Federal Breast Implant LitigationThis is the latest of several proposed settlements in the federal breast implant litigation. Judge Sam Pointer appeared on Court TV's "In Context" on Wednesday, January 24, 1996 (10pm ET) to explain the fine points of the proposal.
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ALABAMA
Southern Division
In re:
SILICONE GEL BREAST IMPLANT
PRODUCTS LIABILITY LITIGATION
(MDL 926)
Master File No. CV 92-P-10000-S
HEIDI LINDSEY, et al.,
Plaintiffs;
-vs.-
DOW CORNING CORPORATION, et al.,
defendants.
Civil Action No. CV 94-P-11558-S
BREAST IMPLANT LITIGATION NOTICE
Please read this Notice carefully.
It affects your legal rights.
TO: All Lindsey class members and others identified as
possibly being
breast implant recipients.
You are notified:
* that, due to the amount of Current Disease Compensation
Claims that
would be approved under the criteria of the global settlement,
benefit levels based on the grids in the original notice would
be
severely "ratcheted" and would result in such a large number
of
additional opt-outs that the settling defendants would
withdraw from
the settlement
* that, because of reductions in benefit levels, all Lindsey
class
members now have an option to exclude themselves from the
class and
thereby be able to pursue, if they choose, litigation on an
individual basis
* that Lindsey class members may, alternatively, remain in
the class
for the time being, with statutes of limitation and repose
being
suspended until they decide on what action to take
* that, to reduce the extent of ratcheting of benefits that
would
otherwise occur, a revised "claims-made" settlement program
is being
offered by Bristol, Baxter, 3M, McGhan, and Union Carbide
to some--
though not all--members of the Lindsey class
* of your potential benefits, rights, and options, if eligible,
under
this revised settlement program
* of these important dates under the revised settlement
program:
April 1, 1996 deadline to register under revised settlement
program for those who have not previously
registered with Claims Office but want to
preserve their "Second Opt-Out Right"
Dec. 16, 1996 deadline to file forms preserving status as
"Current Claimant" and to claim "rupture"
benefits
under revised settlement
Dec. 15, 2010 end of 15-year period of revised settlement
program
* that eligible implant-recipients who previously opted out of
the
Lindsey class may rejoin the class and accept benefits of the
revised
settlement program
CONTENTS OF NOTICE
THE LITIGATION
1. Cases ..................................................1
THE "GLOBAL" SETTLEMENT
2. Settlement Approved.....................................1
3. Opt-Outs from Global Settlement.........................1
4. Registration and Claims.................................1
5. "Current Disease Compensation Claims" and
"Ratcheting" under Global Settlement....................1
6. Efforts to Reduce Ratcheting............................2
SECOND OPT-OUT RIGHT
7. Opt-Out Right...........................................2
REVISED SETTLEMENT PROGRAM
8. General Description.....................................3
9. Settling Defendants under Revised Settlement............3
10. Eligibility.............................................3
11. Registration; Proof of Manufacturer Form;
Classification of Participants..........................4
12. Benefits for Participants who have had at least
one Bristol, Baxter, or 3M Breast Implant...............4
(a) Explantation Benefit................................4
(b) Long-term Benefits..................................5
(c) Special Options, Benefits, and
Protections for "Current Claimants".................5
(d) "Advance Payments"..................................6
13. Benefits for Participants Qualifying because of
"post 8/84 McGhan" Silicone-gel Breast Implants.........6
14. Benefits and Options for "Late Registrants".............7
15. Status of Recipients of Mentor Implants.................7
16. Status of Recipients of Bioplasty Implants .............8
17. Status of Recipients of Dow Corning Implants ...........8
18. Definition and Status of "Foreign Claimants" ...........8
19. Children of Breast Implant Recipients...................9
20. Limits on Obligations of Defendants;
Additional Opt-Out Rights...............................9
21. Pre-existing Disease; Successive Claims................10
22. Claims of Health-care Providers........................10
23. Releases...............................................11
24. Effect of Appeals......................................11
25. Defendants' Positions; Inadmissibility of Settlement...11
26. Incorporation of Terms of Global Settlement............11
ATTORNEYS' FEES AND EXPENSES
27. Privately-retained Counsel.............................11
28. Funding of "Common Benefit" Fees and
Expenses..........12
29. Employment of Attorneys................................12
CLAIMS ADMINISTRATION
30. Claims Office..........................................12
31. Fund Administration....................................13
32. Filing of Elections, Forms, and Documentation..........13
33. Documentation..........................................13
34. Court Review of Claims Office Determinations...........13
ADDITIONAL INFORMATION
35. Court Filings and Other Documents......................13
36. Assistance.............................................13
EXHIBITS
B1. List of Settling Defendants and Released Parties
E1. Revised Disease/Symptomology Definitions and
Compensation Levels
G. List of Implant Brands and Manufacturers
THE LITIGATION
1. Cases.
Thousands of lawsuits seeking damages for death or injuries
allegedly
resulting from breast implants are pending in many state and
federal
courts. The federal cases are coordinated in the United States
District Court for the Northern District of Alabama ("the
Court")
before Chief Judge Sam C. Pointer, Jr., in a Proceeding
known as In
re Silicone Gel Breast Implant Products Liability Litigation,
MDL No.
926, Case No. CV 92- P-10000-S. Over a dozen breast
implant cases
have already been tried, with considerable expense and time,
in state
and federal courts--with some verdicts favorable to plaintiffs
and
with some favorable to defendants.
THE "GLOBAL" SETTLEMENT
2. Settlement Approved.
In April 1994 Judge Pointer preliminarily approved a
proposed
"global" settlement under Fed. R. Civ. P. 23(b)(3) on behalf
of a
broad class of persons with respect to pending or potential
claims
against the then settling defendants for present or future
personal
injury or death caused by or involving breast implant
products. On
September 1, 1994--after extensive notice to potential class
members;
after opportunity to object, comment, and "opt out"; and after
several days of hearings--Judge Pointer approved this
settlement. The
settlement order was entered in a case identified as Lindsey,
et al.
v. Dow Corning Corporation, et al., Case No. CV 94- P-
11558-S, and
the class was generally referred to as the "Lindsey" class.
3. Opt-Outs from Global Settlement. ("First" or "Initial" Opt-
Out)
A major question while the proposed global settlement was
pending was
whether the number of persons electing under Fed. R. Civ. P.
23(c)(2)
to "opt out" (or exclude themselves) from the proposed
settlement
would be so large that the then settling defendants would
exercise
their reserved option not to proceed with a settlement that
might
obligate them to pay more than $4.2 billion to the remaining
class
members. Although a substantial number of potential class
members
(over 10,000) did opt out, the then settling defendants
concluded to
proceed nevertheless with the settlement. Those who did not
opt out
were enjoined by the Court from pursuing or instituting
lawsuits
against the then settling defendants pending implementation
of the
settlement.
4. Registrations and Claims.
Lindsey class members were advised that, if they wanted to
make
claims under the "Current Disease Compensation Program"
of the global
settlement, they were required to submit claim forms (with
supporting
documentation) to the Claims Office by September 16, 1994.
Later
orders of the Court extended to October 17, 1994, the
deadline for
submitting supporting documentation, and to March 1, 1995,
the
deadline for domestic class members to register with the
Claims
Office to avoid being treated as "late registrants." (Under
terms of
the settlement and notice, late registrants would receive
benefits
only if and to the extent settlement funds were not exhausted
by
benefits paid to class members who timely registered.)
Eligible
"foreign" class members who did not register with the Claims
Office
by March 1, 1995, were precluded from obtaining benefits
under the
settlement or from proceeding with litigation in courts in the
United
States, but retained their full rights to pursue claims in the
judicial and administrative tribunals of their own countries.
5. "Current Disease Compensation Claims" and
"Ratcheting" under Global Settlement.
At the time the global settlement was approved, it could not
be known
whether, or to what extent, the benefits that might be
approved under
the Schedule of Benefits for Current Disease Compensation
Claims
(ranging from $105,000 to $1,400,000 for domestic
claimants) would
exceed the $1,200,000,000 to be set aside under the
settlement for
such benefits. For that reason, the settlement provided that
the
amounts shown in the Schedule were subject to potential
reduction (or
"ratcheting") but that, in such event, all registered class
members
would be so notified and be given a second opt-out right in
order to
pursue litigation rather than accept reduced benefits. The
defendants
would, however, then have an option to withdraw from the
settlement
because of the number of such additional opt-outs.
Promptly after the settlement was approved, the Claims
Office began
processing registrations and evaluating those with "current
claims."
