BREAST IMPLANT NEWS
RESPONSE TO MR. TRACHTMAN'S LETTER OF 02/05/04
the Tort Claimants Committee sent a letter to the Clerk of the Court
for the United States Court of Appeals for the 6th Circuit asking
for a hearing date "at the earliest possible time" consistent
with that Court's order of October 30, 2003. You can download and/or
read the letter and attachments by going to http://tortcomm.org/
- Nevada Claimants Letter
Richardson, Patrick, Westbrook, & Brickman, LLC
On Link Above To Bring Up Letter
A MESSAGE FROM THE NEVADA APPELLANTS TO ALL
CORNING BREAST IMPLANT CLAIMANTS
As we celebrate
the good news and the good works of selfless plaintiffs' lawyers,
breast implant support groups and breast implant survivors who gave
so much of their time and energies and managed, against all odds,
to get the FDA to nix silicone breast implants from re-entering
the market, we are reminded that these lawyers, groups and survivors
stood firm on principle.
As most knowledgeable plaintiffs' lawyers, support groups across
the country and breast implant survivors understand, for years and
years the Nevada appellants - - who are in complete agreement with
the Tort Claimants' Committee (TCC) on all issues except one - -
have stood firm on the principle that a non-bankrupt company like
Dow Chemical should not be immunized from the precedent created
by Charlotte Mahlum's successful case in Nevada against Dow Chemical
unless it is willing to file bankruptcy itself. Against all
odds, we prevailed on the bankruptcy judge in Michigan to allow
the Nevadans' claims against Dow Chemical to go forward unhindered
by the Dow Corning bankruptcy. The Plan Proponents - - Dow
Corning and the TCC - - successfully appealed this ruling to the
honorable Denise Page Hood, the U.S. District Court Judge in Detroit.
Thus, the Nevadans' victory before the bankruptcy court - - a victory
which allowed all other claimants such as yourselves to get paid
but still allowed the very few claimants with claims against Dow
Chemical to proceed unhindered - - was short lived.
The Nevadans, the Australians, the U.S. Government and others then
appealed Judge Hood's decision to the 6th Circuit Court of Appeals
in Cincinnati, and the 6th Circuit Court of Appeals reversed and
sent the matter back to Judge Hood for further findings that would
warrant the extreme measure of releasing the non-bankrupt Dow Chemical
from liability against those like the Nevadans who did not consent
to such a release by voting for the Plan. Judge Hood made
findings which purport to warrant that extreme measure, and the
Nevadans and the Australians appealed Judge Hood's decision, again,
to the 6th Circuit. In the meantime, the U.S. Government settled
its appeal with the Plan Proponents (Dow Corning and the TCC)
This entire process of the Plan Proponents' first successful appeal,
followed by the semi-successful appeal of the U.S. Government, the
Australians, and the Nevadans, took four years. Now, the Plan
Proponents have just settled with the Australians, such that the
Nevadans, 48 in number, with pending claims against Dow Chemical
in Nevada, have very recently become "the last women standing" objecting
the Plan. We continue to stand on the important principle
that a non-bankrupt company like Dow Chemical should not be released
from liability. Only Dow Corning, which filed bankruptcy,
should receive that benefit.
Yet sometime principle must yield to reality. The reality
is that no longer can the Nevada women claim that this important
which they are fighting so hard is not holding up the ability of
other women across the country to get paid. Because now, apparently,
it is. Many of you have called our office to applaud our efforts
and say "stick to your guns on fighting the Dow Chemical release"
no matter what. More of you have called our office to suggest
that we now abandon our appeal entirely for the greater good of
women everywhere whose payments are being delayed. Yet White
& Meany can only do what we feel is in the best interests of
their clients, and can only act with the permission of its clients.
As most of you reading this know, the only reason you cannot get
paid while the Nevadans' appeal before the 6th Circuit is still
pending is because of Dow Corning's and Dow Chemical's insistence
that they will not allow the Bankruptcy Settlement and Plan to go
forward so long as ANY appeal of the release of Dow Chemical from
liability is pending. It is this self-serving insistence which
keeps you from getting paid, while at the same time throwing a huge
"guilt trip" on the Nevada women and their various tort and
bankruptcy attorneys for not bowing to this pressure, giving up
and throwing in the towel. That fact, coupled with Dow Corning's
and Dow Chemical's ability to veto any settlement of the Nevadans'
claim under the bankruptcy plan itself, is truly the reason the
Plan cannot go forward. Do not blame the Nevadans. Do
not blame the Tort Claimants' Committee. The blame lies elsewhere.
Using intermediaries, the Nevadans have tried, repeatedly, to negotiate
the resolution of their appeal and break the logjam with Dow Corning
and Dow Chemical, all to no avail. These corporations' words
to the Nevadans can be paraphrased by the late Nikita Khrushchev:
"Because you dared to cross us and continue to do so, we will bury
you." And, they mean it, and they don't care if everyone else
gets buried as well. Indeed, it is in their best financial interests
not to settle with the Nevadans, because that would resolve the
Appeal, and if the appeal is resolved, the Plan would go forward.
