SMOKE - FIRE DOCUMENTS 101 - 150
 
Document #101
01/29/69
SHELL STRENGTH - THICKNESS
RUPTURE
G. Robertson, Dow Corning, memo to Koning regarding a mammary implant ruptured 1 ½ years after implantation which was returned by Dr. Crosby. Robertson states, “(T)he envelope edges adjacent to the rupture, appeared to be of a very low tear strength. The physical properties of this envelope may never have been adequate.” (emphasis added).
CITE: KKH 1654. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

-------------------
Document #102
03/24/69
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
Dr. Franklin Ashley, a clinical investigator for IND 2702, writes to Dr. Frank McDowell regarding an article by Bishoff and Bryson on the carcinogenicity of silicone in fluid in rats and mice. Braley, Dow Corning, has reviewed the article and has stated to Dr. Ashley that: “According to what he says, and he would not want to say this to you, he feels that this article is well written and should not be published. I agree.”
CITE: OOM 320814. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #103
06/10/69
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
Memo from Olson to Frisch with copies to Bennett, Hobbs, Hunter and Radzius regarding “Telephone Communication with Dr. John Wilson of Johnson & Johnson.” Dr. Wilson, toxicologist at Johnson & Johnson, was contacted by telephone regarding their subacute dermal rabbit study on Dow Corning 556 and 360 fluids and Dow Corning MDDX-4-4122 wash resistant base. Dr. Wilson stated that the materials had been applied to rabbit skin daily. All animals showed a trend toward testicular atrophy. “There was a suggestion of dose-response relationship with Dow Corning materials although the effects were not statistically significant. A subacute oral rat study is in progress.” Olson indicated to Wilson that Dow Corning would be concerned about positive findings with the second study and would be agreeable to meeting with them to compare their respective data.
CITE: DCC 281041112, Exhibit to McHard Deposition, Exhibit to K. Olson
Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #104
07/15/69
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION
Food and Drug Research laboratories report on the findings in the chronic parenteral (intraperitoneal) study initiated by Dr. Ballantyne, Rees and Hawthorne at the NYU School of Medicine. After silicone fluid in the peripheral erythrocytes in early hematologic examinations was observed, Dow Corning transferred the study and its financial sponsorship from NYU to Food and Drug Research Laboratories. “When the animals received 51 cc and 62 cc of fluid, inflammatory cells were observed in the spinal meninges (which was not stated in earlier reports). Injections of large volumes of silicone produces wide spread deposition throughout the reticuloendothelial system, silicone vacuole accumulation in cells and a systemic distribution of silicone droplets. 
 
CITE: T 2866 - 2945 (The study is referenced in FDA 26875 - 26889). NOTE: See 06/30/75 entry.
 
-------------------
Document #105
08/06/69
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
Isquith, Dow Corning Biomedical Research Laboratory, memo on the “Current Status of Microbiological research.” Isquith states that: “The main purpose of the survey is to help in establishing the basic relationship between organosilicon structure and biological activity, the further pursuit of which rests with our own secondary stage research activity into the physiology (metabolism, mechanism of action, site of action, etc.) of the compounds and a good screening procedure for identification of developmental potential. (DCC 16000004)
 
Another area for research is the development of a biological assay for determination of organosilicone interferon induction. (DCC 16000004). Dow Corning has developed sufficient expertise in viral methodology to conduct the assay, but “there would be considerable advantage in using such a system (more stable virus, greater lethality) as is currently being employed in a survey for interferon inducers at Dow (Chemical) Human Health by Dr. N. Miner....” (DCC 16000005) He recommends using Dr. Miner’s lab for seeking a long lasting interferon inducer among organosilicone compounds. (DCC 16000006) Finally, another area is the “Investigation of Physiological Effects of Some Organosilicon Compounds.” (DCC 16000011). Isquith concludes that the area of microbiology in relation to organosilicon chemistry “is mushrooming at a pace that even now we are unable to adequately provide this cover. A wise investment at this time would be the hiring of a virologist (M.S. preferably) with training in tissue culture, virology, and immunochemistry. I have not had time to investigate thoroughly, but feel there is a good chance for development of possible potential in the areas of hypersensitivity, graft rejection, and autoimmune disease (arthritis, glomerulonephritis, etc.) which should be within the scope of a person with the training I suggested.” (DCC 16000014)
 
CITE: DCC 16000002 - 160000014, Exhibit 2 to Isquith Deposition, Exhibit 3 to D.McGhan Deposition, Exhibit to Blocksma Deposition (used by plaintiffs and Dow Corning), Exhibit to LeBeau Deposition, Exhibit to Bennett Deposition, Exhibit to Boley Deposition, and Exhibit to Julius Johnson Deposition WITNESS: “Bennett (Authenticated in Isquith, Vol. I, 119-120). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #106
08/14/69
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING
Letter of agreement between Dow Chemical Company, Dow Corning Corporation and Lepetit SpA for a joint development program regarding the biological activity of organosilicon compounds. The agreement requires the full disclosure of all proprietary and confidential information of each party to the agreement to each other party.
CITE: TDCH 1275 - 1276. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #107
11/15/69
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
Doremire memo to Bennett regarding chemical warfare and riot control agents, XZ8-3063. This is a silicone glycol. It goes through the skin as if there was no skin there. “Do you have any suggestions for a chemical that could be added to XZ8-3063 which would cause a variety of effects? These effects could vary from a drug that would act as a simple tranquilizer to a drug which would cause a loss of consciousness.” In the case of riot control, the drug might be effective for ½ hour whereas a chemical warfare use might need 2-4 hours effectiveness. He plans on checking with the “Analytical Laboratory on toxicity information.

