Blais3...being an expert witness?

[Guest guest]

> Subject: Shaw vs Bristol Myers Squibb ( part3)I need

> part 1and 2, I wonder if she won her

> case....love...Lea

>

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> Subject: Shaw vs Bristol Myers Squibb ( part3)

>

> Q. And in response to that request, did you also

> receive what has been marked as Plaintiffs' Exhb.

> 249?

>

> A. I did.

>

> Q. And you have a copy of this there, but I have the

> original that you received; is that correct?

>

> A. That is correct.

>

> Q. I'd like to direct your attention to the back

> page. The date of this document is dated December

> 1981; is that correct?

>

> A. That's correct.

>

> Q. All right. And does that document state

> " Materials used in the Surgitek mammary implant have

> been subjected to implant evaluation in beagle dogs

> for periods of up to seven years " ?

>

> A. Yes. P. Blais D 17-6161

>

> Q. Out of the 10,000 documents that you have

> reviewed, have you ever seen a test of materials

> used in mammary implants subjected to implant

> evaluation in beagle dogs up to seven years?

>

> A. Not at that time, and I don't believe ever.

>

> Q. Now, since you were employed with the Canadian

> FDA, have you worked for other plaintiffs besides

> Lori and Joe Shaw?

>

> A. I have.

>

> Q. And in the course of that, have you been provided

> additional materials about safety testing than just

> the materials you saw while you were employed at the

> Canadian FDA?

>

> A. Yes.

>

> Q. And have you formed an opinion based on your

> experiences, your training, and your review of the

> documents, of whether silicone gel breast implants

> of the type received by Lori Shaw are defective and

> unreasonably dangerous?

>

> MR. GORE: Objection; lack of foundation.

>

> THE COURT: In design or manufacture?

>

> MS. TROUTWINE: I'll first of all ask about in

> design.

>

> MR. GORE: Same objection, Your Honor.

>

> THE COURT: Okay. Overruled. I assume you're P. Blais

> D 17-6262 going to tie up some of the foundation

> issues. I think you will. Go ahead.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Will you state whether you have formed an

> opinion?

>

> A. Yes. I have formed opinions.

>

> Q. And will you tell the jury what is your opinion

> about whether silicone gel breast implants

> manufactured by Medical Engineering Corporation was

> unreasonably defective and dangerous in terms of its

> design?

>

> MR. GORE: Your Honor, so I won't have to interrupt,

> may I have a continuing objection?

>

> THE COURT: You may.

>

> MR. GORE: Thank you.

>

> THE COURT: You may answer, Dr. Blais.

>

> THE WITNESS: In the specific case of the bi-lumen,

> the product was defective in concept, in design, and

> implementation of the design, which is fabrication

> technology; in evaluation for purpose of quality

> assurance; in terms of reference for quality

> assurance; and finally in chemical investigation

> leading to authorization for sale and distribution.

> The product insert, in addition to this, was also

> faulty and defective in yet other areas that would

> P. Blais D 17-6363 take too long to discuss at

> present.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Dr. Blais, this jury has frequently heard the

> term " gel bleed. " Are you familiar with that term?

>

> A. Yes.

>

> Q. And are you familiar with what exactly is the

> chemical composition of gel bleed?

>

> A. It's a large mixture of compounds, mostly small

> molecules, some of which belong to the silicone

> family, some of which belong to other families. But

> in simple language, it's a type of fluid soup.

>

> Q. And do you have an opinion of whether Medical

> Engineering Corporation performed adequate tests on

> the effect of gel bleed on tissue?

>

> MR. GORE: Objection, Your Honor; foundation.

>

> MS. TROUTWINE: I'm sorry, Your Honor. I thought I

> laid an hour long foundation already.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Did you have occasion to study

>

> MR. GORE: Your Honor, could I ask that counsel be

> instructed not to make such statements in front of

> the jury. P. Blais D 17-6464

>

> THE COURT: All right. It's done. We just need to

> know, again, Ms. Troutwine how he knows all of the

> tests that MEC has done, that he's aware that he's

> read them all.

