0001 1 IN THE COURT OF COMMON PLEAS OF CUYAHOGA COUNTY, OHIO 2 - - - - - 3 CAESAR C. DAILEY, Individually and as 4 Administrator of the Estate of Lillian Dailey, 5 deceased, 6 Plaintiff, 7 vs Case No. CV-07-629950 8 OHIO PERMANENTE MEDICAL GROUP, INC., 9 et al., 10 Defendants. 11 12 - - - - - 13 DEPOSITION OF PHILLIP SHUFFER, M.D. 14 TUESDAY, APRIL 29, 2008 15 - - - - - 16 Deposition of PHILLIP SHUFFER, M.D., a 17 Witness herein, called by counsel on behalf of 18 the Plaintiff for examination under the statute, 19 taken before me, Vivian L. Gordon, a Registered 20 Diplomate Reporter and Notary Public in and for 21 the State of Ohio, pursuant to agreement of 22 counsel, at the offices of Buckingham, Doolittle 23 & Burroughs, One Cleveland Center, Cleveland, 24 Ohio, commencing at 11:00 o'clock a.m. on the 25 day and date above set forth. 0002 1 APPEARANCES: 2 On behalf of the Plaintiff 3 Becker & Mishkind Co., LPA, by 4 HOWARD D. MISHKIND, ESQ. 5 JESSICA PERSE, ESQ. 6 Skylight Office Tower 7 1660 West Second Street 8 Suite 660 9 Cleveland, Ohio 44113 10 216-241-2600 11 12 On behalf of the Defendants 13 Buckingham, Doolittle & Burroughs, LLP, by 14 DIRK E. RIEMENSCHNEIDER, ESQ. 15 One Cleveland Center 16 Suite 1700 17 Cleveland, Ohio 44115 18 216-621-5300 19 20 21 - - - - - 22 23 24 25 0003 1 PHILIP SHUFFER, M.D., a witness herein, 2 called for examination, as provided by the Ohio 3 Rules of Civil Procedure, being by me first duly 4 sworn, as hereinafter certified, was deposed and 5 said as follows: 6 EXAMINATION OF PHILLIP SHUFFER, M.D. 7 BY MR. MISHKIND: 8 Q. Good morning. 9 A. Hi. 10 Q. I'm Howard Mishkind and I represent 11 the Estate of Lillian Dailey in connection with 12 a lawsuit that has been brought against Ohio 13 Permanente concerning her death. 14 I understand, Dr. Shuffer, that you 15 were involved in at least one office visit 16 toward the end of 2005 as it relates to Lillian; 17 is that correct? 18 A. Yes. 19 Q. What I'm going to do is ask you some 20 background questions and start out with real 21 simple things, like having you state your name 22 for the record and talk a little bit about your 23 position at Ohio Permanente, your practice then, 24 your practice now, and talk about your 25 involvement with regard to Lillian and then we 0004 1 will be done, okay? 2 A. Okay. 3 Q. Let's start out with the easiest 4 question of them all and that is, can you state 5 your name, your full name for the record. 6 A. Yes, I can. 7 Q. Then go ahead and do it. 8 A. See, I answered. I got you. 9 Q. Very good. 10 A. Phillip Shuffer. 11 Q. And your middle initial is M? 12 A. M. 13 Q. You are originally from San Pedro, 14 California; is that correct? 15 A. I was born in San Pedro. That's 16 south of LA. 17 Q. Did you grow up in California? 18 A. Uh-huh, grew up in LA. 19 Q. Did you go to medical school in 20 California? 21 A. No, I did not. 22 Q. Where did you go to medical school? 23 A. Creighton University. 24 Q. What years did you attend Creighton? 25 A. '84 to '88. 0005 1 Q. Did you proceed directly from 2 college to medical school? 3 A. I did not. 4 Q. Where did you go to college? 5 A. Stanford. 6 Q. What was your degree in at Stanford? 7 A. Double major in biology or 8 biological sciences and anthropology. 9 Q. What year did you graduate? 10 A. '83. 11 Q. What did you do between '83 and '84? 12 A. I did a post-baccalaureate program. 13 I worked for a summer for something like Federal 14 Express and then I went to a post-baccalaureate 15 program. 16 Q. What was that post-baccalaureate 17 program in? 18 A. That was just sort of a way to kind 19 of make your application, you know, to repeat 20 your application in medical school. 21 Q. I take it the first time through you 22 weren't accepted to medical school? 23 A. I'm still on the waiting list to 24 this day at Tufts. That's a fact. 25 Q. After graduating from Creighton in 0006 1 '88, did you then do a residency? 2 A. I did. 3 Q. Where was that? 4 A. I did my residency at, the majority 5 of it at Oakland Naval Hospital, Oakland, 6 California. And the last year, the chief year 7 was at Kaiser, San Francisco. 8 Q. What was your residence in, please? 9 A. OB/GYN. 10 Q. After finishing your last year at 11 Kaiser in San Francisco, tell me about your 12 practice thereafter. 13 A. From '93 until -- that's when I 14 finished -- until I took the job here, I was in 15 the Navy. I had payback time. I was on a naval 16 scholarship, so I was at 29 Palms Hospital, 17 which is a Marine Corps base in southern 18 California. 19 Q. How many years were you in your 20 payback? 21 A. Well, all total, three. That part 22 is two, and then there was one year between my 23 first year of training, internship and second 24 year of training when I was in Okinawa, Japan, 25 and that was '89 to '90. Okinawa, yeah. 0007 1 Q. The last two years would take you 2 from '93 to '95? 3 A. Correct. 4 Q. Were you then honorably discharged 5 in '95? 6 A. Yes. 7 Q. You started practice then where? 8 A. Right here. March 1996. 9 Q. You are an employee of Ohio 10 Permanente Medical Group? 11 A. I'm a shareholder. 12 Q. Also an employee of the corporation; 13 correct? 14 A. Yes. 15 Q. And have been a shareholder and an 16 employee of Ohio Permanente for the last 12 17 years? 18 A. Employee for 12, shareholder for 19 ten. 20 Q. Tell me about your practice. What 21 percentage is GYN and what percentage is 22 obstetrics? 23 A. It's general obstetrics and 24 gynecology. I couldn't give you an accurate 25 percentage, but it's almost 50/50. I mean, it 0008 1 depends. Sometimes it might be 60/40 or the 2 other way around. 3 Q. Where do you practice currently? 4 Which office or offices? 5 A. Offices. Primarily I'm at the 6 Cleveland Heights office, 10 Severance Circle. 7 Sometimes I do some pinch hitting over at the 8 Parma office on Snow Road. 9 Q. When you saw Lillian back in 10 December of 2005, that was at the Cleveland 11 Heights office; true? 12 A. Yes. 13 Q. Do you remember Lillian? 14 A. Some. 15 Q. And would that some be independent 16 of what you are able to gather from your office 17 notes? 18 A. I have some recollection of her that 19 came from those notes. 20 Q. So when you read the record, did it 21 create some type of a picture in your mind as to 22 the patient? 23 A. Yes. 24 Q. We are going to talk about your 25 note. I still have a few more questions about 0009 1 your background, but while I'm on it, would you 2 tell me what you remember, what type of picture 3 you are able to paint in your mind, if that's a 4 fair question, after looking at the note, what 5 you remember about Lillian. 6 A. Pleasant lady. Obese. Black. Fair 7 skinned. Well spoken. Yeah. That's just off 8 the top of my head, you know. 9 Q. Anything else that you can remember 10 descriptive about her, aside from what we will 11 gather that's noted in the record? 12 A. No. Just those things. I make a 13 practice of, you know, having some small talk 14 when you meet someone for the first time, but in 15 her case, I can't remember, you know, what we 16 kind of visited about. 17 Q. You may have had small talk with 18 her, just like you and I had sort of small talk 19 before the deposition started, but you don't 20 remember what the specifics of that small talk 21 was? 22 A. I don't. My purpose in doing that, 23 usually when I'm meeting someone for the first 24 time, consultation or otherwise, it sort of 25 lowers the tone. It calms the situation or 0010 1 whatever, and it's kind of a way of my, dealing 2 with being a male gynecologist. 3 A lot of -- these two ladies will 4 tell you, they are not always comfortable when 5 they walk in the room and see that it's a male 6 gynecologist. So I have a way of habit of 7 visiting just a little beforehand and I can't 8 remember what that was. 9 Q. Along the same lines, do you have a 10 recollection, one way or another, as to whether 11 Lillian was accompanied by anyone or alone? 12 A. She was not. 13 Q. Do you have a recollection -- 14 A. She was not. She was by herself. 15 Q. Do you have a recollection as to 16 whether she seemed overly anxious or concerned 17 about her condition when she presented to you 18 for the first time? 19 A. No. I don't remember her being 20 tearful or histrionic or anything like that. 21 She was pretty even pace speech. Spoke well. 22 So my guess -- I don't know this -- but that she 23 was an educated lady. 24 Q. Fair enough. I want to back up 25 before we remain in the clinical setting. 0011 1 Continuing with your background and 2 training, are you board certified? 3 A. Yes. 4 Q. And are you board certified, I 5 presume, in obstetrics and gynecology? 6 A. Yes. 7 Q. When were you first board certified? 8 A. 1995, November. That's a date you 9 remember. Oral boards, Chicago. 10 Q. Have you been recertified at any 11 time since '95? 12 A. Yes. 13 Q. On how many occasions? 14 A. Every year I do a voluntary 15 maintenance of certification annually. 16 Q. Doctor, I take it that your 17 privileges to practice have never been revoked 18 or suspended; is that true? 19 A. Correct. 20 Q. Have you ever applied for privileges 21 at any hospital and been rejected? 22 A. No. 23 Q. Have you ever been the subject of 24 any disciplinary action before any state medical 25 board? 0012 1 MR. RIEMENSCHNEIDER: Objection. Go 2 ahead. You can answer. 3 A. No, I have not. 4 Q. I suspected that that was the answer 5 but it's one of those routine questions that 6 lawyers -- 7 A. Sounds like it. 8 Q. -- that lawyers like to ask. 9 Have you ever had your deposition 10 taken before? 11 A. Yes. 12 Q. How many times? 13 A. Two times. 14 Q. Is this the third or the second? 15 A. This is the third. 16 Q. Were the other two times involving 17 medical -- regarding patient matters? 18 A. Yes. 19 Q. Were you the physician that was 20 involved in the patient care that resulted in 21 your deposition being taken? 22 A. Loosely in one and primarily in 23 another. 24 Q. How long ago would it have been that 25 your deposition was last taken? 0013 1 A. Pre-2000, I think. I don't remember 2 exactly. 3 Q. The situations that your previous 4 depositions were taken in, were either of them 5 involving GYN issues as opposed to obstetrical 6 issues? 7 A. No. 8 Q. The previous situations were 9 obstetrical as opposed to GYN? 10 A. Correct. 11 Q. This case that involves the issue of 12 uterine sarcoma or uterine cancer or irregular 13 uterine bleeding and things of that nature, an 14 entirely different scenario in the two 15 situations that prompted your previous 16 depositions; is that a fair statement? 17 A. Correct. 18 Q. Have you ever been named as a 19 defendant in any medical negligence cases? 20 MR. RIEMENSCHNEIDER: Objection. Go 21 ahead. 22 A. I guess I don't know exactly. I 23 have been named in other cases that I believe 24 were settled. 25 Q. Let me explain to you before you go 0014 1 any further. I don't want to know, at least at 2 this particular point, and I probably won't ask 3 you whether they were settled or went to trial. 4 My only question is, I want to know 5 whether you were ever named by a patient, either 6 by yourself or with other physicians or perhaps 7 Ohio Permanente Medical Group or Kaiser, but 8 have you been named in a legal document as a 9 defendant where basically a lawsuit was filed 10 against you, regardless of whether it got 11 settled, went to trial? 12 A. In that case, yes. 13 Q. On how many occasions has that 14 occurred? 15 A. I don't know. I can guess. 16 Q. Can you give me an estimate? 17 A. I can give you an estimate. Less 18 than five. Five or less is a better answer 19 maybe. 20 Q. Have any of those cases involved you 21 going to court and providing testimony at trial? 22 MR. RIEMENSCHNEIDER: Objection. 