SMOKE - FIRE DOCUMENTS 1 - 50
 

Document #1
00/00/00
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCEOUS DESREGARD


"Internal Audit and Corrective Action Plan" prepared by Dow Corning of its Toxicology Laboratory. The audit uncovered four studies in which a former Dow Corning employee (Mark Bejarano) created false data and violated Good Laboratory Practices (GLP). The studies which were falsified are a lifetime breast implant gel study in rats, a bio-durability study of elastomer in orthopedic devices, a breast implant elastomer study.

The falsification involved the technician, Bejarano. who created multiple slides from a single animal and labeled them as though they had come from different animals. The report states, "It has been acknowledged by Mr. Bejarano that he: did create multiple slides, made a mistake, acted on his own, acted contrary to his Dow Corning training, and did not tell his supervisor or anyone else what he had done." (p.4 or Temporary Dow Corning Bates Number 411) Dow Corning claims that none of the four studies were published or relied on for data on the safety of breast implants, that an outside audit will also be done, and that Dow Corning will examine its operating procedures for the toxicology laboratory to make sure it complies with applicable regulatory requirements. 

Appendix A is a list of studies in Dow Corning's PMAA master file and a list of studies in Dow Corning Corporation's blue book. Appendix B is a list of studies containing duplicate slides created by Mark Bejarano. Appendix C is qualifications of the consultant.

CITE: DCC 411000406 - 411000525, Exhibit 25 to Zimmer Deposition; Exhibit 4 to 
Bejarano Deposition; Exhibit 5 to Bey Deposition; Exhibit 35 to McKennon Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


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

Document #2
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Research Project Description titled "Organosilicone Anticholesterol Agents" The intent of this experiment is to isolate organosilicon compounds capable of lowering total serum cholesterol in several species and of ameliorating atheromata in rabbits. Data collected coincidental to other experiments have indicated a number of organosilicon compounds that can lower serum cholesterol, triglycerides, and/or phospholipids in normally fed mice and rats.  Dimethylpolysiloxanes can ameliorate atheromata in rabbits.

CITE: DCC 16001089 - 16001091, Exhibit to Bennett Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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


Document #3
00/00/00
ACKNOWLEDGEMTN OF NEED FOR TESTING
COHESIVENESS-LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Research Project Description entitled "Metabolism of Organosilicone Compounds." The intent is to study systematically the absorption, distribution, storage, metabolism and elimination of those organosilicon structures forming the basis of silicon chemistry as exploited by Dow Corning. There have been no systematic explorations of the metabolism of these classes of organosilicon compounds. Such explorations are necessary for their predictive value in selecting and developing efficacious biological applications, and in defining the environmental impact of all present and future products. 

CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition, and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential 

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

Document #4
00/00/00
est. 1970
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING

Draft of the "Proposed Agreement For Cooperative Research Program between Dow Corning and Lepetit Pharmaceutical Company to research the use of silicone compounds in biological systems. "These silicon chemicals will likely be used systemically rather than locally, and their utility in biological systems may dependent more upon their chemical, rather than their physical properties. (p.1) The proposal notes that Dow Corning has acquired information that certain silicones are biologically active and has instituted a Biomedical Research Laboratory in July 1965 "to probe the potential utility of such silicon chemicals across the broad disciplines of biology, i.e., plant sciences, microbiology and animal science." (p. 2) Dow Corning Does have the capability to conduct research on silicons in the pharmaceutical areas while Lepetit "has been engaged in specific endocrine cooperative research program with DC for a period of two years." (p. 3) The proposal states that the parties would cooperate to develop new silicon chemicals as drugs including silicones with activity as androgen depression, central nervous system depression, antimicrobial activity, etc. (pp. 3-4). Additionally, Dow Corning and Lepetit personnel will exchange research and information and will travel to the other's facilities. 

CITE: DCC 2801011379 - 281010391, Exhibit to Bennett Deposition (also used as Exhibit 65 by Dow Corning), Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Isquith Deposition, Exhibit to LeBeau Deposition, Exhibit to Petraitis Deposition, Exhibit to Rowe Deposition, Exhibit 17 to Popoff 
Deposition, Exhibit to Julius Johnson Deposition, and Exhibit to MDL LeVier Deposition. 
WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 455-457). DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #5
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Script of an internal Dow Corning seminar presented by Dr. Isquith, and Tony Bennett and Pat Walters on the subject of microbiology. Isquith states that, "Our (Biomedical Research) primary function is to investigate the microbiology of organosilicon compounds through basic research. A secondary function is the development of utility from the information gathered, either academically or in an applied form. A third function is that of service. We are interested in the preservation, biodegradability, and microbiology of existing Dow Corning products." (p. 2)  Abbott notes that the Microbiology Section has "the capability of conducting research in most areas of microbiology (i.e., Virology, tissue culture, immunology, mycology, bacteriology, etc.)" (p. 3) He notes that one function is to search for organisms capable of silicone degradation. (p.3) There is also a section on Page 3 which is crossed out on Silanols and then a handwritten outline on Silanols (Slide 2) beginning on page 4. Abbott states that silanols have provided "much basic research information on the relationship of organosilicon compounds to microorganisms and has suggested new areas of research." (p. 6) 

