icemaidenz

PLAINTIFFS' TRIAL EXHIBIT LIST
ABSTRACTS FOR DOW CORNING Excerpts
From: "DOW DOCUMENTS" WHERE THERES
SMOKE THERES FIRE

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

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

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

Appendix A is a list of studies in Dow
Corning's PMAA master file and a list of
studies in Dow Corning
Corporation's blue book.

Appendix B is a list of studies containing
duplicate slides created by Mark Bejarano.

Appendix C is qualifications of the
consultant.

CITE: DCC 411000406 - 411000525, Exhibit
25 to Zimmer Deposition; Exhibit 4 to
Bejarano Deposition; Exhibit 5 to Bey
Deposition; Exhibit 35 to McKennon
Deposition.

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Document #2

ACKNOWLEDGEMENT OF NEED FOR
TESTING TESTING

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

CITE: DCC 16001089 - 16001091, Exhibit to
Bennett Deposition.

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Document #3

ACKNOWLEDGEMTN OF NEED FOR TESTING
COHESIVENESS-LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

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

CITE: DCC 16001081 - 16001083, Exhibit to
Bennett Deposition, and Exhibit to Isquith
Deposition.

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Document #4

1970 ACKNOWLEDGEMENT OF NEED FOR
TESTING KNOWLEDGE OF SYSTEMIC
DISEASE MISCELLANEOUS -
COMPLICATIONS MISCELLANEOUS -
ORGANIZATIONAL SURVEY TESTING

Draft of the "Proposed Agreement For
Cooperative Research Program between Dow
Corning and Lepetit Pharmaceutical
Company to research the use of silicone
compounds in biological systems. "These
silicon chemicals will likely be used
systemically rather than locally, and their
utility in biological systems. "These silicon
chemicals will likely be used systemically
rather than locally, and their utility in
biological systems may dependent more
upon their chemical, rather than their
physical properties. (p.1)

The proposal notes that Dow Corning has
acquired information that certain silicones
are biologically active and has instituted a
Biomedical Research Laboratory in July
1965 "to probe the potential utility of such
silicon chemicals across the broad
disciplines of biology, i.e., plant sciences,
microbiology and animal science." (p. 2) Dow
Corning Does have the capability to conduct
research on silicons in the pharmaceutical
areas while Lepetit "has been engaged in s
specific endocrine cooperative research
program with DC for a period of two years."
(p. 3) The proposal states that the parties
would cooperate to develop new silicon
chemicals as drugs including silicones with
activity as androgen depression, central
nervous system depression, antimicrobial
activity, etc. (pp. 3-4). Additionally, Dow
Corning and Lepetit personnel will exchange
research and information and will travel to
the other's facilities.

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

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Document #5

KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE
REACTION

Script of an internal Dow Corning seminar
presented by Dr. Isquith, and Tony Bennett
and Pat Walters on the subject of
microbiology. Isquith states that, "Our
(Biomedical Research) primary function is to
investigate the microbiology of
organosilicon compounds through basic
research. A secondary function is the
development of utility from the information
gathered, either academically or in an
applied form. A third function is that of
service. We are interested in the
preservation, biodegradability, and
microbiology of existing Dow Corning
products." (p. 2)

Abbott notes that the Microbiology Section
has "the capability of conducting research in
most areas of microbiology (i.e., Virology,
tissue culture, immunology, mycology,
bacteriology, etc.)" (p. 3) He notes that one
function is to search for organisms capable
of silicone degradation. (p.3) There is also a
section on Page 3 which is crossed out on


Abbott states that silanols have provided
"much basic research information on the
relationship of organosilicon compounds to
microorganisms and has suggested new
areas of research." (p. 6)

CITE: Temporary Dow Corning Bats Number
671 - 685, Exhibit 4 to Isquith Deposition.

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Document #6

ACKNOWLEDGEMENT OF NEED FOR
TESTING TESTING

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

CITE: DCC 16001084 - 16001085, Exhibit to
Isquith Deposition, Exhibit to LeVier
Deposition.

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Document #7

COHESIVENESS - LIQUID COMPONENT OF
GEL MISCELLANEOUS - COMPLICATIONS
TESTING

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

CITE: DCC 281041877 - 281041882.

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Document #8

KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS TESTING

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

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

Document #9

TESTING TISSUE REACTION

Dow Corning document: "I. Silicone Oils As
Miticides (or mite-repellents)"; "II. Aphid
Control With Silicone Emulsions"; "III. Effect
Of Silicone Emulsions On Mealy Bugs"; and
"IV. Effects Of Silicone Oils On
Cockroaches." The document was authored
by "JWR" (unknown who this is). "Mites do
not willingly invade silicone treated bean
plants if untreated ones are available." (DCC
16001144). Mites are not controlled by
silicone-treated cucumber plants, possibly
because the silicone oil is absorbed into the
plant. A silicone spray was "completely
effective in discouraging them. It is possible
that a minor component, relatively volatile,
may be acting as a contact insecticide." (Id.)

Wild mustard plants sprayed with DC 200
fluid 10 cs. eliminated aphids. "The
impression gained is that the insecticidal (or
repellent) activity is due to some component
of the fluid which has gone (presumably by
evaporation or by becoming chemically
bound within the plant) or a hydroxy-ended
material. It seems worthwhile attempting to
identify the active species and trying to
modify it chemically to obtain a long-term
effect." (DCC 61001145).

Pachysandra plants, infested with mealy
bugs, were sprayed with an antitranspirant
emulsion with 5% silicone. After 5 days, all
mealy bugs on the treated plants were
eliminated. "The silicone appears to be
slower acting here than upon other insects;
possibly a repellent, rather than an
insecticidal, effect is involved." (DCC
61001146).

