AOL File Library: 9,300 to 9,399/9300.zip/AOLDLs/Legal Documents/Silicone Implant Settlement/SILICONE.txt

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Bristol, Baxter, 3M McGhan & Union Carbide Revised
Settlement Program


A. Eligible participants: A non-foreign class member, as
defined in the global settlement, who has or had at least
one implant manufactured or distributed by one of the
settling defendants (or their predecessors and
subsidiaries): Bristol/MEC, Baxter/Heyer-Schulte, 3M,[fn 1]
or McGhan.[fn 2]

      1. Proof of eligibility is to be provided as specified
in II below.

      2. Persons who would other vise be eligible to
participate but for having previously opted out from the
global settlement may participate under the program for
"Other Registrants" if, before 12/16/96 and before
proceeding to trial against a settling defendant, they
withdraw their exclusion and register with the Claims
Office.

      3. Persons are not eligible to participate if their
claims against each of the settling manufacturers from which
they have received implants have been released by settlement
or resolved by final judgment.[fn 3] (If their claims
against a settling defendant have been released or resolved
by final judgment but they also have an implant from another
settling manufacturer, they may participate and be eligible
for prorated benefits paid by the settling defendant(s) with
respect to which there is no release or final judgment).

      4. Children of breast implant recipients are not
eligible with respect to claims of their own personal
injury, and such claims are not released by the recipient's
being in the class. As under the existing settlement,
derivative and representative claims are settled if the
recipient participates in the program, and personal
representatives may act on behalf of deceased or incompetent
class members.
B. Classification of eligible participants:

      1. Current Claimants: eligible participants who mailed
to the Claims Office (a) by 9/16/94 a signed Registration
Form and (b) by 10/17/94 a substantially complete Current
Disease Compensation Form with sufficient documentation to
be classified by the Claims Office under the global
settlement as a current claimant (without regard to whether
any deficiencies in documentation would be classified as
minor or major).

      2.  Other Registrants: eligible participants (a) who
registered with the Claims Office by 3/1/95 but are not
Current Claimants under B1 above or (b) who, having
previously excluded themselves from the global settlement,
withdraw their exclusion and register with the Claims Office
by 12/16/96.

      3. Late Registrants: all other eligible participants
(i.e., all other non-foreign class members with a Bristol,
Baxter, 3M or Post-'84 McGhan implant) who are not Current
Claimants under B1 or Other Registrants under B2 above but
who register with the Claims Office. As under the global
settlement, it is anticipated that at some point the court
will establish a final deadline for persons to register with
the Claims Office.

C. Opt-out Rights of Eligible Participants

      1. Subject to the limitation in C2 below, any eligible
participant may reject the settlement offer by filing an
opt-out election that is received by the Claims Office not
later than 45 days after date of Notification of status of
the participant's registration and claim as provided in I2.
Statutes of limitations and repose will remain suspended for
6 months after the Claims Office receives the opt-out
election.

      2. Late Registrants will not have the opt-out right
described in C1 above unless they register with the Claims
Office by 4/1/96

      3. Current Claimants and Other Registrants may
expedite receipt of the Advance Payments provided in D1 and
E3 below by waiving the opt-out right provided in C1 above.

      4. Certain ongoing opt-out rights are provided in
D2b(2) and E2c below.

D. Benefits for Current Claimants[fn 4]:

      1. Advance Payment. A non-refundable advance payment
of $5,000 will be paid as soon as the Claims Office
determines that a person has not opted out within the time
permitted under C1 (or under C3 has waived the remaining
time to opt out), is a Current Claimant, and has sufficient
manufacturer identification information. Payment will be
made without regard to the status of any appeals relating to
this settlement and without regard to the existence of any
deficiencies in the claim. The $5,000 payment will be
credited against other amounts payable to the claimant under
the settlement or awarded in a judgment recovered against
settling defendants in later litigation,[fn 5] but otherwise
is not refundable unless the Claims Office determines the
claim to have been fraudulently presented.

      2. Compensation. Benefits (less the Advance Payment
under D1 above and subject to reduction under F1 below if
the claimant also has Dow, post-'84 McGhan, or Mentor
implants) to be paid to a Current Claimant, at the
claimant's election, under either Option One or Option Two.

      a. Option One--Fixed Benefits for Current Claimants: A
fixed amount (not increased or decreased by later changes in
claimant's condition) based on disease definitions and
severity/disability categories in the original Disease
Schedule (Exhibit D to global settlement). Upon satisfying
these criteria (and with satisfactory evidence respecting,
implant manufacturer identification), a claimant electing
this option will be paid according to the following schedule
based on the severity/disability level and on whether by
12/16/96 there is appropriate documentation of rupture of a
Bristol, Baxter, or 3M implant. Claims will be processed by
the Claims Office in accordance with all relevant provisions
of the original global settlement.

Option One--Fixed Benefits (Current Claimants Only)

Disability Level - A
Base Amount - $50,000
Supplement if rupture - + $50,000 = $100,000


Disability Level - B
Base Amount - $20,000
Supplement if rupture - + $30,000 = $50,000


Disability Level - C or D
Base Amount - $10,000
Supplement if rupture - + $15,000 = $25,000


     (1) On electing to proceed under Option One, Current
Claimants will, upon satisfying the criteria and approval by
the Claims Office, be paid the specified amount (less the
advance payment) upon full release of all claims against all
settling defendants (and other released parties). The
obligation of settling defendants to pay both the base
amount and the increased amount for ruptures is not affected
by the number or amounts of claims or by the number of
opt-outs. Payments will be made as soon as the claim is
approved and upon execution of a standard-form release,
without regard to the pendency of any appeals. A Current
Claimant initially qualifying only for the base amount will
be paid the rupture supplement (maximum one per claimant) on
proof by 12/16/96 of rupture.

     (2) Payments of $25,000 or less will be paid in a
single lump sum; payments of more than $25,000 will be paid
in two equal annual installments.