CITE: DCC 281014081, Exhibit 3 to Harris County LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, and Exhibit to Ryan Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #108
00/00/70
00/00/71
00/00/72
FRAUD/MISREPRESENTATION
Dow Corning advertisement; “New sterile package provides Silastic Mammary Prosthesis ready to implant. This convenient, sterile blister pack assures greater product reliability, eliminates excessive handling and can be easily opened with scissors.” It also includes references to sizing rings and that the mammary implant no longer is fitted with fixation patches.
CITE: M 700003; M 700008 - 700009. DUPLICATE; M 370049 - 370052; M370108 - 370109; M 370113 - 370114; KKH 62679 - 62682; M 700019 - 700020. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #109
09/20/76
Hobbs, Dow Corning, memo to Hinsch with a copy to Lentz regarding information concerning migration of silicone gels. Hobbs states that experimentation had not demonstrated migration of Dow Corning mammary gel but this factor does not appear to be true for all silicone gels. Hobbs further states that 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.
CITE: M 170104, Exhibit 130 to Burda Deposition; Exhibit 91 to Braley Deposition. DUPLICATE: M 570060. NOTE: The document was listed as 00/00/70 on Plaintiff’s Trial Exhibit List. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #110
01/12/70
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION
Silas Braley, Dow Corning, memo to various Dow Corning employees distributing interim research report on the investigation of Dimethylpolysiloxane Fluid Injections at the Institute of Reconstructive Plastic Surgery, New York University. The interim report states that “our most interesting recent findings indicate that in both mice and rats, injection of large volumes of liquid silicone, either interperitoneally or subcutaneously, in multiple injections, apparently produces a wide spread deposition of this material throughout the reticuloendothelial system. A more recent finding of some interest is that there is an apparent accumulation of silicone vacuoles both within the red cells and the leukocytes of the peripheral blood in mice and rats, which appears about one to three months after injection and persists for several months.” The NIH grant will run out in about one year and these studies will have to be terminated. “It is our feeling that the evidence of systemic distribution of silicone droplets or vacuoles can not necessarily be considered an adverse effect, but is more likely related to total dosage. The dosages employed in animals rarely can be achieved in man with the possible exception of breast injections....”
CITE: T 2881 - 2885. NOTE: The report itself was an Exhibit to the K. Olson
Deposition (KKH 9841 - 9845). This document also has the Bates number OOM 321368 - 321672 on it. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #111
02/02/70
STERILIZATION/CONTAMINATION
J.H. Wetters, Dow Corning Medical Products Plant, Report No. 229 to Burdick with copies to Reilly, Mantle, Piper, Don McGhan, Houle and Robertson regarding “White Particle Contamination of the Mammary Gel.” The major contaminant was found to be crystalline by microscopy and potassium chloride and potassium bicarbonate by x-ray. Wetters cannot explain the presence of potassium bicarbonate. The white poly lined can in which it is contained could possibly be the source of this material.  J.P. Fitzgibbon feels that the crystalline potassium salts are the major portion of the contamination. “Gordon Robertson and Ken Olson should be contacted for an opinion as to whether these potassium salts are harmful.” (MM 234057)
 
CITE: KMM 234056 - 234057. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #112
02/18/70
 
KNOWLEDGE OF LIQUID SILICONE DANGERS
ACKNOWLEDGEMENT OF NEED FOR TESTING
TISSUE REACTION
 
Report prepared Food and Drug Research Laboratories for the Dow Corning Toxicology department. There are relatively little specific experimental data available on the reactivity of biological systems to silastics and polymethylsiloxane (PMSs) fluids. Prior studies by other laboratories showed “significant testicular atrophy resulted” from topical application of a polymethylsiloxane fluid. In the present study, 15 applications of PMS fluid was applied topically on rats, guinea pigs, rabbits and dogs for a 20-day period, and was administered in the diets of rats and rabbits for eight months.  In the rabbits that were topically applied with PMS fluid, “the reduction in the testicular weights of the PMS-treated rabbits is considered biologically significant.”
In the rats that had PMS administered orally for one year, growth was retarded as early as the first week in feeding. The differences in weight gain between the test and control groups was “statistically significant” during the third week, with the weight gain in the test group lower than the control. In the female rats, there were “notable endocrine effects,” smaller ovaries, enlarged pituitary, and increased weight in the adrenals and thyroids.  In the rabbits that had PMS administered orally for eight months, there was a “trend toward decreased testicular size in the test group...,” a tendency toward lower hemoglobin and hematocrit in all rabbits in the test group, “some effect of PMS fluid on sperm maturation...,” and testicular atrophy in the test rabbits.
 