But the Nevadans do care about everyone else. I believe the
Tort Claimants' Committee cares as well. So do numerous
other selfless plaintiffs' lawyers and law firms across the country
with large groups of clients clamoring for resolution of their claims.
I will not convey false hope, but some movement has been made toward
resolution of the Nevadans' appeal, as follows.
First, the 48 Nevadans presently appealing the Plan have elected,
for the greater good of women in the other 49 states, to abandon
their appeal, provided only that their bankruptcy fees are paid
from another fund and not charged against them, just as all other
claimants' bankruptcy fees (i.e., yours) are paid from another fund.
That total sum, for all of the bankruptcy work done over the years
to support the principle we have been fighting for, is slightly
less than $400,000. Once a trust fund is established - - and
where the money comes from is irrelevant - - to pay off a lien that
will be assessed against the Nevadans' settlements and recoveries
when and if their cases settle, the Nevadans will dismiss their
appeal. This trust fund concept is well researched, ethically
proper and workable if there is sufficient interest to fund it.
Second, this offer was made in an open letter to several large plaintiffs'
firms with large inventories of breast implant cases. I will
not name names nor put anyone "on the spot". I will say that,
at least initially, every attorney in these firms who contacted
me expressed enthusiasm for the trust fund concept. The trust
fund concept was a means of resolving the Nevadans' appeal and ensuring
that the Nevadans who abandoned their appeal and lost any potential
chance to pursue Dow Chemical would not have to lose twice and take
less money in settlements than women in the other 49 states.
Recall that the bankruptcy fees of the women in the other 49 states
are paid for by the Estate, namely Dow Corning. Not so with
the Nevada women. If the trust fund is not established, they
will be abandoning the appeal AND eating the fees. This they will
not do and should not be expected to do. Nor should their
That is where the matter sits. If the Nevadans' appeal is
resolved and settled soon as it could be, the Plan can go forward
this year. The TCC's website (address below) verifies this.
Indeed, some aspects of the Plan are already being implemented.
If the Nevadans' appeal is not resolved soon, payments will be delayed
at least another year, and probably two. The Nevadans do not
wish this because they, too, are impacted by the delay. Nor
do they want to delay anyone else in the country from getting paid.
The Nevadans are threatening no one but are instead responding to
the settlement feelers of others.
The honorable 6th Circuit Court of Appeals in Cincinnati has recently
ordered that oral arguments be set on the Nevadans' appeal as soon
as possible. Whichever side loses there will appeal to the
U.S. Supreme Court, causing further delay.
The bottom line is but for the establishment of a $400,000 trust
fund for the Nevada women to pay only their legitimate bankruptcy
fees they incurred over the last several years, these appeals would
cease.Yet I am not going to beg for my clients. I will state
the reality.We still believe fervently that Dow Chemical should
not be released. Yet we temper that belief with the practical result
of fighting to the bitter end to preserve that principle, and have
thus extended the olive branch.
I am not the greatest at math, but it would appear that $400,000
represents less than 1/60th of 1% of the $2.6 Billion Dollar Estate.
For what it's worth. 1/60th of 1%. Go figure.
Feel free to print out this message and give it to your own attorney.
Feel free to call, write or e-mail the Tort Claimants' Committee
free to e-mail me at email@example.com. Have your
attorney e-mail me. I have tried to respond to each and every
breast implant survivor and attorney that has called our office
inquiring about the appeal, and I will continue to endeavor to do
P.S. No one has suggested this is about greed. Indeed, our
law firm has represented our clients with claims against Dow Corning
for over 10 years, and, except for one case against Dow Chemical
and not Dow Corning, has yet to be paid a dime for this 10 years
+ of effort. Nor could anyone remotely accuse the Nevada appellants
of being greedy simply because they have steadfastly stood on a
principle they continue to believe in, but will now abandon in the
interest of others. I call this selfless, but I'm sure a spin
doctor or two out there will try to turn it around against our firm
and our clients. Have at it, if you will. At least now
we have said our piece, so that there can be no misunderstanding
about our position and what we are willing to do.
Geoffrey White, Esq.
of White and Meany
3185 Lakeside Drive
Reno, Nevada 89509
OF TORT CLAIMANT COMMITTEE MEMBER RALPH KNOWLES, ESQ.
OF RALPH KNOWLES - 01/10/04
First let me
thank you for asking, as you always do, for statements in response
to statements of others relating to the work of the Tort Claimants'
Committee. Second, let us pause for a moment to consider the enormous
victory we all achieved in helping the FDA come to the right conclusion,
at least for the moment, in not approving silicone gel breast implants
as safe. As you know, the common belief was that this was a done deal.
You personally sacrificed to help achieve this result as did many
Let me now respond
briefly to Geoff White's latest message and solicitation. I am only
responding for myself as a member of the Tort Claimants' Committee
and not for the other individuals on the Committee.