However, because of the large number of registrations
(approximately
260,000 were mailed by September 16, 1994) and because of
the large
number of those with current claims (projected to be about
100,000),
it became apparent that far more time would be required to
evaluate
all current claims than had been initially anticipated and that
benefit levels would definitely have to be ratcheted. In order
not to
unduly delay the determination about the extent of ratcheting,
the
opportunity for opting out, or the possible withdrawal by
defendants,
samples of these claims were selected for evaluation in a
manner as
to allow reasonably accurate predictions about the extent of
ratcheting.
This study, a summary of which the Claims Office
announced to class
members in June 1995, demonstrated that, given the large
amount of
current claims that would be approved under the disease and
severity
criteria of the global settlement, the scheduled Disease
Compensation
benefits would be severely reduced--to perhaps less than 5%
of the
amounts shown in the schedule. Additionally, by that time,
Dow
Corning, which was obligated to make almost half of the
contributions
to the settlement funds, had become the Debtor in bankruptcy
reorganization proceedings, and its continued participation in
the
settlement was uncertain. These facts led the Court to
conclude not
only that thousands of additional class members would opt
out of the
class, but also that the defendants would withdraw from the
settlement as a result of these opt-outs.
6. Efforts to Reduce Ratcheting.
As required by the global settlement, Plaintiffs' Settlement
Class
Counsel and representatives of the more financially solvent
defendants not in bankruptcy engaged in extensive
conferences during
the Summer and Fall of 1995 and explored various methods
and options
to reduce the extent of ratcheting, while preserving the rights
of
registered class members to opt out as had been guaranteed
under the
global settlement. Ultimately in November 1995 the Court
was
presented with a proposed revised settlement program
approved by
Bristol, Baxter, 3M, McGhan, and Union Carbide.
Although still providing substantially less compensation than
the
Schedule of Benefits contained in the original notice of
settlement,
this program is, in the view of the Court, far superior--for
those
eligible to participate--to the distribution of a conditional
offer
of severely-ratcheted benefits based on percentages of grid
amounts
in that original notice. The benefits to most participants with
only
Bristol, Baxter, or 3M implants under the revised settlement
will be
greater than the ratcheted amounts than would have been
presented to
class members under the original settlement. More
importantly, those
ratcheted amounts would, because of the projected opt- outs
and
withdrawal by the defendants, never have been paid to any
class
member, whereas the benefits offered under the revised
settlement are
not subject to any withdrawal right by the settling defendants
even
if a large number of persons opt out of the revised settlement.
Plaintiffs' Settlement Class Counsel have not approved the
terms of
the revised settlement offer and, indeed, believe that the
settling
defendants should have been willing to offer greater benefits,
and to
more members of the Lindsey class. They do not, however,
object to
class members individually having an opportunity to consider
and
possibly accept an offer of settlement where the terms of that
offer
are clear and understandable--even if less than what Class
Counsel
personally believe would represent a fair settlement value.
Nor do
they dispute that, for those eligible to participate, the revised
settlement provides an opportunity for settlement without
litigation
that, because of the defendants' right to withdraw due to
additional
opt-outs, would not have been provided by sending notices of
ratcheting under the original benefit schedule. While Class
Counsel
have not agreed to the terms of the revised offer, paragraph
18 of
the original notice did not require agreement to a revision,
such as
this, that reduces the extent of ratcheting which would
otherwise
occur.
SECOND OPT-OUT RIGHT
7. Opt-Out Right.
Because of the reduction in potential benefits, members of
the
Lindsey class now have a second right to opt out of the class
and
thereby be able, if desired, to pursue or institute litigation
(including any rights to seek punitive or statutory multiple
damages)
against those who were settling defendants or released parties
under
the global settlement. This opt-out right is provided to all
Lindsey
class members--whether or not eligible to participate in the
revised
settlement--except for those who do not register until after
April 1,
1996, or who, having previously opted out, elect to rejoin the
Lindsey class.
(a) To opt out now, the individual (or her court- appointed
representative) must sign and return to the Claims Office
the
Election Form (included with this Notice), with box 2C
or 3A
marked. The form can also be completed and signed by
the
individual's attorney. In the event of conflict between an
election signed by a class member and an election signed
by
the person's attorney, the former will control.
(b) Those who elect to opt out now should understand that
statutes
of limitation and repose--which have been suspended
during the
pendency of the Lindsey case and, for most class
members,
during the pendency of the earlier-filed Dante class
action--
will resume running 30 days after the Claims Office
receives
this election. Resumption of the running of such statutes
could adversely affect the litigation rights of persons
who
have not already filed lawsuits or who are not prepared to
file any lawsuits within that 30-day period. Accordingly,
the
Court cautions class members against making an
immediate opt-
out election unless they are sure they won't be adversely
affected by such statutes.
(c) There is no fixed deadline for such persons to opt out.
Registered class members can wait to make the decision
whether
or not to opt out until 45 days after they are individually
sent a Notification of Status letter by the Claims Office
explaining their potential eligibility for benefits under
the
revised settlement. These individual Notifications will be
mailed by the Claims Office during 1996 as registrations
and
claims are processed and reviewed. Statutes of limitation
and
repose will continue to be suspended until that decision
is
made, and indeed for many class members as much as 6
months
after such an opt-out election is made. For this reason--
and
to assure the most informed decision by those who may
be
eligible to participate in the revised settlement--the Court
strongly recommends that most Lindsey class members
delay any
decision about opting out until they are sent this
Notification by the Claims Office.
(d) Persons who opt out should understand that their rights
to
institute or pursue litigation claims against Mentor,
Bioplasty, and Dow Corning are subject to certain
restrictions. See 15-17 below. Also, they should
understand
that the companies that are parties to the new settlement
program are prohibited from now engaging in settlement
negotiations and discussions (except on a case-by-case
basis
involving cases that were brought by persons who earlier
opted
out of the global settlement or cases that may be
specifically
set for trial or court-sponsored mediation or arbitration),
and that any recoveries through separate litigation or
settlement are subject to potential sharing in the cost of
services performed by counsel for the "common benefit"
of all
having breast implant claims. See 28 below.
(e) Persons wanting to obtain the Advance Payment and
payment of
other benefits at the earliest possible date can waive this
second opt-out right.
REVISED SETTLEMENT PROGRAM
8. General Description.
The revised settlement program can be described as a
"claims-made"
program. Rather than the settling defendants offering to make
a
prescribed payment into a settlement fund that then would be
divided
in some manner among class members electing to participate
(and
perhaps being subject to cancellation if too many class
members elect
not to participate), the amounts to be paid to individual
participants are essentially unconditional, fixed, and
unaffected by
the number or amount of benefits paid to other participants,
and the
total amount to be paid by the various settling defendants will
be
determined by the number of, and the payments to, the
persons
participating in the settlement.
(a) This revised settlement is being offered by some, but
not all,
of the manufacturers and suppliers involved in the
original
settlement; and, as described in 10 below, not all Lindsey
class members are eligible to participate in the revised
settlement.
(b) The benefits provided are substantially less than the
amounts
shown in the Disease Compensation Schedule of the
original
settlement (which, before ratcheting, could have been as
high
as $1,400,000 for some class members). The maximum
benefits
payable under the revised settlement are $253,000
($250,000
under Long-term Benefits Schedule plus $3,000 for
explanation). Such benefits would be payable, for
example, to
a qualified participant who in May 1993 developed
Systemic
Lupus with a compensation level "A" under the criteria
of the
revised settlement program, and whose only implants,
manufactured by Baxter/Heyer-Schulte, were removed in
May
1994.
(c) At the lower range of benefits, however, the amount
payable to
some eligible participants under the revised settlement
may
actually exceed that described under the global
settlement.
For example, an "Advance Payment" of $1,000 would be
payable
to a qualified participant with a Baxter/Heyer-Schulte
implant
who did not make a Current Disease Compensation
Program claim
under the global settlement and who does not in future
years
either have her implants removed or develop a disease or
symptomology covered under the criteria of either
settlement
program. Also, the amount payable ($3,000) to those
who
qualify for explantation benefits but who would not
otherwise
qualify for any benefits may exceed the amount that
might have
been payable to such persons under the global settlement.
(d) For other qualified participants, benefits should fall
between
these limits, depending on factors such as (1) the
manufacturer(s) of the implant(s), (2) the severity and
disease/symptomology criteria under the global
settlement and
the revised settlement, (3) the time when a claim and
supporting documentation are filed, (4) whether there is
proof
of rupture, and (5) the time when an implant is removed.
9. Settling Defendants under Revised Settlement.
A full listing of the settling defendants participating in the
revised settlement is contained in Exhibit B1. In this Notice,
however, the following short descriptions of these defendants
are
sometimes used for convenient reference:
* "Bristol", meaning Bristol-Myers Squibb Co., Medical
Engineering
Corp. (MEC), and their affiliates, including breast
implants
sold under the "Surgitek" name.
