Dr. Donald Bennett, transcript of videotaped
testimony in regards to Silicone Breast Implants.
This transcript has been retyped and is the exact wording used in the transcript. The transcript is 574 pages long. This document is through pages 106. The first 17 pages were not provided as they were preliminary comments and procedures by the attorneys.
In
The Matter Of:
In Re: Silicone
Breast Implants
(MDL-926)
Donald
R. Bennett, M.D., Ph.D.
Vol.1,
July 18, 1994
Professional Shorthand
Reporters, Inc.
Suite 1615, Pan-American
Life Center
601 Poydras Street
New Orleans, LA 70130
(504) 529-5255 FAX: (504) 529-5257
Original File bennett1.001,285 Pages
Word Index included with
this Min-U-Script
This is the videotaped deposition of Mr. Don Bennett, taken in Chicago, Illinois on this 18th day of July 1994, beginning at 12:10 p.m.. Master File Number CV_92-P-1000-S.
Videographer: Kyle Powell of Legal Process, Incorporated, New Orleans, Louisiana.
PLAINTIFF ATTORNEYS:
Fredric Ellis for the Plaintiffs in MDL-926
Ernie Hornsby for the Plaintiffs in MDL-926
Doug Peters for the Plaintiffs in MDL-926
OBSERVERS FOR PLAINTIFFS
Prince Ainsworth with Fisher, Gallagher & Lewis in Houston, Texas,
representing a group of plaintiffs
filed in state court there and observing today.
Jennifer Adams with O’Quinn, Kerensky, McAninch & Laminack representing Texas plaintiffs, also observing today.
DEFENDANT ATTORNEYS:
Darrell Grams for the Dow Chemical Company
John Donley representing Dow Corning
Renee Honigberg for Dow Corning
Mr. Donley for Dow Corning
Deborah Byrnes on behalf of Medical Engineering Corp., Bristol-Meyers Squibb,
and Surgitek, Inc.
ATTORNEY FOR DR. BENENTT:
Jim Streicker, representing the deponent, Dr. Donald Bennett.
Page 18
This is the videotaped deposition of Mr. Don Bennett, taken in Chicago, Illinois on this, the 18th day of July, 1994, beginning at 12:10 p.m,. In Re: Silicone Gel Breast Implants Products Liability Litigation (MDL-926), Master File Number CV-92_P-1000-S. My name is Kyle Powell. I’m a legal videographer for the firm of Legal Process, Incorporated, which is located in New Orleans, Louisiana. Now counsel will notice their appearance off camera by stating their names and who they represent.
MR. ELLIS:
Fredric Ellis for the Plaintiffs in MDL-926.
MR. HORNSBY:
Ernie Hornsby for the Plaintiff in MDL-926.
MR. PETERS:
Doug Peters for the Plaintiff in MDL-926
Page 19
MR. GRAMS:
Darrell Grams for the Dow Chemical Company.
MR. DONLEY:
John Donley representing Dow Corning.
MS. HONIGBERG:
Renee Honigberg-
MR. DONLEY:
Same.
MR. AINSWORTH:
Price Ainsworth with Fisher, Gallagher & Lewis in Houston, Texas, representing a group of plaintiffs filed in state court there and observing today.
MS. ADAMS:
Jennifer Adams with O’Quinn, Kerensky, McAninch & Laminack, representing Texas plaintiffs, also observing today.
MS BYRNES:
Deborah Byrnes on behalf of Medical Engineering Corp., Bristol-Meyers Squibb, and Surgitek, Inc.
MR. STREICKER:
Page 20
My name is Jeff Streicker and I represent the deponent, Dr. Donald Bennett.
MR. KENNELLY:
Matt Kennelly, also representing the deponent.
MR. BYRNE:
Thomas Byrne representing Plaintiffs in MDL-926.
MR. ELLIS:
We’ll be conducting this deposition in accordance with the protocol for depositions entered in MDL-926. And could you swear the witness, please?
DONALD R. BENNETT, M.D., Ph.D., after having been first duly sworn by the above mentioned Certified Shorthand Reporter, was examined and testified as follows:
EXAMINATION BY MR. ELLIS:
Q: Sir, could you state your full name, for the record, please.
A: Yes. It’s Donald R. Bennett, B-e-n-n-e-t-t.
Page 21
Q: And what is your residential address:
A: 5231 Brookbank—all one word—Road in Downers Grove, Illinois, 60515.
Q: What is your current business address:
A: Current business address is—Do you want the title with it?
Q: Sure.
A: Director, Division of Drugs and Toxicology, American Medical Association, 515 North State Street, Chicago, Illinois 60610.
Q: That’s for the American Medical Association?
A: Right.
Q: Have you ever attended a deposition before, sir?
A: No.
Q: Let me try to explain some ground rules, and try to understand how this works. I’m going to be asking you a series of question during this
Page 22
deposition, and the stenographer over here is going to be transcribing the questions and answers. And after the deposition is over, you’re going to have an opportunity to read that deposition transcript and make any corrections that you would like.
A: Okay.
Q: During the deposition, if I ask you any questions that you don’t understand, I would like to reach an understanding with you that you will tell me that you don’t understand the question or that the question is unclear so I will rephrase it. Is that okay?
A: Sure.
Q: Are you under any—the influence of any drugs or alcohol today that might impair your ability to answer questions?
A: No drugs, no alcohol.
Just for the record, we’ve had two new attorneys just walk in the room. Maybe if they want to notice
Page 23
Their appearance.
MR. SHUFORD:
Mark Shuford on behalf of MDL health care providers.
MR. MARSHALL:
Prentiss Marshall, Jr. for Baxter Health Care.
MR. ELLIS:
Thank you.
EXAMINATION BY
MR. ELLIS:
Q: Sir, what is your date of birth.
A: February the 16th, 1926.
Q: And if we could just discuss your background for a little bit, where did you grow up?
A: I was born in Mishawaka, Indiana, grew up in South Bend, Indiana, until I reached about high school age. We went to—We moved to Florida. My father went bankrupt, got a new job in Florida. I went through high school there and graduated from high school at an academy—
Q: And that--
Page 24
A: --Bolles Academy.