As you and Geoff
both know, I have never personally criticized Geoff or his clients
in any way for their actions in appealing Judge Hood's order confirming
the Plan of Reorganization. Geoff has an absolute right to represent
his clients as he and they think best. I will not begin any such criticism
On the other hand,
I profoundly disagree with the wisdom of the initial appeal and its
continuation. No one should misunderstand the historical position
of the Tort Claimants Committee on the release of Dow Chemical
issue. We fought long and hard against any such release. We only agreed
to it as the years began to go by and it became absolutely apparent
that we would not be able to submit a Joint Plan of Reorganization
unless we agreed to the Dow Chemical release. It was also clear that
the Court would not likely accept any proposed Plan of Reorganization
unless the Dow family agreed with it.
As the negotiations
dragged on, we were literally having victims die. Others desperately
needed (and still need) money for medical care and other necessities
of life. When we reached agreement on all other issues, we simply
could not in good faith with our victims that we represented continue
to delay their rights to either settle or litigate against Dow because
of the release issue. So we agreed to it and the Plan was approved.
I do not regret that decision at all since it was clearly in the interest
of the vast majority of women injured by breast implants.
As you know, we
anticipated that there might be appeals and therefore successfully
negotiated a provision that allows the Claims Office to be up and
running while the appeals would be pending. As a result, that office
is processing claims for those who want to accept the settlement terms
as we speak. But it cannot pay out any money until there is an effective
date and that will not happen until the appeals are resolved.
I have asked Geoff
to talk with his clients and reconsider their continuation of the
appeal. It seems just wrong to me for the appeals of 48 women to hold
up a remedy for the hundreds of thousands of deserving victims any
longer. However, as I stated at the outset, Geoff and his clients
have an absolute right to do what they are doing and we simply have
a disagreement over what they should do.
As to the $400,000.00
being asked for in order to dismiss the appeals, I really have very
little comment. Many lawyers and clients have spent money in this
litigation for the common good that they will never be able to recover.
It is my opinion that no money can or should be spent out of the limited
fund for claimants to help pay Geoff and John's fees and expenses.
I would take the same position as to anyone else who embarked on the
same journey as did Geoff and John. Obviously, what individuals do
with their money in response to Geoff's message is totally up to them.
Finally, the Tort
Claimants' Committee and those working with it continue to spend time
every day trying to do everything we can ethically and legally to
get to an effective date so the victims we represent can finally be
paid. We regret deeply (perhaps more deeply than any except the victims)
the egregiously long time that has passed with no remedy available
against the Dow family. We will continue to do that with the help
of you and all the others who have been so selfless in trying to get
to that day. Let's all hope that 2004 will not end without us getting
White's Final Comments About Mr. Knowles Above Statement - 01/10/04
You may tell your
readers I respect Ralph's opinion and hard work, as he does my opinion
and hard work. I also wanted to clarify that White & Meany
is not seeking a single penny in fees to dismiss the appeal.
Rather, the fees being sought are for bankruptcy counsel. Ralph's
response said "Geoff and John's fees" but it should state "John's
(Bankruptcy counsel) fees." A minor but important
Geoff White, Esq.
Response of Sybil Niden Goldrich Member, Tort Claimants
Dear Toxic Discovery:
I am responding to the correspondence between Geoff White
and Ralph Knowles. I am writing to all of you as a
member of the Tort Claimants Committee and as a breast implant patient
as well. I served on the negotiating team that reached the final
terms of the settlement that for good or ill was approved by 95% of
For the past 8 years I have responded to letters and emails from many
of you who expressed your total frustration with the snail-pace of
the Dow Corning bankruptcy. I have written to many of you and
spoken to many of you sharing your frustration at the bankruptcy proceedings.
It was extremely frustrating to me to see that Geoff White could respond
to Ralph Knowles' letter only by passing the responsibility for the
appeal to his brother, John.
I'm not a lawyer, but I understand that if additional counsel
is hired for a case, the cost for that is given to their clients--in
this case 48 Nevada claimants. I sincerely hope that these 48
people understand that the cost of John White's appeal is, therefore,
All of us understand what a settlement is. It means that nobody
gets exactly what they wanted and that everyone has to give up something for things
that would benefit all. There is no amount of money in
the world that can pay implant patients for the misery their implants
have caused them. Geoff White, John White and their clients know
But most important is that they must understand that just as we have
all settled for less to effect completion of the bankruptcy process,
so should they. Each of them has the right to opt-out of
the settlement to try to get a greater amount of money just as
each of us do. Of course, any claimant who opts out is going to face the risks of
litigation and the possibility of getting less or no money.
It is time for Geoff White and his clients to step up to the table
and allow those claimants who are dying and are gravely ill to see
completion of the bankruptcy quickly. The Nevadans have an opportunity
to do the decent thing without losing their right to opt out and try
for more compensation.
As for Mr. White and his brother, they should accept the fact that
the more their clients receive by opting out, the more their clients
will be able to pay their lawyers for the appeal they lodged
without hurting their final payments.
It's time to end this, honorably and ethically. It
is immoral for 48 people to hold up so many thousands of gravely ill
I urge the 48 Nevadans to think carefully and tell their attorneys
to settle now for the greater good of all.
Many thanks to Toxic Discovery Network for providing a public
forum for this issue.
