UNITED STATES DISTRICT COURT EASTERN DISTRICT OF PENNSYLVANIA THEODORE MILLER, ) ) Civil Action 98-978 Plaintiff, ) ) v. ) ) CONSOLIDATED RAIL CORPORATION, ) Philadelphia, PA ) February 10, 1999 Defendant. ) 9:30 a.m. TRANSCRIPT OF TESTIMONY OF DR. LEONARD SIGAL BEFORE THE HONORABLE JACOB P. HART UNITED STATES MAGISTRATE JUDGE APPEARANCES: For the Plaintiff: ROBERT E. MYERS, ESQ. Coffey & Kaye Two Bala Plaza, Suite 718 Bala Cynwyd, PA 19004 For the Defendant: PAUL F. X. GALLAGHER, ESQ. Gallagher, Reilly and Lachat, P.C. 2000 Market Street Suite 1300 Philadelphia, PA 19103 Audio Operator: B. RATTI Transcribed by: DIANA DOMAN TRANSCRIBING P.O. Box 129 Gibbsboro, New Jersey 08026-129 (609) 435-7172 FAX: (609) 435-7124 Proceedings recorded by electronic sound recording; transcript produced by transcription service. Page  I N D E X VOIR WITNESSES DIRE DIRECT CROSS RE-D RE-C FOR THE PLAINTIFF Dr. Leonard Sigal 3(Gal) 13 28 112 126 10(Mye) EXHIBITS IDENT. EVID. D-208 Physicians papers 120 (Call to the Order of the Court) (Prior proceedings not requested to be transcribed) THE COURT: Mr. Gallagher, call your next witness. MR. GALLAGHER: Dr. Leonard Sigal. LEONARD SIGAL, DEFENDANT'S WITNESS, SWORN COURT CLERK: Please be seated. Please state your full name and spell your last name for the record. DR. SIGAL: Certainly. Leonard H. Sigal, S-I-G-A-L. VOIR DIRE DIRECT EXAMINATION BY MR. GALLAGHER: Q Dr. Sigal, what do you do for a living? A I'm a physician rheumatologist and clinical immunology. Q Would you tell the jury a little bit about your educational background? A I went to medical school at Stanford. Did my internship and residency in internal medicine at Mt. Sinai Medical Center in New York. Then was in practice for two years at an HMO. Then did my fellowships in clinical immunology and rheumatology at Yale where I first became acquainted with Lyme Disease. And finishing my fellowship in 1984, I joined the faculty at the State University of New York Health Science Center at Syracuse. I was there for four years and then came to New Jersey where I joined the Division of Rheumatology at Robert Wood Johnson Medical School and I've been there since, since 1988. Q Can you tell the jury about any honors you've received? A Phi Beta Kappa in college. There was a proclamation offered by the president of the University of Medicine in Dentistry of New Jersey about the work that I've done with Lyme Disease. I can't think of anything else. Q That's enough. How about academic appointments, sir? A I was an assistant professor in immunology and in medicine up in Syracuse. I've been an associate professor of medicine and of pediatrics and of another department called molecular genetics and biology since 1990 or '91 I believe and I'm about to be promoted to professor in the coming year. Q Are you board certified in any field of medicine? A I'm board certified in internal medicine and in rheumatology and board eligible in clinical immunology. Q Are you certified -- are you licensed to practice medicine in any states? A In New Jersey and in New York. My New York licenses is inactive right now. Q Would you tell the jury about your editorial activities? A I've served on the editorial board of arthritis of rheumatism, which the official Journal of the American College of Rheumatology. I am on the editorial board of a journal called The Journal of Clinical Rheumatology and I do a feature, a series of articles on I guess it's entitled -- A The Bulletin of -- Q -- Immunology and Molecular Biology for the Clinician, basically trying to translate science into English. I'm on the editorial board of the Bulletin of Rheumatic Diseases which is the physician publication of the Arthritis Foundation, and am on the editorial board of the new journal called The American Journal of Sports and Medicine, which was recently founded. Q Do you do reviews of other physician's articles for various publications? A Yes, I review articles quite frequently for a variety of journals. Q Could you tell the jury some of the journals you do that for? A I just actually on the train ride down here I just reviewed an article for the Journal of Pediatrics, I reviewed for arthritis and rheumatism, for the Journal of Clinical Immunology, for the Journal of Clinical Investigation, for the Journal of Clinical Rheumatology, a number of journals in medicine, pediatrics and in basic sciences. Q Can you tell the jury just some of the professional associations or affiliations that you have? A I'm a fellow of the American College of Physicians, a fellow of the American College of Rheumatology, a member of the American Association for the Advancement of Science, a member for the Society for Experimental Biology and Medicine and a number of other rheumatology, immunology internal medicine organizations. Q Do you have any research interests, Doctor? A Yes. Q Can you tell the jury what your research interests are? A Our clinical research has been on Lyme Disease, on the way people present to their physicians and quite frequently on the misdiagnoses of Lyme Disease. We are in the terminable phases of developing what I think is a better serologic test, a better blood test to confirm the diagnosis of Lyme Disease. We have been interested for better than a decade now on how the organism make disease because the organism itself is relatively bland, it doesn't do much. But it causes a lot of disease, so we've been doing work on how the organism causes immune damage to the host. And we're now engaging in more research on the way people interpret their systems and give value to their symptoms, understand what they're going through and make interpretations that then causes them to make decisions about how to proceed with their case. The field called endless behavior. Q Can you tell the jury about your non clinical professional activities? A I'm a father, that's about it. Q Have you been involved with the National Institutes of Health? A Oh yes, I've done reviews for the NIH for grant proposals, I've done reviews for the American College of Rheumatology. I serve on a number of committee on the American College of Rheumatology mostly about education, but also on their committee for research most recently. Q You -- do I understand that you review other people's proposals to see if the NIH should give grants? A I haven't done that in a while, but yes. I served in a couple of study sections which are basically a group of people who sit in judgment of other people's grants. Q What do you do with the Council for Graduate Medical Education? A The Council for Graduate Medical Education sends out reviewers every three to five years to accredit various training programs in medicine, but also in the subspecialty like rheumatology, pulmonary, a whole number of those. And they will send me once every four to six months a packet of information, the reapplication packet for another organization that is applying to reaccredit its fellowship in rheumatology. And I will review it and try to come up with the problems, what are the concerns? What -- there's not enough research, there's not enough clinical exposure, they don't see enough of such and such, these are questions that are then given to -- well I hand them over to the reviewer who then goes to the site and determines if this is a program worthy of reaccreditation. They usually do get reaccredited. Q Are you presently a member of various committees of at the Robert Wood Johnson Medical School in New Jersey? A Yes, a number of them. Q Do you do anything at Rutger's University? A I'm on the faculty at Rutger's and we have graduate students from Rutger's working in our laboratory. Q Do you hold any patents? A One, on a piece of a protein, a very small piece of a protein that is of use to us in diagnostic testing. And there will be a number of other patent applications in the not too distant future based on this new serologic test that we have. Q And in addition to teaching at the Robert Wood Johnson Medical School, have you been a visiting professor at other schools? A Yes, most recently at Mercy Medical Center, which is part of the University of Maryland System in Baltimore. Q What are grand rounds, Doctor? A Grand rounds are usually a weekly program. It's an educational forum. So typically medicine has them, pediatrics has them and subspecialties has them. You invite in a speaker to give a talk about a specific topic, so that talk may be on the use of testing, it may be on Lyme Disease, it may be on other tick born infections. It may be illness behavior and those are topics that I quite frequently lecture on. Q How often have you given grand rounds? A Probably something in the range of five or six times a year at various institutions. Q Have you spoken about Lyme Disease, as well as other topics, to various organizations, both at which physicians attend? A Yes, I have. Q How often do you do that? A On average probably a little bit more than once a month. Q How many original articles have you published, do you know? A It's something like 30 chapters and probably about 100 articles by now. Q And how much of what you're written has been about Lyme Disease? A The overwhelming majority. I have some other interests, but the vast majority of the work that I've published has been about Lyme Disease. Q What's an abstract? A An abstract is a very brief, usually one or two paragraphs long description of work that is then either read to a meeting or presented as a poster. So it's not a full length paper. It's often work in progress presented at meetings. Q And how many of those have you done? A Sixty, 70. I've actually stopped doing those. Q And have you actually written any books? A Yes. Q How many have you written? A I've written -- I've edited one book and written another on Lyme Disease. Q Do you treat patients with Lyme Disease? A Yes, I do. Q And where's your practice? A At Robert Wood Johnson Medical School. Q And is that North Jersey? A In New Brunswick. MR. GALLAGHER: Cross-examine. VOIR DIRE CROSS-EXAMINATION BY MR. MYERS: Q That's in central New Jersey, is that correct? A It's in central New Jersey, yes. Q Okay. A It depends on perspective I guess. Q Well I guess if you live in South Jersey that's north, and if you're North Jersey, that's South, I agree. THE COURT: If you live in Pennsylvania it's all New Jersey. MR. MYERS: That's right, or Jersey. And, of course, over in New Jersey we're known as the other people, -- THE COURT: Yes, I know. MR. MYERS: -- the interlopers. Q Dr. Sigal, in your publications have you ever written an article stating that Lymes (sic) Disease can be chronic? MR. GALLAGHER: Objection, Your Honor, this is beyond voir dire. MR. MYERS: No, this is part of his credentialling. THE COURT: No, I'm going to let him answer the question. A I've abandoned -- I have written that in the past but I have abandoned that term as being inaccurate. Q Okay. So as you sit here today, so the jury knows, you've been called to testify in a Lyme Disease case that is concerning a chronic illness or an issue of a chronic illness, is that correct? That's your understanding. A I believe so, yes. Q So you are, with all these publications that you have, correct, other than, and I think I've found the article you were referring to, let me see if I can find that, the article you did in 1993, "Persisting Symptoms in Lyme Disease," in Lyme Disease with P.K. Coyle, who is a neurologist at Stoneybrook? A That's a chapter. Q Is that a chapter? A In her book. Q Okay. A There's an article by a similar title that was published by the American Journal of Medicine I think 1992 or thereabouts, but that's a chapter in Patty Coyle's book. Q Okay. But in 1992 and 1993 you did have a belief that it could be chronic, is that correct? A We were concerned that it might be chronic. Q Okay. But just so that we understand, -- MR. GALLAGHER: Your Honor, I'm going to object again. This is proper for cross-examination. We're getting way beyond voir dire. THE COURT: You know, I think I maybe sorry that I let you go down this road. MR. MYERS: Just one more question. THE COURT: If you want to ask him questions about his resume, that's fine. MR. MYERS: Yes, I'm asking him about his resume. THE COURT: All right. Well let's stick to that and save the rest for his cross-examination. MR. MYERS: Okay, I will. Q In the rest of your -- you have to excuse me, I've been suffering from a cough. In the rest of your resume, sir, with the publications particularly, and the speaking engagements and all that, is it fair to say that you're well known in your field for that view, the view is that you don't believe Lyme Disease could be chronic? A I'm not sure that I would describe my reputation quite that way but that's close. Q Okay. And anywhere on your resume do you have anything that refers to the work that you do for medical health insurance companies with the work that you do in reviewing patient's records to deny coverage for chronic care? A Well I don't do that. So it wouldn't appear on my resume. Q Okay. Are you telling the jury that you don't get asked by insurance companies to review patient records? A That's correct, I do. Q Well -- A But I don't get asked to review records with an eye towards refusing benefits. I get asked to review records. MR. MYERS: Okay. At this point I have no other questions. Thank you, Your Honor. THE COURT: Based on the colloquy and the cross-examination, I find that Dr. Sigal qualifies as an expert and you may examine him accordingly, Mr. Gallagher. Proceed. DIRECT EXAMINATION BY MR. GALLAGHER: Q Dr. Sigal, at the request of my office did you review various records concerning the medical case of Theodore T. Miller? A Yes, I did. Q And what records did you review? You can refer to your report, sir. MR. MYERS: If you're going to do that, could you just tell us which report you're referring to? MR. GALLAGHER: It's October 26th, 1998. MR. MYERS: Well I'm asking the Doctor -- MR. GALLAGHER: Oh okay. MR. MYERS: -- since he's going to be looking at his paperwork. A There's a report dated October 26th, 1998 where I list a series of records that I reviewed. Should I read them all? Q Yes, please. A Okay, summons in a civil action, deposition of Mr. Miller April 11th, 1997 and of Mr. Miller April 22nd, 1998, Kathleen Maloney's letter of September 9th, 1998, Dr. Spitzer's letter of May 16th, 1997, Mark Lucas' letter of September 25th, 1998, Brian Fallon's letter of 7/28/98, Kenneth Liegner's letter of 6/15/98, Robert Bransfield's letter of August 31st, 1998, Vocational Economics Assessment by Vocational Economics dated September 24th, 1998, Dr. Komar's records, Dr. Pendino's records, Dr. Scotti's records, Dr. Ber -- Q Barwiz-Creel. A I was going to butcher her name. Those records. Dr. Costanzo's records, Dr. Would's records, Dr. Costanzo's records again, Dr. Smeltzer's records, Care Stations' records, and then Mr. Miller's records from Conrail, the medical file presented to Burns, White and Hickton, Conrail personnel file and files from Aetna Services, JFK Stratford, Meadowlands Hospital, UMDNJ, Bayonne Hospital, Signature Home Care, Bayonne Hospital Radiology Department, Riverview Hospital, Central New Jersey Radiology, Orthopedic Consultants, Jersey Shore Neurology Associates, Sports Rehab and Physical Therapy, Red Bank Radiologists. And for the report dated November 5th, a series of serologic results, another set of records from Dr. Barwiz-Creel, more records from Dr. Pendino, records from Conrail, a report by Dr. Rissenberg, November 16th, 1998 report of Dr. Maloney dated 9/9/98, Dr. Spitzer's report dated 10/28/98, Dr. Sacchetti's report dated 11/4/98, reports of Timothy J. Michals, both dated 11/6/98, report of Steve Jacobs 11/5/98, Mark Lucas' report 9/25/98 and 10/26/98, a report by Dr. Jerome Staller 10/13/98, a letter from Dr. Donta 10/28/98 and 10/29/98 and his curriculum vitae. On my report of November 24th notes from Dr. Bransfield, records from the Highlands Police Department, Alan Matonti's records from Conrail. Dated December 2nd, records from BBI Clinical Laboratories, a supplemental report by Dr. Spitzer of 11/17/98, report by Terry Schulze. And there's more. MR. MYERS: Wait a minute. Your Honor? THE COURT: Mr. Gallagher, I just noticed it in going through trying to follow Dr. Sigal's various reports, he referenced the report dated I think November 24th, which isn't in my packet of materials. MR. MYERS: I don't have that and I don't have this one December 2nd. THE COURT: December 2nd I've got. MR. MYERS: I don't have that. MR. GALLAGHER: Well all the November 24th report says is what the records -- MR. MYERS: Wait a minute, can I see the reports first? MR. GALLAGHER: Yeah, sure, here. MR. MYERS: Can I see the other one, please? MR. GALLAGHER: Sure. MR. MYERS: No, this is November 16th, I have that. I don't have November 24th or December 2nd. MR. GALLAGHER: There's November 24th. It doesn't say anything other than he saw the records. MR. MYERS: Excuse me, I just want to read it. MR. GALLAGHER: Yeah, go ahead. MR. MYERS: May I have -- do you have other copies of this? I would like -- MR. GALLAGHER: You can keep those. COURT CLERK: I don't have any. MR. GALLAGHER: I'll give them to you. COURT CLERK: Okay. DR. SIGAL: You can have mine at the end. THE COURT: Doctor, can I see your November 24th, if you have it? DR. SIGAL: Absolutely. THE COURT: That's the only one I haven't seen, thank you. DR. SIGAL: Do you want the December 2nd one? THE COURT: No, I got that. DR. SIGAL: Okay. THE COURT: Thank you. MR. GALLAGHER: Your Honor, as the records were coming in from the various -- the constant flow of records coming in in November, December and January from the various treating physicians and I kept sending -- THE COURT: I understand. Listen, I got the picture. MR. GALLAGHER: Apparently my office just kept sending them to the doctor and he just kept reporting back he got them. THE COURT: I got the picture. MR. GALLAGHER: Nothing very substantial in any of those. THE COURT: I think the jury fully understands that Mr. Miller is continuing to undergo