* "Baxter", meaning Baxter Healthcare Corporation, Baxter
International Inc., American Hospital Supply Co. (Heyer-
Schulte)
and their affiliates.
* "3M", meaning Minnesota Mining & Manufacturing Co.,
McGhan
Medical Corp. (Dela.) and their affiliates. (For purposes of
this program, "3M implants" are 3M/McGhan implants
manufactured
wholly or partly before 8/3/84.)
* "McGhan", meaning McGhan Medical Corporation
(Calif.) and INAMED
Corporation. (For purposes of this program, "post 8/84
McGhan"
implants are silicone-gel breast implants manufactured at
or by
McGhan wholly after 8/2/84.)
* "Union Carbide", meaning Union Carbide Chemical &
Plastics Co.,
Union Carbide Corporation, and their affiliates
See Exhibit G for various brand names of implants.
10. Eligibility.
(a) A person who does not timely opt out will be eligible to
participate in the revised settlement program if she
satisfies
each of the following requirements:
(1) is not a "foreign" claimant (see 18);
(2) has not released through settlement all claims against
each
of the settling defendants whose implants were
implanted in
the person (or had such claims resolved by final
judgment);
and
(3) before June 1, 1993, either--
(A) was implanted with one or more breast implants
manufactured by Bristol, Baxter, or 3M, or
(B) was implanted only with one or more "post 8/84
McGhan"
silicone-gel breast implants (or only with one or
more
such implants and with one or more breast implants
manufactured by Bioplasty, Cox Uphoff/CUI, or
Mentor).
(b) An implant recipient who would otherwise be eligible
but for
having earlier opted out of the global settlement may
participate in the settlement (but without opt-out rights
under 7 above) by filing with the Claims Office an
Election
Form before the person proceeds to trial against any of
the
settling defendants. If the form is filed after December
16,
1996, the person will be classified as a "Late Registrant."
(c) As under the global settlement, participation by an
implant
recipient also constitutes participation by that person's
estate and family members with respect to any derivative
or
representative claims. However, any claims by children
of
implant recipients with respect to their own personal
injury
are not covered by the revised settlement, and the pursuit
of
any such claims is not barred by this settlement.
11. Registration; Proof of Manufacturer Form;
Classification of Participants.
(a) Persons eligible to participate in the revised settlement
who
have already registered with the Claims Office do not
have to
re-register (whether or not they filed any claim under the
global settlement). However, they should complete and
file
with the Claims Office the "Election Form" (included
with this
Notice) when they are prepared to make a decision
regarding
possible participation in the settlement, and the failure to
file this form by December 16, 1996, would preclude an
otherwise eligible participant from obtaining the special
benefits and protections afforded to "Current Claimants".
(b) Persons eligible to participate in the revised settlement
who
have not already registered with the Claims Office may
still
participate as "Late Registrants" under the revised
settlement, but must file with the Claims Office the
"Election
Form" (included with this Notice) by April 1, 1996, in
order
to preserve certain rights to opt out later.
(c) All persons who are eligible and may want to participate
in
the revised settlement must also complete and file with
the
Claims Office the Proof of Manufacturer Form (included
with
this Notice). Although there is no fixed deadline for
filing
this form, benefits cannot be paid under the revised
settlement until the participant has filed this form with
supporting documentation, and failure to file this form
and
proof by December 16, 1996, would preclude otherwise
eligible
participants from obtaining the special benefits and
protections accorded to "Current Claimants".
(d) The benefits, options, and protections given participants
under the revised settlement vary based on the following
classifications of participants:
* "Current Claimants": eligible participants who, under
terms
of the global settlement, (1) mailed to the Claims Office
by
September 16, 1994, a signed Registration Form and (2)
mailed to the Claims Office by October 17, 1994, 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).
* "Other Registrants": eligible participants who are not
"Current Claimants" as defined above, but (1) who
registered
with Claims Office by March 1, 1995, or (2) who,
having
previously opted out of the global settlement, withdraw
their exclusion and register with Claims Office by
December 16, 1996.
* "Late Registrants": all other eligible participants who
register with the Claims Office but are neither "Current
Claimants" nor "Other Registrants" as defined above.
There
presently is no deadline for registration, but the Court
may
in the future impose a final deadline for registration,
and
the "Second Opt-Out Right" under 7 above is not
provided to
persons who register after April 1, 1996.
12. Benefits for Participants Who Have Had at
least one Bristol, Baxter, or 3M Breast Implant.
Participants with at least one Bristol, Baxter, or 3M breast
implant
are eligible to receive explantation benefits under 12(a), plus
either long-term benefits under 12(b) or fixed payment
benefits under
12(c). They are also entitled to receive an "Advance
Payment" under
12(d) that will be credited against benefits under 12(b) or
12(c).
(a) Explantation Benefit: A one-time payment of $3,000
will be
paid to participants (other than "Late Registrants") on
proof
of removal of a Bristol, Baxter, or 3M implant after April
1,
1994, and before December 15, 2010 (end of 15-year
program).
Payment is in addition to payments under 12(b) or 12(c)
below.
The settling defendants' obligations to pay their
respective
shares of these payments are unconditional and do not
depend
on how many or how few participants elect to participate
and
qualify for benefits. The Explantation Claim Form
enclosed
with this Notice contains detailed explanations and
instructions for submitting and documenting such claims.
(b) Long-term Benefits. Participants with at least one
Bristol,
Baxter, or 3M implant will be paid benefits under the
above
schedule upon proof, during the 15 years of the program
(before December 15, 2010), of having developed a
disease or
symptomology, at the indicated compensation level, as
defined
in revised settlement. (See Exhibit E1.) These criteria are
more restrictive than those in the original settlement
program.
(1) Benefits of $100,000 or less will be paid in single
lump
sum payment; larger benefits may be paid in 2 or 3
annual
installments. (Defendants are not required to pay more
than
$100,000 to a recipient in any given year.)
(2) If before the end of the 15-year period of program a
participant documents a condition that would entitle
her to
a larger payment than previously received, she would
at
that time be paid the difference between the new
amount and
any amount previously paid under this schedule.
(3) Bristol's, Baxter's, and 3M's obligations are
unconditional
and unlimited in amount (i. e., not affected by how
many or
how few persons accept the revised settlement or by
how
much money they must pay under the settlement) with
respect
to their respective shares of benefits approved under
the
Long-term Benefit Schedule (other than under
12(b)(2))--
(A) for GCTS, PM, or DM benefits payable to a
Current
Claimant who had any claim under the global
settlement
that would have been either approved or treated as
having only minor deficiencies, and
(B) for SS/SLE benefits to a Current Claimant who had
a
claim for SS/SLE under the global settlement that
would
have been either approved or treated as having only
minor deficiencies.
(4) Except as stated in (3) above, the obligations of
Bristol,
Baxter, and 3M to pay their respective shares of
payments
under the above schedule are subject to certain
maximum
limitations. See 20(b) below. However, any failure by
them
to make payments will at that time give affected
participants (other than "Late Registrants") a right to
opt
out and pursue litigation against the defendants. See
20(e)
below.
(c) Special Options. Benefits. and Protections for "Current
Claimants." As an alternative to benefits under 12(b)
above,
"Current Claimants" (defined in 11(d) above) who have
had a
Bristol, Baxter, or 3M breast implant may elect to
receive a
fixed payment under the following Fixed Amount
Benefit
Schedule based on disability/severity levels specified in
the
Disease Schedule of the global settlement for diseases
described in that Schedule (rather than under the more
restrictive criteria of the revised settlement).
Benefits under this Fixed Amount Benefit Schedule
constitute "one-
time" settlement compensation, and will not be increased if,
after
being paid benefits under this schedule, a recipient should
later
develop a medical condition that would otherwise qualify for
higher
benefits under this schedule (other than for "rupture" under
(2)
below) or for higher benefits under the "long- term benefit
schedule"
of 12(b).
(1) Benefits of $25,000 or less will be paid in single lump
sum
payment; larger benefits will be paid in 2 equal annual
installments.
(2) The increase in benefit level for rupture is limited to
"rupture" of a Bristol, Baxter, or 3M silicone-gel
implant
that is established by explantation and documented by
December 16, 1996.
(A) A Rupture Claim Form is enclosed with this Notice
for
use in submitting claims for rupture benefits. To
qualify for benefits, the participant must complete
and
mail this form, with proof of the rupture, to the
Claims
Office in time to be received by the Claims Office by
December 16, 1996.
(B) For further details, including definition of "rupture"
and types of acceptable documentation, see the
instructions and explanation on back of Rupture
Claim
Form.
(3) At the time of being sent their Notification of Status,
Current Claimants will be asked to chose between
schedules
12(b) and 12(c) and they must make this choice before
they
will be paid benefits under either schedule. Those who
choose compensation under schedule 12(c) may not
later seek
compensation under schedule 12(b). Those who choose
compensation under schedule 12(b) may, before being
paid
benefits under schedule 12(b), elect to return to
schedule
12(c) but, in such event, the benefits under 12(c) as
shown
above will be reduced by 25 % .