In the 1950s, Texaco and Shell did studies
on hydrocarbon oils as insect attractants. In
1968, it was found by Gorzinski (of Dow
Corning) that DC 360 fluid appeared to have
an insect attractant and insecticidal
activity. Cockroaches were attracted to the
petri dish with silicone fluid. After coming
out of the fluid, they "never got more than a
few inches from the dish before dying."
These results indicate "some type of activity
existed in the DC 360 fluid...." (DCC
61001147).

CITE: DCC 16001144 - 16001147, Exhibit to
Bennett Deposition, Exhibit 11 to McKennon
Deposition, Exhibit 8 to Harris County
Gehring Deposition, Exhibit to Harris County
and MDL LeVier Depositions, Exhibit to Ryan
Deposition, and Exhibit to Isquith
Deposition. WITNESS: Bennett
(Authenticated in Bennett, Vol. IV, p. 880;15
- 882:8). DISPOSITION: Admitted in Toole (II)
v. Baxter Healthcare.

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Document #10

KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS

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

CITE: DCC 281031092, Exhibit to MDL and
Harris County Tyler Deposition, Exhibit 8 to
Harris County LeVier Deposition, Exhibit to
MDL LeVier Deposition, and Exhibit to Ryan
Deposition, NOTE: See document # 11 for
attachment.

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Document #11

MISCELLANEOUS

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

CITE: DCC 281031093, Exhibit to Tyler
Deposition. NOTE: See document # 10.

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Document #12

VIDEOTAPE PRODUCED AT ZIMMER
DEPOSITION ON D4.

CITE: No Bates Number, Exhibit to Zimmer
Deposition.

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Document #13

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

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

CITE: DCC 260000855 - 260000878.
WITNESS: Exhibit to Zimmer Deposition.

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Document #14

MISCELLANEOUS - ORGANIZATIONAL
SURVEY MISCELLANEOUS - LOBBYING

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

CITE: KKA 210877 - 210886

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Document #15

KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS MISCELLANEOUS -
COMPLICATIONS TESTING

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

CITE DCC 267371444 - 267371466. NOTE:
The document also has Bates numbers QDC
124506 - 124528 on it as well as Bates
numbers MM 369861 - 3698883.

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Document #16

ACKNOWLEDGEMENT OF NEED FOR
TESTING SILICA TESTING TISSUE
REACTION

W.D. Galloway reports on the "Analysis of
Lifetime Carcinogenicity Study of Silicone
Gels" conducted by Dow Corning under GLP
regulations using Sprague-Dawley rats
injected with Q7-2159A and MDF-0193 gels.
Galloway states:

"Both of the gel-implanted groups showed a
large number of cancers compared to the
control group. Particularly striking was the
number of sarcomas (principally
fibrosarcomas) which occurred in the
treated groups."

"The only obvious deficiency is that only one
dose level was used. Ordinarily, three doses
are used, and five are preferred. Based on
the results obtained, I have little doubt that
NTP would classify these substances as
likely animal carcinogens."

"According to Dow Corning, ... the tumors
were peculiar to rats, the so called foreign
body tumors."

"Absent epidemiologic data, and without
waiting for results of additional lifetime
studies, knowledge of the mechanism by
which these tumors was induced is critical
to estimating human risks. It is possible that
the tumors were chemically induced, rather
than being induced by a by a physical
mechanism, as Dow suggests. If this is the
case, then the argument that such tumors do
not occur in man is untenable. If the tumors
were chemically induced, the active agent is
more likely to be one of the several
chemicals which make up the gel, rather
than a metabolically produced reactive
intermediate, since the tumors which did
occur did not occur selectively in
metabolically active organs such as the
liver."

"Recent studies have shown that siloxanes
may act as estrogen-like substances and can
enhance the growth of tumor cells."

CITE: M 780064 - 780065.

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Document #17

COHESIVENESS - LIQUID COMPONENT OF
GEL KNOWLEDGE OF GEL BLEED
MISCELLANEOUS SILICA

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

CITE: KMM 447209 - 4477224

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Document #18

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

Dr. O. Gordon Robinson Presents a paper
entitled "Rate of Rupture of Silicone
Prostheses: Excerpt From A Study Of Over
#3000 Personal Cases and Twenty-Five
Years Experience" at the Symposium on
Reoperative Aesthetic Surgery of the Face
and Breast in Naples. Florida. Robinson
discusses results obtained after 115
patients were followed after the fall of 1990
after receiving breast implants. Of the 115
patients, 57% had rupture of one or both
implants. An additional 20% had moderate to
severe bleed on one or both sides. The
patients had the implants from six months to
25 years. Dr. Robinson concludes that all gel
and bi-lumen implants:

"should be replaced at about the eighth
post-operative year because it can be fairly
well predicted that at this stage the
prostheses in most cases would still be
intact and much easier to replace. If a
period of time longer than twelve to fourteen
years is allowed to elapse, then the
prostheses have a good chance of being
ruptured and the exchange would be much
more difficult.

CITE: PSC Medical Articles CD, J 2698 -
Exhibit 2 to Robinson Deposition, Exhibit 25
to McKennon Deposition. WITNESS:
Robinson. DISPOSITION: Not admitted in
Toole (II) v. Baxter Healthcare

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Document #19

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

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

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

Document #20

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

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

CITE: No Bates Number, Exhibit 4 to
Robinson Deposition. WITNESS: Robinson
DISPOSITION: Not admitted in Toole (II) v.
Baxter Healthcare.

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Document #21