CITE: T 2302 - 2341, Exhibit to K. Olson Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
Document #113
02/19/70
 
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
SILICA
Dow Corning study titled “Acute Inhalation of 14C-Labeled J-DCA” (silica) by Hobbs and Lacefield finds that the acute inhalation of a relatively large amount of J-DCA appears to confine its residence and effect to the lung. The low levels of J-DCA found systemically is a strong indication that the acute adverse response is confined to the lung. This would also indicate the lung to be the target organ from a chronic exposure.

CITE: DCCF 5008903 - 5008907, Exhibit to K. Olson Deposition. Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #114
03/02/70
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING
D. Ballantyne letter to E. Hobbs, Dow Corning, answers questions about the investigation regarding dimethylpolysiloxane fluid raised by Hobbs’ letter of 02/19/70. Current findings show an apparent accumulation of silicone vacuoles that were observed on the erythrocytes of rats only. He currently has studies underway on mice and baboons but the results are not substantial at this time. A research paper should appear in the April issue of the Reticuloendothelial Society.
 
CITE: T 2888 - 2889. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #115
04/13/70
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION
Olson memo to Boone with copies to Hunter, Hobbs, Koning, Radzius and Stark regarding “Inflatable Mammary Toxicology.” He responds to Boone’s memo stating, “The stability of dextran solutions in an implant situation over the long haul, particularly if there is diffusion of body fluids across the membrane would be difficult to accurately assess without biological data generated under use conditions. It is important to know these things prior to marketing. With my cursory knowledge of the problem I would tend to feel that such a device might cause some patients and Dow Corning some degree of grief. I would think that a rather extensive clinical investigation is indicated in order to assess benefit versus risk for Dow Corning.”
 
CITE: KMM 146382-146384. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #116
04/14/70
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION
“Two-Year Implant Studies with Silastic Materials in dogs” by S. Carson and Food and Drug Research Laboratories for Dow Corning Corporation. Carson states: “A two-year study was undertaken to evaluate the effects associated with implantation of silastic materials into three sites of beagle dogs. Its purpose was to determine the tissue reaction and systemic effects associated with the implantation of silastic materials into subcutaneous, intramuscular, or intraperitoneal areas in dogs and to evaluate these responses to the implants with relation to time. No adverse findings were seen which could be associated with the implantation of the test materials. Fibrous capsule formation is the only histomorphologic change found in these animals. Capsule formation was of a 1 to 2+ thickness during the first six months of study and ranged from 2+ to 3+ thickness during the final examination after two years of test. In several cases, inflammatory cell reactions were also found. These were however anticipated, and were observed at the six-month and two-year sacrifice periods.  The findings, therefore, are primarily associated with a minimal degree of foreign body reaction and no adverse systemic pathological manifestations are associated with the implantation of the silastic materials.
 
CITE: T 1529 - 1572. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #117
04/20/70
TESTING
TISSUE REACTION
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
A study contracted to Food and Drug Research Laboratories by Dow Corning entitles “Two Year Studies with Miniature Silastic Mammary Implants TX-202A and TX-202”B in Dogs, Dow Corning Tox. File No. 1306-3” is sent to Dow Corning. In this study, one of the four dogs died and the three others had a chronic inflammatory response to the implants. While FDRL reports that the only adverse effects two years after implantation are fibrous tissue encapsulation and chronic inflammation, the attached chart (Table 3) shows reactions at 6 months of “large granulomatous mass adjacent to capsule” and “liver and kidney-congested.” Dow Corning submitted this study, with the incorrect chart (Table 3) as part of its PMA Double Lumen Silastic II and Silastic MSI Gel Saline HP application.
 
