Smoke Fire Documents 151

Document #151
06/00/73

COHESIVENESS - LIQUID COMPONENT OF GEL
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

Dow Corning Bioscience Research Laboratory “Research Project Description: entitled “Bioscience Research Support Project - Systemic Migration Of Prosthetic Gel In The Rhesus Monkey.” This cooperative project between Dow Corning’s Medical Products Business and Dr. Gerow will “to examine the efficacy of using the gel as an injection or implantation for mammary augmentation. This project is designed to examine the potential of gel components to migrate systemically from the site of instillation.” (DCC 16001066) “The gel is a complex mixture of which the low molecular weight fraction (up to 1% w/w of the gel; 330 Fluid) is assumed to offer the greatest potential for migration. Present data acquired in rats indicate that such low molecular weight components tend to appear in depot fat and lymph nodes and that maximum tissue concentrations are attained shortly after instillation.... The relative contribution of the various routes of elimination may include the lung, kidneys and liver based on the elimination of orally administered permethylated cyclic tetramer....” (DCC 16001066) None of the data to be gathered will allow definition of the structural types that may migrate. The 330 Fluid fraction components of the gel “are the most likely candidates ... (so) it may be advisable to repeat the study with a gel formulation containing a minimum of low molecular weight linear and cyclic siloxanes.”

CITE: DCC 16001066 - 16001068, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 546: 12-23). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
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Document #152
06/00/73

ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Metabolism of Organosilicon Compounds.” The objective is to “study systematically the absorption, distribution, storage, metabolism and elimination of those organosilicon structures forming the bases of silicon chemistry as exploited by Dow Corning.” (DCC 016001081) “There have been no systematic explorations of the metabolism of classes of organoxilicone compounds. Such explorations are necessary for their predictive value in selecting and developing efficacious biological applications.... A few of the current projects now requiring an understanding of metabolic potential include:

1. In vivio disposition of low molecular wt. linear/cyclic permethylated and hydroxylated siloxanes in the breast prosthetic gel. (DCC Compounds to be evaluated in the rhesus monkey include cyclic and linear D3 through D5.

CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett Depo., Vol. I p. 254-257). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
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Document #153

06/00/73

ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Silicon Adjuvants.” The objective is to “investigate the action of silicon compounds on the humoral and cellular immune response.” (DCC 16001092) “Substances which are non-immunogenic or only slightly immunogenic can often be made strongly immunogenic by simultaneous administration with adjuvants.” (Id.) Because of the drawbacks with presently known adjuvants, research will determine if the cellular or humoral response can be selectively enhanced through the use of organosilicon compounds.

CITE: DCC 16001092 - 16001093, Exhibit to Bennett Deposition (used by plaintiffs and as Exhibit 83 by Dow Corning), Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit to MDL LeVier Deposition. WITNESS: Bennett (Authenticated in Boley, Vol. I p. 141-143 and 153: 19 - 154:12).

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
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Document #154

06/09/73

KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - SALES

Telephone call report by Braley with Dr. F. McDowell with copies to Rathjen, Stark and Bennett regarding Bromley Freeman’s paper on the use of free gel implantation. “I explained Dow Corning’s great concern with this situation and that we had finally gone to outside counsel in Washington for advice. The situation is serious enough that we are going to considerable length to notify all persons that the breast implant is not to be cut open. The outside counsel has felt that the FDA could interpret this used as a drug being furnished in a very elaborate package, and could thus eliminate all beast implants of any kind.”

Dr. McDowell suggested getting an injunction against the FDA concerning the injection program. Braley explained the “impossibility” of this and said that DC does not have sufficient information to give to the FDA yet.

CITE: KMM 112207 - 112208, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
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Document #155

06/16/73

ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning bioscience Research Laboratory “Research Project Description” entitled “Exploratory Hapten Modification.” The objective is to “determine the antigenic (haptenic as well as conjugate) capability of organosilicones of various molecular weights and to explore their potential use as biological tracers.” (KMM 546454) Among the organosilicon compounds to be examined for determination if they function as conjugates or complete immunogens are dimethylpolysiloxanes. Research in this area will most certainly advance our knowledge of the chemical reactions of organosilicone compounds to biological chemicals.... The development of specific antibody in response to organosilicon determinant groups would provide us with an exquisitely sensitive biological tracer for detecting distribution and storage of organosilicones in the body.” (KMM 546455)

CITE: KMM 546454 - 546465, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also has Bates Numbers KMM 491081A - 491083A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 378:21 - 379;16). DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
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Document #156
6/19/73

KNOWLEDGE OF LIQUID SILICONE DANGERS

Joe Radqius, Dow Corning Food and Drug Counsel, memo to numerous Dow Corning employees regarding “misuse of the Silastic Mammary Prosthesis.” Radzius states that, “we are now aware of isolated instances where physicians are purchasing the Mammary Prosthesis and removing the gel from it for subsequent implantation.” (Kmm24296 - 242499). He recommends a warning be put on the data sheets and information brochures. “If the matter is not given our immediate attention, and if the practice continues, Dow Corning may have no alternative but to remove the product from the market because of potential liability.”

