- Document
#451
- 02/02/87
-
-
- TESTING
- TISSUE
REACTION
-
- Rasmussen’s
monthly report for February, 1987, to Ruhr reporting the
deaths of ten more animals due to moribund condition in
the Two-Year Gel Implant Study - M8518-0, bringing the
total number of deaths to 48. Also, “thirteen animals
are presently living out of a total of 21 which are or
have exhibited masses associated with the gel implant.
-
- CITE:
KMM 315219 - 315221. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
# 452
- 02/09/87
-
- TESTING
- SILICA
- TISSUE
REACTION
-
- Siddiqui
reports to Dow Corning regarding a 1987 study of anal
leakage when rats
are subjected to polydimethylsiloxane fluids. The test
materials are Dow Corning 1500 antifoam, a 50/56 mixture
of Dow Corning 200 fluid and Dow Corning 112 compound.
The positive control is 50 cs of Dow Corning 200 fluid.
Siddiqui observes 1) a definite loss in body weights
with all treated animal, 2) mushy.
light-green stools in the animals treated with
the mixture of Dow Corning 200 fluid and Dow Corning 112
compound at 5 or 8 gl kg/day doses and 3) soft and oily
feces in the animals treated with Dow Corning 1500
antifoam at 5 and 8 kg/day doses. The rats showed
gastric endemic and slight intestinal irritation. The report concludes that the material containing small
amounts of silica in polydimethylsiloxane fluids does
not significantly improve the results of anal leakage
previously obtained in the laboratory.
-
- CITE:
T 34186 - 34323. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#453
- 02/23/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- COHESIVENESS
- LIQUID COMPONENT OF GEL
- CONCEALING
FROM FDA
- FRAUD/MISREPRESENTATION
- GEL
MIGRATION
- KNOWLEDGE
OF SYSTEMIC DISEASE
- MISCELLANEOUS
- RECKLESS/CONSCIOUS DISREGARD
- SHELL
DEGRADATION
- TESTING
- TISSUE
REACTION
-
- Robert
LeVier, Dow Corning, memo to Hayes, Rylee, Stark, Thiess,
Weyenberg, and
Yerrick regarding the “Medtox Project Final Report.”
Seven numbered copies of the Medtox Report were issued
to the seven individuals listed above. The final report
replaces the 12/31/86 interim report. Levier asks each
of the recipients to “Please discard the interim
report dated December 31, 1986.: (KMM 298339).
-
- The
purpose of the Medtox project was to formulate a
consolidated understanding
of all internally funded safety studies of silicone
material relevant to the Health Care Business and to
relate the findings to current safety issues as
presented in the literature, by the physician community
and in litigation.
LeVier reviewed four sources of information: the
Corporate Toxicology File 1949
- present, the DC 360 Fluid NDA 2702 file 1974, the
Medical Research Report File
1980 - present, and the Corporate Mainframe Reference
List 1957 - present. The
report will generate a database for Dow Corning to
search and will be available
to the Legal Department. The first and earliest report
LeVier noted was a 1949
publication. He also located and identified in the
appendix 110 reports. The
studies through 1963 were primarily related to antifoam
compounds and emulsions
used in antigas formulations. Thereafter, the studies
were conducted to qualify materials. “Studies in the
1980 - 1986 period are primarily directed toward
requalification of materials that have been in use for
some time.” Levier concludes that the reaction at the
implantation site is an acute inflammation progressing
to chronic inflammation characteristic of a mild foreign
body response and that there is no evidence of systemic
toxicity. LeVier does note, however, that:
Two studies indicate that PDMS injected S.Q. or I.P. in
very large quantities (5 to 62 ml/animal) in mice and
rats is disseminated broadly and polymer is
microscopically visible as deposits in tissue. It is
likely that these deposits are the end-stage result of
phagocytic transport and aggregation of polymer....
Several teratology studies in rats and rabbits
have shown a positive but low incidence of skeletal
defects and increased fetal resorptions.
LeVier acknowledges that silicone fluid and
silicone elastomers can be found in macrophages and
multinucleated giant cells. “The greater incidence of
macrophages and giant cells is more characteristic of a
chronic inflammatory state than usually seen around
elastomer implants in the absence of abrasion
particles.” He notes that the silicone fluid migrates
and is transported to regional lymph nodes. Further,
LeVier concludes that:
The implantation site reaction to silicone gel,
particularly in the form of a fabricated mammary
prosthesis, is similar to that produced by fluid
polymer. In the case of free silicone gel the
distribution compared to fluid polymer resides in the
cohesiveness of the gel.... In the case of free gel,
progressive gel subdivision by connective tissue septa
is superimposed on encapsulation of the entire gel mass.
-
- The
analyses of the internal studies indicates that there
are notable
deficiencies among the reports. LeVier classifies these
as “Nuisance Issues” and
“Substantive Issues.” The nuisance issues include
that the study designs are
outdated, the studies are of limited utility, the
variety of systemic
histopathologic findings is broad, and the majority of
the studies were
conducted by IBT and FDRL. “Both of these companies
are known to have falsified
data in the time period relevant to the studies
conducted for Dow Corning.” He does not think it
likely that any of Dow Corning’s studies were
falsified, but he does not state the basis for this
belief.
Regarding the substantive issues, LeVier states:
There are two specific deficiencies of importance that
tend to limit the utility of the long-term studies in
particular.
-
- 1.
The histopathology of the reticuleondothelial system (RES)
including
liver, spleen, lungs, lymph nodes and bone marrow was
not examined carefully
or systematically in any long-term study. Therefore,
little information is available from these studies with
regard to migration of implanted materials nor with
regard to target tissue effects. Such an examination is
rarely part of a formal toxicity study but the absence
of such an evaluation is often cited as a criticism.
-
- 2.
None of the studies incorporate a critical assessment of
physiologic effects induced by the local inflammatory
reaction. Nor is the nature of the local reaction
assessed in detail. Thus, no information is available
with regard to effects on the immune system, for
example.
-
- In
discussing the limitations of the prior studies, LeVier
admits that there are no studies in which the
inflammatory reactions were described and classified
according to “criteria employed by researchers expert
in the study of inflammation nor have any studies been
designed to detect the range of systemic effects that
could attend a chronic inflammatory state.... Presently,
there are insufficient data to effectively understand
cause and effect relationships or to defend silicones
against the broadening claims of HAD stimulation.:
In
discussing what corrective measures should be taken.
LeVier recommends that
Dow Corning should not replicate any of the studies that
were flawed and outdated. He states:
Replication of existing studies for the sole purpose of
correcting nuisance
problems would be very costly and would consume several
years before results
could be available. Some problems such as too few animal
per group and too many implants per animal could be
corrected but it is improbable that the spectrum of
unrelated pathologic events could be materially
influenced. It is such pathologic events that are used
to claim systemic toxicity caused by silicone implants.
The course of action (corrective measure) that is
recommended is to develop sound arguments in support of
the validity of existing studies.
(emphasis added). LeVier also discusses the
immunopotentiation of silicone and notes that “if
immunopotentiation is prolonged in response to PDMS,
then the probability may be increased that silicone has
an adjuvant like effect of sufficient duration to
promote development of auto-antibodies in susceptible
individuals.”
-
- CITE:
KMM 298296 - 298339. NOTE? The interim Medtox report is
dated 12/31/86.