CITE: F 462 - 483, Exhibit 9 to California Braley Deposition. DUPLICATE: p A75\460 - 17482; T 2363 - 2383. NOTE: See 00/00/73 - F 12 - 16; P 17491 - 17496; and Depo. of Bobby Purkait, MDL 926, p. 50-51, Exhibit 22 (07/09/93). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
Document #118
05/06/70
RUPTURE
SHELL STRENGTH - THICKNESS
J.K. Boone, Dow Corning , handwritten note to F. Stark regarding inflatable mammary development assurance. Boone writes: “The bags for the inflatable mammary prostheses are taken directly from the production of the standard seamless mammary. It is expected that gel filled bags are softened by the gel somewhat, giving an ultimately softer bag with somewhat higher elongation. Thickness of the bags varies with the size and width, but it is ordinarily between 0/010” and 0.020” with the average being about 0/017.  Several individual prostheses were subjected to severe testing (after filling and tube removal). They were slammed repeatedly against a smooth wall. Valves functioned well, bags can be broken under stress without the valves leaking.  To date, 153 of these devices have been submitted to quality assurance, and 18 of these have been rejected for a variety of reason. Leakage through the valve has not been a problem.
It is very difficult to project the eventual clinical failure rate for this device at this time. I would estimate failures less than 1% on devices successfully implanted, another failure rate should be expected for devices damaged during surgery. These will be immediately detectable as these devices are filled. This will cause professional irritation but little liability.  Patients are being cautioned that these devices may break or leak at some later date.... The device now marketed (gel filled) has certainly not been complication free but to date it has not caused us severe liability problems.  Over the long haul, I would guess that we might be sued about as often for hard, painful breasts as for ‘shrinking’ ones.”
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #119
06/01/70
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
SILICA
TISSUE REACTION
Minutes of the Inflatable Mammary Meeting sent to Bennett, Boone, Bennett, Hobbs, McIntyre, Olson, Rathjen and Stark.
CITE: KMM 77733 - 77750, Exhibit to Bennett Deposition and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #120. (ALSO LISTED AS 121.)
06/16/70
TESTING
SHELL STRENGTH - THICKNESS
Boone, Dow Corning, memo to Hobbs and others regarding the “Physical Property Testing on Two Year Implant Specimens.” The study was by Food and Drug Research Laboratories on silicone elastomers implanted intraperitoneally, intramuscularly and subcutaneously. Fifteen dogs were tested with silicone elastomer and seamless mammary constructions. The results showed “in almost all cases (that there has been some rise in durometer with attendant loss in elongation and increase in modulus of the materials.”
 
CITE: T 1573 - 1577. (Document # 121 on the Trial Exhibit List states that this document does not have a Bates Number). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
Document #122
07/08/70
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
Olson letter to Michael Robbins, Pharmaceutical Division of The Dow Chemical Company in Indianapolis, regarding Robbin’s recent request for information on the toxicity of dimethylpolysiloxane when injected intravenously into laboratory animals. A search of the toxicology files at Dow Chemical reveals that preliminary acute and subacute studies were conducted in 1956 on Dow Corning 200 Fluid, 350cs.” He then summarizes the data where 2 of 4 rabbits died immediately after being injected with DC 200 fluid at .50 g/kg, 2 of 4 died at 1 g/kg dose and all 4 died at 2 g/kg dose.
CITE: FDA 27229 - 27230, Exhibit to K. Olson Deposition, and Exhibit to Hinman
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #123
09/23/70
MISCELLANEOUS
SHELL STRENGTH - THICKNESS
STERILIZATION/CONTAMINATION
Dow Corning Corporation Report entitled “Manufacture of Silastic Mammary Prosthesis.” The purpose of this report is to provide a detailed description of the manufacturing processes involved in the production of Silastic Mammary Prostheses. The report gives a detailed description of the manufacturing facilities, product composition, processing materials, component specifications, manufacturing process and quality assurances. This report also includes product run sheets for the seamless mammary prosthesis and packaging component information and specifications.
 
CITE: KMM 223739 - 223806. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
Document # 124
01/21/71
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING
Handwritten memo to Hunter from Bennett regarding “Trip Report -Europe, Jan.  6-20, 1971.” Section 2, beginning on p.10, discusses a visit with Lepetit Pharmaceutical co. in Milano on January 14-15, 1971. Present at this meeting were Wm. Caldwell, Zeller - Director of Central R&D, Carati - Lepetit legal counsel, Levier and Bennett. Levier and Bennett also met with Lerner.
 
CITE: DCC 281011474 - 281011491 (Temporary Dow Corning Bates Numbers 5455 - 5472), Exhibit to Bennett Deposition, Exhibit to Hinman Deposition, Exhibit to Isquith Deposition, Exhibit to Julius Johnson Deposition, Exhibit to LeBeau Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List
Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #125
01/26/71
Wayne Koning, Dow Corning, memo to Forrest Stark regarding a returned implant by Dr. Bankof. Jan Varner reported that this was an “old” style implant and that he “was able to break through the envelope with minimal effort and perhaps there is some degradation of the envelope over a period of time.” Koning reports to Stark that “Jan appears to be loosing confidence in the stability of the envelopes physical properties over an extended period of time because of frequent comments that are being given recently by large volumes (sic) users that he calls on.” Koning also states that, “The terms, friable, disintegration and degradation are being used frequently in some areas to describe the condition of the envelope of removed SILASTIC ® mammary prostheses.” (emphasis added).
CITE: M 570119. DUPLICATE: KMM 335110 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
 
Document #126
03/09/71
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
TISSUE REACTION
Morgan, Dow Corning, memo to Koning, regarding a complaint made by Dr. Condie concerning the composition of the silicone gel in a ruptured implant. The patient developed a reoccurring infection and staph infection four months post-op with fluid “oozing from the wound.” The memo states “the prosthesis was practically empty of gel and what gel was there was extremely fluid and oozed out of the prosthesis and the surrounding tissue.... It appears to me that we have had a gel breakdown but I did not discuss this in any way with Dr. Condie.” (emphasis added)
CITE: KMM 423343 - 423344. DUPLICATE: KKA 152366 - 152367; CO 82 - 83. NOTE: Dow Corning was using V. Mueller as its sales agent. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
Document #127
05/11/71
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION
Dr. Glenn Burt, Department of the Army, letter to Silas Braley, Dow Corning, reporting on an augmentation patient who “encountered a most traumatic experience. On the second postoperative day the patient developed a fever which during the next few days spiked tremendously - as high as 105 degrees - and the patient went progressively down hill so that we had to remove the prostheses on the twelfth post-operative day....  During this time she developed an erythematous rash, joint swellings, considerable weakness, and an enlarged liver, all of which made us feel this was a rejection type phenomenon.” (emphasis added).
 
