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This affidavit is from Dr. Stephen Orlin, an expert witness of the Nevyases 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. 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. DR. ORLIN TESTIFIES ON BEHALF OF NEVYAS
As Noted by Drs. James Salz, Terrence O'Brien, & Kenneth Kenyon regarding myself and two other LASIK casualties. All links will open PDF documents in a new window. 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.
DR. SALZ' REPORTS - RICH TEXT
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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 1
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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. 2
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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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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos
Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244
April 27, 2002 Steven A. Friedman, M.
D. Physician and Attorney at Law 850 West Chester Pike, 1st Floor Havertown, PA
19083 RE: Dominic Morgan v Nevyas Eye
Associates-report on standard of care deviations Dear Dr. Friedman: As you requested, I have examined
your client and reviewed the records you have forwarded to me over the last 3
months. This report will summarize what I believe to be deviations from the
standard of care by Nevyas Eye Associates in the treatment of your client,
Dominic Morgan. His examination will be summarized in a separate report.
1. Mr. Morgan was not an appropriate candidate for an FDA study
where the protocol lists under B, 6 "best corrected visual acuity of 20/40 or
better in both eyes". Even without the FDA study criteria, he would not be
considered a "good candidate for LASIK". Mr. Morgan stated very clearly in his
record and maintains by history that his best-corrected spectacle visual acuity
was never better than 20/50. He did have a refraction on March 10, 1998, which
showed a best corrected visual acuity of 20/40-2 in each eye. While this is
close to 20/40 it is not 20/40. A letter from Dr. Anita Nevyas to Dr. Bellin on
12-18-98 reported his preoperative vision as 20/40-2 to 20/50 and a letter to
Dr. DeJuan on March 27, 2000 reports his best-corrected visual acuity as 20/50.
A letter from Dr. Herbert Nevyas to Dr. Grace Tammera on 8/20/98 reported that
he had 20/50 vision in each eye with full correction before his surgery. This
fact combined with his history clearly noted in the record should have
disqualified him from an FDA study requiring best corrected visual acuity of
20/40 or better. Rather than emphasizing the likely increased risks of
performing LASIK in a patient with already compromised vision secondary to
retinopathy of prematurity (ROP), the notes at the Nevyas Eye Center state that
he is a "good candidate for LASIK". Exclusion criteria C, 5 of the protocol
lists the "Presence of any clinically significant abnormality on physical or
ophthalmic examination that would contraindicate outpatient refractive surgery."
ROP would be a clinically significant abnormality. I do not know of any surgeon
who has performed LASIK on a patient with Mr. Morgan's degree of ROP. He was
simply not an appropriate candidate.
1
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There are 3 problems with performing LASIK on eyes with ROP. The
first is that the retina is already compromised by the primary disease and the
increased pressure in the eye (often 3 to 5 times normal) can by itself damage a
normal retina and this risk would be increased in an already compromised retina
where the macula has been stretched or dragged temporally. Although exams by
retinal specialists has failed to document obvious retinal damage, one cannot
rale out hypoxic or pressure induced damage to the macular area during the
cutting of the flap which would account for his decreased vision.
He does now have abnormal electroretinograms as documented on
April 8, 2002 and February 20, 2000, which indicate abnormal rod and cone
function. This is not surprising in a patient with ROP but of course we do not
have pre LASIK studies to determine if these abnormalities were increased after
his LASIK. If a preoperative ERG was in fact abnormal, that would be an
additional reason combined with the clinical appearance and best-corrected
vision of 20/50 to exclude him from the study. If a preoperative ERG was normal,
we would then have objective evidence that the LASIK surgery caused it to become
abnormal. The second problem with a patient with ROP
is that optic nerve and the nerve fiber layer of the retina are more susceptible
to damage from the increased intraocular pressure from the application of the
suction ring. • Dominic does have abnormal optic nerves, which appear to by
hypoplastic in the photos from 4/6/98 at the Nevyas Eye Center and by my exam.
The report by Dr. DeJuan at Hopkins also describes "anomalous" optic discs.
These small hypoplastic optic nerves are more prone to damage during LASIK.
