Settlement Facility
, 1999
. TABLE OF CONTENTS
DEFINITIONS SFA - 1
Agreement SFA - 1
PURPOSE AND MANAGEMENT SFA - 2
3
of Liabilities SFA - 4
TRANSFER OF ASSETS SFA - 4
Settlement Fund SFA - 5
5
6
Fund SFA - 6
6
FACILITY ADMINISTRATION SFA - 6
6
Function SFA - 6
7
SFA - 7
Administrator SFA - 8
SFA - 8
9
Functions SFA - 9
Funds and Review of Claims Operations SFA - 11
Representatives and Claimants' Advisory Committee SFA - 12
Committee SFA - 12
13
Professionals SFA - 13
PRINCIPLES/REQUIREMENTS FOR RESOLUTION OF CLAIMS
OF SETTLING PERSONAL INJURY CLAIMANTS/IMPLEMENTATION
OF CLAIMS RESOLUTION PROCEDURES SFA - 14
Guidelines SFA - 14
Procedures SFA - 15
Administrator/Provision of Claims Data to Debtor
17
17
Procedures SFA - 18
18
SFA - 18
CLAIMS RESOLUTION OPTIONS/ELECTION PROCESS/ORDERING
18
19
Litigation SFA - 19
Payment Options SFA - 19
19
FUND ALLOCATION/PAYMENT DISTRIBUTION PROCEDURES/
COURT APPROVALS SFA - 20
Payments SFA - 20
20
20
SFA - 20
20
of the Settlement Fund and the Litigation Fund SFA - 20
21
21
21
21
Available for Distribution to Claimants
SFA - 21
22
22
SFA - 22
Facility SFA - 22
Facility SFA - 22
22
Settling Claims SFA - 23
23
Approvals SFA - 23
SFA - 23
to Litigation Fund for Payment of First Priority Payments SFA -
24
Amount SFA - 24
SFA - 25
Administrative Expenses SFA - 25
FINANCIAL MANAGEMENT SFA - 25
Payment SFA - 25
25
MISCELLANEOUS SFA - 28
28
GENERAL PROVISIONS SFA - 29
29
.
reorganization under chapter 11 of the Bankruptcy Code in the United
States Bankruptcy Court for the Eastern District of Michigan, Northern
Division.
resolution of certain Personal Injury Claims through a Settlement
Facility.
on ___________, [1999] (the "Confirmation Order"), the Plan was
confirmed.
this Agreement establishes the Settlement Facility, the purposes of
which are specified at Article II.
Confirmation Order, it is agreed as follows:
1.01 Incorporation of Definitions. All capitalized terms used in
this Agreement and not otherwise defined herein shall have the
meanings assigned in the Plan, Disclosure Statement, the Dow Corning
Settlement Program and Claims Resolution Procedures, the Funding
Payment Agreement, the Litigation Facility Agreement, and the
Bankruptcy Code — in that order. All definitions in the Plan,
Disclosure Statement, and Bankruptcy Code and the Dow Corning
Settlement Program and Claims Resolution Procedures are incorporated
herein by reference.
1.02 Original Global Breast Implant Settlement Agreement — means the
Agreement filed in the United States District Court for the Northern
District of Alabama on March 29, 1994 in the Case of Lindsey v. Dow
Corning, et al., Civ. Act. No. CV 94-P-11558-S (MDL 926).
1.03 MDL 926 Claims Administrator — means that individual appointed
by the MDL 926 Court to serve as the administrator of the MDL 926
Claims Office.
1.04 MDL 926 Claims Office — means the claims office established by
the MDL 926 Court to receive and process claims under the terms of the
Original Global Breast Implant Settlement Agreement and the Revised
Settlement Program.
1.05 MDL 926 — means the multi-district litigation captioned In re
Silicone Gel Breast Implants Products Liability Litigation
consolidated in the United States District Court for the Northern
District of Alabama pursuant to 28 U.S.C. § 1407 by order of the
Judicial Panel on Multi-District Litigation dated June 26, 1992.
1.06 MDL 926 Court — means the Judge and Court with jurisdiction over
MDL 926 and over the MDL 926 Claims Office (which MDL 926 Claims
Office shall be used to perform functions described herein).
Currently, United States District Judge Sam C. Pointer, Jr. presides
over MDL 926. For purposes of this Settlement Facility Agreement, in
the event that the current MDL 926 Judge is unable or unwilling to
perform the functions designated herein, all such functions shall be
performed by the District Court.
1.07 MDL Quality Control Office — means the Quality Control and
Computer Support Office employed by the MDL 926 Claims Office to
provide quality control and computer support.
1.08 Quality Control Supervisor — means the individual or entity
employed by the
Claims Office to establish procedures to assure accurate and
consistent application of Claim eligibility criteria and processing
protocols. This Quality Control Supervisor may be the same individual
or entity that is employed by the MDL 926 Claims Office to perform
data management and quality control functions.
1.09 Revised Settlement Program — means the Program established under
the jurisdiction of the MDL 926 Court in Order No. 27 (Civ. Act. No.
CV 94-P-11558-S, December 22, 1995) and as modified or amended by
subsequent Orders of the MDL 926 Court or procedures of the MDL 926
Claims Office.
1.10 Special Master — means the Special Master appointed by the
District Court under the terms of the Case Management Order and
Litigation Facility Agreement.
2.01 Purpose. The purposes of the Settlement Facility are: (i) to
assume liability for and to liquidate and resolve claims of Settling
Personal Injury Claimants and Settling Other Claimants and to pay
expenses and costs in accordance with the terms of the Plan and this
Agreement and the Dow Corning Settlement Program and Claims Resolution
Procedures ("Claims Resolution Procedures") (Annex A to this
Settlement Facility Agreement), subject to and without exceeding the
available assets of the Settlement Fund as set forth at Section 3.02;
(ii) to supervise the receipt, holding and investing of funds paid to
the Trust in accordance with the terms of the Funding Payment
Agreement and this Settlement Facility Agreement; (iii) to distribute
funds paid to the Settlement Facility to Claimants with Allowed Claims
and for administrative and other expenses in accordance with the terms
of the Funding Payment Agreement, the Litigation Facility Agreement,
and this Agreement; and (iv) to assure that the Trust qualifies as a
Qualified Settlement Fund pursuant to § 468B of the Internal Revenue
Code and the Treasury Regulation promulgated thereunder.
2.02 Management of Claims Resolution. The claims resolution
functions of the Settlement Facility shall be administered by a Claims
Administrator as described in Article IV. The Claims Administrator
shall exercise the powers and obligations set forth in this Settlement
Facility Agreement and shall assure the distribution of payments to
Claimants in accordance with the terms of this Agreement.
2.03 Allocation and Distribution of Funds. The distribution and
payment of funds to Settling Personal Injury Claimants and to
Claimants whose Claims are resolved by the Litigation Facility shall
be administered by the Claims Administrator and the Finance Committee
as defined herein.
2.04 Maintenance of Actions. As specified at Section 4.07, the
Finance Committee shall have the authority to file any action, suit,
or proceeding on behalf of the Settlement Facility or the Trust (as
defined below) or to enforce the obligations set forth in the Funding
Payment Agreement. The Finance Committee shall also defend and
arrange for the defense of any action, suit, or proceeding brought
against the Settlement Facility, the Trust, the Claims Administrator,
the Finance Committee, or any agent or employee of the Settlement
Facility.
2.05 Establishment of Depository Trust. To effectuate the terms of
this Agreement, a depository trust ("the Trust") shall be established
consistent with the provisions of this Section 2.05 and the Plan.
receive, hold, and invest funds in accordance with, and subject to,
the provisions of the Settlement Facility Agreement, the Funding
Payment Agreement and the Litigation Facility Agreement; (ii) to issue
payments and disburse funds at the direction of the Finance Committee
and as provided herein; and (iii) to qualify as a Qualified Settlement
Fund ("QSF") pursuant to Section 468B of the Internal Revenue Code and
the Treasury Regulations promulgated thereunder.
Settling Personal Injury Claimants whose Claims have been Allowed
under the terms of this Settlement Facility Agreement and all
Non-Settling Personal Injury Claimants whose Claims have been settled
by the Litigation Facility. Nothing in this provision is intended to
affect any rights of Settling and Non-Settling Personal Injury
Claimants under the Plan, the Settlement Facility Agreement, and/or
the Litigation Facility Agreement.
The Trustee shall be a [bank with a corporate trust department and net
assets of not less than $ ]. The Trustee shall act
only at the direction of the Finance Committee as specified herein and
shall take no action unless directed by the Finance Committee. The
Trustee may not assign its rights or obligations hereunder. The
Trustee may serve as the paying agent responsible for distribution of
payments, as specified at Section 7.02 herein. The Trustee shall be
entitled to receive a reasonable fee and reimbursement of reasonable
costs and expenses for its services hereunder, subject to Section
7.03(e) herein. It is intended that the costs and expenses of the
Trust and Trustee shall be minimal and consistent with the fees and
expenses incurred in the Revised Settlement Program for comparable
functions.
held harmless from liability under the Trust as long as the Trustee
acts in accordance with the directions of the Finance Committee.
sixty (60) days prior written notice to the Finance Committee, the
District Court, the MDL 926 Court, the Claimants' Advisory Committee,
and the Debtor's Representatives, provided, however, that the
resignation shall not become effective until a successor Trustee has
been appointed.
time by the Finance Committee, subject to approval of the District
Court.
removal of the Trustee, or in the event the separate corporate
existence of the Trustee terminates, a successor Trustee shall be
selected by the Finance Committee, subject to District Court approval.
All funds that are to be paid to the Settlement Facility pursuant to
the Plan Documents shall be paid to the Trust as depository.
Notwithstanding any contrary provision of applicable law, the Trustee
shall invest all funds that are deposited in the Trust as directed by
the Financial Advisor and the Finance Committee as approved by order
of the District Court. All funds that are to be paid by the
Settlement Facility pursuant to the Plan Documents shall be paid by
the Trust. All liabilities and obligations that are to be assumed by
the Settlement Facility pursuant to the Plan Documents shall be
assumed by the Trust but only to the extent that funds to be paid to
the Settlement Facility are available to satisfy the assumed
liabilities and obligations.
substantive law of the State of
[ ], subject, however, to the exclusive reservation of
jurisdiction in specific courts under the Plan and this Settlement
Facility Agreement.
created for the primary purpose of paying debts of the Debtor within
the meaning of Section 11 of the Michigan Revised Probate Code (MCLA §
700.11, MSA § 27.5011) and a Trust created in deposits in a banking
institution or savings and loan institution within the meaning of
Article 1 of New York's Estates, Powers & Trust Law (N.Y. Est. Powers
& Trust Law, § 1-2.20) and all matters relating to the validity and
interpretation of this Trust shall be under the exclusive jurisdiction
of the Court. In accordance with Section 8.7 of the Plan, all actions
involving the Trust shall be brought in the United States Bankruptcy
Court for the Eastern District of Michigan.
3.01 Source of Funds. The Debtor has executed and delivered a
Funding Payment Agreement and an Insurance Allocation Agreement.
Assets shall be transferred to the Settlement Facility in accordance
with the terms of the Funding Payment Agreement and the Insurance
Allocation Agreement. All assets received by the Settlement Facility
shall be administered, held and distributed in accordance with the
terms of this Agreement and the Funding Payment Agreement.
3.02 Allocation of Funds. The funds received under the terms of the
Funding Payment Agreement shall be distributed to Claimants and
allocated for administrative and other expenses and costs in
accordance with the terms of Articles III, V, and VII herein, the
Claims Resolution Procedures, and the Plan.
under the terms of the Funding Payment Agreement, an amount up to the
aggregate sum of $400 million Net Present Value shall be defined as
the "Litigation Fund." The aggregate amount paid to resolve all
Non-Settling Personal Injury Claims, Assumed Third Party Claims, Class
12 Claims, and, to the extent provided in the Litigation Facility
Agreement, Litigated Shareholder Claims, plus defense and
administrative costs associated with resolving Claims under the terms
of the Litigation Facility Agreement, including fees of the Special
Master and defense costs for the resolution of Claims in Classes 4A
and 11-17 (such defense costs and other costs and fees shall
collectively be defined for purposes of this Settlement Facility
Agreement as "Litigation Facility Expenses"), shall not exceed the
Litigation Fund. The assets comprising the Litigation Fund shall be
paid only if and as required to liquidate and resolve Claims subject
to resolution under the Litigation Facility Agreement and to pay
expenses of the Litigation Facility. The Litigation Fund shall be
reserved for the payment of Non-Settling Personal Injury Claims,
Assumed Third Party Claims, Claims of Claimants in Class 12, and, to
the extent provided in the Litigation Facility Agreement, Litigated
Shareholder Claims, and Litigation Facility Expenses, except that the
Litigation Fund may be accessed for purposes of payment of portions of
certain Claims of Settling Personal Injury Claimants Allowed under the
terms of this Agreement under the conditions outlined at Sections 7.01
and 7.03 below.
Settlement Facility under the terms of the Funding Payment Agreement,
and all earnings thereon, if any, except the Litigation Fund, shall be
defined as the "Settlement Fund." The Settlement Fund shall be
reserved for the resolution of Settling Personal Injury Claims and all
Other Claims not subject to the Litigation Fund and all costs and
administrative expenses of the Settlement Facility (not including
costs and expenses of the Litigation Facility) and shall not be used
or accessible for any other reason. Specifically, the Settlement Fund
shall be used for payment of the Allowed amount of Claims of Settling
Claimants in Classes 5-10, 6A, 6B, 6C, 6D and, to the extent provided
in the Litigation Facility Agreement, Litigated Shareholder Claims,
and for the Allowed amount of obligations described at Section 6.14.5
of the Plan, and for payment of the Allowed amount of Claims in
Classes 4A and 11-17 to the extent provided in the Plan and the
Litigation Facility Agreement. To the extent any such obligations are
paid directly by the Reorganized Dow Corning, as specified in the
Funding Payment Agreement and the Plan, such amount(s) shall be offset
against the amounts to be paid by the Reorganized Dow Corning to the
Settlement Facility, as provided in the Funding Payment Agreement.
The Claimants' Advisory Committee must consent to the settlement of
any Claim in Classes 11, 13, 14, 15, or 17 that is channeled to the
Litigation Facility for resolution and such consent shall not
unreasonably be withheld.
Fund is a subfund within the Settlement Fund. Such Fund defines the
maximum aggregate amount that may be paid to Settling Breast Implant
Claimants whose Claims are resolved under Disease Payment Option I and
who are eligible to receive payment for Increased Severity, as
specified at Annex A Section 6.02(d)(viii). The Increased Severity
Fund shall not exceed $15 million Net Present Value.
a subfund within the Settlement Fund. The sum of $36 million Net
Present Value shall be defined as the Other Products Fund. The
maximum amount payable to Settling Other Products Claimants shall not
exceed $36 million Net Present Value. Of the aggregate $36 million,
the sum of $6 million Net Present Value shall be defined as a "Premium
Payment" for purposes of priority of distribution under Section 7.01.
Silicone Material Claimants' Fund is a subfund within the Settlement
Fund. The sum of $57.5 million Net Present Value shall be defined as
the Silicone Material Claimants' Fund. The maximum amount payable to
Settling Silicone Material Claimants shall not exceed $57.5 million
Net Present Value.
3.03 Assumption of Liabilities/Payments. (i) The Settlement Facility
assumes and shall be exclusively liable for any and all liabilities,
present or future, whether such liabilities are liquidated,
non-liquidated, contingent or non-contingent asserted or un-asserted,
fixed or not fixed, matured or un-matured, disputed or un-disputed,
legal or equitable, known or unknown of Debtor now or hereafter
arising in connection with or relating to Claims of Settling Personal
Injury Claimants and Other Claims; (ii) The Reorganized Dow Corning
shall promptly take all appropriate action to transfer to the
Litigation Facility any lawsuit or action that may be or has been
filed against the Reorganized Dow Corning and that arises from any
Claim subject to the provisions of Section 8.4 of the Plan. The
Reorganized Dow Corning shall be reimbursed by the Settlement Facility
from the Litigation Fund for any reasonable expenses, costs, fees,
liabilities, or judgments arising out of or incurred in connection
with any such Claim provided that the Reorganized Dow Corning has
taken prompt action to transfer the Claim as described above. Nothing
in this provision shall be construed to limit or affect the
effectiveness or scope of the channeling injunction.
4.01 Court Supervision. The resolution of Claims under the terms of
this Settlement Facility Agreement and the Claims Resolution
Procedures and the functions in this Article IV (as specified in this
Article IV) and the functions in Articles V and VI herein shall be
supervised by the MDL 926 Court. The MDL 926 Court shall have the
authority to act in the event of disputes or questions regarding the
interpretation of Claim eligibility criteria or management of the
Claims Office. The District Court shall perform all functions
relating to the distribution of funds and all determinations regarding
the prioritization or availability of payments, specifically including
all functions related to Articles III, VII, and VIII herein, and any
functions not specifically designated to the MDL 926 Court.
4.02 Appointment of Claims Administrator.
Claims Administrator shall be . The Claims
Administrator shall be agreed upon by the Tort Claimants' Committee or
the Claimants' Advisory Committee and the Debtor or the Debtor's
Representatives, subject to approval of the MDL 926 Court, to perform
the functions herein. With respect to claims administration
functions, the Claims Administrator shall be supervised by the MDL 926
Court. The Claims Administrator shall be obligated by the terms of
the appointment to perform such functions and assume such obligations
and responsibilities as specified herein. In general, and as
specified more fully in this Settlement Facility Agreement and Annex A
to this Agreement, the Claims Administrator shall be responsible for:
(i) supervising processing of Claims resolved under the terms of this
Settlement Facility Agreement and the Claims Resolution Procedures and
overseeing all aspects of the Claims Office including the Quality
Control Supervisor and the Operations Manager, (ii) preparing and
distributing periodic reports documenting the activity of the Claims
Office, including detailed reports on Claims submissions and
resolutions, and (iii) as a member of the Finance Committee,
performing periodic analyses and estimates regarding the costs and
projected costs of processing and resolving Claims subject to the
terms of this Agreement and of the Litigation Facility Agreement and
any matter or contingency that could affect the sufficiency of funds
for payment of Allowed Claims. The Claims Administrator shall seek
the input and advice of the Claimants' Advisory Committee and the
Debtor's Representatives on all matters of mutual concern and as
specified at Section 5.05.
Claims Administrator resigns or is removed from office or is otherwise
unable to perform the functions of the Claims Administrator, a
successor Claims Administrator shall be selected by the Debtor's
Representatives and the Claimants' Advisory Committee, subject to
approval of the MDL 926 Court. If the Debtor's Representatives and
the Claimants' Advisory Committee are unable to agree on a successor
Claims Administrator, the Finance Committee shall propose a successor,
subject to the approval of the MDL 926 Court.
Administrator (or successor Claims Administrator) shall be (i) an
individual over the age of 35 whose experience and background are
appropriate for the responsibilities hereunder, and (ii) at the time
of appointment and at all times during the term of service,
independent. The Claimants' Advisory Committee and the Debtor's
Representatives may agree to waive certain qualification requirements.
For purposes of this Settlement Facility Agreement, a person is not
independent if such person:
representative of a holder of any Claim against the Debtor or any
other Released Party;
Claim against the Debtor or any Released Party such that the person's
impartiality in serving as a Claims Administrator could reasonably be
questioned;
interests held indirectly through publicly-traded mutual funds) in the
Debtor or any other Released Party;
employee or agent of the Debtor or any other Released Party or related
to any of the foregoing, or otherwise is or was an "insider," as
defined in the Bankruptcy Code, with respect to the Debtor or any
other Released Party;
accountant or attorney or related to any of the foregoing, for the
Debtor or any other Released Party, or an officer, director, employee
or agent of any person or entity that provides (or at any time since
January 1, 1990, has provided) investment banking, financial advice,
accounting or legal services to the Debtor or any other Released Party
or related to any of the foregoing;
(or at any time since January 1, 1990, has represented as an attorney,
agent or otherwise) any interest whatsoever adverse to the interests
of the Debtor or any other Released Party, of the holders of a class
of any Claims against the Debtor or any other Released Party, or of
the holders of any equity interests in the Debtor or any other
Released Party;
director, employee, consultant or agent of the holder of any Claim
against the Debtor or any other Released Party; or
an investment banker, financial advisor, accountant or attorney for
the holder of any Claim against the Debtor or any other Released
Party, or an officer, director, employee or agent of any person or
entity that provides or provided investment banking, financial advice,
accounting or legal services to the holder of any Claim against the
Debtor or any other Released Party.
the duration of the Settlement Facility, subject to death, resignation
or removal.
removed from office by the MDL 926 Court.
Administrator — or his or her delegate — shall have the power to hire
and shall hire and appoint such staff and other appropriate agents,
including the Quality Control Supervisor and/or any persons or
entities performing Claim audit functions under this Settlement
Facility Agreement, as necessary to carry out the functions of the
Claims Administrator under this Settlement Facility Agreement.
Salaries, fees, budgets, and payment terms for any staff, contractors,
or auditors shall be determined by the Finance Committee, subject to
the provisions of Section 7.03(e). The Claims Administrator shall not
have authority to subcontract claims-processing functions without the
consent of the Debtor's Representatives and the Claimants' Advisory
Committee and the approval of the MDL 926 Court. Subject to the
direction of the Finance Committee, which shall coordinate with the
MDL 926 Court as appropriate, and the approval of expenditures by the
District Court, the Trust shall have the authority to enter into such
contracts or agreements as may be necessary to operate the Claims
Office, to hire staff and contractors and/or to obtain services and
equipment and shall have the authority to serve all functions of an
employer.
for the Claims Administrator shall be established by the MDL 926 Court
using the compensation established for the MDL 926 Claims
Administrator as a guideline. In addition, the Claims Administrator
shall be reimbursed for his or her reasonable out-of-pocket expenses
incurred in the performance of his or her duties. All such
compensation and expenses shall be paid from the Settlement Fund. The
Trust will promptly reimburse the Claims Administrator for such
reasonable out-of-pocket expenses.
implementation of the Plan, the Debtor and the Tort Claimants'
Committee shall seek an order from the MDL 926 Court and/or the
District Court designating the actions of the Claims Administrator,
staff and agents in collecting, processing, evaluating and paying
Claims as judicial actions of the court protected, to the maximum
extent allowable by the law, by the doctrine of judicial immunity. If
the MDL 926 Court and/or the District Court do not enter such order,
then the Claims Administrator shall not be liable for his or her acts
or omissions or those of any agent or employee of the Settlement
Facility or the Claims Office unless the Claims Administrator acted
with gross negligence or willful misconduct with respect to the acts
or omissions or in the selection or retention of any such agent or
employee.
Administrator is or may be a party in any action, suit, or proceeding
by reason of the Claims Administrator being or having been a Claims
Administrator of the Settlement Facility, or by reason of the Claims
Administrator serving or having served in any capacity at the request
of and on behalf of the Settlement Facility, the Claims Administrator
shall be indemnified by the Settlement Facility against reasonable
expenses, costs and fees (including reasonable attorneys' fees),
judgments, awards, costs, amounts paid in settlement, and liabilities
of all kinds incurred by the Claims Administrator in connection with
or resulting from such action, suit, or proceeding, with respect to
the actions at issue, if he or she acted in good faith and in a manner
the Claims Administrator reasonably believed to be in or not opposed
to the best interests of the Settlement Facility.
are named in any action relating to their duties, then the Finance
Committee is authorized to retain counsel and arrange for payment of
reasonable expenses, costs and fees (including reasonable attorneys'
fees) incurred by or on behalf of the Settlement Facility, Claims
Administrator, staff, or agents in connection with any such action,
suit, or proceeding, provided the Claims Administrator agrees to
repay such amount if it shall be determined ultimately that the Claims
Administrator is not entitled to be indemnified by the Settlement
Facility.
after notice to the Debtor's Representatives and the Claimants'
Advisory Committee, the Claims Administrator may purchase and
maintain reasonable amounts and types of insurance, including
insurance on behalf of an individual who is or was a Claims
Administrator, employee, or agent of the Settlement Facility against
liability asserted against or incurred by such individual in that
capacity or arising from his or her status as a Claims Administrator,
employee, or agent.
4.03 Establishment of Claims Office/Claims-Processing Functions.
be reviewed, processed and resolved by the Claims Office, which shall
be administered by the Claims Administrator. As more specifically
described herein, the Claims Office shall operate using the
claims-processing staff, procedures, facilities, data management, and
quality control process of the MDL 926 Claims Office. It is expressly
intended that the Settling Breast Implant Claims shall be processed in
substantially the same manner in which claims filed with the MDL 926
Claims Office under the Revised Settlement Program are processed
except to the extent criteria or processing guidelines are modified by
this Settlement Facility Agreement or the Claims Resolution
Procedures, and that the Claims Office shall continue its operations
as they have been conducted under the Revised Settlement Program. The
Claims Administrator, the Claimants' Advisory Committee and the
Debtor's Representatives shall seek all necessary orders from the MDL
926 Court authorizing the use of the MDL Claims Office staff and
facilities and any other orders necessary to implement the provisions
of this Settlement Facility Agreement. The Claims Office staff and
facilities shall operate under the supervision of the MDL 926 Court.
The Finance Committee shall enter into such agreements as are
necessary and appropriate to arrange for payment for use of the MDL
926 Claims Office and to assure appropriate processing schedules. The
Settlement Facility shall pay the costs and expenses of the Claims
Office in accordance with the directives of the Finance Committee,
subject to approval of the MDL 926 Court and subject to the terms of
this Agreement.
shall be selected by the Claims Administrator, subject to input from
the Finance Committee, the Claimants' Advisory Committee and the
Debtor's Representatives and to the approval of the MDL 926 Court.
The Claims Operations Manager shall, subject to the review,
supervision and direction of the Claims Administrator, assume
responsibility for the management of staff and daily operations of the
Claims Office functions relating to or concerning the processing and
resolution of Claims.
