Bristol-Myers Squibb - Deadly Documents

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Could this be the article that someone was looking

for? Love you....Lea

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Original Message -----

From: " Vickie C. " <yorkie@...

" Lea (by way of ilena rose) "

<devans@...

Sent: Friday, March 30, 2001 12:52 PM

Subject: Re: Bristol-Myers Squibb - Deadly Documents?

Maybe these will help

Heyer Schulte references in the DOW Smoke documents

Document #189

02/25/75

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF GEL BLEED TISSUE REACTION

Nawash memo to Salisbury, both of Dow Corning,

regarding low molecular weight gel diffusion.

He writes: " The reactivity between free low molecular

weight silicones and the subcutaneous tissue seems to

be of increasing concern among plastic surgeons. It is

thought that the soft gel used by Heyer-Schulte in the

mammary implant is obtained by mixing low viscosity

silicone fluid in the regular gel. It is also thought

that the low molecular weight components of the fluid

eventually diffuse through the rubber envelope of the

breast implant and elicit the untoward reaction which

is occasionally observed and results in an

undesirable, relatively thick fibrous capsule. I do

not know the actual method used by Heyer-Schulte to

obtain their soft gel: nor do I know the process we

developed for making our own soft gel.

However, If I may, I strongly recommend that we take

measures to insure against the presence of unwarranted

free low molecular weight fluids in our now soft

breast implant.

CITE: M 190133, Exhibit to Nawash Deposition, and

Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #231

04/19/76

COHESIVENESS - LIQUID COMPONENT OF GEL

MISCELLANEOUS - SALES RUPTURE TESTING

on memo to Blackmore, Coyne, Fredricksen,

Pryor, Trischler, Doolittle, Flora, Hauser, McLellan

and Murray regarding a discussion with McGhan

on 04/14/76.

McGhan is now receiving Dow Corning silicone.

For the gel uses McGhan prefers the GE product which

has a lower level of low molecular weight components.

McGhan mammary implants are also more consistent than

Heyer-Schulte's because of the mandrel molding

technique used - the madrels are polyester and cast

individually.

CITE: MMM 1445 - 1450, Exhibit 6 to D. McGhan

Deposition, Exhibit to Horgan

Deposition, Exhibit 43 to County D. McGhan

Deposition, and Exhibit 68 to County Coyne

Deposition. DUPLICATE: MMM 666 -671.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #237

06/00/76

GEL MIGRATION TESTING TISSUE REACTION

G. Frugard's Dow Corning trip report from

Heyer-Schulte's library.

Includes 08/06/76 memo from J. Erhardt to T. Talcott

regarding confidentiality agreement with Dow Corning

requiring all information being confidential for a

period of ten years from the date of disclosure of

delivery. Frugard's trip report was sent to S.

Koorajian and is dated 07/14/76.

Frugard reports that there are both positive and

negative aspects of his trip to Dow Corning. On the

positive side, he feels that he was successful in

bringing back a comprehensive summary of all of Dow

Corning's animal data; or at least " all that I was

given access to " . The negative aspect is that the data

does not answer the key questions concerning migration

and its consequences. Many of the experiments were not

well controlled. The animal studies indicate no

significant pathological findings and, in cases were

there were, they were attributed to experimental

procedures.

Frugard concludes that: " due to the fact that there

was no apparent difference in reaction to any of the

gels, the inflammatory response must be considered to

depend solely on tissue injury and not upon gel

migration. This conclusion is tenuous at best

considering there were no controls. Perhaps all gels

were reactive.... Gel migrates into the capsule....

Unfortunately, the data collected in this study does

not answer questions concerning migration, even though

that was the main objective. I regret the fact that

Dow Corning's data was lacking in quality and left

many questions unanswered. "

CITE MD 114416 - 114428.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #246

07/14/76

DOCUMENT DESTRUCTION TESTING

Milt Hinsch, Dow Corning, memo to Rathjen, Kelley,

Leach, Lentz, Bey, , Hoyt, Mantle, and

regarding " The Milt Hinsch Grant. "

Hinsch turned down a request for funding by Dr. Tanski

which Rathjen supported and then agreed to fund a

similar study by Drs. Horton and Rasato. Rathjen has

suggested that Drs. Horton and Rasato had gone

" shopping " for funding and were turned down by

Heyer-Schulte already. Hinsch responds that it was a

marketing sponsored decision to support Horton and

Rasato because they are product champions.

In response to Rathjen's question about what to do

with the data Horton and Rasato generate, Hinsch

states, " Question number 9 about what will we do with

the data depends upon the data which is generated,

Art. It may turn out that we will take the paper on

which this data is printed, roll it up and light pipes

and cigars with it. " (emphasis added).

CITE: M 190344 - 190345,

Exhibit to MDL Rathjen Deposition, and Exhibit 82 to

county Rathjen Deposition.

Dow Corning Trial List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #252

08/23/76

GEL MIGRATION

KNOWLEDGE OF SYSTEMIC DISEASE RUPTURE

Jim Rudy, President of Heyer-Schulte sends a " Dear

Doctor " letter regarding

" the possible and known problems and complications " of

breast implants. It is noted that subtle processes of

degradation should be expected to occur, and that the

knowledge associated with long-term implantation is

imperfect. If the implant is torn the gel will migrate

and that is why Heyer-Schulte placed warnings in data

sheets in May 1975. Doctors and patients should expect

some patients to exhibit adverse response to silicone

implants.