Q: --would have been in 1943; is that correct?
A: 1943.
Q: Okay. And did you then go into the military during World War II?
A: Yes.
Q: And after the war did you go to the University of Michigan?
A: Yes.
Q: Did you get a degree from the University of Michigan?
A: Four degrees. A Bachelor of Science degree in Zoology, a Master of Science degree in Pharmacology, an M.D. degree, and a Ph.D. degree in Pharmacology.
Q: Let’s see if I can get these days right. In January of 1949 you got your Bachelor of Science in Zoology; is that correct?
A: That’s right.
Q: And in August of 1951 you got your Master’s in Pharmacology?
Page 25
A: Yes.
Q: In June of 1955 you got your medical degree?
A: Right.
Q: And, finally, you got your Ph.D. in Pharmacology in February of 1958—
A: Right.
Q: --correct?
A: The extra year, I took an internship in ’56-57 at St. Joseph’s Hospital in Ann Arbor, Michigan.
Q: Now, let’s go back a little bit through your education. In the early period, the ‘40s, ’46 through ’49 when you were getting your bachelor of science, did you have any exposure to silicone compounds?
A: Not at that time, no.
Q: What about when you were getting your Master’s in Pharmacology?
A: No. That was on a different subject entirely.
Q: What was that subject?
A: The subject was the influence
Page 26
of copper on the action of the digitalis glycosides of the heart.
Q: Copper is a heavy metal?
A: Heavy metal.
Q: Did you study the effects of other heavy metals?
A: Not specifically, no. We principally went with copper, in solution, really, not as a metal itself.
Q: Okay. And in earning your medical degree up through 1955 at the University of Michigan Medical School, did you have any exposure to silicones there?
A: No.
Q: And when I say “exposure to silicones,” I’m including not only any research you may have done but review of any literature concerning silicone or their biological effect.
A: No. No, I didn’t.
Q: Okay. Let’s take the next—Let’s take the whole
period of the ‘50s. You were--
While you were getting your medical degree you were also working towards your
Ph.D in
Page 27
Pharmacology; is that correct?
A: That’s right.
Q: And you ultimately earned that Ph.D. in 1958. During that time period up through 1958 did you have any exposure to silicones?
A: No.
Q: Now, after getting your Ph.D.—Oh, could I you just ask you what your thesis was in?
A: Thesis was on—It was on methods. It was on the papilliary muscle preparation used to study ionotropism, the force of contraction of the heart, to evaluate it as a method and as a test object for determining agents which had a—what we would call a positive ionotropic action.
Q: What—
A: There was no relationship to silicone.
Q: Okay. What does “ionotropic” mean?
A: Ionotropic is—The heart has
Page 28
Characteristics. One of them is ionotropism, which is the strength of muscular contracture.
Q: Now after you got your Ph.D. in 1958, what did you do then?
A: I was at the University of Michigan from 1959 through 1964 in June.
Q: And what did you—
A: I had been on the faculty already as a—I believe an instructor. I was appointed associate professor. I believe it’s on my CV. But I don’t’ know the years there. I think it was 1962, ’63.
Q: Okay.
A: And I taught pharmacology. I had six months of anesthesia training because we were doing clinical studies, again, not on silicone compounds.
Q: Now, when you say that you taught pharmacology, what was both as an assistant professor from approximately ’58 to ’62 and an associate professor—
A: As an associate professor.
Page 29
Q: --From’62 to ’65; is that correct?
A: That’s right.
Q: And just generally can you explain for us in a simple way what pharmacology is or what the study of pharmacology is?
A: Pharmacology is the study of the action of drugs on living matter. Since I was in a medical school, the major emphasis was on the action of drugs in animals and in man.
Q: And is another way to put that that you would look at the biological activity of pharmaceuticals?
A: If you took it in its broadest context, pharmacology cuts across plant sciences, microbiology, and animal sciences, including humans. So it’s—All of that’s biology for—for me at least.
Q: And during your—both when you were a student and a professor, did you do any research where you looked at the biological activity of any types of
Page 30
pharmaceutical drugs?
A: Yes.
Q: What types of drugs did you look at the biological activity of? And I’m now talking up through 1965.
A: One major study was to evaluate analgesics for their cardiovascular effects, as well as their gastrointestinal effects. We then continued to look at a whole series of chelating agents. Chelating agents are agents which combine with metal and their effects on the heart. But the principal research was the study of gastrointestinal physiology.
Q: What do you mean by that, “gastrointestinal physiology”?
A: At that point in time no one had figured out a way to study the longitudinal and circular muscle of the intestine simultaneously and independently in the intact animal. You could put balloons inside the lumen and study the pressure phenomenon, but to actually measure the force of contraction--
Page 31
I went to the engineering mechanics group, and we talked about the use of strain gauges. And by the proper positioning of strain gauges on the intestine at right angles to one another in the intact animal—We would do a surgical procedure, place the instruments in place, and then keep the animals for years and measure gastrointestinal motility, studying both circular and longitudinal muscle separately and independent of one another and recording that on a typical dynograph, recording the force of contractions. And then we would study drugs on that, but the drugs were incidental to the methodology. We were trying to develop the methodology.
Q: So you were trying to measure the force of contracture--
A: Right.
Q: --is that correct?
A: Right.
Q: And you also looked at the effects of various drugs on that force of
Page 32
Contraction—
A: Right.
Q: --using the method that you had developed?
A: Right; to verify—to validate it and to verify it.
Q: And up through 1965—And just of the record in 1965, you became employed at Dow Corning Corporation correct?
A: 1965. July 1st, although I signed a contract with them in April to serve on a consultant basis for approximately three months before I was hired full time at the—at Dow Corning Corporation.
Q: Now, up through—Did you actually start employment there on July 1st, 1965, or did you actually start before then?
A: I didn’t—I would go on a trip. They would ask me to go on a trip and to evaluate certain information. So I was actually employed in part, although it usually was on a weekend
Page 33
or on an evening or something like that that I would—Because I still held a full-time appointment at the University of Michigan during that time.
Q: And that would have been through the end of the academic year in—
A: Right.
Q: --1965?
A: Right.
Q: Do you still have a copy of that consulting agreement that you signed with Dow Corning?