>

> MS. TROUTWINE: All right.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. During the years that you were with the Canadian

> FDA, did you read and study documents about the

> testing that the Bristol-Myers-Squibb-owned

> corporation, Medical Engineering Corporation,

> performed on gel bleed?

>

> A. Very few, if any.

>

> Q. Okay. I didn't ask you what those tests were. I

> asked you if you read every document that you could

> find on testing on gel bleed.

>

> A. No. It's not possible. I've read most.

>

> Q. All right. What ones haven't you read?

>

> MR. GORE: Well, objection, Your Honor.

>

> THE COURT: Yeah. What we're looking for, if you're

> asking him to give his opinion as to MEC's testing,

> is that he knows all of the testing that MEC did. If

> he didn't know, then he can't give his opinion.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Are you familiar with all of the testing that P.

> Blais D 176565 they did?

>

> A. I have read laboriously the larger portion of

> what was presented to various plaintiffs as being

> the totality of the Medical Engineering Corporation

> documents.

>

> Q. All right. And were you involved with efforts by

> Medical Engineering Corporation to prove to the

> Canadian FDA that they had performed adequate

> testing on gel bleed?

>

> A. That's another issue. I have made such studies,

> yes.

>

> Q. All right. And was it your job to consider all of

> the tests that they submitted to the Canadian FDA in

> deciding whether or not Medical Engineering

> Corporation had performed sufficient testing on gel

> bleed?

>

> A. Yes, it was my job.

>

> Q. All right. And did you read everything that they

> submitted to you to prove to you that they had

> adequately tested?

>

> A. I did read such documents as a government worker.

> I did read other documents when I left the system.

> But these were different documents.

>

> Q. All right. I understand. What MEC presented to

> you when you were with the FDA is not everything.

> You've also read other P. Blais D 17-6666 documents

> since you left the Canadian FDA?

>

> A. Correct.

>

> Q. All right. And based on that, do you have an

> opinion of whether Medical Engineering Corporation

> adequately tested the chemical composition of gel

> bleed?

>

> MR. GORE: Same objection, Your Honor.

>

> THE COURT: Well, I'll allow him to give his opinion

> based on the documents that he did receive, as long

> as it's limited to that. We don't know if he got

> them all, but based on the documents he did receive,

> he can render his opinion.

>

> THE WITNESS: There are two opinions. The first

> opinion relates to my position as a government

> worker. With the documents presented to me within

> the process of government review, the opinion at

> that time was that the corporation had not conducted

> sufficient or appropriate tests to authorize

> distribution of the product, assuming the product

> had been new. Later, when I exited the government, I

> gained access to documents which were alleged to

> exist when I was a government worker, and I also

> read new documents which I had not seen as a

> government worker. I concluded that a large fraction

> of allegations presented to me as a government

> worker

>

> MR. GORE: Objection to the allegations P. Blais D

> 17-6767 presented to him.

>

> THE COURT: Sustained. I don't even know what we're

> talking about at this point, but it looks like we're

> floating a little bit. So sustained.

>

> THE WITNESS: I concluded that there was widespread

> variance between what MEC claimed to us was valid as

> a government worker, and later on I discovered that

> the tests that were deemed to have been performed

> were not performed or were not performed competently

> or had results that were contrary to earlier things.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. All right. I'm going to hand you what's been

> marked as Plaintiffs' Exhb. 18 and 19. Do you

> recognize these documents, Dr. Blais?

>

> A. Yes.

>

> Q. And is it true that they announce the formation

> of the Scientific Affairs Committee?

>

> A. It does.

>

> Q. And is it true that they announce studies that

> the Scientific Affairs Committee intended to

> conduct?

>

> A. It does.

>

> Q. Do you know whether those studies were ever done?

> P. Blais D 17-6868

>

> A. I have no evidence

>

> MR. GORE: Well, objection.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. The answer is " yes " or " no. "

>

> Do you know whether those studies ever done based on

> what we reviewed?

>

> THE COURT: I don't know what we're talking about,

> because I don't have a copy of the documents.

>

> MS. TROUTWINE: I'm so sorry, Your Honor.

>

> THE COURT: I just need to know what we're dealing

> with.

>

> MS. TROUTWINE: (Handing document to the Court.)

