Fw: Fw: CONCEALING FROM FDA FRAUD/MISREPRESENTATION]

[Guest guest]

More from our darling Kathi, who died from severe respiratory problems,

her mother died one year before from the same disease..........Lea

> * CONCEALING FROM FDA FRAUD/MISREPRESENTATION

>

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> CONCEALING FROM FDA FRAUD/MISREPRESENTATION

>

> 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. Dow Corning Trial Exhibit List Abstracts

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> 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 Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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 Deposition, and

> Exhibit to Isquith Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #4

>

> 1970 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC

> DISEASE MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - ORGANIZATIONAL

> SURVEY TESTING

>

> Draft of the " Proposed Agreement For ative 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 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 Deposition, and Exhibit to MDL LeVier Deposition.

> WITNESS: (Authenticated in , Vol. II, p. 455-457).

> DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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 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 Silanols and then a handwritten outline on

> Silanols (Slide 2) beginning on page 4. 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. Dow Corning Trial Exhibit List Abstracts

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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 Deposition,

> Exhibit 11 to McKennon Deposition, Exhibit 8 to County

> Gehring Deposition, Exhibit to County and MDL LeVier

> Depositions, Exhibit to Deposition, and Exhibit to Isquith

> Deposition. WITNESS: (Authenticated in , Vol. IV, p.

> 880;15 - 882:8). DISPOSITION: Admitted in Toole (II) v. Baxter

> Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #10

>

> KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS

>

> LeVier, Dow Corning, memo to C. Lentz and 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 County Tyler

> Deposition, Exhibit 8 to County LeVier Deposition, Exhibit to

> MDL LeVier Deposition, and Exhibit to Deposition, NOTE: See

> document # 11 for attachment.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #12

>

> VIDEOTAPE PRODUCED AT ZIMMER DEPOSITION ON D4.

>

> CITE: No Bates Number, Exhibit to Zimmer Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLTON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #18

>

> Post 10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL

> BLEED MISCELLANEOUS - COMPLICATIONS RUPTURE SHELL STRENGTH -

THICKNESS

>

> Dr. O. Gordon 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. 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.

> 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

> Deposition, Exhibit 25 to McKennon Deposition. WITNESS: .

> DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare

>

> Dow Corning Trial Exhibit List PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #19

>

> Post/10/92 KNOWLLEDGE OF GEL BLEED MISCELLANEOUS - COMPLICATIONS

> RUPTURE SHELL DEGRADATION SHELL STRENGTH - THICKNESS

>

> Dr. O. Gordon '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.

> 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, 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 Deposition. WITNESS:

> 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 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 Deposition. WITNESS:

> DISPOSITION: Not admitted in Toole (II) v. Baxter

Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #21

>

> Post 10/92 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -

> COMPLICATIONS RUPTURE RUPTURE - CLOSED CAPSULOMTOMY SHELL

> DEGRADATION SHELL STRENGTH - THICKNESS

>

> Dr. O. Gordon 's charts on the age of prostheses a

> significant number of implants ruptured 6-16 years

> post-implantation, ( observations at surgery 36.9% of his 73

> patients were symptomatic), follow-up (most did not show any change

> in symptoms during follow-up), symptomatic (patient relates to

> prostheses-arthritic profile, refer, and " No Closed Capsulotomies " ),

> asymptomatic (patient happy), and questions ( " Do mammary prostheses

> last forever? What contributes to the silicone envelope wearing out?

> ... How do you tell if an implant is ruptured? ... "

>

> CITE: No Bates Number, Exhibit 9 to Deposition. WITNESS:

> DISPOSITION: Not admitted in Toole (II) v. Baxter

Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #22

>

> Post 10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL

> BLEED KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

> RUPTURE SHELL STRENGTH - THICKNESS

>

> Draft of Dr. O. Gordon 's paper entitled, " Breast Implant

> Removal Or Exchange. " This is a draft of document number 22.

>

> CITE: No Bates Number, Exhibit 10 to Deposition. WITNESS:

> . DEPOSITION: Not admitted in Toole (II) v. Baxter

Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #23 through#31

>

> #23

>

> ANY FOLLOW-UP STUDIES BY DR. O. GORDON ROBINSON.

>

> This includes an abstract by Dr. and Dr. Edwin Bradley

> entitled " Disruption Rate of Silicone Gel Prostheses - A Report of

> 200 Cases " published in the January 1995 issue of the American

> Medical Association Journal.

>

> #24

>

> PHOTOGRAPHS OF PLAINTIFF'S EXPLANT SURGERY

>

> #25

>

> EXPLANTED IMPLANTS OF PLAINTIFF AND PHOTOGRAPHS THEREOF.

>

> #26

>

> MEDICAL RECORDS OF PLAINTIFF.

>

> #27

>

> MEDICAL BILLS OF PLAINTIFF.

>

> #28

>

> PATHOLOGY SLIDES AND TISSUE SAMPLES OF PLAINTIFF.

>

> #29

>

> SPECIMEN BREAST IMPLANTS.

>

> #30

>

> SELECTED COMPLAINT REPORTS, FORMS AND/OR RESPONSES.

>

> #31

>

> ALL PRODUCT DATA SHEETS OF DOW CORNING FOR MAMMARY PROSTHESES.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #32

>

> 09/14/54 SILICA KNOWLEDGE OF SYSTEMIC DESEASE

>

> H.C. Spencer, Dow Chemical, note regarding " Dow Corning Hydrophobic

> Silica. " Testing shows a " high order of toxicity from dust

inhalation. "

>

> CITE: TDC 5488.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #33

>

> 03/28/55 MISCELLANEOUS - COMPLICATIONS SILICA TISSUE REACTION

>

> " Report Of Trip To Saranac Lake Laboratories " by V.K. Rowe of Dow

> Chemical prepared for Dow Corning. Rowe and other Dow Chemical

> scientists visited Saranac Laboratory to verify work they had done

> on D.C. Degusa silica for Dow Corning. Rowe, et al. reviewed the

> work and wrote this report on the conclusions of the tests.

>

> Dow Corning silica consists of crystalline silica. Rowe states that,

> D.C. Degusa (silica) dust is " capable of causing diffuse cellular

> infiltration and fibrotic changes in the lungs and other organs of

> certain types of animals. It also produces bronchitis and sometimes

> emphysema. " However, he concludes that it is not likely to cause

> silicosis " in the ordinary sense of the word. If fibrotic changes of

> the lungs develop in man, they will probably be diffuse in

> character. If exposure is stopped, a measure of recovery is quite

> possible. Exposure to crystalline free silica reactivates and

> aggravates tuberculosis & causes progressive lesions. " (DCC

299000444).

>

> CITE: DCC 266000443 - 266000453, Exhibit to Lynch Deposition, and

> Exhibit to California Braley Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETO/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #34

>

> 01/00/56 TESTING KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Dow Corning Report No. 1377 on " The Physiological Assimilation Of DC

> 200 Fluid " by M.B. Chenoweth (Dow Chemical), R. Holmes and F. Stark.

> A copy was distributed to Collings, Bass, Kauppi, Hunter, Hutchison,

> Hyde, Blackburn, , McHard, CRI, and others including Beamer

> of Dow Chemical. " An increasing use of siloxanes for medicinal

> applications has resulted in the need for information on their

> biological activity. Previous experiments of The Dow Chemical

> Company Biochemical Department has shown that many of these

> compounds were toxicologically inert. It was the purpose of this

> experiment to determine to what extent the polydimethylsiloxanes

> were assimilated, and if so were they were metabolized. " (I 169).

> C14 labeled PDMS in antifoam emulsion was administered to 2 albino

> rats and 2 lactating dogs. " The preoperative care, administering of

> the labeled fluid, sacrificing and dissecting of the animals was

> carried on by Dr. M.B. Chenoweth of The Dow Chemical Biochemistry

> Department. Samples of tissue were analyzed with the cooperation of

> Dow's Radiochemistry Laboratory. " (I 171). With intramuscular

> injection, the C14 siloxane was found in the intestines, right

> adrenal, skin and hair, heart, skull bone, brain, kidney, urine,

> liver, muscle, lung, renal fat, blood and spleen. (I 172). Rats fed

> with the material had siloxane in the ileum, stomach and content,

> bladder and urine and kidney. (I 174). " The actual amount present

> may be greater by a factor of 3 corresponding to total

> polydimethylsiloxane from Dow Corning 200 Fluid and from gum. It is

> unlikely that the polydimethylsiloxane in the gum would be more

> readily assimilated than the lower molecular weight 200 Fluid. " (I

> 174). A lactating dog fed with the material has siloxane in the skin

> and hair, brain, bile,, liver, kidney, heart, milk, urine, skeletal

> muscle, lung, adrenal, and blood. (I 175). A second lactating dog

> also had siloxane in the bile, skin and hair, adrenal, urine,

> spleen, lung, heart, liver, thyroid, pancreas, blood from lung,

> skeletal muscle, and milk. (I 175).

>

> " The studies conducted along these lines (C14 labeled fluid) to date

> have shown that these compounds are absorbed from the

> gastro-intestinal tracts to a slight extent, the amount absorbed

> being of the order of .0001%. Toxicological studies have shown these

> compounds to be inert. " (I 175). There is a cite to the lab

> notebooks for the studies. on 259803.

>

> CITE: KMM 259794 - 259803, Exhibit to County LeVier

> Deposition, Exhibit to Tyler Deposition, Exhibit 20 to County

> Zahalsky Deposition. DUPLICATE: I 167 - 176.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #35

>

> 02/09/56 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS

> MISCELLANEOUS - COMPLICATIONS TESTING

>

> McGregor, Dow Corning, memo to Rowe, Dow Chemical Biochemical

> Research, enclosing 9 samples of silicone fluids for determination

> of the effect of intravenous injection. McGregor wants to know if

> any of the silicone fluids can be tolerated when injected

> intravenously. The silicone samples include 200 fluid, 555 fluid,

> 710 fluid, antifoam AF emulsion (which contains 30% 200 fluid), and

> XEC-5027 (which contains 10% 200 fluid).

>

> CITE: OOT 43674 - 43700, Exhibit to K. Olson Deposition, Exhibit to

> Rowe Deposition, Exhibit 24 to County Rowe Deposition. and

> Exhibit to McHard Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #36

>

> 08/00/57 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS

> MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> Study by Stark titled " The Physiological Activity Of Dow Corning

> 200 Fluid. " By a mechanism unknown at this time, a small amount of

> Dow Corning 200 Fluid is absorbed through the skin by the adrenal

> and kidneys of a rabbit.

>

> CITE: KMM 259804 - 295808.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #37

>

> 10/05/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Dow Corning's version of a " Report Prepared for Dow Corning

> Corporation, Midland, Michigan on Five Silicone Materials. " The

> original report (see document #38 below) was prepared by Dr. W.

> Deichmann of the University of Miami on October 5, 1957 but was a

> report on six silicone materials. This version of Dr. Deichmann's

> report was altered to delete one compound and to delete all adverse

> effects identified in Dr. Deichmann's original report.

>

> In this version, five Dow Corning silicones were fed to albino male

> and female rats for a period of 90 days. The silicones were Dow

> Corning 200 Fluid (50, 350, 1000, 10000 and 60000 cs.). Based on the

> observations of body weight, food intake, hematology, organ weight

> at necropsy, and their gross and microscopic appearance, it was

> concluded that none of the Dow Corning 200 Fluids of the viscosity

> range fed caused any harmful or deleterious effects.

>

> CITE: KKM 7896 - 7930. NOTE: Includes a summary of animal safety

> studies relating to dimethylpolysiloxane fluid. See document #38 for

> the original, unaltered version of Dr. Deichmann's report produced

> by Dow Chemical. This altered version of the report was produced by

> Dow Corning.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #38

>

> 10/05/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Dr. W. Deichmann's original " Report Prepared for the Dow Corning

> Corporation, Midland Michigan on Six Silicone Materials " Six Dow

> Corning silicones were fed to albino male and female rats for a

> period of 90 days. The silicones were Dow Corning 200 Fluid (50,

> 250, 1,000, 10,000, and 60,000 cs.) and Dow Corning Z-4141 Solvent

> Free (the latter compound is the compound deleted by Dow Corning is

> document #37 above).

>

> ORIGINAL REPORT

>

> 2 rats died during experiment there was a marked decreased in the

> number of leukocytes. This difference is considered

> statissignitically significant. It is feeding of apparent there is a

> depression signifi-in the output of granulocytes leukocyte by the

> bone marrow.animals. The livers of the rat fed Z-4141 were

> significantly greater than the controls. This is consistent with of

> the rats fed Z-4141 were the observation of liver damage in these

> animals. The feeding of the six compounds depressed the granulocytic

> or elements of the peripheral tail blood of female rats. The livers

> significantly heavier than the livers of the controls and also

> demonstrated fatty infiltration or degeneration.

