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

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

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

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

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 month. 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

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

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

(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

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

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

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

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 (R) mammary prostheses." (emphasis added).

CITE: M 570119. DUPLICATE: KMM 335110

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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 Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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 Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

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

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 Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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:

(T)here 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.

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

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

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

11/16/72 ACKNOWDEDGEMENT 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

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

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

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

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 - 3006

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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).

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

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

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

06/00/73 COHESIVENESS - LIQUID COMPONENT OF GEL ACKNOWLEDGEMENT OF NEED FOR TESTING GEL MIGRATION

Dow Corning Bioscience Research Laboratory "Research Project Description: entitled "Bioscience Research Support Project - Systemic Migration Of Prosthetic Gel In The Rhesus Monkey." This cooperative project between Dow Corning's Medical Products Business and Dr. Gerow will "to examine the efficacy of using the gel as an injection or implantation for mammary augmentation. This project is designed to examine the potential of gel components to migrate systemically from the site of instillation." (DCC 16001066) "The gel is a complex mixture of which the low molecular weight fraction (up to 1% w/w of the gel; 330 Fluid) is assumed to offer the greatest potential for migration. Present data acquired in rats indicate that such low molecular weight components tend to appear in depot fat and lymph nodes and that maximum tissue concentrations are attained shortly after instillation.... The relative contribution of the various routes of elimination may include the lung, kidneys and liver based on the elimination of orally administered permethylated cyclic tetramer...." (DCC 16001066)

None of the data to be gathered will allow definition of the structural types that may migrate. The 330 Fluid fraction components of the gel "are the most likely candidates ... (so) it may be advisable to repeat the study with a gel formulation containing a minimum of low molecular weight linear and cyclic siloxanes."

CITE: DCC 16001066 - 16001068, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 546: 12-23). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/00/73 ACKNOWLEDGEMENT OF NEED FOR TESTING GEL MIGRATION

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

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

CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett Depo., Vol. I p. 254-257). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/00/73 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE

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

CITE: DCC 16001092 - 16001093, Exhibit to Bennett Deposition (used by plaintiffs and as Exhibit 83 by Dow Corning), Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit to MDL LeVier Deposition.

WITNESS: Bennett (Authenticated in Boley, Vol. I p. 141-143 and 153: 19 - 154:12).

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/09/73 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS MISCELLANEOUS - SALES

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

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

CITE: KMM 112207 - 112208, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/16/73 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF SYSTEMIC DISEASE

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

CITE: KMM 546454 - 546465, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also has Bates Numbers KMM 491081A - 491083A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 378:21 - 379;16). DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

6/19/73 KNOWLEDGE OF LIQUID SILICONE DANGERS

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

CITE: KMM 242496 - 242499, Exhibit to Mantle Deposition, Exhibit 92 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit to Venn Deposition. DUPLICATE: OOM 880025 - 880027.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/00/73 SHELL STRENGTH - THICKNESS

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

CITE: KMM 220138 - 220147.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/01/73 GEL MIGRATION KNOWLEDGE OF GEL BLEED SHELL STRENGTH - THICKNESS

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

CITE: KMM 354646 - 354651, Exhibit to Tyler Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/18/73 FRAUD/MISREPRESENTATION CONCEALING FROM FDA

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

CITE: KMM 243010 - 243015, Exhibit to MDL Rathjen Deposition, Exhibit 4 to Hinsch Deposition, Exhibit to Mantle Deposition, and Exhibit 62 to Harris Country Rathjen Deposition. DUPLICATE: M 880016 - 880018; DCC 24000537 - 24000542; OOM 880016 - 880018.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

10/00/73 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - ORGANIZATIONAL SURVEY TESTING TISSUE REACTION

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

CITE: DCC 282001118-282001149, Exhibit to Bennett Deposition, Exhibit to Petraitis Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition, and Exhibit 1 to Randonovich Deposition. DUPLICATE: LAK 1 - 11.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

10/08/73

(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

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

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

Research will also be conducted on new agonists and chemotherapeutic agents with selected groups of organosilicon compounds. Activities that will be monitored include viral interference induction (interferon), antiviral activity against 4 RNA and 4 DNA viruses, modification of cell growth kinetics and modification of cultural characteristics. Also, the authors seek to establish a method to measure the response and processing of fluids resins and silastic materials in macrophages. (LAK 14)