23 Continuing. 24 MR. MISHKIND: That's fine. 25 A. I have never been in a court. 0015 1 Q. Have you ever served as an expert 2 witness reviewing records to determine whether 3 or not the standard of care was met or deviated 4 from? 5 A. No. 6 Q. Do you have any other family members 7 that are in the medical field other than 8 yourself? 9 A. Well, I have a nephew that's in 10 dentistry, and distantly there is a cousin, I 11 think, that's a physician, but I don't know 12 where he is. We are not in touch. 13 Q. Is your spouse employed through Ohio 14 Permanente? 15 A. No, my wife is not. 16 Q. Have you published any articles in 17 any journals, peer reviewed or otherwise? 18 A. No. 19 Q. Do you do any teaching? 20 A. Loosely, in that in the past we had 21 some residents from Case that would come through 22 the office. That hasn't happened for some years 23 now. So, currently, no. But if the opportunity 24 came up, you know what I mean, I answer 25 questions when I'm at the hospital and that kind 0016 1 of thing, but I don't have a formal schedule or 2 something like that to teach. 3 Q. Do you have a hospital practice at 4 all? 5 A. I do work at hospitals also, if 6 that's what you are asking me. 7 Q. Do you have privileges at local 8 hospitals? 9 A. Yes. 10 Q. Which hospitals? 11 A. I have privileges at Fairview, 12 Marymount Hospital, and Cleveland Clinic. 13 Q. Did you have privileges at all three 14 of those hospitals back in December of 2005? 15 A. Yes. 16 Q. You told me before that your 17 practice, give or take a percentage or so, is 18 50/50 OB/GYN. Was it the same back in 2005? 19 A. Roughly. Maybe a little bit more 20 obstetrics at that point. 21 Q. Have you had a chance to see 22 Dr. Verghese's deposition transcript in this 23 case? 24 A. I have not seen her transcript. 25 Q. Have you talked to her since her 0017 1 deposition was taken concerning this case? 2 A. I don't know when she had that done, 3 and, no, we haven't spoken in a long time. 4 Q. Have you talked to her at any time 5 at all since this lawsuit was filed relative to 6 Lillian Dailey's care? 7 MR. RIEMENSCHNEIDER: Objection. I 8 don't know if you know when the lawsuit was 9 filed. 10 THE WITNESS: I don't. 11 A. And we don't speak often. If you 12 are asking, have I talked to her about this case 13 at all, the answer is no. 14 Q. You are obviously aware that Lillian 15 died? 16 A. I heard that. 17 Q. How did you hear about that, other 18 than from your attorney? If you heard it from 19 your attorney, understand that during the course 20 of the deposition, I don't want you to share 21 with me any information that you derived solely 22 from your attorney. If the source was someone, 23 a caregiver, through word of mouth -- 24 A. Nonlegal people. 25 Q. Exactly. 0018 1 A. Then the answer is no, I didn't hear 2 about it through anyone. I mean, I heard about 3 it through legal. 4 Q. Fair enough. Have you seen the 5 autopsy that was performed? 6 A. No. 7 Q. Other than information that was 8 provided to you by your attorney, do you know 9 what the cause of death was as to what caused 10 Lillian's death? 11 A. Other than what I have heard from 12 them, no. 13 Q. Have you reviewed any of the medical 14 records prior to -- strike that. 15 When you saw Lillian in December, 16 you would have had available to you on the 17 computer the records that would have predated 18 your visit; true? 19 A. That is mostly true. 20 Q. In what respect would it not be 21 completely true? 22 A. Well, when I got a chance to look at 23 my note -- could I take a look at that? 24 Q. Sure, absolutely. 25 A. Right on the second page, something 0019 1 I -- I had heard she had had a CT scan when she 2 was in the emergency room in October of 2005, 3 but I was unable to get that. So that's what I 4 mean. It's mostly true. So that I didn't have. 5 But everything else was, you know, available to 6 me. 7 Q. Okay. From looking at the record, 8 can you tell me whether you would have discussed 9 any of Lillian's care that had led her to your 10 office? 11 In other words, is it likely that 12 you would have talked with, perhaps, Dr. Gibbs, 13 who had seen her prior to your visit? Do you 14 know who I'm referring to? 15 A. I know who she is. 16 Q. Or Dr. Verghese or any of the other 17 physicians, is it likely that on that visit that 18 you would have had communication with any of the 19 other physicians who had cared for her? 20 A. They were available to me had I 21 called them, but I didn't contact any of them. 22 Q. After this December 15th, 2005 23 visit, did you have any further involvement at 24 all with regard to the care or management of 25 Lillian Dailey? 0020 1 A. No, I did not. 2 Q. She obviously was referred for GYN 3 oncologic consultation; true? 4 A. I'm the one that made the referral. 5 Q. Right. And you referred her to who? 6 A. I think I did it to Chad Michener, 7 GYN oncologist at CCF, Cleveland Clinic. 8 Q. Is there a GYN oncologist that is 9 employed by Ohio Permanente Medical Group? 10 A. No. 11 Q. Do you have experience treating GYN 12 oncologic issues? 13 A. Only as a resident. But as a staff 14 physician, only in identifying something and 15 referring, that type of thing. 16 Q. So you are familiar with at least 17 the term differential diagnosis? 18 A. Yes. 19 Q. And in seeing a patient who has 20 irregular uterine bleeding, do you normally go 21 through a differential diagnosis in terms of 22 evaluating the potential causes of irregular 23 uterine bleeding? 24 A. That's fair, yes. 25 Q. And is that something that general 0021 1 OB/GYNs are trained to do when they see a 2 patient that has irregular uterine bleeding, to 3 determine what the differential would include? 4 A. Hopefully any physician. A family 5 practice physician when you look, what is that, 6 is it this, that or whatever, so, yes. 7 Q. And in terms of a differential 8 diagnosis, that would include things from the 9 most dangerous conditions that could cause the 10 patient to die, down to the most benign 11 conditions that are far from life-threatening 12 and can be treated conservatively; is that a 13 fair spectrum? 14 MR. RIEMENSCHNEIDER: Objection. Go 15 ahead. 16 A. I guess. 17 Q. Why don't you define better for me, 18 if you would -- 19 A. I'll try. 20 Q. -- your comfort level. 21 A. My first thought when I see someone, 22 regardless of what they are presenting with, 23 isn't oh my goodness; what will they die from. 24 I guess I want to clarify that for you. 25 Q. Okay. 0022 1 A. But I think most physicians, 2 dermatologists, you know, when someone presents 3 with whatever it is and it's not absolutely 4 clear, then what's the worst thing in the world 5 it could be. But I don't always link that to 6 what would kill them, okay? So I guess that's a 7 clarification point. 8 Q. I appreciate that. In a patient 9 that is in their mid 50s, that's 10 African-American, that is obese, that presents 11 with a history of diabetes, that has a history 12 of some irregular uterine bleeding, whether it's 13 perimenopausal or postmenopausal, do you have 14 within your differential, whether it's at the 15 top of the differential or somewhere in the 16 differential, either uterine cancer or uterine 17 sarcoma? 18 A. Honestly, sarcoma didn't come to my 19 mind, typically because it's so incredibly rare. 20 You mentioned it. So that's why I say that. 21 Q. Sure. 22 A. But broadly speaking, uterine cancer 23 you think about in obese women, whether they are 24 perimenopausal or postmenopausal. 25 Q. In a patient who presents in their 0023 1 mid 50s, either perimenopausal and/or 2 postmenopausal, with diabetes, obese, that also 3 has a history of fibroid tumors that have been 4 documented, do you ever consider within your 5 differential not only uterine cancer, but also 6 the potential of a uterine sarcoma? 7 A. My hesitation in answering, again, I 8 have to tell you, is that sarcoma is not the 9 first thing that comes to my mind. 10 I guess that's important that I say 11 that to you again. Yeah. So do I think of a 12 number of things when someone presents that way? 13 Yes, I do. 14 Q. And if you are -- 15 A. But sarcoma is not on that list. 16 Q. What would need to be on the 17 clinical history or the patient's signs and 18 symptoms to at least have within the 19 differential, whether it's high up on the 20 differential or low on the differential, what 21 would you need to see to consider that the 22 patient may have uterine sarcoma as opposed 23 to -- 24 A. Some other cancer or something? 25 Q. Exactly. 0024 1 A. Okay. For sarcoma to make the list 2 for me, I guess the first thing that comes to my 3 mind is, are there things about that individual 4 patient that makes me think that they have a 5 cancer. I guess that's step one. And I'm going 6 to refer to this now, okay? Is that okay? 7 Q. Let's keep it general right now and 8 then we will dovetail into that patient. 9 A. In that case I'll make a general 10 statement and that's that there are certain red 11 flags, if you will, that appear in a history 12 when you are speaking to someone that are 13 concerning. So that makes you think cancer. 14 To go beyond the, I think this might 15 be a cancer and make the leap into something as 16 rare as a sarcoma, then my concern would be is 17 there some radiologic study that would suggest 18 there is nothing going on with the ovaries and 19 that there is apparently nothing going on in the 20 cavity of the uterus, okay, the endometrium, and 21 is the uterus enlarged. 22 So there is not a precise number in 23 my mind; it's past a certain time and that means 24 sarcoma. It's like a puzzle piece, you know. 25 It's a constellation of things. There is not a 0025 1 thing. Did I answer that? 2 Q. You did. I'm going to ask you a 3 couple more questions to refine that. 4 Is endometrial cancer more common 5 than uterine sarcoma? 6 A. Oh my goodness, yes. 7 Q. In a patient in their mid 50s that 8 has fibroids that are increasing in size on 9 serial ultrasounds, does that at least create an 10 issue within that differential as to whether or 11 not a patient who did not have a prior history 12 earlier in their age, but in their mid 50s 13 demonstrates increasing fibroids on serial 14 uterine exams, is that more consistent with 15 endometrial cancer or is that more consistent 16 with uterine sarcoma? 17 A. I hope I trailed you. I hope I 18 track you on that. 19 MR. RIEMENSCHNEIDER: Note my 20 objection to the question. Go ahead. 21 A. Could you restate that shorter? 22 Q. Sure. 23 A. I don't want to go the wrong way. 24 Q. Can we agree that it's unusual in a 25 patient who is postmenopausal or perimenopausal 0026 1 to have fibroids? 2 A. No, we can't agree on that. 3 Fibroids are awfully common. 25 percent of 4 white women, 50 percent of black women have 5 them, and whether they are perimenopausal or 6 postmenopausal, they can be present. And that 7 in and of itself to a gynecologist I don't think 8 means anything, it's a finding. 9 Q. As women get older and they are in 10 their 50 to 55 range, whether they are 11 perimenopausal or postmenopausal and they have 12 irregular uterine bleeding and have increasing 13 uterine size, that the fibroids are increasing 14 in size, is that a fact that at least creates a 15 concern in terms of whether the patient may have 16 a uterine sarcoma? 17 MR. RIEMENSCHNEIDER: Note an 18 objection as to the characterization of the 19 question. Because I just want to make sure, are 20 we talking does the uterine increase in size or 21 fibroids increase in size, because you said 22 both. 23 Q. What is your understanding as to 24 whether or not -- you had the information 25 relative to the increase from the ultrasounds in 0027 1 terms of Lillian's uterus; correct? 