>

> THE COURT: Thank you.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Based on all the documents you have reviewed

> about Bristol-Myers' manufacture of breast implants,

> the studies they did, the quality control programs,

> do you know whether those studies that they

> announced in those documents were ever done?

>

> A. I've seen no evidence of them.

>

> Q. Okay. Now, when you were with the Canadian FDA

> and Bristol-Myers or Medical Engineering Corporation

> P. Blais D 17-6969 submitted these documents to you,

> was that in response to a ruling that it was up to

> them to prove safety?

>

> MR. GORE: Well, objection, Your Honor. There's no

> evidence that these documents were ever submitted to

> him when he was at Canada.

>

> THE COURT: Correct. You need to back up a bit.

>

> MS. TROUTWINE: All right. I meant to ask that

> question, Your Honor, irrespective of 18 and 19.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Irrespective of 18 and 19, at some point in time,

> did the Canadian FDA order that Bristol-Myers'

> company, Medical Engineering Corporation, were to

> prove that breast implants were safe?

>

> MR. GORE: You know, objection as to relevance. Your

> Honor, we're not in Canada. I don't know what we're

> dealing with.

>

> THE COURT: I don't know the time frame, either. You

> said " at some point in time. "

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. I'll ask specifically. In 1983.

>

> A. In 1983, Canada enacted legislation which forced

> every manufacturer to demonstrate safety and P.

> Blais D 17-7070 efficacy for the purpose of selling

> devices that were introduced after 1976.

>

> Q. All right. And in response to that, did Medical

> Engineering Corporation submit to you documents to

> prove their product was safe?

>

> MR. GORE: Your Honor, I object to this entire line

> of questioning. We're not in Canada.

>

> THE COURT: We're talking about Canadian laws, and

> without knowing exactly what those laws were,

> whether or not breast implants made in the United

> States would have made it to Canada or not I don't

> think is relevant to I just don't think it's

> relevant. At least the way we're going, it isn't. So

> sustained.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Do you have an opinion whether Medical

> Engineering Corporation was motivated to prove to

> you by submitting every document they had to show

> safety?

>

> MR. GORE: Objection. His opinion about the

> motivations of my client, Your Honor

>

> THE COURT: Speculation. P. Blais 17-7171

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. If Medical Engineering Corporation had not been

> able to prove they were safe, would they have been

> able to continue selling them?

>

> MR. GORE: Objection to double speculation, Your

> Honor.

>

> THE COURT: Right. Sustained.

>

> MS. TROUTWINE: Your Honor, this witness has

> testified that it was his job to decide whether it

> was safe or not.

>

> THE COURT: Safe under Canadian law at that time,

> which we don't have before us.

>

> MS. TROUTWINE: I'll move on.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. I'd like to talk for a minute about or ask you

> some questions about whether you are familiar with

> the United States term within the FDA of

> " grandfathering. "

>

> A. Yes. It applies to Canada as well.

>

> Q. All right. And what does the term " grandfather "

> mean?

>

> A. It means any device which is deemed to have been

> in commerce for human usage after approximately P.

> Blais D 17-7272 midyear 1975 in the US or, for that

> matter, approximately April '76 for Canada.

>

> Q. Do you have any knowledge whether the implants

> that were put in Mrs. Shaw were ever approved by the

> FDA?

>

> MR. GORE: Objection.

>

> THE COURT: They were

>

> MR. GORE: The Court's prior ruling.

>

> THE COURT: I don't know how to say this without

> giving something away here.

>

> MS. TROUTWINE: Your Honor, I understood that your

> ruling

>

> MR. GORE: May we approach the bench, Your Honor?

>

> THE COURT: Right. But okay.

>

> (Discussion off the record)

>

> THE COURT: Well, you know what, why don't we take it

> up after lunch. Can we go through other questions?

>

> MS. TROUTWINE: Yes.

>

> THE COURT: Okay.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Well, let's talk a minute about bi-lumens. Can

> you tell the jury what you know about the bi-lumens

> made by Medical Engineering Corporation? What P.

> Blais D 17-7373 did they use for inner lumens?