-
- NOTE:
Includes LeVier memo sending attached Medtox report to
D. Hayes, R. Rylee,
F. Stark, G. Thiess, D. Weyenberg and K. Yerrick. Dow
Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#454
- 02/24/87
-
- COHESIVENESS
- LIQUID COMPONENT OF GEL
-
- Bruce
A. Reuter, International Marketing Manager at “Dow
Corning Wright, responds to Charles A. Vinnik, M.D.’s
letter of 01/16/87 regarding gel biodegradability and
problems with gel cohesivity. He states,
“Biodegradability implies a change in chemical make-up
as opposed to physical change. Using this definition, it
can be said, categorically, that silicone does not
biodegrade as a result of contact with body tissues. We
do know that silicone gel can be physically broken down
into smaller particles either mechanically or by
manipulation in the presence of water or body fluids.:
Thus, “It is the combination of gel in contact with
body fluids and manipulation which causes the physical
breakdown.:
With regard to gel cohesivity, Reuter states that the
gel undergoes a physical change when it is in contact
with body fluids. It becomes less cohesive. Reuter
disagrees with Dr. Vinnik’s contention that Dow
Corning Wright’s “quality assurance testing is more
rigorous than the exercises” Vinnik prescribes. “Our
quality assurance testing is a single episode under
controlled conditions as opposed to a daily manipulation
which varies in force from patient to patient.... There
is no quantitative clinical data to determine how much
concentrated stress an implant can take in a confined
space before fatigue occurs, nor are there any currently
accepted scientific methodologies to test this
phenomenon in situ.”
-
- In
response to the clinical trials on the Silastic II that
Dr. Vinnik participated in, Dow Corning Wright has
decided not to computerize and analyze the data. The
study is considered closed. Dow Corning Wright is also
developing a thick gel high profile teardrop prosthesis
but “no formal evaluation is planned.”
-
- CITE:
M 420161 - 420166. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#455
- 02/24/87
-
- CONCEALING
FROM FDA
- KNOWLEDGE
OF SYSTEMIC DISEASE
- FRAID/MISREPRESENTATION
-
- Steinberg,
Dow Corning counsel, submits information to the FDA
regarding the Two-Year Gel Implant Study of Dow Corning
360 Fluid and the findings of malignant lymphoma.
-
- CITE:
KMM 491863 - 491912. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#456
- 03/24/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- W.
Boley, Dow Corning Wright, memo to Brodhagen, Frisch,
Jakubczak, and others
regarding “Summary of H.E.S. Testing Activities In
Support Of Health Care Businesses For February.” The
first immunotoxicology testing by Dow Corning is
scheduled to begin on April 27. 1987 (25 years after Dow
Corning first sold breast implants). The protocol was
sent to Dow Corning for approval.
-
- CITE:
M 170187 - 170191. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
457
- 04/01/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- COHESIVENESS
- LIQUID COMPONENT OF GEL
- KNOWLEDGE
OF GEL BLEED
-
- Dow
Corning Quality Assurance Department Report 0058 by
Sharon McCoy entitled
“Factors Affecting The Integrity And Stability Of
Q72159A Mammary Gel And Intermediates.” The objectives
of the study were to identify causes of gel penetration
drift, identify causes of gel depolymerization and
determine feasibility of using SiH to vinyl ratios to
predict final gel penetration values. (OOT 41655) On the
issue of depolymerization of the gel, she states that
“Potassium in Ql-0043 appears to cause
depolymerization in the finished product Q7-2159A when
levels exceed 1.75 ppm, taking test repeatability into
account” (Id.)
-
- CITE:
Hancock Deposition, Exhibit to Olson Deposition, and
Exhibit to Isquith
Deposition. OOT 41654 - 41676, Exhibit to Harris County
Burda Deposition,
Exhibit to Petraitis Deposition, Exhibits 11 and 27A to
Dow Corning Trial
Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
458
- 04/10/87
-
- TESTING
- FRAUD/MISREPRESENTATION
- MISCELLANEOUS
- PRODUCT LABELING
-
- I.G.
Hignite, Dow Corning, records the minutes of the
“Health Care Businesses
Board Meeting Minutes - 04/07 - 08/87” The Board
decided to proceed on Talmadge
Holmes’ proposal to acquire 1,250 case histories from
Dr. Ben Gregory. Dow
Corning plans to computerize the data and publish a
paper on the findings. Also,
LeVier presented the results of his Medtox final report
which showed that “there
can be acute to chronic inflammation and mild foreign
bold reaction” from
silicone breast implants. He claims there was no
indication of systemic
reaction. The immunotoxicology testing is now to begin
in September 1987. LeVier
noted that Dow Corning has “not been able to define
how to design experiments that measure antibody
formation from silicones.” Also, the Health Care Board
reported that legal counsel recommended that Dow Corning
settle the Stern case because of “incomplete
information on our implant package inserts....” Dow
Corning recommends a review of all other package inserts
to bring them up to date.
- (emphasis
added).
-
- CITE:
F 817 - 822. Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#459
- 04/13/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE
-
- John
Ludington, Dow Corning, memo to Gene Jakubczak.
Ludington states:
It
has recently come to the attention of Executive
Management of Dow Corning Corporation that preliminary
indications from a current study, indicate adverse
effects of Dow Corning medical gra de silicone gels
placed into the body of highly sensitive test rats. Our
scientific assessment is that this does not represent a
human health concern....
- A
committee is formed comprised of Reed, who will be the
President and Chairman,
Jenkins who will be the legal counsel to the committee,
Rylee, and Stark. He directs the committee to “make
appropriate recommendation for future action in light of
Dow Corning’s legal and ethical responsibilities. This
investigation is a top priority matter.” Ludington
cautions persons not to speculate about these matters
with anyone else.
-
- CITE:
KMM 302536 - 302537, Exhibit to Ludington Deposition,
Exhibit to Reed
Deposition, Exhibit to Stark Deposition, Exhibit 23 to
McKennon Deposition, and
Exhibit 26 to Zimmer Deposition. Dow Corning Trial
Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#460 & 461
- 06/11-12/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- TESTING
- TISSUE
REACTION
-
- An
expert panel was convened at the request of Dow Corning
Corporation to review
and discuss the chemical and biological data base on
silicone gel products along with the relevant medical
data. The purposes of the panel were to provide an
opinion as to whether any of the information reviewed
indicate a significant risk to human health and suggest
additional work which could be undertaken to further
support the safety of these gel products.
-
- The
panel expressed the opinion that the findings of
sarcomas at the implant was
predictable and consistent with the mechanism of foreign
body tumorigenesis. The
panel found that the study finding increased malignant
lymphoma was flawed in
terms of conduct, diagnosis and reporting. “Because of
these problems, the panel
determined that no definitive conclusions could be
reached on the basis of the
- study.
The panel members did, however, recommend that
additional safety data in
the form of a chronic bioassay in a non-rodent species
... and further studies
to elucidate the mechanism of solid state tumorigenesis
in rodents should be
undertaken.” Specifically, the panel recommended that
Dow Corning conduct a
seven-year dog study. The panel recommended that the
tissue be re-examined by
another pathologist and that the data from this study be
re-evaluated after this work is completed.
-
- CITE:
KMM 362273 - 362277 and DCC 267360013 - 267360331 and
DCC 267420044-267420289, Exhibit 8 to Zimmer Deposition
(draft). NOTE: Dow Corning never did
the seven-year dog study suggested by the panel.
DUPLICATE: KMM451887; KMM
366396 - 366712. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
462
- 07/06/87
-
- COHESIVENESS
- LIQUID COMPONENT OF GEL
- GEL
MIGRATION
-
- Dr.
