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Document
#51 COHESIVENESS-LIQUID
COMPONENT OF GEL Silicone
Injection committee Meeting on 05/16-17/64 attended by D.J. Badamo, S.
Braley, C.E. Haberstoch, R.R. McGregor, E.G. Mullison, S.L. Bass,
H.D. Dingman, E. Hodnett, M.J. Hunter, J.A. McHard, A.W. Rhodes and L.F.
Stebleton of Dow Corning; by Drs. Ashley, Blocksma, Dingman, Edgerton,
Goulian, Lederer, Murray and Rees, who are medical consultants; and by
Steve Carson and Bernard Oster of Food & Drug Research Laboratories.
Materials considered for the injectable trials: dimethyl siloxane 360
Medical Fluid “(formerly 299 fluid)”; phenylmethyl siloxanes
including 555- “cyclic, very low molecular weight, 704 - linear, very
low molecular weight, 550 - dimethyl and phenylmethyl copolymer; large
amount of phenyl....” and others. CITE:
DCC 267371390 - 267371417, Exhibit to McHard Deposition, and Exhibit to
K.
Document
#52 FRAUD/MISREPRESENTATION Braley
memo to Ashley, Blocksma, R. Dingman, Edgerton, Goulian, Lederer,
Murray, Rees, Badamo, Bass, H. Dingman, Haberstroh, Hodnett, Honter,
McHard, Mullison, Rhodes, and Stebleton regarding the attached article
in the May 25, 1964 issue of “The Insider”s Newsletter.” Unknown
factors with silicone injections include absorption, migration and
hardening.. Braley writes, “We have no knowledge where the reporter
obtained this information. If anyone knows anything about this, we’d
appreciate hearing from him. We are trying to keep such articles as this
out of the public eye as much as possible.” CITE:
M 350063 - 350064. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#53 Thomas
Rees letter to Braley, Dow Corning, regarding the finding of altered fat
cells in animals sub-cutaneously injected with silicone. Rees states
that the spleens of the mice that have been injected with massive
amounts of the material show definite collection of silicone within
macrophages. CITE:
KMM 167416. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#54 Letter
from Dr. Thomas Cronin to William Rhodes, General Manager of Dow
Corning. Dr.
Cronin reports that Dr. Brauer had to remove seven implants when, at CITE:
KMM 150269 - 150270. NOTE: Ivory flakes were being used to prepare the ----------------------------- Document
#55 EMBOLISM Harry
Dingman, Dow Corning’s Legal Counsel, writes to Ban Smart of the FDA
and informs him of a reported fatality following injection of a
silicone. Dr. Crenshaw,
California, injected a woman with silicone (source and type unknown)
mixed with a vegetable oil. she “then went into a coma in a matter of
a few hours, and died within a few days. Dr. Aronow had not received a
formal coroner’s report, but the informal comment was to the effect
that death was due to fat emboli in the lung and possibly in the liver.
A suspicion of possible encephalitis was being checked by having a
culture run on the brain.” (emphasis added). CITE:
KKM 1275 - 1276. DUPLICATE: KMM 48637 - 48638. Dow Corning Trial Exhibit
----------------------------- Document
#56 “Tissue
Reactions to Injected Silicone Liquids, A Report of Three Cases,”
Archives of Dermatology, Vol. 90, 538-593 by Winer, Sternberg, Lehman
and Ashley. Drs. Oppenheimer and Russell observed fibrosarcomas
developing in 1.7% to 40% of the test animals. Drs. Hur and Neuman
observed malignant epithelial tumors that were believed to be of sweat
gland origin. The conclusion drawn from the test data is that “there
seems to be sufficient evidence at this time that complications of this
nature are to be expected.” CITE:
I 253 - 259, Exhibit 7 to McGhan Deposition, and Exhibit 16 to
California ----------------------------- Document
#57 KNOWLEDGE
OF LIQUID SILICONE DANGERS Dr.
Franklin Ashley writes to Silas Braley, Dow Corning, regarding a “girl
in Las Vegas who received the injections and had the eye trouble.” The
28 year old woman received 30 injections into the breast. Ten
to fifteen minutes following her final injection she noted onset of
nausea followed by dizziness and almost complete loss of vision. At the
same time she developed severe left anterior chest pains without dyspnea
or tachypnea. She was seen
by an Internist who treated her with ACTH thinking that this possibly
represented an anaphylactoid reaction. Visual disturbance cleared
somewhat with ACTH. During this immediate post treatment period she
experienced some loss of memory, as well as poor coordination which
cleared gradually over a period of time. Also noted during this time was
hematuria which lasted for one day only; no recurrence has been noted. One
week following the onset of symptoms she was evaluated by Dr. Albouth,
at which time he noted a questionable positive Rhomberg and
ophthalmologic findings consisting of some loss of visual acuity and
hemorrhages within and anterior to the retina. Follow-up
to date has been over a six month period with the latest notation that
her gait has returned to normal. Her dizziness has disappeared, but she
still experiences some visual difficulties, specifically loss of visual
acuity. (emphasis added). CITE
KKH 63126 - 63127. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#58 KNOWLEDGE
OF LIQUID SILICONE DANGERS Franklin
Ashley, UCLA Center for the Health Sciences, to Braley, Dow Corning,
reporting the death of a patient after various injections of silicone
around the face. (emphasis added). CITE:
M 340057. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#59 CONCEALING
FROM FDA Dr.
Franklin Ashley responds to Silas Braley’s, Dow Corning, letter
concerning a girl in Argentina who was injected with large amounts of
silicone fluid. “I believe this would fit in also with the
observations of Goulian and others where a large quantity was injected
any one time, and was taken up by the lymphatics.
We have not observed this in any of our cases, however, probably
due to the fact that we inject only a small quantity each time.... I do
not think this should be reported to the FDA as it is an isolated case
and from another country, and we do not know exactly what they injected
really.” (emphasis added). CITE:
M 340044. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#60 EMBOLISM Frank
Ashley, M.D., reports to Silas Braley of Dow Corning regarding a
consultation with a patient in Las Vegas. Ashley states, “My
diagnosis, of course, was multiple silicone emboli from the liquid
silicone and possible additives, in the lungs, brain, liver, kidney and
retina.” (emphasis added). CITE:
M 340037. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#61 06/24/65 KNOWLEDGE
OF LIQUID SILICONE DANGERS Dr.