CITE: KMM 242496 - 242499, Exhibit to Mantle Deposition, Exhibit 92 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit to Venn Deposition. DUPLICATE: OOM 880025 - 880027. Dow Corning Trial Exhibit List Abstracts
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Document #157
08/00/73

SHELL STRENGTH - THICKNESS

Dow Corning mammary envelopes are in short supply. There are high losses at the dipping machines for tears and poor release from the mandrels. The reject rate at the dipper is in the range of 50%.

CITE: KMM 220138 - 220147. Dow Corning Trial Exhibit List Abstracts
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Document #158

08/01/73

GEL MIGRATION
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH - THICKNESS

Study by Alcott titled “Physical Comparison Between Camp External Mammary Prosthesis and Dow Corning Silastic External Mammary Prosthesis.” The Camp “Symmetry”, external mammary prosthesis was found to be a tough, somewhat unyielding prosthesis. A good fabrication system is used with good results. No migration of silicone oils through the envelope is likely since the envelope is not a silicone rubber. The envelope may resist body fluid and odors better than silicone rubber. Camp’s advertisement is quite misleading since it implies that the same materials are used in implants.

CITE: KMM 354646 - 354651, Exhibit to Tyler Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #159
09/18/73

FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding “Precise Choice of Words/Accurate Written Reports When Returning Unusable Or/Remove Mammary Implants To Quality Assurance.” Rathjen discusses recent trip reports which used the word “reject” when referring to a physician’s use of the Silastic. Other words or phrases sales person use which Rathjen does not like include “faulty product,” “faulty,” and “defective.” Words like this “are imprecise and could be damaging to Dow Corning if they are used incorrectly when repeating a condition or a set of circumstances.... If a patient elects to file a lawsuit against the surgeon or Dow Corning, the patient’s lawyers have a right to review our written files. Our files must be disclosed and the attorneys are entitled to use our records as evidence to try and prove their case against us.” (emphasis in original).

CITE: KMM 243010 - 243015, Exhibit to MDL Rathjen Deposition, Exhibit 4 to Hinsch Deposition, Exhibit to Mantle Deposition, and Exhibit 62 to Harris Country Rathjen Deposition. DUPLICATE: M 880016 - 880018; DCC 24000537 - 24000542; OOM 880016 - 880018. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #160
10/00/73

ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING
TISSUE REACTION

Publication by Rowlett, Nichols, Bailey and Dion titled “Silicones -Can They Further Improve The Quality of Life?,” Dow Corning News, Vol. 15, No. 4, Sept. - Oct. 1973. Includes a description of the Bioscience Facility, the History of Bioscience activity at Dow Corning. States that 2,6-cis can alter their behavior of the pituitary, the master gland that chemically controls the function of all the other glands in the body. Describes Bioscience research as opportunity-oriented or for developing profit making products.

CITE: DCC 282001118-282001149, Exhibit to Bennett Deposition, Exhibit to Petraitis Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition, and Exhibit 1 to Randonovich Deposition. DUPLICATE: LAK 1 - 11. Dow Corning Trial/Exhibit List Abstracts
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Document
10/08/73

(NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)

Memo from Lake and Ng, Dow Corning, to Isquith and Bennett regarding “Experimental Activities in the Virus and Cell Biology Section of Microbiology 1973-1974.” The laboratory is now functional to analyze metabolism of cell cultures, cytogenetics, serology, ultracentrifugation, chromatography, electrophoresis, and fluorescent, phase and light microscopy. “The broad focus of our mission is to circumscribe those areas in the total realm of virus and cell biology where organosilicon entities manifest exploitable biological activity. Antimetabolite, virucidal, antiviral, interference inducing, or cytostatic activities are being sought.” (LAK 12) Anticipated areas of research include:

A. Endogenous Si and exogenously applied silicates: The notion that endogenous Si and trace quantities of Si play a role in atherosclerosis, connective tissue structure and function, mammalian cell aging, and lymphocyte transformation has prompted interest in this area. (LAK 14)

B. Research will also be conducted on new agonists and chemotherapeutic agents with selected groups of organosilicon compounds. Activities that will be monitored include viral interference induction (interferon), antiviral activity against 4 RNA and 4 DNA viruses, modification of cell growth kinetics and modification of cultural characteristics.