Charles Vinnik writes to Robert Rylee, Dow Corning,
concerning recurrent
problems with gel cohesivity and “runny” gel in Dow
Corning implants. Gene
Jakubczak promised Dr. Vinnik that Dow Corning would
compare gel specifications
on implants returned for evaluation. “Sadly, despite
the fact that I had sent a number of patients’ samples
back ... there has never been any description of
comparison of the returned gel samples with the original
gel standards that were supposedly retained by your
company.... The problem either emanates from the top, or
that people under you are operating contrary to our
explicit agreement....” He continues, “I can only
draw the conclusion that there is a deliberate attempt
at evasion with respect to the level of cohesivity of
the gels used in the original silastic prostheses dating
from approximately 1077. I might further add that the
cohesivity of the Silastic II prosthesis is not as good
as I would like it to be ... compared with one of your
competitors.... The safety factor in terms of patients
not having problems associated with migratory gel and
all of those legal implications to you from that problem
is enormous.” (emphasis added)
-
- CITE:
M 490090 - 490091. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#463
- 07/06/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- MISCELLANEOUS
- ORGANIZATIONAL SURVEY
- TESTING
-
- Weyenberg
and Gehring letter to Shilling regarding joint research
agreement for
identification of agricultural chemicals - modification
of item 10 (changing
agreement from 3 years to 4) and amendment specifying
subsidiaries of the
parties may receive info exchanged under their agreement
and may be employed to
- conduct
work on the program.
-
- CITE:
DCC 2001190 - 2001191. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#464
- 08/05/87
-
- TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- Dow
Corning summarizes data concerning a Two Year Gel
Implant Study in rats
conducted by Industrial Bio-Test Laboratories using the
old gel - MDF 0193, and
responsive gel - Q7-2159A. Dow Corning claims there were
deficiencies in the
original report such as improper tabulation and
evaluation of tumor findings
- including
malignant lymphomas. Hughes Research and Development was
asked to
review the data and tissue samples and, in their second
report, found a treatment-related increase in the
incidence of malignant lymphoma. Dow Corning refuted
this conclusion claiming that the increase in lymphoma
was “stress related viral induced but no basis to
substantiate our opinion.” Dow Corning subsequently
conducted an internal study. An independent panel of
experts convened by Dow Corning reviews all data and
finds that the implant site sarcomas identified in the
studies are predictable due to “solid state”
carcinogenesis in rats, a phenomena which allegedly
poses no significant risk to human health.
-
- CITE:
KMM 491869 - 491881. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#465
- 08/13/87
-
- SHELL
STRENGTH - THICKNESS
- RUPTURE
- CLOSED CAPSULOTOMY
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
- GEL
MIGRATION
- TISSUE
REACTION
-
- Jakubczak,
Dow Corning, sends Dr. Muller a lengthy response to his
questions about implant rupture. He states that a
hypothetical cause of rupture which may be possible but
about which he does not have direct knowledge of is
“Excessive force created when closed capsulotomy is
being performed.” Also, in the event of an implant
rupture, gel can migrate and complications include
“enlarged lymph nodes, scar formation, inflammation,
granulomatous foreign body reaction, presence of foamy
histiocytes, silicone mastopathy, nodule formation, or
other difficulties.... The long term physiological
effects of uncontained gel are not completely known.”
-
- Jakubczak
states that Dow Corning has been tracking the rate of
ruptures since the gel-filled implants were introduced
to the market. “The rate (Of rupture) is less than
).1% for gel filled product. The gel-saline product is
slightly less than that for gel product. The SILASTIC II
mammary implant, to the best of our knowledge, is in the
ballpark or slightly less. For the specific time period
of the last 1970’s our data indicates that the rate of
rupture was the same.”
-
- CITE:
M 460204. DUPLICATE: KKH 75863 - 75871. NOTE: Jakubczak
did have direct
knowledge of ruptures occurring with closed
capsulotomies. Also, Dow Corning did
not track rupture rates like he represents in this
letter. Dow Corning Trial
Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#466
- 09/21/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- TESTING
- TISSUE
REACTION
-
- Talmadge
Holmes, epidemiologist at Dow Corning, memo to Dillon,
Hobbs, Jenkins,
LeVier, Ruhr, Rylee, Stark, Steinberg and Zimmer
regarding an epidemiological study on the relationship
of cancer and silicone breast implants. Holmes notes
that the Deapen study “was limited in that there were
only 6.2 average years of follow-up per person and no
data were collected regarding known breast cancer risk
factors.” A proposal for additional epidemiologic
investigation into the relationship between silicone gel
used in mammary implants and cancer is attached.
-
- CITE:
KMM 387394 - 387397, Exhibit 29 to Zimmer Deposition.
Dow Corning Trial
Exhibit
List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#467
- 09/24/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
-
- Eldon
Frisch, Dow Corning, memo to Hayes, Dillon, LeVier, and
Thiess regarding a
proposal from Nir Kossovsky to study noninfectious
inflammatory reactions in human tissues collected at
autopsy from patients with all types of implants.
Frisch notes that Kossovsky has testified as an expert
for plaintiffs in
- silicone
implant litigation and states, “In my opinion, the
study he wishes to
conduct would be highly worthwhile from a scientific
standpoint, and may confirm
that there are problems with all types of implant
materials, but I am uncertain
of its value to Dow Corning and thus have had a problem
identifying just why Dow
Corning should fund this work.” (emphasis added).
-
- CITE:
DCC 240001004, Exhibit to Dillon Deposition, Exhibit to
Frisch Deposition,
Exhibit to LeVier Deposition, and Exhibit 5 to Harris
County Burchiel
Deposition. Dow Corning Trial Exhibit List Abstracts
-
- ----------------------------
-
- Document
#468
- 11/03/87
-
- KNOWLEDGE
OF LIQUID SILICONE DANGERS
- GEL
MIGRATION
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- Dan
Hayes, Dow Corning, memo to Frisch, Hobbs, LeVier,
Steinberg, the DCW Business Board, Rylee, and Stark
regarding the Dow Corning Wright Keratosis Program.
Hayes asks, “What is the best approach to deal with
silicone migration in this application? How do we
approach the immunology issues that have been raised in
literature in recent years?”
-
- CITE:
DCC 251000386 - 251000387 Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#469
- 11/17/87
-
- TISSUE
REACTION
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- Complaint
Report MW 2030 submitted to Dow Corning regarding a
Silastic implant. The patient developed
“bronchospastic asthma of allergic nature” related
to the silicone. The patient has leakage from her
nipples which is suspected to contain silicone. Dow
Corning agrees to devise a test to detect whether the
discharge was silicone. (emphasis added).
-
- CITE:
KKH 72651. Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#470
- 12/15/87
-
- DOCUMENT
DESTRUCTION
- FRAUD/MISREPRESENTATION
-
- Note
from Winton, Dow Corning, regarding conversation he had
with Don Linkert about the falsification of cure oven
charts. He quotes Linkert as saying that they had gotten
low on inventory and there was pressure to get product
out the door. Winton claims that Linkert told him that
there was some discussion about the problem and the QA
department’s hassling over atypical situations such as
oven cycles. Winton quotes Linkert as saying that he was
aware that a second chart could be run with nothing in
the oven and substitute that chart for the original.
Winton claims that Linkert responded to this suggestion
by saying: “do what you have to, but I don’t want to
know about it.” Mike Mitchell was fired earlier in the
year for falsification of documents.