     (3)  "Rupture" of a Baxter, Bristol, or 3M
implant--which, if documented by 12/16/96, affects benefit
levels for Current Claimants under Option One--refers to the
failure of the elastomer envelope(s) surrounding a
silicone-gel 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(s) after implantation and prior to the explantation
procedure. To qualify for a rupture supplement, the Claimant
must have undergone an explantation operation at which the
rupture was confirmed and must submit a contemporaneous
operative and/or pathology report (and related statements)
documenting the rupture in accordance with the protocol in
Exhibit F. For explantations after 1/1/96, the claimant
shall use her best efforts to cause the removed implant to
be preserved and, if requested by the Claims Office, to
provide the removed implant to the Claims Office or to an
examiner designated by the Claims Office to resolve or
report on the issue of rupture.

      b. Option Two: As an altemative to Option One, Current
Claimants may choose Option Two for long-term benefits under
E2 below. Benefits under Option Two depend on satisfying
during the 15 year period of the program the more restricted
disease and severity criteria specified in Exhibit E (rather
than the disease and severity/disability categories
specified in the Disease Schedule attached as Exhibit D to
the original global settlement notice). Upon satisfying
these criteria and approval by the Claims Office, the
claimant will be paid in accordance with the schedule shown
in E2 below, depending on the new disease/severity criteria.

     (1) The obligation of defendants to pay approved SS/SLE
benefits under Option Two to a Current Claimant whose claim
for SS/SLE under the global settlement would have been
either approved or treated as having only minor deficiencies
(and to pay approved GCTS/PM/DM benefits under Option Two to
a Current Claimant with any claim that under the global
settlement would have been approved or treated as having
only minor deficiencies) is not affected by the number or
amounts of claims, by the number of opt- outs, or by the
maximum cumulative obligations of settling defendants under
E2c below; and, upon execution of mutually satisfactory
releases with individual claimants, the settling defendants
will pay these amounts without regard to the pendency of any
appeals relating to this settlement.

     (2) Current Claimants who elect and qualify for
compensation under Option Two will be treated as also
eligible, during the 15 years of the program, for additional
compensation in the same manner as for Other Registrants and
subject to the provisions of E2c. That is, if a Current
Claimant who receives a payment under Option Two later
develops during the 15 years of the program a condition that
would entitle her to a larger amount, she would at that time
be entitled to the difference between the new compensation
amount and any amount previously paid. If at that time she
does not receive this increase because of the maximum
cumulative obligations of the defendants under E2c below,
she would have the same opt-out right as stated in E2c.

     (3) Current Claimants electing Option Two may, at any
time during the 15 year period of the program before being
awarded benefits under Option Two, elect to return to Option
One but with a 25 % reduction in the amount they would
otherwise receive under Option One.

3.  Post-'84 McGhan implants. Current Claimants with only
Post-'84 McGhan implants (or only Post-'84 McGhan implants
plus implants from Bioplasty, Cox Uphoff/CUI or Mentor)
shall be eligible for Option One benefits as set forth in
D2a above, excluding rupture supplements. Payments to such
claimants are not payable until 30 days after the Court's
Final Order with respect to this Revised Settlement Program
becomes final. Thereafter, payments will be made to
claimants with approved claims upon execution of a standard
form release.

E. General Benefits for Participants

      1. Explantation expenses. Although not recommending
explantation absent some specific medical reason to do so,
the settling defendants will pay $3,000 to Current Claimants
and Other Registrants who, after 411194 and within the 15
years of the program, have a Bristol, Baxter, or 3M implant
removed (without the surgery also involving reimplantation
of a silicone-gel implant).

      a. The obligation of settling defendants to make this
payment is not affected by the number or amounts of claims
or by the number of opt-outs, or by the amount of money paid
as benefits under E2 below. This $3,000 payment is not
subject to refund (unless the participant later elects to
opt-out under C1), but would be credited against any
judgment against settling defendants in subsequent
litigation by the participant.[fn 6]

      b. Payment of these expenses does not reduce the
amount of a participant's benefits under E2 (or the amount
of benefits for Current Claimants under Option One).

      c. Explantation expenses are not payable to "Late
Registrants".

      d. Although intended only as means to defray medical
costs of explantation, the amount will not be reduced as a
result of the person actually incurring less than $3,000 in
expenses, whether as a result of a smaller charge for the
explantation procedure or as a result of insurance or
governmental health programs.

      e. In addition, as an optional alternative to the
$3,000 assistance offer, the settling defendants in the
future may provide a list of surgeons willing to perform
explantations, if the claimant so chooses, without any
charge personally to the claimant.

      2. Compensation. On proof of satisfying, during the
15-year period of the program, the revised disease and
severity criteria specified in Exhibit E, eligible
participants will be paid (subject to reduction under F1
below if the participant also has Dow, Post-'84 McGhan, or
Mentor implants) compensation under the following
schedule,[fn 7] depending on the new disease/severity
criteria.


Option Two -- Long-Term Benefits

Disease -- Severity Level: SS/SLE--A
Amount: $250,000

Disease -- Severity Level: SS/SLE--B
Amount: $200,000

Disease -- Severity Level: SS/SLE--C
Amount: $150,000

Disease -- Severity Level: GCTS/PM/DM--A
Amount: $110,000

Disease -- Severity Level: GCTS--B
Amount: $75,000


      a. Benefits are to be paid in annual installments (as
needed) of $100,000. These benefits are in addition to any
payment related to explantation under E1 above.

      b. If during the 15 years of the program the person
develops a condition that would entitle her to a larger
amount than she has previously received, she would at that
time be entitled to the difference between the new
compensation amount and any amount previously paid.

      c. The maximum obligation of the defendants to make
payments under this program (E2) is $755,000,000 (less
amounts paid for explantation expenses of Other Registrants
under E1 above[fn 8]), with obligated payments as follows:

 --  Bristol's cumulative obligation under E2 ($400,000,000)
increases in the amount of $27,600,000 per year for the
first 10 years and $24,000,000 per year for the next 5 years
(less amounts paid by it for explantation expenses of Other
Registrants under E1)

--  Baxter's cumulative obligation under E2 ($193,000,000)
increases in the amount of $13,300,000 per year for the
first 10 years and $12,000,000 per year for the next 5 years
(less amounts paid by it for explantation expenses of Other
Registrants under E1)

--  3M's cumulative obligation under E2 for 3M implants
($132,000,000) increases in the amount of $9,100,000 per
year for the first 10 years and $8,200,000 per year for the
next 5 years (less amounts paid by it for explantation
expenses of Other Registrants under E1)

