SMOKE - FIRE DOCUMENTS 251 - 300
 
Document #251
08/12/76
 
MISCELLANEOUS - COMPLICATIONS
Dr. John Wolfe, Detroit Medical Center, writes to Milt Hinsch of Dow Corning expressing concerns regarding silicone mammary prostheses. Wolfe writes, “I would like to stress to you that the present prostheses composed of silicone are more than an inconvenience but a very serious problem. Very often women who have an augmentation have severe mammary dysplasia. Severe mammary dysplasia is related to a high incidence of developing breast cancer. Prostheses effectively block from view a great amount of the breast tissue on radiographic examination.... We have the situation where implants are being put into breast which are at high risk for developing breast carcinoma and we are seriously impairing our ability to recognize the carcinoma in its early and curable stage.”
CITE: COM 361 - 362. DUPLICATE; GEG 4090. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential  
 
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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 Harris County Powell Deposition, Exhibit to Harris County LeVier Deposition, Exhibit to Nawash Deposition, and Exhibit 140 to Harris 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
 
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Document #253
08/24/76
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
TESTING
TISSUE REACTION
Hobbs memo to Atwell, Bey, LeVier, Radzius, Ryan, A. Smith, F. Stark, A. Gamon, “C. Lentz, R. Maneri, L. Tyler, J. Wehrly and D. Weyenberg regarding “2,6-cis Toxicity Action Meeting - 8/23/76.” The parties met on 8/2/76 and discussed and agreed to the following activities: all products having potential for 2,6-cis formation will be identified along with their known uses: existing data will be reviewed to determine estrogenic potency of various low molecular weight organosilicon compounds when compared to 2,6-cis and/or DES: all areas will be identified where 2,6-cis is a known process by-product.
 
CITE: DCC 281031680 - 281031681, Exhibit to Harris County Tyler Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #254
09/20/76
GEL MIGRATION
E. Hobbs, Dow Corning, Memo to Milt Hinsch and Charles Lentz providing information on the migration of silicone gels. Experimentation utilizing various animals has not demonstrated migration of Dow Corning mammary gel. However, “Gels having a low consistency due to low levels of cross-linker appear to migrate along tissue planes in much the same manner as large injected doses of silicone fluid.” One gel, in a test situation having a low cross-linker material, moved from its original implant site apparently along tissue planes aided by gravity.
CITE: D 972, Exhibit 141 to Harris Country Rathjen Deposition, and Exhibit 2D to Harris County Talcott Deposition. DUPLICATE: M 170104; M 570060; DCC 8200611. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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
 
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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 Peters Deposition, Exhibit to Harris County Rudy Deposition, Exhibit 97 to Harris County Rathjen Deposition, Exhibit 2D to Harris 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
 
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Document #257
10/01/76
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE
STERILIZATION/CONTAMINATION
TISSUE REACTION
Donald Barker, M.D., presents a paper, “Reactions to Silicone Implants in the Guinea Pig,” to the Scientific Session of the American Society of Plastic and Reconstructive Nurses.

CITE: GEG 4000 - 40006. NOTE: Paper was published in the Aesthetic Plastic Surgery in 1978, authored by Barker and Sherrill Lee Schultz, R.N. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #258
10/09/76
SHELL STRENGTH - THICKNESS
Bill Overton, a Dow Corning sales representative, files Complaint Report L76001 regarding service problems and thick envelopes on Silastic Round mammary implants. In an accompanying memo dated 10/19/76 from Overton to Hinsch, Leach, Darling, Brodhagen, Woodard, Hoyt, Schultz, and VerVoort, Overton states that, “Frankly, I was a little surprised to see such a difference in the comparison (between the new Silastics and the Silastics in Dr. Forrest’s inventory).... Dr.  Forrest stated he felt the new SILASTIC stock had an envelope about three times as thick, and also stated he would be able to feel the thick envelope in a patient.... I know he was upset more at this point when he sort of threw the implants from his locker onto the floor. If the implants I picked up from Dr.  Forrest are typical of mammary product we are making today, I can’t help but feel I will loose half of my business in the next six months. I prefer giving a few extra out for breakage than lose $100M in sales.... We cannot afford to make noticeable changes if we expect to retain present market.” Dow Corning’s Quality Assurance Reliability Engineer noted that the returned implants did exceed envelope thickness specifications and that there was inconsistency in envelope thickness specifications and that there was inconsistency in envelope thickness on the same implant as well as in comparing implants. (emphasis added).
CITE: CRM 200 - 203. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #259
10/13/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
Report of 10/12/76 phone call from Dr. Colocho to Rathjen regarding 6 of Dr.  Colocho’s patients with palpable nodes in the axillary area, and Dr. Colocho’s “very real concern” regarding possible gel bleed.
 
CITE: KKM 42792, Exhibit of Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #260
10/15/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
Letter to Dr. Colocho from Rathjen submitting questions regarding Dr. Colocho’s 6 implant patients with palpable nodes.
 