C. Also, the authors seek to establish a method to measure the response and processing of fluids resins and silastic materials in macrophages. (LAK 14)

CITE: LAK 12 - 15, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, and Exhibit 1 to Radonovich Deposition. WITNESS: Bennett (Authenticated in Lake, Vol. 11, p. 306:19-23). DISPOSITION Not introduced in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts

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Document #161
12/04/73

MISCELLANEOUS - SALES

Art Rathjen memo to numerous Dow Corning Employees informing them of an “Album For Clinical Photographs, Silastic Mammary Prostheses.” This album is later used by sales persons.

CITE: DCC 24000523 - 24000524, Exhibit 23 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/13/73. DUPLICATE: DCC 266000237. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #162
12/13/73

MISCELLANEOUS - SALES

Maurice Popple memo to Art Rathjen, both of Dow Corning, stating, “Art, I am in receipt of your pornographic picture album and think it’s a great idea. As you are aware, salesmen spend long weeks away from home and such an album is a comfort to take along. I am awaiting with adrenalized anticipation the next batch of photos .... Anyhow, I have always considered myself a leg man so I don’t claim any special expertise (sic) in the subject area.”

CITE: KMM 46084, Exhibit 24 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/04/73. DUPLICATE: DCC 24000967. Dow Corning Trial Exhibit List Abstracts
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Document #163
01/22/74

ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
STERILIZATION/CONTAMINATION
TESTING
TISSUE REACTION

Abbott memo to Stark with copies to Bennett, Larson, Rathjen and Robertson regarding “Summary of Gel Review Meeting, January 16, 1974.” All of the gel samples except X-30885 showed a reaction when implanted in rabbits at Huntingdon, suggesting that some gel samples may not be properly cured and “will, therefore, show a reaction.” Also, he recovered the volatiles from the gel which consisted of cyclic pentamer and constituents larger than pentamer. Many gel samples tested are “highly contaminated with bacteria. Also the samples that gave a reaction at IBT were found to be contaminated. The number of organisms is so high that the antibiotics in the tissue culture medium will not control them There is a possibility that the organisms involved are resistant to the antibiotics which are in the medium. In a recent study in our laboratory, it was found that S. auras (gram positive) can survive in mammary gel for approx. 120 days. Because of this data, we would like to isolate and identify the bacterial that are present in the gel.”

CITE: T 21169 - 221172, Exhibit to Harris Country LeVier Deposition and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
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Document #164
01/23/74

KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Boley and LeVeir memo regarding organosilicon immunopotentiators. Forty-eight silicon-containing compounds were examined in guinea pigs for their ability to enhance serum antibody levels. Nine of the compounds showing high enhancing activity were further evaluated in a rat model. Of the nine, four prolonged and enhanced serum antibody levels.

CITE” DCC 281061454 - 281061486 (Temporary Dow Corning Bates Numbers 16362 - 16377), Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts
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Document #165
02/18/74

SHELL STRENGTH - THICKNESS

Tom Talcott, Dow Corning, memo to Boone, Stark, Ringey, Hoyt, Houle, Polmanteer, and Brodhagen regarding “Control of the Aesthetic Character of our Soft Contour Mammary Prosthesis.” Talcott states:

Some of us have felt for some time that we need to do much better on envelope thickness control for the round prosthesis. Gel control maybe also, but this is another separate subject. Envelope thickness control appears even more important in the soft contour product line. This is because of the general shape of the product. The envelope if too thin can be extended and/or sag, allowing the peak of the projection to be grossly underfilled. There are also some severe irregularities in the tooling for this product line that contribute to the problem in certain sizes.

CITE: KKM 21110. Dow Corning Trial Exhibit List Abstracts
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Document
03/00/74

(NOT ON PLAINTIFF’S EXHIBIT LIST)

Handwritten document produced by Dow Corning synopsizing three classified Dow Corning reports: 1) Lake, Isquith and Bennett report “Status of Biological Testing of Sila-adamantoner compounds, Dow Corning Internal Report 4234”; 2) Lake, Schultz, Radonovich, Dittenber and Kociba report “Joint Research Contract Report, February 197_, Evaluation of the Syrian hamster fibroblast system for direct and host-mediated carcinogen bioassays”; and 3) Lake, Radonovich and Boley’s 1975 report “Immunopotentiating activity of dimethylpolysiloxanes and phenylmethylpolysiloxanes. In preparation for submission to Infection & Immunity.” The note states that patent memos have been submitted on antigen modification, immunopotentiators, and silicone substitutes for tissue culture.