>

> DOW CORNING ALTERED REPORT

>

> only 1 rat died there was an apparent decrease in the number of

> leukocytes. This is not statistically ficant. The dietary DC 200

> fluids had no cant effect upon the counts of the treated The feeding

> of the five compounds had no harmful deleterious effects. None of

> the organ weights differed from the controls.

>

> CITE: TDC 6079 - 6100. Dow Corning Trial Exhibit List Abstracts

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> Document #39

>

> 10/09/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning,

> enclosing the results of the review of the six Dow Corning silicone

> compounds. He informs McGregor that all six compounds depressed the

> granulocytic elements of the peripheral (tail) blood of the female

> rats, and that the livers of rats fed Z-4141 were significantly

> heavier than the controls and demonstrated fatty infiltration or

> degeneration.

>

> CITE: M 420103.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #40

>

> 12/09/57 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

> TESTING TISSUE REACTION

>

> Letter from K.J. Olson and checked by V.K. Rowe, Dow Chemical

> Biochemical Research, to R.R. McGregor of Dow Corning with copies to

> H.H. Gay (Dow Chemical) and E.M. (Dow Chemical ??) on " Results

> Of Range Finding Microbiological And Toxicological Tests on B-756-92

> (a linear dimethylpolysiloxane of 6 units end-blocked with

> 2,4,5-trichlorophenxy radicals - being evaluated as potential

> fungicide for athlete's foot). " The tests showed appreciable

> antifungal activity. " If large amounts of the material are allowed

> to remain in contact with large areas of skin, absorption may result

> in systemic injury and may even produce death. " Slight hyperemia

> followed the 3rd and 4th application and the rabbit died " possibly

> due from systemic injury due to absorption through the skin. " The

> other 2 rabbits also died.

>

> Attached is a data sheet prepared by Olson and McCollister, a

> toxicology work sheet, " Request For Applications Testing, " and eye

> contact, skin contact - irritation, and skin contact absorption test

> records. NOTE: The document is stamped, " This Report Is The Property

> Of The Dow Chemical Company. "

>

> CITE: TDC 6158 - 6175, Exhibit to K. Olson Deposition, and Exhibit

> to McHard Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #41

>

> 04/09/58 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC

> DISEASE MISCELLANEOUS MISCELLANEOUS - COMPLICATIONS TESTING TISSUE

> REACTION

>

> " Pharmacological Test Data For Various Organofunctional Silicon

> Compounds, Report No. 1641, " by Speier of Dow Corning.

> Pharmacological screening test data for 61 organofunctional silicon

> compounds are examined for use in drugs. In early 1952, a program

> was agreed upon with Eli Lilly for the pharmacological examination

> of assorted organofunctional silicon compounds. " The screening of

> these compounds has shown that a great many organofunctional silicon

> compounds and polymers have totally unexpected activities. Certain

> ones proved to be acutely toxic, even though closely similar

> structures were not especially toxic. " (DCC 281002214).

>

> All the results are contained in Mellon Institute notebook 318 - all

> 61 tests in this study contain a reference to notebook 318. There is

> also a reference to Earl Warrick's work at the Mellon Institute at

> 281002226.

>

> CITE DCC 281002213 - 281002230, Exhibit to Tyler, MDK and

> County Depositions, Exhibit to Deposition, Exhibit to McHard

> Deposition, and Exhibit to Deposition. WITNESS:

> (ancient document exception to hearsay). DISPOSITION: Not introduced

> in Toole (II) v. Baxter Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #42

>

> 07/31/58 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

> TESTING TISSUE REACTION

>

> Olson, Dow Chemical Biochemical Research, letter to McGregor, Dow

> Corning, with copies to Gay, Dow Chemical, and McHard regarding the

> results of skin irritation, skin absorption and acute oral feeding

> tests on Dow Corning 555 Fluid and Ethylan (a modified lanolin),

> file no. T2.42-54-1.

>

> In McGregor's 06/05/58 letter to Rowe he indicated that Helen Curtis

> Industries had observed untoward systemic effects in rabbits and

> rats due to absorption of the material through the skin. Autopsy

> revealed small yellowish bubbles and petochone (illegible) on the

> liver and lungs. Olson applied the material to the skin of rabbits

> and fed it to another group for 5 days/ The results for the skin

> sensitization tests are illegible. There was a questionable to mild

> kidney disturbance in animals fed 555 fluid.

>

> The conclusions on 6532 state that DC 555 fluid has a low acute oral

> toxicity, is essentially non-irritating to the skin upon prolonged

> repeated contact, and that there is no indication that the material

> is absorbed through the skin in sufficient amounts to produce

> systemic damage. Attached is a toxicology work sheet, " Requests For

> Screening Or Application Testing, " and skin contact absorption and

> acute oral toxicity test results.

>

> CITE: TDC 6526 - 6555, Exhibit to McHard Deposition, and Exhibit to

> K. Olson Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #43

>

> 07/05/62 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Olson and Sadek, Dow Chemical Biochemical Research, letter to

> McHard, Dow Corning, on toxicity by subcutaneous injection of Dow

> Corning 200 Fluids and Dow Corning 555 And 550 Fluids. Dow Corning

> 200 fluid 10 cs. resulted in a moderate inflammatory response in the

> subcutis as indicated by the presence of polymorphonuclear cells and

> a very large mononuclear cells. " This type of inflammatory reactions

> is interpreted as due to infection. " With DC 555 and 550 Fluid, all

> injection sites showed evidence of inflammatory reaction indicated

> by the presence by mononuclear cells and polymorphonnuclear cells.

>

> CITE: TDC 7493 - 7515, Exhibit 9 to Hancock Deposition, Exhibit to

> McHard Deposition, and Exhibit to K. Olson Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #44

>

> 07/12/62 SHELL STRENGTH - THICKNESS

>

> S. Braley, Dow Corning, reports on a telephone call with Dr. Gerow

> regarding his findings from the use of the saline silastic

> prosthesis. A leak was discovered during implantation and Dr. Gerow

> " sealed it with cement on the operating table.... " Also, he wanted

> Dow Corning to " make the Gel gooier. " Dr. Gerow reports that the

> saline he has been using in some of the silastic sacs has been in

> animals for nine months and that the body sets up a chemical

> balance. He has analyzed the fluid inside the sacs after this nine

> months and found protein, SO4 ions and also indications that the

> body had set up a balance of magnesium and other ions. Finally, Dr.

> Gerow stated that the " direct injection technique has worked out

> beautifully. "

>

> CITE: M 320001 - 320002.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #45

>

> 09/14/62 TESTING

>

> Dow Chemical Texas Division, Agricultural Research, study by F.C.

> , K.G. Seymour, and J.B. on " Tropical Application Of

> Various Solvents And Solutions To Evaluate Dermal Irritation. "

> Report No. 210. The report was circulated many persons including

> K.W. McCory of Dow International; persons at Bioproducts: Adm., J.E.

> ; An.Sci. R and D, T.A. Hymas; Plt.Sci. R and D, K.C.

> Barrons; Midland BRC Files, L.J. Lippie: Registration Section. G.E.

> Lynn; Synthesis Group, W. Reifschneider; and Formulation Res., J.W.

> VanValkenburg; to V.K. Rowe of Biochemical Research; and to the

> following persons at Pitman-: C.W. Hinman, G.R. Burch, and D.C.

> Brinkman.

>

> Dow Corning 200 fluid - silicone oil with 49% espesol 5 content was

> administered in 10 cc dosages to shaved strips on the hide to test

> for suitable solvents for Ruelene. Dow Chemical hoped to find a

> solvent that didn't damage the hides of cattle when Ruelene was

> administered. The DC 200 fluid was rated ad bad, which indicated

> that the hide had extreme cracking or sloughing at 10 and 16 days

> after application. (TDC 7542).

>

> CITE: TDC 7537 - 7543.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #46

>

> 10/04/62 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID

> COMPONENT OF GEL KNOWLEDGE OF GEL BLEED KNOWLEDGE OF LIQUID SILICONE

> DANGERS SHELL STRENGTH - THICKNESS TISSUE REACTION

>

> S.Braley, Dow Corning, memo regarding telephone call to Dr.

> D. Cronin. Braley told Cronin that the uncatalyzed breast material

> could not be sent out because there were too many problems with it.

> The problems with measuring and the variability of both the base

> material and the mixing techniques necessitates different amounts of

> cross-link resulting, along with the variability in mixing

> techniques, can cause difficulties.

>

> Dr. Gerow was also on the telephone and talked about the

> results he was getting regarding tissue reaction to the direct

> injection of the material.

>

> Cronin said that he is not concerned about leakage if he were to use

> the thin material because a film forms around the implant retaining

> the material in place. Cronin said that he is getting chlorine,

> potassium and proteins both in and out through the wall of the bag.

> This is on apparently good bags.

>

> It was decided that it would be wise to continue the work for long

> range testing for the acceptability of the material.

>

> CITE: OOM 320665 - 320666.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #47

>

> 10/31/63 KNOWLEDGE OF LIQUID SILICON DANGERS GEL MIGRATION

>

> Dr. Walter Berman writes to Silas Braley, Dow corning, reporting on

> his injection of silicone fluid in mice. Two days after injection,

> silicone was found in most organs including the brain, liver,

> spleen, intestinal wall, adrenal and kidney. He also found " evidence

> of at least radio activity and most probably silicone in the brain

> and all of the various other organs.... "

>

> CITE: M 420051 - 420052.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #48

>

> 11/27/63 TESTING TISSUE REACTION

>

> Dow Chemical's Bioproducts Department report by Whitney, Pollock and

> ey on " Fluorosilanes As Fumigants. " Six flourosilanes:K-56,425 =

> n-propyltrifluorosilane; K-56,426 = ethylmethyldifluorosilane;

> K-57,317= trimethylfluorosilane; K-59,489 = mehtyltrifluorosilane;

> K-59,697 =chlorometthyldifluoromethylsilane; K-58,739 = silicon

> tetrafluoride; andK-681 = methyl bromide were evaluated as fumigants

> for control of insects and microorganisms. All were very active

> against post-embryonic stages of tests insects. Tri and difluoro

> silanes were active against bacteria and molds. Most of the

> compounds killed all flour beetle eggs at one lb/1000 cu. ft. with a

> 16-hour exposure.... A patent disclosure has been submitted and

> further research is recommended for these and related compounds.

>

> Results of toxicological work with mammals is reported in reports

> 55.11-56425-1, 55.11-56426-1, 55.11-56427-1, 55.11-57317-1, and

> 55.11-2-1. the usefulness of these compounds has been reported in

> Patent Disclosure no. 16193. NOTE: None of these reports or patent

> disclosures were produced to the PSC.

>

> " Further exploration of the biological and physical properties of

> these and related compounds is recommended. "

>

> CITE: TDC 8901- 8904.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #49

>

> 00/00/64 MISCELLANEOUS - COMPLICATIONS SILICA

> STERILIZATION/CONTAMINATION TISSUE REACTION

>

> Braley, Dow Corning, states in the Trans American Society of

> Artificial Internal Organs, " The Medical Silicones, " that electrical

> charges exist on the surface of the silicone elastomer. Silicone

> elastomers are described as non-adherence products, nothing will

> stick to them " However, because of the dialectic (sic) properties of

> silicone rubber, it will develop a surface charge and can hold dust,

> lint, (etc.).... This is not true adhesion. " Additionally, the

> reason that the attempt to create a silicone vascular prostheses, to

> be inserted in a blood vessel, failed is because of the electrical

> charges on the surface which caused the blood to clot at the ingress

> end of the silicone prostheses tube.

>

> Braley also describes the chemical composition, the characteristics

> and the various applications of silicone.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #50

>

> 01/13/64 GEL MIGRATION KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> McHard memo to Hunter with copies to Braley, Dingman, Hobbs, and

> Stebleton regarding " Notes on visit to Battelle Memorial Institute

> on December 19, 1963. " McHard and Hobbs met with representatives of

> Battelle and discussed the " Toxicology of silicones - past and

> future. ... 1. Variation in toxicity with animal species. 2. Effect

> of polymer size on toxicity. 3. Extent of body metabolism. 4. Fate

> in kidney and liver. 5. Fate of catalysts. 6. Extent of

> carcinogenicity. " Also discussed was silastics for breast implants.

