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Deposition of Defense Expert in Duragesic Lawsuit

Posted in Duragesic / Fentanyl

This is the deposition of Bruce Goldberger, Ph.D., an expert witness in Hendelson v. Johnson & Johnson.  That case ended with a multimillion dollar verdict against Johnson & Johnson.

To the best of my knowledge, plaintiffs have won every Duragesic fentanyl lawsuit that’s gone to a jury.  If you think you should speak to an attorney regarding injuries you think were caused by a fentanyl patch like Duragesic, contact me and I’ll put you in touch with a lawyer who will investigate your claim.

THE VIDEOGRAPHER: This is the videotaped deposition of Dr. Bruce Goldberger in the matter of Lee Hendelson versus Johnson and Johnson Company, et al, Case Number 05-81116 CIV-HURLEY.

This deposition is being held at VanLandingham, Durscher and VanLandingham. The address is 201 Southeast 2nd Avenue in Gainesville, Florida. The date is May 24th, 2007. The time is 1:40 p.m. The court reporter is Jennifer Witwer. My name is RL Minnich. I'm the videographer.

Would counsel now please introduce themselves.

MR. ORR: Jim Orr on behalf of Mr. Hendelson.

MR. ANGWIN: Edward Angwin on behalf of Mr. Hendelson.

MR. AUCIELLO: Ernest Auciello on behalf of the defendants.

THE VIDEOGRAPHER: Now would the reporter please swear in the witness.

THE COURT REPORTER: If you'll raise your right hand.

Do you swear or affirm the testimony you're about to give will be the truth, the whole truth, and nothing but the truth?

THE WITNESS: I do.

THE COURT REPORTER: Thank you.

THEREUPON: BRUCE A. GOLDBERGER, Ph.D., was called as a witness and, having been first duly sworn, was examined and testified as follows:
DIRECT EXAMINATION
BY-MR.ORR:

Q. Could you please state your full name?

A. Bruce A. Goldberger.

Q. And what is your profession?

A. I'm a forensic toxicologist. I'm employed as professor and director of toxicology at the University of Florida in the College of Medicine in the departments of pathology and psychiatry.

Q. And what is the subject of the testimony you'll be offering in this case?

A. Interpretation of the Fentanyl in Mr. Hendelson.

Q. And what are your qualifications to testify on that subject?

A. My educational background includes a BA degree in zoology and MS and Ph.D. degrees in forensic toxicology. I've been employed in the field of forensic toxicology since the fall of 1982, been at the University since October of 19 — 1994.

Q. And you've been hired by the defendants as an independent expert; is that correct?

A. I have.

Q. And you — do you see your role as one where you're supposed to have your own independent opinions as opposed to being an advocate for any one party or the other?

A. Absolutely.

Q. And do you see that role as one where you should be objective?

A. Always.

Q. And do you see that role as one that you should be seeking the truth?

A. Always.

Q. So would it be fair to describe your role in this case as one of an objective truth seeker?

A. Yes.

Q. Would you — would you consider yourself a scientist?

A. I am a scientist.

Q. Now, in the law we have various burdens of proof like preponderance of the evidence and beyond a reasonable doubt. Do you have any similar types of burdens of proof in the area of forensic toxicology?

A. When I testify I do, of course. I testify in criminal cases as well as civil cases, so the burden is different in each area.

Q. But unrelated to the law, does your field of toxicology have any type of, you know, scientific certainty types of burden of proof?

MR. AUCIELLO: Objection, form. Go ahead.

A. That's a — that's a good question. I've never thought of it that way. In my practice at the University of Florida I practice to the extent that I can defend my data and my results, so they — I find them to be very definitive in the way that I present them.

In the case of an expert witness, the role is a little bit different because I'm using data from the medical examiner, data from the medical records, and data from a toxicology laboratory that I'm not affiliated with and will form the best opinions based on that.

Q. So you see the opinions that you come up with in your role of an expert witness as less definitive than the positions you arrive at in connection with your job at University of Florida?

A. No, I wouldn't say it exactly that way. See, in the role at the University of Florida my job is to produce reliable and accurate test results that can be used to prosecute a civil or a criminal matter, and in no circumstance in my more than ten years at the University have I been in a situation where I have not been able to provide data to that extent. As an expert, I do form definitive opinions, but I'm using other person's, other people's data, so I'm in a different position in that matter.

Q. You mentioned reliable and accurate. How certain does something have to be in your opinion to be reliable and accurate? I mean, 99 percent sure it's that way, 100 percent, like one plus one equals two, or how certain does it have to be?

A. Yeah. Well, in the case of postmortem drug interpretation, oftentimes it's not possible to be absolutely certain because of factors such as postmortem drug redistribution, something I'm certain we'll talk about today. In the case of the identification of a drug, so the identification of Fentanyl in Mr. Hendelson, that needs to be done with the utmost accuracy and precision, so we can rely on the quantitation from the laboratory.

But then we move to the next level which is less certainty; what does this figure mean? So we're very certain with the work that we do and the reports that we issue, and that's what I talked about before, that it has to be very reliable, very definitive and very defensible. But when we move to the interpretation, that's where you may have experts differing in their opinions.

Q. And do you understand that the burden of proof that's applicable to this case is more likely than not?

A. Yes.

Q. So if it's 51 percent one way and 49 percent the other way, the 51 percent wins?

A. Absolutely, yes. Very different than a great amount of my testimony which is done in criminal court, which is then done beyond a reasonable doubt. Essentially there's no lack of certainty in that testimony.

Q. And do you ever testify in those criminal matters beyond a reasonable doubt based on postmortem values or concentrations from toxicology testing?

A. Yes, I have. Most of my testimony in criminal matters deals with the prosecution of living defendants involved in vehicular homicide cases, but I have also testified in cases involving decedents whose blood and tissues were tested in my laboratory and I was asked to provide an interpretation for the court.

Q. And in doing that, you have looked at postmortem values and then espoused opinions that you felt reached the level of beyond a reasonable doubt?

A. Yes. In most of those cases the toxicology is abundantly obvious. In many of these cases I've worked with the US Attorney's office in the prosecution of physicians who were essentially selling prescriptions and then, as a result, a number of their patients had died, and the toxicology, as I said, is abundantly obvious. And even with the consideration of redistribution or other factors, it's clear.

Q. In terms of more likely than not, what did Adam Hendelson die from in your opinion?

A. Well, as you know, I'm not a medical doctor. I don't practice medicine in the state of Florida, so in a technical way I'm not certain whether the courts would allow me to testify in terms of cause and manner of death. Of course, I express opinions regarding cause and manner of death, but I'm not — courts don't typically allow a toxicologist to do that.

Q. Well, let me — let me interject there. You would agree, wouldn't you, that the sole cause of death was toxicology related, right?

A. Well, not necessarily. And there are other possibilities that could be considered. For example, Mr. Hendelson was taking Vioxx, and we know what the current state of Vioxx litigation is today. Now, I'm not testifying today that he died because he was taking Vioxx, but that's a possibility.

Did he die of a sudden cardiac arrythmia unrelated to his ingestion of his medications? That's always a possibility. Or did Dr. Perper hit it on the head, which was a combined drug overdose involving Citalopram, Mirtazapine and Fentanyl? That's okay, too, but as Dr. Perper said, he goes with what the best evidence shows. There are no postmortem drug tests to support ingestion of Vioxx. I'm not aware of a laboratory that offers Vioxx testing, for example.

Q. You're not aware of any evidence that suggests that he died of a cardiac arrythmia, are you?

A. Well, he does die when his heart stops, so technically that is a cardiac arrythmia. Whether there's evidence to support that, there is no evidence at this time to support a cardiac arrythmia.

Q. And there's no evidence to support that Vioxx played any role in his death, correct?

A. No evidence to support that, but if there was no Fentanyl, Citalopram or Mirtazapine in this case, it could be — could fall under that Vioxx litigation.

Q. Assuming that the Broward County Medical Examiner is correct that there is no other pathological cause of death other than the medications, would you then agree that the sole cause of death was toxicology related?

A. Yes.

Q. And that's the opinion of the Broward County Medical Examiner's office, that is, that the death was caused solely by the medication that was in his system?

A. That was Dr. Perper's final conclusion.

Q. And you agree with that, correct?

A. At this point.

Q. And with respect to the Fentanyl level found in Adam's blood, it was 9.4; is that correct?

A. 9.4 nanograms per milliliter.

Q. And you believe that if a sample had been taken peripherally, that it possibly might have shown a lower number; is that correct?

A. More than likely, yes. This was heart blood.

Q. And it's possible that if the sample had been taken peripherally as opposed to from the heart, that it wouldn't have been any less. That's possible, right?

A. I'm sorry, I didn't understand that.

Q. Yeah. If the blood sample had been taken peripherally as opposed to from the heart, it's possible, isn't it, that the peripheral sample would not have showed any less of a concentration of Fentanyl, correct?

A. So I think what you're asking is that there may be no difference between peripheral and a heart.

Q. Right.

A. Maybe, but not likely.

Q. Why do you say it's not likely?

A. My review of the literature. There's some papers that were just recently published — I was able to retrieve them today before deposition — that support evidence of postmortem drug redistribution involving Fentanyl. One of the papers I brought shows that the peripheral concentration was one third the concentration from the central compartment.

Q. And we'll get to those studies here in a little bit.

A. Okay.

Q. And, in fact, it's possible that if the sample had been taken peripherally, that the concentration found there might have been more than was found in the heart blood. That's possible, too, right?

A. Anything's possible. It's when you look at the scientific literature, what does it support, what does it suggest, and it suggests that with this drug, that it's going to redistribute, which results in higher blood concentrations when the blood's collected from the central compartment, from the chest.

Q. Well, I'd like to talk about reasonable possibilities. Like, for example, if I said — if I asked you is it possible that I'm pregnant, what would you say?

A. Probably not.

Q. That's not really a reasonable possibility, is it?

MR. AUCIELLO: I just want to put on the record, but I won't interrupt you anymore, an objection to imposing standard of possibilities from the plaintiff's perspective in this case, but go ahead.

A. I mean, I can tell you what the possibility of myself being pregnant.

Q. Okay.

A. Okay. See, I don't know you well enough to know your organs.

Q. Let's switch it to you. Let's switch it to you. Is it — is it possible that you're pregnant right now?

A. Definitely not.

Q. So I would like to talk about reasonable possibilities. Is it reasonably possible that if this sample had been taken peripherally, that it might have actually shown a greater concentration of Fentanyl than the sample taken from the heart?

MR. AUCIELLO: Objection, form.

A. No, I don't think that's reasonably possible. It's possible but not reasonably possible. See, in my work when I talk with my medical examiners, like Dr. Middleburg talks with his medical examiners — he talks with more than I do — but the question always is, what was the concentration at the time of death in relation to when the autopsy was conducted?

And labs like Middleburg's lab and my lab and Perper's lab, we do a pretty decent job in measuring the drug and we can do that accurately, precisely, but we can't tell you with great specificity and accuracy what the level of the drug was at the time of the death. And it could be less than, equal to or higher than.

But the abundance of the scientific literature supports that these drugs, Fentanyl especially does redistribute, resulting in a higher blood concentration when the blood is collected from the heart.

Q. And you're in agreement with the accuracy of the concentrations found by the Broward County Medical Examiner's office, correct?

A. Generally. In my report I indicated that the exhibits that were provided by Mr. Wagner were incomplete in my opinion and didn't include calibrated data and the chain of custodies and the batch analysis forms were missing, so I'm trusting them at face value.

If you had asked me for a data package from my laboratory, I would have provided to you all the batch forms, all the — all the chain of custody forms, all the calibrators and all the controls, as would Dr. Middleburg. These were missing. I'm assuming that the assay that was used by Mr. Wagner was calibrated. There's no evidence to show it was not, but I'm assuming.

Q. As you sit here today, you don't have any reason to dispute the accuracy of the levels of these medications found in the heart blood?

A. Well, I can dispute them to the level that I did in my report that these data were not provided. And I'm not surprised sometimes when I do have an opportunity to review data packages from laboratories where mistakes are made, and that's why we do ask for these data.

Now, he may not have chain of custody forms. They may operate under the assumption that once the sample's entered the laboratory, then there's no need for chain of custody. That's wrong, because we use chain of custody daily, as does Dr. Middleburg at his lab.

Q. Is this what you're looking for right here?

(Document tendered.)

A. This is a calibration curve for Fentanyl.

Q. And have you seen that before?

A. I'd have to look at my data package to see if that's in there.

Q. But is this the part of the information that you indicate in your report that you hadn't been able to see?

A. It is. I do have that (indicating). What I don't have are the actual files, the chromatograms for — the different standards that are used to construct the calibration curve.

There's actually a slight mistake on that curve if you look at it carefully, is that it appears to me that he's drawing the curve through zero zero point. You can see that little box says zero zero. That's improper. Now, it's not — in this case because the assay looks well calibrated, it's not going to change the quantitation by much, but it will change it a bit if you remove that zero zero point. That's what I would look at if I had all the data.

Q. When you say it wouldn't change it by much, like, what percentage?

A. Well, I'm only going to guess maybe five or ten percent, but maybe not even by that much, to be honest with you, I don't know, couldn't tell you.

Q. Would it effect it one way or the other, do you know, whether it be higher or lower?

A. I'm not certain, not certain at all.

Q. And so what the Broward County Medical Examiner's office did was — is they took a sample of blood from Adam's heart; is that correct?

A. Dr. Perper did or his assistant did during autopsy.

Q. And then they also looked at the other possible causes of death, like a heart attack, cancer, stroke, aneurism, and they didn't find any of that stuff; is that right?

A. To the extent that they did, yes.

Q. And it looks like they did a thorough job in doing that in reading their report; is that fair?

A. Yes. There's still causes of death that can't be ruled out, one of which would be an adverse reaction to Vioxx, or another would be, say, a conduction problem in the heart.

Q. And so then they took this blood sample and then they tested it for various foreign substances in it, right?

A. They did. They tested for prescription drugs, over-the-counter medications, and illicit drugs also.

Q. And so in that testing they found a couple of different medications that were in Adam's system; is that right?

A. They did.

(Plaintiffs Exhibit-1 was marked for identification.)

Q. And the report on that I've handed to you and marked as Exhibit Number 1; is that correct?

A. Yes.

Q. And although you may not have all the information to determine that the tests were done properly, as you sit here today you don't have any information to suggest that the tests weren't done properly, correct?

MR. AUCIELLO: Objection, form.

A. That's correct.

Q. And the value of Fentanyl that was found in the heart blood was 9.42, correct?

A. Yes. Do you need it back?

Q. Yes. Thank you. And then what they did is they went to toxicology literature to see what levels found in other deceased persons of those various drugs were found to have been lethal in those people, correct?

MR. AUCIELLO: Objection, form.

A. Based on my review of Dr. Wagner's and Dr. Schuler's (phonetic) deposition, I guess after Dr. Schuler was — had his memory refreshed, it turns out he had a discussion with Dr. Perper on the significant of these — significance of these findings. I don't think Wagner ever talked to Perper but it was clear that Schuler did.

Now, when I issue a toxicology report, I don't need to refer to the scientific literature on the significance of those findings, and neither would any of my doctors require that. There are times that one of the doctors that I work for will call me on a case so they feel comfortable with the declaration and certification of the cause and manner of death, but in the 3,000-plus cases a year that I certify toxicology reports on, I'd say I'd only talk to doctors on less than five percent of my cases, probably closer to only one or two percent.

Q. And in what percent of the cases that you're a consultant on do you have to look at the medical literature?

A. Only on drugs that are new to me that I'm not familiar with. For example, Strattera is a relatively new medication, and I consulted with Dr. Middleburg on it. We had sent the sample to his lab for quantitation, and seems he probably has the best familiarity with that drug at this current time, so he helped me out tremendously.

So actually, as a toxicologist, I deferred to a colleague of mine to get that information. But most oftentimes I'll review the toxicology report and it is abundantly obvious what my opinions would be, but like I said, doctors are cautious people and they want to be sure they get it right.

Q. And if you did have a question and you wanted to look at what has been published on that particular drug, what literature would you look at?

A. I'd refer to a number of reference books and journals and even resources on the Internet.

Q. And which ones do you use?

A. For reference books there's a book, Disposition of Drugs and Chemicals in Man, I think I got that right, by Randy Baselt. It's a red book, a big red book. And then there's another book, I don't know the exact title but it's been referred to as Clarke, C-L-A-R-K-E, that has reference values and useful information analytically and pharmacologically and toxicologically on drugs. In terms of journals, I would go to PubMed, P-U-B-M-E-D, and do a literature search online and retrieve articles that seem to be relevant.

