would not 
     exist under applicable state or federal law.

     SEC. 5. ACTIONS AGAINST BIOMATERIALS SUPPLIERS.

       (a)(1) Except as provided in subsection (b) of this Act, no 
     claimant may bring an action for harm caused by an implant 
     against a person, who has not registered with the Secretary 
     of Health and Human Services, pursuant to Section 510 of the 
     Federal Food, Drug and Cosmetics Act, and the regulations 
     issued thereunder, and included the implant on a list of 
     devices filed with the Secretary pursuant to Section 510(j) 
     of the Federal Food Drug and Cosmetics Act and the 
     regulations issued thereunder.
       (2) Notwithstanding subparagraph (1), a claimant may bring 
     an action, other than as provided in subsection (b) of this 
     Act, against a person who, with respect to claimant's 
     implant, is the subject of a declaration issued by the 
     Secretary under Section 6(a) of this Act, or is a seller of 
     the implant that allegedly caused harm to the claimant.
       (b) No claimant may bring an action for harm caused by an 
     implant against a biomaterials supplier, and no biomaterials 
     supplier shall be liable for harm to a claimant caused by an 
     implant, unless the claimant shows, by a preponderance of the 
     evidence, that--
       (1) the raw materials or component parts delivered by the 
     biomaterials supplier either were not the product described 
     in the contract between the biomaterials supplier and the 
     person who contracted for delivery of the product, or failed 
     to meet any specifications that were--
       (A) 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;
       (B) published by the biomaterials supplier, provided to the 
     manufacturer by the biomaterials supplier, or contained in a 
     master file submitted by the biomaterials supplier to the 
     Food and Drug Administration, and currently maintained by the 
     biomaterials supplier, for purposes of premarket approval of 
     medical devices; or
       (C)(i) included in the manufacturer's submissions for 
     purposes of premarket approval or review by the Food and Drug 
     Administration under Section 510, 513, 515 or 520 of the 
     Federal Food, Drug and Cosmetic Act (21 U.S. Code 
     Sec. Sec. 360, 360c, 360e or 360j) that have received 
     clearance from the Food and Drug Administration, (ii) that 
     were provided by the manufacturer to the biomaterials 
     supplier and not expressly repudiated by the biomaterials 
     supplier prior to the manufacturer's acceptance of delivery 
     of the raw materials or component parts; and
       (2) such conduct was an actual and proxminate cause of the 
     claimant's harm.
       (c) No claimant may bring an action for harm caused by an 
     implant against a person who licenses a biomatierals supplier 
     to produce raw materials or component parts.
       (d) The applicable statute of limitations shall be tolled 
     during any period in which claimant has filed a petition with 
     the Secretary of Health and Human Services under section 6 of 
     this Act.

     SEC. 6. REVIEW BY THE SECRETARY OF NON-REGISTRATION.

       (a) The Secretary may, on its own motion or upon petition 
     by any person, after notice to the affected persons and 
     affording an opportunity for an informal hearing, issue a 
     declaration that a person, with respect to the implant that 
     allegedly caused claimant's harm,
       (i) should have registered with the Secretary under Section 
     510 of the Federal Food, Drug and Cosmetics Act (21 U.S.C. 
     360), and the regulations issued thereunder, but failed to do 
     so or
       (ii) should have included the implant on a list of devices 
     filed with the Secretary pursuant to Section 510(j) of the 
     Federal Food, Drug and Cosmetic Act (21 U.S.C. 360(j)), but 
     failed to do so.
       (b) Any petition filed pursuant to subsection (a) shall be 
     immediately docketed by the Secretary, and the Secretary 
     shall issue a final decision within 180 days of the filing of 
     the petition.

     SEC. 7. PROCEDURES FOR ACTIONS AGAINST A BIOMATERIALS 
                   SUPPLIER.