-
- CITE:
DCC 80062087 - 80062088. DUPLICATE: DCC 17015132 Dow
Corning Trial Exhibit
- List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
-
- ----------------------------
-
- Document
#471
- 12/31/87
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DESEASE
-
- Eldon
Frisch, Dow Corning, outlines the “Keratosis
Program” and the biological tests needed. Biological
assay data is needed for “defense against
litigation.... Because of the findings from silicone gel
implant studies, both internal and regulatory
requirements for assurance of the biological safety of
subdermal silicone fluid will be particularly critical
and demanding.”
-
- Frisch
states that the “must time-consuming and expensive
study will be an assay
of carcinogenic potential” as will reproductive and
developmental toxicity assays. “Prior studies will not
suffice” since they were inconclusive. Both studies
showed increases in skeletal deformities and increased
in utero mortality rates in animal reproduction studies.
Also, the Dow Corning internal study, Frisch claims, is
“distrusted scientifically and was of questionable
statistical design.”
-
- CITE:
KMM 407480 - 407482. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#472
- 00/00/88
-
- SHELL
STRENGTH - THICKNESS
- MISCELLANEOUS
- PRODUCT LABELING
-
- Dow
Corning Territory Strategy Sheet by Bill Fargie states
that, “I need to increase anxiety level of surgeons
re: litigation and broken shells. Most of board
certified (surgeons) in my territory are beginning to
see alarming number of implants with ‘loss of shell
integrity’....I need label revise on all Plastic
packaging - everything confusing and difficult.”
-
- CITE:
KAA 64021. Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#473
- 01/00/88
-
- KNOWLEDGE
OF SYSTEMIC DISEASE
- FRAUD/MISREPRESENTATION
-
- Hayes,
Dow Corning, writes Dear Doctor letter regarding
immunological reactions
to silicone. He encloses a position paper. The position
paper criticizes the research done by the Japanese by
claiming that fluids used were often adulterated and by
claiming that the adjuvant concept is broadly
misunderstood. The
paper gives a brief description of the research that has
been done on the problem and then states:
Unfortunately,
all animal studies reported to date have been founded
upon incomplete experimental designs, and
interpretations and speculations that extend well beyond
the support that can be provided by the data.
-
- CITE:
KMM 122710 - 122712. DUPLICATE: MD 145633 - 145635. Dow
Corning Trial
Exhibit
List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#474
- 01/22/88
-
- KNOWLEDGE
OF LIQUID SILICONE DANGERS
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- Frisch,
Hobbs, LeVier, and Steinberg, Dow Corning, author a
report “keratosis
Program Team Report.” One of the issues this team has
identified is to negotiate
an IDE program with the FDA that would allow Dow Corning
to do only short-term
evaluations of silicone fluid injections for keratosis”
without the requirement
for extensive clinical and laboratory studies.” The
silicone to be injected is
Dow Corning 360 Fluid. The team assumes that, “Prior
studies sponsored by Dow
Corning (carcinogenic, reproductive and developmental)
will not suffice. The protocols and designs of prior
studies were not adequate by today’s standards, and in
some studies the findings left unanswered questions.”
-
- The
team notes that bioassays which must be addressed
include carcinogenic,
pharmacokinetic and immunologic. “Immunologic studies
are not on the FDA general
list and are not included in projected costs, but
because of the current flurry of publications alleging
immunogenic reactions to silicones FDA may want these
studies done. Internally, evaluation of the immunogenic
potential of silicone fluids is currently being planned,
and it is believed these data would apply to 360 fluid
even if the fluid involved in the study were 200
fluid.”
-
- Furthermore,
the team states:
FDA will probably require adequate data to assure safety
prior to allowing the
- clinical
investigation to proceed. FDA’s concerns will most
likely center on
carcinogenicity and reproductive/developmental toxicity
issues. Dow Corning
currently has neither human nor animal data to address
these issues in a
statistically valid, scientific fashion. The
reproductive/developmental toxicity
- issue
could perhaps be temporarily waived by not including
women who may have
children, but this still leaves the carcinogenicity
issue unresolved. (emphasis added).
-
- CITE:
KMM 407502 - 407540. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#475
- 02/01/88
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- RUPTURE
- SHELL
STRENGTH - THICKNESS
-
- Letter
from Franklin Wilder, The Hartford, to Greg Thiess,
Senior Managing
Attorney at Dow Corning, about a woman who struck her
breast when slipping at a
grocery store, allegedly causing one or both implants to
rupture. Wilder questions, “Is there a standard for
rupture force? The reason for this question is that it
is foreseeable that a woman may hit her breast, or
suffer some trauma and this force imparted to the
implant. (sic) Has Dow Corning performed any studies
along these lines?” (emphasis added).
-
- CITE:
KKM 42522. Note: See 02/04/88 response Dow Corning Trial
Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
-
- ----------------------------
-
- Document
#476
- 02/04/88
-
- DOCUMENT
DESTRUCTION
- FRAUD/MISREPRESENTATION
- CONCEALING
FROM FDA
-
- Harvey
Steinberg, in-house legal counsel for Dow Corning, memo
to the File
regarding the “GMP Records Review.” This document is
the basis for Griffin
Bell’s finding in his October 12, 1992 report that Dow
Corning falsified oven
temperature charts, and has a typed note at the top:
“Attachment I, APPROVED FOR
- PUBLIC
DISSEMINATION ON OCTOBER 12, 1992.” Steinberg writes
that”
In
late Fall, 1987, Sandy Brondstetter, a sister of a
mammary area employee,
advised
her supervisor, Ken Montague, that dummy over (sic) cure
charts were
being made in the mammary area. Brondstetter and
Montague investigated and
- found,
under a desk blotter in the mammary area, an actual
chart evidencing an interim oven shutdown for a lot
where a chart for a cycle not exhibiting any such
shutdown had been submitted with the lot history
record....On December 1, at a meeting with T. Bartolo,
Boone and Winter were advised that Bartolo were
completely unaware of any problems with the cure ovens
that would lead to anybody even having a need to be
concerned about charts, at least since the new
controllers and recorders were installed in late 1986 or
early 1987. He admitted that with the old equipment
there were a number of problems with the recorders with
the result that a substantial number of problems with
the recorders with the result that a substantial number
of the curing charts evidenced atypical curing cycles
and required management review and clearance. Bartolo
admitted that he had personally prepared mocked-up
charts to submit in place of the actual charts where,
based on his technical knowledge of the limits of the
cure cycle, he could conclude that the product had
actually been cured a fully sufficient amount of time
even if outside of the SOP/specs for the product. His
knowledge of cure cycle was based upon his co-authoring
the TS&D reports documenting that intermediate
interruptions do not interfere with the proper cure of
the silicone materials where the total cycle time, at
the specified cycle temperature, is achieved. He
repeated that, to the best of his knowledge, this
practice stopped with the installation of the new
equipment.
-
- ***
The investigation reasonably established that the cure
ovens would kick off in the middle of a cycle an average
of about once a week (four times a month)
whereas
an actual review of the mammary charts showed only 3 out
of 104 lots as
anything
other than a perfect. non-interrupted cycle. Of those 3,
none
- represented
a substantial intermittent downtime (e.g. overnight) as
did the
chart discovered hiding under the desk blotter. A
subsequent review of an
additional 84 mammary chart turned up only 2 less than
perfect samples. In
contrast, a review of cured non-mammary silicones showed
about 20% of cure runs
- evidencing
over shutdowns, a number consistent with the once-a-week
expectation.The memo also states that Les Schnoll
reviewed the lot history records for 1985-1987 and that
all lots passed the test evidencing proper gel cure.