> Battelle's study showed that the physical properties of silicone

> rubber when implanted were significantly affected/decreased. Also,

> " There was considerable discussion on how the various polymer sizes

> may be transported across the G.I. tract and how they may find their

> way into the kidney, liver, and subsequently, the urine. "

>

> CITE: KMM 299059 - 299063.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #51

>

> 05/16-17/64 COHESIVENESS-LIQUID COMPONENT OF GEL KNOWLEDGE OF LIQUID

> SILICONE DANGERS KNOWLEDGE OF SYSTEMIC DISEASE TISSUE REACTION

>

> 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.

> and L.F. Stebleton of Dow Corning; by Drs. , 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. Olson Deposition. DUPLICATE: m 30531 - 30558; KMM

> 183981 - 184009.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #52

>

> 05/28/64 FRAUD/MISREPRESENTATION GEL MIGRATION MISCELLANEOUS -

> COMPLICATIONS TISSUE REACTION

>

> Braley memo to , Blocksma, R. Dingman, Edgerton, Goulian,

> Lederer, Murray, Rees, Badamo, Bass, H. Dingman, Haberstroh,

> Hodnett, Honter, McHard, Mullison, , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & confidential

>

> Document #53

>

> 09/22/64 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Rees letter to Braley, Dow Corning, regarding the finding of

> altered fat cells in animals subcutaneously 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> < Document #54

>

> 09/24/64 TISSUE REACTION SHELL DEGRADATION SHELL STRENGTH -

THICKNESS

>

> Letter from Dr. Cronin to , General Manager of

> Dow Corning. Dr. Cronin reports that Dr. Brauer had to remove seven

> implants when, at intervals of 2-4 months, a blister would start in

> the scar and gradually break down. " (S)ome clear, straw colored

> fluid would be released "

>

> CITE: KMM 150269 - 150270. NOTE: Ivory flakes were being used to

> prepare the implants prior to surgery.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #55

>

> 11/12/64 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> 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 List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #56

>

> 12/00/64 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -

> COMPLICATIONS TISSUE REACTION

>

> " Tissue Reactions to Injected Silicone Liquids, A Report of Three

> Cases, " Archives of Dermatology, Vol. 90, 538-593 by Winer,

> Sternberg, Lehman and . Drs. Oppenheimer and 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 Braley Deposition. DUPLICATE: PSC Medical Articles CD, J

> 3598 - 3603.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #57

>

> 12/08/64 KNOWLEDGE OF LIQUID SILICONE DANGERS TISSUE REACTION

>

> Dr. lin 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #58

>

> 01/29/65 KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> lin , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #59

>

> 04/01/65 CONCEALING FROM FDA KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> Dr. lin 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #60

>

> 05/27/65 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> , M.D., reports to Silas Braley of Dow Corning regarding

> a consultation with a patient in Las Vegas. 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #61

>

> 06/24/65 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> 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 - 3803.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #62

>

> 10/05/65 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -

> COMPLICATIONS SILICA 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, Document #1

>

> CONCEALING FROM FDA FRAUD/MISREP

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #63

>

> 10/27/65 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID

> COMPONENT OF GEL GEL MIGRATION SHELL DEGRADATION SHELL STRENGTH -

> THICKNESS TESTING TISSUE REACTION

>

> 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 Deposition and Exhibit

> to D. McGhan Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #64

>

> 11/15/65 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> Dr. 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. lin , Dr. Ralph Blocksma, Dr. Dingman, Dr.

> Milton Edgerton, Dr. Dicran Goulian, Jr., Dr. Francis Lederer, Dr.

> ph Murray, Dr. Norman Orentreich, and Dr. Rees.

>

> Dr. 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. 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #65 01/14/66 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE

> OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE

> REACTION

>

> McHard memo to Bass with copies to , 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 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, 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #66

>

> 06/06/66 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> 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, , Dingman and McHard (all

> of DC) and Drs. Lehman, Marzulli and 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 Deposition, Exhibit to

> Rowe Deposition, and Exhibit to McHard Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #67 07/00/66 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL

> MIGRATION

>

> T. Rees, et al., submits to Dow Corning a report titled " Visceral

> Response to Subcutaneous and Intraperitoneal Injections of

> Polymethylsiloxane in Mice " which evaluates histologically the

> systemic distribution of silicone fluid. Results indicate silicone

> deposition in the spleen, liver, adrenals, pancreas, ovaries,

> abdominal lymph nodes and kidneys of the test animals, suggesting

> distribution by the reticuloendothelial mechanism.

>

> CITE: KKM 31076 - 31087.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #68

>

> 08/02/66 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> Braley memo to , Blocksma, Dingman, Edgerton, Goulian,

> Lederer, Murray, Orentreich, Steve Carson, , , Hunter

> and McHard regarding the attached letter and paper from 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #69

>

> 09/06/66 MISCELLANEOUS - ORGANIZATIONAL SURVEY

>

> Minutes of the Board of Directors' Meeting for Dow Chemical Company

> with a reference to a secrecy agreement with Dow Corning Corporation

> regarding the biological properties of silicones.

>

> CITE: TDC 11625 - 11627, Exhibit to Deposition and to Julius

> Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #70

>

> 10/10/66 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -

> PRODUCT LABELING TESTING

>

> Memo from Don McGhan (at Dow Corning) to McIntyre with copies to

> Pellikka, Hutchison, , 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 Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #71

>

> 10/12/66 MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - SALES

> STERILIZATION/CONTAMINATION TESTING

>

> " Chemical Research Progress Report (Restricted), Report No. 2964, "

> by R. McCarty and J. Speier - all of Dow Corning. Dr. Hunter

> established a committee of , 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 Deposition,

> Exhibit to McHard Deposition, Exhibit to Deposition, Exhibit to

> Isquith Deposition and Exhibit to LeVier Deposition. WITNESS:

> (ancient document exception to hearsay). DISPOSITION:

> Admitted in Toole (II) v. Baxter Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #72

>

> 01/10/67 ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING

>

> Rowe memo to McHard with copies to , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #73

>

> 02/01/67 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF LIQUID

> SILICONE DANGERS KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -

> ORGANIZATIONAL SURVEY 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 Deposition,

> Exhibit to LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to

> Caldwell Deposition, Exhibit to McHard Deposition, Exhibit to Julius

> Deposition, and Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #74

>

> 02/08/67 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE

>

> " 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 407480 - 407482). NOTE: See 12/31/87 entry in Master Timeline.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #75

>

> 02/16/67 KNOWLEDGE OF GEL BLEED KNOWLEDGE OF LIQUID SILICONE DANGERS

> MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> " 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), , Boone, Braley,

> , 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 Deposition,

> Exhibit to McHard Deposition, Exhibit to Rowe Deposition, and

> Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #76

>

> 03/10/67 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> " Summary of Toxicological Testing of Dow Corning FS-1265 Fluid and

> Ointment, Foot Protective " by " jar " (ph 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #77

>

> 03/14/67 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

> County Depositions, Exhibit to Deposition, Exhibit to

> Deposition, Exhibit to Julius Deposition, Exhibit to Himnam

> Deposition, and Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #78

>

> 03/21/67 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE TESTING TISSUE REACTION

>

> 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. 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. ; 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. 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 county Rathjen Deposition.

> DUPLICATE: F 316 - 326.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & confidential

>

> Document (On PLAINTIFF'S LITERATURE LIST)

>

> (this is between #78 & #79)

>

> 04/00/67 (ON PLAINTIFF'S LITERATURE LIST)

>

> F. , 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 Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #79

>

> 04/28/67 GEL MIGRATION KNOWLEDGE OF LIQUID SILICONE DANGERS

> MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> " 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #80

>

> 04/28/67 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING TISSUE

REACTION

>

> " 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 entry. DUPLICATE T 996 - 1029.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #81

>

> 07/19/67 MISCELLANEOUS SILICA STERILIZATION/CONTAMINATION

>

> " 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #82

>

> 08/17/67 CONCEALING FROM FDA FRAUD/MISREPRESENTATION KNOWLEDGE OF

> LIQUID SILICONE DANGERS MISCELLANEOUS - PRODUCT LABELING

> 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #83

>

> 10/18/67 TESTING

>

> J. McHard, Dow Corning, memo to I. Hutchinson, , 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.

>

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> Document #84

>

> 11/10/67 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

SILICA

>

> Hobbs and Himmelsback memo to Barry, , , Fenn,

> Greenhalgh, Hansen, Hargreaves, Hedlund, Hunter, Hyde, Donkle, C.

> Lentz, Maneri, McHard, , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #85

>

> 12/15/67 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING TISSUE

REACTION

>

> 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 Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #86

>

> 01/04/68 MISCELLANEOUS - ORGANIZATIONAL SURVEY

>

> Minutes of the Board of Director's Meeting of Dow Chemical Company

> with a reference to loans and advances made to Dow Corning

Corporation.

>

> CITE: TDC 11702 - 11703, Exhibit to Deposition, and Exhibit

> to Julius Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #87

>

> 02/20/68 KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> Bureau of Regulatory compliance reports on the prosecution of Dow

> Corning, Bass, , and McIntyre for selling a new drug - Dow

> Corning 360 Fluid - without an approved New Drug Application.

>

> CITE I 470. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC

> Attorney Work Product/Privileged & Confidential

>

> Document #88

>

> 02/28/68 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> 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 County Rathjen

> Deposition. DUPLICATE: KKP 16422; FDA 26696 - 26701; I 1333 - 1341;

> KKP 16422 - 16431; M 100145 - 100154.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #89

>

> 03/07/68 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -

> ORGANIZATIONAL SURVEY TESTING

>

> Minutes of the Board of Directors' Meeting of the Dow Corning

> Corporation with reference to the officers of Dow Corning being

> approved to sell to Dow Corning employees common stock in the Dow

> Chemical Company. The minutes also refer to an agreement between Dow

> Corning and Dow Chemical for joint research, development, evaluation

> and commercialization programs on the physiological effects of

> organosilicon compounds.

>

> CITE: DCC 101001529 - 101001543, Exhibit to Deposition,

> Exhibit to Julius Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #90

>

> 04/22/68 TESTING TISSUE REACTION

>

> " Histopathological Findings In Animals of Various Species from

> Experiments conducted by 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #91

>

> 04/26/68 ACKNOWLEDGEMENT OF NEED FOR TESTING CONCEALING FROM FDA

> MISCELLANEOUS - LOBBYING MISCELLANEOUS - ORGANIZATIONAL SURVEY

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 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)

>

> ACKNOWLEDGEMTN OF NEED FOR TESTING MISCELLANEOUS - COMPLICATIONS

> TESTING TISSUE REACTION

>

> Minutes of Meeting at Midland on May 23-24, 1968 with

> representatives form Dow Corning, Industrial Bio-Test, Food and Drug

> Research Laboratories, and the Dow Chemical Company. " Attending were

> , Calandra (IBT), Carson (FDRL), , Frisch, Hobbs,

> Hunter, Hutchison, McHard, Radzius and Rowe, Dow Chemical. The

> subject of the meeting was a " Toxicology Review of Dow Corning

> Products. "

>

> CITE: DCC 281041054 - 281041059.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #94

>

> 05/31/68 TESTING TISSUE REACTION

>

> 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #95

>

> 06/03/68 COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION

TESTING

>

> 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 Country LeVier

> deposition, Exhibit 3 to Country Rathjen Deposition, Exhibit

> 19 to County Zahalsky Deposition, Exhibit to County

> Tyler Deposition, and Exhibit to Weyenberg Deposition.