Sybil Niden Goldrich Member, Tort Claimants Committe
White's Response to Ms. Goldrich - 01/11/04
APPELLANTS' RESPONSE TO SYBIL GOLDRICH'S LETTER RE DOW APPEAL
I'm sure Ms.Goldrich
comments, borne out of the same frustration the Nevadans feel with
a nearly 9 year(!)Bankruptcy process, are heartfelt. However, she
is mistaken, factually and morally. I do not want to get tangled up
with Ms. Goldrich quibbling about the terms of the Dow Plan, but the
entire point of our appeal was that the Nevadans do NOT have a right
to opt-out of the Plan and proceed outside the Plan in the Nevada
courts against Dow Chemical. That they have the right to "opt-out"
of the 10-20-50+ Settlement under the Plan and "opt-in"
to a so called "litigation facility" within the Plan is
not the same thing as being able to proceed outside the Plan in the
Nevada courts against Dow Chemical. Indeed, if the Plan goes forward,
the Nevadans' claims against Dow Chemical are extinguished completely.
They must thereafter proceed only against a faceless, nameless defendant
called "the litigation facility", and in a context that
is NOT a substitute for a straightforward, winnable claim against
Dow Chemical in a Nevada court. But even that claim against Dow Chemical,
endorsed by the Nevada Supreme Court, is being abandoned by the Nevadans,
who stand willing to dismiss their appeal and lose all rights against
Dow Chemical for an accommodation which is relatively minor in the
Speaking of those
accommodations, i.e. the payment of the 48 Nevadans bankruptcy fees
as a condition to their dropping their appeal, Ms. Goldrich is once
again honestly mistaken in her reasoning. She says if additional counsel
is hired for a case that cost should be passed on to the clients,
in this case the Nevada 48. The fact is that bankruptcy counsel were
hired by the Plan Proponents (Dow Corning and the Tort Claimants'
Committee) to do all the bankruptcy work for the Plan Proponents,
and have billed several million dollars for this effort.
None of that cost is being passed on the clients in the other 49 states
who support the Plan. All of that cost is paid for by Dow Corning.
Yet Dow Corning has no legal obligation to pay the Nevada 48's bankruptcy
bill. But being legal and doing equity are two different things. Equitably,
what's good for the goose is good for the gander. It is one thing
to ask the Nevadans to give up their valuable rights against Dow Chemical
and not seek a penny more than anyone else in the rest of the country.
But if they are being asked to do that, and have said "Yes"
to that request, they should not be expected to take a penny less.
That's the point. Having the $400,000 paid off - - regardless of source
- - is just another way of saying the Nevadans in abandoning their
appeal "for the greater good" will not take one penny less
for their claims than anyone else in the country. That is fair.
What is immoral?
Was it immoral for Dow Corning and Dow Chemical not to take the Nevadans'
claims seriously 4 years ago and attempt to settle out with them then?
Is it immoral for a few on the Tort Claimants' Committee such as Ms.
Goldrich to try to pour cold water on the $400,000 Nevada trust fund
concept and actually discourage settlement? Is it immoral for Dow
Corning and Dow Chemical not to step up to the table and pay off this
$400,000 bankruptcy lien? Is it immoral for the Nevadans to stand
on principle for four years, and then stand willing to abandon that
principle "for the greater good" in exchange for the most
minor of accommodations?
Sorry, Ms. Goldrich,
but my clients will not accept your attempt to lay a guilt trip at
their feet. The negativity expressed in your letter makes me wonder
that if the $400,000 suddenly appeared and the Dow appeal was over,
you would be disappointed because the Nevada 48 didn't unilaterally
and unconditionally surrender instead. We won't and we've given up
plenty already. Plenty. We do not have a second pound of flesh to
Now that there
is actual movement toward a common sense way out of the Dow Corning
morass, I do hope you might try to work towards a solution, rather
than criticize those who stand willing to abandon their rights entirely
and give up nearly everything so as NOT to hold up payment to thousands
of ill women.
If you can't generate
support and encourage some to travel an inch to meet the mile that
the Nevadans have traveled, then responsibility for these women not
getting paid is your guilt trip not ours. The Nevadans make no apologies
for their appeal, or for trying to solve the problem.
As an aside, my
response to Ralph Knowles which you found "frustrating"
was simply to clear up a misconception that somehow our law firm would
get a penny in legal fees out of the $400,000. It is not "passing
the responsibility" for an appeal which we are very proud of
to my brother, John, whom I am also extremely proud of. His contribution
to the Nevadans' cause was priceless.
that none of the delay occasioned to date in the bankruptcy process
was caused by the Nevadans. With the stroke of a pen, Dow Corning
could have released the floodgates of money to the victims regardless
of all of the various appeals that were pending. They can still do
so now. They should.
Finally, now that
there is actual and genuine movement towards resolution of the Nevadans'
appeal here's hoping that in the future you support that resolution,
not rain on it. Pride is a terrible thing and
I've been asked to swallow mine for the greater good. That, I did.
Perhaps you might consider likewise. To use your words, "I urge
[you and your constituency] to think carefully and tell [your] attorneys
to settle now for the greater good of all."
Rather than engage
in further discussions about who should be doing what to move the
Dow case along, may we both work constructively together to break
the logjam, and break it swiftly.
