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
Dr. Terrence O’Brien’s Reports re Fiorelli v Nevyas
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.
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
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
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
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 postÃƒÆ’Ã¢â‚¬Å¡Ãƒâ€šÃ‚Âoperative 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.
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.
signature on original scanned document
Keith Wills' Experience
LASIK Gone Wrong
What happened to Keith Wills
When EYES, Windows To The Soul, are broken
By Jo Wills
My husband, Keith R. Wills went to Dr. Herbert Nevyas of Bala Cynwyd, PA, for an evaluation to determine if he was a candidate for LASIK surgery on July 26, 1997. Dr. Robert Levy of Burlington, NJ, recommended Dr. Nevyas, a doctor that was performing LASIK in the area, evaluate Keith for LASIK surgery.
LASIK surgery was scheduled to be performed on my husband’s first eye on August 28, 1997, and the second was scheduled for September 11, 1997. Dr. Nevyas and Dr. Sterling were both present when Keith and I discussed his need to see in detail since he was an amateur astronomer and worked with small parts and wires in computers. Keith discussed his new purchase of a telescope and how his job duties required clear vision. He was told that his vision would be “crystal clear”. Dr. Nevyas even patted my husband on the back and speaking to me said we’ll “take care of this big guy”. Dr. Nevyas followed up with a letter dated July 26, 1997 to Dr. Robert Levy; stating that Keith was an “excellent candidate for LASIK surgery.”
Dr. Nevyas did not inform us that he was using laser that did not have FDA approval. None of the information that he provided prior to the day of the surgery indicated that my husband was going to be a “guinea pig” for the Doctor’s own financial advancement. Apparently he wanted his invention approved by the FDA and then he could market the device as he had done with his other inventions.
One day we got a call and a representative from the doctors office told us that the surgery was going to be delayed because the FDA “had to approve” Keith’s surgery since he had a high degree of myopia. The first surgery was initially scheduled for August 8, 1997 and was pushed back to October 7, 1997. When he was informed that the delay continued, Keith became extremely concerned and had a “gut” feeling that the delays were an indication that he shouldn’t have the surgery. He was concerned about the possible problems that could result from this surgery so he told them he was canceling the surgery. Dr. Nevyas was so concerned over Keith canceling his surgery that he called and went over Keith’s concerns at length. He told my husband that since he was an “excellent candidate” and he had virtually no chance of having any of the problems that he was concerned over. The doctor was aggressive in his attempt to “save” his business and assured my husband that he was not going to have complications so that he would agree to continue with the scheduled surgery. Before the doctor would perform any surgery, we had to submit $5,000.
On the day of surgery, my husband was picked up at our home by a van that was provided by one of Doctor Nevyas’ holdings, The Delaware Valley Laser Institute. The doctor now had a captive audience.
Dr. Nevyas had told Keith that he was not to be concerned about the adverse conditions listed in the “Informed Consent” document that the doctor had Keith sign. [How can a patient have informed consent when a doctor makes verbal representations that differ from the document that he requires his patient to sign before he will perform surgery?]
On October 7, 1997, my husband was seated in the operatory chair and the laser was set in front of him. He was told to look at the red light in the laser, but he told Dr. Nevyas that he could not see the red light. There was some whispering but Keith could not determine what was being said and then the Dr. Nevyas asked him if he could see the red light again and Keith responded “no”. Then Dr. Nevyas told Keith to look straight ahead and not move his eyes. He told the doctor that he couldn’t see so he wasn’t sure if he was looking straight ahead. Dr. Nevyas proceeded with the surgery anyway. AN ADVERSE EVENT!
The same happened during the surgery on his other eye on October 9, 1997. He again could not see the red light but Dr. Nevyas performed the LASIK any way. ANOTHER ADVERSE EVENT!