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/04/73 MISCELLANEOUS - SALES

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

CITE: DCC 24000523 - 24000524, Exhibit 23 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/13/73. DUPLICATE: DCC 266000237.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/13/73 MISCELLANEOUS - SALES

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

CITE: KMM 46084, Exhibit 24 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/04/73. DUPLICATE: DCC 24000967.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/22/74 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS - COMPLICATIONS STERILIZATION/CONTAMINATION TESTING TISSUE REACTION

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

CITE: T 21169 - 221172, Exhibit to Harris Country LeVier Deposition and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/23/74 KNOWLEDGE OF SYSTEMIC DISEASE TESTING

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

CITE" DCC 281061454 - 281061486 (Temporary Dow Corning Bates Numbers 16362 - 16377), Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit to Isquith Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/18/74 SHELL STRENGTH - THICKNESS

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

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

CITE: KKM 21110.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

03/00/74

(NOT ON PLAINTIFF'S EXHIBIT LIST)

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

CITE: LAK 133.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/10/74 SHELL STRENGTH - THICKNESS

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

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

CITE: KMM 220138 - 220147.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/11/74 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING

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

CITE: FDA 27196

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/28/74 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS TESTING

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

CITE: DCC 281001098 - 281001100, Exhibit 3 to Isquith Deposition, Exhibit 70 to Bennett Deposition (used by Dow Corning). and Exhibit to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/20/74 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

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

CITE: DCC 281061389 - 281061395, Exhibit 71 to Bennett Deposition (used by Dow Corning).

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/21/74 MISCELLANEOUS - ORGANIZATIONAL SURVEY

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

CITE: LAK 62 - 64, Exhibit to Bennett Deposition and Exhibit to Tyler Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/23/74 KNOWLEDGE OF LIQUID SILICONE DANGERS

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

CITE: DCC 240000861 - 240000862.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/30/74 MISCELLANEOUS TESTING

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

CITE: DCC 281061484.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/30/74 MISCELLANEOUS - COMPLICATIONS

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

10/02/74 KNOWLEDGE OF SYSTEMIC DISEASE TESTING

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

(Not Listed)

(Note: this is not numbered but is between 174 & 175) 10/21/74 (NOT ON PLAINTIFF'S EXHIBIT LIST)

Memo from G. Robertson, Dow Corning, to Bennett, Bennett, Hobbs, Radzius and Stark with copies to Brodhagen and Larson regarding "Minutes of Product Safety Committee Meeting, October 11, 1974." They discussed proposed changes for mammary gel including using 360 fluid rather than 330 fluid (DCC 267380231).

CITE: DCC 267380231 - 267380234 (page 2 is missing). NOTE: This document also ;has Bates Numbers QDC 118693 - 118696 and MM 220066 - 220069 on it WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 954-968). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/22/74 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS

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

CITE: M 190131, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/26/74 KNOWLEDGE OF LIQUID SILICONE DANGERS TISSUE REACTION

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

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

CITE: DCC 240000051, Exhibit 35 to California Braley Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

00/00/75 KNOWLEDGE OF SYSTEMIC DISEASE TESTING

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

CITE: LAK 65 - 66A, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit 1 to Radonovich Deposition. NOTE: See entry dated 10/30/75. DUPLICATE: DCC 281061469 - 281061470. WITNESS: Radonovich. DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/13/75 SHELL STRENGTH - THICKNESS COHESIVENESS - LIQUID COMPONENT OF GEL RUPTURE

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

CITE: M 570188 - 570189

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/22/75 KNOWLEDGE OF SYSTEMIC DISEASE TESTING

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

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

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

01/22/75 DUPLICATE OF DOCUMENT # 177 (see above).

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/22/75 TESTING MISCELLANEOUS - SALES

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/28/75 KNOWLEDGE OF GEL BLEED

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

CITE: F 541, Exhibit 38 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260794; KMM 19824; FDA 19671 - 19672; M 150001.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/31/75 KNOWLEDGE OF SYSTEMIC DISEASE TESTING

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

Another document is a "Patent Memorandum" by Boley and LeVier with the suggested title of "Immunological Enhancing Activities of Organosilicon compounds and Non-Functional Fluids" which was renamed to "Organosilicon Immunopotentiators." Nine of 48 silicon-containing compounds showed a "strong immunological enhancing" effect. Boley and LeVier wanted to explore possible applications of these compounds including for potentiation of veterinarian vaccines and in the "production of high quality and expensive experimental antibodies."