CITE: M 240089, Exhibit 46 to Hinsch Deposition (used by Dow Corning), Exhibit to D. McGhan Deposition, Exhibit 21 to California Braley Deposition, and Exhibit 5 to Harris County Burchiel Deposition. Dow Corning Trial Exhibit List Exhibit
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
 
Document #128
06/14/71
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION
Dr. Condie writes to Wayne Koning, Dow Corning, regarding a patient with breast implants who developed and “allergic reaction in the skin over the right breast, or an infection in the skin of the right breast. There was slight itching associated with the condition. This was also associated with some swelling of the upper lip and it was felt that she might have angioneurotic edema, however, with antibiotic therapy the cellulitis cleared up. This was approximately 16 days after she was first seen for the condition.” Six months later, the right breast again became red and swollen. Upon aspiration, silicone escaped from the needle’s puncture wound, resulting in wide spread necrosis. The implant was removed and Dr. Condie noted that “it was extremely difficult to remove all of the silicone which was flowing and not gel like in consistency.” Dr. Condie also states that the silicone in this case was “extremely watery and flowed very easily. I cannot help but feel in my own mind that there was something which caused chemical change in the silicone, making it liquid instead of a gel. The culture which was taken showed staph coagulasa positive.” (emphasis added).
CITE: M 570103 - 570104. DUPLICATE: KMM 98372 - 98373; M 240090 -240091. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #129
07/07/71
SHELL STRENGTH - THICKNESS
Manikian, Dow Corning, memo to Boone stating that he has accumulated data on the “long term” stability of the envelope. He refers to three lost of mammaries - 1 from June 1966, 1 from August 1967, and 1 from April 1971. “There are changes in the physical properties of the bag after filling. Contact with the gel seems to soften the bag and lessen its tensile strength.... (W)e neither have data on the properties of a bag immediately after filling nor have in storage a large enough number of units to perform a controlled study.”
CITE: KMM 220303. DUPLICATE: KMM 223111 - 223114. Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #130
12/13/71
STERILIZATION/CONTAMINATION
W. Koning memo to Bill Mantle, Dow Corning, which states “Bill, here is another hairy implant from Jan! Please comment. Too bad they didn’t reject before unsealing the package.”
 
CITE: KMM 423367. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #131
12/00/71
EMBOLISM
GEL MIGRATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
Publication by Blocksma entitled “Experience With Demethylpolysiloxane Fluid In Soft Tissue Augmentation.” Plastic & Reconstructive Surgery, Vol. 48, No. 6, 564-567. The release of silicone fluid for general distribution could make every general surgeon think he has become a plastic surgeon overnight. Used improperly, silicone fluid has a serious potential for harm. Therefore the author is opposed to the release of this material to any but bona-fide plastic surgeons at this time.
CITE: DCC 204005370 - 204005374; Exhibit 71 to Braley Deposition, Exhibit to D. McGhan Deposition, Exhibit 45 to Hinsch Deposition (used by Dow Corning), and Exhibit 99 to Harris County Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #132
00/00/72
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
Article by Bennett, Gorzinski and LeBeau entitled “Structure-Activity Relationships of Oral Organosiloxanes on the Male Reproductive System,” Toxicology And Applied Pharmacology, Vol. 21, 55-67 (1972). The abstract at the beginning of the article states that: “A series of low molecular weight organosiloxanes depressed male reproductive function in the mouse, rat, and rabbit. The rabbit was the most sensitive, and the mouse was the least. Active compounds were found among phenylmethyl-substituted silanes, linear disiloxanes, and trisiloxanes; cyclic trisiloxanes and tetrasiloxanes. Cyclic siloxanes were the most active cyclic.  Monophenylheptamethylcyclotetrasiloxane was quite active; however, the presence of an additional phenyl group enhanced activity providing the 2 phenyl groups had the correct sterile configuration, i.e., 2,6-cis-diphenylhexamethylcyclotetrasiloxane.... A spectrum of activity was noted in the male animal when active compounds were administered po for 3-21 days. Small doses sequentially decreased seminal fluid, seminal vesicle, prostate and testes weight, associated with decreased blood levels of testosterone. Large doses caused adrenal hyperplasia, hepatomegaly, decreased body weight, and decreased serum levels of cholesterol, phospholipids, and alkaline phosphatase.”
 