When the LASIK surgery did not turn out as was expected and Keith was not able to see clearly, Dr. Nevyas performed additional procedures to correct the problems that were created by the LASIK surgery. Each succeeding surgery was called an “enhancement” where the doctor told Keith he would “fine tune” his sight. Enhancements created new problems. When my husband would ask at each visit why he was not seeing any better, Dr. Nevyas would tell Keith to “be patient, it takes time”. The doctor would see Keith at specific intervals, having him wait until each procedure healed.
When another doctor told Keith that his eyes would not get better, and that there was virtually no cornea left to correct, Keith sought the advice of an attorney. A lawsuit was filed in Philadelphia, PA. We were told that the doctor’s malpractice insurance company was bankrupt and that the State’s insurance fund would cover the liability up to a certain limit. If we did get a settlement, no matter how high, it was limited by the State fund’s maximum coverage.
We got our day in court in December 2003, the trial started off with Dr. Levy, Keith’s treating eye doctor testifying against Dr. Nevyas. Dr. Kenyon, an expert witness, from Boston, MA, followed explaining that Keith was injured by the LASIK surgery. Both Keith and I testified. Dr. Nevyas’ expert witness testified at night and the video taped testimony was presented to the jurors the next day. The main point that I got from his testimony was that even Dr. Nevyas’ own defense expert did not agree with Dr. Nevyas and that this expert was confused on pertinent matters.
Then it was Dr. Nevyas turn to defend himself, and he testified that he didn’t have to report my husband's failed surgery as an adverse event. His reasoning was that he had to perform additional surgery on Keith to correct his eyes so he took Keith off the “investigational device study” and did not report his adverse events. He didn’t report Keith’s surgery to the FDA at all.
The purpose of the FDA “investigational device study” is to see if the FDA should approve the equipment for use. He should have noted on the report that Keith, a patient entered into the study had an adverse event and required further surgery which would preclude him from being reported in follow up reports for the study. Keith should not have been dropped off the report, which hid the fact that there was a problem with the laser. The FDA does require that all “adverse events” be reported, not excluded/covered up as had happened in this matter. [I wonder how many other adverse events weren’t reported because Dr. Nevyas had his “own” interpretation of the study requirements.]
I made numerous contacts with the FDA regarding this matter, but have been unable to get anything from them. The FDA has stated that it has previously investigated the Nevyas Laser and will not investigate unless new information is presented. I informed the FDA that we have new information that they did not have previously, the failure of the doctor to include "Adverse Events” on my husband and why. I am disturbed that an agency that is supposed to protect the public from injury by medical equipment, will not address our concerns.
Keith was not able to see the red light in the laser. He was not a candidate for the surgery. He did not give his informed consent.
The FDA requires many documents to be signed before a doctor can enter into an “investigational study” and use equipment that has not been FDA approved. The documents I have seen do not have the required signatures, but the Doctor continued to use his invention, refusing to sign a document that was to be part of an agreement. The FDA should have reviewed Dr.’s files, reports and agreements to determine if he was following the rules, regulations and laws set forth to protect the public.
Since my husband’s surgeries were never reported as adverse events, Dr. Nevyas failed to report as required by law and his agreement, which included parts that he refused to sign. He covered up the problems of his laser by reporting to the FDA that there were NO ADVERSE events on all his reports to them.
Documents that Dr. Nevyas filed the following year indicated that he made a change from the red light in his laser to a green light; he didn’t just make this modification without a reason. The red light was difficult for some patients to see so he made a modification to his laser, my husband was one of those people and now his eyes are permanently damaged.
Is there a pattern here? Dr. Nevyas lied to my husband about “informed consent issues” to convince him to have the surgery. When the Doctor submitted reports to the FDA that omitted required information, he covered up a severe disabling event. It doesn’t even stop here, in Civil Court, Dr. Nevyas lied under oath about the fact that he was not required to report my husband as an adverse event to the FDA. Lies, Lies, Lies.