CITE: M 190376 - 190378, Exhibit 32 to MDL “Rathjen Deposition (used by Dow Corning), and Exhibit 69 to Harris County Rathjen Deposition. DUPLICATE: M 240009 - 240011. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #261
10/23/76
GEL MIGRATION
Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt Wagner, M.D. about a problem with gel migration, “Obviously, whether it is a Dow Corning implant or a competitors’ the fact that this phenomenon would exist is disturbing enough. We have always been conscious of this possibility: therefore, you certainly caught me off guard when you first reported that the gel from one of our implants had indeed migrated to the groin.” Rathjen claims that Dow Corning did not supply any materials to competitors for the manufacture of mammary implants until the first quarter of 1976. General Electric supplied the materials. (emphasis added).
CITE: KKH1719. DUPLICATE: GEG 4009. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #262 (Possible)
10/31/76 (NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)
 
Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt Wagner, M.D. about a problem with gel migration. “Obviously, whether it is a “Dow Corning implant or a competitors’, the fact that this phenomenon would exist is disturbing enough. We have always been conscious of this possibility; therefore, you certainly caught me off guard when you first reported that the gel from one of our implants had indeed migrated to the groin. “ Rathjen claims that Dow Corning did not supply any materials to competitors for the manufacture of mammary implant until the first quarter of 1976. General Electric supplied the materials. (emphasis added).
CITE: GEG 4009. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #263
11/02/76
 
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
 
Dr. Charles Vinnik writes to Art Rathjen, Dow Corning, about a histologic response to a patient whose breast implant ruptured. Dr. Vinnik states that “microscopically it appeared to resemble the reaction (sic) seen around silicone injected breasts.” He also notes that the response to silicone materials in humans is “a very variable thing....” (emphasis added) CITE: KKH 6944 - 6945, Exhibit 47 to MDL Rathjen Deposition (used by Dow Corning). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #264
12/07/76
TISSUE REACTION
Guillermo Colocho. M.D., of New Mexico, letter to Art Rathjen, Dow Corning, enclosing tissue specimens of patients who experienced problems with implants.  Patient number 1 had a small nodule in the right breast three years post-op.  Following biopsy, pathological diagnosis revealed lymphoid hyperplasia. Patient number 2 developed multiple tender nodules and lumps in her breast five months post-op. Following bilateral biopsies, pathological diagnosis revealed bilateral lymphoid hyperplasia.
 
CITE: M 240013 - 240014, Exhibit 32 to MDL Rathjen Deposition (used by Dow Corning), and Exhibit 69 to Harris County Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #265
01/04/77
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
Patent No. 4,001,403 for a method for reducing the reproductive function of mammals by Bennett and McHard. A method for altering the reproductive function of mammals by administering a pharmacologically effective amount of certain fluoroalkyl-substituted organosilicon compounds. As a means of illustration, one can orally or parenterally administer from 1.00 mg. to 100 mg. per kilogram of body weight of an organosilicon compound thereby rendering the subject (either a male or female mammal) infertile.
 
CITE; DCC 281061 - 281061408, Exhibit 73 to Bennett Deposition (used by Dow Corning). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #266
01/10/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF GEL BLEED
Becker, Dow Corning, memo to C. Lentz regarding silicone found in tissue. He writes, “The question of bleed and contracture is indeed of concern by our competitors and the physician. There is no question in my mind that Dow Corning’s leadership position is expected to provide answers to the questions. I am very surprised to find that we do not have any data on Si levels in tissue or the distribution and fate of trace levels of polymer in the body.” (emphasis added).
CITE: F 810, Exhibit to California C. Lentz Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 70 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260614; M 170124; KMM 380071. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #267
10/18/77
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - SALES
Rathjen, Dow Corning, memo to Bey, Hoyt, Hutchison, Lentz, and Nelson regarding “observations Relative To Dow Corning’s Future In The Mammary Implant And External Breast Markets.” Rathjen states; “In my opinion, we, Dow Corning, are no longer the recognized leaders or innovators in either segment; and our present position will continue to decline unless specific measure are taken now to turn things around.... I am powerless to change anything, and my sphere of influence in this business continues to diminish: hopefully, I still have the privilege to express opinions even if they are not shared by all.”
 