4.04 Financial Advisor. The Finance Committee shall select a
Financial Advisor, which appointment shall be subject to the approval
of the District Court. The Financial Advisor shall be an individual,
institution or other entity with experience and expertise in financial
management and shall have primary responsibility for overseeing the
investment of all funds paid to and held by the Trust, for providing
investment instructions to the Trust, and for overseeing the
preparation of financial statements as specified at Sections 7.03(e)
and 8.04. The Financial Advisor shall also oversee, in conjunction
with the Finance Committee, the development of projected funding
requirements under Section 7.01(d) and the assessment of the
availability or adequacy of assets in the Litigation Fund and the
Settlement Fund for purposes of Section 7.03.
4.05 MDL 926 Claims Administrator. The MDL 926 Claims Administrator
may, subject to the approval of the MDL 926 Court, serve as a
consultant to the Claims Administrator, the Claims Office, and the MDL
926 Court to assist in the efficient and accurate operation of the
Settlement Facility. The Settlement Facility shall reimburse the MDL
926 Claims Administrator for such services at a rate or on a basis to
be determined by the MDL 926 Court. The Claims Administrator will
establish, in cooperation with the MDL 926 Claims Administrator, the
Claimants' Advisory Committee, and the Debtor's Representatives a
reasonable schedule for consultation with the MDL 926 Claims
Administrator. It is expressly intended that the MDL 926 Claims
Administrator is authorized to provide substantive guidance,
information and training to the Claims Administrator and the Claims
Operations Manager. It is also expressly intended that the Claims
Administrator and the Claims Operations Manager will seek the guidance
provided by the MDL 926 Claims Administrator and will adopt and abide
by the MDL 926 Claims Administrator's existing protocols regarding
processing methods and interpretation of the Disease eligibility
criteria for Breast Implant Claims (unless modified expressly by this
Settlement Facility Agreement or subsequently by written agreement of
the Claimants' Advisory Committee and the Debtor's Representatives) to
ensure consistent protocols as applicable.
4.06 Appeals Judge. The initial Appeals Judge shall be Frank
Andrews, the existing appeals officer appointed by the MDL 926 Court
to review and decide appeals from decisions of the MDL 926 Claims
Administrator. The Appeals Judge shall be approved by the MDL 926
Court. The Appeals Judge shall perform the functions as a member of
the Finance Committee as specified herein and as the Appeals Judge as
specified in the Claims Resolution Procedures. Any successor Appeals
Judge(s) shall be selected by the Claimants' Advisory Committee and
the Debtor's Representatives, subject to approval by the MDL 926 Court
for purposes of this Settlement Facility Agreement, and shall serve as
an officer of the court(s). If the Claimants' Advisory Committee and
the Debtor's Representatives are unable to agree on a successor
Appeals Judge, the Finance Committee shall select the successor,
subject to the approval of the MDL 926 Court. The Appeals Judge shall
be an attorney and shall satisfy the qualification criteria specified
for the Claims Administrator at Section 4.02(c). The Appeals Judge
shall be compensated at a reasonable rate established by the MDL 926
Court. The Appeals Judge will be reimbursed for any reasonable
out-of-pocket expenses incurred in the performance of the duties
described herein and in the Claims Resolution Procedures. All such
compensation and expenses shall be paid from the Settlement Fund. The
Appeals Judge may be removed by the MDL 926 Court.
4.07 Finance Committee.
composed of three members consisting of the individuals holding the
following positions: the Special Master, a single Appeals Judge (who
shall initially be Frank Andrews), and the Claims Administrator.
and Review of Claims Operations. Subject to the approval and
supervision of the District Court and as specified more fully in this
Settlement Facility Agreement, the Finance Committee shall (1) select
the Financial Advisor and any investment managers to oversee the
investment of the assets paid to the Settlement Facility under the
terms of the Funding Payment Agreement; (2) in conjunction with the
Financial Advisor, provide directions to the Trustee with respect to
investment and management of the assets paid to the Settlement
Facility; (3) in accordance with the provisions of Section 7.01,
conduct the analysis and projections necessary to determine the
availability of funds for payment of all categories of Claims; (4)
develop recommendations for submission to the District Court regarding
the release of funds payable from the Settlement Fund and the
Litigation Fund, as specified at Article VII herein; (5) review
proposed settlements of Non-Settling Personal Injury Claims to
determine the adequacy of funds for payments of such Claims and to
assure processing, litigation and resolution of Non-Settling Personal
Injury Claims within the allotted Litigation Fund; (6) develop
recommendations for submission to the District Court regarding the
necessity for deferrals or reductions in Claim payments; (7) as
specified herein, direct the paying agent to disburse payments for
Allowed Claims or for other purposes approved in accordance with this
Settlement Facility Agreement; and (8) recommend and establish
salaries, benefits, fees and expenses of the Settlement Facility and
Litigation Facility, as specified at Section 7.03(e). The Finance
Committee shall receive all reports and audits regarding Claims
resolution in the Settlement Facility and the Litigation Facility,
including results of quality control reviews and appeals, and may
request and arrange for any additional reports or reviews.
authority to hire and shall hire accountants, and auditors, along with
the Financial Advisor, as necessary, and shall have the authority to
hire such experts and consultants as necessary to prepare the
projections and analyses specified at Sections 5.03 and 7.01 and such
bankers and/or investment managers as may be necessary and
appropriate, subject to the approval of the District Court.
authority to bring actions on behalf of the Trust and the Settlement
Facility and to defend the Settlement Facility, the Trust, the Claims
Administrator, the Finance Committee, and any agents or employees of
the Settlement Facility and to hire counsel and pay reasonable fees in
connection with this authority, subject to the approval of the
District Court.
such general liability and other insurance as necessary and as
required by law with respect to the employees and staff performing the
claims administration functions.
schedule as necessary or as may be directed by the District Court or
the MDL 926 Court (but not less than once each quarter) to make
determinations required for the orderly and prompt payment of Allowed
Claims. Meetings may occur by teleconference or in person at the
discretion of the Committee.
majority vote.
Committee shall be compensated as provided herein from the Settlement
Fund. Specifically, the Claims Administrator shall be paid an annual
salary as determined in accordance with Section 4.02(f) and shall be
reimbursed for reasonable out-of-pocket expenses associated with
performing the duties of the Claims Administrator and acting as a
member of the Finance Committee. The Appeals Judge shall be
compensated at a reasonable rate established by the MDL 926 Court, as
specified at Section 4.06, and shall be reimbursed for reasonable
out-of-pocket expenses associated with performing duties as a member
of the Finance Committee. The Special Master shall be compensated at
a reasonable rate established by the MDL 926 Court for services
performed as a member of the Finance Committee and for reasonable
expenses associated with performing duties as a member of the Finance
Committee. Payment for compensation and expenses of the members of
the Finance Committee for services performed as members of the Finance
Committee shall be made from the Settlement Fund as specified at
Article VIII of this Settlement Facility Agreement.
and Claimants' Advisory Committee. The Debtor's Representatives and
Claimants' Advisory Committee shall attend and participate in
meetings of the Finance Committee, and the Finance Committee shall
consult with and seek the input and advice of the Debtor's
Representatives and Claimants' Advisory Committee.
4.08 Debtor's Representatives and Claimants' Advisory Committee.
Reorganized Dow Corning as appropriate shall appoint representatives
to perform all functions of the Debtor's Representatives as described
herein.
Master shall appoint a Claimants' Advisory Committee consisting of
three (3) members to fulfill the functions described herein and in the
Litigation Facility Agreement and the Funding Payment Agreement.
Notwithstanding this provision, if the Special Master reasonably
concludes that additional members of the Claimants' Advisory Committee
are necessary in order for the Claimants' Advisory Committee to
fulfill these duties, the Special Master has discretion to appoint up
to a total of five (5) members. No member of the Claimants' Advisory
Committee may be a bankruptcy lawyer.
Claimants' Advisory Committee shall attend and participate in meetings
of the Finance Committee as specified at Section 4.07.
Claimants' Advisory Committee shall be authorized to participate in
proceedings in the MDL 926 Court related to the functions, procedures
and operations of the MDL 926 Claims Office and the Revised Settlement
Program. The Tort Claimants' Committee or the Claimants' Advisory
Committee (as appropriate) and Dow Corning or the Reorganized Dow
Corning shall seek any necessary orders permitting the Debtor's
Representatives and the Claimants' Advisory Committee to participate
in such MDL proceedings.
Claimants' Advisory Committee shall be authorized to advise and assist
the Settlement Facility, the Claims Administrator, the Finance
Committee and the Litigation Facility regarding all matters of mutual
concern and as further specified herein or in the Litigation Facility
Agreement.
Claimants' Advisory Committee shall be provided with copies of all
reports, projections, motions, pleadings, or other similar documents
concerning the activities of the Settlement Facility.
the Debtor's Representatives may file a motion or take any other
appropriate actions to enforce or be heard in respect of the
obligations in the Plan, the Funding Payment Agreement, and the
Settlement Facility Agreement, including Annex A thereto.
Advisory Committee shall be compensated by the Settlement Facility at
reasonable hourly rates established by the MDL 926 Court. The
Settlement Facility will pay all reasonable out-of-pocket expenditures
of the Claimants' Advisory Committee.
>From time to time, if and when the Claimants' Advisory Committee
determines that it needs professional advice and assistance beyond the
expertise of the Claimants' Advisory Committee members, it may retain
professionals to perform specific tasks necessary for the Committee to
fulfill its duties and obligations under the Settlement Facility
Agreement, the Funding Payment Agreement, and the Plan Documents.
Except under extraordinary circumstances, the Claimants' Advisory
Committee shall submit a budget in advance of retention of the
professionals indicating the purpose of such retention as well as a
proposed budget specifying tasks, hourly rates, and total cost. If
the Reorganized Dow Corning agrees, then the reasonable fees of such
professionals shall be Fundable Expenditures and will be paid by the
Settlement Facility, subject to approval by the MDL 926 Court. In the
absence of agreement, the Claimants' Advisory Committee may apply to
the MDL 926 Court for authority to hire such professionals for the
purpose, time period and within the budget that the MDL 926 Court
determines to be appropriate and reasonable. Should extraordinary
circumstances arise which do not permit a budget to be submitted in
advance of the retention of professionals for the purposes and in the
manner outlined above, the Claimants' Advisory Committee shall
exercise its best efforts to budget the expenses and fees for the
retention of the professionals and submit them for approval as soon as
practicable, but in no event later than fourteen (14) days after the
retention of the professionals.
successor members of the Debtor's Representatives at its discretion.
Committee shall appoint a successor member upon the resignation or
death of one of its members.
4.09 Special Master. The Special Master shall serve as a member of
the Finance Committee, as specified at Section 4.07. At the request
of the Debtor's Representatives or the Claimants' Advisory Committee
and with the agreement of both the Debtor's Representatives and the
Claimants' Advisory Committee, the Special Master or Appeals Judge may
consult with and assist the Claims Administrator for the purpose of
ensuring and facilitating an efficient and fair operation of the
Settlement Facility consistent with the terms of this Settlement
Facility Agreement. The Special Master or Appeals Judge shall be
compensated at a reasonable rate established by the MDL 926 Court for
such services.
5.01 Claims Resolution Procedures/Eligibility Guidelines.
Injury Claims payable from the Settlement Fund in accordance with the
Claims Resolution Procedures outlined in Annex A. This Settlement
Facility Agreement and Annex A shall establish the exclusive criteria
for evaluating, liquidating, allowing and paying Claims, except as
modified in accordance with Sections 5.05 and 10.06. Claims that
satisfy the eligibility criteria specified in the Claims Resolution
Procedures shall be paid as specified at Section 7.02. Only those
Claims that satisfy the eligibility criteria specified in the Claims
Resolution Procedures as applicable are eligible to receive payment,
except to the extent that the Reorganized Dow Corning accepts Claims
through the individual Proof of Manufacturer Review or the Individual
Review Process for Rupture Claims, as specified at Section 6.02(e)(vi)
of the Claims Resolution Procedures, or otherwise. This Settlement
Facility Agreement and the annexed Claims Resolution Procedures
establish specific guidelines for submitting and processing Claims.
The Claims Administrator shall have discretion to implement such
additional procedures and routines as necessary to implement the
Claims Resolution Procedures consistent with the terms of this
Agreement and subject to the provisions of Section 5.05 of the
Settlement Facility Agreement.
procedures and staff training and shall develop claims-tracking and
payment systems as necessary to process the Settling Breast Implant
Claims in accordance with the terms of this Settlement Facility
Agreement and the Claims Resolution Procedures.
procedures, claims-processing protocols and staff training and shall
develop claims-tracking and analysis systems as are necessary to
process the Claims of Settling Other Products Claimants and Silicone
Material Claimants in accordance with the terms of the Claims
Resolution Procedures and subject to the provisions of Section 5.05 of
this Settlement Facility Agreement.
5.02 Maintenance of Claims Office Staff and Procedures. The Claims
Administrator shall oversee and supervise the Claims Operations
Manager and the Claims Office processing functions.
5.03 Reporting Functions of Claims Administrator/Provision of Claims
Data to Debtor.
Committee shall cause to be prepared and provided to the MDL 926
Court, the District Court, the Debtor's Representatives, the
Shareholders, and the Claimants' Advisory Committee reports
containing, at a minimum, a summary of Claims broken down as
appropriate by the categories of:
Claimants
Claimants
Claims and Non-Settling Personal Injury Claims submitted, reviewed and
approved for payment;
Settling Personal Injury Claims fall (both the condition asserted, as
applicable, and approved), including, at a minimum:
Claims,
Claims based on medical contraindication and their disposition,
Expedited Release Payment Option Claims,
Payment Option Claims (by Covered Condition, Disease Payment Option,
and severity level),
Condition Claims,
Explantation Payment Option Claims,
of First Priority Payments paid in the period and the number and
amount of Second Priority Payments paid in the period,
or subclaims where a review indicates that the distribution of
approved or minor deficiency Claims is substantially departing from
the rates in the Revised Settlement Program,
Implant Claimants requesting compensation under the Increased Severity
Fund and the amounts paid; the number of Claimants requesting
compensation for increased severity outside the Increased Severity
Fund and the amounts paid;
Non-Settling Personal Injury Claims by category;
Administrator, the Appeals Judge, and to Dow Corning under the
Individual Review Process for Rupture Claims, as specified at Annex A
Section 6.02(e)(vi), and the disposition of appeals;
category of Claim and type of deficiency;
and Non-Settling Personal Injury Claims and any information known
about the Claims;
with respect to Settling and Non-Settling Claims (in the aggregate,
not individually) from the Effective Date to the end of the period
covered by the report, and from the end of the prior month to the end
of the period covered by the report; and
manufacturers (Bristol, Baxter, 3M) and the number of such claims
subject to the fifty (50)-percent multiple manufacturer reduction.
District Court may request any additional reports. As soon as
practicable, and prior to the production of the first reports, the
Claims Administrator shall present a proposed format for the reporting
to the Claimants' Advisory Committee and the Debtor's Representatives
for their review and comment.
file with any court) records of all individual payments and
settlements concerning Claims. The Claims Office shall provide such
records to the Debtor's Representatives and the Claimants' Advisory
Committee in computer readable format. The records shall include the
dates of implantation, proof of manufacturer, the amount and date of
payments distributed and settlement options approved and denied. Such
records shall be redacted to preserve Claimant confidentiality.
and Shareholders along with their Insurers shall at their request and
expense, and pursuant to procedures approved by the Claims Office, be
afforded access to and permitted to inspect all documentation and
other supporting evidence submitted by any Settling Claimants who have
been paid as may be necessary for the Debtor and the Shareholders to
receive benefits under insurance policies. The Reorganized Dow
Corning, Shareholders, and Insurers shall maintain the confidentiality
of the Claims information to protect the identity of the Claimants.
5.04 Quality Control and Audit Procedures.
Operations Manager shall have the authority and obligation to
institute claim-auditing procedures and other procedures designed to
detect and prevent the payment of fraudulent Claims. To the extent
applicable, it is intended that the Claims Administrator will apply
and maintain any procedures established by the MDL 926 Claims
Administrator to detect fraudulent claims. Nothing herein is intended
to limit the authority of the Claims Administrator to institute other
appropriate procedures.
must be signed under penalties of perjury. The submission of
fraudulent Claims will violate the criminal laws of the United States
including the criminal provisions applicable to Bankruptcy Crimes, 18
U.S.C. § 152, and subject those responsible to criminal prosecution in
the federal courts.
institute proceedings for appropriate review and relief in the event
of fraud or abuse of the Claims Resolution Procedures. If any review
supports a finding of intentional abuse of the Claims Resolution
Procedures or fraud, the Claims Administrator shall deny the Claim.
shall have authority to enforce these provisions as appropriate.
Administrator shall have the plenary authority and obligation to
institute procedures to assure an acceptable level of reliability and
quality control of Claims and to assure that payment is distributed
only for Claims that satisfy the Claims Resolution Procedures. Such
procedures shall include the authority to require (as a condition to
payment of a Claim) the examination of a Claimant, or the review of a
Claim, by a physician selected by the Claims Office or to require
additional laboratory testing of the Claimant conducted by a
laboratory selected by the Claims Office. The Claims Office shall
bear the expense of any such examination or testing conducted at the
request of the Claims Office. Such procedures shall include the
authority to obtain independent operation audits.
Administrator shall maintain a Quality Control Supervisor. The
Quality Control Supervisor shall institute procedures to evaluate the
claims-processing functions to assure that Claims are processed
accurately and in accordance with the Claims Resolution Procedures.
The Quality Control Supervisor may, to the extent applicable, use
procedures applied in the Revised Settlement Program to assure
appropriate quality control. The Quality Control Supervisor may
simultaneously be employed by the MDL Claims Office. The Quality
Control Supervisor may, with the approval of the Finance Committee,
employ independent auditors to review Claims operations. The
Claimants' Advisory Committee and the Debtor's Representatives may
participate in a joint training session for the purpose of
implementing procedures and guidelines in the Dow Corning Settlement
Program.
The Claims Administrator shall institute mechanisms and shall cause
the Quality Control Supervisor to develop and maintain procedures to
assure that all procedures and claims-processing protocols applied by
the MDL 926 Claims Office with respect to the Revised Settlement
Program are applied by the Claims Office with respect to the Breast
Implant Claims except to the extent modified by this Settlement
Facility Agreement and the Claims Resolution Procedures.
accuracy of claims-processing functions, the Claims Administrator
shall have prepared periodic quality control/operations audits
conducted by an internal Quality Control Supervisor and by outside
auditors. The audits shall be designed to evaluate the accuracy and
consistency of application of the eligibility criteria, the accuracy
of Claims payments, including review of supporting documentation.
conducted, by an independent auditor, random audits to verify evidence
and supporting documentation (including medical records and medical
evidence) submitted by randomly-selected Claimants in connection with
the Claims Resolution Procedures and may audit individual Claims, or
groups of Claims.
5.05 Interpretation of Criteria/Consent of Parties. The Claims
Administrator shall obtain the consent of the Debtor's Representatives
and Claimants' Advisory Committee regarding the interpretation of
substantive eligibility criteria and the designation of categories of
deficiencies in Claim submissions (to the extent such interpretations
and designations have not previously been addressed by the MDL 926
Claims Administrator in connection with the Revised Settlement
Program). The Claims Administrator shall consult with and obtain the
advice and consent of the Claimants' Advisory Committee and the
Debtor's Representatives regarding any additions or modifications to
guidelines for the submission of Claims. In the event of a dispute
between the Debtor's Representatives and the Claimants' Advisory
Committee, the Claims Administrator may determine the issue or apply
to the MDL 926 Court for consideration of the matter. There shall be
no modification of any substantive eligibility criteria specified
herein or in Annex A through the appeals process or otherwise, except
as expressly provided in this Section 5.05 and in Section 10.06
herein.
6.01 Settlement Payment Options Defined.
options for resolving Claims subject to the terms and conditions of
this Agreement and the Claims Resolution Procedures. Allowed Claims
will be paid in accordance with the applicable compensation level
described in the Claims Resolution Procedures and subject to the terms
of this Agreement.
Implant Claimants may select up to three compensation options. All
Settling Breast Implant Claimants are eligible to receive (subject to
the qualification criteria): (a) a one-time Explantation Payment, (b)
a one-time Rupture Payment, and (c) either (i) a payment for an
eligible Covered Condition (under the Disease Payment Option) OR (ii)
an Expedited Release Payment. Breast Implant Claimants with Allowed
Claims who receive payment under the Disease Payment Option shall be
entitled to apply for an additional payment under the applicable
Disease Compensation Schedule as defined in the Claims Resolution
Procedures. Allowed Claims for Rupture and Disease may also receive a
Premium Payment if the District Court determines that sufficient funds
are available to make such payment consistent with the terms of this
Agreement.
Products Claimants are eligible for two separate compensation options,
each of which is mutually exclusive: (a) the Expedited Release
Payment Option OR (b) the Medical Condition Payment Option. The
eligibility criteria and documentation required to qualify for each of
these compensation options are specified in the Claims Resolution
Procedures.
Material Claimants are eligible for the Silicone Material Claimant
Payment Option. The eligibility criteria and documentation required
to qualify for this settlement option are specified in the Claims
Resolution Procedures. Breast Implant Claimants and Other Products
Claimants are not eligible to receive compensation under the Silicone
Material Claimant Payment Option.
6.02 Election Process: Right to Elect Settlement or Litigation. All
Personal Injury Claimants are permitted under the Plan to elect to
settle their Claims under the terms of this Agreement or to litigate
their Claims under the terms of the Litigation Facility Agreement. The
procedures for electing to settle or litigate are specified in the
Claims Resolution Procedures.
6.03 Submission of Claims Forms/Selecting Settlement Payment Options.
In accordance with the Claims Resolution Procedures, the Claims Office
shall distribute to Personal Injury Claimants Claim Forms by which
Claimants can elect one or more settlement options.
6.04 Resolution of Claims. The Claims Administrator shall determine
whether the Claims are eligible based on the eligibility criteria set
forth in Annex A and shall process the Claims according to the terms
and conditions set forth in Annex A.
6.05 Payment of Claims/Execution of Releases. If the Claim qualifies
for payment under the selected settlement option, the Claims Office
shall provide to the Claimant a Notification of Status letter
specifying the settlement amount for which the Claimant qualifies, as
more specifically described in the Claims Resolution Procedures. If
the Claimant qualifies for and accepts the Allowed payment amount, the
Claims Office shall authorize the Claim for payment. Payments shall
be distributed in accordance with the terms of Article VII. The
payment draft or check shall be printed on a document that specifies
and clearly advises the Claimant that endorsement and cashing of the
check or draft shall be deemed to serve as additional documentation of
the release of the Debtor and the Released Parties, as specified at
Section 8.3 of the Plan, and, further, of the release of the
Settlement Facility for any and all Claims or liability. The
Settlement Facility shall retain all canceled checks and shall provide
them (or copies) to the Reorganized Dow Corning and/or the
Shareholders upon request if required in connection with any claim or
action involving the Reorganized Dow Corning or Shareholders,
including, but not limited to, any proceedings involving Insurers.
The Reorganized Dow Corning and Shareholders shall, to the extent
possible, maintain the confidentiality of the Claimants.
7.01 Timing of Disbursements/Prioritization of Payments.
identified on the Settlement Grid, Annex B hereto, as Expedited
Release Payments (for both Settling Breast Implant and Other Products
Claims), Explantation Payments, Disease Base Payments (for Breast
Implant Claims), Rupture Base Payments (for Breast Implant Claims),
Medical Condition Payments for Other Products, and Silicone Material
Payments, along with related administrative costs, are defined as
"First Priority Payments." Payments to be distributed to or for the
benefit of Allowed Claims of Settling Claimants in Classes 4A, 6A, 6B,
6C and 6D, Classes 14 and 15, and, to the extent provided in the
Litigation Facility Agreement, Litigated Shareholder Claims shall also
be defined as First Priority Payments.
Payments for Allowed Claims in Classes 11, 13, 14A and 17 along with
related administrative costs shall be defined as Settlement Fund Other
Payments.
on the Settlement Grid as "Premium Payments" for Breast Implant
Disease Payment Option Claims and Rupture Payment Option Claims and
for Other Products Claims and payments for increased severity of
disease or disability under the Breast Implant Disease Payment Option
(for both Disease Payment Option I and Disease Payment Option II) as
outlined shall be defined as Second Priority Payments. Payments made
to Class 16 Claimants in respect of the obligations in Section 6.14.5
of the Plan that are to be paid by the Settlement Facility shall also
be defined as Second Priority Payments.
distributed to Non-Settling Personal Injury Claims, Allowed Claims of
Claimants in Class 12, Assumed Third Party Claims, and, to the extent
provided in the Litigation Facility Agreement, Litigated Shareholder
Claims along with Litigation Facility Expenses shall be defined as
"Litigation Payments."
Settlement Fund and the Litigation Fund.
in accordance with the terms of this Agreement and the guidelines
specified at Section 7.03 regarding the prioritization of payments.
Second Priority Payments shall only be made as specified at Section
7.01(c) and/or Section 7.03(a).
in accordance with the terms of the Litigation Facility Agreement and
the Case Management Order. The Litigation Fund shall be used solely
for the payment of Litigation Payments (as defined herein), except
that the Litigation Fund may be used to pay First Priority Payments
under the conditions set forth at Section 7.03(b).
and Litigation Fund shall not exceed the aggregate amount of each such
Fund as defined herein.
payment are subject to reduction if necessary to assure payment in
full of First Priority Payments (subject to the limits of the
Settlement Fund and the Litigation Fund). The Settlement Fund and the
Litigation Fund shall be distributed in accordance with the priorities
stated below.
Administrator shall distribute First Priority Payments in respect of
Allowed Claims as soon as reasonably practicable following approval.
