Blais3...being an expert witness? (long but interesting)

[Guest guest]

--- Lea <devans@...> wrote:

> < >

> From: " Lea " <devans@...>

> Date: Tue, 25 Oct 2005 12:07:05 -0600

> Subject: Re: Blais3...being an

> expert witness?

>

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

part 1and 2, I wonder if she won her

case....love...Lea

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

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.)