>

> A. A style of round regular prosthesis called in the

> trade the 15,000 series, and they included rejected

> 15,000 series. It was a policy

>

> MR. GORE: I'm going to object, Your Honor. Move to

> strike.

>

> THE COURT: I'm sorry. I should have been listening.

> I was writing down the last thing that we took care

> of. What is the question again, before we

>

> MS. TROUTWINE: I was asking this witness to tell the

> jury what he knew about Medical Engineering

> Corporation's manufacture of bi-lumens, the kind of

> implant that Lori Shaw got.

>

> THE COURT: And we must have that doesn't sound bad

> to me. Was the answer what was happening here?

>

> MS. TROUTWINE: Yes, sir.

>

> THE COURT: Okay. Just because I didn't hear it, I

> will grant the motion to strike. The jury is to

> disregard it. And now you can proceed while I'm

> listening and see where we're going. P. Blais D

> 17-7474

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Okay. I'd like to show you Exhbs. 71, 73, and

> 129. I'm not going to ask you about 129 right now,

> because they're still getting another copy for the

> defendants. Have you had an opportunity to review

> documents about Bristol-Myers and Medical

> Engineering Corporation's manufacture of bi-lumens?

>

> A. Yes.

>

> Q. And do these documents, which I have just handed

> to you concerning the subject of the inner shell or

> the inner lumen?

>

> A. Some do, yes.

>

> Q. Do some not?

>

> A. Some relate to the outer shell.

>

> Q. Oh, okay.

>

> A. Or the valve.

>

> Q. All right.

>

> MS. TROUTWINE: And plaintiffs move for the admission

> of 71 and 73.

>

> (Plaintiffs' EXBS. 71 and 73 offered)

>

> MR. GORE: Well, Your Honor, just because they have

> something in them that has to do with the inner and

> outer shell, I don't know that it makes them

> admissible. There's a lot of things in here,

> including marginalia and P. Blais D 17-7575 hearsay,

> and I would object to them being admitted into

> evidence.

>

> THE COURT: Well, one thing I'm looking at on 71 is a

> letter from to Stith. That's a clean copy.

> And then in 73, it's included again with a bunch of

> marginalia.

>

> MS. TROUTWINE: Your Honor

>

> THE COURT: So obviously somebody else in fact, it

> looks like the same thing.

>

> MS. TROUTWINE: Your Honor, both exhibits, 71 and 73,

> have been admitted to be true and accurate business

> records kept in the regular course and scope of

> Bristol-Myers MEC's business.

>

> MR. GORE: There's no question about authenticity,

> but relevance and a lot of other things

>

> THE COURT: Oh, I know. Well, 71 and 73 will be

> admitted.

>

> MS. TROUTWINE: Thank you.

>

> (Plaintiffs' EXBS. 71 and 73 offered and received)

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. And can you tell the jury will you summarize

> these lengthy documents for the jury in just 20

> words or less. P. Blais D 177676

>

> A. The first part of the document says we are

> rejecting shells because some parts are too thin.

>

> Q. Can you tell the jury what's wrong with a thin

> shell.

>

> A. It's like a chain that has a weak link in it or a

> bicycle tire that has an area that is prone to

> blistering or blowing up, forming an aneurysm.

>

> Q. And do these documents go on to instruct the

> staff to use those shells for the inner lumens of

> bi-lumens?

>

> MR. GORE: Objection, Your Honor. First of all, it's

> leading.

>

> THE COURT: It is leading. Sustained on that basis.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Would you tell the jury what these documents

> suggest that MEC employees do with thin spots.

>

> A. It says we've looked at the thin spots and we

> feel that you should use them, anyway, providing you

> put them inside a double lumen.

>

> Q. Do you have an opinion about whether using shell

> material that had failed to pass quality control

> checks makes a bi-lumen implant a non-SCL bi-lumen

> implant even more dangerous than a regular implant?

> P. Blais D 17-7777

>

> MR. GORE: Objection, Your Honor. There's no evidence

> that it was ever done.

>

> THE COURT: That's true. Sustained.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Assuming that was done. If the evidence shows

> that it was, in fact, done, would that make such an

> implant even more dangerous?

>

> MR. GORE: Objection as speculation, Your Honor.

