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Another Expert Witness Deposition from the Adams v. Johnson & Johnson Fentanyl Lawsuit

Posted in Duragesic / Fentanyl

Set forth below is the deposition of Michael Kaufman, M.D.  He testified for the plaintiff in a Duragesic lawsuit regarding the cause of death.

The deposition of MICHAEL WOLFSON KAUFMAN, M.D., called by the Defendants for examination, taken pursuant to the Federal Rules of Civil Procedure of the United States District Courts pertaining to the taking of depositions, taken before JOANNE H. RICHTER, a Notary Public within and for the County of Cook, State of Illinois, and a Certified Shorthand Reporter of said state, No. 84-2082, at Suite 1927, Evanston Hospital, 2650 Ridge Avenue, Evanston, Illinois, on the 13th day of February, A.D. 2009, at 10:00 a.m.

(WHEREUPON, the witness was duly sworn.)

MICHAEL WOLFSON KAUFMAN, M.D., called as a witness herein, having been first duly sworn, was examined and testified as follows:

EXAMINATION

BY MR. AUCIELLO:

Q. Sir, would you please state your name, for the record?

A. Michael Wolfson, W-o-l-f-s-o-n, Kaufman, K-a-u-f-m-a-n.

Q. I take it, Doctor, you have given depositions in the past?

A. Yes, sir.

Q. My name is Ernie Auciello. We met a few moments when ago when I came in the room. I represent the defendants in a lawsuit of Linda Adams versus Johnson & Johnson, et al., in the U.S. District Court for the Southern District of Illinois.

We are here to take your deposition because you were identified as a retained expert, is that correct?

A. Yes, sir.

Q. What your professional address?

A. Department of Pathology, Evanston Hospital, 2650 Ridge Avenue, Evanston, Illinois, 60201.

Q. Your date of birth?

A. XX/XX/

Q. Doctor, I will mark as Exhibit 1, copy of your curriculum vitae, which you have provided for me when I got here.

(WHEREUPON, said document was marked Kaufman Deposition Exhibit No. 1, for identification, as of 2/13/09.)

BY MR. AUCIELLO:

Q. Doctor, showing you Exhibit 1, is that a true and accurate copy of your current curriculum vitae?

A. I just have to check one thing to see if it's been updated. Yes, it is complete and up to date.

Q. Doctor, since you have gone through this before, I will dispense with most of the instructions, but, obviously, if you don't understand any question I ask you, please ask me to rephrase it. I will be happy to. Okay?

A. Yes, sir.

Q. If you want to take a break at anytime, you certainly can do that. And I don't expect this to be that long, anyway.

Tell me, briefly, although I have your curriculum vitae, when did you go to medical school?

A. From 1968 to 1972.

Q. And that was at the University of Chicago?

A. Yes, sir.

Q. After leaving the University of Chicago, what did you do?

A. After I left the medical school, I stayed there as an intern and resident in the department of pathology, finishing up in 1976.

Q. Do you —

A. Then, I took a year off for doing a six-month job and a six-month vacation, and then started my fellowship at the University of Texas, M.D. Anderson Hospital for one year, finishing up in July of 1978. I came up to Evanston Hospital and I have been here ever since.

Q. Do you have a subspecialty within the area of pathology?

A. Yes, I do.

Q. What is that?

A. Anatomic pathology.

Q. Tell us what anatomic pathology means?

A. It is the diagnosis of disease states by the gross visual inspection of tissues, as well as their microscopic visualization, to render a diagnosis upon which treatment is based.

Q. Is that type of pathology that's practiced in a hospital like we are today?

A. Yes, sir.

Q. Do you consider it part of your subspecialty to do forensic pathology?

A. Yes. I am not a forensic pathologist by board certification, but I certainly have experience in forensic pathology.

Q. Do you routinely do autopsies at this time?

A. Personally do them, or supervise them?

Q. Personally.

A. Every July I do, because I teach the new residents to do autopsies. So this past July, we did 15. And then I will see what happens this July, but I will do those totally on my own or, certainly, with them, hand in hand.

And then during the other eleven months, I might do maybe a couple of more just for private cases, but not hospital cases, because those would be done by our residents.

Q. What are you boarded in?

A. Anatomic pathology and cytopathology.

Q. Just so it is clear, what is cytopathology?

A. That is an area of subspecialization of anatomic pathology in which the diagnosis of disease states is determined by microscopic analysis of either individual cells that are within fluids, or that may be aspirated as microbiopsies or aggregates. It would be a cellular analysis rather than whole tissues or biopsies or whole organs.

Q. Have you ever held a position for a public entity where you were the person responsible for determining causes of death, such as — in different states it is called different things — medical examiner, coroner, any position like that?

A. I was a coroner's physician during the six months I was working between my residency and fellowship in McHenry County. I wasn't directly employed by the county, but I was paid by the county to do its forensic cases.

Q. At any other time in your career have you held that role?

A. No.

Q. You indicated you are not boarded in forensic pathology?

A. That's correct.

Q. Are you board eligible in forensic pathology?

A. No, I am not.

Q. What would you need to become board eligible in forensic pathology?

A. At this point, I would need to do a fellowship year in forensic pathology, and then take the exam.

Q. Do you know Dr. Jacobi?

A. No, I don't.

Q. You have not, to your knowledge, met him at any professional conferences?

A. Not to my knowledge, no.

Q. You are licensed in the state of Illinois, correct?

A. Yes.

Q. Are you currently licensed in any other state?

A. Yes, sir.

Q. What other states?

A. California, Texas and New York.

Q. Is there a reason why you are licensed in California, Texas and New York?

A. California was because my original intent was to do a residency out there and stay out there. Life takes its strange turns. I never went out there. But I maintained a license because people said if you ever wanted to practice there in the future, that it's best to keep it once you have had it.

I have also worked out there during the years covering my friend who did go out there, so I have been out there a few times covering him, but not recently.

Texas was because I did my fellowship there, and for the same reason, I was told that it would be a good idea to maintain that license.

New York, that was Plan B, if I wasn't going to California, that I was going to go to New York, so I got my license there in anticipation of moving there after my residency, and that never happened, but everybody said you might as well keep those licenses as long as you have them.

Q. Okay. Your position now, I believe you might have said. What is your title here?

A. I am a senior attending pathologist in the department. I am also director of autopsy services for the Evanston Hospital Corporation. I also am the medical director for our Outreach Laboratory Services Corporation.

Q. What are autopsy services in the hospital?

A. We provide the autopsy service. So, I mean, now, we have four hospitals in our unit that all the deceased who wish an autopsy get done here. We also do autopsies for the hospices and nursing homes, which are affiliated with the hospital, so we will do those here, and I am the director of that service.

Q. Is that the context in which you do the 15 or so autopsies every July?

A. Yes.

Q. And during the rest of the year, who does autopsies?

A. The residents always do them once they get trained, so they do them and we, as attendings, supervise them on a weekly basis.

But because I put in four or five weeks in July, I, generally, don't have to do much more than one or two weeks during the regular year since we have about eleven people who rotate.

Q. Doctor, I see you have a listing of publications and presentations in your curriculum vitae.

Are any of these, in your mind, of particular relevance to the issues presented in this case?

A. No, sir.

Q. Have you ever published on toxicology?

A. Not, per se, no.

Q. Obviously, I would expect that you would consider yourself an expert in pathology?

A. Yes, sir.

Q. Obviously, anatomic pathology, correct?

A. Yes.

Q. Do you consider yourself an expert in forensic pathology even though you don't have a board?

A. Yes, I do.

Q. What's the basis for that?

A. Six months' work experience; two, is that many of the cases that we do have forensic implications. In addition to the Evanston Hospital cases, we have a private autopsy service, which has contracts with other hospitals, as well as private families, so that we will do cases which are medical examiner cases, but, for one reason or another, the medical examiner will not choose to do, but we will do those cases.

