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AFFIDAVIT IN RICH TEXT:

AFFIDAVIT

I, Stephen Orlin, M.D., do affirm the following:

1. I have been made aware of the statements made by plaintiff's counsel that the brochures that I give to patients state that they must have healthy retinas free from disease in order to have LASIK. (See Plaintiff's Reply to Motion in Limine to Preclude Testimony of Plaintiff's Experts (Frye) of Dr. Anita Nevyas-Wallace.)

2. The statement made in that brochure is being taken out of context by plaintiff's counsel.

3. The statement made in that brochure does not apply to stable retinas, such as the retinas of the plaintiff at the time that he underwent LASIK surgery by Dr. Anita Nevyas-Wallace.

4. Mr. Morgan's retinas were "healthy" for the purposes described in the brochure.

5. Retinopathy of prematurity, in and of itself, is not a contraindication to LASIK surgery.

6. There is and was absolutely no literature, either in 1998 up and through to the present, stating that retinopathy of prematurity, in and of itself, is a contraindication to LASIK surgery. Moreover, there have not been any animal studies performed to indicate that retinopathy of prematurity, in and of itself, is a contraindication to LASIK surgery, and no indication in this case that Anita Nevyas-Wallace, M.D. was using the plaintiff as a "guinea pig" as asserted by plaintiff's counsel.

7. I stand by my previously expressed opinions as set forth in my previous reports in this case.

Stephen Orlin, M.D.

Testimony of Dr. Stephen Orlin: Wills v Nevyas 

IN THE COURT OF COMMON PLEAS

PHILADELPHIA COUNTY, PENNSYLVANIA

* * * 

KEITH AND JO WILLS H/W: JULY TERM, : 2001

-vs- :

:

HERBERT J. NEVYAS, M.D. :

NEVYAS EYE ASSOCIATES:

DELAWARE VALLEY LASER:

SURGERY INSTITUTE: NO. 2866

 

* * *

Video deposition of STEPHEN E. ORLIN, M.D., held in the law offices of

MARSHALL, DENNEHEY, WARNER, COLEMAN & GOGGIN,

1845 Walnut Street, 19th Floor,

Philadelphia, Pennsylvania 19103, on

Tuesday, December 16, 2003, beginning at 6:43 p.m., before Nancy D. Ronayne, a Court Reporter and Notary Public in and for the Commonwealth of Pennsylvania.

ESQUIRE DEPOSITION SERVICES

1880 John F. Kennedy Boulevard 15th Floor

Philadelphia, Pennsylvania 19103

215-988-9191


APPEARANCES:

LITVIN BLUMBERG MATUSOW & YOUNG

BY: FREDRIC S. EISENBERG, ESQUIRE

The Widener Building Floor 18

1339 Chestnut Street

Philadelphia, Pennsylvania 19107

(215) 557-3320

-- Representing the Plaintiffs

 

MARSHALL, DENNEHEY, WARNER, COLEMAN & GOGGIN

BY: KATHLEEN M. KRAMER, ESQUIRE

1845 Walnut Street 19th Floor

Philadelphia, Pennsylvania 19103

(215) 575-2600

-- Representing the Defendant

BY MR. EISENBERG:

Q. Doctor Orlin, is this your first time testifying for Doctor Nevyas?

A. Again, I think it is but I'm not a 100 percent sure. I have testified on behalf of his daughter Doctor Anita Nevyas in a lawsuit but I don't think that he was a -- he was named in that suit but I stand to be corrected on that.

Q. So just so we're clear, you’re not sure if you've testified and written reports for Doctor Nevyas in any other cases?

A. That's correct, yes.

Q. Okay.

Q. Doctor Orlin, did you actually testify in the Morgan case for Doctor Anita Wiles Nevyas?

A. Again, I think that I wrote a report but I didn't testify.

Q. And you don't remember ever testifying for Doctor Nevyas; you remember testifying for Anita Nevyas but not for Herbert Nevyas?

A. That's correct. Again, I might be wrong, I'm just telling you I don't know.

Q. Okay. I have a report, Doctor, dated April 6th, 2001 in a Fiarelli case, Fiarelli versus Nevyas; do you remember that case?