2 A. I looked. I got the results of two 3 ultrasounds that I wanted to see. 4 Q. And there was an increase in the 5 size of the uterus on those two ultrasounds; 6 correct? 7 A. Correct. 8 Q. Now, was the increase in the size on 9 the two ultrasounds, was that of the uterus, was 10 it of the fibroids, or was it both? 11 A. I would actually say both. Usually 12 when a gynecologist talks about the overall -- 13 we speak of the overall size of the uterus. 14 Q. And you use weeks? 15 A. We use weeks, as if they are 16 pregnant, you know. 17 Q. And in this case, in looking back at 18 the records, there was some descriptions of a 12 19 week size and then there was some other 20 descriptions. 21 Is that a description of the overall 22 size of the uterus or does that take into 23 account the increase in the size of the 24 fibroids, as well? 25 A. That's the overall size of the 0028 1 uterus. 2 Q. And is that overall -- 3 A. And that includes the fibroids. So 4 it's both. 5 Q. So the fibroids at least contribute 6 to the overall size of the uterus? 7 A. We can agree on that. 8 Q. So when you saw her in December, you 9 knew that there was an increase in the overall 10 size of this patient's uterus; correct? 11 A. I knew that. 12 Q. You also knew that there had been, I 13 believe, one endometrial biopsy that had been 14 performed back in, I may be wrong, but I 15 think -- 16 A. I wrote it in here. I can look if 17 you want me to. 18 Q. Go ahead and do that rather than me 19 being wrong because I hate being wrong. 20 A. Then you don't like being human. 21 Shame on you. 22 Q. The record should reflect that was 23 my attempt at humor. 24 A. I could direct you to a 12 step 25 program. 0029 1 The endometrial biopsy was May of 2 2005. That's when it was. 3 Q. And prior to May of 2005 -- and that 4 was done by Dr. Verghese? 5 A. Dr. V. 6 Q. Dr. V. But there wasn't one that 7 had been done back in, for example, October or 8 December of 2004, to your knowledge, was there? 9 A. Not to my knowledge. 10 Q. And when you saw her in December, 11 there had been only one endometrial biopsy; 12 true? 13 A. As far as I knew, yes. 14 Q. So when you saw her, the endometrial 15 biopsy was negative; correct? 16 A. It was within normal limits, yes. 17 Q. I think that biopsy, did it show up 18 .9 centimeter thickness or was that on the 19 ultrasound that showed the uterine wall? 20 A. Endometrial biopsies don't comment 21 on thickness. Ultrasounds comment on thickness. 22 Q. And there was one of the ultrasounds 23 that showed a .9 centimeter thickness of the 24 uterine wall. Do you recall that? 25 A. I don't recall that. 0030 1 Q. One of the ultrasounds did reflect a 2 thickness of .9 centimeters. Is that a normal 3 or abnormal finding in a patient of this age 4 with irregular uterine bleeding? 5 A. In and of itself, that one piece of 6 information doesn't kind of send me one way or 7 another. I guess it would depend on whether the 8 patient was perimenopausal or postmenopausal. 9 Q. Okay. As you are gathering 10 information to work your differential up, you 11 want to gather as much information as you can to 12 try to go down the right path in terms of 13 testing and ultimately leading to a diagnosis; 14 correct? 15 MR. RIEMENSCHNEIDER: Objection. Go 16 ahead. 17 A. Useful information, yeah. 18 Q. Sure. And that's what you did when 19 you saw her; you took history and clinical 20 parameters to do your differential and then to 21 make appropriate recommendations; true? 22 A. Yes. 23 Q. Now, in terms of .9 centimeters 24 thickness of the uterine wall, you said that 25 that in and of itself would not, wouldn't lead 0031 1 you to one diagnosis versus another; true? 2 A. True. 3 Q. What would you need along with a .9 4 centimeter thickness in the uterus in a patient 5 in their mid 50s to start coming up with a 6 differential list of potential diagnoses? What 7 else would you need to know? 8 A. The concern for me would be -- well, 9 are they having irregular bleeding. Ultimately, 10 I guess foundationally, are they postmenopausal 11 or perimenopausal. That shifts things. 12 Q. So irregular uterine bleeding or 13 what is sometimes known as anovulatory bleeding? 14 A. That's one type of irregular 15 bleeding. 16 Q. Whether or not they are 17 perimenopausal or postmenopausal? 18 A. That's the key, yeah. 19 Q. What about diabetes, is that a 20 factor? 21 A. That is a factor. 22 Q. Hypertension, is that a factor? 23 A. Not so much. 24 Q. Do you exclude that in terms of any 25 significance? 0032 1 A. I don't pay attention to that. 2 Q. Fair enough. So diabetes, obesity? 3 A. That is a factor. 4 Q. Ethnicity? 5 A. Not so much. 6 Q. But is it a soft factor or do you -- 7 A. It's like Gossamer, it's that soft. 8 Q. Fair enough. Diabetes, obesity, 9 anovulatory bleeding, age, perimenopausal, 10 postmenopausal? 11 A. Yeah. More than age even, you know, 12 unless they were 70, you know, but whether they 13 are perimenopausal or postmenopausal, that's a 14 key. 15 Q. And then from the standpoint of 16 ultrasound findings, uterine growth of the 17 uterus over a period of time, does that also 18 factor into whether or not or how you arrive at 19 your differential diagnosis? 20 A. That's one of the pieces of the 21 puzzle, yes. 22 Q. Have you in preparation for today's 23 deposition looked back at the notes that were 24 made by any of the caregivers prior to your 25 visit? 0033 1 A. No, I have not looked at the notes. 2 Q. Do you have an independent 3 recollection of what information your 4 colleagues, whether they are in OB/GYN or family 5 practice, what information they have to make 6 their various recommendations or diagnoses? 7 A. The quick answer is no. But I mean, 8 that was available to me, but for where we are 9 now and everything, my note is the main thing 10 that I've looked at. I heard about some things, 11 you know, but that's about it. 12 Q. We know that Lillian had been seen 13 back in October of 2004 by Evelyn James, who is 14 a clinical nurse practitioner. Do you know 15 Evelyn? 16 A. I do know her. 17 Q. When is the last time you had any 18 contact with Evelyn? 19 A. When she retired almost a year ago. 20 Q. Did you know that Evelyn had seen 21 Lillian back in October of 2004 for what was at 22 that time scheduled as a well woman exam? 23 A. I may have known that then, but I 24 can't independently, to use your words, recall 25 that she specifically was the nurse practitioner 0034 1 that saw her. 2 Q. Have you reviewed any of her records 3 to know whether or not she should have referred 4 Lillian to a GYN at the time of that office 5 visit to be seen based upon whatever symptoms 6 she had in October of 2004? 7 A. That I don't recall. 8 Q. So you are not in a position to 9 provide what we refer to as standard of care 10 opinions as it relates to people that came 11 before you in December of 2005 to comment on 12 whether or not what they did was within standard 13 or deviated from standards; is that a fair 14 statement? 15 MR. RIEMENSCHNEIDER: Objection. Go 16 ahead. 17 A. Well, as a board certified 18 gynecologist that's practiced for a while now, I 19 actually think I could make a comment on -- in 20 the realm of general obstetrics and gynecology, 21 I could make a comment on standard of care. 22 Q. Have you reviewed the records 23 sufficiently enough to be able to comment on the 24 standard of care provided by your colleagues 25 prior to your care in December of 2005? 0035 1 A. I haven't combed through records. 2 If I'm deciphering what you are saying 3 correctly, I haven't combed through records to 4 give a complete judgment. 5 I guess I need to go through an 6 entire record or be presented with a scenario, 7 but I could make a comment. 8 Q. Fair enough. The reason I ask that 9 is I don't want to spend a lot of time -- 10 sometimes I come into a deposition and the 11 doctor has reviewed all of the records since you 12 had them and is very comfortable with saying 13 what was done before I saw the patient was 14 appropriate, within accepted standards, and I 15 wouldn't have done anything differently based 16 upon a careful review of the records. 17 Other times doctors say to me, I 18 really haven't reviewed it sufficiently enough 19 and I'm not in a position to provide opinions 20 one way or another. 21 And I just want to know, as you are 22 sitting here right now whether or not you have 23 reviewed the records sufficiently enough to be 24 able to comment on the standard of care provided 25 by those that saw her in October of '04, those 0036 1 that saw her in May of '05 and June of '05 and 2 certainly prior to what you did in December of 3 '05? 4 A. To be completely thorough, I would 5 need to go through all the records, that's true. 6 But I go back to what I said before. If you 7 present something to me, I think I can make an 8 educated comment on it. 9 Q. Okay. 10 MR. MISHKIND: And Dirk, I don't 11 know how comfortable you are with me going 12 through or whether you are intending to have the 13 subsequent caregivers give standard of care 14 opinions. Obviously I don't have a report from 15 him. 16 MR. RIEMENSCHNEIDER: Right. I 17 mean, our reports aren't due anyway. 18 MR. MISHKIND: Right. 19 MR. RIEMENSCHNEIDER: You see 20 objective criteria which he put in his note. 21 I'm not sure what you are asking him. I think 22 that's how he answered the question. 23 If you present him with questions 24 regarding care of some of the previous health 25 care providers in a hypothetical, I think what 0037 1 he said is, based upon his education, training 2 and experience, he might have an answer. I 3 don't know until we hear the question. And if 4 you are just focusing on his care and treatment, 5 then probably everything will move a lot 6 quicker. 7 Q. Well, have you been asked at least 8 at this particular point to provide opinions as 9 to the care that was provided by anyone other 10 than yourself? 11 MR. RIEMENSCHNEIDER: Anything that 12 you and I have discussed is off limits. 13 THE WITNESS: In that case, the 14 answer is no. No one has. 15 Q. And as you are sitting here right 16 now, unless I give to you hypothetical questions 17 as it relates to what was done by Dr. Verghese 18 or anyone else, you haven't formulated any 19 specific standard of care opinions in this case; 20 is that a fair statement? 21 A. That's fair. 22 Q. Okay. Would you agree with this 23 statement, that abnormal uterine bleeding in a 24 peri or postmenopausal woman should be 25 considered a malignancy until proven otherwise? 0038 1 A. It depends on how, whoever that is, 2 is defining abnormal uterine bleeding. Abnormal 3 uterine bleeding in a postmenopausal woman is a 4 big deal. You have to assume that's a cancer, 5 always. 6 In a perimenopausal woman, there is 7 a variety of benign conditions that could give 8 you abnormal uterine bleeding, so it's not 9 necessarily the first thought. 10 Q. I appreciate your answer. It's 11 informative. Let me give you sort of a 12 subcategory of that. 13 In a patient that has abnormal 14 uterine bleeding, whether they are peri or 15 postmenopausal, should a malignancy be within 16 the differential? Not necessarily at the top, 17 could be at the bottom, but somewhere within the 18 differential? 19 A. That's fair. 20 MR. RIEMENSCHNEIDER: Do you want to 21 tell us what you are reading from? 22 MR. MISHKIND: It's my notes. I 23 don't think I have to. 24 MR. RIEMENSCHNEIDER: I agree with 25 you. I didn't know if you were reading from 0039 1 some sort of journal. 2 MR. MISHKIND: Could be. 3 MR. RIEMENSCHNEIDER: If it was, I 4 think in fairness he is allowed to see the 5 entire article. 