Payments shall be paid solely from the amount defined as the
Litigation Fund and shall not in the aggregate exceed the Litigation
Fund. Litigation Payments are subject to deferral or reduction in the
event that the District Court determines, after submission of a
recommendation and findings of the Finance Committee, that payment of
all Allowed or allowable Non-Settling Personal Injury Claims would
exceed the aggregate amount of the Litigation Fund.
Payments shall be deemed "Second Priority Payments." Premium Payments
may not be distributed unless and until the District Court determines
that all other Allowed and allowable Claims, including Claims subject
to resolution under the terms of the Litigation Facility Agreement,
have either been paid or adequate provision has been made to assure
such payments.
interpreted as limiting the discretion of the Finance Committee with
the approval of the District Court to pay lower priority payments and
higher priority payments contemporaneously, so long as the ability to
make timely payments of higher priority claims is reasonably assured.
Distribution to Claimants.
Finance Committee shall, commencing the first quarter after the
conclusion of the opt-out process and on a quarterly basis thereafter
or at the request of the MDL 926 Court or the District Court, prepare
projections of the likely amount of funds required to pay in full all
pending, previously Allowed but unpaid and projected future First
Priority Payments. Such projections shall, to the extent known or
knowable, be based upon and take into account all data (as of the date
of the analysis) regarding (i) the number of Claims filed with the
Settlement Facility, (ii) the rate of Claim filings in the Settlement
Facility, (iii) the average resolution cost of Claims in the
Settlement Facility, (iv) the pending Claims in the Settlement
Facility, and (v) projected future filings with the Settlement
Facility. Such projections shall also state the anticipated time
period for the resolution and payment of such Claims.
months of the operation of the Settlement Facility may take into
account, in addition to the above, the claims resolution experience of
the MDL 926 Claims Office. These projections are not a pre-requisite
to paying First Priority Payments, and nothing in this subsection is
intended to delay the payment of First Priority Payments in respect of
Allowed Claims.
Committee shall, at the request of the Manager or the District Court,
and in any event no less than quarterly, commencing the first quarter
after conclusion of the opt-out process, prepare projections of the
likely amount of funds required in order to pay all Claims and
expenses subject to
be based upon and take into account all data regarding (i) Claims paid
from the Litigation Fund, (ii) expenses incurred,
Claims certified or likely to be certified for trial, (v) past and
projected costs of litigating claims certified for trial and (vi) past
and projected future resolution costs of Claims in pre-trial
settlements. On the basis of such projections, the Finance Committee
shall state the funds projected to be available for the payment of
unpaid Claims subject to the Litigation Fund ("Available Litigation
Funds") taking into account any projected need to access the
Litigation Fund for purposes of payment of First Priority Payments
pursuant to Section 7.03(b). The projection shall also state the
estimated time period for the resolution of such Claims.
projections described above in subparagraphs (d)(i) and (d)(ii) shall
be provided to the MDL 926 Court, the District Court, the Debtor's
Representatives, the Shareholders, and the Claimants' Advisory
Committee.
7.02 Distribution to Claimants.
First Priority Payments shall be distributed as soon as practicable
after approval of the Allowed Claim. The MDL 926 Court may supervise
the coordination between the Claims Office and the paying agent with
respect to distributions to Allowed Settling Personal Injury
Claimants.
The Litigation Facility Manager shall on a monthly basis notify the
Finance Committee of the Allowed amount of Claims resolved by the
Litigation Facility. The Finance Committee shall direct the paying
agent to distribute payments for Allowed Claims resolved by the
Litigation Facility, subject to the provisions of Section
7.01(b)(iii), and shall establish procedures to assure verification of
and appropriate accounting for such payments.
Committee may designate the Trustee as paying agent. The paying agent
shall arrange for the distribution of payments to Claimants upon the
direction of the Finance Committee and the District Court and in
accordance with the terms of this Settlement Facility Agreement and
the Funding Payment Agreement. The timing of all distributions shall
be determined by the Claims Administrator. The Finance Committee
shall have the authority to seek orders from the District Court
generally authorizing distributions of First Priority Payments without
separate orders regarding each such distribution and establishing
procedures for distributing payments involving liens or disputed
payees.
Claims. The Finance Committee is responsible for establishing
procedures to verify the Allowed amount of each Claim certified for
payment so that the correct payments are issued.
Administrator shall adjust the Allowed amount to deduct the amount of
any payments previously made to the Claimant or to the Claimant's
physician or other health care provider under the Dow Corning Removal
Assistance Program, or any payments in prior partial settlements
between Dow Corning and the Claimant not resulting in a general or
full release. Dow Corning shall be responsible for providing to the
Claims Administrator adequate information as determined by the Claims
Administrator or the MDL 926 Court to determine whether such set-offs
apply.
inadequate to pay Allowed Claims in their respective Allowed amounts
due to the timing of the Debtor's payment obligations under the
Funding Payment Agreement, the Finance Committee shall recommend,
subject to the approval of the District Court, proportional payments
(i.e., installment distributions) on account of such Allowed Claims so
that all such Allowed Claims are paid in the same proportions.
based on financial considerations, the need for installment
distributions for Settling Breast Implant Disease Payment Claims
Allowed (1) under Disease Payment Option I in an amount greater than
$25,000, or (2) under Disease Payment Option II in an amount greater
than $100,000.
amount for resolution of Foreign Claimants who elect to settle shall
be computed in accordance with the terms of Schedule III to the Claims
Resolution Procedures.
7.03 Requirements/Procedure for District Court Approvals.
authorization to distribute Second Priority Payments, the Finance
Committee shall file a recommendation and motion with the District
Court requesting authorization to distribute Second Priority Payments.
Such recommendation and motion shall be accompanied by a detailed
accounting of the status of Claims payments and distributions under
the terms of the Settlement and Litigation Facilities, including a
detailed accounting of pending Claims and projections and analysis of
the cost of resolution of such pending Claims as described in Section
7.01(d). The recommendation and motion shall be served on the
Claimants' Advisory Committee, the Debtor's Representatives, the
Shareholders, and all Non-Settling Personal Injury Claimants with
pending Claims, and such Parties shall have the opportunity to be
heard with respect to the motion. The Parties agree to cooperate in
expedited procedures for review and resolution of issues under this
subsection and consent to an expedited hearing. If the District Court
rules that all Allowed and allowable First Priority Claims and all
Allowed and allowable Litigation Payments have been paid or that
adequate provision has been made to assure such payment (along with
administrative costs) based on the available assets, then the Second
Priority Payments, or some portion thereof, may be distributed, unless
the order of the District Court is stayed or reversed on appeal. The
Parties agree that any appeal of an order of the District Court
regarding the provisions of this subsection shall be on an abuse of
discretion standard.
Litigation Fund for Payment of First Priority Payments. In the event
that the Settlement Fund lacks sufficient funds in the aggregate to
pay in full all First Priority Payments, then the District Court may,
commencing on the fourth anniversary of the Effective Date, authorize
the use of the funds defined as the Litigation Fund to pay First
Priority Payments. Such use of the Litigation Fund may occur only
upon an order of the District Court. In determining whether such an
order should issue, the District Court should determine whether the
remaining assets of the Litigation Fund (i.e., the Litigation Fund
after accounting for payment of First Priority Payments on a Net
Present Value basis) will be adequate to pay all Claims subject to the
Litigation Fund. To obtain authorization to distribute Litigation
Fund assets for payment of First Priority Payments, the Finance
Committee shall file a recommendation and motion with the District
Court. Such recommendation and motion shall specify the amount
required to satisfy the Allowed First Priority Payments and contain a
full accounting of the assets and obligations of the Settlement
Facility that supports a conclusion that, absent access to the
Litigation Fund, the First Priority Payments due and payable could not
be made. The recommendation shall also state any projected future
need to access the Litigation Fund for future First Priority Payments.
The recommendation and motion shall be served on the Claimants'
Advisory Committee, the Debtors' Representatives, the Shareholders and
all Claimants who have elected treatment in the Litigation Facility
and whose Claims have not been paid in full. If the District Court
authorizes the use of any portion of the Litigation Fund for payment
of First Priority Payments, and such determination is not stayed or
reversed on appeal, then the Finance Committee may authorize such
distributions of First Priority Payments, and the amounts so
distributed shall be deducted on a Net Present Value basis from the
aggregate amount of the Available Litigation Funds to compute the
remaining Available Litigation Funds. In no event shall the Finance
Committee act inconsistently with an order of the District Court.
District Court, the Finance Committee shall determine the need to
reduce the amount payable to Claimants or to defer payments based upon
the projections described at Section 7.01(d). The Allowed amount of
Claims may be reduced only if: (1) the Finance Committee, subject to
the approval of the District Court, concludes, based on the
projections, that a reduction is necessary to pay in full all First
Priority Payments or (2) the Finance Committee, subject to the
approval of the District Court concludes, based on the projections,
that a reduction is necessary to assure equitable distributions to
Claimants within the aggregate limits of the Settlement Fund, the
Litigation Fund or Other Products Fund as applicable. To obtain
authorization to reduce amounts payable, the Finance Committee shall
submit to the District Court a recommendation including all
projections and analyses supporting the Finance Committee's
recommendation.
and subsequent projections demonstrate that all Allowed Claims can be
paid in full or can be paid in an amount less than the full Allowed
amount but greater than the reduced amount previously Allowed, then
the Finance Committee, subject to the approval of the District Court,
shall make a further distribution to Claimants to assure payment in
full or up to the amounts achievable consistent with the limits on the
Settlement Fund or the Litigation Fund as applicable.
determines that there is a need for a reduction in payment, the
Finance Committee's recommendation to the District Court shall include
a proposed method of reducing Claim payments consistent with the terms
of this article regarding the prioritization of Claim payments.
annual basis the Finance Committee shall submit to the District Court
for approval and to the Claimants' Advisory Committee, the Debtor's
Representatives, the MDL 926 Court, and the Shareholders annual
audited financial statements detailing the payments distributed and
allocated to the Settlement Fund and the Litigation Fund and the
remaining amounts payable to the Settlement Fund and the Litigation
Fund. Such audits shall be prepared by a recognized national firm of
independent public accountants selected by the Financial Advisor and
Finance Committee, subject to approval by the District Court, and
shall include a statement of disbursements allocated to each such Fund
and a statement of the Net Present Value of payments to the Settlement
Facility in the aggregate and Net Present Value of payments made and
allocated to the Litigation Fund, and such audits shall comply with
the terms of Section 8.05.
Expenses. Within forty-five (45) days of the Effective Date and on an
annual basis thereafter, the Finance Committee shall submit to the MDL
926 Court and the District Court for approval, with copies to the
Claimants' Advisory Committee, the Debtor's Representatives, and the
Shareholders, proposed guidelines for payment of all salaries,
compensation, and expenses associated with the operation of the Claims
Office, the Litigation Facility, and the Finance Committee, including
financial management, investment, and audit functions, along with an
annual proposed budget for all such costs and expenses. In preparing
the proposed annual guidelines, the Finance Committee shall adopt
procedures to assure reasonable administrative expenses consistent
with the guidelines and costs of operating the MDL 926 Claims Office,
and the Finance Committee shall for this purpose consult with the MDL
926 Court.
8.01 Establishment of Funds and Accounts/Requests for Payment. The
Finance Committee shall establish a Claims Payment Account and an
Operating Account and such other sub-accounts as are necessary to
hold, manage, invest and distribute funds in accordance with this
Agreement.
8.02 Payment of Administrative Expenses. The Finance Committee shall
establish a procedure to assure that the Trust shall disburse
salaries, compensation payments, and expenses, approved in accordance
with Section 7.03(e), on a bi-monthly schedule. The Finance Committee
may direct the disbursement of such salaries and expenses as have been
approved in accordance with Section 7.03(e) without separate order of
the District Court. The members of the Finance Committee shall submit
monthly statements and requests for reimbursement of expenses and for
compensation to the MDL 926 Court which requests shall include
sufficient detail to permit the MDL 926 Court to determine the
reasonableness of the requests. The Special Master shall provide
separate statements to the District Court for services performed under
the Litigation Facility Agreement and Case Management Order.
Compensation for the Special Master's services under the Litigation
Facility Agreement and the Case Management Order shall be allocated to
the Litigation Fund; compensation for the Special Master's services as
a member of the Finance Committee shall be allocated to the Settlement
Fund. The Trust will distribute payment upon approval of the MDL 926
Court or the District Court as appropriate. Such monthly statements
shall be provided to the Debtor's Representatives and the Claimants'
Advisory Committee. The Finance Committee shall authorize
distributions for all other expenses, including Claims Office
operating expenses and compensation and expenses for the Claimants'
Advisory Committee subject to the provisions of Sections 4.08 and
7.03(f).
8.03 Source of Payments. Except as provided in Section 7.03(b), all
liabilities with respect to Claims subject to resolution by the
Settlement Facility and all expenses of the Settlement Facility shall
be payable solely from the Settlement Fund. All liabilities subject
to payment from the Litigation Fund under the Litigation Facility and
all expenses of resolving such Claims, including costs and fees
incurred in litigating Claims, shall be payable solely from the
Litigation Fund.
8.04 Investment. Investments of monies held in the Trust shall be
administered in the manner in which individuals of ordinary prudence,
discretion and judgment would act in the management of their own
affairs, subject to the following limitations and provisions:
than ninety (90) days, any long-term debt securities, participation
certificates or similar instruments unless (i) such securities,
certificates or instruments are rated "A" or higher by Moody's
Investors Service, Inc. ("Moody's") or "A" or higher by Standard &
Poor's Rating Services, a division of The McGraw-Hill Companies, Inc.
("S&P's"), or (ii) have been issued or fully guaranteed as to
principal and interest by the United States of America or any agency
or instrumentality thereof.
than ninety (90) days, any commercial paper unless such commercial
paper is rated "Prime-1" or higher by Moody's or "A-1" or higher by
S&P's.
than ninety (90) days, any equity security other than preferred stock
rated "A" or higher by Moody's or "A" or higher by S&P's.
instruments issued by any Entity (other than debt securities issued by
the Debtor pursuant to the Plan and debt securities or other
instruments issued or fully guaranteed as to principal and interest by
the United States of America or any agency or instrumentality thereof)
if, following such acquisition, (x) the aggregate market value of all
securities and instruments issued by such Entity held by the Trust
would exceed five (5) percent of the aggregate market value of the
funds held by the Trust, or (y) the securities or other instruments so
acquired would represent more than five (5) percent of all outstanding
securities or instruments of the same class and series; or
issued by any Entity (other than debt securities issued by the Debtor
pursuant to the Plan and debt securities or other instruments issued
or fully guaranteed as to principal and interest by the United States
of America or any agency or instrumentality thereof) to the extent
that the aggregate market value of all securities and instruments
issued by such Entity held by the Trust would exceed five (5) percent
of the aggregate market value of the funds held by the Settlement
Facility.
time deposits and banker's acceptances only (i) if issued by a bank
whose senior long-term debt is rated "A" or higher by Moody's or "A"
or higher by S&P's, (ii) if issued by a bank whose name appears on a
list, maintained by the Trust and reviewed quarterly by the Finance
Committee or an investment manager designated by the Finance
Committee, of banks approved by the Finance Committee or such
investment manager, and (iii) if the term to maturity from the date of
acquisition does not exceed three (3) years and one day. The
limitations of (b) and (c) above shall not apply to such certificates
of deposit, time deposits and banker's acceptances.
not exceed twenty-five (25) percent of the portfolio at cost.
due regard shall be given to safety of principal and to production of
reasonable amounts of current income. The Finance Committee shall not
be under any obligation to invest Trust assets for capital
appreciation, in view of the purposes for which the Trust was created,
but is not prohibited from so doing.
8.05 Accounting Statements and Audit.
commencement of each Fiscal Year, the Finance Committee shall cause to
be prepared budget and cash flow projections covering such Fiscal Year
and such succeeding Fiscal Years for which the Finance Committee
determines such projections are practicable and appropriate.
at the end of each Fiscal Year an annual accounting containing
financial statements of the Trust and the Settlement Facility as of
the end of such Fiscal Year, including, without limitation, a balance
sheet, a statement of receipts and disbursements (which, as to the
Claims, shall be presented in the aggregate and not by individual
Claims and shall also describe all amounts paid to or by the Trust), a
statement of profit and loss prepared on an accrual basis, and a
supplementary schedule of investments and assets listing both
principal and income, audited by a recognized national or regional
firm of independent public accountants selected by the Financial
Advisor and the Finance Committee, subject to approval of the District
Court, and reported on by such firm as to fairness of presentation in
accordance with generally-accepted accounting principles consistently
applied. Such statements shall be submitted to the District Court and
the MDL 926 Court and shall be provided to the Claimants' Advisory
Committee, the Debtor's Representatives, and the Shareholders.
at the end of each of the first three quarters of each Fiscal Year a
quarterly accounting containing unaudited financial statements of the
Trust and the Settlement Facility as of the end of such quarter,
including, without limitation, a balance sheet, a statement of
receipts and disbursements (which, as to the Claims, shall be
presented in the aggregate and not by individual Claims and shall also
describe all amounts paid to or by the Trust, a statement of profit
and loss prepared on an accrual basis, and a supplementary schedule of
investments and assets listing both principal and income reported on,
subject to normal year-end adjustments — as to fairness of
presentation in accordance with generally-accepted accounting
principles consistently applied — by the Trust or by an accountant or
financial officer or agent regularly employed by the Settlement
Facility.
as soon as practicable prior to the commencement of each fiscal year,
a budget and cash-flow projections covering such fiscal year and the
succeeding two (2) fiscal years.
quarterly accounting required by this Settlement Facility Agreement to
the District Court, the MDL 926 Court, the Claimants' Advisory
Committee, the Debtor, and the Shareholders. The annual accounting
shall be filed as soon as available but in no event later than ninety
(90) days following the end of each Fiscal Year. The quarterly
accounting shall be filed as soon as available but in no event later
than forty-five (45) days following the end of the quarter of the
Fiscal Year to which such accounting relates.
8.06 Tax Matters. The Finance Committee shall direct the Trustee to
timely file such income tax and other returns and statements as are
required to comply with applicable provisions of the Internal Revenue
Code and the Treasury Regulations promulgated thereunder, and of any
state law and the regulations promulgated thereunder. The Trust shall
be responsible for paying taxes and any other obligations or
liabilities of any and all kinds whatsoever that at any time are
lawfully levied, assessed upon or become payable in respect of the
Trust or its funds. The Trust shall make any election and provide any
information as may be necessary to qualify as a Qualified Settlement
Fund. The Trust shall not take any action, or omit to take any
action, that could adversely affect the Trust's qualification as a
Qualified Settlement Fund.
9.01 Settlement Discussions; Inadmissibility. Establishment of this
Settlement Program, discussions leading to the Settlement Program and
payments under the Program do not constitute any admission of fault,
liability or damages, and such discussions, this Agreement, the Claims
Resolution Procedures, and all offers and other communications from
the Claims Office to Claimants concerning settlement offers, and
information concerning settlement payments in individual cases or in
the aggregate shall not be admissible or discoverable for any purpose
in any judicial, mediation or arbitration proceeding. Discussions
and/or offers made in connection with the resolution of a Claim
hereunder shall be confidential and shall not be disclosed to other
Claimants or their counsel or to any other Entity.
9.02 Costs. The Settlement Facility and Claimants shall each bear
their own costs, expenses, and attorneys' fees in connection with the
Claims Resolution Procedures.
10.01 Irrevocability. The Settlement Facility is irrevocable. None
of the Released Parties, present or future, or their successors in
interest may hold any beneficial interest in, or have any reversion
to, the income or corpus of the Settlement Facility.
10.02 Recordation. This Agreement shall be recorded in such places
as the Finance Committee, Claimants' Advisory Committee, or Debtor's
Representatives shall deem necessary or advisable.
10.03 Termination/Closure.
Trust shall terminate as soon as practicable after the Reorganized Dow
Corning's obligation to fund under the Funding Payment Agreement is
terminated in accordance with Section 2.01(d) of the Funding Payment
Agreement. The Claims Administrator will use his or her best efforts
to substantially complete and terminate the Settlement Facility and
Trust within sixty (60) days after such termination of the Funding
Payment Agreement. The Claims Administrator shall seek an order from
the District Court confirming that it is appropriate to terminate the
Settlement Facility.
termination of the Settlement Facility under this Agreement, the
Claims Administrator shall remain authorized to wind up the affairs of
the Settlement Facility and the Trust, and thereafter, the Claimants'
Advisory Committee shall be authorized to dispose of the balance, if
any, of any non-reversionary funds of the Settlement Facility after
payment of or adequate provision for any remaining Settlement Facility
or Trust expenses. Any non-reversionary funds shall be distributed,
if cost effective, pro rata to the holders of Allowed Claims
previously paid to Claimants eligible under this Agreement by the
Settlement Facility, or, if such distribution would not be cost
effective, to a neutral medical research institute or university,
selected by the Finance Committee after consulting with the Claimants'
Advisory Committee.
10.04 Severability. Should any provision of this Agreement and Annex
A to the Agreement (except those described in the next sentence) be
held unenforceable, such determination shall in no way limit or affect
the enforceability and operative effect of any and all other
provisions of this Agreement, and the unenforceable provision shall be
reformed, modified or replaced by such provision or provisions as the
Court or the District Court, as appropriate, may approve upon joint
motion by the Debtor and the Claimants' Advisory Committee.
Notwithstanding the foregoing, the following provisions of this
Agreement are not severable: (i) provisions concerning and
establishing the amount payable for any Settling Personal Injury Claim
or the amount or value of any payment, award or other form of
consideration payable to or for the benefit of a Claimant, including,
without limitation, any cash payment or other benefits provided to a
Claimant, (ii) provisions concerning the release of the Released
Parties, or any of them, (iii) provisions concerning the amount or due
date of any payment to be made by the Reorganized Dow Corning to the
Settlement Facility pursuant to the Plan or the Funding Payment
Agreement, (iv) provisions concerning the right of the Trust on behalf
of the Settlement Facility to receive payments pursuant to the
Insurance Allocation Agreement, and (v) any provision that, if
modified or deleted, would cause the Settlement Facility to no longer
qualify as a Qualified Settlement Fund.
10.05 Headings; References. The headings of the Table of Contents,
Articles and Sections herein are inserted for convenience of reference
only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement. Any reference herein to an Article
or Section shall be deemed to refer to the applicable Article or
Section of this Agreement unless otherwise expressly stated herein.
Any reference to an Exhibit, Annex, or Schedule shall be deemed to
refer to the applicable Exhibit, Annex, or Schedule attached hereto,
all such Exhibits, Annexes, and Schedules being incorporated herein
and made a part hereof by this reference.
10.06 Amendments. This Agreement may be amended to resolve
ambiguities or to correct manifest errors contained herein by an
instrument signed by the Reorganized Dow Corning and the Claimants
Advisory Committee. All other amendments, supplements, and
modifications shall require approval of the Court after notice to the
Reorganized Dow Corning, the Shareholders, and the Claimants' Advisory
Committee and such other notice and hearing as the Court may direct,
provided that without the prior written consent of the Reorganized Dow
Corning and the Claimants' Advisory Committee the Agreement shall not
be amended, supplemented or modified if such amendment, supplement, or
modification would, directly or indirectly: (i) increase the
liquidation value or settlement value of any Claim, or the amount or
value of any payment, award or other form of consideration payable to
or for the benefit of a Claimant, including, without limitation, any
cash payment or other benefits provided to a Claimant, (ii) affect the
validity, requirement for or effectiveness of any release of the
Released Parties, or any of them, (iii) increase the amount or change
the due date of any payment to be made by the Debtor to the Settlement
Facility pursuant to the Plan or the Funding Payment Agreement, (iv)
affect the right of the Settlement Facility to receive payments
pursuant to the Insurance Allocation Agreement, or (v) cause the
Settlement Facility to no longer qualify as a Qualified Settlement
Fund.
10.07 Governing Law. This Settlement Facility Agreement shall be
governed by and construed in accordance with the law of the state of
New York without regard to conflicts of law principles.
10.08 Jurisdiction. Except as specifically provided herein, all
matters relating to the validity, interpretation and operation of this
Settlement Facility shall be under the exclusive jurisdiction of the
District Court.
10.09 No Execution. All funds in the Settlement Facility are deemed
in custodia legis until such times as the funds have actually been
paid to and received by a Claimant, and no Claimant or any other party
can execute upon, garnish or attach the Settlement Facility in any
manner or compel payment from the Settlement Facility of any Claim.
Payment of Claims will be governed solely by the Plan, this Settlement
Facility Agreement, the Claims Resolution Procedures, and the Funding
Payment Agreement.
10.10 Confidentiality. Copies of all documents, notices, statements,
reports, projections, motions, or similar documents provided to any
Party or to the Claimants' Advisory Committee or the Debtor's
Representatives under this Agreement shall be provided on a
confidential basis and shall be kept confidential by all other such
Parties, Claimants' Advisory Committee or Debtor's Representatives
unless such information is otherwise publicly available. Such
confidential information provided under this Agreement can be used in
any proceeding in the Court, the MDL 926 Court, the District Court or
any applicable appellate court provided the Party using such
information takes reasonable steps to protect the confidential nature
of the information. Notwithstanding this Section 10.10, the Debtor's
Representatives shall be permitted to distribute any such materials to
the Debtor and the Shareholders.
10.11 Notices. All notices, reports, or documents required by or
authorized under this Settlement Facility Agreement to be provided to
the Parties or others shall be in writing and shall be sent to the
following persons or entities at the following addresses until any
such person or entity gives written notice of a change of address:
Counsel
Counsel
Counsel
. IN WITNESS WHEREOF, the Debtor has caused this
Agreement to be executed by a duly authorized officer or
representative of the Debtor and attested by another duly authorized
officer of the Debtor and the Claimants' Advisory Committee, and the
Trustee have executed this Agreement, all as of ___________, 1999.
.