>

> THE COURT: Well, it is speculation, but I assume you

> will tie that up, Ms. Troutwine, that's what is said

> here in a 1980 document was actually done. So you

> may continue.

>

> THE WITNESS: It would make the implant more

> dangerous, more unreliable, and subject to a shorter

> life span over and above increasing the risk of

> having a defective or an improperly assembled device

> right from the start.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. I'd like now to ask you some questions about SCL.

> Do you know, when did low-bleed technology P. Blais

> D 17-7878 first become available in the breast

> implant manufacturing business?

>

> A. It started in the mid'70s, a little bit after

> that.

>

> Q. Okay. And do you know who was the first company

> to use that technology?

>

> A. It was the Minnesota Mining & Manufacturing

> Corporation, the Scotch Tape people, through their

> division called McGhan Medical.

>

> Q. Okay. And who was the second company to institute

> low-bleed technology?

>

> A. I believe it was a Japanese company called

> Kokanko Geel (phonetic).

>

> Q. Okay. Was Medical Engineering Corporation the

> third company to use low-bleed technology?

>

> A. It was not.

>

> Q. Was it the fourth company?

>

> A. It's either the fourth or the fifth.

>

> Q. I'd like you to assume that our evidence is that

> Lori Shaw in April 1990 received a pair of

> high-bleed bi-lumen implants, non SCL. Do you have

> an opinion whether the sale of high-bleed implants,

> non-SCL implants demonstrates wanton disregard for

> the health of Lori Shaw?

>

> MR. GORE: Objection, Your Honor; foundation P. Blais

> D 17-7979 and qualification.

>

> THE COURT: Sustained.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Do you have an opinion whether it was negligence?

>

> MR. GORE: Same objection, Your Honor.

>

> THE COURT: You're asking for a legal conclusion.

> Sustained.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Do you have an opinion what should be the duty of

> a reasonably prudent manufacturer of breast implants

> to sell only SCL products once that technology

> became available?

>

> MR. GORE: Objection, Your Honor. I think that calls

> for a legal conclusion.

>

> THE COURT: Overruled. Finally got the form of the

> question right.

>

> MS. TROUTWINE: Thanks.

>

> THE WITNESS: I've sort of had my train of thought

> disturbed. Can you please restate it to me. P. Blais

> D 17-8080

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Do you have an opinion about the duty of a breast

> implant manufacturer to sell only SCL products once

> that technology became available?

>

> A. The duty of the manufacturer is to sell the

> product that involves the least responsibility, the

> least risk. That is seen both in the food and drug

> regulatory sense, but also in the business sense as

> well, because that's called liability exposure.

>

> MR. GORE: Well, objection to that, Your Honor, and

> move to strike the answer.

>

> THE COURT: It will be stricken. The jury will

> disregard.

>

> MS. TROUTWINE: The entire answer or just the last

>

> THE COURT: Just the last part.

>

> MR. GORE: Move to strike the rest of the answer as

> nonresponsive, Your Honor.

>

> THE COURT: Overruled.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. Are you familiar with a breast implant

> manufacture owned by Bristol-Myers in Paso Robles?

>

> A. I'm familiar with two such factories.

>

> Q. And are you familiar with whether that plant P.

> Blais D 178181 made high-bleed or low-bleed

> implants?

>

> MR. GORE: Objection to the relevance, Your Honor.

> There's no evidence that this was made there.

>

> THE COURT: Well, that's true. Are we going to tie up

> where the implant was made?

>

> MS. TROUTWINE: Well, Your Honor, it's a low-bleed

> implant.

>

> THE COURT: Well, are you just asking him a question

> of whether implants were made by MEC, period?

>

> MS. TROUTWINE: No, I'm going to discuss a

> controversy concerning low-bleed implants.

>

> THE COURT: Okay. Ask the question.

>

> BY-MS. TROUTWINE: (Continuing)

>

> Q. At the time that the Bristol-Myers Corporation

> purchased that factory, were you involved with a

> controversy at the Canadian FDA concerning those

> high-bleed implants?

>

> MR. GORE: Objection; relevance, Your Honor.

>

> THE WITNESS: I was.