Q. And Baselt, is that how you say it?

A. Baselt, B-A-S-E-L-T.

Q. Baselt and Clarke, would you consider those two reference books to be reliable?

MR. AUCIELLO: Objection, form.

A. They're useful, but you have to understand that there are limitations to those books. For example, Dr. Baselt's book, it's been around for just about as long as I've been practicing, since the early '80s. Much of the data that's in there is based on case reviews that were done even before the book was written.

And in the past toxicologists and pathologists and others took no regard to source of blood samples. So if you read through much that's in Baselt's book, you'll find that there's not that much emphasis placed on the source of the specimen because that wasn't considered to be important 15, 20, 25 years ago.

So when you read the monograph on Fentanyl, for example — and I didn't bring Baselt with me — he would make reference to certain drug concentration ranges that are associated with therapeutic drug administration in living people, toxic concentrations in people who have been administered the drug and maybe recovered from the overdose, and then there's also reference to the postmortem levels. It's a useful book. It's a good starting point. I haven't opened Baselt, though, in probably a month, I don't use it that much.

Q. But you do rely upon it some in your practice?

A. Yes, I will.

Q. And in terms of postmortem numbers, the way Baselt works is that Baselt looks at people that have died in the past and — when it's felt that they died of a particular drug, and then they look at what the heart blood concentration of that drug was in that person, and then you do that again for additional people that have died and it's thought that they died of that same drug, and then after a while you have enough people where there's a range that is thought to be lethal for that particular drug, correct?

A. That's partly correct. Randy Baselt himself did very little research.

He's retired now. He's fully retired and his book has now been taken over by a new editor and a new version is being worked on. But the — what he would do is he would take abstracts from meetings and papers from the literature like I brought today and he would summarize them in the monograph. So he himself didn't do the work, he relied on other people's reports to compile his summary.

Q. So he would compile all the data in the literature, or attempt to?

A. That's right. And even in some papers I brought today the source of the blood sample is not indicated, and that puts us at an uncomfortable position because of redistribution and the importance in the field. You know, even my doctors that provide me my 3,000-plus cases today, oftentimes they don't indicate what the source of the blood specimen is, at least on my form. So if I need — if I need to find out the source, I have to call the doctor and ask them about it, and you hope they remember it or hopefully it's been documented. They have different practices in different offices.

Q. Well, have you gone through the data that's in Baselt to see if the data was based on heart blood versus peripheral?

A. Not recently. I prefer just to go to the original source, so I've brought some of the key papers with me today that are — that are more definitive than someone's perception of them in a monograph.

Q. And in terms of that literature that you've brought, was the vast majority of it based on heart blood samples as opposed to peripheral draws?

A. I don't know. In some of the papers I brought today the source is provided, in others it's not provided at all.

Q. And what is the most common practice today, taking the samples from heart blood or taking it peripherally?

A. It's preferred to take it peripherally. Oftentimes it's impossible because of position of the body, the postmortem interval and there's been coagulation or decomposition, so then they have to resort to taking it centrally from the heart or from the chest or from, say, the inferior vena cava, which is still within the chest but a bit of a distance from the heart. But peripheral by far is preferred.

Q. But what is more common? You say a lot of times you can't do it.

A. I haven't actually calculated how many times we get a peripheral versus a central blood, but I'd say it's about 50/50. I would never fault a doctor for not getting peripheral blood, assuming he tried to get peripheral blood, because even the local doctor that I work with on a regular basis, the first thing he'll try to do, either himself or the tech, is to go for peripheral blood. If they can't get it, then they use central.

Q. What about five years ago?

A. Five years ago you would see more heart bloods being collected than peripheral bloods. And 20 years ago I remember doctors scooping blood from the chest cavity rather than actually getting it from a vessel or from a chamber.

Q. Wouldn't it be fair to say that the vast majority of the data that goes into the lethal range for Fentanyl is based on heart blood samples?

MR. AUCIELLO: Objection, form.

A. If you look at some of the old data, that may be the case. I haven't dissected it to that extent. I rather rely on some of the more modern studies using modern technology where the sources are specified. What you have stated, though, is kind of a common deference where Baselt and others who summarize the old-time literature that was based on heart blood. You know, that's an assumption that could — and that's a speculation. They were collecting peripheral blood 10, 15, 20 years ago.

Q. But it was uncommon, wasn't it?

A. I think it would depend on the doctor and the office and the level of training and the role of the toxicologist in the office. This is how we discovered postmortem redistribution. Graham Jones is one of the first who described it in the literature, probably about 20 years now, where he was looking at the differences between central and peripheral blood and found dramatic differences oftentimes. So I agree in part with what you said, but that leads to too much speculation, so I'd rather rely on modern studies and use those data more definitively.

Also remember, 20, 30 years ago the degree — the degree of accuracy and precision that drugs were measured is not the same as it is today. Today we have gas chromatography mass spectrometry, the technique used by Dr. Schuler and Mr. Wagner, very accurate methods of analysis. But I tell you, 20 years ago, if I was measuring Fentanyl, it would not have been done to the same degree that it is done today.

Q. You say that you believe that likely postmortem redistribution occurred. Can you tell us likely at what level it occurred?

A. The degree?

Q. Yes.

A. No.

Q. So you can't tell us whether it was 1.2 or 2 or 2.5 or 3? You can't tell us?

A. No.

Q. It would be pure speculation for you to put any number or range of numbers on that?

A. It's speculation. I don't like to use the term pure speculation. It's speculation.

Q. Would it be fair to say that the numbers in Baselt are mostly heart blood related numbers?

MR. AUCIELLO: Objection, form.

A. I don't have the monograph with me so I can't tell you for sure.

Q. I think I do have it.

A. If not, I mean, that's okay. I would say that they were heart blood or source unknown.

Q. Yeah, that —

A. That's okay. I mean, I'm okay. I'm comfortable with my answer.

Q. Yeah, but I want to find it —

A. Okay.

Q. — so we're comparing apples to apples.

A. I don't think I have a copy in any of my exhibits.

Q. I think I've got it right here. Here we go.

(Document tendered.)

A. Is this from the most recent edition as far as you know?

MR. ANGWIN: It's from the 7th edition.

THE WITNESS: I think that's the most recent edition.

MR. ANGWIN: It is.

(Plaintiff's Exhibit-2 was marked for identification.)
BY MR. ORR:

Q. I've marked the — what did you call it, the —

A. Monograph.

Q. — yeah, the monograph from Baselt, and I've marked it as Exhibit Number 2.

A. What I wanted to see is whether he, that is, Dr. Baselt referred to Dan Anderson's paper and Muto's paper from 2000, which he did.

So oftentimes when the medical examiner is confused or needs information regarding a case and a drug, what they'll do is they'll go to this table, which is Fentanyl Concentrations in Fatal Cases. And you'll find this type of chart in the majority of the monographs if the data's available. And what this chart is is a compilation of cases that date back to 1984 through 1990. And I know several of these people and I've worked with one of them.

Q. And what does Baselt say is the average lethal concentration of Fentanyl?

A. In this table he indicates 8.3.

Q. And that is probably based almost exclusively on heart blood values, wouldn't you say?

MR. AUCIELLO: Objection, form.

A. I don't know. I don't know. In Baltimore, where I trained and where Dr. Levine worked, there was an awareness regarding postmortem drug redistribution in the '80s, so there was an emphasis on collecting peripheral blood samples. I can't speak to exactly what those samples were. You'd have to speak to Dr. Levine, if he even had access to those data from the '80s. But there was an acute awareness to postmortem drug redistribution there because of some litigation. But I'd have to speculate.

Q. Well, wouldn't that be important to your opinion, knowing whether that was heart blood or peripheral blood?

A. Well, I don't use that range. I look at a — I look at a case and evaluate its merits rather than using Baselt to tell me whether it's lethal or not, because we know that there are individuals out there who are on high dose Fentanyl that may have levels of Fentanyl in their bloodstream higher than 28 or people who are in a hospital in the ICU or the CCU with I.V. Fentanyl with levels that high or higher. So it's look at the case with its own merit.

Q. Well, if the data's based on heart blood and the sample here was taken on heart blood, then what the data is on peripheral blood is really irrelevant, isn't it?

MR. AUCIELLO: Objection, form.

A. Right. But I'd have to speculate to say that these data from 3 to 28 were solely based on heart blood.

Q. What you —

A. And it's probably not.

Q. I mean, what you want to do is you want to compare apples to apples, right?

A. That's absolutely correct, yeah.

Q. And so if you have a bunch of data that shows that in heart blood, Fentanyl ranges between here and here is lethal, and then in Adam you have heart blood within that range, then that is a strong indication that Fentanyl was the cause of death.

MR. AUCIELLO: Objection, form.

A. Yeah, but what if Dr. Perper found 90 percent occlusion of his LAD? Then the Fentanyl would be irrelevant even though it was in a range that falls between 3 and 28.

Q. You said there's some people walking around with levels like 28 out there; is that correct?

A. Well, they may not be walking, but there are people who are cancer patients, for example, that do take high dose Fentanyl. There are people in hospice who get I.V. Fentanyl, as well as people in ICUs and CCUs. You would not typically see a 28 Fentanyl in someone who is given a patch. Also remember that — well, I don't know —

Q. And if you did, something went vastly wrong with that patch, right?

MR. AUCIELLO: Objection, form.

A. No, no, I'd say that that's a bad point.

Q. Patch?

A. No, no, no, no, no, that's bad, because I've documented — I know you have a copy of my abstract also, but we've documented cases, I think we were the first to document the abuse of the patch in a way that was unexpected where the drug is removed from the patch and injected or smoked. So no, it's not the patch's fault.

Q. And that's — you bring up an interesting point, and that's your study. You headed up a study at the University of Florida on Fentanyl-related deaths, right?

A. Back in the early — yes. Yes. A few years ago we started to note an increase in Fentanyl-related deaths here in the state. And the first case that came to a high level of awareness was a male, and I believe he was a student, not here at the University but at another institution, who was at a bar and was then found later dead at home. And we ran our typical toxicology screen and it was completely negative.

I talked to the medical examiner, explained the situation to him, and he was certain it was a drug death because he found nothing else. So he said, well, there was a pipe at the scene. I said, so send me the pipe. He said, no, we sent the pipe to FDLE. That's Florida Department of Law Enforcement. They're our crime lab. He looked up the report and it came back positive for Fentanyl.

So in that case it turned out that the individual removed Fentanyl from the patch and put it in a pipe and smoked it. We missed it because he died acutely, and as you probably already know, Fentanyl requires a special test to measure. You won't see it on a typical drug screen. It's basically reflexed. It's a special test that we would run. When we did that, it was apparent what happened.

And then we started to see cases where people were removing the drug from the patch and injecting it. We've seen cases where people were sharing patches in hot tubs and one would — one individual died, the other person lived but was sedate. And that's what — we were interested in the abuse of the drug, and this was a result of it, this little paper.

Q. And you looked at how many Fentanyl-related deaths?

A. Over the course of the last five or ten years, we looked at hundreds in my lab. In this — in this small case presentation there's three.

Q. I thought that it mentioned —

A. Well, there may be more, but those are three specific cases that I presented in the table on the right. I also refer to the State data. State of Florida does track Fentanyl-related deaths, as well as other drugs, and there's some data in the chart in the center panel that demonstrates that.

Q. So in this study you only carefully looked at three and then you were just citing some data that you were aware of?

A. That's right. We just picked three cases randomly.

Q. And those were Fentanyl-related deaths?

A. Those were.

Q. And were they based on heart blood or peripheral blood?

A. I don't know.

Q. So you were still able to say that these deaths were Fentanyl related even though you didn't know which type of blood was taken as a sample?

A. Yes. That really wasn't the purpose of the study. It wasn't a toxicological study, it was more of a drug trend study. And it was — when this study came out it was somewhat coincidental to when the black box was changed on the Duragesic product, and we had talked with some of the people from the FDA about — about what we had observed with our decedents, that they were injecting the drug.

Q. And in these three Fentanyl-related deaths, the Fentanyl level was similar to the level that Adam had in his blood, correct?

A. They are. A little hard to read, but they are.

Q. One's eight, one's 11, and what's the other one?

A. Nine.

Q. And those were Fentanyl-related deaths?

A. Yes.

Q. And those were Fentanyl-related deaths even though there were other drugs in those people's system; is that right?

A. Yes. In one case, though, where the decedent allegedly had a history of squeezing the contents of the patch into his coffee and drinking, all we found was Citalopram and the Fentanyl. In the other cases one had an elevated concentration of ethanol and some Valium, and the other case had a higher level of Valium plus the Fentanyl, plus an antidepressant.

Q. And in terms of us nontoxicologists, the Citalopram is Xanax, right?

A. No, Citalopram is Celexa or Lexapro.

Q. Yeah, I'm sorry. That's right. The Diphenhydramine is Benadryl?

A. Correct.

Q. And the Diazepam is —

A. Valium or generic.

Q. And the Mirtazapine is what?

A. That is — is that Remeron?

Q. Yes, I think so.

A. Don't see that often. Our governor died with it in his blood, but don't see it that often.

Q. How much did he have in his blood?

A. I don't remember, wasn't very much.

Q. It wasn't causative of his death, was it?

A. No, no, no. He was on a treadmill and just died of a sudden cardiac arrest on the treadmill.

Q. Back to people that may have high levels, in the teens or low 20s, of Fentanyl. Those are people that are taking a lot more Fentanyl than one 75-micro patch, right?

MR. AUCIELLO: Objection, form.

A. Can you ask me that question again? I wasn't clear on what you asked.

Q. Yeah. You had referenced some people that have levels in their blood of Fentanyl in the teens or possibly as high as in the 20s that, you know, they're not dead, right?

A. That's correct.

Q. Those people are taking a much higher level of Fentanyl than would be administered by a properly functioning 75-micro patch; is that right?

A. More likely than not. They could be abusing the patch, but excluding the abuse of a patch, then more likely than not they would be administered Fentanyl intravenously.

Q. And how much Fentanyl would be expected to be found in the blood of a patient who was using a properly functioning Fentanyl patch and they're not abusing the patch?

A. If they're living and not dead?

Q. Yes.

A. Somewhere in the range between one and three nanograms per milliliter.

Q. So the amount found in Adam's blood was at least three times what you would expect to find in a person's blood who was using a 75-micro patch and it was functioning properly and they weren't abusing it?

MR. AUCIELLO: Objection, form.

Q. Correct.

A. But that's not apples and apples, that's apples and oranges, because one is living blood and the other is dead person's blood and it's not fair to compare the two. And we used to think we could do that 20, 30 years ago when I entered the field. We used to — we used to take those numbers and interpret them based on what we read in Baselt, for example, but you can't do that anymore.

Q. And that's a good point. It doesn't matter what the level was in his blood before he died, right?

A. Well, I think that it's important to know what's in his blood before he died, but it's practically impossible unless, say, he was nearly dead and the paramedics collected some blood or he was in the hospital and they happened to get blood during the code, which happens sometimes. But that's not practical, and we don't have it in this case.

Q. But the premorbid level in the blood, the before-death level is irrelevant to determining cause of death because all of the cause of death data is obviously post death, correct?

MR. AUCIELLO: Objection, form.

A. It is. I wouldn't say it's totally irrelevant. It's a good starting point, because what we know oftentimes about a drug is what the desired therapeutic effect — therapeutic concentrations are. On Middleburg's reports, for example, if you've ever had an opportunity to review his reports, even though he's reporting, say, to me on a referral a, say, Clonazepam concentration in the blood of a dead person, he still indicates on the report that the desired therapeutic concentration range would be on a living person. So it's a starting point. So it's not totally irrelevant, it's just a good point, good starting point. It's about the same.

MR. AUCIELLO: Is that the same?

(Document tendered.)

THE WITNESS: You probably downloaded this from the website.

MR. ORR: Yes, I did.

THE WITNESS: I think it's about the same.

(Plaintiff's Exhibit-3 was marked for identification.)
BY MR. ORR:

Q. What have I marked as Exhibit Number 3?

A. This is the poster presentation from the CPPD meeting which we've been discussing for a few minutes. I think my copy is a little prettier than this color copier because your printer ran out of ink, but the substance is there.

Q. Exhibit Number 3 is a true and correct copy of a summary of your study?

A. We call it an abstract or a poster presentation, so it's not subjected to the same degree of peer review as you would find from a journal. It's — it's okay. It's what we do.