TABLE OF CONTENTS
ARTICLE I
DEFINITIONS 1
ELIGIBLE CLAIMANTS 1
of Claims 2
Forms 2
DEVELOPMENT AND DISTRIBUTION OF CLAIM FORMS 2
and Other Forms 2
Deadline/Acknowledgment/Revocation of Election 4
GENERAL PROCEDURE FOR APPLYING FOR BENEFITS 5
Claimants with Prior Filings 5
Submissions 6
THRESHOLD ELIGIBILITY CRITERIA FOR ALL SETTLING CLAIMANTS/INCLUSION OF
FAMILY MEMBERS 6
Silicone Material Claimants 6
SETTLEMENT OPTIONS 7
Implant Claimants 7
Payment Option 7
Options: Proof of Manufacturer 8
Eligibility Criteria and Terms 8
10
Option/Designation of Application of Covered Condition 11
Payment Option Claims 11
Payment Options 13
13
Disease Payment Option I 13
Disease Payment Option I Claims 14
Payment Option I Claims 14
Disease Payment Option II 15
Payment Option II Claims 15
Option II Claims 15
Where Explantation is Medically
Consideration 17
Condition 18
Cardiac Condition 18
Condition 18
Condition. 18
Certain Rupture Claims 19
Administrator/Process. 19
in Individual Review
19
Cure Deficiencies 20
21
Payment Option Program 21
21
Products Claimants 23
Response Associated With Active, Localized Bone Resorption 23
Compensation 23
Compensation 24
24
Compensation for Implant Failure 24
Response Associated With Active, Localized Bone Resorption Payment 26
26
Compensation for Inflammatory
Compensation 28
for Enhanced TMJ Implant Payment Option 29
Submission of Required Documentation for Medical Condition Claims 31
Administrator/Verification
Condition Payment 31
Products Claims/Premium Payments/ Administrative Costs/Additional
Distributions 32
as a Silicone
Fund/Settlement Options 34
Options/Determination
PROCESSING PROTOCOLS 37
Protocols 37
Options 38
Claims 39
Submissions 39
of Manufacturer Submission 40
Rupture Payment Options 41
Rupture Proof 41
Option Claims. 41
Products/Medical Condition 47
Claims 47
Period
Implant Claims 48
Explantation Claims 48
Claims 48
Disease Claims 48
Disease Payment Option Claims 48
Claims 49
PROCEDURE FOR ERROR CORRECTION AND APPEALS 49
ATTORNEYS' FEES 50
ACCEPTABLE PROOF OF MANUFACTURER 52
Breast Implants 52
Record/Requirements for Certified
Records 55
Hip, Knee 71
Records/Requirements for Certified Records 74
Explantation 74
Manufacturers 76
MEDICAL CONDITIONS AND CHARACTERISTICS
OUTLINE OF DEFINITIONS AND CLASSIFICATION CRITERIA 84
DISEASE PAYMENT OPTION 1 84
DISEASE PAYMENT OPTION II 101
SETTLEMENT PROGRAM AND
Procedures" ("Claims Resolution Procedures") outlines the guidelines
for processing, submitting, reviewing, evaluating and resolving
Settling Personal Injury Claims as required by the Plan and the
Settlement Facility Agreement. The Claims Administrator will
administer these Claims Resolution Procedures consistent with the
terms of the Settlement Facility and Fund Distribution Agreement
("Settlement Facility Agreement").
1.01 Incorporation of Definitions. The capitalized terms used herein
and not otherwise defined herein shall have the meanings defined in
the Plan, the Settlement Facility Agreement, the Funding Payment
Agreement, the Litigation Facility Agreement or the Bankruptcy Code —
in that order. All definitions in the Plan, the Settlement Facility
Agreement, the Litigation Facility Agreement and the Code are
incorporated herein by reference.
1.02 Additional Definitions. When used in this Annex A or in the
Settlement Facility Agreement, if capitalized, the following terms
shall be defined as set forth below.
1.03 Base Payment -- shall mean that portion of a Disease or Rupture
Payment for Breast Implant Claimants or Medical Condition Payment for
Other Products Claimants that is designated as a Base Payment on the
Settlement Grid. A Base Payment shall be a First Priority Payment.
1.04 Covered Condition -- shall mean any symptom grouping, medical
condition or disease defined as compensable under Disease Payment
Option I or Disease Payment Option II in Schedule II to these Claims
Resolution Procedures.
1.05 Premium Payment -- shall mean that portion of a Disease or
Rupture Payment for Breast Implant Claimants or Medical Condition
Payment for Other Products Claimants designated as a Premium Payment
on the Settlement Grid. A Premium Payment shall be a Second Priority
Payment.
2.01 Scope of Claims Covered. The Claims of all Settling Personal
Injury Claimants shall be resolved under the terms of these Claims
Resolution Procedures.
2.02 Determination of Eligible Claims Based on Proof of Claims.
a Proof of Claim in the Case will be deemed to have their Claims
registered with the Claims Office. All such forms, documentation, and
the Bankruptcy Court (Daticon) database containing information about
these Claims will be delivered to the Claims Office as soon as
practicable following the Effective Date, if not previously delivered.
The Proof of Claim Form and information contained in the Claimant's
submission in the Case shall be deemed as and shall become Claims
Office files.
not timely file a Proof of Claim in the Case but on whose behalf a
Proof of Claim has been timely filed pursuant to Bankruptcy Rule 3005
("Rule 3005 Claim or Claimant") may file a notice of intent with the
Court as provided in Bankruptcy Rule 3005 to act on her or his own
behalf with respect to such Claim ("Notice of Intent").
Notwithstanding Bankruptcy Rule 3005, a Rule 3005 Claimant will be
entitled to file the Notice of Intent on or before the date that is 90
days after the Effective Date. Such Claimant will thereby have all
rights as specified in the 3005 filing and be subject to all deadlines
applicable to Claimants who are deemed registered under (a) above.
The Claims of Rule 3005 Claimants who do not timely file a Notice of
Intent shall be disallowed.
3005 Claimant timely files a Notice of Intent under paragraph
2.02(b)(i) above and returns a signed Participation Form to the Claims
Office on or before the six-month anniversary of the Effective Date,
as specified in Section 3.02(c) below, such Claimant will have the
right to elect settlement or litigation. Rule 3005 Claimants who do
not timely elect litigation or who do not return a signed
Participation Form to the Claims Office on or before the six-month
anniversary of the Effective Date shall be deemed Settling Personal
Injury Claimants for all purposes of this Annex A to the Settlement
Facility Agreement and the Plan as set forth in Section 3.02 below.
3.01 Development and Mailing of Participation Form and Other Forms.
Administrator in cooperation with the Claimants' Advisory Committee
and the Debtor's Representatives shall develop appropriate
informational materials advising Claimants of settlement options and
procedures for submission of claim forms.
(30) days following the Effective Date, the Claims Office shall mail
to each Personal Injury Claimant (including those Rule 3005 Claimants
who have timely filed a Notice of Intent under Section 2.02(b)(i)
above) a package of materials. The package shall contain:
Claimants shall elect to settle or to opt out of this Dow Corning
Settlement Program ("Dow Corning Settlement Program" or " Settlement
Program") and litigate.
election.
Claims.
completing it. The Proof of Manufacturer Form shall allow Claimants
to check the appropriate boxes to inform the Claims Office of Claims
previously submitted to the MDL 926 Claims Office and/or documentation
for Proof of Manufacturer, Explantation, Rupture or Disease Payment
Option benefits.
Claimants.
Claimants.
Claimants.
Disease/Expedited Release Payment Option for Breast Implant Claimants
will be provided to Claimants who establish that they have acceptable
proof of manufacturer (or a minor deficiency) in their Proof of
Manufacturer submission. See Section 7.02 below.
Administrator shall mail to Claimants only those forms applicable to
the Claimant's covered Dow Corning product or Claim.
accept as timely Claims submissions and Participation Forms that are
submitted in error (but which are otherwise timely, as defined herein)
to the District Court, the MDL Court, or the Revised Settlement
Program.
3.02 Litigation Right and Procedure.
elect to pursue or institute litigation against the Litigation
Facility instead of participating in the Settlement Program. To
obtain resolution under the terms of the Litigation Facility Agreement
the Claimant must affirmatively elect to litigate.
shall inform Claimants of the consequences of an election to settle or
litigate and of the procedures applicable for resolving Claims through
the Settlement Program and the Litigation Facility. The Parties will
provide a form of Participation Form.
for whom a Proof of Claim Form has been timely filed) must make their
election by completing, signing and returning the Participation Form
to the Claims Office on or before the six (6)-month anniversary of the
Effective Date ("Election Deadline"). In the event that an appeal is
filed from the Confirmation Order that raises a Release/Funding Issue,
the Election Deadline shall be one hundred eighty (180) calendar days
after the date the Participation Form is mailed to the Personal Injury
Claimants. To be timely a Participation Form must be: (1) received on
the applicable Election Deadline, (2) postmarked by registered mail on
the applicable Election Deadline, or (3) sent by a delivery service
where the documentation provided by the delivery service contains a
date showing that the material was sent on or before the Election
Deadline. If the Election Deadline or any deadline in the Claims
Resolution Procedures falls on a Saturday, Sunday or federal holiday,
the next business day shall be the applicable Deadline.
Participation Forms only when the Claimant has elected litigation.
Settling Personal Injury Claimants will not receive an acknowledgment
of their election. The Claims Office will notify those Claimants who
elected litigation of their right to revoke that election and allow
such Claimants thirty (30) calendar days from the date of the
acknowledgment to revoke that election to litigate. To revoke the
election to litigate, the Claimant (or the Claimant's counsel) must
submit a written statement confirming the Claimant's decision to
revoke the election. The revocation must be postmarked no later than
30 calendar days after the date of the acknowledgment letter.
on the Participation Form or who do not timely submit a completed
Participation Form to the Claims Office on or before the Election
Deadline shall be deemed "Settling Personal Injury Claimants" for all
purposes of the Settlement Facility Agreement and the Plan.
Deadline, the Claims Administrator shall identify the Non-Settling
Personal Injury Claimants and provide this information to the
Litigation Facility Manager, the Claimant's Advisory Committee, the
Debtor's Representatives, and the Finance Committee.
Participation Form. If the Claimant is represented by counsel, then
the Claimant's counsel must also sign the form confirming that the
Claimant has consulted with that counsel. The failure of the
Claimant's counsel to sign the form will not invalidate the litigation
election.
Participation Form is rejected because it was not submitted by the
Election Deadline may appeal to the District Court.
timely elect litigation will have their Claims administered by the
Claims Office in accordance with the Settlement Facility Agreement and
these Claims Resolution Procedures.
appeal is filed from the Confirmation Order that raises a
Release/Funding Issue but does not result in a stay, the Claims Office
shall commence distribution of Participation Forms and other materials
as set forth at Section 3.01(b) to Personal Injury Claimants and
processing of the submitted Participation Forms and operations
necessary and appropriate to begin processing Claims promptly after
the Effective Date.
3.03 Claim Forms. The Claims Office shall provide to Settling Breast
Implant Claimants who have previously submitted or who submit
acceptable Proof (or proof with only a minor deficiency) of
Manufacturer in accordance with these Claims Resolution Procedures the
Disease Payment Option Form/Expedited Release Payment Option Form.
4.01 General. To apply for compensation, Settling Personal Injury
Claimants must submit appropriate forms and documentation required to
support a Claim as defined at Section 6.02 for Breast Implant
Claimants, Section 6.03 for Other Products Claimants and Section 6.04
for Silicone Material Claimants subject to the terms of subparagraph
4.02 below.
4.02 Submissions for Settling Breast Implant Claimants with Prior
Filings.
Claimants who submitted a Disease Compensation Form, along with the
required medical documentation, to the MDL 926 Claims Office in
connection with the Original Global Settlement or the Revised
Settlement Program are not required to submit these same or new forms
and supporting documents to apply for compensation under the Disease
Payment Option. Breast Implant Claimants may submit new or
supplemental medical documentation in addition to any disease claim
previously filed in the Original Global Settlement or Revised
Settlement Program.
Implant Claimants who submitted a Proof of Manufacturer Form and
acceptable proof or proof with a minor deficiency (as defined herein
in Schedule I, Part I) of one or more Breast Implants to the MDL 926
Claims Office are not required to submit the Proof of Manufacturer
Form and/or documentation to have their Claim processed. The Claims
Office shall, to the extent possible, identify these Breast Implant
Claimants, send them a Notification of Status letter regarding their
Proof of Manufacturer Form and provide Claim Forms applicable to
Breast Implant Claims.
(or that of her counsel) and expense the Claims Office shall provide
the Claimant or his/her counsel a copy of all material previously
submitted by or for the Claimant to the MDL 926 Claims Office or to
Daticon as part of the Proof of Claim in the Case.
Implant Claimants who previously submitted Proof of Manufacturer or a
Disease Claim shall advise the Claims Office in accordance with
Section 7.02(c) of these Claims Resolutions Procedures.
5.01 Eligible Breast Implant, Other-Product and Silicone Material
Claimants. To be eligible to participate in the Dow Corning
Settlement Program the Claimant must satisfy the following criteria in
addition to the specific criteria applicable for each settlement
option:
released the Claim against Dow Corning or its Shareholders (or had
such Claim resolved by final judgment, dismissal or order); and
that (1) a Claim disallowed as untimely by the Court will not be
barred if such Claim can be categorized as a Rule 3005 Claim pursuant
to Section 2.02(b) above and the Claimant fulfills all provisions set
forth therein, and (2) any adverse determination(s) in the Litigation
Protocol, as provided at Section 5.4.1 of the Plan, shall not apply to
or affect any rights of Settling Personal Injury Claims; and
Case or a timely Proof of Claim has been filed on his or her behalf
pursuant to Rule 3005; and
recover with respect to the Claim such that the Claim can be asserted
by another person; and
set forth in Schedule I, Part I and/or II or III, as applicable, of
these Claims Resolution Procedures.
5.02 Family Members. Participation by a Claimant also constitutes
participation by that person's estate and family members, as specified
at Section 5.4.1.4 of the Plan.
6.01 General. This section describes the criteria for Settling
Personal Injury Claimants to obtain compensation. A Claimant who is
eligible for both the Settlement Program for Breast Implant Claimants
and the Settlement Program for Other Products Claimants is eligible to
apply for compensation from both programs for each of his/her covered
products. Claimants who are eligible for or receive compensation as a
Breast Implant Claimant or an Other-Product Claimant are not eligible
to apply for compensation under the Settlement Program for Silicone
Material Claimants.
6.02 Settlement Program For Eligible Domestic Breast Implant
Claimants.
Claimants who satisfy the eligibility criteria of Section 5.01
("Eligible Breast Implant Claimants") may participate in and receive
compensation from any and all of the following options:
payment of $5,000 will be paid to all Eligible Breast Implant
Claimants whose Breast Implant(s) has/have been or is/are explanted
after December 31, 1990 and on or before the tenth anniversary of the
Effective Date.
Option.
Implant Claimants may elect compensation for Disease Payment Option
benefits based either on the disease definitions listed in the
Original Global Settlement (Disease Payment Option I) or on the
criteria set forth in the Long Term Benefit Schedule of the Revised
Settlement Program (Disease Payment Option II) any time on or before
the fifteenth anniversary of the Effective Date.
Implant Claimants may instead release all present and future Claims to
receive Disease Payment Option benefits (but not Rupture or
Explantation Payment Option benefits) and receive an Expedited Release
Payment of $2,000 upon providing acceptable proof of implantation of a
Dow Corning Breast Implant.
Breast Implant Claimant whose Breast Implant(s) has/have been or
is/are explanted on or before the second anniversary of the Effective
Date and who submit acceptable proof that her Dow Corning silicone gel
Breast Implant is ruptured will be compensated a Base Payment of
$20,000 and an additional Premium Payment of $5,000, subject to the
terms of the Settlement Facility Agreement.
Manufacturer.
4.02(b), Eligible Breast Implant Claimants who want to participate in
the Dow Corning Settlement Program must submit to the Claims Office a
Proof of Manufacturer Form and supporting documentation, as defined in
Schedule I, Part I.
must submit acceptable proof of a Dow Corning Breast Implant to
receive benefits. The standards of acceptable proof of a Dow Corning
Breast Implant are set forth at Schedule I, Part I to these Claims
Resolution Procedures.
Implant Claimants who participated in the Revised Settlement Program
and received a fifty (50)-percent reduction in compensation because
they asserted they had or have a Dow Corning Breast Implant must
satisfy the Proof of Manufacturer requirements for a Dow Corning
Breast Implant set forth at Schedule I, Part I of this Annex A to be
eligible under this Dow Corning Settlement Program. Such Claimants
who have a deficiency in their Proof of Manufacturer submission will
be directed to the Claims Assistance Program (defined at Section
7.01(e)). The Claims Assistance Program may submit the Proof of
Manufacturer documentation to the Reorganized Dow Corning for review
and/or to the appropriate manufacturer in the Revised Settlement
Program for consideration of payment.
Criteria and Terms. A one-time payment of $5,000 will be paid to
Eligible Breast Implant Claimants on proof of removal of a Dow Corning
Breast Implant after December 31, 1990 and on or before the tenth
anniversary of the Effective Date. A Claimant may receive payment
under the Explantation Payment Option in addition to payments under
the other compensation options available in the Dow Corning Settlement
Program.
under the Explantation Payment Option will not vary based on the
amount of actual expense involved.
Corning Breast Implant(s) was/were explanted during 1991 shall not be
entitled to an Explantation Payment if they received a replacement
silicone gel breast implant during that explantation procedure.
Claimants whose Dow Corning Breast Implant(s) were removed after
January 1, 1992 shall not be entitled to an Explantation Payment if
they received a replacement silicone gel breast implant either during
that explantation surgical procedure or in any subsequent procedure.
implants removed and replaced with saline implants are eligible to
claim Explantation Payment Option benefits.
have their Dow Corning Breast Implant removed but do not have the
funds to pay for the surgery may request the Claims Office to make
arrangements to compensate the appropriate persons or entities (up to
a maximum of $5,000) directly. The Claims Office shall be authorized
to develop appropriate guidelines for direct payment to the
appropriate person or entity who provided the explantation service
upon receipt from the Claimant and surgeon of all required
documentation, including a signed release. The Claims Office shall
obtain from the Claimant a signed release releasing the Claims Office,
the Debtor, Reorganized Dow Corning, the Claimants Advisory Committee,
and the Released Parties from any claims or actions arising out of the
explant procedure. (Such release will not affect the Claimant's
ability to recover benefits under this Settlement Program.) If the
cost of explantation is less than the $5,000 Explantation Payment
Option benefit, the Claims Office shall pay the difference between the
actual cost and $5,000 to the Breast Implant Claimant. Prior to
disbursing payment for the surgery to the appropriate persons or
entities, the Claims Office shall obtain from the explanting surgeon
and, if applicable, the pathologist, an agreement to complete any
information necessary for the Explantation Payment Option Form and, if
applicable, the Rupture Payment Option Form on behalf of the Breast
Implant Claimant and cooperate with her and the Claims Office to
provide information relevant to these benefits. Claimants will not be
denied an Explantation Payment if they participated in this direct
payment procedure but were not explanted by the deadline for the
Explantation Payment Option solely because the surgeon failed timely
to return documents and/or releases.
discretion, provide a list of surgeons who have advised the
Reorganized Dow Corning of a willingness to perform explantation
surgeries for up to $5,000. If such surgeon agrees, the Claims Office
shall be authorized to release the names of such surgeons to
Claimants. Should any Claimant elect to use any such surgeon and/or
to arrange for payment of such surgeon through the Claims Office as
provided at subparagraph (iv) above, then the Claimant must execute a
release releasing the Claims Office, the Debtor, Reorganized Dow
Corning, the Claimants Advisory Committee, and the Released Parties
from any liability or claim arising out of such surgery (except that
such release will not affect the Claimant's ability to recover
benefits under this Settlement Program). Prior to releasing payment
for the surgery to the appropriate persons or entities, the Claims
Office shall obtain from the explanting surgeon and, if applicable,
the pathologist an agreement to complete any information necessary for
the Explantation Payment Option Form and, if applicable, the Rupture
Payment Option Form on behalf of the Breast Implant Claimant and
cooperate with her and the Claims Office to provide information
relevant to these benefits.
Payment Option the Claimant must submit proof of explantation. Proof
of explantation must contain or indicate the date of the explantation
surgery and may be made by any of the following means:
surgeon;
statement of benefits;
records (including the hospital pathology report);
contemporaneous office notes; or
document, together with confirmation from a medical provider or
insurance company that surgery actually took place as scheduled.
about the Breast Implant Claimant's reason for choosing to have her
Breast Implant(s) removed and will not deny benefits to Breast Implant
Claimants based on the reason for explantation.
may receive only one payment under the Explantation Payment Option,
regardless of the number of qualifying surgeries.
Claimants will receive benefits under the Disease Payment Option upon
proof, on or before the fifteenth anniversary of the Effective Date,
of having developed a Covered Condition defined in Disease Payment
Option I, Schedule II, Part A (the Disease Schedule of the Original
Global Settlement which is called the Fixed Amount Benefit Schedule of
the Revised Settlement Program), or a Covered Condition defined in
Disease Payment Option II, Schedule II, Part B (the Long-Term Benefit
Disease Schedule of the Revised Settlement Program).
Payment Option I consists of the compensable diseases and conditions
defined in the Original Global Settlement and the Fixed Amount Benefit
Schedule of the Revised Settlement Program. Disease Payment Option II
consists of the compensable diseases and conditions defined in the
Long-Term Benefit Schedule of the Revised Settlement Program.
Disease Payment Option II are much stricter than those under Disease
Payment Option I. No claims based solely on atypical or "like"
presentations of disease are compensable for Systemic Lupus, Systemic
Sclerosis, or Polymyositis/Dermatomyositis under Disease Payment
Option II. A Breast Implant Claimant must clearly suffer from those
diseases exactly as defined in Schedule II, Part B. Breast Implant
Claimants who meet the criteria under Disease Payment Option II and
who also have additional signs, symptoms or conditions which are not
required for that disease category will still be eligible for
compensation under Disease Payment Option II. Only four of the
Covered Conditions in Disease Payment Option I — Lupus, Scleroderma,
Polymyositis, and Dermatomyositis — are included in Disease Payment
Option II. One additional Covered Condition — General Connective
Tissue Symptoms (GCTS) — is contained in Disease Payment Option II.
Although many of these GCTS symptoms are somewhat similar to symptoms
and findings contained in the ANDS and ACTD categories of Disease
Payment Option I, the symptoms listed in the GCTS category have
stringent qualifications and requirements.
Option/Designation of Application of Covered Condition. The Disease
Payment Option Claim Form distributed to Claimants will instruct
Claimants to identify the particular Covered Condition for which they
seek benefits.
Option Claims.
Systemic Sclerosis, Systemic Lupus, Polymyositis or Dermatomyositis
shall be reviewed, categorized and paid based on the following
protocol:
Office shall evaluate the Claim under both Disease Payment Option I
and Disease Payment Option II.
Office will send each such Breast Implant Claimant and her counsel a
Notification of Status letter (as described at Section 7.05). The
Notification of Status letter shall advise the Claimant of the
following:
Covered Condition(s) approved.
Disease Payment Option in which each approved Covered Condition falls.
compensation level approved.
deficiencies in any Covered Condition the Claimant identified on the
Claim Form based on both Disease Payment Options regardless of
whether the Claim is approved for any Covered Condition.
Office determines that such Claim has any deficiency under Disease
Payment Option II, then the Claimant shall have one year from the date
of the Notification of Status letter to cure that Disease Payment
Option II deficiency. If the deficiency is not cured within the one
year period, then the Claim will automatically be designated a Disease
Payment Option I Claim, and the Allowed amount of compensation
provided under Disease Payment Option I for that Claim will be reduced
by 25 percent from the amount specified on the Disease Payment Option
I Compensation Schedule and otherwise allowable.
during the one year period for cure of the deficiency the Claimant may
elect to proceed under Disease Payment Option I instead of Disease
Payment Option II. If such election is made prior to the expiration
of the one year period then payments issued under Disease Payment
Option I will not be reduced.
is not approved under either Disease Payment Option, then the Claimant
shall have an opportunity to cure the deficiency as specified at
Section 7.08.
Option Claims shall be reviewed, categorized and paid based on the
following protocol:
Disease Payment Option Claims shall initially be evaluated under
Disease Payment Option I.
Office will send such Breast Implant Claimant and her counsel a
Notification of Status letter (as described at Section 7.05). The
Notification of Status letter shall advise the Claimant of the
following:
Covered Condition approved under Disease Payment Option I;
compensation level approved; and
deficiencies in any Covered Condition the Claimant identified on the
Claim Form but which is not approved.
whose Disease Payment Option I Claim has been approved or has a minor
deficiency shall have a period of sixty (60) days after the date of
the Notification of Status letter to accept the approved compensation
under Disease Payment Option I or to elect to proceed under Disease
Payment Option II. Claimants who have a major deficiency in their
Disease Payment Option I Claim may not elect Disease Payment Option
II.
Claimant has any deficiency in the Disease Payment Option I Claim and
elects to proceed under Disease Payment Option I, then the Claimant
shall have one year from the date of the Notification of Status letter
to cure any deficiencies in the Claim as provided in Section 7.08.
Claimant elects to proceed under Disease Payment Option II, the Claim
will be evaluated under Disease Payment Option II. The Claimant shall
have thirty (30) days following the date the election is required to
be made under Section 6.02(d)(iii)b.3. above to submit any additional
medical records in support of her Covered Condition under Disease
Payment Option II. The Claimant will receive a new Notification of
Status letter regarding her status in Disease Payment Option II. The
Claimant shall have one year from the date of the Notification of
Status letter to cure any deficiencies to obtain a payment under
Disease Payment Option II. If the deficiency is not cured within the
one-year period, the Claim shall automatically be designated a Disease
Payment Option I Claim and any Allowed amount of compensation for the
Claim under Disease Payment Option I shall be reduced by 25 percent
from the amount specified on the Disease Payment Option I Compensation
Schedule. If the original Notification of Status letter identified
any deficiencies in the Claim under Disease Payment Option I and the
Claimant has failed to cure such deficiencies within the one-year
period following the return to Disease Payment Option I, the Claimant
shall be eligible to receive the Expedited Release Payment in
accordance with Section 7.08(b)(ii).