>

> DUPLICATE: M 100155 - 100174; DCC 242031103 - 242031121; FDA 43184 -

> 43202.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #96

>

> 07/16/68 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE

>

> FDA: Dr. 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #97

>

> 08/08/68 GEL MIGRATION TESTING TISSUE REACTION

>

> 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 List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #98

>

> 10/09/68 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Hobbs, Toxicologist at Dow Corning, letter to Dr. 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 Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #99

>

> 10/17/68 FRAUD/MISREPRESENTATION MISCELLANEOUS - COMPLICATIONS

> MISCELLANEOUS - PRODUCT LABELING TESTING

>

> Olson memo to Pail with copies to , Currie, Gergle, Hobbs,

> Hunter, McHard, Radzius and Vaughn regarding " Suitability for

> Industrial Use of Protective Hand Cream Formulated with Dow Corning

> FS-1265 Fluid Unstripped of Cyclic Trimer. " The Dow Corning

> Toxicology Department recommends the use of Protective Hand Cream,

> industrially, does not pose a significant hazard, and " represents an

> appropriate risk for Dow Corning. " Olson reviews the studies to date

> on FS-1265 Fluid including studies by IBT - 20 day subacute dermal

> study in rabbits (spermatogenic depression was found to be mild to

> moderate in the controls and not significantly different in the test

> groups); one-year dietary feeding study in rats ( " There was evidence

> of decreased spermatogenesis in the male test animals " ); IBT - 14

> week dermal toxicity in rhesus monkeys (biopsies at 30-days showed

> testicular hypoplasia); Dow Chemical (cyclic trimer possesses a

> relatively high acute oral toxicity); and IBT - acute percutaneous

> absorption study. He recommends industrial use of Protective Hand

> Cream containing less than 15 p.p.m. of cyclic trimer and that this

> is an appropriate risk. " We wish to emphasize that the front label

> flagrantly (sic) misrepresents the product from an efficacy

> viewpoint. All data generated to date shows, unequivocally, that the

> cream does not protect against the irritating properties of the

> chemicals studied. Ethically, such advertising leaves much to be

> desired and is frowned upon by government agencies and all who are

> charged with matters pertaining to consumer protection and proper

> representation "

>

> CITE: DCC 218041771 - 281041776, Exhibit to K. Olson Deposition, and

> Exhibit to LeVier, Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #100

>

> 11/29/68 KNOWLEDGE OF SYSTEMIC DISEASE TESTING TISSUE REACTION

>

> 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

> distributed outside Dow Corning Corporation. "

>

> CITE: T 2033 - 2096, Exhibit 35 to Deposition (used by Dow

> Corning), Exhibit 29 to MDL Rathjen Deposition (used by Dow

> Corning), and Exhibits 19 and 20 to Zahalsky Deposition. DUPLICATE:

> FDA 27384 - 27409.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #101

>

> 01/29/69 SHELL STRENGTH - THICKNESS RUPTURE G. on, Dow

> Corning, memo to Koning regarding a mammary implant ruptured 1 1/2

> years after implantation which was returned by Dr. Crosby. on

> states, " (T)he envelope edges adjacent to the rupture, appeared to

> be of a very low tear strength. The physical properties of this

> envelope may never have been adequate. " (emphasis added).

>

> CITE: KKH 1654.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #102

>

> 03/24/69 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE

>

> Dr. lin , a clinical investigator for IND 2702, writes to

> Dr. McDowell regarding an article by Bishoff and Bryson on the

> carcinogenicity of silicone in fluid in rats and mice. Braley, Dow

> Corning, has reviewed the article and has stated to Dr. that:

> " According to what he says, and he would not want to say this to

> you, he feels that this article is well written and should not be

> published. I agree. "

>

> CITE: OOM 320814.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #103

>

> 06/10/69 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> Memo from Olson to Frisch with copies to , Hobbs, Hunter and

> Radzius regarding " Telephone Communication with Dr. of

> & . " Dr. , toxicologist at & ,

> was contacted by telephone regarding their subacute dermal rabbit

> study on Dow Corning 556 and 360 fluids and Dow Corning MDDX-4-4122

> wash resistant base. Dr. stated that the materials had been

> applied to rabbit skin daily. All animals showed a trend toward

> testicular atrophy. " There was a suggestion of dose-response

> relationship with Dow Corning materials although the effects were

> not statistically significant. A subacute oral rat study is in

> progress. " Olson indicated to that Dow Corning would be

> concerned about positive findings with the second study and would be

> agreeable to meeting with them to compare their respective data.

>

> CITE: DCC 281041112, Exhibit to McHard Deposition, Exhibit to K.

> Olson Deposition, and Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #104

>

> 07/15/69 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Food and Drug Research laboratories report on the findings in the

> chronic parenteral (intraperitoneal) study initiated by Dr.

> Ballantyne, Rees and Hawthorne at the NYU School of Medicine. After

> silicone fluid in the peripheral erythrocytes in early hematologic

> examinations was observed, Dow Corning transferred the study and its

> financial sponsorship from NYU to Food and Drug Research

> Laboratories. " When the animals received 51 cc and 62 cc of fluid,

> inflammatory cells were observed in the spinal meninges (which was

> not stated in earlier reports). Injections of large volumes of

> silicone produces wide spread deposition throughout the

> reticuloendothelial system, silicone vacuole accumulation in cells

> and a systemic distribution of silicone droplets.

>

> CITE: T 2866 - 2945 (The study is referenced in FDA 26875 - 26889).

> NOTE: See 06/30/75 entry.

>

> Document #105

>

> 08/06/69 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC

> DISEASE TESTING

>

> Isquith, Dow Corning Biomedical Research Laboratory, memo on the

> " Current Status of Microbiological research. " Isquith states that:

>

> " The main purpose of the survey is to help in establishing the basic

> relationship between organosilicon structure and biological

> activity, the further pursuit of which rests with our own secondary

> stage research activity into the physiology (metabolism, mechanism

> of action, site of action, etc.) of the compounds and a good

> screening procedure for identification of developmental potential.

> (DCC 16000004)

>

> Another area for research is the development of a biological assay

> for determination of organosilicone interferon induction. (DCC

> 16000004). Dow Corning has developed sufficient expertise in viral

> methodology to conduct the assay, but " there would be considerable

> advantage in using such a system (more stable virus, greater

> lethality) as is currently being employed in a survey for interferon

> inducers at Dow (Chemical) Human Health by Dr. N. Miner.... " (DCC

> 16000005) He recommends using Dr. Miner's lab for seeking a long

> lasting interferon inducer among organosilicone compounds. (DCC

> 16000006)

>

> Finally, another area is the " Investigation of Physiological Effects

> of Some Organosilicon Compounds. " (DCC 16000011). Isquith concludes

> that the area of microbiology in relation to organosilicon chemistry

> " is mushrooming at a pace that even now we are unable to adequately

> provide this cover. A wise investment at this time would be the

> hiring of a virologist (M.S. preferably) with training in tissue

> culture, virology, and immunochemistry. I have not had time to

> investigate thoroughly, but feel there is a good chance for

> development of possible potential in the areas of hypersensitivity,

> graft rejection, and autoimmune disease (arthritis,

> glomerulonephritis, etc.) which should be within the scope of a

> person with the training I suggested. " (DCC 16000014)

>

> CITE: DCC 16000002 - 160000014, Exhibit 2 to Isquith Deposition,

> Exhibit 3 to D.McGhan Deposition, Exhibit to Blocksma Deposition

> (used by plaintiffs and Dow Corning), Exhibit to LeBeau Deposition,

> Exhibit to Deposition, Exhibit to Boley Deposition, and

> Exhibit to Julius Deposition

>

> WITNESS: " (Authenticated in Isquith, Vol. I, 119-120).

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #106 08/14/69 ACKNOWLEDGEMENT OF NEED FOR TESTING

> MISCELLANEOUS - ORGANIZATIONAL SURVEY TESTING

>

> Letter of agreement between Dow Chemical Company, Dow Corning

> Corporation and Lepetit SpA for a joint development program

> regarding the biological activity of organosilicon compounds. The

> agreement requires the full disclosure of all proprietary and

> confidential information of each party to the agreement to each

> other party.

>

> CIT: TDCH 1275 - 1276.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #107

>

> 11/15/69 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

>

> Doremire memo to regarding chemical warfare and riot control

> agents, XZ8-3063. This is a silicone glycol. It goes through the

> skin as if there was no skin there. " Do you have any suggestions for

> a chemical that could be added to XZ8-3063 which would cause a

> variety of effects? These effects could vary from a drug that would

> act as a simple tranquilizer to a drug which would cause a loss of

> consciousness. " In the case of riot control, the drug might be

> effective for 1/2 hour whereas a chemical warfare use might need 2-4

> hours effectiveness. He plans on checking with the " Analytical

> Laboratory on toxicity information.

>

> CITE: DCC 281014081, Exhibit 3 to County LeBeau Deposition,

> Exhibit to Rowe Deposition, Exhibit to Deposition, Exhibit

> to McHard Deposition, and Exhibit to Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #108 00/00/70 00/00/71 00/00/72 FRAUD/MISREPRESENTATION

>

> Dow Corning axhibit to McHard Deposition and Exhibit to K. Olson

> Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #63 10/27/65 ACKNOWLEDGEMENT OF NEED FOR TESTING

> COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION

>

> CITE: M 700003; M 700008 - 700009. DUPLICATE; M 370049 - 370052; M

> 370108 - 370109; M 370113 - 370114; KKH 62679 - 62682; M 700019 -

> 700020.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #109

>

> 09/20/76

>

> Hobbs, Dow Corning, memo to Hinsch with a copy to Lentz regarding

> information concerning migration of silicone gels. Hobbs states that

> experimentation had not demonstrated migration of Dow Corning

> mammary gel but this factor does not appear to be true for all

> silicone gels. Hobbs further states that gels having a low

> consistency due to low levels of cross-linker appear to migrate

> along tissue planes in much the same manner as large injected doses

> of silicone fluid.

>

> CITE: M 170104, Exhibit 130 to Burda Deposition; Exhibit 91 to

> Braley Deposition. DUPLICATE: M 570060. NOTE: The document was

> listed as 00/00/70 on Plaintiff's Trial Exhibit List.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #110

>

> 01/12/70 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Silas Braley, Dow Corning, memo to various Dow Corning employees

> distributing interim research report on the investigation of

> Dimethylpolysiloxane Fluid Injections at the Institute of

> Reconstructive Plastic Surgery, New York University. The interim

> report states that " our most interesting recent findings indicate

> that in both mice and rats, injection of large volumes of liquid

> silicone, either interperitoneally or subcutaneously, in multiple

> injections, apparently produces a wide spread deposition of this

> material throughout the reticuloendothelial system. A more recent

> finding of some interest is that there is an apparent accumulation

> of silicone vacuoles both within the red cells and the leukocytes of

> the peripheral blood in mice and rats, which appears about one to

> three months after injection and persists for several months. " The

> NIH grant will run out in about one year and these studies will have

> to be terminated. " It is our feeling that the evidence of systemic

> distribution of silicone droplets or vacuoles can not necessarily be

> considered an adverse effect, but is more likely related to total

> dosage. The dosages employed in animals rarely can be achieved in

> man with the possible exception of breast injections.... "

>

> CITE: T 2881 - 2885. NOTE: The report itself was an Exhibit to the

> K. Olson Deposition (KKH 9841 - 9845). This document also has the

> Bates number OOM 321368 - 321672 on it. Dow Corning Trial Exhibit

> List Abstracts PENDLETON/PSC Attorney Work Product/Privileged &

> Confidential

>

> Document #111 02/02/70 STERILIZATION/CONTAMINATION

>

> J.H. Wetters, Dow Corning Medical Products Plant, Report No. 229 to

> Burdick with copies to Reilly, Mantle, Piper, Don McGhan, Houle and

> on regarding " White Particle Contamination of the Mammary

> Gel. " The major contaminant was found to be crystalline by

> microscopy and potassium chloride and potassium bicarbonate by

> x-ray. Wetters cannot explain the presence of potassium bicarbonate.

> The white poly lined can in which it is contained could possibly be

> the source of this material.

>

> J.P. Fitzgibbon feels that the crystalline potassium salts are the

> major portion of the contamination. " Gordon on and Ken Olson

> should be contacted for an opinion as to whether these potassium

> salts are harmful. " (MM 234057)

>

> CITE: KMM 234056 - 234057.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #112

>

> 02/18/70 KNOWLEDGE OF LIQUID SILICONE DANGERS ACKNOWLEDGEMENT OF

> NEED FOR TESTING TISSUE REACTION

>

> Report prepared Food and Drug Research Laboratories for the Dow

> Corning Toxicology department. There are relatively little specific

> experimental data available on the reactivity of biological systems

> to silastics and polymethylsiloxane (PMSs) fluids. Prior studies by

> other laboratories showed " significant testicular atrophy resulted "

> from topical application of a polymethylsiloxane fluid. In the

> present study, 15 applications of PMS fluid was applied topically on

> rats, guinea pigs, rabbits and dogs for a 20-day period, and was

> administered in the diets of rats and rabbits for eight months. In

> the rabbits that were topically applied with PMS fluid, " the

> reduction in the testicular weights of the PMS-treated rabbits is

> considered biologically significant. "

>

> In the rats that had PMS administered orally for one year, growth

> was retarded as early as the first week in feeding. The differences

> in weight gain between the test and control groups was

> " statistically significant " during the third week, with the weight

> gain in the test group lower than the control. In the female rats,

> there were " notable endocrine effects, " smaller ovaries, enlarged

> pituitary, and increased weight in the adrenals and thyroids.

>

> In the rabbits that had PMS administered orally for eight months,

> there was a " trend toward decreased testicular size in the test

> group..., " a tendency toward lower hemoglobin and hematocrit in all

> rabbits in the test group, " some effect of PMS fluid on sperm

> maturation..., " and testicular atrophy in the test rabbits.