6 MR. MISHKIND: No, he isn't. 7 MR. RIEMENSCHNEIDER: I disagree 8 with you. You can go on and ask the question. 9 MR. MISHKIND: Thanks. I appreciate 10 the conversation. 11 Q. If Lillian was postmenopausal, as I 12 understand it, from what I learned from 13 Dr. Verghese and from perhaps even some of the 14 policies that you folks had at Ohio Permanente, 15 postmenopausal means no menses for greater than 16 one year and not on any hormone replacement 17 therapy? 18 A. Correct. 19 Q. Now, we know that Lillian was not on 20 any hormone replacement therapy prior to May of 21 2005; correct? 22 A. I think that's true. 23 Q. At least according to the records, 24 didn't Dr. Verghese put her on some, was it 25 estrogen or progesterone? 0040 1 A. I believe she was placed on a 2 progestin. 3 Q. Okay. Now, Mr. Riemenschneider 4 faxed over to me yesterday the department of 5 obstetrics and gynecology practice guidelines. 6 Are you familiar with those? 7 A. They exist, yes. 8 Q. And being that you are a shareholder 9 of Ohio Permanente Medical Group, do you have 10 any involvement in reviewing and revising those 11 practice guidelines from time to time? 12 A. Loosely, yes. 13 Q. Tell me what you mean by loosely. 14 A. Well, I have the opportunity to make 15 a comment if something should be revised or 16 changed or something like that. So that's what 17 I mean by that. 18 But I'm not the original author of 19 any, I don't think -- maybe one of the 20 obstetrical ones -- but I'm not the author on 21 any of the gynecological ones. 22 Q. Is there a committee at Ohio 23 Permanente that is specifically assigned to the 24 review and revision of practice guidelines? 25 A. The last time that we went over the 0041 1 guidelines, it was something that was done as a 2 department. So I think they were -- I don't 3 know the computer terms -- but they were posted 4 so that we could look at them and make comments 5 and then get it back to the department head. 6 Q. Who is the department head? 7 A. Charles Zonfa. 8 Q. Who was the department head back in 9 2005? 10 A. Well, I can't remember when it 11 changed, but it was Mark Vinstock before that. 12 But he might have been -- I don't remember. 13 Q. The first doctor's name began with a 14 Z? 15 A. Zonfa. 16 Q. Help me out. 17 A. Z-O-N-F-A, Charles. 18 Q. Do you hold a position, a title 19 within the department of obstetrics and 20 gynecology? 21 A. Yes. 22 Q. What is your title? 23 A. I'm the lead physician for the 24 eastside obstetrical/gynecological team. 25 Q. Were you back in 2005? 0042 1 A. This is going to sound bad, but I 2 think I was. 3 Q. What are your responsibilities as 4 lead physician? 5 A. Administrative, additional 6 administrative things. So helping with making 7 the call schedule, writing reviews, you know, 8 that type of thing. 9 Q. When is the last time you had an 10 opportunity to review the practice guidelines? 11 A. An opportunity? 12 Q. When is the last time you reviewed 13 the practice guidelines? 14 A. That's better. Portions of them I 15 think I looked at certainly within the past five 16 years, but I couldn't give you a specific date. 17 Because things haven't changed, you know, 18 dramatically, that's why. 19 Q. Fair enough. Besides the note from 20 your visit, did you review any other portions of 21 Lillian's records to prepare yourself for today? 22 A. No. 23 Q. Have you reviewed anything else 24 outside of the records from Ohio Permanente 25 relative to Lillian to prepare yourself for 0043 1 today? 2 A. Nothing beyond my note. 3 Q. Have you seen any of Lillian's 4 records from, say, The Cleveland Clinic, or 5 anything outside of Ohio Permanente at any time 6 since you saw her back in December of '05? 7 A. No. 8 Q. Have you reviewed -- you hesitate, 9 and in fairness to you I'm going to stop and let 10 you ponder that hesitation. 11 A. The hesitation is usually after you 12 send someone to -- you refer them out. The 13 gynecologic oncologist will send a letter as to 14 how they are doing. And way back then, my guess 15 is that Dr. Michener did that, but I haven't 16 seen that paper, that consultation, thank you 17 for referring this lady, da, da, da type thing 18 in preparation for this. So that's what made me 19 pause. 20 Q. Is it possible that you had some 21 conversations with Dr. Michener at or around the 22 time that she was being treated at the Clinic 23 that you just don't remember at this particular 24 point? 25 A. Unlikely. I do recall calling his 0044 1 secretary to get an appointment scheduled for 2 her, but that was about it. 3 Q. Do you know how common it is for a 4 patient that has uterine sarcoma to die of a 5 pulmonary sarcoma? 6 A. A pulmonary sarcoma? 7 Q. A sarcoma embolism, excuse me. 8 A. A sarcoma embolism. You mean a 9 portion of the tumor -- 10 Q. Embolizing. 11 A. -- breaking loose the tumor and 12 going to the lung? 13 Q. Right. 14 A. I don't know. That sounds 15 incredibly rare. A sarcoma embolism. A blood 16 clot, I have heard of that with any cancer, but 17 I have never heard that. 18 Q. Okay. 19 A. Sarcoma embolism, is that how she 20 died? 21 Q. You have not seen the -- 22 A. I can't answer your question then. 23 Is that the deal? 24 Q. Fair enough. 25 A. That's not fair. You can put that 0045 1 in the record. Now I'm curious. 2 Q. You told me a moment ago that you 3 would have been aware of the ultrasounds when 4 you saw Lillian in December of 2005; that there 5 were previous ultrasounds that had been done; 6 true? 7 A. Yes. 8 Q. Just looking at my notes, the uterus 9 back in December of '04, it looks like the 10 measurements had gone from 14.8 by 10.9 by 9.7 11 versus a previous ultrasound of 12.7 by 9.5 by 12 10.2. 13 If you compare the two sizes of the 14 uterus from December of '04 to May of '05, is 15 that a significant increase in the size of the 16 uterus in a perimenopausal patient who has 17 irregular uterine bleeding? 18 A. It's something worth noting, but in 19 and of itself that doesn't bring me to a 20 conclusion or to a diagnosis. 21 Q. So you would still be working up 22 that differential? 23 A. It's a piece of the puzzle. 24 Q. And again, not arriving necessarily 25 at a definitive diagnosis, but within that 0046 1 differential, would a malignancy be one of those 2 possible diagnoses? 3 MR. RIEMENSCHNEIDER: Objection. 4 A. Possibly. 5 Q. Now, just to refine that, 6 malignancy, would that include the possibility 7 of a uterine sarcoma as well as endometrial 8 sarcoma or would the increase of the size of the 9 uterus in a perimenopausal patient that has 10 irregular uterine bleeding, if you are 11 considering a malignancy -- not necessarily 12 jumping to the conclusion but considering -- 13 would that malignancy be a generic uterine 14 cancer or would you be thinking as a possibility 15 uterine sarcoma? 16 MR. RIEMENSCHNEIDER: Objection to 17 form. Go ahead. 18 A. In the realm of possibility, I 19 guess, yes, but that's a stretch. 20 Q. Yes, uterine sarcoma or would you 21 be -- 22 A. It could be a cancer. I guess in my 23 brain, yes, I guess it could be a cancer, but 24 sarcoma wouldn't enter my mind at that point. 25 Q. Now, what do you need to do to rule 0047 1 in or rule out cancer, even though the patient 2 may in fact be perimenopausal as opposed to by 3 definition postmenopausal? 4 A. For me, I guess -- 5 MR. RIEMENSCHNEIDER: Note an 6 objection as to the generic form of the 7 question. I don't know the specifics. I think 8 it's really generic as to possibilities, but 9 that's what I have an objection to. 10 Q. Go ahead. 11 A. There are some, I think I mentioned 12 earlier, red flags for me that make me think of 13 cancer in a lady and there is a host of things. 14 Do you want me to get specific as to this lady? 15 Q. We are going to very shortly. But 16 in a perimenopausal patient with irregular 17 uterine bleeding that has increase in the size 18 of the uterus from December of '04 to May of '05 19 as described, what I think my question was, what 20 things need to be done to rule in or to rule out 21 uterine cancer if it's within a differential? 22 A. Well, I think most folks -- or I'll 23 speak for myself -- the first thought is a 24 specific type of uterine cancer, endometrial, 25 which I mentioned or alluded to earlier is very 0048 1 common, and so an endometrial biopsy is a useful 2 tool. 3 So if you are thinking that 4 something questionable might be going on, the 5 most return on your effort is going to come from 6 doing an endometrial biopsy. 7 Q. If the endometrial biopsy is 8 negative, can one rule out a malignancy based 9 upon one normal endometrial biopsy? 10 A. Not 100 percent, but very high, you 11 know. There is a good chance that it's not a 12 malignancy. 13 Q. If the patient continues with 14 symptoms in terms of irregular uterine bleeding, 15 even with treatment with an estrogen or 16 progestin treatment after an endometrial biopsy 17 is reported as negative, does that move you one 18 way or another on whether or not there might be 19 a malignancy that just was not diagnosed by the 20 endometrial biopsy? 21 A. I guess in that presentation, the 22 way you offer it to me just now, my thought 23 would go along, is there an anatomic reason for 24 her bleeding versus a hormonal reason. 25 Continue? 0049 1 Q. Please. 2 A. So traditionally I guess there is 3 dysfunctional uterine bleeding which long ago 4 the original definition of that was irregular 5 bleeding that's associated with a hormonal 6 cause. 7 The other is abnormal uterine 8 bleeding, which these days those terms are 9 almost kind of synonymous. But abnormal uterine 10 bleeding points more to anatomic reasons; polyps 11 for example, endometrial polyps. Fibroids, 12 fibroids could be a cause of bleeding. Some 13 mucosal fibroids that, you know, jet into the 14 cavity of the uterus, those could be causes of 15 irregular bleeding too. 16 Q. And within that subset, the anatomic 17 causes of irregular uterine bleeding, if they 18 are associated with fibroids, what can you do to 19 determine whether or not that irregular uterine 20 bleeding that is in fact in a patient who has 21 fibroids, whether or not that patient has a type 22 of cancer, either a sarcoma or some other cancer 23 that is associated with those fibroids, what do 24 you do next? 25 MR. RIEMENSCHNEIDER: Objection. Go 0050 1 ahead. 2 A. That's the sad part about 3 medicine -- gynecology today. You know, there 4 is no, short of surgery, study that can be done 5 that can definitively diagnose a nonendometrial 6 or any kind actually of uterine -- we use that 7 term broadly -- uterine cancer. 8 So we can do something about trying 9 to figure something out preoperatively about an 10 endometrial cancer, but you can't diagnose, to 11 my knowledge -- I mean, a GYN oncologist would 12 maybe say otherwise, I confess to that -- but 13 from a generalist's point of view, I don't think 14 an MRI or what have you would diagnose a cancer 15 in one of those fibroids or within the 16 myometrium, the muscular wall of the uterus 17 itself, you can't diagnose it that way. 18 Q. What about a hysteroscope? 19 A. A hysteroscope is useful for the 20 cavity of the uterus and that's about it. You 21 can look in and say, I see polyps, I can make a 22 comment on the lining of the uterus, what it 23 looks like, you can sample that so you get a 24 histologic answer. 25 And I guess that is firm, but you 0051 1 can't somehow get a biopsy of the myometrium 2 that way or whatever. That's it. 3 Q. I didn't want to interrupt you. 4 Have I been fair to you thus far in terms of 5 answering the questions that I presented? 6 MR. RIEMENSCHNEIDER: Objection. Go 7 ahead. 