Q. Okay. But these are the words of your study, Exhibit Number 3, correct?

A. Those from — those are from my study, yes.

Q. Okay. Do you know whether the predeath level of Fentanyl in someone's blood bears any relationship to the postdeath level if they subsequently die?

A. To be honest, we don't know unless we have antemortem bloods that are drawn immediately prior to death. In my situation we do oftentimes receive antemortem bloods. Dr. Minyard (phonetic), who is the doctor who allowed us to summarize some of her cases, in a good number of her cases she sends us antemortem bloods and postmortem bloods. Oftentimes, more often than not, the values are different.

Q. How different?

A. The postmortems can oftentimes be dramatically higher than the antemortems. Now, granted, I don't know what the time frame is from when they were admitted to the time the blood was drawn, the scope of the treatment, then they died, then they go to the morgue and autopsied, say, the next day. So all that is not known to me, but there are times where the antemortem findings are strikingly different than the postmortem findings.

If you get admitted to an ED in toxicological trouble, you know, overdosing, they'll draw blood right away and send it to their lab for testing, but they may be treated in the ED for a few hours until they do die.

Q. But any testimony attempting to predict what a postdeath number would be based on a predeath number would be pure speculation, correct?

A. It is.

Q. There's just not enough data on it and — there's not enough data, and also you would have to have a whole lot of information about the stuff you were telling me about a minute ago, right?

A. But it's not possible to extrapolate from a postmortem back to an antemortem. We don't have a model to do that.

Q. You can't say with reasonable probability that if someone had X level of Fentanyl right before death, that the postdeath number would necessarily be higher, correct?

MR. AUCIELLO: Objection, form.

A. Depends on the postmortem interval, the route of drug administration, whether they were taking the drug acutely or chronically and other factors, like the source of the blood draw, but still, no, you can't directly correlate the two, but —

Q. You don't have any opinion based on reasonable medical probability related to Adam on that subject, do you?

MR. AUCIELLO: Objection, form.

A. Well, we know the source of the blood draw. The postmortem interval is questionable. That's about all we have other than a drug measure.

Q. And I think at least one, possibly several witnesses on behalf of Alza have already testified that it's impossible to make any judgments regarding what his level of Fentanyl was just before death based on the postdeath number.

MR. AUCIELLO: Objection.

Q. Would you agree with that?

MR. AUCIELLO: Objection to form.

A. That's right. I'm not sure I've read that in any of the materials I had, but again, you can't extrapolate an antemortem value based on a postmortem value.

Q. The predeath value in Adam could have been more or less than his postdeath value; fair?

MR. AUCIELLO: Objection, asked and answered.

A. Well, I said could, but more likely than not it was lower at the time of his death.

Q. And that's based solely on the redistribution?

A. Yes.

Q. But doesn't the postmorbid redistribution phenomenon, isn't that only relevant to the postdeath peripheral draw as compared to the postdeath heart draw?

MR. AUCIELLO: Objection, form.

A. No, but it also plays an important role when you're trying to extrapolate back to or at least get a feeling for what the antemortem drug levels were.

When postmortem drug redistribution was first described, it made the field very complicated because it would depend on whether you're collecting peripheral blood or central blood and how those values would relate to an antemortem value. It used to be assumed that your postmortem value was your antemortem value. That's not the case.

Q. The drug Fentanyl is very — is short acting, right?

A. It's short acting as an I.V. anesthetic. In the form of a patch it's not short acting because it's actually a long-acting medication. It's a three-day patch.

Q. Well, if you put a bunch of this Fentanyl in your mouth and you swish it around, it's going to be short acting then, right?

A. If it's absorbed, which it would be, then it would go into your bloodstream and you may die. If you don't die, it would be short acting.

Q. And if you took a bunch of this liquid from a patch and you put it on your skin and then you put some Saran Wrap around your arm to keep it wet, then in that instance it would be short acting, right?

MR. AUCIELLO: Objection, form.

A. Depends on how rapid the drug can traverse through the — through the skin and into the bloodstream. That's a very crude fashion to administer a drug. I've never seen a case like that before.

Q. Well, they were pretty crude in your study, a few instances, weren't they?

MR. AUCIELLO: Objection.

A. Where they took the drug and put it into coffee or tea, yes.

Q. And so if somebody did something like put it on their arm and put tape over it or wrapped cellophane around their arm, in that instance what you would expect to see is a — is a spike in the Fentanyl level of that person and then it would start to go down fairly rapidly; fair?

MR. AUCIELLO: Objection, form.

A. You know, I'm not really sure, never studied it. I'm not an expert in the absorption of Fentanyl through the skin, you know. Not many people are in that — the way you've just described.

Q. And really what we're talking about right now is the reason why you have no idea regarding what his Fentanyl level was before he died because he could have had some type of big spike and then it could have been on the downward, you know — well —

A. But the scene doesn't seem to indicate that he died acutely necessarily. The scene, to me, looking at the photos, a little confusing. In many of the deaths that I see where people die, if you die acutely, you're going to die doing whatever you're doing. Or if you die due to central nervous system depression, oftentimes people feel sleepy and tired and they'll climb into bed or the couch or sleep on the floor and then they die in that position.

In this case — well, you've seen the photographs. He's dead in his chair. So it's not entirely clear whether he died acutely due to, you know, cardiac arrythmia or he fell asleep and woke up dead. It's not — it's not the typical picture you see from a scene where you read described in the report of someone who dies of central nervous system depression.

Q. Well, he was — he was sitting at his —

A. He was working at his computer, but he wasn't really sitting at his computer because his chair was pulled away.

Q. Well, how acutely can you die from Fentanyl?

A. If you inject it, you can die with a syringe in your arm. What happened when the Heroin up north was, like in Cleveland, was contaminated with Fentanyl, they die with the syringe in their arm. That's how fast.

Q. And so if Adam had this patch on — and you're aware he had an overlay over it, right?

A. His shirt. I'm not sure what you mean by an overlay.

Q. Well, a lot of times people who use the patch, they have trouble with it staying on, and so a lot of times they put an additional plastic film over it. And this plastic film is larger than the patch. It holds it on better. Are you aware of that?

A. I hadn't heard that.

Q. Okay. Well, Adam had the patch on, then he had an overlay over that.

A. So was it Tegaderm or was it duct tape or was it a Band-Aid or what was it?

Q. I don't personally know.

A. I don't think that's what the PDR recommends is to put an overlay over your patch, because that will affect the — certainly it's going to affect the transference of drug. But, no, all I know about the patch is that it was pulled off, because the patch is still available but, you know, it's not in its pristine form, but it was pulled off and it's wrapped within some tape. To me, it's not clear whether that's a medical tape or a surgical tape or duct tape. The patches that come to my laboratory from an ME case, they're pulled from the skin and then placed into a cup so I can look at them if I need to. They're not scrunched up and then put into a tube or box or envelope.

Q. Back to my question. If he's got this patch on and then he's got some type of overlay, whether it's tape or Tegaderm, whatever it is, it's securing this patch to his arm, and then if the medication leaked out from the patch so he had the medication on a — directly on his skin and in a larger area, couldn't he get a spike of the Fentanyl to where he would die acutely?

MR. AUCIELLO: Objection, form.

A. I mean, anything's possible. I'm not aware of that occurring. I haven't seen a photograph of the patch. I don't think Perper described it in the sense that it was covered by an overlay.

Q. If it was covered by an overlay, the scenario I have mentioned would be a reasonable possibility as opposed to the your being pregnant possibility, fair?

MR. AUCIELLO: Objection, form.

A. No, because typically Fentanyl doesn't fall out of or squeeze out of the patch very easily. Have you ever handled a real patch? Hopefully with gloves on, but — because that's what's required. But when you handle a patch, you could move it around in your fingers and you can even kind of squeeze it to some degree and the drug doesn't squirt out. It's not that kind of material.

Q. As long as the patch is not defective, right?

A. I haven't seen a defective patch.

Q. So if the patch — you've never seen a patch to where it didn't get put together properly at the factory?

A. I haven't, no.

Q. Are you aware that there are a bunch of patches like that?

MR. AUCIELLO: Objection, form.

A. There was a specified lot that was defective.

Q. And there are — as a matter of fact, at the plant they've got a big board with pictures of other kinds of defects that they've experienced.

MR. AUCIELLO: Objection.

A. I've never been — I've never been to the plant.

Q. And they have people watching these patches going by to make sure that any of these defects on the board, to make sure they're not present, or to attempt to. Are you aware of that?

A. Well, that's a good thing. That's good — that's required for quality assurance. But they would do the same thing if it was a birth control patch or a testosterone patch. You've got to watch the manufacturing of the patch because the device, the Duragesic device is just like a birth control patch or a testosterone patch or any other therapeutic patch device. It's a very similar construct.

Q. But a birth control patch is not 100 times more strong than morphine, correct?

MR. AUCIELLO: Objection, form.

Q. Is it?

A. No. No, but —

Q. Would I — would I need to handle that birth control patch with gloves?

A. You probably would want to as a man unless you want to get some estrogen in your blood.

Q. I wouldn't die, though, would I?

A. No, and you probably wouldn't be pregnant either. But if–

Q. We can make doubly sure with that patch, though.

A. But just completely hypothetical, just to finish it is if your wife was using the patch and it was defective, she might get pregnant. And if there was some medical reason why she shouldn't get pregnant, then that's important. That's the reason for quality assurance in a plant like the one that manufactures the Duragesic.

Q. Quality assurance would be of absolute paramount importance when you're dealing with a medication 100 times stronger than morphine; fair?

MR. AUCIELLO: Objection to form.

A. It is, but I'm not an expert in the manufacture of medical devices, including the Duragesic patch.

Q. Now, with respect to Fentanyl, we know that people can tolerate that medication — well, strike that.

In terms of the least lethal dose of Fentanyl, there's a range there because different people tolerate the medication in different ways, right?

A. It depends on whose range you look at, but going back to the original question, there is a wide range of therapeutic or effective drug levels because people tolerate the medication. So if you started someone who's naive to Fentanyl, you would expect that they might only tolerate the 25 mc patch, but if they've been taking the drug for a month or two or three, they may require a 50 or 100 mc patch.

Q. And almost all of the difference from person to person in terms of tolerance to Fentanyl is based on their experience in the past with having taken it, right?

A. It would be their recent past, not their distance past, but also as it relates to their degree of pain and their pain threshold.

Q. Well, it doesn't really matter how much pain they're in in terms of whether you can slap four patches on them and they'd be fine. It matters whether they've been using the patch over the last six months; fair?

MR. AUCIELLO: Objection.

A. Not exactly. If you broke your hip and you were in severe pain and they decided to treat you with a Fentanyl patch, I don't think they would, but if they decided to treat you with a Fentanyl patch, they might need a 100-microgram patch to put down the pain. But if you only broke your ankle and they decided to treat you with a Fentanyl patch, which obviously they would not, but if they did, you might only need a 25 patch. We can talk about morphine or any other narcotic. The dose does relate to the severity of the pain.

Q. Right. But whether it will kill the person or not doesn't have anything to do with the severity of the pain.

MR. AUCIELLO: Objection, form.

Q. Fair?

A. Well, it does because your tolerance is much greater if you're in very severe pain. That's why you often wonder how, say, if you did break your hip and they gave you huge doses of morphine, that you still survived, because they might start you with 20, 30 mg's of morphine, but if you just took 10 milligrams without a broken hip, you might die.

Q. Okay. So I'm trying to understand what you're saying here. So if somebody came along and just sawed off both my legs and they gave me a certain level of Fentanyl versus if some — if I just burnt my finger, you're saying that in the situation where my legs got cut off, and they gave me the same amount of Fentanyl in both situations, you're saying I would be less likely to die in the cutting-off-the-legs scenario?

A. Well, it depends on — for example, cutting your legs off and they gave you 25 micrograms of Fentanyl, it wouldn't probably even touch the pain that you were subjected to.

Q. Right.

A. So you would need a 100-microgram patch. Of course, you wouldn't be given Fentanyl in this fashion, just kind of to make that clear.

Q. Yeah.

A. So people who have severe pain, suffer severe injury, blunt force trauma who need drug will get much higher doses of the drug and there is no adverse effect.

Q. Right. But what makes them able to tolerate it is the fact that they've been taking it. I mean, you can't just — you can't just put them on a 100-micro — is it micro? Is that the correct terminology?

A. It's microgram.

Q. Microgram. You can't just put them on a 100-microgram patch when they've never taken any pain medication in their life, can you?

A. No, see, that's not really the case. If, God forbid, on your way home from this deposition you're involved in a — in a horrible traffic accident and you were seriously injured and had lots of pain, they would likely start you on high doses of a narcotic. It might not be Fentanyl but it could be morphine. It could be Fentanyl. But very high doses may be needed to treat your pain and you still may be awake.

Q. And the fact that I'm in severe pain means that I'm less likely to die from that than if I wasn't in severe pain?

A. In a sense. It's not a protective measure exactly, but that's the way it works.

Q. And in terms of tolerance to Fentanyl, I mean, it's somewhat like a person's tolerance to alcohol, fair?

A. When the drug is administered chronically, absolutely. There's some change in regulation of the way that the receptors in their brain work.

Q. A nondrinker might die from an alcohol level of .3 and a heavy alcoholic might be able to go to work at .3; fair?

MR. AUCIELLO: Objection, form.

A. That's true, yes.

MR. ORR: Do you want to take a break real quick?

THE WITNESS: I'm good. Or, yeah, that's fine.

(A brief recess was held from 2:52 to 3:04 p.m.)
BY MR. ORR:

Q. Is it fair to say that it's your opinion that Adam's death was Fentanyl related but other drugs also contributed?

A. Yes, I agree with Dr. Perper in that it was death due to the combined drug effect of the Fentanyl with the other drugs.

Q. And which one was the most important component in your opinion?

MR. AUCIELLO: Objection, form.

A. That's hard to say. That's why it's determined as a combined drug overdose. The most potent of the three drugs is obviously the Fentanyl.

Q. If you take the Fentanyl out of the equation, Adam wouldn't have died, would he have?

A. Probably not, assuming that he — again, going back to our previous discussion a few hours ago, that he did die from drugs.

Q. And you don't have any reason to believe that he died of anything other than the drugs; fair?

A. I'm not a pathologist. I'm going to take Dr. Perper's word for that. I'm just — I offered up other explanations earlier today.

Q. You would defer to Dr. Perper on that?

A. In terms of the pathology, yes.

Q. In terms of eliminating the other possible causes of death, you would defer to him?

A. Well, I'm not sure we can fully eliminate, say, Vioxx, because even in the cases of alleged Vioxx injury, those cases aren't straightforward either, so the pathology exam may look normal, may not be normal. And what I know mostly about Vioxx is what I've read in the newspaper. I'm not an expert in that field.

Q. And what is Vioxx?

A. It's an antiinflammatory medication, prescription medication.

Q. What's it called? I mean, like Benadryl, you know, is called some other scientific name.

A. I don't know off the top of my head what the medication is called.

Q. Now, you mentioned some drug that you felt should have been looked for. That's not the Vioxx, is it?

A. No. It's Clonazepam is the other medication. That's Klonopin with a K.

Q. And why do you think that that should have been looked for?

A. It is also a central nervous system depressant medication. So to fully round out the comprehensiveness of the tests done in Dr. Perper's office, one could have quantitated the Clonazepam and its metabolite, Aminoclonazepam.

Q. Well, they did screen for that, didn't they?

A. Well, not really. They screened for benzodiazepines. In this case the case was already positive for benzodiazepines because of the Valium, the Diazepam that was on board, but there still could be Clonazepam there. No test was run for Clonazepam. I believe what Dr. Wagner said is he looked for some ions on the — in the total ion chromatogram for Clonazepam. That's not the way you test for Clonazepam. That's — that's wrong.

Q. Wasn't there a mass spectra done to rule out the presence of that medication and its metabolite?

A. Not correctly, no. He should know better. Just like I — I wouldn't rule out Fentanyl the same way that he attempted to rule out Clonazepam. What you do is run a specific test for Clonazepam like you would for Fentanyl.

Q. What was done?

A. It's been a while since I looked at these.

So what he did was he knew what ions would be representative of Clonazepam, and he looked into the total ion chromatogram from the mass spectrometer and looked for those ions, and those ions were negative. In my experience with Clonazepam, it requires a specific test. I send my Clonazepams to Dr. Middleburg because the total ion chromatogram that we perform that's commonly performed among all the labs is not sufficient to detect Clonazepam. We have to send them out or run a separate test.

Q. What you're saying is you've done this exact test but then sent a sample off to where, even though this was negative, the more specific test came up and showed that there was that medication in the system?