We will do re-autopsies. If someone dies in jail, we may by request of the family do a re-autopsy.

In addition, I have a medicolegal consulting practice, in which a certain percentage of those cases are of medicolegal import, criminal matters, so that I have done three dozen trials of criminal cases in which pathology was an issue, so, that experience base.

So, certainly, in terms of my training in pathology, as well as my work experience and education, certainly, I feel qualifies me to have expertise in forensic pathology, even though I have not done a formal fellowship in that discipline.

Q. Do you consider yourself an expert in pharmacology?

A. Not, per se, no. The expertise in dealing with drugs is, really, as an anatomic pathologist, utilizing the information that's generated by the toxicology people, who generate a number that I would take and utilize in concert with all the other information that I have to determine the cause and manner of death, what is the approximate cause, what are contributing factors or what are non-issues and that, sifting through all of the pieces of the puzzle.

Q. But, essentially, you don't consider yourself an expert in pharmacology?

A. Correct. I don't run the laboratories or do the testing. I know what to test for, when appropriate. I get the results back. I interpret the results in the context of the case.

Q. All right. And a similar question, do you consider yourself an expert in toxicology?

A. The same answer would apply.

Q. And it would be the same answer for forensic toxicology?

A. I don't distinguish the two, because virtually all toxicology has forensic implications, so that when toxicology is done, certainly, in an autopsy case, it invariably will have implications not only in terms of the cause of death, but circumstances surrounding the death.

Q. Are you familiar with the concept of postmortem redistribution of drugs?

A. Yes, I am.

Q. How so?

A. Well, in dealing with drug levels and in, basically, reading about them and talking to our own toxicologists whether this is important or not, knowing when we do take blood or other sampling where it is taken from, to deal with that issue, either in terms of doing it ourselves if it is our case or in reviewing other peoples' work product, as to where the source of the fluid or tissue was that was tested.

Q. Do you consider yourself an expert in postmortem redistribution of drugs?

A. Only to the extent of what the literature says, since I don't do the testing myself. I am aware of its existence. I am aware of why it may happen in certain cases. And whether it involves any one given case or not is really part of the factors that one deals with in terms of interpreting a given value and the significance of that value in the context of a given case.

Q. Would postmortem redistribution be an area which you would defer to a toxicologist?

A. Well, the concept, no, the concept is pretty clear. On any given drug, there are published, on any given drug, wide ranges of postmortem redistribution and it is usually what's called a factor.

Now, some of these factors have such wide ranges as to make them almost incomprehensible to have a formula. And, in fact, sometimes, it is less than one, such that the heart, which is allegedly the site of higher concentrations, may, in fact, have a lower level than what may be peripherally.

And so when you have a circumstance like that, you have to judge whatever value you have, from whatever the source is, whatever the literature indicates, and how these values, regardless of the range, tie in to all the other factors of the case for you as the ultimate decider of the cause and manner of death, what relative importance these factors have.

Q. But my original question is whether you consider yourself an expert in postmortem redistribution.

And if I understood, your answer would be only as you get it from the literature?

A. Well, that's the only place that one could have a source.

In other words, the toxicologist does the testing. Just generates a number. If there is concern that a given drug has postmortem redistribution, then it is just a question of, for a given case, you would have to do simultaneous values that are in peripheral blood and central blood in the heart on any given case. Most times it is not done.

If it is done, then that's a number. If you have a series of such numbers, they may be published, and then Publisher A has a certain series, Publisher B has a certain series.

All I am trying to indicate is that the range at times is very high, and, in fact, that ratio can be less than one, so that it may work the other way, as well.

But if you have a circumstance where on a given case you only have one value, you can't argue that, “Well, therefore, there is such a wide range that the average is so and so, therefore, I can opine what the value would have been in a peripheral site.”

Q. When you talk about ratios, are you talking about the ratio between a drug found in peripheral blood as opposed to heart or central blood?

A. Yes.

Q. Do you have any expertise in comparing the value or the levels of drugs in postmortem blood versus antemortem blood?

A. Well, it is the same problem, because if you take — depending on where you are getting the blood, because antemortem blood, generally, is going to be from a peripheral site.

And, generally, if you take postmortem blood, it is not going to be from the same peripheral site, so you have a problem.

And also it depends on the time frame between when the blood was drawn antemortem and death, so there would be a certain metabolism factor going on, anyway.

Q. Are you familiar with any studies comparing antemortem fentanyl levels with postmortem fentanyl levels?

A. The values that are in the literature in terms of product distribution are antemortem in the sense of, if you are given — in other words, the studies to determine blood levels are done on people who are alive.

So in other words, if you have a fentanyl patch, you should expect, after steady state of, say, 72 hours, the value is going to be such and such with a standard deviation. That would be an antemortem value.

Now, if you take a postmortem value, part of the problem is that you don't know necessarily when the drug was given relative to death, and you don't know when any given drug may have been effected by postmortem redistribution.

Q. Are you familiar with any studies that compare the level of antemortem drug levels — and I am using the fentanyl, but any other drug you can think of– of an antemortem level with a postmortem level?

A. All I can tell you is what I read in the toxicology books I refer to, when I am dealing with a given case.

And, generally speaking, if it is a forensic pathology literature, they are not talking about antemortem levels. They are talking about postmortem levels.

Generally speaking, the antemortem levels are done in, not drugs of abuse, but by therapeutic drugs. And those are done, essentially, to determine what the blood levels are, the peaks and the troughs, whether they be antibiotics or narcotics, et cetera.

So in the case of fentanyl, they will have a level of drug that would reflect what the blood level would be in a steady state situation.

They will have studies where there would be other kinds of drugs where you would say peak value — just take, for instance, alcohol — what it would be. For instance, alcohol would be a good example. You can have a blood level drawn right before somebody dies, and take the blood level right after the death, and, theoretically, it would be the same.

Q. But my question was, whether you are familiar with any study that compared fentanyl or other drugs taken, measured antemortem, in the same patient, then measured postmortem?

A. No, because the studies that I have read have been postmortem studies.

Q. You happen to have, we will get to it later, Anderson and Muto study here?

A. That was from a previous case I worked on.

Q. Anderson and Muto discusses the ratios between central blood and peripheral blood, correct?

A. They talk about it. And if you look at their cases, some of them had levels that were drawn from central, as well as peripheral. Many had one or the other, but not both.

Q. Right. But there were no antemortem levels measured in Anderson and Muto?

A. Correct.

Q. Do you consider yourself an expert in cardiology?

A. In clinical cardiology, no.

Q. How about in cardiac pathology?

A. Yes, I do.

Q. What's the basis for that?

A. The basis for that being that I, as a surgical pathologist, we get material from the heart, heart valves, myocardial biopsies, pieces of heart from aneurysm repairs, pieces of aorta or other peripheral vessels that we review in autopsy. Virtually, every autopsy, we will have a detailed examination of the a heart. And I think that that certainly qualifies me over the last 35 years or so of that kind of expertise.

Q. Have you ever published in the area of cardiac pathology?

A. I have one article, yes.

Q. Could you tell me which one that is?

A. Publication No. 3. Title doesn't give it justice what the study was about, but it was on heart pathology.

Q. In rabbits?

A. Yes.

Q. Before this case, did you know who Stephen Factor was?

A. I had been on a case, on opposite sides of the case, where he was an expert. I forget which side who was on, but we were on opposite sides.

Q. Other than that, had you had any contact with him?

A. No, I didn't have contact with him then.

Q. You knew him?

A. I knew of him.

Q. Is there anyone here at Evanston Hospital that specializes in cardiac pathology?

A. No.

Q. Do you ever consult with pathologists who specialize in cardiac pathology?

A. First of all, let me take that back. We just had someone come up from Northwestern who is an expert in neonatal or baby congenital heart disease, but I don't count that.