Some of these compounds were tested for their ability to augment or potentiate endotoxin induction of IF. Dow Corning 200 fluid and D4 "show a significant potentiation of endotoxin induced IF." (DCC 281061466).

 There is also a one page abstract of the Lake, Radonovich and Boley report on "Potentiation Of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane." Interferon appears to be involved in the Immune response to bacterial, viral and protozoal infections. Substances able to modulate the interferon response may be useful in the control of many infectious diseases and cancer. This report describes the immunopotentiating activity of some structurally defined linear and cyclic polydimethylsiloxane fluids which have been found to mimic the potentiating effects of mineral oil adjuvants (Boley and Levier Dow Corning Report 4319, 1974).

CITE: DCC 281061451 - 281061468 (Temporary Dow Corning Bates Number 16359 - 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/03/75 KNOWLEDGE OF SYSTEMIC DISEASE TESTING

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

CITE: DCC 281061471 (Temporary Dow Corning Bates Number 16379), Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/13/75 SHELLL STRENGTH - THICKNESS

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

CITE: F 552 - 553, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/14/75 SHELL STRENGTH - THICKNESS

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

CITE: F 549 -551, Exhibit 40 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 446914 - 446916: M 540023 - 540025. NOTE: Why does Marketing decide what is an acceptable envelope?

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/19/75 MISCELLANEOUS

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

CITE: M 400001, Exhibit 84 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/25/75 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL BLEED TISSUE REACTION

Nawash memo to Salisbury, both of Dow Corning, regarding low molecular weight gel diffusion. He writes:

"The reactivity between free low molecular weight silicones and the subcutaneous tissue seems to be of increasing concern among plastic surgeons. It is thought that the soft gel used by Heyer-Schulte in the mammary implant is obtained by mixing low viscosity silicone fluid in the regular gel. It is also thought that the low molecular weight components of the fluid eventually diffuse through the rubber envelope of the breast implant and elicit the untoward reaction which is occasionally observed and results in an undesirable, relatively thick fibrous capsule. I do not know the actual method used by Heyer-Schulte to obtain their soft gel: nor do I know the process we developed for making our own soft gel.

However, If I may, I strongly recommend that we take measures to insure against the presence of unwarranted free low molecular weight fluids in our now soft breast implant.

CITE: M 190133, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/25/75 TESTING

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/25/75 MISCELLANEOUS

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

CITE: KMM 220579, Exhibit to MDL Rathjen Deposition

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/01/75 FRAUD/MISREPRESENTATION KNOWLEDGE OF GEL BLEED MISCELLANEOUS - SALES

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

CITE: KMM 220570, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/13/75 KNOWLEDGE OF GEL BLEED

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

CITE: F 743, Exhibit 43 to Harris County Rathjen Deposition, and Exhibit 12 to MDL Rathjen Deposition (used by Dow Corning). DULICATE: M 16003; M

570062; FDA 19586; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 17.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/16/75 KNOWLEDGE OF GEL BLEED

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

CITE: F 590 - 596, Exhibit to MDL Rathjen Deposition, and Exhibit 44 to Harris County Rathjen Deposition. DUPLICATE: KMM 446988 - 446991: M540064 - 540070.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/16/75 KNOWLEDGE OF GEL BLEED

Tom Salisbury memo to Dow Corning sales force regarding the "Oily Phenomenon With New Mammary Prostheses." Salisbury writes that, "It has been observed that the new mammaries (sic) with responsive gel have a tendency to appear oily after being manipulated. ... You should make plans to change demonstration samples often. Also, be sure samples are clean and dry before customer detailing. Two easy ways to clean demonstration samples while traveling, 1) wash with soap & water in nearest washroom, dry with hand towels, 2) carry a small bottle of IPA and rag."