A: I don’t.
Q: Okay. Now, up through that time period—Let’s call it the spring of 1965—had you had any exposure to any types of silicone compounds?
A: Yes.
Q: And can you tell me the circumstances of that exposure?
A: String gauges require that they be kept insulated, and so in—And I don’t remember quite the dates now, but probably 1961, ’62, somewhere in that range’63, we had heard about strain
Page 34
gauges being embedded in silicone rubber as a way of insulating them and as a way of attaching them to the intestines such that they wouldn’t be affected by secretions and short out, like in any electrical problem. So we had heard about the Center for Aid to Medical Research at Dow Corning Corporation, and so we drove up there and met with a man by the name of Silas Braley, who thought he might be able to help us. And as a result, they fabricated a number of—of different kinds of devices of silicone rubber to embed those. And we finally reached a system which worked quite well in which we could do this all in the intact animal after surgery such that we could keep the animals around for many years, and they could serve as their own controls, because we knew what their normal motility was like, and then when we gave them a drug, we could determine the exact changes that
Page 35
took place rather than having to sacrifice the animal. And that was my—my encounter with them. We tried different sort of room-temperature vulcanizing elastomers. We tried solid elastomers. And that was my first exposure to silicone compounds.
Q: Okay. Now these string gauges that you were using, did you work to develop the silicone rubber coating yourselves, or did you—did Dow Corning do that for you?
A: No. They—If it was an RTV compound—compound, which is a room-temperature vulcanizing type, they often would supply us with the materials, and we would go back to the lab and try and fashion our own devices, if you will. But in the long—That kind of rubber doesn’t contain fumed silica. It’s—it’s not as tough sometimes as the other elastomers. So when we needed to actually have solid silicone rubber that had been
Page 36
prepared under conditions in which it would take more rigorous treatment—You could stretch it: you could do more things with it—they would do that. They would prepare those in their own development laboratories and supply us with the—We would take the strain gauges up, and they would embed them, rather than our taking the stuff back to the University of Michigan.
Q: And did you work with Dow Corning scientists in the ’61 to ’65 time frame in getting these—
A: Chemists.
Q: --rubber products?
A: Yes; chemists in the development laboratories. I don’t remember the names of any of them now, but it was not just Mr. Braley. It was other—other scientists as well.
Q: Did you work with a Dr. Hunter?
A: Yes—No,not a Dr. Hunter. No, I didn’t.
Q: No; not during that time.
Page 37
Just in the ’61 to ’65 time frame.
A: No. Not during that time, no. I didn’t meet Dr. Hunter until late 1964 or early 1965. I believe it was early 1965.
Q: And in fact, Dr. Hunter was one of the people that hired you at Dow Corning, is that correct?
A: That’s right. Mr. Braley had mentioned to me on a visit there that Dow Corning was interested in looking at a different set of materials and rather—other than the silicone rubbers, but other types of organosilicon compounds. And he wondered if I might be interested in the position. I think I took about a month or two. I think I went back again and talked to him briefly about the job description, but he was not completely clear on what that would be, but he said if I was interested, I could talk to a Dr. Melvin J. Hunter, and that’s what I did.
Q: Now, during this time period when you were working with the rubber
compound in connection with your work at University of Michigan, did you work with Shailer Bass?
A: I met Shailer either on the first visit with Dr. Hunter or on the—on the second visit near—it was—They were pretty close together, though.
Q: But that was in connection with your hiring—
A: Yeah.
Q: --and not with the—
A: No.
Q: --encasing of silicone rubber?
A: No, no, no, no. The encasing, the only person I even remember is Si Braley. Because we generally met with him first when you went in, and then he might suggest that you do down to the development laboratories, or he’d take us down there, and we might spend the afternoon working with a chemist, usually a chemist or a chemical engineer in the laboratories actually fashioning and making implants. But not with Dr. Hunter and
Page 39
not with Dr. Bass.
Q: Okay. Now, was that development lab, was that a Dow Corning development lab or a Dow Chemical?
A: Dow Corning.
Q: Did you have any involvement with any Dow Chemical scientists between 1961 and 1965 in connection with the silicone rubber encasing project.?
A: Not in connection the silicone rubber encasing project.
Q: Did you have some other contact with Dow—
A: Yes.
Q: --chemical scientists:
A: Yes.
Q: And can you tell me about that, please? This is again, in the ’61 to ’65 time frame before you were hired at Dow Corning.
A: My PhD. Thesis advisor was Dr. Maynard B. Chenoweth, C-h-e-n-o-w-e-t-h. Dr. Chenoweth was an associate professor at the University of Michigan.
Page 40
He took a job with the Dow Chemical Company, it’s biochemical research laboratories, I believe, in about 1958, ’59. And I would occasionally visit him because I was either working on getting my thesis published or getting advice from him about other pharmacology. At that time I don’t know what the contract was or what the arrangements were, but Dr. Maurice Seevers, S-e-e-v-e-r-s, who was Professor and Chairman of Pharmacology, consulted for the Dow Chemical Company, particularly its biochemical research laboratories. And occasionally the faculty—Dr. Seevers and three or four members of the faculty would go to Dow Chemical Company and answer questions and do what one usually does in consultation. On a couple of those occasions I was asked to go as a faculty person and I did. They usually were trips that lasted no longer than one day, maybe overnight.
Page 41
Q: Now, again, this was the pharmacology department of the University of Michigan that you’re referring to; correct?
A: Right.
Q: And where were the biochemical research labs at Dow Chemical during this period, the late ‘50s and early ‘60s?
A: In Midland, Michigan.
Q: Did you have some understanding that Dow Chemical during the late ‘50s and ‘60s was developing different kinds of pharmaceuticals.
A: Developing—I have to ask the question, were these—They like many units of the heavy chemical industry, were always looking for potential products. I don’t think they had a pharmaceutical company on their own during that period, although someone could easily correct me. They started working with a group in Indianapolis, Indiana early on.
Q: That was called Pitman Moore?
A: Pitman Moore. That’s right.
Page 42
Q: And that was a pharmaceutical company?
A: That was a pharmaceutical company. But we were only asked to comment on some of the work that they were doing in the biochemical laboratories. And, yes, they were looking for agents that might be potential products.