(4) The obligations of Bristol, Baxter, and 3M to pay
their
respective shares of benefits under 12(c) are
unconditional
and unlimited in amount--not affected by how many or
how
few persons accept the revised settlement or by how
much
money they must pay under the settlement. As an
additional
protection to Current Claimants, the obligations of
Bristol, Baxter, and 3M to make payments under
schedule
12(b) to certain Current Claimants, as described in
12(b)(3) above, are unconditional and not subject to
any
maximum limitations.
(d) Advance Payments. As soon as the Claims Office can
determine
that a participant (other than a "Late Registrant") has
submitted satisfactory proof of manufacture of a Bristol,
Baxter, or 3M breast implant to be eligible to participate
and
has waived or not timely elected to exercise her "Second
Opt-
Out Right", the participant will be paid $5,000 if a
"Current
Claimant" or $1,000 if an "Other Registrant", as those
terms
are defined in 11(d) above. These are "advances" in that
they
will be credited against (and reduce) amounts later
determined
to be payable under 12(b) and 12(c) above but will not
otherwise be refundable (in the absence of fraud).
13. Benefits for Participants Qualifying because of
"post 8/84 McGhan" Silicone-gel Breast Implants.
Breast implant recipients who have never received a Bristol,
Baxter,
or 3M implant but are eligible to participate because of
having
received only "post 8/84 McGhan" silicone-gel breast
implants (or
only such implants and Bioplasty, Cox Uphoff/CUI, or
Mentor implants)
are eligible to participate, but with more limited benefits than
provided recipients with a Bristol, Baxter, or 3M implant.
These more
limited benefits will be paid by McGhan (20%), 3M (40%),
and Union
Carbide (40%) to such persons as follows:
(a) Benefits. Such participants will be paid benefits under
the
following schedule upon proof, during the 15 years of
the
program (before December 15, 2010), of having
developed a
disease or symptomology, at the indicated compensation
level,
as defined in the revised settlement. (See Exhibit E1).
"Current Claimants" (defined in 11(d) above) may
optionally
qualify for one-time benefits based on proof of a
disability/severity level and disease defined in the
Disease
Schedule for the global settlement.
(b) Benefits will be paid in a single lump sum payment.
(c) If during the 15-year period of the program, a
participant
develops and documents a condition that would entitle
her to a
larger payment under the revised disease schedule than
previously received under that schedule, she would at
that
time be paid the difference between the new
compensation
amount and the amount previously paid.
(d) The obligations of McGhan, 3M, and Union Carbide to
pay their
respective shares of benefits based on "post 8/84
McGhan"
implants to qualifying Current Claimants based on the
global
settlement disease schedule--and to certain qualifying
Current
Claimants based on the revised disease schedule, as
described
in 12(b)((3)(A) and (B)--are unconditional and do not
depend
upon how many or how few other such Current
Claimants elect to
participate and qualify for benefits. However, "post-8/84
McGhan" benefits do not become payable to Current
Claimants
until the Court's order becomes "Final" and, therefore,
may be
delayed if there is an appeal from approval of the revised
settlement.
(e) Except as stated in (d) above, the obligations of
McGhan, 3M,
and Union Carbide to pay their respective shares of
benefits
based on "post 8/84 McGhan" implants are subject to
certain
maximum limitations. See 20(c) below. However, any
failure by
them to make payments will at that time give affected
participants (other than "Late Registrants") a right to opt
out and pursue litigation against the defendants. See
20(e)
below.
(f) There are no "Advance Payments" or rupture benefits
payable to
implant recipients qualifying for eligibility based on
"post
8/84 McGhan" implants, nor does this revised settlement
program provide benefits for removal of "post 8/84
McGhan"
implants.
14. Benefits and Options for "Late Registrants."
Late Registrants, as defined in 11(d) above, are eligible for
benefits only under 12(b) and 13, and not for explantation
benefits
or Advance Payments. Late Registrants will be paid benefits
under
12(b) only if, when, and to the extent Bristol's, Baxter's, and
3M's
cumulative payments to Current Claimants and Other
Registrants under
12(b) do not exceed their respective maximum obligations as
stated in
20. Late Registrants will be paid benefits under 13 only if,
when,
and to the extent McGhan's, 3M's, and Union Carbide's
cumulative
payments under 13 do not exceed their respective maximum
obligations
as stated in 20. As under the global settlement, Late
Registrants
will have no right to opt out in the event such maximum
limitations
result in their not receiving the full amount shown in the
schedules.
Late Registrants will, however, be entitled to the "Second
Opt- Out
Right" described in 7 above if they register with the Claims
Office
by April 1, 1996.
15. Status of Recipients of Mentor Implants.
Implant recipients who have received one or more Mentor
implants in
addition to Bristol, Baxter, 3M, or "post 8/84 McGhan"
implants, are
eligible to receive the same benefits under the revised
settlement as
others eligible to participate in the revised settlement.
(a) There are no special benefits based on explantation or
rupture
of a Mentor implant.
(b) Persons who have had a Mentor implant but never had a
Bristol,
Baxter, 3M, or "post 8/84 McGhan" implant are not
eligible for
benefits under the revised settlement program. They will,
however, be eligible to participate in distribution of the
approximately $25,800,000 being paid by Mentor under
terms of
a limited-fund mandatory (non-opt out) class settlement
with
Mentor (which was not appealed and became final on
September
10, 1993). The distribution formula for those benefits
will be
set by the Court at a later time, and it is anticipated that,
because of the very limited funds set aside for such
recipients, the Court will give preferential, if not
exclusive, consideration to those who do not have
potential
claims against other implant manufacturers.
(c) Persons who have had a Mentor implant--whether or not
eligible
to participate in the revised settlement--have the same
rights
to opt out as provided to other members of the Lindsey
class.
They should understand, however, that, because of the
earlier
Mentor limited-fund settlement, they are precluded from
instituting or pursuing litigation regarding breast implant
claims against the "Mentor Defendants" (Mentor
Corporation;
Mentor Polymer Technologies, Inc.; Mentor O&O, Inc.;
Mentor
H/S, Inc.; Mentor Urology, Inc.; Mentor International,
Inc.;
and Tecknar Corp.) for implantations occurring before
June 1, 1993.
16. Status of Recipients of Bioplasty Implants.
Implant recipients who have received one or more Bioplasty
implants
in addition to Bristol, Baxter, 3M, or "post 8/84 McGhan"
implants,
are eligible to receive the same benefits under the revised
settlement as others eligible to participate in the revised
settlement.
(a) There are no special benefits based on explantation or
rupture
of a Bioplasty implant.
(b) Persons who have had a Bioplasty implant but never
had a
Bristol, Baxter, 3M, or "post 8/84 McGhan" implant are
not
eligible for benefits under the revised settlement
program.
They will, however, be eligible to participate in
distribution
of the approximately $5,000,000 being set aside by
Bioplasty
under terms of bankruptcy proceeding. The distribution
formula
for those benefits will be set by the Court and the
Bankruptcy
Court for the United States District Court in Minnesota
at a
later time, and, because of the very limited funds set
aside
for such recipients, it is anticipated that the courts will
give preferential, if not exclusive, consideration to those
who do not have potential claims against other implant
manufacturers.
(c) Persons who have had a Bioplasty implant--whether or
not
eligible to participate in the revised settlement--have the
same rights to opt out as provided to other members of
the
Lindsey class. They should understand, however, that,
because
of the Bioplasty bankruptcy proceedings, they are
precluded
from instituting or pursing litigation regarding breast
implant claims against the "Bioplasty Defendants"
(Bioplasty,
Inc.; Bio-Manufacturing, Inc.; and Uroplasty, Inc.).
17. Status of Recipients of Dow Corning Implants.
Implant recipients who have had one or more Dow Corning
implants in
addition to Bristol, Baxter, or 3M implants may participate in
the
revised settlement, but will have reduced benefits under the
revised
settlement in view of their right to present claims related to
their
Dow Corning implants.
(a) Benefits for such participants under 12(b) and 12(c) are
50%
of the benefits for those without Dow Corning implants.
Participants in the revised settlement do not, however,
waive
any claims against Dow Corning, though they should
understand
that any claims against Dow Corning are subject to
certain
automatic stays and other orders that may issue from the
Bankruptcy Court for the United States District Court for
the
Eastern District of Michigan and, to be preserved, may
require
presentation of a proof of claim in that court.
(b) There are no special benefits based on explantation or
rupture
of a Dow Corning implant.
(c) Persons who have received a Dow Corning implant but
never
received a Bristol, Baxter, or 3M implant are not eligible
for
benefits under the revised settlement program even if
they
received a "post 8/84 McGhan" implant.