CITE: F 635, Exhibit 2 to Hinsch Deposition, Exhibit 63 to Harris County Rathjen Deposition, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540071; KKA 152381; KKH 868: KMM 446993: KMM 148337: KMM 518441: DCC 80061333 - 80061334.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/23/75 COHESIVENESS - LIQUID COMPONENT OF GEL

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction, "1 week, 8 days, 192 hours, 11,520 minutes." The Task Force discussed the economic reasons for getting the contours on the market by 10/01/75. Also, "Marketing wanted to use a sealed bottle of gel as a sales aid to show the flowability and cohesiveness of the responsive gel. However, Talcott and Larson discouraged (this) because the gel may not retain constant properties with continued manipulation such as this. The aesthetics of doing this would probably not show our product in a good light." The Task Force decides on "aggressive marketing tactics" including rebates, consignment, back-up units-singles for immediate rupture - replacement, and price breaks for big users.

CITE: F 599 - 601, Exhibit 45 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540087 - 540089.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/01/75 COHESIVENESS - LIQUID COMPONENT OF GEL SHELL DEGRADATION SHELL STRENGTH - THICKNESS TESTING

Study titled "New responsive Gel - '"Effect on Mammary Envelope Physical Properties" by James Vallender, cc to Rathjen. Conclusion, "the new gel seems to cause slightly weaker envelope in ultimate properties but appears to cause slightly less weakening on aging. The difference in effect on physicals by new and old gel is considered insignificant." The study was approved by Matherly and Stark.

CITE: OOT 41627 - 41629, Exhibit to Peters Deposition, Exhibit 112 to Harris County Rathjen Deposition, Exhibit 129 to Burda Deposition (used by Dow Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: F 630

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/30/75 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

Study sent to Dowell by Lince, Pruitt, Neagele, Kenaga, Moss, Hymas Goring, Bjork, Coulter, Johnson, Osborne, Getzendaner, Meulder, Seymour, Sheldon, Barrons, Hinman, Laskowski, Gray, Hunter, Hanson, Little, Kurihara, Hamaker, Meikle, Regoli, Magana, Dalman, Edumura, Geronimo, Turner, Ferguson, Simon, Scott, MacDougal, Shaver, Fears and Regan regarding the rapidity of German roach knock-down with fospirate formulated on dri-die.

Dow Chemical U.S.A. Ag-Organics Research in Walnut Creek, California report by F.H. Dowell on "Rapidity of German Roach Knock-Down With Fospirate Formulated On Dri-Die." The report was distributed to numerous departments within Dow Chemical including Ag-Org. Information Center (M. Lince), Ag-Org. R&D Planning (name illegible), U.S. Area R&D Dir. M.E. Pruitt, Ag-Organics Dept. Manager RD Naegele, Ag-Organics R&D Director R.E, Hefner, Ag-Org. Regist. D. McCollister and E. Kenaga, Ag-Org. Chemistry Dir. R.D. Moss, Ag-Org. An. Health Devel. T.A. Hymas, Plant Sci. R&D Dir. C.A.I. Goring, Ag-Org Areas Pestic. Coord. L.L. Coulter, Corp. Prod. Dept. R.B. Johnson, Ag-Org. Synthesis Res. Mgr. D.W. Osborne, Ag-Org. Residue/Metab. M.E. Getzendaner, Ag-Org. Formulations K.G. Seymour, Ag-Org. Prod. Bus. Mgr. H.W. Sheldon, Ag-Org. R&D Tech. Advisor K.C. Barrons, Chem. Biol. Res. C.W. Hinman, Ag-Org. Environ. Studies D.A. Laskowski, Prod. Plan. Team R&D Spec. H.E. Gray, Res. Mgr. Field R&D R.C. Hunter: persons in the Ag-Org. department at the Walnut Creek lab; and to people in international locations.

The 2% fospirate + Dri-Die Formulation appears to combine flushing action, residual rapid knock-down and indefinite slow residual action, all highly desirable properties in a roach control formulation. Dri-Die (micronized silica gel) is widely used for cockroach control.

CITE: TDCH 345 - 356, Exhibit to Bennett Deposition, Exhibit to Ryan Deposition, and Exhibit to Hinman Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/15/75 MISCELLANEOUS - COMPLICATIONS TISSUE REACTION

Letter to Dr. Fleming from M. Popple, bcc to Rathjen, regarding patient with excessive capsule contraction after mammaplasty

CITE: m 470064 - 470065, Exhibit to MDL Rathjen Deposition

08/12/75 ACKNOWLEDGEMENT OF NEED FOR TSTING KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS TESTING

Dow Corning submits New Drug Application (NDA) for DYMASYL(R) Brand Injectable Silicone for Soft Tissue Augmentation. The NDA 2702. Ancillary to the filing of the New Drug Application, Dow Corning will pursue activities to elicit data relative to safety and efficacy on a long-term basis.