>

> CITE: T 2302 - 2341, Exhibit to K. Olson Deposition, and Exhibit to

> LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

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[Guest guest]

Please read this again....love you all...............Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`

> CONCEALING FROM FDA FRAUD/MISREPRESENTATION

>

> 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. Dow Corning Trial Exhibit List Abstracts

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> 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 Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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 Deposition, and

> Exhibit to Isquith Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #4

>

> 1970 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC

> DISEASE MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - ORGANIZATIONAL

> SURVEY TESTING

>

> Draft of the " Proposed Agreement For ative 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 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 Deposition, and Exhibit to MDL LeVier Deposition.

> WITNESS: (Authenticated in , Vol. II, p. 455-457).

> DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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 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 Silanols and then a handwritten outline on

> Silanols (Slide 2) beginning on page 4. 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. Dow Corning Trial Exhibit List Abstracts

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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 Deposition,

> Exhibit 11 to McKennon Deposition, Exhibit 8 to County

> Gehring Deposition, Exhibit to County and MDL LeVier

> Depositions, Exhibit to Deposition, and Exhibit to Isquith

> Deposition. WITNESS: (Authenticated in , Vol. IV, p.

> 880;15 - 882:8). DISPOSITION: Admitted in Toole (II) v. Baxter

> Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #10

>

> KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS

>

> LeVier, Dow Corning, memo to C. Lentz and 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 County Tyler

> Deposition, Exhibit 8 to County LeVier Deposition, Exhibit to

> MDL LeVier Deposition, and Exhibit to Deposition, NOTE: See

> document # 11 for attachment.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #12

>

> VIDEOTAPE PRODUCED AT ZIMMER DEPOSITION ON D4.

>

> CITE: No Bates Number, Exhibit to Zimmer Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLTON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> 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

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #18

>

> Post 10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL

> BLEED MISCELLANEOUS - COMPLICATIONS RUPTURE SHELL STRENGTH -

THICKNESS

>

> Dr. O. Gordon 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. 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.

> 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

> Deposition, Exhibit 25 to McKennon Deposition. WITNESS: .

> DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare

>

> Dow Corning Trial Exhibit List PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #19

>

> Post/10/92 KNOWLLEDGE OF GEL BLEED MISCELLANEOUS - COMPLICATIONS

> RUPTURE SHELL DEGRADATION SHELL STRENGTH - THICKNESS

>

> Dr. O. Gordon '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.

> 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, 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 Deposition. WITNESS:

> 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 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 Deposition. WITNESS:

> DISPOSITION: Not admitted in Toole (II) v. Baxter

Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #21

>

> Post 10/92 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -

> COMPLICATIONS RUPTURE RUPTURE - CLOSED CAPSULOMTOMY SHELL

> DEGRADATION SHELL STRENGTH - THICKNESS

>

> Dr. O. Gordon 's charts on the age of prostheses a

> significant number of implants ruptured 6-16 years

> post-implantation, ( observations at surgery 36.9% of his 73

> patients were symptomatic), follow-up (most did not show any change

> in symptoms during follow-up), symptomatic (patient relates to

> prostheses-arthritic profile, refer, and " No Closed Capsulotomies " ),

> asymptomatic (patient happy), and questions ( " Do mammary prostheses

> last forever? What contributes to the silicone envelope wearing out?

> ... How do you tell if an implant is ruptured? ... "

>

> CITE: No Bates Number, Exhibit 9 to Deposition. WITNESS:

> DISPOSITION: Not admitted in Toole (II) v. Baxter

Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #22

>

> Post 10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL

> BLEED KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

> RUPTURE SHELL STRENGTH - THICKNESS

>

> Draft of Dr. O. Gordon 's paper entitled, " Breast Implant

> Removal Or Exchange. " This is a draft of document number 22.

>

> CITE: No Bates Number, Exhibit 10 to Deposition. WITNESS:

> . DEPOSITION: Not admitted in Toole (II) v. Baxter

Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #23 through#31

>

> #23

>

> ANY FOLLOW-UP STUDIES BY DR. O. GORDON ROBINSON.

>

> This includes an abstract by Dr. and Dr. Edwin Bradley

> entitled " Disruption Rate of Silicone Gel Prostheses - A Report of

> 200 Cases " published in the January 1995 issue of the American

> Medical Association Journal.

>

> #24

>

> PHOTOGRAPHS OF PLAINTIFF'S EXPLANT SURGERY

>

> #25

>

> EXPLANTED IMPLANTS OF PLAINTIFF AND PHOTOGRAPHS THEREOF.

>

> #26

>

> MEDICAL RECORDS OF PLAINTIFF.

>

> #27

>

> MEDICAL BILLS OF PLAINTIFF.

>

> #28

>

> PATHOLOGY SLIDES AND TISSUE SAMPLES OF PLAINTIFF.

>

> #29

>

> SPECIMEN BREAST IMPLANTS.

>

> #30

>

> SELECTED COMPLAINT REPORTS, FORMS AND/OR RESPONSES.

>

> #31

>

> ALL PRODUCT DATA SHEETS OF DOW CORNING FOR MAMMARY PROSTHESES.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #32

>

> 09/14/54 SILICA KNOWLEDGE OF SYSTEMIC DESEASE

>

> H.C. Spencer, Dow Chemical, note regarding " Dow Corning Hydrophobic

> Silica. " Testing shows a " high order of toxicity from dust

inhalation. "

>

> CITE: TDC 5488.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #33

>

> 03/28/55 MISCELLANEOUS - COMPLICATIONS SILICA TISSUE REACTION

>

> " Report Of Trip To Saranac Lake Laboratories " by V.K. Rowe of Dow

> Chemical prepared for Dow Corning. Rowe and other Dow Chemical

> scientists visited Saranac Laboratory to verify work they had done

> on D.C. Degusa silica for Dow Corning. Rowe, et al. reviewed the

> work and wrote this report on the conclusions of the tests.

>

> Dow Corning silica consists of crystalline silica. Rowe states that,

> D.C. Degusa (silica) dust is " capable of causing diffuse cellular

> infiltration and fibrotic changes in the lungs and other organs of

> certain types of animals. It also produces bronchitis and sometimes

> emphysema. " However, he concludes that it is not likely to cause

> silicosis " in the ordinary sense of the word. If fibrotic changes of

> the lungs develop in man, they will probably be diffuse in

> character. If exposure is stopped, a measure of recovery is quite

> possible. Exposure to crystalline free silica reactivates and

> aggravates tuberculosis & causes progressive lesions. " (DCC

299000444).

>

> CITE: DCC 266000443 - 266000453, Exhibit to Lynch Deposition, and

> Exhibit to California Braley Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETO/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #34

>

> 01/00/56 TESTING KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Dow Corning Report No. 1377 on " The Physiological Assimilation Of DC

> 200 Fluid " by M.B. Chenoweth (Dow Chemical), R. Holmes and F. Stark.

> A copy was distributed to Collings, Bass, Kauppi, Hunter, Hutchison,

> Hyde, Blackburn, , McHard, CRI, and others including Beamer

> of Dow Chemical. " An increasing use of siloxanes for medicinal

> applications has resulted in the need for information on their

> biological activity. Previous experiments of The Dow Chemical

> Company Biochemical Department has shown that many of these

> compounds were toxicologically inert. It was the purpose of this

> experiment to determine to what extent the polydimethylsiloxanes

> were assimilated, and if so were they were metabolized. " (I 169).

> C14 labeled PDMS in antifoam emulsion was administered to 2 albino

> rats and 2 lactating dogs. " The preoperative care, administering of

> the labeled fluid, sacrificing and dissecting of the animals was

> carried on by Dr. M.B. Chenoweth of The Dow Chemical Biochemistry

> Department. Samples of tissue were analyzed with the cooperation of

> Dow's Radiochemistry Laboratory. " (I 171). With intramuscular

> injection, the C14 siloxane was found in the intestines, right

> adrenal, skin and hair, heart, skull bone, brain, kidney, urine,

> liver, muscle, lung, renal fat, blood and spleen. (I 172). Rats fed

> with the material had siloxane in the ileum, stomach and content,

> bladder and urine and kidney. (I 174). " The actual amount present

> may be greater by a factor of 3 corresponding to total

> polydimethylsiloxane from Dow Corning 200 Fluid and from gum. It is

> unlikely that the polydimethylsiloxane in the gum would be more

> readily assimilated than the lower molecular weight 200 Fluid. " (I

> 174). A lactating dog fed with the material has siloxane in the skin

> and hair, brain, bile,, liver, kidney, heart, milk, urine, skeletal

> muscle, lung, adrenal, and blood. (I 175). A second lactating dog

> also had siloxane in the bile, skin and hair, adrenal, urine,

> spleen, lung, heart, liver, thyroid, pancreas, blood from lung,

> skeletal muscle, and milk. (I 175).

>

> " The studies conducted along these lines (C14 labeled fluid) to date

> have shown that these compounds are absorbed from the

> gastro-intestinal tracts to a slight extent, the amount absorbed

> being of the order of .0001%. Toxicological studies have shown these

> compounds to be inert. " (I 175). There is a cite to the lab

> notebooks for the studies. on 259803.

>

> CITE: KMM 259794 - 259803, Exhibit to County LeVier

> Deposition, Exhibit to Tyler Deposition, Exhibit 20 to County

> Zahalsky Deposition. DUPLICATE: I 167 - 176.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #35

>

> 02/09/56 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS

> MISCELLANEOUS - COMPLICATIONS TESTING

>

> McGregor, Dow Corning, memo to Rowe, Dow Chemical Biochemical

> Research, enclosing 9 samples of silicone fluids for determination

> of the effect of intravenous injection. McGregor wants to know if

> any of the silicone fluids can be tolerated when injected

> intravenously. The silicone samples include 200 fluid, 555 fluid,

> 710 fluid, antifoam AF emulsion (which contains 30% 200 fluid), and

> XEC-5027 (which contains 10% 200 fluid).

>

> CITE: OOT 43674 - 43700, Exhibit to K. Olson Deposition, Exhibit to

> Rowe Deposition, Exhibit 24 to County Rowe Deposition. and

> Exhibit to McHard Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #36

>

> 08/00/57 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS

> MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> Study by Stark titled " The Physiological Activity Of Dow Corning

> 200 Fluid. " By a mechanism unknown at this time, a small amount of

> Dow Corning 200 Fluid is absorbed through the skin by the adrenal

> and kidneys of a rabbit.

>

> CITE: KMM 259804 - 295808.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #37

>

> 10/05/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Dow Corning's version of a " Report Prepared for Dow Corning

> Corporation, Midland, Michigan on Five Silicone Materials. " The

> original report (see document #38 below) was prepared by Dr. W.

> Deichmann of the University of Miami on October 5, 1957 but was a

> report on six silicone materials. This version of Dr. Deichmann's

> report was altered to delete one compound and to delete all adverse

> effects identified in Dr. Deichmann's original report.

>

> In this version, five Dow Corning silicones were fed to albino male

> and female rats for a period of 90 days. The silicones were Dow

> Corning 200 Fluid (50, 350, 1000, 10000 and 60000 cs.). Based on the

> observations of body weight, food intake, hematology, organ weight

> at necropsy, and their gross and microscopic appearance, it was

> concluded that none of the Dow Corning 200 Fluids of the viscosity

> range fed caused any harmful or deleterious effects.

>

> CITE: KKM 7896 - 7930. NOTE: Includes a summary of animal safety

> studies relating to dimethylpolysiloxane fluid. See document #38 for

> the original, unaltered version of Dr. Deichmann's report produced

> by Dow Chemical. This altered version of the report was produced by

> Dow Corning.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #38

>

> 10/05/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Dr. W. Deichmann's original " Report Prepared for the Dow Corning

> Corporation, Midland Michigan on Six Silicone Materials " Six Dow

> Corning silicones were fed to albino male and female rats for a

> period of 90 days. The silicones were Dow Corning 200 Fluid (50,

> 250, 1,000, 10,000, and 60,000 cs.) and Dow Corning Z-4141 Solvent

> Free (the latter compound is the compound deleted by Dow Corning is

> document #37 above).

>

> ORIGINAL REPORT

>

> 2 rats died during experiment there was a marked decreased in the

> number of leukocytes. This difference is considered

> statissignitically significant. It is feeding of apparent there is a

> depression signifi-in the output of granulocytes leukocyte by the

> bone marrow.animals. The livers of the rat fed Z-4141 were

> significantly greater than the controls. This is consistent with of

> the rats fed Z-4141 were the observation of liver damage in these

> animals. The feeding of the six compounds depressed the granulocytic

> or elements of the peripheral tail blood of female rats. The livers

> significantly heavier than the livers of the controls and also

> demonstrated fatty infiltration or degeneration.

