Subject: Shaw vs Bristol Myers Squibb (part2)

Subject: Shaw vs Bristol Myers Squibb (part2)

MR. GORE: May I be heard on that, Your Honor?

THE COURT: All right.

MR. GORE: Your Honor, you already ruled with regard to those remote 1981, 1978, whatever, and I'm not going to dredge that up again. Dr. Blais has testified all over the country that he's reviewed some 10,000 documents. He doesn't remember exactly what he reviewed. He doesn't keep track of it. He doesn't have any notes of it. I think it would be wholly improper for him to be able to sit there and say, "Gee, I remember somewhere I reviewed once from 1988." If he has it, I'd be happy to look at it, but to simply say "I remember something from 1988" would be terribly prejudicial and improper. I submit to the Court there is no such document.

THE COURT: He can look at documents, even though the Court has ruled them as inadmissible documents, as a basis for their opinion, but that has to P. Blais D 17-3232 be something that he can be fairly precise on. The Product Insert Data sheets as they apply to this particular product at the time it was installed are very relevant to the case. If you have somebody coming in testifying as to manufacturing, design principles, or methods of testing, or that sort of thing, and in preparation for their testimony they have looked at documents that this Court has ruled are not, in and of themselves, admissible, he can testify to that. It just has to be fairly precise.

MS. TROUTWINE: Yes, sir. I'd like to clear up something. The documents that we're talking about are not package inserts. They're documents that the salesmen used when they visited with the doctors and they made representations. These are documents that were put out in the public domain that people used to convince the medical community that these products had been adequately tested. And as I said, I have an original document. The date is 12/81, and Dr. Blais has a letter that he received it as late as 1982, only six years before her implants were made.

THE COURT: What's the document? Well, I can remember in the last case, I think P. Blais D 17-3333 I'm remembering the last case, I don't want to confuse them, there were some sales reports and things that we allowed in in the last case, simply because they were company documents that explained what they were. It wasn't just a document and then the allegation that these were what were given out. It was a document with a cover letter saying here's what it is and here's what it's for, written by the company. That gave us a perspective.

MS. TROUTWINE: Your Honor I'm handing you Exhb. 245, which is from the manager of regulatory affairs at Medical Engineering Corporation to Dr. Blais when he was with the Department of Health saying that enclosed is a catalog, and one of the items in that catalog THE COURT: Was a demonstrater heart valve?

MS. TROUTWINE: No. If you look at the top 17 paragraph.THE COURT: It says heart valves. Oh, yeah.MS. TROUTWINE: It's in answer to his question in his telephone request that he got a complete catalog, and that it was concerning the breast implants. THE COURT: Okay. Well, this is a letter from Betty Locke to Dr. Blais indicating that a catalog has been forwarded to him. If he can identify the catalog, that at least ties up the letter. P. Blais D 17-3434MS. TROUTWINE: He can identify he has brought the page from the catalog on mammary implants.

THE COURT: Okay.MS. TROUTWINE: And this is a true original from that catalog. And on the back page this document is dated 12/81, but as the letter I just showed you states, he received it later, closer in time to when Ms. Shaw got her implants. On the back page you'll see long term implant studies, and represents that materials used in Surgitek mammary implants have been subjected to implant evaluation in beagle dogs for periods up to seven years.

THE COURT: At that time. I mean, that statement is as of that time, right?

MS. TROUTWINE: Yes, sir.THE COURT: Mr. Gore?MR. GORE: May I see those two documents?

THE COURT: At first glance, it looks like they tie up.MR. GORE: Thank you, Your Honor. Your Honor, the document that you've been handed is dated 1981. It's precisely the document about which you previously ruled because it's so remote in time, it is 1981, there are none later here, certainly P. Blais D 173535 none that I'm aware of, and none that Ms. Troutwine has presented. Apparently it was sent out a few months later in 1982. We're still talking six years we're still talking eight years before the implantation of Mrs. Shaw's prosthesis. And I would also point out that Ms. Troutwine made an important distinction between the sales data sheets and the package inserts which go to the doctor. There isn't one shred of evidence, and there will not be any evidence, that this or anything like it got to or influenced in any way Dr. Wustrack. As a matter of fact, we were informed this morning that they're not even going to calling him as a witness. There is no reason to change the prior ruling and permit this into evidence, because it is so remote and never got to Dr. Wustrack just because it was sent out in 1981, eight years before the implantation.