T. Rees writes a letter to Dr. Silas Braley and Fred Dennett, Dow
Corning Center for Aid to Medical Research. Dr. Rees states “The
inevitable has happened. We found a case of carcinoma of the breast in a
37 year old woman who has had both breast heavily injected with pure
silicone material.” He states’ “The carcinoma itself was a very
small, isolated, intraductal type of carcinoma in the upper portion of
the tail of the breast and there were some involved lymph nodes in the
axilla. There are multiple ‘silicone cysts’ throughout the tissue
and some of the silicone was injected in the immediate vicinity of the
carcinoma. Also of considerable interest is that there is evidence of
silicone deposits in the lymph nodes of the axilla and thus it appears
that the silicone is drained to a certain extent by the lymphatic
system..... We are thinking of writing this up as a case report, but
would like the view of the entire committee before we commence doing so.
We are hesitant to report it because undoubtedly it will create quite a
stir but feel that the case must be reported for the sake of
thoroughness and completeness. We are open to counsel as to just what
manner this should be done. (emphasis added). CITE:
KMM 105815 - 105816, Exhibit to D. McGhan Deposition. DUPLICATE: KMM
3802 ----------------------------- Document #62 ACKNOWLEDGEMENT
OF NEED FOR TESTING Hobbs
memo to Snedeker with copies to McHard regarding “Recommendations for
the toxicological evaluation of J. Treated Dow Corning Silica Type A.”
“At the present time very little is known on the toxicity of the
various treated silicas at Dow Corning.... The exact toxic
manifestations are unknown. They will cause death in laboratory animals
by various routes of administration, including inhalation, for a period
of four hours or less. Although these are high concentrations for a
short period of time. we must assume until proven otherwise that low
concentrations over long periods of time are detrimental to health. It
is therefore our recommendation that acute range-finding studies be
performed on J Treated Silica.” Testing programs (such as annual chest
x-rays of workers) have been run with the cooperation of the Dow Medical
and Biochemistry Departments on problems which have arisen with various
chemicals. The programs at Dow and Dow Corning were dropped but,
“Recently problems have arisen with chemicals and compounds which
indicate that such a preventative medical testing program is not only
desirable but also advisable.... While toxicity studies are being
carried out on some of these materials at the Dow Biochemistry
Department, they are made with animals, usually on short term acute
exposures. This type of information does not indicate what might happen
over long periods of time subjected to less than acute exposures.” The
document also talks about a Medical-Biological-Safety Committee.” CITE:
KKA 230245 - 230249, Exhibit to McHard Deposition and Exhibit to K.
Olson ----------------------------- Document
#63 ACKNOWLEDGEMENT
OF NEED FOR TESTING Burdick,
Dow Corning, memo to Don McGhan, Weiler, VerVoort, and Pellikka
regarding “Mammary Implants.” He states: “There
are still a number of questions concerning our breast units that have
not been answered. We know that a quantity of low molecular weigh
material is exuding from the bag, but that is all. He
suggests a test to extract the material and analyze it. Burdick states: “This
test should tell us how the gel is affecting the rubber bag. Adhesion
and tear strength should also be related to swell. The extractables may
be of low enough molecular weigh to migrate throughout the body. If so,
what quantity are we talking about? CITE:
OOM 321439 - 321449, Exhibit to Bennett Deposition and Exhibit to D. ----------------------------- Document
#64 EMBOLISM Dr.
Ashley authors a paper, “Silicone Fluid And Soft Tissue Augmentation,
as a result of the Boca Raton symposium. “Of significance is the fact
that the clinical use of silicon liquids in man preceded any responsible
and controlled experiments in animals.” As a result of the concern,
ASPRS set up a committee consisting of Dr. Franklin Ashley, Dr. Ralph
Blocksma, Dr. Reed Dingman, Dr. Milton
Edgerton, Dr. Dicran Goulian, Jr., Dr. Francis Lederer, Dr. Joseph
Murray, Dr. Norman Orentreich, and Dr. Thomas Rees.
Dr. Ashley provides a historical overview of the chemical
properties and development of silicone. He notes that with intravenous
injection of silicone fluid in animals, large doses are usually fatal in
rabbits and can produce emboli and death in dogs. He found no tissue
reaction in animals when liquid silicone was injected subcutaneously. Dr.
Ashley also notes that silicone oil “will have a tendency to
disappear” within the body and that: “(S)ignificant
questions ... remain unsolved. First, what is the body distribution
within its tissues of any absorbed material? Second, what is the
ultimate fate of the absorbed material? ... Third, if significant
amounts are absorbed, does the body excrete the material, and if so,
how, and how much? Fourth,
if some is retained, in which organ or organs is a harmful effect
produced - if any? Indeed, there is some evidence that silicone oils may
be transported to far removed tissues and organs. In another study, one
week after the intramuscular injection of a rat with dimethyl
polysiloxane, 90 per cent of the C(14) labeled liquid oil was detected
within the tissues of the intestinal tract. The fate and presence of
silicone oil in human biology is unknown.” (emphasis added). He
further notes that, “In large subcutaneous injections of silicone
fluid, examination of the contents of the abdominal cavity showed that
the mesenteric and omental fat was abnormally firm, with loss of normal
color and adherence to adjacent viscera. This suggests that there may
have been transport of silicone oil through the abdominal cavity.”
(emphasis added). Animal
studies of injection of RTVS 5392 silicone fluid showed tumor
development in rats at eight, fifteen, and nineteen months after
injection. MDX 44010 silicone fluid was also injected in mice, rats and
monkeys. Nearly all animals developed hair loss over the implanted site,
and several rats developed superficial cutaneous ulcers directly over
the silicone mass. Both of these symptoms resolved themselves within six
weeks. He also noted a significant “exothermic reaction,”
“pronounced local reactions,” and tumor development in 3 of 6 rats
at 14 and 16 months post-injection. He concludes: “Although
it is only speculation, the initial exothermic injection reaction and
tissue injury may have provided a carcinogenic influence.... (T)he
incidence of 3:6 (3:22) should not be attributed to random chance
occurrence.... Tumor formation about buried synthetics has had important
consideration by some, but discounted by others.... (A) tumor incidence
of 3:6 or 3:22 indicates a need for further animal experimentation.”