Options. Eligible Breast Implant Claimants who elect compensation
under Disease Payment Option I or whose claims are automatically
designated Disease Payment Option I Claims may not, in the future,
receive benefits under Disease Payment Option II.
Eligible Breast Implant Claimants whose Disease Payment Option Claims
are approved shall have the Allowed amount of their Claim reduced by
fifty (50) percent if they also have acceptable proof of implantation
of a silicone gel breast implant manufactured by or attributed to
Bristol, Baxter or 3M (as such manufacturers are described and defined
in Exhibit G to the Revised Settlement Program, which Exhibit G is set
forth in relevant part at Schedule I, Part III, Section C). The fifty
(50)-percent reduction shall apply to all Breast Implant Claimants
regardless of whether they recovered benefits in the Revised
Settlement Program or whether they recovered any payments in
settlement or judgment, including but not limited to payments
recovered as an opt-out to the Revised Settlement Program.
Payment Option I. Compensation for approved Disease Payment Option I
benefits will be paid under the schedule below,. subject to the
provisions of the Funding Payment Agreement and the Settlement
Facility Agreement.
Original Global Settlement Criteria (Fixed Amount Benefit Schedule of
the Revised Settlement Program) Disability/Severity Level
for Covered Conditions Dow Corning Breast Implant and
no Bristol, Baxter or 3M silicone gel breast implant
A $50,000 + $10,000 = $60,000
B $20,000 + $4,000 = $24,000
C or D $10,000 + $2,000 = $12,000
Payment Option I Claims.
eligible to receive compensation for a Covered Condition that became
manifest prior to the implantation of a Breast Implant except as
provided in this subsection.
category in Disease Payment Option I, no symptom is considered for
purposes of establishing ACTD if it existed before the date of first
implantation with a Breast Implant.
Claimant who, before her first breast implantation, had a Covered
Condition listed on the Disease Payment Option I schedule is eligible
for benefits if that condition increased in severity after
implantation with a Breast Implant. The amount of the benefit will be
the difference between the amount Allowed for the new disease and
disability/severity level and the amount that would have been allowed
for the pre-existing condition.
the provision to adopt and follow the protocols employed by the MDL
926 Claims Office to determine Claims with pre-existing conditions.
Option I Claims. If before the fifteenth anniversary of the Effective
Date an approved Disease Payment Option I Claimant documents an
increase in the severity of her condition that meets the criteria for
Severity Level A under Disease Payment Option I, that Claimant shall
be entitled at that time to apply for an additional payment from the
Settlement Facility based on that Severity Level A Condition. The
maximum amount for which that Claimant may qualify is the difference
between the maximum Allowable payment amount for Level A (which amount
would be $60,000 if the full Premium Payment of twenty (20) percent of
the Base Payment were Allowed) and the amount previously Allowed for
the Claim. This additional payment shall be classified and paid as a
Second Priority Payment and will be paid from the Increased Severity
Fund, subject to the limitations of that Fund as set forth in Section
3.02(b)(i) of the Settlement Facility Agreement, and subject to the
requirements for the distribution of Premium Payments as specified in
the Settlement Facility Agreement.
Payment Option II. Compensation for approved Disease Payment Option
II Claimants will be paid according to the Disease Payment Option II
Schedule below, subject to the terms of the Funding Payment Agreement
and the Settlement Facility Agreement.
Bristol, Baxter or 3M silicone gel breast implant
Scleroderma (SS) or Lupus (SLE);
Compensation Level A $250,000 + $50,000 = $300,000
Scleroderma (SS) or Lupus (SLE);
Compensation Level B $200,000 + $40,000 = $240,000
Scleroderma (SS) or Lupus (SLE);
Compensation Level C $150,000 +$30,000 = $180,000
General Connective Tissue Symptoms (GCTS), Polymyositis (PM) or
Dermatomyositis (DM); Compensation Level A $110,000 +
$22,000 = $132,000
General Connective Tissue Symptoms (GCTS); Compensation Level B
$75,000 + $15,000 = $90,000
Payment Option II Claims. Benefits may not be obtained for a Covered
Condition if the qualifying symptoms existed before the date of the
first implantation with a Breast Implant.
Option II Claims. If, before the fifteenth anniversary of the
Effective Date, an approved Disease Payment Option II Claimant
documents a Covered Condition under Disease Payment Option II that
would entitle her to a larger payment than previously Allowed, the
Claimant is eligible to apply for an additional payment in an amount
equal to the difference between the new amount Allowable and any
amount previously Allowed under this Schedule. This additional
payment shall be classified and paid as a Second Priority Payment.
Payment Option a Breast Implant Claimant must meet the requirements
listed below:
of the elastomer envelope(s) surrounding a silicone-gel Breast Implant
to contain the gel (resulting in contact of the gel with the body),
not solely as a result of "gel bleed", but due to a tear or other
opening in the envelope after implantation and prior to the
explantation procedure.
Rupture Payment Option, Eligible Breast Implant Claimants must submit:
implantation with one or more Dow Corning silicone gel Breast Implants
in accordance with Schedule I, Part I and;
Dow Corning silicone gel Breast Implant has been removed; and
specified at subparagraph (v) below, showing that the removed Dow
Corning silicone gel Breast Implant was ruptured as defined above.
Claimants explanted prior to January 1, 1992 must submit a
contemporaneous operative or pathology report documenting the Rupture.
Claimants explanted after January 1, 1992 and before the Effective
Date must submit a contemporaneous operative report and, if available,
a pathology report together with a statement as to whether the
ruptured implants have been preserved and, if so, the name and address
of the custodian.
Claimants explanted after the Effective Date must submit a
contemporaneous operative report and, if available, a contemporaneous
pathology report. In addition, the Claimant must provide a statement
from the explanting surgeon (or other appropriate professional
approved by the Claims Office) affirming that, in his or her opinion,
the Rupture did not occur during or after the explantation procedure.
This statement must describe the results of the inspection and provide
a factual basis for the opinion (e.g., in light of silicone granuloma
formation on the exterior of the biologic capsule, or findings
concerning the nature of the destruction of the elastomer envelope).
The Claimant shall use her best efforts to cause the removed implant
to be preserved.
explanting surgeon refuses to write the supplemental report giving his
or her opinion of when the Rupture occurred, the Claimant may submit
the supplemental statement from another doctor who examined the
removed implant. Claimants must also submit the contemporaneous
operative report that documents the Rupture and, if available, a
contemporaneous hospital report.
Explantation is Medically
Consideration.
Claimants. Breast Implant Claimants who demonstrate acceptable Proof
of Manufacture based on the criteria set forth at Schedule I, Part I,
Section B (and not on unique identifiers as set forth at Schedule I,
Part I, Section D) of implantation with a Dow Corning silicone gel or
double lumen Breast Implant and that such Breast Implant has not been
removed, and who meet the requirements of subparagraphs 2 and 3 below,
shall be eligible to receive benefits under the Rupture Payment
Option, notwithstanding the fact that the Breast Implant has not been
removed.
To qualify under this subsection, Breast Implant Claimants with
acceptable Proof of Manufacturer as defined in subparagraph 1., above,
must submit documentation of Rupture as defined in the Settlement
Facility Agreement and these Claims Resolution Procedures. The proof
will be deemed acceptable if:
documented by MRI conducted by a qualified facility and read by a
qualified radiologist; and
appropriately high resolution MRI conducted using dedicated breast
coil and applying silicone selective sequences and water suppression
sequences as appropriate using fast spin echo technique or its
equivalent for these purposes; and
definite Rupture (tear or failure of the silicone envelope surrounding
the silicone gel portion of the Breast Implant) confirmed by a finding
of definite "linguini" sign, or a double linguini sign (i.e., linguini
of both envelopes of a double lumen type implant) or "C" signs (where
"double linguini" and "C" signs are as defined in "Magnetic Resonance
Evaluation of Breast Implants and Soft-tissue Silicone," Topics in
Magnetic Resonance Imaging, 9(2): 92-137 (1998)), accompanied by the
presence of silicone observable outside of the envelope surrounding
the silicone gel.
Condition. The Breast Implant Claimant must submit a written
statement and diagnosis by a physician along with supporting
documentation describing a serious chronic medical condition that
precludes the surgical removal of the Breast Implant. The medical
documentation must contain objective findings that will permit the
Claims Administrator to make a determination as to the severity of the
condition and the diagnosis. For a Claim to qualify for a Rupture
payment under this subsection, the Claims Administrator must make a
specific finding that the Breast Implant Claimant's medical condition
is such that the surgery required to remove the Breast Implant is
medically contraindicated (i.e., likely, in the exercise of reasonable
medical judgment, to result in significant complications or have a
significant adverse effect on the Claimant's medical condition). The
medical condition (as described above) must be present at the time of
the MRI discovery of the Rupture and during the period allowed under
the Settlement Program for submission of Rupture Claims. The
following medical conditions, if supported with objective medical
documentation, may support a finding that Breast Implant removal
surgery is medically contraindicated. The Claims Administrator shall
have discretion to accept other similarly serious medical conditions
provided they meet the criteria outlined above.
Severe Cardiac Condition. A Claimant who experienced a myocardial
infarction within six (6) months prior to the time removal surgery
would have to occur to make a timely Rupture claim.
Pulmonary Condition. A Claimant who has severe pulmonary impairment
such as pulmonary involvement with Systemic Sclerosis, Systemic Lupus,
Polymyositis or Dermatomyositis, where such impairment results in a
substantially abnormal diffusion capacity (e.g., diffusion capacity of
less than 30 percent of predicted value).
Condition. A Claimant with a history of Scleroderma renal crisis, or
who is on dialysis or who has severely reduced renal function with
creatine clearance of less than 20 cc/min. measured by an adequate
urine collection.
Claims Administrator may at his or her discretion require a reading of
the MRI by an independent radiologist and/or an independent review of
the medical records to confirm that the removal surgery is medically
contraindicated as defined herein.
shall process Rupture Claims with the understanding that physicians
have and will use different terminology to describe an implant that is
ruptured. Simply because the relevant record does not use the word
"rupture" is not a basis to deny the Rupture Claim.
Rupture Claims. Eligible Breast Implant Claimants whose documentation
of Rupture is classified as unacceptable but whose documentation meets
the criteria at subparagraph b.1. or b.2. below may participate in the
Individual Review Process outlined in this section. Breast Implant
Claimants whose documentation does not meet the criteria at
subparagraph b.1. or b.2. below are not eligible to participate in the
Individual Review Process but such Claimants may appeal their Rupture
Payment Option determination to the Claims Administrator pursuant to
Article VIII of these Claims Resolution Procedures.
Administrator/Process. Within sixty (60) days of receipt of his/her
Notification of Status letter regarding the Rupture Claim, a Breast
Implant Claimant who is eligible to participate in this Individual
Review Process must notify the Claims Administrator in writing of her
intention to participate in this Individual Review Process. The
Claims Administrator shall establish a process to obtain and forward
to Reorganized Dow Corning the Rupture documentation relied on by the
Claimant to support the Rupture Claim. In forwarding the Claimant's
information to Reorganized Dow Corning, the Claims Office shall
maintain the confidentiality of the Claimant's identity and
information. Reorganized Dow Corning may, at its expense, request
that explant materials and/or pathology slides, if preserved, be
provided for the purpose of conducting testing. The Claimant must
promptly comply with the request and, if preserved, provide all
requested materials in the Claimant's possession or control.
Reorganized Dow Corning will have sixty (60) days to accept or reject
the Rupture Claim after the documentation is submitted to Reorganized
Dow Corning. Reorganized Dow Corning shall submit a written response
to the Claims Administrator for each Rupture Claim submitted to it
under this Individual Review Process. The Claims Administrator shall
notify the Claimant of Reorganized Dow Corning's response and, if the
Rupture Claim has been rejected, advise the Claimant of the procedure
for appealing the determination to the Appeals Judge. If the Rupture
Claim is rejected, Reorganized Dow Corning shall return all explant
materials and pathology slides to the Claimant (as directed by the
Claims Office) and provide the Claimant with a copy of any test
results or reports conducted on such materials.
Individual Review Process/Standard for Review. Claimants who meet the
criteria listed below are eligible to participate in this Individual
Review Process. Reorganized Dow Corning shall not unreasonably deny a
Rupture Claim submitted through this Individual Review Process that
includes:
documentation, created before explantation surgery or within a
reasonable time after explantation of the Dow Corning single or
double-lumen silicone gel Breast Implant, demonstrating visual
confirmation of a breach in the elastomer envelope found upon or prior
to removal of the Dow Corning silicone gel Breast Implant, or
documentation demonstrating migration along tissue planes distant from
the site of breast implantation of a substantial mass of material
confirmed by biopsy to be silicone from a ruptured Dow Corning single
or double-lumen silicone gel Breast Implant.
Corning rejects any Claim eligible for and submitted through the
above-described Individual Review Process, the Claimant may appeal to
the MDL Court (or a magistrate or special magistrate designated by the
MDL Court). The decision of the MDL Court is final and binding on
both the Reorganized Dow Corning and the Claimant.
Deficiencies. Breast Implant Claimants who elect to participate in
the Individual Review Process outlined in this subsection may
simultaneously proceed with an appeal to the Claims Administrator
pursuant to Article VIII and this Individual Review Process.
types of proof are examples of unacceptable proof of rupture:
statements from medical personnel recalling that a Claimant's Breast
Implant was ruptured upon explantation, or a similar statement from
the Claimant (or a Claimant's relative or friend).
show that the ruptured Breast Implant has been surgically removed.
affirmatively reveals that the Breast Implant was intact before the
explant surgery, but was ruptured during the explant surgery.
Rupture as defined (including proof that shows only gel bleed).
only the saline portion of a double-lumen Breast Implant ruptured,
leaving the gel portion intact.
after 1/1/92, a pathology report alone, with no contemporaneous
operative report.
Payment Agreement and the Settlement Facility Agreement, Eligible
Breast Implant Claimants who qualify for the Rupture Payment Option
under any of the provisions of this Section 6.02(e) will be
compensated a Base Payment of $20,000 and an additional Premium
Payment of $5,000 regardless of whether they also have a Disease
Payment Option Claim or an Explantation Payment Option Claim.
will not be a multiple manufacturer reduction for the Rupture Payment
Option except as follows: If the Claimant qualifies for both the
Disease Payment Option and the Rupture Payment Option and has received
a rupture enhancement payment under the Revised Settlement Program,
then the Allowed amount of the compensation for both the Disease
Payment Option Claim and the Rupture Payment Option Claim will be
reduced by 50 percent.
Implant Claimants may elect to receive compensation of $2,000 for a
complete release of their right to participate in the Disease Payment
Option. Breast Implant Claimants who elect this Expedited Release
Payment Option will (if eligible) be allowed to recover under the
Explantation Payment Option and the Rupture Payment Option.
Option will be available until the third anniversary of the Effective
Date, except as provided at paragraph (iii) below. The Claims
Administrator shall have the discretion to extend the Expedited
Release Payment Option for an additional time period.
Expedited Release Payment Option, the Claimant must submit acceptable
proof of implantation with a Dow Corning Breast Implant in accordance
with the standards specified at Schedule I, Part I.
Option Program. Eligible Breast Implant Claimants who have a major
deficiency in their Disease Payment Option submission and who fail to
cure the deficiency within one year of the date of their Notification
of Status letter shall be eligible for an Expedited Release Payment
Option notwithstanding subparagraph (i) above.
6.03 Settlement Program for Other Products Claimants. Claimants who
have been implanted and explanted with one or more of the "Other
Products" listed below will be eligible for compensation from the Dow
Corning Settlement Program for Other Products if they satisfy the
eligibility criteria and documentation requirements specified herein.
covered by the Settlement Program for Other Products Claimants are
listed in this subparagraph (a) ("Covered Other Product" or "Covered
Implant"). The specific Covered Other Products are listed at Schedule
I, Part II.
as: A spacer constructed of SILASTIC® sheeting manufactured by Dow
Corning;
Implant;
Implant H.P. of:
implant;
Implant) (Finger, toe, wrist);
is a Claimant who meets the conditions for a Claim as described in
this Section 6.03 and who meets the threshold eligibility criteria
specified at Section 5.01 of these Claims Resolution Procedures and
subsection (c) below regarding the deadline for submission of Claims
under the Settlement Program. Other Products Claims for implants
implanted prior to 1980 are not compensable except that the Claims
Administrator may determine, in accordance with the provisions of
Section 6.03(i), to permit compensation of such Claims if there are
any excess funds in the Other Products Fund (as defined in the
Settlement Facility Agreement) after payment of all Eligible Settling
Other Products Claims.
compensation an Other Products Claimant must submit the appropriate
Claim Form, Proof of Manufacturer and supporting documentation on or
before the second anniversary of the Effective Date.
Claimants. Other Products Claimants may receive compensation under
any one of the following options. Each option is mutually exclusive.
Release Payment consists of payment of the sum of $500 for any Other
Products Claimant who meets the initial eligibility requirement
specified at Section 5.01, and who submits acceptable Proof of
Manufacturer of a Covered Other Product as specified at Schedule I,
Part II. Claimants who elect to receive this compensation will not be
able to receive the Medical Condition Payment. A Claimant is entitled
to one Expedited Release Payment, regardless of the number of implants
or implant types.
Products Claimants may elect to obtain compensation for one of the
specific medical conditions described at paragraphs (ii) a., b. or c.
below ("Medical Condition"). Claimants who meet the eligibility
criteria for any one of these Medical Conditions described will be
compensated in accordance with the schedule at Section 6.03(h). Each
Medical Condition is mutually exclusive and Claimants shall be
entitled to payment for only one eligible Medical Condition for each
Covered Other Product implant type.
Other Products Claimants who submit acceptable Proof of Manufacturer
of a Covered Other Product and who demonstrate that a Covered Other
Product has failed in accordance with the criteria at Section
6.03(f)(i) will be compensated as described in Section 6.03(h).
Associated With Active, Localized Bone Resorption. Eligible Other
Products Claimants who submit acceptable Proof of Manufacturer of a
Covered Other Product and provide acceptable documentation of an
Inflammatory Foreign Body Response as defined at Section 6.03(f)(ii),
will be compensated as described in Section 6.03(h).
Claimants who submit acceptable proof of implantation of a Covered
silicone gel Other Product and who provide acceptable documentation of
a Rupture as described in Section 6.03(f)(iii) will be compensated as
described in Section 6.03(h).
Other Products Claimants who meet the requirements of Section
6.03(f)(iv) will be compensated as described at Section 6.03(h).
provide acceptable Proof of Manufacturer as described at Schedule I,
Part II of any Covered Other Products and who satisfy the initial
eligibility requirements at Section 5.01 herein may elect to receive
compensation of $500. Payment of this sum will release all present
and future Claims the Claimant may have.
Claimants will be compensated for the failure of any Covered Other
Products if they meet the requirements listed below.
Implant types eligible for an Implant Failure Payment consist of:
ORTHOPEDIC IMPLANT;
ORTHOPEDIC IMPLANT — knee, hip;
implant;
implant;
brands are listed at Schedule I, Part II.
Requirements. To obtain compensation for Implant Failure, Claimants
must submit:
Proof of Manufacturer of an Other Product (in accordance with the
requirements for acceptable Proof of Manufacturer specified at
Schedule I, Part II);
that the Claimant meets the initial eligibility requirements as
described at Section 5.01 of these Claims Resolution Procedures;
of Implant Failure as specified at subparagraph c. below.
Compensation for Implant Failure.
"Implant Failure" of a solid silicone or metal implant means a Dow
Corning Other Product that has a tear, fracture, or break which is the
result of fatigue failure, or a separation of implant component parts,
which is seen or observed without microscopic examination at
explantation. To be compensable, the broken implant must cause
clinical failure resulting in explantation.
Implant failure which is directly attributable to the following is not
compensable and such Claims will be rejected by the Claims Office:
(i) an identifiable traumatic event including damage of the implant
during implant or explant surgery, (ii) disassembly of modular parts
that were assembled at or during surgery, but not in accordance with
the manufacturer's specifications, (iii) identifiable abuse or misuse
of the implant documented in the medical records or (iv) occurring
after TMJ implantation used to revise or rehabilitate the
temporomandibular joint following use of a Vitek Proplast implant.
Demonstrate Implant Failure the Claimant must submit:
MRI, roentgenogram or a report from a roentgenogram x-ray report or
MRI report of examination, performed post- implantation of the Other
Product but prior to explant, finding that the Covered Implant has
failed as defined above; and
contemporaneous operative report from the explantation surgery
describing the condition of the Covered Implant upon gross inspection
of the implant by the explanting surgeon, a contemporaneous pathology
report describing the condition of the Covered Implant upon gross
inspection, a statement as to whether the Covered Implant was
fractured, torn or had its structural integrity otherwise compromised
during or after the Covered Implant and explant surgery and the
factual basis for the opinion as to the status of the Covered Implant
before the explant surgery commenced; and
medical and hospital records documenting any traumatic injury/accident
affecting the area of the affected joint or Covered Implant during the
period of time such Covered Implant(s) was/were in place. If no such
records exist, then the Claimant shall provide an affidavit describing
any such events. In the event the Claimant has not experienced a
traumatic event or sustained injury to the affected joint during the
time the Covered Implant was in place, the Claimant shall submit an
affidavit attesting to the fact; and
preserved, the identity and the location of the custodian of the
removed Covered Implant(s). The Claims Administrator may require the
presentation of the removed Covered Implant(s) for examination by an
individual or entity designated by the Claims Administrator to confirm
the Implant Failure.
Claimants who satisfy the eligibility criteria shall be compensated
according to the Base Compensation Level specified at Section 6.03(h).
the event that the Claim Form or supporting documentation is
deficient, the Claimant shall have six (6) months from the date of the
Notification of Status (deficiency) to submit additional documentation
to cure the deficiency.
Associated With Active, Localized Bone Resorption Payment. To obtain
compensation for Inflammatory Foreign Body Response, the Claimant must
meet the following requirements:
Implants eligible for an Inflammatory Foreign Body Response Payment
consist of:
JOINT ORTHOPEDIC IMPLANT;
JOINT ORTHOPEDIC IMPLANT.
brands are listed at Schedule I, Part II.
Proof of Manufacturer of the Other Product (in accordance with the
requirements for acceptable Proof of Manufacturer specified at
Schedule I, Part II); and
that the Claimant meets the initial eligibility requirements as
described at Section 5.01 of these Claims Resolution Procedures; and
of Inflammatory Foreign Body Response as specified at subparagraph c.
below.
Compensation for Inflammatory Foreign Body Response.
"Inflammatory Foreign Body Response" means a cellular response
characterized by the presence of macrophages and giant cells
containing particles of silicone, polyethylene, or metallic alloy
found at the site of a localized, active bone resorption with a
scalloped, balloon, or erosive pattern in the bone adjacent to the
implanted joint. To be compensable, the Inflammatory Foreign Body
Response must be the result of dysfunction of the Covered Implant
causing clinical failure and resulting in explantation.
Inflammatory Foreign Body Response which is attributable to the
following is not compensable and such Claims will be rejected by the
Claims Office: (i) damage to the Covered Implant during implant
surgery; (ii) identifiable abuse or misuse of the Covered Implant
documented in the medical records; (iii) if affirmatively documented
in the medical records, the patient's extreme sensitivity to the
implanted materials; (iv) Inflammatory Foreign Body Response
attributable to a prior bone resorption condition; or (v)
implantations used to revise or rehabilitate the temporomandibular
joint following use of a Vitek Proplast implant.
demonstrate an "Inflammatory Foreign Body Response," the Claimant must
submit:
pathology slides or a pathology report, of tissue or bone resected at
explantation from the site of the active, localized bone lysis
adjacent to the Covered Implant documented by the studies described in
subparagraph (2) below, which show findings of macrophages and giant
cells containing particles of polyethylene, silicone or metallic
alloy; and
MRI, roentgenogram or a report from a roentgenogram, x-ray report or
MRI report of examination, taken within one month prior to
explantation, which shows findings of active, localized bone lysis
with a scalloped, balloon or erosive pattern in the bone adjacent to
the implanted joint; and
explantation surgical notes or treating surgeon's pre-explantation
office notes stating that the revision or explantation surgery was
required because of bone resorption due to Inflammatory Foreign Body
Response as defined at subparagraph c.1. above.
who satisfy the eligibility criteria shall be compensated according to
the Base Compensation Level specified at Section 6.03(h).
event that the Medical Condition Payment Option Form or supporting
documentation is deficient, the Claimant shall have six (6) months
from the date of the Notification of Status (deficiency) to submit
additional documentation to cure the deficiency.
Claimants who document implantation with one of the following silicone
gel Covered Implants are eligible to receive compensation for a
Rupture of the Covered Implant if the criteria listed at subparagraphs
b. and c. below are met:
chin;
facial;
testicular
brands are listed at Schedule I, Part II.
Proof of Manufacturer that the Other Product (in accordance with the
requirements for acceptable Proof of Manufacturer specified at
Schedule I, Part II); and
that the Claimant meets the initial eligibility requirements as
described at Section 5.01 of these Claims Resolution Procedures; and
of Rupture as defined at paragraph c.2. below.
Compensation.
Rupture. "Rupture" means the failure of the elastomer envelope(s)
surrounding a silicone gel Covered Implant to contain the gel
(resulting in contact of the gel with the body) not solely as a result
of "gel bleed" but due to a tear or other opening in the envelope
after implantation and prior to the explantation procedure.
be eligible for compensation, the Claimant must have experienced a
Rupture of a Covered Implant and the Rupture must be confirmed by
explantation of the Covered Implant for which a Rupture is claimed.