Q: Okay. Now, did you have any understanding, when you would make these visits to the biochemical research labs of Dow Chemical Company in the late ‘50s and early ‘60s, that they were working with Pitman Moore scientists from Indiana?
A: I don’t remember that at all. I—I know at the time they might have been working possibly with Abbot, because one of the compounds we were asked to comment on was methoxyflurane, Penthrane, and I believe that was—ultimately became an Abbott product. But our only duties as consultants were to respond to their questions. It was not—we did not visit
Page 43
other laboratories working on the same compounds. That was Dow Chemicals’ business, not ours.
Q: Do you remember some of the—
MR. GRAMS:
Excuse me. Before you—Darrell Grams for Dow Chemical. I move to strike the testimony as nonresponsive. It was also speculative. There’s no foundation for those statements.
EXAMINATION BY MR. ELLIS:
Q: Do you remember some of the names of the Dow Chemical scientists that you dealt with in the late ‘50s and ‘60s when you were at the University of Michigan?
A: Dr. Chenoweth was one. Dr. Irish was another, Don Irish, Dr. McCarthy, Les McCarthy. I—I can see a face, but I can’t put a name with it.
Q: Okay. I know it’s a long time, and I’m asking for just your best memory and I--
Page 44
A: Sure.
Q: --appreciate that. Now, in your visits to Dow Chemical in Midland in the late ‘50s and early ‘60s did you gain any knowledge that they were looking at any type of organosilicons or silicone compounds for pharmacological activity?
A: I have no recollection of that at all. In fact, I think I made a special visit to see Dr. Chenoweth when I was thinking of taking a job with Dow Corning, because I just—As any student, I was seeking his advice as to whether or not to take the position, and I knew nothing to speak of about Dow Corning. I thought he might be able to help me make a decision.
Q: Let’s go into this decision just a little bit. Your first conversations about a potential job at Dow Corning, late 1974, early ’65 with Silas Braley, at that point did you have an understanding that Dow
Corning was engaged in research concerning pharmaceuticals?
A: My understanding was that they were not.
Q: And did you have—did Dr. Braley—I’m not even sure if he’s a doctor.
A: That—
Q: Go ahead. I’m sorry.
A: Maybe I need to—Pharmaceuticals, I think at that point they had antifoams, things of that sort that might have been used medically, but they were not—not pharmaceuticals in the sense one thinks of, I think, when you think of Abbot or Upjohn. And I meant it in that context. They may have had products which were in the pharmaceutical area, but I know very little about the corporation, as such, and its products.
A: There weren’t drugs in the classic sense?
A: In the classic sense. That’s right.
Page 46
Q: We’ll get back to antifoams later, Doctor with more of that. Did you ask Silas Braley why Dow Corning was interested in hiring somebody with pharmacology background at that time period?
A: You say did I ask him?
Q: Yes. Did you make an inquiry to that effect?
A: No. They—They approached me. Mr. Braley said that they were thinking of studying the pharmacology or--activity of—I don’t remember how it was phrased now, but they—It would be a different division of activity than what they currently were doing. And that was it. And he left it up to Dr. Hunter and Dr. Bass to describe what that would be.
Q: And did you have any understanding of what they were currently doing in 1964 such as making silicone rubber or other products like that?
A: I knew they were making silicone rubber. From what I’d read in
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the scientific literature, I knew—You can’t be around the development labs like we were without understanding that hydrocephalus shunts—There was talk about artificial kidneys, artificial hearts. There was talk about the use of fluids for burn therapy, all sorts of things, you know. But that was the extent of my knowledge. It was all hearsay.
Q: Did you have any understanding around this time frame—time frame of late ’64, early ’65 that Dow Corning was manufacturing silicone gel breast implants? That is before you got there, obviously.
A: I—I’m not sure that I did. I honestly can’t answer that question. I just—Not specifically that product as such. That doesn’t mean that I didn’t know, but if it—It was not an item at that point in time. One reads more about, you know, like the hydrocephalus shunts and things of that sort.
Page 48
Q: You had an understanding—Correct me if I’m wrong—in late ’64 when these discussions first came up that Dow Corning made a variety of silicone products that were implanted in the human body; correct?
A: Uh-huh (indicating affirmatively) Oh, yeah. I knew that.
Q: Okay. And, in fact, the—The rubber that you were dealing with, you knew, had other applications—
A: Sure.
Q: --in the human body; correct?
A: Yeah. I did know that.
Q: And did you do any literature review concerning the-any toxicity of silicone compounds, biological activity associated with silicone compounds up through late 1964?
A: No. I did not. There was no need to—The application we had only demanded that it work and keep the electrical system intact. It was not anything to do with biological activity, so we didn’t have to research anything
Page 49
there. I did start to look at the literature when I potentially was offered a job, because I wondered what—what might be out there. But that was just the same sort of cursory evaluation you’d do if you were thinking of changing jobs, and that was a major shift for me.
Q: I guess what I am trying to get at is you knew that these silicone products were implanted in human beings—
A: Uh-uh. (indicating affirmatively.)
Q: --in the early ‘60s, and before you had these discussions about a job opportunity in a, quote, new field with Dow Corning were you under the impression that the silicone products were inert?
Counsel, I’m sorry. There’s a fan back here, and we’re having a little trouble hearing, if you could speak up a little bit. And, Dr. Bennett, as well, if you can help us by trying to
Page 50
speak up a little bit, we’ll be able to hear more clearly.
MR. ELLIS:
Sure. I’ll repeat that question.
EXAMINATION BY MR. ELLIS:
Q: You’ve testified that you knew that Dow Corning was producing various types of silicone products that were implanted in the human body in the 1960s. And before these discussions took place where you were approached about a job in a, quote, new field, were you under the—Were you operating under the belief or assumption that the silicone was inert?
A: I was not operating under that belief. I had read it in the literature, that silicone was purported to be inert. I’m not sure I knew what that term meant, “inert”.
Q: Can you tell us about when you were approached about this job and what the Dow Corning representative said to you about this job and this new area that they were looking into?