(emphasis added). He notes that human clinical experience in 35 patients
noted breast abscess and apparent tumor formation. He reports on three
cases of carcinoma of the breast in women following injection of
silicone fluid. One woman developed a palpable axillary lymph node eight
months following injection and required a radical mastectomy.
Surrounding the cancerous lesion were “multiple small silicone cysts.
The silicone was also found in the axillary lymph modes removed with the
radical specimen.” “At least two deaths are known to have followed
the subcutaneous injection of 100.0ml. or more of Dow Corning 360
Medical liquid given in one single administration.... At least one
patient is known to have developed blindness during the subcutaneous
injection of Dow Corning 360 Medical liquid.... There is no reason to
believe that the human will tolerate intra-arterial and/or intravenous
injections any better than the experimental animals. (emphasis added). CITE:
M 360096 - 360141. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#65 ACKNOWLEDGEMENT
OF NEED FOR TESTING McHard
memo to Bass with copies to Bennett, Dingman, Hunter, W.T. Rossiter and
Rowe regarding “Toxicological testing of Dow Corning Pan Shield.”
McHard is reporting on the results of a meeting today with Rowe and
Bennett regarding DC Pan Shield. An initial formulation of this product
indicated no apparent toxicological problems. However, the catalyst
wasn’t potent enough to cure on the pan; therefore a new catalyst was
used and the product reformulated. Based on the results of the testing
with the first catalyst, no toxicological problems were anticipated and
so marketing decisions were made about the product. As they got into the
90-day testing program, the toxicological information was insufficient
to assure the degree of product safety necessary. Therefore, Rowe,
Bennett and McHard met today (1/14/66) to review this product. “(I)t
is our recommendation that marketing studies, even short-termed pilot
tests, be postponed until product safety data can be accumulated.”
“There are indications that adequate non-toxic oral levels may not be
achieved. “It should also
be borne in mind that if Dow Corning were obliged to defend the safety
of this product today in a court of law, we would be at a serious
disadvantage since we could be forced to disclose all data which has any
bearing on the components of the product. You can well appreciate what
our position would be in this event?” CITE:
DCC 281041086 - 281041087. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#66 ACKNOWLEDGEMENT
OF NEED FOR TESTING Minutes
of meeting with the FDA in Washington DC regarding Dow Corning 555
Fluid. Present were Steve Carson and Bernard Oser (FDRL), Otis Fancher (IBT),
Bass, Bennett, Dingman and McHard (all of DC) and Drs. Lehman, Marzulli
and Nelson with the FDA. McHard reported on the chemical composition of
DC 555 and a summary of Dow Corning’s 555 fluid Safety Evaluation
Program. DC 555 has been used in cosmetic preparation for 12 years. It
was decided to have more detailed subacute tests performed on rabbits at
IBT. The testicular size of the test rabbits was reduced and
spermatogenesis was depressed on microscopic examination. The effect was
traced to the DC 555 fluid in the hand cream. FDRL then evaluated the
fluid and found no such activity in rats or guinea pigs, noted a
marginal effect in dogs, and observed activity in the rabbit but not as
severe as that noted at IBT. “A
consultation was held with Drs. Oster*, Carson*, Calandra (Industrial
Bio-Test Labs.), and Rowe, toxicologist of the Dow Chemical Company.
These consultants felt that the data were indicative of a species
specific response and therefore it was suggested that a male monkey
series be started in which the material would be applied dermally
repeatedly.” The studies were done at IBT. A dose applied dermally
repeatedly.” The studies were done at IBT. A dose of 5 mg.kg. produced
a statistically significant effect. McHard mentioned that “the effect
requires 20 days of daily application in the rabbit, but the effect is
not grossly present until the 16th-17th day.: Oral
studies in monkeys was begun in 1965. It was noted that in the orally
dosed males, it was difficult to obtain ejaculate and a subsequent
biopsy at 5 months of oral dosing in the males showed a marked
depression of spermatogenesis at the 2000 mg.kg. level, and 2 of 3
monkeys showed spermatogenic depression at the 50 mg.kg. level. McHard
commented on the isolation of chemical species to determine the active
agent. Dow Corning has not yet identified the specific structure which
causes the observed systemic effect. McHard also commented on the
quality-control of the product. McHard also noted that no ill effect had
been observed or reported from people at Dow Corning exposed in the
production area. Dingman hoped that the findings on DC 555 fluid would
not cast any reflections on DC medical grade 360 fluid or industrial
grade 200 fluids. CITE:
KMM 418744 - 418775, Exhibit to Bennett Deposition, Exhibit to Rowe ----------------------------- Document
#67 KNOWLEDGE
OF LIQUID SILICONE DANGERS T.
Rees, et al., submits to Dow Corning a report titled “Visceral
Response to CITE:
KKM 31076 - 31087. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#68 KNOWLEDGE
OF LIQUID SILICONE DANGERS Braley
memo to Ashley, Blocksma, Dingman, Edgerton, Goulian, Lederer, Murray,
Orentreich, Steve Carson, Bennett, Bennett, Hunter and McHard regarding
the attached letter and paper from Thomas Rees. Rees’ letter is dated
7/26/66 and notes that this is a privileged communication. “I hope
this work doesn’t open a can of worms but I can’t see any
alternative to publishing it.” The draft paper notes that subcutaneous
administration of massive amounts of silicone produces considerable
alteration of the tissue structure of the subcutis. The fat cells in the
immediate vicinity of the encapsulated silicone show varying degrees of
atrophy and the intracellular fat contains small regular vacuoles.