8 A. Yes. 9 Q. I haven't cut you off? 10 A. No. You could've given me some 11 money or whatever, that would've gone over 12 better, but no. 13 Q. Short of that? 14 A. Short of that, I guess so. 15 Q. From what you gathered in looking at 16 the records, was there any consideration of 17 doing any further diagnostic studies, such as a 18 hysteroscope, on this patient prior to seeing 19 her in December of '05? 20 A. Unfortunately, no. No. Again, I'm 21 going by, I have the benefit of the 22 retrospectoscope, you know. 23 Q. Sure. 24 A. So, no. An endometrial biopsy is 25 the first thing absolutely that should have been 0052 1 done and on here it says when it was done. But 2 that's about it. 3 Q. If a hysteroscope had been done in 4 this case, knowing what you saw and what your 5 ultimate diagnosis was, do you know what 6 additional information that would have provided 7 in this patient? 8 MR. RIEMENSCHNEIDER: Objection. If 9 you know. 10 Q. You can go ahead and answer. 11 A. In my opinion, it would not have 12 given me -- well, the endometrial biopsy was 13 useful to say whether something is a cancer or 14 not in the lining of the uterus, okay? 15 A hysteroscope is a stretch, but you 16 could have seen, perhaps, a polyp or something 17 in the cavity that the pipelle things you do the 18 biopsies with didn't detect. 19 But that by itself, that wouldn't 20 have led me to cancer. That would have actually 21 drawn me more towards what I defined as abnormal 22 uterine bleeding. 23 Q. Would a hysteroscope have been 24 useful in terms of arriving at an earlier 25 diagnosis of uterine sarcoma? 0053 1 A. No, absolutely not. 2 Q. If one has reason to suspect on a 3 differential that the patient has uterine 4 sarcoma, I think you told me a moment ago that 5 one of the modalities, unfortunately, that you 6 have to implement if you believe that there is 7 uterine sarcoma is a hysterectomy? 8 A. Well, a GYN oncologist could answer 9 that better. But from a generalist, if there is 10 a uterine -- again, I'm using that term broadly 11 to include a lot of things -- a cancer of the 12 uterus, that's a referral. They make the call 13 as to how they proceed. 14 Q. Are D&C's and hysterectomies used in 15 patients who are perimenopausal or 16 postmenopausal where there is a high index of 17 concern that the patient's irregular uterine 18 bleeding is a manifestation of uterine cancer or 19 uterine sarcoma? 20 A. Neither would be used with a 21 sarcoma, I don't believe. Again, you would have 22 to ask a GYN oncologist to be more specific, but 23 D&C's are done, but again, that's sort of, 24 that's not even as useful, I don't think so, as 25 an endometrial biopsy. 0054 1 Q. An endometrial biopsy, what is that 2 going to tell you in a patient who ultimately 3 has uterine sarcoma? 4 A. It tells you what pathology, if any, 5 is in the cavity of the uterus. 6 Q. The fact that the endometrial biopsy 7 in May was negative, what does that tell you as 8 to the status of her uterine sarcoma at that 9 point in time? 10 A. It doesn't make a comment on the 11 sarcoma. 12 Q. Now, do you have any reason to 13 believe that in May of 2005 -- you saw her in 14 December of 2005 -- do you have any reason to 15 believe that she didn't already have a uterine 16 sarcoma about four or five months earlier? 17 MR. RIEMENSCHNEIDER: Objection. Go 18 ahead. 19 A. I think I missed you just there. 20 You are asking me, I think, looking backwards in 21 hindsight, could she have not had a sarcoma in 22 May of 2005, is that correct? Is that what you 23 are asking? 24 Q. Sort of, but let me rephrase it to 25 make sure how you reworded it and how I meant 0055 1 it. 2 We know the endometrial biopsy was 3 reported as negative? 4 A. It was negative. 5 Q. Because it was negative, does that 6 tell you anything relative to whether she had 7 uterine sarcoma? 8 A. Or did not have. 9 Q. Or did not have uterine sarcoma? 10 A. It does not answer that question. 11 Q. Do you have an opinion as to why -- 12 do you have an opinion to a probability as to 13 whether or not she had uterine sarcoma back in 14 May of 2005, notwithstanding the negative 15 endometrial biopsy? 16 A. My speculation would be that she 17 did, in fact, have a sarcoma before. 18 Q. You use the term speculation. Is 19 that just speculation or is that an opinion to a 20 reasonable degree of probability more likely 21 than not? 22 A. More likely than not, I suppose, but 23 I'm not an expert on that and these are rare, 24 so -- 25 Q. Do you have an opinion more likely 0056 1 than not as to how long prior to May of 2005 she 2 had the uterine sarcoma even though we have the 3 negative endometrial biopsy? 4 A. I can't give you a good time course 5 on that. I can't answer that. I don't have a 6 good opinion. 7 Q. If I'm summarizing what you told me, 8 that more likely than not in May of 2005, even 9 though there was a negative endometrial biopsy, 10 your opinion is that she probably had uterine 11 sarcoma at that time. As to how long before she 12 had it -- 13 A. I can't answer that. 14 Q. -- that would be speculation as 15 opposed to probability; is that a fair 16 statement? 17 A. Yes. 18 Q. Do you know what frequency 19 endometrial biopsies are done where they are 20 reported as a false negative in a patient who 21 does have uterine sarcoma? 22 A. I do not know that answer. 23 Q. All right. Let's talk about your 24 visit. You saw her on December 15th and the 25 reason for the visit was what? 0057 1 A. She had had an ultrasound. I'm 2 going by what is listed here. And it was to 3 review that ultrasound with her. 4 Q. The notes for the reason for the 5 visit, were they written by you at that point or 6 were they written by a nurse? 7 A. A medical assistant wrote the 8 majority of what's up there. Some of that is my 9 scribble. 10 Q. Help me out with who, if you know, 11 was the medical assistant. 12 A. I do. It was Ms. Wesley. It's 13 listed down here, nurse signature, MA. 14 Q. Got it. Under last menstrual 15 period, I'm not sure whether that January 2005 16 is -- well, strike that. 17 There is a box for postmenopausal 18 hysterectomy or ABN. What does ABN stand for? 19 A. Abnormal. 20 Q. And someone put postmenopausal? 21 A. That was not me. 22 Q. The reason for the visit and all of 23 that information would have been recorded when 24 you saw the patient; correct? 25 A. Correct. 0058 1 Q. You didn't change that from 2 postmenopausal to perimenopausal, did you? 3 A. No. I should have. That would have 4 been more accurate. But that's the nurse's 5 notes, and as a rule, we don't change the 6 nurse's notes. 7 Q. You didn't record anywhere in your 8 notes that the patient was perimenopausal as 9 opposed to postmenopausal, did you? 10 A. I didn't write that down 11 specifically, but I did, at least for myself, 12 wrote down some bleeding that she had had. This 13 is just shorthand for me. 14 Where it says last menstrual period 15 I put January of 2005, until now, that arrow. 16 So what that said to me, she had been having 17 bleeding off and on. 18 Q. Now, it's important, is it not, to 19 recognize in order to come up with a definitive 20 statement as to whether the patient is 21 perimenopausal or postmenopausal, it really is 22 important to know when the patient had their 23 last menstrual period; correct? 24 A. It's useful. 25 Q. And do you recognize in this case 0059 1 that there are various notes by various people 2 recording the last menstrual period at different 3 points in time in this case? 4 A. I don't know that. 5 Q. There are some references that the 6 last menstrual period was June or April of 2004. 7 There's some reference or suggestion that it 8 might have been December of 2004. There is a 9 reference, you made a reference of January 2005 10 until now, which may or may not be a suggestion 11 that that was her last menstrual period. 12 But is it, in your experience, is it 13 common in a woman who is in their 50s, that is 14 having irregular uterine bleeding, to use 15 perhaps inexact terminology in responding to 16 what's going on with their uterine bleeding as 17 to whether or not it is representative of a 18 period as opposed to spotting and bleeding? Do 19 you follow what I'm asking you? 20 A. I think so. I guess I can't give 21 you just a blanket yes or no on that. 22 Q. I'm not asking for a blanket yes or 23 no. You can qualify it. But what I'm trying to 24 understand, and guy-to-guy here, how does one 25 really nail down from a woman in her late 40s to 0060 1 early 50s that is having problems, irregular 2 uterine bleeding, to really determine when did 3 you last have what was really a normal menses? 4 A. That's difficult to do. 5 Q. Does it require careful history and 6 inquiry of the patient? 7 A. I guess it depends on what's going 8 on with that individual patient. I'll go on 9 with that -- 10 Q. Sure, go right ahead. 11 A. -- in this particular case. 12 Q. That's fine. 13 A. All right? There were overwhelming 14 things that presented themselves to me and drew 15 my attention quickly after talking to her, you 16 know, and taking her history, that took me 17 beyond labels, if you will, okay? 18 So, you know, it would have been 19 nice, I guess, if I had written down the 20 patient's age -- it's already listed -- but the 21 patient is perimenopausal. I don't always write 22 that in my notes, I confess. That's just kind 23 of the way I do it. 24 But the other overriding things in 25 the puzzle, you know, the overall puzzle of the 0061 1 way she presented drew me to the conclusion that 2 I made. 3 So it was almost immaterial in 4 regard to her whether, you know, when exactly 5 was her last cycle, you know, because I had 6 information, objective information that I could 7 look at. 8 That, plus history, plus the 9 limited, you know, experience by that time that 10 I have had as a board certified gynecologist. 11 So that took me to the conclusion. 12 Q. Okay. So we can agree, at least, in 13 terms of the statement of when your last 14 menstrual period was, in an older patient who 15 has had irregular bleeding sometimes defining a 16 set date as to when they last had a menstrual 17 period can sometimes be difficult? 18 MR. RIEMENSCHNEIDER: Objection. Go 19 ahead. 20 A. It can be difficult, but it's one 21 piece of information that we use. I don't mean 22 to quibble with that too much. 23 Q. You are not quibbling. 24 A. But I guess when you see someone, it 25 really is an individual type of a thing. And I 0062 1 confess to you that in medical school and taking 2 histories, man, everything was extremely, in my 3 mind at least, black and white. 4 So, you know, I wanted gynecology to 5 be a Betty Crocker cookbook, I admit it. You 6 are this, it must be this, you do this. 7 And the older I get -- I'm 47 now -- 8 it doesn't always work that way. So, for 9 example, the average age of a woman going 10 through menopause is 51 and a half. 11 Well, in medical school I would've 12 held on to that like that's everything and you 13 can't be 53 and not be postmenopausal. Well, I 14 have seen ladies that are 58 and they are still 15 having, you know, had their climacteric, where 16 they ended having cycles. So I have learned a 17 lot -- not that I know a lot -- but I have been 18 exposed to a lot over time, so that's why I keep 19 bouncing off of you that whole thing with a 20 specific date. 21 The fact she is having bleeding, she 22 has not, other than with pregnancy, had a span 23 of 12 months or more of no bleeding. By 24 definition, at least for me, she was 25 perimenopausal. 0063 1 Q. Simply because she has not had a 2 span of no bleeding over a 12 month period and 3 one uses the term perimenopausal, that is not an 4 excuse for considering whether or not the 5 bleeding is potentially related to some form of 6 cancer; true? 7 A. True. 8 Q. Okay. Now, when you saw her, did 9 you -- you didn't do an exam, did you? 10 A. I did not. 11 Q. Tell me why. 12 A. The brief answer is because I had 13 all the information that I needed and doing the 14 exam wasn't going to change my plan of 15 management. 