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Expert Witness Deposition Explains Postmortem Distribution of Fentanyl

Posted in Duragesic / Fentanyl

Dr. Herrold Leikin, M.D., was an expert witness in a Duragesic fentanyl patch case.  He testified on behalf of the plaintiff in Adams v. Johnson & Johnson.  Set forth below is the text of his deposition in that case.

The deposition of JERROLD B. LEIKIN, 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 Glenbrook Hospital, Suite 3000, 2150 Pfingsten Road, Glenview, Illinois, on the 13th day of February, A.D. 2009, at 1:00 p.m.

(WHEREUPON, the witness was duly sworn.)

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

EXAMINATION

BY MR. AUCIELLO:

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

A. Jerrold Leikin L-e-i-k-i-n.

Q. What is your professional address?

A. 2150 Pfingsten Road, Suite 3000, Glenview, Illinois, 60026.

Q. Doctor, I know you have given depositions before, so if I ask any question that you don't understand, please be sure to tell me and I will be happy to rephrase it.

A. Yes, sir.

Q. Dr. Leikin, we are here because you have been identified as an expert for the plaintiff in a case called Adams versus Johnson & Johnson pending in the Southern District of Illinois. You are a retained expert in that case?

A. Yes, sir.

Q. Showing you what I will mark as Exhibit 1, is that a true and accurate copy of the report you issued in the case?

A. Yes, sir.

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

BY MR. AUCIELLO:

Q. Does that report reflect all of the opinions you intend to give in this matter?

A. I believe so.

Q. I just want to make sure I understand them all.

You note that the 12.2 level that Mr. Adams was found to have, postmortem, would not be expected to occur from a 75-microgram patch?

A. Yes, sir.

Q. You also note that you would expect a postmortem level to be 4 nanograms per milliliter?

A. I would expect it to be less than that.

Q. Less than 4?

A. Yes.

Q. And from that, I take it, you are of the opinion that postmortem redistribution would not effect the level in this case?

A. It can effect it. That's possible, yes.

Q. What is your opinion regarding the degree of postmortem redistribution that would have occurred in this case, or that could have occurred in this case?

A. I cannot articulate a specific number, per se. “Degree” implies there is a number, so I cannot articulate a specific number, but I do agree that postmortem redistribution can occur.

Q. In light of postmortem redistribution occurring, are you able to use the 12.2 and so-call back calculate what


Mr. Adams' fentanyl level was while he was alive?

A. I cannot give a specific number.

Q. Do you believe anyone can do that?

A. I don't believe anyone can give a specific number.

Q. Do you have an understanding as to what the parameters of postmortem redistribution are with fentanyl, that is, what I mean by that is, how much or how little can postmortem redistribution effect the fentanyl level?

A. I have seen written documentation ranging from 1.2, 1.6, around 2.6, in that ballpark, and those are ballpark numbers.

Q. I think the 2.6 is quoted in the 8th edition of Baselt?

A. Yes.

Q. And the 1.2 and 1.6 come out of some Anderson and Muto work?

A. Anderson work, and I believe we are both aware of an affidavit that he produced in a particular case, yes.

Q. But if you look at the current version of Baselt — I know you are a medical toxicologist, not a forensic toxicologist, correct?

A. Correct.

Q. Do you still rely on the Baselt text for data type information?

A. “Rely” means that I go to it to make a diagnosis, and I don't do that. I use — I believe it is a guide, a fairly reliable guide.

Q. And Baselt makes reference to, it is another study, that finds postmortem redistribution could occur in a ratio of up to 2.6, I believe?

A. 2.6, I believe it was, yes, in the 8th edition. He doesn't have it in the previous edition.

Q. In the previous edition he quotes the Anderson and Muto study in 2000?

A. 1.6.

Q. As an average?

A. Yes, I agree.

Q. The 6th edition also refers to the range that Anderson and Muto found that, I believe, was .07 to 4.6?

A. Without having it in front of me, that sounds about right.

For the record, I have given you both editions, actually.

Q. You have given me both editions. Was there a 7th in between?

A. There is a 7th. I did not include it. I did not feel there were substantive changes between 6 and 7.

Q. So if postmortem redistribution has a role in the case, and we will use the number here, if Mr. Adams had had a living level of 3.5, if postmortem redistribution applied at a 0.7, it would actually reduce his postmortem findings?

A. I don't understand that question.

Q. Let's look at Baselt's 6th edition, the Anderson and Muto data.

What is the range of postmortem redistribution that they report?

A. He says what you articulated earlier, range of .7 to 4.6, so an average of 1.6.

Q. Let me backtrack. Do you have an opinion as to what Mr. Adams' fentanyl level was at the time just before his death?

A. I do not have a specific number. As I articulated, I don't know how anyone could give a specific number.

Q. If we just say that level was 3.5 —

A. Fine.

Q. If we look at the postmortem data in Baselt and apply the average, which would be 1.6, that would, theoretically, increase the postmortem findings by a factor of 1.6?