CITE: M 410001 - 410003, Exhibit 25 to Harris County Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/12/75 KNOWLEDGE OF GEL BLEED MISCELLANEOUS - COMPLICATIONS TISSUE REACTION

Dr. Upton (Cronin"s associate) letter to Rathjen regarding capsular contracture. Dr. Wilflingseder and Dr. Laub have been able to demonstrate small particles of free silicone inciting inflammatory reactions in adjacent soft tissue. They have noted the same phenomenon. "Although the etiology of the problem is multifaceted, I am sure, we still wonder if the surface of the silicone polymer plays a significant role."

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

CITE: DCD 173003034, Exhibit 27 to MDL Rathjen Deposition (used by plaintiffs and Dow Corning), Exhibit 120 to Harris County Rathjen Deposition. DUPLICATE: M 190146.

08/28/75 TESTING

Tony Abbott, Dow Corning, memo to Bey and numerous other employees regarding "Mammary Gel Biocompatability." Abbott states that he now has a test procedure (Tissue Cell Culture) for evaluating biocompatability of products on a lot to lot basis. Each lot of mammary gel consists of several drums of materials. "Test results show that there is a difference in the biocompatability of the gel on a drum to drum basis." Abbott also recommends a permanent solution to the problem with the butyl carbitol acetate solvent as a catalyst. Wil Larson is working on this.

CITE M 170101 - 170103.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/03/75

(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

(this document is between #202 & #203)

Memo from Art Rathjen, Dow Corning, to Drs. Anderson, Ashley, Barrett, Blocksma, Dingman, Dufourmoutel, Edgerton, Epstein, Giannestine, Goulian, Murray, Orentreich, Rees, Smith, Stark and Vinnik regarding "News Release - Silicone Fluid Injection." "Because of legal complications, any inquiries from the media should be referred to Silas Braley or Joseph Radzius at Dow Corning." Rathjen encloses a Dow Corning news release stating that it has filed a New Drug Application with the FDA requesting approval to market silicone fluid for injections.

CITE: M 350161 - 350163, Exhibit 29 to Harris County Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/10/75 KNOWLEDGE OF LIQUID SILICONE DANGERS

Silas Braley, Dow Corning, Summarizes a phone call with Dr. Charles Vinnik in response to the press release. Braley states that Dr. Vinnik:

"wanted to know what we were doing about preventing this use so that all of the incapable people don't get a hold of it for this kind of use.... He said that the Moss subcommittee in Congress is all poised waiting for Vinnick's (sic) statement to jump on an investigation of the silicone fluid injection story. He has been keeping a lid on this all along.... He said he felt that the information we have had given to us by the investigators is faulty. That his information is much greater and much better and shows that volumes of silicones under high pressure can cause all kinds of things that we do not have in our study. He said that the longest we had was four years in monkeys and even that showed fat necrosis. He explained fat necrosis as being identical with the situations he has seen in the patients that he has treated in Lass Vegas. (emphasis added).

CITE: DCC 240000054. DUPLICATE: KKM 3364.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/29/75 MISCELLANEOUS - COMPLICATIONS SILICA TISSUE REACTION

Letter to Rathjen from Dr. Laud regarding Dr. Wilflingseder's discovery, and publication, of silicon dioxide (silica) in breast capsule specimens and "I was able to tell him what I had learned at Dow Corning."

CITE KMM 29957.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

10/06/75 TESTING

Abbott, Dow Corning, reports on "biocompatibility Evaluation Of Mammary Gel." "The problem with biocompatibility is the butyl carbitol acetate solvent in the catalyst.... There are localized high concentrations of BDA in the gel. Evaluation of the compatibility of the solvent with the gel has shown that BCA does not mix in the formulation at a very desirable rate." Also, "Visual observations of uncured gel shows the presence of globules or highly contracted pockets of the solvent.... The permanent solution to the problem involves the replacement of the present solvent with a different solvent or a different catalyst system."