       (a) In General.--The procedural requirements set forth in 
     subsection (b) shall apply to any action by a claimant 
     against a biomaterials supplier.
       (b) Procedural Requirements.--
       (1) A claimant may not bring an action against a 
     biomaterials supplier unless the manufacturer of the implant 
     is named as a party, except if the manufacturer is subject to 
     service of process in no jurisdiction in which the 
     biomaterials supplier or is also subject to service of 
     process or unless litigation against the manufacturer is 
     barred by applicable law.
       (2) No action may be brought by any claimant against a 
     biomaterials supplier unless, at the time the claimant brings 
     the action, the claimant submits an affidavit--
       (A) declaring that the claimant has consulted and reviewed 
     the facts of the action with qualified specialists, whose 
     qualifications the claimant shall disclose;
       (B) including a written determination by a qualified 
     specialist that the raw materials or component parts actually 
     used in the manufacture of claimant's implant were raw 
     materials or component parts described in Section 5(b)(1), 
     together with a statement of the basis for such a 
     determination;
       (C) including a written determination by a qualified 
     specialist that, after a review of the medical record and 
     other relevant material, the raw material or component part 
     supplied by the biomaterials supplier and actually used in 
     the manufacture of claimant's implant was a cause of 
     claimant's harm, together with a statement of the basis for 
     the determination;
       (D) on the basis of the qualified specialists' review and 
     consultation, that the claimant (or the claimant's attorney) 
     has concluded that there is a reasonable and meritorious 
     cause for the filing of the action against the biomaterials 
     supplier.
       (c) Dismissal.--
       (1) In any action subject to this Act, a defendant may, at 
     any time at which a motion to dismiss may be filed under 
     applicable law, move to dismiss the action on the grounds 
     that the defendant is a biomaterials supplier and--
       (A) claimant has failed to satisfy the conditions in 
     Section 5(a) that would permit claimant to bring an action 
     against defendant;
       (B) defendant was not a seller of the implant which 
     allegedly caused harm to the claimant; or
       (C) claimant has failed to comply with the provisions of 
     subsection (b).
       (3) Defendant may submit affidavits demonstrating that 
     defendant has not included the implant on a list, if any, 
     filed with the Secretary pursuant at Section 510(j) of the 
     Federal Food, Drug and Cosmetic Act (21 U.S.C. 360). Claimant 
     may, in response to such a motion, submit affidavits 
     demonstrating that the Secretary has, with respect to the 
     defendant and the implant that allegedly caused claimant's 
     harm, issued a declaration pursuant to Section 6(a) of this 
     Act, or that defendant was a seller of the implant.
       (3) No discovery shall be permitted against the defendant 
     who has filed a motion to dismiss under subparagraph (1), 
     other than discovery necessary to determine a motion to 
     dismiss for lack of jurisdiction, until the court has ruled 
     on the motion to dismiss filed pursuant to subsection (1).
       (4) A defendant shall conclusively be deemed to be a 
     biomaterials supplier and not to be subject to suit except 
     pursuant to section 5(b) of this Act, and a motion to dismiss 
     under subsections (c)(1)(A) or (c)(1)(B) shall be granted, 
     unless the claimant submits valid affidavits demonstrating--
       (A) with respect to a motion under subsection (c)(1)(A), 
     that the Secretary has, with respect to the defendant and the 
     implant that allegedly caused harm to the claimant, issued a 
     declaration pursuant to Section 6(a) of this Act; or
       (B) with respect to a motion under subsection (c)(1)(B), 
     that the biomaterials supplier was a seller which held title 
     to the implant as a result of purchasing or selling the 
     implant after the implant was manufactured and entered the 
     stream of commerce.
       (5) The court shall rule on the motion to dismiss filed 
     under subsection (c) solely on the basis of the pleadings and 
     any affidavits, including affidavits submitted under 
     paragraph (2). If the pleadings and affidavits raise genuine 
     issues as to material facts with respect to a motion under 
     (c)(1)(C), the motion may be treated as a motion for summary 
     judgment pursuant to subsection (d) of this section.
       (d) Summary Judgment.--
       (1) A biomaterials supplier shall be entitled to entry of 
     judgment without trial if there is no genuine issue as to any 
     material fact as to each element set forth in Section 5(b). A 
     genuine issue of material fact shall exist only if the 
     evidence submitted by claimant, if found by a jury to be 
     credible, would be sufficient to allow a reasonable jury to 
     reach a verdict for the claimant.
       (2) In the event that the court, under applicable rules, 
     may permit discovery prior to ruling on a motion for summary 
     judgment, such discovery shall be limited solely to 
     establishing whether a genuine issue of material fact exists.
       (e) A biomaterials supplier shall be subject to discovery 
     in connection with a motion under subsection (c) or (d) 
     solely to the extent permitted by the applicable state or 
     federal rules for discovery against non-parties.
       (f) In the event claimant has filed a petition for a 
     declaration pursuant to Section 6(a) with respect to a 
     defendant, and the Secretary has not issued a final decision 
     thereon, the court shall stay all proceedings with respect to 
     that defendant until the Secretary has issued a final 
     decision.
       (g) The manufacturer of the implant shall be permitted to 
     file and conduct the proceeding on any motion filed pursuant 
     to subsection (c) or (d) if the manufacturer and the other 
     defendant(s) have entered into a valid and applicable 
     contractual agreement in which the manufacturer agrees to 
     bear the cost of or to conduct such proceeding.
       (h) The court shall require the claimant to compensate the 
     biomaterials supplier (or a manufacturer appearing in lieu of 
     a supplier pursuant to subsection (d)) for attorney fees and 
     costs, if the claimant named or joined the biomaterials 
     supplier, but the court found the claim against the 
     biomaterials supplier to be without merit and frivolous.

     SEC. 9. EFFECTIVE DATE.

       This Act shall take effect on the date of its enactment and 
     shall apply to all civil actions pursuant to this Act 
     commenced on or after such date, including any action in 
     which the harm or the conduct which caused the harm occurred 
     before the effective date of this Act.

     SEC. 10. SEVERABILITY.

       If any provision of this Act, or the application of such 
     provision to any person or circumstance is held to be 
     unconstitutional, the remainder of this Act and application 
     of the provisions of such to any person or circumstance shall 
     not be affected thereby.

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