treatment, probably even as we speak. A And there are yet more, if you'd like me to continue reading. MR. MYERS: Just let me read the letters, please? MR. GALLAGHER: Let him -- (Pause) MR. MYERS: Is there a total of six reports? MR. GALLAGHER: I don't know. MR. MYERS: I just want to make sure I have all of the reports. MR. GALLAGHER: One, four, right, that's three, four, do you have the January 27th, '99 report? I've got the fax that says that you do. MR. MYERS: I have January 27th. MR. GALLAGHER: Right, I think that's substantive. MR. MYERS: That's six reports you've got? MR. GALLAGHER: One -- well do you have this one? THE COURT: Well I think there's six. I see there's October 26th, that's one. MR. MYERS: Right, I've got that one. THE COURT: November 5th, that's two. MR. MYERS: I'm sorry, what was the second one, Your Honor? THE COURT: October 26th is one, November 5th is two. MR. GALLAGHER: November 5th. THE COURT: November 16th is three, November 24th is four, December 2nd if five and there was one in January? MR. GALLAGHER: January 27th, '99. DR. SIGAL: January 27th, '99. THE COURT: Can I see that one? That's six. I don't have that one yet. That sounds like six to me. MR. GALLAGHER: Okay, all right. THE COURT: Go ahead, Mr. Gallagher. BY MR. GALLAGHER: Q All right. Doctor, as a result of -- first of all, let me ask you this, in your practice do you get calls from other physicians to do case reviews? A You mean do I get calls from physicians to discuss cases where -- Q Yes. A -- I have not seen the patient? Q Yes. A Yes, quite frequently. Q All right. Is that -- is there anything in the literature where that happens on a regular basis? Is there some journal where every -- A I see what you're saying. Quite frequently as a teaching exercise a case will be presented in its -- with details but it's broad outlined. And the reader is invited basically to try to understand the case based on what's written. Those are called clinical pathological conferences, CPCs, and they're part of the educational process that's been an ongoing series from the Massachusetts General Hospital published in the New England Journal of Medicine since before any of us were born, long before that. And it's a standard part of teaching. We have morbidity and mortality conferences where we try to reconstruct what happened to a patient who unfortunately has died. And as for rendering opinions to physicians who are calling, this happens all the time. They run a case -- the expression we use is, can I run a case by you, and you're constantly doing that in academic settings for each other certainly in the hallway, and I get phone calls not infrequently from people outside of the institution staying this is what is going on with my patient, what do you think I should do next, and I don't have the opportunity of examining the patient, but I have information presented to me by the physician and then I can render a judgment. I'm not the treating physician, of course, but I can at least come up with a reasonable direction for the physician to next take. Q Doctor, did you reach a conclusion to a reasonable degree of medical certainty as to whether Mr. Miller ever had Lyme Disease? A Yes. Q And what was your opinion? A I thought it was possible based on what his report of was described as being an erythema migrans lesion that he might very well have had Lyme Disease, but I had absolutely no proof of that. Q And would you explain to the jury what you mean by that? A Well infection with this organism, it's called Borrelia burgdorferi starts usually with after the tick bite where you're inoculated, starts off with a rash. And so what happens is the organism grows and begins to swim away from the tick bite site. And you develop a redness that expands, sometimes with central clearing, and that's erythema migrans, and I suspect that you've seen pictures of that, if not here then certainly in the newspapers. The rash of erythema migrans is essentially diagnostic of the infection. So, in fact, this gentleman had an erythema migrans rash, he may have had Lyme Disease. There's other things that can look like the rash of Lyme Disease, and it requires somebody with a little bit of experience to look at the rash and decide, yes, this is erythema migrans or no, it's not. But there's no record -- there's no report in the record that I could find describing that rash by a treating physician. So I'm left with a report by somebody a number of years down the line, so I don't know for a fact that that was -- it's a very long answer to a very short answer, I don't know for a fact that that was Lyme Disease. Q Now what about if a patient comes to you and doesn't -- and gives you the history, how do you go about determining if, in fact, he has Lyme Disease if you haven't seen the erythema migrans? A You take a history. You do what physicians have been doing for umpteen years, you take a detailed history in an unbiased fashion, and by that I mean you have no preconceived notions about what's going on with the patient, you just take a history and then do a physical examination and then you think it through. And then depending on what's present by history and physical, you may come to the conclusion that there's a reasonable likelihood that this is Lyme Disease, or that clearly that that's exactly what was happening. And you can frequently do that on the basis of a competent history and good records. Q In reviewing Mr. Miller's records, did you see any objective findings that would be compatible to Lyme Disease on a clinical basis? A Objective clinical findings means physical findings or laboratory findings, things that you can put your hands on. Everything else is symptoms. So a report of headache or neck pain or joint pain is a report, it's a symptom, that's not objective. There are lots of symptoms that could conceivably be due to Lyme Disease but there are no physical findings and no laboratory tests that I came across in all those readings that make a good case for there having been Lyme Disease. Q What about you've seen the reports from the Ibenex Laboratory concerning Lyme -- the Lyme urine antigen test which -- what -- doesn't that prove he has Lyme Disease? A The Lyme urine antigen test has been around for a number of years. It's of no proven value in the diagnosis or management of Lyme Disease. There have not been sufficient studies published anyplace that would suggest that it's a valuable test. So to this point it's a number that I cannot interpret but it's not -- it's of no proven value. Q What about the serum blood tests that were done, the various serum blood tests? A A large number of tests were done and none of them were positive, none of them suggest prior exposure to Borrelia burgdorfei. Q How about the neuropsychological testing by Dr. Rissenberg? A Neuropsychological testing is very valuable in documenting abnormalities in Lyme Disease and there are some patterns that are quite suggestive of Lyme Disease. There are no patterns that are diagnostic of Lyme Disease, none. So there are patterns that are seen in patients with Lyme Disease, but the same patterns can be seen in lots of other diseases, so there's nothing diagnostic about that. The results are conflict with other results and I would have to say that the results that the neuropsychological testing that I reviewed do not compel a diagnosis of Lyme Disease. Q Did you see any evidence of central nervous system damage in the records that was caused by Lyme Disease? A There are symptoms that are reported but there are no objective findings that would compel a diagnosis of Lyme Disease. Q Doctor, what would you recommend that be done with the care of Mr. Miller? A I would suggest that this gentleman not continue on antibiotics because all drugs have toxicities and I would hope that he would not be exposed to further potential damage. I would hope that his care would address the problems that he's experiencing which strike me as being -- there's documentation -- I shouldn't say documentation, there's a statement by him that he does not sleep, that he's constantly fatigued. He may, in fact, have a sleep disorder as part of an overall depression. I would hope that his care would be changed drastically because I don't think that what he's getting right now is good for him either physically or psychologically. Q Would you -- in the diagnosis and treatment of -- in the diagnosis of Lyme Disease and subsequent treatment of Lyme Disease, is there a debate going on in the medical community? A There are many debates about Lyme Disease in the medical community, yes. Q What about -- THE COURT: We've heard most of them. DR. SIGAL: Hmm? Q What about Lyme -- DR. SIGAL: I'm sure there are more, Your Honor. THE COURT: Oh yes. Q What about specifically with regard to Lyme Encephalopathy and the are of patients that may have Lyme Encephalopathy? A There is no question that the organism that causes Lyme Disease can cause encephalopathy, which means basically the brain does not work properly. It's just a big word for the fact that the brain doesn't work properly. But another big phrase that's used to describe that is tertiary neuro borreliasis, borreliasis because it's derived from the borrelia organism and it's a direct use of a term that was coined years ago tertiary neuro syphilis, and the thought being that there's some analogies between the third stage of syphilis and the third stage of neurologic Lyme Disease. Patients with tertiary neuro borreliasis can experience concentration memory difficulties. They can experience agitation. They can experience depression. It's a very nasty disease. There are classic patterns on neuropsychologic testing. These people are positive by blood tests. They're usually positive in the spinal fluid, you can find antibodies in the spinal fluid. Treatment is with intravenous antibiotics and with a lot of reassurance and waiting because it takes, in the cases that I've taken care of, it can take 18 months before you see a really good response, but the patients typically do respond, and by that I mean they get better. They return function. Q Mr. Miller, in the records, is there any findings -- never mind, the jury knows, I've asked that. Doctor, how many times have you testified regarding Lyme Disease before today? A In a court of law? Twice for workman -- no, actually one of them was not for Lyme Disease. Once in a workman's comp case for Lyme Disease and probably something in the range or five or six other times. Q How much are you charging my office for reviewing all of these records and coming to Philadelphia to testify? A It's a fee of $560 per hour. Q Do you have any idea -- you do have an idea of approximately what it is, don't you? A To this point it's probably in the range of six or seven, $8,000, something like that. Q And how many legal cases have you reviewed concerning Lyme Disease? A Overall probably something in the range of two dozen. I haven't two dozen reports -- Q Two dozen meaning 24? A Yes. I haven't done two dozen reports, but I've probably something in that range. Q And over what period of time have you done that? A I guess the first was in 1988 or '89 when I first came to New Jersey, so it's been about ten years. Q Is there any -- is there something, from a medical point of view, is there something inherently wrong with the treating a patient for Lyme Disease if they don't have it? Is there a nil effect as a result of that? A Yes. Q What -- A And I've written about that. The issue I think there is at least twofold. The first is that if you give a patient a diagnosis that's incorrect, that person will get the wrong treatment. The second is that if you give the person the wrong treatment, you're exposing that person to the risk of the underlying disease progressing untreated. And the third and in many ways I think the most devastating is that the model that you're using and that you're giving the patient to consider is one of a chronic illness that obviously is never going to go away because I've been on antibiotics for -- and I've heard this on a number of occasions from patients, I've been on antibiotics for six months, a year, two years and I'm no better. The doctor tells me that I've got a chronic infection that's never going to go away. And I personally can't imagine what kind of an emotional toll that would take on an individual. It must be incredibly frightening to really believe that you've got an infection that's never going to go away. MR. GALLAGHER: Thank you, Doctor. Cross-examine. CROSS-EXAMINATION BY MR. MYERS: Q Good morning, Doctor. A Good morning. Q Doctor, I'm going back to my initial questioning. You've been involved in this case at the request of Mr. Gallagher's firm since October, is that correct? A Yes, the first letter was dated -- to me was dated October 8th, 1998. Q Okay. Now you've told us how many reports you've rendered on behalf of the Gallagher firm, six all together now, and -- A Yes. Q -- unfortunately I didn't get to see all of them before today, but I'm not going to go into that now, how many letters have they sent to you? A These six -- Q You've referenced the number of letters that they've sent to you. A The six to which I was responding and three more that I've never had the opportunity to write a report about. Q Okay. And you've had conversations with any of Mr. Gallagher's staff, sir? A Yes. Q Okay. Now every time we do this, and obviously there's nothing wrong with this, I'm not bringing it up for that reason, but that's part of your $560 an hour charge, is that correct? A I don't have a stop watch by my phone, so I basically don't want to charge him for telephone calls that amount to a few minutes. Q Okay. Well I realize you don't have a stop watch, but according to your first report you billed him for five hours and 25 minutes, is that correct? A Yes. Q That's about as close to a stop watch I guess as you can get, right? A Well but that's work at home. Q Okay. And that's -- A On evenings and weekends. Q And that particular charge for that first report, which is how many pages? A Of review or how many pages of the report? Q How many pages is your report? A Five pages. Q That charge is $3,033, correct? A Yes. Q And your second report of November 5th is how many pages? A Two. Q And what was your charge for that report? A One thousand, $74 for one hour and 55 minutes. Q And your report of November 16th, 1998, what was your charge for review of records and your report on that one? A $700. Q How many pages is that report, November 16th? A Two. Q And your November 27th report, sir, how many is that? A Twenty-fourth, November 24th. Q The 24th? A Yes. Q Okay. A Two pages. Q And what was your charge for that? A One hundred and $87 for 20 minutes. Q And your December 2nd report? A It was two pages long and $280 for 30 minutes. Q And your last report of January 27th? A Is three pages long. It was 1.75 hours, $980. Q Okay. And what other time did you bill for? A I haven't billed for the most recent series of information I've gotten. Q And how many hours did it take you to review that? A I don't have that accounting in front of me. Q Well approximately how many hours did you take to review it? A A few more hours. Q And so that was before today, is that correct? A Yes. Q And how about today, how are you being compensated for today? A I don't recall if I ever had a conversation about that. I -- other than my colleagues have told me that you can bill a flat rate for a half day in court, so I guess that's what we'll do. Q Well you've appeared in court before, is that correct? A Yes. Q And what have you billed for half days in court in the past? A Probably something in the range of $2500, something like that. Q Okay. Are you telling us that that is what you're going to charge for today is half day testimony, $2500? A This is an interesting way of negotiating my fee, but I guess that's what we're going to do. Q Well if I'm helping Mr. Gallagher to save him some money, I'll be glad to do it since they have expended quite a bit so far. Now is that $2500, is that included in that estimate of yours from six to seven to $8,000 -- A No. Q -- or is that an addition? A You asked me how much I'd billed to this point. Q Oh okay. So we're talking somewhere between 10 or $11,000, is that correct? A Probably a little less than that, but yeah, something of that sort. Q Okay. Now my understanding in your participation of other law cases is that the fees that you've generated from cases like this you get to keep yourself, is that correct? A That's right. Q And the fees that you generate from reviewing records that insurance companies send you you also get to keep yourself, is that correct? A That's correct. Q So in terms of this one case, you've said you've been involved in how many other legal cases? A Probably something in the range of two dozen. Q Okay. And you've testified how many times in court actually? A Five or six times I should think. Q And how many times by deposition? A Probably another four times, five times, something of that sort. Q Okay. Now you said you testified in a workman compensation case, is that correct? A Yes. Q In that case, did that involve Lyme Disease? A One of them did and one of them did not. Q Okay. But all these cases you're involved with, do any of them -- do they all usually involve the issue of Lyme Disease like this? A Not necessarily. Q Well tell me. A Well as an example I have a patient who has psoriatic arthritis and bursitis at the bottom, her bottom and is a schoolteacher and is unable with her -- her two grades -- her second grade and is unable to work. So I testified in a workman's comp court in New Brunswick on her behalf. Q Out of -- A She's my patient. Q Out of the two dozen or so cases then, how many approximately would involve Lyme Disease? A Probably something like 20. There have been a number of Lupus patients and such, but the rest of that. Q Now approximately, and I asked this case in the beginning to sort of get these out of the way so I can get more to the care of Mr. Miller, but