CITE: LAK 133. Dow Corning Trial Exhibit List Abstracts
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Document #166
04/10/74

SHELL STRENGTH - THICKNESS

J.L. Boone, Dow Corning, memo to Hoyt, Talcott, Emmons, Polmanteer and Ringey regarding production analysis for 1973-74. He chronicles problems during 1973 consisting of gel shipments, gel yellowing and platinum level adjustments, extraordinary high tear losses, reject rates as high as 50% in some months, contamination with “lemon-scented I.P.A.,” and irregular thickness in envelopes which cause a loss of 10,000 bags and a 10% breakage rate. During 1974, Dow Corning experienced “extraordinarily high reject rates” with yields of approximately 20-35% of the actual output. Reject losses were heavy at every step and particularly at dipping and placing.

Boone states that the fixation patch on the envelope “covered up air bubbles and other flaws that will reject the NFP style.” Manufacture of the NFP mammary requires considerably more skill and diligence. This is a “permanent problem inherent in the design....” (emphasis added).

CITE: KMM 220138 - 220147. Dow Corning Trial Exhibit List Abstracts
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Document #167
06/11/74

KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING

Memo from Hobbs, Dow Corning, to Needleman about a study of DC 200 fluid injected intravenously in rabbits. Seventeen of the twenty eight rabbits tested died during the study probably due to lung, liver and kidney congestion.

CITE: FDA 27196 Dow Corning Trial Exhibit List Abstracts
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Document #168
06/28/74

KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING

United States Patent No. 3,821,373 for “Organosilicon Compositions In Methods Of Treatment Involving Increasing The Dopamine Content Of The Brain” granted to Donald R. Bennett and Robert R. Levier of Dow Corning. The patent is for the method by which the dopamine content of the brain is increased by administering 2,6-cis. The purpose of this is to alleviate some of the symptoms caused by Parkinsonism, manganese poisoning, and similar diseases.

CITE: DCC 281001098 - 281001100, Exhibit 3 to Isquith Deposition, Exhibit 70 to Bennett Deposition (used by Dow Corning). and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #169
08/20/74

MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Patent No. 3,830,912 for a method for decreasing the reproductive function of mammals by Bennett and McHard, A method for altering the reproductivity function of mammals by administering a pharmacologically effective amount to certain organosilicon compounds. As a means of illustration, one can orally or parenterally administer from 1.0 gn. To 5000 mg. per kilogram of body weight or an organosilicon compound thereby rendering the subject infertile.

CITE: DCC 281061389 - 281061395, Exhibit 71 to Bennett Deposition (used by Dow Corning). Dow Corning Trial Exhibit List Abstracts
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Document #170
08/21/74

MISCELLANEOUS - ORGANIZATIONAL SURVEY

Bennett memo to Tyler regarding technology generation and patents. Crises primarily initiate needed technological change in biological affairs rather than long range planning. Bioscience Research has a better credibility and interface with outside biological businesses that it often has within Dow Corning. Consensus between Dow Corning Legal and Federal Regulatory Agencies regarding all biomedically-related activities and products should exist rather than the current practices such as guarded “win-no lose” or compromise mechanisms.

CITE: LAK 62 - 64, Exhibit to Bennett Deposition and Exhibit to Tyler Deposition. Dow Corning Trial Exhibit List Abstracts
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Document #171
09/23/74

KNOWLEDGE OF LIQUID SILICONE DANGERS

Frisch, Dow Corning, letter to James McDonough, Department of the Army, regarding his letter of 09/12/74. Frisch states, “I want to emphasize that we do not recommend implantation of the gel except when fabricated in devices with intact silicone elastomer capsule.”

CITE: DCC 240000861 - 240000862. Dow Corning Trial Exhibit List Abstracts
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Document #172
09/30/74

MISCELLANEOUS
TESTING

Bennett memo to Bennett, Hobbs, Larson, Radzius and Stark regarding the product safety committee meeting. Handwritten note to complete gel chg. (Mam) and the Lake transformation screen.