Schnoll also reviewed the complaint trends and found no
unusual events or activities. “
- Based
on the above, it was concluded that all product fully
met quality
standards and the issue was merely a personnel and
documentation concern.” Dow
Corning suspended for 30 days all implicated individuals
and supervisors and gave them stern warnings and
lectures on the importance of documentation.
-
- CITE:
DCC 105000001 - 105000003. Dow Corning Trial Exhibit
List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#477
- 02/04/88
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- RUPTURE
- SHELL
STRENGTH - THICKNESS
-
- Greg
Thiess, Senior Managing Attorney at Dow Corning, Letter
to Frank Wilder,
The Hartford, about a breast implant case filed against
Dow Corning. Thiess
states, “With respect to your question concerning any
Dow Corning studies on the
force that a mammary implant could withstand once placed
inside of the female breast, Dow Corning has done no
such studies.” (emphasis added).
-
- CITE:
KMM 42521. Note: See 02/01/88 entry. Dow Corning Trial
Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#478
- 03/25/88
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
- TESTING
-
- Board
of Directors’ meeting showing a report that early test
results show that D4 has a toxic effect on daphnia in
low concentrations and that further testing is planned.
-
- CITE:
DCC 101003623 - 101003626, Exhibit 10 to McKennon
Deposition, and Exhibit
to Weyenberg Deposition.
-
- ----------------------------
-
- Document
#479
- 05/02/88
-
- MISCELLANEOUS
- ORGANIZATIONAL SURVEY
-
- “Dow
Corning Organizational Survey.” “Our manufacturing
technology lags 10 years
behind state-of-the-art with regard to control and
automation. This is especially apparent if you compare
the Midland plant (oldest DC plant) with some of the
European plants.” With regard to Dow Corning’s
commitment to quality, the comment is made that,
“Managers say ‘improve quality,’ but don’t show
any interest. They need to ‘walk the talk.;” Also,
“We should emphasize permanent fixes rather than
temporary ones ... usually the emphasis is to do things
as quickly as possible, especially when it comes to
changing over the use of equipment.”
-
- A
comment from Production and Manufacturing was, “Good
quality programs, but NO
follow-up. We’ve made the same suggestions for fixing
problems for the past two years and we see nothing being
done to fix the problem.... Dow Corning does not accept
the fact that quality costs money....” A criticism
voiced is the “over-emphasis on profitability,” the
constant emphasis on sale/profits/results,” the
pressure for quantity over quality, and an emphasis on
“political savvy” instead of qualifications to get
ahead.
-
- Also,
employees complain about “Ineffective decision-making
process:
bureaucratic, with blurred responsibilities, CYA
(‘cover your ass’) effect.
Politics, game-playing, ‘good old boy’
network.” “SOPs ... are outdated, never been written
or written by people who do not do the work. Lack of
quality standards for products, which results in
different interpretation of what is a good product and
what isn’t. Often engineering and lab do not agree so
it is left up to the operator to take responsibility and
make a judgment call about continuing to run the
line.”
-
- On
the topic of Dow Corning’s reactive, short term focus,
the RDE&S Professionals write, “We have too much
short-term thinking and fire-fighting, especially from
TS&D and marketing. This detracts from long-term,
fundamental research.”
-
- CITE:
KMM 247952 - 247965. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#480
- 05/11/88
-
- TESTING
DOCUMENT DESTRUCTION
- FRAUD/MISREPRESENTATION
-
- Eldon
Frisch, Dow Corning, memo to Bauer regarding “Animal
Implant Reactions To
Breast Prostheses.” He encloses the 11/29/68 study in
dogs conducted by Food and
Drug Research Laboratories which he has redacted.
-
- Frisch
states:
A large number of materials were tested in this single
study. Thus, when
information pertinent to all materials and all animals
is considered the report
is rather confusing, difficult to interpret, and can
easily be misrepresented to
a jury as happened in the Stern case. Accordingly, all
data not pertinent to the
- four
dogs who received SILASTIC 372 elastomer (the envelope
material) and the
miniature breast implants and the control animals have
been removed. Data were
deleted by covering the copy with paper or tape, and
nothing has been added.
-
- CITE:KMM
200817-200862. Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#481
- 05/23/88
-
- TESTING
- TISSUE
REACTION
-
- PATHCO
Inc. reports to Dow Corning on a “Two-Year Gel Implant
Study (B7811) In
Sprague Dawley Rats.” Gels MDL 0193 and Q7-2159A were
implanted subcutaneously
in rats at Industrial Bio-Test Laboratories.
- Microslides
were prepared by Hughes Research and Development. The
study was
evaluated histopathologically by Hughes R&D. At the
request of Mark Zimmer, Dow
Corning, PATHCO Conducted a complete wet tissue audit
and histopathologic evaluation of the study.
-
- Evidence
of toxicity/carcinogenicity for all four silicone gels
tested was
restricted to the implant site. All four gels were
associated with the presence
of mesenchymal neoplasms in at least on sex. Gel 1208
was associated with
neoplasms in both sexes, Gel 1209 with neoplasms in
males only and Gels 1210 and
- 1211
with neoplasm in females only. Dysplasia of the capsule
of the implant, and
apparent preneoplastic lesion, was seen with all four
gels in females and with
Gel 1208, 1209, and 1210 in males. Other lesions
associated with all four gels
were fibrosis of the capsule, the presence of
extracapsular gel, and
- inflammatory
changes both within the capsule and in the immediate
extracapsular
tissues.
-
- CITE:
R 14267 - 144314. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#482
- 07/25/88
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- MISCELLANEOUS
- ORGANIZATIONAL SURVEY
- TESTING
-
- Letter
agreement between Dow Corning (signed by Weyenberg) and
Dow Chemical
(signed by Perry Gehring) regarding the 08/01/84 Joint
Research Agreement for Identification of Agricultural
Chemicals. Dow Corning proposes this agreement be
extended an additional 3 years.
-
- CITE:
DCC 2001192. Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#483
- 07/25/88
-
- GEL
MIGRATION
- TESTING
- TISSUE
REACTION
-
- FDA:
An internal FDA review of the epidemiological study
involving 3,000 women in California by Dr. Dennis Deapen
and his colleagues, Pike, Casagrande, and Brody, to
determine if breast implants increase the chance of
developing cancer, concludes there were “numerous
sources of errors, biases and methodological
limitations.” Also:
“this study has not contributed greatly to our
understanding of the relationship between breast
implants and the risk of breast cancer.
Furthermore, it is known that silicone can
migrate to other body sites away from the site of
implantation. Even with all the biases inherent in the
study design, the authors did note a higher number of
observed cases of cancers at other sites than expected
(24 observed versus 15.8 expected).
Based on these results and the fact that silicone
can migrate to other sites, the authors should have
addressed this issue by including cancers at other
sites, instead of limiting their study to only breast
cancer.
-
- CITE:
M 780066 - 780069; Attachment 3 to Staff Report prepared
by the Human
Resources and Intergovernmental Relations Subcommittee
on Government Operations,
December, 1992, p. 9. NOTE: See 05/10/89 ENTRY. See
00/00/00 (M 780074 -
780078), 00/00/87 (M780070 - 780073), 08/17/89 (M 780079
- 780090) and 08/03/88
(M 780056 -780063 entries; possible attachments to this
document. DUPLICATE:
- M790025
- 790029. Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#484
- 08/09/88
-
- TESTING
- CONCEALING
FROM FDA
- KNOWLDEDGE
OF SYSTEMIC DISEASE
-
- FDA:
M. Stratmeyer, Acting Chief, Health Sciences Branch of
FDA to Director, office of Science and Technology, memo
with attached report regarding analysis of Dow Corning
data on carcinogenicity of silicone gels. “As you will
see, the conclusion of this report is that silicone can
cause cancer in rats; there is no direct proof that
silicone causes cancers in humans; however, there is
considerable reason to suspect that silicone can do
so.” The FDA Reviewer finds that patients were studied
for an average of 6.2 years which is “probably too
short to detect breast cancer... considering that the
latency period for foreign body carcinogenesis in humans
appears to be in the range of 20-30 years.”