CITE: KMM 39105 - 39121.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

10/30/75 COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION KNOWLEDGE OF SYSTEMIC DISEASE TESTING

Dow Corning Bioscience Research Report No. 4509 by Lake and Radonovich entitled "Action of Polydimethylsiloxanes on the Reticuloendothelial System of Mice: Basic Cellular Interactions and Structure Activity." The abstract for this report states that:

"Because of their hydrophobic character, dimethylpolysiloxanes of various viscosities are known to distribute to the reticuloendothelial system (RES) in association with phagocytes. The site, magnitude, specificity and time course of murine RES response to high doses of various dimethylpolysiloxane fluids has been studied to characterize the basic cellular interaction and immunological consequences of dimethylsiloxane administration. Type I interferon production and clearance of colloidal carbon were used to assess RES function. Linear 3,4 and cyclic 4,5 dimethylpolysiloxanes when given parenterally to mice caused a transient response in lymphoreticular tissues with a maximum at 48 hours. This response was found to involve phagocytic cells (macrophages) such that augmented amounts of Type I endotoxin-induced interferon are made. Carbon clearance by the RES is also depressed with the same time course as this hyper-reactivity to interferon induction. Hexamethyldisiloxane and dimethysiloxanes greater than 5 siloxy units do not cause these changes, but do cause a characteristic eosinophilia at an intraperitoneal inoculation site.

A consistent hypothesis for this observed increase in early interferon production is that dimethylsiloxanes in the 305 size range are sub-lethally surface active in macrophages of the RES. Like lead acetate and mineral oil-surfactant mixtures, which are known to augment early interferon production, low molecular weight dimethylsiloxanes decrease the phagocytic capacity of macrophages. Because endotoxin is not cleared (phagocytosed) or detoxified, the viable but phagocytically impaired macrophages undergo a prolonged and more complete interaction with endotoxin. (OOT 42327)"

CITE: OOT 42325 - 42352, Exhibit 1 to Radonovich Deposition (abstract only), Exhibit 23 to Harris County Hayes Deposition, Exhibit to Harris County Tyler Deposition, Exhibit 11 to Zimmer Deposition, Exhibit to Lake Deposition, Exhibit to Isquith Deposition, and Exhibit 23 to Harris County Rich Deposition. DUPLICATE: DCC 281001636 - 281001662; DCC 281061445 - 281061450. WITNESS: Radonovich.

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/03/75 MISCELLANEOUS - COMPLICATIONS TISSUE REACTION

Letter to Rathjen from Dr. Laub regarding the Toronto meeting. "Dr. Bob Briggs from New Jersey has seen several patients from the original study (mostly Orentreich patients) who have had intractable swelling. ... This case is similar to the ones reported at a meeting in Mexico City several years ago by physicians from Buenos Aires. ... I have followed patients myself in this are 'suffering' from the same condition. ..."

CITE: KKM 31788, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document (no number) dated 11/7/75

11/07/75

(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

Memo from Larson, Dow Corning, to Talcott with copies to Bey, Rathjen, and Kelley regarding "Capsule Formation & Mammary Implants." Larson states that Stark commented in a staff meeting that "implanted silica causes the formation of a very heavy tough capsule.... Possibly we could minimize capsule formation around the mammary prosthesis if they were over coated with a pure silicone polymer.... These are the basis for the concept that maybe some exposed silica on the very surface of the envelope rubber can cause excessive capsule formation and that this might be minimized if the capsule were formed and interfaced against pure silicone polymer." On M 190174 there is a handwritten note from Talcott to Ron Kelley: "I'd like more proof of silica at interface causing problems."

CITE: m 190174 - 190175. NOTE: M 190175 is a duplicate of M 190174 but it has different marginalia on it.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/18/75 MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD TESTING

Memo to Boone, Leach, Meads, Polmanteer & Talcott from Bey regarding capsule contracture studies. "Our TS&D budget situation for 1976 is simply this, we have considerably less discretionary spending money for 1976 than we had in 1975. I can't see any way we can support these proposals in 1976. I suggest we discourage the proposals as much as possible...."