CITE: DCC 281000743 - 281000755. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 547-548). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
-------------------
Document #133
04/00/72
FRAUD/MISREPRESENTATION
Dow Corning advertisement: “The Silastic Mammary Prosthesis makes a world of difference.” Over the past ten years “we have initiated 207 rigid quality control tests to assure the reliability of every prosthesis manufactured. We have continued to make significant design improvements. It is simply the most reliable answer to breast augmentation and restoration following subcutaneous mastectomy.”
CITE: M 700010. DUPLICATE3: KKH 62691; KKH 62692; M 370064; M 370065; M370106; M
370123: M 700011. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #134
04/07/72
GEL MIGRATION
“Dimethylpolysiloxane Fluid 14C (Dow Corning 260 Medical Fluid 14C) Distribution and Disposition In Rats Following Subcutaneous Injection,” by LeBeau and Gorzinski of the Research Department of DC. A copy was sent to Ryan, Bennett, Braley, Hunter, Isquith, Frye, LeVier, Speier, Stark, Boley and others. DC 360 fluid was administered subcutaneously to rats to measure the distribution of the fluid in expired air, urine and feces at 8, 30, 60 and 90 days. The highest percentage (.94%) was detected at the original injection site <10% was detected in urine and feces. “There was a ubiquitous distribution of low concentrations of radioactivity in the tissues and organs (<.02%). However, lymphatic tissue near the injection site had a higher (ten-fold) concentration of radioactivity of all tissues and organs examined suggesting migration via lymphatic routes.” Rodents receiving massive subcutaneous doses of silicone fluid were examined histopathologically. Droplets of vacuoles were found throughout the reticuloendothelia systems including the regional lymph nodes and extending to the liver, spleen, kidneys and adrenals. Definitive proof of silicone fluid in the droplets was not demonstrated but the authors assumed it was silicone fluid.
CITE: KMM 260056 and KMM 270609 - 270623, Exhibit to Bennett Deposition (used by plaintiffs and Dow Corning), Exhibit to Isquith Deposition, Exhibit to K. Olson Deposition, and Exhibit 3 to Harris County Rathjen Deposition. NOTE: The exhibit list also lists Bates Numbers T 2765 -2780 but there are no documents in the binder with these numbers. DUPLICATE: DCC 205001829 - 205001841; KMM 173800 -
173816; DCC 204004553 - 204004580; Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #135
04/24/-26/72
TESTING
FRAUD/MISREPRESENTATION
Article entitled, “Toxicological Studies, quality control, and efficacy of the Silastic mammary prosthesis” is published in the journal Medical Instrumentation. Authors are Gordon Robertson and Silas Braley of Dow Corning.  The article cites and discusses the FDRL Report on “Two-Year Studies With Miniature Silastic Mammary Implants” (P 017460 - 017496). Robertson and Braley reprint the 6 month test results in Medical Instrumentation and claim that these are the results after 2 years of implantation.
 
CITE: F 12 - 26, Exhibit to Palensky Deposition, Exhibit 19 and 20 to California Braley Deposition, and Exhibit to LeVier Deposition. DUPLICATE: KMM 249816 - 249822, J 5223 - 5226. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #136
05/04/72
TISSUE REACTION
SHELL STRENGTH - THICKNESS
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
Silas Braley, Dow Corning, letter to Dr. Douglas Lake expressing his reservations about the use of silicone to fill inflatable implants. He states: There is a very good reasons for this: the silicone fluid being of the same basic nature as the silicone polymer used to make the rubber will dissolve into the rubber and very seriously weaken and soften it... Another factor which must be taken into consideration if a silicone fluid is used to fill a silicone rubber bag, is that the outer surface of such a bag will become oily with the silicone fluid. This means that the fluid is now capable of being absorbed by the body and very extensive toxicological work would have to be done to prove that this is not deleterious to the tissues.... We rejected the silicone fluids for the above reasons and went immediately to silicone gel. (emphasis added). 
 
CITE: KMM 141906 - 141907, Exhibit 32 to California Braley Deposition.
 
-------------------
Document #137
07/14/72
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
Dow Corning Research Report No. 4006 (formerly classified) entitled “A Toxicological Evaluation Of Trimethylsilanol (Me3Si(OH2) In The Rat.” The authors postulated that two potential end products of the biological degradation of trimethyl en-blocked linear dimethylpolysiloxane polymers or cyclic dimethylpolysiloxane polymers might to Me3SiOH and Me2Si(OH)2. Other studies are currently underway at Dow Corning’s Biomedical Research Department to determine the potential for degradation of dimethylpolysiloxan polymeric species. (p. 4) The authors conclude that there were no significantly different dose-related values for body weight, food consumption, hematology or organ weight ratios for liver, kidneys, adrenals, heart or gonads. There did appear to be a modest dose-related significant elevation of blood glucose in the Me2Si(OH)2 treated rats. There may also be a slight depression of the triglyceride blood level at the low dose of Me3SiOH and total lipid is at the low level of normality for this group as well. (p. 13)
 
CITE: DCC 281001689 - 281001726 (Temporary Dow Corning Bates Number 3424 - 3461), Exhibit 49 to Bennett Deposition (used by Dow Corning), Exhibit to Frye Deposition, and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #138
08/18/72
MISCELLANEOUS - COMPLICATIONS
SILICA
TESTING
TISSUE REACTION
Robert LeVier and Michael Jankowiak, Dow Corning, report on “The Effects of 20 CS DC-360 Fluid And Related Linear/Cyclic Dimethylpolysiloxanes Administered Orally And Dermally For Four Weeks To Male And Female Rats On Whole Body Oxygen Consumption, Serum Total Cholesterol, Organ Weights, And Silicon Distribution.” There was increase in tissue thyroid weight; potential of accumulation increasing cholesterol; and slight increases in silicone levels for heart, serum, urine, liver and thyroid. In addition, the female rat appeared to accumulate more silicone than did the male rat.
 