>

> THE COURT: I don't know what the relevance is. It

> may be relevant or may not be, but I think we're

> going to have to hear that outside the presence of

> the jury to see if it's relevant to this case.

>

> MS. TROUTWINE: Your Honor. May we approach P. Blais

> X 17-82 82

>

> the bench?

>

> (Discussion off the record)

>

> MS. TROUTWINE: I have no further questions of this

> witness.

>

> THE COURT: Mr. Gore?

>

> MR. GORE: May I have just a moment, Your Honor?

>

> THE COURT: Yes, you may.

>

> (Pause)

>

> CROSS-EXAMINATION BY-MR. GORE:

>

> Q. Good morning, Dr. Blais.

>

> A. Good morning, sir.

>

> Q. Doctor, as I understand your testimony, you have

> a Doctor of Philosophy degree in physical chemistry;

> is that correct?

>

> A. I don't have a Doctor in Philosophy. It's a

> physical chemist, and I have a doctor's degree in

> physical chemistry.

>

> Q. Is not a Ph.D. a Doctor of Philosophy in some

> field?

>

> A. It's misleading. A Ph.D. is a Doctor, if you

> wish, of Philosophy.

>

> Q. It's your opinion that it's misleading to refer

> to a Ph.D. as Doctor of Philosophy? P. Blais X 17-83

> 83

>

> A. I'm not a philosopher, if that was your question.

>

> Q. Okay. Doctor, you don't consider yourself an

> expert in all fields of science, do you?

>

> A. No.

>

> Q. You testified about having taken some courses and

> doing some postdoctorate work, but you do not have

> an engineering degree, do you, sir?

>

> A. No.

>

> Q. And you're not licensed as a registered engineer;

> is that correct?

>

> A. That is correct.

>

> Q. You are not an expert in biology, are you, sir?

>

> A. It depends. Biology is not by itself a

> discipline.

>

> Q. Well, let me be more specific, then. You're not

> an expert in the field of medical biology or

> cellular biology; is that correct?

>

> A. I am not.

>

> Q. And you are not a microbiologist; is that

> correct?

>

> A. That is correct.

>

> Q. And you're not a medical doctor?

>

> A. I'm not a clinician.

>

> Q. You are not qualified as a medical doctor? P.

> Blais X 17-84 84

>

> A. I'm not a clinician. I'm not qualified. I do not

> have a profile of a physician.

>

> Q. And you are not formally trained as a

> toxicologist; is that correct?

>

> A. I am not a toxicologist. I do not belong to

> toxicological associations. I do not have

> certificates in toxicology.

>

> Q. You also are not trained in and do not have

> certificates in pathology; is that correct?

>

> A. That is correct. That is a medical discipline, at

> least in this state.

>

> Q. Dr. Blais, you don't consider yourself a

> specialist in breast implants, do you?

>

> A. I don't know how to answer your question. People

> are seldom able to consider themselves what the

> world regards them as. I'm a specialist in implants,

> high-risk implants, which comprise breast implants.

> I don't know how my peers would consider me.

>

> Q. Let me be more specific: You've never worked for

> a breast implant manufacturer, have you?

>

> A. That is correct.

>

> Q. You've never worked in any other industrial

> capacity concerning the design, manufacture and

> testing of breast implants?

>

> A. That is correct. P. Blais X 17-85 85

>

> Q. You've never seen a breast implant made in a

> factory; is that true?

>

> A. That's more difficult to answer.

>

> Do you include or exclude video recordings?

>

> Q. Well, apparently you've seen some video. Have you

> ever been in a manufacturing plant where a breast

> implant was made?

>

> A. I've visited many plants, many who had operations

> similar to what is conducted for breast implants.

> But I have not physically seen an actual

> manufacturing of a breast implant in an integrated

> fashion.

>

> Q. Doctor, you don't presently have any official

> appointments at any university, do you?

>

> A. I never have.

>

> Q. And your company that you owned is called

> Innoval; is that correct?

>

> A. That is correct.

>

> Q. And that is in Ottawa, is it?

>

> A. That is correct.

>

> Q. You've never worked for a breast implant

> manufacturer regarding specifically the design,

> testing, and manufacture of breast implants,

> correct?