Cases of optic nerve damage have been reported following LASIK have been
reported even in normal eyes. The LASIK procedure can cause subclinical ischemic
damage to the optic nerve or nerve fiber layer of the retina but not enough to
result in obvious optic nerve atrophy or pupil defects. The visual field testing
(Goldman) performed at Wilmer shows paracentral scotomas in both eyes and the
interpretation by Dr. Zack on 12/6/99 describes, "specific loss including a
number of common disorders, most commonly glaucoma." Clearly Dominic does not
have glaucoma so these field defects point to damage from the increased
intraocular pressure during LASIK in an abnormal optic nerve. The GDX study from
March 27, 2000 also shows abnormal nerve fiber layers in both eyes which would
usually indicate glaucoma but here is simply an indication of his ROP. If
feasible I recommend Patterned Visual Evoked Potential testing to evaluate his
optic nerve function. The third problem with an ROP patient involves the
controversy of whether to center the excimer ablation over the pupil, as
recommended by Guyton Ellis and Hunter, or over the visual axis, as suggested by
Wachler and Buzzard. Although this argument is often moot in most normal eyes,
the dragged macula in ROP and the significant positive angle Kappa make this a
more significant decision in an 2
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ROP patient. Indeed, the inability of Nevyas to be certain where
to properly center the excimer ablation in an ROP patient is another reason why
LASIK was inappropriate. The topography following the LASIK appears to be well
centered over the pupil. Because Mr. Morgan visual axis or "line of sight" is
not looking through the center of the pupil, this may be partially responsible
for his visual aberrations and decreased vision. It does not appear that this
issue was ever discussed with Mr. Morgan as a potential problem with doing
surgery on him as opposed to a truly "good candidate. The Nevyas note of 4/27/98
mentions the "patient was looking nasal to fixation target intraop" and that
there was "temp decentration OS." It is possible that Mr. Morgan's line of sight
to his temporally pulled macula passes through a peripheral portion of his
ablation rather than the central portion and that may explain some of his
decreased vision and night symptoms of glare and ghost images. Under these
circumstances it may have been more appropriate to center his ablation over the
line of sight rather than the pupillary center. This mismatch between the center
of the ablation and the temporally displaced macula as a possible explanation
for Mr. Morgan's difficulties is also mentioned in the letter from Dr. DeJuan
and the letter from Dr. Paul Maurius Bear dated 7/21/99. 2. Violation of FDA and
Code of Federal Regulations on promotion and other practices. These regulations
state that the investigator shall not: "(a) Promote or test market an
investigational device until the FDA has approved the device for commercial
distribution and (d) Represent that an investigational device is safe or
effective for the purposes for which it is being investigated." Mr. Morgan
states and it is confirmed on his patient history dated 3/10/98 that he came to
the Nevyas Eye Associates because he heard a radio commercial on station KYW. I
have reviewed the script of radio advertisements, the Nevyas web pages, and a
promotional Videotape of a program that was shown on cable television and may
have been distributed to patients. I have been told that all of these materials
were used during the FDA investigation of the Nevyas Laser. None of these
materials included the FDA required warning that the device is limited to
investigational use only. The ads also represent that the procedure is safe, and
in fact the TV ad shows a simulated blurred 20/200 vision quickly dissolving
into a sharp 20/20 vision. There are numerous other representations that the
procedure is safe and effective. If patients were responding to these
advertisements and then were entered into the FDA study, that would represent a
serious deviation from the standard of care and one that I am sure the FDA would
be interested in these practices. It would also appear that the poor results
obtained by Mr. Morgan with the significant decrease in his best corrected
spectacle visual acuity of more than 10
3
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letters were not properly reported to the FDA and that more
patients were recruited for the study than were authorized by the FDA. 3.