CITE: M 190186, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/10/75 KNOWLEDGE OF LIQUID SILICONE DANGERS

Telephone call report by Silas Braley regarding a call with Richard Samuels about a grand jury investigation being done on Hal Ellison for doing injections of silicone fluid. Ellison had been receiving Dow Corning fluid through a company called Silaco. Braley states that, "I told Mr. Samuels that we had been fighting, the breast injections since we had heard about them and were trying to get the information across to people. We find now that people are very confused about breast injections vs. breast implants and I explained that the latter are both ethical and legal and that the problems of injections do not apply. I asked for his help in differentiating between these two procedures so that those women who have had surgical augmentation will not worry when they read about the horrors of injections." (emphasis added). The call report notes that additional phone calls from Mr. Samuels occurred throughout the morning. Joe Radzius, Dow Corning legal counsel, advised Braley that Dow Corning's position "from here on in" was "no comment."

CITE: KKM 3537 - 3538

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/12/75 KNOWLEDGE OF GEL BLEED

T. Talcott, Dow Corning, memo about a telephone call from Dr. Frank Gerow. Gerow attended a meeting in Phoenix recently and reported that "the general tone to him was something is coming through the envelope to the tissue." Gerow concluded that Dow Corning needed a "100% tied up gel now." Talcott writes that he's inclined to agree that something's coming through the envelope. "Could it be miscellaneous contamination during our manufacturing process? Do we need an audit of the process?'

CITE: F 636, Exhibit to Frisch Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit 64 to Harris County Rathjen Deposition. DUPLICATE: M 170143; M190203; FDA 32914; DCC 242031351 - 242031352.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/12/75 TESTING

Franklin and Annelin, Dow Corning, report on "Subcutaneous Implants Of Developmental Prosthetic Gels In Monkeys And Rats: Examination Of Tissue Deposition And Urinary, Fecal, And Respiratory Elimination Routes." "In the rats, dosed with the new production gel, only the axillary lymph showed an increase in total silicon; a similar increase in hexane extractable silicon was not observed.: In the monkeys, "the low cross-linker formulation moved along tissue planes and formed only a very thin capsule."

CITE: KMM 140087 - 140104, Exhibit to Frisch Deposition, Exhibit 42 to Hinsch Deposition (used by Dow Corning), Exhibit to LeVier Deposition, Exhibit 45 to Harris County Peters Deposition, Exhibit 115 to Harris County Rathjen Deposition, Exhibit 88 to Harris County Talcott Deposition, Exhibit 92 to Bennett Deposition (used by Dow Corning), Exhibit 15 to MDL Rathjen Deposition (used by Dow Corning), and Exhibit to Isquith Deposition. DUPLICATE: P 17497 - 17515.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/12/75 SHELL STRENGTH - THICKNESS RUPTURE ACKNOWLEDGEMENT OF NEED FOR TESTING

Rathjen, Dow Corning, memo to various Dow employees regarding Breast Symposium in Phoenix, Arizona on November 23-26, 1975. Reports that Dow has lost the number one position as "the innovator." He states:

"Surgery was performed by members of the faculty, put on tape, edited and viewed during the three day course. Each manufacturer donated implants for this use. Dr. Eugene Courtiss and Dr. Robert Winslow used our prostheses. In both instances the doctors broke an implant during their surgery. Fortunately these were edited from the tape; but ours were the only ones to break, and they really let us know about it. The Medical Products Business should consider a full scale research program to fully evaluate the current status of our gel (chemistry, toxicology) and to begin a concentrated program to develop a dry gel (dry to touch, cohesive, non-adhesive with absolutely no bleed). I would also like to see the development of a radio-opaque envelope which would allow the examination of an implant "in situ" if and when capsular contracture is suspected. How contracture develops by observing an implant "in situ" could contribute to a better design of an implant. (emphasis added).

CITE; M 190200 - 190202, Exhibit to Mantle Deposition, Exhibit 80 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

00/00/76 FRAUD/MISREPRESENTATION

Dow Corning brochure, "Facts You Should Know About Your New Look," Which contains the following question and answer: "How long will the implants last? Based on laboratory findings and human experiences to date, a gel-filled breast implant should last for a lifetime." (emphasis added).