CITE: KMM 12998 - 13000 and 13004, Exhibit to MDL Rathjen Deposition, and Exhibit 83 to Harris County Rathjen Deposition. DUPLICATE: m 190101. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #268
02/10/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
Will Larson, Dow Corning, memo to Art Rathjen, Becker, Bennett, Bey, Kelley and Lewis concerning an allergic reaction in a patient of Dr. Vanduyn. The patient was implanted with a Silastic Mammary Prosthesis, No Fixation Patch. One month following implantation, the patient contracted the flu. Shortly thereafter, the implant “broke through” the healed incision and the implants were removed. The augmentation was redone and, within days after the surgery, the implants again “broke through.” Dr. Vanduyn suggested a possible allergic reaction and asked if there were any similar reports. Larson told him, “I was unaware of any allergic reaction to silicones” (emphasis added).
CITE: M 240368 Dow Corning Trial Exhibit List Abstracts
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Document #269
02/17/77
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING
Larson, Dow Corning, memo to Bennett, Hoyt and Rathjen regarding mammary bleed. “The permeability of silicone elastomers is a well known phenomena....  Permeation in this case is ... toxicologically unknown.... It is of great concern because of what can be made of the unknown....” Also, “We would also anticipate bleed may be a function of heretofore unmeasured factors, e.g.  manipulation and stress.... Dow Corning’s product development direction has been an attempt to strike a balance between: 1)What we factually know about bleed.  2)What gel and envelope polymer intermediates can be produced. 3)What toxicological data we have on materials. (and) 4What is a marketable product....  In conclusion, any physiological effect or consequence of this permeation remains speculative. What can be done and what should be done is an open topic of discussion.” (emphasis added).
CITE: OOM 320448 - 320449, Exhibit to MDL Rathjen Deposition, and Exhibit 71 to Harris County Rathjen Deposition. DUPLICATE: KMM 176928; KKH 2263: M 150002 - 150003: M 190423 - 190424.   Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #270
02/25/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
SHELL STRENGTH - THICKNESS
Rathjen, Dow Corning, memo to Hoyt, C.Lentz, and Nelson stating, for the record, his objection to the Product Marketing Group’s (“PMG”) decision to market the Silastic Inflatable Mammary Prosthesis. Rathjen believes a six month review of clinical experience with the implant is necessary before a meaningful assessment could be made regarding the efficacy of the implant. At the time, Dow Corning was only six weeks into a clinical trial on the inflatable. He cites Bob Becker who reported to the PMG that, based on his investigation of the envelope production, he believed the quality of the inflatable envelope now was no better than when Dow Corning made it in 1971-72, when the inflatable line failed.
CITE: KMM 3333245 - 333426, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #271
03/11/77
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD RUPTURE
 