A. I remember it now, yes.

Q. Now, is that Doctor Herbert Nevyas?

A. I'd have to see it but I think it is, yes.

Q. Without -- do you remember that case, Doctor?

A. No, I don't remember the details, no.

Q. Did you go in court and testify for him in that case?

A. Again, I honestly don't remember.

Q. Do you remember any of the opinions that you had in that case?

A. I don't remember.

Q. Do you know whether one of your opinions, Doctor, had to do with pupil size?

A. Yes, again, I don't remember.

Q. Do you know that -- or at least I'll represent to you, Doctor, that one of your opinions had to do with pupil size; would you agree with me, Doctor?

A. Again, I don't remember.

Q. Well, it wasn't that long, ago Doctor, it was 2001, it was two years ago that you issued this report. You've only been involved in seven or eight cases and you don't remember this case?

A. I've said I don't remember.

Q. Okay. Do you remember examining Ms. Fiarelli?

A. Again, I don't remember.

Q. Do you -- did you have any conversations with Doctor Nevyas about the Fiarelli case at any point in time?

A. I don't remember.

Q. Your opinion in the Fiarelli case in terms of pupil size, Doctor, you said, pupil size is now known to be a risk factor for postoperative halos particularly in high myopes, however, this too was not clearly recognized in 1997. This too was not clearly recognized in 1997 and was not an absolute contraindication to LASIK surgery. Does that refresh your recollection, Doctor, as to your opinion?

BY MR. EISENBERG:

Q. Does that refresh your recollection, Doctor, as to offering an opinion for Doctor Nevyas in another case?

A. Again, I'm not trying to be difficult but I said in the beginning I don't remember. If you would show me the report maybe I would -- I would remember it but I just -- you ask me isolated questions and I just don't remember.

Q. Sure, I'll be happy to show you the report that you issued. It's on the same letterhead at the University of Pennsylvania. It's dated April 6th, 2001. It's for another attorney here in Philadelphia, and the case name is Fiarelli versus Nevyas. And this is an expert report that you issued for Doctor Nevyas.

Q. My question, Doctor, is, does this report refresh your recollection that you testified --

A. Yes.

Q. -- for Doctor Nevyas before tonight?

A. Yes, it does.

Q. Is this the only other occasion that you testified for Doctor Nevyas?

A. Again, I don't remember. It might, I didn't anticipate getting tat report so maybe there's another one I just don't know.

Q. Have you ever written a report, Doctor, that's critical of Doctor Nevyas' conduct?

A. No, I haven't.

Q. So we at least know of two reports that you've written defending Doctor Nevyas and we don't know any reports or you've testified there are no reports where you've been critical of him?

A. That's correct, yes.

Q. Now we established that you and Doctor Nevyas know each other professionally?

A. That's correct, yes.

Q. You both work here in Philadelphia, you both are a member of many of the same local organizations and national organizations?

A. That's correct.

Q. And did you both do work at Scheie Eye Institute?

A. Yes, we did.

Q. Is that how you got to know Doctor Nevyas?

A. Probably, he was an attending there part-time attending when I was a resident.

Q. So he's more senior than you?

A. Yes, he is.

Q. Okay. Did you do any work under Doctor Nevyas?

A. No, I didn't.

Q. Now, you said you had attended national conferences with Doctor Nevyas, did I get that right?

A. No. I -- I've been to a conference where he might have been there but we didn't attend them together.

Q. How about New Orleans in 2001, were you two together in New Orleans in 2001, the American Academy of Ophthalmology?

A. Again, I was there and he might have been there too.

Q. But you don't remember?

A. I don't remember, no.

Q. Okay. Why don't I refresh your recollection, Doctor. The American Academy of Ophthalmology Scheie Eye Institute alumni reception at the Windsor Court, New Orleans, November 12th, 2001 And I'd like this to be zoomed in on if you would. In this picture, Doctor Orlin, which I'll show you, I'm showing you for the camera right now, right here is a picture of Doctor Nevyas, can we see that on the camera?