--  3M's cumulative obligation under E2 for Post-'84 McGhan
implants ($12,000,000) increases in the amount of $800,000
per year for 15 years (less the amount, if any, that its
payments under D3 for Post-'84 McGhan implants exceed
$76,800,000)

--  McGhan's cumulative obligation under E2 for Post-'84
McGhan implants ($6,000,000) increases in the amount of
$400,000 per year for 15 years (less the amount, if any that
its payments under D3 for Post-'84 McGhan implants exceed
$38,400,000)

--  Union Carbide's cumulative obligation under E2 for
Post-'84 McGhan implants ($12,000,000) increases in the
amount of $800,000 per year for 15 years (less the amount,
if any, that its payments under D3 for Post-'84 McGhan
implants exceed $76,800,000)

If these cumulative limitations in any year result in any
participant not being paid the full amount (or installment)
shown in the schedule, then such person would at that time
have the option either (1) to accept a reduced amount based
on the defendant's obligated payment (with a carry forward
of the unpaid portion for potential payment in future years
if within the defendant's obligated payments) or (2) to opt
out from the settlement, with the rights to pursue
litigation against the settling defendants for compensatory
damages (but not punitive or statutory multiple damages).
Participants electing to opt out (a) must first return any
amounts previously paid under the program (other than for
explantation expenses or, for Current Claimants, as an
Advance Payment) and (b) shall be given the opportunity, if
they so elect, to participate in non- binding mediation, in
accordance with procedures to be established by the court,
in an effort to resolve their claims.

      d. Benefits to Late Registrants under this program
will, as under the terms of the global settlement, be paid
only if, when, and to the extent the defendant's cumulative
payment obligations under this program exceed the payments
to other participants claiming under this program; and such
Late Registrants will have no right to opt out because of
failure to receive the full amount shown in the schedule.

      3. Advance Payment. A non-refundable advance payment
of $1,000 will be paid as soon as the Claims Office
determines that a person has not opted out within the time
permitted under C1 (or under C3 has waived the remaining
time to opt out). is an Other Registrant, and has sufficient
manufacturer identification information of having had a
Bristol. Baxter, or 3M implant. Payment will be made without
regard to the status of any appeals relating to this
settlement and without regard to the existence of any
deficiencies in the claim. The $1,000 payment will be
credited against other amounts payable to the claimant under
the settlement or awarded in a judgment recovered against
settling defendants in later litigation,[fn 9] but otherwise
is not refundable unless the Claims Office determines the
claim to have been fraudulently presented.

F. Multiple Implants

      1. Amounts payable are, in general, not diminished by
a person's having one or more implants manufactured by other
companies in addition to implants from the settling
defendants. However--

      a. If a participant has received one or more Dow
implants in addition to one or more Bristol, Baxter, or 3M
implants, the benefits provided under Option One and Option
Two (but not the amount of the Advance Payment or the amount
for explantation expenses) will be reduced by 50%. For
example, if a Current Claimant qualifying under Option Two
for a payment of $200,000 had one or more Bristol implants,
one or more Dow implants, a Mentor implant, a McGhan implant
manufactured after 813184, and an implant whose manufacturer
could not be identified, her compensation would be reduced
to $100,000.

      b. If a participant does not have a Dow implant, but
has one or more Post-'84 McGhan or Mentor implants in
addition to one or more Bristol, Baxter, or 3M implants, the
benefits provided under Option Two (but not the amount of
the Advance Payment or the amount for explantation expenses)
will be reduced by 25 % .

      c. Persons who have received one or more Post-'84
McGhan implants and one or more Dow implants but who have
not received any Bristol, Baxter, or 3M implant are not
eligible to participate under this Revised Settlement
Program.

      d. Participation in this program does not release
claims a participant may have against entities and persons
that are not the settling defendants or Released Parties
under Exhibit B1. Participants are, however, cautioned that
bankruptcy rules provide a stay at the present time against
institution or pursuit of claims against Dow Corning, and,
to preserve claims against Dow Corning, participants may
need to file appropriate claims in the bankruptcy court.

      2. The obligations of the settling defendants to make
payments under this program are several, not joint, and are
limited to the approved claims involving implants from that
defendant or with respect to which that defendant is
agreeing to make payments.

      a. If a person has implants from more than one of
Bristol, Baxter, or 3M, their obligations are divided simply
on the basis of the number of such defendants whose implants
the claimant had.[fn 10] For example, if a person had one or
more Bristol implants, one or more Baxter implants, a
Post-'84 McGhan implant, and a Mentor implant, and (after
the 25% reduction for Post-'84 McGhan and Mentor implants)
was entitled to a $150,000 payment, then Bristol would be
responsible for payment of $75,000 and Baxter for payment of
$75,000.

      b. The obligations of McGhan, 3M, and Union Carbide
with respect to payments to persons who have only Post-'84
McGhan implants (or only Post-'84 McGhan implants and
implants from only Bioplasty, Cox Uphoff/CUI, or Mentor) are
also several. 3M and Union Carbide shall each be obligated
to make 40% of each such payment, and McGhan shall be
obligated to make 20% of each such payment.

G. Attorney Fees and Administrative Expenses

      1. Fees and expenses of attorneys representing an
individual participant in the program are to be paid by the
participant (or from benefits payable to her under this
program) in accordance with the arrangements made between
the participant and the attorney, but the court is reserving
the power to set some appropriate standards and limitations
on those arrangements (such as precluding the inclusion of
explantation reimbursement from the calculation of a
recovery-based contingent fee). Amounts payable to
participants will not be subject to any reduction for fees
and expenses of attorneys for representing the plaintiff
class or for other "common benefit" services.

      2. Pursuant to Order No. 13, 6% of the amounts paid to
participants under this program will be paid by defendants
as a surcharge (in addition to benefits paid to
participants) into the previously established fund as a
means for compensating and reimbursing counsel providing
"common benefit" services. Under terms of that order,
participants would receive on a pro-rata basis an increase
in individual benefits should the court determine that the
amount of the fund exceeds the reasonable fees and expenses
chargeable against it.

      3. Amounts previously paid by defendants under the
global settlement to support operations of the Claims Office
and for other administrative purposes will remain under the
court's jurisdiction for those purposes. Settling defendants
will pay such additional sums for operations of the Claims
Office during the 15-year period of the program as
determined by the court (in consultation with the settling
defendants) to be necessary for that purpose. Allocation
among settling defendants of the amounts paid for Claims
Office and administrative expenses shall be based upon the
number of claimants applying for benefits allocable to each
of the settling defendants, and shall be adjusted on an
on-going basis as necessary by the Court.

