My Lasik experience started in 1998. I'd been hearing about Lasik surgery for some time, and after wearing thick glasses for thirty years, I decided to look further into laser vision correction. In March, 1998, I went for my initial consultation at Nevyas Eye Associates in Bala Cynwyd (Philadelphia area), Pennsylvania. They were advertising extensively (for Lasik...with a laser under \r\nan IDE (Investigational Device Exemption) - Please see the (Nevyas Eye Associates section of this site). At over four hours, the pre-op exam seemed very long, but was not complete, due to my prior history of 'retinopathy of prematurity' or ROP (I was born two and one-half months early, and received too much oxygen in the incubator, thereby damaging some retinal nerves). Anita Nevyas-Wallace, the doctor (who performed my Lasik surgery) stated she foresaw no problems and thought me to be a good candidate. Two weeks later, my initial evaluation was complete, and I was reassured I was to be a "good candidate" for this Lasik procedure. I was NOT told that a change in prescription gave me better than the 20/50 Best Corrected Visual Acuity (BCVA) I ever had, and that instead of the Lasik, the new prescription would have worked just as well if not better than what I was seeing (refracted to 20/40 -2 according to their records).

Because of the ROP, Dr Nevyas-Wallace sent me to see a retinal specialist in their own group to determine whether this would cause any problems in connection with Lasik. I was told there would be no contraindications (problems), and again was reassured that it would be okay to have surgery. I did not ever expect to have 20/20 vision, and was happy with the 20/50 (or maybe a line better, 20/40) prediction the doctor assured me, since the 20/50 was my best correction with glasses. I was elated at the thought of not having to wear glasses anymore, and with the very promising outcome predicted, and being told several times I was a good candidate, decided to have surgery.

Two weeks later, I had surgery on my left eye, and a week after that, on my right eye. The day after, looking through the plastic shield was probably the best vision I ever had in each eye without glasses, but during the daytime only, and did not last. My night vision was filled with halos, starbursts, glare, and ghosting. My vision was still way off, and fluctuated severely, depending on light levels. I was told that as my corneas healed, my vision should improve, and the severe night problems would stop, usually in about three to six months. Later I was told this could take up to one year. After the first year, the doctor just kept adding on time, finally stating the problems I was experiencing could be permanent. Almost seven years later, I still have these same problems.

At one day post-op and four days post-op, each cornea looked okay according to the doctor, but I was still experiencing problems. About two weeks after surgery, I was fitted for soft contacts to determine whether the problems could be eased while my eyes healed. I went through three different prescriptions in as many months. The third month, I was fitted for gas-permeable hard contact lenses, because of continued problems. Consequently, I decided to see another ophthalmologist for another opinion, as I was getting more and more upset with the way I was seeing and what I was being told.

This is my nineteenth visit since my initial consultation five months ago. These visits have been averaging between two to eight hours, with about 15-20 minutes with the surgeon. Yes, I'm getting more frightened by now, especially after hearing what my second opinion doctor told me, that he could not help me get my vision back to what it was prior to Lasik. After five more visits, the surgeons at Nevyas Eye decided that the problems were retinal due to the ROP.

After three more months and three more visits, the doctors were unable to help me. More gas perms and the same results, So I went to another specialist, this time at Wills Eye Hospital, and they couldn't help me either (and that's number twenty four!).

In July '99, Dr. Herbert Nevyas, the doctor who runs the laser center (Anita's father) I went to told me "Deal with it...People lose their sight every day...I'll see you in 8 months" (as I stated in depositions)...I was livid!

1999 brought even more distressing results. Five more retinal evaluations, three more corneal evaluations.

The following month, I had a low vision evaluation. My prescription was changed again, but not with better results. I then ventured to John Hopkins' Wilmer Eye Institute in Baltimore. After seeing several world renowned specialists, I still could not get any help for my post-Lasik eyes. After another visit to the laser center where I had surgery, and another visit to a low vision specialist, it was decided that glasses and contacts would not work. I was fitted for bioptic and mirage lenses. How fitting it is to have Lasik surgery and not be dependent on glasses (due to the fluctuation of vision and constant focusing of these glasses, they were essentially useless)! How I looked like a freak with these things on, and boy, how people stare at what they do not understand!

Two more visits and I ended the year 1999. How pathetic this is...over eighteen months and thirty four visits to doctors and hospitals, and still nobody was able to help me. I was determined to find somebody who could help my post-Lasik eyes and get my vision back to where it was prior to Lasik. I know that something happened, because I did not have these problems prior to Lasik.

In 2000, things did not get any better. Same problems, no help for my vision. Again I ventured back and forth between doctors still seeking to get my vision back prior to Lasik. Eight more visits to end the year, for a total of forty six visits to different doctors and hospitals. Nobody was able to help me.

I am pretty much done with the doctors now, because NOTHING CAN BE DONE. I've had three visits in 2001, and five in 2002. Of the visits in 2002, I saw Dr. James Salz in California (who afterwards became one of my experts for my medical malpractice lawsuit), one of the (if not THE) foremost authorities in this field. Another top Doctor I saw was Dr Terrence O'Brien at John Hopkins. Bottom line is after reviewing ALL of my records since having had Lasik, I cannot be corrected because some of the damage was due to increased pressure from the suction cups used to lift the corneal flaps. Dr. Salz stated I SHOULD NOT HAVE EVER BEEN CONSIDERED A CANDIDATE FOR LASIK and submitted to my attorney many reports.

 

Excerpt of deposition of Herbert Nevyas: Morgan v Nevyas:

PAGE 1 - Cover page - Oral deposition of Herbert Nevyas in Morgan v. Nevyas

PAGE 2 - "Q: As far as the KYW information that was broadcast on the air, what time frame did that run from? A: I don't remember-There was very little. We had a few  I think we had some advertising on KYW to let people know what we were doing as far back as '93 or '94 and I'm not sure what was done in the next couple of years. I really don't recall. I'm not even sure there was much around that time, if any, I think  if I think back to '94 or '95, we had some advertising at that time. I don't think there was later."