CITE: Temporary Dow Corning Bats Number 671 - 685, Exhibit 4 to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #6
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Research Project Description titled "Antiparkinsonism Activity of 2,6-cis- and 2,6-trans- (PHMESIO)2(ME2SIO)2)."  The objective is to evaluate PhMeSiO)2(Me2SiO)2) as an anti-parkinsonism agent. It has been shown that these compounds increase whole brain dopamine within 5 days of daily oral administration.

CITE: DCC 16001084 - 16001085, Exhibit to Isquith Deposition, Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #7
00/00/00
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING

Report titled "Discussion of Toxicology of Various Dow Corning Products." Topics include gel bleed, silicone transport across the skin, the need for further testing. Dr. Carson recommended that all possible evidence of adverse effects be collected with supporting data of literature on our part to show that Dow 
Corning has no part in these. The presence of Low Molecular Weight in 350 cs. is the same as in lower cs.

CITE: DCC 281041877 - 281041882. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #8
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS 
TESTING

Handwritten synopsis by Lake titled "Status of Biological Testing of Sila-admantoner Compounds, Dow Corning Report 4234" of research projects and patent activity. It includes notes regarding fibroblasts and immunopotentiation, antigen modification, and joint research on in vitro carcinogen bioassay.

CITE: LAK 133, Exhibit to Radonovich Deposition, Exhibit to Boley Deposition, and Exhibit to Lake Deposition.

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

Document #9
00/00/00 
TESTING
TISSUE REACTION

Dow Corning document: "I. Silicone Oils as Miticides (or mite-repellents)"; "II. Aphid Control with Silicone Emulsions"; "III. Effect Of Silicone Emulsions On Mealy Bugs"; and "IV. Effects Of Silicone Oils on Cockroaches." The document was authored by "JWR" (unknown who this is). "Mites do not willingly invade silicone treated bean plants if untreated ones are available." (DCC 16001144). Mites are not controlled by silicone-treated cucumber plants, possibly because the silicone oil is absorbed into the plant. A silicone spray was "completely effective in discouraging them. It is possible that a minor component, relatively volatile, may be acting as a contact insecticide." (Id.) Wild mustard plants sprayed with DC 200 fluid 10 cs. eliminated aphids. "The impression gained is that the insecticidal (or repellent) activity is due to some component of the fluid which has gone (presumably by evaporation or by becoming chemically bound within the plant) or a hydroxy-ended material. It seems worthwhile attempting to identify the active species and trying to modify it chemically to obtain a long-term effect." (DCC 61001145).Pachysandra plants, infested with mealy bugs, were sprayed with an antitranspirant emulsion with 5% silicone. After 5 days, all mealy bugs on the treated plants were eliminated. "The silicone appears to be slower acting here than upon other insects; possibly a repellent, rather than an insecticidal, effect is involved." (DCC 61001146).In the 1950s, Texaco and Shell did studies on hydrocarbon oils as insect attractants. In 1968, it was found by Gorzinski (of Dow Corning) that DC 360 fluid appeared to have an insect attractant and insecticidal activity. Cockroaches were attracted to the petri dish with silicone fluid. After coming out of the fluid, they "never got more than a few inches from the dish before dying." These results indicate "some type of activity existed in the DC 360 fluid...." (DCC 61001147).CITE: DCC 16001144 - 16001147, Exhibit to Bennett Deposition, Exhibit 11 to McKennon Deposition, Exhibit 8 to Harris County Gehring Deposition, Exhibit to Harris County and MDL LeVier Depositions, Exhibit to Ryan Deposition, and Exhibit to Isquith Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 880;15 - 882:8). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #10
00/00/00 
KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS

LeVier, Dow Corning, memo to C. Lentz and Nelson regarding "Activities Related to 2,6-cis." There are twelve Dow Corning Products currently being sold by the Medical Business that could contain levels of 2,6-cis originating from SBM-18 in excess of the estimated allowable body burden. Medical Products has no active program to identify replacement stock other than conversion of developmental products based on SGM-18 wherever possible. The greatest concern rests with the replacement identified for SGM-18 (elastomer) in that it may be necessary to re-qualify the new stock for medical use including long-term implantation studies.

CITE: DCC 281031092, Exhibit to MDL and Harris County Tyler Deposition, Exhibit 8 to Harris County LeVier Deposition, Exhibit to MDL LeVier Deposition, and Exhibit to Ryan Deposition, NOTE: See document # 11 for attachment. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #11
00/00/00
MISCELLANEOUS
Table of 2,6-cis levels in selected products which was attached to LeVier's memo (see document # 10 above). MDX-4-4514 (elastomer), shunts, penile implants, chin implants, and other products all contained 2,6-cis.