But do I consult with anybody for heart pathology issues?

Q. Do you? Yes.

A. No, I don't.

Q. Never have?

A. No.

Q. By the way, going back, you mentioned that there were publications relating to toxicology that you would use. What would those publications be?

A. The ones that I own. I have them on my shelf here. I have got the Baselt textbook. I have got the Karch textbook. I have got the Ellenhorn textbook. Those would be my three main ones that I use.

Q. Do you rely on them?

A. Yes, I rely on them in the sense that they are referral books. They have reliable information. They are, certainly, not either — none of them are authoritative in and of themselves, but I think they are reliable reference sources, yes.

Q. In particular, I can see Baselt. Baselt's chapter on fentanyl, do you find that reliable?

A. Yes, to the extent that it is a reliable resource. But, again, it is a question of reliability versus it being authoritative. It is not authoritative.

Q. The Baselt book has data in it, correct?

A. Yes.

Q. Do you question the data in the Baselt book as it relates to fentanyl?

A. I don't question the data in anything. I mean I just — it is, basically, a purview of what the literature is, with the various references.

I don't think he has a particular bias, shall we say, on any given literature, but I would read it and take the information there and coordinate that with all the other factors of the case, so whatever the toxicology —

You have to remember what a forensic pathologist does, or what an autopsy pathologist does is he or she takes information from all sorts of stuff, clinical records, radiology, from consultations, from slides, for any toxicology, any other biochemistry, put all of that information together, and come up with what, in your opinion, is the best fit, and that's what you do.

So as far as the Baselt information goes, it may be what it is. It is not anything more than relaying what — and, basically, parroting what's out there from other articles, so every chapter on any drug will have multiple references, and that is just the reality.

Q. Did you use or rely on the Baselt book in reaching your opinions in this case?

A. No, I did not.

Q. Are you familiar with Dr. Karch's book? That's the other one.

A. I am familiar with it. I have used it, yes.

Q. Likewise, you would find the data in there to be reliable?

A. Well, again, it relates to people's work. I don't think any of these guys do, necessarily, research on every single drug. They rely on what's there in the literature as a review, so I think that's reliable, but not authoritative.

Q. How do you define “authoritative”?

A. Basically, whatever is said there is the absolute truth. There is no reason for anybody else to write anything else, because it is the word of God.

Q. What edition of Baselt do you have?

A. 7th.

Q. Is there an 8th out now?

A. I don't know, because I was reading in — Dr. Evans makes reference to an 8th edition, and I thought I had the most recent one. And I think this is dated about 2004, so if there is a new one, I am not aware of it.

Q. Doctor, unless I have mixed this up, in the retained witness disclosure given to me by plaintiffs, there is a reference to Baselt.

Is that something you provided counsel?

A. It may be whatever — I think I gave a copy of this to Mr. Carlson. That may be his chapter in there.

Q. It appears to have two pages, or the fentanyl chapter in Baselt —

MR. CARLSON: That's even possible that's what was attached to Dr. Leikin's report, too, because he was provided a copy of that, so I don't know.

BY THE WITNESS:

A. That may have been research I did for the DiCosolo case.

BY MR. AUCIELLO:

Q. Would you agree with the reference in Baselt that states that the studies that they looked at, looking at peripheral to central ratios, they average 1.6?

A. First of all —

Q. — with fentanyl, I should say?

A. Right, there are probably many references to that. But the 1.6 is an average in and of itself, so that half them are less than 1.6. As I said, some of them are even less than 1.0.

Q. My question was, do you agree with it?

A. No, I don't agree — I agree that that was their conclusion. I could also say there are other articles that may say it is higher and may say it may not be a factor at all.

What I am saying is all you can say is that even taking 1.6, (a), it doesn't apply in this case because we have a peripheral blood draw; (b), even if you were to take 1.6 and say it is a central blood draw, and you divide the 12.2 by 1.6, you still have a value that's far and above standard deviations for what a therapeutic level —

Q. I am talking about postmortem redistribution, not —

A. What I am saying is that I don't agree that any postmortem distribution applies in this case, number one.

Number two, even if you were to argue that it was, you don't know what that number is.

Three, even if you were to take 1.6 as the ratio and say, “Well, the 12.2 is really 1.6 higher than what it really was,” you still have a value — do the math — of 7.625, which is multiples over what the drug manufacturer says that the steady state level should be after 72 hours of 1.7, plus or minus .5 or .7, as standard deviation. So you have a number that is multiples over that, that cannot be accounted for by the normal usage of that drug.

Q. Is what you are telling me, is that an issue of toxicology or pathology?

A. Is what, the number?

Q. The analysis you just gave me of trying to calculate whether blood level could be consistent with a therapeutic dose.

A. That, you can just get from product literature. In other words, the product literature states that the value of the fentanyl patch, the 75-milligram patch after 72 hours of steady state, would be 1.7 nanograms per milliliter plus or minus .5 or .7. That's out there in the drug literature. That's what they are proposing — that's what they are saying.

So if you have that as the baseline, and that's what it should be, even taking the 12.2, even dividing that by 1.6, you still come up with a number that is now 4-1/2 times what it should have been.

So I am just saying that that is a toxicologic analysis. But what my job is as pathologist is to take that toxicologic analysis and factor that in to all of my information about a given case as to its significance or insignificance.

Q. And isn't it true that Anderson and Muto found a range of postmortem redistribution that went from as low as 0.7 to as high as 4.6?

A. That's true.

Q. And if Mr. Adams had an antemortem level of 3, a postmortem redistribution in a ratio less than 4.6 could account for the postmortem findings?

A. No, because the blood that was drawn in this case was not central blood. When they talk about right heart blood, they talk about getting blood from the inferior vena cava.

This was blood up in the neck, subclavian superior vena cava. Wherever this was from was not in what I would describe as central cardiac blood.

Q. What vessel was the blood taken from this case?

A. Dr. Evans thought it was the subclavian. I was under the impression, normally, if you were to get blood there, the only place you could get blood would be the superior vena cava.

Q. Is it your opinion that peripheral blood does not experience postmortem redistribution?

A. No, because that's the basis of the ratio. The ratio is the peripheral, which many people use as femoral blood, but it is that ratio of femoral blood to central cardiac blood that defines the redistribution.

Because, otherwise, you could say, “Blood taken antemortem is redistributed. What makes antemortem blood any different than postmortem blood?”

Q. My question was, does postmortem redistribution occur in peripheral blood?

A. No, because that defines the baseline.

Q. So antemortem levels would be the same, if you could take fentanyl levels in the patient before they died —

A. And then immediately kill them?

Q. — and shortly after their death, the antemortem level would match the peripheral?

A. If you had enough of a large series, yes.

Q. Have you seen any literature where antemortem — I think I asked you this — antemortem levels, even inadvertently were obtained in the same patients and, thereafter, a postmortem peripheral draw was done?

A. No.

Q. Would you find that useful if that were done to look at the results?

A. No.

Q. Why not?

A. Because I cannot imagine how you would know when a patient was about to die. And factoring in the metabolism of the drug that goes on in between, the manner in which the blood was drawn antemortem, how much of a dilutional factor there may have been in terms of how the blood was obtained, it is just not obtained in the same fashion.

I have never heard of such studies that would show such a striking difference. I mean, all of forensic toxicology is predicated on, basically, postmortem levels of drugs of abuse.

If you have normal drugs, they are based on what the level of therapeutic level would be, given the way a drug is administered. And then you compare them to decide whether the levels there are of a value that are toxic, that are fatal or associated with fatalities, and how those values, when generated, compare with other factors that may be a more competent cause of death.

What you are looking for in an autopsy is the most competent cause of death, and you take all of these factors involved.