Intraperitoneal injections or subcutaneous doses in excess of a
total dose of 7 ml in mice resulted in widespread microscopic lesions by
3 months. The silicone also produced a generalized alteration of the
abdominal and epicardial adipose tissue. The fat cells showed a finely
granular, eosinophilic cytoplasm. “In many abdominal organs which
included adrenals, lymph nodes, liver, kidney, spleen, pancreas, and
ovary, focal infiltrates of macrophages with abundant clear cytoplasm
were encountered. The nature of the cytoplasive material within the
macrophages has not been ascertained, but it is presumed to be silicone
as those lesions did not occur in control animals. The early adrenal
lesions were found at the corticomedullary junction; as the lesions
become more extensive they extended through the entire cortex. In the
liver. lesions were observed in all parts of the hepatic lobule. The
results of this study indicate that dimethylpolysiloxane fluid is
deposited in the spleen, liver, adrenals, pancreas, ovaries, abdominal
lymph nodes, and kidneys of mice when given by intraperitoneal injection
of small amounts or by subcutaneous injection of large amounts, 7-8 ml.
Smaller subcutaneous doses, 1 ml. of liquid silicone in the same animal
species occasionally causes similar lesions which occur only in the sona
reticularis of the adrenal glands.” “The mechanism of absorption and
systemic distribution of silicone fluid in mice is still unknown. Venous
embolism or phagocytosis with distribution in the reticuloendothelial
system seems to be likely possibilities. Most visceral lesions did not
occur prior to three months following injection except in isolated
instances. This delay seems to implicate the reticuloendothelial system
as being the most likely method of transfer.” CITE:
KMM 31074 - 31087. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#69 MISCELLANEOUS
- ORGANIZATIONAL SURVEY CITE:
TDC 11625 - 11627, Exhibit to Bennett Deposition and to Julius Johnson ----------------------------- Document
#70 KNOWLEDGE
OF LIQUID SILICONE DANGERS Memo
from Don McGhan (at Dow Corning) to McIntyre with copies to Pellikka,
Hutchison, Bennett, Burdick, Weiler and Diamond regarding “Biological
Testing of 360 Fluid, Our Project No. 5152.” Steve Carson of FDRL,
Harry Dingman of Dow Corning’s legal staff, and McGhan “strongly
suggest” that Dow Corning not proceed with biological testing of Dow
Corning 360 fluid in containers smaller than 440 pounds. McGhan asks
McIntyre to “review your marketing objective for 360 Medical Fluid and
determine if biological labeling and certification is required in
container sizes smaller than 440 lbs. in order to increase sales of the
product.” CITE:
KKA 7168, Exhibit to D. McGhan Deposition. Dow Corning Trial Exhibit
List ----------------------------- Document
#71 MISCELLANEOUS
- COMPLICATIONS “Chemical
Research Progress Report (Restricted), Report No. 2964,” by R. McCarty
and J. Speier - all of Dow Corning. Dr. Hunter established a committee
of Bennett, Hobbs, McCarty, Stark, Weyenberg and Speier to isolate and
identify a pharmacologically active substance believed to be present in
DC 555 fluid.. Silanols are
referenced on DCC 281002126 - 281002126 - they are “profoundly
toxic” and have effect as a CNS depressant. Silanols have been under
study since 10/65. There is a reference to the Mellon Institute on DCC
281002127. Also note that Dow Corning was using Dow Chemical’s animals
and testing facilities. CITE:
DCC 281002121 - 281002162, Exhibit to Bennett Deposition, Exhibit to ----------------------------- Document
#72 ACKNOWLEDGEMENT
OF NEED FOR TESTING Rowe
memo to McHard with copies to Bennett, Dingman, Heuerman, and Hunter.
This memo is in reply to the 12/16 memo from McHard on Product Safety.
Rowe has looked over the IBT testing outline and feels that “in
general, (it) contains the type of information I believe is necessary.
However, I do believe that some of the work which has been listed should
be done at an earlier stage and a minimum of liability.” Rowe gives
advice on the types of tests and the timing of the necessary tests in
his critique of the IBR testing plan. Further, “I also have my doubts
about the wisdom of selling the material, even though it is intra-state,
before you at least have long-term studies going, and the data indicates
no likely hazard. I realize that intra-state sales can be made without
FDA approval, but nevertheless, if you were challenged, I fear that you
would have difficulty in convincing any court that you had acted in a
responsible way even though you might be within the limitations of the
Federal Food, Drug, and Cosmetic Act.” He states that he will be happy
to discuss any of these matters further with McHard. CITE:
DCC 281041120. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#73 ACKNOWLEDGEMENT
OF NEED FOR TESTING Minutes
of the meeting of the Executive Committee. Includes notes regarding a
joint agreement with The Dow Chemical company pertaining to certain
silicone products designated as DC-555, DC-555A, and compounds derived
from and related thereto, and a joint development agreement relating to
the physiological effects resulting from ingestion or injection into the
systems of animals and men of particular physiologically active
silicones. CITE:
DCC 1010001438 - 101001440, Exhibit to Bennett Deposition, Exhibit to ----------------------------- Document
#74 “Report
to Dow Corning Corporation Rabbit Teratogenic Study, TX-114,” by
Industrial Bio-Test Laboratories. Nine test groups consisting of fifteen
pregnant does were used in this study. It appears that TX-114 produces
no adverse effect upon maternal growth or upon the ability to carry the
reproduction process successfully form six to eighteen days inclusive.
The number of resorption sites noted appears to be proportional to the
total amount of material administered. It is felt that this reflects
system damage to the maternal organism which obscures the secondary
effect upon the developing fetal system. At a level of 200 mg/kg
subcutaneously, slight alterations (clubbing of extremities and
umbilical hernias) were observed in proportions which approach the upper
limits of an expected non-treatment group. “(I)t is felt that the
material is non-teratogenic. However, the incidence of abnormalities
seen at lower levels, especially 200 mg/kg, would lead to a conclusion
that the teratogenic potential of the material should be investigated in
at least one other species and possibly in another rabbit strain.”