CITE: DCD 154000169 - 154000188, Exhibit to Bennett Deposition. NOTE: The exhibit list identified this document as T20844 - 20863. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #139
10/17/72
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
SHELL STRENGTH - THICKNESS
Dr. Gregory letter to Rathjen regarding an implant he ruptured unknowingly during surgery. Three months after implantation, the patient experienced redness on her breast and perforation of the skin with the implant protruding outside and “Gel dripping out of the hole.” He says that this “may be a blessing in disguise, because perhaps we have all been trying to make too soft and too fragile an envelope. I do not believe that the old envelope would have perforated as easily as this one did with the mosquito hemostat. Perhaps the viscosity of the Gel may have to be reconsidered in view of this particular type complication.”
CITE: KMM 54876 - 54877, Exhibit 9 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: B 949 - 950. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #140
11/16/72
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
Dr. Bennett, Dow Corning, “Bioscience 1972 Status Repost.” Bennett states that “The interaction of the Chemicals in the biological organism can be detrimental to the consumer. A chemical which has no overt direct action in its own right but potentiates the action of a second chemical taken into the organism simultaneously, forces us to consider each produce in its use situation to make sure that this phenomenon is not a hazardous one if it exists.” (p., 1) Also, biological research in all areas is being constrained because of economic considerations. “There is considerable interest in chemicals which affect viruses, cancer, population control, immuno-therapy, animal and plant hormones, aging, and genetic engineering.” (p.2)
Bennett recounts the major projects of each of the segments of the Bioscience Research Department: Animal Sciences - there is a continuing Evaluation of 2,6-cis, working with KABI and others; Microbiology - a program has been developed based on the creation of antimicrobial activity on surfaces of many diverse types; Plant Sciences - they are exploring antitranspirant activity of polydimethylsiloxane fluid; and Metabolism of Organosilicon Compounds - Bennett believes this unit is the “keystone in the development of silicon chemicals in profitable biological applications as well as continuing to assure the Corporation of the safety of present products.” (p. 4)
CITE: DCC 16001173 - 16001178, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. III, p. 630-631). DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document 141
00/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION
Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Antimicrobial Research” prepared by Dr. Isquith. The objective is to “investigate the effect of ‘substrate-bonding’ of organosilicon antimicrobial agents on their potency; spectrum of activity; reaction to their agents (i.e., protein, lipids, detergents; mode of action; biodegradability; and toxicity in comparison to similar non-silicon containing agents.” (DCC 16001104) Isquith notes that Weetall and co-workers published a series of articles on the use of alkoxysilanes to immobilize enzymes on inert surfaces, and that this technology is currently being developed as a processing aid in various industries. He states, “The bonded biologically active agent concept is further expected to greatly alter the immunological field....” (DCC 16001105) He notes a potential business opportunity for Dow Corning.
CITE: DCC 16001104 - 16001109. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #142
00/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE SILICA Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Exploratory Virus and “Cell Biology” Prepared by Dr. Robert Lake. The objective is to “Examine the role of enjogenous Si, organosilicon modified viral antigens, and endogenously applied organosilicon compounds in modifying humoral and cellular-mediated immune response to animal viruses.” (LAK 50) There are three approaches to viral diseases - immunological, host-resistance, and chemotherapy. Defining a role for silicon containing chemicals in the immunological or host-resistance approaches will require examination of the basic interaction of these chemicals with the lymphoid elements of the cellular immune system, i.e., lymphocytes, monocytes, and granulocytes.  When organopolysiloxanes are installed in the blood, lungs, peritoneum or GI tract of the body, they illicit a selective interactive with macrophages.  Macrophages are the first to encounter and process viral antigens in the immune response and “virtually control the outcome of and recovery from virus infection.” (LAK 50) The material is phagocytized by neutrophils and macrophages, redistributed to lymphoid tissue and a fibrous wall builds around the material. It is this interaction of macrophages that Dr. Lake would like to study because “the potential for organosilicones as modifiers of immunological phenomena has not been exploited.” (LAD 52) He states, “Critical variables such as polymer type, size, and organofunctional groups on the time course of these cellular responses have never been reported.” (LAK 50) CITE: LAK 50 - 52, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit 1 to Randonovich Deposition, Exhibit to Boley Deposition, Exhibit 4 to Lake Deposition, and Exhibit to LeVier Deposition, DUPLICATE: LAK 47 -49.  WITNESS: Bennett (Authenticated in Isquith, Vol. II p. 423:15 -424:11).
 