MS. TROUTWINE: Your Honor, might I respond?

THE COURT: Is there a subsequent catalog that changes that statement?

MS. TROUTWINE: We have not found that they produced one oh, that changed it? No.

THE COURT: Well, eliminated it, I guess is what I'm saying.

MS. TROUTWINE: No, sir; did not retract it, P. Blais D 17-3636 did not change it, did not withdraw it.

MR. GORE: Are you saying it's in the subsequent catalogs?

MS. TROUTWINE: Do you have one?

MR. GORE: Of course not.

MS. TROUTWINE: We don't, either.

MR. GORE: Then you don't have the evidence. There is nothing in any subsequent catalog.

THE COURT: If this is a representation that MEC made back in '82 and it's a misrepresentation, it could be relevant and it could be admissible, unless, of course, it was changed prior to the manufacturer of the implants that are used in this case and prior to any information that Dr. Wustrack. I'm trying to figure out how that would apply.

MR. GORE: Your Honor

MS. TROUTWINE: Your Honor

THE COURT: Just a minute.

MR. GORE: Excuse me.

MS. TROUTWINE: This is evidence that these are representations being made to the governmental agencies responsible for supervising these products.

THE COURT: I understand that. But I'm trying to put it in a time frame.

MS. TROUTWINE: Yes, sir. P. Blais D 17-3737

THE COURT: A company that may have made a misstatement or lied outright some years prior on a product that's not involved in a case here, I'm trying to figure out how that makes the case here without it has to make the case here. There has to be something in here that makes it relevant to the case here. Otherwise, it doesn't pass the relevancy test. I don't have a problem on just the fact that this happened six years before. I don't have a problem on that at all. That's not my concern, but it's close enough in time. I'm just concerned about, "So what?" That's what you have to ask: "So what if that did occur? How does that affect this particular case?"

MS. TROUTWINE: Might I ask a few questions of this witness to help with a offer of proof.

THE COURT: Sure. You may.

BY-MS. TROUTWINE: (Continuing)

Q. All right. Dr. Blais, was the document marked as Plaintiffs' Exhb. 249, the original of which the judge is holding, intended to apply to all mammary products made by Medical Engineering Corporation?

A. The document title is "Mammary Implant Product Information." That is the applicability of the document, and that is the purpose for which it was presented. P. Blais D 17-3838

Q. Dr. Blais, in this case the plaintiff received bi-lumen implants, not SCL. Were bi-lumen implants made in 1988 and '89 that were not SCL the same in all material respects as bi-lumen implants being made in December 1981?

A. The implant in question is deemed to have been made unchanged since from 1976 through to its withdrawal in the late '80s. That was an assertion presented by the manufacturer in order to qualify its products for continuing Canadian sale.

Q. Dr. Blais, do you have an opinion of the responsibility of the pharmaceutical company to retract a statement, a representation, once it has been made if that representation is not correct? Do you have an opinion?

A. Yes.

Q. And will you tell the judge what your opinion is about the responsible I'm going to rephrase my question. Do you have an opinion about the responsibility of a reasonably prudent pharmaceutical manufacturer to retract a representation about long-term safety testing once an incorrect representation has been made?

A. Such retraction must take place, and it must also be made prominently so that it will be seen by P. Blais D 17-3939 individuals concerned with those issues.

Q. And can you tell the judge, practically speaking, why that is.

A. Because physicians have no time to read a continuously changing product insert. They read it once, and then they then see a subsequent printing which looks the same. They will not examine it in detail. They will assume what was true then is true today. Therefore, any major changes of this nature, the attention of the reader must brought out prominently.

