x ---------------------------- x
MAUREEN MILLAR and PAUL W. MILLAR,
Guardians ad Litem for Tara C. Millar, infant and
MAUREEN MILLAR and PAUL W. MILLAR,
individually, Plaintiffs,
- v -
WILLIAM B. GLENN, M.D., et al., Defendants.

CIVIL ACTION
DEPOSITIONS OF:
LEONARD H. SIGAL, M.D.
x ---------------------------- x

C O M P U T E R I Z E D T R A N S C R I P T of the stenographic notes of the proceedings in the above-entitled matter as taken by and before CHERYL A. MARTIN, a Certified Shorthand Reporter, at the offices of ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL, Medical Education Building, One Robert Wood Johnson Place, New Brunswick, New Jersey 08901, on Monday, August 12, 1996, commencing at fifteen minutes after twelve o'clock in the afternoon.

A P P E A R A N C E S

ELKIND, FLYNN and MAURER, ESQS.,
BY: IRA M. MAURER, ESQ., 122 East 42nd Street, Suite 1512 New York, New York 10168
For the Plaintiffs.

ORLOVSKY, MOODY and SCHAAFF, ESQS.,
BY: JAMES H. MOODY, ESQ., Monmouth Park Corporate Center 187 Highway 36, Suite 202 West Long Branch, New Jersey 07764
For the Defendants, William B. Glenn, M.D. and John J. Kenny, D.O.

A P P E A R A N C E S
BOGLIOLI, O'MARA and MIRRA, ESQS.,
BY: JAMES M. COOLAHAN, ESQ., 121 Monmouth Parkway West Long Branch, New Jersey 07764 For the Defendants, Little Egg Harbor Board of Education.

I N D E X
Witness Direct Cross Redirect Recross LEONARD H. SIGAL, M.D. By Mr. Maurer 5
EXHIBITS MARKED FOR IDENTIFICATION
Exhibit Description Page
P-1 Legal Reports 3
P-2 Curriculum Vitae 3
P-3 Summary of Medical Malpractice cases 3
P-4 Report dated 06/27/96 3
P-5 Letter dated 02/26/96 7
P-6 Letter dated 05/20/95 7
P-8 EKG report, Dr. Alpert, Jersey Shore Medical Center 49
P-9 EKG report, Dr. Lloyda Rivera dated 11/10/92 52
P-10 Consultation Report, Date of Request 11/10/92, two pages 64
P-11 Second sheet of P-10 66
P-12 Roche Biochemical Laboratory Report 129
P-13 Lyme Western Blot report, 07/22/94 136
P-14 Western Blot IGG report, 07/22/94 138
(Legal reports are received and marked P-1 for identification. Curriculum Vitae is received and marked P-2 for identification. Summary of Malpractice Cases is received and marked P-3 for identification. Report prepared by Dr. Sigal is received and marked P-4 for identification.)

L E O N A R D H. S I G A L, M.D., Sworn.

MR. MAURER: When I noticed Dr. Sigal's deposition, I attached a rider to the Notice of EDT, which basically was Mr. Orlovsky's rider and then I added some additional matters relevant to this deposition. I then discussed the content of the rider over the telephone with Mr. Orlovsky and he advised me that he had no problem and no objection with any of the items listed in the rider, with the exception of draft reports between Dr. Sigal and defense Counsel's office for which he would claim a privilege. I confirmed the substance of that conversation and understanding in a letter, which I faxed to Mr. Orlovsky's office approximately a week and a half ago. Today's Monday. Last Friday, August 9th, a letter was faxed to my office, in my absence, under signature of Paul Schaaff, Jr., from Mr. Orlovsky's office, in which a number of objections were raised to the content of the rider for the very first time. This does not permit me time to seek relief from the court for those matters which are not -- those items in the rider, which are not being produced and leaves me at a distinct disadvantage, since we are one month before the trial date. For that reason, I am going to proceed with the deposition, reserving all rights to seek relief from the court. And I would hope that we might be able to avoid that by Dr. Sigal and Counsel producing the additional information possibly before the end of this deposition today, if time permits. But I am going to start with the deposition in any event, reserving my rights.
DIRECT EXAMINATION BY MR. MAURER:
Q. Dr. Sigal, good afternoon. My name is Ira Maurer and I represent the plaintiffs in this case. As you know, I have asked defense Counsel to produce you here today so I can ask you questions relevant to this matter. I would ask you to listen to my questions carefully and wait until I finish the question before you answer so that the court reporter can get a clean record and to make sure that you hear my complete question and understand it. If you don't understand anything I ask you, please let me know. Sometimes I ask inartful questions and I will be happy to rephrase them; okay?
A. (No verbal response.)
Q. It's also necessary that you answer verbally.
A. Yes.
Q. If you need to take a break, please let me know. If something comes up and you get beeped, we'll stop. Were you retained in this matter on behalf of Dr. Kenny and Dr. Glenn by Mr. Orlovsky's office?
A. On behalf of Dr. Glenn, yes. Dr. Kenny, I became involved in Dr. Kenny's case only afterwards.
Q. When were you first contacted with regard to this matter?
A. I honestly don't recall.
Q. Do you have any notes or records here which you brought with you which would --
A. I --
Q. -- assist you in answering?
A. I don't believe so. I can't tell you precisely the date that I first received information about this case or, for that matter, the date that I was first contacted.
Q. Do you know approximately when it took place, if not the exact date?
MR. MAURER: And if Counsel has a record.
MR. MOODY: I will see if I can find it.
MR. MAURER: Please.
A. There's a letter dated February 26, 1996, with my name misspelled. That would appear to be the sort of introductory letter from the law firm that accompanied a series of materials.
Q. What was that date?
A. Hmm?
Q. What was the date of the letter?
A. February 26th, my daughter's birthday.
Q. And could I see that letter?
A. (Witness complies.)
Q. Thank you. The letter in question is from John Orlovsky?
A. Yes.
Q. And it enclosed 13 different listed items, which I presume you reviewed after receipt?
A. Yes.
MR. MAURER: Why don't we mark the letter as plaintiff's exhibit five?
MR. MOODY: Okay. (Letter dated 02/26/96 is received and marked P-5 for identification.)
BY MR. MAURER:
Q. Besides the materials referred to in what we've mark as exhibit five, have you received any other materials since that time for review in this matter?
A. Yes, I received an envelope and a letter dated May 20th, 1996, which included articles written by Dr. Donta, plus I'm not sure. That's that. And then I have a letter here dated June 13th, 1996.
Q. I'm sorry. What was the date?
A. June 13th, 1996, apprising me of the fact that the court has ordered that we serve our expert the report upon plaintiff's Counsel no later than July 5, and so the report was forthcoming shortly thereafter.
MR. MOODY: Let me see that letter.
BY MR. MAURER:
Q. You said the letter dated 05/20 1996, which we'll mark as exhibit six, enclosed articles by Dr. Donta. Did it enclose anything else?
A. I don't -- offhand, I do not recall, but that's what the letter states.
Q. There's --
A. And it's stapled to those articles.
Q. You handed defense Counsel a stapled stack of documents. Is that a deposition transcript?
A. That's a deposition transcript from Dr. -- Doctors Glenn and Kenny, which I do not believe was included at that time.
Q. When did you get it?
A. I believe I got that along with the other materials as mentioned previously.
Q. That's referred to in exhibit five. May I see that letter dated 05/20/96?
MR. MOODY: There's two of them.
THE WITNESS: Two letters.
MR. MAURER: The 05/20/96 letter I would ask that we mark as exhibit six, please. (Letter dated 05/20/96 is received and marked P-6 for identification.)
MR. MAURER: And we'll mark the 06/13/96 letter as exhibit seven. (Letter dated 06/13/96 is received and marked P-7 for identification.)
BY MR. MAURER:
Q. Have you received any other correspondence from defense Counsel in this matter?
A. I do not believe so.
Q. Did you speak with Mr. Orlovsky on the telephone, or someone else from his office, before receiving the 02/26/96 letter marked as exhibit five?
A. I did.
Q. Were arrangements made at that time regarding your fee?
A. I do not recall. I presume so, but I do not recall.
Q. Do you have any billing records pertaining to your work in this matter?
A. They are part of the report dated June 27th.
MR. MOODY: You might have it attached to the report there.
BY MR. MAURER:
Q. The last page of the four page document marked as exhibit four indicates that you had spent eight hours and 40 minutes at a rate of $560 an hour --
A. Correct.
Q. -- as of July 3rd, 1996, for a total fee of $4,853.
A. Correct.
Q. How much time have you spent pertaining to this matter up until the start of this deposition since that billing dated July 3rd, '96?
A. Certainly no more than an hour.
Q. When was that hour spent?
A. Over the course of the period from July 3rd until now.
Q. Did you prepare -- withdrawn. Did you review any materials in preparation for this deposition?
A. Yes, I looked briefly at my notes, at the typed report and at some of the records that I reviewed in the first place.
Q. And how long did you spend doing that?
A. Probably something in the range of half an hour to 40 minutes.
Q. When was that done?
A. Between July 3rd and this date.
Q. Did your hourly for doing this type of work go up in the last six months?
A. I don't believe so.
Q. How long have you been charging $560 an hour for this kind of work?
A. Probably something in the range of a year. I don't -- I do not recall precisely when my rate went up.
Q. So, your fee last changed sometime in 1995, give or take?
A. I believe so, yes.
Q. And at that time it went up from what?
A. From $500 per hour to $560.
MR. MOODY: This you're done with?
MR. MAURER: For the moment, yes.
MR. MOODY: Okay.
BY MR. MAURER:
Q. Doctor, you've been board certified in rheumatology since 1979?
A. No, I was board certified in internal medicine in 1979, finished my fellowship in rheumatology and clinical immunology in 1984 and took the boards in the fall of 1984.
Q. You're not trained in infectious diseases, are you?
A. No, I am not.
Q. With what degree of frequency do you see patients in practice --
MR. MOODY: I will just -- okay. You haven't finished your question, I'm sorry.
Q. In other words, separate from all the other administrative duties that you have in your various positions here at Robert Wood Johnson and so forth, would I be correct that you do see patients for diagnosis and treatment?
A. Yes.
Q. When do you see them, what are your hours for seeing patients?
A. For emergencies basically whenever is necessary, but for scheduled clinics, I have a clinic on Tuesday that starts at noon and ends at about five or 5:30. I have a clinic on alternating Thursdays that starts at one and usually ends at about three or 3:30. I have a clinic on Friday that starts at about eight in the morning and usually ends at about two in the afternoon. I also have a VA clinic every third Wednesday afternoon starting at one and ending at usually about 4:30. That's done in rotation with the other two faculty members here.
Q. And when did you --
A. In addition to that, I'm on the consultation service on rheumatology usually three or four months a year and I'm on the ward service admitting general internal medicine patients this year. This academic year it will be for two four week blocks.
Q. When did you start with the Thursday one to 3:30 clinic that you mentioned?
A. A month ago, thereabouts.
Q. And when did you start with the VA clinic, which you said I think is every third Wednesday?
A. Yes, that was started in December or January.
Q. December '95, January, '96?
A. Precisely.
Q. In addition to your administrative and teaching responsibilities and your examination and treatment of patients, are you also participating in a Lyme disease vaccine efficacy trial sponsored by Cannaught labs?
A. We did participate in that. Our aspect of that trial is terminated.
Q. As of when?
A. The last follow-up, I believe, was March or April of 1996. No, I take that back, of '95. It's a two year trial and it was one year in follow-up after the second year of the trial. So that's been over and the information transmitted to Connaught for analysis over the course of the last almost year.
Q. So that was completed in the spring of '96, in terms of your involvement with that?
A. '95, yeah. It was a two year vaccine trial.
Q. Plus a year of follow-up?
A. It was originally planned to be one season of vaccination, one year follow-up.
Q. And they extended it?
A. And they extended it to two years of active vaccination versus placebo and a one year follow-up beyond that. And that ended, I believe, in the fall of '95, and we've been finishing up the records and dealing with Connaught Laboratories about that, but we don't see patients from that vaccine trial any longer.
Q. You were one of three locations where that trial took place?
A. We were one of -- I think it was more like eight or 11 areas that were doing that vaccine trial.
Q. For Connaught?
A. Yeah, the vaccine trial included sites in Wisconsin, Connecticut, Long Island, Westchester County. I believe Mass -- yes, Massachusetts.
Q. Where in Massachusetts?
A. I believe on the Cape. I'm not precisely sure, but certainly we were not -- there were more than three sites.
Q. Are you sure you're not confusing it with the Smith Kline --
A. We were not part of the Smith Kline trial, so I couldn't be confusing them.
Q. How many people were enrolled here at Robert Wood Johnson for the Connaught vaccine study?
A. Thirteen hundred none.
Q. And were you the principal investigator for that study here?
A. Yes, I was.
Q. And were you compensated by Connaught directly or indirectly for your work as principal investigator?
A. What do you mean? Can you clarify the question?
Q. Connaught paid for the cost of running the trial here at Robert Wood Johnson, didn't it?
A. Correct.
Q. And as principal investigator, were you compensated directly by Connaught or indirectly?
A. Do you mean did I as an individual receive funds?
Q. Yes.
A. No, I did not. The monies went to the Department of Medicine and are in an account in the Department of Medicine.
Q. And were those funds that were paid by Connaught to the Department of Medicine used for anything other than the vaccine trial that was run here?
