THE COURT: Okay. Good morning, folks. We're back on the record in the case of Shaw versus Bristol-Myers and Medical Engineering Corporation, 9312-08347. I've just been handed a stack of information that I could spend the rest of the morning reading. Is that what the parties wanted me to do? I can't read it now. It's plaintiffs' motion to compel cross-examination and defendants' motion in limine to limit the scope of a Dr. Pierre Blais. And is it the desire of the parties that I take the morning off and read this? Because I certainly haven't read it now, and I can't do it in a few minutes.

MR. GORE: Your Honor, if I may briefly. We were informed late Friday for the first time that Dr. Blais would be testifying today, and that is why we just have the motion here this morning.

THE COURT: Okay.

MR. GORE: We are not asking the Court to preclude him from testifying. We are asking him to be limited he's a Ph.D. in chemistry to limit him to 17-4 4 testimony in his fields for a variety of reasons set forth in our papers, based upon the prior testimony of this particular witness. I don't know that it is really necessary for the Court to review those prior to his going forward with testifying. So I think we could proceed this morning.

THE COURT: Okay. Well, we always try and limit the experts to the field in which they show some expertise, either by training or education or lifelong experience. That's kind of what we try and do.

MR. WILLIAMS: We don't have any plans to ask Dr. Blais causation questions about this plaintiff. He was in the Canadian regulatory authority. He was in charge of product safety for the Canadian equivalent of the FDA. He's very familiar with the breast implant companies, especially with MEC. And that's his area of expertise, biomaterials and regulation and products safety, and that's what we intend to ask him about. He's not going to comment on any individual causation question at all.

THE COURT: Okay.

MR. WILLIAMS: The motion we filed, Your Honor, is an attempt to get an opportunity to cross-examine the author of the ACR board statement, Dr. John Sargent, and what's attached to the motion are some primarily an 17 5 5 excerpt of his testimony before a federal judge in Reno on a Daubert hearing in December, where he testified that he was an expert not only for 3M since 1994, but also for Bristol-Myers at least one case. And since he is the author of the statement, we would like the opportunity before we have to rest our case sometime next week to take a short deposition of him where we can cross-examine him about that statement, since the statement has come into evidence. We can have other lawyers do that wherever he may be. He's based in Nashville, as I understand it.

MR. GORE: May I respond very briefly, Your Honor?

THE COURT: All right, Mr. Gore.

MR. GORE: Number one, the ACR statement is not in evidence. The Court ruled it is not in evidence. Number two, with regard to the ACR statement, Mr. Williams opened the door in opening statement and on direct examination of one of his witnesses and, therefore, it was used, parts of it, as ordered by the Court. Number three, I don't know who Dr. Sargent is, I have no control over him. If he's in Tennessee somewhere he's not an employee of the defendants.

THE COURT: Well, if you can find me some of 17-6 6 those statements that you indicate were made on opening statements and in direct examination of another witness through the transcript or something, that will be helpful.

MR. GORE: We'll do, Your Honor.

THE COURT: I'm not going to rely on my memory.

MR. WILLIAMS: Your Honor

THE COURT: Just helpful.

MR. WILLIAMS: It's true I mentioned it, but only after a vigorous motion in limine to keep it out.

THE COURT: I understand.

MR. WILLIAMS: I also mentioned it on Dr. Silverman, but again not until after I had renewed our motion in limine to keep it out.

THE COURT: I understand. And let me review one other thing. We had some difficulty with a lay witness in the questions that were asked Friday, and I know we're going to probably have a few other lay witnesses testify again. I couldn't understand why we were having a problem because we've not had the problem before in other cases, but it just dawned on me that the questions had been formed differently and that's why we were running into a problem. A lay witness can testify to anything that is relevant as part of a present state of mind condition, 17 7 7 but when questions are asked of a lay witness that say, "What did plaintiff say about her general state of health" or "How was plaintiff feeling," those are clearly inadmissible, because there's no way of telling whether or not they're really an 803(3) question. But if the question is asked, as they have been in the other cases, based on the pleadings did plaintiff ever complain of chronic fatigue; if yes, when, where, under what circumstances. Did the plaintiff ever complain of headaches; yes, when, where and under what circumstances those are appropriate, because they ask the question directly under the exception, but when the general question is the state of health, it's a hearsay calling for a hearsay statement in general without me knowing from the question that the exception is being gleaned at. And in terms of physical observation, that's fine, too. But that's not a hearsay issue. It's how did you observe plaintiff before, after, that sort of thing; what physical characteristics did you notice, as opposed to general state of health, would call for hearsay as being rather nonspecific, calling for speculation on the part of the witness. I think as we go through it again with lay witnesses hopefully we won't have a problem. Anything else we need to take up before we 17 8 8 start or before we get the jurors?