Performing surgery on the right eye when the left eye sustained a loss of
best-corrected visual acuity from 20/40 -2 to 20/70. On 4/27/02 the clinical
notes state that the patient "feels vision is weaker since Fri. and night time
is a problem." The refraction was -0.25 -0.75 x 80 = 20/70 (the target for this
eye was mono vision for the left eye of about -2). Thus the patient had a
significant over response to the laser, had complaints about the quality of his
vision and his night vision, and had lost at least 2 lines of best-corrected
visual acuity. Despite these problems, Dr. Nevyas impression was that he was
"doing well" and recommended and performed LASIK surgery on the dominant right
eye on 4/30/98. The imbalance between the two eyes that the patient experienced
should have been corrected with a contact lens or glasses in the right eye while
the situation in the left eye was evaluated. The left eye eventually regressed
to about -1.25 so it may actually have been possible for him to continue simply
wearing glasses and a contact lens may not have been necessary. This is
especially true since the patient had a previous history of strabismus surgery
and he may not have had true stereopsis so the anisometropia may have been
easily tolerated and surgery on the right eye could have been deferred
indefinitely. 4. 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 and records review, I attribute his loss of
vision and visual complaints 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. Within
a reasonable degree of medical certainty, it is my opinion that LASIK caused all
the problems discussed above and in my report to occur. LASIK surgery usually
does not provide a patient with vision better than his or her best corrected
vision with spectacles or contact lenses. Although common, this surgery is not
without risk, and the practice is not to perform surgery on patients who already
have compromised vision secondary to severe eye conditions. By avoiding patients
whose vision is already compromised to this degree we leave the patient a
"safety net" in case the procedure leaves them with less than
4
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desirable results. Certainly Mr. Morgan's ROP places him within a
category of patients who needed that net, and Dr. Nevyas-Wallace took that net
away. Yours truly, James J. Salz, M. D. signature on original scanned document
Nevyas v. Morgan 5
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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos
Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244
September 16, 2002 Steven A.
Friedman, M. D. Physician and Attorney at Law 850
West Chester Pike, 1st Floor Havertown, PA 19083 RE:
Reply to defense expert reports Dear Dr. Friedman:
I have reviewed the additional documents you forwarded to me.
These documents include: deposition testimony of Drs. Herbert Nevyas, Anita
Nevyas, Joan Nevyas, John Dugan, Sheldon Morris, Ira Wallace, Edward Deglin,
Richard Sterling, MRI reports, IME report of Dr. Stephen Orlin, his patient
information guide, web page document as well as some FDA documents and
appointment documents for Herbert and Anita Nevyas to the Pennsylvania Eye
Surgery Institute. The review of these additional records does not change any of
the opinions previously expressed in my original report. I have also reviewed
the expert report of Dr. Stephen Orlin and Dr. Amos Willis about your client
Dominic Morgan. Dr. Orlin focused on 4 aspects of Mr. Morgan's condition.
1. Progressive cataract formation. I agree with Dr. Orlin that
Mr. Morgan's "nuclear sclerotic" cataracts are minimal, not responsible for his
visual loss, non- progressive, and not related to his Lasik surgery.
2. Retinal damage. I agree with Dr. Orlin that Mr. Morgan's past
ophthalmic history was complicated and significant for Retinopathy of
Prematurity (ROP). I would agree that there was no medical reason to evaluate
his retina for his retinopathy of pre-maturity (ROP) if surgery was not being
contemplated. The term retinopathy in his diagnosis of ROP means the retina is
abnormal. Lasik is customarily performed on patients with normal retinas and so
there would be no deviation of the standard of care to not perform visual field
testing and ERG's on patients with normal retinas undergoing Lasik. This was not
the case with Mr. Morgan, however. Since his retina was abnormal, with a pulled
macula and decrease in his best corrected visual acuity non invasive testing
like visual fields and ERG would have been a valuable way to assess the extent
of his damage. Dr. Orlin's patient information guide about laser vision
correction states in response to the question How do I know if I am a good
candidate for laser vision correction? "Patients who are 21 years of age or
older, and have healthy eyes which are free of retinal problems, corneal scars,
and any eye disease are suitable." 1
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It is simply not within the standard of care to perform LASIK on
patients' with ROP like Dominic. Nevyas's own protocol and criteria are written
evidence confirming this standard of care. During the LASIK procedure the
intraocular pressure is raised 3 to 4 times the normal value. Optic nerve damage
and retinal damage have rarely been described as a complication of LASIK in
normal eyes. Since there is no other explanation for his decreased vision, it
has to be concluded that the procedure damaged his already abnormal retinas and
optic nerves. Mr. Morgan could not give informed consent since his ROP should
have excluded him from surgery and he was not given that information. It is
clear that Dominic would not have been harmed had he not undergone the LASIK
surgery. The fact that Dominic can read 20/40 on a near vision test certainly
does not mean he has 20/40 distance vision as Mr. Morgan has residual myopia and
is thus receiving a magnified near image. The fact that he voluntarily read
20/40 at near gives evidence that he is giving us an honest examination and is
not trying to make his condition appear to be worse than it is. It is not
uncommon for nearsighted patients to have better uncorrected near vision than
their best corrected distance vision. 3. Ablation centration. Mr. Morgan's postoperative topography merely shows that
his ablations are centered over his pupils, not necessarily over his line of
sight. . In most patients, the difference between centration over the pupils vs.