CITE: DCC 281031093, Exhibit to Tyler Deposition. NOTE: See document # 10. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #12
00/00/00 
VIDEOTAPE PRODUCED AT ZIMMER DEPOSITION ON D4.

CITE: No Bates Number, Exhibit to Zimmer Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #13
10/08/92
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS
TESTING

"Catalog and Review of D4 Studies." This is a list of all studies by Dow Corning on D4. There is a handwritten note at the top that says: "Meeting Oct. 16, 1992, Stark/Bey/Zimmer."

CITE: DCC 260000855 - 260000878. WITNESS: Exhibit to Zimmer Deposition. Dow 
Corning Trial Exhibit List Abstracts
PENDLTON/PSC Attorney Work Product/Privileged & Confidential

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

Document #14
00/00/00
MISCELLANEOUS - ORGANIZATIONAL SURVEY
MISCELLANEOUS - LOBBYING

List of "Desired Product Champion Features" includes that the relationship with the product champion should fit the Dow Corning Silicone Group Business Strategy. "PC (product champion) needs to understand and buy-in to the Silicones Group Business Strategy." Listed features include that the PC serve as a substantive resource to Dow Corning, be loyal to the company, have positive peer influence, be politically astute, and demonstrate teamwork with Dow Corning. The document lists the names of product champions in the United States and Europe and includes a manual prepared by Lois Duel dated September 1, 1989 which addresses issues such as the desired product champion features, the role of the product champion, product champion management and specific product champion issues.

CITE: KKA 210877 - 210886 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #15
00/00/00
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING

Confidential report entitled "Chronology of Silicone Injection." The report provides a historical account from Dow Corning's perspective of the use of liquid silicone injections and the establishment of the Center for Aid to Medical Research. It notes that Dow Corning 200 fluid was used for industrial applications. When the Medical Products Division was established in the early 1960's, the 200 fluid was designated Dow Corning 360 Medical Fluid. The report notes that, "The original label on the new product carried the inscription formerly Dow Corning 200 Fluid.'" (DCC 267371450) The report also discussed the indictments against Dow Corning officials for distributing the drug, 360 fluid, and the pleas of no contest which were eventually entered.

CITE DCC 267371444 - 267371466. NOTE: The document also has Bates numbers QDC 124506 - 124528 on it as well as Bates numbers MM 369861 - 3698883. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #16
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
SILICA
TESTING
TISSUE REACTION

W.D. Galloway reports on the "Analysis of Lifetime Carcinogenicity Study of Silicone Gels" conducted by Dow Corning under GLP regulations using Sprague-Dawley rats injected with Q7-2159A and MDF-0193 gels. Galloway states:"Both of the gel-implanted groups showed a large number of cancers compared to the control group. Particularly striking was the number of sarcomas (principally fibrosarcomas) which occurred in the treated groups." 

"The only obvious deficiency is that only one dose level was used. Ordinarily, three doses are used, and five are preferred. Based on the results obtained, I have little doubt that NTP would classify these substances as likely animal carcinogens." "According to Dow Corning, ... the tumors were peculiar to rats, the so called foreign body tumors." "Absent epidemiologic data, and without waiting for results of additional lifetime studies, knowledge of the mechanism by which these tumors was induced is critical to estimating human risks. It is possible that the tumors were chemically induced, rather than being induced by a by a physical mechanism, as Dow suggests. If this is the case, then the argument that such tumors do not occur in man is untenable. If the tumors were chemically induced, the active agent is more likely to be one of the several chemicals which make up the gel, rather than a metabolically produced reactive intermediate, since the tumors which did occur did not occur selectively in metabolically active organs such as the liver." "Recent studies have shown that siloxanes may act as estrogen-like substances and can enhance the growth of tumor cells."

CITE: M 780064 - 780065. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #17
00/00/00
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS
SILICA

Dow Corning materials identification list for final devices. It lists all materials used in final devices with a Dow Corning code number. The two manufacturing sites, Michigan and Tennessee, use different identification codes. The list also gives material formulations, indicates the need for a low-bleed outer shell liner, identifies whether "responsive" gel or "firm" gel is used, and notes the percentage of silica used in the formulations.