      H. Documentation. Current Claimants, Other
Registrants, and Late Registrants may, throughout the 15
year period of the program, submit documentation respecting
manufacturer identification, medical conditions and
disability, and other matters affecting eligibility or
entitlement to benefits in accordance with governing
procedures. The Claims Office may, however, establish
regulations relating to the submission of medical
documentation and setting reasonable periods at which to
conduct evaluations or re-evaluations of a person's
eligibility and benefits based on supplemental submissions
and for submission of supplemental documentation after
notice of deficiencies. Initial documentation showing
manufacturer identification must be presented to the Claims
Office no later than 12/16/96 by participants claiming
status as Current Claimants, as must documentation of a
claim for rupture supplement under Option One.

      I. Claims Office Procedures. The Claims Office will
continue to process and evaluate all domestic registrations
and claims submitted to it as expeditiously as possible, but
will give priority of consideration to claims in which the
claimant has indicated having a Bristol, Baxter, or 3M
implant.

      1. Protocols governing the required identification of
manufacturers of claimants' implants are included in the
attached Exhibit F. In order to be processed as a Current
Claimant, a form to be provided by the Claims Office
regarding proof of manufacturer identification must be
received by the Claims Office by 12/16/96; earlier
presentation of the form will expedite processing of Current
Claims. The manufacturer defendants agree to provide
reasonable assistance (including access to their records) to
claimants who have difficulties in identifying the
manufacturer of their implants from their own medical
records. At their request, defendants shall be afforded
access to documentation and other supporting evidence
submitted by a claimant to identify manufacturers of her
implants (but redacted to preserve the confidentiality of
the claimant's identity), and shall bring to the Claim
Administrator's attention any submissions not covered by
existing protocols. In such instances, defendants and
Settlement Class Counsel shall have the opportunity to
submit to the Claims Administrator written suggestions for
amendments or additions to the existing protocols to address
the questions raised by the claimants' offers of proof. Any
amendments or additions to the promulgated protocols will be
published on the Claims Office computer bulletin board and
be made available on request to any class member or
attorney.

      2. Processing of Claims: As claims are processed and
evaluated, the Claims Office will send each participant a
Notification of Status indicating whether her proof of
manufacturer identification is satisfactory; whether she is
classified as a Current Claimant, Other Registrant, or Late
Registrant; whether any documentation submitted in support
of a rupture supplement under Option One is satisfactory;
whether she is entitled to any Option One payment (and, if
so, the amount of such payment); whether there are any
deficiencies in the submission; and whether there is a
deadline for submitting supplemental documentation relating
to deficiencies. If there are deficiencies in any of the
materials that are subject to correction, the Notification
will so advise. This Notification, which triggers the
opt-out period under C1, will be sent to the last address
provided to the Claims Office, with a copy to the person's
attorney if one has been indicated.

      3. The Claims Office will continue to implement
procedures designed to detect and prevent payment of
fraudulent claims. It should be recognized, however, that
these procedures cannot be fully implemented preceding
Advance Payments under D1 and E3 above in view of the goal
to make such payments as soon as possible.

      4. Under its plenary responsibilities to assure an
acceptable level of reliability and quality control of
claims, the Claims Office may require, without expense to
the claimant, an examination or review by a physician or
laboratory selected by the Claims Office.

      J. Funding. Each settling defendant will pay into the
fund established by the court such amounts as, from time to
time during the 15 year period of the program, are estimated
by the court with the assistance of the Claims Office to be
needed (after considering undistributed funds previously
contributed to the fund by that defendant) to pay benefits
(or installments) for which that settling defendant will
become obligated to pay during the next 3 months. The fund
will maintain appropriate records defining amounts
contributed and disbursed with respect to each settling
defendant and with respect to the Current Claimant and Other
Registrant programs. The obligations of the defendants to
contribute to funding of Option Two under E2 (except as
specified in D2b(1)) are limited to annual cumulative
amounts indicated in E2c above. As an initial reserve,
Bristol, Baxter, and 3M will each pay into the fund by
January 15, 1996, at least $125,000,000.

      K. Miscellaneous.

1. Establishment of the settlement program and payments
under the program do not constitute any admission by
defendants of fault, liability, or damages, and will not be
admissible in evidence in the event a participant at some
point opts out and proceeds with litigation against the
defendants (except that any judgment obtained by participant
will be reduced by any payment under this settlement).

     2. All of the Released Parties identified by the
settling defendants in Exhibit B1 are released to the same
extent as are the settling defendants.

     3. Subject to appropriate conditions to protect
claimant confidentiality, insurers for settling defendants
will be afforded access to appropriate records of the Claims
Office as may be necessary for defendants to receive
benefits under such insurance policies.[fn 11]

     4. Subrogation-type claims by insurers or governmental
agencies based on payment of medical expenses of
participants will, to the extent enforceable under
applicable laws, be the responsibility of eligible
participants; settling defendants will have no additional
responsibilities to such insurers and agencies and will be
protected by participants against such claims.

     5. Where this program establishes deadlines for filing
elections, supporting materials, etc. with the Claims
Office, the materials must be actually received at the
Claims Office by 5pm, central time, on that date. Fax
transmissions will not be acceptable.

     6. The various elections under this program may be made
either by the participant or by the participant's previously
designated attorney. In the event of a conflict between
elections made by a participant and the participant's
attorney, the participant's election controls.

     7. The court shall appoint an independent public
accounting firm to (a) conduct an annual financial audit of
the Claims Office in accordance with Generally Accepted
Auditing Standards and (b) conduct an audit or audits of the
processing of claims by any outside claims evaluators.
Reports will be made available to the parties subject to
appropriate conditions to protect claimant confidentiality.

     8. Settling defendants and Released Parties
will--subject to the provisions of this program--be fully,
completely, and forever released from all claims of
non-foreign class members who have at least one breast
implant manufactured by one of the settling defendants or
their predecessors or subsidiaries, including derivative
claims of their spouses, children, parents, and others; and
such class members, including those with derivative claims
(but excluding the claims of children for their own injury),
will be permanently enjoined from asserting, instituting, or
prosecuting any breast implant-related claim against a
settling defendant or released party.