MR. GORE: May I be heard, Your Honor?

THE COURT: All right.

MR. GORE: In that last answer, Dr. Blais slipped back into the product insert. That isn't what we're talking about here.

THE COURT: Right.

MR. GORE: What we're talking about is a data sheet. The fact is, Your Honor, not only that one, not only the ones prior, but all of the product data sheets were made available in the MDL document discovery. Plaintiffs' counsel had access to all of the subsequent product safety data sheets. Why is that the latest one that's been presented to the Court? Because it's the latest one in which that statement is made. I assure you if it was P. Blais D 17-4040 made in any subsequent ones, you would have it before you. You do not. It's their proof. This is so remote. I ask that the Court adhere to its prior ruling.

MS. TROUTWINE: Your Honor, these defendants are subject to a request for production, and if they have a later one where, in fact, it was retracted, we renew our request that they produce it.

MR. GORE: Your Honor, they've all been made available to them.

MS. TROUTWINE: Then give us the Bates number, Mr. Gore.

THE COURT: This kind of sounds like the last time around.

MS. TROUTWINE: I'm sorry. I heard that the last time around they did not exhibit the proper dignity for this Court.

THE COURT: Well, we had a little bit of a problem with that. We're better. Well, I don't know. It's right on the line for me, but as I read the sales sheet, it says, "Long-term Implant Studies in Dogs." And as you read the whole thing, which is the section apparently that plaintiff is interested in, it says, "Materials used in the Surgitek mammary implant have been subjected to implant evaluation in beagle dogs for a period of up to seven years. Test P. Blais D 17-4141 animals were given frequent physical examinations for determination of untoward results, such as carcinogenic reaction. Specific animals are sacrificed annually with complete histiopathic examination of the implant sites and implanted prosthesis and up to 24 body organs. Those materials implanted in dogs today have shown no adverse reaction to carcinogenic activity." When I first read this over, I couldn't be sure that they're talking about beagles kept alive for seven years or that they've done beagle studies for seven years, because they say there's you read it altogether, animals are sacrificed annually. So I guess there's probably even two ways to read that. The plaintiff reads it as

MS. TROUTWINE: The first sentence, "Materials used in mammary implants have been subjected to evaluation for periods of up to seven years in beagle dogs for periods up to seven years."

THE COURT: But you could read that as you did the studies for seven years, not that there was a seven-year old dog. I that's not my concern at the moment, I guess.

MS. TROUTWINE: In fact, defendants will have adequate opportunity to argue that to the jury in closing. P. Blais D 174242

MR. GORE: We can argue a lot of things on closing, but we shouldn't have to with regard to inadmissible evidence.

THE COURT: Well, I honestly don't think that this jury is going to make up their mind on a study of beagle dogs done 15 years ago or not done. It might have something to do with punitive damages issue. Well

MS. TROUTWINE: It certainly goes to the credibility of this party, also.

MR. GORE: Your Honor, I don't want to keep arguing, but I do think we have a relevancy situation.

THE COURT: Oh, it's strictly a relevancy situation, as I see it.

MR. GORE: That Dr. Wustrack ever heard of it, let alone saw it.

THE COURT: That's true, but that's not your issue. Your issue, as I understand it, Ms. Troutwine, is that the company itself is just not telling the truth on certain tests. Not whether Dr. Wustrack even knew about this, because apparently he didn't, unless you're going to bring him in and say, "Yes, I read this and knew about it at the time I recommended these things to Ms. Shaw."

But if he's not going to say that, then you're offering it for the company's alleged lack of testing and P. Blais D 17-4343 standards as it leads up to the ultimate implants put in Ms. Shaw. They're somewhat relevant in that the implants haven't changed very much, because they couldn't get them grandfathered in. Okay. Your objection is noted, Mr. Gore. I'll allow it in.

MS. TROUTWINE: Your Honor, I know of no other the only other matter that I know of that you have previously talked about, is last week we had an Exhb. 17, and it was a letter where we had been asking a witness about a line in the letter that said the most

MR. WILLIAMS: Paragraph 7 and 9 on page 3.