Page 51
A: They said they were interested in exploring organosilicon compounds for biological activity. If I recall correctly, I think they were thinking in terms of animals and man. I’m not sure it was the full spectrum of biology. But in any event, they were going to look at biological activity of silicone-containing compounds, and they needed someone to direct that operation.
Q: Were you surprised by that?
A: Yes, and excited.
Q: And why were you surprised?
A: Well, surprised in the sense that I thought it represented a great opportunity. Pharmacologists depend upon new molecules, new areas of exploration. My sense was that there had not been much done with silicon-containing compounds, and, therefore, this represented a whole new field of exploration, and I thought that would be exciting. So, I was surprised, I guess—surprised in the sense that I had been—Maybe I lucked out, been asked to be
Page 52
The first to take a look.
Q: Kind of a cutting edge?
A: Cutting edge. That’s right. For me it was cutting edge at that time.
Q: And you said that during those discussions or after the—maybe the first discussion while you were contemplating taking this job at Dow Corning, you went back and looked through the literature. And did you find any literature that talked about the biological activity of silicone-containing compounds?
A: Not very much. Not very much. There was more there than I had seen. I didn’t find that out until I had access to libraries like at Dow Corning, where they had much more in terms of capacity than I would have or that we—you would normally keep, necessarily, at the University of Michigan libraries. But—But not a lot. Very little.
Q: Is if fair to say that if one
Page 53
looked very, very closely in 1964, that there were hints in the literature of some types of biological activity.
MR. DONLEY:
I’m sorry. I can’t even hear the question.
MR ELLIS:
I said is it fair to say that in 1964 when he did this literature search, that what you found, that there were hints of biological activity of silicone-containing compounds?
MR DONLEY:
Objection to the form and to the mischaracterization of his prior testimony.
THE WITNESS:
Am I supposed to answer that?
MR DONLEY:
Yes.
MR. ELLIS:
Oh, I’m—
MR. DONLEY:
You can answer.
EXAMINATION BY MR. ELLIS:
Page 54
Q: --sorry. I didn’t explain the objection routine. Let me just explain it now.
A: No, I was trying to remember and—
For your benefit, Dr. Bennett, from time to time in the deposition, since we know you’re new to the process, lawyers who are not questioning will make objections in order to preserve the evidentiary record. You may—Unless your counsel instructs you otherwise, you may go ahead and answer the question as posed, if you feel that you fairly can.
THE WITNESS:
Thank you. I don’t think I knew—I knew a very few examples that I’d found. And I’m trying to even think of one. I have to be careful that it wasn’t—I wouldn’t think of three or four examples that I learned about after I came on the scene, but specifically one of them in particular--
Page 55
No, I honestly can’t remember—In fact, that was probably one of the reasons I agreed to—to go. There wasn’t really that much out there, and it—And it did look like an opportunity to study things that had not been done.
Q: Did you make any effort to determine if this was viable? I mean before you’re taking this new position where you’re going to look at the biological activity of silicone-containing compounds, a cutting-edge field, did you make any effort to see, you know: Am I going to be wasting my time here, or is there really something here?
MR. DONLEY:
Objection.
THE WITNESS:
I didn’t make that—that great an effort. I thought I had made enough to convince my wife to make the change, to convince people who were telling me: What are you going to do?
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You know, one—One makes those decisions sometimes very structurally. And I think it represented an opportunity for me, and I took it.
EXAMINATION BY MR. ELLIS:
Q: Did either Mr. Braley or your subsequent discussions with Mr. Hunter—or Dr. Hunter and Dr. Bass about the position, did they tell you about any research or findings that Dow Chemical had made concerning biological activity of silicone-containing compounds?
A: No.
Q: Who else did you interview with apart from Braley, Hunter, and Bass, if you remember?
A: I think I met Ludington—and I think I met Jack Ludington on that visit, but I can’t be certain of that. I met someone in personnel. I thought it was Jack Ludington. I think it is.
Q: Did you meet Dr. Goggin before taking the job?
A: No. Dr. Goggin I don’t think was there yet.
Q: Do you know who the president was at that time?
A: The president was Collings, and engineer. Now—Or he was chairman of the board. If Dr. Bass was president, then Collings was chairman of the board and moved on. I just don’t remember all that—Yeah. And I think I—I think I did meet Dr. Collins, retrospectively. Dr. Hunter may have taken me by to introduce me to him.
Q: You understood that this was going to be a fairly high position at Dow Corning?
A: I didn’t know enough about the corporate structure at that point to know. I was pleased to be able to talk to people who obviously had some authority in the corporation, but I didn’t—I assumed, perhaps because it was a small corporation at the time, that—But I certainly met with people who were making the decisions in the company before I interviewed—when I interviewed.
Q: now, when you talked about—when you talked to Dr. Hunter you understood that he had been with the company a fairly long time—
A: yes
Q: --and had substantial experience in silicone technology?
A: yes.
Q: and what did he tell you about the job and this what I’ll call new field or new area that they wanted to get into?
A: if I was excited about it, Mel was excited about it too. I firmly believe that he saw great opportunities in the whole branch of pharmacology or discipline. And so he explained it in that way.
So I had every reason to think that I would receive support: that he was interested in it. Dr. Bass seemed to be interested in it, not to the degree Dr. Hunter was, certainly, but he was not negative. He was very positive. Dr. Collings did not comment much.
And I—when you say
Interviewed with Mr. Braley, I didn’t-- Mr. Braley notified of the position. I really didn’t go back to see him again.
Q: Okay. And Silas Braley really did not know the details of the position
Or—
A: If he knew them, he never—he never—he let Hunter describe the job description to me.
Q: Okay. Did you have an understanding that you were going to have a laboratory?
A: I understood that, yes, it would—it was going to be a hands-on type—I would not be in administrative research; that I would actually be doing work.
Q: You actually were going to do hands–on work in the laboratory yourself--
A: Right.
Q: -- and not just be in an administrative—
A: That’s right.
Q: --position?
A: That’s right
Q: And did they show you a laboratory that you would have access to during the interviews?
A: I—They did not show me a laboratory. I cannot remember whether we discussed then or after I arrived at Dow Corning the opportunity to use a lab on contract, that is, to lease or to rent a lab.