The Claimant must submit:
verified contemporaneous operative report and, if available, a
pathology report documenting the Rupture; and
Products Claimants explanted after the Effective Date must submit a
contemporaneous operative report and, if available, a contemporaneous
pathology report. In addition, the Claimant must provide a statement
from the explanting surgeon (or other appropriate professional
approved by the Claims Office) affirming that, in his or her opinion,
the Rupture did not occur during or after the explantation procedure.
This statement must describe the results of the inspection and provide
a factual basis for the opinion. The Claimant shall use his or her
best efforts to cause the removed Covered Implant to be preserved.
Ruptured Covered Implant(s) has/have been preserved, a statement of
the identity and the location of the custodian of the Covered
Implant(s). The Claims Administrator may require the presentation of
the removed Covered Implant(s) for examination by an individual or
entity designated by the Claims Administrator to confirm the Rupture
and/or that the Covered Implant was manufactured by Dow Corning.
Products Claimants must submit the Rupture Payment Option Form, Proof
of Manufacturer and supporting documentation demonstrating proof of
Rupture on or before the second anniversary of the Effective Date,
except that notwithstanding the provisions of Section 6.03(c),
Claimants explanted within the 90-day period preceding the second
anniversary of the Effective Date shall have until thirty (30) days
after that deadline to submit the Form and supporting documentation.
Claimants who satisfy the eligibility criteria specified herein shall
be compensated according to the Base Compensation Levels described at
Section 6.03(h) below.
event that the Rupture Payment Option Form or supporting documentation
is deficient, the Claimant shall have six (6) months from the date of
the Notification of Status identifying the deficiency to submit
additional documentation to cure the deficiency.
Requirements for Enhanced TMJ Implant Payment Option. To qualify for
the Enhanced TMJ Implant Payment Option, the Claimant must document
the following:
of Manufacturer of a Dow Corning TMJ product as specified at Schedule
I, Part II; and
that the Claimant meets the initial eligibility requirements as
specified at Section 5.01 of these Claims Resolution Procedures; and
Documentation of an Implant Failure as specified above at
6.03(f)(i); or
Documentation of an Inflammatory Foreign Body Response
specified above at Section 6.03(f)(ii); and
the TMJ secondary to an Implant Failure or Inflammatory Foreign Body
Response which dysfunction either impedes mastication, affects speech
or causes lower facial deformity; and
greater "Permanent Impairment of the Whole Person" as a result of the
dysfunction stated at subparagraph (iv) above. Permanent Impairment
shall mean the presence of a medically determinable permanent physical
impairment of the whole person, as to the temporomandibular joint, in
accordance with the guidelines established in the position paper,
"Guide to Evaluation of Permanent Impairment of the Temporomandibular
Joint," as published in The Journal of Cranialmandibular Practice,
April 1997, Vol. 15, No. 2, and the guidelines established by the
American Medical Association in its publication, Guides to the
Evaluation of Permanent Impairment (4th ed.).
eligible for compensation, the Claimant must submit medical records
from a Board-certified oral and maxillofacial surgeon who has
physically examined the Claimant and personally documented the
findings and signs required to evaluate and determine such impairment.
The Claims Administrator may consider documentation of impairment by
any physician but such documentation from a physician who is not
Board-certified in oral or maxillofacial surgery shall not be
conclusive proof of an impairment meeting the standards defined
herein. The Claims Administrator may independently review appropriate
medical evidence to evaluate impairment.
Eligible Other Products Claimants who satisfy the criteria under this
section shall be compensated according to the Enhanced Compensation
Level specified at Section 6.03(h) .
Required Documentation for Medical Condition Claims.
claim for a Medical Condition Payment the Claimant must submit the
documentation described herein, and to be considered by the Claims
Office all medical records/proof submitted must consist of records of
the physician(s) who has/have examined the Claimant, made the specific
finding, observed the specific symptom and contemporaneously
documented the same. The physician must be a Board-certified
physician specializing, as appropriate to the Claim, in oral
maxillofacial, orthopedic, podiatric, urologic or plastic surgery.
acceptability of supporting documents, the Claims Administrator shall
accept only personal examination findings, laboratory results and
diagnoses that are in writing and submitted under the authority of the
examining physician or laboratory. The physician whose records are
relied upon must have been licensed to practice medicine in the
applicable jurisdiction at the time the diagnosis or examination is
made.
Administrator/Verification of Evidence.
Administrator shall determine the presence of a compensable condition
and the absence of exclusionary factors and shall approve Claims if
the information in the records satisfies the requirements for
compensation specified herein. The Claims Administrator shall require
such further submissions as necessary to confirm the compensable
condition and absence of exclusionary factors.
Section 5.04 of the Settlement Facility Agreement, the Claims
Administrator may (a) obtain independent reports or evaluations from
medical physicians to assist in the review of any Claimant's
submission, (b) audit the reliability of medical evidence, and (c)
exclude medical evidence of questionable validity.
Section 6.03(f) for one of the qualifying conditions, the Allowed
amount shall be as specified below, subject to adjustment as specified
in Section 7.03 of the Settlement Facility Agreement, subparagraph
(ii) below and Section 6.03(i) below.
Implant Type Base Payment Enhanced
Payment
Chins, facial and nasal implants $2,500 N/A
Small Joint Orthopedic
(fingers, wrists, hands, toes) $2,500
Large Joint Orthopedic:
$7,500
$5,000 N/A
TMJ $2,500 $5,000
Testicular and penile $2,500 N/A
Claims Administrator shall have the authority to reduce payments to
Other Products Claimants who: (1) qualify under the Medical Condition
Payment Option and (2) whose Other Product has been implanted for more
than five years. Such authority to reduce payments shall occur only
if the Claims Administrator determines, after evaluating all timely
filed Other Products Claims and placing such Claims on the
Compensation Schedule, that without such a reduction, the amount of
the Other Products Fund may be insufficient to pay all Settling Other
Products Claims the full amount specified by the Compensation Schedule
(Section 6.03(h)). In computing any reduction in the payment amount,
the Claims Administrator shall give consideration to a mechanism for
reducing payments that increases the amount of the reduction for each
year the implant has been implanted beyond the fifth year of
implantation. Nothing in this subparagraph shall affect the
obligations of the Claims Administrator and Settlement Facility
regarding the limitations imposed by the Other Products Fund on
payments to Other Products Claimants or the provisions of Section
7.03(c) of the Settlement Facility Agreement.
Claimant by Implant type and will not vary depending on the number of
Implants within an Implant type.
Claims/Premium Payments/ Administrative Costs/Additional
Distributions.
compensation amounts at Section 6.03(h), as specified in the
Settlement Facility Agreement the aggregate amount that may be paid
for resolution of Claims of Settling Personal Injury Claimants
(including both payments to Claimants and administrative expenses)
based on Other Products shall equal the sum of $30 million Net Present
Value, (which amount shall be deemed a "Base Payment Amount") plus the
sum of $6 million Net Present Value which sum shall be deemed and
treated as a Premium Payment (collectively, the "Other Products
Fund").
and evaluate all timely Other Products Claims before distributing
Medical Condition Payments to Other Products Claimants. In the event
that the Allowed payments to Other Products Claimants based on the
criteria and compensation schedule outlined herein equals a sum less
than the Other Products Fund, then the Claimants' Advisory Committee
shall determine guidelines to distribute the sum equal to the amount
by which the Allowed aggregate amount is less than $36 million Net
Present Value to the Other Products Claimants with the most serious
injuries or conditions.
projected administrative costs in connection with the resolution of
Other Products Claims. In the event that a projection that takes into
account actual claims-processing experience indicates that
administrative costs will exceed ten (10) percent of the Other
Products Fund, then the Claims Administrator shall, in consultation
with the Debtor's Representatives and the Claimants' Advisory
Committee, develop an administrative process that will allow
resolution of the Other Products Claims within the limits of the $36
million Net Present Value Other Products Fund with administrative
costs not to exceed ten (10) percent of that amount. Such projection
of administrative costs may be based on a sufficient random sample of
initial Other Products Claims (as determined by the Finance Committee)
and the calculation of administrative costs for purposes of this
section shall include direct costs of processing such Claims on a
per-claim basis and an appropriate pro rata share (reflecting the
sample or reviewed group of Claims as a percentage of all Other
Products Claims submitted and projected to be submitted) of general
costs that have been or will be incurred in connection with staff
training, quality control reviews and reporting related to Other
Products Claims.
6.04 Silicone Material Claimants.
Material Claimants are Claimants who meet the following requirements:
Manufacturer as set forth at subparagraph (b) below; and
criteria in Section 5.01 of these Claims Resolution Procedures; and
Corning Breast Implant or Other Products Implant.
Claimant must:
as defined at Schedule I, Part III, of implantation of a silicone gel
breast implant identified as a Bristol, Baxter, Bioplasty, Cox-Uphoff,
or Mentor breast implant on Exhibit G to the Revised Settlement
Program (a "Qualified Breast Implant"); and
Manufacturer of a Qualified Breast Implant implanted after January 1,
1976 and before January 1, 1992.
Material Claimant. To be eligible, the Silicone Material Claimant
must submit (1) a Proof of Manufacturer Form listing all breast
implantations along with documentation necessary to demonstrate
acceptable proof of implantation of at least one breast implant
meeting the requirements of (b) above, (2) an affirmative statement
identifying all other breast implantations and manufacturers of such
breast implants, (3) an affirmative statement that the Claimant has
never been implanted with a Breast Implant or Other Product, and (4)
for Silicone Material Claimants seeking compensation under the Disease
Payment Option as provided at subparagraph (e) below, all
documentation required to document a Covered Condition as specified in
Section 6.02 and Schedule II of these Claims Resolution Procedures.
Options. As provided in the Settlement Facility Agreement, the sum of
$57.5 million Net Present Value shall be allocated for resolution of
Claims of all Silicone Material Claimants, including all
administrative expenses associated with the processing, resolution and
payment of all Silicone Material Claims.
Settlement Payment.
entitled to apply for either the Expedited Release Payment Option or
the Disease Payment Option. The criteria for compensation under each
Option shall be the same criteria established under Section 6.02 of
these Claims Resolution Procedures.
submit their Claim Forms and supporting documentation on or before the
second anniversary of the Effective Date.
Silicone Material Claimants' Fund until each timely Silicone Material
Claim is reviewed and evaluated under the Settlement Option selected.
Material Claims, the Claims Administrator shall determine the amount
that can be Allowed for each Silicone Material Claim based on the
settlement option approved and the number of eligible Silicone
Material Claimants. The Silicone Material Claimants' Fund shall be
allocated on a proportional basis such that all Silicone Material
Claimants who elect the Expedited Release Payment Option receive the
same amount, subject to the terms of subparagraph (v) below and such
that Silicone Material Claims under the Disease Payment Option are
Allowed in an amount no greater than 40 percent of the Allowed amount
for Breast Implant Claimants under the equivalent level of the Disease
Payment Option Compensation Schedule.
the Silicone Material Claimants' Fund, Silicone Material Claimants
shall be required to marshal recoveries from the manufacturers of
their breast implants. Silicone Material Claimants who do not marshal
all recoveries from all manufacturers by the deadline for submission
of Silicone Material Claims are not eligible to receive a payment.
All such recoveries received by or for the benefit of the Silicone
Material Claimant shall reduce, on a dollar-for-dollar basis, the
amount otherwise Allowable under the terms of this Section 6.04. For
purposes of this subparagraph, those Silicone Material Claimants whose
sole manufacturers are not released under or are not participating in
the Revised Settlement Program and consist specifically of Bioplasty,
Cox-Uphoff, or Mentor shall be deemed to have marshaled all recoveries
and there shall be no reduction of the Allowed amount for such
Claimants based on any other recovery. Claimants who have both a
breast implant made by Bioplasty, Cox-Uphoff, or Mentor and any breast
implant made by any other manufacturer (except a Claimant who is
classified as an "Other Registrant" as defined in the Revised
Settlement Program with only a post-August 1984 McGhan breast implant,
along with a Bioplasty, Cox-Uphoff, or Mentor breast implant) will be
required to marshal all recoveries by such other manufacturers as
stated above. The Claims Administrator shall determine whether all
recoveries have been marshaled and shall require the Claimant to
document the amount of recovery so that the Allowed amount can be
calculated.
distribute any excess amount in the Silicone Material Claimants' Fund
after allocation to Claimants in accordance with paragraph (e) above
to eligible Silicone Material Claimants on a pro rata basis.
6.05 Foreign Claimants.
Classes 6A, 6B, 6C, and 6D, Settling Foreign Breast Implant Claimants
shall be subject to the terms of and entitled to select and receive
compensation under the options outlined in Sections 6.02 of these
Claims Resolution Procedures and Settling Foreign Other Products
Claimants shall be subject to the terms of and entitled to select and
receive compensation under the options outlined in Section 6.03 of
these Claims Resolution Procedures.
establishes alternative Claims facilities as set forth below, all
Claim Forms and documents submitted to the Claims Office must be in
English. Claim documentation originally in a language other than
English must have a translation into English attached, along with the
translator's statement (under penalties of perjury) attesting that the
translator is proficient in English, that the document has been
correctly translated and that the translator has no personal or
business relationship with the Claimant or the Claimant's attorney.
Notwithstanding the above, no such translation shall be required for
medical and hospital records offered as Proof of Manufacturer if,
without any translation, the Claims Office will be able to determine
that the proof is acceptable under any of items 1-4, 6, 9-12 and 15 of
Schedule I, Part B.
single Claims facility in Europe and a single Claims facility in South
America for the purpose of processing Claims of Settling Foreign
Claimants. Such facilities, if established, shall be designed to
receive and process Claims in languages other than English. Such
facilities shall be permitted, under the direct supervision of the
Claim Administrator, to review and evaluate Settling Foreign Claims in
accordance with the guidelines and criteria specified herein and in
the Settlement Facility Agreement. The Claims Administrator shall
institute mechanisms to assure that Claims processed by any such
facility are processed in the same manner and consistent with Claims
processed by the Claims Office.
approved by any such Foreign Claims facility shall be issued by the
Trust upon the direction of the Finance Committee. The Claims
Administrator and paying agent shall institute procedures to assure
accuracy of payment and application of the appropriate adjustment to
the Allowed payment as specified at paragraph (d) below.
be established and maintained only if the Claims Administrator
determines that the administrative cost — on a per-claim basis — of
resolving Claims with such facilities is equivalent to or more cost
efficient than the per-claim cost of resolution of the same categories
of Claims by the Claims Office. For purposes of determining the
equivalent administrative costs, the Claims Administrator shall not
include in the calculation of per-claim resolution costs any fees or
expenses associated with investment of funds, the distribution of
payments, issuance of reports, or costs of the Finance Committee.
who qualify for payment shall be a percentage of the Allowed amount
specified in the applicable Compensation Schedule. Such percentage
shall be computed based on Schedule III to these Claims Resolution
Procedures. The percentage of payment is based on the Claimant's
country of residence.
7.01 General Guidelines.
otherwise provided herein or in the Settlement Facility Agreement or
subsequently modified as provided in the Settlement Facility
Agreement, the Claims Office shall process all Claims in accordance
with the guidelines and protocols established by the MDL 926 Claims
Office. The Claims Administrator may consult with the Claimants'
Advisory Committee and Debtor's Representatives regarding the
applicability of any particular guidelines.
procedures to maintain the confidentiality of all Claim files and
Claimants' identities and shall not disclose such information to any
person except to the extent provided herein or in the Settlement
Facility Agreement.
Facility Agreement, the Claims Administrator shall institute
procedures to assure consistency of processing and of application of
criteria in determining eligibility and to ensure fairness in
processing of Claims and appeals and to ensure an acceptable level of
reliability and quality control of Claims.
Claimant (and/or her counsel) at the Claimant's cost with access to
his/her file and shall maintain a system by which Claimants (and/or
their counsel) can determine the current status of his/her Claim by
contacting the Claims Office.
and input from the Claimant's Advisory Committee, shall develop, staff
and maintain a program for providing claims assistance ("Claims
Assistance Program"). This program shall be a part of the Claims
Office, staffed by employees of the Claims Office, and is intended to
provide assistance to all Claimants about Claims Office procedures,
eligibility guidelines, submission requirements (including
documentation required), deficiencies, appeal procedures, the status
of a Claimant's Claim, processing requests to the Reorganized Dow
Corning for individual acceptance of Proof of Manufacturer that have
been classified as unacceptable by the Claims Office, and processing
submissions to Dow Corning under the Individual Review Process for
Rupture Claims outlined at Section 6.02(e)(vi) of these Claims
Resolution Procedures. The Claims Assistance Program shall not
represent Claimants, provide legal advice or serve as an advocate for
Claimants.
7.02 Order of Processing.
Breast Implant Claimant's Proof of Manufacturer submission before
processing Disease Payment Option Forms. The Claims Office shall to
the extent possible identify those Claimants who have previously
alleged implantation of a Dow Corning Breast Implant.
shall record and process information, if applicable or if available
from the Claimant's submission, about the proof for Explantation and
Rupture Payment Options based on a review of the Proof of Manufacturer
submission.
acceptable proof or a minor deficiency in their Proof of Manufacturer
submissions may submit Disease Payment Option Forms. The Claims
Office will not process Claims for Disease Payment Option benefits
unless the Claimant has submitted acceptable (or has only a minor
deficiency in) Proof of Manufacturer of a Dow Corning Breast Implant.
of Manufacturer and other Claim Form(s) shall request information
regarding whether the Breast Implant Claimant:
for one of the benefit options (i.e., has never filed documentation
with the MDL 926 Claims Office);
documentation (Proof of Manufacturer and/or disease documentation)
with the MDL 926 Claims Office and received a Notification of Status
letter from the MDL 926 Claims Office concerning her eligibility for
disease benefits under the Revised Settlement Program;
documentation (Proof of Manufacturer and/or disease documentation)
with the MDL 926 Claims Office and has no additional documentation to
submit for the Dow Corning Settlement Program;
documentation (Proof of Manufacturer and/or disease documentation)
with the MDL 926 Claims Office and has supplemental documentation to
be considered under the Dow Corning Settlement Program; or
making a Disease Payment Option Claim, the particular Covered
Condition for which the Claimant seeks to apply.
processed in FIFO order within each option category based on the
submission date.
Office may process Claims for payment options selected by a Claimant
either simultaneously or seriatim so as to expedite processing and
payment and is encouraged to process Proof of Manufacturer,
Explantation Payment Option, and Rupture Payment Option Forms
simultaneously.
Office will review a Disease Payment Option Claim upon receipt of:
(1) a request by the Claimant to review a previously submitted disease
claim as specified in paragraph (c) above or (2) receipt of new or
additional documentation regarding the Disease Payment Option Claim.
In accordance with Section 7.02(c), the Claims Office will provide
Claimants with appropriate forms by which they can request a review of
their prior submission. If the Claimant does not so notify the Claims
Office in accordance with Section 7.02(c) and does not submit any
additional documentation by the time all other pending Disease claims
have been reviewed, then the Claims Office will evaluate the Claim
based on the prior submission.
distribute payment in accordance with the Settlement Facility
Agreement. Payments for each benefit option selected by a Claimant
can be made separately so that distribution of payments need not await
final review of all benefit options sought by the Claimant. For
example, assuming eligibility, payment for Explantation Payment Option
benefits can be made immediately and need not await final review of
other types of benefits the Breast Implant Claimant has sought (e.g.,
the Breast Implant Claimant can receive an Explantation Payment Option
benefit even though review of her Rupture submission or Disease
Payment Option submission has not yet been completed).
Payment Option Claim is approved at a compensation level lower than
that applied for may either accept the lower compensation level or
Covered Condition or seek to cure the deficiency in the higher
compensation level, subject to the time limitations specified at
Section 7.08 of these Claims Resolution Procedures.
7.03 Notification of Status for Proof of Manufacturer Submissions.
Manufacturer submission, the Claims Office shall provide to the
Claimant a Notification of Status letter as provided below.
the Claimant of:
Proof of Manufacturer of a Dow Corning product and the settlement
options and deadlines, if any, available to her/him;
has a deficiency and, if it does, the Notification of Status letter
shall specifically identify the deficiency, state whether it is a
minor or major deficiency, and inform the Claimant of procedures for
correcting the deficiency including the availability of the Claims
Assistance Program and/or appealing the ruling to the Claims
Administrator.
of Status letter shall state whether the Claimant has submitted
acceptable proof of one or more silicone gel breast implant(s)
manufactured by Bristol, Baxter or 3M (as these implants are
identified on Exhibit G to the Revised Settlement Program).
Submission. Minor deficiencies in the Proof of Manufacturer
submission include:
Manufacturer of a Dow Corning product but did not submit a Proof of
Manufacturer Form.
copy of medical records for acceptable proof where required (items 2,
10, 11 and 14 listed at Schedule I, Part I, Section B.).
physician has been submitted (item 5 in the list of acceptable proof,
Schedule I, Part I, Section B. but no explanation was included as to
why medical records are not available to supply manufacturer proof.
physician has been submitted (item 5 in the list of acceptable proof,
Schedule I at Part I. B. but the physician has failed to provide the
basis for his/her conclusion that the Claimant received a certain
brand of implants.
is no identification on the records themselves indicating that these
records relate to the Claimant.
statement or proof the Claimant submitted came from the physician or
someone on the treating facility or physician's staff.
contradictory evidence of the brand of implant the Claimant received.
For example, the operative report lists one brand, but the Claimant
submitted a label of another brand, and both types of proof reference
the same surgery.
Breast Implant showing one of the unique identifiers but has not
provided a statement from the explanting physician identifying the
implant in the photograph as one removed from the Claimant.
Proof of Manufacturer submission shall be directed to the Claims
Assistance Program. If the Claimant cures the deficiency, the Claims
Office will send to the Claimant the Disease Payment Option Claim
Form.
7.04 Notification of Status for Explantation and Rupture Payment
Options.
Products Claimants, the Notification of Status letter shall state
whether the submission is acceptable pursuant to Sections 6.02(c),
6.02(e), or 6.03(f)(iii) as applicable. If the submission is not
acceptable, the letter shall specifically identify the deficiency and
inform the Claimant of procedures for curing the deficiency, the
availability of Claims Assistance Program and/or the process for
appealing the determination to the Claims Administrator.
are four minor deficiencies in Rupture proof.
Breast Implant was removed before the Effective Date, the Claim has a
minor deficiency if the Breast Implant Claimant failed to state
whether the ruptured implant has been preserved and, if so, the name
and address of the custodian.
Effective Date, the Claim has a minor deficiency if the Breast Implant
Claimant failed to provide the Claims Office with the required
statement concerning preservation of implants or failed to provide a
statement from the explanting surgeon (or the hospital pathologist, a
physician who assisted in the explantation surgery or from another
doctor who examined the removed implant, as provided herein) affirming
that, in his or her opinion , the Rupture did not occur during or
after the explantation procedure and providing a factual basis for
that opinion.
1992 but did not submit a pathology report or indicate that the
pathology report was unavailable, the Claim has a minor deficiency
that can be cured by submission of the report or the required
statement.
supporting documentation demonstrating Rupture but did not submit a
Rupture Payment Option Form, the Claim has a minor deficiency which
can be cured by submitting the Rupture Payment Option Form.
proof by sending to the Claims Office the appropriate written
statement, clearly marked at the top as Rupture Proof.
7.05 Notification of Status for Disease Payment Option Claims.
the Breast Implant Claimant and her counsel of the results of the
evaluation of the Claim, as specified at Section 6.02(d) herein, and
shall inform the Claimant of the election options.