the line of sight is minimal but in Dominic it was significant because of his
ROP and markedly abnormal positive angle kappa. I would agree that the lack of
improvement in his vision with a hard contact lens rules out significant
irregular astigmatism as a cause. It does not preclude loss of vision caused by
the fact that he is not looking through the optical centers of his ablations,
which are centered over his pupils. He is looking through a peripheral area of
the ablation, rather than the center of the ablation. The lack of improvement
with a hard lens does point to damage to the retina, nerve, or both as the
primary cause for most of his impairment.
4. Aberrations. I would agree that the higher order aberrations
are not responsible for Mr. Morgan's daytime vision but they do provide
objective evidence of his night vision complaints. He most likely would have had
the same increase in night aberrations whether or not he had ROP. He was at
increased risk of these aberrations because of his large scotopic pupils
(6.5mm). In his report dated May 29th, 2002 Dr. Willis states that 20/40 -2
would be considered by most physicians to represent 20/40 visual acuity. Most
physicians have not conducted and are not familiar with PDA studies. Mr. Morgan
was being enrolled in an PDA study, which specified a minimum requirement of
best-corrected vision of 20/40. It did not specify vision of approximately
20/40, around 20/40 or 20/40-2. It is very simple, the 20/40 criteria can be
20/40 or 20/40 +1 but it cannot be 20/40 -2 or -3. I have been involved in 7 PDA
studies of laser vision correction as principal investigator so I am very
familiar with the PDA requirements. Mr. Morgan should have been disqualified
from consideration based on this fact alone.
2
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Dr. Willis also tries to cloud the issue about what is a
clinically significant abnormality and its role as an exclusion criteria. He
admits that ROP is a clinically significant abnormality and goes on to say it
does not contraindicate refractive surgery because "no one has a significant
degree of experience in operating on patients with ROP." That is precisely the
point. Mr. Morgan was told he was a "good candidate for LASIK." In fact, Mr.
Morgan became a human subject for the study of LASIK in a patient with ROP. The
Nevyas FDA study was designed to test their laser in normal myopic eyes. Mr.
Morgan did not consent to be in a study of LASIK in patients with ROP to see
what would happen. Had he been in such a study, a responsible IRB and the FDA
would have had serious concerns about proceeding with such a study, particularly
in both eyes of a patient until the preliminary results in at least one eye
could have been evaluated. The informed consent would have been much different,
as would the discussion of risks and benefits in the informed consent. When we
first began investigations in laser vision correction (PRK) in 1990, the FDA
required waiting 6 months between eyes and these were normal eyes. Performing
Lasik in Dominic Morgan was a violation of the FDA protocol. Even if the
protocol never existed, performing LASIK on Dominic Morgan was a serious breach
of the ophthalmic community standard of care. Dr. Willis also states that it is
not uncommon for Lasik patients to have continued improvements with time.
Although that may be true to a minor degree with some patients, in my experience
with thousands of patients, a decrease in best corrected vision to the 20/70 to
20/80 level 4 to 5 days after surgery, even in a normal eye, should have been a
red flag to not proceed with surgery on the other eye until the outcome was more
clearly established. In the vast majority of patients, a 3 to 4 line loss in the
best-corrected vision several days after surgery in the absence of obvious
causes such as dry eye, striae, or inflammation, is a serious cause for concern
and surgery on the second eye should have been deferred. Mr. Morgan was not
informed that surgery on his dominant eye should be deferred until the result in
his left eye was well established. In fact, he was misinformed that the initial
loss of vision in his left eye was temporary and that it was appropriate to
proceed with surgery in his second eye. This represents an additional lack of
informed consent and an additional failure to meet the proper standard of care.