16 Q. Tell me what information you had at 17 hand that obviated an exam and caused you to 18 implement the medical management that you did, 19 please. 20 A. Sure. Her history on the second 21 page of my note towards the middle there, I'll 22 decipher it. 23 Q. Sure. 24 A. The key is, lost 20 pounds in three 25 months. That screamed at me. And then the 0064 1 other is complaining of bloating and early 2 satiety. 3 Q. What is early satiety? 4 A. That means you get full quicker. 5 You go out on a holiday to eat your favorite 6 meal at a restaurant and you used to eat the 7 entire plate of food and now you can only eat 8 half of it and man, I'm full, I can't eat 9 anymore, that kind of thing. 10 Q. Okay. 11 A. So those two pieces of information, 12 again, for me, that said, oh my goodness, I 13 think this lady has a cancer. Then it turned 14 into, well, what kind of cancer. 15 Then I looked at the, at least for 16 me, objective information and so that's why I 17 didn't have to rifle through a bunch of notes or 18 whatever. 19 I had the most recent ultrasound, 20 the 9th of December. You see it there. The max 21 number dimension on the uterus was 17.7. And 22 then I tried to go back as far as I could again 23 to get an objective. I didn't want to see an 24 eight or nine ultrasounds or what have you. 25 I went back to the one before 0065 1 that -- which there may have been others, I 2 admit -- but November of 2004, 12.7. 3 So, you know, that piece of 4 information by itself concerned me, but if you 5 add that to the information of losing weight 6 without trying to lose weight, I do remember 7 that from her history, and the bloating and 8 early satiety made me think, oh, and the fact 9 that she had a negative endometrial biopsy. 10 And another objective finding here, 11 her ovaries weren't seen. Typically if there is 12 something going on, like an ovarian cancer or 13 something, ovaries are enlarged or something 14 unusual about them and that didn't show up in 15 this case. 16 And then finally there was no free 17 fluid, which for epithelial tumors, fallopian 18 tube or ovarian cancers, not always, but a 19 suspicious finding if there is a bunch of free 20 fluid. 21 So getting back to that differential 22 diagnosis stuff that we talked about early on, 23 that's what made me, you know, putting all this 24 together, it made me think, oh my goodness, this 25 might be one of those really rare tumors in the 0066 1 muscle of the uterus itself and I think it might 2 be a sarcoma. That's how I came to that. 3 Q. Fair enough. You also noted that 4 you were unable to access the record, I think it 5 says, for October '05? 6 A. She had gone to the emergency room 7 and had a CT scan and I'm not sure what was 8 going on that day, but I couldn't get that 9 result up. 10 Q. Do you know why you were able to 11 access the November '04 ultrasound but not an 12 ultrasound between November and the ultrasound 13 that was done on -- what was the date of that -- 14 on December 9th? 15 A. I didn't look for it. I didn't look 16 for it. Did you mean to ask me about the CT 17 scan just then? 18 MR. RIEMENSCHNEIDER: He already 19 said he went from the farthest one back he could 20 see to the most recent. That's what he 21 testified to. 22 Q. I guess, were you aware of the fact 23 that there was an ultrasound done between 24 November of '04 and December of '05? 25 A. At the time of this visit, I think I 0067 1 was, but I didn't look for it. 2 Q. You saw, obviously, a significant 3 growth in the uterus between November of '04 and 4 December of '05 comparing the ultrasounds? 5 A. In roughly a year, yes. 6 Q. As to the growth between November of 7 '04 and May of '05, which also had shown a 8 growth. 9 If you had seen the patient back in 10 May of '05, with the growth, do you know what 11 you would have done at that time? 12 MR. RIEMENSCHNEIDER: Objection. 13 Asked and answered, I think before, but go 14 ahead. 15 Are you saying she has the same 16 clinical findings in December? 17 MR. MISHKIND: No. 18 Q. If you had seen her in May with the 19 ultrasound showing the growth between November 20 of '04 and the description that I gave to you 21 before in May of '05, do you know what you would 22 have done at that point in time? 23 MR. RIEMENSCHNEIDER: Objection. 24 Q. Go ahead. You can answer the 25 question. The objection is for the record. 0068 1 A. You guys speak a different language. 2 I would have to be in that situation 3 and I would have to have a history and I would 4 have to be able to have the option of examining 5 her. 6 Q. Okay. 7 A. So I can't answer that fairly. 8 Q. Fair enough. That's all I can ask 9 of you. 10 Your impression on your December 11 visit, tell me what your impression was, please. 12 A. Right here. Clinically suspicious 13 findings for sarcoma. 14 Q. And then your plan? 15 A. Was to refer her to the oncology 16 folks, to the GYN oncology at CCF. 17 Q. And below that, I'm not sure what 18 that says. 19 A. Clearly written, it says options 20 reviewed. Will pursue GYN oncology 21 consultation. Will reorder CT if unable to 22 find. 23 Q. And what CT? The CT from October of 24 '05? 25 A. Right. 0069 1 Q. What were you looking for on the CT 2 that you could not clinically appreciate from 3 the ultrasound? 4 A. The one thing that would have been 5 useful -- it wouldn't have changed my 6 recommendation or my management -- it was a 7 curiosity, I admit -- to see some comment on the 8 retroperitoneal lymph nodes. 9 In gynecology, ultrasounds are the 10 most useful thing for us, in my opinion, in 11 regard to making a comment on ovaries or the 12 uterus, et cetera. But with a CT scan, that's 13 not going to tell me an awful lot about the 14 uterus, per se, or even the ovaries to an 15 extent, but it will tell me about the lymph 16 nodes. And if the lymph nodes were enlarged, 17 then that would have even heightened my 18 suspicion that something bad was going on for 19 her. 20 Q. Even though you are not a GYN 21 oncologist, in a uterine sarcoma, do you 22 normally see on CAT scan lymph node involvement? 23 A. I don't know that. I don't know 24 that. 25 Q. Do you know what the staging is for 0070 1 uterine sarcomas? 2 A. No. I probably knew it when I was 3 taking my boards. 4 Q. Fair enough. 5 A. But I don't know even if there is 6 one. I imagine there is, but I don't know it. 7 Q. You don't know what the five year or 8 ten year survival is for early stage uterine 9 sarcoma versus late stage, Stage 1 versus Stage 10 4? 11 A. I don't know that, but it's probably 12 horrible. 13 Q. Do you know what Stage 1, what the 14 five year survival is on an early stage uterine 15 sarcoma? 16 A. I would be guessing. 17 (Discussion off the record.) 18 Q. November '99 and some notes circled 19 there, tell me about what that says and why it's 20 there. 21 A. Just to have an idea of how far back 22 could I go and see an exam by someone I 23 respected. I respect all the folks in my 24 department, but, you know, just to see what they 25 thought when they did an exam on her. Did they 0071 1 think she had a fibroid uterus then. 2 Q. So back in November of '99 there was 3 an exam done by a C. Dawson? 4 A. Yes. 5 Q. Is that Dr. Dawson? 6 A. That's Nurse Practitioner Dawson. 7 Q. And at that time, what did Nurse 8 Practitioner Dawson some, oh, six years earlier, 9 what did you note her exam to show? 10 A. Well, it was just a general exam and 11 she put uterus was normal size. 12 Q. So that's the reason that you have 13 that note there? 14 A. Just, you know, how far back could I 15 go where she had an exam that I could find. But 16 then taking into account also, though -- and 17 this is the thing, she was obese when I saw her 18 and she was obese, I believe, then too. 19 Q. On the left-hand side under your GYN 20 progress notes, you have number one, pelvic 21 mass. Is that your handwriting? 22 A. Where are we? Oh, right here? 23 Q. Correct. 24 A. Yes. 25 Q. Now, is the pelvic mass, is that 0072 1 something that you determined based upon looking 2 at the ultrasounds? Or how did you mark down 3 pelvic mass? 4 A. I put down pelvic mass because when 5 we did our -- this is called an encounter -- 6 encounter progress notes in the past, you would 7 list only what you knew. 8 So, for example, putting down rule 9 out cancer or something, that's not supposed to 10 be a proper diagnosis, but a proper diagnosis 11 would be, well, she has this big thing. And 12 just putting fibroid uterus was a little too 13 vague, I thought, so I put something also vague, 14 pelvic mass. 15 Q. Now, the notes have indicated that 16 she had a uterine leiomyoma NOS. Is that 17 nonspecific? 18 A. Not otherwise specified I think 19 that's what it means. 20 Q. And uterine leiomyoma, that's a 21 fibroid tumor; is it not? 22 A. Yes. 23 Q. A leiomyoma could be benign, 24 depending on the histology of it; it can be 25 malignant as well; correct? 0073 1 A. Rarely, but yes. 2 Q. So uterine leiomyoma not otherwise 3 specified doesn't necessarily tell you the 4 histology of that? 5 A. It doesn't tell you that. 6 Q. Okay. Did that help you in marking 7 down pelvic mass? 8 A. I didn't even see it. 9 Q. Fair enough. Then number two, it 10 looks like number two, you have status post 11 something. 12 A. Clearly written, that's a G1P1. 13 That means she was pregnant once and had one 14 child. 15 Q. Got it. 16 A. Clearly written. 17 Q. And then above that? 18 A. No cervical dysplasia. 19 Q. What significance was that? 20 A. She had no history of abnormal PAP 21 smears or, you know, I was just being complete. 22 Actually this part, if you can kind of pretend 23 you don't see anything written on the page other 24 than the number one, this other stuff is just 25 standard. When I meet a patient, there is some 0074 1 basic questions I ask. 2 So, pregnancies, put that on. Have 3 you had any abnormal PAP smears. Any family 4 history of any female cancers. That's the thing 5 you are about to ask me about probably. Negative 6 family history for gynecologic cancer. That's 7 what is written there. 8 Q. And the endometrial biopsy, you had 9 lower or midway on the left side of the page was 10 May of '05 and that was within normal limits? 11 A. Correct. 12 Q. And then below that, tell me what 13 you have written. 14 A. By history, had CT at the Cleveland 15 Clinic Foundation, CCF, October '05 but unable 16 to access record. 17 Q. Got it. Okay. Did you initiate a 18 referral then based upon your exam? 19 A. I did. 20 Q. And that was then to The Cleveland 21 Clinic? 22 A. Yes. 23 Q. Did you discuss with Lillian after 24 reviewing the ultrasounds, going through her 25 history, seizing on the weight loss, seizing on 0075 1 the bloating and the early satiety -- 2 A. Early satiety. 3 Q. After seizing on that information, 4 did you share with her your concerns? 5 A. I did. 6 Q. Do you remember that conversation? 7 A. Not completely, but broadly I do. 8 Q. Do you recall having, in a general 9 fashion, the interaction with her and explaining 10 your concerns? 11 A. Yes. 12 Q. And her reaction to the concerns? 13 A. Somewhat. I mean, I don't 14 remember -- you know, I remember that she didn't 15 become tearful and out of control or anything 16 like that. But she, you know, in a level way 17 listened to me and I shared my concerns about 18 her. It's a hard conversation. 19 Q. Absolutely. Do you have any 20 recollection of her defining for you just how 21 long she had been having the irregular bleeding, 22 if at all, prior to January of 2005? 23 A. I don't remember that specifically. 24 We did talk about her pain. 25 Q. And when had she first had an onset 0076 1 of pain? 2 A. I wrote in my note, symptoms of 3 abdominal and pelvic pain since the middle of 4 October and I didn't put '05, but that would 5 have been, you know, the most recent October. 6 Q. If you had the bloating, the weight 7 loss, the increase in the ultrasound findings 8 and didn't have a complaint of abdominal pain, 9 would that have caused you to consider or not to 10 consider sarcoma? 11 MR. RIEMENSCHNEIDER: Objection. Go 12 ahead. 13 Q. Do you understand my question? 14 A. The feature you took out was pain? 15 Q. Correct. 16 A. The first two that I told you about 17 before, the weight loss and the bloating and the 18 early satiety, that says probably some kind of 19 cancer to me, but it doesn't tell me what type 20 of cancer that is. 21 I mean, for example, with that 22 history alone, that could be bowel cancer or 23 something, which it would be a lot more common, 24 you know. So it wouldn't direct me to sarcoma. 25 Q. Well, was the abdominal pain a 0077 1 critical fact in your considering that she had a 2 uterine sarcoma? 3 A. Not critical. A feature, but not a 4 critical feature. 5 Q. Is it fair to say that your clinical 6 suspicion and perhaps your differential 7 diagnosis of uterine sarcoma and thus referral 8 for evaluation wasn't predicated on the fact 9 that she had pain since the middle of October? 10 A. The key thing for me was the weight 11 loss and the early satiety and the bloating. 12 Q. And also, in fairness to you, and 13 correct me if I am wrong, the increase in the 14 uterus comparing the ultrasounds? 15 A. With normal or not abnormal, let's 16 say, ovaries seen and no free fluid, yes, that's 17 what steered me to a muscular type of a tumor in 18 the uterus. 19 Q. So the things that really are 20 important on that differential is the increase 21 in the uterus from November of '04 to December 22 of '05, the weight loss, the bloating, the fact 23 that she also had had a negative endometrial 24 biopsy? 25 A. Uh-huh. Not in that order, but, 0078 1 yes. 2 Q. And the pain, while it's 3 interesting, isn't really a significant clinical 4 factor? 5 A. No. 6 MR. RIEMENSCHNEIDER: Objection. 7 Q. Is that a fair statement? 8 MR. RIEMENSCHNEIDER: I think he 9 already told you what the pain was, but go 10 ahead. 11 A. Well, it's a feature but not a, oh 12 my goodness, because you have pain, you must 13 have cancer. I don't put it together that way. 14 Q. Okay. So you wouldn't say if the 15 patient has an increase or a rapid increase in 16 uterine size and pain, therefore you think 17 uterine sarcoma? 18 A. No. Actually, you know, pain is 19 something we see a lot of and what will happen 20 with fibroids under usual conditions is that it 21 outgrows its blood supply and there is an 22 ischemic change that happens, and so you get 23 this ache, this pain, you know, but that's from 24 the fibroid. 25 Q. So you can actually have a uterine 0079 1 sarcoma without there being pain associated with 2 that phenomenon? 3 A. I think so. I don't know, but I 4 think so. 5 Q. Why don't we do this. I would like 6 to talk to my associate. I'm probably three or 7 four minutes from finishing. I'll take probably 8 a minute. 9 (Recess had.) 10 - - - - - 11 (Thereupon, STUFFER Deposition 12 Exhibit 1 was marked for 13 purposes of identification.) 14 - - - - - 15 Q. Doctor, just for purposes of 16 identification, Plaintiff's Exhibit 1, is this 17 two of the pages from your encounter on December 18 15, 2005 -- recognizing that there are some 19 other pages of printed forms, and then it looks 20 like there may be the referral form that you 21 used to send the patient to the Clinic -- but is 22 Exhibit 1 the nurse's notes, the encounter form 23 and your handwritten notes that we have been 24 talking about? 25 A. The majority of that is my written 0080 1 note. 2 Q. Now, on the first page of Exhibit 1, 3 along the left-hand side, this is generated by 4 the computer based upon the patient's clinical 5 history? 6 A. Prior visits. 7 Q. So when you see the patient -- just 8 to sort of walk through how this document 9 develops -- Exhibit 1, along the left-hand side, 10 we have her stamp and the date of her visit; 11 then under GYN progress sheet, we would have 12 areas for vital signs to be filled in, and then 13 her age would be filled in by the computer, 56 14 years, three months, and then her primary 15 doctor's name, and then the problem which would 16 go from -- 17 A. The dermatofibroma. 18 Q. All the way down to -- 19 A. Hemorrhage not otherwise specified. 20 Q. And all of this information then 21 would be information based upon her clinical 22 history and treatment that had been provided 23 prior to your seeing her; correct? 24 A. Yes. 25 Q. And then the next thing that would 0081 1 happen is your medical assistant would mark down 2 the reason for the visit, would take the vital 3 signs, and then you are presented with this form 4 with whatever information has now been filled 5 out; is that a fair sort of chronology? 6 A. Yes. 7 Q. Now, a patient who is in a female 8 climacteric state -- I may be mispronouncing 9 that -- that is by definition postmenopausal; 10 correct? 11 A. Well, it varies by who actually 12 fills out this form. I mean, climacteric in and 13 of itself means what you said. 14 Q. Postmenopausal? 15 A. It means at the time of a last 16 menses. 17 Q. But by definition -- and I 18 understand that you are not the one that was 19 responsible for -- 20 A. Right. It could have been a 21 nongynecologist that wrote that done. 22 Q. But in any event, whether it was a 23 nongynecologist or whoever it was, it would have 24 been information set forth by someone prior to 25 Lillian being seen by you or even by the medical 0082 1 assistant on that date; correct? 2 A. Someone put that there. 3 Q. Okay. And whether it's accurate or 4 not, what this indicates as we look at the 5 record when this form is prepared and waiting 6 for Lillian to be seen, this indicates that the 7 patient was postmenopausal, correct, not 8 perimenopausal; true? Whether it's accurate or 9 not, that's what it says? 10 A. That's the thing. It is listed 11 there. 12 Q. Okay. And I'm not quibbling with 13 you, for whatever reason, but it does indicate 14 on the document that when we look at what the 15 definition of this state, climacteric, female 16 climacteric, or climacteric, that means 17 postmenopausal; correct? 18 A. It means last menses. Last menses, 19 your climacteric is when you have your last 20 cycle. It's not synonymous with postmenopausal. 21 Q. Well, where it says female 22 climacteric state, what is that telling you? 23 A. In fact, I didn't see this until you 24 are pointing it out to me now, but that phrase 25 doesn't say a lot of anything to me. 0083 1 Q. Is it your testimony under oath that 2 that is or is not used as a phrase to define a 3 patient who is more than one year since her last 4 menses? 5 A. I don't know that. Some people 6 might use it to mean something like that. 7 Q. And the reason I ask that is because 8 earlier on in the deposition, I think you used 9 that term when I was asking you about 10 perimenopausal and postmenopausal, I think you 11 did use the term climacteric? 12 A. Right. 13 Q. So is it fair to say you used the 14 term female in a climacteric state to mean a 15 patient who is postmenopausal? 16 A. I would use that to note that that 17 patient had had her last cycle. 18 Q. More than one year previously? 19 A. No. That she had just had her -- I 20 have to qualify and say, when I use the term, 21 that means, the climacteric means that's the 22 last cycle that that patient had. 23 You could make that comment, to go 24 further, say that, well, my last cycle was eight 25 months ago or something. Well, by the 0084 1 definitions we used before for postmenopausal 2 that doesn't make her postmenopausal. 3 Another way of looking at it, that's 4 the opposite term to menarche. Menarche is when 5 a young lady has her first period, her first 6 cycle, her first menses. 7 Q. All right. In any event, whatever 8 the definition and whatever the significance of 9 this, we will leave it to perhaps someone else 10 to interpret. 11 A. Someone that has a dictionary or 12 something, yeah. 13 Q. That term and the notation of 14 postmenopausal checked by the -- 15 A. Medical assistant. 16 Q. -- medical assistant would have been 17 preprinted and checked by her before you asked 18 the patient any questions; correct? 19 A. That is correct. That is completely 20 correct. 21 Q. Now, can we agree that in a 22 perimenopausal woman who has a thickened 23 endometrium, that has increasing uterine 24 fibroids, that is obese, that has abnormal 25 uterine bleeding, that that description may or 0085 1 may not be consistent with a malignancy? 2 A. It's possible. 3 Q. That would be an accurate statement; 4 it may or may not be consistent with a 5 malignancy? 6 A. That's possible. I mean, that's a 7 possible presentation of a malignancy, I 8 suppose. 9 Q. And certainly in terms of a 10 differential, that would be something that you 11 would consider -- not necessarily arrive at a 12 definitive diagnosis -- but if you have a 13 patient who is perimenopausal, with a thickened 14 endometrium, with increasing uterine fibroids, 15 that's obese, that has abnormal uterine 16 bleeding -- 17 A. When you say increasing uterine 18 fibroid, you mean increasing uterine fibroid 19 size? 20 Q. That's correct. 21 A. That's in the realm of possibility, 22 yes. 23 Q. And you would include that somewhere 24 in that differential diagnosis; true? 25 A. Somewhere in there. 0086 1 Q. Okay. Now, in a patient who is 2 postmenopausal, with or without thickened 3 endometrium, with uterine fibroids, obese, with 4 abnormal uterine bleeding, can we agree that 5 that description from a differential standpoint 6 is malignancy until proven otherwise? 7 A. Right. The key in that being 8 postmenopausal, any kind of bleeding. 9 Q. Got it. 10 A. First thought, rule out cancer. 11 Q. In a perimenopausal obese female? 12 A. Endometrial cancer, with what I just 13 said. Endometrial cancer is that first thought 14 to be complete with what I first said. 15 Q. In a perimenopausal obese woman with 16 abnormal uterine bleeding, with uterine 17 fibroids, is the institution of progestin or 18 Provera, is that within the standard of care? 19 A. That's a reasonable way to address 20 the problem. 21 Q. Now, the reason you do that is that 22 you hope that the progestin or the Provera will 23 help with the abnormal uterine bleeding; 24 correct? 25 A. Control it. That's a miserable 0087 1 thing for a patient. They don't want to bleed. 2 That's why they come to see you. 3 Q. If the patient does not respond to a 4 progestin in a patient who is defined as 5 perimenopausal, what is the standard of care in 6 terms of how long you continue the patient on 7 the progestin? 8 MR. RIEMENSCHNEIDER: Just note an 9 objection as to the expert opinions. You are 10 asking him about standard of care issues. It's 11 a hypothetical without seeing the records and so 12 on and so forth. 13 MR. MISHKIND: Your objection is 14 noted, Dirk. Go ahead. 15 A. There is no -- my opinion, I don't 16 believe there is a typical amount of time that 17 everyone uses before they say the drug therapy 18 has failed and now we need to look at other 19 things. 20 I think a lot of folks would -- I 21 pick three months roughly, but that's the way I 22 do it. Some people might be a little less, some 23 people a little more. It varies on the age of 24 the patient and the clinical circumstances. 