Notification of Status letter shall specifically identify the
deficiency, state whether it is a minor or major deficiency, and
inform the Claimant of procedures for correcting the deficiency and/or
appealing the ruling to the Claims Administrator. For Claims with
major deficiencies, the Notification of Status letter shall also
inform the Claimant that she may release all present and future rights
to the Disease Payment Option and instead, receive $2,000 as an
Expedited Release Payment. If the Claim is approved at a lower
compensation level or Covered Condition than that applied for, the
Notification of Status letter shall state the deficiency or the
reason(s) why the higher level or Covered Condition was not approved.
the Breast Implant Claimant of any of the following deficiencies:
symptoms. It is not possible to give one precise definition of the
word "documented" because its meaning is often dependent on the
particular symptom involved. Generally, it means that it is based on
some reliable information other than simply the Claimant's complaint
or oral history. For some symptoms, "documented" means that the
physician has verified the symptom on physical examination. For
others, particularly those that are entirely subjective, it can mean
that the physician has questioned the Claimant sufficiently to be able
to form a professional opinion, utilizing all that doctor's knowledge
and training, that the complaint is a valid one. "Documented" can
also mean that written notations of that symptom are found several
times in the Claimant's past medical records. This deficiency can be
cured, then, by providing (1) proof of verification of the symptom
through physical examination; (2) a supplemental statement from the
Claimant's Qualified Medical Doctor ("QMD") as defined at Schedule II,
Part A revealing that (s)he questioned the Claimant sufficiently about
this symptom and concluded that the complaint is valid; or (3)
additional medical records reflecting that the Claimant complained
about this symptom on other occasions.
determination of the Claimant's disability were not submitted with the
Claim.
relied on some documents in making a disability determination, but
those other documents have not been submitted the Claim will be deemed
deficient. Before the Claims Office can confirm the Claimant's
disability, the Claims Office must have all of the records that the
QMD used to make the disability determination. The Claimant can cure
this deficiency by filing those documents.
for a compensable condition.
medical records or a supplemental statement from the Claimant's QMD
reflecting any additional symptoms that the Claimant has that satisfy
the criteria of Schedule II, Part A.
documents indicate that the Claimant is not disabled by a compensable
condition.
reveals that the Claimant is not disabled. If this is correct, this
deficiency can possibly be cured by providing a statement from the
Claimant's QMD or treating physician describing the Claimant's current
disability and providing a satisfactory explanation for the
contradictory information submitted earlier.
documents indicates that the disability determination is inconsistent
with the disease criteria of Schedule II, Part A.
a determination of the Claimant's disability, but information about
the Claimant's pain or limitations on his/her activities (either in
the QMD's statement or elsewhere in the Claimant's records) conflicts
with the requirements for that disability level. This deficiency can
possibly be cured by a statement from the Claimant's QMD or treating
physician assigning a disability level that is appropriate for the
Claimant's condition or providing information about the Claimant's
disability that is consistent with criteria for that level. If the
Claimant's supplemental documentation provides new information in
support of the disability level the Claimant originally claimed, the
Claimant should provide an explanation for the contradictory
information submitted earlier.
information about the Claimant's condition to evaluate whether the
disability determination is consistent with disease criteria of
Schedule II, Part A.
physician made a determination of the Claimant's disability, there is
not enough information in the Claimant's file to allow the Claims
Office to determine if that disability level was appropriately
assigned by the physician. This deficiency can be cured by providing
a supplemental statement from the Claimant's treating physician or QMD
describing the Claimant's level of pain or limitations on his/her
activities. If the Claimant's disability is caused in part by a
disease or condition that is not compensable under Disease Payment
Option I, the Claimant can only be approved for the level of his/her
disability that is caused by the Covered Condition. In that
situation, the Claimant should make sure that in describing the
Claimant's Covered Condition, the physician clearly indicates the
extent of the Claimant's disability caused by the Covered Condition
covered by Schedule II, Part A.
documents indicates that the Claimant is no longer disabled by a
Covered Condition.
that the Claimant is no longer suffering from any earlier disability
the Claimant may have had. This deficiency can only be cured if the
Claimant is once again disabled. The Claimant should provide a
statement from her QMD or treating physician describing the Claimant's
current disability and explaining the change from her earlier-reported
condition.
determination by a treating physician or QMD of the Claimant's
disability.
of the Claimant's disability by either the Claimant's treating
physician or a QMD. If the Claimant's file did contain a disability
determination from a physician, this deficiency can be assigned if the
Claims Office is unable to confirm that the physician who made that
disability determination was either a treating physician or an
appropriate Board-certified specialist. This deficiency can be cured
by obtaining a determination of disability from the Claimant's
treating physician or a physician Board-certified in one of the
specialties qualifying as QMD specialties.
symptom to qualify for a compensable condition.
symptoms to qualify for the applicable disease or condition. This
deficiency can be cured by providing medical records or a supplemental
statement from the Claimant's QMD reflecting any additional symptoms
the Claimant has that meet the criteria for that Covered Condition.
Claimant received her first breast implant.
suffered from the specified ACTD symptoms before she had her first
breast implant. The Claims Office is not permitted to credit those
pre-existing symptoms. The only time this deficiency can be cured is
if there are typographical errors in the dates in the Claimant's
records. If there are indeed typographical errors in those dates, the
Claimant must provide an affirmative statement from the physician
whose records contain those errors explaining in detail the nature of
those errors and the true dates that should have been reflected in
those records.
not signed.
signed QMD statement or diagnosis.
or severity level was not signed.
that physician's signature. A Claimant can cure this deficiency by
having the QMD sign a copy of the original statement or diagnosis, and
filing that signed copy with the Claims Office. If the deficiency
noted is lack of signature on the disability statement, the Claimant
should ensure that the statement which the physician signs is the one
that contains his or her determination of the Claimant's disability.
documents indicates that the compensable condition from which she
suffered before her first beast implant has not increased in severity
or disability since that breast implant was implanted.
from the disease noted on her Notification of Status letter before she
received her first breast implant. That condition is compensable only
if it increased in severity or in its impact on the Claimant's
disability after implantation. The Claimant can cure this deficiency
by providing either a supplemental report from her treating physician
or QMD that affirmatively reveals that her condition has worsened to
the point that she is now in a higher compensation category or medical
records that demonstrate that increase.
whether the specified lab tests were performed by the method required
by the criteria in Schedule II or if the results of those tests meet
the criteria in Schedule II.
tests noted be performed by a certain stated method or that the
results of those tests meet certain minimum values. If the Claimant's
tests did meet that stated criteria but her original documentation
failed to reveal that fact, the Claimant can cure this deficiency by
providing a statement from either the lab or the physician who ordered
the test reflecting the method by which it was run and the results
reported in the value required by the settlement. If the Claimant's
tests did not, in fact, meet the stated criteria, the Claimant can
cure the deficiency by having them re-taken in the manner required by
Schedule II.
criteria of Schedule II.
Claimant's file to meet the criteria that Disease Payment Option I
specifies. The complaints may not rise to the level required for the
Claims Office to credit the Claimant with that particular symptom, or
the records revealed that the complaint fell within a category
affirmatively excluded by the Disease Payment Option. This deficiency
can be cured by providing either a supplemental statement from the
Claimant's QMD or the medical records demonstrating that her symptom
does indeed meet the criteria stated in Disease Payment Option I.
information about the Claimant's condition to evaluate whether the
disability determination is consistent with the criteria in Schedule
II.
information about the Claimant's symptoms for the Claims Office to
know that the criteria for the claimed disability level have been
satisfied.
C: Under Disease Payment Option I, the definition of Level C provides
that the Claimant must be experiencing moderate pain on a regular or
recurring basis. The pain must be due to the Claimant's ACTD or ANDS.
To cure the deficiency, the Claimant should look at her claim
documentation to see what ACTD or ANDS symptoms she has to check if
all of the ACTD or ANDS symptoms are ones that normally have no pain
component, like alopecia, chronic fatigue, or loss of function of the
breast. If that is the case, then the Claims Office cannot approve a
"C" disability rating unless there is evidence that the Claimant is
experiencing pain from one of these symptoms or unless the Claimant
supplies evidence that she has an additional symptom from the Disease
Payment Option I that does cause pain. If the claim documentation
does mention a pain-related symptom, the Claimant should look at her
Notification of Status letter to see if another deficiency is listed
that specifically mentions that symptom. For example, if the Claimant
has had myalgias but her Notification of Status letter says that the
myalgias have not been "documented" and myalgia was her only
pain-related symptom, then the Claims Office cannot verify a "C"
disability level until the Claimant has provided a supplemental
documentation to satisfy the "documented" requirement. This
deficiency might also be assigned because there is nothing upon which
the Claims Office could base a conclusion that the pain is "regular or
recurring" if the Claimant's physician described the pain as being
only "mild" or "slight."
B: If the Claimant's physician assigned disability level "B" and her
Notification of Status letter states the deficiency listed above, the
Claimant should read the definition of that level and look to see
whether the "B" level is based on severe pain or an inability to do
certain activities. If the "B" determination was pain-related, the
Claimant should look to see what ACTD or ANDS symptoms are found in
the Claimant's documentation. If there are no symptoms that cause
pain, that fact may explain this deficiency. If there are
pain-producing symptoms, the Claimant should look to see if there is
any evidence that these symptoms result in severe pain on a regular or
recurring basis. Generalized statements about "severe pain" may not
be enough. The Claims Office needs to be able to verify that the
ACTD/ANDS symptoms themselves are the cause of that severe pain. If
the "B" level is based on limitations of the Claimant's activities,
the Claimant should look to see if there is any information provided
concerning what activities are limited. A conclusory statement alone,
with no information about the Claimant and her limitations, will
result in this deficiency being assigned. Is there a connection
between the specific activities that the Claimant can no longer do and
the ACTD/ANDS symptoms that she has? The Claimant's disability must
be due to the Claimant's compensable condition. The Claims Office
must have enough information about what the Claimant's limitations are
and the cause of those limitations to be able to verify that her
condition meets the settlement's requirements for a "B" disability
level.
A: If the Claimant's physician assigned disability level "A," the
Claimant should keep in mind that the settlement's definition of this
assigned disability level is a difficult one to meet. The Claimant
must be unable to do any of her normal activities or only be able to
do a very few of them. The Claimant should review the Claim documents
carefully to ensure that there is enough description of her daily life
and limitations to allow a reader to know that she does indeed meet
this strict definition of total disability. It must be clear that the
Claimant's total disability is due to the symptoms of her applicable
disease or condition.
7.06 Notification of Status for Other Products/Medical Condition.
the Other Products Claimant and her counsel of the results of the
evaluation of the Claim as specified at Section 6.03.
Notification of Status letter shall specifically identify the
deficiency, state whether it is a minor or major deficiency, and
inform the Claimant of procedures for correcting the deficiency and/or
appealing the ruling to the Claims Administrator.
7.07 Notification of Status for Silicone Material Claims.
the Silicone Material Claimant and her counsel of the results of the
evaluation of the Claim as specified at Section 6.04.
Notification of Status letter shall specifically identify the
deficiency, state whether it is a minor or major deficiency, and
inform the Claimant of procedures for correcting the deficiency and/or
appealing the ruling to the Claims Administrator.
7.08 Guidelines for the Timing of Submissions/Time Period to Cure
Deficiencies for Breast
Implant Claims.
Explantation Payment Option Claims must be submitted on or before the
10th anniversary of the Effective Date.
Option submission is not acceptable, the Notification of Status letter
shall so inform the Breast Implant Claimant and her counsel and shall
identify with specificity the deficiencies, state what documentation
is needed to correct the deficiencies, inform the Claimant of the
availability of the Claims Assistance Program and/or the process for
appealing the determination of the Claims Administrator. If the
deficiencies are corrected timely, the Claims Office shall issue a new
Notification of Status letter stating that the Claim has been
approved.
six (6) months from the date of the Notification of Status letter to
cure a deficiency in her Explantation Payment Option Claim.
Claims. Eligible Settling Breast Implant Claimants who do not
otherwise release their Disease Payment Option may apply for Disease
Payment Option benefits at any time on or before the fifteenth
anniversary of the Effective Date.
Option Claims. Except as provided at Section 6.02(d)(iii), the
following defines the deadlines for curing deficiencies in Disease
Payment Option Claims:
date of the Notification of Status letter to cure any deficiency in
the Claim.
deficiency within the one-year period are still eligible to receive
the Expedited Release Payment Option (even if the Expedited Release
Payment Option has concluded).
deficiency within the one-year period shall not be barred from
submitting a Claim and receiving payment for a new compensable
condition that manifests after the conclusion of the one-year period
(provided that the Claimant has not otherwise released all Disease
Payment Option Claims).
relating to the submission of medical documentation and set reasonable
periods during which to conduct the evaluation or re-evaluation of a
Claimant's eligibility and benefits based on supplemental submissions
and for submission of supplemental documentation after notice of
deficiencies. Generally, the Claims Office will not review a
Claimant's submission(s) in response to a deficiency notice more than
twice; however, the Claims Administrator may conduct a third review
after the completion of the review of all other Claims for Disease
Payment Option Benefits.
the Rupture Payment Option Form and supporting documentation set forth
at Section 6.02 on or before the second anniversary of the Effective
Date, except that Claimants explanted within the ninety (90)-day
period preceding the second anniversary of the Effective Date shall
have until thirty (30) days after that deadline to submit the
appropriate Form and supporting documentation.
Payment Option Form or supporting documentation is deficient, the
Claimant shall have six (6) months from the date of the Notification
of Status letter identifying the deficiency to submit additional
documentation to cure the deficiency.
8.01 Error Correction. Claimants who believe the Claims Office made
a mistake may write to the Claims Office detailing the information the
Claimant feels should be corrected. If the Claims Office determines
that it did make a mistake, it will correct the error and notify the
Claimant in writing.
8.02 Error Correction Procedure. The error correction procedure is
an administrative procedure which ensures that the records of the
Claims Office relating to the status of a Claimant's Claim and the
Claim itself are as accurate as possible. It is not the same as the
appeal process set forth at Sections 8.04 and 8.05. The appeal
process at Section 8.04 is only available after all possible
corrections have been made, and the Claimant has submitted all
documentation (s)he wishes to be included in the determination of the
Claimant's eligibility or in the processing of any Claims.
8.03 Record for Appeal. Before a Claimant can appeal, (s)he must
first submit any additional documentation (s)he wishes to have
considered. If, after the Claims Office reviews the supplemental
documentation, the Claimant is still dissatisfied with the
determination, (s)he can appeal to the Claims Administrator by filing
a written document, clearly marked as "Appeal to Claims
Administrator." In that document, the Claimant should identify the
determination with which the Claimant disagrees and state the reasons
for the disagreement.
8.04 Appeals to the Claims Administrator. If the Claimant is
unsuccessful in his/her efforts to cure any deficiencies or if the
Claimant is dissatisfied with the allowed benefits, (s)he may appeal
the decision to the Claims Administrator. The appeal is limited to
the benefit status contained in the Notification of Status letter.
Because there may be multiple Notification of Status letters for each
of the settlement options, Claimants may appeal each of the rulings.
The Claims Administrator shall conduct a de novo review and promptly
issue a ruling in writing to the Claimant and/or his/her counsel. The
Claims Administrator may request further submissions from the
Claimant, or may seek further information from the Claimant's
physicians in deciding the appeal.
8.05 Appeals to Appeals Judge. Claimants who disagree with the
ruling of the Claims Administrator may appeal to the Appeals Judge by
submitting a written statement outlining the Claimant's position and
statement as to why the Claimant believes the Claims Office and Claims
Administrator have erred. The Appeals Judge shall review the appeal
record and Claim file in deciding the appeal. The Appeals Judge shall
apply the guidelines and protocols established in this Annex A to the
Settlement Facility Agreement, including the provisions of the Revised
Settlement Program as adopted by this Annex A, and the appeals process
shall not result in any modification of substantive eligibility
criteria. Any appeal that involves a new interpretation of the
substantive eligibility criteria must be submitted to the Debtor's
Representatives and the Claimants' Advisory Committee consistent with
Section 5.05 of the Settlement Facility Agreement. The Appeals Judge
shall issue a determination on the appeal in writing. The decision of
the Appeals Judge will be final and binding on the Claimant. The
decisions of the Appeals Judge will be served on the Claimant (and
his/her counsel), the Debtor's Representatives, and the Claimants'
Advisory Committee.
8.06 Dow Corning's Role in Appeals. Dow Corning will have the same
right to participate in individual appeals as the manufacturers
participating in the Revised Settlement Program. Dow Corning shall
have no right of appeal or review from determinations made by the
Claims Office.
9.01 Privately-Retained Counsel. Fees and expenses of attorneys
individually retained by Claimants who do not timely elect litigation
will be borne by such persons based on applicable state law and the
individual arrangements made between them and their attorneys, but
subject to the limitations indicated below.
Claimant who elects to participate in the Dow Corning Settlement
Program shall not exceed the sum of:
such Claimant;
such Claimant; and
$50,000 paid to such Claimant.
Payment Option or Expedited Release Payment Option benefits shall not
be counted as amounts paid to a Claimant for purposes of calculating
the above limitations.
advice concerning their rights or to provide services either in
presenting a Claim under the Dow Corning Settlement Program or in
instituting litigation, but they will be responsible for the fees and
expenses of such attorney as explained above. Claimants are not
required to have private counsel to submit Claims under the Settlement
Program.
9.02 Common Benefit/Substantial Contribution Claims. In the event
that the Proof of Claim(s) filed on behalf of and seeking contribution
to the Common Benefit Fund established in Order No. 13 issued by the
MDL 926 Court (In re Silicone Gel Breast Implants Products Liability
Litigation, Order No. 13 (Establishing Plaintiffs' Litigation Expense
Fund to Compensate and Reimburse Attorneys for Services Performed and
Expenses Incurred for the Common Benefit)) is/are withdrawn, then
claims for substantial contribution consistent with the standard under
Section 503(b) of the Bankruptcy Code may be asserted, and neither the
Reorganized Debtor nor the Shareholders will oppose any such claims if
asserted by a member of the Tort Claimants' Committee on the ground
that the claimant is or was a member of the Tort Claimants' Committee.
Nothing in this Section 9.02 will limit the Reorganized Debtor's or
Shareholders' rights to oppose such claim on the merits. The
compensation and/or reimbursement for any substantial contribution
claim shall be determined by the District Court and any amounts
Allowed by the District Court shall be paid by the Trust (subject to
the direction of the Finance Committee) from the Settlement Fund. The
Tort Claimants' Committee agrees to use its best efforts to attain the
withdrawal of the Claim(s) filed on behalf or for the benefit of the
Common Benefit Fund (defined above), and if such Claim(s) is/are not
withdrawn, to oppose the Allowance of any such Claim(s)..
SCHEDULE I
PART I. Breast Implant Claimants
and manufacturer names that may be used in medical records to describe
a Dow Corning Breast Implant. The brand/manufacturer names listed in
Part A below identify a Dow Corning product if the Claimant submits
acceptable Proof of Manufacturer, as defined at Part B of this
Schedule I, Part I.
Claims Administrator shall apply the protocols and procedures
developed in connection with the Revised Settlement Program for
evaluating documentation of manufacturer proof, including procedures
for evaluating Claims submitted with inconsistent, incomplete or
contradictory manufacturer proof.
Brand/Manufacturer Name Status
Cronin Covered: 1963-1971
Dow Corning, Dow Corning Wright, DC, or DCW Covered
Mueller, V. or V. Mueller Covered for implants implanted after
1/1/68 and before 8/31/74
SILASTIC or Silastic Covered
SILASTIC II or Silastic II Covered
SILASTIC MSI or Silastic MSI Covered
Varifil Covered
If the medical or hospital records says only "silastic-type" (lower
case) without any additional identifying information (e.g., lot or
catalog number) Not Covered
"silastic" — in all lower case letters — contained in the
contemporaneous operative report for breast implantations occurring
prior to 1969 provided there is no other information in the Claimant's
records inconsistent with a Dow Corning product. This shall be used
as a brand name only if the Claimant does not have explant records
demonstrating a unique identifier. Covered.
"silastic" — in all lower case letters — for implantations during or
after 1969. Not Covered.
the types of proof that shall be acceptable proof:
report of the surgery — written at or near the time of the
implantation surgery — that specify a Dow Corning brand name or Dow
Corning as the manufacturer, as specified in Part A above.
medical records that contain the implant package label demonstrating a
Dow Corning Breast Implant. Note: a certified copy is only required
if the label —
affirmatively reveal it to be a part of the Claimant's hospital or
medical records and
serial number, or catalog number on it.
implant label/sticker clearly comes from the hospital's
contemporaneous record of the implant surgery, has other information
relating to the claimant's hospitalization on that page, and has
sufficient patient identification for the Claims Office to tell that
it came from the Claimant's records, it falls into the acceptable
proof category of contemporaneous hospital records, and does not have
to be certified. If the hospital records are organized so that the
implant label/sticker was put on a page by itself, it must be
certified.
lot, serial or catalog number. The Claims Office will maintain a list
of these numbers, to ensure that no duplicates are used. These labels
do not have to be certified.
written at the time of the implantation surgery — that specify a Dow
Corning brand name or Dow Corning as the manufacturer as set forth in
this Schedule I, Part I, Section A.
implanting physician (or a responsible person at the treating facility
where the implantation took place) attesting that the Claimant was
implanted with a Dow Corning Breast Implant. The person making this
affirmative statement must also provide the basis for that conclusion.
This type of proof is acceptable only if the records outlined in
subparagraphs 1 and 2 above are not available, and must include a
description of what steps were taken to secure the types of proof
outlined in subparagraphs 1 and 2 above and explain why those records
were not available. The statement of steps taken can be provided by
the Claimant's counsel. This statement cannot rest upon unacceptable
proof as noted in at Section E below.
by the implanting physician reasonably close to the date of the
surgery, naming the type of implant used as set forth in this Schedule
I, Part I, Section A.
physician (or other physician or appropriate professional who examined
the Claimant's implant during or after removal surgery) — written at
the time of the examination of the Breast Implant — if that physician
or other appropriate professional points out a specific characteristic
of the Breast Implant that is on the list of characteristics unique to
Dow Corning implants as specified at Section D, below.
Implant that shows one of the characteristics unique to a Dow Corning
Breast Implant, as specified at Section D, below, if the photograph is
accompanied by a statement from the explanting physician identifying
the Breast Implant in the photograph as one (s)he removed from the
Claimant.
control sheets, with cross-references to the Claimant, that reasonably
appear to be contemporaneously kept records in the hospital or
implanting physician's office.
contained in the Claimant's medical or hospital records relating to
the implant surgery. If the Claims Office cannot determine that the
invoice or packing list actually was included in those records, they
may require a certified copy of the records or a supplemental
statement from the records custodian.
or style of implant circled or otherwise marked, if contained in a
certified copy of the Claimant's medical or hospital records relating
to the implant surgery which were compiled and/or produced before or
about the time of that surgery.
Claimant and dated close to the date of the implantation surgery,
accompanied by other contemporaneous medical or hospital records
verifying that the implantation surgery actually occurred and
identifying Dow Corning as the manufacturer of the Breast Implant.
Dow Corning to the Claimant, her representative or her physician
acknowledging that the Claimant's breast implants were manufactured by
Dow Corning.
participation in Dow Corning's PREP program as documented by a signed
PREP brochure, statement, or similar document if contained in a
certified copy of the Claimant's contemporaneous medical or hospital
records.
Assistance Program (after March 1992) documented by correspondence
enclosing payment for uninsured medical expenses issued under the
program based on receipt of proper documentation. If the Claimant is
identified by Dow Corning as having participated in the Removal
Assistance Program, the Claimant need not submit additional proof.
Record/Requirements for Certified
is a copy of records with a certificate attached, usually signed by
the custodian of records for that office or facility, affirming that
the attached pages are true and correct copies of records in a
particular patient's file.
the implant package label, the Claimant must provide a certified copy
of the medical records that contain that label.
certified medical records are acceptable. The original certificate
and original records do not have to be submitted as long as a
photocopy is submitted.
identifiers of a Dow Corning Breast Implant(s) shall be considered as
acceptable proof where the removed implants are examined by a
physician who identifies the manufacturer or brand. See paragraph 7
of Section B above:
manufactured between 1969 and 1973 a high profile contour "ski slope"
design implant with Dacron® fixation patches on the posterior with the
upper portion of the implant being concave and the bottom portion
convex. If the fixation patch has detached from the implant, then the
Claims Office shall accept and shall deem as acceptable proof a
photograph of the implant showing an imprint consisting of 3-4 linear
impressions of the Dacron® mesh embedded in the elastomer shell.
white Dacron® knit mesh loops were either sewn or bonded to the
elastomer patch surface with the fixation patches in turn bonded to
the envelope posterior. Products with the following configurations
of fixation patches are acceptable:
manufactured between 1963 and 1965, a single large Dacron®
mesh-reinforced fixation patch covering all or almost all of the
posterior implant surface of a silicone gel-filled implant with a
prominent non-everted peripheral seam where the fixation patch is
constructed of Dacron® mesh-reinforced silicone elastomer sheeting to
which non-embedded Dacron® mesh had been sewn with Dacron® sutures.
(1963-1965)
manufactured between 1963 and 1969, four (4) Dacron® mesh-reinforced
fixation patches, one in each quadrant on the posterior implant shell,
asymmetric or symmetric, with a distinct peripheral seam everted or
non-everted, where the fixation patches are constructed of Dacron®
mesh-reinforced silicone elastomer sheeting to which non-embedded
Dacron® mesh has been sewn with Dacron® sutures.
manufactured between 1968 and 1982, two (2) to five (5) circular
Dacron® mesh fixation patches on the posterior implant shell of the
embedded/pleated design, consisting of a clear elastomer disc about
22-25mm diameter, with a pattern of embedded Dacron® mesh in a pleated
pattern, with the actual Dacron® mesh present or absent.
manufactured between 1968 and 1976, a dumbbell-shaped Dacron®
mesh-reinforced fixation patch on the posterior implant shell,
together with one, three, or four additional round fixation patches on
the implant shell. Internal to the dumbbell-shaped fixation patch are
either two round shell holes (one larger than the other) separated by
a slit in the shell, or a single round shell hole.
between 1971 and 1975, an eccentrically placed racetrack (oval) shaped
posterior shell patch, Dacron® mesh-reinforced, outside the implant
shell. Internal to the patch are either two round shell holes (one
larger than the other) separated by a slit in the shell, or a single
round shell hole.
proximal round part, attached to which is a distally rounded leaflet
valve. The junction of the proximal and distal parts of the valve is
also rounded (flared). (This identifier applies to Saline implants
implanted or manufactured between 1979-1984; and to gel/saline
implanted between 1981-1992)
as an imprinted logo on the posterior (for double-lumen implants such
markings are only present on the inner lumen patch):
1992)
and (b) Designation Number imprinted together on the posterior
centered or near the patch of the implant envelope. These shell
markings consist of a single letter or one or two numerals
approximately 4mm height with a close-by series of three or four
approximately 2mm height numerals. For double-lumen implants such
markings will be on both shells. The following Mandrel Codes and
Designation Numbers are acceptable:
20, 30, 40, 50, 60 or single uppercase letters A-R) (1969 to 1992) and
(three, or rarely four, digit numbers where the characters are
between 1/16 inch and 5/64 inch (1.5 mm to 2.0 mm) in height (1974 to
1992).
orientation bar (a linear raised strip of elastomer permanently bonded
to the posterior of the shell of contour shaped implants) aligned with
the long axis of the implant (1975 to 1986).
surface covered by tiny micro pillars (1989 to 1992).
proof will be eligible for the Settlement Program. The following
examples will be considered unacceptable proof of a Dow Corning Breast
Implant.
of a friend or relative) regarding the brand name or manufacturer of
her implants.