-
- CITE”
M 780055. DUPLICATE: FDA 29449 - 29457. Dow Corning
Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#485
- 09/23/88
-
- TESTING
- KNOWLEDGE
OF SYSTEMIC DISEASE
- TISSUE
REACTION
-
- Dr.
Selwyn, Statistics Unlimited, Inc., prepares a
“Statistical Analysis for
Two-Year Gel-Implant Study of Q7-2159A and MDF-0193 in
Sprague Dawley Rats
(M8518-0)” for Dow Corning which concludes that
“Carcinogenesis is noted in mammary gels in
significant amounts.” (KMM 388066 - 388150: KMM
2726331 - 272637). Histopathological analysis
demonstrated “increased incidences of fibrosarcomas at
the implant site which were highly significant for both
the Q7-2159A group and the MDF-0193 group, and in both
sexes.” Incidences of non-neoplastic findings were
statistically greater in the Q7-2159A group males than
in the control group for the following: “chronic
capsular inflammation, implant site dysplasia, fibrous
capsule at the implant site, implant site necrosis,
extracapsular gel, acute and chronic pyelitis, necrosis
in the liver, seminal vesicle secretion (reduced or
absent), stomach necrosis, and thymic region
hemorrhage.”
-
- CITE:
KMM 388067 - 388150. DUPLICATE: KMM 272631 - 272637. Dow
Corning Trial
Exhibit
List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#486
- 10/21/88
-
- TESTING
- TISSUE
REACTION
-
- Dow
Corning Report 153 concerning “A Two Year Gel Implant
Study Of Dow Corning
Q7-2159A
and Dow Corning MDF-0193 In Rats.” “Implantation
site-associated
mesenchymal
tumors (i.e., sarcomas) were seen in both silicone gel
treatment
groups at an incidence of 23-24%. The sarcomas were
associated with the
- connective
tissue capsule of the implanted materials and the
majority were
fibrosarcomas.” The study also found “depressed”
survival rated among male rats
implanted with Q7-2159A and those implanted with
MDF-0193. “The biologic relevance of the observation
is unknown.” Dow Corning claims the sarcomas are
explained by the “Oppenheimer effect” - solid state
carcinogenesis.
-
- CITE:
P 17215 - 17390. NOTE: See 03/00/88 and 08/15/88
entries. Silicone gel
does not have the same smooth characteristics as the
implants used in the tests
which gave rise to the “Oppenheimer effect” theory.
DUPLICATE: KKP 136919 -
13626; T 15805 - 15926. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#487
- 11/28/88
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- MISCELLANEOUS
- COMPLICATIONS
- SHELL
DETERIORATION
- SHELL
STRENGTH - THICKNESS
- TESTING
- TISSUE
REACTION
-
- LeVier,
Dow Corning, memo to Hayes, Rylee, Rusk and Stark
regarding gel tox studies. LeVier states that the
following actions should be taken:
Large
volume studies designed to evaluate a possible chemical
tumorigenesis
effect
but solid state tumore will not necessarily be seen in
this study
because of the large volumes doses used. Envelope
studies designed to obtain
2-year implantation data in the rat on both components
of the Silastic II shell.
-
- Threshold
determination and material comparison studies designed
to estimate
the gel volume/surface area threshold for initiation of
the solid state effect of non- silicone materials under
state of the art experimental conditions.
LeVier
also gives dosage parameters for rats and mice.
-
- CITE:
DCC 267420828 - 267420829. Dow Corning Trial Exhibit
List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#488
- 12/14/88
-
- TESTING
- TISSUE
REACTION
- KNOWLEDGE
OF SYSTEMIC DISEASE
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- SILICA
-
- John
Yan, Mentor, reports on his trip to Dow Corning. He
notes that Dow Corning
uses the Statistical Process Control Method to assure
product reliance. Mark
Zimmer, Dow Corning’s veterinarian, presents Dow
Corning’s internal study on the
two-year rat study. (No reference is made to IBT’s or
Hughes Research findings
nor to other “expert” panel and their
recommendations.) “Dow Corning found the
test animals to develop dysplasia, chondrosarcoma,
fibrosarcoma, and sarcoma....
(T)hey found a 52% incidence of site related tumor
formation with the rats and
24% incidence with the female rats.” Yan notes that
Dow Corning purchases all of
its fumed silica from Cab-o-Sil.
-
- Yan
also notes that, “At present, teratogenicity,
immunological, and pharmacokinetic studies have not been
initiated on the gel.” (emphasis added).
Dow Corning did not share with Mentor the Master
File for the Gel.
-
- CITE:
MMD 167731 - 167733. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
-
- ----------------------------
-
- Document
#489
- 01/06/89
-
- MISCELLANEOUS
- SALES
-
- Weigel
and Thiess, Dow Corning, author “Facts You Should Know
About Product
Liability And Dow Corning Corporation.” The document
states:
-
- OVERRIDING
IMPACT: PRODUCT LIABILITY IS A COST OF QUALITY WHICH HAS
A
SIGNIFICANT
EFFECT ON THE COMPANY’S PROFITABILITY.
-
- PRODUCT
LIABILITY COSTS ARE INCREASING...AND WE HAVE INDICATIONS
THAT OUR
LIABILITY COSTS ARE HIGHER THAN OTHER COMPANIES IN
SIMILAR BUSINESSES.
THE PRODUCT LIABILITY TREND IS DIRECTLY CONTRARY TO DOW
CORNING’S EXPERIENCE
WITH WORKERS COMPENSATION AND PROPERTY INSURANCE COSTS
WHERE OUR STRONG
PREVENTION
PROGRAMS HAVE LED TO COSTS WELL BELOW INDUSTRY AVERAGES.
SINCE 1978, DOW CORNING’S GLOBAL SALES HAVE INCREASED
174%; PROFITS HAVE
INCREASED 141% AND PRODUCT LIABILITY PREMIUMS INCREASED
571%. IN THE U.S. AREA
IN 1988 IT TOOK $57M IN SALES AT CURRENT ROS TO PAY ITS
SHARE OF THE PREMIUM.
IN 1978, TOTAL PRODUCT LIABILITY PREMIUMS PAID GLOBALLY
BY DOW CORNING WERE
$1.4M (40% OF THE TOTAL INSURANCE PREMIUMS PAID).
PRODUCT LIABILITY PREMIUMS IN
1987
WERE $8.0M, WHICH REPRESENTS 59% OF THE TOTAL
PREMIUM....
SINCE
1978, INTERPRETATION OF THE U.S. STANDARD OF STRICT
LIABILITY HAS BECOME
INCREASINGLY LIBERAL; THUS, PUNITIVE DAMAGE AWARDS HAVE
RAPIDLY ESCALATED. IN
RECENT YEARS JURIES HAVE INCREASINGLY FOUND ALMOST ANY
FAILURE IN A PRODUCT TO
CONSTITUTE A DEFECT FOR WHICH DAMAGES CAN BE AWARDED.