A. Exactly. So the test that Dr. — or Mr. Wagner ran is not a Clonazepam-sensitive test. Clonazepam is one of the more difficult benzodiazapine drugs to test. We've attempted to set up an assay in my laboratory for the last couple years and just can't manage to do it, and I have a pretty good staff.

Q. And what's the street name for that medication?

A. Well, prescription would be Klonopin.

Q. And you're not going to be testifying in this case that Klonopin played any role in the death of Mr. Hendelson, are you?

A. I would say — no, I won't say that, but I might say that it wasn't adequately screened for or tested for and it cannot be ruled out.

Q. And the test that was done, wouldn't it rule out any sort of above-therapeutic range for Klonopin?

A. I don't think so. You could ask Mr. Wagner or Dr. Schuler, but I don't think so, not in my experience.

Q. And this is kind of like the other potential causes of death in that you don't — not aware of any evidence to suggest that he did die of something else, just like here you're not aware of anything to suggest that Klonopin played any role in his death, correct?

MR. AUCIELLO: Objection, form.

A. To some extent that's correct. It's like trying to prove a negative. It's very difficult.

Q. In terms of the level of Fentanyl in Adam's blood at the time that he died, do you believe that it was eight or higher?

A. I don't know.

Q. Seven or higher?

A. I can't say.

Q. Six or higher?

A. Maybe.

Q. Five or higher?

A. I just don't know. There's no way, there's no scientific model or unscientific model to make that determination.

Q. And what would be the average amount of postmortem redistribution that you would expect with respect to the Fentanyl found in the heart blood in Adam under the facts of this case?

MR. AUCIELLO: Objection, form.

A. It could be small to several fold greater.

Q. Do you have a range?

A. No. We could see what Dr. Baselt has to say, if he says at all. He says Fentanyl may exhibit postmortem redistribution. In a study of 13 fatalities, heart/femoral blood concentrations averaged 1.6 with a range — these are my words — of .7 to 4.6. It's based on Dan Anderson's and Mr. Muto's work from LA County.

Q. And what's the average or the mean?

A. Average, same as mean, is 1.6.

Q. And if you're trying to determine what likely happened, wouldn't it be fair to go with the average?

MR. AUCIELLO: Objection, form.

A. Maybe it's better to go with the median, but I don't know what the median is. Median would be the middle value. But it's only speculation. That's all you have.

Q. But if you're charged with trying to figure out what likely happened, more likely than not, don't you think it would be fair to go with the median?

MR. AUCIELLO: Objection, form.

A. No. I'd rather say that I don't know, I can't say because of postmortem drug redistribution, but I'm comfortable saying that more likely than not it's higher than it was at the time of death. That's the case with most drugs of this nature.

Q. And you're only saying that because most of the time postmortem redistribution occurs, right?

A. With most drugs in most instances and circumstances postmortem drug redistribution occurs. It's a very common phenomenon.

Q. And it usually is more of a phenomenon with respect to drugs that are in the system at a higher volume, right?

A. Well, you see more redistribution when the patient is taking a drug chronically. When you have an acute overdose, a bolus of drug, depending on how the bolus was administered, the likelihood for redistribution may be great or not so great. But when someone's taking the drug on a chronic basis, there can be or there is an accumulation of drug in the tissues, and that's where the redistribution comes from is the transference from drug from tissue back into the fluid.

Q. So if there was a leak out of this patch and too much medication got into Adam at one time and killed him, that would be a situation where you might not have the same amount of postmortem redistribution than you would if the patch was functioning properly?

A. Not —

MR. AUCIELLO: Objection, form. Go ahead.

A. Sorry. Not necessarily. It also — studies have also shown that certain drugs have a predisposition to be attracted to certain tissues, like heart tissue or lung tissue. And I don't know — well, that hasn't been studied with Fentanyl so we don't know what its propensity might be for particular tissues. So does it have the propensity to accumulate in cardiac tissue? I can't answer that question. Drugs like antidepressants will tend to accumulate in the central compartment in those tissues.

Q. Okay. But I thought you just told me that in a situation where a significant amount of the medication is put in at once, that you tend to see less postmortem redistribution than if somebody is taking the medication at a steady rate. Isn't that true?

A. That's acute versus chronic. In your allegation that may be acute on top of chronic, so that's even more complicated.

Q. And —

A. Because my reading of the record is that he was taking, using the patch on a chronic or a regular basis, wasn't the first time he applied a patch.

Q. So at least the chronic part that he was taking, say, a level of between one and three, what you're saying is you would expect to see more postmortem redistribution as to that amount versus any amount that might have gotten in improperly?

MR. AUCIELLO: Objection, form.

A. No, all I'm saying is that it confuses the matter. So which degree of the drug is from release of tissue because of the chronic administration and which portion of the drug is, say, from the alleged defect and which portion of the drug is from the administration? I can't say.

Q. So it just further confuses this issue of postmortem redistribution, right?

A. Well, I don't think — it doesn't really confuse the issue, it just supports my opinion that we can't reliably say what the antemortem, just-prior-to-death drug level for Fentanyl was.

Q. Which really doesn't matter since all of the data on what is a lethal dose of Fentanyl is based on postdeath numbers, right?

MR. AUCIELLO: Objection, form.

A. Lethal, obviously, because that means death.

Q. So if you want to try and determine what is a lethal amount of Fentanyl in the blood, you want to look at all of the tests done in years past on people that have passed away and had Fentanyl in their blood, right?

A. You can do that if you — but the best way to do that is also to know the source and the way the drug is measured. One concern, again, just to emphasize the importance of this, is that the measures of the drugs done ten and 20 and 30 years ago were not done at the same level of accuracy and precision as they are today.

In the journal that I edit, I edit the Journal of Analytical Toxicology, if someone submits to the journal a case report, hypothetically a Fentanyl case report, we require them also to present accuracy and precision data on the way that they measure Fentanyl so we know that this isn't a spurious result, that this isn't a mistake.

Q. An anomaly.

A. Right. So who's to say that that 28 in Dr. Baselt's range is an anomaly? I can't say.

Q. And levels as low as three have killed people, right?

A. Yes.

Q. And that's why you don't want to put a patch on someone that's never taken pain medication before, because the patch, a 75-microgram patch is designed to deliver up to potentially three — a three level in the blood, right?

A. Yes, it can.

Q. So since a three has killed some people, then you wouldn't want to put it on someone that had absolutely no tolerance, right?

A. But that's not the case with Mr. Hendelson. He's had a chronic hip injury and had chronic hip pain and back pain and was taking narcotics for years, so he was tolerant. And those drugs weren't working, so the standard of care was followed, that is, don't administer a Fentanyl patch to someone who's not naive. Administer to someone who's tolerant.

Now, back in — when he died in 2003, I'm not sure what the warning was at that time. I don't think the warning actually indicated that. But today we know what the black box warning says, and it should only be administered to people with tolerance.

Q. And so Adam, he was tolerant to Fentanyl at a level of three, right?

A. I don't know what level he was tolerant to, but he was tolerant to Fentanyl at the level that the patch was administering.

Q. Which, your understanding, it's supposed to deliver between one and three, right?

A. The desired therapeutic concentration range is somewhere between one and three.

Q. Then probably he was tolerant to that level, right?

MR. AUCIELLO: Objection, form.

A. Yes, tolerant to whatever level was in his bloodstream.

Q. There's no reason to believe that he was tolerant to nine; fair?

A. Probably not.

Q. And the other medications, he'd been taking those for a long time, too, right?

A. Some of them. I think — I looked at the psychiatrist's notes and some of those, I can't recall the exact dates that they were prescribed, but he was — had sought out recent help from a psychiatrist, and that psychiatrist was prescribing these medications for his depression.

Q. And the Citalopram, again, I'm sorry, what's the street name on that?

A. Well, prescription name would be Celexa or this Lexapro.

Q. I think I've seen a commercial on Lexapro.

A. Probably a few.

Q. I'll go with that one. So the level of Lexapro found was .55, right?

A. That's right.

Q. So he was tolerant to that — he should have been tolerant to that level, right?

MR. AUCIELLO: Objection, form.

A. Possibly.

Q. Well, if we're going about —

A. Probably.

Q. If we're going to more likely than not, he was probably tolerant of that; fair?

A. Okay.

Q. Well, okay or do you agree?

MR. AUCIELLO: Object, foundation.

A. Well, I know where you're going and I —

Q. Where am I going?

A. Well, even Dr. Perper can't quantify the degree at which each drug was working within Hendelson's brain. And if he could, then he might have just said it was a Fentanyl overdose or maybe he would have said it was only a Mirtazapine overdose. But we can't quantify those effects, so the most accurate way is to do what he did, which was declared as a combined effect of all three.

One could even include the Diphenhydramine. Benadryl, if you've ever taken it, is a sedative, and even at low doses, has the same effect as a .08 alcohol has. So we could even expand Dr. Perper's cause of death to include Diphenhydramine. I'm not going to rewrite it, I can't do that legally, but we could include Diphenhydramine in that formula.

Q. And — but in terms of the Lexapro, he was probably tolerant of that level, right?

A. I don't know exactly, but — I can't quantify that.

Q. Was the level found in his blood the level you would expect to have found in him the day before he died if he was taking that medication as prescribed?

A. Possibly, but that's assuming that the .55 was the same concentration that was in his bloodstream at the moment he died, and I don't know, for the same reasons I don't know about Fentanyl.

Q. In terms of the Benadryl, the level found was .01, right?

A. Well, it says less that .05. It's — oh, you'll label that.

MR. ORR: Yeah, I've got to be a little more specific on this one. What are we at, 4?

(Plaintiff's Exhibit-4 was marked for identification.)
BY MR. ORR:

Q. I'm showing you what's been marked as Exhibit Number 4.

Let me ask you real quick, you relied upon Exhibit Number 1 in rendering your opinions in this case, right?

A. I did. I even reproduced it to some degree on my report.

Q. And this is the type of document that experts in your field rely upon on a regular basis, correct?

MR. AUCIELLO: I'm going to object in that your Exhibit 1, which I didn't notice, has the handwritten notes on it that I don't believe are contained in the Exhibit 1 that he reviewed.

MR. ORR: Okay.

THE WITNESS: I think I might have both versions.

MR. AUCIELLO: You might have both versions.

THE WITNESS: Yeah, because I do have Perper's exhibit and I think I have a virgin copy also.

But yes, I rely on these. I produce these.

Q. All the time?

A. All the time. Mine don't look like Mr. Wagner's, but I do produce toxicology reports on a regular basis.

Q. And the same goes for Exhibit Number 4?

A. My reports look somewhat like this. He's using a system from Agilent, A-G-I-L-E-N-T. I don't use the same procedures that he uses to quantify drugs. Mine's a little different, plus I don't have all of his — all of his data that I like to review.

Q. And the level of Benadryl was .01, correct?

A. No, it's just — it's less than .05. When you get down to those low limits, Mr. Wagner did what he was appropriately supposed to do, which was just report it as less than .05. This number on the right, the .01 is meaningless.

Q. He had a low level of Benadryl in his blood?

MR. AUCIELLO: Objection, form.

A. A .05 is low.

Q. And if I took — Benadryls I think typically come in 25-milligram tablets?

A. I don't know actually.

Q. I think you can take one or two depending on your preference.

A. I don't know.

Q. Do you know how much you would have in your blood if you took, say, one Benadryl and then you tested it, you know, an hour later or so?

A. I'd have to look in Baselt to see. That's the reason why I Baselt is if you ask me that question, I don't have an encyclopedic memory, so I'd have to refer to Baselt. That's a good place to start. So, no, but a single dose of Benadryl is known to have some same cognitive effects, central nervous system effects as an 08 alcohol, so it is a sedative.

Q. But you don't know whether the level found in his blood would be consistent with him taking a Benadryl the day before or whether it would be consistent with him taking a Benadryl two hours before he died?

MR. AUCIELLO: Objection, form.

A. I don't know.

Q. Wouldn't that be important to your opinion in this case?

A. Well, I couldn't tell you. I did tell you, which, to be more accurate, we could include other drugs within the parentheses that Dr. Perper included on the death certificate, we could also include the Diazepam and the Nordiazepam, which are also both central nervous system depressants.

Q. Well, it looks like that they did look at Baselt and determine that it was below the range that you would expect to see in someone's blood if they had recently taken a Benadryl, right?

A. Yeah. I don't know where they got that from. Again, Baselt's not definitive or authoritative. I quantify hundreds of Diazepams a year. It's a low level. But think about it this way, is that if you have lots of drugs at low levels, the combination of those drugs can result in death as well as one huge dose of one drug can result in a death. In this case you have a mixture of Citalopram, Diazepam, Mirtazapine and Fentanyl, I'm not sure if I missed one, there's five that are all central nervous system depressants, when mixed together would cause central nervous system depression.

Q. But there's no known danger associated with mixing these particular drugs, is there?

MR. AUCIELLO: Objection to form.

A. Not usually, no.

Q. As opposed to, you know, some drugs, for example, you know, all the commercials on TV, they'll say, you know, here's this great drug, don't take it if you're taking this because it would be bad news. You've seen that?

A. I've seen that.

Q. That's a different scenario that's not applicable here, right?

A. Not necessarily. You may still have metabolic competition in the liver with some of these drugs, so they may be competing for substrate in the liver through the cytochrome P450 system, so there may be some competition here. The science isn't well defined at this point where you can use it in a diagnostic sense, but maybe five or ten years from now when you go to the doctor for a problem, he may know what your genetic makeup is and he can personalize your medicine so you get the right medication. Right now we can't personalize medication.

Q. So the competition that you're talking about, though, had been going on for months since he'd be taking these medications for months, right?

MR. AUCIELLO: Objection, misstates the evidence.

A. Yeah, I don't know how long he was taking each one of those medications. I didn't review the medical records to that detail.

Q. But if he had been taking all these medications together for some period of time — well strike that.

The Lexapro, what's the therapeutic range for that?

A. In my casework we see routinely blood concentrations that are less than .5 as high as one milligrams per liter. Those can be in cases where it's an incidental finding or it could be in combination with other drugs that resulted in death.

Q. But in terms of the level you would expect to find in the blood if a person was taking Lexapro as prescribed, what would you expect the levels to be?

A. Well, there's no specific expectation when you do a postmortem. When you do measures in living people, then there is an expectation to some degree. And I don't have Baselt with me, but it would be I would estimate probably from .1 to .3. That's off the top of my head. And I don't know what's reported in Baselt or what's reported even in the package insert from Lexapro.

Q. But to learn that information, where you would go is Baselt?

A. Baselt or to the package insert. The package insert would have the data from the clinical trial.

Q. And all those package inserts are compiled in the PDR?

A. They are. I don't buy a PDR anymore because you can get these off the Internet.

Q. And so what you're talking about in terms of the therapeutic range of .5 to one, that's where you take a whole bunch of people that died of something else and they happened to be taking Lexapro and there's no reason to believe that they were taking it other as — other than as prescribed, and what you're saying is in that scenario you typically see .5 to one?

A. No, I see .5 to one or even higher in a wide range of cases and I see less than .5 in cases. I see them in cases where they're — the deaths are due to blunt trauma from a car crash. I see them in cases where someone purposely hangs themselves. I see them in homicides. I see them in cases where there's mixed drug intoxication so that a decedent takes a handful of a whole variety of medication. It's not straightforward.

Q. Is there any reason to believe in this case that Adam was taking the Lexapro other than as prescribed?

A. Can't say. Hard to say. You can look at pill counts. That gives you some insight on whether the drugs were taken according to what was prescribed. They can be misleading. Pill counts can be misleading. You could also look at the stomach contents. They didn't do any measures of drugs in the stomach contents.

Q. And I'm not asking you if you can determine whether he was taking it as prescribed. I'm asking you if you're aware of any evidence that points to or suggests that he was not taking it as prescribed.

A. I don't know. It's possible he took one or two more than he was supposed to because he was forgetful. I didn't know Mr. Hendelson. Or maybe he missed a dose. No one can say.

Q. Well, I'll ask it a different way. Please tell us about the evidence that suggests that Adam was taking the Lexapro in an amount more than it was prescribed.

MR. AUCIELLO: Objection, form.

A. Yeah, I don't have that.

Q. And the doctor that prescribed the Lexapro knew he was on these other medications, right?

MR. AUCIELLO: Objection, form.