     9. This program will continue to be subject to the
court's previous orders concerning contribution and
indemnification claims against the settling defendants and
Released Parties.

     10. This settlement program resolves--subject to its
terms--all breast-implant related claims (including
derivative claims of spouses, parents, children, and others)
against the settling defendants (and their respective
Released Parties) by non-foreign class members who have at
least one breast implant manufactured by one of the settling
defendants or their predecessors or subsidiaries unless such
class members (a) opted out of the settlement class under
the global settlement during the 1994 opt-out period (and do
not withdraw their exclusion under A2), (b) opt out of this
settlement program under C1 above, or (c) exercise an
additional opt-out right as provided in sections D2b(2) and
E2c above. All claims for compensation must be made by the
end of the fifteenth year of the program (12/15/2010). Any
claim by such a class member not made during that period
would be forever barred.

     11. Unless otherwise provided, the terms used herein
are as defined in the Breast Implant Litigation Settlement
Notice, the Breast Implant Litigation Settlement Agreement,
and the Court's Final Order and Judgment dated September 1,
1994, together with any prior orders incorporated therein by
reference. Benefits under this program are in lieu of all
other benefits that participants and their attorneys might
have had under the global settlement.

     12. The obligations of Bristol, Baxter, and 3M to fund
Option Two benefits for both Current Claimants and Other
Registrants will be suspended if the provisions of A, B, C,
D, E, J, K1, K2, K4, K8, or K10 are challenged on appeal and
will be cancelled (together with McGhan's, 3M's, and Union
Carbide's obligations to provide payments for Post-'84
McGhan implants) if any of those provisions are disapproved
on appeal.



EXHIBIT B1

Settling Defendants

Baxter Healthcare Corp.
Baxter International Inc.
Bristol-Myers Squibb Co.
Inamed Corp.
McGhan Medical (Calif. Corp.)
McGhan Medical Corp. (Dela. Corp.) a/k/a McGhan Medical/3M
McGhan NuSil Corporation
Minnesota Mining & Manufacturing Co. a/k/a 3M Company
Medical Engineering Corp.
NuSil Corp.
NuSil Technology
Union Carbide Chemical & Plastics Co.
Union Carbide Corporation


Released Parties

Aesthetech Corp.
American Heyer-Schulte Corp. f/k/a Heyer-Schulte Corp.
American Hospital Supply Corp.
Franklin L. Ashley
Baxter Acquisition Sub., Inc.
Baxter Corporation
Baxter Travenol Laboratories, Inc.
Baxter World Trade Corp.
Lawrence Birnbaum
Robert Bishop
Bristol Myers Squibb Canada, Inc.
Cabot Medical Corp.
Angelo Cappozzi
CBI Medical, Inc. a/k/a CBI Medical Electronics, Inc.
CooperSurgical, Inc.
CooperVision, Inc.
CUI Corporation
CVI Merger Corp.
CV Sub 1987, Inc.
Edwards Laboratories, Inc.
Derwood Faries
Jack Fisher
Vicki Galati
John Hartley
Robert J. Helbling
Inamed BV
Inamed Development Co.
Richard P. Jobe
Real Lappierre
Linvatec Corp.
Anita Kost McAteer
Harold Markham
Jacqueline Markham
Lottie Markham
Markham Medical Ass'n
Markham Medical International, Inc.
Markham Surgical Specialties
Mark/M Surgical
Mark/M Resources, Inc.
G. Patrick Maxwell
Donald K. McGhan
McGhan Limited
MEC Subsidiary Corp. f/k/a Surgitek, Inc.
Natural "Y" Surgical Specialties, Inc.
W. John Pangman, II
Vincent R. Pennisi
Poly Plastic Silicone Products, Inc.
Schulte Medical Products
Diran M. Seropian
Paul Silverstein
Scott Spear
Specialty Silicone Fabrications, Inc.
Sirod Corp.
H. E. Sterling
Summit Medical Corp.
Surgitek, Inc.
Kuros Tabari
John P. Tebbetts
Travenol Laboratories, Inc.
Kurt Wagner
Edward Weck, Inc.
Edward Weck & Company, Inc.
John L. Williams
Wilshire Advanced Materials, Inc.
Wilshire Foam Products, Inc.
Wilshire Technologies, Inc.
Zimmer, Inc.
Zimmer International, Ltd.
3M Australia Pty
3M Canada, Inc.


The "Released Parties" mean the above-listed individuals and
entities, the above-listed Settling Defendants, and their
respective present and former foreign and domestic parents,
subsidiaries, and affiliates; their respective foreign and
domestic successors, predecessors, sales representatives,
independent sales representatives, distributors,
transferees, insurers, and assigns; and their respective
present, former, and subsequent officers, directors, agents,
servants, proprietors, owners, shareholders, and employees,
except that the term "Released Parties" (1) does not include
doctors, hospitals, and other health-care providers who
furnished medical services directly to a Class Member unless
they are specifically named above, (2) does not include
doctors specifically named above with respect to claims
against them based upon their furnishing medical services
directly to a Class Member, and (3) does not include such
individuals and entities to the extent their alleged
liability does not arise out of any affiliation or
relationship with the Settling Defendants.


EXHIBIT E--Revised Disease and Severity Definitions

I. General

      A. A claimant must file with the Claims Office all
medical records establishing the required findings or
laboratory abnormalities. Qualifying findings must have
occurred within a single 24-month period within the five
years immediately preceding the submission of the claim.
(Findings supplemented in response to a deficiency letter
sent by the Claims Office do not have to fall within the
24-month period outlined above.)

      B. If exclusions are noted for a required finding, the
physician making the finding or ordering the test must
affirmatively state that those listed exclusions are not
present. The physician recording a GCTS finding or making a
disease diagnosis must also affirmatively state that the
qualifying symptoms did not exist before the date of first
implantation. (This statement can be based upon patient
history so long as consistent with medical records in the
physician's possession.) Failure to make these affirmative
statements will result in a deficiency letter. All
underlying office charts, radiology/pathology reports, and
test results must be supplied to the Claims Office.