>

> A. As you formulate the question, I would have to

> answer " yes. " P. Blais X 17-86 86

>

> Q. And I take it, then, you have never participated

> in the manufacturing and production of a breast

> implant, correct?

>

> A. It depends on your definition. My prior answer

> was that I did, in fact, work for a breast

> prosthesis manufacturer, and it does have all the

> ramifications of your second questions.

>

> Q. What manufacturer was that?

>

> A. Mentor Corporation.

>

> Q. When did you work for Mentor?

>

> A. I was a consultant for them in the 1990-'91

> period.

>

> Q. You were a consultant, you were not employed by

> them, correct?

>

> A. My understanding is that a consultant is

> employed. I don't know about Oregon law, but I do

> know about Ontario law.

>

> Q. So it's your understanding that you were actually

> employed by the Mentor Corporation?

>

> A. A consultant is employed, retained, whatever term

> you wish to use. It fulfills the definition of an

> employee.

>

> Q. Now, Doctor, you've talked about reviewing

> documents from various manufacturers of breast

> implants, correct? P. Blais X 17-87 87

>

> A. That is correct.

>

> Q. And I think you indicated that you believe you

> have reviewed somewhere in the range of 7 to 10

> thousand documents over the years?

>

> A. I missed the part did you limit these documents?

> We had several questions in that area.

>

> Q. I'm sorry. Let me withdraw it and make it clear.

> You said that you've reviewed documents from a

> variety of breast implant manufacturers over the

> years

>

> A. Correct.

>

> Q. And I'm not limiting it to my clients. I'm not

> broadening it to the entire universe of documents

> you reviewed. I think you said, Doctor, that you've

> reviewed between 7 and 10 thousand documents?

>

> A. I'll accept that.

>

> Q. You don't keep any records of those documents?

>

> A. No, it would make no sense.

>

> Q. You don't keep any notes on the documents as

>

> you've reviewed them, do you?

>

> A. No. It's not possible.

>

> Q. Do you still have those 7 to 10 thousand

> documents that you say you reviewed?

>

> A. I've never had them. They were reviewed P. Blais

> X 17-88 88 incidental to various projects usually

> from other people's data bases, including the

> library of one manufacturer. I have never had those

> documents in my possession.

>

> Q. Well, if you've never had them in your

> possession, how did you review them?

>

> A. In the same way that someone goes to a public

> library and peruses documents or books.

>

> Q. I'm confused, Dr. Blais. I thought you told us on

> direct examination that when you were with the

> Canadian government, you had actually received a lot

> of documents from other manufacturers and had them

> in your hand and reviewed them.

>

> A. That is true. I also said that after I left

> government even, but that does not mean I do not

> own, stockpile, inventory, or somehow retain such

> documents.

>

> Q. Now I think we're on the same page. You had them,

> reviewed them, but didn't keep them for the reasons

> you explained?

>

> A. Correct.

>

> Q. And I think you told us that subsequent to

> leaving the Canadian government, you received some

> volume of documents, company documents, from

> plaintiffs' attorneys?

>

> A. I've received some. P. Blais X 17-89 89

>

> Q. And you haven't retained those?

>

> A. In many cases I had what is called a

> confidentiality agreement that these documents were

> either destroyed on the instructions of the

> defendants or the plaintiffs, or in some cases they

> were returned.

>

> Q. Okay. Now, my question, Dr. Blais is, if you can

> estimate, among the 7 to 10 thousand documents that

> you believe you have reviewed from all of the breast

> implant manufacturers, from whatever source you got

> them, can you give us an estimate as to what

> percentage of those were from Medical Engineering

> Corporation?

>

> A. I will give you a lower limit of about 40 percent

> and an upper limit of about 60 percent. And by I

> have to be to give you a caveat yet. They include

> documents which are regarded as collateral. They

> include, for example, documents from your suppliers,

> your client's suppliers.

>

> Q. Oh, so some of these 7 to 10 thousand documents

> you got were not from plaintiffs' attorneys, were

> not from MEC, but were from some other companies'

> suppliers?