Eldon Frisch, Dow Corning, in a 12/331/87 document, claims that this
study was inconclusive. “©lubbing of extremities and umbilical
hernias were near the upper limit....” (emphasis added). CITE:
I 661 - 702. DUPLICATE: KMM 115833 - 115873; (Referenced in KMM ----------------------------- Document
#75 KNOWLEDGE
OF GEL BLEED “Discussion
Of Toxicology Of Various Dow Corning Products.” A meeting was held on
02/16/67, present were Steve Carson (FDRL), Fancher (IBT), V.K. Rowe
(Dow Chemical), Bennett, Boone, Braley, Bennett, Dingman, Hobbs, Hunter,
Don McGhan, McHard and Radzius. They discussed the IND’s on file with
the FDA including the IND for burned hand, the silicone injection IND,
the bladder treatment IND, applications for Silastic rubber dental liner
and dental impression material such as permanent tooth implants using
Silastic rubber to anchor tissue contact material, implant testing on
new or modified formulations, corneal implants, in-dwelling catheters,
needle and syringe treatment, DC 360 medical fluid, elastomer for
coating pacemakers, comparison of the reproductive studies carried out
at FDRL including the findings of club footing and resorption as a
result of the treatment, DC FS-1265 fluid and foot and hand protector
products (“A recent report as a result of a one-year feeding in rats
did seem to show a dose-related effect on testis and accessory sex organ
weight but V.K. Rowe thought that because of the species difference and
the time involved in the test and the fact that the test was oral and
not dermal and since all of the dermal data looked good, there should
not be any reason to suspect this product” (DCC 281041880), and tests
on Dow Corning 555 fluid and 360 medical fluid.
A discussion was also held on the different viscosity grades of
“Dow Corning 200 fluid or Dow Corning 360 fluid” compare with regard
to polymer size distribution. Although higher viscosities show broader
distributions, “there appears to be almost as much of the lower
polymer ends in the 350-centistoke” as in the lower viscosities.
(DCC281041877). The agenda is located at 281041882. CITE: DCC 281041877 - 281041882, Exhibit to Bennett
Deposition, Exhibit to McHard Deposition, Exhibit to Rowe Deposition,
and Exhibit to LeVier Deposition. ----------------------------- Document
#76 MISCELLANEOUS
- COMPLICATIONS “Summary
of Toxicological Testing of Dow Corning FS-1265 Fluid and Ointment, Foot
Protective” by “jar” (Joseph Radzius). It was reported to the FDA
in June 1966 that Phenylmethyl polysiloxane - DC 555 fluid - exhibited
biological activity, i.e., a depressant effect on spermatogenesis and a
reduction in testicular size. Dow Corning elected to withdraw the
product form the market. Very
recently Dow Corning received a report from FDRL on a 12-month oral
administration of FS-1265 fluid in rats which also showed a dose-related
spermatogenic arrest, depressed testicular and seminal vesicle size
similar to that observed for 555 fluid. Thus, this fluid also exhibits
biological activity. CITE:
DCC 281041861 - 281041863. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#77 TESTING Dow
Corning study titled “Biologically Active Organosilicon compounds,
Report No. 3035,” by McCarty, Lee and Burk. Test data on 83
organosilicon compounds which have proved active in biological screens.
The activity listed includes anti-cancer, anti-malarial, anti-echistosomasis,
anthelmintics, soil bonding agents, premergent herbicides, post-emergent
herbicides, anti-coccidiosis, fungicides and bactericides, contact
insecticides, fumigants, anti-crusting agents, and general
pharmacological screen in which the compounds were examined for use in
drugs. Dow Chemical does the screen on agricultural, animal science,
solvent stabilizers, etc. on these compounds. CITE:
DCC 281002231 - 281002247, Exhibit to Tyler MDL and Harris County ----------------------------- Document
#78 KNOWLEDGE
OF LIQUID SILICONE DANGERS S.
Carson, Food and Drug Research Laboratories, issues report entitled
“Summary of Histopathological findings in Primates.” Findings
include cystic spaces with vacuolated cell and a few foreign body type
cells in soft tissues and around minor salivary gland tissue and
skeletal muscles, cystic spaces with vacuolated cells and foreign body
type giant cells in both breasts, acute necrotizing pneumonitis in the
lungs, similar changes in the submaxillary gland, degenerative changes
in the kidneys, pleural fibrosis and edema in the lungs, small and large
cystic spaces in the dermis and subcutaneous tissues, focal
calcification in the adrenal glands, chronic stomach inflammation, and
chronic phclonephritis in the kidneys. Include letter sent from F.
Ashley to S. Carson dated 12/02/66 enclosing pathological slides showing
area and amount injected and the autopsy date of the animal. Includes
letter from S. Carson to S. Sternberg
dated 01/04/67 enclosing slides prepared from tissues of sumi apes sent
by Dr. Ashley; a member of the Silicone Injection Committee of the Dow
Corning Corporation (Carson and Food and Drug Research Laboratories are
consultants for Dow Corning Corporation). Carson writes: “The
tissues which Dr. Ashley submitted together with information regarding
total volumes injected and the date of the last injection (copy
enclosed) represent some of the most critical tissues available in the
United States since they involve between two and three years of chronic
study....This material represents the closest parallelism to human
experience that we have been able to obtain in any animal studies to
date. ...
We have mentioned that this material is precluded from use in mammary
tissue augmentation. However there is a considerable black market in a
Japanese product which contains a similar silicone fluid with some type
of oil.” CITE: T 822 - 832, Exhibit 107 to Harris county Rathjen
Deposition. DUPLICATE:
F 316 - 326. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
(On PLAINTIFF’S LITERATURE LIST) (this
is between #78 & #79) 04/00/67 (ON
PLAINTIFF’S LITERATURE LIST) F.
Ashley, S. Braley, T. Rees, D. Goulian and D. Ballantyne author “The
Present Status of Silicone Fluid in soft Tissue Augmentation”
published in Plastic and Reconstructive Surgery, Vol. 39, No. 4,
411-420. The clinical use of silicone liquids in man preceded any
responsible and controlled experiment in animals.
The unresolved problem related to silicone is migration to
distant organs, cautioning against its use for mammary augmentation. The
authors report one case of unnecessary force during the injection of
silicone that may have caused blindness in one patient by possibly
disrupting the arterial or venous system. They also caution against using silicone fluid with any
additives such as olive oil. CITE:
PSC Medical Articles CD, J 157 - 166. Dow Corning Trial Exhibit List ----------------------------- Document
#79 GEL
MIGRATION “Reproduction
Study, Albino Rats, TX-114, Dow Corning Tox. File No. 1059-5”
conducted by Industrial BIO-TEST Laboratories, Inc. and sponsored by Dow
Corning Corporation. PDMS, 350 cs., was tested for its effects on
fertility, reproductive performance, embryongenesis and perinatal and
postnatal performance in rats and rabbits. Albino rats given up to 1000
mg of TX-114 per kilogram of body weight daily by subcutaneous injection
show normal growth patterns, have the desire to mate and the ability to
conceive, carry the reproduction process to parturition and are able to
successfully nourish the resulting progeny. The offspring are free of
external and internal malformations and are judged to be normal as
indicated by both normal survival indices and progeny body weights.