MS. TROUTWINE: Let me start over.

THE COURT: My note on 17 was the objection was based basically on relevancy and there were some indications that the letter needed to be redacted, and I indicated that I would revisit it if it was redacted.

MR. WILLIAMS: Judge, we have a problem with redacting a letter a few pages long because of the big deal Mr. Gore made in opening statement about us taking things out of context. It's in favor of the defendants that plaintiffs are selecting here and there and just picking little things and throwing them to the jury and claiming they mean something they don't. And when a jury gets a letter that they only see the title and page 3, a P. Blais D 174444 couple paragraphs from, it looks like Mr. Gore's right, that we're taking things out of context.

THE COURT: I can give the jury a curative instruction indicating that I have ruled that the entire letter contains information that is not relevant to this case, so we have redacted the letter they're not going to understand "redacted" reduced the letter. If you're that concerned about it, I don't have a problem telling the jury, because by the time they're done, they're going to have a lot of redacted documents. And they've already seen redacted and edited versions of video depositions. They already know how the case is running, and I can give you

MS. TROUTWINE: Your Honor, might I hand you Exhb. 17 and ask you to look at a couple of things here?

THE COURT: Sure.

MS. TROUTWINE: The first paragraph talked about chloroplatinic acid, which is a known neurotoxin and very dangerous. On page 2

THE COURT: Um-hmm.

MS. TROUTWINE: On page 2, paragraph 5-A states that our gel will not run or migrate through body tissue. And last week when we played Wilf Lynch, he was asked about this document and that paragraph, and that they had P. Blais D 17-4545 no evidence at all to make that statement. On page 3 and actually someplace else, I can't seem to lay my hands on right now they say that the only residual in the implant from the process is the chloroplatinic acid, which is such a dangerous neurotoxin. Then on page 3, you know, they admit to gel bleed. They admit they don't know what's in the gel bleed and that they ought to study it, and then that sentence that the plaintiffs have pointed out, which is that the real interesting question is where does gel bleed go. And it's signed by the president of the company. So the entire document is very pertinent, and I was going to lay that foundation with this witness and go through various paragraphs so that we might have the whole document into evidence.

THE COURT: This is not a rupture case. That's one thing I note. And that statement on page 2-5-A says our gel is noted for its consistency, and when a gel is ruptured, the gel will not run or migrate through the body tissues. That clearly is not an issue in this case.

MS. TROUTWINE: However, you have already P. Blais D 17-4646 allowed that evidence with Mr. Lynch.

THE COURT: Well

MS. TROUTWINE: Here's another one, item 4, that there are 50 to 60 thousand of mammary implants sold in the United States and Canada a year. And with the other world markets, it adds another 20 to 25 thousand, and that's relevant to this case.

THE COURT: From 1977.

MS. TROUTWINE: Yes. As of that period of time.

THE COURT: It's an estimate. Mr. Gore?

MR. GORE: Well, Your Honor, we could spend all morning talking about parts of this letter. I think the Court's ruling is proper. It should be redacted, it should be redacted as suggested the other day. As you pointed out, there are going to be a lot of those in this case. There are many of these things, include chloroplatinic acid.

THE COURT: Whether it's a jury instruction or a document, Oregon law has been pretty consistent, Ms. Troutwine. If there are items in there that are admissible or not proper, it renders the entire jury instruction or document inadmissible. It's that simple. There are clearly things in this letter that are not P. Blais D 17-4747 admissible in this case. If you can redact it down to those items that are directly admissible in this case or directly relevant to this case, I'll certainly consider letting it in. But there's no question that there's a lot of information in this document that should not come into this case. It's misleading, confusing to the jury, and doesn't have anything to do with the case. If you want the whole document in, it's out.

MS. TROUTWINE: Your Honor, what I would like to do with your permission is to ask this witness about paragraph 1, the chloroplatinic acid and the number of sales. And I will move for admission ahead of time right now, and understand that you have taken that under advisement until such time as the plaintiffs are able to redact from this document and re-present it again another morning. Would that be all right?