Law Offices of White and Meany
3185 Lakeside Drive
Reno, Nevada 89509
ADDITIONAL RESPONSE OF RALPH KNOWLES TO
POSTINGS OF GEOFF WHITE - 01/27/04
I have asked Toxic Discovery to post another message to implant
claimants and their attorneys in response to the e-mails and postings
from Geoff White and because of the many e-mails the Tort Claimants
Committee has received from suffering victims wondering why they can’t
receive what is due them under the Joint Plan of Reorganization with
Dow Corning. Though this is said with no hostility and with respect
let it be clear that the only reason relief isn’t available
is the continued appeal of the terms of the Plan by Geoff and his
48 clients. I respect the right of Geoff and his clients to continue
the appeal. But I do not think it is fair to the thousands of implanted
claimants to infer that the delay is the fault of the these claimants
and/or their attorneys who have been not paid the $400,000 demanded
by Geoff for his dismissal of their appeal of the Plan.
Even if the Tort Claimant Committee thought it wise or just to pay
the $400,000 demand from the $2.35 billion fund (NPV) for claims (and
I do not think it wise or just), it could not do that. There is no
provision in the Plan which was overwhelmingly approved by implant
claimants that would allow such a payment. It simply cannot and should
Some have suggested that the $400,000.00 demand should be paid to
Geoff by lawyers and claimants. Let me make my position very clear.
If other lawyers want to pay the $400,000 demand out of their pockets
or from their fees so be it. I will not do that because there are
many lawyers and claimants who have provided true benefits to the
victims of Dow Corning implants who will never be reimbursed all of
their fees and expenses.
If other lawyers disagree and want to pay Geoff out of their pockets
or from their fees, so be it. However, I would suggest that before
that is done, Geoff and his brother, John White, at least agree to
1. Geoff and John should post on the internet an itemized statement
of all expenses and fees being requested;
2. Geoff and his clients should agree in advance that if attorneys
agree to try to collect or pay money to Geoff that he and his clients
will dismiss the appeal now and take whatever money is ultimately
3. No money should under any circumstances be taken from monies due
to claimants for this purpose.
It is painful to read the hundreds of e-mails and letters from victims
who are suffering enormously because the Plan cannot be carried out
in full with payments while the appeal is pending. But the cause of
the continuing delay cannot be placed on victims or their lawyers.
And, the Tort Claimant Committee has, and is, doing all it legally
and ethically can to bring the appeals to an end.
Let us all hope that reason and humane thought will prevail and
that we have an effective date soon.
Mr. White's Counter
Response To Mr. Knowles - 01-28-04
WE ARE NOT THE PROBLEM, BUT WE OFFER A
SOLUTION THE 48 NEVADA APPELLANTS’ REPLY TO RALPH KNOWLES INFLAMMATORY
“ RESPONSE TO POSTINGS OF GEOFF WHITE
Ralph Knowles claims “no hostility” towards me and my
clients and claims he has respect for our position, but his latest,
lengthy e-mail posting is nothing short of hate mongering predicated
on ignorance. His “additional response to the e-mails and postings
from Geoff White” is troubling in that I have no idea what he
is responding to. Apparently, Mr. Knowles has felt rightly deserved
pressure from his constituency of breast implant clients to deal meaningfully
with the 48 Nevadans and their attorneys, yet he attempts to deflect
this pressure with holier-than-thou statements about how wrong it
would be to settle the appeal in the best interests of his constituency.
That is ironic and sad.
Don’t forget what the Nevadans’ appeal is and has been
all about. In 1995, three lawyers and three law firms - - one from
Alabama, one from Massachusetts and one from Nevada - - achieved an
important verdict against Dow Chemical for a wonderful lady named
Charlotte Mahlum, a verdict that was upheld by the Nevada Supreme
Court. I was proud to be part of that team.
The Joint Plan of Reorganization (the Plan) negotiated between Dow
Corning, Dow Chemical and the Tort Claimants’ Committee took
that verdict and that Nevada Supreme Court decision and essentially
threw it in the trash can. The Tort Claimants’ Committee, on
its own, decided that Dow Chemical should be released. They made this
decision without consulting the Nevadans and without consulting me.
We were blind-sided, and left with no choice but to fight the Plan’s
provision that Dow Chemical was released from liability to the Nevadans.
My brother, John White, Jr., happened to be a bankruptcy attorney,
and we went to battle for the 48 Nevada clients with pending claims
against Dow Chemical that were destroyed by the Plan. Against all
odds, we won before the bankruptcy judge in Dow Corning’s home
state of Michigan.
Judge Spector ruled that the Plan could go forward and everyone
who voted for it and wanted to get paid could get paid. This was in
1999. And, Judge Spector also protected the Nevadans by saying that
those claimants who claim special rights against Dow Chemical and
voted against the plan could pursue their cases against Dow Chemical,
which, after all, was not bankrupt.
Let it be clear that the only reason the rest of the country couldn’t
get paid starting way back in 1999 is the Tort Claimants’ Committee’s
decision to join with Dow Chemical and Dow Corning and appeal Judge
Spector’s interpretation of the Plan to allow everyone who voted
Yes and wanted to get paid to get paid, while still protecting the
No voters’ (including the Nevadans’) rights.