Q. My only question was whether or not if there were a study that showed a differing value between an antemortem blood draw shortly before death and a peripheral draw, that would not be instructive to you? You wouldn't find that — that wouldn't change your opinion?

A. It wouldn't change my opinion. It may be instructive, but it wouldn't change my opinion.

Q. Is your opinion that the blood drawn in this case was peripheral?

A. Yes.

Q. Where did Dr. Jacobi say he drew the blood?

A. He said he drew it in the neck area.

Q. Was it loose blood?

A. It wasn't quite clear to me. It sounded like it was coming from the superior vena cava, that he was getting blood that was in the neck region that may have been — when he opened it up, and he may have sliced into the jugular vein and he was drawing blood out of that area, or the superior vena cava coming down from the subclavian.

My impression was that he was getting blood from that area. And whether he actually put a needle into the actual lumen of the vein, or in the course of doing the neck dissection there was loose blood there that he got out, one way or another, that was blood that came from the region of the right subclavian jugular superior vena cava area.

Q. It wouldn't matter to you if it was loose blood in the chest?

A. No.

Q. Are you an expert in pharmacokinetics of drugs?

A. No, not — no.

Q. Doctor, you provided me a list of depositions.

A. And trials.

Q. And trials. Do you know how many depositions and trials are listed on here?

A. No.

MR. AUCIELLO: Please mark this as Exhibit 2.

(WHEREUPON, said document was marked Kaufman Deposition Exhibit No. 2, for identification, as of 2/13/09.)

BY MR. AUCIELLO:

Q. When were you first engaged to be an expert in this case?

A. September 18th, 2008.

Q. Seems obvious, but I will just make sure, for the record, but you had nothing do with the autopsy of James Adams in 2005?

A. That's correct.

Q. Am I to understand that you disagree with the findings of Dr. Jacobi in his finding that Mr. Adams died of a cardiac cause of death?

A. I do disagree, yes.

Q. You understand that Dr. Jacobi had the benefit of doing the autopsy himself, correct?

A. Well, I am not sure that's an advantage, but he did the autopsy himself.

Q. You are telling me, between you and he, the pathologist who does the autopsy doesn't have an advantage in reaching conclusions over another pathologist who reads what he wrote and looks at slides?

A. No, because his written record is what he saw, what he did. The slides I looked at, which is his work product, the drug data that was generated was generated from a report which both he and I had the advantage of seeing. His gross descriptions and what they are, they are in written form.

So I do not see the advantage that he has having done the autopsy and, theoretically, writing down everything he saw and did, from me receiving that work product.

Q. So you are in just as good a position to evaluate the cause of death of James Adams as is Dr. Jacobi?

A. Yes, I am. Plus, I would say, in some ways, better. In the sense that when he wrote the report, he either did not know, necessarily, the entire history. He did not — he made a certain assumptions that Mr. Adams was a chronic user of the fentanyl patch, when, in actuality, he was a novice. This was only his second patch.

One could argue that I had more information than he did, and am in a better position to talk about his case. And I am not even talking about issues of general experience base in terms of what we do and how we evaluate things to suggest that he is at an advantage over me. I disagree with that completely.

Q. Dr. Jacobi concluded that Mr. Adams died of a cardiac arrythmia. Is that a correct statement of his finding?

MR. CARLSON: Object to form.

BY THE WITNESS:

A. Everybody dies of cardiac arrythmia, so that is a useless concept.

BY MR. AUCIELLO:

Q. I will rephrase the question. What did Dr. Jacobi list as the cause of death?

A. Well, ultimate severe coronary artery atherosclerosis, with the contributing factor of a toxic level of fentanyl.

Q. Now, do you disagree with severe cardiac atherosclerosis?

A. Well, if you take 70 percent, 70 percent is not considered severe. 75 percent plus is considered severe. That's quibbling. I agree with him it was 70 percent, so.

Q. You agree with him that that caused his death?

A. No, I disagree that caused his death.

Q. You disagree with Dr. Factor, as well?

A. Yes, I do.

Q. You disagree with Dr. Evans, the toxicologist?

A. In terms of what?

Q. Any of his findings related to this case.

A. He didn't really have any findings. He was just relating what he did, how he did it, and what values they were. He was noncommittal about a lot of things that he should have been noncommittal about. He, certainly, did not opine about the cause of death.

Q. At the time of trial, are you going to question the competence of Dr. Jacobi?

A. No.

Q. You admit to me that he is a competent forensic pathologist?

A. He is a competent pathologist. It is just a question of differing opinions. Clearly, his competency led him to believe that the value of fentanyl was toxic, even knowing or questioning whether there was postmortem redistribution, whether postmortem values equaled or unequaled antemortem values, or anything like that. His conclusion was that it was a toxic value.

Now, he wasn't aware that this was the first go-around. He certainly was, in my mind, unappreciative — you want me to critique his —

Q. I just want to know when we get to trial whether you are going to make aspersions onto the abilities of Dr. Jacobi. Are you going to say he is less than competent, less than educated, anything like that?

A. No, I will not. I will just say we reached different conclusions, and I will give you reasons why I believe my opinions, based on his data that he generated, I think, in my opinion, lead to a different conclusion.

Q. Now, you would agree that when Dr. Jacobi did the autopsy, though, he was not being paid by either party to this lawsuit?

A. That's correct.

Q. He was doing it as a part of his ordinary day-to-day function?

A. That's correct.

Q. You, when you looked at it, are doing it having been retained by the plaintiffs, correct?

A. I am looking at it in a completely objective fashion. To suggest that because I am paid by the plaintiff I will shade my opinions based on what the plaintiff wants me to say, I think is clearly mischaracterization of what my role here is.

My role, frankly, is to be a friend of the court, to explain to the court what my take on this is. And, believe me, if I didn't agree with what I am saying here, I wouldn't be sitting here and Mr. Carlson would have to get somebody else.

Q. But my question was, simple, that when you reviewed this, you did it when you were hired by the plaintiffs to do this and you are being paid by the plaintiffs?

A. That's correct.

Q. What is your charge for doing consulting work such as this?

A. My charge for consulting work is $300 an hour. For deposition time, it is $400 an hour.

Q. And I don't want to add all of these up. How many cases involving pharmaceuticals have you been involved in before?

A. Multiple, I mean, if you include alcohol, but there are drug cases where there have been drug overdoses or contributing factors.

In terms of total cases I have been consulted with over the last 27 years or so, it is probably about 800 by this point. I get about 50 cases a year. Clearly, may be three or four involve some sort of drug overdose or alcohol intoxication.

Q. You said you were engaged in a previous case called DiCosolo?

A. Yes, sir.

Q. Did you render opinions or issue a report in that case?

A. The written report, I don't know. Clearly, the lawyer who had retained me knew of my opinions, but, apparently, it was not necessary for me to — as I said, I, certainly, didn't testify at the trial. I read about the results in the newspaper, like everybody else, and I don't honestly recall whether I was ever deposed on that case.

Q. You don't believe you issued a report?

A. I don't know. I don't remember.

Q. In this stack of material here that's clipped, and the top item is the Anderson and Muto material, this is something that you obtained through that case?

A. Well, it was either given to me or I generated it myself, so I could tell you which was which, but — did you want me do that?

Q. No.

A. For instance, here this article I got myself, because it was gotten from our hospital library here.

Q. When did you start doing consulting work?

A. About 1981.

Q. Is it all civil cases or civil and criminal?

A. Some criminal cases. Probably about 50 criminal cases over the years.

Q. Out of approximately 800?

A. 800, approximately 800.

Q. Excluding the criminal cases, is there a ratio as to how often you are retained by the plaintiffs in a civil suit versus the defendants in a civil suit?