(Plaintiffs' EXB. 17 offered)

THE COURT: Sure. Let's have the offer of proof and see what you're going to ask, so that we don't have to send the jury out again.

MS. TROUTWINE: All right.

THE COURT: Do you have a copy of the document, Blais? P. Blais D 17-4848

THE WITNESS: My apologies. I do not.

THE COURT: (Handing document to witness.)

THE WITNESS: Thank you, sir.

THE COURT: Okay.

BY-MS. TROUTWINE: (Continuing)

Q. Directing your attention to paragraph 1 of Exhb. 17, do you know the propensities of chloroplatinic acid?

A. Yes.

Q. And is chloroplatinic acid a neurotoxin?

A. Yes.

Q. And can you tell the judge, please, what is a neurotoxin? Is that an element that has an adverse impact on the neurological system?

MR. GORE: Objection for lack of qualification.

THE COURT: Okay. Well, you can keep going. The jury's not here. You're making your complete offer of proof. He's made an objection for lack of qualification.

BY-MS. TROUTWINE: (Continuing)

Q. All right. And I direct your I'm sorry. We didn't finish that. P. Blais D 17-4949 Can you tell the judge about chloroplatinic acid in about 20 words or less.

THE COURT: Well, excuse me. If you're going to qualify him to tell me about that acid and his background and how he knows it and how it relates, you probably can't do it in 20 words if you've got an objection on the table.

MS. TROUTWINE: I see.

BY-MS. TROUTWINE: (Continuing)

Q. Can you please describe for the judge what it is about your background that you came in to work or have knowledge about chloroplatinic acid.

A. As a basic chemist, a bench chemist, I am forewarned regarding the hazardous properties of these compounds, as a practicing laboratory specialist, and I would be forced to convey this warning to anyone who worked for me with the same compound.

Q. And when you were with the Canadian FDA, did you have occasion to work with pharmaceuticals that used chloroplatinic acids in minute particles?

A. I'm aware of such compounds, yes, and I did work with them.

Q. Yes. And are you familiar with the hazards of chloroplatinic acid? P. Blais D 17-5050

A. I am. I have read the literature on the topics and I have seen its effects.

Q. And can you describe for the judge what those hazards are.

MR. GORE: May I have a continuing objection, Your Honor?

THE COURT: Yes, you may.

MR. GORE: Thank you.

A. The literature on chloroplatinates, chloroplatinic derivatives, forewarns of neurotoxic potential damage to the ability of nerves to conduct or to convey information for strictly chemical reasons at low dose and at high dose.

Q. And are you familiar with Medical Engineering Corporation's use of chloroplatinic acid in the manufacture of breast implants?

A. Yes.

Q. And in Exhb. 17, does the president of Medical Engineering Corporation admit to the use of chloroplatinic acid as a catalyst in the manufacture of Medical Engineering Corporation's breast implants?

A. Yes.

Q. And can you explain to the judge how that is used as a catalyst.

A. With your permission, I have to correct an P. Blais D 17-5151 error in the document. Paragraph 1 refers to chloroplatinic acid. Chloroplatinic acid is not the actual compound used in this, nor is it metallic platinum. It's a reaction product which is regarded as an organometallic with far greater toxicity than the stated chloroplatinic acid.

Q. In the event it was chloroplatinic acid, as admitted in this document, that would that have risk?

A. Yes. It had risk of its own or less than the actual form used.

Q. Okay. Directing your attention to paragraph 4 on the second page, which states that the president of the company estimates 50 to 60 thousand pairs of mammary implants were sold in the United States and Canada per year, in your work with the Canadian FDA, based on your study of the documents, do you have an opinion whether that, in fact, is true? Roughly.

A. I don't know. At the time the company represented that they were selling much less than that, I believe the figures stated here are slightly inflated.