PAGE 3 - "Q: How did you get approved for laser surgery if they didn't have a laser? A: By taking courses that they gave. They may have been using a laser at a laser center. I'm not sure. This was some years ago. to be certain, I'm referring to formal hospital privileges and not A: I'm not sure. I don't recall whether it was formal hospital privileges or whether it was their approval for using the Summit laser at that time. I do not recall. I had no intention of using it, so I don't remember."

PAGE 4 - "Q: Do you know if Dr. Nevyas-Wallace has performed LASIK at any hospital?" "A: I don't know. Not as far as I know, let's put it that way. Not as far as I know."

PAGE 5 - "Q: In all of the meetings and courses that you've attended, has there been any mention of any patient who had LASIK who had a similar condition to Mr, Morgan?" "MS. KRAMER: I'm going to object to the form and ask if you can define "similar condition." "Q. A similar condition would be a history of retinopathy of prematurity with a large positive angled kappa." "A: Not to my recollection."

PAGE 6 - "Q: Doctor, do you have any income earned as an ophthalmologist that comes to you other than via Nevyas Eye Associates or Nevyas Eye Associates of New Jersey? MR. LAPAT: Objection. MS. NEWMAN: Objection. MS. KRAMER: You can answer it. A: Income earned as an ophthalmologist that comes to me? That is assuming that I have income earned as an ophthalmologist that comes to me from the corporation. The answer is no. Q: Doctor, do you have income from the Nevyas Eye Associates or Nevyas Eye Associates of New Jersey? MR. LAPAT: Objection. Again, that has no bearing on this litigation. A: Probably not, no. Q: They don't pay you? A: No."

PAGE 7 - "Q: What was the purpose of working with MDTV?" "A: They were going to make a video which we could use to show our patients, give them some idea of the refractive surgery we do, and they were going to put it on some public access channels to show people what we were doing."

PAGE 8 - "Q: Are you familiar with the requirements for driving a car, the requirements I am talking as far as vision for driving a car in Pennsylvania, what they are? A: Pretty much."

"Did you ever tell Mr. Morgan that he should not drive? A: I don't think so. I don't recall that." (Comment - 7 years after this deposition Herbert wrote a letter to NJ DMV (I believe as an act of vindication) to make sure my license was revoked.)

PAGE 9 - "Q: Did you consider the possible diagnoses of malingering, hysteria, nuclear sclerosis or a physical problem that is retinal as being a complication of LASIK surgery? A: No. Q: Did you consider malingering, a physical problem that is retinal, hysteria or nuclear sclerosis as being an adverse event following LASIK surgery? MR. LAPAT: Objection. MS. KRAMER: Go ahead.You can answer. A: Absolutely not."

PAGE 10 - "Q: If the patient, when examined preoperatively, doesn't show any evidence of nuclear sclerosis  I' m not sure I understood your answer. Does that mean you could anticipate nuclear sclerosis? A: No, we would anticipate it by examining him, and if we saw it developing, not operate him. Q: I take it since he was operated that it wasn't seen? A: It was not. It seemed to be developing now afterwards. It has been several years."

PAGE 11 - "Q: Doctor, do you see that, "No change in ghost image with hard contact lenses"? A: Yes. Q: Are you able to identify who wrote that note? A: That is Dr. Anita Wallace.That is the first mention I see of a ghost image.There is no complaint of a ghost image. She just said that there is no change in any. I don't even know that there were any."

 

ALL PAGES

Excerpt of deposition of Anita Nevyas-Wallace: Morgan v Nevyas

 

note: Dr. Orlin was expert witness for Drs. Herbert Nevyas and Anita Nevyas-Wallace in several of lawsuits. Below are his opinions in my lawsuit and transcript of video testimony in the Wills v Nevyas lawsuit.

Affidavit regarding LASIK and Retinopathy of Prematurity (ROP)

AFFIDAVIT OF DR. STEPHEN ORLIN

This affidavit is from Dr. Stephen Orlin, an expert witness of Drs. Herbert Nevyas and Anita Nevyas-Wallace in several lawsuits. He clearly states "Retinopathy of Prematurity, in and of itself, is not a contraindication to LASIK surgery". It also states as an expert of the Nevyases, that my retinas were "healthy" for practical purposes of LASIK.

Currently, only the rich text format is available.

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.

Other Cases v Nevyas

Fiorelli v Nevyas

Excerpt of deposition of Herbert Nevyas: Fiorelli v Nevyas:

PAGE 1 - Cover page - Oral deposition of Herbert Nevyas in Fiorelli v. Nevyas

PAGE 2 -

PAGE 3 - "Q. And my understanding, from Anita's deposition, is that Anita is your daughter?" "A. Anita's my daughter. Other than to say it's a pity that this woman has resorted to lawsuits, that's all. We haven't discussed the facts of the case at all."

PAGE 4 -

PAGE 5 - "Q. Was corneal thickness a factor in planning the Lasik surgery prior to March of 1997?" "A. I really don't know if it was a factor or not. Obviously, the gross appearance of the cornea was. I do not have in the record here -- perhaps you have it; I'm not sure, since I didn't see the patient initially --"

PAGE 6 -

PAGE 7 - MS. POST: Objection to the form. If you know." "A THE WITNESS: The purpose of the procedure was the same as any of myopic Lasik procedure: to relieve the patient of the myopia, which made her dependent upon glasses or contact lenses, and in her case made her absolutely blind and helpless without an optical prosthesis."

PAGE 8 - "Q. Okay. There is a note on the operative form about the laser keratome stopping on its forward and its backward pass." "A. Yes."