>

> DOW CORNING ALTERED REPORT

>

> only 1 rat died there was an apparent decrease in the number of

> leukocytes. This is not statistically ficant. The dietary DC 200

> fluids had no cant effect upon the counts of the treated The feeding

> of the five compounds had no harmful deleterious effects. None of

> the organ weights differed from the controls.

>

> CITE: TDC 6079 - 6100. Dow Corning Trial Exhibit List Abstracts

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> Document #39

>

> 10/09/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning,

> enclosing the results of the review of the six Dow Corning silicone

> compounds. He informs McGregor that all six compounds depressed the

> granulocytic elements of the peripheral (tail) blood of the female

> rats, and that the livers of rats fed Z-4141 were significantly

> heavier than the controls and demonstrated fatty infiltration or

> degeneration.

>

> CITE: M 420103.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #40

>

> 12/09/57 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

> TESTING TISSUE REACTION

>

> Letter from K.J. Olson and checked by V.K. Rowe, Dow Chemical

> Biochemical Research, to R.R. McGregor of Dow Corning with copies to

> H.H. Gay (Dow Chemical) and E.M. (Dow Chemical ??) on " Results

> Of Range Finding Microbiological And Toxicological Tests on B-756-92

> (a linear dimethylpolysiloxane of 6 units end-blocked with

> 2,4,5-trichlorophenxy radicals - being evaluated as potential

> fungicide for athlete's foot). " The tests showed appreciable

> antifungal activity. " If large amounts of the material are allowed

> to remain in contact with large areas of skin, absorption may result

> in systemic injury and may even produce death. " Slight hyperemia

> followed the 3rd and 4th application and the rabbit died " possibly

> due from systemic injury due to absorption through the skin. " The

> other 2 rabbits also died.

>

> Attached is a data sheet prepared by Olson and McCollister, a

> toxicology work sheet, " Request For Applications Testing, " and eye

> contact, skin contact - irritation, and skin contact absorption test

> records. NOTE: The document is stamped, " This Report Is The Property

> Of The Dow Chemical Company. "

>

> CITE: TDC 6158 - 6175, Exhibit to K. Olson Deposition, and Exhibit

> to McHard Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #41

>

> 04/09/58 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC

> DISEASE MISCELLANEOUS MISCELLANEOUS - COMPLICATIONS TESTING TISSUE

> REACTION

>

> " Pharmacological Test Data For Various Organofunctional Silicon

> Compounds, Report No. 1641, " by Speier of Dow Corning.

> Pharmacological screening test data for 61 organofunctional silicon

> compounds are examined for use in drugs. In early 1952, a program

> was agreed upon with Eli Lilly for the pharmacological examination

> of assorted organofunctional silicon compounds. " The screening of

> these compounds has shown that a great many organofunctional silicon

> compounds and polymers have totally unexpected activities. Certain

> ones proved to be acutely toxic, even though closely similar

> structures were not especially toxic. " (DCC 281002214).

>

> All the results are contained in Mellon Institute notebook 318 - all

> 61 tests in this study contain a reference to notebook 318. There is

> also a reference to Earl Warrick's work at the Mellon Institute at

> 281002226.

>

> CITE DCC 281002213 - 281002230, Exhibit to Tyler, MDK and

> County Depositions, Exhibit to Deposition, Exhibit to McHard

> Deposition, and Exhibit to Deposition. WITNESS:

> (ancient document exception to hearsay). DISPOSITION: Not introduced

> in Toole (II) v. Baxter Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #42

>

> 07/31/58 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

> TESTING TISSUE REACTION

>

> Olson, Dow Chemical Biochemical Research, letter to McGregor, Dow

> Corning, with copies to Gay, Dow Chemical, and McHard regarding the

> results of skin irritation, skin absorption and acute oral feeding

> tests on Dow Corning 555 Fluid and Ethylan (a modified lanolin),

> file no. T2.42-54-1.

>

> In McGregor's 06/05/58 letter to Rowe he indicated that Helen Curtis

> Industries had observed untoward systemic effects in rabbits and

> rats due to absorption of the material through the skin. Autopsy

> revealed small yellowish bubbles and petochone (illegible) on the

> liver and lungs. Olson applied the material to the skin of rabbits

> and fed it to another group for 5 days/ The results for the skin

> sensitization tests are illegible. There was a questionable to mild

> kidney disturbance in animals fed 555 fluid.

>

> The conclusions on 6532 state that DC 555 fluid has a low acute oral

> toxicity, is essentially non-irritating to the skin upon prolonged

> repeated contact, and that there is no indication that the material

> is absorbed through the skin in sufficient amounts to produce

> systemic damage. Attached is a toxicology work sheet, " Requests For

> Screening Or Application Testing, " and skin contact absorption and

> acute oral toxicity test results.

>

> CITE: TDC 6526 - 6555, Exhibit to McHard Deposition, and Exhibit to

> K. Olson Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #43

>

> 07/05/62 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> Olson and Sadek, Dow Chemical Biochemical Research, letter to

> McHard, Dow Corning, on toxicity by subcutaneous injection of Dow

> Corning 200 Fluids and Dow Corning 555 And 550 Fluids. Dow Corning

> 200 fluid 10 cs. resulted in a moderate inflammatory response in the

> subcutis as indicated by the presence of polymorphonuclear cells and

> a very large mononuclear cells. " This type of inflammatory reactions

> is interpreted as due to infection. " With DC 555 and 550 Fluid, all

> injection sites showed evidence of inflammatory reaction indicated

> by the presence by mononuclear cells and polymorphonnuclear cells.

>

> CITE: TDC 7493 - 7515, Exhibit 9 to Hancock Deposition, Exhibit to

> McHard Deposition, and Exhibit to K. Olson Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #44

>

> 07/12/62 SHELL STRENGTH - THICKNESS

>

> S. Braley, Dow Corning, reports on a telephone call with Dr. Gerow

> regarding his findings from the use of the saline silastic

> prosthesis. A leak was discovered during implantation and Dr. Gerow

> " sealed it with cement on the operating table.... " Also, he wanted

> Dow Corning to " make the Gel gooier. " Dr. Gerow reports that the

> saline he has been using in some of the silastic sacs has been in

> animals for nine months and that the body sets up a chemical

> balance. He has analyzed the fluid inside the sacs after this nine

> months and found protein, SO4 ions and also indications that the

> body had set up a balance of magnesium and other ions. Finally, Dr.

> Gerow stated that the " direct injection technique has worked out

> beautifully. "

>

> CITE: M 320001 - 320002.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #45

>

> 09/14/62 TESTING

>

> Dow Chemical Texas Division, Agricultural Research, study by F.C.

> , K.G. Seymour, and J.B. on " Tropical Application Of

> Various Solvents And Solutions To Evaluate Dermal Irritation. "

> Report No. 210. The report was circulated many persons including

> K.W. McCory of Dow International; persons at Bioproducts: Adm., J.E.

> ; An.Sci. R and D, T.A. Hymas; Plt.Sci. R and D, K.C.

> Barrons; Midland BRC Files, L.J. Lippie: Registration Section. G.E.

> Lynn; Synthesis Group, W. Reifschneider; and Formulation Res., J.W.

> VanValkenburg; to V.K. Rowe of Biochemical Research; and to the

> following persons at Pitman-: C.W. Hinman, G.R. Burch, and D.C.

> Brinkman.

>

> Dow Corning 200 fluid - silicone oil with 49% espesol 5 content was

> administered in 10 cc dosages to shaved strips on the hide to test

> for suitable solvents for Ruelene. Dow Chemical hoped to find a

> solvent that didn't damage the hides of cattle when Ruelene was

> administered. The DC 200 fluid was rated ad bad, which indicated

> that the hide had extreme cracking or sloughing at 10 and 16 days

> after application. (TDC 7542).

>

> CITE: TDC 7537 - 7543.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #46

>

> 10/04/62 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID

> COMPONENT OF GEL KNOWLEDGE OF GEL BLEED KNOWLEDGE OF LIQUID SILICONE

> DANGERS SHELL STRENGTH - THICKNESS TISSUE REACTION

>

> S.Braley, Dow Corning, memo regarding telephone call to Dr.

> D. Cronin. Braley told Cronin that the uncatalyzed breast material

> could not be sent out because there were too many problems with it.

> The problems with measuring and the variability of both the base

> material and the mixing techniques necessitates different amounts of

> cross-link resulting, along with the variability in mixing

> techniques, can cause difficulties.

>

> Dr. Gerow was also on the telephone and talked about the

> results he was getting regarding tissue reaction to the direct

> injection of the material.

>

> Cronin said that he is not concerned about leakage if he were to use

> the thin material because a film forms around the implant retaining

> the material in place. Cronin said that he is getting chlorine,

> potassium and proteins both in and out through the wall of the bag.

> This is on apparently good bags.

>

> It was decided that it would be wise to continue the work for long

> range testing for the acceptability of the material.

>

> CITE: OOM 320665 - 320666.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #47

>

> 10/31/63 KNOWLEDGE OF LIQUID SILICON DANGERS GEL MIGRATION

>

> Dr. Walter Berman writes to Silas Braley, Dow corning, reporting on

> his injection of silicone fluid in mice. Two days after injection,

> silicone was found in most organs including the brain, liver,

> spleen, intestinal wall, adrenal and kidney. He also found " evidence

> of at least radio activity and most probably silicone in the brain

> and all of the various other organs.... "

>

> CITE: M 420051 - 420052.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #48

>

> 11/27/63 TESTING TISSUE REACTION

>

> Dow Chemical's Bioproducts Department report by Whitney, Pollock and

> ey on " Fluorosilanes As Fumigants. " Six flourosilanes:K-56,425 =

> n-propyltrifluorosilane; K-56,426 = ethylmethyldifluorosilane;

> K-57,317= trimethylfluorosilane; K-59,489 = mehtyltrifluorosilane;

> K-59,697 =chlorometthyldifluoromethylsilane; K-58,739 = silicon

> tetrafluoride; andK-681 = methyl bromide were evaluated as fumigants

> for control of insects and microorganisms. All were very active

> against post-embryonic stages of tests insects. Tri and difluoro

> silanes were active against bacteria and molds. Most of the

> compounds killed all flour beetle eggs at one lb/1000 cu. ft. with a

> 16-hour exposure.... A patent disclosure has been submitted and

> further research is recommended for these and related compounds.

>

> Results of toxicological work with mammals is reported in reports

> 55.11-56425-1, 55.11-56426-1, 55.11-56427-1, 55.11-57317-1, and

> 55.11-2-1. the usefulness of these compounds has been reported in

> Patent Disclosure no. 16193. NOTE: None of these reports or patent

> disclosures were produced to the PSC.

>

> " Further exploration of the biological and physical properties of

> these and related compounds is recommended. "

>

> CITE: TDC 8901- 8904.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #49

>

> 00/00/64 MISCELLANEOUS - COMPLICATIONS SILICA

> STERILIZATION/CONTAMINATION TISSUE REACTION

>

> Braley, Dow Corning, states in the Trans American Society of

> Artificial Internal Organs, " The Medical Silicones, " that electrical

> charges exist on the surface of the silicone elastomer. Silicone

> elastomers are described as non-adherence products, nothing will

> stick to them " However, because of the dialectic (sic) properties of

> silicone rubber, it will develop a surface charge and can hold dust,

> lint, (etc.).... This is not true adhesion. " Additionally, the

> reason that the attempt to create a silicone vascular prostheses, to

> be inserted in a blood vessel, failed is because of the electrical

> charges on the surface which caused the blood to clot at the ingress

> end of the silicone prostheses tube.

>

> Braley also describes the chemical composition, the characteristics

> and the various applications of silicone.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #50

>

> 01/13/64 GEL MIGRATION KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> McHard memo to Hunter with copies to Braley, Dingman, Hobbs, and

> Stebleton regarding " Notes on visit to Battelle Memorial Institute

> on December 19, 1963. " McHard and Hobbs met with representatives of

> Battelle and discussed the " Toxicology of silicones - past and

> future. ... 1. Variation in toxicity with animal species. 2. Effect

> of polymer size on toxicity. 3. Extent of body metabolism. 4. Fate

> in kidney and liver. 5. Fate of catalysts. 6. Extent of

> carcinogenicity. " Also discussed was silastics for breast implants.

> Battelle's study showed that the physical properties of silicone

> rubber when implanted were significantly affected/decreased. Also,

> " There was considerable discussion on how the various polymer sizes

> may be transported across the G.I. tract and how they may find their

> way into the kidney, liver, and subsequently, the urine. "

>

> CITE: KMM 299059 - 299063.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #51

>

> 05/16-17/64 COHESIVENESS-LIQUID COMPONENT OF GEL KNOWLEDGE OF LIQUID

> SILICONE DANGERS KNOWLEDGE OF SYSTEMIC DISEASE TISSUE REACTION

>

> 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.

