-
- Document
#551
- 01/07/93
-
- COHESIVENESS
- LIQUID COMPONENT OF GEL
- KNOWLEDGE
OF SYSTEMIC DISEASE
- MISCELLANEIOUS
- COMPLICATIONS
- TESTING
-
- Zellner,
Dow Corning, memo to Area S&T Directors regarding
updates on D4 studies. Zellner states that studies
indicate that D4 is safe for the use as a cosmetic
ingredient, D4 has a very low toxicity level and that
Dow Corning retain the Industrial Hygiene Guideline of
10 ppm for D4 and D5. Zellner insists that these studies
were conducted by an independent group of scientists.
-
- CITE:
DCC 17005456 - 17005457, Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ---------------------------------
-
- Document
#552
- 03/09/93
-
- TESTING
-
- Paul
Klykken, Galbraith, Woodhiser, Duwe, Mudgett, Nash and
Malczewski, Dow
Corning, report which duplicates an original study
performed by Dr. John O. Naim
of University of Rochester. Both studies show that
silicone is not biologically inert and therefore can
cause autoimmune response.
-
- CITE;
DCC 267010511 - 2670010530. DUPLICATE: DCC 260000234 -
260000251. Dow
Corning
Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ---------------------------------
-
- Document
#553
- 03/22/93
-
- TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- FDA:
An FDA Talk Paper references two studies that show
silicone gel can act as
an antibody adjuvant. This supports the causal
relationship between silicone gel-filled breast implants
and autoimmune disorders.
-
- CITE:
BMS 68289 - 68291 Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
-
-
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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
-
- ---------------------------------
-
- 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.
-
- ---------------------------------
-
- 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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