A. It is about two-thirds defense and about one-third plaintiff, and that's really in medical malpractice.

I don't view this as that kind of case. Any of the toxicology/alcohol kinds of auto accidents, I have no knowledge because the sides are always strange and I never know.

Q. Are most of your cases medical malpractice cases?

A. Yes.

Q. I would take it, most of the criminal cases involve substances like alcohol?

A. Most of them involve somebody who died, usually by violent means, and alcohol may have been there, but it wasn't necessarily the major event.

Q. Have you ever worked with Mr. Carlson before?

A. No, I have not.

Q. Since we have the Anderson and Muto studies sitting in front of us, do you regard the Anderson and Muto study as being reliable or authoritative?

A. Certainly, not authoritative. It is reliable only to the extent that it relates data either generated from their studies or other peoples' studies. But that's all you could say. It is just one article in which there are many other articles that probably exist.

MR. AUCIELLO: Let's move on to your report.

(WHEREUPON, a document was marked Kaufman Deposition Exhibit No. 3, for identification, as of 2/13/09.)

BY MR. AUCIELLO:

Q. Doctor, is Exhibit 3 a true and accurate copy of the report you issued to Mr. Carlson in letter format on October 12, 2008?

A. Yes, sir.

Q. And it contains a listing of everything you reviewed in this case?

A. Up to that point. I subsequently have looked at the deposition of Dr. Evans.

Q. Anything else since then?

MR. CARLSON: He was also given the report of Dr. Factor and Dr. Kaplan. Evans, Factor, Kaplan, pathology, yes, that's it.

BY MR. AUCIELLO:

Q. Other than this list and then the expert reports from the defense experts and the deposition of Dr. Evans, is there anything else you have reviewed?

A. No, sir.

Q. Did you issue any other reports other than this one on October 12, 2008?

A. No, sir.

Q. Did you speak with anyone other than Mr. Carlson or Mr. Carlson's office concerning this case?

A. No, sir.

Q. On the second page, you make mention of a known product defect in the 75-microgram fentanyl packages, you called them?

A. Yes.

Q. What was the known defect with the 75-microgram patches in April 2005?

A. Those were in the information that was provided me in the DiCosolo case that talked about the product recalls, and the leaking of the drug patches that gave excessive drug levels with some deaths. And, obviously, the DiCosolo case was such a death. And it talked about the product recalls and the lot numbers, et cetera.

Q. Is it your opinion that Mr. Adams used a recalled patch?

A. I don't know.

Q. Is it your opinion that there was a product defect in 2005 that caused leaky patches?

A. I don't know in terms of when these were done. Mr. Carlson told me this morning that there was a subsequent recall, I think he said in 2006 or 2008, again, with the same product difficulties about leaking patches. So it apparently has been an ongoing problem. Having said that, all I can say is that there is clearly a history, an ongoing history with this product, delivery system.

Q. What was the known product defect that Mr. Adams would have experienced in April of 2005?

A. Excessive, I don't want to say “leakage,” but excessive output of the fentanyl from this delivery system, such that it gave more than the expected dose delivery timing.

Q. And your basis for that?

A. That what, he had —

Q. That opinion.

A. Basically, the levels that he was given, (a), he died, and (b), the level that was generated at the time of his death, which was clearly at variance with what the product manufacturer said would be the product range of therapeutic delivery.

Q. Other than the drug level, which you have talked about, what other evidence do you have about the known product defect in 2005 that caused excessive output for the delivery system?

A. Only what was given from the Cushing law firm to me. I didn't do any independent investigation beyond what was there. They just gave that to me for background information.

Q. This stack of materials includes the Anderson and Muto study, two copies of it, actually, copies of Duragesic packaging. This is from the Janis DiCosolo case?

A. Yes, sir.

Q. These are copies of the packaging which she had?

A. Yes.

Q. You have got printouts of news reports regarding a recall from Janssen in February 16th, 2004?

A. If that's when it was, yes.

Q. What does the recall on February 16, 2004 have to do with this case in April of 2005?

A. Well, number one, is — well, you have got to work backwards, okay, and working backwards really, literally, goes from the generation of the toxicology to the fact that he died, to the factors that go into the reasons why he died, the timing of when he died, the value of the fentanyl that was there, the fact that a couple years before that there were problems.

I just found out today that subsequent there were problems, and so that the idea being that, (a), the package that he may have taken, either the first or the second patch, or both, was defective. And it may have just been a defective one in a lot that might otherwise have passed quality control. And Mr. Carlson was telling me about how the manufacturing company would quality test these things. And I am, certainly, not an expert in critiquing their methodology, but it was just the idea that this has, apparently, been a problem over the years.

And that once one determines the cause of death here, and once one eliminates other possible causes of death, then one has to look at the fentanyl, look at a value, which clearly was at variance with what it should have been, and have to reach the conclusion that one or both of the patches that Mr. Adams took were defective.

That doesn't necessarily mean — and we don't have the lot number from which this came from. But even if the lot number was not one that was ever recalled, and may have been sitting on the shelf for a year or so even after the recall, but even if it was not, it doesn't guarantee that there wasn't defectiveness in one or both of the patches that he took.

Q. My question was, what does the February 16, 2004 recall have to do with this case which occurred in April of 2005.

A. That's what I am telling you, that, for one, because there were recalls, it was initially one lot and then they expanded it to three or four other lots.

We don't know for sure that the pharmacy where he took it from had returned all of those lots. We don't know whether —

Q. Is it your testimony that CVS sold Mr. Adams a recalled patch after the date of the recall?

A. No, that's not my testimony.

Q. You were testifying just now that you thought that was a possibility.

A. It is a possibility, but testifying is, in my mind, within a reasonable degree of certainty. It is more probably true than not. I am not saying that. I am saying it's a possibility.

Q. Using that standard, more likely than not, with reasonable scientific certainty, what was the defect in the patch that Mr. Adams used, if any?

A. The delivery system, in some fashion, delivered drug at a rate that was higher than it should have, through either some manufacturing defect or product design defect. I don't know. I am not into the engineering of this thing. But for some reason, certain ones of these were defective causing death of people and overdose of people, such that this has been reported, which is why they were recalled.

All I am suggesting is that it is possible in view of the way the quality control was working, even in lots that may have been passed that there weren't necessarily — or, you couldn't exclude that they were defective.

Q. What was the defect that occasioned the 2004 recall?

A. My understanding was these were delivering an amount of drug in a more rapid fashion than they should, causing blood levels to be higher than the levels it should be in a distribution from the patch at a lower level that would give the steady state level that it should be.

Q. Where did you get that information?

A. Those would be from the product recalls, of what it was supposed to do, or the product literature about what its purpose is.

Q. Are you going to present yourself as an expert in the design of transdermal products such as Duragesic patches?

A. No, I am not.

Q. Are you going to state to the jury at the time of the trial that there was a defect in a Duragesic patch used by James Adams?

A. Yes.

Q. The basis of that would be the drug level in his system and the 2004 recall?

A. No, I am just saying that, historically, there were problems in the past with this drug, with this particular level, 75-milligram level. This is a history of that particular drug.

Q. Are you concluding because of the 2004 recall that there must have been a defect in the 2005 patch, is that fair?

A. And in subsequent recalls, too, also would give evidence that there is, for whatever reason, some product design flaw or some manufacturing flaw. I am not here as an expert. I am just here as a pathologist, putting all the pieces of information together.

We have somebody who died, and you have to decide, as a pathologist, why did he die and why did he die 96 hours after he starts this medication. Why does he die the day after the second patch is put on, when other things were all steady state?

All of the other multiple drugs he was on in therapeutic levels were done in steady state.

The heart disease, in my mind, was a steady state, certainly, over the several months it was going on and, certainly, during the several months since his accident with getting hit by the cow, all of these things were steady states.