(d) Persons who have received a Dow Corning implant--
whether or
not eligible to participate in the revised settlement--have
the same opt-out rights as other members of the Lindsey
class.
They should understand, however, that any claims
against Dow
Corning are subject to certain automatic stays and other
orders that may issue from the Bankruptcy Court for the
United
States District Court for the Eastern District of Michigan
and, to be preserved, may require presentation of a proof
of
claim in that court.
(e) Implant recipients will likely be mailed a separate notice
from the Bankruptcy Court for the United States District
Court
for the Eastern District of Michigan explaining
procedures and
possibly deadlines for presenting or preserving claims
against
Dow Corning.
18. Definition and Status of "Foreign Claimants".
"Foreign Claimants" were defined in the global settlement,
and
continue to be defined under this Notice, as being breast
implant
recipients (i) who were not citizens or resident aliens of the
United
States, (ii) whose breast implants were all implanted outside
the
United States, and (iii) who had not received any
compensation from
any then settling defendant or released party for breast
implant
injuries or expenses under the laws or procedures of a
country other
than the United States. Such persons were offered more
limited
settlement benefits under the global settlement than the
domestic
members of the Lindsey class, but were also provided
additional
guarantees regarding opt-out rights, as well as the
opportunity (if
they did not participate affirmatively in the global settlement)
to
pursue breast- implant claims in the administrative and
judicial
tribunals of their own countries. Foreign claimants from
Australia
and the Canadian provinces of Ontario and Quebec were
excluded from
the Lindsey class unless they affirmatively opted into the
settlement.
(a) After issuance of the notice of the global settlement, this
Court in several orders relating to foreign recipients who
had
opted out of the global settlement concluded that
litigation
in courts of the United States by citizens of Australia,
Canada, and England is barred under the doctrine of
"forum non
conveniens" (without prejudice to pursuit of claims by
such
persons in Australian, Canadian, and English courts), but
that
litigation in the courts of the United States by some
citizens
of New Zealand is not barred under that doctrine. In
those
orders the court did not specifically address claims by
opt-
out foreign claimants from other countries, but indicated
that
such litigation rights would be resolved by applying the
principles used in addressing issues relating to the
Australian, Canadian, English, and New Zealand
claimants.
(b) Preferring administrative resolution or litigation--in this
country or in other countries--over any immediate
settlement
as a means to address claims of Foreign Claimants, the
settling defendants under the revised settlement program
are
not now making any offer to settle in this forum the
pending
or potential claims of Foreign Claimants, and such
persons are
not eligible for benefits under the revised settlement
program. The defendants' declination to provide
settlement
offers to such persons at this time in this forum does not,
however, preclude the possibility of their willingness to
consider settlement of such claims outside the terms of
this
settlement offer, whether in courts of the United States or
in
judicial or administrative tribunals of other countries.
(c) Foreign Claimants who want to pursue or institute
litigation
in the United States against Bristol, Baxter, 3M,
McGhan, or
Union Carbide have the right--as guaranteed under terms
of the
global settlement--to do so (subject to any objection by
those
defendants under doctrines such as "forum non
conveniens"),
but, to do so, must exercise their "Second Opt-Out
Right" as
described in 7 above, either at this time or after being
mailed a Notification by the Claims Office regarding
their
status. To eliminate any need to make this decision
prematurely, they are allowed to delay making this
decision
until sent the Notification by the Claims Office, with
statutes of limitation and repose in this country being
suspended until 30 days after the time allowed in that
Notification for opting out.
(d) Foreign Claimants who want to pursue or institute
claims
against implant manufacturers or distributors in the
judicial
or administrative tribunals of their own countries may do
so,
and need not file any further form or election with the
Claims
Office.
19. Children of Breast Implant Recipients.
The revised settlement program does not provide any special
benefits
to children of breast implant recipients. Such children are,
with
respect to any claims for personal injury or death allegedly
resulting from their mother's breast implant, hereby excluded
from
membership in any class previously established by the Court,
and any
such claims may be brought before December 15, 1997, or, if
later,
within two years after the claim accrues or the child attains
the age
of majority under applicable state law.
20. Limits on Obligations of Defendants; Additional Opt-Out
Rights.
(a) 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).
(b) If a claimant has had 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. For example, if a claimant had one or more
Bristol implants, one or more Baxter implants, a "post
8/84
McGhan" implant, and a Mentor implant and was
entitled to a
$150,000 payment, then Bristol would be responsible for
payment of $75,000 and Baxter for payment of $75,000.
Enhancement payments for rupture and explantation
benefits are
the sole responsibility of the defendant whose implant
ruptured or was explanted.
(1) The obligations of Bristol, Baxter, and 3M to make
payments
under 12(a), 12(c), and 12(d) are not subject to any
maximum limitations.
(2) As explained in 12(b)(4), their obligations to make
payments under 12(b) (other than to certain Current
Claimants as explained in 12(b)(3)) are subject to
certain
limitations; namely, a maximum of $725,000,000 (less
amounts paid for explantation expenses of Other
Registrants), with their respective obligations for such
12(b) benefits being as follows:
* Bristol's cumulative obligation for such 12(b)
benefits
($400,000,000) increases in the amount of
$27,600,000 per
year for the first 10 years and $24,800,000 per year
for
the next 5 years (less amounts paid by it for
explantation expenses of Other Registrants)
* Baxter's cumulative obligation for such 12(b)
benefits
($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)
* 3M's cumulative obligation for such 12(b) benefits
($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)
(c) The obligations to pay benefits under 13 based on "post
8/84
McGhan" implants are divided between McGhan (20%),
3M (40%),
and Union Carbide (40%).
(1) Their respective obligations to make payments to
Current
Claimants are not subject to any maximum limitations.
(2) As explained in 13(e), their obligations to make
payments
under 13 (other than to Current Claimants as explained
in
13(d)) are subject to certain limitations; namely, a
maximum of $30,000,000, with their respective
obligations
for such benefits being as follows:
* McGhan's cumulative obligation for such benefits
($6,000,000) increases in the amount of $400,000 per
year
for 15 years (less the amount, if any, that its payments
to Current Claimants based on "post 8/84 McGhan"
implants
exceed $38,400,000)
* 3M's cumulative obligation for such benefits
($12,000,000)
increases in the amount of $800,000 per year for 15
years
(less the amount, if any, that its payments to Current
Claimants based on "post 8/84 McGhan" implants
exceed
$76,800,000)
* Union Carbide's cumulative obligation for such
benefits
($12,000,000) increases in the amount of $800,000 per
year
for 15 years (less the amount, if any, that its payments
to Current Claimants based on "post 8/84 McGhan"
implants
exceed $76,800,000)
(d) The settling defendants are to pay into the fund
established
by the Court and maintained by the Escrow Agent 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 and the Escrow Agent to be needed (after
considering undistributed funds previously contributed to
the
fund by that defendant and the limitations under (b) and
(c)
above) to pay benefits (or installments) for which that
settling defendant will become obligated to pay during
the
next 3 months. For further information concerning the
fund,
see 31.
(e) If the cumulative limitations stated in (b) and (c) above
result in any year in a participant (other than a Late
Registrant) 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 (i) must first return any amounts previously paid
under
the program (other than for explantation expenses or as
an
Advance Payment) and (ii) shall be given the
opportunity, if
they so elect, to participate in procedures to be
established
by the Court, in an effort to resolve their claims.
(f) If a participant's claims against one settling defendant
have
been released or resolved by final judgment, she will be
paid
only the prorated benefits due from other settling
defendants
with respect to which her claims have not been released
or
resolved by final judgment.
21. Pre-Existing Diseases; Successive Claims.
(a) For claims under the revised settlement based on the
revised
disease criteria (Exhibit E1)--
(1) benefits may not be obtained for a disease or
condition if
the qualifying symptoms existed before the date of the
first implantation; and
(2) a claimant receiving benefits under the Long-term
Benefit
Schedule may make an additional claim during the 15
years
of the program if, as a result of additional symptoms,
she
can establish that she is entitled to a higher level of
compensation either because of a new disease or
symptomology or because of an increase in the
compensation
level. In such event, amounts previously paid will be
subtracted from the amount otherwise payable for the
new
condition.
(b) For claims under the revised settlement based on the
disease
and disability/severity schedule of the global settlement,
the
provisions stated in the original notice govern the effect
of
symptoms and disabilities that existed before the
claimant's
first breast implant. Under those provisions, no symptom
is
considered for purposes of establishing ACTD if it
existed
before the date of first implantation. A participant who,
before her first breast implant, had another covered
disease
listed on the original disease schedule would, if the
benefit
level based on the disease or disability/severity increased
after that implant, be eligible for benefits measured by
the
difference between the amount payable for the new
disease and
disability/severity level and the amount that would have
been
payable for the pre-existing condition.