FAILURE TO WARN HAS BECOME
A MAJOR SOURCE OF LIABILITY FOR ALL BUSINESSES.
(emphasis added).
-
- CITE:
KKA 41392-41393
Dow
Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#490
- 03/01/89
-
- TESTING
- TISSUE
REACTION
- DNOWLEDGE
OF SYSTEMIC DISEASE
-
- Siddiqui,
Kolesar, Zimmer, and Hobbs, Dow Corning, report on “A
90-Day Sub-Chronic Inhalation Toxicity Study Of
Octamethylcyclotetrasiloxane (D4) In The Rat.”
Exposure resulted in slight growth retardation and lower
food consumption in females. There was also an increase
in liver weights that was statistically significant,
leading the authors to conclude that “these data
indicate that D4 has an effect on the liver.”
-
- CITE:
T 40150 - 40276, Exhibit 34 to Zimmer Deposition.
DUPLICATE: KKP 15029 -
155. Dow
Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#491
- 03/27/89
-
- TESTING
-
- Eldon
Frisch, Dow Corning, responds to the request by Emanuel
Horowitz of the Johns Hopkins University for industry
technical data and standards on medical grade,
implantable silicone.
-
- There
is no general agreement on the standards for implant
grades of silicone
elastomers, nor for other applications. Unfortunately,
other than allowing
everyone to say a standard has been written, ASTM F604
“Silicone Elastomers Used
in Medical Applications” is hardly worth the paper it
is printed on. I would like to see it revised, and
believe I improved the language of Section 1.4 on
biocompatibility when it was last reviewed, but I also
know that attempting to make the major revision needed
would create a lot of controversy, many negatives, and
approval would be difficult. (emphasis added).
-
- CITE:
DCC 17043724 - 17043727 Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
-
- ----------------------------
-
- Document
#492
- 04/17/89
-
- ACKNOWLEDGEMENT
OF NEED FOR TESTING
- MISCELLANEOUS
- COMPLICATIONS
- TESTING
- TISSUE
REACTION
-
- Dow
Corning Report 82 by H.M. Mehendale entitled
“Evaluation of the liver
Microsomal Enzyme Induction Potential of D-5.” In the
University of Mississippi
Medical Center study, sponsored by Dow Corning, D5 was
administered orally to 24
female rats. “D5 was found to induce hepatomegaly with
recovery after cessation
- of
dosing. The enlargement appeared to be due to a net
enlargement in liver
mass. D5 was found to be an inducer of drug metabolizing
microsomal enzymes and
to resemble phenobarbital in this regard. However, D5
differed from phenobarbital in that it decreased the
P-450 hemoprotein content of the microsomes.”
-
- CITE:
P 15182, Exhibit to Isquith Deposition. DUPLICATE: F 433
- 460. Dow
Corning Trial Exhibit List abstracts
PENDLETON/PSC Attorney Work Product/Privileged &
Confidential
-
- ----------------------------
-
- Document
#493
- 05/22/89
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- SILICA
- KNOWLEDGE
OF SYSTEMIC DISEASE
- MISCELLANEOUS
- RECKLESS/CONSCIOUS DISREGARD
-
- LeVier,
Dow Corning, memo to Birdsall, Steinberg and Groh
regarding “Risk Assessment: Carcinogenic Potential Of
Silicone RTV Elastomers And Foams Containing Celite
Super Floss Or Celite 315 Fillers.” Attached is the
first draft of a risk assessment overview necessitated
by the recent discovery that the supplier of silica had
been using cristobalite and other crystalline silicas in
materials that comprise the elastomer. LeVier states:
“The majority of health care elastomer products employ
amorphous silica as the reinforcing filler. These fumed
amorphous fillers have been shown by X-ray defraction
analysis to contain no crystalline fraction. However,
RTV’s in the form of elastomers and foams are based on
older tin catalyzed formulations that use Manville
Celite Super Floss (CAN#: 68855-54-9) or Cilite 315
(CAN#:61780-53/2) as the reinforcing filler (MSDS’s
attached). These
silicas are generically classified as flux calcinated
diatomaceous earth. It has recently been learned from
the silica manufacturer that Celite Super Floss contains
up to 63% cristobalite and Celite 315 contains up to 23%
cristobalite. Cristobalite and other crystalline silicas
have been classified by the International Agency for
Research on Cancer (IARC) as probably carcinogenic for
humans.” (emphasis added).”
-
- The
products affected by this discovery include 382 Medical
Grade Elastomer which was discontinued in 1987:
“for economic reasons related to additional safety
testing required to investigate the availability and
effects of stannous octoate catalyst degradation
products (the subject of a 1987 Risk Assessment)....
This product was sold to many other manufacturers and
individual physicians....
Dow Corning has also recently licensed the 382
technology to the World Health Organization (WHO) for
the purpose of manufacturing and selling a contraceptive
vaginal ring. Dow Corning’s supply position in the
later application has not yet been fully defined. The
cristobalite component in these materials ranges from
about 10 weight percent to 30 weight percent.
The highest concentration of crystalline silica
occurs in 382 Medical Grade Elastomer.”
- LeVier
reviews the Dow Corning data on stannous octoate RTV
formulations and
concludes that “there are no long-term animal
implantation data available.” The human data from
inhalation studies of silica show that “crystalline
silica can increase the incidence of lung cancer....
There is sufficient evidence for carcinogenicity of
crystalline silica to experimental animals. There is
limited evidence for the carcinogenicity of crystalline
silica to humans.” LeVier’s risk assessment
conclusions are that:
-
- 1)
Unmodified crystalline silicas including
cristobalite-containing silicas are probably
carcinogenic for humans via inhalation exposure.
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- 2)
The probability that crystalline silicas are
carcinogenic for humans via parenteral exposure is less
certain
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- 3)
but existing animal data indicates that such silicas
administered parenterally may be carcinogenic for
humans....
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- 4)
The effect of in situ plasticizer treatment of Celite
silicas on their possible carcinogenicity is unknown
except on a theoretical basis.
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- 5)
Theoretical
considerations lead to the prediction that treated
crystalline silicas could be less carcinogenic than
unmodified crystalline silicas....
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- 6)
“An (sic) life-time rat study of the potential
carcinogenicity of treated Celite silicas cannot provide
unequivocal proof that such silicas cannot be
carcinogenic for humans.