PAGE 9 - "Q. Can you tell me what significance, if any, the fact that the keratome is recorded as having stopped three-quarters of the way on forward and one-quarter of the way on the backward pass?" "THE WITNESS: The significance is that the microkeratome that was in use at that time, and is still in use pretty widely, had a gear system which could sometimes hang up momentarily, and if the laser hesitates, it could create some unevenness in the cut making the corneal flap. The significance here is that it stopped toward -- I don't know -- the three-quarters was recorded either by the nurse or the optometrist who was assisting, who obviously couldn't be looking in the microscrope, -but it looked to them as if it hesitated when it was pretty well through the pass and, therefore it would have no significance really except to, you know, we note everything that happens in the procedure. No clinical significance."

PAGE 10 - "Q. Is there any indication in the record or in the notes that Cheryl was not looking at the light?" "A. There's no way we could know. We have to tell her what to do and then we can only tell by the topography whether her optical axis was indeed lined up with the laser beam center."

PAGE 11 - "Q Okay. Do you know why the lensectomy on the left eye was done seven days after the Lasik on the right eye?" "A. Well, from the record, I gather the patient was unhappy with the imbalance now and wanted to get something done on the other eye, and why it was done as a lensectorny rather than as a Lasik, I could give you my assumptions but I don't recall discussing it."

PAGE 12 - "MR. KAFRISSEN: What he testified to is that he couldn't recall exactly what he did during this surgery but here are the things that the doctor normally does as an assistant." "THE WITNESS: I must take exception. These are things I might have done as an assistant. Other people might have done them too."

PAGE 13 - "Had you ever discussed her between the previous surgery and May I5 surgery with Doctor Nevyas Wallace?" "A. Probably there was some discussion but I don't recall. Most likely, Doctor Nevyas-Wallace told me what the situation was and what she had planned, but I don't recall that specifically. She may have mentioned it to me, but she is quite expert on her own and I do not monitor each thing she does. In fact, she's got a national and international reputation particularly in the interpretation of elevation topographies."

PAGE 14 - "Q. Okay. With regard to the left eye, as of May 21 27, 1997, what was your assessment?" "A. I have nothing there except that it looked normal. I didn't note any abnormalities. I would have noted abnormalities."

PAGE 15 - "Q. Okay. Did the second enhancement have the desired effect as of 7/11/1997?" "A. I haven't testified what the desired effect was. I think you should ask Doctor Wallace exactly what she was hoping to accomplish. It looks like, from her record, that the vision was much better and refractive error was reduced. She had very little astigmatism and essentially no refractive error. If that's what she was aiming to accomplish, then she was successful."

 

PAGE 16 - "Q. Let me get -- I'll get to that in one minute. Did you note that the lens was decentered prior to the July 14 surgery?" "A. No." "MS. POST: Did he make any notation that it was?" "MR. KAFRISSEN: Yes."

FULL Deposition of Herbert Nevyas Fiorelli v Nevyas 

Full Deposition of Anita Nevyas Fiorelli v Nevyas

 

 

Wills v Nevyas

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?

  1. 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.

 

Nevyas Deviation of Standard of Care

 

As Noted by Drs. James Salz, Terrence O'Brien, & Kenneth Kenyon regarding myself and two other LASIK casualties.

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DR. SALZ' REPORTS

The following reports were after seeing Dr James Salz, who afterwards became an expert in my medical malpractice lawsuit against my LASIK doctors. These are his reports, and are filed with the Philadelphia courts:

This was what was determined after waiting for all of the medical reports to come together, as was reported from my attorney to the arbitrator:

1. After LASIK, Mr. Morgan saw Nevyas-Wallace's group for almost 2 years, as well as several other ophthalmologists, seeking to correct his worsened vision. The records confirm that Dominic told Nevyas-Wallace and the other ophthalmologists what each told him, that Dominic obtained some copies of records to take from one to the other, and that sometimes the ophthalmologists wrote or telephoned each other, but no ophthalmologist had copies of all the medical records from all the other ophthalmologists.

2. The only persons to review copies of the entire medical records appear to be Dr. O'Brien (after he became an expert) and Dr. Salz. One cannot be certain what Dr. Orlin and Dr. Willis reviewed.

The early post-LASIK period:

3. Nevyas-Wallace initially told Dominic that all his problems were temporary and would pass with time, first 3 to 6 months, then 6 to 12 months. Meanwhile, Nevyas-Wallace wrote in the records that there were problems in centering the laser ablation during the left eye LASIK procedure (operative note 4/23/98), with resultant temporal decentration in the left eye (medical records 4/27/98, 5/4/98), and nasal decentration in the right eye (medical record 7/6/98).

4. Three other ophthalmologists seeing Dominic Karen Fung, M.D. (medical record 8/3/98), John Dugan, M.D. (medical record 8/25/98), and Michael Belin, M.D. (medical record 1/25/99) told Dominic and wrote that they were concerned with LASIK causing decentration problems. Dr. Dugan sent Dominic to Dr. Laibson. [see telephone call note to Laibson's partner Dr. Rapuano in Laibson records] Dr. Dugan also sent Dominic to Johns Hopkins, [deposition Dugan p. 73] and after Dr. Dugan talked with Dr. Guyton (see below, on 6/19/00) he wrote both that he was uncertain, as well as writing about decentration.

The later post-LASIK period:

5. Peter Laibson, M.D. wrote (letter 2/23/99): "I think it is either a retinal problem (you are familiar with his past history of regressed retinopathy of prematurity with peripheral lattice degeneration) or possibly other factors, which are not obvious on the objective examination."