While I respect the right of Ralph Knowles and the Tort Claimants’
Committee to join in Dow Chemical’s and Dow Corning’s
appeal of Judge Spector’s ruling, that appeal dealt a severe
blow to all that voted Yes on the Plan, and all that voted No. It
set in motion years of delay, delay that was not caused by the Nevadans.
Incredibly, Mr. Knowles seeks to blame the Nevadans for his self-inflicted
wounds, and the wounds that his pride is inflicting on his constituency.
Up until a few months ago, Mr. Knowles policy toward the Nevadans
was simply to ignore them and their appeal. Where was Mr. Knowles
in 1999 when I made a settlement overture on behalf of my clients
that could and would have ended their appeal then? Or in 2000? Or
in 2001? Or in 2002?
My clients’ decision to end their appeal without seeking a
penny in additional compensation for their rights against Dow Chemical
has generated as much negative response as positive. There are those
that say we should stand and fight Dow Chemical to the bitter end
no matter what, the principle being that if we allow Dow Chemical
to get away with injustice and inhumanity towards women this time,
they’ll ruin more people’s lives, with virtual impunity,
the next time they get a chance.
There is another group of women who are gravely ill from silicone
injections from Dow Chemical and claim that I am prejudicing them
severely by advising my clients to abandon their appeal for the greater
good of Ralph Knowles’ larger constituency.
There is a third group of women whose children are gravely ill from
silicone transferred from their mother to them and claim our dropping
the appeal will severely prejudice their children’s ability
to recover from Dow Chemical. Yet in the end, a lawyers’ duty
is to do what is in the best interests of his clients, and dropping
the appeal is in my clients’ best interests. We have elected
to do this for the greater good.
Mr. Knowles’ “take” on all this is that he rejects
even the most modest “relief” for the Nevadans, i.e. that
if they drop their appeal they should have their bankruptcy fees paid
, just like all the rest of the women in the country’s fees
are paid. He says that “simply cannot and should not happen.”
He says he won’t stand in the way, but he won’t encourage
settlement. He jumps from this to classic hate mongering.
Despite knowing that I am not seeking a single penny for myself
or my law firm, he continues to imply otherwise. Despite knowing that
the trustee of the trust fund into which the nearly $400,000 to pay
the Nevadans’ bankruptcy fees will be placed won’t have
to pay a single penny without seeing an itemized statement, Mr. Knowles
now wants a public posting of all bankruptcy fees and expense. The
implication is that the attorneys for the Nevadans might just make
Perhaps Mr. Knowles will publicly post an itemized billing for the
several million dollars in bankruptcy fees paid to his very fine bankruptcy
lawyers to oppose the Nevadans every step of the way.
Mr. Knowles suggests the Nevadans should abandon their appeal on
the hope and prayer that someone, somewhere, somehow will come up
with the funds to put the Nevadans equal to the rest of the country.
Not $10 Million dollars for their claims against Dow Chemical, not
a few million, not a million. Just their bankruptcy fees. While before,
the Nevadans wanted and deserved special rights according to the law
of their state, they have now abandoned that quest. Now they seek
only equality. And now we know who is seeking to prevent that and
who is holding up the ability of thousands of sick and injured women
to get paid.
If Mr. Knowles had invested the same amount of time he spent on
public relations on trying to achieve this basic equality for the
Nevadans, this case would be over.
I pray that Mr. Knowles will find it in his heart to recognize that
his pouring cold water all over the settlement overtures being made
in this case is the only reason relief isn’t available to his
constituency, as well as to the Nevada appellants. He should drop
his foolish pride.
Mr. Knowles Reply
To Mr. Whites Comments of 01/28/04
I ask all to simply read my message and make up your
own mind as to whether it in any way resembles "hate-mongering"
as stated by Geoff. I don't think any useful purpose is served by
responding to Geoff's statements.
Any further questions
concerning the above? Please e-mail us at : firstname.lastname@example.org
Pathway for Sponsors Seeking Approval of Breast Implants
The Food and Drug
Administration (FDA) today revised its guidance document for breast
implant sponsors to more clearly define FDA's recommendations for
breast implant marketing applications and to reflect the availability
of new information about the framework for assessing the safety and
effectiveness of these products. The draft guidance document has been
released for public comment and is available at http://www.fda.gov/cdrh/ode/guidance/1239.html.
"The FDA, sponsors,
and the clinical community have learned a great deal about breast
implants, especially silicone gel-filled breast implants, over the
last 10 years," said Mark B. McClellan, M.D. Ph.D., Commissioner of
Food and Drugs. "Based on this knowledge, this revised guidance is
our view on the information needed to provide a reasonable assurance
of safety, and to allow women and physicians to make informed decisions
about silicone implants."
"FDA is committed
to working with sponsors and the scientific community to provide a
clear, scientifically appropriate, and up-to-date pathway for demonstrating
safety and effectiveness, and we welcome comments on this draft guidance,"
Commissioner McClellan said.
document updates a previous version published in February 2003. The
previous version of the guidance document has been useful to sponsors
and FDA in preparing and reviewing pre-market approval (PMA) applications.