Treatment with TX-114 from implantation through the completion of
organogenesis did not produce teratogenic effects in the rat. Lactation,
measured in rats by dosing parental animals from the end of fetal
organogenesis through the lactation period, was unaffected by daily
subcutaneous administration of TX-114. CITE:
P 13605 - 13611. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#80 KNOWLEDGE
OF LIQUID SILICONE DANGERS “Studies
of the Effects of Dow Corning 360 Medical Grade fluid (MDX-4-4011) on
Reproduction in Rats and Rabbits” conducted at Food and Drug Research
Laboratories and sponsored by Dow Corning. This polysiloxane compound
was subcutaneously administered to rats and rabbits. One significant
effect is a dose-related incidence of in-utero mortality at 200mg. and
1000 mg. during the third trimester of rat pregnancy. (FDA 26359 -
26377: T001064 - 001103). Eldon Frisch, Dow Corning, in a 12/31/87
document claims that this study was inconclusive. The fetuses of some
rats had “slight increase in frequencies of incomplete developed
sternebra and incomplete closure of cranial bone. Some rabbits in the
FDRL study had slightly higher in utero mortality.” CITE:
T 1064 - 1103 (Referenced in KMM 407480 - 407482). NOTE: See 12/31/87 ----------------------------- Document
#81 “Dip
Coated Mammary”, project no. MD-50 by P. Lange, L. Crusen. This report
constitutes the final phase in the transfer of Medical Development
Project No. 50, dip Coated
Mammary, to the Medical Products Plant. This report contains the raw
material specifications, formulations, manufacturing procedures,
formulation specifications and the dip coating procedure and
specifications. CITE
KMM 320434 - 320454. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#82 CONCEALING
FROM FDA MISCELLANEOUS
- RECKLESS/CONSCIOUS DISREGARD Women’s Wear Daily article titled
“Dow Corning Indicted on Breast Expanding Fluid.” charges include
illegal distribution and improper labeling of Medical Fluid 360. It is
charged that the labeling failed to include adequate directions for use
and adequate safety warnings. The indictment also charges that the drug
had not been approved by the FDA and had not been exempted from the
normal requirements of the Food, Drug and Cosmetics Act. CITE:
GEG 8984 - 8986. Dow Corning Trial Exhibit List Abstracts ---------------------------- Document
#83 TESTING J.
McHard, Dow Corning, memo to I. Hutchinson, Bennett, Dingman, Hunter and
Don McGhan describing the policy in the toxicological evaluation of
Silastic silicone rubber for implant use. It involved a two year
implantation in dogs with one interim sacrifice in six months. Providing
there was no toxicity and tissues looked normal, marketing could begin
after six months. Based on recent information from the Medical Products
Division, he believes that Dow corning is not strictly adhering to its
toxicological evaluation policy. CITE:
KMM 337147. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/privileged & Confidential ----------------------------- Document
(NOT ON PLAINTIFF’S EXHIBIT LIST) (this
is listed between #83 & #84) 10/30/67 (NOT
ON PLAINTIFF’S EXHIBIT LIST) Hobbs,
Dow Corning, memo to H. Dingman, Hutchison, Don McGhan, McHard, and
Pellikka regarding “Minutes of Meeting Held October 27, 1967.” The
meeting was held at the request of Hutchison: “to discuss toxicity
testing of SILASTIC implants and more specifically the penile implant. Ira
expressed his feelings relative to the necessity of 2-year toxicity
studies on new materials in dogs. In general he feels the 2-year study
is not necessarily due to the absence of carcinomas being produced when
foreign bodies have, through the years, been implanted into the human
body. Ira did feel the 2-year data would be advantageous to have on
record in case of product liability and also if and when the FDA assumes
the regulation of devices. J.A.
McHard expressed the recommendations of the Product Safety Committee
based on advice from various Dow Corning consultants, i.e., Steve
Carson, V.K. Rowe, Joe Calandra and (illegible). This recommendation is
that new SILASTIC (illegible). This recommendation is that new SILASTIC
(illegible) to be used for long-term implants shall have a 2-year
carcinogenicity study in dogs. Preliminary
marketing could begin after the testing had progressed six months if
tissues are normal.” CITE
DCC 204001107 - 204001108. ----------------------------- Document
#84 MISCELLANEOUS
- COMPLICATIONS Hobbs
and Himmelsback memo to Barry, Bennett, Clark, Fenn, Greenhalgh, Hansen,
Hargreaves, Hedlund, Hunter, Hyde, Donkle, C. Lentz, Maneri, McHard,
Nelson, Quinn, Ragborg, Ringey, Stinton, Tyler, Weyenberg and Zeman
regarding “Status of the Toxicity and Industrial Safe Handling of J-DCA.”
J-DCA is Dow Corning Silica A; results from a recent study indicate that
under certain conditions, exposure to this “will cause significant
change in the links.” CITE:
DCC 281041072 - 281041074. Dow Corning Trial Exhibit List Abstract ----------------------------- Document
#85 KNOWLEDGE
OF LIQUID SILICONE DANGERS Food
and Drug Research Laboratories issues its report to Dow Corning
Corporation, “Studies of the Effects of Injected Dow Corning 360 Fluid
In Dogs.” Fifteen beagles were subcutaneously injected with Dow
Corning 360 fluid in the scapular region for ten successive days. There
was a shifting of the injected mass, signs of mange, fluctuations in
weight, elevations of the hemoglobin concentrations, differentials in
the leukocytic counts, congestion and changes in all organs. One of the
beagles died with congestion of the liver, kidneys and heart accompanied
with hemorrphagic changes in the lungs and the adrenals.