CITE: DCC 281061484. Dow Corning Trial Exhibit List Abstracts
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Document #173
09/30/74

MISCELLANEOUS - COMPLICATIONS

Bioscience Research Quarterly Status Report - July 1 - September 30, 1974. There are reports on 2,6-cis and KABI; Microbiology’s work on biodegradation, the environmental effect on soil microflora, antimicrobial surface treatment, nonabsorbable antimicrobials, development of carcinogen bioassay - “Dow Chemical has yet to indicate the extent to which they will support this project,” antigen modification, and modulation of interferon response - “Four compounds ... (Me2Si0)4 (and others) have been shown by W. Boley to have immune adjuvant activity and are also being examined for their ability to potentiate IF induction.” (LAK 56). Under Plant Sciences, there are reports on antitranspirants, large tree transplanting, cherry cracking, hormonal - siloxqane diols could retard opening of flower and leaf buds, insecticide - “previous information on spider-mite, mealy-bugs and aphids has been confirmed and extended. Additional work has been done on mosquito larvae, tomato hornworm and potato beetle, for all of which DC 200 fluid is effective, and on white fly and ladybird larvae, which are not harmed by the fluid.” (LAK 58). Under Environmental, there is a report on the Idaho project - silicon analysis of foliage, soil and water samples: and the Salzburg Road project - spills of silicone fluids on soil to look at plant damage, effects on flowering and effect on percent coverage of the plant species.

CITE : LAK 53 - 59, Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Weyenberg Deposition, Exhibit 9 to Harris County Gehring Deposition, Exhibit to Tyler Deposition, Exhibit to Ryan Deposition, Exhibit 5 to Lake Deposition (used by Dow Corning), and Exhibit to LeVier Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol III, p. 749-750). DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
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Document #174
10/02/74

KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Bioscience Research Report No. 4319 by Boley and LeVier, Dow Corning, entitled “Immunological Enhancing Activity Of Organosilicon Compounds And Non-Functional Fluids.” Forty-nine (49) silicon-containing compounds were examined in guinea pigs to screen for “potential adjuvant activity.” Nine compounds showing “good antibody producing activity” were evaluated for their ability to enhance serum antibody levels. Four compounds including (Me2Si0)4 showed good adjuvant activity. Dow Corning plans future work to evaluate these four compounds for their ability to enhance the antibody response to viral, bacterial and soluble proteins antigens.

Organosilicon compounds can stimulate the immune response. No information is currently available about the mechanism of action of these compounds.

CITE: T 21287 - 21304, Exhibit to Dillon Deposition, Exhibit to Frye Deposition, Exhibit to Bennett Deposition, Exhibit 14 to Edwards Deposition, Exhibit to Isquith Deposition, Exhibit to Harris County Klykken Deposition, Exhibit to LeVier Deposition, Exhibit to Lynch Deposition, Exhibit to Lake Deposition, Exhibit to D. McGhan Deposition, Exhibit to Palensky Deposition, Exhibit to Weyenberg Deposition, Exhibit to Compton Deposition, Exhibit 3 to Harris County LeVier Deposition, Exhibit 18 to Zimmer Deposition, Exhibit to Boley Deposition, Exhibit 1 to Harris County Boley Deposition; Exhibit to Hudson Deposition, Exhibit 23 to Harris County Rich Deposition, Exhibit to Harris County Burda Deposition, Exhibit to Frisch Deposition (used by Dow Corning), Exhibit to Oppelt Deposition Exhibit to Peters Deposition, Exhibit 10 to California Braley Deposition; Exhibit 1 to Dallas Espinoza Deposition, Exhibit to Radonovich Deposition, and Exhibit to Harris County Tyler Deposition. DUPLICATE: This was originally listed as P 14028 - 14046 on the exhibit list; DCC 80061481 - 80061530: F 86 - 103; DCC 281001575 - 281001589. WITNESS; Bennett (Authenticated in Boley, Vol. I, p. 155:4-24).

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 (Not Listed)

(Note: this is not numbered but is between 174 & 175)

10/21/74

(NOT ON PLAINTIFF’S EXHIBIT LIST)

Memo from G. Robertson, Dow Corning, to Bennett, Bennett, Hobbs, Radzius and Stark with copies to Brodhagen and Larson regarding “Minutes of Product Safety Committee Meeting, October 11, 1974.” They discussed proposed changes for mammary gel including using 360 fluid rather than 330 fluid (DCC 267380231). CITE: DCC 267380231 - 267380234 (page 2 is missing). NOTE: This document also has Bates Numbers QDC 118693 - 118696 and MM 220066 - 220069 on it WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 954-968).

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 #175
11/22/74

ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS

Stark memo to Frisch, Rathjen & Talcott with copies to Hoyt and Nelson regarding “Capsular Contracture Studies.” Stark writes, “THE WELL IS DRY! we cannot give financial support for more studies of capsular contracture in ‘74 and ‘75 ... I think our future role in these studies should be to provide input on the technology of silicones and to provide samples of materials.”