 “Thoughts relative to Meeting - March 10 - Inflatable - Telephone Conversation with Mel Nelson - March 11.” Dow Corning held a meeting on March 10 with Hoyt, Meads, Bennett, LeVier, Leach, Petraitis, Radzius, Hinsch, Criger, Steele, Rathjen, and Lewis. The author is unidentified but believe it is Rathjen. The author states: “I sat there and listened to the various opinions that were offered and it became evident to me that actually it was a matter of having everybody stroke one another hoping that a consensus of opinion would be developed that would allow a positive decision on the distribution and sales question with nobody taking firm responsibility for a final decision. In the meeting, when it got around to the legal aspects of product liability, Joe Radzius read the memo that had been delivered by Norm Lewis which stated that our liability was wide open and if we did have any problem that Dow Corning would have a very difficult time defending its position and the recommended course of action by Steve Giadard, Harry Dingman, and Norm Lewis was that we not accelerate the calendar (sic) or time relative to our distribution and sales of the product. The ultimate decision of this meeting was of course that they would continue on there (sic) course for a projected May 1 distribution and sales limited area and therefore, they were willing to take a chance over and above the recommendations of the legal department.
I continued to hold my position that I did not feel that it was prudent for Dow Corning to consider an early distribution and that we should wait until at least a six month period when the (sic) clinical evaluation data would be in and evaluated and therefore, I was certainly in the minority when Hoyt put it all to a vote at the end of the meeting.
Between Thursday, the 10th of the March and Friday, the 11th of March, I had occasion to think about this and I felt that I still couldn’t live with this decision and therefore, at approximately 8:15 on Friday, March 11th, I called Hemlock and spoke with Mel Nelson. In doing so I told him I was concerned because the meeting yesterday was the fourth meeting on this same subject and it (sic) indicated to me that people were still uneasy and not entirely committed and to have such indecision requiring these repeated meetings to go over the same subject indicated a shakiness (sic) on the part of the parties concerned. I told Mel that I actually really felt that the people in that conference room on Thursday afternoon really wanted to be stroked. There was safety in numbers. I asked him who the person would be that one individually would be held accountable if this project were to get underway and things were to go to hell in a bushel basket, I did not get an answer to that and of course I think that Mel felt that ultimately he would be the one that had to make an accounting for this. But I find it hard to believe that he would allow himself to succumb to the pressures of several of the members of the Marketing Department and possibly Ron Kelley of TS&D, simply for the sake for getting 500 inflatable mammary prostheses out in 1977, which would only amount (to) $70,000. I think that the disregard for a plan and our disregard for the ethics of clinical testing and product reliability for (sic) to sale isn’t worth jeopardizing for the sake of this small amount of money.
My second point to Mel on the phone was that I truly believe that this decision , as fostered by John Hoyt and Chuck Leach, is a violation of Ray Maneri’s Codes of Business Conduct. I think the Marketing Department Planned very poorly and I think the PMG has not been very realistic in pushing forward in this and therefore, a decision to go ahead with an early marketing date violates Maneri’s Codes of Business conduct in the U.S. area that was circulated by all Dow Corning employees. Ray has very emphatically stated in his little pamphlet (sic) that Dow Corning “Dow Corning will strive to assure product efficacy, assure that its products are of the highest practical quality and that product characteristics and potential hazards are made clearly known to the user.” If they go with an early market introduction date, they have violated that statement in the code. Further on in the same pamphlet, it states “the product sold by Dow Corning will be thoroughly tested to determine their effect on the environment.” Here again I feel that an early distribution would violate that part of the code. I made both of these points to Mel Nelson and pointing out that we were succumbing to Marketing pressure. I also brought up the subject of a problem we had years ago when the Marketing Department and Gordon McIntyre elected to distribute all the (sic) silicone foley catheter in the southern California area prior to any conclusive testing relative to safety and efficacy.  That decision turned out to be a real fiasco (sic) in several months we had telephone calls and letters and telegrams from hospitals and Urologist and nurses from southern California relating incidents of balloon failure, balloons coming off the end of the catheter, etc. and immediately we had to cease and while we retrieve (sic) all of these catheters, our legal council (sic), Joe Radzius was down in Washington trying to keep the lid (sic on this thing so it would not become an official recall. This meeting on Thursday, bothered me because Joe was back in that meeting offering Legal Council (sic) which was opposite what had been voiced by Steve Gaidard and Harry Dingman and Norm Lewis in the memo that was left for Joe to discuss. All three of these people including the chief legal council (sic) for the corporation, Steve Giadard stated that there (sic) recommendation that we not go with an early market distribution, Joe on the other hand (stated) that he felt that the risk was worth it. I felt his contribution at the best (sic) biased because he had already made it known to the Corporation that he is resigning and so whatever he said would have little effect anything that would transpire past March 31, when he officially leaves the employment of Dow Corning.
I mentioned to Mel that I felt that the strength of the position by the Marketing Department, namely Hoyt, Leqach, Hinsch also pivoted on their having to save face within the last week they had a general sales meeting down in Houston and I come to find that they did announce to the sales force that the inflatable was coming and it would be offered for limited distribution. Now here some of these problems are being posed to them and would require their having to go back to the sales force and tell them that there (sic) initial decision was incorrect and retract all that they have said and therefore their credibility as being challenged I think that it wasn’t in the best interest of this corporation to go down and tell the salesmen in the first place we are going to have a product, while it was still under test.
I think that we are indeed putting Dow Corning’s name and reputation on the line for a measly (sic) $70,000 and there is not (sic) guarantee that there would be sale of pairs between May 1 and the end of the year. Finally I said to Mel Nelson that for the last several years we have (been) under strict criticism (sic) by the American society of Plastic and Reconstructive Surgeons because of our position with the silicone injection program. When we first got involved with the A.S.P.R.S. with the silicone symposium, we were accused as a Corporation of disregarding safety and efficacy data to jam our product through so that we could recoup (sic) some of our investment dollars and we were looked at as a large corporation who disregarded safety and efficacy standards to make money. I had to defend Dow Corning’s position in this regard at the California Plastic and Reconstructive Society meeting last year because the same accusation was made that we were more interested in profit and dollars then (sic) we were in ethics and good testing. I told Mel that one of our current clinical evaluators for the inflatable was Dr. Verner Lindgren who is Vice-President elect of the A.S.P.R.S. and also Fred Grazer who, both of these men being very active in Society matters. I would find it hard (to) believe and in fact I would find it a very difficult thing to do, to go and have to tell these men that now that they are testing the product, that Dow Corning has taken upon themselves to market this product. Therefore I wanted a written statement from the Business stating the rational and the decision behind this move and that I would use that statement when these investigators were to be informed of Dow Corning’s decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn’t even gotten that far to consider what the ramifications would be and what the impact would be on these investigators were to be informed of Dow Corning’s decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn’t even gotten that far to consider what the ramifications would be and what the impact would be on these investigators and that this would be something that would have to be looked at in great detail. While I find this whole matter very disconcerting (sic), I personally am very uneasy about the whole thing. I find it hard to believe that after so many difficult experiences in the past that management for the Medical Products Business would be so narrow -- in their vision that they are going to go out and promote a product that has not been tested. It is my sincere hope that there will be a reversal to this decision. (emphasis added).”
CITE: KMM 333230 - 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #272
03/16/77
GEL MIGRATION
Dr. Swanson calls Eldon Frisch, Dow Corning, noting that he had written to Zeke Bennett urging that Dow Corning undertake appropriate studies to determine the potential migration of silicone elastomer particles throughout the body. Dr.  Niebauer, San Francisco, is presenting a paper and speech about silicone particle migration in monkeys, particularly in the liver. also, Dr. Rose from the Massachusetts Institute of Technology will propose his theory on silicone elastomer degradation by interaction with lipids at the upcoming Biomaterials Meeting. Frisch suggests that Dow Corning attend these meetings and publish their own position that “biodegradation does not occur.” He also suggests an animal study at the University of Michigan because they are “open to suggestions.” (emphasis added).
CITE: M 190441 - 190443, Exhibit to Harris County Tyler Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #273
03/22/77
MISCELLANEIOUS - COMPLICATIONS
TISSUE REACTIONS
Complaint report from Dr. Tony Emmett filed by Green. Report states that Dr.  Emmett has removed implants after a cancer was found in the breasts. This is one of several such cases sighted by Emmett. The cancer cells have seemed to follow the capsule.
 