>

> A. That is not correct. The documents, although were

> part of MEC files, were not from within the company

> of MEC. They were, instead, from what are called

> preferred suppliers, examples being Dow Corning.

>

> Q. I see. So you got some documents from Dow P.

> Blais X 17-90 90 Corning?

>

> A. Incidental to from files pertinent to Dow

> Corning. Not from Dow Corning, per se. I have never

> obtained documents from Dow Corning except in the

> regulatory context.

>

> Q. So since you left the Canadian government in 989

> you have never received any Dow Corning documents

> from any Plaintiffs' attorney?

>

> A. No, but not necessarily in connection with MEC

> cases.

>

> Q. Well, that's wasn't my question. Have you ever

> received any Dow Corning documents from plaintiffs'

> attorneys?

>

> A. I have seen many Dow Corning documents from

> plaintiffs' and from defense attorneys.

>

> Q. Now, if I understood your testimony a moment ago,

> Doctor, you estimate that the MEC documents that you

> have reviewed constitute about between 40 to 60

> percent of the documents that you have reviewed.

>

> A. Correct.

>

> Q. All right. Let me take the upper limit that you

> talked about. When you said 7 to 10 thousand, let's

> say 10 because the math is easy. That would be,

> assuming the total universe was 10,000 documents,

> somewhere between 4 and 6 thousand documents related

> to MEC that P. Blais X 17-91 91 you've reviewed?

> Would that be fair?

>

> A. That's a good estimate.

>

> Q. Do you have how many documents MEC has with

> regard to breast implants?

>

> A. It depends on how you separate the documents,

> whether you use a single Bates stamp as meaning one

> document or whether you would take, for example, the

> let's take the beagle study, which may contain

> several hundred pages, as separate documents.

>

> Q. Let me ask a specific, Doctor. Isn't it a fact

> that you have not reviewed all existing documents

> from MEC relating to manufacturing and quality

> assurance, quality control, and other subjects?

>

> A. I have assumed so, because I've found that many

> of the documents currently in libraries are not the

> ones I remember when I was in the regulatory affairs

> business. In other words, I find the documents that

> I knew existed are not reproduced in the current

> libraries by MEC. Therefore, I accept your statement

> as being valid.

>

> Q. And would it be fair to say, Dr. Blais, when

> we're talking about the total universe of MEC

> documents relating to manufacturing and quality

> assurance, quality control, and other breast implant

> subjects, may exceed six million pages? P. Blais X

> 17-92 92

>

> A. Yes, but that's misleading, because the six

> million will contain detailed production data on

> individual batches. For example, to give you a more

> appropriate answer, MEC may have made some of in the

> order of 300,000 implants and maybe 7, 8 hundred

> batches. Each batch contains what we call a

> birthday, but these pages globally are not

> meaningful. They are only meaningful in what we call

> the law history for the implants that we are

> discussing. So the number appears disproportionately

> large.

>

> Q. Dr. Blais, whatever the number is, if, as you

> say, you have reviewed only 4 to 6 thousand MEC

> documents, how do you know that the other five and a

> half or the other six million or whatever the other

> number is are not relevant or not significant if you

> haven't seen them?

>

> A. I've not seen them. I assume there's other

> material there that would be valuable, but what I

> have reviewed has proven sufficient to form the

> opinions I've expressed.

>

> Q. I see.

>

> MR. GORE: Your Honor, would this be a convenient

> break?

>

> THE COURT: It is. Time for lunch, folks. P. Blais X

> 17-93 93 Leave your notes on your chairs, don't

> discuss the case among yourselves or with anyone

> else, and we'll see you back at 1:30.

>

> (The jury retired to the juryroom: 12:00 p.m.)

>

> THE COURT: Okay. Ms. Troutwine, what was the

>

> other question that you were going to ask Dr. Blais

> that we held until the lunch hour?

>

> MS. TROUTWINE: I can't remember.

>

> THE COURT: I can't, either.

>

> MS. TROUTWINE: Your Honor, we'll think about it on a

> full tummy.

>

> THE COURT: Well, that works for me. That was the

> magic word. Okay. We're in recess until 1:30.

>

> (Recess: 12:00 - 1:30 p.m.)

>

>

>

>

>

>

>