In summary, the reports by Dr. Orlin and Dr. Willis do not change my opinions
about the deviations from the standard of care by Dr. Nevyas and the damages to
Mr. Morgan, which resulted from his Lasik surgery. Sincerely, James J. Salz, M.
D. signature on original scanned document Nevyas v. Morgan
3
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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos
Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244DECLARATION OF JAMES J.
SALZ, M.D. I, James J. Salz, M.D. make this
declaration subject to the penalties of 18 Pa.C.S.A. Sec. 4904 relating to
unsworn falsification to public authorities: 1. I
update my curriculum vitae and that of Dr. O'Brien: I am Chair and Dr. O'Brien
is Secretary of the International Society of Refractive Surgery/American Academy
of Ophthalmology Executive Committee for 2003. Dr. O'Brien and I are both well
acquainted with the standards of care regarding the selection of patients for
LASIK. 2. Dominic Morgan had (and still has)
Retinopathy of Prematurity (ROP), a disease of the retinas caused by premature
birth. In other words, Dominic had significant preexisting retinal disease.
3. Everyone agrees Mr. Morgan's ROP was significant. Defense
expert Dr. Orlin stated, "His past ophthalmic history was complicated and
significant for retinopathy of prematurity." [Orlin report 2/1/02, p.l, emphasis
added] Defense expert Dr. Willis stated, "ROP is a clinically-significant
abnormality in the sense that it represents a preexisting abnormality in the
eye..." [Willis report 5/29/02, p. 1, emphasis added]
4. The patient information brochure distributed by defense expert
Dr. Orlin to his patients warns, "Laser vision correction is not for
everyone....Patients who are 21 years of age or older, and have healthy eyes
which are free of retinal problems, corneal scars, and any eye disease are
suitable." [Laser Vision Correction/LASIK brochure of Scheie Eye Institute,
pp.1, 13, emphasis added] 5. Defendant Nevyas-Wallace
claimed that she "used," " followed," and "adhered to" [Nevyas- Nevyasx
deposition p. 103] her written protocol calling for exclusion of any person who
had, "any clinically significant abnormality on physical or ophthalmic
examination that would contraindicate outpatient refractive surgery." [Nevyas-Wallace's
protocol for LASIK, Exclusion Criteria, emphasis added]
6. LASIK is elective surgery. Because it is elective, the
standard of care requires a high degree of predictability of results. People who
are candidates for LASIK are those with conditions for which there is adequate
experience to predict (not guarantee) a good result. It is not the standard of
care to say, as does defense expert Dr. Willis, "The fact that no one has a
significant degree of experience in operating on patients with ROP does not
suggest that it is inappropriate to perform elective surgery on these patients."
[Willis report 5/29/02, p. 1] To the contrary, no one (except Nevyas-Wallace)
has any experience performing LASIK on patients with ROP, so no one can predict
a good result, and it is below the standard of care to perform the surgery.
--------------------------------------------------------------------------------
7. Dr. Willis' statement is incorrect and disingenuous; as I
previously reported, there are no reports in the literature of anyone ever doing
LASIK on a patient with ROP like Dominic. As I previously reported, I am unaware
of any ophthalmic surgeon ever having done LASIK on a patient with ROP like
Dominic. During the last two years as I have traveled around the country,
including Philadelphia, I have asked other ophthalmic surgeons if they were
aware of such a thing, or would do such a thing. The answers are uniformly no;
everyone believes it is predictable that a poor result would be the likely
outcome. 8. Since performing elective
LASIK on virtually any significant eye or retinal abnormality or disease is
below the standard of care, the ophthalmic community literature does not
piecemeal list each significant eye or retinal abnormality or disease "in and of
itself." The literature employs more useful generic categorical warnings.
9. As I previously reported, there are multiple reasons why
performing LASIK on Mr. Morgan was below the standard of care. These included:
A) doing his dominant right eye one week after getting poor
results in the left eye. I previously reported why going ahead with the right
eye in the face of poor results in the left was below the standard of care.