these insurance reviews, these are when insurance companies ask you to look at records to determine whether or not they should pay for the care or not of a Lyme Disease patient, is that correct? A I'm not sure that all of them are of that sort, but -- Q Most of them are, aren't they? MR. GALLAGHER: Objection, Your Honor, let the witness answer. MR. MYERS: I'm sorry, Your Honor. THE COURT: Yes, let him answer the question. Q I'm sorry, I thought you were done answering. A No, no, I talk a lot. Q That's okay, that's why we're here for. A For your sake I hope not. Insurance companies are interested to know if the person, in fact, has Lyme Disease. And if the person has Lyme Disease, what is the appropriate treatment for the manifestations of Lyme Disease that are present. And so I'm not asked to turn off the spigots, as it were, I'm asked to render an opinion does this person have Lyme Disease and what's the appropriate treatment for this person. Q And approximately how many cases do you get a month from insurance companies to review to determine if somebody has Lyme Disease? A I can't remember the last time an insurance company file cross my desk. It's been at least six months. Q Okay. Over the past five years how many have you reviewed? A Probably 40, something in that range. Q Okay. And do you charge the same hourly rate? A Yes, but they're typically much smaller folders. Q Okay. Now in addition to that, do these medical insurance companies also ask you to determine whether or not if somebody has Lyme Disease whether or not their care should extend past a certain point? A What do you mean by care? Q Whether or not they should pay for antibiotic therapy let's say past a month. A Well that's an arbitrary number but yes, I've been asked to determine or to make recommendations regarding the duration of therapy. Q All right. And so what insurance companies have you given this advice to, what different medical insurance companies? A Prudential and Aetna and Antham are the ones that come to mind. Q How about Blue Cross and Blue Shield? A Yes, I've reviewed one or two cases for Blue Cross/Blue Shield and once actually for Blue Cross/Blue Shield of Iowa. Q Now you told us before that you do -- now as you sit here today, have you ever treated a Lyme Disease patient with antibiotics past 30 days? A Yes. Q Okay, is that oral or intravenous? A Twice intravenously for six weeks and the current recommendation for oral therapy of arthritis is four to six weeks and we typically err on the side of six weeks. Q Okay. As you sit here is it your testimony and your recollection that you've never treated somebody with Lyme Disease with antibiotics past six weeks? A No, I take that back, I have. At the insistence of a patient who had moved to Virginia, I extended her Doxycycline against my better judgment to some three, four months. Q Okay. Is that the only patient? A I believe so. Q So other than that one patient, it's my understanding that you have never treated your patients with Lyme Disease past six weeks either on oral or IV antibiotics, is that correct? A It's certainly not my routine. I can't recall having done it again. Q Okay. And, in fact, and let me ask you this, that raises an interesting issue, sometimes you're asked by these medical insurance companies to review these records for that, is that correct? A Yes. Q And then some of these treating doctors want their patients to be treated more than six weeks, is that correct, with antibiotics? A That has been the case on occasion, yes. Q And so your position in this is well known in your field, is it not? A You might say. Q Okay. And yet you have a clinic where you treat patients who are covered by medical insurance, is that correct? A Yes. Q Did you ever tell your patients that under no circumstances you will ever treat them for more than six weeks with antibiotics of Lyme Disease? A I never say never about anything in medicine. I deal with the patient as an individual and come to a decision about what needs to be done for that individual patient. But if you're asking is it my routine to treat people who are not feeling well for six months or a year or two years or ten years, the answer is no, it's not my routine. Q Now these people feel that they have Lyme Disease and they can't get or they won't get antibiotic therapy from you for more than six weeks, you often go to other physicians for care, is that correct? A They often care to other physicians, yes. Q Yes. In fact, some of those physicians have been Dr. Bransfield. Do you know Dr. Bransfield? A I've never met the gentleman, no. Q But you've known some of your patients have gone to be treated by him, is that correct? A I don't know that. I've seen some patients who have seen him. I'm not aware of any of my patients going to see him. Q You're also aware that some of your patients have gone on to treat with Dr. Liegner, is that correct? A I suspect that may be true but I have no evidence to that effect. If a patient leaves my practice, I don't know where they go. Q Okay. Now in terms of all of these cases that you do, all the case that you do either in terms of testifying by way of deposition or in trial which relate to Lyme Disease and also in terms of the work that you've done for at the request of insurance companies to review records, approximately how much of your time or practice is devoted to let's call it a medical legal type of review? A As a percentage? Q If that would be the easiest way for you to estimate that. A I would think probably 10 percent perhaps. Q Okay. Now it's my understanding, Doctor, am I correct, that you have never had the pleasure of meeting Mr. Miller, is that correct? A This is true. Q And you were never asked to examine Mr. Miller, is that correct? A That's correct. Q Is there an advantage to a physician for treating a physician or a patient over a long period of time, to get to know the patient, get to see the patient, answer questions, make the movements of physical examinations, take the mental health status examination? A If one is to treat the patient, those are required. You can't treat in absentia. Q Oh, I see. So it's your understanding when you received this request from Mr. Gallagher's firm that you would not render treatment or have any responsibility with regard to Mr. Miller, is that correct? A That's true. Q That's true. And you have no doctor patient relationship with Mr. Miller, is that true? A Not explictly, no. Q Not explictly, did he ever come to you as a patient? A No. Q Did any of his treating doctors ever refer him to you -- A No. Q -- for a consultation or for treatment? A No. Q And, in fact, it was Mr. Gallagher's firm that contacted you that got you involved in this case, is that correct? A Yes. Q Did Conrail's medical department in 1995, 1996, 1997, during that time period, they never contacted you for your consultation, is that correct? A I don't believe so. Q Are you aware that in June of 1997 the Conrail medical department disqualified him from service on the basis of Lyme Disease? A I read about that, yes. Q Okay. Now my recollection, correct me if I'm wrong, is that a physician, whether you're a treating physician or not, has an obligation to an individual such as Mr. Miller, whether you're the treating doctor or not, is that correct? Isn't there some sort of obligation, the Hippocratic oath, to take care of all mankind and all that sort of thing? A And all that sort of thing. Yes, there is a responsibility that I think a -- I think that if you are a compassionate and responsible physician, you have a responsibility to all patients. Q Okay. Now I believe because of something that due to graduation you never actually took the Hippocratic oath, is that correct? A That's correct. Q And did you ever read it? A Yes, many years ago. Q Many years ago. Do you remember the paragraph, "Whatever houses I may visit I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief," remember that part? A Not explictly. Q Anything in the Hippocratic oath in terms of your findings, your findings -- if I can understand what Mr. Gallagher asked you in the questions, you -- one of your opinions is based on the fact that no doctor saw Mr. Miller have a rash, is that correct? A That's part of my conclusion, yes. Q Part of it but that's a significant part of it, is that correct? A Actually not a significant part but it is a part. I'm not sure if semantics is an argument we need to have. Q I don't want to -- I'm not trying to mix words with you, believe me. Is it important for somebody with a tick exposure that they have a rash or not, in your mind -- A Is it -- Q -- if you're going to decide -- A -- important if somebody has a tick exposure if they have a rash? Q Sure. A Yes. Q Okay. That's something that would lead you to further questioning to determine whether or not that person has Lyme Disease, correct? A Yes. Q But, I mean, it's I think the one thing we can all agree on is that Lyme Disease is a clinical diagnosis, is that correct? A Based on findings, yes. Q Okay. But you've said that many times yourself, have you not? A Yes, and I've been misquoted very many times. Q Well I don't want to misquote you. Let me go back to Lyme Disease of New Jersey, a Practical Guide for New Jersey Clinicians, is that yours? A Yes. Q And by the way, interesting enough, in that -- on page I, you say some very nice things about Dr. Terry Schulze from the New Jersey Department of Health, is that correct? A Absolutely. Q In fact, he is preeminent in his field as an entomologist, is he not? A Preeminent? He is eminent in his field. Q He is eminent in his field. A Yes, absolutely. Q He is the number one bug guy in New Jersey, isn't he? A I'm not sure Terry would like that, but one could put it that way, yes. Q Well I hate to keep saying entomologist on my notes because it's informal, but -- THE COURT: I put bug man on my notes, so -- MR. MYERS: Because I don't know to spell entomologist. THE COURT: I don't either. Q Okay, so -- A He's an expert in ticks and other creepy crawly things. Q Okay, and that's somebody that you would rely on in terms of receiving information about ticks, ticks' behavior, where they like to hang out, how they grow, what kind of food they like, all that sort of thing? A I think I know enough about entomology at this point to satisfy my own needs, but if I had questions, I would certainly contact Terry among other people. Q Okay. Did you ever contact a guy named Jacobs from Penn State, an entomologist? A I was part of the panel at Penn State a number of years ago, so I may have met him. But no, I've never contacted -- I don't believe I've ever contacted him for information about ticks. Q As far as you know, did he ever do any work in New Jersey, any research work? A Who he? Q No, Mr. Jacobs? A Did Mr. Jacobs ever do any research in New Jersey? Q Yes, as far as you know. A Not that I'm aware of. Q Okay. In this document that you prepared, you were one of the principal authors, correct? A Yes. Q You said that Lyme Disease is not a serologic diagnosis, it is a clinical diagnosis, is that correct? A Yes. Q And a clinical diagnosis, when a patient -- well first of all, would you ever treat a patient who you don't see personally? A No. Q Okay. Now is part of a clinical diagnosis taking a history from the patient? A Yes. Q Is part of a clinical diagnosis taking or performing an examination of the patient? A Certainly. Q And there are various aspects of that examination, isn't there? A Absolutely. Q And is part of the aspects of that examination is that you actually put your hands on the patient to look for things, touch for things, -- A Yes. Q -- feel for things? And in terms of that, in terms of that, that's a very important part of arriving at a clinical diagnosis of a patient, is that correct? A Yes. Q Isn't history the most important part of a diagnosis, a in Lyme Disease? A Certainly. Q And if a patient comes to you, unless they're proven to be some absolute lunatic or somebody who likes to get, you know, just treat with doctors, you accept their history as true, isn't that correct, unless it's disprove somehow? A I evaluate the history on a case by case basis. Q Right. And then -- and, in fact, as you found in your own practice, not every Lyme Disease patient has observed a rash, is that correct? A That's true. Q And not every Lyme Disease patient that you've treated remembers a tick bite, is that correct? A Most of them don't, in fact. Q Most of them don't, because they're all little creatures. A They're little. Q So -- and, in fact, and I don't remember the percentages, maybe you can tell us, in what percentage do Lyme Disease patients not even know they were bitten by a tick? A It's probably something in the range of two-thirds do not recall the tick bite. Q Do not recall the tick bite. And how many of the patients don't recall the rash? A That's a matter of some debate. There was a study published in the New England Journal of Medicine in a pediatric population suggesting that better than 90 percent of the patients had erythema migrans at one time or another, the rash of Lyme Disease, at one time or another. The original figures that we sort of grew up on was that 50 to 70 percent of patients would have erythema migrans. That perhaps is a little too low, excuse me, so it may be more than that. Q Okay. So you can diagnose Lyme Disease for people who don't remember the tick bite and who don't remember seeing a rash, is that correct? A If they have other objective findings that suggest Lyme Disease, -- Q Right. A -- certainly. Q Okay. But in terms of -- isn't it -- well let's say if you were positive if you had seropositivity, is that the right term? A That will do. Q Okay. A Sure. Q All right. I'm not a doctor, I'm just a mere lawyer, that's why I don't want to use the wrong term, if seropositivity, what that means is let's say they have five bands of the western blot out of ten, which is, as we all heard ad nauseam in the case so far, that it's for reporting purposes, epidemiological, whatever the term is, by the CDC. If you see the five out of ten bands, that would be considered seropositive, correct? A Yes, then you have to interpret what that means, but yes, that would be a positive test. Q And then you have to make the interpretation. And that could be - - and they could get that result and have not seen the ticks and not seen the patient, that is the patient, is that correct? A That's correct. Q Okay. Now as part of the history then when a patient comes into you and tells you about a tick bite, then would you accept that as true? A That would I accept what as being true? Q If a patient tells you, Doc, I think I've got Lyme Disease, I don't know, but I got a tick bite six months ago, do you accept that as true when the patient comes into your office? A I ask more questions about it, but yes, I would be inclined to accept it as being true, that's what the patient is telling me. Q Right, that's part of your thing with the patients. Now do you then ask your patient, did you see a rash, gee, I don't know. They don't even know they saw a rash. Do you accept that whether they -- then you don't know whether they saw a rash or not, is that correct? A If they don't know, they don't -- if They don't know that they had a rash, then they don't know that they had a rash. Q But if the patient tells you they saw a rash and you're the first doctor they saw, then the only thing you have to go on is the word of that patient, is that correct? A Right, but I try to get more information about what that rash was. Q About what the rash is. Now I know you've reviewed lots of materials in this case. I mean, the complaint, why did you review the economic report in the case, vocational economics, what has that got to do with your testimony? A It was sent to me and I -- Q Did you look at it? A I want to read it. Q All right. A I like to be complete. Q Complete. Okay. You're not going to talk about numbers or anything, I hope. A I hope not. Q We had enough testimony about that already. A I hope not. Q Okay. A It's also not my area of expertise. I'm not sure that you want me to say anything about it. Q Now in terms of all that, a review of your records, the medical records that -- and I know that you reviewed some of the medical records from a Dr. -- let's start with Dr. Spitzer who testified yesterday, as a matter of fact, Dr. Spitzer, did he call you on this case? A No. Q Did Dr. Spitzer send his report to you? A No, I got it from Mr. Gallagher. Q Okay. So Dr. Spitzer didn't consult with you in making his report, is that correct? A No. Q As far as you know? Well you would know that whether he had consulted you, so he didn't consult, correct? A No. Q Okay. Now do you know Dr. Spitzer got involved in this case? A I have no idea. Q Would it matter to you in any way that he was hired by Mr. Gallagher's firm just for the purposes of this litigation? A Would it matter to me? Q Yes. A I assume he's an honorable man and he's telling the truth, regardless of who is paying the bill. Q Well you don't know that he's -- I mean, you weren't aware that he was not a treating physician of Mr. Miller? A Oh, that was apparent in his report. Q Oh, okay. So you knew that he got hired for the purpose of this litigation just like you, is that correct? A That was apparent from his report. Q Okay. Good. Now in terms of do you know how Dr. Maloney got involved in this case? A I presume it was the same way. Q So you know that Dr. Maloney was hired for the same reason? A Yes. Q And you're aware that Dr. Maloney never treated Mr. Miller, is that correct? A Yes. Q And who was the other one? Spitzer, -- MR. GALLAGHER: Dr. Sacchetti, Dr. Michals. Q Oh, Dr. Michals. A The neuropsychologist. The same. Q The same. You're aware of Sacchetti and Michals, they're all hired by Mr. Gallagher, none of them are treating physicians of Mr. Miller, is that correct? A That's quite clear. Q So you presumed that they're honorable but you don't think that the fact that they're getting paid by Conrail to come to this case has any effect on their opinions? A I presume that they are as honorable as the treating physicians in this case, that they are all telling the truth. Q Okay. Well the treating physicians, Dr. Bransfield, believes he has Lyme Disease, is that correct? A That is apparently correct. Q And apparently Dr. Bransfield also thinks he has neuropsychological impairment as a result of the Lyme Disease, is that correct? A That's Dr. Bransfield's belief, yes. Q That's not your field, psychology and psychiatric, right? A Except insofar as it deals with Lyme Disease, no. Q Okay. Well you're not trained as a psychiatrist, is that correct? A That's correct. Q And you're not trained as a neuropsychologist, is that correct? A Absolutely not. Q In fact, your training is for rheumatology, is that correct? A And clinical immunology, yes, and internal medicine, which includes the care of people who have psychological problems. Q But it does not include the specialty of infectious disease as Dr. Spitzer, is that correct? A That's correct. Q Okay. You read Dr. Donta's report, is that correct? A Yes. Q He's an infectious disease expert or an infectious disease physician up in Boston someplace, right? A Boston University, yes. Q Right, is he at the medical school up there or something? A Yes. Q So he works in a medical school like you do, doesn't he? A Different medical school. Q Different, yeah different, but he's got a job in medical school just like you, right? A He has a job in a medical school. I don't know what he does. Q Okay. Did you read on his letterhead what his chairmanship is of or -- A He's in infectious disease at Boston University. Q Right. And this chairman at the Boston University Medical School, it was his opinion based on the review of the records, like you reviewed the records without meeting Mr. Miller, that he thought Mr. Miller had Lyme Disease, is that correct? A That was Dr. Donta's expressed opinion, yes. Q In fact, you and Dr. Donta had that one thing in common that neither one of you actually examined Mr. Miller, got to meet with him, take the history and perform your own examinations of him, is that correct? A We have that in common but -- MR. GALLAGHER: Your Honor, I'm going to object because there's no evidence as to what Dr. Donta actually reviewed, as there is evidence as to everything Dr. -- THE COURT: If he knows, if he knows. MR. GALLAGHER: Yes. MR. MYERS: Okay. Q Now in terms of -- with your experience in Lyme Disease, would you agree with me that you would perform an examination of a patient entirely different than a neurologist? A Not entirely different but there might be some differences in attention paid. Q But you -- there's more nuance as to Lyme Disease that you would look for since you've done so much work in it than somebody who doesn't do the kind of work or the amount of work that you do, is that correct? A I think that's probably true? Q Right. And you would actually be able to look for more things than somebody like a Dr. Maloney or a Dr. Michals who don't deal with Lyme Disease like you do on an every day basis. A I'm not sure that's true. Q When you looked at Dr. Maloney's resume and Dr. Michals' resume and Dr. Sacchetti's resume, did you see that they had not been involved in any specific research or publishing in any way in the field of Lyme Disease? A I don't recall having seen the resumes. I saw the reports but I don't -- I guess I did. Q Had you seen their names in peer review articles or articles or anything like that? A No, but one need not have published in peer review journals to have a little bit of expertise in the field. Q Now whether you agree with them or not, you've seen Dr. Liegner's name in articles, correct? A Once or twice, yes. Q And you've seen Dr. Bransfield too? A In articles? No, I've not. Q In what? What did you see him in? A I've seen reports as I reviewed for this case. Q And, in fact, didn't you in some academic literature actually reply back to him on something he wrote? A You mean did he write a letter to the editor in response to a paper that I wrote? Q Or something like that, and then you wrote a response to that. A I honestly don't recall. That's possible, I just don't recall. Q Okay. Now are you aware that Mr. Miller testified in this case that after each tick exposure that he did, in fact, develop a rash? A I was aware from the materials that I read that he developed a rash once. I wasn't aware that it was both times. Q So you weren't aware of that of his testimony in this case, is that correct? A I had not seen transcripts of his testimony here, no. Q Okay. Were you made aware that there was a witness that came in that one of the exposures who also had some exposure with ticks, although it might have been a different tick? A No. Q Were you made aware of that? Is there any question in your mind, any question in your mind that when Dr. Schulze says that the environments that Mr. Miller were working in on those two occasions could support ticks? A Is there any doubt in my mind that Terry said that there could be ticks there? Q Yes. A No. Q Okay. Now and, of course, you know Dr. Schultz as you've told us, right? A Schulze, yes. Q Schulze. I'm sorry. Thank you for correcting me. So you were aware that the leading entomologist in New Jersey is of the opinion that both of the environments that Mr. Miller said that he was exposed could support ticks but you weren't aware that Mr. Miller said that he had rashes on both occasions, is that correct? A That's a compound question. I was aware of the fact that Terry said that there was a possibility that ticks might be able to survive in that environment, yes. Q Okay. Have you diagnosed people with Lyme Disease who have less than four or five bands on a Western blot? A Yes, because the IGM criteria are different. Q Okay. Do you recall ever giving a lecture or was a video taken of you giving a lecture to medical insurance companies about Lyme Disease? Do you remember doing that? A I believe so, at Antham? I'm not sure, but I believe so. Q And do you remember something like that? A Yes, I believe so. Q And insurance companies always have -- in fact, insurance companies invite you to come in and talk with their people, is that correct? A I've done it once. I wouldn't say that they do, it was done once. Q Okay. And you've also been invited by corporations to come in and talk with their employees, right? A Yes, AT&T. Q Yeah, you know, to tell them, you know, watch out for ticks and these are the things you can do and all that, is that correct? A Yes. Q When did you do that? A When did I do that? Q Do you remember? A It's been a number of years. Not recently. Q Well how -- yeah, not long ago. A But since I've been in New Jersey. Q Okay. And you've been in New Jersey since? A '88. Q 1988. A Early '90s, I should think. Q Pardon me? A The early '90s I should think. Q Early '90s. Okay, at any time during that time do you remember the Consolidated Rail Corporation calling you in to give information to its employees or its health people about ticks and about tick born diseases such as Lyme? A No, I do not. Q My understanding, Doctor, is that you did some work earlier in your career with Dr. Steer, Alan Steer? A Yes, I did. Q He's a chief of rheumatology at Tufts? A He is now. Q He is now. A At the time he was at Yale. Q Right. And did -- what time period did you work with him? A 1981 through 1984. Q Okay. I'm going to show you a letter that he sent to Dr. Liegner and ask you, did you ever have occasion to talk to Dr. Steer about his belief about the climacticity of Lyme Disease? A I'm sorry, can you repeat the question? Q Read the letter first, I'm sorry. A All right. (Pause) A Yes. Q Okay. And in that letter he stated, "Because they were able to culture the spirochete, they certainly proved that one may have persistent infection after intensive antibiotic therapy and despite seronegativity," do you agree with that? A I have not had the opportunity of reviewing those pieces of information, but that's what the letter says. Q Okay. Do you agree with that? A That one can conceivably have infection that persists after antibiotic therapy? Q And despite seronegativity? A It's not been my experience. Q Okay. Now just for the purposes so we know who Dr. Alan Steer was, is that somebody that you trained under? A Yes. Q And was that at Yale? A Yes, as I said before, he was at Yale at the time. Q Okay. And was he in charge of the program that you were at? A No, he had one of the laboratories in the division of rheumatology. Q Oh. A And actually I didn't work in his laboratory, I worked in clinical immunology. Q But at that time was he the one that was sort of leading the work at Lyme that you eventually got into? A One of two people, yes. Q One of two people. In fact, he just got a grant, didn't he, about doing research into the chronic -- whether Lyme Disease is chronic or not? A I'm not sure what grant you're referring to. I hope he got a grant recently, that would be good for him, but I'm not aware of what you're talking about. Q Do you know a Dr. Detweiler? A Yes. Q And is that someone else who is doing work in Lyme? A He has been for a number of years, yes. Q Okay. And you're aware that Dr. Detweiler was awarded part of that grant that Dr. Steer got to do research -- A Yes. Q -- into the chronic nature of Lyme? A Yes. Q And Dr. Steer got him involved in that grant, didn't he? A I'm not sure that's the case but apparently they are working together on this project. Q Did Dr. Steer ask you to work with him on that project? A No, he did not. Q There was a, and maybe you can help me if there's a lot of them, there's an article called "Reversible Cerebral Hyper Profusion in Lyme Encephalopathy," do you remember it's an article abstract? Did you review that? A Yes. Q And Dr. Steer was one of the authors of that? A Yes, he is. Q Is that -- and I don't want to go into -- we could go into the study but I don't -- is it something to do with spec scans? A Yes. Q And we can conclude "that Lyme Encephalopathy have hyper profusion of frontal subcortical and cortical structures that is partially reversed after," what is that, Ceftriaxone? A Ceftriaxone. Q That's an antibiotic? A An intravenous antibiotic. Q Okay. "And spec cannot be used alone to diagnose Lyme Encephalopathy or determine the presence of a CNS infection," correct? Do you remember that study? A Yes. I've read the paper, yes. Q And is that says that Lyme Encephalopathy is a "neuropsychiatric disorder beginning months to years after the onset of infection of Borrelia" -- A Burgdorferi. Q -- "burgdorferi." And that was part of Dr. Steer's study, is that correct? A I don't know what you mean by part of Dr. Steer's study. Q He was an author of that. A It was a paper written by Eric Logiman (phonetic) and Alan as one of the authors, yes. Q Is Dr. Steer the individual who is responsible for articles which relating to Lyme get published in the New England Medical -- what's it called? A New England Journal of Medicine. Q New England Journal of Medicine. A Is he responsible for what articles get published? Q Is he sort of the one who reviews the articles before they go in there? A I doubt it. I doubt that he's the only one -- I can guarantee he's not the only one. Q But he's one of them? A I have -- I'm not privy to the editorial decisions of the New England Journal of Medicine. You have to ask Dr. Casserer (phonetic) who is the editor. MR. MYERS: If Your Honor pleases, I'm not sure when you want to take a break this morning? THE COURT: Well probably about 11. MR. MYERS: Okay. Q Doctor, do you want some water? A No, thank you. Q Okay. Doctor, when you did this publication, Lyme Disease of New Jersey, a Practical Guide for New Jersey Clinicians, at that time that was what, '93, '94, somewhere around there? A No, I think it was 1990 or '91. It was earlier than that. Q It says, let me show you this, it says June of '93. A Oh, I thought it was earlier than that. Right. Q Just so we know it's yours. A Yeah, I thought it was earlier than that. Okay. Q That's your publication, correct, or you worked with this? A Yes. Q You worked with it. A It's a publication of the Academy of Medicine of New Jersey but I worked on it, yes. Q It says primary author Leonard H. Sigal, that's you. A So it would seem. Q And at that time you also talked about in terms of diagnosing -- diagnosting, diagnostic testing for Lyme Disease, pardon me, it says, "Lyme Disease remains a clinical diagnosis with laboratory testing used for confirmation," is that correct? A Yes. Q And also when you talked about the different tests, under where it says future promise, there was a polymer raised chain reaction, right? A Polymerized chain reaction, yes. Q I'm sorry to mispronounce that. A serum, you'll have to pronounce this one, -- A Serum Borreliacydal assay (phonetic). Q That's it. A It means you can test to see if the serum of the patient kills the organism in a test that's done by the Gunderson Institute out in Wisconsin. Q Okay. And also antigen detection assays urinary antigen tests, is that correct? A That was something that was in the development phase at that point, yes. Q All right. As Mr. Gallagher pointed out on his direct examination, two of the tests at least that appear positive from the reports of the laboratory are the Lyme -- I'm sorry, are the urine antigen tests from that Ibenex Laboratory that he referred to which you don't accept, is that correct? A That's one of -- I'm not aware of another test, but that is a test that has turned positive, yes. Q Okay. Are you -- were you aware that there were two urine antigen tests? A I don't recall how many urine antigen tests were done. Q Okay. Were you given this last one, I have marked this as 16-F, - - MR. GALLAGHER: What's the date of it? MR. MYERS: Pardon me, 2/4/99. A The 96, yes. Q Oh, you got that one? A Yes. Q Now the earlier antigen tests had a result of what was it, 47 or something like that? A That sounds familiar. Q And this one says 96, is that correct? A Yes. Q And, pardon me, with a number of 96 according to this laboratory, it's highly positive for Lyme, is that correct? A That's their interpretation, yes. Q That's their interpretation. By the way, you did review the records of Dr. Komar, correct? A Yes. Q Dr. Komar was his initial treating physician, is that correct? A Yes. Q And you're aware that on April 15th, 1997 that he actually said or rendered the opinion that Mr. Miller was suffering from Lyme Disease, is that correct? A Yes. Q Okay. In fact, he said "This letter is to inform you that I have been treating Mr. Ted Miller for two years with the diagnosis of Lyme Disease. I am his internist and with the continuation of signs, symptoms, history and serology data, along with infectious disease consultation, Ted Miller was placed on numerous antibiotics for his Lyme Disease. As you know, ticks carry and cause Lyme Disease. Patient on two separate occasions has stated to me that a considerable tick exposure while at work for Conrail in 1993, 1995 with multiple ticks were attached to him. In my medical opinion, all the sequela of Lyme Disease, including muscle joint aches, concentration disturbance, headaches, depression, anxiety, mood swings are casually related to Mr. Miller's Lyme Disease and since this is going on for years, even with treatment it is my opinion that these sequela are of a permanent nature." And you did review that, is that correct? A Yes. Q And you also reviewed, did you not, a Lyme Disease statement of medical necessity by Dr. Komar which indicated what his examination of Mr. Miller was, is that correct? Did you review this? A I read this, yes. Q Okay. I've already marked that as Exhibit 48, and then -- pardon me again, Doctor, and then in part of his examination which he did he mentions encephalopathy he says yes, is that correct? A This is not an examination, this is a statement of medical necessity. Q Okay. Well you don't -- A There's a difference. Q But are you telling this jury that you don't think his treating doctor didn't examine him? A Having reviewed the records leading up to this from December 1995 up until May 20th, which is the day before this was filled out, there are no physical findings documented on those forms, on the patient's encounter forms that would suggest that he had joint inflammation, joint swelling. He documents symptoms in those records, -- Q Okay. A -- not physical findings. Q Okay. Well let's go over this then since I understand what you're inferring from the records. Now let's go over what Dr. Komar actually wrote. Under neurological he wrote, encephalopathy he said yes, is that correct? A Yes. Q Under peripheral neuropathy he said is that early Lyme? A I have no idea what that says. Q Okay. Under arthritis, affected joint or joints? A Knees, ankles, shoulders, wrist. A Right. Q Joint affusion, -- A Yes, joint -- Q -- what does he say? A He says joint affusion, yes, joint swelling, yes, arthralgia, yes, fibromyalgia, yes, chronic, yes, progressive, yes. Q Slow down, slow down. Joint affusion, let's just go back to that first one. A Yes. Q What does that mean? A Swollen joint, full of fluid. Q Full of fluid. You don't think he found that? A It's not documented in any or his patient encounter forms. Q So he just guessed that Mr. Miller had joint or did he see him walking around like this? I mean, when a doctor comes up with a -- when he writes down joint affusion, he has to look at the joint and see that it's swollen, isn't that correct? A You just asked me two questions. I don't know where Dr. Komar came up with these conclusions, but his -- the physical findings documented in the medical record do not support those statements. Q Joint swelling, he says yes, is that correct? A Yes. Q Arthralgia, what's that? A Arthralgia is not a physical finding, it means joint pain. Q But he says yes. A Yes. Q So for two joint -- I'm sorry, physical findings he says yes, and then for the symptoms he says yes, correct? A Yes. Q And fibromyalgia he puts down yes, pardon me? A Correct. Q Chronic he says ye. A Yes. Q Progressive he says yes. A Yes. Q And then he signs it Komar at the bottom, correct? It's his signature? A Part of it, yes. Q Part of it. And it's dated May 21st, 1996, is that correct? A That's correct. Q I'll find it. Ah, here we go. The other Lyme antigen test, which was dated -- well it says received August 28th. A Of 1998. Q Of 1998. A Yes. Q And that's when it's at 47, correct? A Yes. Q And where it says -- and that's highly positive also according to this test, according to this laboratory, is that correct? A Yes. Q So from, I can't add it up, from August 28th until January '99 their result from the same laboratory went from 47 to 96, is that correct? A I'm not sure what that means, but that's correct. Q Okay. Now, Doctor, were you aware that June 2nd, 1997 Mr. Miller had gone to an emergency room because of his shaking, his tremors, he couldn't stop doing it? A He couldn't stop doing it? I -- Q Do you remember seeing that record? A I believe so. Q Okay. MR. MYERS: Your Honor, pardon me, it's 11:00, do you want to -- THE COURT: I think this is a good time -- MR. MYERS: Okay. THE COURT: -- to take a ten minute break. MR. GALLAGHER: Is it much more -- I'm just going to ask him, do you have much more, Mr. Myers, on cross? MR. MYERS: Yes. MR. GALLAGHER: Okay. THE COURT: Okay. A ten minute recess. You can step down, Doctor. (Jury out) (Court recess) THE COURT: How about that, bring the jury back. MR. GALLAGHER: Before -- oh we'll talk another -- we'll do it another time. THE COURT: Okay. (Jury in) THE COURT: Okay. MR. GALLAGHER: Take the stand, Doctor. THE COURT: Go ahead, Mr. Myers, you may continue your cross- examination. MR. MYERS: Thank you. BY MR. MYERS: Q Doctor, when I asked you earlier about the files for insurance companies that you have reviewed, did you recall, and I'll give you the date in a minute, on August 12th, 1996 testifying that at that time you had recalled reviewing approximately somewhere between 30 and 50 files? A I don't recall. Q Okay. Would you like to see your testimony? A I presume you're reading correctly. Q In the case of Mullar versus William Glenn, M.D. (phonetic). A Glenn, yes. Q Do you remember that case? A I remember the case. Q That was a case that involved Lyme Disease too, is that correct? A Yes. Q And you also recall testifying at that deposition that the majority of the insurance companies insurance files that you reviewed result in your expressing opinions that the patients did not have Lyme Disease, is that correct? A I think that's true. Q All right. Do you recall also testifying that Lyme Disease could evolve into much more serious conditions involving the pulmonary system? A I testified Lyme Disease could cause pulmonary complaints? Q You were talking about cardia myopathy? A Yes. Q There was some question about whether untreated Lyme Disease would evolve into some heart problem? A There has been some debate about that. Seemingly it does occur in Europe. It doesn't seem to happen in the United States. Q Okay. And that was one of the issues in that case? A I honestly don't recall. Q Do you recall testifying in that case that a positive test is only considered and is not diagnostic for Lyme Disease? A That's a true statement. I don't know that I said that in that case but that is a true statement. Q Okay. And do you agree that the CDC criteria for reporting purposes for a western blot is five out of ten bands? A IGG. Q Right. A And two out of -- or two out of three IGN, depending on the duration of the infection. Q Okay. And but that is not a diagnostic tool, is that correct? A It's a confirmatory tool, not a diagnostic tool. Q Right. In fact, negative doesn't mean you don't have it, the tests are just used to confirm whether somebody has it or not, is that correct? A Under certain circumstances people can be negative by blood tests. Q All right. And, in fact, the CDC and later the Food and Drug Administration would caution physicians that the mere use of a western blot was not diagnostic but it was only for reporting purposes in terms of their guidelines, is that correct? A I'm not sure what the question was. Am I aware that the Food and Drug Administration and the CDC cautioned people that they shouldn't use the western blot as being diagnostic? I wasn't aware of that but it seems a reasonable caution. Q Okay. A Because the blood test does not make a diagnosis of Lyme Disease. Q All right. Okay. But you'll with me then it's not for diagnostic -- it is not a diagnostic tool in and of itself, the western blot, is that correct? A Standing alone in isolation, no. Q Right. A As part of an overall strategy which includes history, physical and an analysis, yes. Q And do you recall whether or not you had testified that -- do you recall being asked the question for Lyme Disease, "If a patient who has Lyme Disease and does not get treated early enough, if there is a delay in the onset of treatment, that that can also cause permanent damage, can't it?" and you said, "Potentially yes." Do you remember that response? A No, I do not, but it's a true statement. Q And people who -- some of your patients that you referred to in your testimony complained of flu like symptoms, that is people who had Lyme Disease, is that correct? A Well we've gotten away from the term flu like. We call it virus like and I don't think that it's necessary to go into the details of why but there are people in early disease, many people who have what seems like a virus like syndrome early on in the course of infection, yes. Not later, but early. Q I'm just going through these, I've asked you a number of questions, I don't want to be repetitive, so that's why I'm just flipping through here and asking you what I haven't asked you yet. (Pause) Q When I asked you about taking a patient's history, there's no question in your mind that that is the most significant aspect of diagnosing Lyme Disease, is that correct? A I believe it's the most significant part of analysis of any patient, Lyme Disease or other. Q And that's something a patient should -- a physician should do every time they see the patient, is that correct? A I'm not sure that one needs to take a complete history every time one sees a patient in follow up, but certainly at the very least inquire about interim changes. Q Okay. Do you remember being asked this question, "Do you keep track of your patient's progress again in the treatment of Lyme Disease? Do you keep track of the patient's symptomatology, the subjective symptomatology as reported by the patients on a periodic basis when you see them?" And your answer is, "All symptomatology and is subjective, and the answer is yes, I do and that's not limited to Lyme Disease. It is proper practice of medicine, regardless of the disease being treated, it's called history. Question: Is this something a physician in practice should do each and every time they see a patient? Answer: Yes, anything less is malpractice." Do you remember giving that response? A No, I don't, but it sounds like a reasonable answer to the question. Q Doctor, have you conducted any of your own studies, any of your own research as to the effect of antibiotic therapy for durations longer than six weeks? A Have we done any studies on -- Q Have you done any research or studies on that? A No. Q Is continuous fatigue a symptom of Lyme Disease or could be a symptom of Lyme Disease? A It can be but it's ubiquitous in our society, unfortunately. Q How about in somebody who never had it before and then had tick bites? A What's the question? Q If somebody has tick bites and before that had never had fatigue problems, and some time after the tick bites developed fatigue problems, would that raise in your mind the suspicion that the fatigue could be from Lyme Disease? A I would look to see if there's any evidence of Lyme Disease because if fatigue is the only manifestation of Lyme Disease, I don't think it really exists. Q Okay. Can a Lyme Disease patient have weight loss or gain? A Anybody can have weight loss or gain. Q That's not my question. A Anybody, including people with Lyme Disease. Q Okay. Let's talk about people with Lyme Disease, okay? A Right, but the questions that you're asking are relevant to the real world that expands beyond Lyme Disease because they are non specific findings that can be seen by anybody in society. Q I understand that but when you look at patient's history or actually when you talk to a patient, find out what their problems are, what they're complaining about, in your own history that you do in patients who you suspect have Lyme Disease or they suspect they have Lyme Disease, you actually perform a pretty extensive history, don't you? A Yes, we do. Q In fact, -- A And we inquire about weight loss or weight gain, but that's not a very common complaint for a Lyme Disease patient. Q You require -- not inquire about -- you do a neurological exam to see if there's varied neurological components, correct? If there's -- A Yes. Q Correct? And you see there's a sensory questions whether or not the person is being -- has over sensitivity to hearing, light, smell, those kinds of things, right? A Those are relatively uncommon. The sensory changes that one sees in Lyme Disease are numbness, tingling, electric sensations, Q Right. But these are all questions that are asked of the patients? A Yes. Q Right. Whatever information or knowledge you're trying to get from the patients when you take a history. A I'm trying to get an understanding of what's going on with the patient. Q What other kinds of symptoms do you look for in Lyme Disease? A My history is not -- I referred to this briefly earlier. I don't enter the room saying this is Lyme Disease, therefore, I will look for Lyme Disease symptoms. I enter the room saying, this is an individual who is not well, a question has been raised about the possibility about of Lyme Disease based on our prior experience with Lyme Disease and the experience of others in academic centers. Most of the patents who come to a quote "Lyme Disease center" at an academic center don't have Lyme Disease. So I approach the patient interested to know if they've got diabetes or Lupus or rheumatoid arthritis or multiple sclerosis or strokes or osteoarthritis or any one of the dozens of other diagnoses that have eventually from those evaluations of people who thought they had Lyme Disease. Q And I'm sorry that I didn't make myself understood properly. I just simply asked you, why don't you -- whether you have a preconceived notion or not, I'm sorry I didn't ask you that, I just merely asked why don't you give us an overview of the kind of symptoms Lyme Disease patients have exhibited to you over the years? A Well that wasn't my understanding of your question. Q Okay. A Patients with Lyme Disease can -- I suspect that our friends here have heard this before, but we'll go at -- we'll do it again. Patients with Lyme Disease in the early localized manifestations can have a rash, they can have virus like syndrome which can include joint pains and muscle pains and fatigue and achiness, low grade fever, high grade fever is relatively uncommon but low grade fever. Those people who are severely ill with their erythema migrans. I begin to wonder about the possibility of co-infection because there are other micro organisms that can be spread along with Borrelia burgdorferi. Early disseminated Lyme Disease, the organism invades the blood vessels and escapes from the initial site of inoculation and people can develop heart disease, about 8 to 10 percent of untreated patients will develop heart disease. A small percentage, about the same can develop meningitis, they can develop facial palsy, they can develop peripheral neuropathies. Peripheral neuropathies simply means the peripheral nerves don't work properly and there can be pain or there can numbness. Occasionally there's paralysis but that's relatively uncommon. The meningitis causes stick neck and headache. Some mental clouding occasionally but usually it's relatively mild. Other nerves can be affected. In -- and that's early decimated Lyme Disease. In the late manifestations of Lyme Disease can include what we call a migratory polyarthritis which means multiple joints are affected and they move around, not the joints but the inflammation can pop from joint to joint to joint. Later still some patients will develop a chronic arthritis, usually a single joint, most often the knee. The knee can be very swollen, it can be stiff, it can be painful, but usually it's more stiff than painful. And this thing that I mentioned earlier tertiary neuro borreliasis can develop. And tertiary neuro borreliasis includes things like concentration of memory difficulties. It can include peripheral neuropathies, often sensory and quite often quite subtle. And that's pretty much it. There are rare examples of inflammation of the eye has been well described. There are rare manifestations early in disease including liver inflammation. We believe now that that represents co-infection in many cases. There are other features of Lyme Disease or Lyme borreliasis, as they call it in Europe, that are found in Europe that are exceptionally uncommon in the United States. I'm sure I'm missing one or two rare examples. There have been a few examples of inflammation of the muscle called myositis. Very uncommon but it has been described. And there are other manifestations that basically amount to single case reports, so they're not common at all. Q If Lyme Disease is not treated or is not treated successfully, what can Lyme Disease patients develop? A We can go into any one of the manifestations that I've just mentioned. Q And it could be -- some of those could be pretty disabling, huh? A That is true. Q Now do you recall being asked to testify in the case of Brandon Owens, an infant, a case involving his mother versus a Dr. Shaw? A Shaw, yes. Q Shaw, that was actually three different cases, is that correct? A It's a cluster of cases, yes. Q A cluster of cases and that also dealt with Lyme Disease, is that correct? A Yes. Q And that was another -- in those three case you had rendered the opinion that there was no Lyme Disease, is that correct? A That's correct. There are other -- there are actually more cases than that against the same physician. Q Okay. And you've been hired to testify in his behalf in all of those cases? A No, not on the physician's behalf, on the patient's behalf. Q I mean -- A In a number of cases. Q Right. A Not all of them I don't think, but I think there are something like 13 or 14 cases against him. Q Okay. Would you say that with your training, that you are very sensitive in terms of the information that you gain yourself of your own physical examinations of your patients? A I believe that is the case, yes. Q Now you were asked at this time you were also involved in the serum trials? Were you involved in testing serums for Connaught Laboratories (phonetic), the serum to prevent Lyme Disease? A What you are referring to is the vaccine trial. There's a Lyme Disease vaccine -- Q Vaccine. A -- that was put out by -- that was tested by Connaught. And as part of the evaluation of the patient's -- of the subjects that we saw, we were allowed to do serologies locally, blood tests locally to aid in the diagnosis of patients who might have developed Lyme Disease during the course of the trial, but beyond that no, we were not the central laboratories for that trial test. Q You weren't the principal investigator? A I became the principal investigator, yes. Q And -- A And I'm the lead author on the paper that appeared in the New England Journal of Medicine. Q What was the result of that? A The vaccine is effective and safe. Q And then there is a number of malpractice cases out there that's physicians in the laboratories now -- MR. GALLAGHER: Objection, Your Honor. Q -- involved with the side effects of those, is there not? THE COURT: If he knows. A Against whom? Q Against you, against Connaught Laboratories, against a whole bunch of people. A There've been no malpractice cases against me, and as for the rest, I can't speak about that. I know of one, but that's -- we can talk about that if you like, but I have nothing to do with that one. Q Okay. Do you recall testifying on behalf of the Metro North Railroad in a case where a railroad worker had claimed he had gotten Lyme Disease as a result of working outdoors, do you remember that case? A There was a gentleman who claimed he got Lyme Disease from working on the railroad, yes. Q And you testified on behalf of Metro North in that case, is that correct? A Yes, I did. Q Doctor, could you have a different interpretation of another physician with like face palsy or facial palsy, whatever you called it? A Can I have a different interpretation? Q Yeah, do doctors have different interpretation -- if somebody says I have a problem with my face, you may call it Bell's palsy and somebody else may not call it Bell's palsy -- may call it something else? A Bell's palsy refers to a seventh nerve or facial palsy where no explicit cause is identified, that's what a Bell's palsy is. If you're saying can I have a different interpretation of what a facial palsy is, I don't know what else anybody else would call it except perhaps Bell's palsy. That's a misuse of the term in the setting of Lyme Disease. Q Let me ask you this to get more specific, before this case, did you ever review records of Dr. Spitzer in any other case, in any other reason? A I don't believe so. Q Okay. And before this case have you ever reviewed any of the records of Dr. Michael or -- A Maloney? Q Maloney? A No. Q Okay. A I don't believe so. Q When you take a history from a patient and when you examine them, are there certain clues a patient can give you from your own observations? Not from words that the patient tells you -- A You mean body language, that sort of thing? Q Body language. A Oh certainly. Q Okay. And in terms of when you treat patients, you use that, that sort of extra sense that you developed over the years to see that body language of a patient, is that correct? A When I'm the treating physician, yes. Q That's correct. Can Lyme Disease patients develop rashes behind their knees? A You mean can they develop erythema migrans behind their knee? Q Yeah. A If they're bitten by a tick behind their knee, yes, they can develop erythema migrans. It's actually quite a common place to have erythema migrans. Q Oh. How about around the waist? A That's another common place. A tick seeks out places that are warm and moist, so it typically winds up in the groin, underneath the beltline, behind the knee, armpit. Q So won't have to worry about getting one on the top of my head then? A Most adults don't get it on the top of head, regardless of their ground cover. Q Well when you're folically impaired you think you're sort of immune to that, but -- A Well don't go rolling around on the grass, you know. Q Okay. A That's why children get tick bites in the head, presumably, where they roll around in the grass whereas adults are a little more circumspect about these things. Q I wish I would have known that when my kids were younger, because -- all right. Doctor, did you review the article of "Neuropene Neurology" authored by Pat Coyle and Richard Lipton? A Which journal? Q It was an article -- A In European Neurology? Q I believe it is. A And what's the title? Q "Neuropene Neurology." Let me just -- this will help your recollection. Going back to your deposition of February 5th, 1996 in Owens versus Shaw case, "Are you aware of some of the literature which has recently been released, published about chronic refractory seronegative neuro borreliasis? Answer: Which literature are you referring to? Question: Specifically the article of "Neuropene Neurology" authored by Pat Coyle and Richard Lipton. Are you familiar with that case?" A I think that's "European Neurology." Q Oh, "European Neurology?" A I think that's the case. Q Okay, and your answer was "Yes, there's no question there's no question there's such a thing as seronegative Lyme Disease," do you remember that response? A It does occur, yes, or at least it's been reported. It's exceptionally uncommon but it's been reported in individual cases. Q But it's out there, isn't it? A You make it sound as though it's stalking us. No, I believe it probably does happen, but it's exceptionally uncommon. Q Okay. Doctor, if somebody doesn't treat with antibiotic for Lyme Disease, you've already told us about some of the things that they could develop. You've also told us on direct examination that you're concerned about people who are misdiagnosed with Lyme Disease and are subjected to antibiotic therapy that there could be some side effects in the long run, is that correct? A Yes. No, not in the long run. I'm concerned about the exposure to the antibiotics, but I'm also concerned about the psychological impact of carrying this diagnosis. Q What about the psychological and physical impact of the under diagnosis of Lyme Disease that goes untreated and where medical care is turned down because an insurance company has an opinion from a doctor who says there ain't no such thing, do you ever take that into consideration? MR. GALLAGHER: Objection, Your Honor, this isn't about an insurance company. I'm Conrail or at least I'm representing Conrail. THE COURT: I'll let him answer but I don't want it to go much further. A I take my responsibilities, both in the clinic and in reviewing records, very seriously. And I realize that every time I write a piece of -- I write a word on a piece of paper, it has ramifications far beyond my own petty concerns. So I do not lightly write an opinion to an insurance company, a lawyer, an employer, whomsoever. Q Okay. Well, Doctor, what you've done in this case is you've rendered an opinion which concerns the future of a man's life without even meeting him, isn't that correct? A I've rendered an opinion. Q Without even meeting him, without even examining him, without even getting to know him, is that correct? A I've never had the pleasure of meeting the gentleman, no. Q And is it fair to say that after you testify today you'll have nothing else -- you'll never see him again, never talk to him, never hear from him, is that correct? You have no responsibility to him as a doctor, is that correct? A I believe I do, actually. Q Oh, you do? You're not his treating doctor, are you? A No. Q So if the jury believes your testimony that he doesn't have Lyme Disease, that affects his future for the rest of his life. That affects whether he gets medical care past 1999. What responsibility do you have you -- that you have to him if you're wrong? A I don't believe I'm wrong. Q And others doctors do, don't they? A Other doctors have invented a diagnosis of Lyme Disease in this gentleman that I don't think is supported by any objective findings. And I think that to continue his treatment along the lines of Lyme Disease is not in his best interest. Q Well when you say not in his best interest, have you ever been wrong in the treatment of your own patients? A I believe so. Q So if you're wrong with Mr. Miller, he has no future, he has no recourse if you're wrong, isn't that correct? A I don't believe that's the case. Q He has no recourse against you if you're wrong in this courtroom because you're not his treating physician. He can't sue you for medical malpractice, because you have no -- MR. GALLAGHER: Objection, Your Honor. Q -- legal responsibilities, -- THE COURT: Mr. Myers. Q -- isn't that correct? THE COURT: Mr. Myers, don't badger the witness. Just ask him a question. Q In one of your reports you have referenced a spec scan that was interpreted by Dr. Rashid or Fawwaz Rashid, is that correct? A Yes, and then reinterpreted by his boss, apparently. Q Right. Not apparently, we've heard ad nauseam that it was interpreted by Dr. Van Heertun because Mr. Gallagher even showed him Dr. Vanderdent's book. And the reinterpretation by the chairman of the department, in a sort of way, you're chairman of your department, right? A In a sort of a way. Q Well you're a chairman, right? You're the chief. A I'm a chief, I'm not a chairman. I'm a chief. Q Well you're a chief, right? And he's the head of his department, correct? A Yes. Q So in reinterpreting or looking at the scan and coming up with his own opinion, he found that the brain spec scan could be consistent with, among other things, Lyme Disease, is that correct? A It could be compatible with Lyme Disease, yes. Q It could be compatible with Lyme Disease. So if you look back on here, now that we have Dr. Van Heertun's interpretation, it could be compatible with Lyme Disease, now that you know that Mr. Miller who had reported two rashes, two rashes after both tick exposures, now you know that he has two positive urine antigen tests, and he's been explained by a neuropsychologist, two psychiatrists, and is treated by Dr. Liegner and Dr. Komar, his internist, all those people have come to the conclusion based on that data, that evidence that this man has Lyme Disease, is that correct? A Those are their interpretations, yes. Q Since you've been involved in this case since I believe it was October? A October -- Q Yeah, October. A October 8th was the date of the letter, the initial letter from Mr. Gallagher. Q Since October, I assume, as a man of good will, you're strong in your views, is that correct? A Thank you. Yes, I believe I am. Q I assume that your belief is so strong that you have communicated your strong and firm belief to his treating physicians to hey, stop doing it, get onto something else, isn't that what you've done in this case? A No, of course not. Q Isn't that your obligation under the Hippocratic Oath to go where you have to go with a patient and make sure that he's getting taken care of by whoever whom properly, isn't that your obligation under that oath? A I'm not sure that Hippocrates foresaw malpractice cases and this kind of thing, but here I am today saying that I think that his care should be changed. So now it's in the record, is it not? Q Isn't the record -- now answer my question, whatever houses -- MR. GALLAGHER: Objection, Your Honor, he answered the question. THE COURT: No, he didn't. He didn't. Q -- I may visit, you're supposed to take care of the sick. How do you take care of the sick if you don't contact his doctors who you think is wrong? How do you take care of the sick, by getting paid by Conrail -- MR. GALLAGHER: Objection, Your Honor. Q -- to come before this jury -- MR. GALLAGHER: Objection, Your Honor. Q -- and not treat this patient? THE COURT: Mr. Myers. MR. GALLAGHER: Objection, Your Honor. THE COURT: Sustained. The jury will disregard Mr. Myers' childish outburst and please stop it. A Was there a question in there? I didn't think so. Q Brain spec scan, as you said, was consistent with Lyme Disease, correct, among other things? A Among many other things, yes. Q Okay. In his medical history, you got his Contrail medical records, is that correct? A Yes. Q This man, before he had tick bites, had no symptoms of joint pain, arthritis, is that correct? A He had no symptoms of joint pains, that would seem to be the record, yes. Q Right, and he had no problems of sleeping 16 to 20 hours a day, is that correct? A That's correct. Q He didn't have an over sensitivity to noise or smell or sight or light, is that correct? A It's not stated in the record. Q Did you see it in any of the Conrail medical records that he had any of those problems? A I just answered your question, it's not stated in the record. Q You reviewed his medical records from Conrail, correct? A Yes. Q Doctor, you testified in your opinion how long a tick has to be on somebody before they can get the exposure of Lyme Disease? A I'm not sure that I've ever testified to that effect, but I've reviewed the literature on that. Q You never testified that you thought a tick would have to be on someone for 48 hours? A If I were asked that question, that's what I would say. It's actually probably more than 48 hours. Q Were you given the history concerning Mr. Miller that he had been removing ticks from himself for days after each exposure? A I seem to recall something to that effect in the record, yes. Q Now the physicians' records that you reviewed, do the physicians all conduct -- did they all conduct the same physical examination of Mr. Miller? A I have no way of knowing. I wasn't there. Q Okay. In fact, you have stated in the past "that especially when a problem of a diagnosis is clearly not known, that the history and physical examination must be complete in order to document what's going on," is that correct? A If one is the treating physician, absolutely. Q Okay. Do you also remember testifying in the case of Elizabeth Klein? A Yes. Q Is that a case involving Lyme Disease? A If I'm not mistaken it's a case not involving Lyme Disease. If I'm not mistaken, this is a lady who had a breast mass that was misdiagnoses as being Lyme Disease of the breast. Q No, the question there was whether or not she had Lyme or not, is that correct? A I believe she was misdiagnosed as having Lyme Disease, instead had breast cancer. Q Right. Doctor, other than the income you derive from the medical legal cases, the cases you -- that you accept from -- or the files that you review for insurance companies, my understanding that the other monies that you would get from lectures and stuff are turned into your school, is that correct? A That's incorrect. Q Oh, I thought you -- you keep those too? A Yes. Q Okay. A They underpay us so they allow us to keep those records -- those fees. Q Doctor, back in 1991 did you serve at a NIH state of the art conference, the National Institute of Arthritis and Muscular Skeletal and Skin Diseases on a therapy panel -- A Yes, I did. Q -- with Raymond Detweiler, Alan Steer and Kenneth Liegner? A I'm not sure that Alan was on that panel. There was a diagnostic and a therapeutic panel. I don't remember who was on which. Q Okay. Let me show you -- that's okay. Perhaps this will refresh your recollection. A Yes. The chair was the late Sheldon Wolfe. Q Right. Now do you remember under the importance of medical history and physical examination, "An accurate and detailed medical history and careful physical examination form the basis required for arriving at a correct diagnosis for Lyme Disease?" A That's a question? Q Do you remember that statement being published by -- A Yes, it's pretty much the same statement that we've discussed on a number occasions, yes. Q And the conclusion -- one of the conclusions of the conference was "later manifestations of Lyme Disease are more difficult to treat, sometimes requiring longer and more intensive use of oral antibiotics or parenteral administration of antibiotics, particularly in patients with CNS involvement. The efficacy of long courses of antibiotic therapy remains to be demonstrated and needs further study," correct? A Yes. Q Do you remember reviewing the article "Seronegative Lyme Disease," one of the authors being Raymond Detweiler? A New England Journal of Medicine 1992, '93, something like that? Q Yes. A Yes. Q And was that part of the academic information you had in terms of supporting the findings or the opinions that one could have Lyme Disease and be seronegative, is that correct? A Is that part of the academic or part of the information base that one uses in thinking about Lyme Disease? Q Yes, sir. A Yes. Q And what about this article, "A seronegative chronic relapse in neuroborreliasis" -- A Borreliosis. Q -- by Lawrence Lipton, Lowery and Coyle, European Neurology? A That's the one you were referring to previously. Q Okay. And you have reviewed that? A I've read it. Q Okay. A In medicine, review means you review it for the editorial board. I've read it, I did not review it. Q Now you had mentioned earlier in direct that something was being developed about a new test for Lyme Disease? A Yes. We're in the process of doing that now. Q You're in the process -- well isn't it a fact that Dr. Steven Phillips have wrote an article about the culture test that he has developed up in Connecticut? A Yes. Q And that is being investigated at this point, is that correct? A It's been published. I don't know that it's being investigated. Q Okay. And -- A The studies have apparently been done. Q And, in fact, it's hoped that that will establish the gold standard in laboratory diagnosis of Lyme Disease, is that correct? A We all hope for gold standard. I have no idea. I have not reviewed the paper, I don't know the data. Q Okay. Have you reviewed Dr. Fallon's article, "Functional Brain Imaging and Neuropsychological Testing in Lyme Disease?" A I've read it, yes. Q Okay. A It was published in a supplement to clinical infectious disease, I believe? Q Yes. And from your information, Dr. Fallon works a great deal with brain spec scanning, is that correct? A That's the impression I've been given by his testimony. Q Okay. And here's an old article, and maybe -- I don't know if you remember it or not, by Preac, Mursick, Weber, Fister, Wilsky, Gross, Procop (phonetic) about survival Borrelia burgdorferi in antibiotically treated patients with Lyme borreliasis? A Borreliasis. Q Borreliasis. A Yes. Q Okay. A It's a European study. Q Okay. And there's another European study that from 1993, I think you mentioned it, "Persistence of the same Borrelia burgdorferi in ligament is issue from a patient with chronic Lyme borreliasis?" A Yes, Austria or Germany, yes. Q Okay. Did you review Dr. Bransfield's extensive examination of Mr. Miller? A Yes, I did. Q That's these charts, this, right? A Yes, I looked at those. Q Okay. Did you see any other physician who made as compressive examination of Mr. Miller, did you find any other physician in their records that they did as comprehensive examination of Mr. Miller as Dr. Bransfield? A They did different evaluations in the neuropsychological testing. Q Okay, comprehensive examination. A This is a psychiatric examination. Those were neuropsychlogic evaluations. I presume -- they may very well have been equally as comprehensive but just in a somewhat different direction. Q Okay. Well you recall that he was -- he did an examination, he was asking questions and getting a history and doing examinations, and I'll go through it quickly, memory processing, cognitive processing, imagery, thought processing, mood symptoms, behavior symptoms, psychiatric syndromes, sleeping, eating, sexual, temperature controls, headaches, cranial nerves, seizures, et cetera, et cetera that involved psychiatric and physical examinations, did it not? A He did a neurologic evaluation. I'm not sure that he evaluated all the joints and such. Q He did a neurological, he also did a muscular skeletal, is that correct? A Okay. Q Do you want to look at your records? A I don't have those here with me. Q Okay, let me show it to you. A I will accept as a fact that he did all those things. Q But I'm asking you, is there any other physician's records that indicate that they did as thorough an examination as Dr. Bransfield? A I don't believe that anybody's records are quite so -- Q Prolific? A -- thick. Q Thick. Okay. Now, Doctor, and something that I went briefly with Dr. Spitzer, in terms of, and wherever you view these other physicians, your philosophy of treating Lyme Disease is distinctly different than the philosophy of Drs. Fallon, Liegner and Bransfield in this case, is that correct? A So it would seem. Q So it would seem. But, I mean, you know that from a historical perspective as well as currently, is that correct? A You mean in general what they do as opposed to in this specific case? Q In general. I mean, before this case, you had known about the treatments by Drs. Liegner, Bransfield and Fallon, is that correct? A I had come across some of their patients in the past, yes. Q Okay. But you've read some of the things they've written to, isn't that correct? A Well I've never read anything that Dr. Bransfield has written except for patient records. I've read a few papers by Brian Fallon. He does not -- does not focus on treatment. He focuses more on identification of psychological and psychiatric problems in Lyme Disease patients and Ken's -- Dr. Liegner's work, most of it I've come across in records of patients that I've consulted on where I've seen the -- Q Pardon me, pardon me. A -- patient, taken a history, done a physical examination, laid on hands, done the kind of work that I'm supposed to be doing for the patient when I'm the treating physician. Q Right. But in terms of your philosophy concerning your findings and your philosophy and your treatment philosophy concerning Lyme Disease and their's, it's distinctly different, is that correct? A There are differences. Q There are major differences, isn't there? A In certain circumstances, yes, I believe that's correct. Q And part of the major differences is in your belief that antibiotic therapy should stop at a certain point and they have the belief that antibiotic therapy should continue, is that correct? A That's part of the difference, yes. Q That's part of the difference. And also part of the difference is your belief that there is no chronic Lyme as opposed to their belief that there is chronic Lyme Disease, is that correct? A I'm not sure that that's a fair statement. Earlier you asked me if there is such a thing as possibly chronic Lyme Disease and I said yes, there is a possibility. So I would not answer your question. Q Okay. Well if you don't get better, if you've diagnosed your patient with chronic Lyme and you give them the six weeks of antibiotic therapy and they don't get better, then what do you do? A I re-evaluate. If -- in the clinical practice of medicine you constantly have to re-evaluate. You do things to your patient, hopefully for your patient and you re-evaluate. And if somebody does not get better, you have to go back to basic principles and ask yourself, did I make the correct diagnosis? The majority of patients who are treated with antibiotics for Lyme Disease who don't get better seem not to have Lyme Disease initially. It was an initial misdiagnosis, a statement that Ray Detweiler has made in public and I've made in public, and I believe that Alan Steer has made in public as well. You have to reconsider in the absence of a response, of a clinical response and of objective changes should lead a responsible physician to ask the question, was I right in the first place or is it possible that I somehow missed something. Q Well how can you have chronic Lyme Disease? Then according to you all Lyme Disease should be cured by antibiotics so there would be no chronic Lyme Disease, is that correct? A That's not true. Q Well you just said if somebody you think has Lyme doesn't get better after six weeks of antibiotic therapy, you're going to question your initial diagnosis. A Of course. Q In the same breathe, you're saying well I do believe there's a chronic Lyme Disease. Chronic means something that goes on for a long time, correct? A Yes. Q And that could go on for years? A Yes. Q So as you sit here today, you are telling us, are you not, that you do believe that some people with Lyme Disease could have it for years? A No, I believe that people who have Lyme Disease can be ill in the aftermath of their Lyme Disease. A perfect example of that is Lyme arthritis that does not respond to antibiotics and now there's reasonably good evidence to suggest that what's happened is the immune mechanisms have taken over causing inflammation of the joint, having nothing to do with the persistence of organism because the organism is absent. The same thing we believe is going on in neurologic disease in some cases, and in the majority of patients that we've seen, their ongoing illness, their ongoing not feeling well has nothing to do with Lyme Disease. Q Well I guess what I don't understand then, and maybe you can help me, then you don't -- is there chronic Lyme Disease or just the sequela of Lyme Disease that you think is chronic? A There are many patients who have the sequela of -- who have things that happen after Lyme Disease. The perfect example being that not infrequently people with Lyme Disease will have sleep disorder as part of their Lyme Disease. And the sleep disorder does not go away. And so if you have persistence of sleep disorder, you may have later problems, including the syndrome called fibromyalgia. But that's not active infection causing fibromyalgia. Q Oh, okay, then maybe this will help me understand it then. Then what you're saying is, and correct me if I'm wrong, is that once you have Lyme Disease, you contract it, you get it from the ticks, that there are certain things that, like a domino, it causes other things to develop which can affect the patient, but it starts with the Lyme Disease, is that correct? A There are patients in whom that is the case, yes. Q Oh, I see. So you can get the Lyme Disease and develop some of these other sequela that can, in fact, be disabling, is that correct? A It can happen. Q Okay. So with just going back to my original question, because then maybe you did answer that, and I'm sorry, I don't quite understand it, I understand that aspect of it now, thank you, what I'm asking now is, just look at active Lymes Disease and it's Lyme, I keep putting an S on it, I know that's a problem, -- A I've noticed that. Q When I was in school I used to say Illinois too and I never could get that right until later. But if you look at Lyme Disease, active Lyme Disease, in your opinion you're telling us that should stop, the active Lyme Disease should be stopped by the antibiotic therapy, correct? A Yes. Q So in that sense, is it fair to say you don't believe in chronic Lyme Disease itself, the Lyme Disease itself, only the sequela, something that it causes to happen afterwards, is that what you're saying? A No, I'm not saying that. Q Well then I'm sorry, then I did not then -- then let me ask it a different way because as a layperson it's very difficult to understand this. Lymes Disease, Lyme, not Lymes, Lyme Disease, when somebody develops Lyme Disease, they come in, you treat them for a certain period of time, you expect them to no longer have active Lyme Disease after a certain period of time on antibiotic therapy, correct? A Yes. Q Okay. A Can we define the term though, if we'd say active infection with the organism? Q Okay, active infection. So in all cases, 100 percent of the cases, it's cured though from antibiotics, is that what you're saying? A No. Q Okay. So there is some Lyme Disease, active Lyme Disease that can continue past that stage? A Active infection. Q Yes. A There are examples of people who have not taken their antibiotics, have not absorbed their antibiotics, whatever, who seem to have not been successfully treated with their early disease. Q Okay. Now -- A They've gone onto later manifestations. It's exceptionally rare, but it does happen. Q Okay, when you say absorption, there's just something about the body that doesn't take in -- A Correct. Q -- the drugs correctly in the -- A As am example, in the old days, Tetracycline, if you took Tetracycline along with milk, the Tetracycline bonded with the calcium, it didn't absorb the calcium from the milk, didn't absorb the Tetracycline. Q Okay. But if we get past that initial stage now of treatment, then is it fair to say that a Lyme Disease patient, somebody who had active Lyme Disease, can continuing -- can continue, in suffering from various symptoms of the disease, pass the stage of the active virus, did you say? A No, it's a bacteria. Q Active bacteria. A Spirochete. Q Spirochete. A If you've asking can you be treated for Lyme Disease, have the infection eradicated and continue not to be well, the answer is, of course, yes, especially if your physicians don't attend to what you really have at the time. If they continue to treat an infection that's already gone, antibiotics do not treat sleep disorder, they do not treat depression, they do not treat fibromyalgia and we've proven that in my CV. If you don't attend to what the patient really is, which is to say if you don't ask the question, why is my patient not getting better, is it possible that I'm missing something, is it possible that I was wrong in the first place or maybe I was right in the first place but there's something else going on now, if you don't attend to those issues, the patient doesn't get better. Q And then in terms of the treatment itself, looking back on the treatment of Drs. Liegner and Bransfield, isn't it fair to say in review of their records that they've ruled out a certain number of other diseases that may have caused those same symptoms? A They looked at some things, yes. Q Okay. Now so at this point, at this point, since you now know from the testimony of Mr. Miller that it's true that he had the rashes, he had the tick bites, he had the rashes and he developed all these symptoms, wouldn't it be fair to say at some point he may have had active Lyme Disease? A I said that earlier. Q Okay, so then -- A It's a possibility. Q It's a possibility. So taking that possibility then that what he could be suffering from today is a sequela from that original Lyme Disease active spirochete, is that correct? A Based on my review of the information available, I don't believe that's the case. Q If Mr. Miller -- going back to that, you reviewed Conrail's medical records, he had no other medical problems before that, what else is causing it? A This gentleman can have a variety of different things that may cause symptoms that have nothing to do with Lyme Disease. The world does not come to a halt after you're bitten by a tick. People's medical conditions change. You can be involved in an inhalational accident. Q Right. A You can be in a car accident. You can -- I mean, any one of a cogillion different psychological problems can afflict you and they have nothing to do with Borrelia burgdorferi and, therefore, will not respond to antibiotics. Q And that's what separates your opinion in this case from his doctors, is that correct? A My opinion and some others as well, yes. Q Well your opinions and the other doctors we've heard from in the last day or so, but in your position, your position differs in that respect from the treating doctors, correct? A Yes. Q And so in terms of your opinion, the other treating doctors may not have been wrong by finding that he had an active Lyme Disease at some point, is that correct? A It's a possibility. Q Okay. Is it a stronger possibility now in your mind knowing that he had two tick exposures followed by rashes followed by flu like symptoms? A Well at the beginning of this experience with you we started off with two episodes of tick exposure and one rash. Then it became two -- Q No, no, that's the information you had. A That's right. At the beginning of our interaction this morning I was aware of two sets of tick exposures and one rash not corroborated by a physician's observation. This morning I found out that there were two rashes and now in the last 25 seconds I'm told that they were associated with flu like symptoms. So if the case continues to change, then perhaps there are differences, but I'm not really sure that I can accept the changes that are accruing to this case as being part of the analysis. People's recollections change, especially when they've immersed themselves in the literature of Lyme Disease. Q Wouldn't it have been better for you, then, in terms of your expertise, to actually sit down with Mr. Miller and ask all these questions that you know are important since you're an expert in the field? A I was able to review a lot of records. Q Answer my question. Answer my question. A If you'd give me a chance, I'll be glad to answer your question. Q Please. A I've reviewed a lot of information and I did not see that there was gaping holes in the amount of information that I had. Q I think we could all agree, Doctor, and correct me if I'm wrong, but don't you think you're just a little bit more experienced in talking to a patient than the other doctors who testified for Mr. Gallagher for Lyme Disease? A Not necessarily. For Lyme Disease? Perhaps. Q For Lyme Disease. A But if you're talking about a competent infectious disease person and a competent neurologist, I don't think that I'm any better in taking a general history and both of these people can certainly have read about Lyme Disease and can certainly make valid -- can certainly get proper information and make valid conclusions based on their prior experience. Q What about an infectious disease expert who doesn't believe in chronic Lyme Disease? Are you aware that Dr. Spitzer testified that he doesn't believe in chronic Lyme Disease? A That may not be his personal experience. MR. MYERS: Thank you. I have no other questions. THE COURT: I'm glad you looked at the clock. MR. GALLAGHER: Pardon me? THE COURT: I'm glad you looked at the clock. MR. GALLAGHER: Sure. If I can have just 30 minutes or -- THE COURT: It has been the pattern in this case that oft times cross- examination lasts longer than direct. MR. GALLAGHER: Right. THE COURT: In my experience of practicing and trying cases for 30 years I often found that to be the case. REDIRECT EXAMINATION BY MR. GALLAGHER: Q Doctor -- THE COURT: Sometimes by my own mouth. Q Doctor, in this particular case, are Dr. Fallon, I don't know if my grammar is right I'll say are, are Dr. Fallon, Dr. Liegner and Dr. Bransfield going to what could be a sequela of Lyme Disease their punitive diagnosis of Encephalopathy and saying he has an Encephalopathy and now we're going to go back because he said he got bit by a tick and had a rash, the Encephalopathy must be from a Lyme Disease, is that correct? Isn't that how their rationale -- A This is, as they teach you in debating class, post hoc a reprover hoc (phonetic). You know, everything -- Q Explain the Latin. A Everything that happens after an event is not necessarily because of the event. If I cross the street and it rains this afternoon, I did not cause it to rain. I am not the rain God. So one can be exposed to ticks. One can, in fact, have had Lyme Disease and develop medical problems years later and the two need not necessarily be related. It's a fallacy, it's a possibility, but to jump to that conclusion that there's a relationship between the two is very dangerous. I mean, it's dangerous for the patient because the patient is then burdened with the diagnosis that's unsupportable and incorrect. Q So in this case do you agree with me -- A Yes. Q -- that's the -- A Yes, I believe that's the case. Q They went to the end and they make a punitive diagnosis of Encephalopathy and then jump back to the beginning and say, aha, it must have been from Lyme Disease, correct? A I believe that is the case. Q And, in fact, the Lyme Disease itself, the infection by the spirochete was never documented anywhere in the medical records, is that correct? A That's correct. Q Now in those medical records you were shown a statement of medical necessity. I'd like you to refer to pages beginning at 43 and going backwards to 37, and go through what Dr. Komar wrote with regard to December of 1995 through I guess May 20th, the day before he wrote the statement of medical necessity as to what he -- A Right. Q -- as to what he saw in the patient, not what the patient told him but what he saw. MR. MYERS: Objection. Another document showed an examination, not his characterization. I object to his characterization of it. THE COURT: Well we all understand and I remember this subject coming up at least a half dozen times in this case, that there were two written documents produce by Dr. Komar. One is this certificate of medical necessity on which he reports what he reports, and the other are his actual office treatment notes. And I fully understand, I'm sure the jury fully understands, that there have been witnesses who have testified that on the former form he answers affirmative to certain physical symptomatology and I believe the question of this doctor was whether there is reflections of those observations in the treatment notes. MR. GALLAGHER: Exactly. THE COURT: It's proper redirect in light of the time you spent with the form, so I'm going to let him answer. Am I right, Doctor? DR. SIGAL: I believe so. THE COURT: All right. I figured that out. Look at that. DR. SIGAL: Who am I to argue, but that is correct. THE COURT: Well -- A On 11/20/95 bronchial asthma is the diagnosis. Under extremities, normal ortho, which I presume refers to the muscular skeletal system, although I'm not really sure, it's a peculiar way of putting together a record, but it says N. MR. MYERS: Objection to his presuming. Now he's presuming what another doctor -- THE COURT: Don't editorialize. Q All right, what does ortho mean in medical terms? A I can only presume that ortho refers to the muscular skeletal system. Q Orthopedics deals with the muscular -- A Muscles, joints and bones. Q The word joint is associated with muscles and bones, right? A Yes, I can only assume that. MR. MYERS: Your Honor, can we just ask Mr. Gallagher not to lead his witness? THE COURT: Yes, don't lead him, he is yours. I know that -- MR. MYERS: Right, this is redirect. A Well on 11/20/95 there's normal for extremities, normal for ortho, normal for neuro. On 12/11/95 there's normal for extremities, it looks like cranial nerves 2 through 12, but it doesn't say anything abnormal about them and ortho negative, which is a minus sign with a circle around it. 3/11/96, extremities without, it's an S with a bar across the top which in medical abbreviation without CCE clubbing sycosis or edema. It's just a common way of dealing with changes that can be seen, especially in the fingers and toes. Q What's edema? A Edema is swelling. Q So it's -- A Negative. Q Negative for swelling. A And ortho, there's nothing written in. This is 3/11/96. 3/20/96 again extremities without clubbing sycosis edema, ortho arthralgia and myalgia. Those are not physical findings, those are symptoms. And it means -- Q What does that mean? A Arthralgia means joint pain and myalgia means muscle pain. Q Does that mean that someone is telling the doctor that he has muscle pain or -- A Yes, that's what it means. There are no objective findings here of inflammation, that's what it means. That was 3/20/96. Q I think it's page 37 was the next one. A Well no, that was page 41. We're working our way forward. There's a -- that's not a medical record. 4/5/96, without clubbing sycosis edema, orth arthralgia. Again, no physical findings to suggest an abnormality, just the symptoms are listed. 7/8 -- we're out of -- Q You have to go -- A We're out of order. We're out of order. This is 7/8/96, which is after the statement of necessity, but 5/20/96 is without clubbing sycosis edema, ortho, Lyme:arthralgia. Q Which? A Which means he has joint pains and the doctor says that it's Lyme Disease. Q Okay. A But there are no objective findings in any of these -- on any of these pages. Q Now a Bell's palsy, how soon after an exposure to ticks does a Bell -- that someone develop a Bell's palsy -- strike that. After exposure to a tick, if the patient develops Bell's palsy, in order for the Bell's palsy to be a objective sign of Lyme Disease, how soon after the exposure does Bell's palsy have to manifest itself? A Okay, I'll try to rephrase that to make it a little clearer, to me anyway. Q Sure. A Seventh neuropalsy, facial palsy, facial droop occurs as a manifestation of Lyme Disease. About 10 percent or so of patients will have it. It can occur a day after the tick bite, that's very uncommon. It's typically about a month or so after the tick bite, a few weeks to a month or so, and it's been reported as long as six or so months after. It's very unusual. It's usually within the first few weeks of the infection. But to have a seventh neuropalsy, facial droop, a year and a half after a tick bite I think most rational physicians would say that the two are not related to each other. Q And if the palsy manifests itself in connection with it shortly after a manifestation of shingles, what would that mean? A I would be concerned that the man or woman patient had herpes as a possible cause of the seventh neuropalsy because shingles is a skin feature of herpes infection, a virile infection. Q Are tremors a side effect of antibiotics? A I don't believe so. Q Is diarrhea a side effect of antibiotics? A Yes, it can happen after antibiotics, with antibiotics. Q What other side effects can antibiotics have? A Oh, antibiotics can cause bone marrow problems. They can basically wipe out your ability to make red cells, white cells and platelets. Rash. You can have an allergic reaction to the antibiotic. And there are others but those are I think common ones. Q Doctor, in the cases you've reviewed to determine whether or not there was Lyme Disease, have you found cases -- have you rendered opinions where yes, in fact, there was Lyme Disease? A Oh certainly. Q Now you used the ubiquitous for some of the symptomatology that Dr. Bransfield is relying on in saying this patient has Lyme Disease, what -- just explain what ubiquitous means? A That was in reference specifically to fatigue. Being tired is unfortunately part of the 1990s for many people. We're overworked, underpaid, running around, children, career and we're tired. Lord knows I am, especially after this morning. And the problem, of course, being -- THE COURT: Do you see those ten people? DR. SIGAL: I know. THE COURT: This is day eight. A Yeah, unfortunately I'm a very long winded individual and I'll try to keep it short. Ubiquitous means it's all over and it is all over. We're all tired. And so to say that isolated fatigue is a manifestation of Lyme Disease, I do not believe that is the case. I've never seen such a case. Q Now is it -- basing your experience, and we'll limit it to the cross rotations that you treat in the area of of what you're practicing medicine, is Lyme Disease being over diagnosed or under diagnosed? A Now, again, my experience is that of a referral physician, so I'm not see a cross section of society. I'm seeing what walks in my door and what crosses the wires to my ear. But certainly my impression is that Lyme Disease is over diagnosed and over treated and it's an opinion that we published on and it's an opinion that Alan Steer and others have published on as well. So it seems like a pretty routine experience that only about a quarter to a third of the patients referred to a university based Lyme Disease program, if you will, actually ever had or have at the time of evaluation Lyme Disease. So it means that two-thirds to three-quarters of the patients either don't have it or never had it. Usually never had it. Q Doctor, there was reference to Dr. Liegner's letter on cross- examination. Is this the response from the -- well first of all, is this a letter I think it goes to the annuals of -- A Of internal medicine. Q -- internal medicine, okay. And this is found, and I don't know the exhibit number but it -- or maybe there never was one, but it's the physician's papers, clinical guidelines parts I and part II of the American College of Physicians and the Annuals of Clinical -- Annuals of Internal Medicine. I'll mark it D-206. A 206? MR. GALLAGHER: Yeah, 207? A That's a lot. MR. GALLAGHER: No, it's not that many. COURT CLERK: 207. MR. GALLAGHER: 207, thank you. COURT CLERK: No, 208, I'm sorry. MR. GALLAGHER: 208, okay. Q Who did -- Doctor, does it show here a letter from Dr. Liegner to the editor? A Yes. Q Who -- A In response to the article. Q In response to the article. Who responded in a letter -- who responded to the letter that Dr. Liegner wrote, what are the names of the people? A Peter Tugwell (phonetic), who is up on Ottawa, Alan Steer, who is in Boston at Tufts New England Medical Center, and Art Weinstein who at the time was at New York Medical College. Q Would you read to the jury the response by those individual, and I think the first -- it's about the first two paragraphs that are responding to Liegner specifically, and then after that they respond to Dr. McCaulley. A Oh, I'll be delighted. Q So just read those. A "Dr. Liegner and Ms. Coshavar (phonetic)," who I believe is in his office, "and Dr. McCaulley raise the issue of the frequency in implications of false negative results on laboratory tests in patients with true Lyme Disease. Liegner and Coshavar suggest that such patients may have negative alisa results but positive or suspicious western blots, claiming that this differs from the experience with HIV testing. In good laboratories with careful calibration of alisa," that means an alisa that works and have been of proven value, "this has not been the case. In these laboratories alisa almost always yields positive or indeterminate results in cases of true Lyme Disease. Liegner and Coshavar state that the presence of one or two high specific bands may be a vital clue to diagnosis. The problem is that the bands are not completely specific." That's certainly been our experience. "For example, approximately 25 percent of normal people, normal controls have the 23 KD BEM," that means have antibodies against the 23 KD BEM. KD is just the size of the protein on western blot. "Carefully designed studies with well characterized patients in appropriate controlled groups have shown acceptable levels of diagnostics specificity only when multiple bands of specific molecular weights are required for diagnosis. We disagree that withholding empirical treatment from seronegative patients with suspected Lyme Disease will cause 'incalculable irreversible neurologic injury.' With attenuated antibody response, the disease itself is also attenuated and tends to respond rapidly to antibiotics at whatever stage therapy is given." Do you want me to read the McCaulley response as well? Q Why not? A Let's give it a go. "Dr. McCaulley refers to Shadick (phonetic)," that's Nancy Shadick at Brigham and Women's Hospital in Boston, "and colleague's article. It is true that the study is unclear about which patients were asymptomatic and which were symptomatic and it is difficult to distinguish between those with active disease and those with positive serologic results who no longer had active infections. This study included patients with several non specific symptoms including those consistent with chronic fatigue syndrome. This case controlled study lacked the rigor of a longitudinal cohort design." It wasn't a perfectly designed study is what Peter Tugwell is saying there. "Furthermore, the criteria for the alisa western blot used differed from those proposed and evaluated in our papers and adopted by the Centers for Disease Control and Prevention." A lot of people have some difficulty with Nancy's work. I'm not questioning her work, she's a fine scientist, but it's a very difficult paper to interpret. Q All right. Now, Doctor, there's another one that we heard about a band 41 KD? A Yes. Q Is that a common band or -- A I have it, as it turns out. Q Did you ever have Lyme Disease? A No, never. 41 KD is the flagellin, it's the protein that allows the organism to move. And as it turns out, the flagellin of Borrelia burgdorferi is quite similar to the flagellin that one finds in the Borrelia that are in your mouth and the flagellin that is in a number of bacteria in your gut. And so a lot of people, I wager a number of people in this room, including myself, have antibodies against the 41 KD, 41 KD being the size of the protein. Never having had Lyme Disease, never having been exposed to Borrelia burgdorferi, I probably don't know how to spell the thing either, so antibodies against the 41 KD are very common in society and totally non specific. Q Are you familiar with the writings of Dr. Halpern? A John Halpern? Yes, absolutely. Q Is John Halpern in his writings commented on Lyme Encephalopathy? A Yes. Q What is Halpern, what's Halpern's position on that. In order to diagnose someone with Lyme Encephalopathy, what does he say has to be done before you can expect a conclusion? A Well John's attitude I think is much like my attitude and much like many of the academics who think about Lyme Disease a lot, and that is they were always looking for objective findings. It's not enough to say that I don't think -- I'm not thinking clearly, I'm not concentrating, my memory is shot. And I, therefore, have Lyme Disease. What one looks for is objective abnormalities that strongly suggest that diagnoses, that move you in that direction. Seropositivity is virtually universal in that population, one. Two, you can do a spinal tap to look for antibodies in the spinal fluid. That is not universal, but it is very, very common and the spinal fluid is essentially always abnormal with at least an elevated pressure to demonstrate there's ongoing inflammation in the brain. The absence of any abnormality on spinal fluid analysis is strong evidence that it's not what we once thought was going on, which is to say not really Lyme Disease. Neuropsychologic testing, there are discrete patterns, although not unique to Lyme Disease. And by that I mean there are lots of people who have these patterns, this pattern that is specific to Lyme Disease. Many people who don't have Lyme Disease and can have this pattern of abnormality, but that pattern of abnormality in the right clinical setting is evidence in favor of a diagnosis of Lyme Disease. Certainly looking for objective abnormalities is crucial in making the diagnosis of central nervous system Lyme Disease and embarking upon a treatment strategy. Q Now, Doctor, based on your review of the -- everything you reviewed earlier, you told them you reviewed earlier, and based on the cross-examination you've been subjected to, as well as this redirect, has your opinion change with regard to Mr. Miller as to whether or not he ever had Lyme Disease? A No, not really. MR. GALLAGHER: Thank you, Doctor. THE COURT: I carefully wrote down, Mr. Myers, all of the subjects covered on the redirect. MR. MYERS: A lot of subjects. THE COURT: Yes, I know that, but it's an infinite number, so -- MR. MYERS: I wouldn't say it was. THE COURT: All right. I'm just -- RECROSS-EXAMINATION BY MR. MYERS: Q Doctor, John Halpern, that's your school of thought in terms of his -- he also believes there's no chronic Lyme Disease, is that correct? A Well as it turns out he is my school of thought, we both graduated from the same college, but we don't have identical ideas on the subject. I don't know that John says that there's no such thing as chronic Lyme Disease. Q Now, Doctor, in some of the things that you -- you keep mentioning the term objective findings, objective, right? Objective findings is when you go look at a patient and go find something, correct? A It's something -- Q Or one of them? A It's something you can put your hand on. Q Now why don't you ask Mr. Gallagher to put your hand on Mr. Miller then? MR. GALLAGHER: Your Honor, I'm going to object. I wasn't allowed to get an examination by this doctor because I had so many other doctors examine him. MR. MYERS: Oh wait a minute. Oh, no, no, no, that's an absolutely incorrect and that's a false statement. THE COURT: Now wait a minute. MR. GALLAGHER: Well I'll tell you what -- MR. MYERS: He got experts THE COURT: Now wait minute. MR. GALLAGHER: Your Honor, I -- MR. MYERS: He got a plethora of experts. THE COURT: Stop. Both of you, stop. MR. GALLAGHER: Perhaps the Doctor is wiling to examine Mr. Miller now. THE COURT: Both of you -- no, sit down. MR. GALLAGHER: Okay. THE COURT: Both of you sit down. Sit down, Mr. Myers. Now, listen, let me tell you, ladies and gentlemen of the jury, that there is rule of civil procedure, it's called Rule 35. It permits a party to request the opportunity for a doctor to conduct a physical examination of an opponent in the case. In certain cases that was done here. In certain cases it wasn't done. That's the end of it. MR. GALLAGHER: Okay. THE COURT: Go ahead. MR. MYERS: Thank you, Your Honor. BY MR. MYERS: Q Now you've mentioned the term objective findings over and over, but is not Lyme Disease a clinical diagnosis, yes or no? It's a clinical diagnosis, isn't that correct? A That is a statement taken out of context. Q A statement taken -- okay. A And we've been over this before. Q I know. It's a statement conducted in your book, -- A It's a statement -- Q -- Lyme Disease is a clinical diagnosis, correct? A Yes, it is a statement taken out of context. Q Okay. Now in terms of all the people he mentioned, all these doctors, there are doctors of whatever percentage of your profession or however number, there's a number of doctors who do not believe in chronic Lyme Disease, is that correct? A There may very well be, I have not taken a poll. Q Okay. A I don't mean to be facetious, I'm just not -- Q Well you don't. And the point is, sir, from your work in the field it's well known that you don't believe in chronic Lyme active infection, is that correct? A I don't know what people believe I think. Q Okay. Well you publish it, you put it out. It's out in the academic world, it's out in literature your beliefs, correct? A I believe that many patients who are diagnosed as having quote unquote "chronic Lyme Disease" don't have that. That's in the literature, yes. Q Okay. That's in your literature. A I can only attest to what I publish. Q All right. A Yes, that's what I published. Q Right. Fine. That's all I'm concerned about, it's all I'm asking you about. And that's well known. So if somebody wants to have you examine a patient who allegedly has chronic Lyme, who has treated with antibiotics past a certain period of time, it's no surprise to that person, entity, anyone what your opinion is going to be, isn't that correct? A I don't believe that's true. I'm not contracted with to answer the question in one way or another. Q Okay. A I'm contracted with to review a case -- Q But it's -- A -- and render an opinion. Q Okay. But in all of these opinions that you've done in litigation, in all these reports that you've done for insurance companies, the predominant majority of your views is consistent with your view on this case, isn't that correct? MR. GALLAGHER: Objection, Your Honor. Is he talking about the opinion he reached or the medical methodology that he used? THE COURT: I think he's asking a pretty simple question, which is when Dr. Sigal has testified in other cases and rendered opinions in other litigation, is he usually finding no Lyme Disease. MR. GALLAGHER: Oh, okay, it's that question. THE COURT: Am I right, Mr. Myers, that's -- MR. MYERS: Yes. MR. GALLAGHER: Is that -- okay. THE COURT: You can answer that question. A In the majority of the cases the patients have not had Lyme Disease. In the cases where I think they have Lyme Disease, I've urged the insurance company to pay for the intravenous antibiotics or whatever. Q In those patients -- A Or ask for a further evaluation of the patient to be sure what's going on. Q Did you ever follow up with those patients who were denied the cover for additional antibiotic therapy to see what happened to them? MR. GALLAGHER: Objection, Your Honor, it's beyond the scope of redirect. THE COURT: Sustained. Q Doctor, isn't it fair to say that the positions that you've taken for a number of years in your philosophy in this field allow you to obtain monies for grants for research on certain areas? MR. GALLAGHER: Objection, Your Honor, it's beyond the scope. THE COURT: Sustained. A It's also incorrect. THE COURT: That's why I wrote down the list. MR. MYERS: Okay. Let me ask one more question then so we can get to lunch. THE COURT: Okay. I'll give you my list if you want. Q Doctor, have you been asked to appear before the Connecticut Attorney General for the hearings on the issues of under or over diagnosis of Lyme Disease and insurance company's payment of medical bills? A No. MR. MYERS: Thank you. No other questions. THE COURT: Thank you, Doctor, you're finished. You may step down. DR. SIGAL: In many ways. Thank you. THE COURT: Thank you for your help. MR. GALLAGHER: Thank you, Doctor. (Proceedings continue but not requested to be transcribed)