> and L.F. Stebleton of Dow Corning; by Drs. , 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. Olson Deposition. DUPLICATE: m 30531 - 30558; KMM

> 183981 - 184009.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #52

>

> 05/28/64 FRAUD/MISREPRESENTATION GEL MIGRATION MISCELLANEOUS -

> COMPLICATIONS TISSUE REACTION

>

> Braley memo to , Blocksma, R. Dingman, Edgerton, Goulian,

> Lederer, Murray, Rees, Badamo, Bass, H. Dingman, Haberstroh,

> Hodnett, Honter, McHard, Mullison, , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & confidential

>

> Document #53

>

> 09/22/64 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Rees letter to Braley, Dow Corning, regarding the finding of

> altered fat cells in animals subcutaneously 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> < Document #54

>

> 09/24/64 TISSUE REACTION SHELL DEGRADATION SHELL STRENGTH -

THICKNESS

>

> Letter from Dr. Cronin to , General Manager of

> Dow Corning. Dr. Cronin reports that Dr. Brauer had to remove seven

> implants when, at intervals of 2-4 months, a blister would start in

> the scar and gradually break down. " (S)ome clear, straw colored

> fluid would be released "

>

> CITE: KMM 150269 - 150270. NOTE: Ivory flakes were being used to

> prepare the implants prior to surgery.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #55

>

> 11/12/64 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> 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 List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #56

>

> 12/00/64 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -

> COMPLICATIONS TISSUE REACTION

>

> " Tissue Reactions to Injected Silicone Liquids, A Report of Three

> Cases, " Archives of Dermatology, Vol. 90, 538-593 by Winer,

> Sternberg, Lehman and . Drs. Oppenheimer and 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 Braley Deposition. DUPLICATE: PSC Medical Articles CD, J

> 3598 - 3603.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #57

>

> 12/08/64 KNOWLEDGE OF LIQUID SILICONE DANGERS TISSUE REACTION

>

> Dr. lin 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #58

>

> 01/29/65 KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> lin , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #59

>

> 04/01/65 CONCEALING FROM FDA KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> Dr. lin 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #60

>

> 05/27/65 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> , M.D., reports to Silas Braley of Dow Corning regarding

> a consultation with a patient in Las Vegas. 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #61

>

> 06/24/65 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> 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 - 3803.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #62

>

> 10/05/65 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -

> COMPLICATIONS SILICA 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, Document #1

>

> CONCEALING FROM FDA FRAUD/MISREP

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #63

>

> 10/27/65 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID

> COMPONENT OF GEL GEL MIGRATION SHELL DEGRADATION SHELL STRENGTH -

> THICKNESS TESTING TISSUE REACTION

>

> 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 Deposition and Exhibit

> to D. McGhan Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #64

>

> 11/15/65 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> Dr. 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. lin , Dr. Ralph Blocksma, Dr. Dingman, Dr.

> Milton Edgerton, Dr. Dicran Goulian, Jr., Dr. Francis Lederer, Dr.

> ph Murray, Dr. Norman Orentreich, and Dr. Rees.

>

> Dr. 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. 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #65 01/14/66 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE

> OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE

> REACTION

>

> McHard memo to Bass with copies to , 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 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, 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #66

>

> 06/06/66 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -

> COMPLICATIONS TESTING TISSUE REACTION

>

> 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, , Dingman and McHard (all

> of DC) and Drs. Lehman, Marzulli and 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 Deposition, Exhibit to

> Rowe Deposition, and Exhibit to McHard Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #67 07/00/66 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL

> MIGRATION

>

> T. Rees, et al., submits to Dow Corning a report titled " Visceral

> Response to Subcutaneous and Intraperitoneal Injections of

> Polymethylsiloxane in Mice " which evaluates histologically the

> systemic distribution of silicone fluid. Results indicate silicone

> deposition in the spleen, liver, adrenals, pancreas, ovaries,

> abdominal lymph nodes and kidneys of the test animals, suggesting

> distribution by the reticuloendothelial mechanism.

>

> CITE: KKM 31076 - 31087.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #68

>

> 08/02/66 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> Braley memo to , Blocksma, Dingman, Edgerton, Goulian,

> Lederer, Murray, Orentreich, Steve Carson, , , Hunter

> and McHard regarding the attached letter and paper from 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #69

>

> 09/06/66 MISCELLANEOUS - ORGANIZATIONAL SURVEY

>

> Minutes of the Board of Directors' Meeting for Dow Chemical Company

> with a reference to a secrecy agreement with Dow Corning Corporation

> regarding the biological properties of silicones.

>

> CITE: TDC 11625 - 11627, Exhibit to Deposition and to Julius

> Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #70

>

> 10/10/66 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -

> PRODUCT LABELING TESTING

>

> Memo from Don McGhan (at Dow Corning) to McIntyre with copies to

> Pellikka, Hutchison, , 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 Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #71

>

> 10/12/66 MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - SALES

> STERILIZATION/CONTAMINATION TESTING

>

> " Chemical Research Progress Report (Restricted), Report No. 2964, "

> by R. McCarty and J. Speier - all of Dow Corning. Dr. Hunter

> established a committee of , 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 Deposition,

> Exhibit to McHard Deposition, Exhibit to Deposition, Exhibit to

> Isquith Deposition and Exhibit to LeVier Deposition. WITNESS:

> (ancient document exception to hearsay). DISPOSITION:

> Admitted in Toole (II) v. Baxter Healthcare.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #72

>

> 01/10/67 ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING

>

> Rowe memo to McHard with copies to , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #73

>

> 02/01/67 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF LIQUID

> SILICONE DANGERS KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -

> ORGANIZATIONAL SURVEY 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 Deposition,

> Exhibit to LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to

> Caldwell Deposition, Exhibit to McHard Deposition, Exhibit to Julius

> Deposition, and Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #74

>

> 02/08/67 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE

>

> " 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 407480 - 407482). NOTE: See 12/31/87 entry in Master Timeline.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #75

>

> 02/16/67 KNOWLEDGE OF GEL BLEED KNOWLEDGE OF LIQUID SILICONE DANGERS

> MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> " 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), , Boone, Braley,

> , 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 Deposition,

> Exhibit to McHard Deposition, Exhibit to Rowe Deposition, and

> Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #76

>

> 03/10/67 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> " Summary of Toxicological Testing of Dow Corning FS-1265 Fluid and

> Ointment, Foot Protective " by " jar " (ph 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #77

>

> 03/14/67 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

> County Depositions, Exhibit to Deposition, Exhibit to

> Deposition, Exhibit to Julius Deposition, Exhibit to Himnam

> Deposition, and Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #78

>

> 03/21/67 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE TESTING TISSUE REACTION

>

> 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. 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. ; 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. 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 county Rathjen Deposition.

> DUPLICATE: F 316 - 326.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & confidential

>

> Document (On PLAINTIFF'S LITERATURE LIST)

>

> (this is between #78 & #79)

>

> 04/00/67 (ON PLAINTIFF'S LITERATURE LIST)

>

> F. , 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 Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #79

>

> 04/28/67 GEL MIGRATION KNOWLEDGE OF LIQUID SILICONE DANGERS

> MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> " 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #80

>

> 04/28/67 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING TISSUE

REACTION

>

> " 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 entry. DUPLICATE T 996 - 1029.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #81

>

> 07/19/67 MISCELLANEOUS SILICA STERILIZATION/CONTAMINATION

>

> " 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #82

>

> 08/17/67 CONCEALING FROM FDA FRAUD/MISREPRESENTATION KNOWLEDGE OF

> LIQUID SILICONE DANGERS MISCELLANEOUS - PRODUCT LABELING

> 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #83

>

> 10/18/67 TESTING

>

> J. McHard, Dow Corning, memo to I. Hutchinson, , 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.

>

> PENDLETON/PSC Attorney Work Product/Privileged & Confidential

>

> Document #84

>

> 11/10/67 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

SILICA

>

> Hobbs and Himmelsback memo to Barry, , , Fenn,

> Greenhalgh, Hansen, Hargreaves, Hedlund, Hunter, Hyde, Donkle, C.

> Lentz, Maneri, McHard, , 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #85

>

> 12/15/67 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING TISSUE

REACTION

>

> 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 Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #86

>

> 01/04/68 MISCELLANEOUS - ORGANIZATIONAL SURVEY

>

> Minutes of the Board of Director's Meeting of Dow Chemical Company

> with a reference to loans and advances made to Dow Corning

Corporation.

>

> CITE: TDC 11702 - 11703, Exhibit to Deposition, and Exhibit

> to Julius Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #87

>

> 02/20/68 KNOWLEDGE OF LIQUID SILICONE DANGERS

>

> Bureau of Regulatory compliance reports on the prosecution of Dow

> Corning, Bass, , and McIntyre for selling a new drug - Dow

> Corning 360 Fluid - without an approved New Drug Application.

>

> CITE I 470. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC

> Attorney Work Product/Privileged & Confidential

>

> Document #88

>

> 02/28/68 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> 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 County Rathjen

> Deposition. DUPLICATE: KKP 16422; FDA 26696 - 26701; I 1333 - 1341;

> KKP 16422 - 16431; M 100145 - 100154.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #89

>

> 03/07/68 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -

> ORGANIZATIONAL SURVEY TESTING

>

> Minutes of the Board of Directors' Meeting of the Dow Corning

> Corporation with reference to the officers of Dow Corning being

> approved to sell to Dow Corning employees common stock in the Dow

> Chemical Company. The minutes also refer to an agreement between Dow

> Corning and Dow Chemical for joint research, development, evaluation

> and commercialization programs on the physiological effects of

> organosilicon compounds.

>

> CITE: DCC 101001529 - 101001543, Exhibit to Deposition,

> Exhibit to Julius Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #90

>

> 04/22/68 TESTING TISSUE REACTION

>

> " Histopathological Findings In Animals of Various Species from

> Experiments conducted by 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #91

>

> 04/26/68 ACKNOWLEDGEMENT OF NEED FOR TESTING CONCEALING FROM FDA

> MISCELLANEOUS - LOBBYING MISCELLANEOUS - ORGANIZATIONAL SURVEY

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 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)

>

> ACKNOWLEDGEMTN OF NEED FOR TESTING MISCELLANEOUS - COMPLICATIONS

> TESTING TISSUE REACTION

>

> Minutes of Meeting at Midland on May 23-24, 1968 with

> representatives form Dow Corning, Industrial Bio-Test, Food and Drug

> Research Laboratories, and the Dow Chemical Company. " Attending were

> , Calandra (IBT), Carson (FDRL), , Frisch, Hobbs,

> Hunter, Hutchison, McHard, Radzius and Rowe, Dow Chemical. The

> subject of the meeting was a " Toxicology Review of Dow Corning

> Products. "

>

> CITE: DCC 281041054 - 281041059.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #94

>

> 05/31/68 TESTING TISSUE REACTION

>

> 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #95

>

> 06/03/68 COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION

TESTING

>

> 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 Country LeVier

> deposition, Exhibit 3 to Country Rathjen Deposition, Exhibit

> 19 to County Zahalsky Deposition, Exhibit to County

> Tyler Deposition, and Exhibit to Weyenberg Deposition.