B) violating Nevyas-Wallace's own written protocol requiring
pre-operative best corrected visual acuity (BCVA) in both eyes of 20/40 or
better. I previously reported that it is below the standard of care not to
follow one's own protocol. C) failing
to provide a "safety net." I previously reported that the standard of care is to
provide a "safety net" in case the procedure produces less than desirable
results. By doing LASIK in Mr. Morgan with his significant pre-existing ROP, by
violating Nevyas-Wallace's own written protocol requiring pre-operative BCVA in
both eyes of 20/40 or better, and by operating when a good result could not be
predicted, Nevyas-Wallace took away that safety net.
D) uncertainty how and where to center the laser ablation.
E) barotrauma (i.e. pressure trauma) during application of the
suction ring or cutting of the corneal flap, causing further damaging to
pre-existing damaged retinas and optic nerves.
10. At the risk of repeating what I previously reported, I
address the last two items. 11.
Uncertainty how and where to center the laser ablation:
a) As I previously reported, there is an argument in the
literature about how and where to center the laser for doing LASIK in normal
eyes. Some ophthalmic surgeons prefer to center the laser ablation over the
pupil, as recommended by Guyton, Elk's and Hunter. Others prefer to center the
laser ablation over the visual axis or "line of sight," as recommended by
Wachler and Buzzard. Each claims that its method of centration is better. In
normal eyes this argument is of little practical consequence because people with
normal retinas essentially see through the pupil center. Thus, either way, the
area of laser ablation ends up being virtually identical.
b) In ROP patients this literature argument would be an issue of
great importance because nobody knows how or where to properly center the laser
ablation.
--------------------------------------------------------------------------------
c) Unlike people with normal retinas who see through the pupil
center, those with ROP see nasally to the pupil center. Because the macula is
dragged temporally and has a positive angle kappa, the visual axis or "line of
sight" is shifted nasally. In other words, the potential areas of laser ablation
would be quite different from each other.
c) Dr. Willis tries to minimize this literature argument and
important issue by writing, "Though some controversy exists as to whether
centration on the pupil is appropriate, opinions generally favor centration on
the visual axis." [Willis report 5/29/02, p. 2]
d) The point is that nobody knows how or where to properly center
the laser ablation in patients with ROP. Nobody has adequate experience to
predict a good result, and thus nobody can properly say that a ROP patient is a
"good candidate for LASIK." For this reason alone, LASIK in ROP is below the
standard of care: 12. Barotrauma:
a) As I previously reported, during LASIK a suction ring is
placed on the eye to flatten the cornea and keep the eye from moving. The
increased pressure on the eye, often 3 to 5 times normal, can damage even a
normal retina or optic nerve. From the time the suction ring is put on the eye
until it is removed, vision appears dim or goes black.
b) World-wide literature documents barotrauma damage during LASIK
even in eyes without any pre-existing retinal or optic nerve abnormality. As
examples I refer to Principles and Practice of Refractive Surgery (USA), Lasik
Principles and Techniques (USA), Laser in Situ Keratomileusis-induced Optic
Neuropathy (USA), Bilateral macular hemorrhage after laser in situ
keratomileusis (Argentina), and Macular hemorrhage after laser in situ
keratomileusis for high myopia (France).
c) Nevyas-Wallace's own Bilateral Simultaneous Lasik patient
information form states that this significantly increased pressure during LASIK
can damage even a normal retina. d)
Dominic had "clinically-significant... pre-existing abnormality in the eye..."
[Willis report 5/29/02, p. 1] The retinas were clearly damaged with retinopathy.
The maculas were dragged temporally, meaning the optic nerves were abnormally
stretched, and also dragged temporally. As I previously reported, Dominic had
abnormal optic nerves, which appeared to be small and hypoplastic in the
pre-operative photos 4/6/98 at the Nevyas Eye Center and by my exam. The report
by Dr. DeJuan at Johns Hopkins described "anomalous" optic discs..
e) Pre-existing retinal and optic nerve abnormalities make eyes
more susceptible to virtually any kind of trauma, including barotrauma. The
ophthalmic community literature does not piecemeal list each significant eye or
retinal abnormality or disease "in and of itself," but employs more useful
generic categorical warnings. Barotrauma is one of these generic categorical
warnings, and is widely written about - somebody is always being punched in the
eye, etc. f) Even if there were nothing
in the literature about barotrauma aggravating preexisting retinal and optic
nerve abnormalities (and there is), the point remains that nobody has adequate
experience to predict a good result, and thus nobody can properly say that a ROP
patient is a "good candidate for LASIK." For this reason alone, LASIK in ROP is
below the standard of care.