CITE: KMM 447209 - 4477224 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #18
00/00/00
Post 10/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson Presents a paper entitled "Rate of Rupture of Silicone Prostheses: Excerpt From A Study Of Over #3000 Personal Cases and Twenty-Five Years Experience" at the Symposium on Re-operative Aesthetic Surgery of the Face and Breast in Naples. Florida. Robinson discusses results obtained after 115 patients were followed after the fall of 1990 after receiving breast implants. Of the 115 patients, 57% had rupture of one or both implants. An additional 20% had moderate to severe bleed on one or both sides. The patients had the implants from six months to 25 years. Dr. Robinson concludes that all gel and bi-lumen implants: "should be replaced at about the eighth post-operative year because it can be fairly well predicted that at this stage the prostheses in most cases would still be intact and much easier to replace. If a period of time longer than twelve to fourteen years is allowed to elapse, then the prostheses have a good chance of being ruptured and the exchange would be much more difficult.

CITE: PSC Medical Articles CD, J 2698 - Exhibit 2 to Robinson Deposition, Exhibit 25 to McKennon Deposition. WITNESS: Robinson. DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare Dow Corning Trial Exhibit List
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #19
00/00/00 
Post/10/92
KNOWLLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson's abstract of a paper entitled "Disruption Rate Of Silicone Gel Prostheses - A Report Of 200 Cases." 200 patients from 02/91 - 10/92 had their silicone gel implants removed. The time from implantation ranged from six months to 25 years. Robinson found that 104 or 52% had one or both implants ruptured, 43 or 21.5% had severe bleed, and 147 or 73.5% had "distortion" - rupture plus severe bleed. Based on this data, Robinson projected future rupture rates using the Kaplan-Meier survival curve, and concluded that in 20 years, only 3.4% of the patients will have both prostheses still intact.  He states, "Gel filled mammary prostheses wear out and in a certain predictable time frame. Based on this study, patients can be advised with a certain degree of accuracy as to the probable condition of their prostheses." 

CITE: No Bates Number, Exhibit 3 to Robinson Deposition. WITNESS: Robinson 
DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

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

Document #20
00/00/00
10/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE 
SHELL STRENGTH - THICKNESS

Dr. O. Golden Robinson presents a paper entitled "Breast Implant Removal Or Exchange: which updated his prior study of 200 patients. He has seen an additional 100 patients and presents nine charts of statistics. Chart 2 lists "symptoms" of patients including burning and pain, numbness and tingling in extremities, joint and muscle pain, joint and muscle dysfunction, enlarged liver, flu symptoms, loss of appetite, swelling, arthritis symptoms, fibrocystic disease, deformity, kidney failure, vision problems, chronic fatigue, lupus, rash, insomnia, and hair loss. Of the 300 patients, 154 had a ruptured prosthesis, and 214 had a "disrupted" prostheses, i.e. loss of integrity of the silicone shell or severe silicone bleed where silicone "strings out at least 12 inches from intact capsule." (p.1).

CITE: No Bates Number, Exhibit 4 to Robinson Deposition. WITNESS: Robinson 
DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial 
Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #21
00/00/00
Post 10/92
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
RUPTURE - CLOSED CAPSULOMTOMY
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson's charts on the age of prostheses a significant number of implants ruptured 6-16 years post-implantation, ( observations at surgery 36.9% of his 73 patients were symptomatic), follow-up (most did not show any change in symptoms during follow-up), symptomatic (patient relates to prostheses-arthritic profile, refer, and "No Closed Capsulotomies"), asymptomatic (patient happy), 
and questions ("Do mammary prostheses last forever? What contributes to the silicone envelope wearing out? ... How do you tell if an implant is ruptured? ...."

CITE: No Bates Number, Exhibit 9 to Robinson Deposition. WITNESS: Robinson 
DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #22
00/00/00 
Post 10/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL STRENGTH - THICKNESS

Draft of Dr. O. Gordon Robinson's paper entitled, "Breast Implant Removal Or Exchange." This is a draft of document number 22.

CITE: No Bates Number, Exhibit 10 to Robinson Deposition. WITNESS: Robinson. 
DEPOSITION: Not admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #23 through#31

00/00/00 #23
ANY FOLLOW-UP STUDIES BY DR. O. GORDON ROBINSON.
This includes an abstract by Dr. Robinson and Dr. Edwin Bradley entitled 
"Disruption Rate of Silicone Gel Prostheses - A Report of 200 Cases" published 
in the January 1995 issue of the American Medical Association Journal. 

00/00/00 #24
PHOTOGRAPHS OF PLAINTIFF'S EXPLANT SURGERY

00/00/00 #25
EXPLANTED IMPLANTS OF PLAINTIFF AND PHOTOGRAPHS THEREOF.

00/00/00 #26
MEDICAL RECORDS OF PLAINTIFF.

00/00/00 #27
MEDICAL BILLS OF PLAINTIFF.

00/00/00 #28
PATHOLOGY SLIDES AND TISSUE SAMPLES OF PLAINTIFF.

00/00/00 #29
SPECIMEN BREAST IMPLANTS.

00/00/00 #30
SELECTED COMPLAINT REPORTS, FORMS AND/OR RESPONSES.