A. By 60 percent, that's one interpretation.

Q. What other interpretation would there be?

A. The other interpretation is that — well, depends where the blood was drawn. Your question did not articulate that, so one would have to take that into account.

Q. Finish the answer.

A. And it depends if we are talking whole blood versus serum. This appears to be whole blood. It appears the levels here were whole blood, in this sense, but I believe that's one interpretation that could be made, yes.

Q. Basically, we just, basically, take the 3.5 times the 1.6, and get the answer?

A. As a general range, that might be appropriate.

Q. And to make it mathematically so that I can do it, if you use the ratio of 2, it would simply double the amount of fentanyl found?

A. Yes.

Q. Instead of 3.5, it would be 7?

A. 7, I agree.

Q. Why do you believe that postmortem redistribution did not — I take it, you believe did not significantly effect the levels in this case?

A. I am not saying anything about the levels. In fact, I just articulated that I can't give a specific number. I don't believe it effects the interpretation.

Q. So you have no opinion one way or the other whether postmortem redistribution effected the findings on autopsy of Mr. Adams?

A. As far as the interpretation, that's correct. As far as the interpretation of this entire case, that's correct. I don't believe postmortem redistribution will effect the interpretation, the clinical interpretation.

Q. It may have occurred, but it doesn't effect the clinical interpretation?

A. That's correct. Very well may have occurred.

Q. And you don't have an opinion as to the range of which it might have occurred in this case?

A. I can't articulate as far as — well, your question said “range.” You mean range of fentanyl levels, or range of postmortem redistribution?

Q. Range of postmortem redistribution.

A. I articulated earlier that the previous studies, I am not quarreling with those numbers, in this sense, but beyond that, I can't say.

Q. All right. Why do you hold the opinion in your report that the 12.2 level would not be expected to occur from a 75-microgram patch?

A. Because in all my readings, experience and evaluation of this, I would not expect a level of 12.2 from a patch.

Actually, in Baselt's books, he has quotes of what antemortem expectations would be, in this sense, and so I would not expect a level like this either antemortem or postmortem.

Q. You would not expect him to have a 12.2 antemortem level from the 75-microgram patch?

A. I agree.

Q. Do you have understanding of how much the amount of fentanyl in a person's body can vary when they use a properly functioning 75-microgram patch, without abusing it, using it exactly as you are supposed to?

A. Well, the standard deviation it lists here is about .6, .7, in that ballpark, nanograms per cc.

Q. Have you seen any other studies relating to how much people have in their blood when they have been using a 75-microgram patch?

A. Yes, I don't recall them as I sit here, but I am sure I have seen other studies. And that would probably be somewhat consistent with other studies I have seen.

Q. So you would expect in a living level it to be within one or two standard deviations of the 1.7?

A. I agree.

Q. It gives us a range of somewhere less than 1 all the way up to 3?

A. I agree. I absolutely agree.

Q. Those would be living levels?

A. Yes.

Q. Postmortem redistribution doesn't occur in the living, right?

A. No, I would agree, by definition.

Q. When a person dies, however, the drug redistributes, as the term states, correct?

A. That's a possibility. I am not going to say that that's an actuality, happens 100 percent of the time, but that is a possibility.

Q. Why is it that you would not expect a postmortem 12.2 to occur in a patient who was using a 75-microgram patch?

A. Because I believe that that is so far away from the normal values. Almost an order of magnitude. Key word being “almost.” I am not saying it is an order of magnitude. It is almost an order of magnitude of what would be expected, and so I would not expect that high disparity between postmortem changes in this individual. I am speaking about Mr. Adams.

Q. Where would the line be where you would think that this would be not surprising? If the postmortem level had been 8, would that still be —

A. I still would not expect it.

Q. Even though you acknowledge that postmortem redistribution can effect it with a factor of 1, 2, and according to Anderson and Muto, even 3 or 4?

A. I am saying it is a possibility. I would not expect it. I agree —

Q. You acknowledge it is possible to get these amounts? You just don't think it is likely, is that fair?

A. It is possible to get it. I don't think it is likely. I think it is less likely if it is not heart blood, much, much less likely.

Q. But you would acknowledge that postmortem redistribution does occur with peripheral blood?

A. I would say it can occur. I don't think it does occur. I think I just said that.

Q. What can and does and would and possible, we have got a lot of those words in there.

A. That's correct. I am telling the truth, the whole truth.

Q. That's all you are asked to do. if it is possible, say it is possible.

Let me rephrase that question. Would you believe it is possible for Mr. Adams to have had a therapeutic level of fentanyl while he was alive and end up with a 12.2 postmortem level when his autopsy was done?

A. Heart blood, or as articulated in deposition?

Q. Loose blood taken from the chest area.

A. Heart blood. I did not interpret the depositions as being, actually, cardiac blood, in the sense. That's the question I need to know.

Q. If it was peripheral blood, let's assume it was peripheral blood, would you believe it was possible that Mr. Adams could have had a therapeutic fentanyl level while he was alive and had a 12.2 at the time of autopsy after death?