CITE: M 190131, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #176
11/26/74

KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION

Silas Braley, Dow Corning, telephone call report of his conversation with Dr. Charles Vinnik. Braley states:

“ Dr. Vinnik then launched into a very extended discussion of how terrible he thinks the silicone fluid injections are and the fact that it is going to mean the financial ruin of Dow Corning if we ever get it approved by the FDA. He said that he had just treated the wife of a doctor from Saginaw who had obtained pure #360 medical fluid directly from a friend at Dow Corning in the days before it was restricted. She had exactly the same typical inflammatory and foreign body reaction that the patients he had seen from Kleifgen and Dr. Haines in Las Vegas. He said he has seen some good results in the face and thinks this is put in in (sic) tiny amounts and in a highly vascular area, but to put it into other areas of the body, he feels is catastrophic. He said he is going to do everything he can to prevent this from ever becoming cleared until further work has been done. He has gone to Senator Cannon and to the FDA commissioner to protest the clearance of the IND. He states that he will offer himself as an expert witness against anybody who chooses to use it in the future. (emphasis added).

CITE: DCC 240000051, Exhibit 35 to California Braley Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #177
00/00/75

KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Abstract of Lake, Radonovich and Boley report entitled “Potentiation of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane.” D4 increases serum interferon levels in mice induced with bacterial endotoxin, apparently potentiating production of “early” interferon induced by endotoxin but not viral-induced “late” or “virus-type” interferon. Forty-eight hours after intraperitoneal inoculation, mice exhibit weight loss, decreased spleen/liver weight ratio, decreased in vivo carbon clearance and peritonial monocytosis.

CITE: LAK 65 - 66A, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit 1 to Radonovich Deposition. NOTE: See entry dated 10/30/75.

DUPLICATE: DCC 281061469 - 281061470.

WITNESS: Radonovich.

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
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Document #178
01/13/75

SHELL STRENGTH - THICKNESS
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE

Brashier, Dow Corning, memo to Salisbury and VerVoort regarding a patient of Dr. Goldwyn’s who reported a “stringy gooey substance” that was coming out of a woman’s breast who had just been implanted. The patient snipped the substance with a scissors. The implants were removed and replaced and the same thing happened.

CITE: M 570188 - 570189 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #179
01/22/75

KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Study by Lake, Radonovich and Boley with abstract titled “Potentiation of Endotoxin Induced Interferon in Mice Treated With Octamethylcyclotetrasiloxane.” D4 has been found to increase serum interferon levels in mice induced with E. coli endotoxin. Because spleen cells but not peritoneal exudate cells from D4 treated mice continue to produce augmented amounts of endotoxin-induced IF upon removal and incubation in vitro, a direct interaction between IF producing lymphoreticular organs and D4 is being considered.

CITE: LAK 67, Exhibit to Radonovich Deposition, and Exhibit to Boley Deposition.

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Document #180

(Note: this is all that is listed for #180)

01/22/75

DUPLICATE OF DOCUMENT # 177 (see above). Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential Document #181 & 182 (Note: #181 (ALSO LISTED AS #182)

01/22/75

TESTING

MISCELLANEOUS - SALES

Hoyt, Dow Corning, memo to Rathjen with copies to Salisbury, Talbot, Thompson, Houle, Meads, Leach, Polmanteer, Boone and Nelson regarding “Mammary Prosthesis Task Force.” He announces that a Dow Corning Task Force has been organized to further development of the Silastic Mammary prosthesis, Low Profile Round and Contour, with “flo gel” and which will be packaged in a new sterile container. Permanent members of this committee include: A. Rathjen (Chair), D. Houle, T. Salisbury, J. Thompson, and T. Talcott. Active consultants include: T. Abbott, G. Robertson, W. Larson, and Z. Bennett. The deadline for product introduction is 06/01/75. There is a 90-day gel implantation test scheduled with Biometric. Although there was no planned gel testing at Dow Corning’s Biomedical facility, this was requested by Robertson.

Hoyt writes that:

“I can’t emphasize enough the urgency and importance of this project for the business in 1975.The basic assignment is to insure rapid commercialization of a new mammary prosthesis product line, incorporating new shapes, sterile pack, and responsive gel. The low profile round - targeted for June 1 introduction/ low profile contour - by September. The many variables connected with this particular program make it a challenging management assignment but we can and must make it happen. How this assignment is handled in detail is up to the Task Group. We are primarily interested in the final result.... Because of our market position and tight corporate business situation as we progress into 1975 we really cannot accept any delays in getting the product onto the market. The big mammary prosthesis sales months will be May, June, and July in which approximately 36% of our total business sales will be made. Missing one of those months would have a dramatic impact. We could, and might be able to accept trade-offs, but certainly not delays.... I would like to emphasize that this task and the assignment of all members has received total Business and PMG support.