When deposed, Dr. Laibson would not answer all pertinent questions. Asked by defendants if LASIK was responsible for Dominic's loss of visual acuity, Dr. Laibson said that Dominic*s problems were more than the LASIK flaps [deposition Laibson p. 20-21] and "I can say that the LASIK surgery looked like it was done appropriately; and that as far as visual loss is concerned, I don't know how to answer that question." [deposition Laibson p.24, 25] When asked again by defendants if LASIK was responsible for Dominic's loss of visual acuity, he said, "I don't know."[deposition Laibson p.26] When further pressed by defendants, he rephrased the question to avoid answering what was asked: "I felt it was not likely that if he really did have 20/40 that the LASIK was responsible for the reduction in vision to 20/70." [deposition Laibson p.27, emphasis added] When plaintiff's attorney asked, "Doctor, would you consider the use of the suction cup and the increased intraocular pressure as one of the other factors that you're referring to?" he answered, "I have no comment on that" [deposition Laibson p.38] and later, "I'm not an expert."[deposition Laibson p 43] He explained that the cornea alone could not explain Dominic's problem, so there had to be another problem. [deposition Laibson p 55-56]

6. Nevyas-Wallace wrote (medical record 3/8/99): "Phone call from patient...He says Dr. Michael Belin and Dr. Peter Laibson each said the cornea looks fine and that the problem must be retinal." Thereafter Nevyas-Wallace continued to assure Dominic that his problems would clear up with time, but what was written in Nevyas-Wallace's medical records changed.

7. Sheldon Morris, M.D. when asked specifically if cataracts were present, wrote there were no significant cataracts and Low VA [visual acuity] related to retinal problems."[medical record 4/17/00] At deposition Dr. Morris said he did not know if the retinal problems were worsened by the LASIK procedure or independent of LASIK. [deposition Morris p. 22]

8. Nevyas-Wallace wrote (medical record 4/26/99): "Impression: Retinal problem. Rule out hysteria."

9. Paul Beer, M.D. wrote (letter 7/21/99): "The explanation that was raised by one of the previous consultants, that his refractive surgery is not aligned with the physical location of his macula, may be very reasonable."

10(A). Nevyas-Wallace wrote (medical record 7/26/99): "Impression: Topography shows central ablation, and no increase (in vision) with contact lens. Therefore, problem is retinal."

10(B). Nevyas-Wallace wrote (medical record 10/11/99): "Impression: Discussed in detail - that as per Drs. Laibson, O'Brien, and Belin, the cornea and topography are excellent and that slight drop in visual acuity is symptomatic with marginal acuity at the onset. Also that retinal factors including retinopathy of prematurity likely to be responsible." This implied that retinal factor other than retinopathy of prematurity were present, and Nevyas-Wallace repeated her implication [deposition Nevyas-Wallace p. 212]: "I discussed matters in detail and I explained to him that I agreed with Dr. Laibson and Dr. O'Brien and Dr. Belin in their assertions that both the appearance of the cornea and the corneal topography are excellent and that slight drop in visual acuity is symptomatic and that retinal factors, including his retinopathy of prematurity, are likely to be responsible."

11. Eugene DeJuan, M.D. wrote for diagnoses: "Question of optical phenomena and retinal degeneration or ischemia secondary to vacuum [cup for LASIK]." (Johns Hopkins medical record 11/29/99)

12. David Fischer, M.D. wrote (letter 3/3/00): "The more insidious causes of diminished vision concern the retina which your LASIK surgeons felt were the culprit. Your fluorescein angiogram was felt to be normal as were your visual fields. The ERG showed mild retinal dysfunction, cause to be determined. During LASIK procedures a suction cup is placed on the eye causing increased intraocular pressures. Could this be a factor as a long-term optic neuropathy which may also be related to your retinopathy of prematurity? I'm afraid these are questions that I cannot answer and I'm hopeful that the doctors at Johns Hopkins can elicit these answers for you."

13. David Guyton, M.D. saw Dominic at Johns Hopkins in June 2000. Dr. Guyton stated, "I could say from that that the refractive surgery wasn't the only thing which was decreasing his vision." [Guyton deposition p. 19] When Dr. Guyton was asked by defendant, "What amount is it would not be related to Lasik then, over from where to where?" he explained that LASIK was responsible for the decrease to 20/70 and postulated cataracts (unrelated to LASIK) for 20/70 to 20/125. [Guyton deposition p. 20-21] Dr. Guyton stated that he deduced cataracts by a process of elimination [Guyton deposition p. 45] since they were barely visible, and suggested waiting [two years] to see if there would be any progression. Absent progression he felt cataracts could not be part of Dominic's visual problem. (letter 6/19/00 and deposition pp. 22, 23, 38, 39).

14. The other two Johns Hopkins doctors, Eugene DeJuan, M.D. (with his fellow, Joseph Harlan, M.D.) and Terrence O'Brien, M.D., did not believe the barely visible cataracts were significant, but did not regard waiting as unreasonable.

15. Defense expert Dr. Orlin examined Dominic 1/30/02 and stated, "over the past two years, these [cataracts] have remained minimal and non-progressive," [Orlin report 6/12/02, p. 2] and neither he nor defense expert Dr. Willis suggested any significant visual loss from cataracts.

16. When plaintiff's expert Dr. Salz examined Dominic 4/27/02, almost 2 years after Dr. Guyton, there still was no cataract progression. Dr. Salz reported no cataract problems, and was then able to conclude with medical certainty that Dominic's problems were causally related to decentered laser ablation, and retinal and optic nerve damage.

17. Terrence O'Brien, M.D., having waited 2 years after Dr. Guyton, agreed with Dr. Salz and became a plaintiff expert. All experts' reports were "set aside" in determining outcome of arbitration.


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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244April 27,2002

Steven A. Friedman, M. D. Physician and Attorney at Law 850 West Chester Pike, 1st Floor Havertown, PA 19083

RE: Dominic Morgan's examination on 4/27/02

Dear Dr. Friedman:

As you requested, I have examined your client and this report will summarize my findings.

History Mr. Morgan stated that his best-corrected visual acuity was never better than 20/50 on numerous previous examinations secondary to his retinopathy of prematurity. The 20/50 visual acuity was confirmed on his driver test examination. He also stated that he went to the Nevyas Eye Center because he heard a radio commercial on KYW. He was told he was a " good candidate" for LASIK despite his ROP. After surgery on his left eye he complained about the quality of his vision and problems with his night vision and was told that it was normal at that stage and would improve with time. These assurances were the reason he consented to surgery on his right eye.