00/00/00 #31
ALL PRODUCT DATA SHEETS OF DOW CORNING FOR MAMMARY PROSTHESES. Dow Corning Trial 
Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #32
09/14/54
SILICA 
KNOWLEDGE OF SYSTEMIC DESEASE

H.C. Spencer, Dow Chemical, note regarding "Dow Corning Hydrophobic Silica." Testing shows a "high order of toxicity from dust inhalation."

CITE: TDC 5488. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #33
03/28/55
MISCELLANEOUS - COMPLICATIONS
SILICA 
TISSUE REACTION

"Report Of Trip To Saranac Lake Laboratories" by V.K. Rowe of Dow Chemical prepared for Dow Corning. Rowe and other Dow Chemical scientists visited Saranac Laboratory to verify work they had done on D.C. Degusa silica for Dow Corning. Rowe, et al. reviewed the work and wrote this report on the conclusions of the tests. 

Dow Corning silica consists of crystalline silica. Rowe states that, D.C. Degusa (silica) dust is "capable of causing diffuse cellular infiltration and fibrotic changes in the lungs and other organs of certain types of animals. It also produces bronchitis and sometimes emphysema." However, he concludes that it is not likely to cause silicosis" in the ordinary sense of the word. If fibrotic changes of the lungs develop in man, they will probably be diffuse in character.  If exposure is stopped, a measure of recovery is quite possible. Exposure to crystalline free silica reactivates and aggravates tuberculosis & causes progressive lesions." (DCC 299000444).

CITE: DCC 266000443 - 266000453, Exhibit to Lynch Deposition, and Exhibit to California Braley Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETO/PSC Attorney Work Product/Privileged & Confidential

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

Document #34
01/00/56
TESTING 
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Dow Corning Report No. 1377 on "The Physiological Assimilation Of DC 200 Fluid" by M.B. Chenoweth (Dow Chemical), R. Holmes and F. Stark. A copy was distributed to Collings, Bass, Kauppi, Hunter, Hutchison, Hyde, Blackburn, Bennett, McHard, CRI, and others including Beamer of Dow Chemical. 

"An increasing use of siloxanes for medicinal applications has resulted in the need for information on their biological activity. Previous experiments of The Dow Chemical Company Biochemical Department has shown that many of these compounds were toxicologically inert. It was the purpose of this experiment to determine to what extent the polydimethylsiloxanes were assimilated, and if so were they were metabolized." (I 169). C14 labeled PDMS in antifoam emulsion was administered to 2 albino rats and 2 lactating dogs. "The preoperative care, administering of the labeled fluid, sacrificing and dissecting of the animals was carried on by Dr. M.B. Chenoweth of The Dow Chemical Biochemistry Department. Samples of tissue were analyzed with the cooperation of Dow's Radiochemistry Laboratory." (I 171). With intramuscular injection, the C14 siloxane was found in the intestines, right adrenal, skin and hair, heart, skull bone, brain, kidney, urine, liver, muscle, lung, renal fat, blood and spleen. (I 172). Rats fed with the material had siloxane in the ileum, stomach and content, bladder and urine and kidney. (I 174). "The actual amount present may be greater by a factor of 3 corresponding to total polydimethylsiloxane from Dow Corning 200 Fluid and from gum. It is unlikely that the polydimethylsiloxane in the gum would be more readily assimilated than the lower molecular weight 200 Fluid." (I 174). A lactating dog fed with the material has siloxane in the skin and hair, brain, bile,, liver, kidney, heart, milk, urine, skeletal muscle, lung, adrenal, and blood. (I 175). 

A second lactating dog also had siloxane in the bile, skin and hair, adrenal, urine, spleen, lung, heart, liver, thyroid, pancreas, blood from lung, skeletal muscle, and milk. (I 175). "The studies conducted along these lines (C14 labeled fluid) to date have shown that these compounds are absorbed from the gastro-intestinal tracts to a slight extent, the amount absorbed being of the order of .0001%. Toxicological studies have shown these compounds to be inert." (I 175). There is a cite to the lab notebooks for the studies. On 259803.

CITE: KMM 259794 - 259803, Exhibit to Harris County LeVier Deposition, Exhibit to Tyler Deposition, Exhibit 20 to Harris County Zahalsky Deposition. DUPLICATE: I 167 - 176. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #35
02/09/56
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING

McGregor, Dow Corning, memo to Rowe, Dow Chemical Biochemical Research, enclosing 9 samples of silicone fluids for determination of the effect of intravenous injection. McGregor wants to know if any of the silicone fluids can be tolerated when injected intravenously. The silicone samples include 200 fluid, 555 fluid, 710 fluid, antifoam AF emulsion (which contains 30% 200 fluid), and XEC-5027 (which contains 10% 200 fluid).