Q: Okay. Where was that lab located?
A: That lab was located at Dow Chemical Company.
Q: Now, was that lab located at the biochemical research labs you had—
A: No.
Q: --visited before?
A: No. It was across the street.
Q: Across the street from biochemical research labs at Dow Chemical?
A: It was—I don’t know. I can’t remember the title of it. I think it was the Toxicology Laboratories.
Q: Okay. Now, was that Building 1803?
A: Yes. That’s it.
Q: Now, did you have—When did you learn that you were actually going to be working in the labs at Dow Chemical facilities? Is that before you were hired or after?
A: I knew they were going to make some attempt—I didn’t know whether we were going to build a small structure or just what we were going to do. But I knew it would be hands-on work. I knew there was always the potential to work—to lease space from the Dow Chemical Company. Beyond that, I didn’t know. And I don’t remember. I honestly don’t remember.
Q: Did you—Well strike that. When you showed up for work your first day, I take it, somewhere around June of 1965, whose facilities did you actually go to?
I’m sorry, Rick. I didn’t
Hear that last one.
EXAMINATION BY MR. ELLIS:
Q: I said: Whose facilities did you actually go to?
A: I went to Dow Corning that first day. I can’t remember the day I went to the 1803 building, I just can’t remember.
Q: Was it soon after arriving at Dow—
A: It seemed—
Q: --Corning?
A: --to me like it was soon after that, but it could have been a few months. It could have been a few weeks. I just don’t remember, because there—there was a lot of—We took some time to learn about the corporation, to go through human resources, personnel at that time, things of that sort. But I—I’m sure I went by to see Chenoweth. But, I don’t remember when the lease contract was set up for 1803.
Q: Did you have involvement in setting that up, or was that handled--
A: I know I didn’t sign anything. That may be a reason I don’t remember anything. I’m sure we talked—If I did it, it would have been: But I don’t remember anything. I’m sure we talked—If I did, it would have been: How much space do you think you need, that sort of thing, But I can’t remember.
Q: Do you remember dealing with anyone at Dow Chemical concerning the issue of using their labs in 1965?
MR GRAMS:
Objection
Dow Chemical
THE WITNESS:
I don’t—I don’t specifically. Dr Rowe, it was my understanding, headed up the 1803 building, but he was—That’s where his unit was housed.
EXAMINATION BY MR. ELLIS:
Q: That’s the toxicological—
A: Toxicological facility.
Q: --for Dow Chemical?
A: Right. And I am sure they must have at
Least had to go through him and probably others in Dow Chemical in order to see if he had the space, if he were willing to rent the space.
Q: Did you have an understanding around that time period in ’65 when you got there that Dr. Rowe’s lab at Dow Chemical was performing any other functions for Dow Corning in connection with silicone products?
A: The only thing I knew right after I hired on and probably—probably before, but not too much before, was that he and others, whom I’ve forgotten at the moment, had published a fairly extensive publication on the toxicology of silicone products from the standpoint of industrial handling and toxicology, not with regard to—to their pharmacology or their implants or things of that sort.
Q: Did you have any understanding in 1965 that Dr. Rowe’s lab at Dow Chemical was performing any types of toxicology testing for Dow Corning?
A: Other than that one study that
I’m thinking of that received so much attention in the literature because it was one of the first and earliest studies of the industrial—the safety, the hazards associated with the handling of industrial chemicals at Dow Chemical, I don’t recall any other contracts as such for silicones.
Q: Did you have any understanding that Dr. Rowe’s lab was independently looking at any silicone products?
A: Do you mean independent of Dow Chemical?
Q: Independent of Dow Chemical.
A: No. No. I didn’t—They were courteous enough to offer us space. We did not inquire as to what—
Q: They were doing?
A: Yes; what they were doing as such.
Q: Now, how did you go about setting up this new what later became the Bioscience Department? You get there. You don’t have a staff. How did you go about in the first few months to set it up?
A: In a sense, that was played out for me. I hardly had to be a manager, because we simply—I learned that they had a special problem at that time.
Q: And what was that special problem?
A: The special problem was the identification of the material which affected the reproductive system of rabbits.
Q: You later found that that was a compound called 2,6-sic: correct?
A: That was some three years later that we found that out. The original fluid was a phenylmethyl fluid which I knew as 555.
Q: Okay. Can you tell me about this incident with Dow Corning 555?
A: That was the reason I was hired on as a consultant prior to the time that I came to work. As soon as I signed the contract they informed me that they had one instance of biological activity that they were particularly interested in,
and it was this discovery/incident/occurrence, that they had been notified by their contract organization, toxicology organization who did some of their routine screening for hazards in Philadelphia—And that was the report that we got back—that—that it was reproductive effects.
And they wondered what that could be due to, and, one, initially, they weren’t certain it was a contaminant in the fluid. They weren’t certain it was the fluid itself. No one knew much about it. But they wanted to find out as much about it as they could.
Q: At the time that incident happened—And I take it this is some adverse report that they got, adverse toxicology report on DC 555; is that correct?
A: I’m going to question your use of the word “adverse” there. I’m very familiar with adverse drug reactions.
Q: Okay. Well, correct my language if we’re not—
A: Well, you said__
Q: --communicating, because I understand that certain terms have a certain meaning.
A: right. Adverse drug—You know, an adverse event for a pharmaceutical brings to mind—
Q: Right
A: --certain things. If it was—
Q: Let me see if I can reword it.
A: Okay.
Q: Well, maybe why don’t we ask it this way.
What did you understand was the nature of the report concerning this DC fluid?
A: It was a straightforward toxicology report. You have sent us this material. We have found this effect. If that causes you a problem, you may want to do something about it. You may choose to restudy it. You may wish to confirm it. That—This whole series of things comes to mind as an investigator.
Q: Okay
A: And that’s all it meant was some believed it, some didn’t, depending upon—But in any event what’s what we understood.
Q: Okay. So—
A: So we had to do something about it.