By updating its guidance document, FDA is more clearly identifying
the type and amount of scientific data that will allow FDA to evaluate
whether these products are safe and effective.
new recommendations in the draft guidance document involve mechanical
testing, modes and causes of rupture, clinical study information,
postapproval requirements, and labeling. The new recommendations are
Information section has been modified to recommend that
the mechanical testing be designed so that it can predict clinical
outcomes, such as how long breast implants will last before rupturing
in the body.
Rupture Testing of Total Device section has been modified
because the methods currently used do not appear to simulate the
observed rates of rupture. FDA is now recommending that a sponsor
develop a new test methodology that can accurately predict rates
of rupture over time. As stated in the guidance document, FDA
believes that retrieval study data, which accurately define the
mode(s) and cause(s) of rupture, may be helpful in the design
of the new test methodology.
Testing section has been modified, updating the previous
section called Bleed Rates of Silicone Gel or Alternative Filler.
FDA now recommends that a sponsor develop a new gel bleed test
that more closely mimics conditions in the body to identify and
quantify the chemicals that bleed (leach) out of the shell over
time. This information will help FDA in evaluating the safety
of these products, and will help provide adequate information
to women who might be considering breast implants.
MODES AND CAUSES OF RUPTURE
A new section, Modes and Causes of Rupture, has been added to
the guidance document, updating the previous section called Retrieval
Study. The new section clarifies FDA's recommendation that a sponsor
characterize the modes and causes of rupture. These data will
help predict how rupture rates change over time and help allow
an adequate assessment of the safety of the product.
In the guidance document, FDA recommends that modes and causes
of rupture be addressed by the following:
* a retrieval study involving examination and testing of breast
implants that have been removed from patients
* an assessment of a sponsor's manufacturing processes for the
shell to determine whether any allowances for imperfections, such
as bubbles and contaminants, may be related to device rupture
* an assessment of the surgical techniques that increase the risk
of rupture to better guide doctors on the best way to implant
* a comprehensive literature review of durability based on studies
of explanted devices.
Information section has been modified to clarify that,
although a sponsor may submit a PMA with a minimum of two years
of clinical data, this data may not be sufficient to demonstrate
a reasonable assurance of safety and effectiveness. FDA may recommend
the submission of additional premarket data to describe the rates
of complications (e.g., rupture and re-operation), to reasonably
predict the safety profile of the device over its lifetime, and
to address safety concerns, such as the risk of gel migration
for silicone gel-filled breast implants. For example, if, after
two years, a sponsor does not have a sufficient number of patients,
sufficient follow-up, or appropriate analyses to reliably predict
the rupture rate and the clinical consequences of rupture over
time, additional clinical follow-up may be recommended to allow
an adequate assessment of the safety and effectiveness of the
A new subsection,
titled Rupture of Silicone Gel-Filled Breast Implants,
has been added to the guidance document, updating the previous
subsection called Silent Rupture for Silicone Gel-Filled Breast
Implants. The revised section focuses on rupture as a whole, not
just silent rupture, and includes new recommendations for data
collection. FDA now recommends that a sponsor provide the following
data as part of its Core Study:
* the rate and rate of change of rupture over the expected lifetime
of the device
* the frequency of ruptures observed (intracapsular, extracapsular,
and migrated gel). For all patients with ruptured implants undergoing
explantation, FDA recommends that a sponsor provide tissue sampling
data of the surrounding breast tissue and capsule to confirm whether
or not gel implant constituents are present.
* characterization of any local health consequences of ruptured
The guidance document recommends that the duration of follow-up
and the follow-up rates of the subset of patients undergoing MRI
screening for rupture (i.e., MRI cohort) should be adequate to
define the silent rupture rate and, accordingly, the overall rupture
Tissue Diseases (CTDs) subsection has been modified to
clarify our recommendations regarding data collection on CTDs
and CTD signs and symptoms. FDA recognizes that much has been
learned over the last decade on this issue, including data and
analysis from the 1999 Institute of Medicine (IOM) report on the
safety of silicone breast implants, and that the Core Study is
not designed to examine a potential linkage between breast implants
and the development of CTDs. We do, however, recommend that a
sponsor collect information on diagnoses of CTD as part of the
overall safety assessment on its device.
A new section,
titled Supplemental Clinical Information, has
been added to the guidance document. Because of the limited size
of a Core Study, FDA recommends that a sponsor provide additional
clinical information on its device (e.g., retrospective or prospective
data from adjunct and/or European studies), as well as relevant
information from the published literature, to address the following
issues related to implant rupture:
* the frequency of observed intracapsular gel, extracapsular gel,
and migrated gel, as well as the destination of the migrated gel
* a detailed description of the local health consequences experienced
by all patients with ruptured implants, including the severity
of these consequences, and their clinical course
* the incidence, prevalence, and timing of silent ruptures that
progress to symptomatic ruptures
* the incidence, prevalence, and timing of intracapsular ruptures
that progress to extracapsular ruptures.
titled Supplemental Literature Information, has
been modified. FDA continues to recommend that a sponsor provide
a supplemental literature review on specific topics such as CTDs
(including fibromyalgia), mammography issues, neurological disease,
ability to lactate, and offspring issues (safety of milk for breastfeeding
and second generation effects). However, in this updated guidance
document, FDA now specifies that it recommends a current literature
review beginning with the 1999 IOM report and explains that the
purpose of this information is to provide up-to-date information
for women who might be considering breast implants.