CITE: OOT 43674 - 43700, Exhibit to K. Olson Deposition, Exhibit to RoweDeposition, Exhibit 24 to Harris County Rowe Deposition. and Exhibit to McHard Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #36
08/00/57
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Study by Stark titled " The Physiological Activity Of Dow Corning 200 Fluid." By a mechanism unknown at this time, a small amount of Dow Corning 200 Fluid is absorbed through the skin by the adrenal and kidneys of a rabbit.

CITE: KMM 259804 - 295808. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #37
10/05/57
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning's version of a "Report Prepared for Dow Corning Corporation, Midland, Michigan on Five Silicone Materials." The original report (see document #38 below) was prepared by Dr. W. Deichmann of the University of Miami on October 5, 1957 but was a report on six silicone materials. This version of Dr. Deichmannís report was altered to delete one compound and to delete all adverse effects identified in Dr. Deichmann's original report.  In this version, five Dow Corning silicones were fed to albino male and female rats for a period of 90 days. The silicones were Dow Corning 200 Fluid (50, 350, 1000, 10000 and 60000 cs.). Based on the observations of body weight, food intake, hematology, organ weight at necropsy, and their gross and microscopic appearance, it was concluded that none of the Dow Corning 200 Fluids of the viscosity range fed caused any harmful or deleterious effects.

CITE: KKM 7896 - 7930. NOTE: Includes a summary of animal safety studies relating to dimethylpolysiloxane fluid. See document #38 for the original, unaltered version of Dr. Deichmann's report produced by Dow Chemical. This altered version of the report was produced by Dow Corning. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #38
10/05/57
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Dr. W. Deichmann's original "Report Prepared for the Dow Corning Corporation, Midland Michigan on Six Silicone Materials" Six Dow Corning silicones were fed to albino male and female rats for a period of 90 days. The silicones were Dow Corning 200 Fluid (50, 250, 1,000, 10,000, and 60,000 cs.) and Dow Corning Z-4141 Solvent Free (the latter compound is the compound deleted by Dow Corning is document #37 above).

ORIGINAL REPORT 
DOW CORNING ALTERED REPORT
2 rats died during experiment 

There was an apparent decrease in the number of leukocytes. This difference is considered statistically significant. It is apparent there is a depression in the output of granulocytes by the bone marrow. 1 rat died.  There was an apparent decrease in the number of leukocytes. This is not statistically significant. The dietary feeding of DC 200 fluids had no significant effect upon the leukocyte counts of the treated animals.

The livers of the rat fed Z-4141 were significantly greater than the controls. This is consistent with the observation of liver damage in these animals.  None of the organ weights differed from the controls 
The feeding of the six compounds depressed the granulocytic elements of the peripheral tail blood of female rats. The livers of the rats fed Z-4141 were significantly heavier than the livers of the controls and also demonstrated fatty infiltration or degeneration. The feeding of the five compounds had no harmful or deleterious effects

CITE: TDC 6079 - 6100. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #39
10/09/57
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS 
TESTING
TISSUE REACTION

Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning, enclosing the results of the review of the six Dow Corning silicone compounds. He informs McGregor that all six compounds depressed the granulocytic elements of the peripheral (tail) blood of the female rats, and that the livers of rats fed Z-4141 were significantly heavier than the controls and demonstrated fatty infiltration or degeneration.

CITE: M 420103. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #40
12/09/57
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Letter from K.J. Olson and checked by V.K. Rowe, Dow Chemical Biochemical Research, to R.R. McGregor of Dow Corning with copies to H.H. Gay (Dow Chemical) and E.M. Adams (Dow Chemical ??) on "Results Of Range Finding Microbiological And Toxicological Tests on B-756-92 (a linear dimethylpolysiloxane of 6 units end-blocked with 2,4,5-trichlorophenxy radicals - being evaluated as potential fungicide for athlete's foot)." The tests showed appreciable anti-fungal activity. "If large amounts of the material are allowed to remain in contact with large areas of skin, absorption may result in systemic injury and may even produce death." Slight hyperemia followed the 3rd and 4th application and the rabbit died "possibly due from systemic injury due to absorption through the skin." The other 2 rabbits also died.

Attached is a data sheet prepared by Olson and McCollister, a toxicology work sheet, "Request For Applications Testing," and eye contact, skin contact - irritation, and skin contact absorption test records. NOTE: The document is stamped, "This Report Is The Property Of The Dow Chemical Company."

CITE: TDC 6158 - 6175, Exhibit to K. Olson Deposition, and Exhibit to McHard Deposition.  Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #41
04/09/58
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

"Pharmacological Test Data For Various Organofunctional Silicon Compounds, Report No. 1641," by Speier of Dow Corning. Pharmacological screening test data for 61 organofunctional silicon compounds are examined for use in drugs. In early 1952, a program was agreed upon with Eli Lilly for the pharmacological examination of assorted organofunctional silicon compounds. "The screening of 
these compounds has shown that a great many organofunctional silicon compounds and polymers have totally unexpected activities. Certain ones proved to be acutely toxic, even though closely similar structures were not especially toxic." (DCC 281002214).