CITE: T 1202 - 1209, Exhibit to Petratis Deposition. DUPLICATE: T
1251 - 1302; KKH
8185 - 8290; FDA 33172 - 33227; F28 -79. Dow Corning Trial Exhibit List ----------------------------- Document
#86 MISCELLANEOUS
- ORGANIZATIONAL SURVEY Minutes
of the Board of Director’s Meeting of Dow Chemical Company with a CITE:
TDC 11702 - 11703, Exhibit to Bennett Deposition, and Exhibit to Julius ----------------------------- Document
#87 KNOWLEDGE
OF LIQUID SILICONE DANGERS Bureau
of Regulatory compliance reports on the prosecution of Dow Corning,
Bass, Rhodes, and McIntyre for selling a new drug - Dow Corning 360
Fluid - without an approved New Drug Application. ----------------------------- Document
#88 KNOWLEDGE
OF LIQUID SILICONE DANGERS Steve
Carson, Food and drug Research Laboratories, issues a Supplement to the
Report on “Studies of the Effects Of Injected Dow Corning 360 Fluid
350 cs In Dogs. “ Following a single subcutaneous injection, silicone
was transported to all organs via the lymphatic or vascular network. “(D)espite
parenteral route of administration, C(14) (DC 360 Fluid) was present in
the gastrointestinal tract, in the aorta and apparently in the lymphatic
pathways as evidenced by the lymph nodes, and salivary glands, thus
suggesting that transport and distribution in these animals was via the
vascular system, the lymphatic, and recirculation via the bilary
tract.” Distribution
occurs throughout the entire body with no apparent concentration in any
specific organ. In Dow Corning’s Toxicology Report Reference 99, Dow
Corning’s abstract states, “The distribution of radioactivity was
ubiquitous with evidence of greater activity in liver, spleen, kidneys,
heart, lungs and brain. CITE:
T 38842 - 38866, Exhibit 3 to Harris County Rathjen Deposition.
DUPLICATE: ----------------------------- Document
#89 ACKNOWLEDGEMENT
OF NEED FOR TESTING Minutes
of the Board of Directors’ Meeting of the Dow Corning Corporation with
CITE:
DCC 101001529 - 101001543, Exhibit to Bennett Deposition, Exhibit to ----------------------------- Document
#90 TESTING “Histopathological
Findings In Animals of Various Species from Experiments conducted by
Thomas D. Rees” is prepared S. Carson and Food and Drug Research
Laboratories for Dow Corning Corporation. Findings using mice include
various tissue reactions in the liver, spleen, kidney, fat, adrenal
glands, pancreas, ovaries, uterus, endometrium, lymph nodes, small
intestine, and stomach. Findings
using rats include various tissue reactions in the fat, spleen, kidney,
pancreas and adrenal glands. Findings in guinea pigs include various
reaction in the fat, kidney, pancreas, adrenal glands, spleen and liver.
Findings using hamsters include various tissue reactions in the fat,
spleen and kidneys. CITE:
T 1467 - 1528. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#91 ACKNOWLEDGEMENT
OF NEED FOR TESTING Rowe,
Dow Chemical, letter to Goggin, the new President of Dow Corning (who
was recently transferred from Dow Chemical), regarding Dow Corning’s
need to establish its own toxicology laboratory. Rowe states that Dow
corning has a “poor image” with the FDA which is “partly deserved,
partly undeserved.” He suggests that Dow corning needs a “change in
philosophy” to turn its image around. He writes: “Respect
in Washington or elsewhere cannot be acquired except by earning it
through demonstrated competency, integrity, and an open willingness to
cooperate. I have had the feeling at times in the past that these
desirable characteristics have not always been apparent, in fact, it has
seemed to me that there has been a reluctance to deal openly with FDA.
An antagonistic approach toward FDA usually, in my experience, results
in a reaction on their part which, sooner or later, becomes apparent in
one form or another and will be regretted.” (p. 1) Rowe recommends
that Dow Corning create a position entitled “Director of Government
Regulatory Relations” to interact with the FDA and help Dow
Corning’s image. He also recommends that Dow Corning Establish a
toxicological laboratory in-house so that they are able to “know and
understand the physiological properties of all such materials.” (p. 6)
The Dow Corning laboratory should be patterned after the Dow Chemical
laboratory. Rowe recommends Dow Corning hire Ken Olson of Dow Chemical
for this position. He also explains that: “It appears to me that one of the most important areas for toxicological study of DC materials, particularly those designed for use in or on human beings, is that which may be called biochemical. By this I mean studies which will completely describe the fate of materials applied to, or administered to, the intact living organism including animals and plants.” (p. 9) CITE: DCC 410000031 - 4100000040, Exhibit 2 to Bennett Deposition, Exhibit 1 to LeBeau Deposition, Exhibit 6 to K. Olson Deposition, and Exhibit to Rowe Deposition. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential Document ----------------------------- #92
& #93 05/23-24/68 (this is listed as #92 & #93) ACKNOWLEDGEMENT
OF NEED FOR TESTING Minutes
of Meeting at Midland on May 23-24, 1968 with representatives form Dow CITE:
DCC 281041054 - 281041059. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#94 TESTING FDA:
“Informational Materials Supplied To clinical Investigators”
provided to the FDA sponsored by Dow Corning corporation for Dow Corning
360 Medical Fluid 100 Centistokes (as used for the immersion of burn
victims). The purpose of this study is to evaluate continual immersion
therapy as a treatment modality in the management of the burned patient.
The fluid in which the patient is to be studied is Dow Corning 360
Medical fluid of a viscosity of 100 centistokes. Dow Corning 360 Medical
Fluid (MDX-4-4066 Fluid) is a dimethylpolysiloxane fluid and is
identical to the product known to FDA scientists as Dow Corning 200
Fluid except that more rigid quality control procedures have been
established for the medical grade product. This
fluid had been tested on pigs, monkeys, rabbits and dogs at Food and
Drug Research Laboratories. Observations were made of the effects of
administration to rabbits and rats of diets containing 1% Dow Corning
360 Medical fluid, 50 or 350 centistokes, for eight to twelve months,
respectively. These were compared to effects resulting from
administration of the basal ration alone. No significant differences
were found between the groups receiving the polysiloxanes and the basal
control in growth or any of the parameters of physiological function,
organ weight, or tissue morphology.