CITE: COM 4331 - 433 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #274
03/28/77
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
Dow Corning employee, D. Petraitis, memo regarding bleed studies for Dr. Barker.  There is serious concern whether any gel bleed data should be released to the public because “any general release of this data could be misinterpreted or misconstrued, and could result in severe repercussions in the public sector.” (emphasis added). Also, “The bleed measurement may not be representative of actual in vivo results.... I still believe that Dow Corning should convey the impression that we are indeed working in this area.” (emphasis added).
CITE: F 633. DUPLICATE: KMM 264592. NOTE: Del Petraitis later worked for McGhan Nusel. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document 275
03/31/77
TISSUE REACTION
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
Leach, Dow Corning, memo to Bob Levier regarding “Contracture Phenomenon.” Leach refers to recommendations made by Pat Walters on contracture and states that Dow Corning has taken no significant action on any of Walter’s recommendations, except for a “half-hearted” low priority program at Northwestern University. He reports that he is losing customers because doctors believe Dow Corning implants bleed more than others. Leach writes: Several of our customers looking to us as leaders in the industry, asked me what we were doing. I assured them, with crossed fingers, that Dow Corning too had an active ‘contracture/gel migration’ study underway. This apparently satisfied them for the moment, but one of these days they will be asking us for the results of our studies....l I am not sure where this unrest is leading but suspect that our PMG, as the steward of Dow Corning’s implantable products, should not be to (sic) comfortable with our current lack of focus and coordinated leadership relating to this entire issue. I suggest that this question be addressed at our next PMG Meeting and clear definition given as to what answers we can reasonably be expected to have, and what steps need to be taken to fill whatever gaps that may exist in our needed storeroom of knowledge.  In my opinion, the black clouds are ominous and should be given more attention. (emphasis added).
 
CITE: F 717 - 718 (Handwritten note, “R-grand push. Where does Ron Kelley stand w/summarizing available data? John.”)’ M 190439 - 190440 (Handwritten note, “Chuck, excellent memo. We must not be complacent as in past. Unlikely other co.’s research will favor us. Are we going to do something? Dick.”) Exhibit to
MDL Rathjen Deposition. DUPLICATE: F 683 - 684; GEG 4028 - 4029; KMM 140266 - 140267. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #276
04/13/77
SHELL STRENGTH - THICKNESS
Petraitis, Dow Corning, memo to LeVeir, Rathjen, et al. about returned inflatable implants. One of the implants had a pinhole leak which Petraitis believed was not caused by procedures. Concerned about the problem Petraitis recommends a halt to the current program plan as he is convinced the current envelope is “questionable.” Cycle testing had raised doubts regarding the envelope, confirmed subsequently by the pinhole leak problem. He recommends Dow Corning officially halt all additional clinical implantation, continue close monitoring of those patients with inflatable implants to develop a data base, emphasize improved envelope production and take a conservative, responsible attitude before gearing up again. Finally, he strongly recommends Dow Corning not take any assumptions regarding their envelope quality improvements until they have some definite history.
CITE: KMM 333250, Exhibit 9 to Hinsch Deposition, and Exhibit to Petraitis Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/privileged & Confidential
 
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Document #277
05/03/77
FRAUD/MISREPRESENTATION
SHELL STRENGTH - THICKNESS
STERILIZATION/CONTAMINATION
Hinsch, Dow Corning, memo to Kelley, Metevia and Petraitis regarding a conversation he had with Jim Cox. The topic of conversation was Cox-Uphoff’s method of manufacturing mammary prostheses. Hinsch first states that at Cox-Uphoff, when raw materials are received, they undergo additional filtering because they are not as clean as they would like to have them. Secondly, Hinsch comments on Cox’s vulcanization times. Jim Cox suspects that he and the people on the West Coast vulcanize their gel implants longer than Dow Corning. Cox’s comments lead Hinsch to believe that there is some correlation between his longer vulcanization time and the lack of oily feel on the prosthesis. The third and final comment concerned manufacturing double lumen implants. “Jim conceives that he can ‘dump’ gel implants which are not ideally manufactured by using them in these Double Lumen Prostheses.... This is something we should keep in mind should we eventually move into the area of double lumen type of implants.”
 