CITE: M 650012 - 650019, Exhibit to Harris Country Jakubczak Deposition, 27 to Harris County Peters Deposition (used by Dow Corning), Exhibit to MDL Rathjen Deposition, and Exhibit 77 to Harris County Rathjen Deposition. NOTE: From 1963-73, Dow Corning only "warned" of fluid accumulation and foreign body reactions in its product inserts. From 10/74 - 09/76, Dow Corning added to its product inserts the following for the Silastic implant: capsular contracture/firmness, pain or discomfort from surgery, ptotic breasts, additional surgeries/implantations, and the risks associated with surgery. See PSC World of Warnings for Dow Corning and Dow Corning Wright.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/07/76 FRAUD/MISREPRESENTATION KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS - COMPLICATIONS STERILIZATION/CONTAMINATION TISSUE REACTION

Testimony of Joseph Radzius to the California legislature regarding silicone injections. He states that DC's study "absolutely contraindicates injection of the fluid in the mammary area."

CITE: M 350149 -350155, Exhibit 33 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition, NOTE: The document also has the Bates Numbers DCD 173002728 -173002734 on it.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/15/76 SHELL STRENGTH - THICKNESS

Tom Talcott memo to Kelley and Rathjen, Dow Corning, discusses the recent Phoenix Breast Symposium in which Dow Corning introduced its new mammary. During the taped implantation surgery, two of Dow Corning's implants ruptured/broke. Talcott expresses dismay that at Dow Corning the consensus was that the envelope was "good enough" despite finding:

"gross thin spots and flaws in the form of significant bubbles.... The allowable flaws are written into our current specifications.... When will we learn at Dow Corning that making a product "just good enough' almost always leads to products that are 'not quite good enough'? It is unfortunate that the thinner dispersion, four dip method proved by Bartolo and Vallender in early 1974 appeared too expensive to plant personnel to even try, although a much higher acceptance rate would be obtained. I sincerely hope this experience will convince us to support programs for 'high quality' rather than 'just enough quality' in the future. (emphasis added).

CITE: F 534, Exhibit 65 to Harris County Rathjen Deposition. Exhibit to MDL Rathjen Deposition. DUPLICATE: DCC 8003157; M 600007; KMM 140185; KMM 380078.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/22/76 TESTING

Dow Corning stated a Two-Year Implant Study with Q7-2159A and MDF-0193 at Industrial Bio-Test Laboratories (IBT).

CITE: Referenced in KMM 390371. NOTE: See 02/03/78 entry.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/23/76 ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees (Mammary Task Force) regarding "Research/Testing - Mammary Gel/Envelope." Rathjen states, "I have suggested verbally and in writing that we better get going on a basic long range project relative to gel, its formulation, toxicology, etc. over and above what is now underway. The same goes for the envelope. The complaint report from Dr. Horowitz Manchester, Conn., is just one more flag." (emphasis added).

CITE: F 809, Exhibit to MDL Rathjen Deposition, and Exhibit 76 to Harris County Rathjen Deposition. DUPLICATE: M 170171: M 580066: KKA 152383: DCC 17016569: KKA88865: KMM 447050.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/16/76

Rathjen, Dow Corning, memo to the IND 2702 clinical investigators - Ashley, Blocksma, Dingman, Edgerton, Goulian, Murray, Orentreich and Rees - regarding "Proposed California Legislation To Control Injection Of Silicone Fluid." Dr. Ashley disagrees with regulating injections and states that breast injection should be a contraindication to the use of liquid silicone.

CITE: M 350147 - 350148, Exhibit 33 to Harris County Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

03/03/76 TISSUE REACTION RUPTURE

Dr. Terino presents a paper on "Technique and Results of 50 Breast Capsule releases" at the California Society of Plastic Surgeons. He reports a 36.5% rate of contracture. Also, a Dow Corning implant was removed 10 years post-op. "Upon opening the capsule bilaterally there was a thick sticky layer of silicone outside the envelope. On taking the implants out bilaterally there was no perforation from the envelope whatsoever, but there was clearly silicone on the outside. And pathology showed extensive foreign body giant cell granulomas."

CITE: M 290302 - 290306.

03/17/76 TISSUE REACTION KNOWLEDGE OF GEL BLEED

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding a paper presented by Dr. Edward Terino at the California Society of Plastic Surgeons on 03/03/76. The paper discussed a Dow Corning Silastic implant removed 10 years post-op. Silicone was found on the outside of the implant and "pathology showed extensive foreign body giant cell granulomas.... This event, as described by Dr. Terino, cannot be ignored. An attempt must be made to get an answer or explain this phenomenon before the manuscript is submitted to the J