So the only new thing that happened to this guy was that he started on the fentanyl patch. And, literally, the day after he gets the second patch put on, he is found dead, and with a level that, clearly, was multiples higher than anything that the product manufacturer would have determined to be the appropriate drug level.

And so me, as pathologist, says, “What, given all these factors, what is the most likely event here?” And, to me, this is the most likely event.

Q. This is, what, a defect, that you can't tell me what it is?

A. No, that he died of a toxic level of fentanyl on his body.

Now, how it happened is in some fashion the drug was, essentially– the output of that patch was greater than it should have been. These patches are supposed to last 72 hours. And in some fashion, the drug, either the first go-around and then the second go-around, or just all together in some fashion reached a level that in combination with the other drugs he was on, basically, caused his death at that particular point in time.

Q. My question is still, when you wrote your report, before you knew about subsequent recalls and talked to Mr. Carlson this morning, when you wrote your report about the known product defect on Page 2, you were referring to the 2004 recall, correct?

A. Yes.

Q. You don't know what the defect was that specifically caused the 2004 recall, do you?

A. That's not true. They talk about that in the product recall in terms of the way these patches are working, that they are leaking. And in some fashion that they were leaking, or they were getting to the skin surface to be absorbed in a greater rate than they should have, causing the levels.

Q. Are you giving opinions as to whether gel on the skin would be absorbed at a faster rate than inside the patch?

A. I don't know the mechanism of how it happened. All I know is it happened. It, certainly, happened in the DiCosolo case, and in my impression it happened here.

I am not suggesting that, or not testifying that CVS was selling stuff that they knowingly knew was supposed to be recalled, and they sold it, anyway.

I am just suggesting, in some fashion, one or both of the patches that Mr. Adams took were defective.

Q. For the same reason that the 2004 patches were defective?

A. Yes. It may have been a different reason why they were going at an increased amount. They may have fixed one problem. There may have been another problem. I don't know. I am not into the manufacture.

Q. You are the expert who wrote the report saying there was a known product defect that caused Mr. Adams to die.

I want, out of this deposition, I need to know what that known product defect was that you believe occurred in April of 2005 that caused Mr. Adams to die, to the greatest specificity you can give me.

MR. CARLSON: I object as asked and answered. Go ahead.

BY THE WITNESS:

A. In some fashion, the product was defective in that it delivered a level of drug in an amount more than it should have, such that the circulating blood level and its physiologic effect became toxic and, ultimately, fatal.

BY MR. AUCIELLO:

Q. Did you see the patch that was worn by Mr. Adams?

A. No, I did not.

Q. Did Dr. Jacobi see the patch that was worn by Mr. Adams?

A. Yes, he did. He threw it out.

Q. Did he observe or note a defect in the patch?

A. I don't think he would know whether one existed or not.

Q. Did he observe or note a defect in the patch?

A. That implies that it was something that could be observed and noted, and so the question is unanswerable, because it implies that such a defect would be noticed.

Q. Is it your testimony that the defect that caused the 2004 recall would not be noticed?

A. I don't know. I don't know in terms of the people who had the problems whether they noticed anything different. Some of them were, clearly, during the process of manufacturing, or in there they talked about that the gel, or whatever, was actually leaking out of the patches before they even got them on there. But other ones, apparently, not.

Q. Back to my original question. Did Dr. Jacobi observe or note any defect in the patch?

A. None that he stated, but, again, that question presupposes that such a defect would be observed or noted, and I don't think that that is a fair question.

Q. Dr. Jacobi did not note a defect in the patch in his written report, correct?

A. If you have a circumstance where a defect is not noted, how could he note something that you would not necessarily know?

Q. Dr. Jacobi did not note a defect in the patch in his written report, is that correct?

A. That's correct.

Q. In his deposition, did he give any indication that he observed anything unusual about the patch that he removed from Mr. Adams' body?

A. No, he did not.

Q. Did you read Mrs. Adams' testimony?

A. Yes.

Q. Did you find in that deposition any evidence that Mr. or Mrs. Adams observed any leaking from any patch that was used by Mr. Adams?

A. No.

Q. Are you familiar with the Food & Drug Administration?

A. I am not sure what you mean by “familiar.” I know it exists.

Q. As it relates to the 2004 product recall that you referenced earlier.

A. If they were the ones who called the recall or told the manufacturer to do the product recall, I don't know how it got to that point.

Q. Do you know what a Class II recall is?

A. No.

Q. Going back to your report, you do not agree that it was a cardiac arrythmia caused by atherosclerosis that caused Mr. Adams' death?

A. Correct.

Q. You believe it was fentanyl toxicity?

A. Yes, in conjunction with the other drugs that he was on, but that was the proverbial straw. In other words, he was on other narcotics, although in therapeutic range.

I can't eliminate the possibility that in conjunction with these drugs that the toxic level of fentanyl was, you know —

Q. What was the recommended dose for Duragesic for Mr. Adams to be placed on?

A. My understanding was he prescribed the 75-milligram patch to be replaced every 72 hours.

Q. That's what he was prescribed. What was the manufacturer's recommendation for the dosage he should have received?

A. I don't know.

Q. Did you read Dr. Grimm's deposition?

A. Yes.

Q. Isn't it true that Mr. Adams was on 60 milligrams of Avinza when he was first prescribed Duragesic?

A. I know he was on the drug, but I don't know what the drug level was.

Q. If he was, in fact, on 60 milligrams of Avinza, are you familiar with the product insert for the Duragesic patch?

A. Only to the extent that it was given to me.

Q. I don't think I see it there.

A. Sorry, this is the PDR.

Q. I will rephrase the question. Did you make any investigation to determine whether the dosage given to Mr. Adams was appropriate under the circumstances?

A. I have no opinions about that.

Q. Why do you have no opinions on that?

A. Because that's standard of care on the part of the clinician in terms of what clinical judgments they used to do their prescriptions. And so I would have no opinions about the appropriateness or inappropriateness of any drugs that were prescribed.

Q. And it is not of concern to you the amount of Duragesic being prescribed in the fashion as recommended? All you care about was the 75-microgram patch?

A. No, what I am saying is that if one wants to make argument that this was poly-drug abuse and the fentanyl was the final straw, I don't have a problem with that.

But the issue is, that is a standard of care question, did Dr. Grimm adhere or not adhere to the standard of care. I don't have any opinions about that.

Q. I am not interested in that. I am just interested whether he followed the manufacturer's dosing instructions in the package inserts, whether or not it violates the standard of care.

A. I don't know.

Q. It would not be something of concern to you in your role here?

A. No, it would not.

Q. Would you agree with me that fentanyl does not cause cardiac arrythmia?

A. I would agree.

Q. Fentanyl does not cause atherosclerosis?

A. I agree.

Q. What was the height and weight of Mr. Adams when he died?

A. He weighed 200 — at least, in the autopsy report, 250 pounds, and I don't know whether that was an estimate, and his height was 5′ 10″.

Q. Did he have a history of heart disease in his family?

A. I have to look at my notes. I don't, specifically, recall one way or the other.

Q. He was also found to have what Dr. Jacobi described as a fatty liver, is that correct?

A. Yes.

Q. Does fatty liver mean something to you as a pathologist?

A. Yes.

Q. That's a term of art?

A. Yes.

Q. Can liver dysfunction cause drug levels in blood to be higher than normal?

A. Well, depends on what you define as “function.” I did not believe his fatty lever caused his liver to dysfunction, as far as what a liver does, in terms of metabolism, in terms of making blood clotting products, in terms of secreting bilirubin.

Q. That wasn't my question.

A. I understand. Your question is, theoretically, if you are cirrhotic and have liver insufficiency, yes, it could effect drug levels.

Q. You put in your report there is no indication that Mr. Adams' liver was not functioning at — I am assuming you mean “at normal levels at the time his death”?