CITE: M 190413 - 190417,

Exhibit 159 to County Deposition,

Exhibit to County LeVier Deposition,

Exhibit to Nawash Deposition, and

Exhibit 140 to County Rathjen Deposition.

DUPLICATE: GEG 004050 - 004054;

KMM 262028 - 262032;

BAX 36899 - 36903.

WITNESS: Rudy Exhibit 34; Hyans Exhibit 24.

DISPOSITION: Admitted in Toole (II) v. Baxter

Healthcare. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #255

09/20/76

KNOWLEDGE OF LIQUID SILICONE DANGERS TISSUE REACTION

Dr. C. Vinnik writes a letter to Art Rathjen of Dow

Corning, copying Dr. Brody of ASPRS. Dr. Vinnik

reports on a patient with a breast implant who

developed a lump in her left breast. During surgery

Vinnik noted that the Heyer-Schulte implant was intact

and the lump or mass was eternal to the capsule.

Vinnik notes that the pathologist's report showed:

" extensive fibrosis and granuloma formation that I

have seen previously with silicone injections.... I do

not know what the implications of this problem are,

however, one consideration must be that there was

extensive reaction within the tissue to the silicone

gel with which it was in contact. I believe this is a

serious matter and is something that the Standards

Committee of the American Society of Plastic and

Reconstructive Surgeons should ultimately consider. I

might add that the type of reaction described in this

case is similar to that of injected silicone gel as

reported several years ago by Dr. Boo-Chai of

Singapore.

You will recall that Dr. Boo-Chai ran a series of

breast injections with silicone gel through a

dissection subcutaneous pocket with disastrous

results.... It certainly goes along with reactions I

have seen with silicone gel extrusion by another

manufacturer utilizing the General Electric gel. "

(emphasis added).

CITE: DCC 24000504 - 24000506,

Exhibit to MDL Rathjen Deposition. DUPLICATE: M 190364

- 190366; CO 21 - 23; KHH 54148 - 54150. Dow Corning

Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #256

09/22/76

GEL MIGRATION TISSUE REACTION

Milt Hinsch memo to the Dow Corning sales force

concerning Dow Corning's response to Heyer-Schulte's

" Dear Doctor " letter discussing problems and

complications of gel-filled mammary prosthesis. Hinsch

claims that Dow Corning's implants are considered

" non-active in the body " and he " would not expect

shape or softness to change appreciably. " Also, Dow

Continues " to test 100% for cohesive gel during

production " and " their gel offers the softest possible

feel while retaining cohesiveness. " Hinsch states

that, " there are no cases of Dow Corning gel

migration. Conversely, in documented cases where the

envelope was ruptured, the gel did not migrate. " He

claims that all materials are subjected to " extremely

sensitive " tests for tissue reaction and must show no

tissue reaction to be accepted. Hinsch states that Dow

Corning does not plan a written response to the "

" Dear Doctor " letter.

CITE: M 240432 - 240433,

Exhibit 8 to Hinsch Deposition (plaintiffs),

Exhibit 44 to Hinsch Deposition (Dow Corning),

Exhibit to s Deposition,

Exhibit to County Rudy Deposition,

Exhibit 97 to County Rathjen Deposition,

Exhibit 2D to County Talcott Deposition,

Exhibit 113 to Burda Deposition, and

Exhibit to MDL Rathjen Deposition.

DUPLICATE: GEG 4048 - 4049; M 880029 - 880030; OOM

880029 -880030.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

Document #278

05/16/77

MISCELLANEOUS - LOBBYING MISCELLANEOUS -

ORGANIZATIONAL SURVEY

Helmer memo to regarding Breast Implant

Manufacturers Association, California meeting. 515(:

First meeting of manufacturers called by Dick Compton

of McGhan because he " desired that an association be

formed of the manufacturers of breast implants. " Al

Cohen requested a study be jointly funded by

manufacturers on the issue of constrictive capsules.

Tom Talcott of Heyer-Schulte tells Jerry Helmer of

Surgitek that Heyer-Schulte is not in favor of a trade

association research program. Other manufacturers are

not in favor of trade association for joint research

either and inform Dr. Jack Fisher, ASPRS, they would

instead support a workshop to discuss issues with

plastic surgeons.

CITE: MEM 415 - 417,

Exhibit to Lynch Deposition,

Exhibit to D. McGhan Deposition,

Exhibit to Deposition, and

Exhibit to Compton Deposition.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged &

Confidential

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At 10:08 AM 3/17/01 -0800, you wrote:

PLEASE POST

Dearest Ilena: Does anybody in our group know where

there are any " deadly documents " for BMS? I would

certainly like to hear from anybody who does have any

information. (A while ago, perhaps a couple of years

or so, I think Myrl Jeffcoat put something out on

Surgitek.) My second set of implants were Surgitek.

Here in Canada, BMS is telling lawyers that they have

no documents that pertain to any woman's case

regarding breast implants!

Love as always........

Lea