CITE: OOM 320455. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC attorney Work Product/Privileged & Confidential
 
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Document #278
05/16/77
MISCELLANEOUS - LOBBYING
MISCELLANEOUS - ORGANIZATIONAL SURVEY
Helmer memo to Sanders regarding Breast Implant Manufacturers Association, California meeting. 515(B): 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 Sanders Deposition, and Exhibit to Compton Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #279
05/26/77
RUPTURE
SHELL STRENGTH - THICKNESS
Complaint analysis prepared by Woodard and forwarded to Rathjen.
 
CITE: M 460026 - 460028 and M 570200 - 570203, Exhibit to MKL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #280
06/16/77
SHELL STRENGTH - THICKNESS
RUPTURE - CLOSED CAPSULOTOMY
A.H. Rathjen, Dow Corning, reports a telephone call from Dr. Ben T. Gregory regarding two incidents of ruptured mammaries immediately upon attempting to “pop a capsule,” i.e., performing a closed capsulotomy. Upon explantation, Dr.  Gregory found a quantity of loose gel. The doctor called to let the company know that, “He does not subscribe to those in his profession who claim that—under no circumstances when you ‘pop a capsule’ will you break and implant.”
 
CITE: M 570125, Exhibit 13 to Harris County Rathjen Deposition. DUPLICATE: M 240322; KKH 001616.
 
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Document #281
08/12/77
TISSUE REACTION
SHELL STRENGTH - THICKNESS
RUPTURE
Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen’s article on capsular contracture. Frisch states, “during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity.... Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process.” Frisch also states that ruptures most likely occur because “during certain activities such as love making, vigorous hugging, strenuous physical exercise,” and that “physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant.” (emphasis added).
 
CITE: OOM 320474 - 320476. NOTE: Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #282
08/24/77
 
KNOWLEDGE OF GEL BLEED
COHESIVENESS - LIQUID COMPONENT OF GEL
 
John R. Hilliard, Dow Corning, writes to Bob Gruber of Surgical Appliances Industries Inc., regarding a new gel to consider as an alternative to the current gel. The new gel, X7-2339, bleeds only 60% more than the current gel, Z7-2339, while the pre-1976 gel bleeds almost 600% more than the current gel.
 
CITE: M 250044. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #283
08/31/77
 
TISSUE REACTION
 
Dow Corning Telephone call report noting a person who developed severe bilateral infections seven days post-op. She entered the hospital with a temperature of 105 degrees in a “life threatening situation. Upon opening up the chest cavity, the doctor found large quantities of puss. ... In an effort to forestall a potential lawsuit, I told the doctor that I would recommend free replacement of these prostheses—even though no rupture upon removal.
 
CITE: KHH 35213. Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #284
09/07/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DESEASE
Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a silicone injection patient who developed a mass the size of an orange and experienced reddening, hardness and itching at the injection site on the thigh.  The pathology report notes there was a “chronic inflammation reaction.”
 
CITE: KMM 418633 - 418656, Exhibit to MDL Rathjen Deposition. DUPLICATE: I 6182
- 6190. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #285
09/07/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a silicone injection patient who developed a mass the size of an orange and experienced reddening, hardness and itching at the injection sit on the thigh.  The pathology report notes there was a “chronic inflammation reaction.”
 
CITE: KMM 418633 - 418656, Exhibit to MDL Rathjen Deposition. DUPLICATE: I 6182 - 6190. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #285
09/29/77
SHELL STRENGTH - THICKNESS
RUPTURE
Petraitis, Dow Corning, memo to Roush and Becker setting forth “The Reasons For Proceeding With An Inflatable Introduction.” Petraitis notes that the clinical evaluations “indicated a high incidence of deflations: but claims that most were caused by small pinholes in the envelope. He assumes he can improve the envelope to prevent these pinholes by making it thicker. Petraitis concludes, “I feel that any risk associated with marketing the inflatable made from the improved envelope without additional clinicals is certainly worth taking.... The decision to delay introduction is equivalent to eliminating the product forever.”
 
CITE: KMM 149569 - 146570, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #286
09/30/77
ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
 
Roush, Dow Corning, memo to the Medical Business Board announcing that the Implants PMG has decided to introduce the inflatable mammary prosthesis at the Plastic Surgery Show on October 30, l977. There is a risk being assumed in doing this since the product has not been clinically tested. The PMG believes, however, that the risk of the Product not performing is much smaller than the risk of losing market share. Dow Corning was concerned with a permanent loss in market share unless it moved quickly. (emphasis added).
 
CITE: KMM 333267. DUPLICATE: KMM 149564 - 149566. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #287
10/03/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD FRAUD/MISREPRSENTATION
 
Rathjen, Dow Corning, memo to PMG and MPPBB (Medical Products Business Board) reiterating his objection to marketing the inflatable prosthesis when there are doubts about its efficacy. He notes, “This suggestion was turned down because some members of this business thought the product would indeed stand up. Well, it hasn’t!” Rathjen believes the product’s efficacy should be determined after clinical trials and not merely “on the bench....” He believes it is a “moral issue ... whether Dow Corning was really, truly being honest and straightforward with our customers?” He recommends the product be tested further on 50 patients over the next four to five months and hard facts be developed before introduction as surgeons believe a ten percent deflation rate is absolutely unthinkable. (emphasis added).
 