CITE: F535 -540, Exhibits 35, 37 and 94 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: In a rush to get the product to market, Dow Corning cut the 90-day study short by 10 days. See 04/25/75 entry, which is the result of the 80-day study. DUPLICATE: M 630061 - 630061; M 540001 - 540006. Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #183
01/28/75

KNOWLEDGE OF GEL BLEED

Art Rathjen memo to numerous Dow Corning employees regarding “Gel Bleed - New Gel In Mammary Prostheses Scheduled For June 1 Introduction.” Rathjen writes that, “there is only a two week period before the new ‘flo-gel’ is scheduled to be formulated and filling begins. A question has not yet been answered is whether or not there is an excessive bleed of the gel through the envelope.... We must address ourselves to this question immediately.... The stakes are too high if a wrong decision is made.” (emphasis added).

CITE: F 541, Exhibit 38 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260794; KMM 19824; FDA 19671 - 19672; M 150001. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #184
01/31/75

KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Patent Memorandum Number 4320 by Boley, Lake and LeVier entitled “Organosilicon Immunopotentiators” is received by Dow Corning’s Patent Department on this date. The memorandum essentially outlines findings that various organosilicon fluids potentiate the formation of humoral antibody, modulate cell mediated immunity and promote the induction of interferon by stimulation of the immune system.” The document also includes a memo dated 08/03/76 from J.I. Pulley to LeVier noting that this patent memorandum has been inactivated and “that Dow Corning would probably not reactivate work in this area in the near future.” Another memo dated 07/15/76 from Pulley to LeVier notes that “Dow Corning is no longer actively involved in this (the use of silicone fluids as immunopotentiators)....”

Another document is a “Patent Memorandum” by Boley and LeVier with the suggested title of “Immunological Enhancing Activities of Organosilicon compounds and Non-Functional Fluids” which was renamed to “Organosilicon Immunopotentiators.” Nine of 48 silicon-containing compounds showed a “strong immunological enhancing” effect. Boley and LeVier wanted to explore possible applications of these compounds including for potentiation of veterinarian vaccines and in the “production of high quality and expensive experimental antibodies.” Some of these compounds were tested for their ability to augment or potentiate endotoxin induction of IF. Dow Corning 200 fluid and D4 “show a significant potentiation of endotoxin induced IF.” (DCC 281061466). There is also a one page abstract of the Lake, Radonovich and Boley report on “Potentiation Of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane.” Interferon appears to be involved in the Immune response to bacterial, viral and protozoal infections. Substances able to modulate the interferon response may be useful in the control of many infectious diseases and cancer. This report describes the immunopotentiating activity of some structurally defined linear and cyclic polydimethylsiloxane fluids which have been found to mimic the potentiating effects of mineral oil adjuvants (Boley and Levier Dow Corning Report 4319, 1974).

CITE: DCC 281061451 - 281061468 (Temporary Dow Corning Bates Number 16359 - 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #185
02/03/75

KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Patent department memo to Boley, LeVier and Lake regarding organosilicon immunopotentiators patent memo assigned #4320.

CITE: DCC 281061471 (Temporary Dow Corning Bates Number 16379), Exhibit to Lake Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #186
02/13/75

SHELL STRENGTH - THICKNESS

J. Thompson, Cow Corning, memo to A. Rathjen that the new low profile round envelopes are being dipped on the automatic dippers at a rate of 1,000 bags per day, but, “PROBLEM: NO SPECIFICATION EXISTS TO Q.C. THESE BAGS!!! WHERE IS IT?

CITE: F 552 - 553, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document 187
02/14/75

SHELL STRENGTH - THICKNESS

Dow Corning’s Mammary Task Force meets. The minutes of the meeting report that Dow Corning is “15 weeks, 170 days, 2,568 hours (and) 154,080 minutes” from the 06/01/75 deadline. Will Larson reported gel migration in monkeys with the new gel. A “major point of contention” is that, “No specification exists on the acceptable thickness for the low profile round envelope.” TS&D and Production have differing opinions on what is acceptable. There has also been a breakdown in the special fabrication program, evidencing that acceptable envelope fabrication was a problem. “RIGHT NOW I (Rathjen) CONSIDER THIS THE MAJOR PROBLEM CONFRONTING THE TASK FORCE. I RECOMMEND THAT FILLING WILL NOT COMMENCE UNTIL THERE IS AN AGREEMENT BETWEEN MARKETING, TS&D AND PRODUCTION AS TO WHAT IS AN ACCEPTABLE ENVELOPE! (emphasis in original).