Q. Now, Doctor, taking a look again at your report that you issued in this case. It's fair to say that you reviewed the medical records and – for Mr. Wills before issuing this report?

A. Yes.

Q. What medical records did you review?

A. Certainly remember reviewing Doctor Nevyas' medical records.

Q. Do you have them with you here tonight?

A. No, I don't.

Q. What other medical records did you review?

A. Again, I'd have to see the pile that I was given, I don't remember whether there was a report from I think an optometrist and I don't remember his name. He might have been the person who referred Mr. Wills to Doctor Nevyas in the first place.

Q. Do you know his name, Doctor?

A. I don't remember, no.

Q. You don't remember that either?

A. No.

Q. Do you remember any of the other doctors' names and records that you reviewed?

A. I read the records from Doctor Kenyon and his report but I don't remember any other ophthalmologist medical records.

Q. Okay, Doctor, you don't remember any of what I'll call subsequent treaters, any of the doctors who treated Mr. Wills after he left Doctor Nevyas' care?

A. He -- as I recall, Mr. Wills was referred to Doctor Nevyas by an optometrist. Doctor Nevyas then did the treatments so I reviewed all his records. And then in all likelihood he went back to the optometrist who referred him to Doctor Nevyas in the first place, so I would have reviewed those records as well. But again, I just do not recall the doctor's name and I'm not sure if there was more than one optometrist involved.

Q. In the medical records you reviewed of Doctor Nevyas, what was his measurement for his pupil size, for Mr. Wills' pupil size?

A. His pupil size in demi-illumination was six and a quarter millimeters in both eyes I think.

Q. And the laser ablation zone you indicated was five millimeters?

A. That's correct, yes.

Q. Do you know what kind of laser Doctor Nevyas was using?

A. No, I don't.

Q. Do you know the status of that laser?

A. No, I don't.

Q. Do you know whether Doctor Nevyas had to submit documents to the FDA in connection with that laser?

A. I think he did, yes.

Q. Do you know whether he reported Mr. Wills to the FDA in connection with that laser?

A. From my recollection and reviewing Doctor Nevyas' deposition he did have to speak to the FDA about Mr. Wills' case, yes.

Q. Have you seen any documents that were sent to the FDA in Mr. Wills' case by Doctor Nevyas?

A. Again, no, I don't think so, no.

Q. We can agree, Doctor, that one of your opinions in this case is that Mr. Wills degree of myopia of nearsightedness was considered to be acceptable for LASIK surgery in 1997?

A. Yes.

Q. In fact, I think you go on to state that this degree of nearsightedness is still acceptable for surgery providing other tests are done including corneal thickness measurements?

A. That's correct, yes.

Q. Is that test an important test, that corneal thickness measurement test?

A. It is, yes.

Q. Is that something you do, Doctor?

A. Yes.

Q. Before you operate on your patients?

A. Yes, it is.

Q. Why do you do that?

A. Well as I alluded to earlier, it's important to know what the thickness of the cornea is because you have to be sure that you leave a certain amount of untreated cornea in the bed before -- I mean after the operation has been done. It's somewhat controversial as to what the amount of cornea is required to prevent weakening or ectasia of the cornea from developing. The standard conventional wisdom is that it should be in the order of 250 microns but again, there's some doctors leave less than that and some doctors who leave more than that. So that's the basic importance of doing pachometry measurements.

Q. And as you said you do it?

A. I do, yes.

Q. And we know your opinion is you don't think that it was important in this case because it didn't have any effect on Mr. Wills' outcome?

A. That's correct, yes.

Q. But, Doctor, are you critical of Doctor Nevyas, just to be fair, that he didn't do this test?

A. Well, again, I think that it’s something that I would have done, yes.

Q. So if someone was practicing here at Penn under your supervision, Doctor, and they didn't do this particular pachometry test would you be critical of that, Doctor?