A. They were used --
MR. MOODY: If you know.
A. They have been used to pay salaries of individuals on our staff, secretaries, lab technicians.
Q. People who all worked in the trial?
A. Some people who worked in the trial. We had to pay a lot of overtime to secretarial and laboratory staff. The monies that were left over at the end of the trial have been used to help support the Division of Rheumatology, but have not been used to support my salary in any way.
Q. How much money was left over from the trial that was used by the Division of Rheumatology?
MR. MOODY: I will just object to the relevancy. Go ahead, if you know.
A. I don't know precisely.
Q. Let me ask you this. I'm not going to ask too many of these questions. There was a contract, I presume, between Connaught and Robert Wood Johnson --
A. Correct.
Q. -- for running the vaccine trial?
A. Correct.
Q. What did the total contract call for in terms of payment to Robert Wood?
MR. MOODY: Same objection.
Q. Approximately.
A. I really don't know offhand. It's well in excess of a million dollars, but I don't know offhand.
Q. Is it in excess of two million dollars?
A. I don't believe it comes up to that much, even with the addition of the second year.
Q. Your best approximation would be what?
A. One point five, one point six million.
Q. And that money was intended to cover what specifically?
A. It was intended to cover the costs of the trial and to reimburse the university for the costs of the personnel who were doing the trial. So that means the fellows, the faculty members, the nurses, the technicians, the clerical staff, the rental of automobiles. We had buttons made up as a promotional device. We had paperwork that had to be done, an incredible amount of xeroxing that had to be done, all of which run up costs.
Q. And are you on salary through the Department of Rheumatology?
A. Through the Department of Medicine, yes.
Q. And were any funds that were paid to Robert Wood Johnson by Connaught with regard to the Lyme vaccine efficacy trial used to pay any portion of your salary?
A. As I said a few minutes ago, not one penny of the Connaught income has been used to pay my salary.
Q. What's the basis for that statement?
MR. MOODY: Well, I'm going to object. I don't understand the relevancy as to this line of questioning. I have let you go on asking him questions about this program, but what relevancy do these questions have to this case and what his salary might be or the source of the income? He's already indicated to you that his salary was not paid or a portion of it paid through that program. I don't know why we have to go any further then that.
MR. MAURER: Just a little bit further and I'm stopping.
MR. MOODY: What's the question you wanted --
MR. MAURER: I think it's relevant to the general topic that I have been getting into with regard to income.
MR. MOODY: Well, he's indicated to you that not one penny from that study was used to pay his salary. How clearer can he make it to you to indicate that that was not where his income comes from?
MR. MAURER: Let me ask one last question to clarify it.
BY MR. MAURER:
Q. Were the funds were made by Connaught segregated by Robert Wood Johnson so you can state with certainty that none of the money was used to pay your salary?
A. My intent in my answer was to state that the monies are in an account. That account is not used -- is not drawn upon to support my salary. I did not get salary nor did I get a bonus in salary from the Connaught account. My salary is paid for in part by state line, that's monies supplied to the University of Medicine and Dentistry and then divided up amongst the various schools for salary support. The rest of my salary is paid for on the basis of a small percentage of my clinical income. It's called a clinical supplement in the formula that is used here in the Department of Medicine and that is the sum total of my salary.
Q. Do you consider yourself to be a leading authority in the field of Lyme disease diagnosis and treatment?
MR. MOODY: I will object to the form of the question. I don't know if you understand or if you need him to clarify what he meant by "leading authority".
A. I would not typify myself or describe myself as being a leading authority. I would describe myself as having some knowledge about Lyme disease and some insights. I would be not so egotistical as to claim to be a leading authority.
Q. At the start of this deposition you produced a stack of documents, which the reporter marked as exhibit one. Am I correct that this stack of documents represents all copies of any reports you've written for attorneys regarding to Lyme disease matters, as far as you know?
A. Yes, that is correct.
Q. Is this an all inclusive grouping or are there other matters, which are not included in this, because you couldn't find a report or you couldn't recall the name of the matter or something like that?
MR. MOODY: As it pertains to Lyme disease?
MR. MAURER: Yes, and litigation.
A. What I did was went back into my computer and looked at every document in the appropriate file seeing if it pertained to Lyme disease and was a review for a legal firm and presented all of those. So, to the best of my abilities to review my own computer, that is all inclusive.
Q. How many are there?
A. I didn't count.
Q. With regard to the legal matters, would I be correct that the opinions you've expressed for attorneys has either been that the diagnosis of Lyme disease is incorrect or that the patient has been over treated?
A. Are you asking is that the sum total of all my opinions?
Q. With regard to the opinions you've expressed for attorneys.
MR. MOODY: Involving Lyme disease.
MR. MAURER: Right.
A. I suspect that a large percentage of them would be described as you have just stated, but I don't know that I have never stated that somebody, in fact, had Lyme disease -- in fact, now that I think of it, I do know for a fact there's at least one case that comes to mind where I thought the diagnosis of Lyme disease had been correct and the physician had missed it. There have been other circumstances in which I have stated that a patient may have had Lyme disease, but that the physician did all that was considered prudent in community standard in looking for the diagnosis of Lyme disease, but I don't believe I have rejected the diagnosis or nay say the diagnosis in every case.
Q. Do you know the name of the matter where you believe you expressed the opinion that the patient did have Lyme disease?
A. Offhand, I don't.
Q. Would you have a report pertaining to that?
A. I would -- I presume it's in that stack.
Q. Marked as exhibit one?
A. Yes.
Q. In addition to the work you've done for attorneys, you've also done work for insurance companies; is that correct?
A. Yes.
Q. Let me just go back for a moment. Is it fair to say that the work that you've done for attorneys has averaged about one case per month in the last couple of years?
A. Probably not. First of all, when you say, "couple," do you mean two or do you mean in the last few years?
Q. Let's say two years.
A. Probably not. Probably less than that.
Q. With reference to your work for insurance companies, how long have you been doing that?
MR. MOODY: When you're talking about, "work for insurance companies," would you just --
MR. MAURER: Where he's been retained as a medical expert to express an opinion with regard to the subject of Lyme disease, either that the diagnosis is right or wrong, that treatment is called for or not called for, something like that.
MR. MOODY: Referring to outside of the legal matters that he's given you reports on that may indirectly have come to him through an insurance company?
MR. MAURER: Right, I'm just referring to insurance company work.
MR. MOODY: Okay.
A. There have been -- I have probably been doing this for something in the range of five years. I have been in New Jersey since 1988, so that's eight years, and this did not come up for the first few years that I was in New Jersey.
Q. Do most of the matters you've involved yourself in with regard to insurance companies deal with the subject of Lyme disease?
A. Yes.
Q. Approximately how many files have you reviewed for insurance companies in the last five years with regard to Lyme disease, as I have defined the area of inquiry?
A. It would be a pure guess. I really don't know.
Q. Would it be reasonable for me to say that you've reviewed a few dozen files?
A. Yes.
Q. And that a reasonable guesstimate would be somewhere between 30 and 50 files?
A. Perhaps.
Q. Would I be correct that the vast majority of the matters that you've reviewed for insurance companies have resulted in you expressing opinions that the patient did not have Lyme disease?
A. I -- certainly a number of them have led me to believe that the diagnosis of Lyme disease was not documented by the materials that I have received.
Q. Would I be correct that the vast majority of the files that you've reviewed have led you to express the opinion that the records did not support a diagnosis of Lyme disease and there have been only be a few insurance files that you've reviewed where you did think the diagnosis of Lyme disease was appropriate?
A. I suspect that the majority of the files that I have read did not contain sufficient information for me to say that the diagnosis of Lyme disease was assured.
Q. And there have only been a few files where you express the opinion that the diagnosis of Lyme disease was appropriate based on your review of the records; isn't that true?
A. There have certainly been a number where I have thought that the diagnosis of Lyme disease was correct and that the current -- the form of therapy that was being proposed was correct. There have been a large of number of files where I thought the diagnosis of Lyme disease was correct, but I disagreed with the management.
Q. Well, I'd like to try and -- you've said there have been a number of cases where you thought the diagnosis of Lyme disease was correct. You've testified earlier this year as an expert for the defendant, didn't you?
A. Yes.
MR. MOODY: If you're going to cross him, I'm going to --
MR. MAURER: I'm not going to cross-examine him. I just want to clarify one point.
MR. MOODY: Okay.
MR. MAURER: I'm not going to go through a whole long thing.
BY MR. MAURER:
Q. In that deposition, if I'm not mistaken, I believe you indicated there had been only a few cases where you expressed the opinion that the diagnosis of Lyme disease was supported by the documentation. So, what I'm trying to clarify is: Is it only a few cases or is it a number of cases, as you just answered to me a moment ago?
A. Well --
MR. MOODY: A few cases or a number of cases of what?
MR. MAURER: Where he felt that Lyme disease, as a diagnosis, was appropriate based on his review of the records.
A. I guess it would be helpful if we defined terms here, because a few and a number --
Q. That's why I'm asking.
A. -- have overlapping shades of gray. To be honest with you, I cannot give you a precise number --
Q. If --
A. -- but there certainly have been cases I have reviewed where I thought that the evidence was sufficient to suspect that there was, in fact, the diagnosis of Lyme disease.
Q. Let me ask you this: When you use the term, "a few cases," what do you mean?
A. Perhaps a dozen.
Q. Are you an expert with regard to Ixodes scapularis or dammini?
A. With respect to what aspect of the two?
Q. Are you an expert in the sense of being the equivalent of an entomologist?
A. Or an acarologist, no. One who studies ticks, no, I'm not.
Q. And is it fair to say that you would defer to an entomologist, who does have an expertise with regard to Ixodes scapularis and Ixodes dammini?
MR. MOODY: Opinions in what sense?
MR. MAURER: Opinions with regard to the feeding habits of deer ticks, for example?
A. The knowledge that I have about ixodic ticks is based on the literature. In fact, I should say all of my knowledge of ixodic ticks depends upon the literature and conversations that I have had with a variety of acarologists around the United States at various meetings.
MR. MAURER: I move to strike. It's not responsive.
Q. I'm asking you if you would defer to an entomologist, who has an expertise with regard to deer ticks and with specific reference, for example, to the feeding habits of deer ticks or do you consider yourself on an equal level in terms of being able to express a valid opinion weighted the way such that an entomologist's opinion should be weighted?
MR. MOODY: I will object to the form of the question and the broad nature of the question. I don't know how that question can even be answered in the form that you've asked it. You can answer the question, if you understand it.
A. What I had intended to say in my response was that my knowledge of ixodic ticks is based on the literature written by those experts. And so if it came to a question about the specifics of the feeding pattern of ixodic ticks or the behavior of ticks within their habitat, I would be able to state that Dr. Fish, spelled the way you would expect, has said such and such, but it would be best if the question were to be about ticks to speak directly to the source.
Q. Do you know Dr. Terry Schulze?
A. Yes, I do.
Q. Have you read his report in this case?
A. No, I have not.
Q. Are you aware that he is involved as an expert in this matter?
A. Am I? No.
Q. Incidentally, the report that you prepared in this matter marked as exhibit four contains opinions that you have regarding this matter; is that correct?
A. Yes.
Q. Have any of the opinions expressed in that report, marked as exhibit four, changed since you wrote the report?
A. No.
Q. Are there any additional opinions that you've expressed to anyone in this matter that were not covered by that report? In other words, I want to know if that expresses all the opinions that you have in this matter to date.
MR. MOODY: Including the reference to the other doctor involved? Just so there's no misunderstanding, there were two doctors. You had asked him earlier about --
MR. MAURER: It's all inclusive.
MR. MOODY: All right.
A. I don't believe that I have expressed any other opinions, aside from those contained in the report.
Q. Would you agree that the vast majority of Lyme disease cases are the result of bites from deer ticks usually in the nymph stage in the months of June and July?
A. I would agree that the vast majority of cases of Lyme disease are due to nymphal ixodic ticks. I might expand that a little bit to include a month or so earlier and, perhaps, a little bit later. But yes, I would agree.
Q. And would you also agree that the greatest time of activity and the highest risk for being bitten by a nymphal stage deer tick is in the first week of June or thereabouts?
A. I wouldn't feel comfortable being quite so precise about the dates.
Q. Have you reviewed the statistical data that is maintained by the Department of Health in the various states in the metropolitan region?
MR. MOODY: As to what? I mean as to the --
MR. MAURER: As to the --
MR. MOODY: -- specific reference to June, the first week in June or some other reference?
MR. MAURER: When nymphal stage deer tick bites are reported.
A. I have not reviewed the records of the health departments in the tri-state area to find out if, in fact, the first week of June is the maximum number of tick -- of tick bites by nymphal stage ticks.
Q. Would you agree that the first week of June is a high risk time for being bitten by a nymphal stage tick?
A. It is a high risk time, yes.
Q. What percentage of the nymphal deer tick is infected with Borrelia burgdorferi?
A. It depends on where you're talking about.
Q. Please explain.
A. There are certain areas where -- like Great Island off the shore of Massachusetts where essentially one percent are infected. The same thing goes for Shelter Island apparently. If one goes to the center of Newark, there are very few ticks there and in all likelihood none them are infected. It depends on the area. It also depends on the year. As an example, if one were to go to Hunterdon County five years ago, one would probably have found a significantly lower percentage of the ticks infected than one is finding in 1996.
Q. Are you familiar with the area where Tara Millar is claiming she was bitten by a deer tick in 1992?
A. I have never been there.
Q. Are you familiar with the location? Do you know the location?
A. No.
Q. Are you familiar with the Pine Barrens?
A. Yes.
Q. And what's your understanding with regard to whether or not the Pine Barrens are an area that was considered to be endemic for deer ticks that were infected with the Lyme bacteria back in 1992?
A. Certainly in the period between 1990 and 1992, there was an emerging problem with Lyme disease in the Pine Barrens. We actually documented that with our colleagues down in Camden.
Q. What do you mean by, "an emerging problem"?
A. In the township we had studied there had never been reports of Lyme disease. And in that period there were new reports of Lyme disease and so the very real possibility of an emerging focus of Lyme disease was raised.
Q. Would you agree that if someone is bitten by a deer tick and is asymptomatic and has no clinical sequelae, that it is appropriate not to treat that patient?
MR. MOODY: Are you talking about immediately upon being bitten by this deer tick? I mean can you give me or can you give the doctor some time frame as it pertains to your question?
BY MR. MAURER:
Q. Let's say within a period of weeks to a month or two, in that range.
A. Our recommendation is that an asymptomatic tick bite not be treated prophylactically because what you're prescribing is prophylactic antibiotics.
Q. And you don't believe that is appropriate?
A. Based on a study done by Gene Shapiro and published in the New England Journal of Medicine and a doctor study done by Costello and published in Infectious Diseases a number of years ago on the subject of acquiring Lyme disease in a tick bite is low enough that clinical evaluation is prudent and that serologic follow-up is probably indicated, but that prophylactic antibiotics would not be indicated. And, in fact, there's a study published in the New England Journal of Medicine from Johns Hopkins, which did a cost benefit analysis on this question and came to the conclusion that unless the risk of obtaining Lyme disease from a known tick bite is greater than 1.36 percent, that it is not - in a strictly cost benefit analysis - it is not prudent to prophylactically treat.
Q. So, am I correct, then, that if a patient has no known EMC rash and no signs or symptoms suggestive of Lyme disease, that you don't recommend prophylactic treatment with antibiotics but do recommend that the individual return for serologic work-up with regard to testing for Lyme disease if the patient has a known tick bite?
A. In part, yes. Let me just amend that statement and then I can tell you precisely what we do tell people. And that is if somebody is -- has a known tick bite, or strongly suspects that it was a tick bite, we tell the person -- I do not give people a listing of all the signs and symptoms of Lyme disease. I don't think that it's fair to be quite so exclusive. What we tell patients is that if you feel ill or if there's any change in your health that you can't easily explain, call us. And if there is no rash at the site of the tick bite, there's no change in health or no sense of ill health, that you should return in approximately six to eight weeks. We will at that time obtain a blood test. And if you are still seronegative at that point, then in all likelihood you did not get Lyme disease from the tick in question.
Q. And if the -- withdrawn. The test that you would do after approximately six or eight weeks, even if the patient had no signs or symptoms suggestive of Lyme disease, would be an ELISA and --
A. And Western blot.
Q. You would do both at the same time?
A. Yes, the reason being that there are rare occasions when the ELISA is still negative, the IgM -- when the IgM ELISA is still negative, but the IgM Western blot may be beginning to convert. So, in order to be as all inclusive as possible and as sensitive a screen as possible, we will do the Western blot on those patients as well.
Q. I just want to ask you a few basic questions. I apologize for having to ask them, but I have to make a record, Doctor. Would you agree that Lyme disease is a clinical as opposed to a serologic or laboratory diagnosis?
A. Yes, I would.
Q. And would you agree that Lyme disease is multisystem inflammatory disease caused by infection with a bacteria known as Borrelia burgdorferis?
A. Yes, I would.
Q. Would you agree that there is a marked variation possible in the clinical expression of Lyme disease from one patient to another?
A. Yes, but there is -- yes.
Q. Is Lyme disease referred to in different categories, early localized disease, early disseminated disease, and late Lyme disease or tertiary neuro borreliosis?
A. Tertiary borreliosis is part of the clinical spectrum of late manifestations of the infection, but yes.
Q. Is the early localized disease characterized in approximately 50 to 70 percent of the patients by nonspecific symptoms, such as a virus-like syndrome?
A. The older series of patients with Lyme disease would suggest that there's a reasonably high incidence of that kind of symptomatology. The more recent series suggests that it's a significantly milder infection than the original clinical series would have suggested.
Q. Was I correct in making reference to the nonspecific symptoms consistent with a serous-like syndrome as being part of the picture you see in the early localized disease?
A. Yes, it can happen.
Q. And that virus-like syndrome can include fatigue, malaise, lethargy, headache, myalgia, arrhythmia and regional or generalized lymphadenopathy?
A. Those would not be symptoms. Those would be signs. But yes, you're correct.
Q. And would I also be correct that the virus-like syndrome that I just asked you about can be associated with symptoms resembling a summer cold?
A. Yes, in the absence of coryza, which would be a runny nose, stuffed nose, sinusitis and typically in the absence of things like diarrhea. So the upper respiratory infection syndrome and the viral gastroenteritis syndrome are not features of that virus-like syndrome.
Q. Do some Lyme disease patients, in your experience, have early localized disease, which manifests itself with symptoms consistent with an upper respiratory illness?
MR. MOODY: I will just object to the form of the question. You can answer.
A. I don't recall having seen a patient, who comes in with erythema migrans and an upper respiratory infection.
Q. What about that group of patients that doesn't have the erythema migrans rash, have you seen any patients, who were subsequently diagnosed with Lyme disease who presented with symptoms similar to or appearing like an upper respiratory illness?
A. I do not recall having seen a patient whose initial presentation without erythema migrans include runny nose, stuffed nose, sinusitis. We've seen many patients who had that kind of symptom complex who were essentially misdiagnosed as having Lyme disease, but I do not recall having seen such a patient in whom the diagnosis of Lyme disease was confirmed.
Q. Is there a correlation between the severity of the initial illness of Lyme disease and the presence of multiple lysemia lesions with progression to later stages of Lyme disease?
A. You're asking now about two correlations.
MR. MOODY: Which one do you want him to answer?
Q. Well, let's ask about the first one.
A. Is there a correlation between multiple erythema migran illness and the severity of the illness?
Q. Yes.
A. That has been stated in many papers.
Q. Including your own?
A. I believe so. Alternatively, I have seen patients with multiple EMC and not aware that they had them, a mere rash does not guarantee in any individual case the association occurs.
Q. The second stage or phase of Lyme disease, as I referred to it before, the early disseminated disease, that includes heart problems, does it not?
A. It can in about eight percent of adults, yes.
Q. And within the context of the heart problem area, would I be correct that that includes conduction defects?
A. Yes.
Q. Mild cardiomyopathy?
A. Yes.
Q. Myopericarditis?
A. Yes, rarely.
Q. Tachyarrhythmias?
A. Very uncommon, but yes, it's been described.
Q. Very mild congestive heart failure?
A. Yes.
Q. Bundle branch block?
A. Yes, fascicular block.
Q. Within which of those items that I just asked you about would you characterize a sinus arrhythmia?
A. None.
Q. What is a sinus arrhythmia?
A. Sinus arrhythmia -- let me back up for a second to give you a broader picture of what's going on in the heart. The heart has a muscular system that needs to be coordinated. If it all pumps at once, if it all contracts at once, you've got a fatal arrhythmia, so things need to be orchestrated. They're orchestrated by a conduction system that starts with a sinoatrial node, or sinus arrhythmia node. That signal, that's the pacemaker in a normal heart. That then gets conducted to the atrioventricular node. When the electrical stimulus goes to the rest of the heart, to the bulk of the muscle of the heart and pumping occurs, the sinoatrial node is an independent pacemaker. It puts out a signal of regular sort, but there are some variations in that. And so one of those irregularities has to do with inspiration for a variety of reasons that I don't think we need to go into here. So, there can be sinus arrhythmia, a mild variation in heart rate, based on something as simple as respiratory rate.
Q. Can Lyme disease cause a sinus arrhythmia?
A. No, I'm not aware of that being the case. Sinus arrhythmia is a normal variation. Can it cause a blockage of the signal between the sinoatrial node and atrioventricular node, yes, but it would not surprise me were there to be a report in the literature of arrest or of arrhythmia due to the blockade of the signal between the sinus arrhythmia node and the atrioventricular node. As I recall, there are three separate electrical wires between those two nodes and so it would require a significant amount of dysfunction, but it wouldn't surprise me if such a thing exists. But sinus arrhythmia is a normal variation. I don't see how one could as describe that Lyme disease.
Q. Is sinus arrhythmia always a normal variation --
A. It depends.
Q. -- or are there times when it's abnormal?
A. There are a variety of abnormalities of atrial conduction. There is atrial fibrillation, there is -- which would be abnormal and is clearly a sign of pathology. There is something called a wandering atrial pacemaker, which is clearly a sign of pathology. There is delay due to stretching of the atrium due to other problems. That's clearly an abnormality. But sinus arrhythmia is too broad a term. It's a grab bag of a series of problems.
Q. If a cardiologist were to perform an EKG on a patient and list a sinus arrhythmia abnormality in the EKG report findings, based on your experience in reviewing medical records, would you conclude that that cardiologist is determining that that specific finding was abnormal in that patient?
MR. MOODY: I'm going to object to the form of the question. Again, I don't know how he can answer a question without knowing who it is your specifically referring to, and the facts and circumstances regarding the treatment that was rendered and what the cardiologist found or didn't find as part of his evaluation and work-up.
MR. MAURER: Well, what I'm asking is, and I think he can answer this without any problem, is:
Q. In your experience, do cardiologists normally list sinus arrhythmias as an abnormal finding in an EKG report unless they have concluded that this was an abnormal finding in the patient?
MR. MOODY: I'm going to object as to what a cardiologist may or may not list in some sort of report. I don't see how that has anything to do with the case, first of all. And secondly, I don't know what it is you're trying to ask the Doctor. I mean how a cardiologist interprets a study?
BY MR. MAURER:
Q. Well, normal findings are not listed as an abnormality in an EKG report, are they?
MR. MOODY: Again, I'm going to object. I don't understand what the relevance is.
A. I'm not sure where you're going either, but normal findings are reported.
Q. As normal?
A. No, normal findings are reported. There are a variety of measurements and findings that one reports on an EKG. The interpretation may be that they are abnormal or normal, but to say arrhythmia, arrhythmia simply means an irregularity of rhythm. That's all it means. I need to know which atrial arrhythmia you're referring to before I can say it's abnormal or normal. But minor variations in atrial frequency, if you will, is not necessarily a sign of underlying heart disease. You need to tell me which arrhythmia before I can render any sort of a judgment about the pathology. But an EKG reading - if you'd like to give me one, I can show you - an EKG reading includes a variety of measurements, a variety of descriptions which may or may not be abnormal.
MR. MAURER: Why don't we mark as plaintiff's exhibit eight an EKG report of Dr. Mitchell Alpert from the Jersey Shore Medical Center records? (EKG report of Dr. Mitchell Alpert, Jersey Shore Medical Center, is received and marked P-8 for identification.)
BY MR. MAURER:
Q. On the top of the report it says, "Interpretation: Tracing shows sinus rhythm and a normal EKG." Is that what you were talking about when you say that reference to the sinus rhythm does not mean in and of itself that there's anything wrong with it, that it can be a normal finding?
MR. MOODY: Could we get some identification as to what EKG you're referring to?
THE WITNESS: This is --
MR. MAURER: It's November 11, 1992.
MR. MOODY: And it's an EKG performed on?
MR. MAURER: On Tara Millar.
MR. MOODY: Of that date?
MR. MAURER: In this case, yes.
MR. MOODY: I'm sorry. Your question is?
BY MR. MAURER:
Q. Is the interpretation given on this particular EKG report consistent with what Dr. Sigal was telling me, that the mere reference to the sinus rhythm finding doesn't mean there's an abnormality, in fact that is a normal finding, is that what you were telling me before?
A. This being interpreted as being a normal EKG, there's a little irregularity in rhythm right here, but apparently the cardiologist -- there's quite a bit of irregularity in the rhythm here, but the cardiologist is satisfied that that's normal.
Q. You say there's quite a bit of irregularity in the sinus rhythm?
A. There is irregularity in the rhythm strip in the bottom. This is lead II, roman numeral two. This a strip which is a continuous monitoring of the EKG and there is some irregularity in the rate of the heart. However, the morphology of the EKG is entirely normal throughout and, therefore, the cardiologist was reassured that this was a normal EKG. Now, recall please that I'm not a cardiologist and I'm not a pediatric cardiologist.
Q. So, you would defer to a cardiologist's interpretation of a sinus rhythm being normal or abnormal over your own interpretation?
A. I defer to a pediatric cardiologist to read that EKG and for he or she to tell me what's going on.
Q. And would rely on that opinion as opposed to your own in that particular area?
MR. MOODY: For what?
MR. MAURER: For the purposes of diagnosis and treatment of the patient for Lyme disease.
A. I wouldn't -- I wouldn't narrow that to just Lyme disease. If I have a pediatric patient, and that child has an EKG, and if there are subtle abnormalities, I will ask the cardiologist, "What do you think about these changes?" These differences from the strict normal and I would listen to that opinion.
Q. And rely on that doctor's expertise in that particular area, when considering the overall picture?
A. Yes.
Q. Let me show you a report from the same Jersey Shore Medical records for an EKG report dated 11/10/92, pertaining to Tara Millar, which indicates it was reviewed by Dr. Lloyda Rivera.
MR. MAURER: And let's mark it as exhibit nine. (EKG Report of Dr. Lloyda Rivera dated 11/10/92 is received and marked P-9 for identification.)
BY MR. MAURER:
Q. Would you be kind enough to look at the document we've marked as exhibit nine, Dr. Sigal?
A. (Witness complies.)
MR. MOODY: Before you ask the question, let me just put an objection on the record. This Doctor wrote a report dated June 27, 1996, with regard to a question pertaining to Lyme disease and whether or not it was a condition that could have or should have been diagnosed by two doctors that we presently represent. I don't know what the relevancy has to do with the questions that you're now asking the Doctor as to an EKG study and whether or not the Doctor agrees or disagrees with what a cardiologist may have interpreted during a study that was done presumably at Jersey Shore Medical Center. I'm looking at your clients' Answers to Interrogatories in which it talks about the experts that you intend to call as witnesses. I don't see any reference whatsoever to any of these experts being called for purposes other than to testify about deer ticks, the habitats, Lyme disease, prevention and causation.
MR. MAURER: I will save you some time. Look again at your Doctor's report and you'll see why it's relevant.
MR. MOODY: Could you point out to me what's relevant in the report about the EKG study from Jersey Shore Medical Center?
MR. MAURER: Off the record.
MR. MOODY: Yes. (Whereupon an off-the-record discussion is held.)
MR. MOODY: We did take a break in order for Counsel to discuss with us outside the purpose of these questions and I again object based upon that discussion that took place, but Doctor, you can answer the question, if you understand it.
A. What is the question?
Q. I hadn't asked one yet.
A. Oh, good. We'll get there.
Q. You didn't forget it.
A. Okay.
Q. This particular cardiologist, Dr. Rivera, interpreted the tracing of the EKG as showing a sinus arrhythmia. You've looked at the report itself, which shows the tracing on the bottom. Do you see any evidence of an irregular sinus rhythm?
A. That's essentially the same pattern as seen the next day, when the reading is a normal EKG.
Q. The reading by the cardiologist, Dr. Alpert said that he thought it was a normal. Actually, he didn't say that. Oh, no. He said it was a normal EKG and you're saying that the previous day's EKG shows a similar pattern. So this shows two different cardiologists coming up with a different opinion regarding that particular part of the EKG, doesn't it?
A. I'm not quite sure that's the case. I suspect that -- I can't possibly be expected to know what was in Dr. Alpert's mind, but my suspicion is that when a pediatric cardiologist, if in fact Dr. Alpert and Dr. Rivera are pediatric cardiologists, I don't know that, but when a pediatric cardiologists sees a sinus arrhythmia in a ten-year-old, this kind of sinus arrhythmia, the interpretation is this is respiration variation and that this is a normal EKG for a ten-year-old.
Q. That's your assumption based on your own knowledge?
A. Yes, again, acknowledging full well that I'm not either a pediatrician nor a pediatric cardiologist, but I can tell you that this EKG is not evidence of Lyme carditis.
MR. MOODY: When you say, "this," so we have it on the record, which exactly --
THE WITNESS: The two EKGs are essentially the same, the November 10th and 11th tracings. As far as my understanding of Lyme carditis, and I have reviewed that literature reasonably carefully and written on it, neither of those tracings should be viewed as evidence of Lyme carditis.
MR. MOODY: And those were marked for identification as?
MR. MAURER: Eight and nine.
MR. MOODY: Eight and nine.
BY MR. MAURER:
Q. Is a tachyarrhythmia the same thing as a sinus arrhythmia?
A. Again, the term "arrhythmia" is a very broad one. There are -- the terms that are used in cardiology are tachyarrhythmia, which means a rapid heart rate, defined arbitrarily as a rate above 100. And there is something called a bradyarrhythmia, which is defined arbitrarily as being a heart rate less than 60. There are many causes of tachycardia, tachyarrhythmia, too rapid a heart beat, that are based on problems in the atrium. They would be distinctly uncommon as manifestations of Lyme disease. And the only reason I say, "distinctly uncommon," as opposed to I have never heard of it, as opposed to, perhaps, it never happens, it's just because it's possible that I have never heard of it, but it's not an arrhythmia of Lyme disease.
Q. I'd like to ask you some more fundamental questions just for the record. Would you agree that some patients with early disseminated Lyme disease do not recall having or seeing an EMC rash or any prior illness suggesting Lyme disease?
A. Yes.
Q. Is progression to musculoskeletal features uncommon in the treatment of Lyme disease?
A. Yes.
Q. Do roughly 75 to 80 percent of patients experience noninflammatory or inflammatory joint disease in months to years after the initial onset of Lyme disease?
A. I believe you're referring to Alan Stier's paper in the Annals of Internal Medicine a number of years ago. 1987, I believe. That was the series that was described of patients with erythema migrans, who went on to later manifestations, because they were not treated with antibiotics in the early days. I do not know in 1996, what percentage, or 1992, for that matter, what percentage of patients, who were not treated for early manifestations of Lyme disease, would go on to later manifestations, but the literature suggests that that's the case, but it's based on a previous era of experience.
Q. I was referring to the Archives of Internal Medicine, July, '96, "The Lyme Disease Controversy: Social and Financial Costs of Misdiagnosis and Mismanagement," at page 1494.
A. Except that that's not my work. That is a quote from a paper written by Alan Stier.
Q. Which you --
A. Published in the Annals of Internal Medicine.
Q. Which you included in your own article?
A. Yes, as a reference.
Q. In some patients late Lyme disease may be the initial feature of Lyme disease, correct?
A. I believe I have written that, yes.
Q. And in other patients, who may show signs of the early localized and early disseminated disease, a rapid progression to the later manifestations has also be seen; is that correct, where there's been lack of treatment?
MR. MOODY: I will object to the form. You can answer it, if you understand it.
A. Rapid progression. There are patients who had erythema migrans and will rapidly develop a meningitis or a seventh nerve palsy. There are patients who get bitten by a tick and will develop arthritis as, perhaps, the first manifestation of Lyme disease. I -- there are patients who can develop an encephalopathy relatively quickly after the onset of their Lyme disease. So, I guess the answer is yes.
Q. Based upon your review of the materials sent to you regarding Tara Millar in this matter, have you reached a diagnosis as to what you think her condition or conditions were at various times referred to in the material?
MR. MOODY: Well, I've got to object to the broad nature of the question. If you want to ask him specifically as to certain time frames, I have no objections. But to just say a time frame within the material that you reviewed doesn't give us any idea of whether you're talking about '92, '89, '96.
MR. MAURER: All right.
BY MR. MAURER:
Q. Let's say from the summer of 1992, into the fall of 1992. The tick bite in question took place in June of 1992.
A. Right.
Q. As a reference.
A. In having reviewed this material and having thought it through, I did not have an alternate diagnosis to offer, but I did not have sufficient information to come up with an alternate diagnosis.
Q. Doctor, are you aware -- withdrawn. Doctor, were you aware before I showed you the EKG records, the reports that we mark today as exhibits eight and nine, that Tara Millar was admitted to the Jersey Shore Medical Center in the fall of 1992?
A. Independently I don't recall.
Q. Have you ever been given a copy of the Jersey Shore Medical Center records pertaining to the fall of 1992 admission that I'm referring to?
A. Is it included in that bill of particulars?
Q. You're referring to the letter of two --
A. Right.
Q. -- twenty-six ninety-six, marked as exhibit five? I will let you look and see. I don't believe so.
A. As I said, I did not recall having seen those EKGs and I don't recall -- I don't recall having seen records from Jersey Shore Medical Center.
Q. If a patient is admitted to a hospital for a period of time for treatment of an illness, and you are evaluating the patient's records and history to determine whether Lyme disease is or is not an appropriate diagnosis among other things, would you agree that review of the hospital admission record is something that should be done?
MR. MOODY: I will object to the form of the question, if you understand it.
A. If my concern is did the patient acquire Lyme disease in June of 1992, then the mere fact that she may or may not have had Lyme disease in November of 1992, doesn't necessarily help me. Because it's not as though she was exposed in the first week of June, 1992, and thereafter was whisked away to a place of low endemicity or non-endemicity. She could have acquired Lyme disease in July, August, September or October, any time prior to that admission. So, if the question is in 1996, do you think that this young lady ever had Lyme disease, then certainly review of that medical record would be important.
Q. And you have not done that in this matter?
MR. MOODY: Has not done what in this matter?
Q. Reviewed the Jersey Shore Medical Center record at any time before this moment pertaining to Tara Millar's admission to the Jersey Shore Medical Center in or about November of 1992, correct?
A. I do not recall having seen it.
Q. Dr. Sigal, am I correct that your opinion, as expressed on the third page of your 06/27/96 report to Mr. Orlovsky --
MR. MOODY: Do you have it over there?
A. May I just respond to your previous question about having seen records? I do have some sheets from that admission.
Q. What are does "some sheets" mean, Doctor?
A. What I have here is routine laboratories dated November 15th and November 10th. Complete blood counts dated November 10th, 13th and 15th. A urinalysis dated November 10th. And a ELISA for Lyme disease 11/10, a Western blot dated 11/10, a urine culture dated 11/10 and one dated 11/15. A CT scan of the head dated November 11. A consultation sheet, I presume, from the cardiologist.
Q. Can I see that, please? Please continue.
A. And an echocardiogram result from November 10th. An EEG done November 10th. And that's what I have from that time. Now, on the basis of that, I did not know that she was admitted to the hospital, although these things could as easily have been done as an outpatient.
Q. The consultation report that I asked you to hand to me while you were going through your records is a two page document that appears to be dated on the line where it says, "Date of request, 11/10/92."
MR. MAURER: I'm going to ask the reporter to mark it as exhibit ten. (Consultation report, Date of Request 11/10/92, two pages is received and marked P-10 for identification.)
BY MR. MAURER:
Q. Let me show you the first page where we put the exhibit sticker. Does this consultation report indicate to you the nature of the consultation in terms of specialty?
A. It would be my conjecture.
Q. I thought you indicated before that it was a cardiology consultation report?
A. It is my conjecture that this is a cardiology consultation, but since I don't know, I can't even read the name, I don't know the name of the physician here, I can't very be sure that this is for a pediatric cardiology evaluation.
Q. Now --
A. Here it says pediatric cardiology.
Q. On the second page?
A. Well, on another page it says pediatric cardiology. And given the fact that this repeats a physical examination and is a different handwriting, I don't know for a fact that the two are, in fact, the same consultation. If this were one consultation, I would not expect to see a physical examination here on one hand and another physical examination here on the other hand.
Q. So you think they're two separate documents?
A. I --
MR. MAURER: Why don't we mark them as separate documents? The first one we marked as exhibit ten will be one page and the second one will be exhibit 11. (Second page of D-10 is received and marked P-11 for identification.)
BY MR. MAURER:
Q. Now, with regard to exhibit ten, on the bottom of the page there is an "A". Does that refer to assessment?
A. Yes.
Q. And would I be correct that next to that it makes reference to Lyme disease?
MR. MOODY: Are those words written?
A. Yes, they are.
Q. And after that, can you read the next --
A. I presume that's the word "with".
Q. And then says, "R/O" for rule out --
A. Yes.
Q. -- sinus --
A. That's probably bradycardia.
Q. Meaning the slowing --
A. A slow heart rate.
Q. And on exhibit 11, instead of "A" they wrote "ASS" for assessment?
A. Yes.
Q. And could you read for me what you believe is written there?
A. I believe this is a sinus arrhythmia, an episode of sinus tachycardia. There is - I can't read that - evidence of Lyme myocarditis. This could say there is no evidence of Lyme myocarditis, I just don't know.
Q. That would be a total guess on your part?
A. Absolutely, but there's more there than just the words, evidence of myocarditis could be congestive heart failure, shortness of breath, peripheral edema, which is not documented there.
Q. On the top of the third page of your report to Mr. Orlovsky --
A. Yes.
Q. -- would I be correct that was your opinion, that there is no proof that Tara Millar had Lyme disease in 1992?
A. That's what I state here.
Q. Based upon the cardiology consultation notes that we just marked as exhibits ten and 11, would you agree that that may have been in error based upon what the cardiologists have written in those two exhibits?
MR. MOODY: Well, you asked him about one line on each of the two exhibits and not the entire document. The first document, P-10, which --
MR. MAURER: Please don't direct him to the part of the exhibit, it's a speaking objection.
MR. MOODY: I'm not directing him to a part of the exhibit. What I'm suggesting to you, this came from your clients' Answers to Interrogatories. I have the same forms, apparently, of what the doctor has, part of which has been cut off and clearly something that is difficult to read, because it's a copy. Now you're asking him about whether or not or what the cardiologist may have reported. I'm just saying to you I object on the basis that all you asked him to look at was one line and read one line of that report on the record, not what the entire report said.
BY MR. MAURER:
Q. Based upon what was indicated under assessment in each of those two exhibits, would you agree that your statement that there was no proof that Tara Millar had Lyme disease in 1992, may have been in error?
A. I can't answer that question.
Q. Why?
A. Thank you. It is common practice, when one is getting a referral, to accept as given the referring physician's assessment. This consultation accepts as a given the diagnosis of Lyme disease. There is no documentation in this -- on this sheet by the consultant that independently makes the diagnosis of Lyme disease. Therefore, the mere fact that in the assessment it says, "Lyme disease," this physician is accepting the referring physician's assertion that this is Lyme disease. It's sort of -- recalling Abraham Lincoln's comment that just because you call a tail a leg doesn't mean that it's a leg.
Q. Well, in the exhibit we marked as exhibit 11, the second line that you refer to, where you said, there is evidence or there is no evidence, you weren't sure what was written.
A. Well, it's certainly more --
Q. Let me finish my question, please. It makes reference to the words, "evidence of Lyme myocarditis", correct? That part you can read?
A. The line says, "There is," something, "evidence of Lyme myocarditis."
Q. And if that doctor was expressing the opinion that his interpretation was that there was evidence of Lyme myocarditis, would you agree then that your statement in your report that there's no proof that the child had Lyme disease in 1992, may have been in error?
A. May I see that document, please?
MR. MOODY: I will object to the form of that question.
Q. Sure.
A. That line has two conclusions. One is that there's evidence of myocarditis, if in fact this is a statement that says there is Lyme myocarditis, if that is the assertion of the consultant, then there are two aspects of this. One is that there is evidence of myocarditis and the other is that there's evidence that it's Lyme myocarditis. If one looks at the examination, one finds irregular heartbeat with sinus arrhythmia, which is not a manifestation of Lyme disease affecting the heart, at least not in the literature of which I'm aware. Myocarditis would manifest as evidence of heart muscle dysfunction, which would include peripheral edema or pulmonary edema. Now, the extremities reveal no peripheral edema. The lungs are clear. There's no evidence of pulmonary edema. Therefore, I have no evidence of myocarditis here.
Q. What's the diagnosis of Lyme myocarditis?
MR. MOODY: I don't know if he was finished. I just object. Were you finished with your answer?
THE WITNESS: No, I wasn't, actually.
Q. Go ahead.
A. And this physician states in line two, "The patient developed Lyme disease." This physician does not state that there is independent evidence in favor of the diagnosis of Lyme disease. This physician, I presume as well, is accepting the assertion of the referring physician that there is Lyme disease.
Q. Would it be -- are you done? I don't want to cut you off?
A. But there is no independent proof of this being Lyme disease, neither consultant gives you the evidence that that consultant is using to make a diagnosis of Lyme disease. They are accepting the assertion of the referring physician.
Q. I understand.
A. Pure and simple.
Q. Doctor, would an ELISA test that comes back as reported positive for antibodies to the Lyme bacteria be considered independent evidence supportive of a diagnosis of Lyme disease, assuming it's consistent with balance of the patient's picture?
A. Not necessarily.
Q. Do you discount positive ELISA tests?
A. No.
Q. What are the recommendations of a positive ELISA tests?
A. I follow the recommendations of the Center for Disease Control and Prevention and that is that an independent -- and ELISA positive should be confirmed, corroborated by a Western blot. So that your question referred to an ELISA. A positive ELISA could be due to the fact that the patient has syphilis. It could be due to the fact that the patient has subacute bacterial endocarditis, rheumatoid arthritis or lupus, any one of a number of other infections, including Epstein-Barr infection. So an isolated positive ELISA doesn't proof anything.
Q. Is a positive ELISA test in a patient who's got symptoms consistent with an illness, loosely defined illness, a result which must be considered when evaluating the patient's total picture to arrive at a diagnosis?
A. A positive ELISA for antibodies against Borrelia burgdorferis in a patient with illness as a state needs to be corroborated by a Western blot before one can accept it as evidence of prior exposure to Borrelia burgdorferis.
Q. But it's evidence that should not be ignored, it must be considered, correct?
A. It is not evidence of Lyme disease, however.
Q. Well, it's evidence which you say must be viewed in the context of additional information, correct? You're saying it should be confirmed by a Western blot?
A. There are false positive ELISAs, which abound. A positive ELISA by itself cannot be viewed as confirmatory of prior exposure to Borrelia burgdorferis. It must be confirmed by Western blot.
Q. The actual incidence of false positive ELISA results in normal persons is about four to five percent nationwide; is that correct?
A. Approximately, a little bit higher in some endemic areas supposedly.
Q. Well, in your published articles you refer to it as four to five percent, have you not?
A. Yes.
Q. And that was referring to your experience, I assume, in seeing Lyme patients here in New Jersey, among other things?
A. Yes, among other things, yes.
Q. Am I correct that seroconversion can take up to six to eight weeks following a tick bite by a tick that's infected with Borrelia burgdorferis?
A. Yes, we discussed this earlier.
Q. So, Lyme disease serologic tests are usually negative in the first two to three weeks of illness?
A. They're often negative. They may be positive.
Q. They're usually negative, aren't they, in your experience?
A. There often negative, but they may be positive.
Q. The confirmatory Western blotting technique that you have made reference to has some limitations, doesn't it?
A. All tests have limitations.
Q. Well, I'm referring to the Western blotting technique at the moment.
MR. MOODY: Limitations?
Q. Would you agree there are limitations to the technique?
A. All serologic tests have limitations, yes.
Q. First of all, Western blotting may be negative in very early Lyme disease; is that true?
A. Yes.
Q. And it can take up to six weeks for a patient to produce sufficient antibodies for Borrelia burgdorferis to be detected on Western blotting?
A. It can. It's certainly faster than ELISA.
Q. Would you also agree that after antibiotic therapy, even unsuccessful therapy, there may be a loss of reactivity even in Western blotting?
A. Not a loss. I think what you may be saying is that people, who get treated -- we should back up a second. People who get antibiotics early in the course of their disease may never make antibodies. The mechanism behind that is unclear, but that's been documented in a number of cases.
Q. I'm not talking about seronegativity right now. I'm asking you if a patient, who may be reactive on serological testing can, after treatment with antibiotics, end up reverting back to a situation where they've lost reactivity and end up with a negative Western blot; is that true?
A. In what clinical circumstance?
Q. Any that you're aware of.
A. If you're saying that patients with Lyme disease can be treated and cured of their infection and become seronegative, the answer is yes. Likewise, patients can be treated and cured and continue to be seropositive. They can continue having reactivity by the standard assays.
Q. I'm referring to patients who are not cured, but who have been treated with antibiotics and then a positive ELISA is followed by a negative Western blot test. Isn't it true that also can happen and that's one -- that demonstrates one of the limitations to the Western blotting technique?
A. If you're saying that a patient has Lyme disease, is treated with an adequate therapy and goes from being positive to negative, I have not had that experience.
Q. I'm not characterizing whether the therapy is adequate or not.
A. You said unsuccessful therapy earlier.
Q. Meaning that they still have infection present.
A. Right, so that's inadequate therapy. I have not independently done studies of patients with Lyme disease where I treated them with an adequate therapy to see if their blood tests, that were previously positive, had gone to negative, despite the fact that they've gone -- I don't really think I can answer that question properly.
Q. The other area of limitation of the Western blotting technique has to do with inaccurate interpretations from one laboratory to another; true?
A. Yes.
Q. Or variations --
A. Yes.
Q. -- in the quality of the tests and interpretation from one lab to another?
A. You just added two things. One is that the techniques may be done improperly. There's really no excuse for that in the 1990s. The technique is relatively commonly done and easily done, if one follows the instructions of the manufacturer on the kit. Interpretation is another matter entirely. The current recommendations from the Center for Disease Control and Prevention are relatively straight forward. There are other laboratories that choose not to use that interpretation. I don't know how they came up with their criteria for positive or negative Western blot, but it is certainly not the same kind of meticulous scientific study that went into the CDCP recommendations.
Q. Well, so long as you brought that up, I will skip more to an area that I was going to ask you about. The CDC criteria for making a diagnosis of Lyme disease --
A. Excuse me, the CDC criteria are not for making a diagnosis of Lyme disease.
Q. That's what I want to go --
A. Therefore, it's serologic confirmation of a serologic Lyme disease.
Q. Would you agree with me that that the criteria given out by the Center for Disease Control are not a set of diagnostic criteria, they are an epidemiologic definition of what they consider to be an incontrovertible case of Lyme disease?
A. Are you talking about the serologic criteria or epidemiologic criteria? There may be two sets of criteria you may be putting in the same sentence.
Q. I was referring to the serologic criteria for diagnosing Lyme disease with Western blotting.
A. No, what you're referring to, I think, is the CDC criteria, which are the epidemiologic criteria for the clinical definition for a case of Lyme disease. Those are the criteria that must be met in order to report a case. Those criteria should not be used to make the clinical diagnosis of Lyme disease. They were never intended for such use. Those are clinical criteria, they include erythema migran lesion of greater than five centimeters, then a series of other clinical findings, any one of which is sufficient to satisfy their definition and, therefore, can be reported for the use of epidemiologic follow-up of a geographic area. So, it's a tracking technique. It's not a diagnostic criteria.
Q. So, the criteria with regard to the interpretation of Western blotting, which has been issued by the Center for Disease Control, of ex-number of bands having to be present with specific numbers having to be present, that's something that, in your opinion, should be used to make a diagnosis of Lyme disease based upon a positive Western blot test?
MR. MOODY: I will object to the form.
A. I do not make a diagnosis of Lyme disease based on the numbers.
Q. Considered, I'm saying considered.
A. Considered what?
Q. Considering the positive results on Western blotting as part of the overall picture reaching a diagnosis.
A. A positive Western blot represents relatively strong evidence that the patient was once exposed to Borrelia burgdorferis. It doesn't make am diagnosis of Lyme disease at the time that the blood sample was drawn. It is simple a marker and a reasonably good marker of prior exposure.
Q. Would you agree that early, even an adequate antibiotic therapy can blunt or totally abrogate the response in Lyme disease representing a potential cause for false seronegativity and later disease?
A. That has been in the literature and I believe it, yes.
Q. There's a study that you've referred to in one of your published articles, which suggests that follow-up testing in Lyme disease is usually not helpful, because a decrease in serum antibody levels does not constitute a resolution of Lyme disease and persistence of elevated levels does not mean the infection has not been cured. Is that something you still believe is correct?
A. Yes.
Q. Would you agree there's no correlation whatsoever --
A. Actually, can I amend that statement just to add on to it?
Q. Sure.
A. Thank you. In a patient, who is asymptomatic after treatment, follow-up testing is not warranted, because the mere persistence of antibodies does not prove ongoing infection. In a patient, who is treated and is not asymptomatic and has persistence of findings referable to Lyme disease, follow-up testing may be warranted and must be interpreted appropriately.
Q. All right. Would you agree there's no correlation between antibody levels and the ultimate outcome of a Lyme disease patient?
A. There's evidence to suggest that people, who are remarkable seropositive early on in the course of the disease may have a poorer prognosis. That's not my work, but I have read that in the literature. It's clear that the mere fact that one has a very high antibody level does not necessarily mean that that person is very ill. Likewise, you can be dreadfully ill with Lyme disease and have relatively low levels of antibody. So, the test itself is not of great corollate with clinical findings.
Q. I'd like to ask you some questions regarding explanations for persistence of symptoms after antibiotic therapy for Lyme disease. Would one explanation for persistent symptoms be that the Lyme disease is just slowly resolving and that it takes time for the disease to run its course?
A. Yes.
Q. Would another reason for persistent symptoms be that irreversible tissue damage, caused by the Lyme infection, is present which will not improve with further antibiotic therapy?
A. That's one potential explanation, yes.
Q. And would you also agree that if therapy for Lyme disease is delayed, it's possible that tissue damage caused by the infection can result?
A. Yes, alternatively there are people who get antibiotic therapy very quickly who, for whatever the reason nonetheless, do develop permanent damage. So, it's not only because antibiotics are delayed, there are intrinsic factors in the genetic wiring, if you will, of an individual that may predispose that individual to developing chronic Lyme disease, later manifestations, whatever you want to call it, regardless of how rapidly therapy was begun.
Q. Are you saying that there are some patients who will not respond to what is considered to be an appropriate treatment regimen in terms of antibiotic therapy for Lyme disease?
A. There are a number of potential explanations for that kind of phenomenon.
Q. But I'm asking you if you're saying that?
A. Yes, and there are a number of potential explanations for that, including things like noncompliance and nonabsorption of the antibiotic.
Q. Or possibly insufficient duration of treatment?
A. But what you said was adequate therapy. One of the potential explanations for why people don't get better is because their physician didn't give them either the appropriate drug, the appropriate dose, the appropriate duration of therapy.
Q. Or didn't treat them early enough, that's another possibility, isn't it?
A. For?
Q. 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 can also cause permanent damage, can't it?
A. Potentially, yes.
Q. And one of the reasons for that is that there is proven early dissemination of the Borrelia burgdorferis to the central nervous system in some patients, correct?
A. There is proven dissemination, it's one that's best documented, was central nervous system, yes. May I return to something we discussed earlier?
Q. I'd rather you not for the moment. Perhaps off the record you can tell defense Counsel what it is you'd like to bring up and he can ask you that.
A. Actually, it's something that he's just showed me that relates to what we were discussing previously.
Q. Well, bring it up later, then.
A. Okay.
Q. Would another cause of persistent symptoms be that the bacteria that causes Lyme disease is believed to possibly survive within the cell structure where it's more difficult to kill the bacteria?
A. Well, that's speculation, first of all. And second of all, an organism that resides solely within cells can't cause systemic disease.
Q. Unless the organism comes out of the cell?
A. Precisely.
Q. When there is no level of antibiotics present within the human being's system to kill it and it can then proceed to duplicate itself or reproduce; is that correct?
A. Or there's no antibody because the organism seems to be easily killed by the presence of antibody, but that's speculation. The theory that the organism becomes intracellular within a human has never been demonstrated.
Q. Would another possible explanation for persistent symptoms in a Lyme disease patient be sterile inflammation caused by dead bacteria?
A. Yes, that's also speculation, although there is at least one experimental model that suggests that might be the case.
Q. I don't now to pronounce this word, cytokines?
A. Cytokines.
Q. I have read that dead or live organisms, Lyme bacteria, can cause immune cells to produce a variety of cytokines in vitro?
A. Correct.
Q. What does that mean in layman's terms?
A. The word cytokine is a compound. And "kine" means it's the same root for kinetic energy, which means movement or activity. These are compounds that are made by certain cells that communicate with other cells and basically tell other cells what to do or modify the function or structure of other cells. These compounds were first described in immune mechanisms and there are cells that make chemicals that communicate with other immune cells that either activate or repress or whatever. One of the things that can potentially go on in a closed space in the body, be it in a joint or within the central nervous system, is that there might be persistence of dead organisms. That then elicits the production of cytokines that then cause either persistence of inflammation or may cause damage or dysfunction of local cells. That dysfunction can be mediated by the cytokines themselves or by things that are made by cells that have been acted upon by cytokines.
Q. Is another possible explanation for persistent symptoms after what you viewed as adequate treatment of antibiotics for Lyme disease what has been referred to immunologic phenomena and is that what you were just talking about or is that something else?
A. That is something additional. What you're referring to now, basically what you're doing is you're coming up with a series of points that I made in an article that I published in the American Journal of Medicine a number of years and ago and has been revisited in my paper in the Archives of Internal Medicine in July, and in other places as well. What I said in the original article is that it's possible for there to be persistence of organisms. It's possible for there to be persistence dead organisms no longer infected. But the next step is it's a possibility that something in the organism resembles something in human tissue and that the immune response to the organism, which can now be gone, eliminated from the field of battle, that that immune response may persist. And now what you've got is an autoimmune phenomenon, immune mechanisms acting against cells, auto aggression, if you will, predicated upon what's called molecular mimicry. An alliteration, I can assure you, I did not make up. And in that circumstance, something in the pathogen, in the organism, resembles something in human tissue. The immune response to the pathogen recognizes the human tissue and causes ongoing damage of an autoimmune nature. That's purely speculative. We have worked in the test tube, in the petri dish, that suggests that that may be the case, but it's certainly nothing that I would feel comfortable bringing to clinic. It's speculation at this point.
Q. Is it accurate to say that currently there's no test available which can differentiate between a bacteriologic cure with persistent symptoms and persistent active Lyme disease infection?
A. There is nothing commercially available today that allows one to do that. We are working on such a test right now and think we have one, but it is not commercially available. It is an experimental technique in August of 1996.
Q. You've written fairly recently about a Lyme disease counterculture, correct?
A. Yes, before we leave the issue, there are two other issues that I think need to be raised in that list of why should somebody have ongoing symptoms referable to prior Lyme disease. And that is that something new has happened. The person once had Lyme disease, has been treated and cured and now something else has happened. And the final -- and in our experience by far the most common is that the initial diagnosis of Lyme disease was in error and, therefore, the antibiotics the person has received would not be effective, because the initial diagnosis of Lyme disease was in error. And that I think leads directly into your next point about a counterculture, if you will.
Q. Well, you believe that many cases of Lyme disease are actually misdiagnosed; is that correct, based on your experience?
A. It's not a belief. It is my experience and the experience of others at academic Lyme disease centers, where research is done. Belief implies that I sort of made this up out of my own theories. In our experience here and in the experience of others, that is the fact.
Q. Do you know a Dr. Dorothy Petrucha?
A. I know of her. I have been in a room where she has been, but I do not know her.
Q. Are you familiar with any of her work with regard to treating pediatric Lyme disease cases?
A. I have seen some patients who have seen her previously.
Q. In some of your writings dealing with the Lyme disease counterculture, you make reference to local clinicians who hold themselves out as experts in the field of Lyme disease, true?
A. Yes.
Q. Do you consider Dr. Petrucha to fall in that category?
A. Do I consider that she thinks herself to be a Lyme disease expert?
Q. No, I'm asking you if you would cast Dr. Petrucha within that category as you've written about?
MR. MOODY: Well, I will just object from the standpoint that this doctor says he doesn't know her, other than possibly having seen her in a room. So how is he going to give an opinion one way or the other?
MR. MAURER: Because he says he has reviewed some cases she has treated.
MR. MOODY: He said he had patients, who came to him, who may have seen her.
BY MR. MAURER:
Q. And did you review any of the records in any case?
A. Yes.
Q. I renew question. Based on your contact with Dr. Petrucha in reviewing records pertaining to her diagnosis and treatment of Lyme disease in children, would you describe Dr. Petrucha as one of these local clinical experts who you've referred to?
A. I think that many patients in that geographic area consider her to be a Lyme disease expert.
Q. I'm asking you what you consider based on your contact with her patients and your review of medical records referring to treatment she's rendered to those patients.
MR. MOODY: Same objection. You can answer.
A. All I can say is that I have seen a few of her patients who went to see her because they thought she knew quite a bit about Lyme disease. Everything else is based on hearsay, people telling me what is going on at Jersey Shore Medical Center. But I have not observed these things on my own, so I'm not sure it's fair for me to label her with any term except a pediatric neurologist, who has an interest in Lyme disease and sees many patients, who think they have Lyme disease and considered by many patients to be a Lyme disease expert.
Q. Do patients, in your experience, who have fibromyalgia, normally have a myocarditis condition connected with that myo - I'm sorry - with that fibromyalgia condition?
A. Fibromyalgia is a noninflammatory condition. If a patient with fibromyalgia were to have myocarditis, it would have to be as a separate entity.
Q. " -Itis" meaning inflammatory?
A. Inflammation.
Q. Inflammation.
A. Yes, like tonsillitis, appendicitis, cystitis.
Q. Do patients who have rhinitis or sinusitis normally exhibit as a component to either of those two conditions a myocarditis?
A. Normally?
Q. Yes.
A. Hardly. The answer is no.
Q. In some of the articles that you've written regarding the Lyme disease counterculture, you've expressed or given consideration to the fact that patients and their families are frequently aware of the possible late manifestations of Lyme disease and are increasingly anxious about possible long term, irreversible damage that might result if the Lyme disease diagnosis is missed, correct?
A. Yes, I'm not sure that I have used the term, "Lyme disease counterculture," in multiple papers, however. You said, "In the papers that you've written." I think it may just be in one, but I'm not a hundred percent sure. You probably know that better than I.
Q. Is that anxiety that you've written about something that has existed here in New Jersey in the 1990s?
A. Yes, very much so.
Q. And would you say that that anxiety level has created an environment for you which has, in many situations, presented you with difficulties in convincing patients that they do not have Lyme disease who come to see you?
A. It's not only me that has to deal with that environment. Yes, there's a field of sort of psychosociologic research called illness behavior and the study of the interpretation and performance that people ascribe to symptoms. So, the interesting phenomenon is there are patients who have real disease, but do not consider themselves to be sick and there are other patients who do not have any definable organ pathology, who consider themselves to be very ill. What's happened is that the anxiety that people feel surrounding Lyme disease has seemingly caused them to take on symptoms that cannot be ascribed to organic disease and convince those people that they, in fact, have a disease. And, quite frequently, the concern seems to be that it's Lyme disease.
Q. To your knowledge, were any serologic tests performed on Tara Millar's serum positive or interpreted as positive for Lyme disease in 1992?
A. November, 1992, according to my review of the information, a diagnosis of Lyme disease was made, although the serologic test in November 1992, was negative. In parenthesis, "A negative ELISA and a negative Western blot." And that's in my letter of June 26, 1996.
Q. So is your answer to the previous question that there were no positive Lyme tests done on Tara Millar in 1992?
A. I am unaware of that being a positive blood test in 1992. I have not seen the results of one.
Q. If there were any, would you agree that your statement to the contrary in your report was in error?
MR. MOODY: Well, I would object, unless you have proof to show him that there was a positive one. I don't know how he can answer that. You're asking him to speculate as to whether his opinion would change without telling him the basis on which --
MR. MAURER: I think --
MR. MOODY: -- your --
MR. MAURER: I think it's fair to ask the Doctor.
BY MR. MAURER:
Q. Would your opinion regarding the diagnosis or the impropriety of diagnosing Lyme disease in 1992, change at all if you became aware that there was a positive ELISA test in the fall of 1992?
A. Well, originally what you asked is would I agree that my statement was in error if you could show me a positive result. And, clearly, if there's a positive result of which I was not aware, this statement would be in error, although I have not yet seen such a result. Would I now diagnose her as having Lyme disease on the basis of a positive serologic test? I'd have to see what you're talking about. I need a little more detail than just a positive -- is it an ELISA corroborated by a Western blot, what is the pattern of the Western blot. There's more information that is needed before I could render any sort of value judgment.
Q. If Tara had a positive ELISA and the cardiologist -- one of the cardiologists, who saw her at Jersey Shore during her hospitalization, diagnosed a Lyme myocarditis and you had the history of a known tick bite in the first week of June of 1992, would you agree that you're now approaching a level of information which would have to cause you to give real concern to the possibility that she had Lyme disease in the fall of 1992?
A. If --
MR. MOODY: I will object to the form. Go ahead.
A. If a young lady, in November 1992, had documented myocarditis and had a tick bite in June of that year, would I have to consider the possibility that it was Lyme disease as the cause of the myocarditis? Certainly. Would I have to assume that ascribing a myocarditis to Lyme disease was correct on the basis of an assertion by the referring physician, no. I would require, first of all, that there be objective evidence of a cardiomyopathy, which just means dysfunction of the heart muscle. And as it turns out, the echocardiogram done on November 10, 1992, reads normal study. There is no evidence of Lyme myocarditis. The reason for that is it doesn't make any difference if it's Lyme disease or other than Lyme disease. What she's got here is a normal echo. There's no evidence of dysfunction of the heart muscle. And as a result, there's no myocarditis. So, if she's seropositive or seronegative at that point, she doesn't have Lyme myocarditis, because she doesn't have myocarditis. And as it turns out, during this hospitalization, she was found to be seronegative. So, not only does she not have myocarditis, but she has no evidence of prior exposure to Lyme disease.
Q. Would Tara's being treated with an antibiotic for Lyme disease between October 22nd, 1992, and the time of her testing during the Jersey Shore hospitalization be a possible explanation for why her serology was interpreted as negative for Lyme disease during her hospitalization during November of '92?
MR. MOODY: Objection to the form. You can answer.
A. I think it's very unlikely and I will tell you why.
Q. That's okay. Would you agree, Doctor, that there are no serological tests currently available commercially which are good enough to pinpoint the onset of Lyme disease?
MR. MOODY: You're referring to now, '96, or back in 1992?
MR. MAURER: Now.
A. What do you mean by "pinpoint"?
Q. To be able to pinpoint the onset of infection.
A. There are serologic patterns that suggest relatively early -- that suggest that the infection was acquired relatively recently. There are patterns that suggest that it was acquired more than eight to 12 weeks ago. You can't be precise. You can't say that any test tells you it was acquired two weeks ago versus three weeks ago. You can say with reasonable assurance that the infection was probably acquired four or six weeks ago as opposed to more than 12 weeks ago.
Q. Can you really be that specific, Doctor, or is it really -- or is the test result really just a marker that can be useful in evaluating the patient?
A. The patterns are suggestive. The patterns are suggestive, but at that point in becomes interpretation by the physician.
Q. So, am I correct that as of today, there are no commercially available serologic tests for Lyme disease that permit you to pinpoint the onset of the disease with any degree of accuracy?
A. I think I disagree with that. I think there are tests that are available that help you in a broad way determine when the disease was likely to have started.
Q. You're saying help you in a broad way, but you are not permitted by any of the tests currently available to pinpoint exactly when the person became infected, are you?
A. Well, the term "pinpoint" is a little bit vague. If by pinpoint you mean was it two weeks ago as opposed to three weeks ago, no. If by pinpoint you mean was it three weeks ago as opposed to maybe three years ago, yes.
Q. One test or if comparing tests can you do that?
A. At an example, if one does Western blot analysis, an IgM and IGG, if you find somebody who is IgM seropositive and IGG not, that implies a relatively recent onset of infection. If, on the other hand, one finds IGG seropositivity by Western blot and the IgM is negative, the implication is that the infection was not relatively recent. And, in fact, this is -- these are the patterns of reactivity that are described in some detail in the Centers for Disease Control and Prevention criteria for the interpretation of Western blot analysis.
Q. On the second page of your report, which we marked today --
A. Four.
Q. -- as exhibit four --
A. Yep.
Q. -- second paragraph. You state, "Only about one percent of unengorged tick bites eventuate in Lyme disease. Only one third of all tick bites are observed - thus she could have been bitten by a tick at another time and acquired Lyme disease at another time (below)." First question, Doctor: What is the basis for your statement a fact that only about one percent of unengorged tick bites eventuate in Lyme disease?
A. Gene Shapiro had a study published in the New England Journal of Medicine probably two years ago based on a large cohort studied in Connecticut in an area of proven endemic Lyme disease.
Q. Also in the same paper, third paragraph, you state, "The degree of documentation by Mrs. Millar is extreme," was that a medical observation that you were making?
A. In a sense, yes.
Q. Would you consider Mrs. Millar, based upon your review of materials in this case, to fit the pattern of anxious New Jersey residents who are concerned about Lyme disease being missed as a diagnosis and going on to develop third stage disease? Does she fit that pattern?
A. There seems to be an implication of a pejorative quality to that.
Q. Meaning?
A. What I see in this degree of documentation is a woman who is aware of Lyme disease and concerned about Lyme disease as it my affect her family.
Q. Well, in what sense was it a medical observation that the degree of documentation by Mrs. Millar is extreme, as you refer to it in your report?
A. In a prospective fashion, she was noting a variety of things that I do not routinely see in even the most vigilant of parents. And so I thought it reasonable to comment on the fact that this was a high degree of documentation.
Q. Suggestive that she did what?
A. Suggestive of the fact that she documented everything along the way.
Q. Are you suggesting that she has fabricated any of the documentation that you've seen?
A. I'm not suggesting anything of the sort. I'm simply making an observation.
Q. You, in the same paragraph, appear to question Mrs. Millar's conduct in terms of things she did or did not do with regard to seeking care for Tara, would you agree?
MR. MOODY: I will object to the form of the question as to your interpretation of what he wrote.
A. I found it peculiar that someone who demonstrated such concern about Lyme disease, who had a spray can of tick removal chemical available for use routinely and who clearly was well educated about Lyme disease and concerned about Lyme disease, I found it peculiar that if she thought -- if while she was documenting all of these findings and she felt that inadequate attention was being paid to Lyme disease, I found it peculiar she did the not seek care elsewhere. I could assure you if either of my daughters were not getting adequate care from that physician, I would take them to another physician immediately.
Q. Would you agree that the lack of documentation in Dr. Kenny and Dr. Glenn's records referable to much of what Mrs. Millar claims happened between June and October, 1992, in terms of her communication with the doctor's office, is inconsistent with what Mrs. Millar claims happened?
MR. MOODY: Let me just object to the question. Are you asking whether he found inconsistency between what the record revealed versus what she says?
MR. MAURER: Yes, which I think she was making reference to.
MR. MOODY: Okay.
A. One side is saying that phone calls were made, appointments cancelled -- an appointment was cancelled and no documentation was given in the medical record. The other side is claiming apparently that no such phone call was made and that no such cancellation was affected. There's an inconsistency here.
Q. If Mrs. Millar's version of what she claims happened in terms of her interaction with Doctors Kenny and Glenn's office did, in fact, take place, would you expect that to be recorded in the doctor's office records in some fashion?
MR. MOODY: Do you mean if everything that she says in her deposition occurred, would everything be included in the doctors' records with regard to those?
MR. MAURER: Some, if not all.
BY MR. MAURER:
Q. Would you expect any of that to be noted in the doctor's records pertaining to Tara?
A. If everything happened as she said, I would expect that it would have been documented, but I find it difficult to believe that that's what happened, at least in one circumstance.
Q. Doctor, I move to strike as not responsive. I'm going to ask the reporter to read back the question and I ask you to focus on the question, okay?
MR. MOODY: I think he did.
MR. MAURER: Well, I don't think he focused on what I asked and he started to go off into another area, so I'd ask the reporter to read it back, please.
MR. MOODY: I disagree with you, but the court will make that determination. (The Reporter reads back,
"QUESTION: If Mrs. Millar's version of what she claims happened in terms of her interaction with Doctors Kenny and Glenn's office did, in fact, take place, would you expect that to be recorded in the doctor's office records in some fashion?")
A. I believe my -- I will be right back. Before I go, if these things happened as described, I would expect them to be documented in the chart, but I find it difficult to believe that happened as described, given other pieces of information that were available to me for review. I will be right back. (Whereupon a brief recess is held.)
BY MR. MAURER:
Q. You made reference to other pieces of information available for your review before you left. Do you know where you were in your answer or do you want it read back?
A. Could you read it back? (The Reporter reads back,
"ANSWER: I believe my -- I will be right back. Before I go, if these things happened as described, I would expect them to be documented in the chart, but I find it difficult to believe that happened as described, given other pieces of information that were available to me for review. I will be right back.")
A. So the current question is what were the other pieces of information?
Q. That you referred to.
A. Yes, first of all, Dr. Glenn demonstrates, as I say in my letter, demonstrates a very good grasp of the facts of Lyme disease. He's attended courses, he's read and, in fact, I believe he's actually written a paper about Lyme disease or at least was a coauthor on a paper about Lyme disease.
Q. Are you sure about that?
A. That's my recollection.
Q. Have you been given a copy of it or have you seen a copy of it?
A. No, but my recollection is that he reported someplace that he was a coauthor of a paper on Lyme disease.
Q. Do you know if that's accurate personally, do you know? Have you verified it?
MR. MOODY: Has he verified what?
A. Well, if you're asking me have I seen a copy of the paper, the answer is no, I have not seen a copy of the paper. But my recollection is that it appears in his CV.
Q. Do you have a copy of his CV?
A. It's in here someplace.
Q. Could you produce it?
A. It' in here someplace. Publications, "Lyme Disease with Concurrent Urelcocosis," Journal of the American Osteopathic Association, Volume 94, issue number seven, July, 1994, coauthor. It's not a standard way of listing publications, but then he's not an academic. He's a clinician. But I do not subscribe to or read the Journal of American Osteopathic Association on a regular basis.
Q. Why not?
A. I'm not an osteopath. There are a lot of journals that I don't have the opportunity of reading regularly.
MR. MOODY: Were you completed with or had you finished your answer or were you --
THE WITNESS: I believe that was responding to the question.
MR. MOODY: I wasn't sure if you completed your answer or whether you were interrupted in between, as far as the article.
THE WITNESS: I think that's it.
MR. MOODY: Okay.
BY MR. MAURER:
Q. In terms of acceptable methods of conducting a medical practice and maintenance of medical records and charts within a private office, would the failure to document the interaction that Mrs. Millar claims took place between herself and the office of Dr. Kenny and Glenn, between June and October of 1992, if same took place, constituted a deviation from accepted medical standards of care and treatment?
MR. MOODY: I will just object from the standpoint of you have not raised that previously as an allegation that there was a deviation by the doctors through any expert reports that I recall seeing in this case. So, if you're now going to bring this up as an entirely new issue, as to whether or not the records were kept in the normal course of how they should be kept, I will object to this Doctor giving an opinion on that.
MR. MAURER: Are you directing him not to give an opinion?
MR. MOODY: Yes, unless you can show me somewhere where it's been raised as an issue.
MR. MAURER: I don't have my file here with me.
MR. MOODY: All right.
MR. MAURER: I couldn't possibly do that. My file's very large and I have no independent recollection one way or the other.
MR. MOODY: Okay.
MR. MAURER: Do you have the Answers to Interrogatories?
MR. MOODY: Your clients' Answers to Interrogatories?
MR. MAURER: Yes.
MR. MOODY: And there's no reference in there to it.
MR. MAURER: Are you sure?
MR. MOODY: If you're talking about expert reports, I didn't see an expert report that indicated that there was some allegation being raised in this case that there was an improper manner in which the records were kept or that they were not documented properly or something to that effect.
MR. MAURER: Are you saying that the plaintiff has not claimed separate and apart from Dr. Donta's report that there was a deviation, a failure to maintain records properly or are you just saying it's not in Dr. Donta's report?
MR. MOODY: I didn't see it in his report and I didn't see it by way of Answers to Interrogatories.
BY MR. MAURER:
Q. In 1992, was it possible for a physician to make a diagnosis of a viral upper respiratory infection with any degree of medical certainty?
MR. MOODY: I will just object from the standpoint of "possible" and "certainty". I will just object to the form of the question, but if you understand it, you can answer.
A. Viral upper respiratory infections are a very common diagnosis in general practice, in the general practice of medicine and in the general practice of pediatrics. We don't document the virus. There are hundreds of viruses capable of causing upper respiratory symptoms. So within a reasonable degree of certainty, surely, one can say this looks like an upper respiratory infection due to a virus, but in the overwhelming majority of cases, there is absolutely no proof of it being a viral infection.
Q. Doctor, are the signs of a flu similar to a viral upper respiratory infection?
A. I don't know what a flu is. Unfortunately, it's one of those terms that gets used very, very nonspecifically.
Q. Well, have you heard the term flu-like illness used in the context of characterizing the symptoms of a patient who's being evaluated for possible Lyme disease?
A. Yes, I have heard that term and it's a term that we are doing our best to get rid of from the Lyme disease literature, because of the nonspecificity and because quite frequently a "flu" includes upper respiratory complaints, including rhinorrhea, runny nose, sinus congestion, cough, symptoms that are distinctly unusual as manifestations of Lyme disease.
Q. Unusual but sometimes occur?
A. I have never seen it. If one looks at the literature about early -- symptoms associated with early Lyme disease, these are certainly nowhere near prominent. If you were to ask me has there never been a case of Lyme disease, where the person had a sniffle, I would have to say I don't know and I suspect it's possible, but this is not a clinical syndrome that strongly suggests or even should suggest Lyme disease as an explanation in the absence of erythema migrans.
Q. On the third page of your report, exhibit four, you state, "There is claim that a physician familiar with Lyme disease, practicing in an endemic area, and his staff behaved in a fashion contrary to all common sense in avoiding any clinical contact with the patient and then explicitly cancelled an appointment for serologic testing" semicolon.
A. I hope so.
Q. That's good to see. "I find this unbelievable, given the responses in the Glenn deposition." If, in fact, that is exactly what happened in this particular case, would you agree that the doctor's conduct constituted malpractice?
MR. MOODY: If what, if all those statements are true?
MR. MAURER: Yes.
A. Well, the issue here is if a physician practicing in an area where there is a lot of Lyme disease, dealing with a patient whose mother is very concerned about Lyme disease and the physician knows about Lyme disease, if that physician went out of his way to call the patient -- the patient's mother to cancel an appointment for what is a reasonable serologic test six to eight weeks after a claimed tick bite, if that were to be the case, I would question the physician's judgment, yes.
Q. And would you believe that would constitute malpractice if that's what happened?
A. The reason I'm hesitating is I'm just trying to think about what people knew in 1992. It's not fair to apply 1996 standards to 1992 practice. The issue here is what was the community standard about testing in the aftermath of a known tick bite. I know what I would do in 1996, and I don't think that my mind has changed since 1992, but that practice may not have been clearly established in the community in 1992.
Q. Doesn't the literature suggest the contrary, that by the summer of 1992, that practice was very much established in the State of New Jersey with regard to serologic testing under the circumstances that you made reference to in that paragraph?
A. If, in fact, that's the case, then you're correct, this would represent malpractice. However, I'm trying to put myself in the position of reviewing this case in 1992, not in 1996.
Q. By the way, would any of the opinions you expressed in that paragraph or in response to these last few questions change if the doctor cancelled the originally scheduled appointment for a Lyme test immediately after the appointment was scheduled as opposed to doing it six to eight weeks later? Would that change anything?
MR. MOODY: I object to the form the question and its broad nature. You say his response to the last few questions. Now, I don't know what his response to the last questions were in connection when you're now asking him about just one test being cancelled.
MR. MAURER: All I'm saying is he gave -- in discussing the various components of what he understands happened, he made reference to the tests being cancelled six to eight weeks later and I want to make sure that his opinions wouldn't change if the time when the doctor cancelled the test was immediately after the test was scheduled, or the appointment was scheduled to do the test.
MR. MOODY: Do you understand?
THE WITNESS: I think so.
Q. Which, in fact, is the facts in this case, I'd ask you to assume.
A. Assume. If a patient -- if the mother of a patient were to call and say, "My daughter was bitten by tick a few days ago. I would like to have her tested six to eight weeks from now," and the physician were to call back the next day and say, "Don't bother," I would disagree with that. But that's from the 1996 prospective.
Q. That's also based on your not having changed your approach to that --
A. Right.
Q. -- since 1992, correct?
A. That's correct.
Q. All right.
A. But, again, the practice of medicine at a referral centers is very different from the practice of medicine in the real world.
Q. You're saying that clinicians out in the trenches, so to speak, who are not at a Lyme disease referral centers, have a different standard than that which would be applied to you in 1992?
A. No, I'd prefer to look at it the other way. I'd prefer to say that the way we approach a case of possible Lyme disease at a referral centers is quite different from the way a practicing clinician thinks a case on a day to day basis.
Q. In 1992, you published an article entitled, "Current Recommendations for the Treatment of Lyme Disease," which appeared in something called Drugs.
A. Yes, great name. It's an international journal of pharmacology.
Q. And in that you provide a guide chart of the diagnosis and treatment of suspected Lyme disease; is that correct?
A. Yes.
Q. And did you consider that guide chart to reflect an appropriate standard of care for the diagnosis and treatment of suspected Lyme disease in 1992, when you published this?
A. It is what I suggested in 1992, whether that is the community standard of care in New Jersey, I can't state.
Q. Even though you practiced in New Jersey at that time?
A. But, again, the practice of medicine at a referral centers is almost by definition different than the practice of medicine in, if you'll pardon the expression, the real world. If you'd like me to expand upon that, I'd be glad to.
Q. That's okay.
A. I do not mean by these responses, by the way, to cast doubt on the quality of medical care by community physicians. I used to be a community physician. Not here, but elsewhere. The point is that the way one approaches a case in a referral center is different.
Q. Would you agree that in evaluating whether or not malpractice took place in this particular matter, a good portion of the issue has to do with determining the accuracy or inaccuracy of the reporting of Mrs. Millar at her deposition as to what she claimed happened --
MR. MOODY: I object to the form.
Q. -- with regard to her communication with Doctors Kenny and Glenn's office, true?
MR. MOODY: Objection to the form of the question.
A. It's the story of Rushamon. There are two very different statements about what happened.
Q. And would you agree, then, that a substantial portion of this claim has to do with deciding the accuracy of the information provided by Mrs. Millar versus Doctors Kenny and Glenn and that does not call for an opinion by a Lyme disease expert?
MR. MOODY: Objection.
Q. Would you agree with that?
MR. MOODY: Objection to the form of the question. Go ahead.
A. I think what you're asking is --
MR. MOODY: Well, don't guess. If you don't understand the question, make him rephrase it.
A. Let me just phrase it to you in the English that I understand and, perhaps, we can come to an agreement here. I think what you're saying, one might not need be a Lyme disease expert to realize one of the issues here is one side says one thing and the other side another thing and that's an important issue in this case, is that what you're asking?
Q. Yes. You would agree with that?
A. One need not be a Lyme disease expert to realize that that's the case, yes.
Q. Is that right? And you've expressed a number of opinions in your report marked as exhibit four which have nothing to do with your background and training as a Lyme disease expert, true? It's just your personal response and opinions based upon your review of the treatment that you reviewed; isn't that true?
A. I wouldn't typify myself as a Lyme disease expert, first of all. It has nothing to do with any insights I have into Lyme disease. It does, however, have to do with the fact that I have been on the faculty of medical schools for 12 years now and I'm the person who's supposed to be training internists and family practitioners to go out and practice family medicine. So I think, when I look at a medical record and, as an example, see bad documentation or in exactness of language, or the absence of statements that need to be made absent physical findings, absent historical features, the inability to go and take the next step in asking questions, when I see that, one need not have any insight to Lyme disease in order for a faculty member in a medical school to have an opinion about what's going on in the case.
Q. Which in this case would be that there was malpractice, if there was a failure to report as claimed by Mrs. Millar?
MR. MOODY: I will object to the form of the question. That was not his testimony earlier. If that's what you're suggesting --
MR. MAURER: I'm asking him another question.
A. A proper medical record should include documentation of telephone calls made. That means telephone calls received and responded to by the staff, as well as the physician. Since a lot of communication goes on between the nurse, the office manager, even the receptionist and the patient, or the patient's parents, those things should be documented.
Q. For example, you would expect Doctors Kenny and Glenn to have documented a reported tick bite with a tick having been removed from Tara; is that true, if it was reported to their office?
A. If that was reported to them, yes, I would expect that.
Q. Would you expect it to be recorded in the chart if it was reported to their office?
A. I don't know what their practice is like. And the reason -- what I'm saying here is that in an endemic area for Lyme disease, or even more important, forget about Lyme disease, in an area where tick bites happen every day in everybody seemingly, that kind of thing probably would not be documented in the chart. I don't -- but I don't know, because I wasn't there and this is pure speculation on my part.
Q. Dr. Sigal, if someone comes in the clinic here at Robert Wood Johnson and reports they were bitten by the tick and they removed the tick from their body, is that something that you would expect to be entered into the chart here?
A. If they came to us and at a visit they said this to us, yes. If they came and were sitting in an examining room with me and said, "I was bitten by a tick three days ago," I see patients like that all the time. But if somebody were to call up and say, "I was bitten by a tick," it might not get documented.
Q. Even if that was your patient?
A. I am not the -- again --
Q. I'm talking about a primary treating physician.
A. I'm not a primary treating physician. I am a referral physician, a point that the insurance companies and managed care organizations make to me all the time. I am not the primary care physician for these patients.
Q. Then are you in a position, if you're not a primary treating physician, to give an opinion, then, on the standard of care for a primary treating physician, such as Doctors Kenny and Glenn, who are osteopaths?
A. Yes, I am. I don't believe -- are both of them osteopaths? I believe one of them is. I'm not sure that the other one is. I believe he's an M.D. But, in any event, having been -- the mere fact that I do not have the role of primary care physician in 1996, first of all, does not mean I have never done it and, in fact, I have. I was a practicing internist at an HMO and I was the director of internal medicine at that HMO for two years, first of all. Second of all, I supervise medical students, interns and residents, who take on that role in other settings. And so I am part of their training. I am still an internist, even though I do not practice internal medicine as my primary subspecialty nowadays.
Q. Doctor --
A. I'm board certified in internal medicine.
Q. -- I'd like to focus back on what the appropriate practice for a primary treating physician, who was treating a patient on an ongoing basis; okay? If a patient, who is one of your patients as a primary treating physician, hypothetically were to call or the parent were to call and say, "I have removed a tick off of my daughter," would you consider that to be an important bit of information that should be entered in the chart for reference in the future in determining appropriate care, testing and treatment? Would you expect that in 1992?
MR. MOODY: Referring to a call to the office and giving it to the secretary or calling the office and speaking to the doctor? I'm not sure of your question.
Q. First let's say the staff and then we can say the doctor.
A. The problem again is that I do not know what the circumstances were in the office in 1992. If every five minutes they were getting phone calls from people saying that my daughter was bitten by a tick, it may very well be they were not documenting every single tick bite. Vastly more important than documenting a tick bite is the kind of follow-up you give to those people. We now know that the risk of getting Lyme disease from a known tick bite is very small. However, the follow-up given to that patient is really important.
Q. Was your answer whether it be to the staff or to the doctor?
A. I suspect that physicians might be more likely to document that, because once you've spoken to the patient, in all likelihood someone's pulled the chart for you to have it in front you to review. But, again, I don't know what the -- what was going on in the circumstances of that practice at that time. At that time of year.
MR. MAURER: I have a copy of a Roche Biomedical Laboratory report that we're going to mark as exhibit 12. It's a report that indicates the date of specimen was 10/23/92 and that it pertained to Tara Millar. (Roche Biomedical Laboratory Report is received and marked P-12 for identification.)
BY MR. MAURER:
Q. I'm going to show what we've marked as exhibit 12, Doctor.
A. This is a report dated 10/28, specimen date 10/23 1992, labeled as being a specimen from Tara Millar, sent by Dr. Parvin Motemaden. And it an ELISA or an E-L-A, ELISA for Lyme disease READ as being 1.11.
Q. And that was interpreted as what?
A. As being positive.
Q. For what?
A. As being positive.
Q. Positive for what? What does it say? It's positive for what?
A. The interpretation is as follows: "Elevated antibody levels indicated previous infection only with appropriate clinical findings." Lyme disease spirochete antigens cross react with those of relapsing fever, syphilis, and leptospirosis, sinus arrhythmia, ASAs. Up to 90 percent of acute patients may be positive by EIA. Convalescence titer requires weeks-months to peak. Early treatment may abort the antibody response. The index is read as being 1.11. A result of greater than 1.0 is read as being positive followed by the statement supplemental testing by Western blot number 163600 is recommended for positive EIA results.
Q. Doctor, this was interpreted as positive for antibodies to the Lyme disease bacteria; is that correct?
A. I believe so, yes.
Q. Have you ever seen this report before?
A. I have seen mention of this report before. I do not recall if I have seen this itself, but there's mention in the chart of a positive test in November, 1992.
Q. Well, actually you indicated --
A. I'm sorry. No, I'm sorry. I have a record of a positive test in 1994.
Q. And that was a Western blot at the time, wasn't it?
A. In 1994, I have -- a positive serologic test is mentioned in 1994. I do not believe it was a Western blot.
Q. Is it relevant to whether or not she should be diagnosed in 1994 as having Lyme disease?
A. Is what relevant?
Q. Whether or not it was a positive Western blot versus a positive ELISA in 1994; is that an important thing to note?
A. It is an important point to note, yes, if she had a positive ELISA versus a positive Western blot in 1994.
Q. You did not note which it was in your report?
A. Had it been a positive -- I believe that there is mention in a letter or a note by Dr. Petrucha that there's a positive serologic test. I do not believe that I saw the results. Had I seen the results, I feel sure that I would have written it in and, in fact, my notes state that she's rheumatoid -- I'm sorry, that's November of 1992. I do not believe that I had those results. I believe that I was reporting on a statement in another communication.
Q. Would I be correct that your statement that there was no objective evidence consistent with -- withdrawn. Let me find the language.
A. Top of page three.
Q. I think there two spots where you said something.
A. Middle of page two, is there a serologic test prior to -- positive prior to 1994?
Q. First of all, let me ask you this. In the previous paragraph you ask the question, "Is there any objective evidence of Lyme disease in this case?" Is a positive ELISA at the time objective evidence of Lyme disease, which has to be considered in the entire clinical picture? Is it evidence to be considered when viewing the entire picture?
A. It is evidence to be considered, but in and of itself does not constitute proof of exposure.
Q. No one serologic test is proof positive, which should be relied upon in and of itself to diagnose Lyme disease, true?
A. Lyme disease remains a diagnosis made by clinicians, not by laboratory. However, were one to find a remarkably positive Western blot in October or November of 1992, one would have to say this child has been exposed to Lyme disease at sometime if the past. At that point, one could not say that the onset of the disease was the first week of June, as opposed to the first week of July, as opposed even to the middle of July.
Q. I want to focus back on your statement that there was no objective evidence of Lyme disease in this case. Isn't it true that the positive ELISA test, which we've just identified as exhibit 12, is some evidence, objective evidence of Lyme disease; isn't that true?
A. No.
Q. I'm not saying it's something that in and of itself should be the basis for a diagnosis, but isn't it true that it's one piece of evidence that has to be considered by someone in determining whether or not a patient has Lyme disease?
A. It is a piece of the puzzle. It in itself does not constitute proof of exposure to Borrelia burgdorferis and the report itself states that Western blot testing -- supplemental testing by Western blot is recommended by positive EIA results, which was not done. This a weak positive ELISA, 1.11 is very marginal activity. In many laboratories a ratio less than 1.2 is considered to be borderline and not positive. So, this is a weak positive ELISA that is not corroborated by Western blot in and of itself is not be viewed as proof of exposure to Borrelia burgdorferis, regardless of date.
Q. Doctor, is ELISA an objective test or subjective test?
A. It an objective test.
Q. And the results of the ELISA test constitute evidence to be considered, true? Without going into a whole long explan