Q. Directing your attention to page 3 of Exhb. 17, and particularly paragraph 9, do you agree with the statement that the interesting question is what does migrating silicone do to tissue? P. Blais D 17-5252

A. I apologize. I've lost the exact location.

Q. Paragraph No. 9, page 3, the next to the last sentence.

A. (Pause - referring.) I read it for the record: "Of course, the real interesting question is what does any migrating silicone do to the tissue?" I agree it's particularly interesting, but it was known at the time.

Q. And how was it known at the time? Where was that knowledge?

A. Because much purer forms of silicone oils, without adulterants, had been tested for direct injection with publicly known adverse reactions. And I believe legislative action forbidding the practice was enacted in at least one state.

Q. And is Exhb. 17 the kind of document you would read and look to in forming an opinion on the safety of breast implants?

A. It would be taken into consideration in particular if it was addressed to a practicing clinician seeking advice and guidance for his practice.

Q. As, in fact, it is, correct?

A. That's correct.

Q. And would this document form the basis of an opinion about whether the breast implants that Lori Shaw P. Blais D 17-5353 received were unreasonably dangerous and defective?

A. It would seem that the document minimizes the risks grossly and unjustifiably, at least in the eyes of practicing physician.

Q. And, in fact, is that part of the risks of the breast implant that people were not aware of the full truth?

A. At the time I investigated the area, it was worse. There were attempts to hide the areas of risk that prevailed for many years until the late '80s.

Q. Okay. But, Dr. Blais, my question to you was, would this document be one of the factors on which you would base your expert opinion on whether the implants Lori Shaw received were defective and unreasonably dangerous?

A. In part, yes.

MR. GORE: Your Honor, may I inquire briefly?

THE COURT: Certainly.

BY-MR. GORE: (Continuing)

Q. Dr. Blais, you just said this would be misleading to a practicing physician. You are not a physician, are you?

A. No.

Q. What's Cisplatin? P. Blais D 17-5454

A. Cisplatin is an antitumor drug, which means simply a particular structural form of a molecule which contains platinum at the center. The term "Cisplatinum" (phonetic) has no meaning in either chemistry or lay language. It is simply a convenience.

Q. Perhaps you misheard. I didn't ask about Cisplatinum. I asked about Cisplatin.

A. Cisplatin is I believe it is proposed for prosthetic cancer. It is a drug that comes with the same instructions for use. It is referenced in the physicians' manual.

Q. Is Cisplatin chloroplatinic acid?

A. No. It is an organic derivative based on Cisplatinum. It is an organometallic, or at least an aminated compound derived from Cisplatinum.

Q. So it's clear to you that Cisplatin is not chloroplatinic acid?

A. Cisplatin is a trade name.

Q. My question is, Dr. Blais, is Cisplatin chloroplatinic acid? "Yes" or "no."

A No.

Q. And Cisplatin is the antitumor drug that is warned about to be neurotoxic, correct?

A. All compounds bearing the same structural relationship are neurotoxic. Cisplatin, the trade name P. Blais D 17-5555 and also its generics, contain advisory cautions for users that relate to neurotoxicity.

Q. Is chloroplatinic acid platinum?

A. No. It is a compound of

Q. There is a difference between platinum and chloroplatinic acid, is there not?

A. Of course. Platinum is a metal, shiny metal suitable for jewelry.

Q. And the catalyst used in making MEC's breast implants is platinum, is it not?

A. It is not.

Q. It is not? What is it?

A. It's a molecule that resembles the generic Cisplatin, with an added molecule which renders it even more soluble in fatty tissue. Think of it, if you wish, as a super cisplatinum.

Q. Is it your opinion that the catalyst used in making MEC's is chloroplatinic acid?

A. It is not.

MR. GORE: All right. Your Honor, if I may address this letter now?

THE COURT: All right.

MR. GORE: I'll take it in reverse order. The one part in paragraph 9 is already in that sentence. I don't have any problem with that. It's already in, that P. Blais D 17-5656 it would be an interesting question.

THE COURT: Right.