CITE: KMM 333259 - 333261, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: OOM 321512 - 321514. NOTE: The deflation rate with the inflatables over a nine month period was 12%. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #288
10/06/77
KNOWLEDGE OF SYSTEMIC DISEASE
STERILIZATION/CONTAMINATION
TISSUE REACTION
Hobbs memo to Atwell, Bey, Lentz, LeVier, Owen, Pearce, Ryan, A. Smith, F.  Stark, J. Campbell, S. Guittard, L. Tyler and D. Weyenberg regarding “Minutes from 2,6-cis meeting of 9/20/77.” Certain unvulcanized food grade elastomers contain 250-450 ppm 2,6-cis, 996 resin contains approximately 50 ppm, and DC 550 fluid using the new process contains 1-5 ppm. The verbal results of the genetic tests on 2,6-cis show positive results and “indicate aggressive action is necessary to evaluate the potential hazard of this impurity.” Hobbs states that he has obtained technical and legal opinions from Joe Raddzius and Dr. Steve Carson.
CITE: DCC 281031108, Exhibit to Tyler Deposition, and Exhibit to LeVier
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #289
10/20/77
COHESIVENESS - LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
STERILIZATION/CONTAMINATION
Peters, Dow Corning, memo to Chandler with copies to Lentz Wendel and Rathjen regarding mammary gel review, part II. The molecular weight given for the gels are much lower than actual since the gels have a significant amount of branching and are polydispersed. X7-2151 would be the better gel for implantation since for a given penetration it has a high molecular weight distribution. The report also lists trace metal amounts for various gels.
CITE KMM 453922 - 453928. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #290
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
 
Log of a telephone conversation in which Rathjen, Dow Corning, tells Dr. G.  Perrin he is unhappy with the marketing department’s decision to introduce an inflatable mammary that had a 14 percent deflation rate when tested. He says he was concerned about the decision and feels “there is an ethical matter involved here.” Dr. Perrin replies “if you are too hasty (sic), things backfire on you.  Both of us know that....” (emphasis added).
 
CITE: KMM 255487 - 255488 
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Document #291
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
Log of a telephone conversation between Dr. Glazer and A. Rathjen, Dow Corning.  Dr. Glazer says he is surprised they were putting the inflatable mammary implant on the market without all of the data being collected and feel such a move is premature. Rathjen agreed and stated, “There is no two ways about that, but it hasn’t been tested....” Rathjen feels that he has “been muscled and I am mad because here we said we were going to stop and retrench and they insisted the thing keep going.” Rathjen states that he is prepared to resign because his “reputation is on the line as it relates to the silicone injection fluid....” (emphasis added).
CITE: KMM 194463 - 194466, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #292
11/10/77
GEL MIGRATION
Dr. Jerrold Abraham responds to Eldon Frisch’s letter of 10/21/77. He states, “I am quite disappointed by your letter of October 21, 1977. It seems you remain unwilling to accept the fact that I am able to identify the silicone material in the tissues and to separate it from contamination from dust, glass, etc.... The FDA has expressed interest in supporting some limited studies, but they will not of course, support studies designed to improve your implantable devices. They must limit their support to studies testing available devices already on the market.”
“I must have examined human tissue from patients with implants and find no difficulty in identifying the silicone material migrating from prostheses in joints.” (emphasis added). Dr. Abraham goes on to request an opportunity to review animal specimens from earlier studies and informs Frisch of improved detection techniques. “This latter technique has provided additional confirmation that the material we are looking at is indeed the polydimethylsiloxane rubber. I urge you to reconsider and to aid in this study of your long term animal implantation experiments.”
CITE: OOM 320482 - 320483. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #293
12/07/77
FRAUD/MISREPRESENTATION
Jim Bolland, Dow Corning, responds to Woodard analysis of Arm No. 0964 and “Complaint Forms And Their Resolution.” He indicates that the complaint procedure does not seem like it designed to give doctors qualitative information regarding their complaint. “If the idea of returning defect material to you is to cover ourselves from the liability point of view then perhaps we should know this and we will be careful not to tell the doctor that he can expect a full report when his complaint is being investigated.”
 
CITE: COM 494. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #294
12/15/77
SHELL STRENGTH - THICKNESS
RUPTURE
Frank Lewis, Dow Corning, Memo to Milt Hinsch regarding the “inordinate rate” of ruptures occurring with mammary implants. Lewis lists four doctors who are experiencing “abnormal percentage(s) of ruptures.” Dr. Don Davis of Lansing, Michigan with 14%, Dr. Fusilero of Lorain, Ohio with 32%, Dr. James Scarcella of Lakewood, Ohio with 12% and Dr. Richard Straith of Detroit, Michigan with 11%.  Lewis states, “I am sure some of these were the fault of the doctor, but that alone could not account for such a high percentage of ruptures. These doctors have on the average ten years of experience in this procedure.”
 