22. Claims of Health-care Providers.
(a) Under current terms of the revised settlement program,
reimbursement and subrogation-type claims by insurers,
governmental agencies, and other health-care providers
will,
to the extent enforceable under applicable laws, be the
responsibility of participants; the settling defendants will
have no additional responsibilities to such insurers,
agencies, and providers for participants electing to accept
benefits under the revised settlement.
(b) However, additional settlement negotiations are
presently
underway between the settling defendants and many of
the
private health-benefit providers and insurers which
attempted
to intervene in the global class settlement to assert
reimbursement or subrogation claims. The general nature
of
these discussions is that, in exchange for additional
payments
to such providers and insurers by the settling defendants-
-
over and above their obligations to pay benefits to
participants under the revised settlement--such providers
and
insurers would agree not to pursue reimbursement or
subrogation claims against implant recipients
participating in
the revised settlement. As of the printing of this Notice,
these discussions have not resulted in a final agreement
approved by those parties, but they are sufficiently
promising
as to justify advising eligible participants of this potential
supplemental agreement that would be of substantial
benefit
under the revised settlement program to many implant
recipients. Updated information regarding the status of
these
negotiations will, when available, be posted on the
Claims
Office recorded- message telephone line (800-887-6828);
and,
if the negotiations are successful, you will be advised of
the
details in the Notification of Status letter to be sent to
you
by the Claims Office.
23. Releases.
(a) Eligible implant recipients who do not timely opt out
will for
themselves (and for their personal representatives and
family
members with respect to representative or derivative
claims)
waive and release, except as provided in 20(e), their
rights
to institute or pursue breast-implant related claims
against
the Settling Defendants and Released Parties identified in
Exhibit B1.
(b) Claims against Dow Corning and other manufacturers,
distributors, or suppliers of breast implants or component
parts of such implants--or against doctors, hospitals, or
other health-care providers--not listed in Exhibit B1 are
not
part of the revised settlement and are not released or
dismissed. Claims against Mentor, Bioplasty, and Dow
Corning
may, however, be barred or restricted as a result of prior
settlements or bankruptcy proceedings, as explained in
15-17
above.
24. Effect of Appeals.
An appeal does not suspend the obligation of settling
defendants to
make payments under 12(a) or, upon receiving an executed
standard-
form release, under 12(c) or 12(d). Depending on the issues
raised,
an appeal may suspend the obligation of defendants to make
payments
under 13 and (unless a mutually satisfactory release is
executed)
under 12(b).
25. Defendants' Position; Inadmissibility of Settlement.
(a) Although agreeing to the revised settlement, the settling
defendants continue to deny any wrongdoing or any legal
liability of any kind. They have agreed to the revised
settlement not only because of the risk of adverse
judgments
in some cases, but also because of the substantial time,
expense, and other burdens they would incur even in
successfully defending against thousands of existing
cases and
cases that might be filed in the future. These defendants
believe that, at the same time, the settlement will also be
in
the best interests of those who have been implanted with
their
products by expediting the time for resolving claims and
that,
by taking advantage of the potential savings in
"transaction
costs" resulting from a class settlement, the amounts
actually
paid to many participants under the settlement would, in
their
opinion, exceed recoveries that might be obtained
through
individual claims and lawsuits.
(b) Establishment of and negotiations leading to the revised
settlement program, and Claims Office determinations
and
payments under the program, do not constitute any
admission by
the settling defendants of fault, liability, or damages and
will not be admissible in evidence in any proceeding for
such
purposes or as evidence of ownership, control, agency, or
relationship between the settling defendants and the
released
parties in the event an implant recipient proceeds with
litigation against the defendants (except that any
judgment
obtained by such a person will be reduced by any
payment under
this settlement).
26. Incorporation of Terms of Global Settlement.
The revised settlement program implements paragraph 18 of
the notice
of the global settlement by reducing--for those eligible to
participate--the extent of ratcheting that would otherwise
occur and
by preserving--for those not eligible to participate--their
rights to
opt out of the class (while providing an extension of the
period
during which statutes of limitation and repose would be
suspended).
Except to the extent modified by or inconsistent with the
terms of
this Notice, the settlement terms announced in the April 1994
notice
(including, for example, provisions relating to contribution
and
indemnification claims against the settling defendants and
released
parties) remain in effect and govern rights, obligations, and
options. The benefits provided under the revised settlement
supersede
and are in lieu of all benefits that participants and their
attorneys
might have had under the global settlement. The Court retains
general
powers to administer and implement the settlement, including
the
power to interpret the terms of the settlement and to resolve
on an
equitable basis conflicting claims to benefits arising because
of
death of a participant or asserted assignments or liens relating
to
payment of benefits.
ATTORNEYS' FEES AND EXPENSES
27. Privately-retained Counsel.
Fees and expenses of attorneys individually retained by
Lindsey class
members who have not previously opted out, whether in
presenting
claims under the global settlement, or in presenting claims
under the
revised settlement, or in instituting or pursuing claims as new
"opt-
outs" will be borne by such persons based on applicable state
law and
the individual arrangements made between them and their
attorneys,
but subject to certain limitations indicated below.
(a) The fees charged by individually-retained attorneys to
an
implant recipient who accepts the terms of the revised
settlement shall not exceed the sum of--
(1) 10% of the first $10,000 paid to such participant
under the
settlement;
(2) 22.5% of the next $40,000 paid to such participant
under
the settlement; and
(3) 30% of the amount in excess of $50,000 paid to such
participant under the settlement.
(b) Amounts paid to or on behalf of participants as
explantation
benefits shall not be counted as amounts paid to a
participant
for purposes of calculating the above limitations.
(c) The Court reserves the power to establish additional
standards
and limitations affecting the expenses that individually-
retained attorneys may charge those participating in the
revised settlement.
(d) Benefits payable to participants under 12, 13, and 14
shall
not be subject to any reduction for fees and expenses of
class
counsel for representing the Lindsey class or for other
"common benefit" services (or for administrative
expenses of
the Claims Office and others in implementing the revised
settlement).
28. Funding of "Common Benefit" Fees and Expenses.
Order No. 13 was entered in CV92-P-10000-S in July 1993
in order to
provide for the fair and equitable sharing among breast-
implant
recipients who presented claims in federal court of the cost of
the
special services performed, and expenses incurred, by
attorneys
acting for the "common benefit" of all such claimants.
Services in
conducting common discovery, for example, would be
beneficial not
only to implant recipients who later chose to pursue
litigation, but
also to those who later accepted a settlement offer prompted
at least
in part by the existence of such discovery.
(a) As a means for complying with Order No. 13, the
settling
defendants under the revised settlement program will pay
into
the previously established fund an amount equal to 6% of
the
amounts paid under 12, 13, and 14. These payments will
be paid
as a surcharge and will not reduce the amounts payable
to
participants under 12. 13. or 14.
(b) Order No. 13 continues in place, and will continue to
govern
the resolution, whether by trial or settlement, of breast-
implant claims of persons who do not accept (or are not
eligible to participate in) the revised settlement, but who
either were members of the Lindsey class (and did not
exercise
their initial right to opt out) or, although not members of
the Lindsey class (whether because they were ineligible
or
because they exercised their initial right to opt out) now
or
in the future have breast-implant claims that are filed in
or
properly removed to federal court. What this means is
that 6%
of the "gross monetary recovery" obtained by such
persons,
whether by trial or settlement, is to be withheld and paid
into the common-benefit expense fund.
(c) Under terms of Order No. 13, if the amounts paid into
the fund
exceed the amounts ultimately approved by the Court as
proper
charges against the fund, the excess will be distributed to
implant recipients on a pro-rata basis as the Court
determines
to be fair and equitable.
29. Employment of Attorneys.
You may retain an attorney of your own choice for advice
concerning
your rights or to provide services either in presenting a claim
under
the revised settlement or in instituting litigation, but you will
be
responsible for the fees and expenses of such attorney as
explained
in 27. You are not required, however, to have private counsel
in
order to submit claims under the revised settlement.
CLAIMS ADMINISTRATION
30. Claims Office.
The Claims Office will continue to process and evaluate
registrations
and claims as expeditiously as possible, but may give priority
of
consideration to claims by claimants who, through Proof of
Manufacturer forms, indicate they may have had a Bristol,
Baxter, 3M,
or "post 8/84 McGhan" implant (with particular priority to
claims by
those who have waived "Second Opt-Out Rights") and may
defer
consideration of submissions by those who appear to be
ineligible
under the revised settlement program.
(a) As claims are processed and evaluated, the Claims
Office will
send each person 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, if a Current
Claimant, any documentation submitted in support of a
rupture
supplement is satisfactory; 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 7(c), 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.