     II. Scleroderma (SS): A claim for scleroderma must
include a diagnosis of systemic sclerosis/scleroderma made
by a board-certified rheumatologist based upon personal
examination of the patient. [Exclusion: localized
scleroderma] Supporting medical documentation must
affirmatively reveal that the major or at least two of the
minor criteria listed below are present:

      A. Major criterion: Proximal scleroderma - symmetric
thickening, tightening, and induration of the skin of the
fingers and the skin proximal to the metacarpophalangeal or
metatarsophalangeal joints. The changes may affect the
entire extremity, face, neck, and trunk (thorax and
abdomen). Description of this criterion is adequate if the
board-certified rheumatologist records that physical
examination of the patient revealed scleroderma skin
thickening, and adequately describes the parts of the body
where that thickened skin was found.

      B. Minor Criteria:

      1. Sclerodactyly: Above-indicated skin changes limited
to the fingers.

      2. Digital pitting scars or loss of substance from the
finger pad: Depressed areas at tips of fingers or loss of
digital pad tissue as a result of ischemia.

      3. Bibasilar pulmonary fibrosis: Bilateral reticular
pattern of linear of lineonodular densities most pronounced
in basilar portions of the lungs on standard chest
roentgenogram; may assume appearance of diffuse mottling or
"honeycomb lung." These changes should not be attributable
to primary lung disease.

Compensation Levels:

      A. Death resulting from SS, or severe chronic renal
involvement manifested by a glomerular filtration rate of
less than 50% of the age- and gender-adjusted norm, as
measured by an adequate 24-hour urine specimen collection.

      B. Clinically significant cardio-pulmonary
manifestations of scleroderma[fn 1*] or proximal scleroderma
on the trunk (thorax and abdomen).

      C. A diagnosis of scleroderma in accordance with the
above criteria that does not involve the findings in A or B
above.

III. SLE (Lupus): A claim for SLE must include a diagnosis
of SLE (lupus) made by a board-certified rheumatologist
based upon personal examination of the patient. [Exclusion:
mild lupus (SLE not requiring regular medical attention
including doctor visits and regular prescription
medications)] Supporting medical documentation must
affirmatively reveal that at least four of the following 11
criteria are present:

Criterion -- Definition

1.  Malar rash -- Fixed erythema, flat or raised, over the
malar eminences, tending to spare the nasolabial folds

2.  Discoid rash -- Erythematous raised patches with
adherent keratotic scaling and follicular plugging; atrophic
scarring may occur in older lesions

3.  Photosensitivity -- Skin rash as a result of unusual
reaction to sunlight, by patient history or physician
observation

4.  Oral ulcers -- Oral or nasopharyngeal ulceration,
usually painless, observed by a physician

5.  Arthritis -- Nonerosive arthritis involving two or more
peripheral joints, characterized by tenderness, swelling, or
effusion [exclusion: erosive arthritis]

6.  Serositis -- a) Pleuritis -- convincing history of
pleuritic pain or rub hears by a physician or evidence of
pleural effusion, or b) Pericarditis -- documented by ECG or
rub or evidence of pericardial effusion

7.  Renal disorder -- a) Persistent proteinuria greater than
0.5 grams per day or greater than 3+ if quantitation not
performed, or b) Cellular casts -- may be red cell,
hemoglobin, granular, tubular, or mixed

8.  Neurologic disorder -- Seizures -- in the absence of
offending drugs or known metabolic derangements, e.g.,
uremia, ketoacidosis, or electrolyte imbalance

9.  Hematologic disorder -- a) Hemolytic anemia - with
reticulocytosis, or b) Leukopenia -- less than 4,000/mm
total on two or more occasions, or c) Lymphopenia -- less
than 1,500/mm on two or more occasions, or d)
Thrombocytopenia - less than 100,000/mm in the absence of
offending drugs

10. Immunologic disorder -- a) Positive LE cell preparation,
or b) Anti-DNA: antibody to native DNA in abnormal titer, or
c) Anti-Sm: presence of antibody to Sm nuclear antigen, or
d) False positive serologic test for syphilis known to be
positive for at least 6 months and confirmed by Treponema
pallidum immobilization or fluorescent treponemal antibody
absorption test

11. Antinuclear antibody -- An abnormal titer or antinuclear
antibody by immunofluorescence or an equivalent assay at any
point in time and in the absence of drugs known to be
associated with "drug-induced lupus" syndrome


Compensation Levels:

      A. Death resulting from SLE, or severe chronic renal
involvement manifested by a glomerular filtration rate of
less than 50% of the age- and gender-adjusted norm, as
measured by an adequate 24-hour urine specimen collection.

      B. SLE with involvement of one or more of the
following: glomerulonephritis, seizures in the absence of
offending drugs or known metabolic derangements, Lupus
Psychosis, myocarditis, pneumonitis, thrombocytopenic
purpura, hemolytic anemia (with hemoglobin of 10 grams or
less), severe granulocytopenia (with a total white cell
count less than 2000), or mesenteric vascillitic

      C. A diagnosis of lupus in accordance with the above
criteria that does not involve the findings in A or B above.
(Default compensation level.)

III. Polymyositis (PM) /Dermatomyositis (DM!: A claim for
polymyositis or dermatomyositis must include a diagnosis of
the disease made by a board-certified rheumatologist based
upon personal examination of the patient. Supporting medical
documentation must affirmatively reveal that the following
criteria are present:

- for polymyositis, the first four criteria without the
rash; - for dermatomyositis, three of the first four
criteria, plus the rash (#5).

Criteria:

1. symmetrical proximal muscle weakness;

2. EMG changes characteristic of myositis including (a)
short duration, small, low amplitude polyphasic potential,
(b) fibrillation potentials, (c) bizarre high-frequency
repetitive discharges;

3. elevated serum muscle enzymes (CPK, aldolase, SGOT, SGPT,
and LDH);

4. muscle biopsy showing evidence of necrosis of type I and
II muscle fibers areas of degeneration and regeneration of
fibers, phagocytosis, and an interstitial or perivascular
inflammatory response;

5. dermatologic features including a lilac (heliotrope),
erythematous, scaly involvement of the face, neck, shawl
area and extensor surfaces of the knees, elbows and medial
malleoli, and Gotton's papules.


Compensation Level:

All confirmed PM/DM diagnoses will be compensated at the
GCTS/PM/DM--A level.