All the results are contained in Mellon Institute notebook 318 - all 61 tests in this study contain a reference to notebook 318. There is also a reference to Earl Warrick's work at the Mellon Institute at 281002226.

CITE DCC 281002213 - 281002230, Exhibit to Tyler, MDK and Harris County Depositions, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, and Exhibit to Ryan Deposition.
WITNESS: Bennett (ancient document exception to hearsay).
DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #42
07/31/58 
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Olson, Dow Chemical Biochemical Research, letter to McGregor, Dow Corning, with copies to Gay, Dow Chemical, and McHard regarding the results of skin irritation, skin absorption and acute oral feeding tests on Dow Corning 555 Fluid and Ethylan (a modified lanolin), file no. T2.42-54-1.In McGregor's 06/05/58 letter to Rowe he indicated that Helen Curtis Industries had observed untoward systemic effects in rabbits and rats due to absorption of the material through the skin. Autopsy revealed small yellowish bubbles and petochone (illegible) on the liver and lungs. Olson applied the material to the 
skin of rabbits and fed it to another group for 5 days/ The results for the skin sensitization tests are illegible. There was a questionable to mild kidney disturbance in animals fed 555 fluid.

The conclusions on 6532 state that DC 555 fluid has a low acute oral toxicity, is essentially non-irritating to the skin upon prolonged repeated contact, and that there is no indication that the material is absorbed through the skin in sufficient amounts to produce systemic damage. Attached is a toxicology work sheet, "Requests For Screening Or Application Testing," and skin contact absorption and acute oral toxicity test results.

CITE: TDC 6526 - 6555, Exhibit to McHard Deposition, and Exhibit to K. Olson Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #43
07/05/62
KNOWLEDGE OF LIQUID SILICONE DANGERS 
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION


Olson and Sadek, Dow Chemical Biochemical Research, letter to McHard, Dow Corning, on toxicity by subcutaneous injection of Dow Corning 200 Fluids and Dow Corning 555 And 550 Fluids. Dow Corning 200 fluid 10 cs. resulted in a moderate inflammatory response in the subcutis as indicated by the presence of polymorphonuclear cells and a very large mononuclear cells. "This type of inflammatory reactions is interpreted as due to infection." With DC 555 and 550 Fluid, all injection sites showed evidence of inflammatory reaction indicated by the presence by mononuclear cells and polymorphonnuclear cells.

CITE: TDC 7493 - 7515, Exhibit 9 to Hancock Deposition, Exhibit to McHard Deposition, and Exhibit to K. Olson Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #44
07/12/62
SHELL STRENGTH - THICKNESS

S. Braley, Dow Corning, reports on a telephone call with Dr. Gerow regarding his findings from the use of the saline silastic prosthesis. A leak was discovered during implantation and Dr. Gerow "sealed it with cement on the operating table...." Also, he wanted Dow Corning to "make the Gel gooier." Dr. Gerow reports that the saline he has been using in some of the silastic sacs has been in animals for nine months and that the body sets up a chemical balance. He has analyzed the fluid inside the sacs after this nine months and found protein, SO4 ions and also indications that the body had set up a balance of magnesium and other ions. Finally, Dr. Gerow stated that the "direct injection technique has 
worked out beautifully." 

CITE: M 320001 - 320002. Dow Corning Trial Exhibit List Abstracts 
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #45
09/14/62
TESTING

Dow Chemical Texas Division, Agricultural Research, study by F.C. Turner, K.G. Seymour, and J.B. Jackson on "Tropical Application Of Various Solvents And Solutions To Evaluate Dermal Irritation." Report No. 210. The report was circulated many persons including K.W. McCory of Dow International; persons at Bioproducts: Adm., J.E. Johnson; An.Sci. R and D, T.A. Hymas; Plt.Sci. R and D, K.C. Barrons; Midland BRC Files, L.J. Lippie: Registration Section. G.E. Lynn; Synthesis Group, W. Reifschneider; and Formulation Res., J.W. VanValkenburg; to V.K. Rowe of Biochemical Research; and to the following persons at Pitman-Moore: C.W. Hinman, G.R. Burch, and D.C. Brinkman.Dow Corning 200 fluid - silicone oil with 49% espesol 5 content was administered in 10 cc dosages to shaved strips on the hide to test for suitable solvents for Ruelene. Dow Chemical hoped to find a solvent that didn't damage the hides of cattle when Ruelene was administered. The DC 200 fluid was rated ad bad, which 
indicated that the hide had extreme cracking or sloughing at 10 and 16 days after application. (TDC 7542).

