In this February 1994 jury trial against the implant manufacturer, Gladys Laas was awarded $5.2 million in compensatory damages. Her husband was awarded $1 million for loss of consortium. Dow Corning was liable for 80% of the verdict. Dow Chemical was liable for the remaining 20%.
The jury found Dow Corning guilty of misrepresentation and engaging in a false, misleading or deceptive act or practice that was a producing cause of the plaintiff's injuries.
The finding against Dow Chemical was on the count of aiding and abetting. This was later overturned and Dow Corning assumed 100% of the liability.
GLADYS J. LAAS, ET AL VS. DOW CORNING CORPORATION, ET AL
CAUSE NO. 93-04266
IN THE DISTRICT COURT OF HARRIS COUNTY, TEXAS
157TH JUDICIAL DISTRICT
CAUSE NO. 94-19485
JENNIFER H. LADNER VS. DOW CORNING CORPORATION, ET AL
IN THE DISTRICT COURT OF HARRIS COUNTY, TEXAS
157TH JUDICIAL DISTRICT
FEBRUARY 1, 1995
For the Plaintiffs:
MITHOFF & JACKS
One Allen Center Penthouse
Houston, Texas 77002
O'QUINN, KERENSKY, MCANINCH & LAMINACK
2300 Lyric Centre Bldg.
Houston, Texas 77002
WILLIAMS, BLIZZARD & McCARTHY
440 Louisiana, Suite 1710
Houston, Texas 77002
For the Defendants:
BAKER & BOTTS
300 One Shell Plaza
Houston, TX 77002
McFALL, SHERWOOD & SHEEHY
909 Fannin, Suite 2500
Houston, TX 77010
KIRKLAND & ELLIS
200 East Randolph Drive
Darrell M. Grams
WISE & MARSAC
11th Floor Buhl Building
Detroit, Michigan 48226
BE IT REMEMBERED that upon this the 1st day of February, 1995, A.D., the above entitled and numbered cause came on for hearing before the Honorable Michael H. Schneider, Judge of the 157th District Court of Harris County, Texas; and the following proceedin
gs were had, viz:
MR. BERNICK: I think I'm finally ready here, Your Honor. May I proceed?
THE COURT: Thank you for your argument, sir. And you may start your argument.
MR. BERNICK: Thank you. Good afternoon. I'm going to talk to you about three things this afternoon. Two of them are going to be familiar.
One is what science says today; No. 2 is history -- what happened during the course of the years when we were in this business, what do we say, what do we do and why -- and lastly I'm going to put down here something that's a little bit cryptic here, and
I'm going to call it invitations.
What do I mean?
These first two items are evidence in this case. You have heard about the science, and you've heard about the history. That last item ought to have a line kind of drawn above it, because it's not the evidence in the case.
The invitations are arguments that you have heard, questions that have been raised, suggestions or indications that have been made that in our view lead you away from the evidence. Indeed, they're designed to lead you away from the evidence.
And before I stop talking this afternoon, I've got a list of those invitations. And they're so interesting and they're so attractive, I'm not going to tell you what th
e list is. I'm going to save it. I've got them written down right here on the board.
But you heard one of them this morning. And it was so new and it was so remarkable, I haven't put it down yet. You heard the statement made by counsel for the Plaintiffs; and the statement ran, "This case is about ethics, not the science and not the che
Do you remember that? It was a part of a discussion about ethical responsibility and how a company should behave ethically. That statement is a wrong statement. This case is about ethics. Ethics is a part of our responsibility. That's part of our history and our obligation.
But this case is also about science. It's shot so through with science, you can't even examine the ethical issue without bumping up against the science. If you judge, "Did somebody behave right or did they do wrong? Did they act intentionally? Did th
ey act with conscious indifference and they're a scientist"--how can you begin to judge their ethics until you understand a little bit about what they were doing from a scientific point of view?
This case is about ethics, and it's about science. And that statement was an invitation to you. It was an invitation that said, "We want you to just focus on the history, you, the jury, because the science is not quite that important."
That's an invitation. Resist that invitation. Judge us by the history, look at our ethics and our conduct; but by God, take a look at the science as part of the context in which we acted and as addressing the f
undamental issues that we face not only here in this courtroom but we face as part of the broader issue about whether this product caused harm to people.
And that brings me to talking about the science. Why is science today so important? The reason that science today is so important is that it addresses the central issue. Do breast implants cause disease generally and with respect to these two women in
That issue is so central that as you look through your charge, you'll see that there is not a single question that you will be asked that doesn't get into precisely that question.
Take a look at Question No. 1, "Was there a design defect or any marketing defect or any manufacturing defect," et cetera, et cetera, et cetera, "that was a producing cause of any illness or injury to Gladys Laas or Jennifer Ladner?" Causation is part of
Question No. 2, "Was there a misrepresentation regarding the implants that was a producing cause of any illness or injury?"
And if you take a look and see, you'll see that all of the questions that are posed to you, each and every single one of them, bumps up against the issue of, "Is there a relationship between these implants and these diseases?"
You will see that all claims are affected by this issue and the science that addresses it.It's not an excuse. It's shot through as part of the law in this case, the law that comes from the Court.
There's a third reason why science today is so important. Not only is it part of the law and part of the su
bstance of the case, it's also a guide. And what I mean by that, it's something for you. You've sat through weeks of testimony, weeks of evidence. You've heard from a lot of different people about a lot of different things.
Science gives you a measuring stick, a standard against which to judge people and to judge what they say.
Why? Science has got rules. Science is a discipline. Science is a process.
Those rules are not political. Those rules are not emotional. Those rules are not driven by an
y individual among us. They're not different rules for Baylor, for Harvard, for the University of Michigan. They're not different rules for anybody.
They are the rules of science. They are the rules of a process that's designed to find truth on issues like this central issue. They give you objectively and they give you reliability, just the kinds of things that you all must be focused on as you sit
here and shift through the evidence.
Does that mean that you have got to become a scientist? No. Nobody expects that. You're here because of your common sense and your common experience.
But you all have had the opportunity -- as you agreed to do in this courtroom several weeks ago, you've had the opportunity to see the scientists on the stand, every single one of them, and to ask of them in your own minds, "Are they telling me about the
rules and requirements of standards that apply to their work? Are they telling me about that, and are they following them?"
And if you will go back and take a look not
about where somebody has his office, not about what city somebody happens to be from but about whether they told you about the rules and they told you how they complied or failed to comply with the rules of science, you will have a tremendous powerful guid
e for judging the evidence that relates to all aspects of this case.
It's a standard that's unwavering. It's a standard that's reliable. Will you be able to understand all of it? No. None of us understands all of it. The scientists don't understand all of it, as you saw from cross-examination.
But we all aspire to achieve that, because in the process of aspiring to achieve it, we grasp the truth in these matters.
What about history? History focuses on conduct. All the issues pertain to conduct. And you'll see that the instructions that you have here give a range of different ways to look at conduct. There is an instruction that deals with negligence. What's negligence? Lack of ordinary care. That's what negligence is.
But there are claims and there are issues that are much more severe than that and are very important. There are claims and there are issues that go to things like gross negligence.
The gross negligence instruction looks something like this. It looks exactly like this, in fact. "Gross negligence means more than momentary thoughtlessness, inadvertence or error of judgment. It means such an entire want of care as to establish that t
he act or omission in question was the result of actual"--not supposed or possible or maybe-- "actual conscious indifference," knowing that you are being indifferent.That's the claim. That's the issue that you face when it comes to gross negligence.Then there are claims of fraud. We knew, it is claimed; we understood, it is claimed; we intended, it is claimed, to tell somebody something that was wrong and had them rely on it. So you've got a broad spectrum going to more and more severe types of allegations. These claims here or these issues or this evidence of science today affects all claims.Why is this evidence of history being offered? It's being offered in part because the Plaintiffs here are pursuing enhanced damages. How do you go about judging something like that? Well, the science is part of it. Lois Duel is a scientist. This company acted through scientists. There's no such thing as a company having an actual conscious indifference. The company acts through people, through the employees. You've heard from Ms. Duel. She's one of those employees. You've heard from Bill Boley, an
other employee; Paul Klykken, another employee; Sue Peters, another employee. All of these people are the people that you're talking about when you think about, "What is it that they knew and what is it that they did?" And that brings us to the most difficult part of the case and one that we're expecting, indeed anticipating, that you will address. You are sitting in judgment on individual people working as part of an organization for what they thought and what they said and what they did over a thirty-year period of time.It's a very difficult process in the technical area. We --Lois, the people who testifies, me on behalf of my client-- have confidence that you will do your absolute best to do that right.
We're not afraid of it. We're prepared for it. We accept responsibility for what we did in each and every aspect. Each document, each act is before you for you to render your judgment.
Let me go through science today. I have prepared a series of charts, which, as you can see, I always like to do. It helps me stay organized.
Science today. "Do breast implants cause disease" has several steps.
Let me turn this off for a moment.
The first one is bleed. Do implants bleed? What do they bleed? How much do they bleed over what period of time? Do they rupture? When do they rupture? Why do they rupture? As a result of these phenomena, is there migration? Does the material move
throughout the body? Where and when does it move? When it moves and when it comes to rest, does it cause immune disease generally?
That's the big one right there. Does it cause a problem? And what about Dr. Ladner and Mrs. Laas? Do they have those particular problems?
I'm going to go through and provide what I believe are the answers to those questions based upon the evidence that you have seen.
How much bleed takes place? What is it and how much takes place?
Bleed is PDMS fluid. Uncontested, known for a long time. That's what it is. That's the unreacted or loose fluid inside the gel, such as it can get out and escape.
How much? .6 grams per year is the best data what we have. That's about a quarter of a thimble per year.
Now, something came up this morning where Mr. Mithoff says, "Well, with respect to his client, the implant lost all kinds of weight. It must have bled out."
That was never raised with any witness on the stand, never an opportunity for you all to hear the pros and cons. All that I can tell you is that when you go back and
and retire, you will see a report of complaint filled out by Dow Corning
, the one that he referred to this morning for giving the weight; and you will see in that report that between the time that the implant came out and the time that it was weighed, months passed, that the opportunity for any kind of evaporation that would t
ake place -- and it went through a sterilization process, which, as you've heard, involves heat.
Is there any secret about why the implant weighs less? What happened to the saline water that was left in the implant when it was removed and the fact that in the end, it would weigh less?
And if this issue had been raised while somebody was on the stand, wouldn't you have had the opportunity, as you've had throughout this case, to see the pros and cons of that particular fact, instead of being greeted with it as we're sitting here today?
Can implants rupture? Yes, they can. What causes rupture? Trauma. There's no doubt about that. And what's the easiest way to see that? The implant in the body is inside of a fibrous tissue capsule. It is undisputed in
this case that this fibrous tissue capsule has got strength and it's less elastic. The only way that this can be formed to break is if that capsule breaks; and the only way to break the capsule is to have force.
It's just the way it is. It's a scientific fact.
How much trauma? That's a little bit harder. The evidence is disputed on that subject. We believe that the best evidence shows that the trauma has got to exceed normal living activities. It's been tested out. That's what the data shows.
How severe are we talking about? That is much less certain, and I would acknowledge that. That's now approaching the limits of our science. That's what we can say about rupture.Is there degradation? Does the implant material disintegrate over time in the human body? The answer to that question is no. You say, "Well, you were prepared to say that this was a little bit loose over here. How can you be so definite about that?" The answer is that all of the data says that.
You saw Dr. Piziali's tests. H
e took implants that had been in place for years. He cut coupons; a limited number of implants, but lots of coupons. Every coupon was an opportunity to observe the material and how it behaved. And consistently that data showed no degradation in material
properties over time.
And you don't have to take Dr. Piziali's word or his evidence as being gospel. You heard him testify that since the early 1960s, other researchers have done precisely that type of research and precisely that type of experimentation,
taking implants out, stretching them, seeing what their tensile properties are. And consistently the evidence coming back says, 'Absence of degradation."
This is a biostable material from a physical properties point of view.
What about migration? Is there migration? Yes, there is. You learned at the beginning of the case that migration is--well, it goes all over the body. And you saw that from very early studies. Now you're smarter about that issue.
There are two types of materials. There is the gel, and then there is the fluid portion or what's called the mobile component.
What does it take to get the gel to move? It takes force. Those are the case reports where after closed capsulotomy, the gel is found to go up here into the axilla.
The gel migration takes force. It just doesn't go out. It doesn't want to go out. It's a lump.
What about the fluid portion? That can move more easily but in very small amounts. You heard the testimony about the very early studies, .0001 percent. You heard
the testimony about the very recent studies where gel without an envelope was put in an animal and .006 percent, .009 percent parts per million, were found to migrate.
So the fluid fraction migrates in parts per million As you put these two things together, what's bleed? It's a small process.
How far does it go? Well, it can move, but in even smaller amounts. We're not talking about--you had an image at the beginning of the case that stuff just goes all throughout your bo
dy, silicone in your tissues. It's not the case. it's not the science. It's a different phenomenon.
Immune disease generally. Immune disease generally is the central scientific issue in this case. And what is remarkable about that is that here, there's a debate.
How much does it cause to rupture? here, there is very, very little contest; but the data is not great data.
We had Mr. Moalli. You heard Dr. Moalli testify from the stand. This is laboratory data. It's not from people. Here what you find -- and I'm going to review it in a separate chart -- is that the data is so unequivocal -- it's not gray. It's all the same. And it's data from people. We don't have to rely upon the laboratory.
In all of the closing arguments that you have heard today from the Plaintiffs, where did you hear reference to one single one of those studies, one of them, where they said, "Let me tell you about X. Let me tell you about this piece of data"? Not once. Why? I guess because this case is about ethics, not about science and chemistry. Huh-uh, this case is about both ethics and science.
Breast implants and disease. Back at the very beginning when I opened, I gave -- I tried to give some road maps. One road map was, "Make sure you focus on what material is involved."
Remember, we began with the silicone chip and the silica sand and the silicone implant and we went down the chain until we got to PDMS?
That worked pretty well. Everyone stayed focused on PDMS in this trial.
The second chart was one that said, "When you're going to talk about the science of whether there's a link, focus on what's being discussed." There is inflammation. That's not immune disease. There is immune cell stimulation. That's not immune disease. You will hear data on all of these. Do your best to keep them straight. I'm going to review that same organization that I began with, because it's a guide to where we are today. Inflammation refers to the cells coming to the site of a wound. It refers to the formation of that tissue capsule around the implant. You've heard testimony from the people on the Plaintiff's side who have talked about inflammation. The inflammation does not equal immune disease. It just doesn't. How do breast implant materials, silicones, compare with other materials? Do they cause more inflammation or less inflammation? You heard Dr. Kossovsky admit silicone is among the least reactive materials. That is undisputed in this case. There is no biomaterial that has achieved a greater degree of acceptance
for the lack of a significant inflammatory response than silicone. The only adverse mention you've heard in this whole trial about inflammation was a four-dog study done in the late 196s. We're going to come back to that.
And remember, Dr. Lappe' admitted that what probably was causing inflammation there was Dacron, not the silicone itself. How do we stand on inflammation? We stand very well on inflammation. Inflammation. The absence of significant inflammation is the reason this material became accepted.
What about immune cell stimulation? Immune cell stimulation is all of these very technical tests that you've heard about: T cell proliferation, the Kossovsky test, the Memphis test, the Houston test. Does that equal immune disease? The answer was no. Every one of those people-- Dr. Smalley told you the answer was no. Dr. Kossovsky told you the answer to that was no. What do you have to do before you can talk about disease? You have to have clinical validation to talk about disease.
Is that present here? The answer is no.
Your Honor, is this a good time? I can show these or go on to something else.
THE COURT: Yes, sir. How long will it take you to do that?
MR. BERNICK: I can probably cover that in about two minutes.
THE COURT: All right, sir.
MR. BERNICK: And then we'll take a break. Dr. Kossovsky, again, the issue is: Do these tests that they do tell you about disease?
Cross-examination, December 5, "It would be premature for you to represent to this jury that the presence of these autoantibodies is significantly related to the existence or presence of these diseases. Correct?
"Answer: It would be inappropriate for me to represent that to the jury, and I certainly hope I have not represented that to the jury."
What's he saying? Not been clinically validated, not tied to disease. And interestingly Dr. Kossovsky's test was never done for purposes of these two women. You never heard of any data from that test from Dr. Kossovsky.
When he tried to do correlations between his test and disease -- remember he had 256 women? They all went through the test. And I asked him each and every step that had to be fulfilled, and the last step was cross-reactivity.
How many women out of the 256, all of whom said that they were sick -- how many of them did he have cross-reactivity? "Is it true that of the people involved in the study, you were only able to identify two people, two people, that actually had, by your own measure, cross-reactivity to native protein? "Answer. That is correct.
"Question: And that is less than 1 percent.
"That is correct." That's why he can't say it is clinically valid. His own study shows that it ain't. That's the data. That's the testimony. What do you have for Smalley? The Memphis test. "Isn't it true that neither your test," the Memphis test, "nor the Houston test," Dr. Lappe's test, "will tell you that a given patient is sick? Correct?
"Answer: That's correct.
"Is it also true that neither your test nor the Houston test will tell you whether a given patient has clinical symptoms? Correct?
"Answer: That's correct."
Again, no clinical validity. These are research tools.
Remember when I confronted Dr. Smalley with the Peters paper that he said supported his position and they had that chart? Dr. Smalley is looking for proliferation and response to silica, and he says he finds it indicating a response to silicone. So I said, "In how many cases do the two line up?" He found only one person that had both response to silica and response to silicone out of all of his patients. It just doesn't hold up. That's why research must continue. And what's the best test of how good Smalley's data is? He did analyze blood sera from Dr. Ladner and Mrs. Laas. What did he find out?
Dr. Ladner, who we know has lupus, we know has lupus -- "At a result of 85," which was her test result, "isn't it true that Ms. Ladner falls into the same range as people who have taken exactly the same test and are asymptomatic, they're not sick? Correc
"Answer: That's correct."
According to his test, Dr. Ladner is not a sick woman. He can't distinguish between who is sick and who is not sick.
That's the problem with the test. It doesn't tell you anything about disease.
Was Dr. Ladner alone? No.
Mrs. Laas -- "In the case of Mrs. Laas, she's got a 45 test result."
"She's down here, is she not," pointing to the graph.
"Yes, sir. "She's again in the same area where people who are asymptomatic have the same result. Correct?
You've been shown that Houston test. You've been shown the Memphis test. These are tests that are being done by researchers. They're doing interesting work. They don't tell you anything about whether somebody has disease or sickness.
There are tests which have been clinically validated. The ANA test has been clinically validated. Mrs. Laas does not have positive ANAs. Controlled studies have been done of breast implant recipients. No increased incidence of positive ANAs. They told you about the research tests. They haven't told you about the ones that have been clinically validated.\par
I'd better take a break.
THE COURT: Thank you, sir.
All right. Ladies and gentlemen, we're going to take a break at this time. Please remember your instructions; and that is, do not discuss this case with anyone, not even among yourselves. Do not form or express any opinion about the case at this time u
ntil you actually take the jury charge to the jury room.\par
Something very important is that--
THE BAILIFF: Order in the court.
THE COURT: Thank you, sir. The goal today is to complete these arguments so that you can go right into the jury room tomorrow with no problem. I say "no problem." I mean no time problem.
It's very important to understand that. Because of that, I'm going to extend a little bit beyond the time that we normally go. My goal is to be out of here by 5:15. Please keep that in mind if you need to make a call to anyone to let them know that you
're going to be a little bit later today. All right. I'll ask the audience, if you will, please, to cooperate as you have all day to let the jury be excused first; and then you can leave at that time. Mr. Bledsaw, would you please escort the jury out? Thank you, sir.
All right. The Court will stand in recess for fifteen minutes. [Brief Recess]
THE COURT: All right.
Mr. Bailiff, please bring the jury in.
[The following proceedings were had in open court with the jury present.]
THE COURT: Please be seated, ladies and gentlemen.
All right. Thanks. Let's proceed.
MR. BERNICK: We're getting to the good stuff right here, the studies. We talked about the studies in opening. We talked about the studies in cross-examination. And we're going to talk about them now. They're the most important thing in this case.
There has been another invitation that was made this morning on these studies. These were the Ivory Tower folks, the bean counters with the statistics.
That's an invitation. That's a "Don't pay attention to that. Don't look at that."
Look at them. They are absolutely critical.
Research is being conducted in this area and on a very intensive basis by people literally all over the world And you've heard about the published studies that reflected that ongoing effort.
The purpose of that research is to address the fundamental issue that we have here today and inform everybody, inform the public, inform women with breast implants who are here in court, who are not here in court, who are all over the world. It's information. It ma
kes people smart, enables them to make decisions. It increases their fears or allays their fears. The information is for all of you. Consume it. Deal with it. Figure out whether you think it's reliable, but certainly focus on it. That's who it's bein
g done for.
You heard about six controlled studies. We understand why people do controlled studies. We know that women with or without breast implants in the general population will get sick, have a wide variety of illnesses, all the illnesses that aff
The only way to find out in a reliable fashion whether breast implants are causing a problem is to see whether women with breast implants get sick more frequently.
That's what the controlled studies are. That's why they're done. There is no debate about that.
There was not a single expert who came in to testify here who said, "Controlled studies? Ah, we don't need those. They're not important. We don't need to research that Ivory Tower stuff." Everybody recognizes -- everyone is focused on these studies, so there's no debate about the importance of the controlled studies among the scientists.
The six studies looked at two things. They looked at actual rheumatic disease, rheumatic immune disease; and they also looked at symptoms, because the effort was that even if something right not actually be a given rheumatic disease, if we're picking up
the symptoms, we can find out something about that.
And the symptoms are particularly important -- are less im
portant for Dr. Ladner much more important for Dr. Ladner, much more important for Mrs. Laas in a way that I'm going to illustrate for you here this afternoon. And this is a very, very critical point. The studies that focus on these symptoms are the Wells study and the Mayo Clinic study.
Ivory Tower? Look at these people. These are people who are not only the statisticians, they're plastic surgeons. They're people from dermatology and continuous surgery in rheumatology. These are people who treat pe
ople. These are the people with the hands-on practicing medicine interest.
They want not only to have information from their own experience, they want to have the benefit of this very sophisticated research. That's why they're involved in this process.
The Wells study is the first one. The Wells study lists all the symptoms that they've looked at. And you see I've got blue and green dots. The green dots, we're going to get to in a minute; and the blue dots, we're going to get to in a minute. But ju
st keep in mind the number of different symptoms that I've dotted here, because I'm going to come back to that in a moment. But that's the list of symptoms. New England Journal of Medicine,
the Mayo Clinic study, Ivory Tower. They've got a bunch of authors. Where are they from? Department of Rheumatology and Internal Medicine. These are people treating people. They want the research. Mayo Clinic. Is Mayo Clinic an Ivory Tower organization? Mayo Clinic is a very, very sophisticated prestigious c
linic. Treat people. Treat their problems. Recognize their ailments and try to deal with them. They wanted this research done, too. Mayo Clinic also looked at symptoms in addition to diseases, and again I've got some dots here we're going to come back to. What was the result of all of these different studies? No increase in immune disease. Reputable-- nationally-reputed organizations, sophisticated research, consistent conclusion again and again and again. And each of these organizations was consi
stent and sophisticated enough that when there were limitations on their studies, they came right up and told you. And we saw some of the limitations of those studies; and we saw how the limitation on one study would be addressed by another, how the Mayo
Clinic study came up and picked up a weakness in the Schustermann study.
That's how science works. You don't go for a long-shot deal that involves a million people. You do a bunch of studies and then see how they fit together.
We now have the mature body of research just in these six published studies, extensive data on the central issue in this case and a clear unequivocal answer.
Research must continue, but this is where we are. And the continuing research also was relied upon in support of Dr. Blackburn's testimony. He said that there are ten or twelve additional controlled studies that have now come out in preliminary or abstr
act form. I'm going to draw a little dotted line. On the other side of that line, I'm going to put one article about a new disease in quotes. It's Dr. Patten's article.
Why did I draw the dotted line? It's not a controlled study. Indeed I should put-- I didn't put down Dr. Patten. It should be Dr. Ostermyershoyd, because Dr. Patten is not the principal author for this article.
And Dr. Patten, whom you heard this morning, is a reviewer, a peer reviewer, for all of these different publications. None of them were used. This got submitted for publication in the Keyo Journal of Medicine
in Japan in June of 1994. With all of this interest, with all of this focus, why shouldn't it be in The Annals of Neurology?
Why shouldn't it be here in this country for people to see? Why can't he subject it to the same peer review that he's prepared to subject papers that come of his review? Why is it all the way over there? And you heard that not only is it over there and authored by somebody else and has no controls, you also heard that you can't make anything of this data. It's got data all over the map. There's no protocol for this study.
And in the end, this new disease-- it doesn't even have criteria. You can't tell what it is. It's just something new. It's breast adjuvant disease. It's a name. That's what you heard on the other side of this coin.
It's very hard to follow up on that type of theory. It's very hard to follow up on that type of claim in a systematic way. But we do have something.
Remember the symptoms? Remember how I dotted these tables here? Dr. Patten at last lists a bunch of symptoms that he reports in his patients who he believes have neurological disease.
These are all of the symptoms that he reports: weakness, fatigue, muscle aches and pains morning stiffness, joint pain, dry eyes, shortness of breath, all of these things. And do you know what the dots are? The dots are all of the symptoms where there
is an overlap with the controlled studies. So Patten lists--or Ostermyershoyd lists all of these. And each and every one of those is also the subject of the controlled study by Dr. Wells.
And with regard to the Mayo Clinic, again there is overlap. All the blue dots are particular symptoms that Dr. Patten or Ostermyershoyd are focusing on that are also focused on in these controlled studies by these recognized organizations. So there's a little overlap here that give us the opportunity to test, to say, "Well, that's great for the Keyo journal. What if we really did a rigorous analysis? What would we find out?"
And what we find out is that when it comes to these symptoms, all this laundry
list of symptoms, there may be one or two symptoms out of the whole bunch that have even an elevation. When you go into the controlled studies, the new disease is just not borne out.
This was a piece-- this article was crafted for export. It was crafted to raise an issue without addressing data and determining scientific validity. At least, though, we have some angle on it, some hook some way of bringing it back into what science re
cognizes are the rules and the procedures and the disciplines in testing it.
And when we do that, we find out it's just wrong. It's just wrong. It does not have support. The Wells study says it doesn't have support, insofar as they have reviewed symptoms.
Bear those dots in mind, because when we get to talking about Mrs. Laas, we're going to talk about the green ones, the green dots.
That's our view of the studies.
What did you see on cross-examination of the Plaintiffs' own expert, Dr. Busch?
"As you sat there in January of 1994, Dr. Busch, isn't it a fact that
no one had reported to you any controlled study, either prospective or retrospective, which reported a connection between breast implants and any increase in disease? Isn't that a fact?"
He has to recognize that.
January 1994- and this is again the trial testimony in this case-- "Wasn't your testimony in this case-- "Wasn't your testimony in your own words at the time-- that is, in this prior deposition-- that given this pending research, the association of breas
t implants and disease was a possibility?" And even today, he agrees it is a possibility. That's what Busch says.
"Each and every one of these researchers who are now reporting -- and a lot of people are now looking at this issue of, 'Is there an association ,' a lot of people looking -- nobody doing the controlled study is finding that association. Correct?
"Answer: Not yet."
And he has to acknowledge that that's true.
What about Dr. Biggs, the surgeon who is kind of, at least in his own mind and his own words, looking at it from the outside, testified for the Plaintiffs in this case?
"Isn't it true, Doctor -- what you said, Dr. Biggs, isn't it true that after all this controversy in 1991, you spoke to the press in 1992? Remember that?
"You gave an interview; and in your own words, you addressed the question of whether science had established a link between breast implants and disease and you said that you didn't segregate the complaints about silicone. Some are very serious, but you h
ave not seen a lick of good science which substantiates a connection between breast implants and disease. Correct? "Answer: Was that in the paper?
"I think I was misquoted, because I don't think I would ever use the term 'not a lick.'" He then goes on to say what is the same thing, "That's not my syntax, but I think I probably did say there was not a link. Maybe I said 'link' instead of 'lick,'" and he never retracted the statement. Dr. Biggs was not saying in 1992 and he's never changed the view that a link has not been established between breast implants and disease.
What has he told his patients?
"When did you start telling your patients who were getting silicone gel-filled implants that silicone gel-filled implants have been shown to cause immune disease? When did you start telling your patients that? "I haven't told my patients that."
He doesn't believe it's true. Dr. Biggs doesn't believe it's true. "Have you ever revised your informed consent process to reflect the fact that a question has been raised about whether breast implants cause immune disease? "I don't recall." It doesn't even stand out in his mind whether it is an informed consent. He's telling women -- established breast implants cause disease.
What about Dr. Burns, the one who was -- almost the entirety of his business is focused on matters that involve referral from lawyers? "Isn't it a fact that when it came to telling the lawyers, as just read from the deposition" -- this is again trial testimony here -- "what you actually told them wa
s that you could figure out no other reason; therefore, it had to be breast implants. Correct? Isn't that what you said? "Answer: True. "And therefore, Mrs. Laas fell into the category of all these women. With respect to virtually all of them, you have said, 'There's nothing else I can think of; and therefore, it must be breast implants.'" That's science? Is this what we're relying upon here in this courtroom is, "Gee, I can't think of anything else; therefore, it must be breast implants," particula
rly when all of these controlled studies are out there for our benefit and for our consumption? Is that what you want to rely on? What about Dr. Busch? Again, the theory is new disease, from Dr. Patten or Dr. Ostermyershoyd, new disease, new entity.
What does Dr. Busch think about new disease? Again, Dr. Busch, "Isn't it a fact that you are not aware of any unique disease, any specific disease, that is specific to women who have breast implants? True statement?
b Dr. Busch does not ascribe to the viewpoint being advocated in this courtroom through this Patten/Ostermyershoyd article. He doesn't believe there's a unique disease. What's going on? Which one of these excerpts do we ascribe to?
Dr. Busch says that the association is a possibility. He says there's no new disease. And yet in the same breath, we hear about his colleague down the hall, Dr. Patten, who says that there is a new disease. But he's not willing to publish it in the Uni
ted States where it will get reviewed and it will get studied. And take a look at what these people do in addition to what they say.
Dr. Busch: "360 fluid has been used for decades to lubricate the syringes that are used for hypodermic needles. Correct?
"Answer: A silicone fluid has, yes, sir."
Has he taken the step of saying it shouldn't be done anymore because he believes that silicone causes problems?
\tab I said, "Well, you asked me. Have you told anyone at Baylor that orally; that is, that silicone fluids shouldn't be used in hypodermic syringes? "Question: Your answer was no. Correct?
"May I have the document, sir?
"Your answer was no. Correct? He says, "No, I haven't told anyone." He's never taken that step. Judge him by his actions as well as his words. What does Dr. Lappe' say about silicone? What does he do about silicone in light of all this research? Does he say that silicone shouldn't be used in the human body? You heard him admit that it could be. Does he say that breast implants shouldn't be used in the human body? He doesn't say no. He doesn't say, "Under the appropriate circumstances, yes."
Why would anyone say that if a link had been established between breast implants and disease? Why would anyone say that?
Let's come back to our master chart here. Immune disease generally, what does science say today? Controlled studies say no. It's that simple.
What does that mean about this last step? That's one of the hard parts of the case. There is only one answer to the last step. We can talk, and we will talk, about the indiv
idual medical history for Dr. Ladner and Mrs. Laas. We will deal with that. But whether implants caused disease does not depend upon any individual. What science says doesn't depend upon any individual case. It's a broader issue. It's a broader proble
m. These studies say that the answer to this must be, on its face, no, it cannot be, as a matter of science. A scientist would say, "Why even address the issue? It's been resolved."
In court, we will. We'll talk about these individuals. There's been some discussion about, "Well, maybe there's susceptibility." Where does that come from? Where is the study that says that there's individual susceptibility? What is the individual susceptibility for these two women? It's just out of nowhere. The studies don't say that. There's no data to support that. It's because it's the only thing that they can do that's left, is to suggest it. The science, the studies, say no. Science can stop talking. Lawyers have got to keep on talking, so I'm going to talk about Ladner and Laas and go down the same list here.
Was there bleed from Dr. Ladner's implants? The answer is yes. How much? Well, she had her implants in from '88 until '93. That's about five years, so she's got somewhere over a thimble, one thimble plus of bleed, based on that data. And we recognize
that there are limitations to that data. But the implants were not in for all that long, and what we're talking about in Dr. Ladner's case is bleed. Rupture? No. Migration? No, there's no evidence
of any migration. Might there be microscopic migration that nobody can pick up? Yes. Is it possible? Yes. Do we see any evidence of it? Has anything been presented that says there's any gel migration? No, there can't be gel migration. Any fluid le
ak migration? Maybe a little bit. We just don't know. What about immune disease generally? Well, again, if the science has provided us with the right answer, the answer here has got to be no. And in her particular case, of those five or six controlled
studies, many of them include lupus, not just one. We have -- the Strom study includes lupus, the Mayo Clinic study includes lupus, the Schustermann study includes lupus. She falls squarely within the scope of this research. What happens if you get to the individual medical history for Dr. Ladner? Does it somehow provide another answer? It provides the same answer. I want to go through that a little bit. Remember the ACR criteria? I'm sure they're just vivid in your mind. The ACR criteria are the
criteria of The American College of Rheumatology, and they specifically speak to the issue of lupus.
These are the ACR criteria for lupus. And Remember, we went down the list with Dr. Spindler and with Dr. Blackburn, picking out the different criteria and whether she met them or not.
All you need for a diagnosis of lupus under these criteria are four positive criteria. She had five positive criteria. And what Dr. Sure's book said was that means that she has classic lupus. Dr. Spindler said, "Well, I'm not sure what 'classic' means. I'm prepared to say 'more than definite.'"
96-percent certainty was his figure. Dr. Spindler, in this trial -- if we follow through on the criteria, he says he doesn't know what Sure means. We know that four is what he established as definite.
"I see. So two is possible, three is probable, four is definite, and you say five is not classic. Is that your testimony?
"Answer: What I am saying is that many is not a number that he has given us.
"Question: How about more than definite? Would you agree with that?
He doesn't think that's what Sure has in mind, but he would be comfortable with that.
"Isn't it true that these classification criteria, when tested for sensitivity and specificity, have the accuracy of 96 percent in the diagnosis of lupus arising in the general population, not drug-induced lupus but lupus in the general population?
Now, Dr. Ladner not only meets those particular criteria, she also has got associated symptoms. And remember, the associated symptoms are the symptoms that are not part of the criteria but are usually seen with lupus. And we went through the list, fatigue, alopecia --which is hair loss-- Raynaud's, lymphadenopathy. "All these criteria, all these symptoms, arise in people who have lupus in the general population regardless of whether they have breast implants. Correct? "Answer: That's correct.
"Morning stiffness. She has that?
Again, symptoms that re in the general population. Now, he wanted to point out some distinctive features of her lupus; but he also conceded that lupus always has distinctive features. "Question: She's got a whole series, many associated symptoms that are fully consistent with spontaneous lupus in the general population. Correct? "Yes, sir. She meets the criteria. "Would you agree with me that even in the general population with spontaneous lupus, nothing to do with breast implants, each person has got his or her own fingerprint of disease? "Answer: I think the expression of the clinical presentations are different for each individual."
And then we went through what he was pointing to as some of her special features. Unilateral lymphadenopathy, lymph node swollen on only one side, but that was only once. When he examined her on the 4th of November, the condition wasn't present anymore;
and she still has lupus. Dry eyes. A lot of people who get lupus get dry eyes. That's called Sjogren's syndrome. He said, "Well, he has speckled" -- "she has speckled versus homogenous ANA." Well, it turns out that she also has homogenous ANA. Each and every one of these factors.
And finally, at the time that he wrote his letter and he had a diagnosis, was his diagnosis atypical, unusual, lupus? At the time that -- in June 1994, he wrote the letter, "Isn't it true that you have listed all the symptoms that she had? You said that
she met the criteria, the ARA criteria. "Yes, sir.
"And isn't there nowhere in the letter that you wrote to her where you say she's got atypical lupus as opposed to lupus within the meaning of the criteria? Correct? "Answer: Yeah. Looking at that, I was waiting for the remainder of the tests. If you will see in the following paragraph, I suggested some further explanations.
"And then once all this was completed, I would formulate a definitive diagnosis with her." That's a working diagnosis. But then he went on to say that he has never written another letter. The only diagnosis that he has ever reduced to writing is that she has lupus within the meaning of the ARA criteria. "Has she responded to the removal" -- "what has she responded to?" We went through this for awhile, and we finally got to an agreement.
"Implants are" -- again, he's going to agree with me, "Implants are taken out, she does not report improvement. She changes the medication, she reports improvement. She goes off the medication, she's okay for a time. And then she gets worse, and then s
he goes back on the medication. Correct, Dr. Spindler?
Implants are removed, and she doesn't get definitively better. medication is given for lupus. When the right medication is given, she responds. What does that tell you? She's just got lupus, plain and simple. That's what it is. It's unpleasant. It'
s a problem. It's tragic. We believe -- Dr. Blackburn believes it's a mild case. There is no evidence that there's any precipitous kind of deterioration, but it's a fact. And it's not a fact that it responds to the implants. It's
a fact that it responds to medication for lupus that people take when they get lupus in the general population. That's a fact.
When we look to the individual medical history, the doctor-practicing medicine history, we get the same result as we do from the controlled studies. She's got a classic case of lupus, a type of lupus that has no evidence of being increased in the populat
ion of women with breast implants. What about Mrs. Laas? What happens if we go to her particular history? Her history is more
complicated. There's no doubt about that. The key to understanding the history is to focus on the different parts of the analysis. We've tried to do this during the course of our case and I'm not sure if it was clear or if it came across so I'm going t
o review it a little bit again. Different people supplied different pieces of what is really in the end a puzzle but have some fairly straightforward answers. Bleed? Yes, there was bleed over a period of years. Rupture? Yes, there was rupture. What c
aused it? There had to be trauma. That capsule had to get broken. And remember that in the mammography and ultrasound report, there was a record that said that within the breast area, there was a movement toward the axilla, in this direction here, up in
And remember the capsule, when it was removed, had that odd shape to it? Classic, what is reported in the literature, in the plastic surgery literature, as being associated with trauma. It's just plain. It's right out there. It's visual that
that's what took place.
How much trauma did she experience? I told you before, a vary gray area; and we acknowledge that that's a very gray area. Dr. Piziali wrestled with that. He said, "Our data says it's got to be pretty significant." He calls it minor trauma. But it's o
utside of an ordinary living-day experience. Yet she doesn't remember that, and we have no reason to doubt her word. How do you reconcile those two? The only way to reconcile it is that there was some trauma. It was not a car ac
cident. It was not running into a pole. It was not being struck. It was maybe an unusual movement. You saw in Dr. Piziali's tables that unusual rolling motions can cause a significant amount of stress. Is it her fault? No, it's not her fault. Is it the responsibility of the implant? Absolutely it's the responsibility of the implant. But there was some trauma that caused her rupture.\par
Is there any evidence of degradation? No. The implant was examined. The thicknesses were measured, and there was no loss of thickness in that envelope. There was some trauma that caused her rupture.
Migration. Migration is another somewhat complicated thing, but I think it has gotten in the end some simple answers. There was some evidence noted of movement toward the axilla; but by the time the implant was removed, the capsule had grown back over i
And you remember Dr. Puszkin in his report saying precisely that. Dr. Puszkin reviewed the surgical report, "According to the report, at least at the time the impla
nts were removed, they were within intact tissue capsules. Your answer was yes. Correct?
The operative report reflects that at the time that Gladys Laas' implants were removed, the capsule was intact. The gel was contained. Now, that gel had undergone some change. We know and it's in our package insert that if there is a rupture and gel is
exposed to tissue, it undergoes a physical change. It can become looser. And here obviously was, at least what was left of it when we examined it. Did it go anywhere? Did this ruptured gel move anywhere? There's good evidence on that. There's good evidence that says, "No." And what is that evidence that there was no migration of the gel. It comes from the biopsy slides. Remember that the biopsy was taken from the pectoralis muscle.
The implant is in place. There's tissue capsule around it. It's a subpectoral implant, which means that the muscle comes like this. Here's the chest wall back here. It's under the muscle instead of being ove
r the muscle and under the breast tissue. Subpectoral. When this was removed, remember Dr. Puszkin -- we drew the sketch and Dr. Brumbach talked about the same thing.
A coupon, a biopsy, is taken from the pectoralis muscle and examined precisely to see if there's silicone that's moved away from the capsule. Do you remember those sketches? And remember what his testimony was?
The pathology report itself said no silicone in the muscle sample, "When we go to the pectoralis muscle right in the area of where the implant was ruptured, we find, according to the pathology report, no evidence of silicone. Correct?
"Answer: That's correct."
"That's correct." So we got data right from the source that tells us that there has not been a movement of silicone away from the area.
What happened in the other areas of the biopsy? Obviously the biceps biopsy, no evidence of silicone. Sural nerve -- we've gone from the implant to the pectoralis muscle to the biceps. Now we're all the way down here, and we're talking about the ankle. "Isn't it true that there was no finding of silicone there either?
"Answer: There is none."
When it comes to this particular slide, he's got to have somebody else like a neuropathologist look at it. And that was Dr. Brumbach. And Dr. Brumbach's testimony was identical, no evidence of silicone in the pectoralis muscle, no evidence of silicone
in the biceps muscle, no evidence of silicone in the sural nerve. So when you get down to the microscopic examination of all of these differe
nt tissue samples, none of them showed silicone; and that's why we say, "Was there a rupture? Was there trauma? Yes. Yes. Was there migration? We see no evidence of it. Might it be so tiny that it will only be picked up by Carbon-14 tracing," which i
s what they do in these very sensitive tests? Yes, that's a possibility; but we see no extraordinary movement of silicone as a result of the rupture.
What about immune disease? Again, if we follow through on these control studies, the answer to this must be no. You don't resolve that issue by looking at an individual.
In her particular case, though, we still have a medical record to look at -- and I want to go through the medical record very briefly -- to see if there's any variance from what we see here.
For that purpose, I've got a separate chart.
First, with regard top the rheumatic findings -- these are the rheumatologists. And again, I know that this evidence came at you kind of like this. The rheumatologists do make some findings. They find a
rthritis, bursitis and tendonitis -- both Dr. Blackburn found that and Dr. Burns found that --not related to the implant. What about the ANAs? Those are those seralogical tests that do have some clinical validity. They were negative.\par
What about the gag problem, the swallowing problem. This esophageal dismotility study again is normal. This is the study that was done at Memorial City Medical Center; interpretation, basically a normal study. There are some observations, but the overa
ll assessment is that she's normal in that area.
What's the bottom-line assessment? Does she have rheumatic disease? Dr. Ladner does have rheumatic disease, lupus. Does Mrs. Laas have rheumatic disease? According to Dr. Burns, the answer is no.
"So you don't believe she has any rheumatic diseases associated with breast implants. Correct?
She is not a rheumatic-disease case.
Dr. Warren Blackburn, our expert, also said no.
What about Dr. Busch? He doesn't know of anyone who believes that she has it.
Analysis is not over. We've got to go to the other side of the chart. And now we have to consider, "What about the neurologic side? Does she have a neurological disease?" And again, this kind of came in pieces; but it's absolutely critical.
Biopsy. On our experts, you heard from Neil Rosenberg and Robert Brumbach. Robert Brumbach is the only neuropathologist that you heard from in this case. Board certified. How does he read the biopsies? Normal.
MRI. How did Dr. Rosenberg look at the MRI? He says that it's basically a normal MRI.
What about the Spect scan? Remember the Spect scan?
He says that it has some minimal findings but that the most logical explanation was hypertension. And he may have specified something else, but I can't recall right at this point in time. What about the nerve conduction velocity tests? He says she has carpal tunnel syndrome and one other -- one other minor finding and otherwise normal.
Washington University. Remember all those different antibodies and we had to figure out which ones were specific and which ones were not specific?
He's the only one in this case that walked you through those antibodies to show you how the articles read and how the tests read. These were all nonspecific findings, which means that they're not specific, they don't tell you if there's any particular disease that's at work.
That's where Dr. Rosenberg -- this is where our experts came out, is that this is basically a normal picture with small variations that are not due to any underlying problem much less a problem with the implants.
Dr. Patten. Remember we were the ones who read you what Dr. Patten had testified to in his deposition. Dr. Patten. He specifically was asked, Bernard Patten, the same questions; and we wrote them down. And here are the excerpts that you were read.
"In the case of Mrs. Laas, would it be your view that for all the reasons you have indicated, the MRI scan did not show significant changes?
"That was my opinion, yes."
That was the MRI.
What about on
the Spect scan, a bunch of admissions on the spect scan? Unilateral abnormality is not typical of what he says he finds in women with breast implants. That's correct. How did you guys know that? Well, we've been looking at his stuff for a while.
"Are you aware of any study or data which would suggest that the Spect scan findings for Mrs. Laas are abnormal given her age?
"Are you aware of any studies which would link up the type of Spect scans you found with regard to Mrs. Laas to breast implants?
"Well, that's what I was talking about. I think we'll find that there will be some patients like her that have breast implants but her findings are not the typical ones we usually see but what we will come out and say are more probably than not related t
o breast implants so I have to agree with you that in her case, I think that this reflects a decreased blow flood and I believe she did have problems with the cerebral blood flow as part of that as reflected in the changes in the magnetic scan. But wheth
er it is related to the breast implants, I can't say." What about the biopsy? Remember, it was Dr. Patten who reads his own biopsies.
"Is it true that asymmetric nerve conduction findings" -- I'm sorry. These are NCVs -- "are not typical of demyelinating disease, the kind of things you say you think she has -- do you see any evidence from the abnormal findings in the electromyography a
nd the nerve conduction velocity tests of demyelinating disease?
"Are you aware of any studies or any data which says that the nerve conduction and electromyography findings for Mrs. Laas are abnormal for a person of her age?
"No." What about the biopsy?
"Indeed, in a person of Mrs. Laas' age, you would expect that as many as 25 percent of the women who have evidence of demyelination for reasons unrelated to breast implants.
"Answer: Now you're getting a lot smarter.
"Is that true?
"Answer: Yes."Are you aware of any data or any studies which say that the type of demyelination that she herself has, given her age, is due to anything other than age? Can you say that as an expert, an expert?
"No, I'm not. The studies do demonstrate that as we age, we lose the myelin fibers; and I think that that is well recognized. So whether her fiber loss is related to age or something else, I don't know. And finally the Washington University results, which, on their face, cite that they're nonspecific, "I want to know whether you are aware of any study which correlates findings of elevated IGG" -- and these are the differe
nt -- "and correlates those results to actual clinical manifestations of disease. "Answer: I believe that I am and I have read such but I don't have them with me. I could fish them out, I'm pretty sure. "Do you believe that that correlation is a strong correlation? "No, I do not." An amazingly consistent picture. You take the objective tests, the ones where we're not depending on anything but the machines and the equipment, the MRI, the Spect scan, the NCV, Washington University. We take the biopsy
slides. And everybody seems to be in loud and clamorous agreement. We don't see evidence of a problem related to the breast implants. What about the exams? Well, we had Dr. Burns. Dr. Burns did a neurologic exam, even though he is a rheumatologist, on December 8 of 1992. We've shown that to you all. Does he report any neurological problems, sensation problems, abnormalities, reflex problems? Normal. Dr. Ancando, a neurosurgeon, does a neurological exam in June of 1993 at Dr. Burns' request. What does Dr. Ancando say? Has some weaknesses reported but basically a normal examination.
What about Dr. Rosenberg in November of 1994? There were some abnormal findings -- remember gait, the eye-hand coordination -- those were it -- and some decreased sensation but not of a kind that is associated with organic neurological disease. A normal examination.
What about Dr. Patten? Dr. Patten is interesting because Dr. Patten, when confronted with Dr. Ancando's examination in his deposition and as read to you at trial -- what does he say?
"Do you have any reason to believe that the examination that was performed by Dr. Ancando and the results that are reported in Exhibit 4 were inaccurate at the time that they were rendered?
"No, I don't."
He can't disagree with Dr. Ancando. Neurological disease. Dr. Ancando reports none. Dr. Rosenberg reports none. What about Dr. Patten? Well, first he talks about chronic inflammatory, demyelinating neuropathy. Then he walks away from that. And then finally he com
es back out with his diagnosis of breast adjuvant disease.
Breast adjuvant disease.
That's what he says she's got. That's that new disease in his article. That's the one that Busch says doesn't exist. Is it a neurological disorder? Get this. "Are you aware of any rheumatologist who has published or written a paper saying that adjuva
nt breast disease is a neurological disorder? "Answer: No. And I haven't written that one myself. I don't believe adjuvant breast disease is a neurological disorder." Dr. Patten. That's where the picture sits with neurological disease...
What about symptoms, the complaints and the symptoms? They are very significant. She has fatigue. She has myalgias, which are muscle pains. She has concentration difficulties. These are the three things that are identified in the records as having
used her requirement to the hospital. They are a very potent combination. There are not to be underestimated. They are severe. Are they related to disease? She doesn't have a rheu
matic disease, so the answer here is "No." She doesn't have neurological disease, we believe, according to the weight of the evidence; so the answer here is "No." Are they in some other fashion related to the implants? I'm running out of time, so I'm going to have to hustle through this. These are among the complaints that the Wells study specifically examined to see if they're related to breast implants. Each one of these green dots represents a symptom that Mrs. Laas is reporting, from easily tired,
fatigue, to muscle pain, myalgias. And there are others.\par
We could take you through the questionnaire where she's got joint swelling, painful joints, itching, hair loss. These are all the same symptoms that the Mao clinic has studied and that the Wells study has studied.
What is their conclusion? The answer is that they're not related, which then brings us to the only other alternative, depression. Mr. O'Quinn says that we're saying she's crazy. We're not saying she's crazy. We're not saying any such thing. We're not saying -- Barbara Bush has come down with depression. Is she crazy?
This is a biological process. It's a biological disease. It affects a tremendous number of people. That kind of characterization leads to a misunderstanding of the people and a misunderstanding of the problem and a misunderstanding of the disease.
What fits with this? History. You saw the history in the medical reports.
The symptoms. This is the Bible that the psychiatrists use for diagnostic purposes. She fits
the description. Her own doctors have medicated her for it. Are they saying it's something that she's just crazy, it's a problem with her? Huh-uh. They respect the problem. They want to deal with the problem. It's a real problem. It's a significan
t problem. It's a debilitating problem. What brought it about? The easy answer to that is "timing." If you take a look at Dr. Burns' own testimony, Dr. Burns saw her in 12/92; and she was at this level. He saw her again in May of '93. She had retire
d from the hospital, and she had suffered a significant decline. That's what the testimony was.
What happened during that period of time? What happened during that period of time is that on December 16 or 1992, she went in to have a biopsy taken by Dr. Patten. He didn't even examine her before he took the biopsy. He just took the biopsy.
He internally concluded that she had breast adjuvant disease before the biopsy report was completed and before she had a medical examination; and he faxed her the res
ults on December 28 of 1992, before she was even examined. She then gets hospitalized, the implants are removed, she gets treated and then the decline starts.
Where is the balance that has been explored by Dr. Patten here? Dr. Patten had balanced in his deposition on all of these different findings and different problems. Can you find anywhere in his reports that same sense of balance?
He says here, Washington University, "not a strong correlation."
When he writes this letter to Mrs. Laas, does he say that? He doesn't say that.
He says, "These are the types of antibodies that work away and destroy the nervous system." There's a tremendous stressor here, a tremendous problem. It all fits together.
This is the only explanation that fits. It fits diagnostically. It fits historically. Her own doctors have ascribed to this explanation.
Does it minimize it? It doesn't say that it's not a problem. It recognizes the problem for what it is.
Mr. O'Quinn says, "Well, let's take a look and see about the individual medical treatment because the doctors treating know what the story is."
How has she responded to the treatment? Dr. Patten's operating on the theory that she has a neurological disorder or something like a breast adjuvant disorder, and he treats her for it.
Has she responded to the treatment? No.\par
If you take a look at the theory, that underlies Dr. Patten's treatment, he is just -- it's just not there.\par
The best evidence that the non-Ivory Tower explained is wrong is that it has not worked.
This is the analysis.
In the case of Dr. Ladner, very strong, very clear, because it's so focused on lupus. Lupus has been studied, and she's got it.
If you talk about Mrs. Laas, it's much more complicated because you have to sort out the pieces. But once they are sorted out and you take a look at the testimony, there is one answer that remains. It is the best and most logical explanation. It's the
explanation that science warrants.
Let me then bring to a close talking about the scientific story, because I am very much running out of time.
This case presents a very, very difficult choice. The Plaintiffs here are two very fine women. Their families are fine people. Everybody knows that. They both have significant problems. Everybody knows that. The future is uncertain. Everybody knows
Based upon the condition of Dr. Ladner, there is a reason to be hopeful that she will continue to have a mild case, that she will have the ability to practice internal medicine if not cardiology, and she will go forward.
With regard to Mrs. Laas, the disease that we're dealing with here has a more uncertain type of prospect; and it's not clear what will happen. So there is uncertainty.
And all of those factors drive you to the point of saying, "What can be done for these people? They're such deserving people."
We do not question that for one moment; but when we were here in this room and you were all sitting out over here in the jury selection process, I said to you "My client is going to present the science."
The science presents the answers to these questions. The science was our business. It was our life's blood in this business. We have a scientific technical process.
I said, "If the science shows that we are right" -- even though it's not our burden of proof, we're going to demonstrate the science. "If it shows we're right, will you all commit to develop the personal courage to act on it even if all of your personal
sympathies run the other way, every single one of them?" And there was sile
nce in this room, a lot of people and no one spoke, because I think everybody recognized that that is a very hard question. But nobody raised their hand to say that they weren't prepared to step up to the task. Not anybody. Not any of you.
This is an opportunity -- this is an important case. Everybody is sitting here watching. You all have spent weeks listening to the evidence. Are you going to be prepared to look at the science and say, "I want to use that as my guide," and give the rig
If you are, I think that you will give the answer that I have indicated here, as what the evidence showed. It's going to be hard, but I think that it's the only answer that's available.
So when you hear the invitation, "This case is about ethics. It's not about" -- turn the invitation down. Focus on the science. Focus on it critically -- everybody critically, all of the experts, me, the evidence -- and reach your conclusion based on t
Let me spend a few minutes talking about history. I've got the history. I was going to go through this and just cover every single point. I'm not going to have a chance. That's okay. I think I can do it.
There have been suggestions at the beginning of this case that somehow Dow Corning wasn't going to say it was responsible for something, that we were going to point the finger at somebody. We were going to point it at the Plaintiffs who were going to poi
nt it at the doctors or we were going to point it somewhere because we're not prepared to step up to th
e plate and accept the responsibility; and we said, "No. This was our product. It was our responsibility. And we're prepared to stand by that commitment." There are three basic obligations that I think are associated with that. One is to work with materials that are acceptable and to test them to make sure that they're safe. It's clearly out obligation. There's no quarrel on that.
The second is to monitor the performance of the implant and see if there are problems and then respond to them.
The third is to look for things like specific immune disease, "Is it really an issue? Is it really a problem?" What's been said here this morning was that it was not tested before it was sold, there were disastrous results from the injection process and the FDA banned it, we should never have gone into this business.
Then later on, we either knew and failed to act or we were ignorant -- either way, it's bad -- and once we finally found out in the mid-1980s, we concealed the truth. These are all statement that were made here in court.
I think you know already that those statements are wrong. They're wrong because you saw the cross-examination of Dr. Lappe' and the cross-examination of Dr. Busch and you saw each one of those statements taken on and yet they were made here this morning
like none of that ever occurred. We're back to the old labels about the nefarious company, the company that didn't care, it was just trying to crank out that profit. Take a look at the golden nose. Remember that little pamphlet? It tells you the story of what happened before 1964. Before 1964, we weren't even in this business. We had an organization called the Center for Aid to Medical Research, CAMR. We gave doctors fluid. We gave doctors rubbers. We gave doctors gel formulations, RTV formulations. They used them for medical purposes. They came back with dramatic, amazing results. They reported to us that this material was doing a terrific job. The disastrous results were disastrous results from misuse of the material i
n the Far East where they mixed it up with petroleum jellies, deliberate additives that were designed to stimulate an immune response. The experience from the proper use of pure silicone was a favorable experience.
There were dog studies. You heard Dr. Lappe', that there were three or four different dog studies before 1964. There was clinical experience before 1964.
We got into this business because after years of working with the doctors, we felt that there was a real prospect here not only in terms o
f a business but in terms of taking and dissembling more broadly these new medical devices, including hydrocephalic valves, including breast implants.
Was there testing on breast implants specifically? Sure, there was.
Dr. Cronin spent 18 months implanting these materials in dogs. He implanted it in women. Breast implants were sent out to 50 different doctors for implantation before 1964. All of this was done. The reports back were uniformally good.
Was there a misuse of the material? Yes.
Did the FDA decide to regulate future injection? Yes.
Now, does that mean -- if you would expected that there were disastrous results, the FDA would have said, "No way" to more injection. They didn't say that.
We have the IND that took place in this period of time. The IND was a sanctioned use of silicone injected fluid.
Why would the FDA ever do that if it were a problem?
This showed none of the problems that had been reported in Japan because it was new and good and pure materials.
What happened in the 1970s? In the 1970s, we weren't ignorant. We did a totally separate purpose; but at the same time, outside researchers were looking at the pure materials and finding that they were fine. We neither knew and failed to act nor were we ignorant. We had knowledge. The knowledge said, "No problem." By the time Mrs. Laas had her implants in place, there was a substantial history of research that was associated with this product: immune studies, sensitization studies, immunopath studies. All of them had bee
n done over the years. None of them showed any problems. The testimony is that there were no reports of any systemic disease prior to the time that she had her breast implants put in, again associated with the pure materials. Implant performance, bleed was known. Remember the editorial by Dr. Brody in 1977? The instructions will tell you that our obligation was to warn the doctors. Look to the instruction. It says it specifically. Look for it carefully.
The doctors knew about bleed.
Mr. O'Quinn s
aid, "Everything depended upon keeping the fluid in the bag." That's absolutely wrong. Everybody knew about bleed. If everything depended upon keeping the fluid in the bag and not having bleed, then once bleed occurred, why would the FDA be all over our
b If the FDA was also looking at fluid injection at the same time, they knew about the whole thing. They weren't telling us to take this product off the marketplace.
These are statements that don't square with the evidence. They don't square with
history. They don't square with the facts. They're designed to inflame you, to get you looking away from the history, away from the facts at just the time when you are going to be determining ethical conduct, "Did we behave improperly or not?" Implant was performance. What about rupture? Was rupture known? Yes, it was, from trauma.
Was it disclosed? Yes, it was. It was in our surgical techniques brochure. You've seen that as well.
What about the representation in "Facts You Should Know," that the implants would last a lifetime?
Take a look at it again.
And remember Dr. Biggs' testimony. That was not a statement that the implants will never rupture. Rupture was a known complication. It was a statement that they won't deteriorate, that absent some trauma, they will, in fact, last a lifetime. How do you do that? Remember Dr. Piziali. He gave you all of the different studies that had been done over the years to determine implant deterioration going back to the Sanuslog study on dogs in the earl
y 1960s to Langley and Swanson in the 1970s. That statement was, "Based upon what we know to date"; and it was absolutely true. It was based upon that and firmly based upon that. That was a true statement, not a false statement.
During this period of time, it said that we concealed, that we knew about the immune system issue and we concealed. Again, the label that's not the facts. This issue arose in the literature. There were case reports in the plastic surgery journals that
dealt with this issue. It then became our responsibility to follow up on that issue, but it wasn't concealed. It was open. We revised the package insert.
There was testimony from Mr. Hayes that it wasn't always read. What did we do about it? We came out with the PREP program through a "Dear Doctor" letter. Remember that warranty? It says, "Tell your patients. Reports of immunological reaction -- and i
f they have them, we'll replace the implants. There was no concealment. Go back to your notes. Go back to your memoirs. Don't trust the labels. They're just plain wrong. And that brings me back to the last topic that I wanted to cover, which are the invitations, the ones where you're sent a message that says, "Don't look at something or bypass something."
Here's one, unseen management. That's the one that says, "Gee, you've heard from Ms. Duel, you've heard from Dr. Klykken, you've heard from Mr. Boley and you've heard from Sue Peters. But do you know what? There were these meetings when they weren't th
ere, and everybody was deciding we're going to keep the product on the marketplace even though it's hazardous," and the management was behind it.
And you saw -- it was like looking at the task force minutes -- all the people there that we haven't shown up with here in court. Now, that theory would make sense if the people that were doing the work who were in the trenches felt there was a problem,
they were telling management and management was ignoring them. But that's not what happened.
We have the people who were in the trenches here to tell you that, in fact, they didn't believe that there was a problem. They never reported a problem to management because they didn't believe that it existed.
Mr. Boley does his proposal. And remember the question was, "Well, when you left the health care business board, you weren't there when they voted.
Mr. Boley's proposal was funded. The research got done.
He worked with Itteri; and then when Itteri finished its work, they hired Dr. Klykken to execute on that program. There was no conflict with management. There's no unseen management. Task force minutes. Why would we have minutes if the issue was so controversial? You saw all the issues that got raised. Baylor got protection. That's the argument that says, "Dr. Patten's at Baylor. He deserves special treatment in this courtroom. Dr. Busch is at Baylor. He deserves special treatment in this courtroom. Baylor got to be the fabulous institution that it is by looking for quality. Everybody at Baylor is subjected -- s
hould be subjected both there and here to the ultimate scrutiny for the quality of their opinions. The people from Baylor shouldn't be protected. Counsel for Plaintiffs ought to be saying, "I invite your scrutiny of these people as if they were never at Baylor. Let's see how good they are." It's our view that when you subject them to that scrutiny -- when you take a look at Dr. Busch's cross-examination, what happened to his testimony? When we take a look at Dr. Patten's paper, it doesn't stand up.
And the fact that they're at Baylor is no protection in this courtroom from your scrutiny and your judgment. Dow Corning hard line. You heard that this morning, "Dow Corning is in here fighting with no apology and no regrets." It's not the answer. It's not the truth.
Our position is that we accept full responsibility for what we did. And we put the issue of whether we discharged that responsibility squarely with you, with the jury. The jury is the ultimate harsh light of whether you've done right or
whether you've done wrong. The only hard line we're taking is that the decision should be made on the evidence, not on something else. This is an important case. The evidence is the only basis for your determination.
Finally we come to litigation like it's a bad word. What's the invitation here? In the 1980s, lawyers were involved in history. Therefore, there must be something bad. That's been the suggestion, "Oh, do you see his name on the memo? He's a lawyer.
There must have been something bad going on if he's a lawyer." Yet you heard at the same time that this company had a substantial settlement of a case in 1984 in this area on these issues. Very old science to date, but it was significant.
What in the world company wouldn't have lawyers take a look at what's going on? What kind of -- of course, there are going to be lawyers. The issue is whether the science still got done, whether the scientists were still calling the shots on the research
; and you've seen that they were. Bill Boley made a proposal, and the research got done. He said the package insert should be revised. The package insert got revised.
1992. we now have other cases that are on file and other trials that are taking place. What's the message? "Where there's smoke, there must be fire. Why would all these people sue?" And yet it's part of our system that our courts are open. If there'
s controversy in the media, people can go file suits. Yet under our system, when you file a suit, it means nothing. It's when you come to trial that the evidence actually is decided.
Do people like to come to trial? No. Is there sometimes no choice but to come to trial? The answer is yes.
And there have been other trials. I've tried one other case. Mr. O'Quinn has tried a couple of other cases. Those are not before you. What is before you here today --we'd love to talk about them. I'm sure both of us would. But what's before you today is this case and this evidence. This is not a reason to avoid the evidence. This is all the more reason to focus on the evidence and be controlled by it.
And finally we come to Bernick University, the defense organization. For your patience, I promise everybody here that they'll get a diploma from Bernick University for listening to me for so long.
Of course we've got a defense organization. We've got a lot of lawsuits. How in the world could we not have a defense organization?
Lois Duel has to go to different trials. Why? Because we want the juries to see Lois and to hear her testimony live and to make a judgment about Lois Duel. You can't do that without an organization.
We've got experts that go to different places. Why? It takes a lot of time to learn this subject matter and become versed in it and become proficient. And what is the whole focus of this organization? To put the matter in your hands so that you can se
e not only the ethics, which we believe support us, but the sciences.
I have just run out of my time precisely. I very much appreciate your patience during this long trial. The Judge is -- everyone is right. It's in your hands.
I will not get an opportunity now to respond to the Plaintiffs, but I urge you to think about what's taking place in this trial as we have the Plaintiffs and we have the defense witnesses and we have the Plaintiffs' witnesses and we have cross-examination.
For everything that you hear, think to yourselves, "What have I heard Mr. Bernick or one of the witnesses say that deals with that issue? Is it a label? Is it an invitation that's now going to be offered to you or is it the evidence?"
I appreciate your time.
THE COURT: All right. Thank you, sir.
Ladies and gentlemen, we're exactly on time. The parties agreed to their time before they started. We've got eighteen more minutes from Mr. O'Quinn and twelve from Mr. Mithoff, and then we'll be through.
We're going to take a fifteen-minute break.
Please remember your instructions. You are not to discuss this case with anyone.
I'll ask Mr. Bledsaw to please escort everyone outside.
I'll ask the audience in the gallery to please remain standing in your place until the jury has exited the courtroom.
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