MR. GORE: Just a housekeeping matter. Because at the end of the day on Friday we did not have the opportunity to cross-examines Mrs. Cammie Shaw, we would advise the Court and counsel that we will not need to cross-examine and will not require her to return.

THE COURT: Thank you.

MR. WILLIAMS: Thank you.

THE COURT: Do you want me to advise the jury of that, or Mr. Gore, do you want to advise it, or just not mention it?

MR. GORE: I think just not mentioning it, Your Honor.

THE COURT: All right.

THE COURT: Good morning, folks. It looks like you all got here by dog sled or what.Okay. We're continuing, of course. The plaintiff is in the presentation of their case. And your next witness?

MS. TROUTWINE: Plaintiffs called Dr. Pierre Blais.

THE CLERK: Be seated. Please state your name and spell your last name for the report.

THE WITNESS: Pierre, middle initial J.B., Blais. B-L-A-I-S.

THE CLERK: Thank you.

THE WITNESS: Thank you.

MR. GORE: Objection, Your Honor. There's no evidence that Bristol-Myers ever manufactured breast implants.

THE COURT: Okay. Do you want to back up and see if this witness knows that?

BY-MS. TROUTWINE: (Continuing)

THE COURT: He can continue.

BY-MS. TROUTWINE: (Continuing)

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

THE COURT: All right.

MS. TROUTWINE: I want this on the record. (The following bench conference was held P. Blais D 17-2222 outside the hearing of the jury:)

MR. GORE: What we're talking about here is subsequent to the Court's ruling that the FDA can't come in. It's Congressional and shouldn't come in.

MS. TROUTWINE: Your Honor, I have

THE COURT: Subsequent is not allowable.

MS. TROUTWINE: Your Honor, I have some law. (The following proceedings were held within the hearing of the jury:)

THE COURT: Okay. Folks, it's going to be a discussion. Sorry for the inconvenience, but if you'll leave your notes on your chair, we'll get back to you as soon as we can.

THE COURT: Okay. Ms. Troutwine, apparently you wish to make an offer of proof? You may do so.

MS. TROUTWINE: I do, sir. Thank you. Let me lay a foundation with a couple of more questions about this, and then I would like to tell you about some research that I was able to do on this particular subject.

BY-MS. TROUTWINE: (Continuing)

THE COURT: That's what I have.

THE WITNESS: Perhaps you could point out

MS. TROUTWINE: '92.

THE COURT: It was printed in '93.

THE COURT: Go ahead. Finish.

MS. TROUTWINE: Yes, sir. I also want to state that the prior rule, Oregon Evidence Code Rule 803(8), the legislative comments about this stated that, "The legislative assembly intends that this paragraph not provide a sweeping exception for public records. Factual findings are to be strictly construed to allow evidence on those reports." And that's the information I have for you. Other District of Kansas, and I can give you these citations allowed FDA records concerning a pacemaker. The Ninth Circuit allowed findings by the Federal Aviation Administration. The Fourth Circuit allowed findings from the Federal Center for Disease Control in the toxic-shock case. Maybe Mr. Gore was even involved in that. In the case of Roth v. Black & Decker, the Eighth Circuit allowed excerpts from the report of the P. Blais D 17-2626 United States Consumer Products Safety Commission. In another case, Kehm v. Proctor & Gamble, the Eighth Circuit also allowed the Center for Disease Control findings to come in on tampon cases. Again, Your Honor, last week I had stated to you that the plaintiff, a single individual woman with limited means, has not been able to play on the same field as this mighty pharmaceutical company that is the defendant, and instead, the United States Government has conducted investigations. And it's highly prejudicial to the plaintiff if these investigations cannot come in. This investigation was being conducted by its own terms not by the testimony of Dr. Blais, but by its own terms, it says when it was published in December 1992, it was the result of a three-year investigation. And so this investigation was going on at the time that Mrs. Shaw received her implants. Mrs. Shaw was not told by these manufacturers, "By the way, do you know that we're currently being investigated by Congress, and that the FDA is currently considering a moratorium on our product if we're not able to prove safety and efficacy?" And so at this time we would move for admission of Plaintiffs' 206. (Plaintiffs' EXB. 206 offered)

