TOXIC ALERTS!

Last Updated 03-19-04

LATEST BREAST IMPLANT NEWS

Dow Settlment Resolution
click to read press release


_______________________________________________

02/07/04

NEVADAN'S RESPONSE TO MR. TRACHTMAN'S LETTER OF 02/05/04

Pending

________________________________________________

FEBRUARY 5, 2004

Today, 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/
__________________________________________________

Dow - Nevada Claimants Letter
Richardson, Patrick, Westbrook, & Brickman, LLC

Click On Link Above To Bring Up Letter

01/29/04

_____________________________________________________________

A MESSAGE FROM THE NEVADA APPELLANTS TO ALL

DOW CORNING BREAST IMPLANT  CLAIMANTS

01/09/04

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 principle for
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 counsel.

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 at
www.tortcomm.org.  Feel free to e-mail me at gwhite@whiteandmeany.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 so.

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.

Respectfully,

Geoffrey White, Esq.

Law Offices of White and Meany
3185 Lakeside Drive
Reno, Nevada  89509
775.828.9999
775.828.9998 Fax

_____________________________________________________________
 
RESPONSE OF TORT CLAIMANT COMMITTEE MEMBER RALPH KNOWLES, ESQ.
______________________________________________________________

STATEMENT 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 others.

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 today.

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 there together.

_________________________________

Mr. 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 distinction.

Geoff White, Esq.

Posted by requested 01/12/04

_________________________________

Response of Sybil Niden Goldrich Member, Tort Claimants Committee- 01/11/04

_________________________________

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 us. 

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, theirs alone.

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 that. 

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 people.

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.


Sincerely,

Sybil Niden Goldrich Member, Tort Claimants Committe

___________________________________

Mr. White's Response to Ms. Goldrich - 01/11/04

NEVADA 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 larger picture.

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 give you.

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.

Remember also 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.

Geoffrey White, Esq.
Law Offices of White and Meany

3185 Lakeside Drive
Reno, Nevada 89509
775.828.9999

__________________________________________________________________

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 not happen.

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 the following:

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 raised.

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.

Ralph Knowles

----------------------------------------------------------------------------------

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 something up.

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.

Respectfully,

Geoffrey White

----------------------------------------------------------------

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.

Ralph Knowles.

__________________________________

Any further questions concerning the above? Please e-mail us at : nevadaappellantscomments@toxicdiscovery.com

___________________________________

FOR IMMEDIATE RELEASE
P04-01
January 8, 2004

http://www.fda.gov/bbs/topics/NEWS/2004/NEW01003.html 

Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Provides 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.

This guidance 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.

The substantive 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 as follows:

      MECHANICAL TESTING

  1. The General 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.

  2. The Fatigue 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.

  3. The Bleed 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

  4. 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 these devices
    * a comprehensive literature review of durability based on studies of explanted devices.

    CLINICAL STUDIES

  5. The General 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 device.

  6. 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 implants.

    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 rate.

  7. The Connective 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.

  8. 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.

  9. The section 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.

  10. The Postapproval 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, such as:

    * 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 patient
    * continued collection of bench data regarding modes and causes of rupture
    * an education and certification program to train doctors with regard to proper surgical technique, patient selection, patient monitoring, and
    * management of complications in order to obtain access to the implant
    * continuation or initiation of a registry.

    LABELING

  11. The Physician 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 rupture
    * gel bleed results
    * other supplemental information based on a current literature review.

The recommendations 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.

Draft Guidance Document (PDF)
Federal Register Notice of Availiability of Guidance Document

__________________________________________________________________

NOW Encouraged by FDA's Refusal to Approve Silicone Breast Implants
28 minutes ago

To: National Desk, Medical Reporter

Contact: Lisa Bennett of National Organization for Women (news - web sites), 202-628-8669, ext. 123, communications@now.org

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 company's application.

"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 next."
_________________________________________________________________

FDA 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.

Silicone breast 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.________________________________________________________________

11-05-03

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 that advice.

"I really have a lot of angst" about the panel's vote, said Dr. Thomas Whalen of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. "I felt morally compelled -- it sounds corny, but morally compelled -- to do something about it."

Silicone gel implants were highly popular until 1992, when fears that leaking silicone caused serious diseases prompted the Food and Drug Administration to end routine sales. Now one manufacturer is seeking an end to the ban, arguing that silicone implants have been exonerated of causing serious diseases like cancer or lupus.

Last month, the FDA asked outside scientists for advice. In a two-day meeting, dozens of women blamed silicone implants for permanent disfigurement and dozens more begged for access to them.

The advisers recommended, on a 9-6 vote, the sale again of implants but only under very strict conditions. These include additional safety tests and warnings to recipients about lingering safety questions and the frequent need for repeated operations because of painful scar tissue and other problems.

As the panel's chairman, Whalen could not vote unless there was a tie. But in a letter obtained Tuesday by The Associated Press, he wrote FDA Commissioner Mark McClellan and five members of Congress about his "very strong reservations concerning this vote."

"Long-term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated," Whalen wrote.

Also "extraordinarily troubling," he added, is the enormous costs that women face for additional surgeries and removal of broken or painful implants. "This is a public health issue of no small import that must be addressed should the FDA second this misguided panel decision," Whalen said.

__________________________________________________________________

TCC WEBSITE UPDATE DATED NOVEMBER 4, 2003

On October 30, 2003, the Court of Appeals for the 6th Circuit ordered that the Nevada appeal be scheduled for oral argument "at the earliest practicable date." This is the last appeal remaining challenging the Amended Joint Plan of Reorganization of Dow Corning. As soon as this appeal is resolved, the Amended Joint Plan can go "effective" and allow claims to be paid. The TCC is committed, as it has been throughout, to doing everything in its power to push for the earliest possible Effective Date.

In related news, the Court of Appeals for the 6th Circuit rejected, for the third time, the brief submitted by the Korean claimants that challenges Judge Hood's Order allowing Australian claims to be processed in Australia. The Court of Appeals returned the brief and reset the briefing schedule. Please note that the appeal will not hold up an Effective Date once the Nevada appeal is resolved. The Korean appeal relates only to the order on the Australian processing option; it does not affect the overall appeal of the Amended Joint Plan.

In Settlement Facility news, the TCC would like to remind claimants and attorneys to check the September 29, 2003 Update regarding additional ways to establish product identification for Dow Corning implants. The TCC is interested in hearing from you about product identification and any other problems you are experiencing. Please contact us at info@tortcomm.org.

Copyright© 2011 Toxic Discovery , Web Design Acker Design