DEPOSITION; admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #143
00/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DESEASE
Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Organosilicone Polymer Particle Technology.” The objective is to “Synthesize uniform particles of a number of organosilicon resin polymers” to create reactive drug sites on these particles. The particles could be given locally or systemically as direct drug deliver systems, i.e., the instillation of a local anesthetic bonded to an organosilicon resin in joint spaces, GI tract, etc. to relieve pain. They could also be diagnostic or therapeutic uses such as binding antigen and/or antibody or used in diagnostic immunological tests. (DCC 16001050)
 
CITE: DCC 16001050 - 16001055. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #144
00/00/73
TESTING
FRAUD,MISREPRESENTATION
Robertson and Braley, Dow Corning, author “Toxicological Studies, Quality Control, And Efficacy Of The Silastic Mammary Prosthesis,” relying on the 1970 dog study. They use a chart to illustrate complications and claim that the findings are the results at the end of the two-year study, when the chart is actually the findings at six months.
CITE: T 3003 - 3001 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #145
00/00/73
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION
A Dow Corning study examines the suitability of injectable silicone fluid for soft tissue augmentation. Four observed positive tumorigenic findings of fibroadenoma and fibrosarcoma are dismissed as tumore characteristically and typically seen spontaneously in rodents and not related to treatment with silicone fluid. Data reveals phagocytosis evidenced by the presence of macrophage histiocytes and basal giant cells, with absorption of silicone and deposition throughout the reticuloendothelial system.
CITE: KMM 48449 - 48498. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #146
03/12/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
SHELL DEGRADATION
Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Biodegradation” prepared by Dr. Isquith of Dow Corning. The objective is “To determine the ability of microorganisms to biodegrade a polydimethylsiloxane (PDMS) structure and the subsequent microbial fate of its degradation products.”
CITE: DCC 16000273 - 16000279. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #147
03/19/73
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
Study from Bennett, Statt, LeBeau, Golzinski, E. Wiessbruger, J. Weissburger and Ulland regarding item 17, “Primate Absorption and Elimination Balance Studies Including Pulmonary, Urinary, Biliary and Fecal Excretion of T-butanol, Trimethylsilanol, Dimethylilanediol and Hexamethyldisiloxane,” item 18, “Primate Absorption and Elimination Balance Studies Including Pulmonary, Urinary, Biliary and Fecal Excretion of Octamethyl-cyclotetrasiloxane and 2,6-cis-Diphenylhexamethylcyclotetrasiloxane,” item 19 “Chronic Toxicity and Carcinogenicty of Industrial Chemicals and Pesticides.” CITE: DCC 281061215 - 281061216, Exhibit 56 to Bennett Deposition (used by Dow Corning).
 
-------------------
Document #148
04/05/73
EMBOLISM
KNOWLEDGE OF LIQUID SILICONE DANGERS
STERILIZATION/CONTAMINATION
Report by S. Braley, Dow Corning, of telephone conversation with Mrs. Herman D.  Jones of the Georgia Crime Lab regarding a death caused by a breast injection of silicones. Pathologist reports large amounts of silicone emboli in the brain and lungs. In the case of the breast tissue, the silicone was dripping out. Current testing equipment and procedures will accurately test for the carbon silicon bond but will not detect where the silicone came from, whether there were additives in the silicone or whether it was pure silicone. They will detect whether they were phenyl methyl silicones or all methyl.
 
CITE: KMM 305064 - 305065. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
-------------------
Document #149
05/02/73
SHELL STRENGTH - THICKNESS
RUPTURE
Gary Corbeill, Reliability Engineer for Dow Corning, analyzes a Silastic Round implant returned by Drs. Terino and Sengleman to Bill Mantle, who in turn sent them to Art Rathjen. Corbeill states that, “Due to their thin ‘skin’ these mammaries are delicate and will rupture when subjected to undue pressure.” (emphasis added).

CITE: CR 160 - 161. NOTE: Bill Mantle is the sales representative for the Los Angeles area. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

-------------------
 
Document #150
05/22/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Exploratory Antigen Modification,” prepared by Dr. Isquith of Dow Corning. It was later re-titled “Silicon-containing Antigens.” The objective is “To determine the capability of organosiclicon-midified antigens to stimulate or reduce immunogenic response.” Isquith suggests a direct modification of antigens by chemical attachment of low molecular weight organosilicon moieties” as an alternative to other antigens (such as peanut oil) which cause adverse health effects. (KMM 546449) He states that, “This project is aimed at examining the effect, if any, of silicon-modification on known antigens. The value will be in the immuno-therapeutic valve of the modified effects. An increase or decrease in antibody synthesis, caused by antigen modification, may be desirable.” (KKM 546453)
 
CITE: KMM 546448 - 546453, Exhibit to Bennett Deposition, Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Radonovich Deposition, Exhibit to Isquith Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also has the Bates Number KMM 491075A - 491080A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 355: 1-6 and 357: 13- 16). DEPOSITION: Not introduced in Toole (II) v Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product Privileged & Confidential

 

TO DOCUMENTS: 151 - 200