Requirements section has been modified to clarify that
FDA may exercise its statutory authority to require sponsor compliance
with conditions of approval or other postapproval requirements,
* a Core postapproval study. For silicone gel-filled breast implants,
FDA believes that annual physician follow-up, rather than mail-in
survey follow-up, may be appropriate, primarily because some important
complications, such as silent rupture, cannot be assessed by the
* continued collection of bench data regarding modes and causes
* an education and certification program to train doctors with
regard to proper surgical technique, patient selection, patient
* management of complications in order to obtain access to the
* continuation or initiation of a registry.
Labeling and Patient Labeling sections
have been modified to recommend that a sponsor include information
in the labeling for breast implants on the following:
* method(s) and frequency of screening for rupture
* clinical management of suspicious intracapsular and extracapsular
* gel bleed results
* other supplemental information based on a current literature
in the guidance document will assist sponsors in providing adequate
information to allow FDA to assess whether the data demonstrate a
reasonable assurance of safety and effectiveness of breast implants.
This information will allow women and physicians to make informed
decisions regarding the use of these products.
Guidance Document (PDF)
Notice of Availiability of Guidance Document
Encouraged by FDA's Refusal to Approve Silicone Breast Implants
28 minutes ago
National Desk, Medical Reporter
Contact: Lisa Bennett of National Organization for Women (news - web
sites), 202-628-8669, ext. 123, email@example.com
WASHINGTON, Jan. 8 /U.S. Newswire/ -- "The National Organization
for Women is encouraged by the FDA (news - web sites)'s decision not
to approve the immediate return of silicone breast implants to the
market," said NOW President Kim Gandy. "We have been saying
all along that there is simply not enough long-term data to warrant
telling hundreds of thousands of women that they are safe to use."
In October 2003, a Food and Drug Administration (FDA) advisory committee
conducted hearings to consider allowing silicone gel-filled breast
implants back on the market after an 11-year ban. The FDA withdrew
silicone implants from general use in 1992 following numerous reports
of illness following rupture and leakage.
The advisory committee voted 9-6 to allow the implants back on the
market; however, the non-voting chair of the panel sent a letter to
the FDA Commissioner expressing strong reservations about the safety
of the devices.
Yesterday, the FDA sent a "not-approvable" letter to Inamed
Corp., the manufacturer that applied for authorization to sell its
silicone implants to a wider market. (The implants are currently available
to mastectomy patients and in clinical trials). The FDA has requested
additional information from Inamed in order to further review the
"I found it astounding that, with less than three years of data
presented by Inamed, the panel went ahead and recommended approving
silicone implants," said Gandy, who testified at the advisory
committee hearings. "I am relieved to hear that the full FDA
is taking the health of women more seriously."
"Most of the serious health problems with silicone implants develop
seven to ten years after implantation. In a symposium NOW held last
year, top health experts agreed that further research must be done
before putting even more women at risk," Gandy said. "NOW
applauds the FDA's caution, and we will be watching to see what happens
Nixes Inamed Silicone Breast Implants
Thu January 8, 2004 07:59 AM ET
NEW YORK (Reuters)
- Inamed Corp. said U.S. regulators rejected its application to market
silicone breast implants, indicating a tough road ahead if it wants
to eventually bring the product to market.
Shares of Inamed dropped to $42.94 in electronic trading before the
market opened from their closing Nasdaq price of $49.80 on Wednesday.
The U.S. Food
and Drug Administration requested more information on the implants
before it would review its approval application further, the company
said in a statement just before midnight Eastern time. Inamed said
it would cooperate with the agency.
Inamed also said
the FDA planned to release a "revised breast implant guidance"
document at a press conference at 1 p.m. EST (1800 GMT) on Thursday.
implants were banned 11 years ago because of safety concerns, but
an advisory panel to the FDA in October voted 9-6 in support of reintroducing
them on the market.
The two-day advisory
panel meetings included heated arguments from both advocates and opponents
of the implants. Major studies have found no definitive evidence that
the implants caused chronic diseases, but many women are convinced
that leaking silicone from the devices made them ill.
In November, the
chairman of the advisory panel, Dr. Thomas Whalen, sent a letter to
FDA Commissioner Mark McClellan, saying he had "very strong reservations"
about allowing the reintroduction of silicone breast implants because
long-term safety questions remained.
At the October
panel review, Inamed acknowledged its implants carried the risk of
rupturing, but said most women in clinical trials were happy with
them. The company promised long-term monitoring for potential complications.
Rival Mentor Corp.
in December submitted an application to the FDA for approval of its
own silicone breast implants.________________________________________________________________
WASHINGTON - In
a highly unusual move, the chairman of a government advisory panel
that reluctantly backed resuming sales of silicone gel breast implants
now is urging federal health officials and lawmakers to disregard