IV. General Connective Tissue Svmptoms (GCTS):

A claim for GCTS does not have to include a diagnosis for
"General Connective Tissue Symptoms," but the medical
documentation must establish that the combination of
findings listed below are present. [Exclusion: classical
rheumatoid arthritis diagnosed in accordance with the
revised 1982 ACR classification criteria.]

For compensation at Level A:

(1) any two findings from Group I; or

(2) any three non-duplicative findings from Group I or Group
II.


For compensation at Level B:

(1) one finding from Group I plus any four non-duplicative
findings from Group II or Group m; or

(2) two findings from Group II plus one non-duplicative
findings from Group III.


The following duplications exist on the list of findings:

- rashes (#3 and #8)

- sicca (#2 and #12)

- serological abnormalities (#4 and #9)


In addition to the medical verification of the required
findings, a claim for GCTS must include the affirmative
physician statements outlined in "General Guidelines" above


GROUP I FINDINGS

      1. Polyarthritis, defined as synovial swelling and
tenderness in three or more joints in at least two different
joint groups observed on more than one physical examination
by a board-certified physician and persisting for more than
six weeks. [Exclusion: osteoarthritis.]

      2. Keratoconjunctivitis Sicca, defined as subjective
complaints of dry eyes and/or dry mouth, accompanied (a) in
the case of dry eyes, by either (I) a Schirmer's test less
than 8 mm wetting per five minutes or (ii) a positive
Rose-Bengal or fluorescein staining of cornea and
conjunctiva; or (b) in the case of dry mouth, by an abnormal
biopsy of the minor salivary gland (focus score of greater
than or equal to two based upon average of four evaluable
lobules.) [Exclusions: drugs known to cause dry eyes and/or
dry mouth, and dry eyes caused by contact lenses.]

      3. Any of the following immune-mediated skin changes
or rashes, observed by a board-certified rheumatologist or
board-certified dermatologist: (a) biopsy-proven discoid
lupus; (b) biopsy-proven subacute cutaneous lupus; (c) malar
rash -- fixed erythema, flat or raised, over the malar
eminences, tending to spare the nasolabial folds [exclusion:
rosacea or redness caused by sunburn]; or (d) biopsy-proven
vasculitic skin rash.

GROUP II FINDINGS

      4. Positive ANA greater than or equal to 1:40 (using
Hep2), on two separate occasions separated by at least two
months and accompanied by at least one test showing
decreased complement levels of C3 and C4; or a positive ANA
greater than or equal to 1:80 (using Hep2) on two separate
occasions separated by at least two months. All such
findings must be outside of the performing laboratory's
reference ranges.

      5. Abnormal cardiopulmonary symptoms, defined as (a)
pericarditis documented by pericardial friction rub and
characteristic echocardiogram findings (as reported by a
board-cerlified radiologist or cardiologist): (b) pleuritic
chest pain documented by pleural friction rub on exam and
chest x-ray diagnostic of pleural effusion (as reported by a
board-certified radiologist); or (c) interstitial lung
disease in a non-smoker diagnosed by a board-certified
internist or puknonologist, confirmed by (I) chest x-ray or
CT evidence (as reported by a board-certified radiologist)
and (ii) pulmonary function testing abnormalities defined as
decreased DLCO less than 80% of predicted.

     6. Myositis or myopathy, defined as any two of the
following: (a) EMG changes characteristic of myositis: short
duration, small, low amplitude polyphasic potential;
fibrillation potentials; and bizarre high-frequency
repetitive discharges; (b) abnormally elevated CPK or
adolase from the muscle (outside of the performing
laboratory's reference ranges) on two separate occasions at
least six weeks apart. (If the level of the initial test is
three times normal or greater, one test would be
sufficient.) [Exclusions: injections, trauma,
hypothyroidism, prolonged exercise, or drugs known to cause
abnormal CPK or aldolase]; or (c) muscle biopsy (at a site
that has not undergone EMG testing) showing evidence of
necrosis of type 1 and 2 muscle fibers, phagocytosis, and an
interstitial or perivascular inflammatory response
interpreted as characteristic of myositis or myopathy by a
pathologist.

     7. Peripheral neuropathy or polyneuropathy, diagnosed
by a board-certified neurologist, confirmed by (a) objective
loss of sensation to pinprick, vibration, touch, or
position; (b) symmetrical distal muscle weakness; (c)
tingling and/or burning pain in the extremities; or (d) loss
of tendon reflex, plus nerve conduction testing abnormality
diagnostic of peripheral neuropathy or polyneuropathy
recorded from a site that has not undergone neural or
muscular biopsy. [Exclusions: thyroid disease,
antineoplastic treatment, alcoholism or other drug
dependencies, diabetes, or infectious disease within the
last three months preceding the diagnosis.]


GROUP III FINDINGS

      8. Other immune-mediated skin changes or rashes,
observed by a board-certified rheumatologist or
board-certified dermatologist: (a) livedo reticullaris; (b)
lilac (heliotrope), erythematous scaly involvement of the
face, neck, shawl area and extensor surfaces of the knees,
elbows and medial malleoli; (c) Gotton's sign, pink to
violaceous scaling areas typically found over the knuckles,
elbows, and knees; or (d) diffuse petechiae.

     9. Any of the following serologic abnormalities: (a)
ANA greater than or equal to 1:40 (using Hep2) on two
separate occasions separated by at least two months; (b) one
or more positive ANA profile: Anti-DNA, SSA SSB, RNP, SM,
Sc1-70, centromere, Jo-1 PM-Scl, or double-stranded DNA
(using ELISA with standard cutoffs); (c) anti-microsomal,
anti-cardiolipin, or RF greater than or equal to 1:80.

     10. Raynaud's phenomenon, evidenced by a
physician-observed two (cold-related) color change as a
progression, or by physician observation of evidence of
cold-related vasospasm, or by physician observation of
digital ulceration resulting from Raynaud's phenomenon.

     11. Myalgias, defined as tenderness to palpation,
performed by a physician, in at least three muscles, each
persisting for at least six months.

     12. Dry mouth, subjective complaints of dry mouth
accompanied by decreased parotid flow rate using Lashley
cups with less than 0.5 ml per five minutes. [Exclusion:
drugs known to cause dry mouth]


EXHIBIT F--Protocols for Manufacturer

Identification and Proof of Rupture

I. General

The following protocols shall govern the methods of proving
(1) the identity of a particular settling defendant as the
manufacturer of a claimant's implant[fn 1**] and (2) the
fact that a claimant experienced a rupture in one of the
settling defendant's implants.