(b) The Claims Office will continue to implement
procedures
designed to detect and prevent payment of fraudulent
claims.
To deter potential fraud, all claims must be signed under
penalties of perjury. Since the Postal Service will be used
in
the processing and payment of claims, submission of
fraudulent
claims will violate the criminal laws of the United States
and
subject those responsible to criminal prosecution in the
federal courts.
(c) 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.
(d) Expenses of the Claims Office will continue to be paid
from
the funds initially provided under terms of the global
settlement, with such supplemental contributions from
the
settling defendants as, during the 15-year period of the
program, the Court determines to be necessary for such
purposes and without reducing the benefits payable to
participants under the revised settlement program.
(e) Operations of the Claims Office will be subject to the
continuing jurisdiction of the Court and subject to Court
review.
31. Fund Administration.
The fund into which the settling defendants' payments will be
made is
a continuation of the MDL 926 Settlement Fund established
under Order
No. 15, with Texas as its domicile, location, and place of
creation
and administration, and with eligible participants being its
beneficiaries. Ann Tyrrell Cochran, Claims Administrator,
has general
responsibilities for collecting, collating, processing,
evaluating,
and quantifying claims. Edgar C. Gentle, III, has been
designated as
Escrow Agent and as Chairman of the Investment
Committee, with the
duties approved by the Court by order dated November 23,
1994 (as
modified by further Court orders). Also on the Investment
Committee
are Don Springmeyer (plaintiffs' designee) and Todd M.
Poland
(defendants' designee).
32. Filing of Elections, Forms, and Documentation.
(a) All elections, forms, and documentation described in
this
Notice are to be filed with the Claims Office, and not
with
the Court. Please do not send "courtesy" copies to the
Court.
Please do not send additional copies of materials with a
request for acknowledgment--handling of duplicate
copies only
results in increased administrative costs and delay.
(b) Deadlines for providing elections, forms, or
documentation to
the Claims Office are to be determined by the date such
items
are actually received in the Claims Office, rather than
date
of mailing. Facsimile transmissions are not acceptable.
33. 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 December 16, 1996, by
participants
claiming status as Current Claimants, as must documentation
of a
claim for rupture supplement under 12(c)(2).
34. Court Review of Claims Office Determinations.
A claimant dissatisfied with the decision made by Claims
Officers may
appeal to the Claims Administrator and, if still dissatisfied,
may
seek a further review, on the basis of the record evidence, by
the
Court (or a person designated by the Court to conduct such
review).
No other appeals or reviews are permitted, and the settling
defendants will have no right of appeal or review from
determinations
made by the Claims Office.
ADDITIONAL INFORMATION
35. Court Filings and Other Documents.
You may inspect documents on file with the Court at the
office of the
Clerk, 1729 Fifth Avenue North, Birmingham, Alabama,
35203, during
regular business hours and may obtain copies of these
documents (such
as the revised settlement program and the Court's order
approving
transmittal of this offer to class members) by payment of the
prescribed charges. The Clerk's office is not permitted to give
legal
advice. The Claims Office (800-600-0311 and 713-951-9106)
is
authorized to answer administrative and clerical inquiries
relating
to claims and the claims process, but not to give legal advice.
Contact the Claims Office if you need a copy of the Disease
Schedule
that was transmitted with the original global settlement
notice.
36. Assistance.
You should save this Notice for reference concerning your
rights and
benefits, the claims process, the important deadlines, and
telephone
numbers. In addition to the limited information available
from the
Claims Office (see 35 above), you may obtain further
information
concerning the revised settlement and your rights and options
in any
one or more of the following ways:
* by reading the enclosed booklet, entitled "Questions and
Answers", which has been approved by the Court.
* by consulting an attorney of your own choice. (Note: the
advice
given by private counsel is not monitored, reviewed, or
supervised by the Court.)
* by watching the cable TV program on Court TV on
Wednesday,
January 24, 1996, at 9 PM CST. (Note: this program,
intended to
complement the written notice, will provide general
information
only and will not provide legal advice regarding particular
claims.)
* by attending one of the regional meetings or participating
in
the telephone conference to be scheduled by the Court.
See
insert accompanying this Notice. (Note: these meetings
and this
conference will provide general information only, and will
not
provide legal advice regarding particular claims.)
* by requesting legal assistance from Settlement Class
Counsel by
calling 513-651-9770. (Note: although this program has
been
approved by the Court, the Court does not monitor,
review, or
supervise the advice given by such persons.)
* by contacting any of the various "support groups" formed
to
provide assistance to breast implant recipients and their
families. (Note: these support groups operate
independently of
the Court, and their communications and advice are not
monitored, reviewed, or supervised by the Court.)
This Notice has been approved by Judge Pointer for
distribution to
breast-implant recipients as an official notice of the Court
PERRY D. MATHIS
Clerk of the Court
ATTACHED EXHIBITS:
B1 List of Settling Defendants and Released Parties
E1 Revised Disease/Symptomology Definitions and
Compensation Levels
G List of Implant Brands and Manufacturers
FORMS (separate documents, but included in mailing):
Election Form
Proof of Manufacturer Form
Explantation Claim Form
Rupture Claim Form
EXHIBIT B1--Revised Settlement
Settling Defendants
Baxter Healthcare Corp.
Baxter International Inc.
Bristol-Myers Squibb Co.
Inamed Corp.
McGhan Medical Corp. (Calif. Corp.)
McGhan Medical Corp. (Dela. Corp.)
a/k/a McGhan Medical/3M
Medical Engineering Corp.
Minnesota Mining & Manufacturing Co.
a/k/a 3M Company
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.
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
Anita Kost McAteer
Donald K. McGhan
McGhan Limited
McGhan NuSil Corporation
MEC Subsidiary Corp. f/k/a
Surgitek, Inc.
Natural "Y" Surgical Specialties, Inc.
NuSil Corp.
NuSil Technology
W. John Pangman, II
Vincent R. Pennisi
Poly Plastic Silicone Products, Inc.
Schulte Medical Products
Diran M. Seropian
Paul Silverstein
Sirod Corp.
Scott Spear
Specialty Silicone Fabrications, Inc.
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 E1--Revised Disease/Symptomology Definitions
and Compensation
Levels
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 metatarsophalangeal 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 or 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
sclerodermal(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.
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 findings and 2-D Echo doppler or
angiography
with hemodynamic measurements showing pulmonary
artery
pressures of greater than 25 TORR).
III. Lupus (SLE)
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:
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 heard 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
vasculitis.
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.)
IV. 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.
V. General Connective Tissue Symptoms (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 III; or
(2) two findings from Group II plus one non-duplicative
finding
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-certified
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 pulmonologist, 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
elevatedCPK or
adolase from the muscle (outside of the performing
laboratory's
reference ranges) on two separate occasions at least sixweeks
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 sitethat has not
undergone EMG testing) showing evidence of necrosis of
type 1 and 2
muscle fibers, phagocytosis, and an interstitialor 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
sensationto
pinprick, vibration, touch, or position; (b) symmetrical distal
muscle weakness; (c) tingling and/or burning pain in
theextremities;
or (d) loss of tendon reflex, plus nerve conduction testing
abnormality diagnostic of peripheral neuropathy
orpolyneuropathy
recorded from a site that has not undergone neural or
muscular
biopsy. [Exclusions: thyroid disease, antineoplastictreatment,
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 G -- Implant Brands and Manufacturers
The left-hand column is a list of companies, implant brands,
"designer" implant names, and other names or phrases that
might be
used in medical records to describe a particular type of breast
implant. The column to the right identifies the company with
which
that brand is associated for purposes of this revised
settlement
program. If implantation date ranges are supplied for an
implant an
appropriate notation is to the right of each date range.
Implants noted as Mentor (for post 8/84 McGhan benefits)
that have a
star (*) before Mentor will be treated as Baxter implants if a
Baxter
lot number can be supplied for that implant Lists of lot and
serial
numbers for Bristol, Baxter,and 3M implants are available
from the
Claims Office upon request.
To prove that a McGhan implant which was implanted after
August 2,
1984, was wholly or partly manufactured before that date
(and
therefore can be treated as a 3M implant rather than a post
8/84
McGhan implant), you should provide proof of the 3M name
or
qualifying serial number. A list of McGhan serial numbers
qualifying
as 3M implants is available from the Claims Office upon
request.
Notations after the names Mentor or Bioplasty that say "(for
purposes
of post-8/84 McGhan benefits)" mean that they can be
considered as
Mentor or Bioplasty implants for purposes of determining
eligibility
under the program described in this notice, but that no
determination
can be made at this time as to whether one of these implants
will
trigger eligibility under the distribution program for the
Mentor or
Bioplasty funds. Further clarification of the status of those
implants will be included in the more detailed information
that will
be available later about the Mentor and Bioplasty funds.