A. I cannot say it is impossible. I cannot envision how that possibly can occur.

Q. You are saying it is possible, but you don't think it would occur?

A. No, I said while I am not saying it is impossible, I can't envision how it could occur. I cannot envision that possibility, but I am not saying it is impossible.

Q. If it was heart blood, what would your answer be?

A. I would say it's more possible. I won't say it is impossible, but, again, I would stand by that I would not expect it.

Q. And the basis of this is because you already told me you couldn't predict how much postmortem redistribution would occur?

A. Right, I agree, as far as a specific number.

Q. No one can predict how much it will occur?

A. I think I testified to that.

Q. And Anderson and Muto found a ratio as high as 4.6 between the peripheral and heart blood, correct?

A. I will go one step further. I am aware of other articles that found even higher, if you go at their extreme of ranges.

Q. Are you familiar with any articles dealing with a living patient whose blood was measured with fentanyl before they died and then was measured after death?

A. As I sit here, I don't recall any. I probably reviewed at some point in my career, but I don't recall, as I sit here.

Q. Have you ever seen a case report from the Journal of Forensic Sciences, January 2008, lead author is Karen Woodall, as relates to the oral abuse of fentanyl patches.

A. I don't recall.

Q. The point of the study relates to oral abuse of the patches, which is not exactly what I am going to ask you about.

In the case, a specific case is described, a 42-year-old female, who was found nonresponsive. Emergency services were called and she was taken to the emergency room department at which time blood was drawn.

A. Okay.

Q. Thereafter, she expired, and an autopsy was done thereafter.

A. Okay. Great.

Q. Unusual circumstance, correct, because most people don't measure living fentanyl levels?

A. Hypothetically, I agree. I would. If this patient came to see me, I would.

Q. Right. But, routinely, doctors don't measure fentanyl levels?

A. I agree. I couldn't agree more.

Q. If this patient's peripheral — her blood drawn in the hospital, while still living, revealed a 14-nanogram per milliliter fentanyl level —

A. Okay.

Q. It is a high level, correct?

A. I am not arguing that point.

Q. (Continuing) — you would expect that her postmortem level would be close to 14?

A. No.

Q. Why not?

A. Because she hadn't — in that situation, she probably is not in the distribution phase yet, completed distribution phase.

I am assuming — I have not, or I don't recall the exact case that you are talking about, but oral transdermal, she probably didn't have it in there for three days overall. She probably hadn't reached steady state yet, so that wouldn't apply to this discussion.

I am assuming that that's a very hyperacute situation in the sense from what you are describing. And with an oral transdermal patch, as we know, it takes a while for it to be totally distributed, so I would expect that not to apply. But, go ahead.

Q. You mean her level would continue to rise, anyway, for reasons other than postmortem redistribution?

A. No, I saying the postmortem level may not reflect the antemortem level.

Q. Postmortem level never reflects the antemortem level, does it?

A. No, it can. I said postmortem redistribution can occur. I said it doesn't occur 100 percent of the time, in this sense, but it is more likely to reflect it if it is in the post-distribution phase, if the drug has already distributed, had time to distribute throughout, not while it is being absorbed.

Q. Does absorption stop at death?

A. Systemic absorption, yes. Local absorption, maybe not.

Q. Would it surprise you if this patient had a postmortem level, peripherally, of 28?

A. Wouldn't surprise me.

Q. And a postmortem level central blood, heart blood, of 32?

A. Wouldn't surprise me.

Q. And those ratios, the ratio between the 28 and 32 would actually be consistent with Anderson and Muto, would it not?

A. I believe it would be compatible.

Q. About 1.6 between the peripheral and the heart blood?

A. Yes.

Q. But the case would indicate a ratio of 2 in the peripheral blood between the time before death and after death, it increased by a factor of 2, from 14 to 28?

A. From 14 to 28. But as I said, there are so many other variables with that, that I don't think it applies to a person who hasn't reached steady state.

Q. You don't know whether this lady reached steady state or not?

A. The one you described?

Q. Right.

A. Obviously, no. Let me it put it this way: I suspect she didn't.

Q. If she was abusing the fentanyl patches orally, she wouldn't reach steady state in the six days you would when you used the patch on your skin, correct?

A. I agree.

Q. Buccal absorption is faster than that?

A. That's why it's done that way.

Q. If you go to abuse a fentanyl patch, you are going to suck on it, right?

A. Well, I wouldn't.

Q. If a person is going to abuse the fentanyl, they are going to put it in their mouth because the absorption is much faster?

A. I would think so.

Q. Have you done studies to see how long it would take to get steady state from oral abuse of fentanyl patches?

A. I can honestly say I have not.

Q. Are you aware of any other studies that measured the fentanyl level of a living person and then measured it after death in peripheral and central locations?

A. As I said, I don't recall, as I sit here. I probably have seen them, but I don't recall it, as I sit here.

Q. You have testified in other related cases relating to Duragesic patches?

A. That's correct.

Q. During the course of preparing in those cases, you have never seen an article or a case report indicating that being done?