--------------------------------------------------------------------------------
13. Because nobody could legitimately predict a good result for
DM, and he was not a fit candidate for LASIK, DM was a human "guinea pig. Dated:
signature on original scanned document Nevyas v. Morgan
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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos
Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244
DECLARATION OF JAMES J. SALZ, M.D.
I, James J. Salz, M.D. make this declaration subject to the
penalties of 18 Pa.C.S.A. Sec. 4904 relating to unsworn falsification to public
authorities: 1. I update my curriculum
vitae and that of Dr. O'Brien: I am Chair and Dr. O'Brien is Secretary of the
International Society of Refractive Surgery/American Academy of Ophthalmology
Executive Committee for 2003. Dr. O'Brien and I are both well acquainted with
what is meant by "healthy" or "stable" retinas.
2. "Health" means "free from disease." "Healthy" retinas means
retinas "free from disease." 3.
"Stable" means "staying unchanged." "Stable" retinas means retinas "staying
unchanged." 4. Defense expert Dr. Orlin
distributes a brochure for patients in his office warning, "Laser vision
correction is not for everyone...Patients who are 21 years of age or older, and
have healthy eyes which are free of retinal problems, corneal scars, and any eye
disease are suitable." [Laser Vision Correction/ LASIK brochure of Scheie Eye
Institute, pp. 1,13, emphasis added] The brochure states, "This booklet... is
for informational purposes only." [id, p.2]
5. Everyone agrees Dominic Morgan's Retinopathy of Prematurity (ROP)
was significant. Dr. Orlin stated, "His past ophthalmic history was complicated
and significant for retinopathy of prematurity." [Orlin report 2/1/02, p.l,
emphasis added] Defense expert Dr. Willis stated, "ROP is a
clinically-significant abnormality in the sense that it represents a
pre-existing abnormality in the eye..." [Willis report 5/29/02, p. 1, emphasis
added] 6. Dr. Orlin's statement, "Mr.
Morgan's retinas were 'healthy' for the purposes described in the brochure" is
illogical. Retinas are either healthy or they are not. Dominic's retinas were
clearly not healthy "for the purposes described in the brochure" or any other
purpose. 7. Dr. Orlin's statement, "The
statement made in the brochure does not apply to stable retinas, such as the
retinas of the plaintiff at the time he underwent LASIK..." is also illogical.
It equates stable retinas with healthy retinas, and that is simply not correct.
Stable retinas does not mean healthy retinas.
--------------------------------------------------------------------------------
8. While knowing if Mr. Morgan's retinas were "stable" at the
time he underwent LASIK is useful, it is not the issue at hand. Whether the
retinas were stable or not before LASIK, the retinas were certainly not healthy
or normal before LASIK, and the real issue is would those abnormal retinas be
"stable" after LASIK? They would not, and it was predictable they would not,
causing Dominic's visual problems. 9.
There are only so many ways I can say it: Doing LASIK in a ROP patient like
Dominic is below the standard of care. Dr. Orlin is, no doubt, embarrassed that
his patient brochure contradicts his position in this case, but the fact is the
brochure is accurate, and Dr. Orlin is trying to avoid his own contradiction.
Dated: signature on original scanned document Nevyas v. Morgan
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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos
Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244
DECLARATION OF JAMES J. SALZ, M.D. I,
James J. Salz, M.D. make this declaration subject to the penalties of 18
Pa.C.S.A. Sec. 4904 relating to unswom falsification to public authorities:
1. I update my curriculum vitae and that of Dr. O'Brien: I am
Chair and Dr. O'Brien is Secretary of the International Society of Refractive
Surgery/American Academy of Ophthalmology Executive Committee for 2003. Dr.