Registry.
who examined the implants during or after removal surgery, if
identifiers not on the list of unique identifiers found herein at
section D above are the basis of the identification, or the physician
fails to specify the characteristics assumed to be unique, or the
physician merely opines, based on his or her experience, that the
prosthesis was made by a certain manufacturer.
implanting physician, attempting to supply the acceptable proof found
in section B above but qualifying the affirmative statement concerning
the type of implant used in a particular patient by phrases like "if I
remember correctly" or "to the best of my memory." Statements from
medical personnel describing their typical or general practices
concerning implant usage during a given time period will be
unacceptable proof (For example, a statement from the doctor's nurse
that "we usually used Dow Corning implants").
implanting physician, attempting to provide the acceptable proof set
forth in section B above, that does not name the Claimant as a person
receiving a particular type or brand of implant will be treated as
unacceptable proof.
manufacturer of implants the surgeon planned to use, without
confirmation from the implanting physician (or in records relating to
the implant surgery) that type of implant was actually used.
fully with the Claims Office, including the staff members working in
the Claims Assistance Program and individual Claimants in providing
assistance for and acceptance of manufacturer identification of Dow
Corning Breast Implants, including using its best efforts to provide a
list of physicians and hospitals to whom Dow Corning sold Breast
Implants, listing the time frame of sales to these physicians or
hospitals, and providing a list of lot numbers, serial numbers, and
any other identifying information about Dow Corning Breast Implants.
The Reorganized Dow Corning will also review, at the request of the
Claims Office and/or the Claims Assistance Program, Proof of
Manufacturer submissions that do not meet the standard for acceptable
proof. The Reorganized Dow Corning's agreement to accept individual
submissions shall have no precedential effect with respect to any
other Claims unless expressly agreed to in writing by Reorganized Dow
Corning and the Claimants' Advisory Committee. The Reorganized Dow
Corning and the Claimants' Advisory Committee will provide a joint
training session for the Claims Office on Proof of Manufacturer for
Dow Corning products.
PART II. Other Products Claims
Parts A and B of this Schedule I, Part II lists the implant brands and
manufacturer names that may be used in medical records to describe a
Dow Corning Other Product. The following brand/manufacturer names
identify Dow Corning products if (i) the form of acceptable proof is
as specified at Sections D and F below; (ii) it is clear from the
Claimant's records as a whole (including product descriptions and any
lot or catalog references) that the brand/manufacturer name was used
in those records to signify a Dow Corning product and not simply as a
generic statement signifying the use of an other product implant
(examples of generic references include the terms "silastic-type" and
"silastic" (all lower case)); (iii) there is nothing in the records
that is inconsistent with the conclusion that the brand/manufacturer
name is a Dow Corning product; and (iv) the dimensions, design, shape,
chemical make-up and unique identifiers are consistent with a Dow
Corning product. Examples of inconsistent information include lot,
size, catalog number, brand or style descriptions that do not describe
any known Dow Corning product or that are consistent with another
manufacturer's product.
they appear in the medical records together with an acceptable product
name.
Product Names Years Dimensions
Hip or Knee Joint Dimensions provided as necessary to
the Claims Office.
Chin
Small
Med. Small
Medium
Large Length
(mm)
30
34
38
48 Width
(mm)
5
7
8
8
1968 - 1992
( mm)
21
27
33
42 Width
(mm)
3
5
7
9
1978 - 1992
Q7-2307 1978 - 1992
Nose -- (Solid Elastomer) Implant
1965 - 1992
Small
Medium
Large Length
(mm)
29
29
29 Depth
(mm)
4.8
6.0
8.0
Technique
1965 - 1992
(Shirakabe Design)
1982-1992 Length Length Width
Size (mm) (mm) (mm)
I, II, III 35 60 9.5
& Soft
Testicular
Youth
Adult Diameter x Height
2 cm 2 ½ cm
2 ½ cm 3 ½ cm
1963-1972
1963-1972 . (Gel Filled) Type Initial
Product Model
(Lattimer Design) 1972-1979
Size
Child
Youth
Adult
(avg)
Adult
(lge) Width
(cm)
2.0
2.4
2.8
3.0 Height
(cm)
2.5
3.4
4.2
4.7
Implant, (Lattimer Design) 1972-1979
Implant II, (Lattimer Design) 1979-1992
II, (Lattimer Design) 1979-1992
Penile No inflatable silicone penile prostheses are Dow Corning
products
Design) 1967 - 1973 Length Width Height
12cm 10mm 12mm
1967 - 1973
1968 - 1973 Length Width
1973
Width Width
Size (cm) (cm) (cm)
Small 10.5 2.22 1.71
Medium 11.7 2.22 1.69
Large 13.1 2.22 1.68
1984
Design) 1978 - 1984
Design, Patent Number 3,991,752) 1978 - 1984
labeling)
Design) 1978 - 1991 Length
Size (mm) (mm) (mm)
10 mm 80 120 10
11 mm 90 110 11
labeling)
H.P. (Subrini Design) 1979 - 1991
Temporomandibular Joint
of paddle-shaped SILASTIC® silicone sheeting manufactured by Dow
Corning) 1987 - 1992 (in mm)
Size 1 50 20 0.8
Size 2 55 22 0.8
Size 3 61 24 0.8
constructed of paddle-shaped SILASTIC® silicone sheeting manufactured
by Dow Corning) of:
8" x 6" x .005" Non-Reinforced
8" x 6" x .007" Reinforced
8" x 6" x .040" Non-Reinforced,
6" x .020"
Angled Great Toe
MODIFICATION 1978 - 1993 Oval Shape (3 sizes)
Short Diameter: 13 - 16 mm
Long Diameter: 15 - 18 mm
Stem Length: 12 - 17 mm
Great Toe
Oval Shape (5 sizes)
Short Diameter: 12 - 18 mm
Long Diameter: 14 - 21 mm
Overall Length: 18 - 28 mm
1993 Oval Shape (5 sizes)
Short Diameter: 11 - 17 mm
Long Diameter: 13 - 20 mm
Overall Length: 18 - 32 mm
1984 - 1993 Oval Shape (5 sizes)
Short Diameter: 11 - 17 mm
Long Diameter: 13 - 20 mm
Overall Length: 18 - 32 mm
1993 Oval Shape Head (5 sizes)
Overall Height: 12 - 17 mm
Head Length: 13 - 20 mm
Head Width: 11 - 17 mm
Hammertoe
1982 - 1986 (7 sizes)
Diameter: 6 - 8 mm
Stem length: 8.4 - 9.1 mm
Width: 2.0 - 5.3 mm
DESIGN 1987 - 1992 (7 sizes)
Diameter: 6 - 8 mm
Stem length: 8.4 - 9.1 mm
Width: 2.0 - 5.3 mm
Flexible Hinge Toe
1978 - 1985 (14 sizes)
Length: 28 - 73 mm
Width: 8 - 21 mm
Thickness: 5 - 12 mm
stems) 1986 - 1993 (14 sizes)
Length: 28 - 73 mm
Width: 8 - 21 mm
Thickness: 5 - 12 mm
Stem) 1986 - 1993 (6 sizes)
Length: 37 - 51 mm
Width: 16 - 20 mm
Thickness: 8 - 11 mm. Wrist
1974 (5 sizes)
Length: 75 - 137 mm
Width: 16 - 28 mm
Thickness: 7 - 10 mm
1985 (5 sizes)
Length: 75 - 137 mm
Width: 16 - 28 mm
Thickness: 7 - 10 mm
1982 - 1985 (5 sizes)
Length: 75 - 137 mm
Width: 19 - 35 mm
Thickness: 7 - 10 mm
MID-SECTION WITH SHORT DISTAL STEM) 1986 - 1993 (5 sizes)
Length: 63 - 109 mm
Width: 19 - 35 mm
Thickness: 7 - 10 mm
MID-SECTION WITH SHORT DISTAL STEM WITH GROMMETS) 1991 - 1993
(5 sizes)
Length: 63 - 109 mm
Width: 19 - 35 mm
Thickness: 7 - 10 mm
Carpal Lunate
1976 (3 sizes)
Length (Head): 15 - 18 mm
Width (Head): 12 - 16 mm
Length (Stem): 8 - 10 mm
1977 -1990 (5 sizes)
Length (Head): 15 - 20 mm
Width (Head): 15 - 19 mm
Length (Stem): 6 - 8 mm
1987 - 1993 (5 sizes)
Length (Head): 15 - 20 mm
Width (Head): 15 - 19 mm
Length (Stem): 6 - 8 mm
Carpal Scaphoid
1977 (3 sizes, right; 3 sizes, left)
Width: 13 - 16 mm
Thickness: 10-12 mm
DESIGN) 1987 - 1993 (5 sizes, right; 5 sizes, left)
Width: 11-18 mm
Thickness: 9-15 mm
(no stem)
(7 sizes, right; 7 sizes, left)
Width: 16-24 mm
Thickness: 11-18 mm
Stem Length: 6-9 mm
1988 - 1993 (5 sizes, right; 5 sizes, left)
Length: 25 - 32 mm
Width: 12 - 16 mm
Thickness: 10 - 13 mm
Radial Head
1975 (3 sizes)
Overall Length: 35-43 mm
Diameter (Head): 19-24 mm
Height (Head): 10-15 mm
1986 (8 sizes, includes x-long)
Overall Length: 32-55 mm
Diameter (Head): 19-23 mm
Height (Head): 10-22 mm
(8 sizes, includes x-long)
Overall Length: 32-55 mm
Diameter (Head): 19-23 mm
Height (Head): 10-22 mm
Scapholunate
sizes, left; 4 sizes, right)
Length: 34 - 42 mm
Width: 16 - 19 mm
Thickness: 15 - 19 mm
Trapezial
1979 - 1993 (2 sizes)
Head Diameter: 16-19 mm
Stem Diameter: 5-9 mm
Stem Length: 5.3 mm
Trapezium
(5 sizes)
Length: 29-46 mm
Diameter (Head): 13-17 mm
Thickness (Head): 9-14 mm
1986 (5 sizes)
Length: 27-43 mm
Diameter (Head): 12-16 mm
Thickness (Head): 9-13 mm
(5 sizes)
Length: 27-43 mm
Diameter (Head): 12-16 mm
Thickness (Head): 9-13 mm
sizes)
Length: 27-43 mm
Diameter (Head): 12-16 mm
Thickness (Head): 9-13 mm
Ulnar Head
1975 (4 sizes)
Overall Length: 27-41 mm
Height (Head): 13-19 mm
1986 (8 sizes)
Overall Length: 32-50 mm
Diameter (Head): 8-16 mm
Height (Head): 14-25 mm
(7 sizes)
Overall Length: 30-43 mm
Diameter (Head): 9-15 mm
Height (Head): 12-18 mm
Condylar
1993 (13 sizes)
Oval Shape
Overall Height: 8-26 mm
Head Length: 6-18 mm
Head Width: 4-16 mm
Tendon Passer
1993 (1 size)
Oval Shape Head
Overall Length: 181 mm
Head Length: 6.7 mm
Head Width: 5.3 mm
Tendon Spacer
1993 (4 sizes)
Oval Cross Section
Length: 240 mm
Short Width: 1.5-3 mm
Long Width: 3-6 mm
Finger Joints
1974 (8 sizes)
Length: 30-74 mm
Width: 11-17 mm
Thickness: 5-9 mm
1985 (11 sizes)
Length: 25-81 mm
Width: 8-18 mm
Thickness: 3-10 mm
(11 sizes)
Length: 25-81 mm
Width: 8-18 mm
Thickness: 3-10 mm
Grommets) 1986 - 1993 (11 sizes)
Length: 25-81 mm
Width: 8-18 mm
Thickness: 3-10 mm
sizes)
Head Diameter: 9-14 mm
Overall Length: 19-26 mm
Stem Length: 13-17 mm
product-specific unique identifiers together with dimensions, design,
shape and chemical make-up shall be considered acceptable proof where
the removed implants are examined consistent with the standard of
acceptable proof as specified at Section D, below.
following logos etched or engraved on the implant during manufacture
as visible on the explanted device:
FOLLOWING LOGO:
solid silicone chins.
implants, a one centimeter (1cm) triangular patch of DACRON® velour
fabric placed in the center of the posterior side of the implant with
the base of the triangle sitting at the midline of the implant.
nose or face implants.
elastomer testicular implants.
testicular implants (1972-1979), a DACRON® woven fabric reinforced
fixation tab located on one exterior end of the ovoid-shaped device.
The initial design had the fixation tab with square corners (years)
later modified with round corners (years).
implants (Lattimer Design, 1979-1991), if the medical record
references a removable Teflon® insert strip in the suture loop.
penile implants.
prostheses were made by Dow Corning.
consistent with a Dow Corning product
scaphoid, great toe or grommets constructed of titanium metal.
paddle-shaped silicone sheeting with catalog and lot numbers
(together) specific to Dow Corning.
acceptable proof, based on implantation records, that the Other
Product was manufactured by Dow Corning:
surgery — written at or near the time of the implantation surgery —
that specify a Dow Corning brand name or Dow Corning as the
manufacturer, as specified at this Schedule I, Part II, Sections A and
B.
records that contains the implant package label demonstrating a
Covered Implant. Note: a certified copy is only required if the
label:
reveal it to be a part of the Claimant's hospital or medical records,
and
number and lot number together on it.
label/sticker clearly comes from the hospital's contemporaneous record
of the implant surgery, has other information relating to the
claimant's hospitalization on that page, and has sufficient patient
identification for the Claims Office to tell that it came from the
Claimant's records, it falls into the acceptable proof category of
contemporaneous hospital records, and does not have to be certified.
If the hospital records are organized so that the implant
label/sticker was put on a page by itself, it must be certified.
or catalog number accompanied by sufficient hospital records to
determine that the Dow Corning product was actually implanted into the
Claimant. The Claims Office will maintain a list of these numbers, to
ensure that no duplicates are used.
the time of the implantation surgery — that specify a Dow Corning
brand name or Dow Corning as the manufacturer as set forth in this
Schedule I, Part II.
physician attesting that the Claimant was implanted with an Other
Product. The physician making this affirmative statement must also
provide the basis for that conclusion. This type of proof is
acceptable only if the records outlined in (a), (b), (c), or (d) above
are not available, and must include a description of what steps were
taken to secure the types of proof outlined in (a), (b), (c), or (d)
above and explain why those records were not available. This
statement cannot rest upon unacceptable proof as noted in Section F,
below.
implanting physician reasonably close to the date of the surgery,
naming the type of implant used as set forth in Schedule I, Part II.
sheets, with cross-references to the Claimant that reasonably appear
to be contemporaneously kept records in the hospital or physician's
office.
Claimant and dated close to the date of the implantation surgery,
accompanied by other contemporaneous medical or hospital records
verifying that the implantation surgery actually occurred and
identifying Dow Corning as the manufacturer of the implant.
the Claimant's medical or hospital records relating to the implant
surgery. If the Claims Office cannot determine that the invoice or
packing list actually was included in those records it may require a
certified copy of the records or a supplemental statement from the
records custodian.
authorized Dow Corning representative specifically acknowledging that
the Claimant's implants were manufactured by Dow Corning.
Records/Requirements for Certified Records.
is a copy of records with a certificate attached, usually signed by
the custodian of records for that office or facility, affirming that
the attached pages are true and correct copies of records in a
particular patient's file.
the implant package label, the Claimant must provide a certified copy
of the medical records that contain that label.
certified medical records are acceptable. The original certificate
and original records do not have to be submitted as long as a
photocopy is submitted.
Specified unique identifiers of Dow Corning Small Joint Orthopedic
Implants and Large Joint Orthopedic Implants shall be considered
acceptable proof when demonstrated as specified at paragraphs (a),
(b), and (c) below.
created at or within 30 days of the time of explantation, that
describe a Unique Identifier from Section C of this Schedule I, Part
II of a Dow Corning Large Joint Orthopedic Implant or Small Joint
Orthopedic Implant product.
one of the Unique Identifiers of a Dow Corning Large Joint Orthopedic
Implant or Small Joint Orthopedic Implant as set forth at Schedule I,
Part II, Section C. The photograph must be accompanied by a statement
from the explanting physician identifying the implant in the
photograph as one (s)he removed from the claimant. The photograph must
also be accompanied by statement advising of whether this implant has
been preserved. The Claims Administrator may require the presentation
of a removed implant if preserved.
identity and location of the custodian of the implant. The Claims
Administrator may require the presentation of the removed implant(s)
for examination by an individual or entity designated by the Claims
Administrator.
herein as acceptable proof or proof expressly agreed to by Dow Corning
in a writing provided to the Claims Office will be sufficient to
establish Proof of Manufacturer of a Dow Corning Other Product. Any
other proof will be deemed unacceptable proof of a Dow Corning
implant. The following are examples of unacceptable proof:
friend or relative) regarding the brand name or manufacturer of
his/her implants.
supply the acceptable proof at Section C above if identifiers not on
the list of unique identifiers are the basis of the identification, or
the physician fails to specify the characteristics assumed to be
unique, or the physician merely opines, based on his or her
experience, that the prosthesis was made by a certain manufacturer.
physician qualifying the statement concerning the type of implant used
in a particular patient by phrases like "if I remember correctly" or
"to the best of my memory." Statements from physicians describing
their typical or general practices concerning implant usage during a
given time period will be unacceptable proof (for example, a statement
that "we usually used Dow Corning implants").
physician, attempting to provide the acceptable proof set forth in
Section D (e), above, that does not name the Claimant as a person
receiving a particular type or brand of implant will be treated as
unacceptable proof.
implants the surgeon planned to use, without confirmation from the
implanting physician (or in records relating to the implant surgery)
that type of implant was actually used.
capitalization of the first letter and other indications of a Dow
Corning product shall be unacceptable proof that a Dow Corning product
was used in the Claimant.
number, brand name, dimensions, chemical make-up and unique
identifiers consistent with a non-Dow Corning implant.
including the staff of the Claims Office by providing a list of lot
numbers, catalog numbers and any other identifying information about
Dow Corning Other Products.
PART III. Silicone Material Claimants
Settlement Program for Silicone Material Claimants, the
brand/manufacturer names listed at Exhibit G to the Revised Settlement
Program (as reproduced at Section C. below) and Exhibit G2 to the
Foreign Revised Settlement Program (as reproduced at Section D. below)
as attributable to Baxter, Bristol, Cox-Uphoff, Mentor or Bioplasty
shall identify a breast implant product covered under the Silicone
Material Claimant Settlement Program if the Claimant submits
acceptable Proof of Manufacturer as defined at Section B below.
acceptable under the Revised Settlement Program along with the unique
identifiers specified in the Revised Settlement Program for breast
implants manufactured by the entities listed at Section A above shall
be acceptable Proof of Manufacturer for purposes of the Silicone
Material Claimant Settlement Program. The types of proof identified
as unacceptable proof under the Revised Settlement Program for such
manufacturers shall be deemed as unacceptable proof for purposes of
the Silicone Material Claimant Settlement Option.
(Adjusted to include only those Identified as Baxter, Bristol,
Cox-Uphoff (CUI), Mentor, or Bioplasty.)
The left-hand column is a list of companies, implant brands,
"designer" implant names, and other names or phrases that might be
used in medical records to describe a particular type of breast
implant. The column to the right identifies the company with which
that brand is associated for purposes of the Revised Settlement
Program. If implantation date ranges are supplied for an implant, an
appropriate notation is to the right of each date range.
Implants noted as Mentor that have a star (*) before Mentor will be
treated as Baxter implants if a Baxter lot number can be supplied for
that implant.
Brand/Manufacturer Name Status in Revised Program
3M 3M
AHS Baxter
Aesthetech Bristol
American Heyer-Schulte Baxter
American Hospital Supply Baxter
Ashley
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Baxter Baxter
Becker Mentor
Biomanufacturing Bioplasty
Bio-oncotic Bioplasty
Bioplasty Bioplasty
Birnbaum Baxter
Capozzi
Implanted before 9/1/71
Implanted after 8/31/71
Bristol
Baxter
Cavon Bristol
CBI Medical Bristol
Cooper Surgical Bristol
Corbet Bristol
Cox Uphoff CUI
CZV/CRS (Croissant Versafil Low Profile) CUI
Dahl Bristol
Directa Span Mentor
DRI CUI
DRIE CUI
Edward Laboratories Baxter
EHP (Enhanced High Profile) CUI
Edward Weck & Co.
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Flat Span Mentor
FZV/SFV (Round Versafil LP Tissue Expander) CUI
Georgiade Bristol
Gibney CUI
Guthrie
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Hartley Baxter
Heyer-Schulte
Implanted before 3/31/84
Implanted after 3/30/84
Baxter
*Mentor
Heyer-Schulte Mentor Mentor
Intrashiel
Implanted before 8/3/84
3M
Intravent CUI
IOC (Cylindrical Intraoperative Tissue Expander) CUI
IOM (Intravent Intraoperative Expander) CUI
IOS (Spherical Intraoperative Tissue Expander) CUI
Isle Mentor
Jenny Baxter
Jobe Baxter
Klein Bioplasty
Mammatech Bioplasty
Mark/M Surgical
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Markham
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Markham Medical Int'l
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
McGhan
Implanted before 8/3/84
3M
MEC Bristol
Medical Engineering Corporation Bristol
Meme Bristol
Meme ME Bristol
Meme MP Bristol
Mentor Mentor
MFE (Man Facelift Expander) CUI
Microcell CUI
Misty Bioplasty
Misty Gold Bioplasty
Mueller, V.
Implanted 11/1/78 to 3/30/84
Baxter
Munna Bristol
Natrashiel 3M
Natural Y
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Norman Bristol
OHP (Oval High Profile) CUI
OLP (Oval Low Profile) CUI
Optimam Bristol
Pangman Baxter
Papillon Bristol
Perras Bristol
Perras-Papillon Bristol
Polyurethane
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Poly Plastic
Implanted before 9/1/71
Implanted after 8/31/71
Bristol
Baxter
Poly Plastic Adjustable Baxter
Quin-Seal Bristol
Radovan Mentor
RCP (Round Conical Profile) CUI
RCR (Ruiz-Cohen Expanders) CUI
RDD (Reverse Double Lumen DRIE) CUI
RDL (Reverse Double Lumen) CUI
RDL-XPAND CUI
RDX (Round Double Lumen) CUI
Replicon Bristol
Reverse Double Lumen CUI
RHD (Round High Profile) CUI
RHP (Round High Profile) CUI
RLD (Round Low Profile DRIE) CUI
RLP (Round Low Profile) CUI
Roger Klein Bioplasty
RTV/RTT (Smooth/Textured) CUI
Ruiz-Cohen CUI
RZV/SRV (Rectangular Versafil Tissue Expander) CUI
SCC (Cylindrical Tissue Expander) CUI
SCL Bristol
SCS (Crescent Tissue Expander) CUI
SEE (Mini-crescent Tissue Expander) CUI
Seropian Baxter
SFS (Saline Fill Skin and Tissue Expander) CUI
SGO (Saline Gel Oval) CUI
SGR (Saline Gel Round) CUI
Siltex Mentor
Siltex Becker Mentor
Siltex Spectrum Mentor
SLP (Single Lumen Adjustable) CUI
SLS (Longitudinally Curved Tissue Expander) CUI
Snyder Bristol
SOE (Small Oval Tissue Expander) CUI
SOS (Ear Shaped Tissue Expander) CUI
Spectrum Mentor
SPS (Pear Shaped Tissue Expander) CUI
SRS (Rectangular Tissue Expander) CUI
SSS (Spherical Tissue Expander) CUI
Sterling Baxter
Summit Medical Bristol
Surgical Specialties Bristol
Surgitek Bristol
SWS (Wedge Shaped Tissue Expander) CUI
SZR (Round Low Profile Sizer) CUI
Tabari Baxter
Tecknar Mentor
TLL (Triple Lumen Round) CUI
Travenol Baxter
Tri-Lumen CUI
TRL (Tri-Lumen Implants) CUI
TSO (Triple Lumen Low Profile Oval) CUI
TSR (Triple Lumen Round Low Profile) CUI
Uroplasty Bioplasty
Versafil CUI
V. Mueller
Implanted 11/1/78 to 3/30/84
Baxter
Vogue Bristol
Wagner Baxter
Webster Bristol
Weck
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Williams Baxter
Wood Bristol
The left-hand column is a list of companies, implant brands,
"designer" implant names, and other names or phrases that might be
used in medical records to describe a particular type of breast
implant. The column to the right identifies the company with which
that brand is associated for purposes of the Foreign Settlement
Program ("FSP"). If implantation date ranges are supplied for an
implant, an appropriate notation is to the right of each date range.
BRAND/MANUFACTURER NAME STATUS IN FOREIGN SETTLEMENT PROGRAM
3M 3M
AHS Baxter
Aesthetech Bristol
American Heyer-Schulte Baxter
American Hospital Supply Baxter
Ashley
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78 Bristol
Baxter
Bristol
Baxter Baxter
Birnbaum Baxter
Capozzi
Implanted before 9/1/71
Implanted after 8/31/71
Bristol
Baxter
Cavon Bristol
CBI Medical Bristol
Cooper Surgical Bristol
Corbet Bristol
Dahl Bristol
Edward Laboratories Baxter
Edward Weck & Co.
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78 Bristol
Baxter
Bristol
Georgiade Bristol
Guthrie
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
Bristol
Baxter
Bristol
Hartley Baxter
Heyer-Schulte
Implanted before 3/31/84
Implanted after 3/30/84 Baxter
Generally not covered; may be Baxter on special proof--see explanation
following table
Intrashiel
Implanted before 8/3/84
Implanted after 8/2/84
3M
Generally not covered; may be 3M on special proof--see explanation
following table
Jenny Baxter
Jobe Baxter
Mark/M Surgical
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78 Bristol
Baxter
Bristol
Markham
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78 Bristol
Baxter
Bristol
Markham Medical Int'l
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78 Bristol
Baxter
Bristol
McGhan
Implanted before 8/3/84
Implanted after 8/2/84 3M
Generally not covered; may be 3M on special proof--see explanation
following table
MEC Bristol
Medical Engineering Corporation Bristol
Meme Bristol
Meme ME Bristol
Meme MP Bristol
Mueller
Implanted 9/1/74 to 10/31/78
Baxter
Munna Bristol
Natrashiel 3M
Natural Y
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78 Bristol
Baxter
Bristol
Norman Bristol
Optimam Bristol
Pangman Baxter</