A. I can't recall that, seeing that. I may have seen it, but I can't recall.

Q. Back to your opinions. The autopsy was done by a Dr. Jacobi?

A. That's my understanding.

Q. It was done in Indiana, correct?

A. That's my understanding.

Q. He made a conclusion as to the cause of death, correct?

A. To a certain extent, yes.

Q. You lost me with the “to a certain extent.” Did he make a determination of cause of death?

A. He made a determination. I don't know if it is a conclusion.

Q. Isn't it true that Dr. Jacobi determined the cause of death to be cardiac arrythmia, secondary to coronary artery atherosclerosis?

A. That's what he has down there, yes, along with other things.

Q. He has also that a contributing condition was fentanyl toxicity?

A. That's correct.

Q. Do you disagree with his finding that death was caused by cardiac arrhythmia, secondary to coronary artery atherosclerosis?

A. I have no opinion.

Q. Do you believe that fentanyl in toxic levels causes coronary artery atherosclerosis?

A. No.

Q. Does fentanyl in toxic levels cause cardiac arrythmia?

A. Indirectly, very, very, very, very, very indirectly, yes.

Q. Very indirectly, in such that it would cause respiratory suppression that would ultimately cause other damage, which would cause damage and then ultimately cause cardiac arrythmia?

A. Yes. I couldn't have said it better.

Q. You are not going to come to court and disagree with Dr. Jacobi's findings?

A. I am not going to disagree with what he has written here. I am not — I am not saying I don't disagree. I am saying I have no opinion.

Q. Is it because it is outside your area of expertise?

A. To a certain extent, but not to a complete extent. I wasn't asked to really comment on his comments, so I was not asked to directly comment on that aspect.

Q. You weren't asked to determine the cause of death of the patient?

A. I was not asked to determine the cardiac aspect to it.

Q. So as I come out of this deposition, the only thing I have got to make sure I absolutely come out of here is knowing what basic opinions you are going to give at trial.

Right now I understand you are going to say that a 12.2 postmortem level you would not expect to find from use of one 75-microgram patch?

A. Used appropriately.

Q. Used appropriately?

A. That's correct.

Q. You are assuming it was used appropriately?

A. That's correct.

Q. Is there anything else you are going to say?

A. Well, what's in my letter, pretty much what's confined in my letter.

Q. You do put in there that these narcotic levels — I don't know, are you referring to — you said, “particularly the fentanyl are significant contributing factors to Mr. Adams' death.”

A. I believe it is.

Q. It would not have caused the cardiac arrhythmia —

A. Just for the record, I spelled that wrong, but–

Q. So how was the fentanyl, in your mind, in your opinion, a significant contributing factor?

A. Well, basically, I believe that there was some degree of narcosis as described by his wife's deposition, Page 66; that had I seen him at that time that she describes him, on the early morning of April 29th, I believe, in that sense, I would have treated him for fentanyl toxicity.

Q. Based on what did she say?

A. That he mumbled something, I think those were the words. It sounds like, and I am paraphrasing, that he was barely arousable, or something like that, in a sense.

That doesn't sound like a heart attack to me. That sounds like fentanyl toxicity. And had I seen him at that particular time, whether I had these levels back or not instantaneously, I would treat him for fentanyl toxicity.

Q. Based just on the fact that he mumbled?

A. Based on the fact that he was barely responsive. That would be compatible with what I have down here, central nervous system depression.

Q. Is there anything else in that deposition other than the fact that he mumbled? And you are interpreting that as barely responsive?

A. I think that's compatible with barely responsive. I am saying this is compatible with central nervous system depression. I am not going to quantitate it.

Q. Sleeping is compatible with central nervous system depression, correct?

A. Not pathologic, no.

Q. Would it not cause him to sleep, initially, if he was at toxic levels of opiates?

A. That's a pathological reaction. Yes, it would cause somnolence, absolutely, but that's a pathological reaction. Sleep is not. That's physiological.

Q. Everyone that sleeps doesn't need to be treated for fentanyl toxicity?

A. I couldn't agree more, but that's physiologic, not pathological.

Q. So you believe that even if Dr. Jacobi wasn't wrong with the primary cause of death, you believe that fentanyl was the contributing factor?

A. Absolutely.

Q. You state in your report, “Fentanyl, even at elevated doses, rarely exhibits any direct cardiac arrhythmia effect”?

A. I testified to that earlier, that's correct. Indirectly, yes.

Q. And you also indicate, “There does not appear to have been any significant cardiac-related symptoms exhibited by Mr. Adams prior to his death.”

A. Yes, that's correct.

Q. Okay. How much medical care did Mr. Adams receive prior to his death? Had he been to a doctor his whole life?

A. She said rarely. I guess he had an appendectomy 29 years before, in the sense, if I am not mistaken. There is multiple visits from the January — from the time the cow hit him, so to speak, to April 29th, there are multiple, multiple visits.

But prior to, I believe, January something '05, I think he rarely visited a physician was the testimony.

Q. Did Mr. Adams have back pain and chest pain?

A. He had back pain.

Q. Can chest pain be radiated to the back?

A. Rarely, yes.

Q. You are an emergency room physician, correct?

A. You bet.

Q. If you see a patient with back pain, is it within your differential diagnosis that it might be a coronary or cardiac origin for that pain?

A. Very rarely, yes. Very rarely, yes.

Q. Is it rarely in your differential diagnosis, or is it always in your differential because it rarely occurs?

A. It is rarely in my differential diagnosis and it rarely occurs, both.

Q. You feel like you would have to rule it out in an emergency room setting if someone had back pain?

A. No. No, I don't get EKGs on everyone that comes here with back pain, or on every patient I see. That's not the standard of care, to my knowledge.

Q. Did Mr. Adams receive an EKG in weeks before —

A. I saw a rhythm strip. I did not see a 12-lead EKG. Actually, I saw a rhythm strip within a few days of his death.

Q. Do you know what the cause of Mr. Adams' back pain was?

A. Musculoskeletal trauma.

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

A. Yes.

Q. The orthopedic surgeon that was treating him?

A. Yes.

Q. Is it true that Dr. Grimm indicated he could find no physiologic cause for the degree of pain that Mr. Adams was experiencing?

A. I don't know if he actually said that, but I got — that was the partial understanding. I did not investigate that aspect.

Q. Mr. Adams had what was described as a fatty liver?

A. I would agree, it appears.

Q. You didn't see his liver, though, right?

A. No. I am just answering your question.

Q. He had a fatty liver, correct?

A. It appears that may be the case.

Q. Can liver abnormalities or liver dysfunction effect the metabolism of drugs?

A. Theoretically, yes.

Q. If your liver doesn't work, as well, it takes longer to metabolize drugs out of the system, correct?

A. Theoretically, yes.

Q. And the amount of drug in your system depends on what goes in and what comes out, correct?

A. Theoretically, yes.

Q. So if it comes in at the same level and it goes out slower, your levels are going to get higher?

A. That's a possibility, hypothetically.

Q. Well, I mean, with my hypothetical, it is more than a hypothetical. If you put the same amount of drug into the body, and the body isn't able to metabolize it as quickly as you would expect, the level would be higher than you would expect, wouldn't it?

A. That's hypothetical, because it depends upon the severity of the liver disease. It depends upon the nature of the liver disease, other liver functions tests being abnormal, things like that. There are so many other variables with that. That's why I am saying, hypothetically, I agree.

Reality-wise, in most cases, it doesn't really make much of a difference.

Q. Do drug levels vary from person to person?

A. Yes, that's why everyone talks about ranges.

Q. Why do drug levels vary from person to person?

A. There may be some differing degrees of variability of liver metabolism, of renal excretion, of biodistribution or distribution of the drug, so there may be some variables for that, but it is a relatively small amount of variability.

Q. What would you think the variability would be with most opiates?

A. We talked about fentanyl being the standard deviation, .6. We are talking .6 nanograms per cc. That's pretty small in the overall scheme of things, and so I think most other opiates probably tall into that degree of range. But there is different variability when one takes into account tolerance and things like that.

Q. Are you familiar with a study done by Merkin Dontay about switching patients from fentanyl to methadone?

A. Fentanyl to methadone?

Q. I think it was methadone. Yes, opioid plasma concentrations during a switch from transdermal fentanyl to methadone.

A. Not familiar with that, as I sit here.

Q. I am not particularly interested in the switch to methadone, but he measured the fentanyl — another case where he measured fentanyl levels.

A. Sure.

Q. And you are not familiar with it, correct?

A. I am not familiar with that article, as I sit here. I am not saying I haven't read it, but I am not familiar with it.

Q. I take it, you believe that postmortem redistribution did not play a significant role because you believe it was peripheral blood that was drawn?

A. That's part of it, but the very small part of it. Actually, the sentence says, “did not play a significant role in the clinical interpretation.”

Q. Whose clinical interpretation?

A. Mine, and I believe most other reasonable physicians. And when I talk about physicians, I am talking about medical physicians or DO's.

Q. I think I understand that. Go back to the stuff that we usually cover at the beginning of the deposition.

A. Sure, whatever you want.

Q. I am going to mark as Exhibit No. 2, a list of the depositions you have given.

A. Yes, since 2000.

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

BY MR. AUCIELLO:

Q. Is this an up-to-date list?

A. I think I have done a couple of other depositions in January and February. May have done one other this month, but I don't remember, so there may be one or two missing.

Q. It is up to a month or so ago?

A. Yes.

Q. What percent of your professional time do you spend doing medicolegal consulting?

A. About 20 percent, roughly.

Q. And is there an area of specialty that you have in your consulting business?

A. Toxicology.

Q. Forensic toxicology or medical toxicology?

A. To me, the same thing.

Q. Is there a difference between forensic toxicology and medical toxicology?

A. I suppose to a lot of people there is.

Q. To you?

A. To me, medical toxicology means the active care and treatment of patients that are overdosed or have adverse side effects or any toxicological issue, in the sense.

Forensic means, kind of, a backdating, so to speak, to try to recreate what happened. I have heard definition of forensic being defensible in court and those aspects. And when one is treating a patient, medically, there are some forensic aspects to it.

Q. But a forensic toxicologist works in a lab and evaluates samples of blood taken from people living or deceased, and draws conclusions from those tests they do to those samples?

A. I agree with half of that.

Q. What part don't you agree with?

A. I agree with the part about a laboratory toxicologist or laboratory analyst, as far as analytical toxicologists. I agree that I don't do that part. I don't sit in a lab and analyze that.

But I am called upon to interpret it. And I believe to interpret such levels, one has to do it in a clinical context, and one can only do it if one sees patients.

Q. When you interpret it as a medical toxicologist or emergency room physician, you are interpreting it on living patients, right?

A. Most of the time, yes.

Q. Here at this hospital, when you are practicing, they don't call you to ask you to look at the fentanyl level of a dead person?

A. I can honestly say that that hasn't happened, but I have been called about, retrospectively, to look at people who have died within the hospital or other hospital settings and try to recreate that. That happens about few times a year.

Q. You don't, generally, go to a medical toxicologist to determine cause of death.

A. Why not? Why wouldn't one?

Q. Don't medical examiners or coroners usually do that?

A. They, usually — you are right, they usually do that, but there have been occasions they have called me to help them out.

I am not saying it is very frequent, but there have been occasions.

Q. In your medicolegal work, are most of the cases civil cases or criminal cases?

A. Virtually all civil.

Q. Are they categorized as medical malpractice cases?

A. Not too many are. Probably less than 20 percent.

Q. What are most of them?

A. Most of them are workers injuries, impairment issues, that sort of thing.

Q. Do you use a service for the billing on these cases?

A. Yes.

Q. What is that service called?

A. I believe for this one it is INSPE.

Q. What does INSPE do?

A. They do some, like, secretarial work. They make some arrangements. They do the billing. They do the collecting.

Q. Now, does INSPE only work for you, or do they work for many people?

A. I hope they work for many people, not just for me.

Q. Is it an expert referral service?

A. I believe that's one of the things they do.

Q. Do they advertise?

A. Maybe they do. I don't know.

Q. If an attorney is looking for an expert on a particular subject matter, they can call INSPE and be referred to someone in that area?

A. I believe so.

Q. And then when you work, I take it, people pay INSPE and then INSPE pays you?

A. Yes.

Q. Do they get a percentage?

A. I believe so, yes.

Q. Do you know what that percentage is?

A. About 20 percent or so.

Q. Did this case come to you through INSPE?

A. I know INSPE is involved. I don't know if Mr. Carlson called me directly or called INSPE and INSPE sent it to me.

Q. There is just a document here. We will mark this as Exhibit 3.

A. That's it, so they probably — by this, it is probably that Mr. Carlson called INSPE first.

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

BY MR. AUCIELLO:

Q. You said that's one. Are there other services similar that you work there through?

A. Yes, Expert Resources in Peoria Heights, Illinois, and TASA, somewhere in Pennsylvania.

Q. TASA, I have heard of.

A. Yes.

Q. You are listed with TASA?

A. I believe so.

Q. If lawyers call TASA and need a medical toxicologist, it could be referred to you?

A. Could be, yes.

Q. Do they also do the billing and keep a percentage?

A. Yes, same with Expert Resources.

MR. AUCIELLO: Next, Exhibit 4, the CV, I believe, you provided us this morning.

THE WITNESS: Up to date.

(WHEREUPON, said document was marked Leikin Deposition Exhibit No. 4, for identification, as of 2/13/09.)

BY MR. AUCIELLO:

Q. I believe you said that's an up-to-date CV?

A. Yes.

Q. This is also in the stack. I am not going to mark it until I find out what it is.

What is that?

A. Actually, it is all together. It is, as per your request, you asked me, as per one of your writers, if it is called a writer, something like that, you asked for materials that were in my file, or that I had reviewed, or something along those lines, so this is as per your request.

Q. So these are pieces of literature that you reviewed as a part of your review in this case?

A. Yes.

Q. Is this everything you reviewed?

MR. CARLSON: Stuff underneath it.

BY THE WITNESS:

A. Yeah, there are things underneath. I saw Dr. Karch's book, but I don't know if I independently reviewed it for this case.

There was a Journal Analytical Toxicology article late last year that I know I reviewed, but I don't think I specifically reviewed it for this case.

MR. CARLSON: Is that the October '08?

BY THE WITNESS:

A. Yes.

BY MR. AUCIELLO:

Q. The Hennepin County article?

A. I did review the whole article for the record. That's the abstract of it.

Q. What conclusions or facts did you draw from that article that are relevant to this case?

A. None. It, just, more or less, I believe, is compatible with what I am saying.

Q. Do you believe that fentanyl readings, postmortem fentanyl readings, would be more accurate if they were taken from the liver?

A. That was one of their conclusions. And, in fact, I will go one step further. If you remember, or as you have in front of you, they gave specific numbers, in this sense.

I think it is an overstatement. I think hepatic levels may be able to assist, but I don't think one can make a firm diagnosis just with that in the usual circumstances.

Q. Were femoral fentanyl concentrations higher than heart concentrations in that study?

A. I remember there was a wide variation, in that sense, so there may very well may have been some. I also remember there were only about nine or twelve patients.

Q. Nine.

A. Nine, okay. So in that study, there were fewer patients than the other studies that we had articulated that were covered in Baselt's book, in this sense, so I recall that aspect.

Q. Are you familiar with any general literature among toxicologists, whether they be forensic or medical, that drawing conclusions from postmortem drug levels is very difficult?

A. It can be, yes. It can be. I agree.

Q. And that it would be good to find alternate ways to measure drugs in postmortem settings that would more accurately reflect what the drug level was in life?

A. I will go one step further. Ideally, one would like to have two sites determination, ideally. Virtually, all the cases I have been involved with, that's never happened.

When I say “two sites,” I mean two sites for blood specimen.

Q. One peripheral, one sentinel?

A. Yes. Taking it one step further, Dr. Karch, I think, says that, too.

Q. That's who I was thinking about. You have Dr. Karch's brand new book?

A. Not only do I have his brand new book, but as you can see from my — I hope it is in my CV, I just reviewed it for Journal of Clinical Toxicology.

Q. Did he get a favorable review?

A. Kind of.

Q. You agree with everything that's in it?

A. I don't agree with everything that's in — no, I don't agree with everything. That's not the point.

I think his other books are more complete, let me put it this way. This is too short, or too brief, for this subject.

Q. Are you familiar with his chapter on fentanyl?

A. Maybe we are not talking about the same book.

Q. Brand new book. I have seen it this morning.

A. I will show you what book I am talking about. I am talking about a book that fentanyl is only mentioned once on Page 143.

Q. This wasn't Page 143.

A. We are talking about two different books.

Q. Who is Dr. Karch?

A. A physician that, I believe, is a pathologist.

Q. He has published a lot on drug levels and toxicology?

A. Through CRC Press, primarily, yes.

Q. A publisher? I don't know who that is.

A. That's a publisher, yes. He has several books through CRC Press.

Q. Is he generally respected in the field?

A. What field do you mean?

Q. In your field.

A. Well, my field, I don't think he is as well-known as a medical toxicologist.

Q. Is he well-known among forensic toxicologists?

A. Maybe so. I can't speak to that. Probably so. But in medical toxicology, I don't think he is as well-known.

Q. Do you have an opinion as to whether the fentanyl, in a transdermal patch, would continue to infuse after death?

A. Locally, that's a possibility.

Q. It would infuse locally into the blood that was local, correct?

A. Passive diffusion local, that's a possibility. I don't think it is a likelihood, but it is a possibility into that area.

Q. Of course, blood isn't circulating after death?

A. I couldn't agree more.

Q. But the blood does get moved around when the body is moved around?

A. Hypothetically, I suppose it can. I can't speak as far as — I can't quantify that.

Q. I don't know if anybody can.

A. Right. I suppose, hypothetically, that could occur.

Q. You also provided me two copies of your article “Postmortem Toxicology.”

A. Yes, I meant to provide one, but I will give you both.

Q. Have you reviewed the reports of Dr. Factor and Dr. Kaplan?

A. Yes.

Q. Dr. Factor is a pathologist. Do you have any disagreement or opinions relating to his conclusions?

A. I don't have any opinion.

Q. Okay. It is outside your area of expertise?

A. I don't think it is completely outside my area of expertise, but, again, I was not really asked to look into the cardiac aspects.

Q. Dr. Kaplan, have you heard of Dr. Kaplan?

A. Yes.

Q. Is he forensic toxicologist?

A. That's my understanding.

Q. You have disagreement with his conclusions?

A. Yes.

Q. Which of his conclusions do you disagree with?

A. Okay. You are focusing on the last page?

Q. The three conclusions.

A. Okay. No. 1, I disagree. And I think I have stated that earlier, in this sense, overall.

No. 2, I suppose, the first sentence is hyper-legalistically correct, the principal cause of death, but he did — it is listed on the death certificate, overall. And so, No. 2, to me, implies that the coroner/pathologist did not determine that fentanyl was a contributing cause of death, or had anything to do with the death. And I believe it being on the death certificate implies that it does. But the way Dr. Kaplan states No. 2, that could be misleading.

But, most importantly, and I don't know if he is saying Conclusions 1, 2 and 3 are in priority. I don't know if there is priority. It doesn't talk anything clinical. It doesn't talk about the clinical circumstances.

One has to look at the clinical circumstances, which I articulated earlier, in this sense. And then he goes on to say that other drugs he was taking contributed to cardiac events causing his death.

Well, they were in a much lower, either, therapeutic or subtherapeutic range, in this sense, unlike the fentanyl concentration. And there may be postmortem redistribution issues with those, in this way. So even to include Point No. 3, I believe, is misleading.

Q. You would disagree with it?

A. Yes, I disagree with it in the context.

Q. So you disagree with all his statements of opinion in here? The statement of fact of what the corner and pathologist determined is accurate, but you disagree with all of his opinions?

A. Yes, respectfully disagree.

Q. Sure. Did you review Dr. Grimm's testimony?

A. Yes, it is on my letter, yes. I also reviewed, for the record, Dr. Evans' testimony.

Q. Okay. Right. Do you have any disagreement with Dr. Evans?

A. No.

Q. Dr. Grimm prescribed an initial dose of 75 micrograms per hour?

A. That's my understanding.

Q. Does that exceed what is recommended in the package insert for this patient?

A. It might.

Q. If he was on 60 milligrams of Avinza, and using the conversion table, that would translate to a 25-microgram patch?

A. That's why I said “it might.”

Q. Would Mr. Adams, being on a higher initial dose than recommended by the manufacturer, potentially cause him to have a higher fentanyl level?

A. I have no opinion.

Q. Do you have an opinion as to whether Dr. Grimm's prescribing three times the recommended dose would violate any standards of care?

A. I have no opinion, and I don't know that he did prescribe three times.

Q. Are you familiar with the package insert?

A. It is in my book, yes. The answer is yes.

Q. And there is a conversion table, correct?

A. There is absolutely a conversion table, but I also note that Mr. Adams was on other opioid products at various times, including OxyContin and Ultram.

Q. Which would indicate some preexisting tolerance for opioids?

A. I agree with the exact word you said, “indicate.”

Q. So he wasn't an opiate-naive person when he was prescribed a Duragesic patch?

A. I agree with that.

Q. Would you agree that he — and you may not have an opinion at all.

A. Okay. Sure.

Q. (Continuing) — that he had at least a 70-percent blockage of his coronary arteries?

A. I have no opinion on that.

Q. An EKG can't necessarily predict a cardiac arrythmia, can it?

A. Arrhythmia?

Q. Arrhythmia.

A. I think an EKG is diagnostic for cardiac arrhythmia while you are having it, yes.

Q. But not before? You could have a normal EKG, and then have a cardiac arrhythmia?

A. That's possible.

Q. When you evaluate people for potential heart attacks or other cardiac issues in the emergency room, just because they have a normal EKG for a point in time doesn't rule it out?

A. I agree. It helps, but I agree it doesn't rule it out.

Q. Have you yourself conducted any studies to determine what the expected fentanyl level would be in the blood after use of a 75-microgram patch?

A. No, sir.

Q. Have you reviewed any clinical studies or anything beyond the package insert concerning that issue?

A. I've got a lot of articles here, in the sense, so, I guess, the answer would be yes.

Q. What have you reviewed that addressed the expected fentanyl level in the blood after the use of a 75-microgram patch other than the package insert?

A. It is in Baselt's book. I just testified to that.

Q. Where in Baselt's book, the 8th edition?

A. 8th edition, I think it is the first paragraph under Blood Concentration.

Q. This is the 1.1 to 2.6 range for the 75?

A. That is compatible with what my understanding is.

That's also, for the record, in Poisondex. That's the database which I have supplied.

Q. What's the source of that data, do you know, the source that Baselt got it?

A. Well, I think it says in there, but as I sit here I don't recall exactly.

Q. I can look it up later.

A. May have gotten it from the package insert, but I cannot articulate it.

Q. What I am looking for is any studies you may have looked at other than the ones that were referenced in the package insert. None come to mind?

A. None come to mind as far as primary studies. As I have said, I have given two or three recitations of databases that articulate it.

Q. What does it say in your database? Is it the same data that you got —

A. Actually, it is a little bit more extensive.

Q. But this comes right out of the package insert, doesn't it?

A. It probably does. I did not get it from the package insert.

Q. Where did you get it from?

A. Poisondex. Actually, DRUGDEX.

Q. You got it from a website?

A. No, it is database.

Q. A database?

A. It is not a website.

Q. You don't know where they got it?

A. No, I think they got it from the package insert.

Q. So, my point is to try to find any data you are looking at that doesn't come from a package insert. And if there isn't anything, you could tell me that, and we will move on.

A. As I articulated, I don't know of any others at this time. I probably did, but I noted it in a couple of review articles, review databases.

Q. You also brought a packet of materials that you reviewed relating to Mr. Adams' care?

A. Yes. By the way, for the record, it was also in Anderson's article.

Q. Okay.

A. Just, for the record. Yes, this was supplied by Mr. Carlson.

Q. And it is a booklet with a chronology followed by the death certificate, the autopsy —

A. Medical records.

Q. — medical records.

A. I believe there is autopsy records in there, too.

MR. AUCIELLO: I am just going to mark the chronology, because you are going to get my chronology when you depose my experts.

Thank you, Doctor. I have no further questions.

THE WITNESS: Thank you.

MR. CARLSON: Reserve.

FURTHER DEPONENT SAITH NOT.