Just one month before our trial, a Louisiana doctor was found guilty of violations of the same federal laws. The FDA publication, P03-92, dated November 5, 2003 states that a Louisiana Doctor was violating federal laws related to the conduct of clinical studies. FDA Commissioner Mark B. McClellan, M.D., Ph.D. made this statement: “This penalty sends a clear message that FDA will not tolerate conduct that can put patients at risk and erode the trust between research subjects and the medical research community.” For example, studies of high risk devices such as ophthalmic lasers must be conducted according to an investigational plan reviewed and approved by FDA and an investigator must obtain informed consent from each participant. In addition, the device cannot be used on patients before the study begins. The Louisiana Doctor’s violations are listed below and almost mirror what happened to my husband when he went to Dr. Nevyas.
· Used an unapproved laser on patients before the study began;
· Treated more subjects than allowed under the study plan that was approved by FDA;
· Ignored parameters of the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients;
· Failed to submit complete, accurate, and timely reports to FDA about the ongoing study; and
· Misrepresented that he was using an FDA-approved laser to treat patients when, in fact, the procedures were performed with an unapproved, experimental laser.
The Nevyas Excimer Laser’s ablation [removal of tissue from the body by surgical or other means] zone was 5 mm, and my husband pupils were 6.25 mm, which is considered relatively large. Using a laser on a patient with pupils larger than the laser’s ablation zone was known to cause the same problems that my husband suffers from. Clearly Dr. Nevyas should have informed my husband that this almost guaranteed that he would have an adverse result. Due to the fact that Keith had large pupils, Dr. Nevyas should never have considered Keith a candidate for LASIK let alone report that he was an “EXCELLENT CANDIDATE” as in the letter to Dr. Levy.
Dr. Nevyas did not perform the Pachemetry test, it has been indicated by experts that this test would have shown that my husband was not a candidate. My husband’s cornea is now too thin to perform further corrections to his eyes.
On 7/21//97, we visited a website “QuackWatch”, where Dr. Herbert J. Nevyas, MD, authored a page on Refractive Surgery. It stated: “Laser-in-situ keratomileusis (LASIK): The first corneal flap is made as in ALK, and an extremely precise underlying cut is made with an Excimer Laser. LASIK techniques can be used to correct astigmatism and farsightedness as well as myopia. The results are nearly always predictable, there is no postoperative discomfort, and glare is uncommon. The operation is preferred by eye surgeons throughout the world who have sufficient experience and have access to the necessary equipment. Several eye-surgery centers in the United States have FDA approval to perform LASIK, and some individual ophthalmologists have acquired unapproved but high-quality devices through foreign channels.”
“About the Author:
Dr. Nevyas, who specializes in refractive surgery, is Clinical Professor of Ophthalmology at the Medical College of Pennsylvania. His main office and ambulatory surgical center is located in the Philadelphia area at Two Bala Plaza, Bala Cynwyd, PA 19004. Telephone: (610) 668-2777.”
Only recently when I searched the “QuackWatch” website I discovered it is operated by Dr. Stephen Barrett who married Judith Nevyas and they live in a suburb outside of Philadelphia. When the above article was published on the website, it appeared to be an official site endorsing Dr. Nevyas by allowing him to publish with them since they had investigated Dr. Nevyas as an authority on the matter. It appears that I was misled and this was only a “health promotional” site for a family member.
On 2/13/2003 that same website included a revision dated 4/24/1999, which included an expanded list of complications. [This may have been a result of lawsuits filed against Dr. Nevyas and his associates.]
I would like to know why we were not protected against this doctor and why the FDA failed us in this matter. We tried to obtain copies of the official documents to use in our medical malpractice lawsuit, but the FDA, stated they were confidential and they would not be released.
Those documents could have been presented to the jury showing that this was not an approved laser, and that the doctor had even misled the government by providing inaccurate reports, documents and representations.
After the civil court trial was over, jury members stated that if they had known this information it would have changed their decision. The documents were requested from the doctor but he refused to present them in court. They were requested as part of the pre-trial discovery, but not submitted by either the doctor or the FDA. Just prior to the doctor’s testimony, my attorney informed his attorney to bring the documents to court but they were never provided.
