Legal Documents

Silicon Implant Case Settlement

In this Oct. 13, 1995 proposed settlement, women involved in a class action suit against makers of silicone breast implants were offered substantially than they had received under a previous settlement. More than 430,000 women who claimed to have suffered illnesses relating to their implants applied for relief under the 1993 settlement. Dow Corning, the primary defendant in the suit, declared bankruptcy in May 1995, due to the class settlement and numerous individual suits against it. The awards previously ranged from $100,000 to $2 million. The new settlement grants awards of $10,000 to $250,000.


 
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. 
 

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