-
- CITE:
KKA 1601 - 1608 Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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- ----------------------------
-
- Document
#494
- 09/08/89
-
- CONCEALING
FROM FDA
- FRAUD/MISREPRESENTATION
- MISCELLANEOUS
- RECKLESS/CONSCIOUS DISREGARD
-
- Patricia
Lang, a consulting toxicologist, writes to Birdsall, Dow
Corning, with copies to Stark, Ovsenik, Frith and Benson
enclosing her assessment of Dow Corning’s toxicology
laboratory and its efforts to comply with Good
Laboratory Practices (GLP). Lang states:
“In
the last two weeks it has become apparent that though
some actions are being
implemented
to bring HES into compliance, the general feeling within
the lab is
one of chaos. This can be explained, at least in part,
by the fact that there is
no management with a full understanding of laboratory
function to give
direction, and get things implemented. Until now, the
three consultants you
hired, Charles Frith, Barry Benson and myself, have been
trying to take the
place of management, with very limited success. The only
real progress to date
has been in educating some of the personnel in general
theory behind Good
Laboratory Practice regulations. This does not mean that
these people are
trained, just educated to some degree.... With the
pressures put on the
already-too-few people to generate SOP’s in the past
two weeks (especially the
ones for Zybion), I was hearing many comments indicating
that these documents
will be generated haphazardly, without respect to
whether they are accurate or
not. Because the department has so much breadth and so
little depth, there are
not natural double-check systems to assure that either
bad science or poorly
thought out procedures (let alone poorly written sets of
instructions) do not
get put into place.... Since there is so much work to be
done to bring the lab
into compliance, any SOP’s which get approved in the
new system, will have to be
followed for a long time before anyone has time to
rewrite them. They should be correct and complete the
first time.” (DCC 80112044) Under the “Personnel”
section, Lang notes that:
“The consultants you hired were TRYING to take the
place of a manager of
toxicology. Because they were not part of the group, and
only had the ear of
- Brian
Hobbs (who apparently was given the authority to make
decisions which
should not have been his to make), they were not able to
do the job that is
needed to be done. As stated several months ago, IT IS
ESSENTIAL THAT A GOOD
MANAGER OF TOXICOLOGY BE HIRED IMMEDIATELY. The Dow
Corning management style
is not conducive to running even an adequate toxicology
laboratory.” (DCC 80112045) She goes on to note that
Dow Corning’s toxicology department has serious
problems working its Xybion computer system, that it
hasn’t been maintained and that inexperienced persons
are operating it. (Id.) Further, she notes many problems
with formulation of policies on scientific issues:
“At the present time, the WRONG people are making
decisions (in some cases
the WRONG decisions) which impact upon the science being
performed. The
policies which I am addressing include, BUT ARE NOT
LIMITED TO, use of Room
Log Books for entry of study information, secondary
review of raw data or
calculations, assurance of room conditions (light cycle,
temperature and
humidity), health check by veterinarian prior to study
assignment, proper
anesthetization procedures for animals, training
procedures for various
tasks (as necropsy, weighing organs, ect.), supervision
of weekend activity,
and authority of study directors to assure proper study
conduct. This list
is far from complete.” (DCC 80112045 - 80112046) Lang
notes that the
- pathology
procedures need a “complete overhaul.” She states”
“Documentation
is extremely poor at present, and no one in HES fully
understands the requirements in this area.... A plan
must be written to bring this group up to industry
standard as soon as possible. Just getting this
department into compliance will take several
months....” (DCC 80112046)
-
- CITE:
DCC 80112043 - 80112071, Exhibit to Isquith Deposition
(used by Dow
Corning). Dow Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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- ----------------------------
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- Document
#495
- 11/15/89
-
- KNOWLEDGE
OF LIQUID SILICONE DANGERS
-
- E.
Frisch, Dow Corning, memo to B. Lipscomb regarding the
“keratosis IDE” and the information necessary to
convince the FDA that the material is safe. He notes
that the FDA’s position is that animal studies are
useful for safety while clinical studies are only useful
for efficacy. Frisch acknowledges that Dow Corning’s
“primary focus has been on efficacy,” even with the
clinical studies. “Safety
data ... are scant and based on superficial external
examination of the injection site” that does not
include any detail or blood chemistries, urine analysis,
liver function studies, or examination for lymph node
enlargement. Key studies needed are carcinogenesis
pharmacokinetics, developmental and reproductive
toxicology, and immune response. Frisch notes that
LeVier has a copy of a 9 page letter from the FDA to the
Ortho division of J&J rejecting their IDE
application for cosmetic uses of silicone fluid.
(emphasis added).
-
- CITE:
KMM 407633 - 407634. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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- ----------------------------
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- Document
#496
- 12/04/89
-
- CONCEALING
FROM FDA
- ACKNOWLEDGEMENT
OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE
-
- 515(B):
Dr. Jack Fisher (ASPRS) informs “All Members of BIRAC,
Old and New” about progress report since ASPRS
convention in San Francisco. He notes four concerns of
the PSEF Board of Directors and those of BIRAC:
-
- 1)
that manufacturers had written the RFP and they thought
Colton was going to do this;
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- 2)
concerned that all southern California bidders
would be excluded; 3) concerned that one manufacturer
stated that it would only fund two issues from a longer
list that PSEF wanted studies; and 4) concerned and
“disappointed that the study does not address the
connective tissue issue.... Based on our very best
clinical judgment and scientific understanding, we
believe that CT disease issue will forever loom until we
meet it head on.” (emphasis added). PSEF is also
deeply concerned about the reporting requirements - the
potential delays in notification of study results. PSEF
believes “these restrictions to be an infringement of
academic freedom and a potential embarrassment to
foundation (PSEF).”
-
- CITE:
KKA 43763 - 43769A. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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- ----------------------------
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- Document
#497
- 01/31/90
-
- TESTING
- TISSUE
REACTION
- KNOWLEDGE
OF SYSTEMIC DISEASE
-
- Crofoot,
Stanton, Siddiqui, and Zimmer, Dow Corning, report on
“A 14 - Day Subchronic Oral Gavage Study With
Hexamethylcyclotrisiloxane In Rats.” Oral
administration of the test material, D3, “may produce
increases in liver weight at dose levels as low as 100
mg/kg and perhaps as low as 25/kg in the male rat....”
The authors state that the “toxicologic significance
of the liver weight increases cannot be made.”
-
- CITE:
T 37322 - 37409, exhibit 36 to Zimmer Deposition.
DUPLICATE: T 37447 - 37490.
Dow
Corning Trial Exhibit List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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-
- ----------------------------
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- Document
#498.
- 02/08/90
-
- SHELL
STRENGTH - THICKNESS
- MISCELLANEOUS
- RECKLESS/CONSCIOUS DISREGARD
-
- Jim
Curtis memo to John Dillingham, both of Dow Corning,
regarding deficiencies in the stocking and shipping
process at the Arlington plant. He states:
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- “I
can tell you that the stock here in Arlington is mixture
of old and new units. Eight year old SILASTIC II units
are in a bin with 2 month old units.
And the people that pull the implants from the
bins to fill orders tell me that they will pull any,
with no attention to the lot number (production date).
When I asked why we had eight year old implants, I was
told that many implants are returned from territory
stock and mixed in the bins with the new implants.... If
the system goes unchanged, the customer will develop the
perception that our implant quality is very
inconsistent. (emphasis added).
-
- CITE:
KKA 5640. NOTE: A listing of the useable life and shelf
life for Dow
Corning products is located at KKA 097708 - 097710. Dow
Corning Trial Exhibit
List Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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- ----------------------------
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- Document
#499
- 02/08/90
-
- MISCELLANEOUS
- MISCELLANEOUS
- ORGANIZATIONAL SURVEY
- SILICA
-
- Burda,
Dow Corning, prepares a “Product Structure Of Silastic
Mammary Implant
(1964 To The Present)” in which he lists all of the
products Dow Corning has
manufactured and their component parts. Contains charts
that show silica content
and corporate and manufacturing organization.
-
- CITE:
DCC 17007927 - 17007993. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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- ----------------------------
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- Document
#500
- 02/19/90
-
- CONCEALING
FROM FDA
-
- 515(b)
Lois Duel writes to other manufacturers suggesting that
the epidemiology
studies be funded only by manufacturers, and that ASPRS
be excluded. She claims
the basis for this position is the “need to preserve
the confidential nature of
the study content as its supports PMA submissions by
sponsoring manufacturers.” Duel further suggests that
ASPRS and PSEF play a modified role such as PR efforts.
-
- CITE:
MEX 28736 - 28738. Dow Corning Trial Exhibit List
Abstracts
- PENDLETON/PSC
Attorney Work Product/Privileged & Confidential
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TO
DOCUMENTS: 501 - 550
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