His current complaints include the following: vision fluctuates a great deal, some days worse than others and changes during the same day depending on lighting conditions; cannot see to drive at night; he still has a driver's license but has essentially given up driving; at dusk, everything becomes even more blurry and he sees starbursts around lights; during the day he gets by OK, cannot read road signs but he feels he could drive in familiar areas; all these symptoms are worse in his right eye, especially at night.

Examination:

Uncorrected visual acuity OD 20/100 +2, OS 20/100 -

VA with present glasses OD -1.00 -0.50 x 11 = 20/100, OS -0.75 -0.25 x 26 = 20/80 -1

Refraction OD -0.50 -0.50 x 90 = 20/80 +, OS -1.50 = 20/80 +

Cycloplegic refraction OD -0.50 -0.50 x 90 = 20/100 with triple images of chart letters

OS - 1.25 = 20/100 with triple images of chart letters

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Keratometry OD 41.50/41.75 x 107 clear mires, OS 42.25/42.62 x 90 clear mires Pupil diameter in dark room with pupilscan OD 6.4mm OS 6.5 mm Pachymetry OD .46 mm OS .48 mm

Slit lamp examination—clear corneas with well-healed LASIK flaps OU, normal pupils, no afferent pupil defect, lens shows faint trace nuclear sclerosis in the posterior half of the lens nucleus while the anterior half is clear.

Fundus examination with pupils dilated, both direct and indirect reveals hypoplastic optic nerves with essentially no cup and no obvious pallor OU, prominent temporal peri-papillary atrophy and temporal displacement of macula OU

Humphrey Topography shows relatively small but well centered ablations in both eyes with the lower end of the ablation at the edge of the photopic pupil of about 3 mm. The corneal irregularity measurements are increased to 2.63 OD and 2.49 OS (normal up to 1.5) copy enclosed

Wavescan readings with the Alcon Humphrey System are included. These were performed with normal lighting with pupils of 4.59 mmOD and 4.23mm OS and again with pupils dilated to more closely simulate night conditions when the pupils were 7.6mm OD and 7.4mm OS. The defocus and astigmatism readings with the smaller pupil are quite normal and agree with the minor residual refractive error in both eyes. Both of these values increase with larger pupils because the unablated area of the cornea is measured and this simply reflects the relatively small ablation diameters. The most common aberrations following LASIK are Coma and Spherical Aberration and these values are acceptably low with pupils of about 4.5 mm. For example the spherical aberration for OD is 0.38 OD and 0.16 OS. When the pupils are dilated simulating night conditions, spherical aberration increases to 2.33 OD and 1.72 OS. This represents almost a six-fold increase for OD and a tenfold increase for OS.

Comment: Mr. Morgan has been examined by several highly qualified experts since his LASIK surgery in an attempt to explain the decrease in his best-corrected visual acuity. The possible mechanisms include retinal damage, optic nerve damage, a combination of both; optical problems related to positive angle kappa and an ablation centered over the pupil, and early cataract changes. Based on my examination, I attribute his loss of vision to a combination of all except the cataract. I do not feel the minimal lens opacity is sufficient to explain his loss of vision. This would not explain why his vision became worse immediately after the surgery in both eyes. Dr. Guyton suggested the minimal cataracts as a possible explanation in June of 2000 and suggested that if the cataracts were at fault we would expect to see progression in the lens changes and further decrease in his visual acuity. It is almost 2 years since that exam and today, his visual acuity was better than the 20/125 recorded by Dr. Guyton and the lens changes are still minimal so this goes against the thought that the cataracts are at fault.

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Mr. Morgan's increased night symptoms are readily explained by the small ablation diameters evident on his topography combined with the fact that his scotopic pupils are about 6.5 mm. The dramatic increase in his spherical aberration in both eyes when his pupils are dilated correlates well with his subjective complaints. The spherical aberration is also higher in the right eye and he has more complaints about his night vision in that eye.

Sincerely,

signature on original scanned document Nevyas v. Morgan

3

 

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DR. TERRENCE O'BRIEN'S REPORTS CONCERNING MY CASE:

The following reports were after seeing Dr Terrence O'Brien, a leading Lasik specialist, who afterwards became an expert in my medical malpractice lawsuit against Drs. Herbert Nevyas and Anita Nevyas-Wallace. These are his reports, and are filed with the Philadelphia courts.

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Terrence P. O'Brien, M.D. Associate Professor of Ophthalmology External Diseases and Cornea Director, Ocular Microbiology Director, Refractive Eye Surgery The Eye Surgery Center at Green Spring Stettin 10753 Falls Road, Suits 305 Lutheivilte, MD 21093 410-S83-2820/FAX 410-583-2842 Email: tobrien@jhmi.«du

June 7, 2002

Steven A. Friedman, M.D., J.D.

850 West Chester Pike, 1st Floor Havertown, PA 19083

RE: MORGAN, DOMINIC JHH: 4-3200368

Dear Dr. Friedman:

I have had the opportunity to carefully review in detail all of the medical records related to Dominic Morgan's care, including the recent defense medical exam provided by Dr. Steven Orlin in Philadelphia, Pennsylvania, as wel! as the comprehensive ocular evaluation conducted by Dr. James Salz in Los Angeles, California. In addition, I reviewed the MD-TV videotape "Infomercial Transcript" that Dr. Anita Nevyas-Wallace used to promote the "Nevyas Excimer Laser" without providing information to viewers regarding the investigational status of the Excimer laser with the FDA.

In review of Dr. Salz' extensive examination and conclusions, I am of the opinion in complete agreement with Dr. Salz to the best degree of medical probability that the care rendered by Dr. Anita Nevyas-Wallace on behalf of Dominic Morgan fell below standard for LASIK surgery at the time. Indeed, I completely agree with Dr. Salz that Dr. Nevyas-Nevyasx failed to appropriately screen Mr. Morgan and exclude him as a viable candidate for LASIK surgery based on his extensive prior ophthalmologic history which would have predicted a less than optimal result, as he has ultimately experienced with the surgery performed by Dr. Anita Nevyas-Wallace.