Q: And this incident had obviously occurred before you got there and led to your hiring: correct”
A: It—I think that’s probably speculation, and I don’t want to speculate. I think I was hired because of a vision that Dr. Hunter had with regard to organosilicon materials and their activity. I don’t think he just hired me because they were trying to solve this problem, although it sure made it very convenient all of a sudden to—If you have somebody in-house, it’s a lot different than contracting things to the outside, and you can discuss this more openly, if you will, at the moment and try
Page70
and get at the root cause of the problem. So, I don’t think they hired me for that reason. I think they probably really wanted to get on with the biological activity except this took precedence because it was a toxicological finding.
Q: So if—
MR. DONLEY:
It I might object, for the record, to the speculation. Respectfully to Dr. Bennett, I note that it appeared to go beyond the question and involves speculation.
EXAMINATION BY MR. ELLIS;
Q: Is it fair to say that the Bioscience Research Department, your group, your understanding of its initial mission was both to solve a problem that had arisen—
A: Right.
Q: --in connection with the DC 555, but was also part of a larger vision to be able to develop the biological capabilities of certain
Page 71
silicone-containing products?
A: Yes.
MR. DONLEY:
Objection to the leading.
EXAMINATION BY MR. ELLIS
Q: Did you have knowledge as to which lab had found the problem with the DC 555 fluid? Is that Food and Drug Laboratories?
A: No. No. I believe it was an—a contract organization out of Philadelphia. The only name that sticks in my mind that I can remember was possibly the director was a many by the name of Kay, that that would be wrong.
Q: Okay
A: I’m sure I knew it at one time. I don’t remember now. But I don’t think it was the Food & Drug—I know it wasn’t the Food & Drug Research Laboratories out of New York.
Q: When you arrived at Dow Corning in 1965 was DC 555 still on the market and commercially available?
Page 72
A: Yes.
Q: Was it subsequently taken off the market?
A: Yes.
Q: Okay. And due to this problem that had been found?
A: Yes.
Q: Now, apart from the DC 555 what I’ll call problem, did Dr. Hunter or anyone else at Dow Corning where Dow Corning tell you about any other research that had been done in the 1950’s by Dow Corning where Dow Corning had examined some silicone compounds and found some biological activity?
Objection.
THE WITNESS:
I can’t remember anything specifically, if he did.
EXAMINATION BY MR. ELLIS:
Q: Let me show you a document, and I’ll show you where I’m getting this from. This is the Dow Corning News. It’s an edition that was published in September or October of 1973 concerning the
Page 73
bioscience—
A: Yes.
Q: --Research Department.
A: Right.
MR. ELLIS:
I know you have a copy of it. I brought it with us today. For the record, this is LAK—LAK 1 through 11.
EXAMINATION BY MR. ELLIS
Q: And do you remember when this publication came out?
A: Uh-Huh (indicating affirmatively).
Q: 1973?
A: Right.
MR. GRAMS:
Excuse me, Rick. Which page are you on?
MR. ELLIS.
I am going to be turning to page 3—
MR. GRAMS:
I’m sorry. I thought you—
Page 74
--Entitled—
MR GRAMS:
--gave a page.
MR. ELLIS:
--“history of Bioscientist Activity at Dow Corning.”
EXAMINATION BY MR. ELLIS:
But just before I get to that, do you remember when this publication came out in 1973?
A: Yes.
Q: And this was a publication that was generated by Dow Corning employees in-house, correct?
A: That’s right.
Q: It was for distribution within Dow Corning?
A: Yes—
Q: Okay.
A: --to Dow employees.
Q: And you got—And they came and took pictures of the lab and the—
A: Right.
Q: --people who worked there?
A: Right.
Page 75
Q: And you were interviewed in connection with the--
A: Right.
Q: --publication? And in this article they talk about the research of the—the Bioscience Research Department; correct?
A: Uh-huh (indicating affirmatively).
Q: And was that in connection with preparation for this deposition?
A: Yes.
Q: While we’re on that issue, apart from discussions that you’ve had with your attorneys about this deposition and preparing for it, have you had any discussions in the last few months with a--an attorney, John Donley, who represents Dow Corning Corporation?
A: Yes.
Page 76
Q: Okay. And can you tell me when you had those discussions?
A: I did not write down the exact dates, but-
Q: Not the exact dates, just generally.
A: It’s been the last four months.
Q: And how many discussions have you had with him?
A: A couple. Two
Q: Were they both phone conversations or did you actually meet with Mr.—
A: No. I met with him.
Q: Did you come to his office in Chicago, or did he come to your office?
A: He came to my office.
Q: How long did you spend with Mr. Donley?
A: I think we spent two or three hours on—on certainly one occasion, perhaps about that long on another.
Q: Okay. And were you represented by your own counsel at that
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Time or was that—
A: No. I was not.
Q: Did Mr. Donley bring any documents for you to review when he met with you?
A: One document, that I recall.
Q: Okay. Is that a 1975 study by Lake and Radonavitch?
A: Yes.
Q: And he provided you with a copy of that?
A: He did.
Q: And you had not seen that study before; is that correct?
A: I had not ever seen the study before.
Q: Because that had been written in 1975 after you left Dow Corning; correct”
A: That’s right.
Q: Did he discuss that Lake-Radonavitch study with you?
A: No.
Q: He just showed you a copy of it?
Page 78
A: He showed me a copy and asked me what I thought of it.
Q: Did you read it—
A: And—
Q: Did you read it at that time?
A: I read it. But I provided nothing, no information to him on my feelings about it.
Q: Apart from that Lake-Radonavitch study that Mr. Donley provided you, within the last couple of months has he provided you any other documents?
A: I can’t remember any at the moment.
Q: Did he talk to you about the history of the Bioscience Research Department during these two visits?
A: Yes. We discussed that.
Q: Okay. Did he tell you that there would probably be an interest in taking your deposition?
A: That’s the first time, I believe, I understood that I probably would have to come—and—come to
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this deposition—or not this deposition but a deposition.
Q: Did he talk to you about any specific studies that you may have done while you were at Dow Corning such as metabolism studies or—
A: Yes.
Q: And you reviewed those with Mr. Donley?
A: Not the details at all; not many of the details as such.
Q: Okay. Had you ever met Mr. Donley before?
A: I want to say about a year ago, I believe.
Q: And, that would have been sometime during 1993?
A: (Witness nods head affirmatively.)
Q: And what was that occasion, sir?