25 Q. When you saw this patient in 0088 1 December, she was still on the progestin? 2 A. You know, I don't remember that. 3 It's listed down here as one of her medications. 4 But current medications that a patient has 5 listed, that doesn't mean that she has actually 6 been taking it. Maybe she stopped it a month 7 ago or something, I don't know that part. I 8 don't recall that part. 9 Q. It doesn't say anything in here 10 about the progestin having been stopped a month 11 earlier, does it? 12 A. It doesn't on this paper, but I can 13 tell you, you know, back when we did encounters 14 this way -- we do them a little bit differently 15 now -- the medications that are listed are the 16 prescribed medications that a patient has, but 17 whether they are compliant and take it or not, 18 isn't always counted on. 19 Q. Doctor, do you have any evidence in 20 this case at all to suggest that this patient 21 who had been on progestin was no longer taking 22 the progestin or someone had told her to stop 23 taking the progestin prior to December of 2005? 24 A. I don't have anything I can point to 25 to prove that one way or the other. 0089 1 Q. If a patient who is presumed to be 2 perimenopausal and is on progestin but yet 3 continues to bleed, is that of clinical concern 4 to you? 5 A. Yes. 6 Q. And what does that suggest to you in 7 a patient who is on progestin, perimenopausal, 8 but continues to bleed? 9 A. I think we talked about this before. 10 MR. RIEMENSCHNEIDER: We have. 11 A. I might be wrong. But there is a 12 difference between a hormonal etiology for the 13 bleeding -- I call that dysfunctional uterine 14 bleeding -- versus abnormal uterine bleeding; 15 abnormal uterine bleeding being related to an 16 anatomic etiology. 17 Q. If the patient is on progestin -- to 18 make sure we are clear, because I am not. 19 A. Okay. 20 Q. And I'm not sure we did 21 specifically, if the patient is on progestin for 22 four or five months and continues to have 23 abnormal uterine bleeding, is that suggestive of 24 an anatomic problem or is that suggestive of a 25 hormonal problem? 0090 1 A. If the patient is compliant with the 2 medication -- we will presume that -- and still 3 has bleeding, my thought would be -- this is 4 after adjusting doses and that kind of thing -- 5 that there was possibly some anatomic reason for 6 the bleeding. 7 Q. In your clinical experience, how 8 long would you in a post -- in a perimenopausal 9 patient who is obese, who has thickened uterine 10 fibroids, obese, how long do you believe that it 11 would be reasonable and prudent to have the 12 patient on progestin where the patient continues 13 to have abnormal uterine bleeding without doing 14 something else? 15 MR. RIEMENSCHNEIDER: Objection. 16 You just asked that question. 17 MR. MISHKIND: No, I didn't. 18 MR. RIEMENSCHNEIDER: Yes, you did. 19 MR. MISHKIND: Dirk, your objection 20 is noted. 21 MR. RIEMENSCHNEIDER: You know what, 22 I'm going to prove it to you because I'll have 23 her read it back. 24 MR. MISHKIND: No, you are not going 25 to do that. It's my deposition. 0091 1 MR. RIEMENSCHNEIDER: Then I'll 2 instruct him not to answer. 3 MR. MISHKIND: Wait a second. 4 MR. RIEMENSCHNEIDER: Don't start 5 raising your voice with me. 6 MR. MISHKIND: I did raise my voice 7 about two octaves. But I'm asking a question 8 and let me redefine the question and then we 9 will have whatever discussion you want to have, 10 Mr. Riemenschneider. 11 I asked him -- 12 Q. If you are treating a patient that 13 has abnormal uterine bleeding that is 14 perimenopausal, that has uterine fibroids, and 15 you personally have prescribed progestin to the 16 patient, yet the patient continues to bleed, in 17 your practice, how long do you continue that 18 patient on the progestin before you personally 19 look to see whether or not it is something -- 20 because it's not responding, the bleeding is not 21 stopping -- how long do you continue the 22 progestin? 23 MR. RIEMENSCHNEIDER: Objection. 24 Asked and answered. I think you phrased it a 25 little different there, but you asked standard 0092 1 of care issues of him before. Go ahead and 2 answer the question. 3 A. If I have an advantage of an 4 endometrial biopsy that is normal or within 5 normal limits, then the amount of time for me 6 realistically will be somewhere between three to 7 possibly six months. 8 Because what I do is start on one of 9 the progestins, medroxiyprogesterone acetate -- 10 that's Provera -- and potentially change it to 11 norethindrone acetate -- that's a different type 12 of progestin -- or consider another drug 13 therapy. So I hope that answers your question. 14 Q. It does. If the patient is 15 postmenopausal and has uterine bleeding, is the 16 use of progestin within the standard of care? 17 A. If I have the advantage of an 18 endometrial biopsy that is negative, then that's 19 a reasonable thing to do, absolutely. 20 Q. In a patient who is postmenopausal, 21 that has a thickened endometrium, by ultrasound 22 has increasing uterine fibroids, and has 23 irregular uterine bleeding, is it within the 24 standard of care to give that patient progestin? 25 A. In my opinion, okay -- I don't know 0093 1 if I can speak to the standard of care for every 2 gynecologist in the country -- but I think 3 that's a reasonable thing to do. I'll stop at 4 that. 5 Q. Is the length of time that one 6 would -- 7 (Pager interruption.) 8 Q. In a postmenopausal patient, same 9 characteristics, that you put the patient on 10 progestin, is there a period of time that you 11 would allow the patient to stay on progestin, 12 postmenopausal? Is it shorter than in a 13 perimenopausal patient? 14 MR. RIEMENSCHNEIDER: Objection. Go 15 ahead. 16 A. The same clinical picture; the 17 difference only perimenopausal or 18 postmenopausal? 19 Q. Yes, doctor. 20 A. It depends on kind of what that 21 patient's willing to do. So I talk about 22 options to folks. 23 Even with Ms. Dailey, with Ms. 24 Dailey, if you look at my plan, I put options 25 reviewed, so I wanted -- and I pushed her -- I 0094 1 wanted her to get seen by a GYN oncologist, but 2 I talked about other ways we may have approached 3 that. 4 So, likewise, with what you are 5 saying to me, I individualize it to that 6 patient. I'm not skirting you, that's the 7 truth. 8 So there is not, you know, three 9 months and not a day longer with the 10 postmenopausal, six months and not a minute 11 longer with a peri, I can't get that specific 12 with you. 13 Q. Is it less acceptable to continue a 14 patient on progestin that is postmenopausal that 15 continues to have abnormal bleeding as compared 16 to that same patient that is perimenopausal? 17 MR. RIEMENSCHNEIDER: Objection. Go 18 ahead. 19 A. I think that most folks would look 20 more, have more questions, more interest in a 21 postmenopausal patient versus a perimenopausal, 22 but I can't, you know, I can't make a blanket 23 statement about that. 24 Q. Okay. 25 A. Again, I prefaced all those answers, 0095 1 I know I have a normal endometrial biopsy. 2 Q. And with a normal endometrial 3 biopsy, if you have a postmenopausal woman that 4 is on progestin but continues to bleed, what is 5 within your differential that is different than 6 a perimenopausal patient that has that normal 7 endometrial biopsy that is on progestin but 8 continues to bleed? 9 MR. RIEMENSCHNEIDER: Objection. Go 10 ahead. 11 A. Not an awful lot is different, 12 because my thought with each of them leans more 13 towards, you know, if things aren't working with 14 medical therapy, then, you know, there's a polyp 15 or something like that that's contributing to 16 this bleeding. I have had patients like that. 17 Q. You talked about the options. Was 18 your primary suggestion to her that she be seen 19 by a GYN oncologist because of your concern 20 about potential for sarcoma? 21 A. Absolutely. 22 Q. And she followed through on your -- 23 A. She did. And I think she actually 24 had a sarcoma. 25 Q. Now, you would have been 0096 1 responsible, would you not, to have provided 2 information to the Clinic as it relates to the 3 patient's clinical history so that when she is 4 seen at the Clinic, you really would have been 5 sort of the last connection from Kaiser to the 6 Clinic by way of history? 7 A. Right. Well, I would be the last 8 written piece of information that they would 9 see. I have seen the patient. I would make out 10 the referral, but they would have access to all 11 of her prior records too. 12 Q. Sure, okay. 13 In terms of your visit, outside of 14 the records, is there anything that you recall 15 in terms of your encounter that we haven't 16 talked about during the deposition today? 17 Anything in terms of what you said to her or how 18 she responded? 19 A. I can't recall anything else. 20 Q. Okay. And are there any symptoms or 21 clinical findings that you feel are important to 22 talk about in terms of why you arrived at the 23 diagnosis that you did without doing an exam on 24 that day, why you didn't feel that an exam was 25 necessary beyond what we have already talked 0097 1 about? 2 A. Nothing beyond what we have talked 3 about. 4 Q. Have I given you a fair opportunity 5 to describe the clinical history and your 6 findings with Lillian in this case? 7 MR. RIEMENSCHNEIDER: Objection. Go 8 ahead. 9 A. Yes. I mean, what do I compare it 10 against? 11 Q. It's okay. 12 A. That's okay. 13 Q. I don't want to be accused by anyone 14 of not being fair and not giving you an 15 opportunity to explain things; that's why I'm 16 asking you, have I given you an opportunity to 17 explain things and perhaps even qualify certain 18 things as we are talking about perimenopausal 19 versus postmenopausal? 20 A. We had an open discussion. 21 Q. And I have been fair to you? 22 MR. RIEMENSCHNEIDER: Objection. 23 A. Yes. 24 MR. MISHKIND: Thank you. No further 25 questions. 0098 1 MR. RIEMENSCHNEIDER: We'll reserve 2 signature. 3 - - - - - 4 (Deposition concluded at 1:30 p.m.) 5 (Signature not waived.) 6 - - - - - 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0099 1 AFFIDAVIT 2 I have read the foregoing transcript from 3 page 1 through 97 and note the following 4 corrections: 5 PAGE LINE REQUESTED CHANGE 6 7 8 9 10 11 12 13 14 15 16 17 PHILLIP SHUFFER, M.D. 18 19 20 Subscribed and sworn to before me this 21 day of , 2008. 22 23 Notary Public 24 25 My commission expires . 0100 1 CERTIFICATE 2 3 State of Ohio, 4 SS: 5 County of Cuyahoga. 6 7 8 I, Vivian L. Gordon, a Notary Public within and for the State of Ohio, duly 9 commissioned and qualified, do hereby certify that the within named PHILLIP SHUFFER, M.D. was 10 by me first duly sworn to testify to the truth, the whole truth and nothing but the truth in the 11 cause aforesaid; that the testimony as above set forth was by me reduced to stenotypy, afterwards 12 transcribed, and that the foregoing is a true and correct transcription of the testimony. 13 I do further certify that this deposition 14 was taken at the time and place specified and was completed without adjournment; that I am not 15 a relative or attorney for either party or otherwise interested in the event of this 16 action. I am not, nor is the court reporting firm with which I am affiliated, under a 17 contract as defined in Civil Rule 28 (D). 18 IN WITNESS WHEREOF, I have hereunto set my hand and affixed my seal of office at Cleveland, 19 Ohio, on this 5th day of May, 2008. 20 21 22 Vivian L. Gordon, Notary Public 23 Within and for the State of Ohio 24 My commission expires June 8, 2009. 25 0101 1 INDEX 2 DEPOSITION OF PHILLIP SHUFFER, M.D. 3 4 BY MR. MISHKIND: 3 7 5 6 EXHIBITS 7 8 Exhibit 1 was marked 79 12 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25