MR. GORE: The part about paragraph 4, about the sales, I don't know however in the world the sales in 1977 is relevant when we're talking about what was made in 1988, 1989, and inserted in 1990. So I think it's totally irrelevant and terribly remote. But, thirdly, with regard to the first paragraph about chloroplatinic acid, it says, "platinum such as chloroplatinic acid." It is not chloroplatinic acid, and Dr. Blais has just testified that the catalyst is not chloroplatinic acid. The first paragraph should not come in, Your Honor.

THE COURT: Well, I'll tell you this: The jury wouldn't have followed any of this.

MS. TROUTWINE: Your Honor, as I have stated offered before, plaintiffs will go through the letter, redact what based on the statements you have made about your response to this letter, we will redact what we feel, in fairness, should be redacted based on what you've had to say. I

THE COURT: You did talk about chloroplatinic acid, but if that's not a part of what's done here, I assume you're not going to talk about it now that you know that. P. Blais D 17-5757

MS. TROUTWINE: Well, since that's his testimony, I can't.

THE COURT: All right. So that won't be an issue. I don't know, as far as the sales figures, I'm not sure of the relevancy, particularly since Dr. Blais says he doesn't really agree with those estimates. Are you going to

MS. TROUTWINE: No.

THE COURT: So that's not going to be an issue at least as to this document. Okay. I think we're okay.

MS. TROUTWINE: And I have no other exhibits which, you know, might cause a problem that I know of.

THE COURT: Well, I have allowed 245 and 249 to be received. 245 is the letter to Dr. Blais from Betty Locke-Wiles (phonetic), but we referred to her as Betty Locke. And 249 is apparently the sales sheet, but I don't have it marked that way. I have the original, apparently.

MS. TROUTWINE: Your Honor, I ask that this witness be allowed to keep the original.

THE COURT: That's fine.

MS. TROUTWINE: And here's your copy.

THE COURT: And as far as the P. Blais D 17-5858

(Plaintiffs' EXBS. 245 and 249 offered and received)

THE COURT: Exhb. 17, it's not admitted, because there's so much in it in its present configuration that is not admissible. But if it's appropriately redacted, we can take a look at it later and reconsider it. But in the meantime, Dr. Blais, to the extent that we have covered this this morning, you can refer to a line or two in the document, but the document itself is not in. Okay. We'll take it up to lunchtime, then. Tell the jurors, Cindy, if you will, we'll take up it to lunch, so they need to be pretardy to sit for an hour. Do you folks need a couple minutes? Five-minute recess.

(Recess: 11:00 - 11:05 a.m.)

THE COURT: Okay. Let's go get the jury.

(The jury returned to the courtroom: 11:08 a.m.)

THE COURT: Okay. Folks, as I told you before, we sometimes have these little interruptions to determine what direction we're going and seeing what's relevant and what isn't to the issues in this particular case. That's something that I always have to do. It's not what is interesting or what one side or the other may or may not P. Blais D 17-5959 feel is appropriate. It's when I have to make the call and make sure we stay on track. That's what we've been working on. It's perfectly routine. Don't take anything by it. You may continue, Ms. Troutwine.

MS. TROUTWINE: Thank you, sir.

BY-MS. TROUTWINE: (Continuing)

Q. Dr. Blais, during the years you were with the Canadian FDA, was it your job to make a decision whether a pharmaceutical product was safe to go inside the human body?

A. I had to make many decisions on many products, but not pharmaceuticals at such. My job was with medical devices.

Q. Okay. And a breast implant was considered a medical device?

A. That is so.

Q. All right. And in the course of your job, did you have occasion to talk to the president of Medical Engineering Corporation and request information from them?

A. I did so officially through communications through the regulatory affairs specialist, and I believe I spoke to several of their executives, including the P. Blais D 17-6060 last serving president.

Q. Okay. And I'm going to hand you Plaintiffs' Exhb. 245 and 249. And can you tell the jury what is Exhb. 245.

A. Exhb. 245 is a response of the regulatory affairs specialist, with a copy to their president Dr. I believe it's Mr. David H. Sanders. It's in response to my request for information and promotional material on their products.

To be continued in part 3