A. Yes.

Q. And the same way you'd be critical of Doctor Nevyas?

A. Yes.

Q. Now, he also didn't do what’s called a cycloplegic refraction; do you know what that is, Doctor?

A. Yes.

Q. Why don't you explain that for the members of the jury?

A. Well, basically what a cycloplegic -- what a refraction is it’s a measurement of the person's need and strength for eyeglasses. When you have a nearsighted person or a myope as we call it, when light comes into your eye just like when light comes into a camera those rays of light have to be focused on the back of the eye or in the analogy of a camera, have to be focused on the film of the camera in order to get a clear picture. In a nearsighted person the rays of the light coming into focus in front of the retina not because the refractive power of the eye is too strong but because the eye is actually too long. So relative to the length of the eye that focusing is in front of the retina and thereby we call it nearsightedness or shortsightedness. And when you refract somebody you work out with a series of lenses how much lens power that patient needs in order to move that focal point from in front of the retina on to the retina.

And the way we do it is we put different lens of different strengths in front of the patient's eye and when the patient sees the chart clearer, clearer and until it's perfectly clear that end point would be considered to be the refraction. There's two ways of measuring somebody's refraction. One would be with a pupil un-dilated in the normal natural state. And the other way would be with the pupil dilated or as we call it cyclopleged. It's not the dilation of the pupil that's important the cycloplegia paralyzes the ability of the eye to focus, thereby giving a more objective refractive outcome than what you would have if the patient was able to accommodate, because with them accommodating they're refractive error can change.

But the point of it in this particular case is that it is not really relevant firstly because of the patient's age, and secondly, because of his myopia. And the reason for that is if you have a lot of optics involved, so I hope that the jury will understand what I'm saying, but when you have light rays that are in front of the retina, in other words, they come to be focused before the retina, if that patient would accommodate the accommodative process moves that point of refraction further away from the retina. So by means of accommodation a myope would essentially be making their vision blurrier than what it is without the corrections. So myopes really do not accommodate unless they are wearing the refractive corrections. So it is possible to do a non-cycloplegic refraction in a myope and get an accurate measurement of their refraction as opposed to someone who is farsighted where they -- because of their farsightedness they are constantly accommodating so you get a much more unpredictable measurements.

So in my practice again, a measurement, an un-cyclopleg refractive correction in a myope is much more accurate than it would be in a hyperope, in other words, a farsighted person. So I think that the refractive error in a myope is pretty much the same in what you can get with a cycloplegic versus a non-cycloplegic refraction. And the other point is that when people get older they start to lose their ability to accommodate so it's even less of an issue in somebody of Mr. Wills' age who is already starting to lose his accommodative powers so there's no reason necessarily to paralyze his ability or to accommodate. So in a long-winded way I've tried to explain that even though a cycloplegic refraction was not done it probably didn't have much bearing on the outcome of this case.

Q. Would you agree with me, Doctor, that it is a more objective test, that cycloplegic refraction?

A. It is a more objective test particularly in a hyperope not that much so in a myope.

Q. Did you read Doctor Nevyas' testimony that he -- wherein he said that cycloplegic was not as accurate and not as objective?

A. I did read that, yes.

Q. And did you agree with that?

A. Not entirely, no.

Q. Why not? Why don't you explain for the members of the jury where you and Doctor Nevyas differ?

A. Well, one thing he did allude to which might have some bearings when you cycloped somebody one of the so called side effects of the cycloplegia is that you make the pupil bigger. And when the pupil is bigger you can induce small aberrations of distortions in their refraction. So that's the point that he was trying to make in that you do induce, which is in fact probably correct, that you do induce some aberrations in the refraction but I cycloped people when I refract them. I cycloped patients when I refract them and the point that I'm trying to make is that in an older patient my cycloplegic and un-cycloplegical refractions are usually very, very comparable in their measurements.

Q. Again, Doctor, is this one of the tests you would have run on Mr. Wills had you been performing LASIK procedures back in 1997?

A. Yes, it would have been.

Q. So that's the second thing you would have done, you would have done pachometry and you would have done a cycloplegic refraction?

A. Again, I would have but I'm not sure I'm allowed to offer an opinion, I don't think that had any bearing on the outcome of this particular case.

Q. We're going to get to your opinions in a second, Doctor. You have offered an opinion is it true, Doctor, that the diameter of the ablation zone by the laser has a bearing on the subsequent risks for -- for inducing visual aberrations, particularly if the pupil diameter is larger than the ablation zone?