A. That's correct.

Q. Mr. Adams sought no medical attention throughout most of his life until he had his back injury, correct?

A. I don't recall.

Q. You didn't have a history of liver enzyme levels or treatment and care relating to his liver, correct?

A. That would probably be correct.

Q. What would cause a fatty liver?

A. There are many causes. It could be obesity, in and of itself. It could be steatohepatitis. Diabetes can cause it. People who have gastric bypass surgeries. People who are malnourished may have fatty livers. People who are alcoholic may have fatty livers. Those are major reasons.

Q. Mr. Adams was, what, 37 years old?

A. I thought he was 48.

Q. Sorry. I am looking at your years of experience. How old was Mr. Adams?

A. I think he was 48.

Q. Is it unusual for a 48-year-old man to have a fatty liver?

A. No, it depends on the circumstance. If he was obese and 250, it is getting up there. If he was diabetic or prediabetic, that wouldn't surprise me.

Q. Do you know whether he was diabetic?

A. No, I do not know. I have no indication he was, so that that's out there. He may have non-alcoholic steatohepatitis.

Q. Do you know what caused Mr. Adams to have a fatty liver?

A. No, I don't.

Q. From his wive's deposition, you don't know whether he had consumed alcohol, other narcotics, had any other health condition that would cause the fatty liver?

A. Narcotics wouldn't do it, but I don't know what his alcohol intake was.

Q. I take it, 250 pounds, you would consider him obese?

A. I didn't do his BMI.

Q. 5′ 10″, 250, isn't obese?

A. No, it is. I am up there, too, but I am also 6′ 3-1/2″. He was on the large side, shall we say.

Q. Last page of your report, sir, you indicate that the steady state fentanyl levels should be 1.7, plus or minus .7?

A. Correct.

Q. Is that one standard deviation?

A. I would probably think that was, at least, one. It may be three. Generally, when they do standard deviations, something like this, it is probably three, which would be 95 percent of the people.

Q. So three standard deviations would get you to 95 percent of the people?

A. One standard deviation is two-thirds. Two standard deviations, I think, is 95 percent, three, I think, is, like, 99 percent. Basically, this was from the product manufacturer's package insert.

Q. So if one standard deviation were .7, that would take it to 2.4, correct?

A. No, it doesn't work that way. Oh, in terms if it was one standard deviation, but I suspect it probably was more than one standard deviation.

Q. Assume for me .7 is one standard deviation. With three standard deviations at .7, what would that take the level to?

A. It may only be another point. It is difficult to know, because it is a bell-shaped curve. And so the remaining third, only one-sixth of the people would be higher than that if it was just one standard deviation, but I suspect it is probably two or three.

Q. Are you familiar with any studies measuring the amount of fentanyl in people's blood while using Duragesic patches?

A. I think this is results of the studies. In other words, the product manufacturer's package insert states that this is what the values should be.

Q. Other than the information in the package insert, are you familiar with the blood levels of people using Duragesic patches?

A. No, we talked about that, again, in antemortem blood studies that were done. So, clearly, these would have been presented prior to the patch's acceptance by the FDA as approved.

Q. When was the patch approved by the FDA?

A. I don't know.

Q. You indicate the blood was drawn from the superior vena cava, correct?

A. Correct.

Q. That's not an error in your report?

A. Well, it was from — clearly, whether it was from the jugular vein or from the subclavian vein, it was in the neck. And so the lowest thing in the neck is the superior vena cava.

So whether it was a needle insert or whether he was just, sort of, taking blood as he was opening up the neck, my impression was that's what he said. But, clearly, the idea being that it was not an injection extraction from either the right atrium or the right ventricle or the inferior vena cava.

Q. Let's go down to the next paragraph. You believe that Dr. Jacobi was wrong in concluding that cardiac ischemia leads to arrhythmia causing death?

MR. CARLSON: Where does Dr. Jacobi say that?

BY THE WITNESS:

A. It says, “I do not believe that his death was due to any cardiac ischemia,” implying it was from coronary artery disease.

BY MR. AUCIELLO:

Q. You are saying that Dr. Jacobi was wrong in blaming the death on coronary artery disease?

A. I don't like the word “wrong.” I just say I have a different opinion. In my opinion, he was in error, but I don't like the word “wrong.”

Q. I will change my question.

A. We disagree in terms of our conclusions.

Q. Is this an area where reasonable pathologists can disagree?

A. Yes, I think that would be an area, if it was based on the full information that Dr. Jacobi did not have. The full information being that he discounted the fentanyl, because he thought that this was a chronic usage, and so, therefore, drug levels could be higher without any respiratory depressed effect.

Q. Did you read his deposition?

A. Yes, I did.

Q. Did he back down from any of his opinions in his deposition?

A. The things I disagreed with in his dep, if you want to talk about that, or just what he backed down on?

Q. Did he change his mind? He was presented with facts when he was deposed, and he didn't change his opinion as to the cause of death in this case, did he?

A. Well, yes, he did. He said he backed off on it being a toxic level, because he said he was a, quote, “chronic user.” That was on Page 29.

Q. That would be another thing that you think he is in error on, because in his report he said it was a toxic level.

In his deposition, he gave less emphasis to that level —

A. That's correct.

Q. — in determining the cause of death?

A. Correct.

Q. You disagree with that?

A. Disagree with what?

Q. Him giving less emphasis to the toxic level in determining cause of death?

A. Yes, I do.

Q. You also disagreed with his interpretation of what the fatty liver would do to Mr. Adams' drug metabolism?

A. He says that he admits that if his liver was bad, that the fentanyl would have had a greater effect.

And I am saying that his liver was not bad to that extent. In other words, he has all the other drugs that he has taken. None of those were in toxic levels.

If the liver had problems metabolizing drugs, all of those levels should have been greater than therapeutic levels, yet none of them were. So, in fact, some of them were subtherapeutic.

So to suggest that it was only the fentanyl that was elevated, I think, does not make any physiologic sense.

Q. What enzymes metabolize fentanyl?

A. I don't know.

Q. Do you know the different enzymes that would metabolize the other drugs he was taking?

A. No, but the idea being a liver cell functions with all its enzymes or not because it is dead, or because suboptimally working across the board. It doesn't selectively choose to be unable to metabolize one drug versus another.

Q. This is another area where you believe Dr. Jacobi, who actually saw and touched and examined the liver, is in error, and you having looked over this case, three years later, is correct?

A. Yes, for the reasons which I have said, that he was not comparing the fact that every other drug was in therapeutic or subtherapeutic range and the fentanyl was not.

Q. Also on Page 3 of your report you make reference to improperly manufactured product.

I take it by putting it in your report that you would consider yourself an expert in the manufacture of Duragesic patches or fentanyl products?

A. No.

Q. Can you tell me what manufacturing deficiencies existed in 2005 that would have caused a defect that caused Mr. Adams to die if Dr. Jacobi was wrong?

A. I don't know the specific defect, except the generic concept that whatever happened caused the release of the drug in a higher/faster rate than what was intended. And whether it was the same defect in 2005 which existed in 2004, I don't know.

Q. Let's move on to Dr. Factor's report. Did you review Dr. Factor's report?

A. Yes, I did.

Q. You disagree with his conclusions?

A. Yes, I do.

Q. He stated that Mr. Adams had high-grade subtotally occlusive disease of the LCX at multiple levels with narrowing of the vessel to 80 percent.

Do you recall him making that statement in Page 3 of his report?

A. Yes, I do.

Q. Do you agree with that statement?

A. No, I don't.

Q. Why not?

A. First of all, the person who was there was Dr. Jacobi, and what he writes is that the proximal third of the circumflex artery features 70 percent occlusion by plaque.