I have contacted numerous local agencies; the Attorney General’s of NJ and PA, the Court System, even the local authorities. Each has told me that the FDA is the agency responsible in this matter. The FDA claims no responsibility; they oversee equipment, not the doctor’s use or practice.
We are a family of 4, two teenage girls who have not been able to spend time with their daddy doing things they enjoy. I have a husband that is no longer the man I married, he cannot enjoy his hobbies and interests and it interferes with the way my husband performs his job duties. I am concerned that we have had to radically change our way of life, not because of an accident, or the aging process, but because someone willfully misled my husband changing the way we all live.
After seeing what happened to Martha Stewart for lying to investigators, I cannot understand why this doctor gets away with his actions, ones that caused actual physical pain and permanent disability to other human beings.
Any assistance in helping us understand why the “system” failed us along with any recommendations as to a direction we may take would be appreciated.
You can visit the Wills' webpage Here
Mr. & Mrs. Wills were also threatened with a lawsuit by the Nevyases attorneys:
Your essay above referred to is replete with false and defamatory statements maliciously designated to injure Dr. Nevyas and Nevyas Eye Associates. Initially you falsely state that Dr. Nevyas stated that your husband's vision would be "crystal clear" and further stated that Dr. Nevyas said "we'll take care of this big guy".
Both of the statements are false. Dr. Nevyas never made any such statements.
You further state that "Dr. Nevyas did not inform us that he was using [sic] laser that did not have the FDA approval."
This statement is false and defamatory because Dr. Nevyas did have FDA approval to use his laser under an investigational device exemption. You know this to be true and therefore falsifying the statement in your essay can only be malicious.
You further state that Dr. Nevyas wanted FDA approval for his laser or because "then he could market the device as he had done with his other inventions."
This statement is false and defamatory. Dr. Nevyas requested an investigational device exemption only for use in his own practice. He did not seek approval to commercially market his laser. Your husband was part of the study which was fully and completely explained to him in writing and nothing that Dr. Nevyas did treated your husband as a "guinea pig" which you falsely and maliciously assert. The study was fully approved by the FDA. In addition, Dr. Nevyas did not call either you or your husband to try to persuade either you or your husband to have the Lasik Surgery. Sending a van to pick up your husband for Surgery was a service provided by Dr. Nevyas for your husband's benefit. He was not required to use the services of a van, nor was he at any time or in any way prevented from leaving Dr. Nevyas' office or the surgical center or notifying Dr. Nevyas that he had changed his mind about the surgery.
You falsely and maliciously state your husband's treatment was not reported to the FDA.
On the contrary your husband's treatment was reported to the FDA.
You falsely state that Dr. Nevyas "lied to my husband about 'informed consent issues'...."
Your husband signed a detailed consent form and then passed a true and false test to make sure he understood what he was signing. You fail to report that the court completely rejected any claim that your husband did not receive informed consent.
You falsely and maliciously state that Dr. Nevyas treated more subjects than allowed under the study plan that was approved by the FDA. You falsely and maliciously state that Dr. Nevyas "ignored parameters of the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients."
All of Dr. Nevyas' treatment was reviewed by the FDA and the study was at no time halted.
You falsely state that "Dr. Nevyas failed to submit complete accurate and timely reports to the FDA about the on going study."
You falsely state that Dr. Nevyas "Misrepresented that he was using an FDA approved laser to treat patients when, in fact, the procedures were performed with an unapproved experimental laser."
Dr Nevyas received FDA approval to use a laser which he used on your husband and you know that as does your husband. The FDA approved the laser for use by Dr. Nevyas under an investigational device exemption.
You falsely state that "Dr. Nevyas should have never have considered Keith as a candidate for LASIK..."
This statement is false and you know it to be false.
You have many other half-truths false statements and malicious innuendo in your essay. The truth is that the FDA approved Dr. Nevyas' study and that your husband went from being virtually blind without assistance of corrective lenses to being 20/20 without any correction at all.