Dr. Friedman, your kind attention to this information and awareness of my opinion to the best degree of medical probability which is in complete agreement with Dr. Salz that Dr. Anita Nevyas-Wallace had substandard care

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Page Two RE: MORGAN, DOMINIC JHH: 4-3200368

related to the treatment provided with LASIK surgery on behalf of Dominic Morgan. If you have any questions regarding this deviation from the standard of care in patient selection and treatment, please do not hesitate to contact me directly at 410-847-3508.

Sincerely, signature on original scanned document

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Dr. Terrence O'Brien's declaration could not be scanned and converted, but can be found above.

 

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DR. TERRENCE O'BRIEN'S REPORTS re Fiorelli v Nevyas

 

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THE WILMER EYE INSTITUTE AT GREEN SPRING STATION The Eye Surgery Center at Green Spring Station 10753 Falls Road, Suits 305 Lutherville, MD 21093 (410) 614-2020 Fax: (410) 583-2842 Email: This email address is being protected from spambots. You need JavaScript enabled to view it. This e-mail address is being protected from spam bots, you need JavaScript enabled to view it Terrence P. O'Brien, M.D. Associate Professor of Ophthalmology External Diseases and Cornea Director, Ocular Microbiology Director, Refractive Eye Surgery FACSIMILE: (215)241-9904

April 6, 2001

Samuel F. Kafrissen, P.C. 1515 Market Street Suite 616

Philadelphia, PA 19102

RE: Cheryl Fiorelli

Dear Mr. Kafrissen:

Thank you very much for your kind inquiry into the ocular conditions and ophthalmologic care provided to Cheryl Fiorelli. I have now had the opportunity to perform a comprehensive review of the medical records of Cheryl Fiorelli from the Nevyas Eye Associates/Nevyasxx Nevyas Laser Surgery Institute from February 4, 1997 through January 4, 1999. In addition, I have reviewed the subsequent records of Cheryl Fiorelli from Richard Tipperman, M.D. from February 3, 1999 through December 16, 1999. Following detailed review of these medical records, I have been provided with a copy of the transcripts from the sworn depositions of Dr. Anita Nevyas-Wallace, Dr. Nevyasx Nevyas and Cheryl Fiorelli and have thoroughly reviewed these documents.

Ms. Cheryl Fiorelli had an ophthalmic history significant for refractive error classified as extreme myopia and high astigmatism. Because of the extremely high myopia and high astigmatism, she had always had reduced visual function that could not be corrected fully with glasses or contact lenses. Because Ms. Fiorelli noted a subjective improvement in the quality and quantity of her vision using contact lenses, she reportedly wore contact lenses from an early age (grade 7). She developed giant papillary conjunctivitis and was treated at the Nevyas Eye Associates in Pennsylvania. She had also received optometric care provided by Dr. Deborah Signorino in Byrn Mawr, Pennsylvania and had worn contact lenses with variable success.

www. xvilmer.jhu.edu

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Samuel F. Kafrissen, P.C. Page 2 April 6, 2001

On February 4, 1997 Ms. Fiorelli was evaluated at the Nevyas Eye Associates by Dr. Ira B. Wallace emergently for an ocular foreign body sensation. She removed her contact lens but continued to experience persistent foreign body sensation. Dr. Nevyasx reported that the ocular examination disclosed a measured visual acuity of right eye: 20/70 and left eye: 20/70+ wearing her eye glass prescription. The intraocular pressures were normal measuring right eye: 19 and left eye: 14. The examination was notable for peripheral corneal neovascxilarization especially superiorly measuring 2-3 mm x 2-3 mm with overlying punctate keratopathy and an irregular epithelium. Dr. Nevyasx requested Ms. Fiorelli to abstain from contact lens wear and initiated topical corticosteroid therapy in the form of Flarex 1 drop, 3 times a day. She was scheduled to return to see Dr. Anita Nevyas-Wallace to evaluate her cornea. Of note, pharmacologic dilation was performed and ophthalmoscopy completed by Dr. Edward Nevyas including examination of the retinal periphery. Dr. Nevyas reportedly observed peripheral retinoschisis but no breaks or retinal detachment.

One week following this appointment, a letter was written by Dr. Anita Nevyas-Wallace, M.D. to BlueCross Personal Choice in Philadelphia, Pennsylvania regarding Ms. Cheryl Fiorelli. hi her correspondence to BlueCross Personal Choice dated February 10, 1997, Dr. Anita Nevyas-Wallace pleaded a case for the medical necessity for refractive eye surgery for Ms. Fiorelli. Dr. Nevyas-Nevyasx contended that refractive surgery "should indeed be covered by insurance, as it is necessary in order for her to be able to function in her work".

On March 3, 1997, Dr. Anita Nevyas-Wallace saw Ms. Cheryl Fiorelli back for a follow-up examination. Her assessment was that Ms. Fiorelli's giant papillary conjunctivitis had improved with the giant papillae under the right lid appearing less elevated.

Dr. Anita Nevyas-Wallace then initially planned to perform LASIK refractive surgery on Ms. Fiorelli's left eye on 3/20/97 at the Nevyasxx Nevyas Laser Surgery Institute and tentatively planned to perform LASEK surgery on the right eye on 4/17/97. A bill for professional services was generated on March 12, 1997 payable by Ms. Cheryl Fiorelli in the amount of $2,100 to Nevyas Eye Associates and $400 to Dr. Signorino for optometric referral for the planned LASIK surgery.