II. Manufacturer Identification

A. Acceptable Proof

The following methods of proof, absent fraud, shall be
clearly acceptable for purposes of establishing that a
claimant's implant (s) were (was) manufactured by one of the
settling defendants:

      1. contemporaneous hospital or surgeon operative
records specifying that the claimant was implanted with a
settling defendant's implant (s);

      2. certified copy of claimant's medical records
containing the implant package label; or

      3. where proof specified under 1 and 2 above is
unavailable: (a) an affirmative statement from the medical
doctor who performed the implantation or from a responsible
person at the treating facility, attesting that the claimant
was implanted with a settling defendant's implants and
providing the basis for that conclusion (which cannot rest
upon unacceptable proof (see IIB below)); and (b) a
statement from the claimant describing the steps taken to
secure proof under methods 1 and 2 above and the reasons for
the unavailability of such proof.

B. Unacceptable Proof

Statements from medical personnel describing their typical
or general practices concerning implant usage during a given
time period, or a statement from the claimant (or a
claimant's relative or friend) that seeks to identify the
manufacturer based upon recollection, shall be unacceptable
as proof of manufacturer identity.

C. Additional Methods of Proof to be Accepted

The settling defendants anticipate that there may be other
methods of acceptable proof of manufacturer identity in
addition to those set forth under IIA above. Accordingly,
counsel for the settling defendants shall consult with the
Claims Administrator and Settlement Class Counsel to
consider additional acceptable methods of proof to be
incorporated into this protocol. Any such methods shall
require the consent of the affected settling defendant(s).


III. Proof of Rupture

A. Acceptable Proof

The following methods of proof, absent fraud, shall be
clearly acceptable for purposes of establishing that a
claimant experienced a rupture in one of the settling
defendant's imPlants.

      1. With respect to ruptures documented by explant
operations that occurred on or before 1/1/92, a
contemporaneous operative or pathology report documenting
the rupture.

      2. With respect to ruptures documented by explant
operations that occurred after 1/1/92, a contemporaneous
operative report and, if available, a contemporaneous
pathology report, together with a statement as to whether
the ruptured implant (s) has (have) been preserved and, if
so, the name and address of the custodian.

      3. In addition to the reports described in IIIA2
above, for explantations after 1/1/96 the claimant shall use
her best efforts to cause the removed implant to be
preserved and the explanting surgeon or other appropriate
professional approved by the Claims Office shall provide a
statement affirming that, in his or her opinion, the rupture
did not occur during the explantation procedure (or
thereafter). The 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).

B. Unacceptable Proof

Non-contemporaneous statements from medical personnel
recalling that a claimant's implant was ruptured upon
explantation, or a similar statement from the claimant (or a
claimant's relative or friend), shall be unacceptable as
proof of a ruptured implant.

C. Additional Methods of Proof to be Accepted.

The settling defendants anticipate that there may be other
methods of acceptable proof of rupture in addition to those
set forth in IIIA above. Accordingly, counsel for the
settling defendants shall consult with the Claims
Administrator and Settlement Class Counsel to consider
additional acceptable proposed methods to be incorporated
into this protocol. Any such proposed methods shall require
the consent of the settling defendants.


===============================

Endnotes

        1. For purposes of this Revised Settlement Program,
3M implants are defined as 3M/McGhan implants implanted (or
manufactured in whole or in part) before 8/3/84.

        2. For purposes of this Revised Settlement Program,
Post-'8 1 McGhan implants are defined as silicone gel
implants manufactured at or by McGhan wholly after 813/81
McGhan. 3M, and Union Carbide have agreed to provide certain
benefits under this Revised Settlement Program to
participants who have or had only Post-'8 I McGhan implants
or who have or had only such implants and implants
manufactured by Bioplasty, Cox Uphoff/CUI or Mentor.

        3. Each settling defendant must provide to the
Claims Office, by December 15, 1995, a list identifying all
such persons.

       4. Current Claimants with only Post-'84 McGhan
implants (or only Post-'84 McGhan implants plus implants
from Bioplasty, Cox Uphoff/CUI or Mentor) will receive only
the benefits set forth in D3 below.

       5. Under certain conditions claimants may have later
rights to opt out and pursue litigation against settling
defendants (See D2b(2)) To exercise such an opt-out right,
the claimant would first have to return any amounts
previously paid (other than the Advance Payment and
explantation payments).

       6. Under certain conditions the participant may have
the later right to opt out and pursue litigation against
settling defendants. (See E2c below )

       7. Other Registrants with only Post-'84 McGhan
implants (or only Post-'84 McGhan implants plus implants
from Bioplasty, Cox Uphoff/CUI, or Mentor) will be eligible
for Option Two benefits as follows: SS/SLE-A,B, or C
--$50,000; GCTS/PM/DM-A -- $20,000; and GCTS-B -- $10,000.

       8. In the event the settling defendants provide a
list of surgeons to perform explantation without charge to
claimants (under E1e above), the settling defendants shall
be entitled to a $3,000 credit per operation

       9. Under certain conditions claimants may have later
rights to opt out and pursue litigation against settling
defendants. (See E2c). To exercise such an opt-out right,
the claimant would first have to return any amounts
previously paid (other than the Advance Payment and
explantation payments).

       10. Enhancement payments for rupture, however, remain
the sole responsibility of the settling defendant(s) whose
implant(s) ruptured.

        11. The court finds that the amounts to be paid
under this revised settlement program by each settling
defendant will, from the defendant's standpoint, represent a
reasonable settlement of compensatory bodily injury claims
from breast implants.

        1*. As manifested by interstitial fibrosis (based
upon physical examination findings and abnormalities seen on
chest x-ray or chest CT) or pulmonary hypertension (based
upon physical examination fundings and 2-D Echo doppler or
angiography with hemodynamic measurements showing pulmonary
artery pressures of greater than 25 TORR).

        1**. The methods of proof set forth in Part II below
apply only to the identification of settling defendant
manufacturers. Each claimant also must provide a complete
implant history. If a claimant is unable to identify another
manufacturer, she must describe the reasonable steps she
took to so identify and state why she was unable to do so.