A. That's correct, yes.

Q. Well, I think in plain English we can agree, Doctor, that what you’re saying is, if the laser ablation zone is smaller than a patient's pupil diameter the risk of developing glare and halo is increased?

A. Again, that's some of it, we are far more aware of in 2003 than we were in 1997. But I would agree that in today I would state that small ablation zone is an increased risk factor for having halos and glare.

Q. But your opinion is that you didn't really know it back in 1997?

A. Well, again, it's something that was alluded to but a lot of the clinical studies that I reviewed state that those were the reasons why they were doing the clinical trial, to see whether or not the optical zone diameter had that much bearing on the outcomes.

Q. Well, Doctor, did you look at the literature before you prepared your opinion in this case?

A. Yes, I did.

Q. Did you bring any of that literature with you here tonight?

A. No, I don't have it.

Q. Okay. Doctor Kenyon testified about literature which was before 1997, we'll call it the pre-1997 literature. And some of the articles he referred to, Doctor, came from the American Journal of Ophthalmology, journal you're familiar with?

A. Yes.

Q. You think that's an authoritative journal, Doctor?

A. Yes. Yes.

Q. How about Ophthalmology?

A. Yes, it is.

Q. How about something called Mosby, refractive keratotomy?

A. Well, Mosby is not a journal. Mosby is a textbook probably.

Q. Okay, something you’re familiar with though?

A. Mosby is a publisher.

Q. Okay. Sorry about. The article, the title of the article was, Refractive Keratotomy. Let's just stick with the article from Ophthalmology. Many of these articles concern PRK; you're familiar with that?

A. Yes.

Q. Did you ever perform that?

A. Yes.

Q. Okay. And they talk about aberrations usually occurring with scarring or haze, or irregular surface healing, you're familiar with that?

A. Yes.

Q. There's a 1995, it’s actually a chapter in Mosby or corneal laser surgery, which talks about aberrations occurring are not due to healing. Are you familiar with that concept?

A. I'm not quite sure what you mean by not due to healing.

Q. Well, what they're showing in these articles, Doctor, is that the corneas can be virtually clear and you can still have these problems of glare and halo?

A. Yes.

Q. Have you read articles like that?

A. Yes.

Q. Doctor, if -- if the problems aren't from the scarring and haze isn't the point of what they’re trying to show here that the visual problems are optical? What I'll call multifocal?

A. Well again, the problems are multifactorial. In other words, there different reasons for there being these problems, one of which might be surface irregularity.

Q. If you take out the surface irregularity, Doctor, and you have a clear cornea, a cornea that's virtually clear, have you read the articles which talk about the ghost imaging and halos occurring in PRK surgery where the corneas are clear?

A. Yes.

Q. Well, how can that be?

A. Well, it could be because of the ablation diameter.

Q. And isn't that precisely talking about here, Doctor?

A. Yes.

Q. And is that -- when you say the ablation diameter that's when the pupil is larger than the ablation zone?

A. No. The ablation diameter is independent of the pupil size. You can have ablation zones of varying diameters. And you can have ablation zones which are larger than the diameter of the pupil, the exact opposite scenario to what Mr. Wills had and the patients can still have halos and glare and multifocal and double vision. So the point of that is that it's not only because of the ablation zone diameter or the size of the pupils that predispose patients to these problems.

Q. But wasn't there a considerable amount of literature, Doctor, written before 1997 which talked about glare and halos developing and visual distortions developing because the pupil size was larger than that ablation zone?

A. Again, a lot of the literature that I reviewed alluded to the points that you are bringing up but the pupil size was not a major factor in a lot of those articles. And again, the pupil size is something that is still not quite clear. I mean there has been as I mentioned right at the beginning of this deposition that the pupil size was originally thought to be significant or not thought to be that significant and then thought to be very significant and now again in 2003 thought to be less significant than it was originally anticipated. So again, I think that you're right in that the optical zone size and the pupil size are factors in all of the equations but they are not exclusive. And I would say for sure that not 100 percent of patients who have ablation zones that are smaller than pupil sizes end up with these sorts of problems.