On March 20, 1997, Cheryl Fiorelli underwent an initial LASIK procedure actually performed to her right eye by the surgeon, Dr. Anita Nevyas-Wallace. Apparently, a registered nurse, Deborah Nevyasx, was in control of the foot pedals of the microkeratome that was used to create the LASIK flap. During the procedure, the microkeratome stopped three-quarters of the way on the forward pass and one-quarter of the backward pass. Both times, Nurse Deborah Nevyasx removed her foot off of the pedal and pressed again as the keratome finished its pass. Dr. Anita Nevyas-Wallace, as the surgeon, apparently did not control the foot pedals of the microkeratome device. The Excimer Laser ablation for the extremely high myopia and high astigmatism was

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Samuel F. Kafrissen, P.C. Page 3 April 6, 2001

performed using a non-approved Excimer Laser ("black box laser"). This Excimer Laser was not formally approved by the U.S. Food and Drug Administration, Medical Device Division. From subsequent reports, the laser engine was a Schwind Compex 201, which is not approved for human use in the United States.

The Excimer Laser ablation that was carried out by Dr. Anita Nevyas-Wallace using the unapproved Excimer Laser was subsequently found post-operatively to be significantly decentered based on computer-assisted comeal topographic analysis. In addition, Ms. Cheryl Fiorelli sustained a marked overcorrection with a significant hyperopic astigmatic refractive result. On the fourth day post-operative (3/24/97), Ms. Fiorelli was complaining of subjective and qualitative disturbances in her visual acuity. Her visual acuity without correction in the right eye measured 2100 pinholing to 20/70. The subjective refraction right eye: (+6.75 -2.25: axis 118 equaled 20/70). On follow-up exam, this major over-correction had a slight regression and on 3/31/97 the subjective refraction measured right eye: (+4.75: -2.25: axis 125 equaled 20/80-). The corneal topographic analysis disclosed a significantly decentered Excimer Laser ablation in the right eye.

On May 12, 1997, the visual acuity without correction right eye measured 20/70 pinholing to 20/40 with a significant halo. There was the previously noted supero-nasal decentration of the ablation.

On May 15, 1997, Dr. Anita Nevyas-Wallace attempted a retreatment of Ms. Fiorelli's right eye in an effort to reduce the disturbing subjective qualitative symptoms of halos and decreased vision resulting in part from the supero-nasal decentration. On 5/19/97, four days status post, the LASIK retreatment in the right eye, the visual acuity without correction in the right eye measured 20/100 pinholing to 20/70. Ms. Fiorelli was still seeing subjective halos in the right eye and complaining of subjectively diminished visual acuity especially at the mid-range distance of about five feet. Her subjective refraction in the right eye: (+4.75 -1.25 x 110 equals 20/60-3).

Ms. Fiorelli's subjective disturbances following the LASIK treatment with the unapproved Excimer Laser with significant decentration persisted through the summer of 1997. On July 7, 1997, the visual acuity without correction measured 20/70 with the hyperopic astigmatic refraction. It was felt that the decreased best corrected visual acuity was in part due to flap striae and due to the decentered ablation as well as the overcorrection. Dr. Anita Nevyas-Wallace then had developed several treatment plans in an effort to improve the poor quality and quantity of vision with yet another laser retreatment. On July 10, 1997, Ms. Fiorelli underwent a third LASIK retreatment to her right eye. On August 25, Ms. Fiorelli was still not driving at night and still complained of subjective halos and poor vision from the right eye. Her visual acuity without

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Samuel F. Kafrissen, P.C. Page 4 April 6, 2001

Measured 20/50 pinholing to 20/50+. The subjective refraction of the right eye disclosed: (+1.75 - 1.25 axis 097 equaling 20/50-).

Despite the initial LASIK surgery and two subsequent surgeries, Ms. Fiorelli continued to have subjective disturbances in her visual function with poor quality of vision and images complicated by significant halo and glare effect with multiple optical images and difficulty driving and carrying out her activities of daily living.

Despite the poor result of the initial surgery in March 1997, Dr. Anita Nevyas-Wallace then elected to proceed with performing a clear lens extraction in Ms. Cheryl Fiorelli's left eye on March 27, 1997, just one week following the initial LAS DC surgery with the initial poor outcome. Despite the high myopia and high astigmatism (left eye: (-14.25: +5.00: axis 010), Dr. Anita Nevyas-Wallace selected a silicone plate haptic intraocular lens, which was inserted into the left eye on March 27, 1997 by Dr. Anita Nevyas-Wallace. Post-operatively, Ms. Fiorelli had a significant residual myopia of over 3 diopters with significant early posterior capsular opacification. On July 14, 1997, Dr. Anita Nevyas-Wallace performed a YAG Laser Posterior Capsulotomy to Ms. Fiorelli's left eye. A repeat capsulotomy was then required on December 14, 1998. In addition, Ms. Fiorelli sustained a significant elevation in intraocular pressure in the left eye following the cataract surgery.

Because of the anisometropia of the left eye compared with the overcorrected right and the dislocated plate haptic intraocular lens with residual thickened posterior capsulotomy opacity, an intraocular lens exchange was performed by Dr. Richard Tipperman on April 9, 1999. The Chiron silicone plate haptic intraocular lens of incorrect power was exchanged with an Alcon acrylic MA60BM of power +6 diopters inserted in the posterior chamber in the ciliary sulcus. Because of the two previous YAG Laser Capsulotomies, it was not possible to safely place the intraocular lens into the capsular bag due to the radial openings in the posterior capsule and the likelihood of lens subluxation. By May 27, 1999, her visual acuity without correction in the left eye measured 20/40-2 pinholing to 20/30-3. The intraocular lens was well centered in the ciliary sulcus with trace cell and flare. The intraocular pressure was elevated to 30 mmHg possibly in response to the topical steroid use and Ms. Fiorelli was discontinued from the steroid and placed on a non-steroidal anti-inflammatory agent Voltaren along with Alphagan twice a day for the increased pressure.