CITE: TDC 7537 - 7543. Dow Corning Trial Exhibit List Abstracts 
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #46
10/04/62
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS 
SHELL STRENGTH - THICKNESS
TISSUE REACTION

S.Braley, Dow Corning, memo regarding telephone call to Dr. Thomas D. Cronin.  Braley told Cronin that the uncatalyzed breast material could not be sent out because there were too many problems with it. The problems with measuring and the variability of both the base material and the mixing techniques necessitates different amounts of cross-link resulting, along with the variability in mixing techniques, can cause difficulties.

Dr. Frank Gerow was also on the telephone and talked about the results he was getting regarding tissue reaction to the direct injection of the material.Cronin said that he is not concerned about leakage if he were to use the thin material because a film forms around the implant retaining the material in place. Cronin said that he is getting chlorine, potassium and proteins both in and out through the wall of the bag. This is on apparently good bags. It was decided that it would be wise to continue the work for long range testing for the acceptability of the material.

CITE: OOM 320665 - 320666. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential 

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

Document #47
10/31/63
KNOWLEDGE OF LIQUID SILICON DANGERS
GEL MIGRATION

Dr. Walter Berman writes to Silas Braley, Dow corning, reporting on his injection of silicone fluid in mice. Two days after injection, silicone was found in most organs including the brain, liver, spleen, intestinal wall, adrenal and kidney. He also found "evidence of at least radio activity and most 
probably silicone in the brain and all of the various other organs...."

CITE: M 420051 - 420052. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC 
Attorney Work Product/Privileged & Confidential

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

Document #48
11/27/63
TESTING
TISSUE REACTION


Dow Chemical's Bioproducts Department report by Whitney, Pollock and Pauley on "Fluorosilanes As Fumigants." Six flourosilanes:K-56,425 = n-propyltrifluorosilane; K-56,426 = ethylmethyldifluorosilane; K-57,317= trimethylfluorosilane; K-59,489 = mehtyltrifluorosilane; K-59,697 =chlorometthyldifluoromethylsilane; K-58,739 = silicon tetrafluoride; andK-681 = methyl bromide were evaluated as fumigants for control of insects and microorganisms. All were very active against post-embryonic stages of tests insects. Tri and difluoro silanes were active against bacteria and molds. 

Most of the compounds killed all flour beetle eggs at one lb/1000 cu. ft. with a 16-hour exposure.... A patent disclosure has been submitted and further research is recommended for these and related compounds. 

Results of toxicological work with mammals is reported in reports 55.11-56425-1, 55.11-56426-1, 55.11-56427-1, 55.11-57317-1, and 55.11-2-1. the usefulness of these compounds has been reported in Patent Disclosure no. 16193. NOTE: None of these reports or patent disclosures were produced to the PSC."Further exploration of the biological and physical properties of these and related compounds is recommended."

CITE: TDC 8901- 8904. Dow Corning Trial Exhibit List Abstracts 
PENDLETON/PSC Attorney Work Product/Privileged & Confidential 

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

Document #49
00/00/64
MISCELLANEOUS - COMPLICATIONS
SILICA STERILIZATION/CONTAMINATION
TISSUE REACTION 


Braley, Dow Corning, states in the Trans American Society of Artificial Internal Organs, "The Medical Silicones," that electrical charges exist on the surface of the silicone elastomer. Silicone elastomers are described as non-adherence products, nothing will stick to them. "However, because of the dialectic (sic) properties of silicone rubber, it will develop a surface charge and can hold dust, lint, (etc.).... This is not true adhesion." Additionally, the reason that the attempt to create a silicone vascular prostheses, to be inserted in a blood vessel, failed is because of the electrical charges on the surface which caused the blood to clot at the ingress end of the silicone prostheses tube.Braley also describes the chemical composition, the characteristics and the various applications of silicone. Dow Corning Trial Exhibit List Abstracts 
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Document #50
01/13/64
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS 
TESTING
TISSUE REACTION

McHard memo to Hunter with copies to Braley, Dingman, Hobbs, and Stebleton regarding "Notes on visit to Battelle Memorial Institute on December 19, 1963." McHard and Hobbs met with representatives of Battelle and discussed the "Toxicology of silicones - past and future.

1. Variation in toxicity with animal species. 2. Effect of polymer size on toxicity. 3. Extent of body metabolism. 4. Fate in kidney and liver. 5. Fate of catalysts. 6. Extent of carcinogenicity." Also discussed was silastics for breast implants. Battelle's study showed that the physical properties of 
silicone rubber when implanted were significantly affected/decreased. Also, "There was considerable discussion on how the various polymer sizes may be transported across the G.I. tract and how they may find their way into the kidney, liver, and subsequently, the urine."

CITE: KMM 299059 - 299063. Dow Corning Trial Exhibit List Abstracts 
PENDLETON/PSC Attorney Work Product/Privileged & Confidential




TO DOCUMENTS: 51 - 100