CITE: F 549 -551, Exhibit 40 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 446914 - 446916: M 540023 - 540025. NOTE: Why does Marketing decide what is an acceptable envelope? Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #188
02/19/75

MISCELLANEOUS

Hommel memo to Rathjen with copies to Hagerman, Salisbury and Leach regarding “Revision of the “Facts About Your New Look” Pamphlet.” Rathjen volunteered to compile information to revise the Facts About Your New Look brochure. Hommel encloses “a series of questions which were submitted during a survey (by Karen Lott) among a number of the ladies working in the advertising agency in Grand Rapids. I think there is merit to giving due thought to these questions while working toward the revision of the booklet.”

CITE: M 400001, Exhibit 84 to Harris County Rathjen 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 #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

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Document #190
04/25/75

TESTING

Biometric Final Report to Dow Corning on “Implantation Study in Rabbits with Four (4) Mannary Gels.” This is a report of an 80 day test using the new flo gel or responsive gel - X7-2159A in rabbits. Results showed the “presence of mild, subacute granulomatous inflammatory lesions....”

CITE: t 3740 - 3755, Exhibit to Peters Deposition, Exhibit 87 to Harris County Talcott Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: P 16689 - 16694. NOTE: The 01/22/75 minutes of the first Mammary Task Force states that this was supposed to be a 90-day test. See also 03/08/75 entry, with interim report of the 90-day test. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #191
04/25/75

MISCELLANEOUS

Boone memo to Talcott, Hoyt, Leach & Salisbury with copies to Rathjen and others regarding the scale up of the new low profile contours and setting of specifications. “I am not prepared to repeat the acrimonious exercises that were encountered during the scale-up and specification setting of the low profile round envelopes. That scale-up was accomplished with the Production Department assuming fundamental responsibility for arriving at optimums after considerable trial and error with eventual prototyping and specification recommendations being done by this department. I am willing to repeat this work with the low profile contour product line because we are certainly the best qualified to do the work. If, however, there are any doubts as to the quality or intensity of our desire to produce the thinnest product manufacturable, I will be happy to relinquish this scale-up responsibility to any other group prepared to man and supervise the equipment on a three-shift basis for the first several weeks of production. This scale-up should lead to procedures, spec recommendations, supporting data, and prototypes illustrating limits of acceptability for all sizes.”

CITE: KMM 220579, Exhibit to MDL Rathjen Deposition Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #192
05/01/75

FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - SALES

Boone memo to Hoyt, Leach & Salisbury with copies to Larson, Talcott, Peters, Brodhagen, Rathjen and Ringey regarding “Oily Effect on New Mammaries.” They have observed that the new mammaries tend “to bleed noticeably after the product is massaged and handled. We are relatively confident that the doctor will not see any appreciable bleed on the product as it is removed from the package. The salesman, however, will experience bleed on his detail samples, particularly the day after they have been squeezed. It would be advisable for the salesman to understand this and clean his detail samples prior to demonstrating to the customer.”

CITE: KMM 220570, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #193
05/13/75

KNOWLEDGE OF GEL BLEED

Tom Talcott, Dow Corning, memo to Larson, Dow Corning Mammary Task Force and other Dow Corning colleagues, regarding silicone gel bleed from implants. He states, “We are hearing complaints from the field about the demonstration samples they are receiving. The general claim is that the units bleed profusely after they have been flexed vigorously. This may tie into the soaking to wash off excess gel which was occurring in the early stages of production or the time interval between fill and cure.... Please run appropriate testing when you receive these samples to determine if a bleed rate problem exists.”

CITE: F 743, Exhibit 43 to Harris County Rathjen Deposition, and Exhibit 12 to MDL Rathjen Deposition (used by Dow Corning). DULICATE: M 16003; M 570062; FDA 19586; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 17. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #194
05/16/75

KNOWLEDGE OF GEL BLEED

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction is “2 weeks, 16 days, 384 hours, 23,040 minutes.” Rathjen began by reading a memo which officially turned the round and low profile rounds “back to its jurisdiction.” The minutes do not say what this jurisdiction is. On the issue of gel bleed, “A range of solutions is possible - from reformulating the gel to eliminating salesmen’s abuse of the product during demonstrations. It seems to be a function of the porosity of the envelope; the lower molecular weight gel passes through the pores more easily, especially after stretching and pulling.”

CITE: F 590 - 596, Exhibit to MDL Rathjen Deposition, and Exhibit 44 to Harris County Rathjen Deposition. DUPLICATE: KMM 446988 - 446991: M540064 - 540070. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential