1 1 IN THE COURT OF COMMON PLEAS 2 CUYAHOGA COUNTY, OHIO 3 JOHN C. NEWELL, et ux., 4 Plaintiffs, 5 -vs- CASE NO. 390126 6 KULDEEP SINGH, M.D., et al., 7 Defendants. 8 - - - - 9 Telephonic deposition of MICHAEL deWIT 10 CLAYTON, M.D., taken as if upon cross-examination 11 before Aneta I. Fine, a Registered Merit Reporter 12 and Notary Public within and for the State of 13 Ohio, at the offices of Weston, Hurd, Fallon, 14 Paisley & Howley, 2500 Terminal Tower, Cleveland, 15 Ohio, at 4:30 p.m. on Thursday, November 30, 16 2000, pursuant to notice and/or stipulations of 17 counsel, on behalf of the Defendant, Kuldeep 18 Singh, M.D., in this cause. 19 - - - - 20 MEHLER & HAGESTROM Court Reporters 21 CLEVELAND AKRON 22 1750 Midland Building 1015 Key Building Cleveland, Ohio 44115 Akron, Ohio 44308 23 216.621.4984 330.535.7300 FAX 621.0050 FAX 535.0050 24 800.822.0650 800.562.7100 25 2 1 APPEARANCES: 2 Ellen Hobbs Hirshman, Esq. (Via telepone) Linton & Hirshman 3 700 West St. Clair Avenue Cleveland, Ohio 44114 4 (216) 781-2811, 5 and 6 Larry S. Klein, Esq. (Via telephone) Leader Building, Suite 230 7 Cleveland, Ohio 44114 (216) 861-0111, 8 On behalf of the Plaintiffs; 9 10 Ronald Rispo, Esq. Weston, Hurd, Fallon, Paisley & Howley 11 2500 Terminal Tower Cleveland, Ohio 44113 12 (216) 241-6602, 13 On behalf of the Defendant Kuldeep Singh, M.D.; 14 Gary H. Goldwasser, Esq. (Via telephone) 15 Reminger & Reminger 7th Floor 113 St. Clair Building 16 Cleveland, Ohio 44114 (216) 687-1311, 17 On behalf of the Defendant 18 Arturo S. Basa, M.D. 19 20 21 22 23 24 25 3 1 MS. HIRSHMAN: For the record, I'm 2 Ellen Hirshman and I'm here in my office 3 communicating and participating in this 4 deposition by phone with Larry Klein. 5 We're both counsel for the plaintiffs. My 6 understanding is that Aneta Fine, the court 7 reporter is present in Ron Rispo's office, 8 correct? 9 MR. RISPO: That's correct. 10 MR. GOLDWASSER: Doctor and madam 11 court reporter, my name is Gary Goldwasser. 12 I am the attorney representing Dr. Basa. 13 THE WITNESS: And that's 14 Goldwasser? 15 MR. GOLDWASSER: Correct. 16 THE WITNESS: Thank you. 17 MR. RISPO: Okay, sir. If you're 18 ready and the reporter is ready we need to 19 swear you in. We're doing this by 20 stipulation long distance. If you would 21 raise your right hand, sir. 22 23 24 25 4 1 MICHAEL deWIT CLAYTON, M.D., of lawful 2 age, called by the Defendant, Kuldeep Singh, M.D. 3 for the purpose of cross-examination, as provided 4 by the Rules of Civil Procedure, being by me 5 first duly sworn, as hereinafter certified, 6 deposed and said as follows: 7 CROSS-EXAMINATION OF MICHAEL deWIT CLAYTON, 8 M.D. 9 BY MR. RISPO: 10 Q. Doctor, I will begin by asking you a few 11 questions regarding your resume. I do have a 12 copy in front of me. It's undated, but I presume 13 that it is reasonably recent in time. It doesn't 14 go into a great detail but we'll find that out as 15 we go along. 16 Do I understand that you were born in Germany 17 or how is it that you had some relationship with 18 Germany? 19 A. I was not born in Germany, I was actually born 20 not far from the eye of Chicago but when I 21 finished my undergraduate degree at Loyola 22 University, in Los Angeles I was doing some 23 research with a German professor and went to 24 Munich to work with a colleague there on some 25 techniques that we were implementing to grow 5 1 cancer tissue in the laboratory. I was at that 2 time also contemplating entering into medical 3 school. So when I went into Munich I had to 4 enter the university so I applied, was accepted 5 to the university and was told that my grades 6 were such that I could enter into the medical 7 school. Only thing is I didn't speak German so I 8 learned German, studied it for about six months 9 very intensively, took an entrance examination, 10 entered the medical school and then after about a 11 year or two I decided to stay in Germany and 12 completed my studies there and spent about seven 13 and a half years in Munich altogether. 14 Q. Would you -- that's very interesting. 15 A. It was kind of a twist of fate that was just a 16 wonderful experience that I didn't know would 17 turn out as favorable as it did but it was a 18 great experience. 19 Q. Can you give us the starting and ending dates of 20 your period in Germany? 21 A. I graduated from Loyola University in 1973, in 22 the summer of '73 and I went to Germany the fall 23 of '74, about a year later. I entered the 24 medical school in the spring of '75 and graduated 25 in the spring of 1982. It's a six year program 6 1 and I was there seven years. 2 Q. I see. Okay. And then you came back to Chicago 3 I take it? 4 A. This is what I did. I entered into my training, 5 first two years of general surgery at the 6 University of Illinois at Cook County Hospital 7 and then four years of urology at the same 8 institution. 9 Q. Okay. You alluded to the fact that you were 10 engaged in researching cancer. I understand that 11 you're a member, you're Board-certified in 12 urology. Can you give us an idea of what your 13 breakdown or division of your training has been 14 in oncology versus urology? 15 A. Well, urology, we have, we are, we do a lot of 16 cancer. We're not pure oncologists such as a 17 internist would be who studies the field of 18 cancer, we're urologic surgeons who deal with 19 prostrate, bladder, renal, kidney cancer, adrenal 20 cancer, testicular cancer and the like. 21 So we, I would say that in an average 22 urologic training program probably a good 50 23 percent of all the work we do is in the field of 24 cancer, one way or another. 25 Q. Are you Board-certified in oncology? 7 1 A. No, not as an oncologist. I'm Board-certified by 2 The American Board of Urology in 1990 and again 3 recertified in the year 2000. 4 Q. How about general surgery; have you specific 5 training or Board-certification in general 6 surgery? 7 A. No, sir. We had two years of general surgery as 8 part of our urologic training. I am not 9 Board-certified in the field of general surgery. 10 Q. And just to exhaust the possibilities, what 11 training do you have, if any, in internal 12 medicine? 13 A. Very little other than what was done in a 14 rotating internship in Germany. Our last year 15 there we serve as interns and it was within two 16 of the three disciplines in the course of one 17 year, in other words, eight months of work was 18 done in the field of internal medicine, general 19 medicine, but it was not a, other than like an 20 internship training, there was no formal three 21 year program with certification afterwards, it 22 was just our internship. 23 Q. Okay. So then do I take it that you have not 24 also practiced in the field of internal medicine? 25 A. That is correct, sir. I have no qualifications 8 1 within that field. 2 Q. Nor in the field of family practice or general 3 practice? 4 A. No, sir. 5 Q. Do you do any surgeries outside of urological 6 surgery or do you do urological surgery? 7 A. I do a lot of urological surgery. I have a very 8 busy surgical practice. The only surgery I 9 really do outside of urologic surgery are things 10 that are directly related to it, meaning that 11 there are times when I'll do a hysterectomy as 12 part of a cancer procedure or times I'll resect 13 bowel or enter the chest for instance to do 14 certain types of urologic surgery. But I do not 15 accept hernias and gallbladders and the such, I'm 16 not involved in the general surgical disciplines 17 in any routine. 18 Q. What percentage of your practice involves actual 19 surgery? 20 A. If you look at revenue, that would be probably 21 the easiest way to look at it would probably give 22 you a good breakdown. It's about 50/50. I 23 generate about 50 percent of all the revenues 24 that I put on the books are in surgery and about 25 50 percent are from seeing patients for urinary 9 1 tract infections and other disorders, stones and 2 such. 3 Q. Would that 50/50 be fairly reflective of your 4 time spent in surgery versus the time spent in 5 the office? 6 A. I would, as far as pure time spent in surgery, I 7 probably spend one and a half days operating a 8 week and spend three days or three and a half 9 days for instance in the office. Now, in the 10 office I'm also caring for the surgical patients 11 and getting patients ready for surgery. I guess 12 we would call some of those duties associated 13 with the surgical case itself, but my time at the 14 operating room table probably reflects about a 15 third of my practice week. 16 Q. I see. That makes it much clearer. Of those 17 patients that you see in the office that are not 18 involved in or scheduled for surgery on an acute 19 basis, what percentage, if any, do you see of, 20 let's say, a general practice? 21 A. The term general practice is one that's been 22 thrown around this case a little bit so I'd just 23 like to clarify general practice by meaning I was 24 not doing an evasive procedure or a diagnostic 25 test, like treating a patient medically for 10 1 kidney stones, treating patients medically for 2 urinary tract infections or other disorders. I 3 would say that in that respect urology is rather 4 unique in that we have a, of all the surgical 5 disciplines, we probably see the largest 6 proportion of patients medically rather than 7 surgically than any other surgical subspecialty. 8 We have an ongoing practice where we manage 9 prostrate cancer, not surgically, we manage it 10 medically so we have a large proportion of 11 patients who would qualify for being followed 12 medically rather than surgically. If you 13 understand what I mean. 14 Q. I certainly do and that's a very helpful 15 distinction. Can I take it one step further? If 16 we were to exclude for purposes of our 17 discussion, and I'm not sure that we have a 18 precise definition for what we're talking about, 19 but we'll work toward it, if we exclude the 20 surgical patients and the oncology patients for 21 whom you are providing medical treatment for 22 their oncology problems, and if I were to use the 23 term courtesy care, that is, unrelated to 24 urological surgery or oncology medical 25 management, do you do any, do you see patients 11 1 for courtesy management, let's suppose we're 2 talking about colds, the flu, respiratory 3 infections and so forth. 4 A. No. I just don't. The only time that that would 5 ever come into play would be if a patient was 6 post-operative or something and they came down 7 with a respiratory tract infection I may, you 8 know, offer them some assistance there but I do 9 no, none of the type of descriptions that you 10 just described. I send those people to their 11 primary general physicians. 12 Q. Can I pursue that one step further, doctor? Of 13 those patients that you've defined as surgical 14 patients, and/or perhaps the medical oncology 15 patients, how much or how often do they come down 16 with incidental, minor complaints which you do 17 treat, if at all? 18 A. I would say very seldomly. The example that I 19 gave you would be for instance somebody who had 20 had surgery but had pain lasting longer than I 21 would expect or somebody who said I had a, I got 22 a tape burn or something of this nature. I don't 23 see patients, even my longstanding oncology 24 patients, I don't see them as a generalist in any 25 way, shape or form. That's very distinctive in 12 1 my practice. I just kind of keep it to urology 2 and even though sometimes we're asked, I refer 3 them back to the physician who they see for their 4 general problems. 5 Q. Okay. Just so we can finish up a few more 6 preliminaries, doctor. Have you ever testified 7 on behalf of a patient or a client of the lawyers 8 involved in this case, either Ellen Hirshman, her 9 associate, Toby Hirshman or Larry Klein? 10 A. I don't think so. Not the Hirshmans for sure. I 11 have not worked with them but I'm not sure how I 12 got in touch with Mr. Klein, but the name sounds 13 familiar although I've never worked with him to 14 my knowledge directly. It's just that his name 15 is familiar to me somewhere. Whether he was on 16 the other side in a case or not, I don't know but 17 I have never worked with the Hirshmans and to my 18 knowledge I've never worked with Mr. Klein and I 19 don't think I've ever worked on the other side 20 either for him defending a physician. 21 Q. You may have already answered this, but do you 22 know how it was you were selected in this case? 23 A. No. I don't really know. In fact, I asked Ellen 24 Hirshman that and she had mentioned through an 25 attorney that she knew who had either discussed a 13 1 case with me or I had written a report for, she 2 got my name and contacted me. Other than that, I 3 don't know. 4 Q. Okay. And have you ever testified in Ohio 5 before? 6 A. No, I've never testified in -- you mean in a 7 courtroom? 8 Q. Yes. 9 A. Or via deposition? 10 Q. Well, I was going to take it step by step. In 11 the courtroom or by deposition. 12 A. In a courtroom, never. I may have given a 13 deposition several years ago on a case. I don't 14 exactly remember if it was in Ohio or not, but I 15 think that's the only time that I even gave 16 deposition testimony. 17 Q. Have you consulted frequently in cases in Ohio 18 that, where you did not give deposition 19 testimony? 20 A. I have probably, I had three cases perhaps 21 referred to me that I've reviewed. I believe 22 that's about it, three cases. 23 Q. Okay. And then in its totality, how many cases 24 do you take per year to review either as a 25 consultant or to testify in a medical malpractice 14 1 setting? 2 A. Probably anywhere from -- seems like it's been 3 kind of busy lately, but probably two to four 4 cases in a year. This is not something I do as a 5 sideline or anything. 6 Q. Well, I don't blame you a bit if you choose not 7 to. Have you testified exclusively for one side 8 or the other or can you give us a breakdown 9 percentage-wise? 10 A. I would say it's been pretty close to 50/50 as 11 far as deposition and/or any testimony. As far 12 as some reviews that people have asked me to look 13 at charts on, it's probably been about the same 14 and I would say the majority of the cases I would 15 say that they're without merit and that's my 16 opinion. So I would say it's probably 50/50, 17 maybe 60/40 plaintiff. Maybe 60/40. 18 Q. Okay. And do you belong to or are you listed, to 19 your knowledge, in any expert witness index 20 service? 21 A. No, sir, I've never, I didn't even know they 22 existed until your deposition with one of the 23 other, with one of the other experts. I didn't 24 even know such a thing existed. That's how naive 25 I am about that process. But I have no knowledge 15 1 of any such organization nor am I part of any 2 such organization. 3 Q. Okay. Can you describe for us the materials that 4 you've been provided in connection with your 5 review for this case? 6 A. Sure. I'll start with a record, notebook was 7 sent to me by Ellen Hirshman with a medical 8 record log with records from Dr. Singh, Dr. 9 Velloze, Dr. Basa, and the Cleveland Clinic 10 Foundation. I have also to my right a number of 11 depositions. I have one deposition of Dr. Robert 12 Steele, I have the deposition of Stewart M. 13 Flechler, M.D., I have the deposition of William 14 Carey, M.D., I have the deposition of Dr. 15 Morganstern-Clarren, M.D., I have a deposition of 16 Dr. Singh, I have a deposition of Dr. Basa, I 17 have a deposition of John C. Newell, I have one 18 of Sabina Velloze, M.D., and I also have before 19 me a letter from, to Mr. Kilbane from Armin J. 20 Greene, M.D., I have a report to Mr. Rispo from 21 David N. Grishkan, M.D., and I have one, a letter 22 to Mr. Kilbane from Martin Resnick, M.D., and 23 also to Jo-Ellen Leach, a nurse-paralegal from 24 Bodnar. I have some additional records which 25 were sent to me late from the Cleveland Clinic 16 1 and from Southwest General Hospital, and I have 2 in my folder, a collection which I do not know if 3 it was complete, of correspondence that came to 4 me with these depositions and records from Ellen 5 Hirshman basically to confirm that the trial is 6 on this date, et cetera, et cetera, your 7 deposition on this date, and usually accompanied 8 the records that were sent. 9 Q. Has Miss Hirshman provided you in her 10 correspondence or with any of the other 11 deliveries, any materials, including medical 12 references? 13 A. No. There are no references here, at all. 14 Unless they came as part of what do you call when 15 you add something onto somebody's deposition? 16 Q. Exhibits? 17 A. When you declare, number one, number two, number 18 three. They're in somebody's deposition or 19 records, that would be the only thing, but I have 20 nothing else that I can recall as a peer review 21 journal or any records of that nature. 22 Q. Okay. And have you, prior to writing your report 23 or in preparation for this deposition, taken the 24 opportunity to consult any of your own medical 25 resources or the literature? 17 1 A. Not directly. This has been going on for about a 2 year and a half so certainly in reading my 3 regular, reading assignments, topics parallel or 4 close to this concerning prostate cancer and 5 treatment of margin positive disease, that's a 6 hot topic in our field, but I would have read 7 that but it's nothing that I sought out, searched 8 and filed for this case. 9 Q. Have you copied and put into your file any of the 10 literature on margin positive disease? 11 A. No, sir. I have in my, in my library there have 12 been some rather extensive articles that have 13 been written, but I, and I have them in my 14 library, but I did not select them because of 15 this case and keep them in the file for that 16 reason. 17 Q. Prior to this deposition, have you been informed 18 in any manner or method that it was the intention 19 of the plaintiff to dismiss Dr. Basa? 20 A. That discussion took place between myself and I 21 was informed of that should I say by doctor, 22 Ellen Hirshman that they were probably going to 23 let Dr. Basa go in this case, but that's about 24 it, I didn't have obviously any input into that, 25 I was just told as the case came along that that 18 1 was probably going to be the case. 2 Q. Were you told directly or indirectly that the 3 decision to dismiss Dr. Basa might be dependent 4 on your testimony? 5 A. No, because I think my conclusions, my 6 conclusions in my report from June 12th were 7 basically parallel -- in the end effect 8 paralleled Dr. Resnick's thought that the 9 pathology itself dictated to a large extent some 10 of the outcomes for Mr. Newell. 11 Q. Well, let me go directly into that subject since 12 we're on it and refer to your report. By the 13 way, have you ever written any reports besides 14 the one dated June 12th? 15 A. When I write, when I do these, I just put it on 16 my computer and edit it as I go along before I do 17 a report, before I have a final report. As 18 records come to me I will add material to it 19 almost as a, not a rough draft but just as an 20 ongoing draft. I have nothing before me but I'm 21 sure I have printed out to correct the English 22 and review it somewhere along the line a copy 23 before the June 12th was sent to Miss Hirshman. 24 I don't have anything other than that June 12th 25 record here. I don't have anything else, but I'm 19 1 sure there was in the production of this letter 2 in which took probably several weeks to put 3 together as I got information, I'm sure there was 4 in my computer or on it, if I put it out to look 5 at the material, I don't have it. As I updated 6 it I just got rid of the old. 7 Q. I appreciate that, doctor. I guess I could have 8 been more specific in my question. The point I 9 was trying to get at is have you delivered, sent 10 or mailed to Miss Hirshman or Mr. Klein another 11 version or draft of this letter? 12 A. Not that I am aware of. This is the only letter 13 that I've, I've had. When I spoke with Miss 14 Hirshman and Mr. Klein the other night, this was 15 what I had, June 12th draft and that's what they 16 had. To my knowledge there's no other things 17 have been sent. I have sent them a letter with 18 some billing statements. I have corresponded in 19 that nature and I have I think those bills here 20 in my folder as well, but nothing that I recall. 21 Q. Have you supplemented this report after reviewing 22 the other materials that were sent to you after 23 June 12th? 24 A. No, sir, I haven't. Even though I did receive 25 some depositions and stuff in the last weeks, I 20 1 have not supplemented this report from June 12th. 2 Q. Have you created any notes either on the computer 3 or handwritten summarizing your observations 4 following the review of these depositions? 5 A. No. I have, I've put probably along the way some 6 stickies just to allow me to go back to what I 7 thought were pertinent issues that I wanted to 8 review, but I have created no reports, written 9 notes other than on the sticky to write the dates 10 of when a person was seen or something. 11 Q. Okay. And last question along those lines, there 12 are identified and accounted for in this case 13 three experts for the plaintiff, including 14 yourself, Dr. Steele, and Dr. 15 Morganstern-Clarren. 16 I guess my question is, have you seen any 17 other reports generated on behalf of the 18 plaintiff concerning this case? 19 A. No. In fact, I have, just what I gave you in the 20 depositions. The only other reports that I have 21 are I believe the ones from the defendant 22 experts, the ones I mentioned to you. I've seen 23 no other reports from Dr. Steele or the other 24 expert for the plaintiff. 25 Q. Based on the names you gave me, I agree that you 21 1 have a complete set and they're all accounted 2 for. 3 If I may then turn to your report of June 4 12th, page two. 5 A. Okay. 6 Q. The first sentence on that page reads, and I 7 quote, "I also find the care of Dr. Basa to be 8 substandard after the surgery." 9 What did you mean by that statement? 10 A. I'm a person who communicates with my patients 11 well. I believe that when I do an operation on a 12 person and an operation that is intended for 13 cure, and if I am unable to achieve that goal by 14 pathology report, meaning the pathologic states 15 where the tumor was, that there were positive 16 margins, that that information goes to the 17 patient and I discuss that with them. They have 18 a right to know that I was unable to clear their 19 body of the tumor that we set out to do, and so, 20 and I start to give them some ideas of what they 21 can expect down the road. So I consider, it's a 22 personal issue, I think more than one of standard 23 of care, it's one of communicating openly and 24 knowledgeably the state of the patient's 25 condition as he moves from operative to 22 1 post-operative state and then to recuperative 2 state. 3 Q. What ideas would you tell your patient in the 4 same position as John Newell as to what they 5 should expect down the road? 6 A. We enter into a surgery with the hope that we can 7 eradicate the disease, render the patient 8 disease-free and achieve long term disease-free 9 survival. If we are unable to accomplish that, 10 then I tell the patient that there's disease 11 left, there's disease left behind that we were 12 unable to get out and that in all probability 13 that disease will continue to grow, that we are 14 not done with your treatment, we are not, this is 15 not the end point of your therapy, we have, we 16 don't know exactly what the future will hold for 17 you, but there are things that we can expect and 18 we will be watching for, and that we as a team 19 will continue to monitor you and we will continue 20 to manage your disease process as it comes 21 forward. 22 Q. You said that you would tell the patient they 23 were not, we were not done with your treatments. 24 What treatments are you referring to? 25 A. That they, that in all likelihood that the 23 1 disease progresses, there will be additional 2 therapy, may need to be applied to, in a 3 palliative fashion or even in an adjuvant fashion 4 to manage this disease, the progression of 5 disease. 6 Q. For the record, would you define what you mean by 7 palliative versus adjuvant? 8 A. Adjuvant therapy is generally a therapy that is 9 applied in conjunction with the curative 10 procedure, i.e., a person undergoes surgery, and 11 then also as part of that, they would undergo for 12 instance radiation or hormonal therapy if there 13 were disease left behind or disease outside the 14 prostrate. 15 Palliative therapy is therapy that we apply 16 to patients that we know will not cure the 17 disease but will retard its growth or diminish 18 the symptoms and manage the stations of the 19 disease in a patient. In other words, you're 20 treating more, you're treating more to suffering 21 or his potential suffering but without the hope 22 of cure. You're kind of putting, trying to hold 23 the tumor down but you know you can't stop it 24 with that therapy. 25 Q. When and under what circumstances would you 24 1 recommend treatment with radiation or hormonal 2 therapy, post surgical excision? 3 A. In a post surgical patient rather than just a 4 patient with cancer? In a post surgical patient? 5 Q. Yes. That is what I intended. 6 A. There are, both of these modes of therapy can be 7 applied to patients who are post surgery who have 8 disease extracapsular to the prostrate, meaning 9 outside the prostate, whether it be locally in 10 the pelvis or in the lymph nodes or even in the 11 bone. Both radiation therapy for localized 12 disease in the prostate fossa, meaning we think 13 the tumor is confined to where the prostate was, 14 can be applied. When the disease, we feel the 15 disease is outside the prostate and outside the 16 prostate fossa where the prostate sits into some 17 of the seminal vesicles, into lymph nodes or into 18 bone, then hormonal therapy, hormonal ablation 19 shall we say is the therapy of choice. 20 Also in patients who have extensive disease, 21 for instance, in a bony structure where there is 22 pain or where there is fear of the integrity of 23 the bone would collapse, a spinal compression, 24 then we would apply radiation therapy to those 25 areas and now in our regimens we have some 25 1 advanced chemotherapy regimens which are being 2 tested and looked at for patients who have failed 3 both radiation and/or hormonal therapy, what we 4 call hormone refractory tumor. Those are really 5 in the end stage of a patient's life. 6 Q. In a patient such as the ones you describe with 7 disease extracapsular, capsular, when would you 8 commence treatment with hormonal or radiation 9 therapy? 10 A. Let's say if you can tell me the answer to that I 11 would be pleased. It is a very difficult 12 decision. Today in our world, 2000, and 2001 13 here, that modality is still left to the 14 physician and patient to decide if they want to 15 go for that because there is no hard-core data to 16 prove that one therapy or timing of a therapy is 17 superior to no therapy at all. There are, 18 however, some patients who respond very well and 19 we can't usually predict them, it's very 20 difficult to, but in my own personal practice, if 21 I was going to apply radiation therapy to a 22 margin positive patient who I thought would 23 benefit from, by his disease, complicated but by 24 the stage, the grade, his age, his desire, et 25 cetera, I would probably start that treatment 26 1 when the PSA reached at least 0.4 and showed two 2 consecutive rises beyond that to prove that we 3 have disease that is indeed ongoing and growing 4 and starting to become a threat. I use that 5 because that's what Jean deKermion uses at UCLA. 6 There is no magic number, there is no optimal 7 time although there are some suggestions that 8 there are some things we can look at but there is 9 no hard-core standard by which we go by. 10 Q. I want to be sure I understood your last 11 response, doctor. You said you would wait until 12 the PSA was 0.4 and then how long after that? 13 A. No. I would wait for a patient to show me that 14 indeed disease is present, that indeed he's 15 having a rising PSA. He has what we call a 16 PSA-only recurrence. Biochemically we have 17 evidence that he has disease still present. 18 That's usually the marker for that is usually 19 about 0.4. Some use 2.0 nanograms of PSA. It's 20 very variable. 21 In my own practice I consider a patient who 22 has a PSA of 0.4 and has two additional rises in 23 PSA after that value, to have indeed recurrent 24 disease. I try to apply the therapy as late into 25 the recovery of the patient as possible to allow 27 1 his wound to heal, his tissues to heal and if it 2 can go two years, terrific. If he doesn't show a 3 PSA rise for several years then he avoids 4 radiation therapy or hormonal therapy for that 5 period of time. So it depends on when the 6 progression of disease occurs. 7 Q. Well, if I understand your statement, doctor, 8 you're saying that if the patient had let's say a 9 0.4 30 days or 60 days after surgery, you would 10 then wait until two more PSA studies were done 11 and it wouldn't matter as long as it's above 0.4 12 what level they actually registered? 13 A. Well, the PSA is not going to go down. 14 Q. Correct. But I assume if it went up to 0.5 in 15 the next study and 0.6 the next study, then he 16 would qualify for hormonal -- 17 A. If I get a PSA as what you said three months 18 later, 0.4, I have patients who'll stay at 0.4 19 for five years. That's just where they run. 20 Don't ask me why, they do. But if I see a 21 continual rise in PSA I'd have documented proof 22 that I have a patient who has disease somewhere 23 in their body. My goal then is to determine 24 whether it's in the prostatic fossa or elsewhere. 25 If it's in the prostatic fossa, I would consider 28 1 as one of my therapy modalities in discussion 2 with this patient radiation therapy. I would 3 also consider hormonal therapy, and I would also 4 consider no therapy at all. Those are the 5 options that the patient would have. 6 Q. I guess to be more specific, does it matter what 7 increment the next two tests are as long as it's 8 above 0.4? 9 A. It's really not that important. If you could 10 infer, if you want to split hairs academically, 11 that PSA doubling time has some prognostic 12 implications. Obviously the faster the PSA is 13 rising, the more aggressive the tumor is growing. 14 Now, that's just a surmise, but makes sense. We 15 don't have to be rocket scientists to figure that 16 out. If I have a patient who's nine years out 17 and his PSA is 0.4 he's nine years out after 18 surgery and his PSA climbs out to 0.4, I'm not 19 going to offer him anything because he may take 20 another nine years to 0.4, but if I have a man 21 who's 0.4 PSA after surgery and three months 22 after that his PSA is 1.2, I have a man who has 23 disease that's on the march. 24 Q. Let me pose it in the form of a hypothetical 25 then. Suppose this patient presents to you 60 29 1 days post surgery, has a 0.4 and then 90 days 2 thereafter he presents with 0.8 and another 30 3 days thereafter presents with 0.9, would he 4 qualify then for radiation or hormonal therapy? 5 A. It would be a consideration to offer him. It 6 would be something I would discuss with him, you 7 bet. 8 Q. Okay. 9 A. The value of PSA as it is is that the disease is 10 there and PSA is the marker by which we measure 11 its growth and so it's not an absolute marker but 12 it is one that gives us an idea of the potential 13 of tumor growth, yes. 14 Q. Okay. I think I understand your point then. The 15 next question is how often would you monitor with 16 PSA studies post surgery? 17 A. My personal, my personal protocol which is I 18 think fairly standard throughout the country is 19 every three months for the first year, if there's 20 no rise in PSA, every six months for the next two 21 years, if there's no rise in PSA annually. If 22 there's a rise in PSA or evidence of disease, 23 recurrence, then I would change my pattern 24 depending on any therapy was offered to the 25 patient so I could monitor that therapy or I 30 1 would see that patient more closely at least 2 every three months to every six months. 3 Q. You may have this information more readily at 4 your fingertips than I. Can you tell us from 5 your study of this case how often and what were 6 the studies, the results of studies on Mr. John 7 Newell post surgery? 8 A. Best of my recollection, and I don't know if I 9 have every one at my fingertips here, but I 10 believe in August of 1995 his PSA was .2. Four 11 months later in 1996, it would be February, it 12 was .3. And a year after that it was .4. From 13 that point on it was about a yearly, next I 14 believe was on February of 1998 the PSA was now 15 4.0. so there was a year interval between the 16 last two PSA's, went from 0.3 in 1996 to 4.0, 17 about a 12 fold rise in PSA in two years. The 18 remainder of his PSA's were done much more 19 quickly, usually on about a three, two to three 20 month ratio and continued to show rise in 1998 to 21 a level of six and a half, I believe it was, and 22 that was in June or July of 1998. 23 Q. Do you have an opinion whether Dr. Basa met the 24 standard for regular testing post surgery? 25 A. Yes. I can't say that he did not meet the 31 1 standard of care. He found the patient in the 2 first two years, he had a very minimal 3 incremental rise in the PSA and there was a big 4 jump in one year, rather unexpected jump of 5 tenfold, from .4 to 4.0. I think he was 6 following his patient, he felt comfortable in 7 that regimen, he was aware he had margin positive 8 disease. If you read the pathology report, he 9 was aware he had a more aggressive lesion than he 10 originally thought he had as he also read the 11 final pathologic grade of the tumor. I follow my 12 patients a little bit closer. I have some of my 13 colleagues who follow them semi-annually or 14 annually. It's really where the physician feels 15 comfortable and also where the patient feels 16 comfortable as you relay this information to 17 them. 18 Q. From your knowledge of the records did Dr. Basa 19 offer the patient hormonal or radiation therapy 20 at any time? 21 A. Not early on, no. There was no discussion to the 22 best of my knowledge of adjuvant or late therapy, 23 either radiation or hormonal as the patient's PSA 24 was rising. 25 Q. And this is true despite the fact that the 32 1 studies reported to him in February of '98 2 indicated a significant rise in the PSA values of 3 4.0? 4 A. Right. 5 Q. Do you find that Dr. Basa -- let me put it this 6 way. Would you, if you were, if you had this 7 patient, offer chemotherapy, hormonal therapy or 8 radiation therapy once the values of the PSA rose 9 to 4.0? 10 A. I would discuss that with them once I have done a 11 restaging of the patient and that means that I 12 would, the patient would undergo a physical 13 examination, particularly a digital rectal 14 examination of the prostatic fossa to see if 15 there's any current disease locally. It may also 16 entail a ultrasound and perhaps even an MRI scan 17 of that area. I would repeat a bone scan to 18 determine that the disease, if he has disease 19 recurrent, which he does, biochemically he does, 20 not in the bone. If he had bony disease often 21 you have local radiation therapy to the prostrate 22 would not help him. 23 So I would first restage the patient, then I 24 would sit down the day that we had a hand and say 25 we think this disease is either in the prostatic 33 1 fossa or it's in the bones or we don't know where 2 it is and then devise therapeutic options for the 3 patient which would encompass all the disease 4 that we could treat, meaning in terms of the 5 bones would not radiate, we would offer hormonal 6 therapy as one therapy we could use. 7 Q. Is there any evidence in the records that you 8 have that Dr. Basa did perform additional studies 9 to stage the disease? 10 A. There was a bone scan done, I do not have the 11 date of it, that was done which was negative. 12 I believe it was, I believe it was in early 13 1998, but the bone scan was negative. I would 14 have to review the record to be sure. I don't 15 have that in front of me. 16 Q. I'm aware of a bone scan, doctor, that was done 17 in March or April of '95 post diagnosis but prior 18 to surgery. Is that the one you're thinking of? 19 A. No, sir. That would be a staging, an initial 20 staging one. I thought there was a -- 21 MS. HIRSHMAN: I'll help you. 22 There's one June 9th, 1998, a bone scan 23 order by Dr. Basa and interpreted by Dr. 24 George. 25 MR. RISPO: Okay. Thank you. 34 1 THE WITNESS: That was negative I 2 believe. 3 MS. HIRSHMAN: Unremarkable scan 4 without evidence of metastatic disease. 5 THE WITNESS: That's the one I was 6 referring to, Miss Hirshman. 7 MR. RISPO: Okay. Thank you, 8 Ellen. 9 Q. You've mentioned several other studies for 10 staging purposes. I didn't write them all down, 11 the reporter has them, I'm sure. 12 Do you have any evidence that Dr. Basa 13 performed any of those other studies, that Dr. 14 Basa himself? Or under his order. 15 A. There were studies done in an MRI scan as well as 16 a CT scan done in August of 1998. I am not sure 17 who ordered it absolutely. I'd have to look at 18 the report, but there was a CT scan and I believe 19 that was done, may have been done through the 20 Cleveland Clinic at that time, but I'd have to 21 look and be sure of that. 22 MS. HIRSHMAN: There is one 23 8-7-98 and then an MRI 8-17-98 but those are all 24 ordered by Dr. Singh. 25 THE WITNESS: By Dr. Singh? 35 1 MS. HIRSHMAN: Yes. 2 Q. That's the way I recall the record, too. 3 A. That's what I thought, too. I just don't say 100 4 percent. 5 Q. Would it be accurate to say, doctor, that 6 assuming the PSA study of 4.0 was in February of 7 '98, that Dr. Basa did not order any diagnostic 8 staging studies until four months afterwards? 9 A. I believe that to be correct, sir. 10 Q. And that he only ordered one of those studies? 11 A. I believe that is also correct, sir. 12 Q. And there's no evidence in the record to indicate 13 that Dr. Basa offered hormonal or radiation 14 therapy? 15 A. That's correct. 16 MS. HIRSHMAN: Not until July at 17 least, correct? 18 MR. RISPO: I believe so. 19 MS. HIRSHMAN: Right. 20 Q. Are you critical, doctor, of the fact that Dr. 21 Basa waited that long to perform the staging 22 studies and/or to offer therapy? 23 A. Not particularly. It's physician-based and 24 patient-based. For instance, I would not do the 25 studies on the patient, in certain patients if I 36 1 was not ready to offer therapy. In other words, 2 I wouldn't just do it to see where the tumor was, 3 I would do it, I would order studies of that 4 nature to help me identify which therapy I should 5 apply based upon where the tumor is. 6 There are people who believe and practice and 7 discuss with their patients that these therapies 8 do not significantly prolong life but may improve 9 quality of life, but some patients will respond 10 and others don't, so there are many physicians 11 who would wait until the patient was symptomatic 12 with either bony pain or other signs before they 13 would offer such therapy. So it is people 14 practice in that fashion. 15 Q. Would you have, in your case, if you had this 16 patient, informed the patient of the importance 17 or significance of the rise in his PSA levels in 18 February of '98? 19 A. Yes, I would have, I've been discussing that with 20 him and I'm very concerned with the biochemical 21 parameters that he's exhibiting. I would be 22 telling him that I am concerned that we have 23 potentially a disease that could cause harm. 24 Q. And at that time would you offer him the 25 opportunity or at least discuss with him the 37 1 scheduling of staging studies? 2 A. Yes, I would have a broader conversation with 3 him, though, discussing what we can do, probably 4 first and then what those results might bring, 5 then determine whether or not we want to go in 6 those directions and if we do then we would 7 discuss about the staging studies that would be 8 necessary to give us that information. 9 Q. So the patient would ultimately make the decision 10 whether to proceed with either the staging 11 studies or the therapy? 12 A. I think the patient at this point has a lot to 13 say about how he's going to be treated in a 14 disease that I can't cure. So I would, I'm not 15 sure I would leave it 100 percent to the patient, 16 but I would be there to provide the best 17 information I could about what is happening at 18 that time, in 1998, what is happening, what the 19 trends are and what one might expect. I would 20 certainly discuss that with him and if they said 21 that knowing all the risks and benefits they say 22 I want to do something about this tumor, or I'm 23 actually quite comfortable, my wife and I want to 24 travel, I don't want to have radiation therapy, 25 we want to go do some things, I would have that 38 1 discussion with them as well. 2 Q. Well, what you're saying is that you wouldn't 3 just leave it in his hands, you would recommend, 4 make a recommendation yourself, wouldn't you? 5 A. I would present the facts to them and say that if 6 you were my dad, this is what I would probably 7 offer you. You have to weigh that in light of 8 your lifestyle, your other co-morbidities of your 9 life and what you and your wife want to do and 10 come to a conclusion with the patient that we 11 both felt comfortable with. 12 Q. If the patient elected to undergo the staging 13 studies with a view to accepting the therapy, 14 would it be fair to say that generally speaking 15 the earlier those therapies commence the better? 16 A. It's not ironclad. At that time it's 17 certainly -- in 1998 it was not. I think it's 18 not clear today, two years later. 19 It would stand to reason that catching the 20 disease earlier may have some advantage, but 21 neither of the therapies that are offered to 22 these patients are in all probability curative. 23 Meaning there's a great probability, a greater 24 than 50 percent probability that these patients 25 would not be cured by their disease, especially 39 1 Mr. Newell's disease. 2 Q. You certainly wouldn't advise the patient to wait 3 as long as possible? 4 A. If they were choosing hormonal therapy, there is 5 no significant data to show that early is, has a 6 survivor advantage over late therapy hormonally. 7 That data does not exist and so it is very hard 8 psychologically for a patient to allow a tumor 9 just to go unchecked, and so we have to look at 10 the whole patient, that's why the patient needs 11 to be involved in that decision-making. 12 Q. And to complete that thought, you wouldn't tell 13 the patient he'd be better off if he waited. 14 A. Not that he would be better off, I would tell him 15 that my personal philosophy is we look at quality 16 of life, not quantity and if we can keep the 17 tumor out of your bones for a longer period of 18 time before it will eventually get there, you may 19 have a better quality of life even though I may 20 not be able to offer you a greater quantity of 21 life. 22 Q. You made the statement back in your report, 23 doctor, Mr. Newell was therefore denied the 24 opportunity for possibly salvage radiotherapy of 25 the regionally localized cancer. 40 1 Could you explain that for us? 2 A. The pathologic stage becomes available to us and 3 the pathologic stage is the stage of the cancer 4 that would, that we get after the prostate's been 5 removed. Prior to surgery we have a clinical 6 stage of what our best guess is with our test 7 exam and everything else. The pathologic stage 8 is kind of a word of God, it tells what the grade 9 of the tumor is and its extension in or outside 10 of the prostate. 11 With that knowledge, that information, and 12 with, if we know we have disease left behind, and 13 we have preoperative testing that tells us 14 there's no disease outside of the prostate, i.e. 15 in the bones, I think that one of the options 16 available to a patient is to undergo kind of a 17 mop-up radiotherapy to that area in the hope that 18 disease left behind, small volume disease is more 19 amenable to therapy with radiation than the 20 native prostate would have been by itself and 21 therefore they may benefit from early 22 radiotherapy in the patient who has known 23 positive margin disease. 24 Q. When would you recommend mop-up radiotherapy? 25 A. My personal philosophy is when the PSA rises as I 41 1 spoke earlier and as far away from the surgical 2 event as possible to allow the patient a full 3 recovery. 4 Q. How long does it take for a patient to have a 5 full recovery from surgery? 6 A. Minimally surgically, six weeks would be trying 7 to avoid radiotherapy in the first six months, 8 and it's rarely indicated in the first six 9 months, but there is much microvascular healing 10 that still goes on that radiotherapy can 11 interfere with and I think that's, most people 12 try to push that out for six months to a year as 13 long as the PSA doesn't show some unusual 14 changes. 15 Most patients manifest the rise of PSA for 16 the first time, six months or so or a year anyway 17 so you're not even looking to give them anything 18 even though you know you have margin-positive 19 disease. 20 Q. When you said that the patient, John Newell, was 21 denied the opportunity for possibly salvage 22 radiotherapy, what date in mind did you have for 23 that kind of radiotherapy? 24 A. I think the, from the record that I have, and I 25 assume that that's all the record there is, as 42 1 far as PSA values, I think in the time frame of 2 February of 1998 when he showed a significant 3 rise in his PSA. I think that would be a time 4 that I think that he should have either been 5 offered some, if you were going to offer him 6 therapy that would be a time in and about that 7 period that you would want to be aggressive with 8 the tumor. 9 Q. And that's because the demonstrated rise in the 10 PSA? 11 A. Correct. You have, it's unfortunate that we 12 don't have any laboratory stuff between that 13 period of time, but that's the first really 14 significant rise in PSA that was documented. 15 Q. I don't have the month, but from your earlier 16 testimony you said the last previous PSA was in 17 1997. Do you have that month handy? 18 A. I believe it's five of the month of February. 19 The fifth day of February. 20 Q. Of '97? 21 A. Yes, sir. 22 Q. So if we were to posit for the purposes of this 23 hypothetical that the PSA studies were performed 24 again in let's say September of '97 -- 25 A. Uh-huh. 43 1 Q. -- and we took an average between the two studies 2 and assumed that this report came back 2.0 PSA 3 studies, would that be the point in time when you 4 would recommend mop-up radiotherapy? 5 A. In my own practice that would be a time when I 6 would seriously consider offering that to a 7 patient and discussing that as an option for him. 8 Yes, sir. 9 Q. So as soon as that PSA study is, has risen and is 10 significantly in excess of 0.4? 11 A. Yes, sir. 12 Q. And are you critical of Dr. Basa, I guess this 13 stands to reason, because he did not offer mop-up 14 radiotherapy in February of '98? 15 A. It's not that he was against the standard of 16 care, I just feel that patients, again, I'm 17 speaking of my own practice, Dr. Basa practices 18 different than I do. My patients understand what 19 these numbers mean. And I, with an informed 20 patient, people understand what's going on and 21 not wondering what's going on. 22 So I don't think Dr. Basa was outside of the 23 standard of care by not offering him radiotherapy 24 because it is not known, particularly in 1997 or 25 '98, that radiotherapy would have a significant 44 1 probability of arresting the disease. Some of 2 these patients who receive radiotherapy, the 3 great majority go on to progress to metastasis 4 and so I don't think Dr. Basa was outside the 5 standard of care. I would have included those 6 discussions with my patient, but he chose not to, 7 yes. 8 Q. I thought I heard you say earlier that he was 9 outside the standard of care and then you ended 10 your comments by saying he was not outside the 11 standard of care. Could you clarify that. 12 A. I do not believe that Dr. Basa was outside the 13 standard of care by not offering his patient 14 radiotherapy. That's the statement, because it 15 is controversial, whether or not this therapy 16 will render the patient in, probability of 17 rendering the patient disease-free. 18 Q. To be sure I understood you, you're saying that 19 you're not critical of the fact he didn't offer 20 it in February of '98, but you would be critical 21 of the fact that he did not discuss it with his 22 patient and give him the option? 23 A. Yes. But that, again, is his style of patient 24 interaction. I exercise a more informed 25 communication between my patients. I don't, I 45 1 think there's a better way to do it than Dr. Basa 2 did but I do not believe that Dr. Basa was 3 negligent in not radiating Mr. Newell. 4 Q. Doctor, do you, in your practice, provide your 5 patients what I would characterize as the highest 6 standard of care? 7 A. I try. I spend a great deal of time creating 8 information booklets for my patients. Each 9 patient that I have receives about a ten or a 15 10 page booklet that I've created in my computer 11 with scanned-in graphs and notes about just 12 making the decision for radical prostatectomy 13 versus radiation as an initial therapy. I also 14 have a book that I create myself and give to the 15 patients, a notebook in a folder with plastic 16 sheets that talks about PSA-only recurrence after 17 radical prostatectomy, what does it mean, what do 18 I do with this, how does it impact my life. I 19 also have a notebook for patients who have 20 advanced prostate disease depicting to them the 21 limits of opportunities we have to arrest their 22 disease but the things that are available and the 23 support systems and the hospice and the whatever 24 is available in our community for them. 25 MR. GOLDWASSER: Excuse me for 46 1 the interruption. This is Gary Goldwasser. 2 For the record, I want to object to Ron 3 Rispo's continued attempt to equate the 4 standard of care in the urological 5 community with that which Dr. Clayton 6 practices. That is certainly not the 7 measure legally. Doctor's repeatedly 8 stated that Dr. Basa as to this subject 9 matter complied with standards of care, 10 albeit not necessarily what he would have 11 done. So for the record, please show my 12 objection. 13 MR. RISPO: Thank you, Gary. 14 Q. One final question on that line, doctor. It's 15 perhaps obvious, but would you agree that 16 whatever the standard of care is, whether it's 17 something less than you practice or more than you 18 practice, Dr. Basa's care in this case doesn't 19 measure up to the way you would practice? 20 MR. GOLDWASSER: Objection. 21 A. May I answer that? 22 MS. HIRSHMAN: Yes, go ahead. 23 A. I would clarify that statement in that I'm 24 looking in hindsight at the case of Mr. Newell's 25 prostate cancer, at his progression of disease 47 1 and how his surgery went and afterwards. I am 2 not, I was not there to hear and be privileged to 3 the conversations that went on between the 4 patient and his family and his physician. 5 Sometimes records aren't as inclusive as they 6 could be, but I practice a very hands-on type of 7 medicine, it's what I -- it's what pleases me, 8 it's what engages me with my patients. At times 9 it's exhausting, but that's just the way I 10 practice. My partners don't necessarily practice 11 that way at all. So it's -- I am not critical 12 that Dr. Basa does not, has not had the 13 opportunity to say I do that with my patients as 14 well, I'm only answering your question what do I 15 do and whether that's above or, it's not below 16 the standard of care, but whether it's the holy 17 high ground, I don't intend to make it sound that 18 way. It's the unique way that I engage my 19 patients. 20 Q. Doctor, I appreciate your answer, let me just ask 21 it this way, though. Do you still stand by your 22 statement in your report that Mr. Newell was 23 denied the opportunity for possible salvage 24 radiotherapy of the regionally localized cancer? 25 A. Yes. He was not offered that nor was it 48 1 discussed with him, so the possibility to have, 2 to have chosen that for Mr. Newell and his wife 3 and Dr. Basa to have discussed it and decided 4 that that might be something that they want to 5 do, he did not have that, the opportunity because 6 he was unaware that that therapy modality could 7 be applied to his cancer. 8 Q. And in your opinion, that opportunity presented 9 in February of '98? 10 A. Yes, sir. I think that that was a point when we 11 had evidence of progression of his disease and 12 that some form of therapy would need to be 13 discussed and applied. 14 MS. HIRSHMAN: Just for the 15 record, I want to mention that it's ten to 16 six our time, ten to three the doctor's 17 time, and we've been going for well over an 18 hour here and we haven't even talked about 19 Dr. Singh. I just want Mr. Rispo who's an 20 attorney for Mr. Singh who's been inquiring 21 this whole time, let you know that the 22 doctor does have scheduled patients in 40 23 minutes. 24 MR. RISPO: We'll beat that time 25 frame. 49 1 MS. HIRSHMAN: I want you to be 2 clear because I don't want you to be cut 3 short. 4 Q. Doctor, according to my clock, it's five to six 5 and I'll promise you we'll be finished before 6 6:40. 7 A. Actually if you want to talk about prostate 8 cancer I'd rather do that than see patients. I 9 love prostate cancer so I'm sorry if that's -- 10 Q. We're getting along fine. I agree listening to 11 it, too. 12 MR. GOLDWASSER: Ron, don't 13 forget since you've chosen to speak about 14 Dr. Basa I certainly would intend to 15 question the doctor about Dr. Singh. 16 MR. RISPO: Okay. I'll do the 17 best I can, Gary. 18 Q. Doctor, we finished up by saying, I think the 19 last previous question was that you felt that 20 radiotherapy, salvage radiotherapy should have 21 been offered in February of '98 and one last 22 question I have on that. 23 A. I should say should have been offered. I think 24 it's one of the things that should have been 25 discussed. There's no convincing evidence that 50 1 in all probability it would have rescued Mr. 2 Newell from metastatic disease, but it is one of 3 the options that could have been offered to him. 4 Q. Okay. 5 A. I took a slap that you said it, either all or 6 none, that would have been a deciding factor. I 7 think it's one of the options that could have 8 been considered but there is no hard-core data to 9 show that this was the standard of care for that 10 period of time. 11 Q. And if it were your patient and you were talking 12 to him, would you have said to him, as you 13 alluded to earlier, that if it were my father I 14 would recommend that you have the radiation 15 therapy? 16 MR. GOLDWASSER: Objection. 17 A. I'm not sure I would have said that he should 18 have the radiation therapy, but I would have 19 offered it to him as one of the options, 20 explained what I thought could be benefited from 21 him, what the risks were as well, and but also 22 tell him that in all probability this will not 23 stop the disease, this will not cure you, but it 24 may be of help to you. You may be one of the 25 fortunate that are cured, but the majority, the 51 1 greater than 50 percent of these patients go on 2 to develop metastatic disease. That's what I 3 would tell him, and if it were my father, I would 4 have tried to help my father with this. I think 5 it would have been a choice I would probably have 6 offered to my own father, yes. 7 Q. Just a stab in the dark, based on your previous 8 explanation, doctor, would it have been better to 9 offer this therapy six months after the surgery 10 assuming that that is the time frame when the 11 heal would be maximized, when you know that the 12 margins are not clear of disease? 13 MS. HIRSHMAN: I object because 14 it has no basis, it does not establish a 15 foundation which is, presented admissible 16 which to be used in a court of law. That's 17 not the issue in this case. 18 MR. RISPO: I believe it is so 19 I'll stand by the question. 20 MS. HIRSHMAN: It's not a proper 21 question. 22 Q. Doctor, would you please explain that to us. 23 A. I would not offer radiotherapy to a patient who 24 only had disease outside the prostate or margin 25 positive disease without biochemical 52 1 documentation of a rise in PSA. The reason is 2 that patients can have prolonged periods after 3 surgery when their tumor is quiet and they're not 4 at threat for progression of disease, and I think 5 the longer you can leave a person without adding 6 additional therapy and its known risks of 7 complication, the better the quality of life is 8 for the patient. 9 So I would not offer all patients with 10 extracapsular disease radiotherapy, I would not 11 offer it to them, I would say we're going to 12 watch them, we'll make that decision as the 13 information comes in down the road, but I would 14 not offer it to them because it is not proven to 15 in all probability arrest the disease. If that 16 was solid data that showed that it would, it 17 would be something I would be bound to offer 18 them, but the data is not there. 19 Q. Now I understand. Okay. Doctor, you used the 20 phrase salvage radiotherapy. When you speak of 21 the word salvage, is that the, in your mind the 22 equivalent of cure or curable? 23 A. It is. If the term salvage is used in both 24 patients who have had surgery and the salvage 25 with radiation or people who have had radiation 53 1 and we salvage by taking off their prostate, what 2 we mean is that there are some centers and some 3 physicians who feel that you may be able to, 4 again, extend cure to a great number of these 5 patients. The numbers are just not that solid 6 that says it's the way we should be doing every 7 patient who has positive margins, but we call it 8 salvage, we're offering them another chance with 9 a modality of therapy which in and of itself 10 could be curative when used as a solitary therapy 11 itself, i.e., radiation can cure prostate cancer 12 when applied alone, surgery can cure prostate 13 cancer when applied alone, and if one is used 14 first and the other, and we have progression of 15 disease, the other can sometimes be applied to 16 try to, again, cure them of the disease and 17 that's where the term salvage comes in. 18 Q. Okay. Your report finishes up by making the 19 statement, as a result, Mr. Newell had to change 20 physicians and was started on LHRH analog therapy 21 at a time when salvage radiotherapy could not 22 help him. 23 Are you saying that the passage of time 24 between February and August was too long to wait 25 for radiotherapy? 54 1 A. I believe my intention was, is that the patient 2 had bony metastasis and once a person has bony 3 metastasis outside of the prostatic fossa, 4 salvage radiotherapy can only be applied to a 5 patient who has localized disease in the 6 prostatic fossa, once that disease is outside of 7 that, the option to use radiotherapy is gone and 8 you have to go to a more systemic therapy such as 9 hormonal ablation. Therefore, when a person has 10 metastatic disease to the bones, or to the lymph 11 nodes, radiation therapy will not be effective 12 and you must go with, and treat the entire 13 patient because you don't know where the disease 14 is, it could be everywhere and that's why 15 hormonal therapy is then the only choice 16 available to the patient at that time. 17 Q. Okay. So then to summarize what you're saying is 18 once he had metastatic disease, it was too late 19 to use or to rely upon radiotherapy alone? 20 A. Correct. Radiotherapy at this stage with 21 metastatic disease would only be to ease pain, 22 stabilize bones that have been eaten by the 23 tumor, but it is in no way intended to try to 24 salvage an unsuccessful radical prostatectomy. 25 Q. So then your statement can be interpreted to say 55 1 that it was too late in August of '98 to offer 2 radiotherapy as the sole -- 3 A. In August of '98 there were diagnostic studies 4 performed which confirmed metastatic disease to 5 the thoracic spine. At that time, radiotherapy 6 could not, would never be applied. Whether it 7 was in a patient postoperatively, or in a patient 8 who had never had surgery but had never had 9 radiation therapy to the prostate, you would not 10 radiate his prostate at that time either. The 11 cat's out of the bag and it's just in metastasis 12 and you must apply a greater therapy, systemic 13 therapy. 14 Q. Doctor, do you have an opinion concerning the 15 percentage reduction or time reduction and 16 survival rate for a patient who has a 20 year 17 history of hepatitis C? 18 A. No. I am ignorant in hepatology. I could not 19 venture any reasonable guesstimate of the impact 20 of that disease on a patient's life, Mr. Newell's 21 life, a younger patient or an older patient. I 22 do not deal with it, I am sad to say I have not 23 done any reading of that topic which is not part 24 of my expertise whatsoever. I'm sorry. 25 Q. Same question, doctor, in a patient who has been 56 1 on a regimen of Immuran therapy, that's, 2 I-M-M-U-R-A-N, for a period of 20 years? 3 A. No. That is a medication I do not prescribe, 4 therefore, I have no experience in its short or 5 long term application and its associated 6 complications or effects on life expectancy. 7 Q. Same question for a patient with moderate 8 coronary artery disease and atrial fibrillation. 9 A. No. I can offer you no particular timelines. I 10 hope those patients do well because that's 11 exactly what my father has and he's done very 12 well for a long time and I wish all those 13 patients well but so I have no experience 14 whatsoever nor can I offer you a professional 15 opinion. 16 Q. Same question for the patient who has all of the 17 previous conditions that I described and 18 noninsulin dependent diabetes mellitus? 19 A. The patients with diabetes certainly have a 20 shorter life expectancy. How much that is, I 21 don't know. I do see patients with diabetes. I 22 could not guesstimate. That's such a broad 23 question. I have young people who die of 24 diabetes and old patients who are living well 25 with it. I only see it as it applies to my field 57 1 in the kidneys, in erectile dysfunction and that 2 but I can't offer you a time frame. Certainly it 3 ravages on the kidney, but I'm not a cardiologist 4 to tell you what it would do in a cardiovascular 5 situation. 6 Q. I'm going to continue, doctor, but I want you to 7 be aware that I'm going to ask you two questions 8 and I wanted you to have the time sequence in 9 mind for each of them so that you're able to 10 address them without confusing one with the 11 other. 12 First question I'm going to ask is do you 13 have an opinion as to what the percentage 14 reduction in survival rate or life expectancy in 15 John Newell was because of the delay in diagnosis 16 of his prostate cancer until March of 1995; and 17 the second question I'm going to ask you is the 18 same, because of his delay in having possibly 19 salvage radiotherapy until or hormonal therapy 20 until April of, I'm sorry, August of '98. 21 Can you address the first question first? 22 What percentage reduction in his survival rate or 23 in life expectancy due to the delay in his 24 diagnosis of prostate cancer until March of '95? 25 A. You have, to clarify that if I may, do you have a 58 1 time frame that you're talking from, from what 2 time to 1995? Are we talking 1991 or just in 3 general life? 4 Q. It's an excellent point and I can only offer to 5 you that the records indicate the last rectal 6 exam was negative in April of '90, and the next 7 PSA study we have is in February of '95. And 8 that was at 15, I believe. 9 MS. HIRSHMAN: Ron, if you want 10 to know if he has an opinion as to whether 11 or not the deviations from acceptable 12 standards of care of Dr. Singh were a 13 direct and proximate cause of a reduction 14 survival rate and life expectancy for this 15 patient, he does have opinions. That's the 16 more appropriate, legally phrased question 17 in the State of Ohio. 18 MR. RISPO: That's not my question 19 and I stand by the previous question. 20 MS. HIRSHMAN: Well, I object. 21 Because the more -- it's so esoteric and 22 doesn't relate to anything, it's just -- 23 because of the diagnosis of March of '95, 24 you want to know what his life expectancy 25 is as a result of Dr. Singh's negligence? 59 1 MR. RISPO: Ellen, this is not 2 your deposition on direct exam. 3 MS. HIRSHMAN: I better shut up 4 then, huh? Okay. I'm sorry. 5 Q. Doctor, I'm going to have the reporter -- 6 MS. HIRSHMAN: Can you answer the 7 question you understand the parameters of 8 this case, you feel best define your 9 opinion? 10 Q. In other words, I'm giving you advanced notice, 11 doctor. What I'm trying to do is distinguish 12 between the care provided to the patient up 13 through March of '95 versus the care provided 14 after '95 and it's in that context that I'm 15 asking you these questions. I'll suggest the 16 reporter read back the question, if that's -- 17 A. I would appreciate that. 18 Q. Sure. Thank you. 19 - - - - 20 (Thereupon, the requested portion of 21 the record was read by the Notary.) 22 - - - - 23 A. First question is can I give you a survival, 24 basically. If he had been, his cancer had been 25 picked up before April of 1995. 60 1 Q. Right. 2 A. The answer to that is unequivocally, yes. His 3 survival, he may have been cured had his disease 4 been picked up two years earlier. With a PSA of 5 15.6 the -- hypothetically give a PSA doubling 6 time of a year, his PSA a year before that would 7 have been somewhere around eight, twice to three 8 times what we would expect for a man his age, and 9 the year before that it would be 1993 or '92, the 10 PSA probably in the four to five range which is, 11 certainly caught the eye of a physician reviewing 12 that lab value. 13 In addition, at the time that he was 14 identified with a PSA of 15.6 and the rectal exam 15 was conducted, it was obvious in Dr. Basa's 16 description of the prostate exam, that he had at 17 least a stage T2 b disease if not T3 disease as 18 it was indurated and firm on one side of the 19 prostate. That condition was probably present a 20 year to two years earlier at least on digital 21 rectal examination, meaning that some abnormality 22 or induration in the rectal exam and/or an 23 elevation of PSA would have in all probability 24 been present in 1992, 1993, certainly in 1994 and 25 that the disease would most probably, most 61 1 probably have been confined to prostate if it had 2 been caught two to three years before it was. 3 Q. Okay. I think that perhaps, doctor, I appreciate 4 your answer and I would have asked the question 5 anyway, but my question really was can you tell 6 me what percentage reduction in his life 7 expectancy or his survival rate there was because 8 of the delay in diagnosis until March of '95? 9 A. Okay. I'm sorry, because I believe that had he 10 been, had what I consider to be appropriate, well 11 known and within the standard of care diagnostic 12 studies of digital rectal examination of PSA in a 13 man over the age of 50, during that time frame, 14 this disease would have been found while it was 15 still confined to the prostate and as such had he 16 undergone the same therapy that he did in 1995, 17 back in 1992 or '93, his survival advantage would 18 be remarkably higher. Patients with disease 19 confined to the prostate have disease specific 20 survival of over 90 percent at ten years. 21 Q. And what percentage reduction did Mr. Newell 22 experience in his survival rate over ten years by 23 the delay in his diagnosis until March of '95? 24 A. Mr. Newell's current status as it is now -- 25 Q. Let's if we can separate out the fact that he did 62 1 not have his salvage radiation therapy. 2 A. Yes. 3 Q. So let's assume we're back in March of '95 and we 4 know he has cancer and we're asking the question 5 without knowing what happened after that date. 6 MS. HIRSHMAN: We're not 7 considering what we know from the surgical 8 specimen? 9 MR. RISPO: I'm trying to separate 10 out -- no. Assuming we know whatever the 11 surgical studies were, but I'm trying to 12 separate out the care provided after 13 surgery from the care provided before 14 surgery. 15 MS. HIRSHMAN: In other words, is 16 there difference between the diagnosis in 17 '95 versus recurrence in '98? 18 MR. RISPO: I guess that's my 19 point, yes. If the doctor probably 20 understands as well. 21 MS. HIRSHMAN: If he had any 22 therapy would it have made a difference. 23 A. I understood it without radiation therapy, just 24 as he was diagnosed in '95 with the pathologic 25 specimen. 63 1 Q. Right. And assuming that at that point -- 2 A. Does he have, and how is that different than how 3 it would have been in 1992? Is that a reasonable 4 summary of -- 5 Q. Actually, no. I'm trying to -- well, yes. 6 First, let's compare '95 to '92, then let's 7 compare '98 to '95. 8 A. Oh, okay. If we compare '95 to '92 we're both 9 dealing with the hypothetical that we had the 10 same surgery done at that time, both times, in 11 '92 and '95. 12 Q. Yes. That's my hypothetical. 13 A. The survival, I would believe, in 1992 would be 14 85 percent at ten years. I think the survival in 15 1995 with at least grade seven and positive 16 margins and PSA starting immediately I would say 17 his survival at ten years was probably somewhere 18 in the 30 percent at best range. 19 Q. And now, taking the fact that he has not had the 20 benefit of salvage radiation therapy in February 21 of '98 until after August of '98, he had hormonal 22 therapy, what percentage reduction, if any, in 23 his survival rate did he experience because of 24 that loss of opportunity at salvage therapy? 25 MS. HIRSHMAN: I think he's 64 1 already answered this but go ahead, doctor. 2 A. I just want to be sure that I understand Mr. 3 Rispo's question exactly. We're assuming, you 4 want me to determine that what his survival loss 5 was because he did not have the opportunity to 6 have radiotherapy as a salvage procedure? Am I 7 correct? 8 Q. Yes, that's basically it. 9 A. Okay. He may have a slight, statistically 10 speaking, a slight advantage, having had 11 radiotherapy over not having radiotherapy and 12 it's just because the data is not there to say 13 concretely that the patients do statistically 14 significantly better with radiotherapy. That 15 data is just not available and in all probability 16 from his pathology in 1995, with or without 17 radiotherapy, the survival advantage with 18 radiotherapy would be minimal, minimal over not 19 having had it. Statistically as we see the data 20 today I just can't say that it would be in any 21 significant amount I can quote that he would have 22 a survival advantage. 23 Q. So you can't quantify it in a percentage? 24 A. It would be, it would be, you know, I would 25 guess -- 65 1 MS. HIRSHMAN: We're not 2 guessing, doctor, because you have to have 3 opinions to reasonable probability. 4 A. Probability is that there would be, perhaps a ten 5 percent, 15 or 20 percent survival advantage if 6 you can arrest some of the tumor with 7 radiotherapy. 8 Q. Okay, fine. 9 MS. HIRSHMAN: It's after 6:15 10 now, guys. 11 MR. RISPO: I know. 12 Q. Doctor, now I'm going to go to page one of your 13 report and ask you a few questions about Dr. 14 Singh. 15 A. Go ahead, please. 16 Q. And Dr. Velloze. I understand from the record 17 that Dr. Velloze offered the, or had the 18 impression in February of '92 that the patient 19 had an enlarged prostate. 20 My question to you is what signs and symptoms 21 would lead a physician to conclude as Dr. Velloze 22 did in February of '95, '92, that he thought the 23 patient had an enlarged prostate? 24 A. I interpret that deposition of that data as 25 probably when Dr. Velloze was taking a review of 66 1 systems of his patients that he has not seen in 2 six months or however long it's been, that as he 3 greets his patient and asks how he's been doing, 4 he would go through various systems and ask how 5 he's doing in each of those. If the patient 6 experienced some urinary symptoms in a man in his 7 50's, any urinary symptoms we think immediately 8 as first thought of a prostatic enlargement. I 9 would, I know that some of the medications that 10 Dr. Velloze prescribed have effects on the 11 urinary tract and can produce some urinary 12 obstructive symptoms as part of their side 13 effect, so I would imagine that if the patient 14 was saying he was either going slow or I'm just 15 guessing or going more often at night. 16 Q. Let me ask the question this way. What are the 17 classic signs and symptoms of prostate 18 enlargement? 19 A. There are two sets of symptoms that we associate 20 with prostatic enlargement. Those are, one is 21 obstructive symptoms, and another is irritative 22 symptoms. And some of these overlap a little 23 bit, but obstructive symptoms are when a patient 24 has incidence of a voiding, has a urge, goes to 25 the toilet and really cannot initiate a stream, 67 1 sometimes walks around a little bit to get a 2 stream started, the stream is then slow, the 3 caliber of the stream is slow, the force is slow, 4 the patient often has terminal dribbling and has 5 a sensation that they have not emptied their 6 bladder completely and oftentimes return to the 7 toilet ten or 15 minutes later to void again. 8 Another set of symptoms which are associated 9 with prostatic obstruction are that of frequency 10 of urination, where they're either not emptying 11 their bladder or their bladder has sustained some 12 damage to it from obstruction. They have urgency 13 as well, difficulty in reaching the toilet once 14 the signal has been received, and they have 15 straining and sometimes some pain with voiding, 16 although that's not really a classic sign of 17 prostatic obstructions. Lesser signs are the 18 patients can't void, that they actually overflow 19 with incontinence or that they have blood in 20 their urine. Those are all some of the signs and 21 symptoms of a prostate enlargement. 22 Q. Can you define your understanding of the term 23 incontinence? 24 A. Incontinence is the loss of urine at a time that 25 is inappropriate for the patient and oftentimes 68 1 without their control. Whether they know it's 2 going to happen or it happens spontaneously, the 3 loss of urine is at an inappropriate time and 4 inappropriate situation for a patient. 5 Q. Is incontinence one of the symptoms that you 6 would include as classic symptoms of enlarged 7 prostate? 8 A. Not solely for that because women have urgency 9 and stress incontinence and they have no 10 prostate. For a man who comes to me with urgency 11 and incontinence, I think of, that usually spurns 12 a little bit more aggressive workup in my hands, 13 because urgency can be caused by not only the 14 prostate but by a pathology going on within the 15 bladder itself. Kidney stones can cause urgency, 16 bladder tumors can cause urgency, urinary tract 17 infection can cause urgency, prostatitis can 18 cause urgency, bowel problems can cause urgency. 19 So urgency incontinence is a symptom that has 20 many etiologies, one of which is the prostate. 21 Q. You're saying there's more than one type of 22 incontinency? 23 A. There are a number of different types of 24 incontinence. There is urgency incontinence 25 where the patient receives a message to go and 69 1 oftentimes has difficulty reaching the toilet, 2 there's a situational incontinence where the 3 person has an urge to go but due to limited 4 mobility, they're in crutches or aged, takes them 5 ten minutes to get there, by the time that 6 happens it's too late. There is stress 7 incontinence which is the inadvertent loss of 8 urine, often caused primarily, experienced by 9 men, especially after radical prostatectomies. 10 There's overflow incontinence where the bladder 11 doesn't contract, or incontinence where the 12 bladder is full, when they bend down they squirt 13 a little off the top, and there's total 14 incontinence where the bowel doesn't work at all 15 where you stand up and it just flows out. 16 There's other types of incontinence which comes 17 from fistulas between bladder and vagina, ectopic 18 ureter with young females with congenital 19 anomalies, and then there's any combination 20 thereof. 21 Q. Do I understand that it's the urgency that, and 22 form of incontinence that would be consistent 23 with enlarged prostate? 24 A. If you're talking about incontinence, 25 incontinence per se is not a real strong symptom 70 1 of prostate enlargement. It's one of the 2 symptoms, but there's so many other things that 3 we would rule out with that, I can't say that's a 4 key symptom of prostatic enlargement. 5 Q. The other things you would rule out would be 6 what, doctor? 7 A. I'm sorry, sir? 8 Q. What other things would you rule out before you 9 came to consider incontinence as a symptom of 10 prostatic enlargement. 11 A. I would look at other more formidable pathologies 12 within the bladder even in the prostate although 13 not uncommon that's not a presenting symptom of 14 prostate cancer. I'd be looking at urinary tract 15 infections, the most common form of urgency 16 incontinence. Next I would be looking at 17 pathology within the bladder by doing a 18 cystoscopy. I would rule out those first and 19 then look at the prostate as perhaps, and the 20 integrity of the bladder, if the bladder looks 21 like it's blown up from chronic obstruction that 22 may be the reason for the urgency incontinence. 23 It's called an unstable bladder, happens in the 24 middle of longstanding prostatic obstruction. 25 Q. And I'm getting right down to the end here, 71 1 doctor. 2 When in your opinion did the standard of care 3 require PSA testing for a primary care physician 4 in the United States, let's say in Ohio? 5 A. I would say the standard of care for PSA testing 6 was established by 1990. It reached its heyday 7 in 1991, '92, '93. It was being used extensively 8 in 1988 although really the heyday of PSA where 9 everybody got a PSA, including their mother, was 10 in 1992 to about 1994 where that was the area 11 where PSA had reached its maximal penetration in 12 the literature, in the community as a new and 13 heralding screening test for prostate cancer and 14 there were never more PSA's done in this country 15 than during that period of time. 16 Q. Do I understand you to say that the PSA testing 17 was the standard by 1994? 18 A. Absolutely. It was before then. 19 Q. And was it the standard of care in 1992? 20 A. Yes. 21 Q. What is the basis for your opinion as to when the 22 standard of care was recognized universally. 23 A. When the test was deemed an invaluable asset in 24 either the detection or the management of 25 prostate cancer, and when it was being employed 72 1 on routine basis, and within the recommendations 2 of organizations such as The American Board of 3 Urology or The American Cancer Society. 4 Q. Is there a different standard of care for 5 urologists, specialists in the field, as compared 6 with a primary care or general practitioner? 7 A. As it applies to PSA? 8 Q. Yes. 9 A. I don't think there's really a difference in the 10 standard of care. Certainly we utilize that tool 11 more often, and we may understand its limitations 12 and its abilities better than our colleagues in 13 the primary care network, but as a primary care 14 physician, caring for a man above the age of 50 15 or a black man above the age of 40 or a man whose 16 family has a history of prostate cancer, PSA 17 testing is indeed the standard of care for both, 18 for both individuals, both for urologists and for 19 the primary care. 20 Q. I guess my question is did the standard for PSA 21 testing become adopted by the urology practice 22 and community before it was adopted for primary 23 care physicians? 24 A. I'm not sure it's really adopted for a physician 25 group, it was adopted as a means of identifying 73 1 men at risk, at potential risk for harboring 2 prostate cancer. It was not a test that was 3 designed to make it easier for the primary care 4 to do that or for the urologists to do that. It 5 is employed by primary care extensively, in fact, 6 90 plus percent of all the patients that I see 7 for prostate cancer come to me with a PSA that 8 was obtained deemed to be outside the norms for 9 that age group and is sent to me for evaluation 10 and so the primary care use this extensively in 11 their routine laboratory studies and evaluation 12 of men above the age of 50 years of age. 13 Q. Put differently, doctor, the same question, but 14 isn't it true that the urology professional or 15 specialty adopted the standard of care for PSA 16 studies before the physicians in the specialty of 17 primary care? 18 A. Certainly the research that went on to determine 19 normal levels and implications of PSA were 20 spearheaded by the urologic services and 21 universities' departments. The application, 22 however, was and the data was widely printed and 23 available to all the peer review journals as it 24 applied to a disease process and all the people 25 who are involved in its screening, detection 74 1 and/or management of the disease. So it was not 2 just done for urologists, it was done through 3 urologists but not, certainly not for urologists. 4 Q. How about timing, doctor? Can you tell us of 5 your knowledge when it was that the primary care 6 physician specialty adopted PSA as a standard? 7 A. When the primary care adopted it? 8 Q. Yes. 9 A. I couldn't tell you that. I'm not sure that 10 anybody cared when they adopted it. The test was 11 determined to be appropriate testing and 12 mandatory testing for men above the age of 50 and 13 it didn't need to be adopted by primary care. 14 You were taking care of the same people so I'm 15 not sure there is a timeline that said okay, the 16 urologists think it's cool and now we think it's 17 cool. It's either cool or it's not cool and it's 18 always been cool. And there's certainly been 19 questions as to who and how late do you do a PSA 20 on a guy who's 85 or a guy who's 25 and those 21 things are pretty clear, but as far as the 22 effective and the meaningful test to help us 23 identify men at risk for prostate cancer, there 24 is not adoption of the orthopedic surgeons and 25 the primary care doctors and the cardiologists 75 1 and the urologists, it's been proved as the 2 therapy or the modality of choice for screening 3 of patients for prostate cancer. 4 Q. Doctor, isn't it true that the, various of the 5 professional organizations arrived at PSA 6 standard testing at later, at different times 7 during the course of the decade, 1990's? 8 A. Yes. There are, there are organizations, I'll 9 clarify this because it needs clarification, 10 there are organizations oftentimes driven by 11 insurance carriers whose idea is that PSA testing 12 isn't all that great, or it should only be done 13 in certain circumstances. These are the people 14 who are not the professionals, nor the most 15 authoritative people. They are people who had a 16 comment but not really based on fact and those 17 comments that were, that pop up here and there, 18 in the same way that radiotherapy as a salvage 19 for a positive margin prostatectomies, we can 20 find people who say it's the best thing since 21 sliced bread and have others who say it's 22 controversial and others who say it does nothing 23 good at all, and the real authority is that the 24 test has been proven to be the screening modality 25 of choice and is accepted as digital rectal exam 76 1 is accepted as the standard of care for 2 evaluation of men at risk of prostate cancer. 3 Whether the American College of Pediatricians 4 thought it was a great test or not is really not 5 that significant. I don't think everybody who is 6 a primary care, in the thought process, they know 7 it's a good test, it's the proper test, it's 8 widely accepted as the modality of choice and it 9 is the standard of care in this country today. 10 - - - - 11 (Thereupon, a discussion was had off 12 the record.) 13 - - - - 14 Q. Doctor, are you familiar with The American 15 College of Physicians? 16 A. Yes. 17 Q. Is it true that The American College of 18 Physicians as of 1997 still did not require PSA 19 testing as a standard of care? 20 A. I'm not aware of, that that's the standard of 21 care. I don't subscribe to The American -- 22 that's a college like many others, but I'm not 23 aware that they consider PSA testing not a 24 standard of care. 25 Q. Same question for The National Cancer Institute 77 1 as of 1997. 2 A. National Cancer Institute, I cannot speak of. 3 Absolutely, I'm not, on their board. I would 4 find that, you mean from 1997 to today or -- 5 Q. No. As of 1997 they still did not require PSA 6 testing as a standard. 7 A. I cannot comment on that, sir, I'm sorry. 8 Q. And last couple of questions, doctor. 9 Are you familiar with Campbell's Urology? 10 A. Yes. 11 Q. I'm looking at the Sixth Edition, 1992, and I'd 12 like to quote from that. 13 A. What page are you on? What volume? 14 Q. Sixth Edition, page 1193. 15 A. Got it right here. Let's take a look. I don't 16 know if I have the Sixth Edition or which one but 17 we'll look. 18 I have the Sixth Edition. 19 Q. Okay. Should I wait for you to -- 20 A. I am just about there. 21 Q. Okay. 22 A. Okay. 23 Q. This is the second column of the middle of the 24 page, paragraph beginning with However. 25 A. Uh-huh. 78 1 Q. And I'm focusing particularly on the last 2 sentence. 3 The role of PSA testing, PSA levels in 4 primary screening is currently debated. Some are 5 strong advocates of its use, and listing the 6 names in parentheses, Catalona and others, 1990 7 and '91, and others are critics, in parentheses, 8 Cooner, et al., 1990 and Scardeno, 1989. 9 My question is do you recognize or do you 10 agree with that statement, that as of 1992 PSA 11 levels were in debate and there were some who 12 were strongly advocating and others who weren't 13 critical of it? 14 A. I think that whether it was in debate, it's not 15 whether the test had validity, it's whether what 16 you do with a guy whose PSA is between four and 17 ten in this zone that we, almost a no man's zone. 18 That's what was in debate. And what was not 19 absolutely proven until later which is now very 20 true, but at that time, in 1989 we're talking 21 1989 here, that the critics were in the infancy 22 of PSA, that the application, like I said before, 23 who should get it, what level is critical, how 24 late do we do it in the patient's life, how 25 often, some of those things had not yet been 79 1 borne out to be the word of God, but the utility 2 of PSA in detecting prostate cancer was 3 well-established. 4 Q. But it wasn't a standard of care? 5 A. In 1989? No, I wouldn't say it was. In 1992 I 6 would say it is. And in 1993 it was. In 1994 it 7 was. 8 Q. What is the edition of the -- 9 A. '95 it was. 10 Q. The text you have in front of you is showing an 11 edition date of 1992? 12 A. I have the critics were in 1990 and 1989. Dr. 13 Scardeno and Dr. Cooner. 14 Q. But the text that we're referring to, Campbell's 15 Urology, was dated or edited or published in 16 1992, wasn't it? 17 A. This one I have, yes. I have on one of the first 18 pages here I have I guess that's a reprint date 19 of 1992. It's a Library of Congress publication 20 date. 21 Q. Would you recognize Campbell's Urology as an 22 authoritative medical reference? 23 A. Yes. 24 MR. RISPO: Thank you. I have no 25 further questions. 80 1 MS. GOLDWASSER: On the record. 2 This is Gary Goldwasser for Dr. Basa. I 3 will not inquire if, in fact, Dr. Basa is 4 going to be voluntarily dismissed before 5 trial. 6 MS. HIRSHMAN: Yes, we're filing 7 a dismissal tomorrow. 8 MR. GOLDWASSER: Very good. Then 9 I have no reason to inquire. Thank you 10 very much. 11 MR. RISPO: Before you hang up, 12 one more formality, doctor. You have the 13 right to review the transcript and/or, we 14 don't have a video here I guess, before 15 it's being used at trial. It's a personal 16 right of your own but amongst counsel we 17 have an agreement to waive signature as 18 respects our respective experts. 19 Will you agree to that? 20 THE WITNESS: Waive signature 21 means that I just, the depo we gave today 22 is as it will stand? 23 MR. RISPO: Yes. 24 MS. HIRSHMAN: We don't have 25 enough time for you to look at it and make 81 1 changes. 2 THE WITNESS: I don't think 3 there's anything here that I feel 4 uncomfortable with or that I didn't 5 understand correctly. I feel that the 6 questions were very straightforward and I 7 think I answered them straightforward so I 8 have no problem with that. 9 MS. HIRSHMAN: One formality, 10 though, Ron. I want to know if Aneta the 11 court reporter can have this typed up by 12 five tomorrow and send this out by 13 overnight mail so the doctor gets it 14 Saturday morning at an address that he 15 indicates would be appropriate to receive 16 it. 17 - - - - 18 (Thereupon, a discussion was had off 19 the record.) 20 - - - - 21 MS. HIRSHMAN: Can you tell where 22 she should send this by overnight mail to 23 you? You'd be receiving it on Saturday. 24 THE WITNESS: I would have it 25 sent to my home. 82 1 MS. HIRSHMAN: Can you give us 2 that, please? 3 THE WITNESS: That is, the address 4 is 900 Taft, like President Taft, Street, 5 in Pismo Beach, P-I-S-M-O, Pismo Beach, 6 California, 93449. 7 MR. RISPO: Okay. We have it on 8 your resume too, doctor. And lastly for 9 the record, we have an agreement to waive 10 the filing requirements. 11 Is that right, Ellen? 12 MS. HIRSHMAN: That's fine. For 13 his depo. 14 MR. RISPO: For his depo. I think 15 we're concluded unless anyone else has 16 anything. 17 MR. GOLDWASSER: All done. Thank 18 you all. 19 MS. HIRSHMAN: Bye. 20 (Signature waived.) 21 22 23 24 25 83 1 2 C E R T I F I C A T E 3 4 The State of Ohio, ) SS: 5 County of Cuyahoga.) 6 I, Aneta I. Fine, a Notary Public within and for the State of Ohio, authorized to administer 7 oaths and to take and certify depositions, do hereby certify that the above-named MICHAEL deWIT 8 CLAYTON, M.D. was by me, before the giving of his deposition, first duly sworn to testify the 9 truth, the whole truth, and nothing but the truth; that the deposition as above-set forth was 10 reduced to writing by me by means of stenotypy, and was later transcribed into typewriting under 11 my direction; that this is a true record of the testimony given by the witness, and the reading 12 and signing of the deposition was expressly waived by the witness and by stipulation of 13 counsel; that said deposition was taken at the aforementioned time, date and place, pursuant to 14 notice or stipulation of counsel; and that I am not a relative or employee or attorney of any of 15 the parties, or a relative or employee of such attorney, or financially interested in this 16 action. 17 IN WITNESS WHEREOF, I have hereunto set my hand and seal of office, at Cleveland, Ohio, this 18 _____ day of _________________ A.D. 20_____. 19 20 _________________________________________________ 21 Aneta I. Fine, Notary Public, State of Ohio 1750 Midland Building, Cleveland, Ohio 44115 22 My commission expires February 28, 2001 23 24 25