MR. GORE: First of all, I think it's important P. Blais D 17-2727 that we note what we're talking about here. We're not talking about an order of or findings of the Consumer Products Safety Commission or any other commission. We're talking about a congressional staff report; not findings of fact, not any order. A staff report from a committee headed by Congressman Conyers, who is well-known to be almost as much of a zealot on these issues as Dr. Blais. More importantly, Your Honor, to prevent exactly what is going on in this court this morning, we filed a motion in limine with regard to collateral actions and subsequent matters. Your Honor ruled that the FDA action and other collateral subsequent matters cannot come into evidence. This is clearly subsequent, it is clearly collateral. It is wholly improper. And although I'm not going to move for a mistrial, that in light of our motion in limine, it's wholly improper for Ms. Troutwine to have even pursued this line of questioning in the presence of jury to taint the jury. They know what we're talking about right now, and they shouldn't, because the Court already ruled that this stays out. I request that the Court adhere to its prior ruling, keep it out, and stop any line of questioning along these lines. P. Blais D 172828

MS. TROUTWINE: Your Honor, plaintiffs will be filing additional offers of proof about the FDA and the FDA finding. And we are going to be having people here who worked closely with the FDA and will be able to testify about that. And we believe we'll be able to persuade you that the evidence law is such that this information should come into evidence. So long as these defendants have continued to represent to this jury that the product was safe, then we should be allowed to present additional evidence of the findings and the investigations of government agencies.

MR. GORE: Your Honor, if I may very briefly, I think Ms. Troutwine and Mr. Williams have an absolute right on behalf of their clients to submit whatever they want to to the Court, but I submit that once the Court has ruled, these matters should not be addressed in the presence of the jury.

THE COURT: I agree. They are more appropriate for offers of proof at the outset, as opposed to bringing them up in the middle of the case. But that's one issue. I'm looking at this as not being an FDA document, of course. It's a staff committee report prepared by the Human by the staff of the Human Resources Intergovernmental Relations Subcommittee of the Committee on Government Operations. It appears at just a P. Blais D 17-2929 glance it is critical of the FDA. It's not a report that makes a statement or carries out an operation, unlike an Oberg. If I can recall Oberg, that was a recall directive prior to the incident are admissible. That's a factual statement placing somebody on notice. This appears to be less than that. And the foreword by the chairman, John Conyers, says that at the last paragraph, "The findings and conclusions contained in this report are those of the staff. They do not necessarily reflect the views of the members of the Committee on Governmental Operations, much less the view of Congress." And so these are this is an acknowledgement that there are findings and conclusions that even the committee doesn't necessarily hold, much less the Congress necessarily hold. And these are this is a appears to be a report directed at the FDA's inadequacy, or alleged inadequacy of following up on studies in this area. I don't think under any circumstances, as I read this and look at some general conclusions of various other companies, of various testing of other companies that are not at issue in this case at all, various devices that are not at issue in this case at all, under any circumstances this would be admissible, P. Blais D 173030 Ms. Troutwine. You'll never be able to persuade me. This would be a clear reversible error. It's not in that section of judicial discretion. It clearly could not come in under any Oregon law that I'm aware of in this form. So your motion to have 206 entered into evidence is denied. Now, do we have anything else coming up that we need to talk about before we bring the jury in here? Another report or something?

MS. TROUTWINE: Your Honor, you have previously ruled on the admission of biocompatibility data sheets dated early in the mid '70s, the late '70s, and as late as 1981. For plaintiffs, who have filed a claim for fraud, those biocompatibility data sheets are very important inasmuch as there are misrepresentations contained in them, and you have previously said they were too remote. This witness has received as recently as 1982 a biocompatibility data sheet representing that there were sevenyear dog studies and had personal knowledge that as late as 1988 and maybe later that this company these defendants continued to make the representation that they had conducted seven year dog studies that showed no untoward results, which, in fact, our evidence proves isP. Blais D 17-3131 a fraudulent misrepresentation. And we're going to be able to tie that up in time. This witness will also be able to express an opinion about the duty of a company to retract such a statement once it puts it out there in the public domain. And so that is a matter that we intend to introduce, or, rather, move for admission into evidence.