CITE: M 240328 - 240329. NOTE: A handwritten comment is at the bottom of the memorandum and reads, “A detailed study of mammary rupture frequency is being made and should be completed by 1/31/78 for the year 1977. Data to be made available from Midland Marketing.” DUPLICATE: F 731 - 732; M 570147 - 570148; M 460300 - 460301; KMM 351899; KKH 1631 - 1632; KHH 67459 - 67460; KKA 88982.
NOTE: No such studies have been located. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #295
00/00/78
 
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
 
Publication by LeVier, Chandler and Wendell titled “The Pharmacology of Silanes and Siloxanes, Biochemistry of Silicon and Related Problems.” pages 473-514. The salient features of silicon chemistry that may be considered of interest to life scientists have been reviewed while the biochemistry of silicon compounds has received only brief comment because this subject remains largely unexplored.  Indeed, so little is known that we continue to categorize structures only on the basis of intended use with some consideration for bioavailability and a few emerging trends relating activity to structure and reactivity. This approach at least allows a clear division of though between popular silicones known for their lack of bioactivity and the less well known reactive silicon compounds.
 
CITE: DCC 281061312 - 281061353; Exhibit 64 to Bennett Deposition (used by Dow Corning). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #296
01/20/78
SHELL STRENGTH - THICKNESS
RUPTURE
 
Rathjen, Dow Corning, memo to various members of the Marketing Department - Nelson, Hoyt, Bey and Hinsch - and to members from Dow Corning’s in-house Legal Department - Steinberg and Lewis. Rathjen reports that the current deflation rate for the inflatable clinicals from January to August 1977 is 22%. Several patients had bilateral deflations.
CITE: KMM 333270. DUPLICATE: KMM 261276 - 261277. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #297
02/28/78
FRAUD/MISREPRESENTATION
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
Tyler memo to Campbell, C. Lentz, John Ryan, Weyenberg, Gergle, Hartlein and Maneri regarding “Adventitious 2,6-cis.” “I am concerned lest Dow Corning employees generate an unwarranted number of documents containing adventitious 2,6-cis.. I see no reason for any documents not authorized or reviewed by C.  Lentz or L. Tyler. Even the verbal communications can be very simple. We know of no health problems associated with the extremely low levels of adventitious 2,6-cis in hundreds of Dow Corning products. However, there could be a ‘business’ risk associated with adventitious 2,6-cis. Because of (the business risk) we are proceeding to eliminate adventitious 2,6-cis from almost all Dow Corning products.” There is a handwritten note to copy to Stark and LeVier.  CITE: DCC 281031106, Exhibit to “Weyenberg Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 9 to Harris County Tyler Deposition, Exhibit to MDL Tyler Deposition, Exhibit to Ryan Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #298
03/02/78
SHELL STRENGTH - THICKNESS
RUPTURE
Dow Corning salesman, Frank Lewis, informs Milt Hinsch that he has experienced an “excessive number of ruptures” in the Detroit area. Numerous doctors report an increase in ruptures and are commenting, “Noticing a difference in the envelope.”
CITE: F 729 - 730. DUPLICATE: M 570150 - 570151; KMM 3919 - 3920. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #299
03/10/78
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING
TISSUE REACTION
Study titled “Biological Evaluation of an Implantable Silicone Gel: Summary of Acute and Chronic Studies” by Lentz, Chandler and LeVier. The authors report:
“The current data do not support the use of X7-2151 gel by direct instillation. While no deleterious effects were noted, the long term localization of the gel is uncertain as is the end point of the tissue reaction. To permit use of this gel by instillation, future studies should address the questions of whether the reaction stops short of complete dispersal of the gel, whether gel fragments are carried to remote sites and if so the fate of this material, whether this reaction is dependent upon the ways of gel injected, and whether a similar fragmentation occurs in humans.”
CITE: DCD 154000246 - 154000266, Exhibit to Weyenberg Deposition. DUPLICATE: KMM 174130 - 174159l. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #300
03/16/78
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
Bob LeVier, Dow Corning, memo to Bey and Nelson (both are in the Marketing Department) proposing development of the implantable gel implant. He writes, “The 180-day rabbit gel implantation study led to two conclusions based on the data:
l. The evidence for progressive subdivisions of gel is sufficient to warrant the conclusion that a hypothesis favoring efficacy in mammary augmentation and/or mammary reconstruction cannot be supported without further experimentation.  
2. The evidence for the presence of small isolates of gel surrounded by potentially phagocytic cells is sufficient to raise a theoretical question concerning dissemination of gel or its components.
LeVier states that animal studies are needed on these issues and on questions relating to gel subdivision “by connective tissue and gel-associated systemic toxicity,” He has designed a study which will provide the “minimally required information ... (in) the shortest practical time course for completion and at as low a cost as possible.” (emphasis added).
CITE: F 744 - 746. DUPLICATE: M 3320004 - 320005. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential  

 
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