A. Yes.

Q. And do you know how long he had been taking the Lexapro?

A. I didn't look to see how long.

Q. Do you know whether he took it on a daily basis?

A. That's how you take Lexapro, but I don't know exactly what his regimen was.

Q. Do you know whether or not he had taken it the day — or within 12 hours of him dying?

A. I don't know.

Q. Is the Lexapro subject to postmortem redistribution?

A. Yes.

Q. At any greater or lesser extent than Fentanyl?

A. Probably to about the same. Who knows? I don't know. I'd have to look at the scientific literature.

Q. And so if he took a Lexapro — had been taking a Lexapro every day and he took a Lexapro on the day that he died, and in the postmortem sample it's within what you would expect to be the therapeutic range —

A. Well, I didn't say it was a therapeutic range. These are just values that we observe in our cases, and these cases are ranging from intentional suicide involving Lexapro and other drugs or cases where it's an incidental finding. These are just — that's the range that I see. I've seen Lexapros ten times or higher than what we have in this case.

MR. AUCIELLO: Just so the record isn't too fouled up, he wasn't on Lexapro, it was Celebrex.

THE WITNESS: Celexa.

MR. AUCIELLO: Celexa, I mean.

THE WITNESS: Celexa.

MR. AUCIELLO: Just so that it's not overly confusing.

THE WITNESS: Celexa.
BY MR. ORR:

Q. But it's the same thing as Lexapro, right?

A. Well, not exactly, but it's close.

Q. Okay.

A. It's still Citalopram, but it's an isomer of Citalopram.

Q. Do you need to change any of your answers so far if we substitute Celexa for Lexapro?

A. No. No. In my lab we can't differentiate between Lexapro and Celexa, and neither can Mr. Wagner and probably even Dr. Middleburg.

Q. Okay.

A. But maybe.

Q. So if he took the Celexa on the day that he died — well, let me get back to the .5 to the one.

Would you call that a normal range found at postmortem?

MR. AUCIELLO: Objection, form.

A. I would avoid using the term normal.

Q. What would you call it?

A. It is what it is. It's a .55. If it was a 5.5 I'd be real concerned because that looks like an overdose. If it was a .055 I probably wouldn't be concerned at all. But .55, might use the term typical, whatever that means. It's what we see. We see Citalopram a lot. It's a very popular medication.

Q. How about this: Would it be fair to say that the .5 to one is typical of what you find in postmortem samples in people that are taking Lexapro or Celexa?

A. Taking — yes, but taking Citalopram according to what's been specified and also in overdose, you know, because you could commit suicide by taking a handful of your Citalopram and a handful of your Mirtazapine and a handful of your Benadryl. I'm not saying that's what Mr. Hendelson did, but I'm just giving you an example that you can see slightly elevated levels of these three drugs, and it's the combination of the three that results in a death where if it was only Citalopram or only Benadryl, maybe there would be no effect.

Q. Can you tell us what evidence, if any, suggests that he was taking any medication in an amount more than the prescribed level?

MR. AUCIELLO: Objection. Other than the benzodiazapine?

A. Yeah, I don't think there was a prescription for Valium. And, of course, there would be no prescription for the Benadryl. It seems to me when I look at the scene photographs his practice of taking medications was reckless. My wife takes multiple medications, and as does my daughter, and very organized in the way that they take their drugs. And the pictures from the scene show bottles everywhere. It's not a — I'd suspect it's not a scene that I would see at your house.

And what becomes problematic is we can't say for sure what his pattern of drug administration was. And it could be that he might miss days and there may be days where he might not be able to keep track of his medication, because he was prescribed a good number of medications. It may explain why his depression was so serious. Maybe the medications weren't working because he wasn't taking them appropriately. Just offering ideas.

But I think it was his shoes that were very organized in the pictures but it was everything else that seemed to be very disorganized in his life.

Q. Let me ask you this: Can you identify for us any evidence to suggest that he took any medication leading up to his death in an amount more than the recommended dosage?

A. No.

MR. AUCIELLO: Objection, same.

A. No, I don't have that, but the pictures just show some level of recklessness when it comes to taking very important medications.

Q. Now, you are aware of some evidence that he received more than the recommended dosage of one medication, right?

A. Which one is that?

Q. The Fentanyl.

MR. AUCIELLO: Objection.

A. No, I don't have evidence of that.

Q. You don't take the 9.4 as evidence of that given that it's three times the designed blood level?

A. No. I have a paper somewhere in my pile here recently published that shows the redistribution of three times. So if we divide the 9.4 by three, we're with three.

Q. And if we had that redistribution with respect to — with respect to Fentanyl, you would also expect to see it with the Celexa?

A. No. They're — they don't parallel one another. They're not hand in hand. The degree at which Fentanyl redistributes may not be the same degree at which Celexa and Mirtazapine and the benzodiazapines would redistribute. It's not predictable.

Q. Well, I just — I just asked you a minute ago whether you would expect to see a rate of postmortem redistribution at any greater or lesser rate for the Celexa than you would for Fentanyl and you said no, about the same rate.

A. I did say that, I think, I can't say what the rate was.

Q. But yet the amount of Celexa found is typical, correct?

A. Typical, yes.

Q. And in terms of what the expected amount of Celexa found in the blood would be of a living person taking Celexa in the recommended dosage, you would defer to whatever it says in Baselt on that?

A. Yeah, I'd actually probably start not with Baselt but I would start with the package insert and I would do a PubMed search and see what the literature reports. I refer to Baselt because that's always a good starting point, but it's not authoritative.

Q. Well, if I just want, as a lawyer in this case, to know what number to go by for that, can we agree upon the package insert number?

A. Yes.

Q. And wouldn't you expect to see postmortem redistribution with respect to the Celexa at a greater rate than the Fentanyl because of its — it's in such a greater volume?

MR. AUCIELLO: Objection, form.

A. What do you mean, greater volume?

Q. Well, you only take a tiny, tiny, I tiny little bit of Fentanyl in terms of the amount of medication and you take a lot more of the Celexa, right?

A. No, it doesn't work that way.

Q. It doesn't?

A. No. Redistribution is affected by a wide range of physiological and chemical properties. The pKa of the drug, the volume of distribution of the drug are some of the factors you would consider.

Q. And what's the lethal range for Celexa?

A. I didn't bring any of my references with me so I can't tell you off the top of my head, but I've seen overdoses in the range of several milligrams per liter or higher. So three, four, five, ten milligrams per liter would be a problem.

Q. You would start looking at the Celexa as a possible cause of death at three or four?

A. When it's alone, but I've seen it lower when it's in combination.

Q. And the Diazepam, what's the street name for that again?

A. The prescription medication is Valium. Probably most people buy it as generic and it's Diazepam.

Q. And the level found there is — was .01, but you indicate that the only meaningful thing is that it was less than .05; is that right?

A. Yeah, I wouldn't quantify it this way, neither would Dr. Middleburg, but it would be at a low concentration consistent with taking a, say, five- or ten-milligram tablet of Valium within a day or two.

Q. And what would be the typical range of Valium found postmortem?

MR. AUCIELLO: Objection, form.

A. We see a lot of Valium, Diazepam in our cases and many of them range from about .1 to .5, the same for the Nordiazepam, which is an active metabolite of Diazepam. We do see — we do see cases where it's in the milligram range, like, one and two and three milligrams per liter. That's not that often, though.

Q. But in terms of the typical range that you see when you don't suspect they were abusing the drug and you don't suspect the Valium as a cause of death, what's that typical range?

MR. AUCIELLO: Objection to form.

Q. The .1 to .5?

A. .1 to .3, sometimes lower.

Q. And then what would the Valium level have to be in order to start looking at that as a cause of death?

A. Well, alone it's oftentimes not the cause of death because it is a very safe drug, but in combination with other central nervous system depressants, including other benzodiazapine and antidepressants and opioids and alcohol, it can produce a synergistic effect. But Valium alone won't kill.

Q. Well, the .01 of Valium is a miniscule amount of Valium in his system, right?

A. I wouldn't call it minuscule. It's low.

Q. He hadn't even taken a Valium anywhere near the time he died, had he?

A. Well, certainly it's possible that he had taken one recently and it was just being absorbed. Dr. Perper didn't have the lab evaluate the stomach contents. But that's probably not the case.

Q. It could have been days —

A. We don't know.

Q. — since he had taken a Valium, right?

A. I'd say a day or two. Very hard to say.

Q. Now, the Diphenhydramine, that's Benadryl, right?

A. Right.

Q. And what would be the typical range found with respect to that medication where they weren't abusing it and you didn't suspect it as a cause of death?

MR. AUCIELLO: Objection, form.

A. Most people don't abuse Diphenhydramine, obviously, but a .05 to a .1 to a .2 is what you would typically see in a case where the Benadryl is only there as an incidental finding.

Q. And the range on the Valium in an incidental finding was the .1 to .3, right?

A. For Valium?

Q. Yeah.

A. I think I said it was — I think that's what I said, .1 to .3, sometimes higher if you're taking more than five or ten milligrams. Some people take a lot of Valium.

Q. So Adam had not taken a Benadryl anywhere near the time that he died, had he?

A. Could have been within the day or so.

THE VIDEOGRAPHER: Five minutes.

Q. Okay. Now, the Mirtazapine, is that how you say it, Mirtazapine?

A. Mirtazapine.

Q. That is the Klonopin, right?

A. No, that's Remeron.

Q. Yeah, I'm sorry. You're right, Remeron.

A. An antidepressant drug.

Q. And the — okay. And the Celexa is an antidepressant, too?

A. It is.

Q. Okay. The Remeron, what would be the typical/incidental range there?

MR. AUCIELLO: Objection, form.

A. .1 to .2 milligrams per liter.

Q. So he had slightly above the typical range, right?

A. Yes. We don't see that much Mirtazapine anymore. It's not commonly used, so I don't have as much familiarity from my casework.

Q. The Valium, would that be subject to postmortem redistribution?

A. It is.

Q. At any greater or lesser rate than the Fentanyl?

A. Probably about the same.

Q. The Benadryl, is it subject to postmortem redistribution?

A. Yes.

Q. At any greater or lesser rate than the Fentanyl?

A. Probably about the same. It can't be quantified. You can look in Baselt and he'll say what the average was and what the range was, but there's a wide overlap and it's very case dependent.

Q. And the Remeron, is that subject to postmortem redistribution?

A. I believe it is. I haven't actually looked in Baselt to see if it is or if there's any studies to support it, but based on the chemistry of the drug, I would expect it to be subject to some degree of redistribution.

Q. At any lesser or greater rate than the Fentanyl?

A. Hard to say. Probably the same. And when I say probably the same, I'm just relating to you that there's a wide range of redistribution. I'm not holding myself to what Baselt has in his book.

Q. So if Adam had died from a car accident and you found .3 of Remeron in his blood alone, that's it, that's the only medication you found in there, you would consider it to be typical or incidental, wouldn't you?

A. Assuming he died from trauma, yes.

Q. And especially if it was taken from heart blood, because there would be some postmorbid redistribution factor, right?

A. Postmortem, yes.

Q. So you believe actually probably the level of Remeron that would have been shown from a peripheral draw postmortem would have been something a little bit less than the .3?

A. Yes.

Q. How much less?

A. Don't know. And I'd say that for all the drugs, because I'll hold to my original statement, which was more likely than not redistribution results in an increase in the drug concentration, but I can't quantify it for you.

Q. And that's really the question is what would you expect to see in a postmortem peripheral draw. It doesn't really matter what the — it's really not relevant trying to figure out what the premorbid values were; fair?

MR. AUCIELLO: Objection, form.

A. Well, be great if we had a peripheral blood draw. We might not even be here today if there was a peripheral blood draw. Maybe the picture, pharmacologic, toxicologic picture would look different. The cause of death may be totally different. Dr. Perper may have decided to have studied the heart in more — more thoroughly or the brain more thoroughly if these results came back normal, in quotes. I can't say. It's only speculation.

Q. But in trying to figure out cause of death, what you do as a forensic toxicologist is you compare apples to apples, right?

A. Well, depends on what I'm doing.

Q. You try and compare — you compare postmortem numbers to the postmortem data from years past, right?

A. No, not really, because I don't refer to Baselt. Now, of course, I have a big database in my brain of the tens of thousands of cases that I've worked on in my career.

Q. That's data from years past, isn't it?

A. That's data from years past. It's not summarized in the same way that Baselt summarized. But if you said cocaine level, 300 nanograms per milliliter, what does that mean, I could tell you. So you tell me Fentanyl, 9.2 nanograms per milliliter, what does that mean, and we would always avoid interpreting the values in a vacuum. Always look at everything else.

THE VIDEOGRAPHER: Going to need to stop.

MR. ORR: Okay.

(A brief recess was held from 3:52 to 3:55 p.m.)
BY MR. ORR:

Q. Do people develop a tolerance to Remeron?

A. To the central nervous system depressant effects, they may. You might know that if you take a medication early on, like an antidepressant medication, maybe the first day or two the person might feel sluggish, but those effects wear off.

Q. Fortunately, I've never experienced that.

Next would be Benadryl. Is there any — do people develop a tolerance for that?

A. If they take it chronically. Most people don't take Benadryl chronically.

Q. How about Valium?

A. Valium definitely, yes.

Q. And the Celexa?

A. Same as the Mirtazapine. After the first initial doses, the sleepiness will wear off.

Q. Okay. The Norcitalopram, what is that?

A. Norcitalopram.

Q. Norcitalopram.

A. That's —

Q. What's the — what's the street name for that?

A. That's a metabolite of Citalopram. It's a breakdown product of Citalopram, as is the Nordiazepam. So they're chemically related. There's a loss of a methyl group.

Q. So it doesn't suggest any other medication in the system?

A. It doesn't. But these metabolites can also be pharmacologically active. The Nordiazepam is pharmacologically active. I'm not certain about the Norcitalopram, if it's active or not.

Q. How about benzodiazepines? Does that suggest another medication?

A. In the urine that's a nonspecific test for a class of drugs called benzodiazepines. The Diazepam and the Nordiazepam would trigger a positive, as would the Clonazepam if it was present.

Q. So as far as we know sitting here today, the only drugs in his system were the Remeron, the Benadryl, the Valium, and the Celexa and the Fentanyl?

A. Five drugs, yes.

Q. And with respect to the Valium and the Benadryl, he had probably not taken one of these in the day before he died; fair?

A. Yes, but don't hold me to it.

Q. Okay. You would agree that somebody wouldn't be taking a sleep aid if they were about to kill themselves?

MR. AUCIELLO: Objection, form.

A. Actually, that's contrary. Lee Hum, who is a toxicologist in Miami Dade, did a study — never published it, I wish he did — years ago that showed that in order to get through the normal inhibitions that one would have when you're getting ready to commit suicide, you know, because, like, there are normal inhibitions to prevent you from committing suicide because it might hurt or you're afraid of the outcome or maybe you'll wake up but you'll be a gork or whatever, what they'll do is they'll take a — they'll drink some alcohol or they'll take something that's available, freely available, like Benadryl, to get through the normal inhibitions.

So in my casework and in Lee Hum's casework when he presented these data, in a large percentage of the cases where people commit suicide, especially when they commit suicide violently, like hanging themselves or shooting themselves, they do take a depressant. It gets you through that process that's, I'm sure, very scary.

Q. And since he hadn't taken the Benadryl in the approximate time frame of his death, that's probably not anything that's relevant to this case, right?

MR. AUCIELLO: Objection, form.

A. I can't say. Benadryl, in addition to being used as a sleep aid, it's also an antihistamine. So actually when it's sold as Benadryl it's sold as an antihistamine. It's sold for, say, allergy relief. It could also be sold as a sleep aid. There's others also like that.

Q. Except the people that buy it for the sleep aid, they pay more money for it, right?

A. Probably.

Q. Note that it's —

A. As a what?

Q. It's ridiculous that they charge twice as much for Nyquil or whatever as they do — you can just buy 500 Benadryl in a thing at CVS, generic, for next to nothing.

A. Yeah, for a sleep aid. I think now they sell more Doxylamine.

Q. Really?

A. Which also is like Benadryl. It is an antihistamine but it also makes you sleepy. But they do charge you more for that.

Q. You're not aware of any evidence that suggests that Adam attempted to kill himself, correct?

MR. AUCIELLO: Objection.

A. It doesn't look like it, no. There's no evidence to support that.

Q. Just some general questions. Could you please tell us exactly what a forensic toxicologist is?

A. Toxicology is the study of poisons, and forensic toxicology is the study of poisons as it's applicable to the court of law. So the work that I do, Middleburg does and others that you've met in this litigation, we practice toxicology but we're also familiar with its application to law.

Q. And what is your opinion of Dr. Middleburg?

A. He's someone who I rely on regularly for toxicological advice, so I like the man and we work together and will continue to work together.

Q. In the absence of any other — strike that.

In the absence of evidence of any other potential cause of death, have you ever rendered an opinion that a person was killed by a particular drug when the heart blood level was just slightly in the lethal range?

MR. AUCIELLO: Objection, form.

A. I hate to ask you, but can you ask me that again?

Q. Yeah.

A. And I think I know my answer, but — or maybe she can read it back.

Q. I can read it. In the absence of any other — oh, strike that.

In the absence of evidence of any other potential cause of death, have you ever rendered an opinion that a person was killed by a particular drug when the heart blood level was just slightly in the lethal range?

A. I don't know. It's possible. I talk to my doctors on a daily basis so after a while it all becomes a blur, so I can't tell you specifically, can't give you an example of one.

Q. Have you testified in any other Fentanyl death cases?

A. I have I think. In some of the US Attorney prosecutions here in the state of Florida of physicians that — some of those physicians were prescribing Duragesic, so the decedents were positive for Fentanyl.

Q. Do you think you could identify those on your list, or do you have a list there?

A. Yeah, I have a more recent list.

(Plaintiff's Exhibit-5 was marked for identification.)

Q. All the better. Let me go ahead and mark that. And if you could just circle the ones. I'm going to put this on the front. Thank you.

A. And there have been several of these cases, so after a while, again, it becomes a blur, so I can't remember exactly if this specific physician prescribed Fentanyl, but I know one or two of them did, so I'll just circle them.

Q. Okay.

A. One of them was US versus Freddie Williams. That was out of Panama City in 2004. Another was from 2006, I'm certain of this one I think, certain I think, but I'm close, Thomas Merrill, US versus Thomas Merrill. I'm looking for one other but I don't think he was prescribing Fentanyl. I can't remember his name. I'll look for one more minute.

I'm circling another, it's State of Florida versus James Graves. I don't think he was prescribing Fentanyl. I think his mixture was OxyContin and Alprazolam and Somas. I don't think he was prescribing Fentanyl, so I'll just put a question mark there. I've testified a lot, so I can't remember everything.

Q. Thank you. Have you done any other work for Alza or the makers of Fentanyl patches?

A. No. This is the first case.

Q. And what law firm hired you in this case?

THE WITNESS: What's the name of your firm?

MR. AUCIELLO: Tucker Ellis.

A. Tucker Ellis.

Q. Have you ever done any work for Tucker Ellis?

A. No.

Q. And what are you charging in this case?

A. My retainer is $1,500, includes three hours, and then I charge 300 per hour.

Q. No matter what you're doing?

A. Well, if I'm travelling to court, I'm not going to charge 300 per hour travelling to court, so I'll charge a prorated fee of $1,500 per day.

Q. Per day for travel or per day court testimony?

A. Per day total, so — are you in West Palm Beach?

MR. AUCIELLO: The trial will be in West Palm beach.

A. The trial's in West Palm Beach, so that's essentially a day for me from work, so it would be $1,500 plus travel expenses.

Q. And how many hours have you spent so far approximately?

A. All together about six hours, includes my initial review, preparation of the report, and then some preparation today before deposition.

Q. And what percentage of your income is related to working for lawyers?

MR. AUCIELLO: You mean — are you differentiating between the criminal cases or the civil cases or just lawyers in general?

Q. Just lawyers in general. Then I'll follow up with the second one.

A. Yeah. Well, I work for lawyers at the University also, but I'll break it up in a way. I have a State salary and then I have my private practice. My private practice is about 50 percent and my State salary is about 50 percent.

Q. And your private practice is entirely working for lawyers?

A. I think so, yes.

Q. And then in terms of the private practice —

A. Or actually not, not.

Q. Okay.

A. Not, because I also do some consulting for the National Football League Players Association, although I think Gene Upshaw is a lawyer. I don't consider that working for a lawyer.

Q. And that's only a small percentage of your time?

A. It's a very small percentage of my time.

Q. And in terms of the breakdown of your private practice of criminal versus civil, what's that?

A. All the criminal work that I do either for defense or for prosecution is carried through the University as a fee for service, so I actually can't give you a figure on how much that generates, but it's a significant amount of revenue in my lab, but I don't see it. When I look at my private practice, about 90 percent of my work is for the defendant and about 10 percent is for the plaintiff. And that does include medical mal, for example, for both sides.

Q. So in terms of civil cases, it's 90 percent defense?

A. Right. And most of that is insurance defense and, say, cases of vehicular homicide or injuries where there's a lawsuit and one party or the other or both are intoxicated.

Q. And why do you think it's resulted that 90 percent of the time the people calling on your services are defense attorneys?

A. Oftentimes I can't help the plaintiff. I get calls from plaintiff attorneys all the time, but my opinions are contrary to their — to their —

Q. Well, I mean, it doesn't seem like it would — it doesn't seem like it would matter. I mean, let's say, for example, it's a car accident. It seems like the defendant would be drunk or stoned just as much as the plaintiff would.

A. Well, here in Florida we do have some tort, tort — what do you call that, tort control?

MR. AUCIELLO: No fault. It's a no-fault state.

Q. Tort reform?

A. So there's some tort reform in this state, and one of the results of tort reform is we have a statute that says that if you're a plaintiff or a defendant in a case and it could be shown that you're impaired, you're at fault. So if you have a 08 blood alcohol and you're walking across the street and you get run over by a car, and even though that — even though you have the right of way, you could be at fault. So we — because of the way the tort reform has gone here in this state, there are times when I do get engaged by the plaintiff, but more often than not it's I'm hired by the insurance company to help defend the claim.

Q. And so do you think you are someone that they call on when they want to say the person is impaired or are you someone they call on when they want to say the person, no, he really wasn't that impaired?

A. I do both. For example, sometimes they say they're impaired based upon an immunoassay test done at a hospital. And I would say you can't do that because that's a presumptive positive test in a urine and you can't correlate what's in the urine to what's in the brain, in the blood. And so those are a good number of my plaintiff cases where there's been an accusation, well, it says your client is impaired by marijuana because his urine tested positive for pot at the hospital. You can't do that.

Q. So you tend to be on the side of the person that's wanting to say, that test doesn't really mean that I was impaired?

A. Sometimes.

Q. I mean, would you say that that's —

A. No.

Q. — mostly the side?

A. No, no, no, no. Most of the time it's I'm working for insurance defense where the plaintiff is involved in a crash and killed and the plaintiff is drunk but they're suing because — they're suing Ford or they're suing Goodyear or the tire company because the tire is defective. But what I'll say is your client was impaired, so when there was a blowout, your — because of their impaired cognition, their impaired motor function, they couldn't apply the brake properly or control the vehicle like one would do when they're sober, things like that.

That's not the only types of cases I do. I also do some product liability. I've done quite a bit of work in the defense of the Ephedra claims.

Q. Can you give me an example of a case where a lawyer called you because the lawyer thinks he's going — you're going to tend to be on the side of, yeah, that person was really impaired?

MR. AUCIELLO: Objection, form.

A. Well, it happens all the time when you have — I've had cases where someone leaves a bar and walks across the street and gets run over. The family of that decedent is likely to sue the driver of the vehicle, but here in the state of Florida with our tort reform, we don't really care that — if we can prove to the court that they were impaired at the time that they got run over and killed, then they're more than 50 percent responsible for the actions and there's no — there's no money in that.

I was — just kind of incidentally, I mean, a long time ago I think Ernie had contacted me on a Fentanyl matter and I got myself kind of eliminated because I was — I wasn't really working with the attorney, but I had been consulted on a case out of California. It was a Fentanyl case.

And in that case I believe — you probably know better than I do. I think he had access to a defective lot of Fentanyl, but his Fentanyl concentration in the postmortem blood was humongous. And I told the guy that I didn't think the patch was applied properly. It looked to me that the patch was being abused. So my opinions were adverse to the plaintiff and he never followed through, never hired me, but I got myself conflicted with Tucker Ellis. And that occurred a few years ago. I just tell the truth, that's all.

Q. Would you agree that if someone has a 75-microgram patch and they're using it properly, and if it's — if it produces an accurate level of five in the blood postmortem, taking into account postmortem redistribution, if you could be all knowing and know exactly what the correct figure is, then you would agree, wouldn't you, that the patch wouldn't be operating correctly, right?

MR. AUCIELLO: Objection, form.

A. So you're telling me that the postmortem was a five and the antemortem was a five?

Q. Right.

A. Then either the patch wasn't operating properly, it was misapplied, the fellow was bathing in a hot tub or jacuzzi or there was an application of a heating pad, something is not correct, or even they injected the contents or applied two fives — or two 50s instead of one.

Q. So if the — if the concentration found in the blood is accurate and everybody agrees on that, you do believe that that is strong evidence of whether either the patch was performing correctly or whether it was being abused in some way; fair?

MR. AUCIELLO: Objection. Objection, form.

A. If it's an accurate antemortem measure and you have a five, that's not consistent with the clinical trial data. But you have to wonder how you got to the five.

Q. Are you aware of any cases of the Duragesic patches administering more Fentanyl than they were designed to administer?

A. To the best of my knowledge, none of my cases analyzed here in this state were associated with that claim. The only case I had some involvement with was the case from California that I mentioned before, but I wasn't involved because I thought the concentration was too high to be consistent with a defective patch.

Q. So in all the cases of Fentanyl-related death that you're aware of, it — they all had to do with abuse of the patch?

A. Abuse or misuse. Remember, there's a difference there between abuse and misuse.

Q. And there was something to where you were able to identify a misuse or an abuse?

A. That's correct.

Q. Like putting it in their coffee or drawing it out with a syringe and injecting it, something like that?

A. Yeah. We even had a recent case where they put it in their rectum.

Q. Nice. You would agree, wouldn't you, that, let's say, in the last ten years thousands of people have died from Fentanyl overdoses related to the Duragesic patch?

MR. AUCIELLO: Objection, form.

A. I can't quantify the exact number, but in the state of Florida we see between 100 and 200 Fentanyl-related deaths per year. Unfortunately, we don't have the funds to go and investigate every one of those cases to determine whether it's a misuse or an abuse situation. And in some of these cases it's an intentional misuse to commit suicide, for example.

Q. So if Florida alone has 100 to 200 per year, then it's a virtual certainty that there have been thousands in the last ten years; fair?

MR. AUCIELLO: Objection, form.

A. Well, I don't like to say thousands because that could mean 2,000 or it could be hundreds of thousands. I don't know how many there. You could check with the CDC to see how many have been reported. But in Florida we run between 100 and 200 per year in the past five years.

Q. And so it would be fair to probably take the population of Florida and now let's see what the population of Texas is, and you're probably going to have similar numbers per capita?

A. Maybe. That's a little bit of a stretch because of demographic differences.

Q. So there's been over 1,000 in just Florida in the last ten years, right?

MR. AUCIELLO: Objection, form.

A. Yes. Yes, there have, I think.

Q. And so it's clearly safe to say that in the last ten years there have been more than 20,000 Fentanyl-related deaths in the United States —

MR. AUCIELLO: Objection, form.

Q. — related to the patch.

A. Yeah. I don't know. I can't give you a number.

Q. Well, if it's 1,000 in Florida in the last — if it's more than 1,000 in Florida over the last ten years and there's 52 states, 51 states — 51, right?

MR. ANGWIN: 50.

A. 50 plus Puerto Rico.

Q. 50, yeah, there's 50 states — well, how about this.

A. Well —

Q. We can clearly say there have been more than 10,000 Fentanyl deaths in the last ten years related to the Duragesic patch.

MR. AUCIELLO: Objection, form.

A. Possibly.

Q. Probably?

MR. AUCIELLO: Objection, form.

A. Probably. I don't know. I've lobbied for better tracking of drug mortality data nationwide, but there's no money for it. It's very expensive. And oftentimes you can't actually determine if it's a misuse or an accidental use or purposeful misuse of a product; very hard.

Q. Well, how are you able to even determine the Fentanyl-related deaths if postmortem redistribution invalidates all the numbers?

A. Because the medical examiner, with his or her knowledge, toxicological knowledge and pathology and all the data that comes in from the medical legal death investigators, they sum up the case. And if you read the death certificate, it doesn't say the cause of death. It says — doesn't it say probable cause of death, if I'm not mistaken? Do you have a death certificate?

Actually, you probably don't have one from Florida. You know, it's confidential. Pieces of it get redacted, so you might not actually have his. But it's the most probable, the most likely cause and manner of death, and it's — it can change.

Q. Which is the standard we're dealing with in this case, right?

MR. AUCIELLO: Objection, form.

A. Probable.

Q. And in your study at University of Florida you relied upon the postmortem samples, just like the Broward County Medical Examiner's office did in this case, right?

A. We do, yes.

Q. You know, when I first started reviewing this case I, you know, I was looking at the Fentanyl and I was thinking the Fentanyl is really the big elephant in the room. Do you think that's a fair characterization?

MR. AUCIELLO: Objection, form.

A. Well, I said before, the agent or drug of most prominence in the case would be Fentanyl.

Q. It's fair to say, isn't it, that the makers of the Duragesic patch are well aware that people using the patch are most often on other medications as well, right?

MR. AUCIELLO: Objection, form.

A. I don't know what the manufacturers are aware of.

Q. They should be aware of that, right?

MR. AUCIELLO: Objection, form.

A. Yes. I think the new package insert addresses that to some degree, if I'm not mistaken.

Q. And would you say that —

(Document tendered to the witness.)

THE WITNESS: Does it say most probable, if you can read it?

MR. AUCIELLO: Referring to the death certificate now.

THE WITNESS: Under Manner of Death it says probable. Under Cause of Death it says immediate cause and then there's other lines. So under — only under manner does it say probable.
BY MR. ORR:

Q. And the Broward County Medical — well, who is it that certifies this?

A. The medical doctor or pathologist. That would be Dr. Perper.

Q. Okay. And he's with the Broward County Medical Examiner's office, right?

A. Yes.

Q. And he's the — he's the head over there, right?

A. He's the chief.

Q. And he didn't mention the Benadryl as a factor, right?

A. He didn't.

Q. And he lists the Celexa and the Remeron and the Fentanyl, but he doesn't list them in the order of importance, does he?

A. You'll have to ask him, because I do have one doctor who I used to work with who would list them in order of importance. So she would have said — she probably would have started with Fentanyl and then moved her way down, but she would have included all the drugs, all the central nervous system depressant drugs.

Q. But that's probably not what happened here since the first one listed was the one that had the least amount, right?

MR. AUCIELLO: Objection, speculation.

A. I don't know. You'd have to ask Perper. There doesn't — there doesn't seem to be a rhyme or reason there. I was thinking maybe it's alphabetical, but it's not alphabetical either.

Q. Maybe he likes to put the big elephant last.

MR. AUCIELLO: Objection, form.

A. You'll have to ask him.

Q. If you take the Fentanyl out, would you have expected Adam to be able to go to school with the levels of those other medications he had?

A. Possibly.

MR. AUCIELLO: Objection, foundation.

THE WITNESS: Here's the answer to that question. It's how they're listed on that report. It goes Citalopram, then Mirtazapine, then Fentanyl.

Q. It's just the order that they're listed on the toxicology report?

A. I think that's the answer, yes.

Q. But it's fair to say, isn't it, that if you take away the Fentanyl, Adam probably could have gone to school and functioned no problem on these other levels of the medications found?

MR. AUCIELLO: Objection, foundation.

Q. Probably?

A. Probably.

Q. Okay. The Martin, Woodall and McClellan study, is that one of the ones you brought?

A. I don't recognize those names, but I might have it. No, I don't have those, or that one.

Q. Do you agree that incomplete distribution of a drug can produce a difference in the peripheral and heart blood concentration?

A. Yes. That's typically associated with an acute overdose, especially when the drug is taken orally.

Q. So that's what we were talking about earlier where if, say, you had a leak of the Duragesic medication out and there was a spike in the Fentanyl level, you could have this incomplete distribution, right?

MR. AUCIELLO: Objection, foundation.

A. I don't know if that's the case. I think that's more likely associated with the oral ingestion of a drug, whether —

Q. The coffee drinker?

A. The what?

Q. The coffee drinker?

A. Coffee drinker?

Q. The guy that put it in the coffee.

A. Oh, possibly, or an overdose of an antidepressant where there would be incomplete distribution of a drug. When it's administered on the surface of the skin, it has to pass through the layers of the skin and into the tissue to be absorbed. I don't know if that is the case with Fentanyl. I'm not convinced that it would be, but it could be.

Q. Do you agree that interpretations of postmortem drug concentrations should be made within the context of the overall death investigation where acquired tolerance, medical history, and pathological findings are all critical issues to be considered in determining the cause of death?

A. Yes. I said that before, although I don't think Dr. Perper went to that degree. He missed the — the heating pad in the picture. I think a lot of people missed it.

Q. Are you aware of any evidence that Adam was — well, strike that.

Where was Adam's patch on him?

A. It was on a shoulder. I don't know if it was the right or left shoulder. It was underneath the shirt, so there actually is no photograph of the patch. It's unfortunate.

Q. Well, they drew a diagram of his body and showed where it was, right?

A. I'd like to see a photograph of it.

Q. Are you aware of any evidence that Adam used a heating pad on his shoulder where the patch was?

MR. AUCIELLO: Objection. Other than the — what he already said?

A. There's a heating pad in the bed. I'm a former chronic back patient, and my physicians recommended the use of a heating pad when I was in bed, and it worked. And be it on your back or your shoulder, your bed gets really hot, if you've ever used a heating pad before. You put it — I mean, he had lots of blankets there and stuff. So you put it in the bed with yourself. It's like having sweats it so hot.

Q. But Adam had not gone to bed that night.

MR. AUCIELLO: Objection, no foundation.

A. But that doesn't matter. He could have been in the bed earlier that day relaxing, getting some relief from his pain with his pad, gotten up. And, you know, the way the Fentanyl is released from the patch, it's not an immediate release. It's a slow release. So there could have been some expedited release of the drug from the patch into the tissue and then he became sleepy and unconscious later.

Q. And do you think that — you've mentioned that the picture of the heating pad might be some evidence that he did that, right?

A. It's very — I think it's very important evidence that is contrary to the use, the proper use of a patch.

Q. And the other piece of important evidence would be the 9.4 Fentanyl finding, right?

A. That's correct. I mean, one could think that the improper use of a heating pad applied to a patch is why he has an elevated Fentanyl level.

I had a fellow, two fellows sharing a patch in a hot tub. One guy fell asleep and woke up later. The other guy was dead in the hot tub. And they were applying the patch with some duct tape. And that's also contrary to the proper use of a patch. Well, of course, they were sharing the patch and there was — that wasn't legal. But the heat does expedite the release of the drug.

Q. Did Adam have any problems with his shoulder?

A. Not that I'm aware of.

Q. His problem was his hip, right?

A. Yes.

MR. AUCIELLO: Objection.

A. But when I had my back pain my hips hurt, my back hurt, my body hurt.

Q. Are you aware of any medical records where he complained of the shoulder where he had the patch?

A. No, I didn't — no.

Q. So there wouldn't have been any reason for him to put a heating pad there, would there?

MR. AUCIELLO: Objection, foundation.

A. No, and I — probably didn't put it there, but like I said before, if you put a heating pad in your bed with your blankets, it gets awful hot awful quick.

Q. Have you been interviewed by the media at any point in the last couple years?

A. Yes.

Q. What did that have to do with?

A. Well, I do a lot of media work. It's part of —

Q. Can I catch you on the O'Reilly Factor?

A. No. You can catch me on Lou Dobbs.

Q. Okay.

A. You can catch me on Mary Grace. You can catch me on CNN. Last week I testified at the Floyd Landis hearing for Floyd. So you can Google my name and you can check and see what I had to say.

Q. So that was another situation where you were saying, no, he didn't really have that in his system, right?

A. Oh, absolutely. The work done by the French laboratory is horrendous.

MR. AUCIELLO: You're not violating any confidentiality by talking about it, are you? I don't know anything about it. I don't —

MR. ORR: I think it was a public hearing.

MR. AUCIELLO: Okay.

THE WITNESS: It was a public hearing, although I'm kind of glad you reminded me because I was told by the arbitrators not to talk about this to the press. I know this is not the press. But I've talked to my friends and colleagues about it, so assuming you're not going to run this tape on the 6:00 news, we're okay.

Q. I won't do that.

A. But basically I was there to critique the — some of the data from the — what's called LNDD, it's the French laboratory. And it really was a mess and did not meet the international standards of practice in the field of toxicology.

Q. So in that situation you're on the side of Floyd is innocent, right?

A. Yes. Well, yeah, he's innocent of doping.

Q. And what else have you been interviewed regarding in the last couple years?

A. I've done quite a bit of work with caffeine in our diet, including tea — well, not teas right now at the moment, but coffees, beverages and decaf. And the decaf story was the top three story out of the University of Florida in its history.

Q. What's the decaf situation?

A. There's caffeine in decaf.

Q. Right.

A. Now, I mean, that's kind of common knowledge, but it was part of an educational piece that we did and got picked up by everybody.

Q. What percentage of a normal cup?

A. It's, depending on what a normal cup is, about ten percent. Some of the Starbucks cups contain upwards of five and 600 milligrams of caffeine, which is huge. So Starbucks decaf only contains maybe between 15 and 20 milligrams.

Q. What else have you been interviewed on?

A. Where's my CV? The Anna Nicole/Daniel Smith matter.

Q. And what was your opinion in that matter?

A. Well, I was just asked to comment on the toxicology report of Anna Nicole and then also discuss the role of methadone with Daniel, because Daniel died of a methadone overdose.

Q. And so in that situation were you supportive of Dr. Perper's opinion?

A. I was, yeah. I wasn't critical of Dr. Perper at all.

Q. And the cause of death in that situation was what?

A. She died of — well, her death was a mixed drug intoxication but the primary drug was chlorohydrate, I believe.

Q. Which is — what's the street name for that?

A. There's no street name. It's a — it's the traditional or typical Mickey Finn drug. It kind of caught everybody off guard because you wouldn't expect to see that drug. I haven't seen a case for years. I reported on a case about 20 years ago. I haven't seen one.

Q. So just like that was the primary drug in that case, the primary drug in this case is the Fentanyl, fair?

A. I said that already.

MR. AUCIELLO: Objection.

Q. And the samples that were taken in that Anna Nicole situation, did they get any peripheral draws?

A. I don't remember. The autopsy report is on the Web someplace, but it's been a while.

Q. So if it was just heart blood, you didn't feel like you needed to throw out the numbers because of that; fair?

MR. AUCIELLO: Objection.

A. It was clear that's what she died from. The concentration — although some people were questioning whether the concentration was toxic or not, in my opinion it was toxic. It was the cause of death. But there were some other drugs, too. It's been a while. I can't remember exactly what all drugs were there.

Q. So you felt like it was the cause of death even though there were some other drugs in there as well?

A. Well, the cause of death I believe, but I don't have complete and accurate recollection of it, was combined drug intoxication, but the — I think it was chlorohydrate was the primary, primary drug.

Q. It was the elephant?

A. Yeah.

Q. You were going to — oh, you have these listed in your resume?

A. Well, to some degree.

Q. Ever been interviewed regarding Fentanyl?

A. No, don't think so.

Let's see. I've appeared on 48 Hours a few times on some investigations that I've assisted with, kind of historical investigations. With Daniel Smith I was on CNN and then MSNBC. With Anna Nicole I was on Fox News and Court TV. With my decaf coffee story I was on the Today Show. I was featured on Court TV a couple years ago.

Q. What was that having to do with?

A. We had a local trial here in Gainesville, a woman who was impaired by marijuana and she was prosecuted for that. She killed a few people in a crash.

Q. And what was your opinion in that matter?

A. That she was impaired by marijuana.

Q. And I guess there's a big debate about whether marijuana really affects your driving; is that right?

A. Well, I'm not sure there's a debate anymore. It definitely does.

I mean, there's others here. You can see them on my resume. I'm not sure I need to go through them all.

Q. Okay. Let's look at the literature you brought.

A. This is — this is a recent report from the International Journal of Legal Medicine. It's from 2007. I don't have a date of publication, but it has a table. And I'll leave these with the court reporter for her to make copies if you'd like. But it shows a Fentanyl femoral blood level of 5.6, in the heart of 19.

Q. In one case?

A. This is in one case, yes. This is involving a child.

MR. AUCIELLO: Can you read off the name of it so the record —

MR. ORR: I'm going to mark it.

MR. AUCIELLO: Okay. If you're going to mark it, yeah.

MR. ORR: Yeah. What number are we on?

THE COURT REPORTER: That will be 6.

MR. ORR: Better memory than me.

(Plaintiff's Exhibit-6 was marked for identification.)
BY MR. ORR:

Q. And Exhibit Number 6, do you agree that this is a reliable article?

A. I just relied on it, so yes.

Q. Okay.

A. This is a to-be-published article, it's in press, in Forensic Science International. And it shows Fentanyl concentrations in postmortem blood specimens and it compares the right and left subclavian, the right and left femoral, and the right and left ventricular blood, so that would be heart blood. And it shows that there are differences between those.

Of course, femoral is the gold standard, most ideal specimen from a postmortem. Subclavian would be a good backup peripheral sample, and then the ventricular blood is the heart blood we've been talking about today.

Q. And how many cases was this looking at?

A. This is — this would be one case obviously.

Q. Just one person, one deceased?

A. Yes.

Q. Don't you think the fair thing to do would be to take this case that's Exhibit Number 6, take this case that I'm now marking as Exhibit Number 7, then go back, say, ten years and look at all the literature and take all the cases where they've compared the heart blood and the peripheral, take them all, you know, maybe throw out the, you know, one or two extremes on the ends, come up with an average and use that? Wouldn't that be fair?

MR. AUCIELLO: Objection.

A. You can't do that. Again, just like you read a quote from someone's paper, that you examine it in its totality. These data just support the principle of postmortem drug redistribution, but in one case of the child we had three to four times redistribution, but in this case looked like we had about two times redistribution. In this report from the American Journal of Forensic Medicine and Pathology, this one is from 2004 so you might have a copy of this. They have four cases, but in the last case they do show the difference between aortic blood, which is next to the heart, and femoral blood. And there's about one in — 1.8 distribution there.

Q. A level of 4.5 — strike that. A level of 4.5 pre death could have killed Mr. Hendelson, correct?

A. Maybe. One thing we haven't addressed, but I indirectly addressed it before, is the degree at which the laboratory can quantify accurately the level of Fentanyl in the blood. In the field of forensic toxicology we typically accept 20 percent. So if Mr. Wagner was high by 20 percent, then we could drop 1.8 from the — from the 9.4.

Q. We could add 1.8, too?

A. Yes. So keep that in mind, too.

MR. AUCIELLO: That last article you referenced was not marked as an exhibit.

THE WITNESS: It's not.

MR. ORR: Oh, okay.

(Plaintiff's Exhibit-7 was marked for identification.)

Q. Exhibit Number 7 is a reliable article in your opinion, right?

A. Yes.

(Plaintiff's Exhibit-8 was marked for identification.)

Q. And same for Exhibit Number 8?

A. Yes. I actually trained Dr. Winecker, so she's a reliable person.

Q. Okay. So is Dr. Middleburg, right?

A. Yes.

Q. The — is Dr. Middleburg one of the most authoritative people in toxicology in the country?

MR. AUCIELLO: Objection, form.

A. I'm not going to use the term authoritative. I don't think he would want you to use authoritative either, if you know Dr. Middleburg at all.

Q. Let me substitute. Do you agree that Dr. Middleburg is one of the most well-respected toxicologists in the country?

A. I'd say he's a respected toxicologist.

Q. What's the name of his lab?

A. National Medical Services. They just changed the name to NMS Labs, I think.

Q. And where is it located?

A. Willow Grove, Pennsylvania.

Q. And do toxicology labs from all over the country send stuff to Dr. Middleburg's lab that are above their capabilities?

A. Yes, including my lab. But that doesn't include Fentanyl. We can measure Fentanyl here.

Q. Could a postmortem peripheral Fentanyl level of 4.5 have killed Adam?

MR. AUCIELLO: Objection to form.

A. Yes, possibly.

Q. Okay. Let me see the rest here.

A. That's the Anderson/Muto article which I know you're familiar with.

(Plaintiff's Exhibit-9 was marked for identification.)

Q. And do you consider it to be a reliable article?

A. Yes. It was the first article to describe postmortem drug redistribution with Fentanyl.

Q. And it has a range of what?

A. I think that's where Dr. Baselt got his range. I don't remember exactly what the range was.

Q. Okay.

A. And I believe you're familiar with this article, too, from the Journal of Forensic Sciences, November of 2004.

(Plaintiffs Exhibit-10 was marked for identification.)

Q. And I've marked that as Exhibit Number 10; is that correct?

A. Yes.

Q. And this is a reliable article?

A. Yes.

Q. Okay.

A. And —

Q. What does it say that's important?

A. It just illustrates a few cases and their Fentanyl concentrations.

Q. Does it deal with postmortem redistribution?

A. I don't think that one did. I don't think so.

Q. Thank you. Okay. The next one?

A. This is a follow-up article from Dan Anderson's article from the same journal published by Kuhlman, et al, K-U-H-L-M-A-N.

(Plaintiff's Exhibit-11 was marked for identification.)

Q. And I've marked that as Exhibit Number 11. Is that a reliable article?

A. Yes.

Q. Does this deal with postmortem redistribution?

A. I think it does. In the discussion it does for sure. And it refers to Anderson's article and discusses and compares their findings to Anderson's Findings.

Q. What were the findings of this particular study marked as Exhibit Number 11 with respect to postmortem redistribution?

A. I don't know if they specify the sources in this one, but we can — I can check for you.

Q. Do you know —

A. Doesn't look like they have sources in this one.

Q. I mean, did this study look at deceased people and have draws from peripheral and heart and compare the two?

A. No. No, that it doesn't.

Q. Okay.

A. This is a very old article, probably don't really need it, I just printed it out because it came up on my search. It doesn't have sources in it.

Q. Is it a reliable article? I

A. Not as reliable as the article from Dan Anderson.

(Plaintiffs Exhibit-12 was marked for identification.)

Q. Okay. I've got one I want to ask you about. It's this one right here. Are you familiar with that article?

(Document tendered.)

A. When I did my PubMed search it didn't come up. I'm familiar with the journal. I'm the editor of the journal, but this is from a special issue, I believe, so I wouldn't have seen it initially. I'm just checking to see if they had sources specified.

It says — well, you underlined it for me or Dr. Middleburg did, quantitation of Fentanyl performed in a blood sample collected from an intact vessel. So that could be classic peripheral, like a femoral, or it could be from IDC, which is not femoral — not peripheral.

So what do you want me to say?

MR. AUCIELLO: I don't think there's a question.

Q. Here, let me take a look at it.

A. Okay. I'll read it later.

MR. ORR: We're at 13 I think.

THE WITNESS: I'm putting them in order, I think.

MR. ORR: 13.

(Plaintiffs Exhibit-13 was marked for identification.)
BY MR. ORR:

Q. So until you read it, you don't know whether this is a reliable — you don't know whether this is a reliable article or not?

A. I don't. It's published in a journal that I edit, so —

Q. Probably is?

A. I mean, I'd say it's as reliable as any of the others, even though that doesn't indicate the source. It's still useful information. It's especially — do they have case histories with these? In table 3 they do have some sources. Look in the column, they show some Fentanyl concentrations in peripheral heart, unspecified, femoral, I'm just not familiar with that paper, so —

Q. Okay. You might look on Page 608 down on the bottom left.

A. I've got it.

Q. There were four cases where they had a peripheral and a heart draw on the same deceased to compare, correct?

A. Yes.

Q. And they found that the range of postmortem redistribution was 1.11 to 1.14, right?

A. I see that. They do go on to comment and refer to Dan Anderson's paper where they say “by comparison,” and they report the range that Dan reported, which was .7 to 4.58.

Q. Because we're dealing with four subjects here, this would be more reliable than, say, one of the articles that just had one?

MR. AUCIELLO: Objection.

A. No, I wouldn't say that. I would want to look at each one of those cases. And perhaps the postmortem interval on these four cases was only two or three hours and the PMI on the case where it was three or four was 20, 24 hours. I can't say.

Q. And so, for example, if somebody came up with a postmortem redistribution rate of three but yet there was two days between the death and the draw, then you would have to take that into consideration, right?

A. Yes. Again, take all facts under consideration.

Q. So because those types of things impact the postmortem redistribution, why wouldn't you want to take all of the data we have and average it?

MR. AUCIELLO: Objection, asked and answered.

Q. Or take the mean?

A. Because there is so much variability that the standard deviation would be so large that doing that exercise would result in an erroneous assumption.

Q. The period between death and draw of the sample here, fairly customary?

A. Well, we don't know exactly what time he died, but I'd say it's typical. He wasn't found until the early morning hours, if I'm not mistaken, but he was probably dead for a while.

Q. Okay. I'm almost done.

A. Good.

Q. On the Remeron, people have taken in the past a whole, whole lot of Remeron and not passed away; is that right?

A. They have.

Q. I mean, people have taken 20, 25, 30 times the recommended dosage and not passed away; fair?

A. I'll take your word for it.

Q. That wouldn't surprise you, would it?

A. No.

Q. And why is that?

A. It's a relatively safe medication when taken alone.

Q. It doesn't have a big effect in terms of respiratory depression; fair?

A. When taken alone. Actually, it's central nervous system depression, which includes respiratory depression.

Q. It doesn't have a big impact in that area?

A. Not as much as a synthetic opioid drug.

Q. Have you ever authored or coauthored any articles or book chapters with respect to the interpretation of postmortem findings?

A. There's a paper — I've written some review chapters on opioids, but the — but never did it really address the interpretation of the findings. But there is a paper that was published in the British Medical Journal about two or three years ago. You can download it from the Web.

Q. Where would I download that from?

A. I'll tell you what citation it is.

Q. Okay.

A. And it's on the public side their website, so you can — you can get it for free. It's Citation Number 50 on Page 20. It's called Forensic Science In The Dock. It was published in the British Medical Journal. It was an editorial that was written by a number of my colleagues, including Olaf Drummer, who was, along with Graham Jones, the first to report postmortem redistribution, Dr. Forrest and Dr. Karch. Do you see that, Number 50, 5-0?

Q. I'm looking somewhere else.

A. Oh, okay.

Q. But I will find it.

A. Okay.

Q. Any others?

A. Not that address your question, no.

That would be it. Like I said, I've written some review articles on opioids but not a — not one that addresses the interpretation of those in a postmortem setting.

Q. Are you familiar with this editorial?

(Document tendered.)

A. That's it.

MR. ORR: That's it.

(Plaintiff's Exhibit-14 was marked for identification.)

Q. Have I marked that as Exhibit Number 14?

A. Yes.

Q. Are those your words?

A. It's my editorial, along with my colleagues.

Q. Okay. But you're in agreement with all those words?

A. Yeah, we weren't happy with the phrase right underneath the title. That was an editorial comment that they added.

Q. What's that?

A. Well, the title of the article is called Forensic Science In The Dock, and then someone put in there, unknowing to us until it was published, which was “postmortem measurements of drug concentration in blood have little meaning.” That's not true.

Q. Okay.

A. They do have importance, like we've talked about today.

Q. You just have to look at the whole picture?

A. Right. And that was the basis for this editorial.

MR. ANGWIN: Can we take, like, two minutes, then we'll be through.

(A brief recess was held from 4:57 to 5:03 p.m.)
BY MR. ORR:

Q. If you look at the data in the literature on postmortem redistribution, actually look at each case, do you believe that we would find that the high levels of postmortem redistribution are almost always associated with really, really high Fentanyl levels in the whole blood —

MR. AUCIELLO: Objection.

Q. — or in the heart blood?

A. Not necessarily.

Q. I mean —

A. So you're saying that a large percentage of the cases where there is redistribution three or fourfold, that it's because the concentrations are high?

Q. Right. What I'm saying is typically if you look at the data and you'll find somebody has a ten in the blood, typically they have a pretty similar number in the peripheral draw, but if they have a 45 in the heart, then a lot of times they'll only have, like, a 15 or a 20 in the peripheral. In other words, the — for the really, really high numbers found in the heart, there tended to be larger premorbid distribution factors.

MR. AUCIELLO: Objection, form.

A. Yeah, I think those data are biased because those people are dying. But you don't have that many people that die at the low levels perhaps, so you might not have the opportunity to look at that many that are at the threes and the fours that, when they redistribute, you'll have a nine or ten or 11. That may be what's going on. I don't know.

Q. I don't really — can you explain that point for me better? I don't understand that.

A. Well, the higher the Fentanyl concentration in the blood, the more likely there's going to be a death. So in these articles that we have there are lots of examples of 10s and 15s and 20s and 30s, but there's not that many at the low end because those people don't die, I think is what you're saying.

Q. Well, I mean, there's a bunch of them in, you know, the eight and in the nine and the ten. The three in your study were all right around ten, right?

A. Right.

Q. I mean, there's a bunch that die at those levels, right?

A. Right. But I see Fentanyl levels in my cases that are ones and twos and threes, probably half of my Fentanyl cases where the levels are low, in the therapeutic, so-called therapeutic range.

Q. But the person still died from it?

MR. AUCIELLO: Objection.

A. Well, they may die due to natural causes or they may be dying due to a combination of the Fentanyl plus alcohol plus other narcotics. Every case — you see a lot of it, so every case is a little different.

Q. Well, but these were all studies of people that have passed away, so all of them were — if we're looking at this data, the data we're looking at is all people that passed away?

A. Right. In some cases there's Fentanyl only, in other cases there's Fentanyl plus alcohol and drugs, there's Fentanyl plus drugs. Every case is a little bit different.

Q. That doesn't affect the postmorbid redistribution, does it?

A. No, no, no, but you said there's a lot of examples where the Fentanyl levels are high. I think that's because when they reach those levels there is a death, whereas when you have in my laboratory lots of Fentanyls that are in the expected range, they're dead but they may not be dead because of Fentanyl. They may be dead because of natural disease or some other cause.

Q. Okay. So if it reaches a really high level, they die, but what I'm saying is when that — if you look at the — say you've got five subjects here and you've got five subjects here. These five here all had a blood level of, say, ten. And then you look at the peripheral. You have a peripheral draw also. Typically you would see around a ten, whereas these five subjects are all, say, in the 30s in the Fentanyl, and then you look at the Fentanyl — you look at the peripheral draw and there would be much less, you know, 15 or what have you. So there was a lot more of a postmorbid redistribution associated with the higher numbers.

MR. AUCIELLO: Objection, form.

A. I don't know if that's the case or not.

Q. Wouldn't that be important? I mean, don't you have to analyze —

A. It's not that predictable, though.

Q. Well, maybe it is if you look at the data.

MR. AUCIELLO: Objection, argumentative.

A. Well, here's a five. I mean, here's a 5.6 in the femoral and a 19 in the heart, so that's contrary to what you just told me. Here's an example.

Q. And so if somebody injects a ton of Fentanyl and they die soon thereafter, obviously, and then the postmorbid draws are taken from both the heart and the peripheral, would you expect to see more postmorbid redistribution there or less?

MR. AUCIELLO: Objection, form.

A. Well, depends on the degree at which the drug has been allowed to distribute in the tissues of the body and whether the individual had been using the drug in the past or not. So I could think of a scenario where there would be redistribution out of the tissue if the individual had been using the drug before, but if the individual hadn't been using the drug before and it's just a single hot shot of drug and death, the redistribution would be different. The profile would look different.

Q. And so there you would expect to have a high level in the heart and a low level in the peripheral or a high level in the peripheral and a low level in the heart?

A. Either one I think. I mean, even in Anderson's paper, which we rely on, we have a case that the heart is 22 and the femoral is 19. So you can't make the assumption that simply because we have a 9.4, that it was above a three at the time he died.

Q. Well, since Adam did die, wouldn't it be reasonable to conclude that the postmortem redistribution was more like that 19 you have there?

MR. AUCIELLO: Objection, form.

A. Which 19?

Q. You said I think —

A. Oh, that example?

Q. Yeah.

A. No, I don't know. I have no idea.

Q. In terms of the —

A. And this — never mind.

Q. Now, you said you testified in the Graves matter. What did that have to do with?

A. Dr. Graves was a physician who was selling prescriptions. I don't think he was the one who — I don't think he was prescribing Duragesic.

Q. But there were a lot of deaths you analyzed related to morphine in that situation, right?

A. I think it was — he was prescribing OxyContin and Xanax and Somas and Lortabs. There were a lot of deaths associated with that physician.

Q. And what were you doing related to that whole investigation?

A. I was running the toxicology on the decedents, and then I was called in by the US Attorney's office to talk to the jury about what I did and how this wasn't a standard of- typical standard of care.

Q. And so you came in and testified that this doctor killed these people by giving them this medication, right?

A. Essentially.

Q. And did you ever rely upon whole blood to testify that the doctor killed anyone?

A. Yes.

Q. And did you ever rely upon whole blood when the whole blood was only two or three times the therapeutic level?

A. I'm certain I did. In these cases there were — there was a Graves cocktail, and in this cocktail involved Oxy and Soma. It's been a while now. I can't remember exactly what the cocktail was, but his patients were getting this cocktail, so they weren't dying from Oxycodone alone. It was a mixture of these drugs. These were clear overdoses.

Q. And were any of those out of Broward County?

A. No. Graves was in the Panhandle, so they weren't in Broward County. There was — there was a physician down in Broward County that got prosecuted at about the same time as Dr. Graves. I wasn't involved in that prosecution.

Q. Are you ever involved in any work that involves toxicology coming out of the Broward County Medical Examiner's office?

A. Only as a consultant like in this case. And I know Dr. Wagner and I know Dr. — Schulman?

Q. Schuler.

MR. AUCIELLO: Schuler.

THE WITNESS: Schuler.

Q. You consider it to be a reliable lab, don't you?

A. Well, I'd like to see everything with this data package. I'm a little discouraged with them placing the zero zero point on their calibration curve. But in my experience, though, they've been very reliable. Sometimes I think they treat their cases to an excess, like Anna Nicole, for example.

Q. In terms of the scene photos, you don't know whether those photos accurately represent the scene before anyone disturbed it or moved any bottles around or anything, do you?

A. No, but you could talk to his roommate, I'm sure, to find out if he moved the bottles around.

Q. Did you read any of the depositions of the police officers or his roommate?

A. I don't think I have the one of his roommate, but there's a statement or two from the police officer in the ME file, if I'm not mistaken, so it describes the investigation of the scene.

MR. ORR: Okay.

MR. ANGWIN: Ernie, can I ask five questions on this, I mean, instead of me whispering back and forth?

MR. AUCIELLO: Yeah.

MR. ANGWIN: Is that okay?

MR. ORR: Yes.
DIRECT EXAMINATION
BY-MR.ANGWIN:

Q. Exhibit 6, can you tell us what that study was about?

A. If I can have it back.

Q. Sure.

(Document tendered.)

A. This was a case of a young girl who ate a patch and died.

Q. Was that a one-year-old baby that accidentally ingested a patch?

A. It's not a baby, but it's a one year old.

Q. It's a one-year-old child. And was that patch being used by the one year old? Was she the one prescribed the patch?

A. Of course not.

Q. So she was opiate naive?

A. Yes.

Q. With ingestion of the patch, with the contents being in the stomach, wouldn't you expect a large amount of Fentanyl to be diffused from the stomach lining to the other — to the other organ areas?

A. Possibly, yes.

Q. And wouldn't that account for the large variation there between the heart draw and the femoral draw?

A. Maybe.

Q. Maybe or probably?

A. I don't know. That's the problem with redistribution. There's no standard, predictable answer, no right answer. That's the answer. There's no right answer.

Q. Well, let me ask you three things about that. One; would that have been an acute death?

A. This would be an acute death.

Q. And in acute deaths isn't it more likely there is going to be more pronounced differences between — more site dependent differences in the Fentanyl levels?

A. There can be if it's oral. See, if it's an intervenous injection, then you have to think about whether the drug had a chance to distribute through the body.

Q. What about in this case?

A. This was oral.

Q. So it's oral, it's an opiate-naive person, and there's oral ingestion of the patch to allow for diffusion?

A. Yes.

Q. And all of those would factor in favor of having a larger concentration in the heart and a smaller concentration in the femoral?

A. I don't know if that's the case or not because the stomach is down here and the heart's up here, so it's too complicated.

Q. Would you agree that with the one year old, the space between the heart and the femoral draws would be a lot closer than it would be in an adult?

MR. AUCIELLO: Objection, relative.

A. Well, technically, yes, they are.

Q. What I'm asking, sir, is can you draw any scientific conclusions to apply to this case from Exhibit 6?

A. Only demonstrating that postmortem redistribution of drugs is not a predictable phenomenon. And this is not the only example. We had some in Winecker's paper. We had some in Anderson's paper. And some in Anderson's paper they're reverse of what we've talked about today.

Q. Did you ever go through the actual information contained in the Anderson Muto paper?

A. The cases themselves?

Q. Yes.

A. No.

Q. The one aberration of 4.6, have you studied that one?

A. In Anderson's paper?

Q. Yes.

A. No. I only have Anderson's paper. I don't have the cases.

Q. Okay. Do you plan to look at that information before you testify at trial?

A. No.

MR. ANGWIN: All right. Thank you.

MR. ORR: We're done.

MR. AUCIELLO: I have some follow-ups.

MR. ORR: Okay.

MR. AUCIELLO: Short, but follow-ups.
CROSS-EXAMINATION
BY-MR.AUCIELLO:

Q. Doctor, you were shown Exhibit 13. That was the article that was handed to you. It was not one you'd brought with you, correct?

A. Yes.

Q. And you were — the provision on Page 608 was directed to your attention talking about a heart/peripheral blood ratio of 1.13 in a particular case. Do you recall that?

A. Yes.

Q. Doctor, in the next case that was described after that underlined, what was the ratio?

A. In one other case a heart blood Fentanyl concentration of point — 6.05 micrograms per liter was recorded in the presence of a femoral blood concentration of 2.66 micrograms per liter, in parens, heart/femoral equal 2.27.

Q. Okay. So that's a 2.27 ratio on the one that followed, correct?

A. Yes.

Q. Now, this report deals with a number of Fentanyl overdoses that didn't involve the use of the Duragesic patch, correct?

A. Yes.

Q. As a matter of fact, Table 3 that you were directed to involves only patients that were using considerable amounts of alcohol at the time they were using Fentanyl, correct?

A. That's a breakout of the ethanol-positive cases.

Q. And three of these involved oral use of Fentanyl, correct?

A. It does.

Q. There is no prescription oral Fentanyl, is there?

A. A lollipop, but —

Q. The lollipop. And that is, per manufacturer's instructions, only for end-stage cancer patients?

A. That's correct.

Q. All right. Is it fair to say this article relates in large degree to Fentanyl abusers?

A. Yes.

Q. When you testified earlier about the deaths, the Fentanyl-related deaths you've seen in your career here in North Florida, you were referring to Fentanyl deaths arising from abuse or misuse, correct?

A. Yes. We also see cases where it's used appropriately, of course.

Q. Right. And it is used appropriately in cases for people who suffer from chronic pain, correct?

A. Yes.

Q. And it is used appropriately for people with end-stage cancer, correct?

A. Yes, and anesthesia, too.

Q. And Fentanyl is also used by anesthesiologists to effect anesthesia during procedures, correct?

A. Correct.

Q. All right. But the deaths you were referring to relate to people abusing Fentanyl, injecting Fentanyl, eating Fentanyl, et cetera?

A. That's correct.

Q. All right. People will do that because of addictive qualities of opiates?

A. That's correct. Fentanyl is highly addictive.

Q. Okay. And for that reason, you have testified on behalf of the federal government in prosecutions of doctors who trafficked in opioids, including Fentanyl, correct?

A. By selling prescriptions.

Q. All right. And you would agree with me that prescriptions such as those for Fentanyl would have a market value among addicts?

A. Yes.

Q. As would Fentanyl patches correctly prescribed to patients?

A. They do have a market value, street value.

Q. Okay. You mentioned Anna Nicole Smith because of your media exposure, correct?

A. Yes.

Q. Now, if I understand it, both Anna Nicole Smith's autopsy and Adam Hendelson's autopsy were done by Dr. Perper, correct?

A. They were.

Q. And as I understand it, the toxicology was done by both labs, correct — the same lab, correct?

A. Done by the same lab. However, with Anna Nicole they also sent additional specimens to National Medical Services, too, to basically check for everything imaginable.

Q. Okay. But essentially both toxicological causes of death were combined drug effects, although they involved different drugs?

A. Yes.

Q. Okay. Last; in the article — or actually, it's an editorial which was marked Plaintiffs Exhibit 14 that — you are in collective part of a group that prepared this?

A. Yes.

Q. In this it makes reference to some drugs having postmortem concentrations, that it may increase as much as tenfold?

A. Yes.

Q. Is that correct?

And that drug concentrations in blood samples from cadavers are site dependent?

A. Yes.

Q. That's still your opinion, isn't it?

A. Yes.

Q. And is it factors such as that that prevent you from being able to draw conclusions from postmortem drug concentrations and conclude that they are the same or measurable from the point of death?

A. That's correct.

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

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

(The deposition was concluded at 5:21 p.m.)