Because of her continued subjective disturbances in quality and quantity of her vision in the right eye following the LASIK procedure and two enhancements performed by Dr. Anita Nevyas-Wallace, she was referred to the Wills Eye Hospital to Dr. Zoraida Fiol-Silva for an attempt at rigid contact lens fitting. With the fitting of a rigid gas permeable contact lens to her right eye, there was an objective and subjective improvement in visual acuity. This suggests the likelihood

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Samuel F. Kafrissen, P.C. Page 5 April 6, 2001

of irregular astigmatism created by the LASIK procedures including the creation of the LASIK flap and the decentered Excimer Laser ablation.

In summary, Ms. Cheryl Fiorelli has a history of exceptionally high myopia and high astigmatism. She had been wearing contact lenses since an early age and developed giant papillary conjunctivitis. A short course at attempted therapy was undertaken. Ms. Fiorelli then underwent elective refractive eye surgery for her extremely high myopia and astigmatism. Dr. Anita Nevyas-Wallace selected the LASIK procedure for the right eye. There were no measurements of cornea thickness obtained pre-operatively despite the availability of an ultrasonic pachymeter at the Nevyasxx Nevyas Laser Surgery Institute. In addition, Dr. Anita Nevyas-Wallace reportedly had been certified in Automated Lamellar Keratoplasty and was familiar with the necessity of comeal pachymetry especially in patients with higher myopia and higher intended Excimer Laser ablations.

During the attempted LASIK procedure, there were difficulties with the microkeratome pass both in the forward direction and in the reverse direction. In addition, following the Excimer Laser ablation on March 20, 1997, there was a marked overcorrection with significant hyperopia and astigmatism created by an apparent decentered ablation. Two subsequent retreatments were performed which reduced the overcorrection and astigmatism and improved the decentration yet failed to correct the irregular astigmatism and qualitative disturbances in vision in association with an exceptionally flat cornea following the extensive ablations.

Just one week after the initial LASIK procedure with poor early outcome, Dr. Anita Nevyas-Wallace elected to perform a clear lensectomy on a young, highly myopic patient. A silicone-plate haptic intraocular lens was selected and placed into Ms. Fiorelli's left eye. There was early posterior capsular opacification in association with the silicone-plate haptic intraocular lens. A YAG Laser Capsultomy was performed. A. second YAG Laser Capsultomy was then repeated. The plate haptic intraocular lens was then decentered. There was significant residual post­operative myopia, which created anisometropia given the marked overcorrection with hyperopia and astigmatism in the right eye. A third operative procedure was required on the left eye to exchange the silicone-plate haptic intraocular lens design of sub-optimal power and to enlarge the posterior capsulotomy. This was accomplished by Dr. Tipperman and fortunately, Ms. Fiorelli experienced a return of better visual function in the left eye. Naturally, as a young, high myope patient she continues to carry a significant cumulative risk for retinal detachment following the clear lens extraction procedure, two YAG Laser Capsulotomies and a third intraocular lens exchange and posterior capsulectomy.

It is my opinion, to the best degree of medical probability, that Dr. Anita Nevyas-Wallace deviated from acceptable standards of care in her surgical judgement in selecting Ms. Cheryl Fiorelli as a candidate for LASIK surgery given her extremely high myopia and astigmatism.

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Samuel F. Kafrissen, P.C. Page 6 April 6, 2001

The failure to obtain corneal pachymetry to accurately assess comeal thickness preoperatively even in 1997 was substandard. The creation of the LASIK flap was complicated by microkeratome failure and stoppage both on the forward and reverse passes as documented in the medical record. Actually, a nurse was controlling the foot pedals of the microkeratome and not the operative surgeon. Moreover, an unapproved laser ("black box laser") was used to perform the Excimer Laser ablation. This Excimer Laser ablation resulted in a markedly significant overcorrection and a post-operative topography indicating a significantly decentered ablation. It is my opinion, to the best degree of medical probability, that this marked overcorrection and decentration created by Dr. Anita Nevyas-Wallace's Excimer Laser treatment using the unapproved laser is the direct cause of Ms. Cheryl Fiorelli's irregular astigmatism and continued subjective visual disturbances in the right eye in association with markedly flat keratometry readings.

The decision to perform early clear lens extraction in a young patient with high myopia in her left eye carries a significant cumulative risk for retinal detachment in Ms. Fiorelli's lifetime. This is increased by the necessity for early YAG Capsultomy following placement of a silicone hap tic plate lens in a highly myopic young individual. Finally, a third major operation to exchange the intraocular lens of suboptimal power and extension of the posterior capsultomy can only increase the long term risk of retinal detachment for her left eye.

Mr. Kafrissen, your kind attention to this information regarding the ophthalmologic care provided to Ms. Cheryl Fiorelli by Dr. Anita Nevyas-Wallace, that in my expert medical opinion, falls below acceptable standards by reasonable practitioners is greatly appreciated. Moreover, Ms. Fiorelli's ongoing problems of poor quality of vision with subjective halos are a direct result of the substandard surgeries performed by Dr. Anita Nevyas-Wallace beginning in March 1997.

If you have any questions, please do not hesitate to contact me directly.

Sincerely,

signature on original scanned document

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Dr. Kenneth Kenyon's Reports

The following are scanned images of Doctor Kenneth Kenyon's reports regarding Keith Wills, another LASIK casualty.

(Click Page # to open in new window)

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The reports of Dr. Kenyon, Dr. Salz, and Dr. O'Brien clearly states the deviation from 'Standard of Care' by Drs. Herbert Nevyas and Anita Nevyas-Wallace of Nevyas Eye Associates.

 

I can only hope and pray that somebody out there will be able to help us, and if you're still not convinced of the risks:

Other horror stories:

www.lasikdisaster.com

www.lifeafterlasik.com

www.visionsimulations.com

www.lasikcourt.com

www.lasikmemorial.com

which are listed at http://www.escrs.org/eurotimes/March2003/primesite.asp also, as well as many others. There are casualties out there who have not posted sites, as well as many others who were offered out of court settlements, and not brought their cases to light due to confidentiality.