>

> DUPLICATE: M 100155 - 100174; DCC 242031103 - 242031121; FDA 43184 -

> 43202.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #96

>

> 07/16/68 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE

>

> FDA: Dr. 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 PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #97

>

> 08/08/68 GEL MIGRATION TESTING TISSUE REACTION

>

> 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 List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #98

>

> 10/09/68 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Hobbs, Toxicologist at Dow Corning, letter to Dr. 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 Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #99

>

> 10/17/68 FRAUD/MISREPRESENTATION MISCELLANEOUS - COMPLICATIONS

> MISCELLANEOUS - PRODUCT LABELING TESTING

>

> Olson memo to Pail with copies to , Currie, Gergle, Hobbs,

> Hunter, McHard, Radzius and Vaughn regarding " Suitability for

> Industrial Use of Protective Hand Cream Formulated with Dow Corning

> FS-1265 Fluid Unstripped of Cyclic Trimer. " The Dow Corning

> Toxicology Department recommends the use of Protective Hand Cream,

> industrially, does not pose a significant hazard, and " represents an

> appropriate risk for Dow Corning. " Olson reviews the studies to date

> on FS-1265 Fluid including studies by IBT - 20 day subacute dermal

> study in rabbits (spermatogenic depression was found to be mild to

> moderate in the controls and not significantly different in the test

> groups); one-year dietary feeding study in rats ( " There was evidence

> of decreased spermatogenesis in the male test animals " ); IBT - 14

> week dermal toxicity in rhesus monkeys (biopsies at 30-days showed

> testicular hypoplasia); Dow Chemical (cyclic trimer possesses a

> relatively high acute oral toxicity); and IBT - acute percutaneous

> absorption study. He recommends industrial use of Protective Hand

> Cream containing less than 15 p.p.m. of cyclic trimer and that this

> is an appropriate risk. " We wish to emphasize that the front label

> flagrantly (sic) misrepresents the product from an efficacy

> viewpoint. All data generated to date shows, unequivocally, that the

> cream does not protect against the irritating properties of the

> chemicals studied. Ethically, such advertising leaves much to be

> desired and is frowned upon by government agencies and all who are

> charged with matters pertaining to consumer protection and proper

> representation "

>

> CITE: DCC 218041771 - 281041776, Exhibit to K. Olson Deposition, and

> Exhibit to LeVier, Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #100

>

> 11/29/68 KNOWLEDGE OF SYSTEMIC DISEASE TESTING TISSUE REACTION

>

> 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

> distributed outside Dow Corning Corporation. "

>

> CITE: T 2033 - 2096, Exhibit 35 to Deposition (used by Dow

> Corning), Exhibit 29 to MDL Rathjen Deposition (used by Dow

> Corning), and Exhibits 19 and 20 to Zahalsky Deposition. DUPLICATE:

> FDA 27384 - 27409.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #101

>

> 01/29/69 SHELL STRENGTH - THICKNESS RUPTURE G. on, Dow

> Corning, memo to Koning regarding a mammary implant ruptured 1 1/2

> years after implantation which was returned by Dr. Crosby. on

> states, " (T)he envelope edges adjacent to the rupture, appeared to

> be of a very low tear strength. The physical properties of this

> envelope may never have been adequate. " (emphasis added).

>

> CITE: KKH 1654.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #102

>

> 03/24/69 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC

> DISEASE

>

> Dr. lin , a clinical investigator for IND 2702, writes to

> Dr. McDowell regarding an article by Bishoff and Bryson on the

> carcinogenicity of silicone in fluid in rats and mice. Braley, Dow

> Corning, has reviewed the article and has stated to Dr. that:

> " According to what he says, and he would not want to say this to

> you, he feels that this article is well written and should not be

> published. I agree. "

>

> CITE: OOM 320814.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #103

>

> 06/10/69 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

>

> Memo from Olson to Frisch with copies to , Hobbs, Hunter and

> Radzius regarding " Telephone Communication with Dr. of

> & . " Dr. , toxicologist at & ,

> was contacted by telephone regarding their subacute dermal rabbit

> study on Dow Corning 556 and 360 fluids and Dow Corning MDDX-4-4122

> wash resistant base. Dr. stated that the materials had been

> applied to rabbit skin daily. All animals showed a trend toward

> testicular atrophy. " There was a suggestion of dose-response

> relationship with Dow Corning materials although the effects were

> not statistically significant. A subacute oral rat study is in

> progress. " Olson indicated to that Dow Corning would be

> concerned about positive findings with the second study and would be

> agreeable to meeting with them to compare their respective data.

>

> CITE: DCC 281041112, Exhibit to McHard Deposition, Exhibit to K.

> Olson Deposition, and Exhibit to LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #104

>

> 07/15/69 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Food and Drug Research laboratories report on the findings in the

> chronic parenteral (intraperitoneal) study initiated by Dr.

> Ballantyne, Rees and Hawthorne at the NYU School of Medicine. After

> silicone fluid in the peripheral erythrocytes in early hematologic

> examinations was observed, Dow Corning transferred the study and its

> financial sponsorship from NYU to Food and Drug Research

> Laboratories. " When the animals received 51 cc and 62 cc of fluid,

> inflammatory cells were observed in the spinal meninges (which was

> not stated in earlier reports). Injections of large volumes of

> silicone produces wide spread deposition throughout the

> reticuloendothelial system, silicone vacuole accumulation in cells

> and a systemic distribution of silicone droplets.

>

> CITE: T 2866 - 2945 (The study is referenced in FDA 26875 - 26889).

> NOTE: See 06/30/75 entry.

>

> Document #105

>

> 08/06/69 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC

> DISEASE TESTING

>

> Isquith, Dow Corning Biomedical Research Laboratory, memo on the

> " Current Status of Microbiological research. " Isquith states that:

>

> " The main purpose of the survey is to help in establishing the basic

> relationship between organosilicon structure and biological

> activity, the further pursuit of which rests with our own secondary

> stage research activity into the physiology (metabolism, mechanism

> of action, site of action, etc.) of the compounds and a good

> screening procedure for identification of developmental potential.

> (DCC 16000004)

>

> Another area for research is the development of a biological assay

> for determination of organosilicone interferon induction. (DCC

> 16000004). Dow Corning has developed sufficient expertise in viral

> methodology to conduct the assay, but " there would be considerable

> advantage in using such a system (more stable virus, greater

> lethality) as is currently being employed in a survey for interferon

> inducers at Dow (Chemical) Human Health by Dr. N. Miner.... " (DCC

> 16000005) He recommends using Dr. Miner's lab for seeking a long

> lasting interferon inducer among organosilicone compounds. (DCC

> 16000006)

>

> Finally, another area is the " Investigation of Physiological Effects

> of Some Organosilicon Compounds. " (DCC 16000011). Isquith concludes

> that the area of microbiology in relation to organosilicon chemistry

> " is mushrooming at a pace that even now we are unable to adequately

> provide this cover. A wise investment at this time would be the

> hiring of a virologist (M.S. preferably) with training in tissue

> culture, virology, and immunochemistry. I have not had time to

> investigate thoroughly, but feel there is a good chance for

> development of possible potential in the areas of hypersensitivity,

> graft rejection, and autoimmune disease (arthritis,

> glomerulonephritis, etc.) which should be within the scope of a

> person with the training I suggested. " (DCC 16000014)

>

> CITE: DCC 16000002 - 160000014, Exhibit 2 to Isquith Deposition,

> Exhibit 3 to D.McGhan Deposition, Exhibit to Blocksma Deposition

> (used by plaintiffs and Dow Corning), Exhibit to LeBeau Deposition,

> Exhibit to Deposition, Exhibit to Boley Deposition, and

> Exhibit to Julius Deposition

>

> WITNESS: " (Authenticated in Isquith, Vol. I, 119-120).

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #106 08/14/69 ACKNOWLEDGEMENT OF NEED FOR TESTING

> MISCELLANEOUS - ORGANIZATIONAL SURVEY TESTING

>

> Letter of agreement between Dow Chemical Company, Dow Corning

> Corporation and Lepetit SpA for a joint development program

> regarding the biological activity of organosilicon compounds. The

> agreement requires the full disclosure of all proprietary and

> confidential information of each party to the agreement to each

> other party.

>

> CIT: TDCH 1275 - 1276.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #107

>

> 11/15/69 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS

>

> Doremire memo to regarding chemical warfare and riot control

> agents, XZ8-3063. This is a silicone glycol. It goes through the

> skin as if there was no skin there. " Do you have any suggestions for

> a chemical that could be added to XZ8-3063 which would cause a

> variety of effects? These effects could vary from a drug that would

> act as a simple tranquilizer to a drug which would cause a loss of

> consciousness. " In the case of riot control, the drug might be

> effective for 1/2 hour whereas a chemical warfare use might need 2-4

> hours effectiveness. He plans on checking with the " Analytical

> Laboratory on toxicity information.

>

> CITE: DCC 281014081, Exhibit 3 to County LeBeau Deposition,

> Exhibit to Rowe Deposition, Exhibit to Deposition, Exhibit

> to McHard Deposition, and Exhibit to Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #108 00/00/70 00/00/71 00/00/72 FRAUD/MISREPRESENTATION

>

> Dow Corning axhibit to McHard Deposition and Exhibit to K. Olson

> Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #63 10/27/65 ACKNOWLEDGEMENT OF NEED FOR TESTING

> COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION

>

> CITE: M 700003; M 700008 - 700009. DUPLICATE; M 370049 - 370052; M

> 370108 - 370109; M 370113 - 370114; KKH 62679 - 62682; M 700019 -

> 700020.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #109

>

> 09/20/76

>

> Hobbs, Dow Corning, memo to Hinsch with a copy to Lentz regarding

> information concerning migration of silicone gels. Hobbs states that

> experimentation had not demonstrated migration of Dow Corning

> mammary gel but this factor does not appear to be true for all

> silicone gels. Hobbs further states that gels having a low

> consistency due to low levels of cross-linker appear to migrate

> along tissue planes in much the same manner as large injected doses

> of silicone fluid.

>

> CITE: M 170104, Exhibit 130 to Burda Deposition; Exhibit 91 to

> Braley Deposition. DUPLICATE: M 570060. NOTE: The document was

> listed as 00/00/70 on Plaintiff's Trial Exhibit List.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #110

>

> 01/12/70 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

>

> Silas Braley, Dow Corning, memo to various Dow Corning employees

> distributing interim research report on the investigation of

> Dimethylpolysiloxane Fluid Injections at the Institute of

> Reconstructive Plastic Surgery, New York University. The interim

> report states that " our most interesting recent findings indicate

> that in both mice and rats, injection of large volumes of liquid

> silicone, either interperitoneally or subcutaneously, in multiple

> injections, apparently produces a wide spread deposition of this

> material throughout the reticuloendothelial system. A more recent

> finding of some interest is that there is an apparent accumulation

> of silicone vacuoles both within the red cells and the leukocytes of

> the peripheral blood in mice and rats, which appears about one to

> three months after injection and persists for several months. " The

> NIH grant will run out in about one year and these studies will have

> to be terminated. " It is our feeling that the evidence of systemic

> distribution of silicone droplets or vacuoles can not necessarily be

> considered an adverse effect, but is more likely related to total

> dosage. The dosages employed in animals rarely can be achieved in

> man with the possible exception of breast injections.... "

>

> CITE: T 2881 - 2885. NOTE: The report itself was an Exhibit to the

> K. Olson Deposition (KKH 9841 - 9845). This document also has the

> Bates number OOM 321368 - 321672 on it. Dow Corning Trial Exhibit

> List Abstracts PENDLETON/PSC Attorney Work Product/Privileged &

> Confidential

>

> Document #111 02/02/70 STERILIZATION/CONTAMINATION

>

> J.H. Wetters, Dow Corning Medical Products Plant, Report No. 229 to

> Burdick with copies to Reilly, Mantle, Piper, Don McGhan, Houle and

> on regarding " White Particle Contamination of the Mammary

> Gel. " The major contaminant was found to be crystalline by

> microscopy and potassium chloride and potassium bicarbonate by

> x-ray. Wetters cannot explain the presence of potassium bicarbonate.

> The white poly lined can in which it is contained could possibly be

> the source of this material.

>

> J.P. Fitzgibbon feels that the crystalline potassium salts are the

> major portion of the contamination. " Gordon on and Ken Olson

> should be contacted for an opinion as to whether these potassium

> salts are harmful. " (MM 234057)

>

> CITE: KMM 234056 - 234057.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

> Document #112

>

> 02/18/70 KNOWLEDGE OF LIQUID SILICONE DANGERS ACKNOWLEDGEMENT OF

> NEED FOR TESTING TISSUE REACTION

>

> Report prepared Food and Drug Research Laboratories for the Dow

> Corning Toxicology department. There are relatively little specific

> experimental data available on the reactivity of biological systems

> to silastics and polymethylsiloxane (PMSs) fluids. Prior studies by

> other laboratories showed " significant testicular atrophy resulted "

> from topical application of a polymethylsiloxane fluid. In the

> present study, 15 applications of PMS fluid was applied topically on

> rats, guinea pigs, rabbits and dogs for a 20-day period, and was

> administered in the diets of rats and rabbits for eight months. In

> the rabbits that were topically applied with PMS fluid, " the

> reduction in the testicular weights of the PMS-treated rabbits is

> considered biologically significant. "

>

> In the rats that had PMS administered orally for one year, growth

> was retarded as early as the first week in feeding. The differences

> in weight gain between the test and control groups was

> " statistically significant " during the third week, with the weight

> gain in the test group lower than the control. In the female rats,

> there were " notable endocrine effects, " smaller ovaries, enlarged

> pituitary, and increased weight in the adrenals and thyroids.

>

> In the rabbits that had PMS administered orally for eight months,

> there was a " trend toward decreased testicular size in the test

> group..., " a tendency toward lower hemoglobin and hematocrit in all

> rabbits in the test group, " some effect of PMS fluid on sperm

> maturation..., " and testicular atrophy in the test rabbits.

>

> CITE: T 2302 - 2341, Exhibit to K. Olson Deposition, and Exhibit to

> LeVier Deposition.

>

> Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work

> Product/Privileged & Confidential

>

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