Clinical experience with silicone immersion has included the
immersion treatment of thirteen healthy unburned control vs. eighteen
burned victims and the immersion treatment of one patient suffering from
toxic epidermal necrolysis. Results
indicates that silicone immersion is contraindicated in burn cases with
open-chest injuries and/or venous cutdown on the leg. Continued
immersion is contraindicated if sever skin rash develops which does not
resolve with adequate skin hygiene and/or rigorous quality maintenance
of the silicone fluid. Immersion
may precipitate or increase hallucination. Immersion results in external
fluid pressure on the chest which may produce sufficient splinting
effect to reduce chest motion and prevent adequate aeration of the lungs
in those patients who are debilitated or who have chest injuries.
Intermittent positive pressure breathing may be required in these cases
to enhance aeration of the lungs. Skin
rash has been observed in immersed patients. Severe and persistent skin
rash which does not resolve with adequate skin hygiene and quality
maintenance of the fluid is adequate reason to terminate immersion. CITE:
KMM 104968 - 105041. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#95 COHESIVENESS
- LIQUID COMPONENT OF GEL Dow
Corning completes a study of the biological distribution of
dimethylpolysiloxane in adult male mice. Significant amounts of
radioactivity were found in the tissues and body fluids analyzed. The
level of absorption and the biological distribution of the radioactivity
were not dependent upon the molecular weight distribution of the fluid
or the method by which the fluids were administered. CITE:
DCC 281001381 - 281001399, Exhibit to Harris Country LeVier deposition,
Exhibit 3 to Harris Country Rathjen Deposition, Exhibit 19 to Harris
County Zahalsky Deposition, Exhibit to Harris County Tyler Deposition,
and Exhibit to Weyenberg Deposition. DUPLICATE: M 100155 - 100174; DCC
242031103 - 242031121; FDA
43184 - 43202. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#96 KNOWLEDGE
OF LIQUID SILICONE DANGERS FDA:
Dr. Wilson writes a letter to Dr. Inscoe of the FDA regarding his
analysis of the reproduction studies done on Dow Corning Medical Fluid
360 by Food and Drug Research Laboratories. He states that the reports
“were not presented in such a way as to inspire complete
confidence....” He also concludes the compound causes an
“appreciable increase in fetal death and resorption in rabbits”
which is dose related and also causes an increase in malformations in
rabbits at certain doses. Thus, “the compound under consideration
cannot be declared to have no teratogenic potential.” CITE:
KMM 128723 - 128724. Dow Corning Trial Exhibit List Abstracts ----------------------------- Document
#97 GEL
MIGRATION FDA:
The FDA recommends that Dow Corning’s IND 2702 remain ineligible for
reinstatement because of the lack of toxicity information, deficient
protocols and the lack of declaration that the IND has no teratogenic
potential. The FDA directs Dow Corning to provide data on the metabolic
fate and migratory sites of silicone, including studies on the kidney
and liver. CITE:
FDA 28545 - 28547. NOTE: See 09/24/68 entry. Dow Corning Trial Exhibit ----------------------------- Document
#98 KNOWLEDGE
OF LIQUID SILICONE DANGERS Hobbs,
Toxicologist at Dow Corning, letter to Dr. Charles Riffkin, The Squibb
Institute for Medical Research, responding to his inquiry about the
distribution and fate of injected silicones. He encloses the study,
“Studies of the Effects of Injected DOW CORNING 360 Fluid, 350 cs., in
Dogs,” stating: “The
results of this study indicate that distribution occurs throughout the
entire body with no pronounced concentration in any specific organ. It
is evident by the preliminary nature of this study that the fate and
chemical nature of the material after it vacates the injection site is
unknown. CITE:
FDA 27154 - 27155, Exhibit to K. Olson Deposition. Dow Corning Trial ----------------------------- Document
#99 FRAUD/MISREPRESENTATION Olson
memo to Pail with copies to Bennett, Currie, Gergle, Hobbs, Hunter, CITE:
DCC 218041771 - 281041776, Exhibit to K. Olson Deposition, and Exhibit
to ----------------------------- Document
#100 KNOWLEDGE
OF SYSTEMIC DISEASE Steven
Carson, Food and Drug Research Laboratories, issues a report on
“Chronic Implantation Studies of Polysiloxanes In Dogs” contracted
by Dow Corning. The report states: “Chronic
implantation studies were conducted in dogs over a three year period
utilizing a variety of polysiloxane materials. When possible comparisons
were made between solid and perforated wafers of individual materials
implanted into intramuscular, subcutaneous and intraperitoneal sites.
The number of implants utilized, provided for microscopic examination of
replicate tissues at each time period, i.e. 3, 9, 24, and 36 months. Inasmuch
as each type of polysiloxane was evaluated independently no direct
comparison between materials is provided, however the physical forms of
each were compared. It may be concluded that in every instance the
degree of reaction about the perforated implants was less intense than
that associated with the solid implant, particularly with respect to the
degree of fibrous reaction or extent of hyalinization or inflammatory
cell reaction. Samples
of polysiloxane materials 370, 372 (including Cronin breast), fine and
coarse sponge, silphenylene and LS each involved samples in which the
physical form of the implant was the major variable. In the instance of
the sponge implants (coarse and fine), a somewhat more intense
connective and fibrous tissue reaction was observed with fine sponge in
the initial 9 month period but lessened markedly at 24 and 36 months.
The prosthetic breast samples with 372 revealed no untoward tissue
reactions. Comparison of cured and uncured samples 386, 382, 5392,
X-3-0855 and Medical Adhesive Type A generally revealed a more severe
inflammatory cell reaction at 3 months in the uncured samples of 386,
5392 as compared to the cured samples. This reaction was absent at 24
and 36 months. The Medical Adhesive Type A differed, in that the initial
tissue reactions were minimal in each. Generally,
no untoward chronic tissue reactions were noted with any of the implant
materials. Systemic tissue responses were not observed at 24 or 36
months. There was no evidence of tumorigenesis, with any of the samples
or at any of the sites of implantation over a 3 year period of testing
in dogs.” The first page of this report states that “this report is
not to be distributed outside Dow Corning Corporation.” CITE:
T 2033 - 2096, Exhibit 35 to Bennett Deposition (used by Dow Corning),
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