A: I can’t remember the specific reason for the call. I just can’t remember at the moment.
Q: He called you—
Page 80
A: Yes.
Q: --sometime during 1993?
A: Yes.
Q: Did he identify himself as an attorney—
A: Yes.
Q: Representing Dow Corning Corporation?
A: Yes, yes.
Q: And did it have something to do with your position at the American Medical Association?
A: I don’t understand.
Q: Well, did it have something to do with some function you were performing for the American Medical Association in your—in you—
A: Well—
Q: --position?
A: --I think he knew that we had—that the American Medical Association had published a report on –on breast implants, and that may—I just can’t remember what I’ve—I just didn’t write it down, and I don’t remember.
Page 81
Q: Well, you ultimately in late 1993, December of 1993, published an article in JAMA; correct?
A: No. I did not publish it.
Q: You authored an article?
A: Nope.
Q: Okay. Could you describe what your involvement was in that publication concerning the American Medical Association report on breast implants?
A: Sure. It’s a—I have to go through a process to tell you.
Q: Sure. Okay.
A: Part of my job is to evaluate drugs, and we publish a text book for physicians. The other part of my job is drug policy and reports in which we respond to requests from a number of sources: The House of Delegates, Board of Trustees, executive management, and the Council of Scientific Affairs. Because of my job working for the Council on Scientific Affairs, I don’t work directly for the. The AMA has what
Page 82
they call about seven or eight councils, if you will, sort of think tanks, because people who generally run for those positions are interested—like Council on Ethics and Judicial Affairs, Council on Medical Services, Council on Scientific Affairs. They decide what they would like to do studies on, come to staff, and ask you to prepare a report.
At that point we’d prepared many reports over the years, one of them—There were two on breast implants. One was Report M. That’s the reason I included it. I had no involvement with Report M at all.
For report C, the second report where I’m listed as staff author, you provide the initial draft to the Council. They then determine who the report will be sent to for review to the outside, for example, like the Food & Drug Administration or/and American Society for Plastic and Reconstructive Surgeons, consumer reps, et cetera.
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They make those decisions. They make those changes. The article belongs to the Council on Scientific Affairs.
In all my 18 years I’ve written many reports. I have never been a spokesperson for the report.
Q: Okay
A: And I would not—I could have taken all my belongings this afternoon, if I elect to—to be the spokesperson for those kinds of reports, because, obviously, they take the responsibility for it, and, therefore, they want to designate who they are that’s going to have it.
But the staff author that’s listed at the bottom is a courtesy which is extended to people to say: Well, you did—You know, you did the initial literature survey, et cetera. But they would be—not upset, but they would feel it inappropriate for me to comment on that report.
So that’s the reason in the
Page 84
sense I’m an author, but—And I’m not an author. And, I don’t know if that helps, but I—
Q: No. It does. And I—
A: Okay.
Q: I’m glad you clarified that, because I didn’t—
A: Yeah.
Q: --understand it. It didn’t look like you had written the whole thing, but—
A: No. I could not—
Q: --I could not tell—
A: And not only that, but the report that—Report C—I’m sure you’ve seen that—and then there’s the published report.
Q: That’s right.
A: Not all reports of the councils go to JAMA. Only a few do. And they have to go through peer review. So when the council has said that this report can for forward, it goes to the board of trustees—
Page 85
Q: Uh-huh (indicating affirmatively).
A: --who, in turn, send it to the House of Delegates, and they vote on it. If they approve it, it’s policy. But, even then, the Journal is sufficiently at arm’s length that they further send it out for more peer review. And so we, as staff, shepherd it through all those machinations and then send it out again.
If Dr. Lundberg chooses to send it out to another person at the FDA or another consumer, it doesn’t matter. He has his choice. We never know where they’re going. We simply get the—the recommended changes back, and we either live with them, change them, or refuse to change them, and then they decide whether or not they’re going to publish it.
So, it’s gone through the process. Probably 50 people have seen that report and had the opportunity to make changes on it from something which
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was originally submitted.
Q: I guess my question was whether Mr. Donley, Dow Corning’s attorney, had called you concerning that report in 1993?
A: We did not discuss the generation of it or anything else or whether it was good, bad, or indifferent. I remember that. I would not have commented on that.
Q: Well, can you help me a little bit about why he would have been calling you during 1993?
What was the question again?
EXAMINATION BY MR. ELLIS:
Q: I said: Can you help me on why Mr. Donley would have been calling you in 1993, anything that you can remember that would help me understand why Dow Corning’s attorney would be calling you in 1993?
A: The only thing I can think of, that
MR. DONLEY
Page 87
I object to the form.
THE WITNESS:
That occurred after I had been contacted by Griffen Bell’s unit. I don’t know how to describe that in your terms.
Q: Griffen Bell’s quote, independent, closed—
A: Investigation.
Q: --quote, investigation?
A: That’s right.
Q: And were you interviewed for that investigation?
A: Yes.
Q: Did they ask you about your work at Bioscience?
A: Yes.
Q: And was Mr. Donley’s phone call to you after—
A: After that.
Q: --the Griffen Bell—
A: Yes.
Q: Did he refer to your interview with Griffen Bell attorneys?
Page 88
A: I don’t remember. If I could remember why—
Q: Did you provide any documents to the Griffen Bell attorneys?
A: No.
Q: How long were you interviewed by the Griffen Bell attorneys for?
A: A half-day. They came in the morning from Atlanta, stayed that morning. We had lunch, finished up, and they went back to Atlanta.
Q: Did they show you some documents during that interview?
A: No.
Q: And did they ask you about the formation of the Bioscience Research Department in 1965?
A: I’m sure there were questions probably related to that.
Q: Did they ask you questions about various studies that were done between 1965 and ’75, when you left, concerning biological activity of organosilicon compounds?
A: It’s hard to talk to me
Page 89
Without talking about the biological activity of organosilicon compounds, because it was the only thing I knew.
Q: That’s why we have you here. But you fully explained what your nine years of research were at Dow Corning—
A: Yes.
Q: --to the Griffen Bell attorneys?
MR. DONLEY:
Objection.
EXAMINATION BY MR. ELLIS:
Q: