February 17, 1998
AM Session
STATE OF MINNESOTA
DISTRICT COURT COUNTY OF RAMSEY
SECOND JUDICIAL DISTRICT
File No. C1-94-8565
The State of Minnesota, by Hubert H. Humphrey, III, its attorney general, and Blue Cross and Blue Shield of Minnesota,
Plaintiffs,
vs.
Philip Morris Incorporated, R.J. Reynolds Tobacco Company, Brown & Williamson Tobacco Corporation, B.A.T. Industries P.L.C., Lorillard Tobacco Company, The American Tobacco Company, Liggett Group, Inc., The Council for Tobacco Research-U.S.A., Inc., and The Tobacco Institute, Inc.,
Defendants.
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THE CLERK: All rise. Ramsey County District Court is now in session, the Honorable Kenneth J. Fitzpatrick now presiding.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Good morning.
(Collective "Good morning.")
MR. CIRESI: Proceed?
Thank you, Your Honor.
(Videotape played.)
MR. CIRESI: Your Honor, the exhibit that will now be identified in the deposition is trial Exhibit No. 3681.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Deposition Exhibit 1504 is Trial Exhibit No. 3683, and we will offer that.
MR. GARNICK: No objection.
THE COURT: Could you stop the deposition, please.
(Videotape stopped.)
THE COURT: Trial Exhibit 3683 will be received.
Could you wait until it's been -- if there's been an offer, wait for any objection and the determination by the court, please.
Thank you.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, we will offer Trial Exhibit 3684, which is identified in the deposition as Exhibit 1505.
MR. GARNICK: No objection.
THE COURT: Court will receive 3684.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Exhibit 1506 in the deposition is Trial Exhibit No. 3685, and we offer it.
MR. GARNICK: No objection.
THE COURT: Court will receive Trial Exhibit 3685.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Deposition Exhibit 103 will be offered as Trial Exhibit No. 2513.
MR. GARNICK: No objection.
THE COURT: Court will receive 2513.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Deposition Exhibit 1514 will be Trial Exhibit No. 3693, and we'd offer it.
MR. GARNICK: No objection.
THE COURT: Court will receive 3693.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Deposition Exhibit 126 will be offered as Trial Exhibit No. 2536.
MR. GARNICK: No objection.
THE COURT: Court will receive 2536.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Deposition Exhibit 1516 will be offered as Trial Exhibit No. 3695.
MR. GARNICK: No objection.
THE COURT: Court will receive 3695.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, the next exhibit will be Deposition Exhibit 1517, which will be offered as Trial Exhibit 3696.
MR. GARNICK: No objection.
THE COURT: Court will receive 3696.
(Videotape continued to be played.)
MR. CIRESI: The next exhibit is Deposition Exhibit 1518, which will be offered as Trial Exhibit 3697.
MR. GARNICK: No objection.
THE COURT: Court will receive 3697.
(Videotape continued to be played.)
MR. GARNICK: Objection to the next question and answer, Your Honor, as being inconsistent with the court's order. Counsel is testifying, and the question relates to periods of time that go beyond Dr. Osdene's tenure.
THE COURT: The objection is sustained.
MR. CIRESI: The next exhibit, Your Honor, will be --
THE COURT: Counsel, excuse me, counsel. As I understand it, that's page 93, lines nine through 12; is that correct?
MR. CIRESI: That is correct.
MR. GARNICK: Yes.
MR. CIRESI: Through 13, Your Honor.
MR. GARNICK: Through 13.
THE COURT: Through 13. I just want the record to show that.
MR. CIRESI: The next deposition exhibit will be 1519, which will be offered as Trial Exhibit 3698.
MR. GARNICK: No objection.
THE COURT: Court will receive 3698.
(Videotape continued to be played.)
MR. CIRESI: The next deposition exhibit is 1520, which will be offered as Trial Exhibit 3699.
MR. GARNICK: No objection.
THE COURT: Court will receive 3699.
(Videotape continued to be played.)
MR. GARNICK: Objection. Same basic grounds as before that is in Your Honor's order, it goes beyond the document, and also it's not limited in time to Dr. Osdene's tenure.
MR. CIRESI: Just asking whether he recalled, Your Honor, which is limited by its question to the time that's related to the exhibit.
THE COURT: The objection is sustained.
MR. GARNICK: And that would be page 132, line 20, to page 133, line two.
MR. CIRESI: The next deposition exhibit, then, would be 145, which will be offered as Trial Exhibit 2554.
MR. GARNICK: No objection.
THE COURT: Court will receive 2554.
(Tape continued to be played.)
MR. CIRESI: Your Honor, the next deposition exhibit, 279, is offered as Trial Exhibit 2688.
MR. GARNICK: If they're offering it, we have no objection.
THE COURT: Court will receive 2688.
(Videotape continued to be played.)
MR. GARNICK: Objection, page 140, line 15 through 21, goes beyond the document, it's not limited in time to Dr. Osdene's tenure, and it is testimony of counsel.
MR. CIRESI: It is directly related to the preceding question, which was the final full paragraph on the second page, and he's being asked a question directly related to that paragraph.
THE COURT: You may respond.
(Videotape continued to be played.)
MR. CIRESI: Exhibit 91 is being offered as Trial Exhibit 2501, Your Honor.
MR. GARNICK: No objection.
THE COURT: Court will receive 2501.
(Videotape continued to be played.)
MR. GARNICK: Objection, again goes beyond the document, beyond that it mischaracterizes Dr. Charles' testimony. And this objection relates to page 142, lines 15 through 21.
MR. CIRESI: This is preparatory to Dr. Charles' testimony which will be offered, Your Honor, and it's also preparatory to asking him a question with regard to his recollection, and it relates specifically to the document in question.
THE COURT: Okay. I'll allow the testimony as subject to a motion to strike after the testimony is received of Dr. Charles.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Exhibit 1529 from the deposition has the Trial Exhibit No. 3708, and we'll offer Exhibit 3708.
MR. GARNICK: No objection.
THE COURT: Court will receive 3708.
(Videotape continued to be played.)
MR. CIRESI: Your Honor, Deposition Exhibit 148 will be offered as Trial Exhibit No. 2557.
MR. GARNICK: No objection.
THE COURT: Court will receive 2557.
(Videotape continued to be played.)
THE COURT: We'll be taking a short recess at this time.
THE CLERK: Court stands in recess.
(Videotape paused at deposition page 229,
line 20.)
(Recess taken.)
THE CLERK: Ramsey County District Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
MR. CIRESI: Thank you, Your Honor. We would offer two previous exhibits that we had not, Your Honor, but were the subject of Dr. Osdene's testimony: Exhibit 3680, which was Deposition Exhibit 1501, and it was at page 37 of the deposition, and Trial Exhibit 3681, which was Deposition Exhibit 1502, and it was at page 41 of the deposition.
MR. GARNICK: No objection.
THE COURT: Court will receive 3680 and 3681.
MR. CIRESI: And the questions now are by Philip Morris's attorney, Mr.
Webb.
(Videotape started at page 230, line 24.)
MR. CIRESI: We have to roll the tape for the next part, Your Honor; that's why it's taking a while.
(Videotape continued to be played.)
MR. CIRESI: That completes the deposition of Dr. Osdene, Your Honor.
We would call Dr. Scott F. Davies to the stand, Your Honor. Dr. Davies.
(Witness sworn.)
THE CLERK: Please state your name and spell your last name for the record.
THE WITNESS: Scott F. Davies, D-a-v-i-e-s.
MR. CIRESI: Doctor, you may want to attach that to your belt. The other -- the other part, not -- there you go.
SCOTT F. DAVIES called as a witness, being first duly sworn, was examined and testified as follows:
BY MR. CIRESI:
Q. Good morning, doctor.
A. Good morning.
Q. Doctor, you reside at 2100 East 43rd Street in Minneapolis, Minnesota?
A. Yes, I do.
Q. And you're presently the director, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine at the Hennepin County Medical Center in Minneapolis?
A. Yes, I am.
Q. And you're also the medical director, chief of medical staff at Vencor Hospital in Golden Valley, Minnesota?
A. Yes, I am.
Q. Doctor, you're here to testify about chronic obstructive pulmonary disease, one of the major smoking-caused diseases?
A. Yes, I am.
Q. Doctor, before we get to your testimony itself, I'd like you to review just briefly your background and education for the jury and the court.
You obtained your B.A. degree from the College of Holy Cross in Massachusetts?
A. Yes, I did.
Q. And then you obtained your M.D. in 1974 from the University of Minnesota?
A. Yes.
Q. And from 1974 to 1975, you were an intern in internal medicine at the University of Minnesota?
A. That's correct.
Q. And from 1975 to 1977, you were a resident in internal medicine at the University of Minnesota; correct?
A. Correct.
Q. With regard to your licensing and certifications, you're a diplomat of the American Board of Internal Medicine?
A. Yes, I am.
Q. You're also a member of the Pulmonary Medicine Subspecialty Boards?
A. Yes.
Q. And you have critical care certification; correct?
A. Correct.
Q. And from 1979 to 1994 you were an assistant professor of medicine at the University of Minnesota Medical School?
A. Yes.
Q. And 1985 to 1994 you were an associate professor of medicine at the University of Minnesota Medical School?
A. Yes.
Q. And from 1994 to the present time you are a professor of medicine at the university's medical school; correct?
A. Yes.
Q. And at the present time you are a course director at the University of Minnesota Medical School in a course entitled "Pathophysiology, Respiratory Medicine?"
A. Yes, I am.
Q. And 1979 to the present time you've also been on the faculty for clinical rotations in pulmonary medicine and critical care medicine at the Hennepin County Medical Center for medical students, medical residents and pulmonary fellows and critical care fellows; is that correct?
A. That is correct.
Q. Can you describe that program a little bit, please, doctor.
A. Well Hennepin County Medical Center is a teaching hospital, one of the four major teaching hospitals of the University of Minnesota. It's a urban, city hospital, and as medical students in their last two years of their training get clinical experience, they rotate and take different rotations or elective rotations at our hospital. And for example, they might do six weeks on an internal medicine ward, and they might do six weeks in an intensive care unit, and they might do six weeks studying pulmonary diseases and that -- by seeing patients and working with the faculty.
The patients in the hospital are generally taken care of by a team, and that team has often a medical student, and then a resident, who's someone who has finished medical school but training to become boarded in internal medicine, and then a faculty member, working together to take care of that patient. And so the students -- about 35 percent of all clinical rotations of Minnesota -- University of Minnesota students are spent at our hospital. It's one of the major teaching sites. And I work with those students and those residents, but in the process of taking care of the patients who come for various different problems.
Q. And doctor, from 1980 up to the present time, how many students at the University of Minnesota Medical School have you taught respiratory medicine to?
A. The second-year course that Mr. Ciresi is referring to is a lecture-type course that goes six weeks in the second -- in the fall of the second year of the medical school, and all the students take that course; it's their introduction to lung diseases. And there's about 200 students, and I've taught the course for 18 years, so basically every student who's come through, over 3,000 students would have taken that course since 1980.
Q. And do you also serve on the faculty at many local and regional post- graduate courses sponsored by various institutions?
A. Yes, I have.
Q. And those institutions would include the Mayo Clinic?
A. Yes.
Q. The University of Michigan?
A. Yes.
Q. And the University of North Dakota?
A. Yes.
Q. And doctor, are you also a member in various professional societies?
A. I am.
Q. Does that include the American Thoracic Society?
A. Yes, it does.
Q. And the American College of Chest Physicians?
A. Yes.
Q. And have you also held various offices and committee assignments in the professional societies that you belong to?
A. Yes, I have.
Q. Have you been the chairman of the Cardiopulmonary Infection Steering Committee of the American College of Chest Physicians?
A. Yes, I have.
Q. Have you also been the president of the Minnesota Thoracic Society?
A. Yes, I have.
Q. Have you also been on the Tuberculosis and Pulmonary Infection Program Committee of the American Thoracic Society, Scientific Assembly on Microbiology?
A. Yes, I have.
Q. And in 1987 to 1982 did you serve as the Governor for the State of Minnesota, the American College of Chest Physicians?
A. Yes, I did.
Q. And doctor, with respect to your primary areas of research at the present time, does that include deep fungal infections?
A. Yes, it does.
Q. And can you describe what that is, please.
A. There are a variety of chronic pneumonias. Most pneumonias are -- we think of, you take an antibiotic and the pneumonia goes away in a week or two, and there's some chronic infections in the lung that last a lot longer and require different antibiotics over a longer period of time, and the one that's most common would be tuberculosis that most people would know about that doesn't go away in a week like a pneumonia, it requires many drugs for many months, and it's sort of more subacute or chronic. There are other chronic pneumonias caused by fungal organisms that you inhale from the soil. Some of them are common in southern Minnesota and northern Minnesota. And they also present like -- not like a bacterial pneumonia where it goes away in a week with an antibiotic, but requiring many months of treatment and presenting a little bit differently. And I've studied the epidemiology of those diseases and the treatment and various clinical -- clinically-related aspects of those diseases.
Q. And have you also done major research in obstructive sleep apnea?
A. I'm part of the faculty at the Minnesota Regional Sleep Disorder Center, which has been in existence since 1978, and it's done a lot of research learning different things about sleep disorders.
Q. And you can tell us what sleep apnea, doctor?
A. Sleep apnea is sort of -- everyone has seen someone snore. It's the far end of snoring where the snoring gets so loud that it's not just rattling the room, but the patient actually sort of chokes and obstructs and then has to wake themselves up again to get breathing again. And those snorers get very tired during day because their sleep is so fragmented and choppy and disruptive. That's what sleep apnea is.
Q. And doctor, during the course of your career have you published in excess of a hundred articles in peer-reviewed journals and books that are used by other physicians?
A. Yes, I have.
Q. And with respect to your practice itself, doctor, is about 20 percent of it spent in treating chronic obstructive pulmonary disease?
A. Ten to 20 percent of my inpatient practice and a slightly higher percentage of my outpatient practice would be seeing patients with chronic obstructive lung disease. I see them every single day when I'm in the hospital and every single day when I'm in the clinic, patients with this problem.
Q. Doctor, can you describe what is chronic obstructive pulmonary disease?
A. The -- the pulmonary part, "pulmonary" just means lung, so it's a lung disease, and the "disease" itself is explanatory. What "obstructive" means is that there's a problem with emptying the lungs. The lungs can't empty normally, so there's obstruction to air flow during exhaling, exhaling is impeded and slowed. And the "chronic" means that the condition is permanent, that it cannot go away. It can partly get better sometimes, but it cannot go away. So "chronic" means a permanent condition in which there's obstruction or slowing of expiration, the patients can't exhale normally. And the "pulmonary" is just that it's the -- it involves the lung and that it is a major disease.
Q. Doctor, how does that compare with like asthma?
A. Asthma also has airflow obstruction and patients with asthma can't empty their lungs. And it's a pulmonary disease. But asthma, the obstruction is due to spasm of the smooth muscles around the little air tubes, and secretions, so that it is not a chronic disease, it can -- in the sense that an attack of asthma can reverse. And someone with asthma can come in at another time when they've been well treated and are not having symptoms and have normal lung function with no obstruction. So it's a reversible obstructive airway disease would be asthma, whereas COPD is a chronic, irreversible sort of like an asthma attack that can never end, that will last forever.
Q. Doctor, we've had Drs. Hurt and Dr. Samet and Dr. Robertson describe for the jury and the court the anatomy of the lung. But I'd like to have you touch briefly on it with respect to how it will impact your testimony here.
Could you go to the exhibit book in front of you and please direct your attention to Exhibit 30054.
MR. CIRESI: Which we would offer for illustrative purposes, Your Honor.
MR. MONICA: Your Honor, I object to counsel summarizing or attempting to summarize testimony from prior witnesses and ask that counsel be instructed to just ask direct questions.
THE COURT: Well I think the question is pretty preliminary.
MR. CIRESI: It was, Your Honor.
THE COURT: I'll let it stand.
MR. CIRESI: Is there an objection to 30054 for illustrative purposes?
MR. MONICA: There is no objection.
THE COURT: The court will receive 30054.
BY MR. CIRESI:
Q. Doctor, if we can start with maybe the depiction in the upper third and work our way down, and if you could describe what is being represented by this exhibit.
A. It's my understanding that you've been shown some normal anatomy of the lungs and how the windpipe is the biggest tube, and then it divides into ever- smaller tubes, so there's a series of branching tubes that carry the air out into the lung tissue. And where we're starting, up on the right part -- this won't show on the screen, but if we start on the very upper right is one of the very small tubes that's already branched 15 times, so it's getting through the -- what's called the conducting airways or the tubes that bring the airway to the lung and it's getting close to the business end of the lung where the oxygen actually goes into the blood and the carbon dioxide comes out into the gas so you can exhale it. This last -- the bronchus at the upper right entering the screen is labeled "Terminal Bronchiole," and that's because it's one of the small terminal broncioles that leads to the business end of the lung where the gas exchange comes to. And then you can see that the next branch of tubes has a few little sacs off the edges, it starts to get little tiny sacs around the edges, not all the way along, but sort of scattered along that tube, and that's called the respirator bronchiole, of which there are several branchings of that. So it means they have some parts in gas exchange because there's little sacs, air sacs actually coming off the tubes, and then it goes all the way to the end, you can see that the little air spaces have sacs all the way around them, and that's all they do. It's done conducting air down, and that's just where the air sits and gas exchange occurs. So this is sort of the terminal, business-end of the lung.
Q. And doctor, at the end you were talking about the alveolar sacs?
A. The alveolar sacs are these little tiny sort of blisters around the edge of those round alveolar ducts at the end.
Q. Can you then describe what is being depicted in the middle third, doctor, of this Exhibit 30054.
A. What --
Can we come down just one second to the top again?
Q. Yes.
A. Because what -- what's important is that when we talk about obstruction, or patients not being able to exhale the air from their lungs, it's chronic obstructive lung disease, and where that happens is in these very small airways, the very small airways are -- that sort of limiting factor for air getting out of this lung and back up into the windpipe and the other bigger pipes that carry it out of -- out of the lung. And the -- the -- so that right where you see the respiratory broncioles is where the obstruction and the problem with can't exhale develops. Patients can't exhale because of problems right in that particular area.
And the two kinds of problems that occur are both related to smoking, and the first is that there are inflammatory cells that gather in that area, inflammatory cells just like would gather in a boil, if you had a boil on your skin they gather there, and they can cause scarring and secretions and narrowing, and that can sort of block the exit of air from the lungs. And the second thing that happens is the lung starts to dissolve right at that point, and the --
In fact, expansion of these air spaces beyond the terminal bronchiole is what the definition of emphysema is, and you've all heard the word "emphysema." It's just large air spaces beyond the terminal broncioles.
So that if we can go up to the second picture, this shows what's called centrilobular emphysema, which is just called that because it's right where these -- these small air tubes come off the respiratory bronchiole, before you get out to the little alveolar sacs at the end. And as the lung tissue gets dissolved, these spaces get larger and larger and larger. So that -- normally they're microscopic, and they become so large that they're even visible to the naked eye as the lung expands.
The next -- the bottom one just shows what's called panlobular emphysema, where the whole air space is totally dissolved, not only the proximal tubes, but all the way out, involving the little tiny air sacs. And it's changes in this -- in this lung, it's -- it's anatomic and pathological changes in this lung that make it not empty, as I'll show you in a minute. But this is where the action occurs, and this is why patients have obstructions. Can't --
Chronic obstructive lung disease, the obstruction is cannot empty the lung of air, and the chronic means it's an irreversible condition.
Q. Doctor, can you direct your attention now to Exhibit 30056.
MR. CIRESI: Which again, Your Honor, we'd offer for illustrative purposes.
MR. MONICA: No objection.
THE COURT: Court will receive 30056 for illustrative purposes.
A. Now there is a little schematic that's just taking one of those respiratory bronchioles that were coming off -- the first branch that were coming off there, starting to get little air sacs, entering the -- the business unit of the lung, and cutting it in side -- sideways, so it's a cross-section of one of these little terminal broncioles. It's a schematic, I drew it, and it's not an actual picture of tissue, but it illustrates what's happening at that point in the lung.
So it says at the top COPD is an obstructive lung disease, that means the lungs cannot empty and that the obstruction, the site of major obstruction occurs in these small peripheral airways. And it has several features why this lung won't empty. Normally when you just relax your lungs -- lungs empty all by themselves. One of the reasons is that there's all these inflammatory cells that gather in and around this airway, and they're marked by little while circles, and they cause swelling and they cause edema and they cause scarring.
Q. What's edema, doctor?
A. Edema is just swelling in the tissue like you might get if you get a burn, and right over a welt -- you know, fluid would come into the tissue and you can see it and it would be raised over your skin.
And the infection-fighting cells are exactly what would happen if you have a boil, and the boil, you know, if you puncture it, there's yellow pus in there, and the cells come in and sit around the airway like that, and even through the wall of the airway. And then in the center I'm trying to show that there are secretions and pus that are in the airway. And you can hear people cough this up when they have -- when they have to get that deep phlegm out of these airways.
So that the two things that this inflammation at this site does is it causes fibrosis and scarring on this airway, which narrows it, and that keeps the lung from emptying. But it also -- these cells are loaded with elastases, and elastases are like meat tenderizer and they break down various tissue structures. And what they will do is start dissolving some of these alveolar walls that normally connect to these small airways. Because the airways have to go through the lung, and so there's lung tissue around them, and normally that lung tissue helps hold them open when you breathe out. And as these alveolar walls are destroyed by the elastases, that's how you get these bigger spaces in the same area, these air spaces that are emphysema.
So when that happens, when these airways are no longer tethered open by tissue, then they tend to be floppy and collapse as you breathe out. So that's the second way in which obstruction occurs, is that these small airways are not supported, they're not tethered open, so they tend to narrow and collapse as the patient breathes out. That's why it's an obstructive disease.
Q. Doctor, we've all had the experience of blowing up a balloon and it's elastic.
A. Right.
Q. And then it loses its -- its resilience, if you will.
A. Right.
Q. Is there any analogous situation?
A. I think on the next slide I was going to show exactly that.
Q. Let me direct your attention, then, to Exhibit 30053.
MR. CIRESI: And we'd offer that for illustrative purposes, Your Honor.
MR. MONICA: No objection.
THE COURT: Court will receive 30053 for illustrative purposes.
A. So in the --
On the top is just the normal situation, again very schematic. Here there's only two alveoli or two air spaces being shown, when in reality there's a hundred million of them. So it's a two-compartment little schematic. And it shows that that's what the normal lung looks like, and the pipes leading to this air space are fairly rigid and they're not narrowed, and they're also stretched open by the tethering tissue around them. Also, the alveoli themselves, as they're stretched, have an elastic property like a balloon, so that they tend to want to empty as soon as you've inflated your lungs. You do the work taking the breath in, and you just relax and the breath empties very naturally without you feeling it or doing any work or using any muscles, and part of that is you stretch the lung and it's like a balloon, and then the pipes are open, and the pipes are well supported and the pipes aren't narrow, and the air just comes out very naturally without any sense of work.
Now the bottom two slides show what happens in COPD. And on the left is illustrated simply the fact that if all this inflammation of these tiny airways causes scarring and secretions and narrowing, that those balloons are not going to be able to empty through those narrowed pipes. So it's a disease where you cannot exhale. And on the right shows you an area of the lung where the supporting tissue has been dissolved, the alveolar walls have been dissolved, and these air spaces are -- are bigger and larger.
And that has two different effects. One is that the airways aren't tethered open by tissues so they tend to just collapse and are floppy, but the other effect is that the balloon has lost all of its elastic properties, so it can't empty partly because it's just distended, and so all of the walls and all the elastic tissue has been dissolved, and just like -- thinking of a rubber balloon that's made of thick rubber and is very hard to blow up, it's going to empty very easily, whereas if you made a balloon of something that was like -- more like Saran Wrap and didn't have any elastic, it's just going to sit there and it's not going to empty very well.
So there's three main factors related to the can't empty part, and all of them are permanent, that's why we call it chronic obstructive lung disease, and the obstruction is related to three factors, scarring and secretions and narrowing of these small airways due to the inflammatory cells, lots of tethering due to the dissolving of the little connections that hold the airways open, due again to the inflammatory cells that gather there, and finally destruction of the lung so it becomes a balloon that hasn't got thick rubber any more and it can't sort of empty forcefully when you relax.
And for all those reasons, what we're used to is taking a breath again, and with an active use of our diaphragm and our muscles, and then relaxing and the lung will just empty, nice and normal. And in these patients, they can not empty, the lungs can't empty normally, and that's what the word "obstruction" is talking about.
Q. Now doctor, do we have some human lungs here that were freeze dried to show a normal lung and one with emphysema?
A. Yes, we did.
Q. Could you step down, please.
MR. CIRESI: Your Honor, could the doctor step down?
Q. Maybe you could -- I could move this up for you, doctor.
A. Well these are --
It's interesting, I saw some of the videos you showed and they looked like just this. But these are real --
MR. MONICA: Your Honor, excuse me, may I lodge an objection, pleases? Your Honor, these lungs, a foundation has not been established as to where they came from and whose lungs they are, and I don't know that this witness has that knowledge, and I would ask that before they be shown to the jury and discussed, that that be established.
MR. CIRESI: Your Honor, these are only being used for illustrative experience. The doctor has had experience in dealing with lungs his entire career, and they're being used for illustrative purposes only to explain to the jury the concept that he's just shown on the illustrative depictions that we've put in, Exhibits 30054, 30056 and 30053.
THE COURT: I think it's appropriate so long as it's just for illustrative purposes.
MR. MONICA: Your Honor, --
MR. CIRESI: Your Honor.
MR. MONICA: -- excuse me, may I go over?
THE COURT: Please.
MR. CIRESI: The normal lung then is Exhibit 30269, 30269, and it's being offered for illustrative purposes only. And he also has a sliced part of the lung, which is Exhibit 30270.
Go ahead, doctor.
A. Okay. First piece is the lung, and it looks like sponge, and you can actually feel it. It's not -- it's sterile and it's not going to cause any harm.
Because these little air sacs are very microscopic, they're tiny, tiny air sacs, just like in a sponge has microscopic, and a sponge has a lot of sponge to it, a lot of tissue to it, and the same is with these lungs, so they have a fairly good structure. And basically as you breathe in through the little air tubes, all the little air sacs inflate, and then you relax and everything empties out to its resting position just naturally with no trouble.
Q. Doctor, could you just maybe move around this side --
A. Sure.
Q. -- so the court and all the jury can see it.
A. Now this is a piece of a similar lung, a normal lung, that's just been sliced with a saw, and what you can do in looking at this is that you can't even see the air sacs. They're so tiny that they're really microscopic, the things I've been showing you on the screen, they're invisible, just like a sponge, you can't look at it and see the individual holes in the sponge, even though you know when you squeeze it and open it, it's going to hold water in those little holes. You can see some of the --
You will see there are holes here in the center, and these are the blood vessels that carry blood to the lung or they're the bigger air tubes that branch through the lung, getting out to the small -- small part. And the units that I'm showing you schematically are very tiny little terminal units of which there are about 60,000 units supplied by one of those, what I showed, terminal broncioles up in the right upper corner of that. And you can all look at this and -- and see that there really is --
Maybe I could pass it around in the tray.
Q. If you put it in the box. If we could, Your Honor.
A. And you can look at this and see that there really is not any visible holes, that the holes are sort of beyong --
Q. Doctor, the clerk will --
You have to let the clerk do that.
(Clerk displays the exhibit to the jury.)
A. I noticed that none of you wanted to really touch it, but if you push on this with your thumb, and it's sort of firm, it's like a firm sponge, and it has tissue to it.
Q. And doctor, do you also have a freeze dried lung of emphysema?
A. We have another lung prepared in the same manner of a patient who died with severe emphysema from -- who was a long smoker.
MR. CIRESI: Your Honor, for illustrative purposes, the doctor will be referring to the Exhibits 30272 and 30273.
A. Now this --
MR. MONICA: Your -- Your Honor, excuse me, we object to these two exhibits. The witness has stated one of them, at least, is from a smoker. That has not been established. I think a foundation needs to be established. I'm not even sure whether this witness has ever seen these before today. And we object to them on that basis.
THE COURT: I think you should establish some foundation.
BY MR. CIRESI:
Q. Doctor, how do you know that that's a smoker's lung?
A. These are from the collection of the pathology laboratory at the University of Minnesota, and the person who has custody of this collection told me that he had in his record that this patient was a smoker.
MR. MONICA: Your Honor, I --
MR. CIRESI: We offer it for illustrative purposes, Your Honor.
MR. MONICA: Your Honor, I object. It's based upon hearsay, and the witness has no first-hand knowledge of these particular lungs.
THE COURT: Okay. I'll allow it for illustrative purposes only.
MR. CIRESI: Doctor, make sure you turn around so everybody can see.
A. Yes, I'm sorry. So this is a lung fixed in the exact identical manner, and this is the whole lung, which doesn't illustrate too much, except that a lot of the tissue has been dissolved, and you can see that it's crinkly and does not have very much substance to it, and that's because these small alveolar sacs have been dissolved and that the spaces with air in it are much, much bigger, and they aren't these microscopic. And that's what emphysema does, is it dissolves the lung tissue. Now we couldn't --
We prepared some sections here, and they're in plastic bags, and you'll notice that the others aren't in plastic bags, and that's because they're so much more fragile that they would fall apart if they weren't in a plastic bag. And when you see at these sections you can actually see the visible holes in the terminal air spaces in the lung that you couldn't see before. When I pass them around, you can just glance at the outer rim and see that there are holes that are so big that they're totally visible to the naked eye. And if you hold it up to the light, you can actually see through it; it's a moth-eaten, dissolved lung where all the tissue that's supposed to form these alveolar walls and hold the gas exchange units in the lung has been dissolved. And this is what emphysema is, it is a dissolving of all these spaces so that the lung becomes moth-eaten and the spaces -- the air spaces beyond the terminal bronchiole are enlarged many times beyond what these normal spaces would be enlarged. And that's what contributes in the three ways that I told you about the inability of this lung to empty. The lung cannot empty. It's an obstructive disease where the patients cannot exhale any more and cannot release the lung -- the air from their lungs because the small air tubes have been narrowed and because there's bigger air spaces so that the -- what air tubes there are are not tethered open by the structure and the tissue of the lung, and because there's no elastic recoil. The other lung snaps back to shape when you stretch it by taking a breath because it's like a thick balloon, and this is just a moth-eaten tissue that has totally lost its structure and can't snap back, so it won't have any elasticity and it can't empty.
MR. CIRESI: Your Honor, could we have the clerk pass those.
(Clerk displays the exhibits to the
jurors.)
Q. Doctor, in the course of your work, do you need to measure lung capacity?
A. Yes. I mentioned, you know, the chronic obstructive lung disease, the obstruction is the fact that the patient can't exhale, and how we determine if someone has it and how we determine how bad it is is by making direct measurements of how well the patient exhales air from their lungs. I told you that the basic problem was that if the person couldn't exhale, that they couldn't empty their lungs normally. And you have to sit and try to think how am I going to -- how am I going to measure that? Eventually, you know, you come up with the idea that you have the patient take a deep breath and blow out as fast as they could, and just measure in some way how fast the air would come out, and that would tell you if there's obstruction to air flow. And that's exactly what we do in the pulmonary lab, is the standard diagnostic test for finding out if you have airway obstruction and finding out how bad it is.
Q. And have you prepared an exhibit which would illustrate what is done, --
A. Yes, I have.
Q. -- and that's 30268?
A. Now --
MR. CIRESI: Your Honor, we would offer 30268 for illustrative purposes.
MR. MONICA: No objection.
THE COURT: Court will receive 30268.
A. Okay. Now this is a graph, and first of all we start at the vertical axis of the graph, and you'll see it says volume, and we're measuring the volume of air that a person can breathe out and we're measuring it in liters, so that there's one, two, three, four and five liters of air. Someone can hold about five liters of air in their lungs. And that volume of air is measured as someone blows it out. And on the right you see it says time, and here in this graph the time is in seconds, one, two, three, four, five, six seconds.
And what we do is we take -- tell the patient, "I want you to take a deep breath, fill your lungs as full as you can with air, and then I want you to breathe it out as hard and as fast as you can until your lungs empty, till they're empty." And we measure exactly what happens to their volume.
And I want you to look only at the top curve for a second, and that's a normal what's called -- this is called the spiro -- spirogram -- spiro is just breathing, gram is a graph of breathing -- and the top line is what's called the normal spirogram. And when the patient -- what you can see is that when the patient breathes out, that little dot where it says FEV1 --
Q. What is FEV, doctor?
A. FEV1 means the --
The F just means that we ask the patient to breathe hard, that they forced their expiration. And E is just the exhaled volume. So it's the forced exhaled volume. The patient takes a big breath and they force it out as fast as they can with a forced exhalation. And the little one just means that that is how much air came out in one second. And that's why if you look where that dot is, it's right above the one second mark on the graph.
And what that shows you is that when a normal person breathes out hard, 80 percent of the air comes out in one second. His lungs -- they're stretched when you take a deep breath, they're really elastic like a stiff balloon, and the pipes that conduct the air out them are held open and they're big enough to empty the lung. And so when you breathe out hard, 80 percent of the air comes out in one second. The rest of the 20 percent comes out in another second or two. So within -- within two or three seconds all of your lung is empty and no more air is coming out, you're just going flat along that curve. So that's what normal lungs are supposed to do. You take a deep breath to the size of your lungs, and if you blow out hard -- you can all try this, you blow out hard and your lungs will be empty in just a second or two and there won't be any more air coming out.
And that's how we measure whether someone has COPD, is by doing a test like this.
Q. Now what is depicted with the second line, which is titled "Moderate Obstruction?"
A. Well the second line is someone who has COPD that's moderately severe, and by -- we mean moderately severe is it's gotten bad enough where in a normal-sized person only about one and a half to two liters of air will come out in one second. And that that reduction is due to the mechanisms that we talked about, the narrowing of the pipes, the dissolving of the tethering of the pipes, and then the loss of elasticity of the lung tissue itself.
And you can see several things about that curve that are different. First of all, if you go up on one second, only about one and a half liters came out, and that's only about a quarter of the air came out in the first second. Instead of 80 percent comes out in the first second, only a quarter of the air came out in the first second. And as long as the patient keeps breathing out and out and out, the lung keeps emptying and emptying and emptying. So it doesn't really get emptied, it just continues emptying until the patient has to stop and take another breath. So this is a lung clearly that can't empty very well. The patient cannot empty the lung.
Then the third graph is just -- it shows what someone with severe, terrible obstruction, and I want you to pay close attention so this because we're going to talk about a patient who has this -- has obstruction this severe and show you an illustration of this. But this is where the FEV1, the amount of air that comes out in one second here, is under one liter of air, so it's about maybe 600 -- .6 tenths of a liter, so it's maybe 20 -- you know, 10 or 20 percent of the lung volume can come out in one second. And you can see that it's slow to come out all the way along the way. It's just the lung cannot empty, and just a little air comes out piece by piece by piece by piece rather than the lung just snapping empty and going right down to empty within two seconds. And that would be someone with very severe obstruction.
And people with moderate obstruction and terrible obstruction, it's not just something you measure in the lab, it's something that translates into real symptoms that cause people real difficulties in -- in living their lives.
Q. How does this manifest itself in terms of a person breathing?
A. Well everybody is -- is different, but patients who have mild obstruction can normally do things pretty well in their day-to-day life. They couldn't run a marathon very well, they couldn't do highly athletic things, but they could walk from place to place and carry on a relatively sedentary job and do okay and not be very bad. When it gets down to moderate obstruction, patients begin to get shortness of breath that interferes with the heavier things they have to do in their day-to-day lives, like walking upstairs, they go to church and there's ten steps up, or if there's a little something unusual or if they have to -- they may be fine walking in from the car, but if they have to carry a 20-pound bag and they get breathless and short of breath and feel hungry for air.
And then when you get to the bottom, the terrible, when the FEV1 gets under a liter, that's where any little activity -- you know, even if the patient is okay at rest, any little activity, walking a few feet, saying eight words, have to take another breath. Doing -- you know, just conversing, walking a little bit, carrying a very light things, anything like that would make the person short of breath. And eventually they end up being in a wheelchair because people have to move them, or a little motorized cart, and they end up with oxygen. Most of the patients have oxygen who have FEV1s under one liter, they have severe obstruction, and they end up with really being very, very disabled. Disabled from work, but disabled also from normal human activities that they're required to have a high quality of life by the severity of the shortness of breath that they have.
Q. Doctor, when someone is breathing with moderate or -- or heavy obstruction or terrible obstruction, is their breathing pattern different than the normal person would have?
A. Well they breathe faster. There's a number of things that -- that they do. They breathe faster because they're short of breath and they're hungry for air, but they also tend to --
One of the problems is because the lung can't empty, when they're ready to take another breath there's already air in the lung. In fact the tubes have collapsed, so the only way you could get a breath is to take a breath on top of a partly-filled lung already. So that they tend to -- the lung volume tends to walk up and up to a higher lung volume so they can keep some little amount of air going in.
When the lung gets up to a very high volume, which it has to be so you can get some emptying -- so the lung can't empty, so the next breath has to be on top of that, can't empty so the next breath has to be on top of that, you end up with a patient who is breathing way up high with big, inflated lungs, and the work of breathing at that mechanical place is very, very hard, and one of the reasons is that the diaphragm is the main breathing muscle, this is the big piston-like muscle that's right under the rib cage. When you breathe in you can see your belly contents will come out as the diaphragm comes down, and what happens is if your lungs get too big, then the diaphragm is totally flat at the beginning of the breath and can't help you, so your main breathing muscle, because of the mechanical problems of not -- of lungs that can't empty, becomes absolutely unable to help you take the next breath. So all you have left are your muscles of your neck and your muscles of your upper chest. And you can sort of watch people who have very big barrel-chest, severe emphysema, and you'll watch them breathe and they use all these neck muscles to breathe, we call them accessory muscles, and all their chest muscles to breathe, and it's very, very hard work, very, very hard work to breathe when the lung is -- when the chest wall's expanded and the diaphragm is flat and won't work and they're having to use all these extra muscles to get a little air on top of these great big lungs that can't empty normally because of this problem.
So you'll see people breathing visibly, you can watch their neck muscles tighten as they sort of fight to take a -- to take a breath in, especially when they work, but sometimes even at rest.
Q. And doctor, have you prepared another graph which shows the effect of smoking in COPD over a period of time?
A. Yes, I have. And I think what it --
I made another graph to show you sort of the natural history of COPD and to talk a little bit about how this happens to a person over a lifetime when they get obstruction of their air tubes, when they get this chronic permanent obstruction of their air tubes.
Q. Can you direct your attention to Exhibit 30059. Is that the illustrative exhibit that you have prepared, doctor?
A. Yes, that --
Yes, it is.
MR. CIRESI: Your Honor, we would offer Exhibit 30059 for illustrative purposes.
MR. MONICA: No objection.
THE COURT: Court will receive 30059.
A. Just like before, I want to go over this graph and just set up the vertical and the horizontal axes. And you can see that the vertical axis is the same, it's volume, and it's volume in liters. And this is the volume of air that comes out in the first second on one of these tests, so this is the F -- the forced exhalation volume in one second, and one liter, two liters, three liters, four liters and five liters. And on the horizontal axis, just like before, we have time, but here instead of time in seconds I have time in years, and time over the whole lifetime of an individual. What happens to your breathing tests from the time you're 20 until the time that you're 70? So it's timing that's marked off in decades of life on the bottom axis.
And if you just start at the -- like I told you before, look at the dotted lines crossing the graph, when obstruction to air flow gets bad enough where your FEV1, the amount you can get out is about one to -- and a half to two liters is where people begin to get shortness of breathe where they do anything unusual, so you can call that shortness of breath with moderate activity. And when you get down below a liter is when you have shortness of breath with any minimal activity where you're really breathless, where you're really disabled, where you face a risk of dying, where you get on chronic oxygen, where you struggle to breathe and fight to breathe even to do normal human activities of your life. So that's where the two liters is moderate obstruction and the one liter is severe obstruction.
Now if you look at the very top line on here, you can see that a 20-year-
old person has a FEV1 -- and I'm using as -- as an example a 20-year-old male who is 70 inches tall, because that's the average height, and that person has an average FEV1 of four and a half liters. The F --
The total size of your lungs is determined by your body size, by your age and by your sex to a certain extent. So we're going to use an example of an average-sized male who is 20 years old. They can blow four and a half liters of air out of their lungs in one second, just like that -- exactly like the top line on the last graph that I showed you.
What happens if you take that person who doesn't smoke and has a normal life experience and follow their breathing tests throughout their whole life? And what you find is that there's a slow, gradual decline in the FEV1 of about 30 cc's per year. That's about like a shot glass smaller. So each year your breath -- the breath that you can force out of your lungs gets about one shot glass smaller over your entire lifetime.
Why is that? Part of it is due to your chest cage getting a little stiffer. It's due to mechanical things as your ribs and your articulation of your ribs with your spine changes a little bit. Even changes in your spine. Part of it is due to the elastic tissue in your lungs gets less tensile, less elastic as you get older. There's physical/chemical changes in elastic tissue. So for whatever reason there's a small dropoff in your first-second volume that happens over your whole lifetime.
But you notice when you're at 70, you're still at three and a half or four liters, you still got double the breathing power that you would need to -- before you even get down into that beginning symptomatic range, and people live out their lives without ever being limited by their breathing power. Their lungs always empty well.
Now the second line shows you that a certain percentage of smokers, probably in the range of 15 to 20 percent of smokers, are -- basically develope an accelerated loss of lung function over their entire lifetime, and those smokers -- what happens to them is that they begin to lose their lung volume faster. Their FEV1 drops about a hundred cc's a year, so roughly about three times faster. And that seems to occur from an early age, from 20 or even earlier. They -- when these subjects start to smoke, their breathing power starts to drop off faster and faster.
And you can see that they're not going to run out of breathing power in their twenties, this is because these two curves are only separating at 50 cc's a year, so it takes a long time and years and years of exposures, but they are losing lung function in an accelerated fashion right from the beginning. And what happens is if they continue to smoke and are susceptible to the effects of smoke, that they gradually in their early forties begin to get into the area of mild obstructive lung disease that we can measure and pick up with these tests.
By the time you follow this other line, when you -- by the time they hit the one liter mark, in other words, a large group of patients who have developed severe COPD, these are the patients that you see riding a cart, oxygen in their nose, unable to walk around the store, disabled people working hard to breathe, those type of patients have an average FEV1 of about a liter, and they reach that at an average age of about 58.
So that the average person with severe COPD is a 58-year-old person who has smoked their whole lifetime and has had this gradual accelerated drop in lung function over their whole span of their -- of their smoking life. And by the time they're 58, they cross that line into severe respiratory disease, severe COPD.
Now what does that mean, to have an FEV1 of a liter when you're 58? Well different doctors have followed large groups of patients where they -- with chronic -- that's irreversible, they tried to treat all the reversible parts and what's left is chronic obstructive lung disease with an FEV1 of one liter about, and they followed them for years in studies and so to see what happens to these people. And when you pick up people right where that line crosses the second -- the bottom dotted line, 50 percent of them die of their lung disease within five years. So these patients are dying of their COPD in their early sixties, late fifties, early sixties to a large -- to large part.
This is a very severe disease which not only causes a lot of shortness of breath, suffering, distress in even doing day-to-day activities, but also leads you to lose your life early and to die of -- of -- a breathless death in your early sixties. And to lose out on that part of your life, your sixties and your seventies where you're retired and where your grandchildren are being born and -- and being raised, and it's -- it's a very tragic and unfortunate time point. Now --
Q. Doctor --
MR. MONICA: Excuse me.
Q. Doctor, when you --
MR. MONICA: Excuse me, Mr. Ciresi. Your Honor, I move that the -- at least the last portion of that answer be stricken as a gratuitous statement, comment by the doctor on philosophy of life or whatever it was. And also I would ask that counsel ask a question and answer instead of a running narrative, Your Honor. I object.
THE COURT: All right. Well the last portion was not responsive to the question.
Try and ask questions, counsel.
MR. CIRESI: All right.
BY MR. CIRESI:
Q. Doctor, when you get to the severe stage, will cessation of smoking help?
A. When you get down to the very severe stage where the FEV1 is a liter, cessation of smoking can help you have less secretions, can improve the quality of your life a little bit, but it does not change the gradual decrease in lung function and it does not change the mortality. So at that point there's some subjective benefits in terms of how much coughing and how much secretions and how many infections, but it does not alter the natural history in terms of the progressive nature of the disease from that point or the dying of the patient from that point.
Q. And the line that's sort of the broken line which says ex-smoker, can you describe what is being depicted there?
A. Well that's one of the most important things, I think, of this whole area, is that if patients have obstructive -- chronic obstructive disease that's still moderate, then if at that point they quit smoking, it can make a drastic difference in the eventual outcome and the natural history of their disease. And that's what lung doctors like myself do, is to try to find people who are developing obstructive lung disease when it's still in its moderate stage when they're in their early forties and work with them to get them to quit smoking.
And what you can see is on that line, there's a line where the hatch line goes off, and the patient is in their mid-forties and say the FEV1 is 22 -- 2.2 liters or 2200 milliliters. What I use in talking to my patients and teaching my patients is I use how much left -- they have left to spend before they have severe COPD.
So if you came in and you were 46 years old and you'd smoked since you were 15 and your FEV1 was 2.2 liters, I would tell you you have 1200 cc's left to spend and -- before you develop this point of severe lung disease. If you continue to smoke during the next 10 or 15 years and you spend it at 100 cc's per year, you're going to reach that point in your mid- to late fifties and you're going to be in this group of people with severe symptoms and major disability.
On the other hand, if you can quit, then you go back to losing it at 30 cc's a year. You don't get your lung function back, you don't jump up to that top line, but you go back to losing it at 30 cc's a year. And if you have 1200 to spend and you spend it at 30 cc's a year, that's going to last you decades, and the middle part of your life is going to have a different course than it will if you run out of breathing power when you hit that dotted line at -- at -- in -- in your late fifties.
Q. So that if they can quit, they will reduce the degenerative condition of the lung; is that right?
A. They will slow the rate of decline of their lung function from the point where they quit, and it can make a drastic difference clinically.
Q. Doctor, can you direct your attention to Exhibit 30057. Is this an illustration of the type of breathing that you described a little bit earlier?
A. Yes, it is.
MR. CIRESI: Your Honor, for illustrative purposes we would offer Exhibit 30057.
MR. MONICA: No objection.
THE COURT: Court will receive 30057 for illustrative purposes.
BY MR. CIRESI:
Q. Can you describe, doctor -- and we'll try to bring it up as you talk about different parts of the exhibit --
A. All right.
Q. -- can you describe what is being depicted here?
A. Now this -- this is an illustration by a famous medical illustrator named Frank Netter, and he's drawing his perception of what someone with bad emphysema looks like as they're trying to breathe. On the top left you can see the schematic of the lung, shows the things that we've talked about. See those two arrows that are vertical in the middle are where the airways are narrowed so they can't empty, and then it shows the big air space with the positive dots in it, which is the emphysema, the sort of holes in the lung because the lung has been dissolved, and the loss of that tissue has -- gets rid of the little tethering structures that hold the airways open and loss of that tissue loses the elastic ability to empty the lung. So this lung can't empty for all those reasons. There's no recoil because the lung has been dissolved and is moth-
eaten. The tethering part of the lung can't open the little airways and the little airways are scarred and narrowed. And this is showing the exact physiology that we talked about.
The reason that I wanted to put this in is that it shows a couple things. If you show me the picture of the patient -- the drawing rather. It shows, for one thing, that -- that this patient's lungs, because of these -- this obstruction, don't empty. He has chronic obstructive lung disease, irreversible, problem exhaling, and so he's trying to compensate and get as comfortable as he can to breathe, and one of the things is the very bottom where the diaphragm is, that big piston that moves air in, you can see that that's flat. Contracting that is not going to do anything for him. He can't get any more air in because that diaphragm is already totally flat. So what he does is lean forward and roll his shoulders forward a little bit and use these big muscles of his neck and his upper chest to get that little bit of air in on top of his lungs that can't empty, to get a little bit of air in on top. And you've seen people breathe like that.
The other thing he's doing is if you look at that top arrow pointing at his lips, one of the ways in which a patient like this can get a little more air out is actually make -- put some backpressure in into the airway. It tends to splint it open just a little bit so there can be more airflow. And on the bottom right, if you can go up again, the bottom right just shows that schematically, is that here on the left that airway is totally collapsed and can't empty at all, and on the right there's a couple of positive plus signs in the airway that the patient has made a little backpressure that just keeps that last little airway from collapsing so he can get a little airway out.
And patients do this automatically. When they take a breath, they sort of give backpressure by (demonstrating by pursing lips) -- just to hold their lung open a little bit and splint these airways so it can empty. And you don't have to teach them to do that, although they do at certain breathing classes, but the patients will do that automatically.
So if we go back up to the picture of the patient, you can see that patient is leaning forward, they don't have a diaphragm any more because their lungs are so inflated and because they can't empty, they're sucking -- they're basically using the anterior chest and their neck muscles to get that little piece of air in, and then to try to empty a little bit they're pursed-lip breathing, closing their lips and (demonstrating by pursing lips) to -- to give back pressure.
We're going to show you a patient who is breathing, and I want you to pay attention during the video part to her lips and just watch how she automatically adjusts to this to try to get that little last little bit of air in. I don't want --
I want you to realize how much difficulty this is to breathe like this. One of the things is that the average size of these lungs is very near to what's called total lung capacity at the end of a breath. Okay? So that their lung capacity is nearly at total lung capacity at the end of a breath, and that means all their breathing has to be done on top of that. So it -- what -- if you do is you just take a very big breath until your lungs are totally full and then pretend you have to start your breath there, and if I do that, the only way I have to get a little more air in is to pull with my neck muscles and my upper chest, and that's it. You know, that's the only way to stay alive is to take that next breath way at the top using the accessory muscles, leaning forward, pressing the stomach in. And it's very much work, the patients get exhausted from breathing hard and doing this intense work of breathing.
And eventually these muscles fail and the patient ends up in the hospital on life support machines, being rested and being taken care of in trying to treat whatever little reversible piece, whatever little infection, whatever little bronchospasm there is.
Q. Now doctor you said -- you mentioned we have a video, and this is illustrative of this breathing that you've been describing?
A. Yes, it is. It shows -- just shows a patient with severe COPD and, you know, the kind of work it entails to just to regular day-to-day activities.
Q. Can you describe the individual that we'll be seeing?
A. The individual is a patient of mine that I've taken care of for 12 years, and she's 52 years old at this time. She's a nurse. She started smoking cigarettes at age 13, was smoking a pack a day by age 14, was -- and has never been able to quit despite really heroic attempts. She's used every resource in the community and every resource that a doctor could give her to help her to quit, including smoking sessions, smoking cessation classes, groups, nicotine gum, nicotine spray, nicotine patches --
MR. MONICA: Excuse me, Your Honor. May I make an objection. I object to the witness carrying on this narrative and describing what his patient has done. This is rank hearsay, Your Honor, and it's a narrative form of hearsay by the witness, and I object to it.
THE COURT: I don't see where this is hearsay. These are the doctor's observations.
MR. CIRESI: That's correct, Your Honor.
THE COURT: And I think they're appropriate. There should be a question directed to the doctor, however.
MR. CIRESI: I will do that, Your Honor.
BY MR. CIRESI:
Q. Did the --
Does this patient have any history of asthma or allergies?
A. No.
Q. How many times has she been hospitalized?
A. Seven times, first time at about age 40 or 41, and in recent years about one time per year, usually for about a week and usually for a bad infection that just sort of tips her over the edge and tips her to the point where she needs help to stay alive.
Q. And doctor, you said she was a nurse. Where did she work?
A. At the University of Minnesota Hospital.
Q. And what was her position there?
A. She was a very senior --
She was a very senior nurse supervisor, managing very a large sophisticated unit for a number of years. Had to take disability retirement in '96 at age 50.
MR. CIRESI: Your Honor, we would offer, then, for illustrative purposes the video. It is Exhibit 30049.
MR. MONICA: Your Honor, we object to the video. It is not a proper representation of what it purports to be, and in addition it's duplicative of Exhibit 30057.
THE COURT: Court will receive 30049 for illustrative purposes only.
(Videotape played.)
Q. Can you describe what we see.
A. There is a patient taking a treatment with a bronchodilator, with a little inhaler that makes a mist containing the medicine to open up the airways a little bit.
Now the the patient is just sitting, and you see there's oxygen in her nose and she has an oxygen tank.
And as she works harder doing some little activities, you'll see that she starts to breathe even more with her lips.
You note she has to stop on the way back up and then stop again in the garage to sort of catch up, coming up this little slope here, this driveway.
THE COURT: We'll recess for lunch, reconvene at 1:45.
THE CLERK: Court will recess, reconvene at 1:45.
(Recess taken.)
THE CLERK: Please rise. The court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
MR. CIRESI: Thank you, Your Honor.
Good afternoon, ladies and gentlemen.
(Collective "Good afternoon.")
BY MR. CIRESI:
Q. Good afternoon, doctor.
A. Good afternoon.
Q. The patient that we saw in the video, was that her ordinary condition on a day-to-day basis?
A. I think one of the hard things about that tape is that that portrays her at a time when she was very good. You'd seen her taking a breathing treatment before to get every little bit of oxygen from the breathing treatment. She was wearing her oxygen. The secretions were white. She wasn't sick so that she needed to come to the hospital or anything else. That was during a time when she was really near her optimal good part of her range.
Q. Doctor, can you turn on your microphone. I think it may be off.
A. Excuse me.
(Discussion off the record.)
BY MR. CIRESI:
Q. Now doctor, looking at the effect of chronic obstructive pulmonary disease from a medical standpoint, how many yearly United States hospitalizations are attributable to chronic obstructive pulmonary disease?
A. I think it's important to realize how very common a problem that this is, and it -- right now probably 10 to 15 percent of all hospitalizations, all hospitalizations in the United States are for treatment of this problem. It's a very, very common problem.
Q. And with regard to leading causes of death in the United States, where does it rank?
A. Right now COPD ranks as the fourth leading cause of death in the United States, behind heart disease, cancer, and I think cerebrovascular disease. But it's the fourth leading cause of death in the United States.
Q. And approximately how many people in the United States per year die from chronic obstructive pulmonary disease?
A. About -- approximately 100,000 deaths per year from this condition.
Q. And what is the overwhelming cause of chronic obstructive pulmonary disease?
A. The overwhelming cause for -- for this condition is smoking cigarettes. It overwhelms all other causes.
Q. Are there any other causes, doctor?
A. There are other causes of COPD that do -- that do exist, and some of them are -- there's a very rare genetic disease where the patient has no -- has -- misses an enzyme that protects you against the substances that dissolve the lung, and this is an anti-elastase. And that -- if you were born without that enzyme, then you get COPD at an early age. But even there smoking plays a dramatic effect on how fast you get it. If you don't smoke, about half of the people get short of breath by age 40 and about half of them have tied by age 55 of COPD, and this is non-smokers. If you smoke, half of them are short of breath by age 30 and half have died by age 40. So that even in that condition, smoking accelerates it.
And I think you have to put that in perspective because the incidence of that rare condition is about one in a hundred thousand patients, so if you look at the whole -- like the metropolitan area, there's 20 or 30 patients with that condition. That's a rare condition. Whereas if you look at the number of patients with COPD, it's in the tens of thousands to upwards toward a hundred thousand. So that you're talking about a rare genetic defect with 20 or 30 patients in this metropolitan area versus something that is incredibly common as a clinical condition.
Q. Are there any other causes other than this rare genetic disease and smoking?
A. We've mentioned that the "chronic" part of chronic obstructive means the irreversible part, the damage to the lung that can't get better, and we talked briefly that asthma is an acute obstructive disease, that if you get the proper treatment, you'll go back to breathing normally and feeling normal. For example --
And that's what so, so terrible about this disease is it is like a asthma attack that isn't going to go away. No matter what you do, it's going to be with you like the patient that we watched. You just want to say "Well let me help you do that. Let me" -- you know, when you're watching her, you want to stop her and help.
And asthma ordinarily is very treatable, but there are some patients with asthma whose asthma condition, as they age and as they have more and more attacks, develops an irreversible part to the asthma so that the asthma itself becomes a chronic obstructive lung disease. But numerically those cases are very tiny; at most five -- five percent of the entire group of COPD.
Q. Now doctor, directing your attention to the medical treatment and medical management of COPD, have you put together a chart which categorizes medical management? And if you could direct your attention to 30060.
A. Yes, I have it.
MR. CIRESI: Your Honor, for illustrative purposes we'd offer Exhibit 30060.
MR. MONICA: No objection.
THE COURT: That's 30060, counsel?
MR. CIRESI: 30060.
THE COURT: That will be received for illustrative purposes.
A. This is just a list highlighting some general topics, more to keep me from forgetting certain things as I go through it.
What we're talking about here is the medical management of COPD, what can a -- can a doctor do for patients with this problem. We've talked --
Q. Doctor, let me ask you one thing first. Is the management of the problem on an overall basis costly?
A. It's extremely costly.
Q. All right. Can we --
A. All parts of the treat -- all parts of the management are very expensive.
Q. Can you then start going through each part of the medical management regimen and describe each one as we go along.
A. Yes. Yes, I will.
We've talked a little bit about the natural history and the effect of smoking cessation on the natural history. COPD is something that occurs in this group of smokers who start smoking early and over decades. They have an accelerated loss of lung function until in their late fifties they reach the severe point where they need a lot of treatment and a lot of support and have severe disability and shortness of breath.
We've talked about smoking cessation as being important, especially early on, at changing the slope of decline of breathing function, so that they can still have an adequate, functional life for years or even decades. And patients do a lot of things to try to quit smoking, a lot of which are very expensive. They, you know, join self-help groups, they take nicotine replacement in various forms, gum, patches, and even a nicotine nose spray. You can see these in any kind of a drug store right on the counter next to the cigarettes. They're for sale without a prescription, over-the-counter, and they're very costly. They cost well over a hundred dollars a month, a hundred dollars a month to replace the nicotine.
There's also for smoking cessation a trial of using anti-depressant drugs which blunt the craving -- are believed to blunt the craving or help a bigger percentage of people quit, and those drugs are expensive.
And then some patients even go so far as to get -- do inpatient. Hazelton and the Mayo Clinic both offer inpatient treatment, quitting regimens, which no insurance pays for, so the patients have to pay for themselves. The program at Hazelton is several weeks long and it's about as much as if you went on a cruise. You know, that's what I tell my patients, spend the money there, see if you can get off rather than doing something enjoyable.
So a lot of money goes into smoking cessation, and a lot of doctors' visits and doctors' work goes to try to help people stop smoking.
MR. MONICA: Your Honor, I object to the running narrative of the witness's answer. The answer was given in the first few sentences, and I ask that the witness be instructed to answer the question directly and to not ramble on. I realize he has to explain his answer, I have no problem with that, but these long, rambling answers, Your Honor, I object to them.
THE COURT: Okay. Ask another question, counsel.
MR. CIRESI: Yes.
BY MR. CIRESI:
Q. Now directing your attention to bronchodilators, can you tell us what that is, sir?
A. Bronchodilators are medicines that relax the smooth muscle part of the bronchiole wall, and they're very common treatment for asthma, and they treat the small asthmatic piece of COPD. A lot of patients with COPD have a little bit of spasm as part of the obstructive disease, those same small airways can have some spasm, but instead of like, for example, someone with bad asthma, their FEV1 might be one liter, and after full treatment it might go to four liters, so it would be completely reversible and the patient will go back to being normal. With COPD it might be one liter when they're sick and have an infection, and with all the extra bronchodilator therapy it might go to 1.3 liters. So they get like a 15, 20 percent improvement. Now that's not much, but sometimes it's crucial for them to be able to live their life and do their job and function.
So the bronchodilators are used and they're either inhaled -- little puffers like asthmatics use. You've seen people with little, you know, meter dose inhalers and they puff on that and it relieves asthma. In some cases they put a liquid right in a little mister, like you watch the patient use in the beginning of that video, and they breathe in over 10 or 15 minutes to get a higher dose. And those bronchodilators cost in the order of probably a hundred dollars a month for this kind, and two hundred dollars a month for the inhaled kinds. And there's a number of different kinds that are -- with slightly different mechanisms, but they're basically asthma-type treatments.
Q. Okay. And doctor, the corticosteroids, can you describe that management.
A. Well drugs like cortisone are very powerful anti-inflammatory drugs and they're used for arthritis and they're used for lots and lots of conditions, and when people are really sick and almost dying with COPD, sometimes just reducing the inflammation in the lung can sort of get them over a very bad spot. Does not fix the lungs, but it can get them over a severe problem. So that oral steroids, like by pill, prednisone pills, are used to get them over very tough spots. And the inhaled cortisone on a chronic basis are sometimes used to try to alter the course. The trouble with inhaled -- inhaled steroids is trying to reduce the inflammation and calm the lung down, and they're never as powerful as directly deeply inhaling something that causes inflammation 20 times a day.
So they do not counteract the effect of smoking, they are nowhere near that powerful, but they are used in this condition. And again, the cost of the inhaled steroids is like a hundred dollars a month. The oral steroids are cheaper, but -- by pill, but they have more side effects.
Q. And doctor, antibiotics, how are they used in the medical management of COPD?
A. Well one of the things that gets people in trouble so they have to go into the hospital, like if they get the flu last month or this month, it's not just the fever and aching -- you know, aching and being sick for a few days, they also can't breathe, and then they can get a secondary infection with bacteria where they cough up green pus and they're infected. And they don't have enough reserve to have a bronchitis, so it sort of tips them over the edge when they have to go into the hospital. And when they get a bacterial infection in the bronchial tree or a bronchitis, they need antibiotics, and the antibiotics are expensive and have to be taken for episodes of bronchial infection.
Q. Are individuals who have COPD more susceptible to other illnesses or diseases?
A. Yes, they're -- they're certainly susceptible to either having the disease more often, like episodes of bronchitis, or not having the reserve so they get sicker and are in danger with the same kind of illness that someone with more reserve could do fine with.
Q. And doctor, how is oxygen used in the medical management of COPD?
A. Now oxygen is very important. And you saw her carrying her oxygen tank. And oxygen is one of the few treatments that actually has been shown to prolong life in severe COPD. And it only works for a small group, maybe a quarter of the patients, because not all patients with COPD have very low oxygen. But the ones that have very low oxygen, either at rest or with exercise, who use oxygen, it -- it basically has been shown to prolong their life by up to two or three years. So that all patients who have resting low oxygen or whose oxygen drops either at night or with exercise, we put on chronic oxygen, and they use that not only to be able to exercise better, to avoid turning blue when they try to exercise, but they also use it as an actual life-prolonging measure. And it -- it prolongs life on the average of -- of two to three years.
It costs two to four hundred dollars a month, depending on whether you have a concentrator, whether you have extra tanks that you carry around.
The patient in the video, when she -- her oxygen level was about 90, which is sort of the low end of normal, and when she would walk 50 feet it would drop below 80, which means blue basically, she would turn blue with walking 50 feet without oxygen. With the oxygen she could walk twice as far without dropping the oxygen level. So it did improve her capacity to exercise. And again what you saw was her exercise with the help of oxygen, with the help of the bronchodilator.
Q. And doctor, pulmonary rehabilitation, how is that utilized in the medical management of COPD?
A. Pulmonary rehabilitation is sort of a controversial subject, because it's not really proven that it prolongs anybody's life by going through different rehab programs, but it definitely makes people able to walk further and gives them a little -- it teaches them to be more relaxed with their breathing, what to do with they run out of breath, it teaches them how to do the pursed-lip breathing, make sure that they're using all their inhalers correctly. It's sort of a setup where they go through all the details of this chronic disease and try to optimally handle all of the details. Can either be done as an outpatient, and there's programs at most of the hospitals that run for like twice a week for six weeks or something like that. I use the program at Abbott Hospital quite a bit because it's right in the neighborhood of our hospital, and my patients, you know, do feel more confidence with their disease, learn about their disease, have a better functional life after going through that program. They don't live any longer.
And the other way you can do it is an inpatient program, and there are several hospitals in town including Vencor, which is the chronic subacute hospital that I work at that has an inpatient program, so people can actually go into the hospital for two weeks and get help with their secretions, with their bronchodilator use, with learning how to take care of their oxygen equipment, with pursed-lip breathing, with all the details of doing as well as they can with a chronic, incurable problem.
Q. Doctor, you talked about a chronic subacute hospital such as Vencor. What is a chronic subacute hospital?
A. Well it's a licensed --
Hospitals are usually licensed as acute hospitals, like the University of Minnesota, Mayo Clinic, St. Mary's down there, Hennepin County, Abbott, but there are a couple hospitals that -- that are licensed under a subacute hospital where the average length of stay, instead of being three or four or five days for acute problems, is more like 30 or 40 days for things that sort of get better week by week and require a rehab component to it rather than the things that are getting better day-by-day. And in -- in the metro area there's two of those hospitals, ones in the west metro, in Golden Valley, and one's Bethesda, which is not too far from here, near downtown St. Paul.
Q. Doctor, hospitalization, is that required in the medical management of COPD?
A. Again it's 10 or 15 percent of all hospitalizations to acute hospitals in the United States, much higher percentage of hospitalizations in chronic long-term acute hospitals. So that many patients, especially when they get a bronchitis or an infection or some intercurrent problem, they have to go into the hospital, be stabilized and get their breathing back up to where it's good.
Q. What's the cost of hospital stays for COPD management?
A. Well they vary according to what needs to be done. But in general if the patient is in a ward bed getting an antibiotics and intensive treatment and things like that, the cost would be in the range of a thousand dollars a day. If they're in an ICU on a breathing machine, on life support, the cost would run from two to three thousand dollars a day. So that the -- you know, hospitalizations have become incredibly expensive, and even a week in the hospital to treat a bad infection associated with COPD would be ten thousand dollars, easily.
Q. All right. Now doctor, it's also mentioned here single lung transplant or lung reduction surgery.
Let's talk about the single lung transplant. Can you describe that aspect of medical management of COPD.
A. Uh-huh. The two things on the right I put in parentheses because they're sort of surgical management rather than medical management, but there are a couple things that are done occasionally to try to help people who are near the end of their life and are desperately short of breath from COPD. And sometimes, like you say, if these lungs are so rotten and so worn out and so terrible, why don't we just give them a new lung, you know, new lungs? And that is done. There are certain number of people, especially people who are young, who don't have other diseases, you know, who have not had other chronic diseases, who get a lung transplant. And they go from not being able to breathe at all to being able to walk and live -- live their life and get a tremendous relief. So that for some of these patients, that can be almost a miraculous type of improvement.
Q. Are there many available lungs in the United States to do lung transplants?
A. The problem is partly in organ -- is in cost, in the complications, and the organ availability. There is at least probably eight to ten thousand people right now in the United States who would benefit from a lung if it were available, and there's only three or four to five hundred a year that are available. So most patients simply can't have one because there aren't available lungs that can be used for transplantation.
Q. Is it an expensive procedure?
A. The cost of a lung transplantation in the first year would run over a hundred thousand dollars, in the range of a hundred thousand dollars.
And the patient -- it's really done for lifestyle reasons. The patient is so short of breath that each breath, they feel like they're suffocating, and they would do anything to get rid of that sense of dyspnea. Because a third of these patients die in the first three months of either rejections or of infections, so the patient that wants to go for lung transplant -- one, they have to get incredibly lucky, a lung has to become available when they need it, and they have to have a chance, a 30 percent chance of dying within months in order for -- you know, to take that chance for what's at the other end, is some patients who get relief of their symptoms.
Q. Are there other sequelae or consequences of a lung transplant other than death?
A. Well a lot of people get rejection of the organ which causes obstruction itself and leads to a recurrence of the shortness of breath. And the patients on transplant -- on -- with lung transplants have to take high doses of immunosuppressive drugs, and they get infections from those drugs. And they have to take high doses of cortisone, which leads to softening their bones, fractures of their spines, necrosis of their hips, they need hip surgery in many cases, cataracts with cataract surgery, so that there's a whole complication of the regimen of drugs that you have to take to keep from rejecting that lung, and it's simply not an available treatment for the tens of thousands of patients who have COPD as they reach the end of their life. It's something that is done in a few -- a few patients.
Q. Doctor, with regard to lung reduction surgery, can you describe that, please.
A. Well that's sort of an interesting story, too. One of the problems that I mentioned to you is these lungs are just too big, and one of the consequences of being too big is the diaphragms, that big muscle that works as a piston for breathing, is flat and can't work, and so people have come up with the idea of removing part of the lung to make the lung smaller so the diaphragm can work again and so that gas exchange with improve, and they actually are helped in this by the fact that emphysema tends to be worse in the top of the lung than in the bottom. There's some regional differences in the disease. So they remove the top third of each lung. They do a surgery where they split the sternum, just like heart surgery, and take out the top third of each lung and then -- then close the patient. And some patients get substantial relief of their shortness of breath, they double their ability to walk, and that lasts for up to a few years.
And that is surgery that's being evaluated to try to figure out which subgroup of these COPD patients have the most benefit and the least risk, so we can pick out people that actually help them with that treatment.
Q. And doctor, is that an expensive treatment?
A. I would guess that the minimal cost for that would be in the range of $20,000. And if you get persistent air leaks or other surgical complications, it can run into ten of -- many tens of thousands of dollars.
Q. Doctor, do some of the COPD patients require permanent life support?
A. Now some patients when -- when they have a bad problem and they have an acute worsening of their disease, they would have to go on life support with a breathing machine. And they either have a tube down their nose into their lung or in their mouth into their lung, or sometimes even a tracheostomy so that they can be put on assisted ventilation with a breathing machine. And hopefully they will get better from their infection, whatever caused them to worsen suddenly will be treated and they will be able to come off that breathing machine.
Sometimes it happens when they get influenza. They have bad COPD and they get influenza, and they can't live without at least temporarily being supported with life support.
Q. Is that treatment expensive?
A. That treatment is -- you know, during the time that you need it, is thousands of dollars a day. And the problem is that some people never get well enough to come off of that breathing machine, and then they sort of have to make the decision whether to come off and be helped to be comfortable with drugs like morphine, or whether to try to make their life as a disabled person as well as they can with chronic life support. If they get to that point, then the costs are tens of thousands of dollars a month for that type of support.
Q. Doctor, if smoking were eliminated as a cause of COPD, would we see a reduction of this illness in the United States?
A. If -- if smoking would gradually disappear and there were no smoking in our culture, in one generation COPD would be a rare condition. It would be something that most doctors didn't see, it would be something that most families didn't have patients or relatives -- it would be an unusual, rare condition rather than the fourth leading cause of death in the United States and the cause of 10 to 15 percent of all hospitalizations in the United States. It would be that dramatic an impact on the incidence of COPD.
MR. CIRESI: Thank you, doctor. I have no further questions.
MR. MONICA: Your Honor, may we have a few minutes to move the Elmo over here?
THE COURT: Let's take a short recess.
(Recess taken.)
THE CLERK: All rise. Court is again in session.
(Jury enters the courtroom.)
THE CLERK: Please be seated.
THE COURT: Counsel.
MR. MONICA: May it please the court.
Good afternoon.
(Collective "Good afternoon.")
BY MR. MONICA:
Q. Good afternoon, doctor.
A. Hello.
Q. Doctor, my name is John Monica and I represent Lorillard Tobacco Company, and I'm going to be asking you some questions this afternoon, not only on behalf of my company, but the other companies, as we have a -- the court has asked us to just have one attorney ask questions of every witness, and we're trying to do that. And so I'll be the attorney who will ask you questions this afternoon.
If you don't understand my questions, please tell me. I'll be glad to repeat them.
A. Okay.
Q. Doctor, chronic obstructive pulmonary disease, is it correct that that disease consists of mainly two subparts, emphysema and chronic bronchitis?
A. The -- the -- it's kind of a -- of a clumsy term because it incorporates two main things, emphysema, which is a pathological description, and chronic bronchitis, which is a clinical description regarding cough and sputum production. So that --
But the reason that it's used so often is that it represents the changes in the lung mainly due to -- to cigarette smoking and almost nobody has pure emphysema or pure chronic bronchitis. So that most patients have features of both of these. The airways are -- have some changes and the lung tissue has been dissolved and they have a mixture of two, so rather than trying to divide a group right in half into emphysema and bronchitis, which really doesn't divide because most patients have features of both, this is sort of a lumping term that's used to describe patients with -- who have to have obstruction, they have to be trouble exhaling, and it has to be irreversible.
Q. But there are gradations in between, but basically at the one end and at the other you have emphysema and chronic bronchitis; right?
MR. CIRESI: Objection, asked and answered.
THE COURT: No, you may answer that. You may answer.
A. As I said, most patients have some of the clinical features which would be described as chronic bronchitis, some of the anatomic features which would be emphysema, and they have features of both of these. So that at the very far end would there be someone with pure emphysema and someone with pure bronchitis? There could be someone whose clinical picture fit more closely pure emphysema and whose clinical picture fit more purely with the bronchitic, but they would be uncommon.
Q. And to -- and to determine where they are -- where the patient is at on the spectrum, you of course would have to review that patient's chart and medical records and talk with the patient; isn't that correct?
A. You can't really totally determine where someone is on that record because emphysema is a pathological diagnosis, and most of the time our diagnosis is made by that spirogram where we do breathing tests, and what we're measuring is actually the degree of obstruction, and we don't get accurate --
So we would never think in terms of putting someone along this -- the area. We would say they have COPD and this is how bad their obstruction is based on the -- the breathing test.
Q. Okay. And by "COPD," we're talking about the disease that we've been -- you've been testifying about today; correct?
A. Yes.
Q. That's the shorthand term for it, "COPD;" correct?
A. That --
Yeah, that's the term we spent a lot of time trying to explain.
Q. Yes.
Now let's try to put things in perspective. Isn't it true, doctor, that if you take lifetime smokers, people who have smoked for their entire lives, that only 10 to 15 percent of lifetime smokers develop symptomatic COPD? Isn't that true, doctor?
A. About 15 percent of people with -- who are lifetime smokers develop symptomatic COPD.
Q. And by the same token, conversely, that means that 85 to 90 percent of smokers do not ever develop symptomatic COPD; isn't that correct?
A. That's correct to a point, although the -- that doesn't mean they have normal breathing tests and that they haven't developed some degree of airway obstruction. That has never been shown, what percentage have absolutely normal lung function. But there are a substantial majority who never get to the point of being disabled by the airflow obstruction.
Q. In fact, it's more than a substantial majority, it's the vast majority. It's 85 to 90 percent.
A. It's about 85 percent.
Q. Yes, sir. And as far as the disease COPD, I believe you said about 10 percent of your inpatients you treat for COPD, about 10 percent of your patients have COPD that requires treatment in a hospital; is that correct?
A. I didn't say that, no.
Q. Well is --
Let me ask you the question, then, directly.
A. Uh-huh.
Q. Isn't it true, doctor, that of your practice, only about 10 percent of your COPD patients require hospitalization?
A. I didn't -- that's --
I didn't mean to say that or imply that at all. I -- I stated that about 10 to 15 percent of all hospital admissions in the United States are due to COPD, but I don't have any number for the percentage of my own patients with COPD who are ever in a hospital. It would be -- I don't have -- have that accurate number.
Q. All right. So you don't know what percentage of your patients require hospitalization --
A. No.
A. -- because of COPD; do you?
A. No.
Q. And you talked about some of the cost figures and in that regard, the last exhibit we had, which is Exhibit 30060 -- and I'm going to put this up just to remind you of which one I'm talking about, and I've -- I've written on mine here, but this is the exhibit I'm talking about, doctor. You went through some cost estimates, do you recall, just a few moments ago on that?
A. Yes, I did.
Q. I'm going to be talking to you about some of those cost estimates. But have you been advised, doctor, that the plaintiffs in this lawsuit are seeking reimbursement for costs that they spent to treat some of the patients who have COPD?
MR. CIRESI: Objection, Your Honor, that's outside the scope of this witness's testimony.
MR. MONICA: Your Honor, this clearly is --
He's talking about costs with regard to this lawsuit, costs for treatment of patients that are relevant to this lawsuit.
THE COURT: Counsel, I don't recall any testimony with regard to costs for this lawsuit. I think you can inquire about his statement on costs generally.
MR. MONICA: Okay.
Q. Doctor, with regard to the costs that you have estimated here, isn't it true that you did not make any kind of a particular study of the costs? These are just your general experience, your general impression?
A. I did make a few phone calls to our pharmacy and ask them how they price out these items, how much one inhaler costs. I called an oxygen -- one of the biggest oxygen vendors. And I have very personal experience of hospital charges and costs from some of the administrative things I did. So I never meant to present it to you as a study of any kind, but I think it's an accurate estimate of some of the costs that are involved in these -- in these items.
Q. And in fact, doctor, as you said, it was not a detailed study or any kind of a study on your part; was it?
A. It was -- it was not a study, no.
Q. It was kind of based upon your experience and a few conversations you had.
A. I stated what it was based upon.
Q. And doctor, let's see if we can establish the extent of what you did do.
Now bear with me, I'm not an artist, but I thought it might be helpful just to put this up. I'm going to try to draw the state of Minnesota here first, doctor.
MR. CIRESI: Is it all right if I look at this one, Your Honor?
THE COURT: If you want to.
MR. CIRESI: We'll see if he's as good as Mr. Bernick.
MR. MONICA: I make no representations.
THE COURT: I think we're going to bring Mr. Bernick back.
THE WITNESS: There's a little bump on the top.
MR. MONICA: That almost looks like Texas. But I --
MR. CIRESI: We can tell you're from Kansas City.
MR. MONICA: I think the -- we can go through the points I wanted to make, even though that is a very crude drawing, I admit.
Q. But anyway, this is the Twin Cities area right -- right here, doctor.
A. Yes, it is.
Q. Now you --
When you were making your inquiries, you -- for example, you didn't check with anyone up here in the Moorhead Fargo area; did you?
A. No.
Maybe put Willmar on there, which is halfway to the South Dakota border straight left. I do outreach there one day a month for several years, and I -- I did talk to some of -- their pharmacy when I was out there. So I have looked at a little at outstate. I'm also from a small town, and I have a family who use some of these products, so --
Q. You didn't check with anyone up in International Falls; did you?
A. No, not up in that bump.
Q. And how about over here by the lake, Duluth. You didn't --
A. No, I did not check Duluth.
Q. Okay. So my point is, as far as the studies -- or the inquiries that you made, they were fairly well localized on the Twin Cities area with a couple of outlying. Is that a fair statement, doctor?
A. That's a fair statement, sure.
Q. And so your --
And admittedly this is a crude drawing, but your -- your inquiries and the cost estimates, then, are really only really relevant and pertinent to the Twin Cities area; aren't they, doctor? They're not a state-wide, they don't purport to be a state-wide figure.
A. No, this is true, but in all fairness, like drug stores are becoming more of a national chain, and if I buy an Albuterol inhaler in a Snyder's store in Minneapolis and in Duluth and in Rochester and in Albert Lea, they may be off by a few pennies, but they're not off by an order of magnitude. These are products that there's a profit margin on. Just like cigarettes wouldn't be double the cost in the Twin Cities as in Willmar, they would be roughly in the same general frame because they're a product with a profit margin.
Q. But doctor, you -- as you said, you didn't actually check in these areas that I've mentioned to see how close the prices were; did you?
A. That is correct.
MR. CIRESI: Objection, asked and answered, Your Honor.
THE COURT: It's been asked and answered now.
BY MR. MONICA:
Q. Now in -- in determining whether a cost, a particular cost is -- is reasonable, doctor, don't you have to look at what was done for that particular charge?
A. I'm not --
I don't exactly know what -- what you mean. Where --
Q. I'll try to rephrase.
A. Maybe you can use an example.
Q. Well to -- let's take an example. Let's, for example, look at a bronchodilator.
A. All right.
Q. To know if that charge is -- is appropriate, wouldn't you have to know if the procedure was really necessary and appropriate?
A. You would have to assume that the patient had some benefit from the treatment. Is that what you're asking?
Q. And not all patients use bronchodilators; do they?
A. Not all patients do use them.
Q. So you'd have to consider whether the individual patient really needed a bronchodilator before you would know if that cost --
A. Right.
Q. -- for that dilator was reasonable, wouldn't you, sir?
A. Right. And that would be determined by the individual doctor working with that patient, testing them, and the patient -- to see if they had an appropriate clinical response to that drug so that the benefit to them was worthwhile.
Q. And doctor, is the same true for all of these entries on this chart that we have on the -- on the screen here?
A. There's --
Q. You got --
A. -- some exceptions. For example, oxygen, it's federally paid for -- I mean the federal payors, like Medicare, you're required to document very precisely what the oxygen level is in the blood. So in order to give oxygen, it's not -- I can't give you oxygen because I think you might feel better. I'm required to show what your PO2 level is or what it does with exercise. There's very stringent criteria for that oxygen and you can't have it unless you meet very uniform standard criteria where it's been shown to do you some good.
The oxygen vendor that we use actually started in Duluth, it's pretty much become a -- it's Arrowhealth, and they -- you know, a lot of the companies have amalgamated, and so I think the oxygen costs throughout the state would be pretty close. And certainly you just can't have a doctor decide to give oxygen. It doesn't work that way. You have to say what are the criteria? Well it's a PO2 less than 60, and you have to show that. The lab that does the blood test has to be certified and you have to present that documentation at the time that you give the oxygen. So I would assume that at least for oxygen, everybody getting it would -- would be -- represent people who would benefit from it.
Q. Yes. But on the other ones that we've talked about, the bronchodilators, the antibiotics, the pulmonary rehabilitation, you'd have to -- to take a look at the individual patient and his chart or her chart to determine whether the cost was necessary and appropriate; wouldn't you, doctor?
A. A doctor would have to be ordering the treatment for an appropriate -- for an appropriate patient. That's -- that would be true.
Q. And in fact, in order to determine if these treatments are necessary, you would want to know, for example, whether a patient had a history of exposure to environmental -- certain undesirable environmental exposures; wouldn't you, doctor? Like say they worked in the coal mine or something like that, you'd want to know that; wouldn't you?
MR. CIRESI: Your Honor, I'm going to object to that as being outside the scope. It's also in improper form.
THE COURT: Sustained.
BY MR. MONICA:
Q. Well doctor, when you are evaluating a patient to determine if that patient has COPD, what are some of the things that you ask the patient? When they -- when they come in to sit down with you for the first time, what are some of the things you ask the patient about?
MR. CIRESI: Objection, Your Honor, outside the scope.
THE COURT: No, you can answer that.
A. Uh-huh. Well a patient often comes with a particular problem. They have a presenting complaint, there's something -- some reason that they're going to the doctor. And if you talk -- so the patient might make an appointment because they have a complaint, something that they're troubled with. Usually that would be shortness of breath on exertion. They've noticed that when they try to do heavy work or carry something or do more work, that they would be short of breath.
The other main symptom would be cough, that they have developed a chronic cough, that they cough up phlegm from their chest and they have a deep, barky cough that persists and just won't go away like a cold would, and they're concerned about that. So those would be the two main symptoms.
Sometimes the patient is just there for a routine exam, and you might question whether they had COPD based on their physical exam, their pattern of breathing, observing them doing the things you do in giving a regular physical examination.
Q. And doctor, you would ask the patient for the family background; wouldn't you?
A. If the patient came in with a complaint, like on a complaint-centered visit, I might not. But if this was my patient, I would have as part of their medical record a complete family history, social history, and a complete review of systems. If I was seeing a new patient that was coming to me for the first time, then I would get that information and it would be part of -- of their record.
Q. And you would need that information to diagnose the patient; correct? That's why you ask the patient for the information.
A. I would need that -- that information to fully understand that person and their health history and their various problems.
Q. For example, you'd want to know if the patient had HIV; wouldn't you?
A. I would -- if it --
I would certainly want to know if the patient had a history of -- of being exposed, having risk factors, having been documented to have HIV. But to my knowledge, that has nothing to do with the question of COPD.
Q. Don't people who have HIV get pneumonia and other respiratory illnesses much more frequently?
A. Patients with HIV do not get COPD.
Q. Don't --
Would you answer my question? Do they get pneumonia more frequently, Your Honor -- ah --
A. Patients are susceptible to a variety of bad infections. One of the problems is that their immune system is wiped out, so they get a whole variety of respiratory and other infections which have to be managed as part of a chronic illness, but --
Q. Which if --
A. -- it has nothing to do with COPD.
Q. Which if they are not managed properly can move into COPD.
A. No.
Q. Wouldn't you want to know if -- if your patient had worked in a factory and had worked grinding fiber glass every day? Would you want to know that?
A. I would want to know what work my patients have done, yes.
Q. And wouldn't you want to know if your patient had worked in a paint factory where the paint was in the air all day and they had breathed the air all day every day while they worked at that paint factory, wouldn't you want to know that?
A. I would want to know what occupations my patients have -- have done, what they've done for work.
Q. And doctor, did -- did you know that we've taken some depositions in this case of Medicaid recipients, and that one woman that I deposed myself has had all these experiences I just mentioned to you?
MR. CIRESI: Excuse me, Your Honor, I'm going to object. And I'm sorry to interrupt, counsel, but he knows that's an inappropriate question. It's already been ruled on.
THE COURT: Counsel, that is an inappropriate question, that has been ruled on in the past. Move on.
MR. MONICA: All right.
BY MR. MONICA:
Q. Doctor, have you examined the individual medical records of any of the Medicaid recipients for whom plaintiffs claim damages in this lawsuit?
A. I don't know who those claimants are. All I can say is that they -- I've taken care of patients every day of my work life for 19 years, and I've certainly represented -- I've certainly taken care of many patients who are receiving Medicaid within the state of Minnesota. So again, I don't know the parameters of -- of the details.
Q. And -- and so then, obviously, doctor, you're not in a position to say if any of those people have COPD because they smoked; are you, doctor?
A. I don't know --
I do not have a list of any of the patients you're talking about. I have no personal knowledge of any such a list.
Q. And by the same token, doctor, you're not in a position to say that any of the medical costs incurred by those patients is reasonable and necessary; are you, doctor?
MR. CIRESI: Objection, Your Honor, there's no foundation for that.
THE COURT: Sustained.
Q. Doctor, when you look at a patient for the first time, you said you're looking for -- you're looking for two things, shortness of breath and -- what was the other one, doctor?
A. I said when a patient comes to me with a complaint, and they come in because they have a patient-centered complaint, that the two most common ones would be shortness of breath and a cough, chronic cough.
Q. And --
A. That's what the patient -- what the patient would bring to me as a complaint.
Q. And if they had those two symptoms, then, you would want to investigate whether or not they were being caused by COPD; correct?
A. Yes.
Q. And by the same token, those same two symptoms can be manifested as a result of other diseases, non- COPD diseases; right?
A. Yes.
Q. And what are some of the other diseases that manifest those two symptoms, non-COPD diseases?
A. Well asthma could present with either shortness of breath on exertion or with cough, and various types of diseases of the lung tissue could present with shortness of breath and/or cough, like pulmonary fibrosis or sarcoidosis. In fact any lung disease -- the lung doesn't have too many ways that it can tell you that it's going bad, and almost any lung disease can present with shortness of breath or with -- or with cough.
Q. So you'd have to investigate those various possibilities in order to determine whether it was COPD you're looking at or one of those other diseases; right?
A. That's -- that is my job.
Q. And again you'd have to look at the patient's chart and the medical history and things like that.
A. Uh-huh.
Q. Correct, doctor?
A. That would be part of the information I would gather.
Q. All right. And as you said, you haven't done that for any patient in this litigation, any Medicaid patient.
MR. CIRESI: Objection, asked --
A. I don't know if that's true or not.
MR. CIRESI: Excuse me, doctor. Objection, it's been asked and answered.
THE COURT: It's been asked and answered.
Q. Doctor, have you talked with any of the damages experts in this case and given your input to any of them?
A. No.
Q. So you're not testifying on any element of damages in this case, to your knowledge?
A. I'm testifying about COPD as one of the severe medical conditions caused by chronic smoking and about the medical management of -- of that condition.
Q. But as far as you know, doctor, your work is not being used in any regard to compute damages.
A. To my knowledge, it is not.
MR. MONICA: I have no further questions.
MR. CIRESI: I have no further questions, Your Honor. Thank you, doctor.
THE COURT: You may step down.
MR. CIRESI: Your Honor, we need to --
THE COURT: Side bar.
MS. NELSON: Your Honor, plaintiffs call Dr. Kenneth Graham to the stand.
(Witness sworn.)
THE CLERK: Please state your name and spell your last name for the record.
THE WITNESS: Dr. Kevin J. Graham, G-r-a-h-a-m.
THE CLERK: Please be seated.
THE WITNESS: Thank you.
MS. NELSON: Good afternoon, ladies and gentlemen.
KEVIN J. GRAHAM called as a witness, being first duly sworn, was examined and testified as follows:
BY MS. NELSON:
Q. Good afternoon, Dr. Graham.
A. Good afternoon.
Q. Dr. Graham, is your mike on?
A. Is it on?
Q. Yes. Okay.
Dr. Graham, would you please briefly explain the expertise you bring to the court and the jury today.
A. What my purpose in appearing today to the court is to talk about cardiovascular disease and the clinical presentation of cardiovascular disease, specifically coronary artery disease or the development and presentation, clinical presentation of blockages in the coronary arteries of the heart, stroke and the loss of blood in some way to the brain, and peripheral vascular disease or decrease in blood flow to the extremities.
Q. And when you say "clinical presentation," what do you mean by the word "clinical?"
A. Much like Dr. Davies, I am a clinician, and every day when I get up it's my job to go and see patients, and that's -- so we deal with patients who present with clinical problems, or hopefully to prevent those clinical problems.
Q. Dr. Graham, before we get into the substance of your testimony, I'd like just to take a moment to review with you your education and your training.
It appears that you graduated from the University of Minnesota Medical School in 1981; is that correct?
A. Yes, ma'am.
Q. And in 1985 you completed an internal medicine residency at Hennepin County Medical Center; is that correct?
A. Yes, ma'am.
Q. Could you just briefly describe to the jury what a residency is in internal medicine?
A. After the completion -- successful completion of medical school, there is a competitive arrangement to go to top internal medicine residency programs. Through the internal medicine program you learn essentially all the inpatient and outpatient modalities of the treatment of the adult patient.
Q. And then you were awarded a cardiology fellowship at the University of Minnesota; is that correct?
A. Yes, ma'am.
Q. And you completed that fellowship in 1988.
A. Yes, ma'am.
Q. So that was a three-year post-residency fellowship.
A. Yes, ma'am.
Q. Could you explain to the jury what the medical field of cardiology involves.
A. After a three-year residency, learning the spectrum of adult medicine and the various specialties within that, touching each of those, a cardiology subspecialty fellowship concentrates on diseases of the vasculature, most specifically the heart, but also dealing with wherever blood flows in the body.
Q. And then, doctor, you received board certification in internal medicine in August of 1985; is that correct?
A. Yes, ma'am.
Q. And then you received a subspecialty board certification in cardiovascular medicine in November of 1989; is that correct?
A. Yes, ma'am.
Q. Now where do you currently practice cardiology?
A. I am a consultant in cardiology at Minneapolis Cardiology Associates, at the Minneapolis Heart Institute, practicing primarily quaternary practice and tertiary practice out of Abbott Northwestern Hospital.
Q. Could you take a moment to describe the work of the Minneapolis Heart Institute.
A. The Minneapolis Heart Institute is a confederate of over now 50 cardiovascular specialists, surgeons, three surgical groups, one cardiology group, which is our group, which is approximately 29 cardiologists, cardiovascular anesthesiologists, interventional radiologists who deal mostly with peripheral vascular disease, and the pediatric cardiologists.
Q. Is the Minneapolis Heart Institute the largest provider of cardiac care in the entire Twin City area?
A. Yes, ma'am, it is.
Q. And have you over time received national recognition for your work with the heart?
A. The Minneapolis Heart Institute has approximately a 20-year history of being a premier single-specialty cardiovascular group. Dr. Robert Van Tassel, who founded the group, brought forth the concept of working with primary care physicians in a single-specialty group, giving high clinical medicine, but then returning the patient almost to the primary care physician for continued ongoing primary care.
Q. Could you briefly describe for us the number of cardiovascular procedures that the Minneapolis Heart Institute does, say, in one year's time.
A. We have roughly somewhere over 25,000 patient visits per year. We physically go to 28 outreach sites in Minnesota and western Wisconsin where one of our cardiologists will drive to Grand Rapids or Willmar or New Ulm to provide outreach consultative services to communities.
We perform about 4,500 diagnostic coronary angiograms a year, roughly 1400 angioplasties, catheter-based interventions which we'll talk a little bit about a little bit later, about the same number of open-heart procedures a year, roughly 1400, putting in approximately 450 pacemakers last year, approximately 150 cardiac defribillators. We have the active transplant program doing approximately 25 heart transplants a year. So we try to offer the entire spectrum of clinical cardiovascular care.
Q. Now limiting your response now to your own practice, could you describe for the court and the jury what the nature of your practice is.
A. I am director of preventive cardiology at the Minneapolis Heart Institute. I spend approximately 95 percent of my time in acute patient care. Of approximately -- of the 95 percent of my time, 75 percent of the time is spent with the full spectrum of cardiovascular care, approximately 15 to 20 percent is -- dealt with what's called primary prevention, which is trying to keep a patient from having the first heart attack, and I have a special interest in what we call secondary prevention, which is once a patient's had a heart attack, keep that patient from coming back again and again by addressing the causative agents that caused them to come for the first time.
Q. Doctor, are you also the chief operating officer and board chair of a company called ProMedicus Systems, Inc.?
A. I am.
Q. And could you briefly describe for us what the work of that company is?
A. It's an offshoot of our medical environment in the metropolitan area, which for most of you in this room I don't have to expound on. We saw the biggest issue over the past half a dozen years or so of being appropriate care, getting the right care to the right patient in the right setting, whether that's in a primary care setting or whether the patient needs to get to a specialist to try and maximize the efficiencies of serving that patient, so that wherever they come, they are served appropriately.
What we have done first through the Heart Institute and now through this company is to try, with a web-based computerized service, to give specialized help to primary care physicians so that they will have specialty help wherever a patient presents. The spectrum of medical knowledge is tremendous and the pressures on primary physicians are tremendous in this atmosphere with that environment that we live in, so we try and give as much help in -- in -- in line with what the mission of the Heart Institute has been since day one, to work with primary care physicians to give best patient care wherever the patient presents.
Q. Doctor, in the early '80s were you medical director and chief of staff at the McNamara Hospital and Nursing Home in Fairplay, Colorado?
A. I was.
Q. Please tell us your experience in working with that nursing home.
A. Between my first and second year of residency, I took a one-year sabbatical, and with that ran a small hospital, 16-bed nursing home, emergency room and clinic that was 88 miles southwest of Denver. It was probably one of the best learning experiences I've ever had to understand what a primary care physician feels, especially in a rural area, when they don't have some specialist right around the corner.
Q. And then between your residency and cardiology fellowship, did you work as director of utilization review for Midway Hospital here in St. Paul?
A. I did.
Q. And what was the nature of that work, doctor?
A. Again focusing on quality of care, I was employed to review charts in order to try and make sure and work with physicians to make sure that patients were appropriately treated in a hospitalized setting.
Q. Now doctor, are you a member of a number of medical associations and societies?
A. I am.
Q. Are you a member of the American College of Physicians?
A. Yes, ma'am.
Q. And the American Medical Association?
A. Yes, ma'am.
Q. And the American Heart Association and its Council on Clinical Cardiology?
A. Yes, ma'am.
Q. And have you served on the board of directors of the American Heart Association, Minnesota affiliate?
A. Yes, ma'am.
Q. And have you worked as the chair of the Physician Cholesterol Task Force of the American Heart Association, Minnesota affiliate?
A. Yes, ma'am.
Q. Is it fair to say, Dr. Graham, that some of your