He states no luminal thrombi or plaque hemorrhages are noted. The remainder of the circumflex artery, which is the distal two-thirds, displays only trace atherosclerotic plaque.

So that's what the person who was there stated, and I accept that as being accurate.

He takes three cross-sections of an artery, which I assume were all from the left circumflex artery, and I agreed with Dr. Jacobi that the maximum this was, was about a 70-percent area of narrowing.

Q. You now agree with me that Dr. Jacobi is in a better position to determine cause of death having done the autopsy than either you or Dr. Factor?

A. No, I already went through that with you that I disagreed with that. And, in fact, I think I have more information than Dr. Jacobi did when he did this report.

Q. All right. Dr. Factor also found acute unstable plaque with plaque hemorrhage and microthrombus in the lumen adhering to the vessel wall.

A. That's what he states, and I disagree with him.

Q. Why?

A. Number one, Dr. Jacobi, who was there, who grossly didn't see anything, who microscopically didn't see anything, made the slides. I looked at it. I didn't grossly see anything from the slides. I didn't see microscopically anything. I have pictures. And if you see anything in these pictures that show any intraplaque hemorrhage or any intraluminal thrombus, then feel free to show me.

Q. Is it true that you are not a specialist in cardiac pathology?

A. That's not true. There is no such thing as a specialist in the sense that there is no board certification to call yourself a specialist.

Am I not a specialist — do I not have specialization in forensic pathology because I don't have boards?

There aren't even any boards in cardiac pathology. Do I have experience? Do I have expertise in cardiac pathology? I do. And you could show the slide to anybody, grossly or microscopically, to Dr. Jacobi, to myself, and through the pictures, nobody is going to see an intraplaque hemorrhage. Nobody is going to see an intraluminal thrombus in that vessel.

Q. You do not specialize in cardiac pathology, is that correct?

A. That's correct.

Q. To your knowledge, Dr. Jacobi doesn't specialize in cardiac pathology, correct?

A. That's correct, but that doesn't mean just because you specialize in something — you are right. The greatest hitter in baseball made out 70 percent of the time. So that doesn't mean that you are still not the greatest hitter in baseball.

Q. He further found multiple focal acute myocardial necrosis focally extending — I won't read it all, because it just makes the transcript difficult to read.

Do you disagree with that, as well?

A. First of all, I would like to look at these slides, again. I didn't see anything originally. Dr. Jacobi didn't see anything originally.

If you were arguing that Dr. Jacobi was in a much better position than me to come up to his conclusions, he certainly didn't conclude that.

Q. Based on your initial review of the slides, you disagree with this?

A. Yes, that's correct.

Q. No. 4, he said one area of the myocardium with necrosis that was four to six hours in duration associated with PMNs extending into the interstitial space.

I can't remember what that stands for. Do you agree with it?

A. No, I disagree.

Q. Because that's something you did not see when you —

A. Originally looked at it, correct.

Q. No. 5, it says a minute focus of myocardial necrosis that was several days old. Did you see that?

A. No, I didn't see anything of the things he said. The only thing that I saw, that Dr. Jacobi saw, was the coronary arteries.

And I said, as Dr. Jacobi did, that was about 70 percent grossly and microscopically.

I also made some other statements about why I felt that that was a non-factor in this case, that Dr. Jacobi maybe disagreed with me. But neither Dr. Jacobi, who you allege is the person in the best position to come up with an impression here, agreed with me, or I agreed with him.

Q. But it is your opinion that you are in a better position than Dr. Jacobi, and Dr. Factor is in a better position than Dr. Jacobi?

A. I don't know if Dr. Factor availed himself of all the information that I did. I don't know if he reviewed everything I reviewed.

Q. Have you reviewed any other fentanyl patch cases other than this one and the DiCosolo case?

A. No, I have not.

MR. AUCIELLO: Let's take a short break. I am just about done.

BY THE WITNESS:

A. Do you want me to look at the slides?

BY MR. AUCIELLO:

Q. You looked at them once already. I don't think it is a useful time. You reviewed it once.

A. I would like —

Q. If you review them again and find something different, then you can supplement that.

A. It wouldn't change my opinions.

MR. AUCIELLO: Let me look at my notes just to make sure I am done.

Let's mark them and call this Exhibit 4.

(WHEREUPON, photographs were marked Kaufman Deposition Group Exhibit No. 4, for identification, as of 2/13/09.)

BY MR. AUCIELLO:

Q. Doctor, you took photographs when you examined the slides in this case?

A. I took photographs when I examined the slides, yes.

Q. I have marked them as Exhibit 4, and the sub-exhibit photographs are numbered 426 through 445 on the back of Exhibit 4.

Just showing you those and ask you if those are true and accurate copies of the photographs you took during your examination of the slides in this case?

A. Yes. I only took pictures of the liver and the coronary artery, but, yes.

Q. And that's what is contained in Exhibit 4. Okay.

Did you review Dr. Yale Kaplan's report?

A. Yes, I did.

Q. Do you know who Yale Kaplan is?

A. No, I don't.

Q. Do you disagree with his conclusions?

A. I don't recall what his conclusions are.

Q. He is a forensic toxicologist.

A. That doesn't answer — that was a nonresponsive answer.

Well, I disagree with his first conclusion. Second conclusion, I disagree with. Third, I disagree to the extent that it contributed to the cardiac events. It may have contributed to respiratory events, as I stated in my opinion report, so I disagree with his third.

I, basically, disagree with his conclusions.

Q. And he has some references. Are you familiar with the writings by Graham Jones on postmortem redistribution?

A. I have the Karch book. If I read it at some point in the past, I did.

Q. Are you familiar with the writings of Dr. Karch himself?

A. No, just his book. Just his book. I assume he writes — he wrote his book.

Q. A lot of times a lot of the articles are not written by the author.

A. I would have to reference his book.

Q. Is that one he wrote himself, or is that one that he solicited chapters from other people?

A. I think he wrote it. This is the latest edition. I just got this.

Q. Would you consider Dr. Karch to be an authority in his field?

A. I think he is well-respected.

Q. Could I see that for a second?

A. This is the 4th edition, and it is dated 2009. Just came out.

Q. Couple of things I wanted to ask you about I thought he might have written, but I couldn't remember.

Doctor, we are looking at your brand new edition of Karch's Pathology of Drug Abuse, 4th Edition.

In that book, at Page 452, under the category Autopsy Findings, Dr. Karch indicates that if, I think, he means illicit, but “if transdermal patches are present, nothing prevents the continuous release of fentanyl after death.”

A. Into the skin, that's correct.

Q. He then concludes, “In such cases, and in instances where multiple patches had been applied, postmortem concentrations may be well over 50 nanograms per milliliter.”

A. I don't know about that. There was only one patch, number one.

Number two is, the problem comes at death, the circulation stops. And so I don't see how that circumstance could even apply in this case. Particularly, when the patch was removed in short order after death. His autopsy was pretty quick after death, so regardless of whatever he is saying.

The other issue, too, is unless you took serial values, how would you even know that that's the case. One of the articles here talked about abusing fentanyl, where people would put multiple patches on to get the high from it, to get levels like that that were that high, but we are not talking about that here.

Q. If Dr. Karch wrote, “If absorption from the patch continues after death and there is no reason to assume that the patch will stop releasing fentanyl at the time of death, high fentanyl concentrations observed at autopsy might mistakenly be considered the cause of death,” you disagree with that?

A. I would have to see the basis of his opinion, but regardless of whatever his opinion is, in this particular case, I disagree with it.

Q. Have you seen any other writings of Dr. Karch where he makes blanket statements about the unreliability of postmortem drug levels?

A. No.

MR. AUCIELLO: I have no further questions. Thank you, Doctor.

MR. CARLSON: I don't have any questions.

THE WITNESS: Reserve signature.

FURTHER DEPONENT SAITH NOT.