Q. Doctor, we can agree though that when the pupil size is larger than the ablation zone the patient should know that they're at increased risk for developing these problems, isn't that a fair statement, Doctor?

A. I think it is a fair statement and anyone who have refractive surgery should be told that they have the risk for developing halos and glare.

Q. But this is a little bit different, Doctor. I'm not talking about anyone. I'm talking about a patient who comes in that presents with a relatively large pupil and the ablation zone is smaller than that, aren't they at increased risk for developing these problems that we're talking about?

A. I would say they probably are at increased risk.

Q. And don't you think those patients should know about that risk?

A. Yes.

Q. And if that was one of your patients would you tell them?

MS. KRAMER: Objection.

THE VIDEOGRAPHER: Stand by please. Time is 7:54, we are now off the record.

MS. KRAMER: My objection is that I can't tell when you're asking the questions if you're talking about today or you're talking about 1997. If you're talking about today, I object.

MR. EISENBERG: We can go back on the record.

THE VIDEOGRAPHER: Stand by please. The time is 7:55; we are now back on the record.

BY MR. EISENBERG:

Q. I know you weren't doing these procedures in 1997, Doctor, so it's a bit of speculation, but if you were doing them, Doctor, is that something that you would tell your patient about, that is that they were at increased risk because of the relationship between the laser ablation zone and the pupil diameter?

A. Again, I'm not entirely sure that that concept was that clear under those -- at that time. It's something that I would mention to the patients and I'm sure that's something that people do mention to their patients certainly in today's environment. And again, I think that I read the consent form that Mr. Wills signed and halos were mentioned in that consent form.

Q. Excuse me. I'm not talking about whether halos and glare are mentioned in the consent form. Did you see anywhere -- you reviewed the consent form, didn't you?

A. Yes.

Q. Did you review both of them, the right and left eye?

A. Yes.

Q. Okay. I'm not asking you, Doctor, whether glare and halo is mentioned. Did you see anywhere in that consent form that it says that because of the relationship between Mr. Wills' pupil size and the laser ablation zone he was at increased risk for developing these problems?

A. No.

Q. Now, Doctor, you talked a little bit about the problems Mr. Wills is suffering from, this distorted vision.

A. Yes.

Q. Did you run any tests, Doctor, to see if Mr. Wills had this distorted vision?

A. Well, the one test that is a good objective way of measuring that problem was not available to me at the time. And that's called wave front aberrometry. Wave front is a very sophisticated way now of measuring higher order aberrations, those are distortions that a patient might be complaining about that under normal examining conditions we wouldn't necessarily be able to detect. So I didn't do that.

Q. Did you review Doctor Kenyon's reports?

A. Yes.

Q. Did you review his report dated December 3rd, 2003?

A. Yes.

Q. And did you see that he ran contrast sensitivity tests?

A. Yes.

Q. Do you disagree with any of his findings on those testings, Doctor?

A. Again, can I look at that again?

Q. Sure.

A. Which report was this, the 21st of January?

Q. No, December 3rd. Have you been given that report?

MS. KRAMER: It's the new one.

THE WITNESS: Yes, but I don't have it here. You showed it to me.

MS. KRAMER: Yes, the new one.

THE WITNESS: Here it is, I'm sorry. Yes, I saw that and I just reviewed it now.

BY MR. EISENBERG:

Q. Do you disagree with anything he has to say in terms of the contrast sensitivity testing, Doctor?

A. No.

Q. Do you know Doctor Kenyon, Doctor Orlin?

A. Again, I know his -- I know who he is, again, not social friends but I'm scarred to say that in just in case you have a picture of him and I at a meeting together. But I don't know him. I know who he is and certainly would recognize him and I've met him and he's been invited to the Scheie Eye Institute where I worked to give talks. He's – I mean a well-known individual.

Q. Doctor, other than the Fiarelli report which I showed you, concerning your opinions on behalf of Doctor Nevyas, and this report now that you've had a little bit more time to think about it, can you remember any other cases where you testified for Doctor Nevyas where the pupil size has been at issue?

A. I don't remember.

MR. EISENBERG: I have no further questions. Thank you, Doctor.