O'Brien and I are both well acquainted with how medical diagnoses are made by
ophthalmologists. For the most accurate diagnoses, the entire medical record
should be available. 2. 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, 3. The only persons to review
copies of the entire medical records appear to be Dr. O'Brien (after he became
an expert) and me. I am not certain what Dr, Orlin and Dr. Willis reviewed. The
early post-LASIK period; 4. 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),
5. Three other ophthalmologists seeing Dominic after LASIK, 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. 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;
6. 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, "1 can say that the LASIK
surgery looked like it was done appropriately; and that as for 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 Joss
of visual acuity, he said, "I don't know."[deposftion Laibson p.26J When further
pressed by defendants, he questioned the accuracy of defendant's medical
records: "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 plaintiffs 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]
7. Nevyas-Wallace wrote (medical record 3/8/99): ""Phone call
from patient...He says Dr. Michael Belin and Dr. Pater Laibson each said the
cornea looks fine and that the problem must be retinal." Thereafter Nevyas-Wallace's
continued to assure Dominic that his problems would clear up with time, but what
was written in Nevyas-Wallace's medical records changed,
8. Sheldon Morris, M.D. wrote (medical record 4/17/00): “Low VA
[visual acuity] related to retinal problems." 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]
9. Herbert Nevyas wrote (medical record 4/26/99): 'Impression:
Retinal problem Rule out hysteria," 10.
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."
11(A). Herbert Nevyas wrote (medical record 7/26/99):
"Impression: Topography shows central ablation, and no increase (in vision) with
contact lens. Therefore, problem is retinal."
(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 retinopatby 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- Nevyasx p. 212]: "I
discussed matters in detail and I explained to him that I agreed with Dr.
Laibson and Dr. O'Brien and Dr. Bella in their assertions that both the
appearance of the cornea and the cornea! 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."
12. 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 11/29199)
13. 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,"
14. 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] Dr, Guyton
stated that the other thing which was decreasing Dominic's vision, which he
deduced by a process of elimination [Guyton deposition p. 45] was barely visible
cataracts (unrelated to LASIK), and suggested waiting [two yean] 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).
15. 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 there were cataracts, but did not regard waiting as unreasonable.
16. When 1 examined Dominic 4/27/02 it was almost 2 years after
Dr. Guyton and there was no progression. As I previously reported, ray opinion
is that there are no cataract problems, and Dominic's problems are 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 me and became a plaintiff expert.
18. Defense expert Dr. Orlin examined Dominic 1/30/02, 2 1/2
years after Dr. Guyton, and stated, ''over the past two years, these have
remained minima] and non-progressive," [Orlin report 6/12/02, p. 2] and neither
be nor defense expert Dr. Willis suggested any cataract problems.
Dated: signature on original scanned document Nevyas v. Morgan
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Beverly Hills Eye Medical Group, Inc.12561 Promontory RoadLos
Angeles, Ca. 90049Phone 323 653-3800 Fax 310 472-4244DECLARATION OF JAMES J.
SALZ, M.D. I, James J. Salz, M.D. make
this declaration subject to the penalties of 18 Pa.C.S.A. Sec. 4904 relating to
unsworn falsification to public authorities:
1. I update my curriculum vitae: I recently wrote a chapter for
an ophthalmology text scheduled for publication in the near future, in which I
discuss the advantages of performing LASIK in each eye on separate days, and I
reviewed the studies and literature on this subject.
2. Two advantages Nevyas-Wallace lists for performing LASIK hi
each eye on separate days, are (1) "The
doctor can monitor the hearing process and visual recovery hi the first eye and
may be able to make appropriate modifications to the treatment plan for the
second eye, increasing the likelihood of a better outcome in the second eye,"
and (2) 'You will be given the
opportunity to determine whether the LASIK procedure has produced satisfactory
visual results without loss of vision..." [Nevyas-Wallace's Bilateral
Simultaneous Lasik patient information form, p.2]
3. Nevyas-Wallace misinformed Dominic, despite the initial poor
result in his left eye, that he was "doing well," and recommended and performed
LASIK surgery on the dominant right eye one week after the left eye.
4. Dominic thus lost the opportunity to "save" his dominant right
eye. 5. As I previously reported, this
was below the standard of care, and is another example of Nevyas-Wallace taking
away the safety net. Dated: signature on original
scanned document Nevyas v. Morgan
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