Brand/Manufacturer Name Status in Revised
Program
3M 3M
AHS Baxter
Aesthetech Bristol
Alloplastic Not Covered
American Heyer-Schulte Baxter
American Hospital Supply Baxter
Arion Not Covered
Ashley
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Baxter Baxter
Bebe Not Covered
Beckein Not Covered
Becker Mentor
Beckman Not Covered
Biocell McGhan
Biodimensional McGhan
Biofill Not Covered
Biomanufacturing Bioplasty
Bio-oncotic Bioplasty
Bioplasty Bioplasty
Biospan McGhan
Birnbaum Baxter
Cabot Not Covered
Calcorian Not Covered
Capozzi
Implanted before 9/1/71 Bristol
Implanted after 8/31/71 Baxter
Cavon Bristol
CBI Medical Bristol
Controle Medicale Not Covered
Cooper Surgical Bristol
Corbet Bristol
Cox Uphoff CUI
Cronin Dow Corning
Cunard Not Covered
CZV/CRS (Croissant Versafil Low Profile) CUI
Dacron Not Covered
Dahl Bristol
Datron Not Covered
Delayell Not Covered
Delcon Not Covered
Directa Span Mentor
Donnell Not Covered
Dow Corning Dow Corning
DRI CUI
DRIE CUI
Dubin Not Covered
DuPont Not Covered
Edward Laboratories Baxter
EHP (Enhanced High Profile) CUI
Edward Weck & Co.
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 1218/78 Bristol
Elicon Not Covered
Emory Not Covered
Etheron Not Covered
Euromed Not Covered
Euro-Silikon (or Euro-Silicone) Not Covered
Fernander Not Covered
Flat Span Mentor
FZV/SFV (Round Versafil LP Tissue Expander) CUI
Georgiade Bristol
Gibney CUI
Grossman Not Covered
Guthrie
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Hamricksholler Not Covered
Hartley Baxter
Heyer-Schulte
Implanted before 3/31/84 Baxter
Implanted after 3/30/84 *Mentor (for post 8/84
McGhan benefits)
Heyer-Schulte Mentor Mentor
Higer-Sol Not Covered
Hoest Not Covered
Hypoplastic Not Covered
Hyra Not Covered
Integra Not Covered
Intrashiel
Implanted before 8/3/84 3M
Implanted after 8/2/84 McGhan
Intravent CUI
IOC (Cylindrical Intraoperative
Tissue Expander) CUI
IOM (Intravent Intraoperative Expander) CUI
IOS (Spherical Intraoperative
Tissue Expander) CUI
Isle Mentor
Ivalon Not Covered
Jackson Not Covered
Jellco Not Covered
Jenny Baxter
Jobe Baxter
Johnson & Johnson Not Covered
Jonas Not Covered
Klein Bioplasty (for post
8/84 McGhan benefits)
Koken Not Covered
Lab Sebbin Not Covered
Lambardozzi Not Covered
Lepetit Pharmaceutical Not Covered
Litz Not Covered
Mammatech Bioplasty (for post
8/84 McGhan benefits)
Magna-Site McGhan
Mann Not Covered
Mark/M Surgical
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Markham
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Markham Medical Int'l
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Mathe Not Covered
Maxwell McGhan
McCormick Not Covered
McGhan
Implanted before 8/3/84 3M
Implanted 8/3/84 to 12/31/91 McGhan
Implanted after 12/31/91 Not Covered
McGregor Not Covered
MEC Bristol
Medasil Not Covered
Medical Engineering Corporation Bristol
Meme Bristol
Meme ME Bristol
Meme MP Bristol
Mentle Not Covered
Mentor Mentor
Metarse Not Covered
MFE (Man Facelift Expander) CUI
MFP Dow Corning
Microcell CUI
Misty Bioplasty
Misty Gold Bioplasty
Morgantil Not Covered
MSI Dow Corning
Mueller V
Implanted before 1/1/68 Not Covered
Implanted 1/1/68 to 8/31/74 Dow Corning
Implanted 9/1/74 to 10/31/78 Not Covered
Implanted 11/1/78 to 3/30/84 Baxter
Implanted after 3/30/84 Not Covered
Mulligan Not Covered
Munna Bristol
Nagor Not Covered
Nagotex Not Covered
Natrashiel 3M
Natural Y
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
NFP (Non-Fixation Patch) Dow Corning
Nicola Not Covered
Norman Bristol
Nortec Not Covered
OHP (Oval High Profile) CUI
OLP (Oval Low Profile) CUI
Optimam Bristol
Pangman Baxter
Papillon Bristol
Paragel Not Covered
Pardue Not Covered
Perifil Not Covered
Perras Bristol
Perras-Papillon Bristol
Phillips Not Covered
Plastigel Not Covered
Plastone Not Covered
PMT Not Covered
Polyurethane
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Poly Plastic
Implanted before 9/1/71 Bristol
Implanted after 8/31/71 Baxter
Poly Plastic Adjustable Baxter
Porex Not Covered
Precision Not Covered
Process Mankind Technology Not Covered
Promotel Not Covered
Quin-Seal Bristol
Radovan Bristol
Rand Not Covered
RCP (Round Conical Profile) CUI
RCR (Ruiz-Cohen Expanders) CUI
RDD (Reverse Double Lumen DRIE) CUI
RDL (Reverse Double Lumen) CUI
RDL-XPAND CUI
RDX (Round Double Lumen) CUI
Regetect Not Covered
Replicon Bristol
Reverse Double Lumen CUI
RHD (Round High Profile) CUI
RHP (Round High Profile) CUI
RLD (Round Low Profile DRIE) CUI
RLP (Round Low Profile) CUI
Roger Klein Bioplasty (for post
8/84 McGhan benefits)
RTV Not Covered
RTV/RTT (Smooth/Textured) CUI
Ruben Not Covered
Rubicon Not Covered
Ruiz-Cohen CUI
Ryscien Not Covered
RZV/SRV (Rectangular Versafil
Tissue Expander) CUI
Satin Lacey Not Covered
SCC (Cylindrical Tissue Expander) CUI
SCL Bristol
SCS (Crescent Tissue Expander) CUI
Sealthen Not Covered
SEE (Mini-crescent Tissue Expander) CUI
Sebbin Not Covered
Secrofft Not Covered
Serbital Not Covered
Seropian Baxter
SFS (Saline Fill Skin and Tissue Expander) CUI
SGO (Saline Gel Oval) CUI
SGR (Saline Gel Round) CUI
Silastic Dow Corning
Silastic II Dow Corning
Silastic II MSI Dow Corning
Silicone Medicale Not Covered
Silimed Not Covered
Siltex Mentor
Siltex Becker Mentor
Siltex Spectrum Mentor
Simiplast Not Covered
SLP (Single Lumen Adjustable) CUI
SLS (Longitudinally Curved Tissue Expander) CUI
Snyder Bristol
SOE (Small Oval Tissue Expander) CUI
Sofgel Not Covered
SOS (Ear Shaped Tissue Expander) CUI
Spectrum Mentor
SPS (Pear Shaped Tissue Expander) CUI
SRS (Rectangular Tissue Expander) CUI
SSS (Spherical Tissue Expander) CUI
Sterling Baxter
Storz Not Covered
Summit Medical Bristol
Surgical Specialties Bristol
Surgitek Bristol
Surigel Not Covered
Switek Not Covered
SWS (Wedge Shaped Tissue Expander) CUI
Synopsis Not Covered
Syntech Not Covered
SZR (Round Low Profile Sizer) CUI
Tab Products Not Covered
Tabari Baxter
TBD Not Covered
Tecknar Mentor
Tis-U-Sol Not Covered
TLL (Triple Lumen Round) CUI
Travenol Baxter
Tri-Lumen CUI
TRL (Tri-Lumen Implants) CUI
TSO (Triple Lumen Low Profile Oval) CUI
TSR (Triple Lumen Round Low Profile) CUI
UHP McGhan
Ultra High Performance McGhan
Unimed/Unitech Not Covered
Uroplasty Bioplasty
Usign Not Covered
Varifil Dow Corning
Versafil CUI
V. Mueller
Implanted before 1/1/68 Not Covered
Implanted 1/1/68 to 8/31/74 Dow Corning
Implanted 9/1/74 to 10/31/78 Not Covered
Implanted 11/1/78 to 3/30/84 Baxter
Implanted after 3/30/84 Not Covered
Vogue Bristol
Wagner Baxter
Webster Bristol
Weck
Implanted before 9/1/71 Bristol
Implanted 9/1/71 to 12/8/78 Baxter
Implanted after 12/8/78 Bristol
Weiner Not Covered
Wenthol Not Covered
Wilshire Tech Not Covered
Williams Baxter
Wood Bristol
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