Smoke Fire Documents 551

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Document #554

04/21/93

CONCEALING FROM FDA

Jim Jenkins, general counsel to Dow Corning, letter to Dr. Charles Vinnik agreeing to indemnify him whenever you are named as a defendant in lawsuits related to Dow Corning’s silicone gel-filled breast implants, except for claims of malpractice arising from surgery.... We are extending this indemnification to you because of the historical role you have played with respect to our products. In turn, you have agreed to cooperate and work together with us in defending this litigation.”

CITE: DCC 80071933 - 80071934, Exhibit to Duel Deposition, Exhibit 116 to Burda Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #555

06/14/93

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Study by Crofoot, Kolesar and Evans regarding an acute and repeated dose inhalation toxicity study with Dow Corning Z-6228 silane in albino rats. The results of this study indicate that Dow Corning Z-6228 most likely will not present a significant acute inhalation hazard. However, repeated exposures may cause injury of respiratory tract under the conditions of this study. It is recommended that further toxicological studies be conducted to investigate the effects of long-term exposure.

CITE: DCC 411000178 - 411000230 (Temporary Dow Corning Bates Number 178 -230); Exhibit 7 to Bejarano Deposition; Exhibit 6 to Bey Deposition, and Exhibit 22 to Zimmer Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #556

07/20/93

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Study by Kolesar, Hoffman, Crofoot, Kowalski. Siddiqui, Evans and Groh regarding a two-week repeated dose inhalation toxicity study of hydrogen chloride and selected chlorosilanes in albino rats.

The results of this study showed no differences between gaseous hydrogen chloride and Me3SiC1, Me3SiC13, and MeSiC13. However, microscopic examination revealed mineralization in the kidneys of females exposed to HSiC13. Whether or not this lesion represents an earlier age-related predisposition to development is not known.

CITE DCC 411000141 - 411000157; Exhibit 6 to Bejarano Deposition; Exhibit 7 to Bey Deposition, and Exhibit 23 to Zimmer Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #557

09/01/93

TESTING

KNOWLEDGE OF GEL BLEED

KNOWLEDGE OF SYSTEMIC DISEASE

Malczewski, Woolhiser, Mudget, Duwe, Galbraith, Nash and Klykken, Dow Corning, report on “A Humoral Adjuvancy Study In The Rat Of Dow Corning Silicone Gel (Q7-2159a) Preparations And Mammary Gel Bleed.” All three sheared mammary gel/BSA preparations demonstrated comparable antibody responses to the positive FCA/BSA control and were significantly greater than that of the non-adjuvant control at 4, 6, and 8 weeks post-immunization. The ability of sheared silicone gel preparations to elicit an adjuvant response does not appear to be a preparation-dependent phenomenon under the conditions of this assay. The adjuvancy potential of mammary gel may not be primarily dependent on the preparation technique. Mammary gel bleed did not elicit an adjuvant response following i.m. administration. The antibody levels generated from this group were equivalent to the non-adjuvant control at all time points measured.

CITE: OOT 48639 - 48655, Exhibit 9 to Klykken deposition in Harris County. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #558

11/24/93

CONCEALING FROM FDA

FRAUD/MISREPRESENTATION

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

TESTING

Study by Busey titled “Audit Report For Dow Corning Corporation Project Number

7088 - A Life-time Implant Study With Dow Corning Q7-2159A In Rats.” The raw data did not appear to have been reviewed in a timely fashion. Deficiencies were detected in the accountability and identification of the animals on study. Raw data was deleted for no apparent reason. Records for the receipt, distribution and archiving of the control article were not present or were incomplete.

Records for the transfer of samples, namely blood samples, within the laboratory were not present. Some of the maintenance records for the balances used on this study were not present. The printed protocol and its amendments were incomplete with regard to identifying personnel assigned to the study, specifically the current study director and pathologist.

CITE: DCC 411000615 - 411000765, Exhibit 10 to Bey Deposition, Exhibit 45 to Zimmer Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #559

01/25/94

CONCEALING FROM FDA

FRAUD/MISREPRESENTATION

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

TESTING

Study by Busey titled “Audit report For Dow Corning corporation Master Schedule Number M8616-0 EPL Project Number 287-005-Biodurability And Tissue Compatibility Of Optimized 55- and 70- durometer H.P. Elastomers.”

No data were present documenting how or where the control samples of each test material were selected and stored control samples were inconsistently used. Some samples were not tested within 48 hours of implant retrieval as specified by the protocol. The test material receipt log does not document the receipt of the DeMattia Bars. There are no precise test article accountability records. There were several inconsistencies among the daily observations, veterinary records and material removed records concerning the loss and re-implantation of implants. The animal daily observation records indicate that daily observations were not recorded after 9/16/87 as specified by the protocol. No dogs were sacrificed at the 6 month interval. There were no environmental records. There were no raw data documenting the histologic preparation of the capsule tissue collected at necropsy. No raw data were present documenting the collection or preparation of the tissue samples for transmission electron microscopy.

CITE: DCC 411000580 - 411000614, Exhibit 11 to Bey Deposition, Exhibit 46 to Zimmer Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document #560

05/25/94

TESTING

TISSUE REACTION

Study by Kolesar, Evans, Hoffman, Siddiqui and Heffel regarding a 14 day repeated dose inhalation toxicity study of Dow Corning X1-6145A additive in albino rats.

No apparent treatment-related clinical signs were observed in animals exposed to 50 ppb of the test material. Statistically significant decreases in body weight were observed in body weight were observed in males exposed to 100 and 200 ppb and females exposed to 200 ppb. Relative liver, kidney, and adrenal weights were increased in males in the 200 ppb group. Also, relative liver weights were increased in females in the 200 ppb group. All lesions in the lung and other organs examined microscopically were considered agonal or spontaneous and unrelated to test article exposure.

CITE: DCC 411000001 - 41000140; Exhibit 8 to Bey Deposition, Exhibit 8 to Bejarano Deposition, and Exhibit 24 to Zimmer Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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Document # 561

06/29/94

FRAUD/MISREPRESENTATION

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD TESTING

Mast, letter to Bejarano regarding the inappropriate actions he took in connection with his responsibilities in Dow Corning’s Health and Environmental Sciences Laboratory; four animal studies; tissue taken from one particular animal and characterized the tissue as being taken from other animals. Bejarano’s early retirement has effectively positioned him to avoid the severe disciplinary actions warranted by his misconduct. Dow Corning cannot overlook the harm that has been done to it and people who depend upon it.

CITE: BEJ 393, Exhibit 15 to Bejarano Deposition.

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Document #562

08/15/94

CONCEALING FROM FDA

FRAUD/MISREPRESENTATION

TESTING

Dow Corning study titled “A Chronic Implant Study in Rats with Dow Corning Q7-2423 and Q7-2551 Elastomers: Audit of Pathology Materials” by Experimental Pathology Laboratories, Inc. The report states:

“The results of the initial slide/block comparison of 20% of the animals revealed several identification discrepancies between the slides and blocks and several slides with missing blocks.”

“This audit revealed several discrepancies in the conduct of the histology phase of the study.”

“The detailed findings from the audit of the blocks and slides and supporting documentation are presented in Appendix A. In addition to the cutting of duplicate slides, a variety of other discrepancies were noted in the identification and histologic preparation of the slides on this study.

CITE: DCC 411000769 - 411000965, Exhibit 4 to Bey Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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