Finally, you include in your 'Guest Book the statement that "Dr. Herbert Nevyas and Dr. Anita Nevyas accused of submitting fraudulent reports to the FDA" which is false and defamatory.
The statement implies that the FDA accused both Dr. Nevyas and Dr. Anita Nevyas of submitting fraudulent reports to the FDA which is false and defamatory. The statement implies that the FDA accused both Dr. Herbert Nevyas and Dr. Anita Nevyas of submitting fraudulent reports to the FDA. You know this to be false.
You also state "Dr. Anita Nevyas Target of FDA Criminal Complaint". This is false, defamatory and maliciously published by you when you know this to be a falsehood. Dr. Anita Nevyas was never a target of an FDA criminal complaint, but in fact has an unblemished record with the FDA.
You must either remove all of these lies from your essay and "Guest Book" or remove the entire document. Your conduct is inexcusable. Your husband has his day in court you presented all of your evidence and the jury found against you as well as they should have. If you wish to avoid litigation remove this filth from the Web by July 5, 2006.
Very truly yours,
Leon W. Silverman
Since the Wills' posting and this response, an email was sent to Jo Wills from Mr. Tarosky answering an email she sent to him.
Dom Morgan's Experience
From Dom Morgan:
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 an 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.
Morgan’s Medical Malpractice Lawsuit
I filed a medical malpractice lawsuit against the doctors who performed my LASIK. The Philadelphia courts dismissed a majority of the claims I had against the doctors, including not allowing anything pertaining to the doctors' investigational laser, any mention of their investigational study, or facts relating to the FDA.
My case was essentially left with nothing to sue for so based on recommendation from the judge I agreed to a binding high/low arbitration.
The arbitrator ruled in the case, I believe unfairly for many reasons, including setting aside all experts' reports.
The Civil Docket Access for this case in the Philadelphia court can be found (HERE).
My Right To Free Speech
When I first started warning others of the potential risks of LASIK surgery, I could not name the Nevyases due to the pending lawsuit.
After my med mal lawsuit, I added the doctors’ names because I believed they should be named based on their investigational study and the documents obtained.
The doctors did not like this, and filed a defamation lawsuit against me. In the course of the 2 years it took for this case to appear before a judge at trial, my website was shut down 3 times, through intimidation and threats of lawsuits against my web hosting companies. On the second attempt, even after a temporary restraining order was denied twice by the courts, my site was shut down due to phone calls and a letter from the doctors’ attorney.
In July 2005, I was ordered by the court to remove the doctors’ names from my website. I appealed the court's decision.
Were My Rights Being Violated?
In the Nevyas Eye Associates section of this site, I believe the documents posted supported all my claims against Drs. Herbert Nevyas and Anita Nevyas-Wallace (Nevyas Eye Associates). The Nevyases have fought hard to keep these documents from the public eye.
There was no confidentiality in the med mal lawsuit, although asked for at the very last moment by the doctors. There was no confidentiality in the defamation lawsuit, although some records have been sealed by the court. I have not ever given away my right to speak (or write) about my case, nor did I give up my right when my website was changed back to its original state in November 2003. The Pennsylvania Superior Court agreed:
Excerpt of THE OPINION OF THE SUPERIOR COURT OF PENNSYLVANIA AS OF MARCH 09, 2007
"In the cease and desist letter, the Nevyases demanded that Morgan “immediately remove this web site and the falsehoods contained within that site or legal action will be instituted against you immediately.” Letter, dated 7/30/05. As noted, Morgan responded to the July 30, 2003 letter on August 1, 2003, in which he noted that he “conformed to your request insofar as to remove any stated libelous reference to the Nevyas and their practice only[.]” N.T., Trial, 7/26/05, at 68. Morgan further wrote in the letter, however, that he would not remove the website in its entirety and will be updating this site or others with facts of my care, treatment, history, all of the legal issues pertaining to my case and all necessary documentation substantiating those facts within the legal guidelines as allowed by the law and the First Amendment which grants me freedom of speech[.] Id., at 68-69. Thereafter, Morgan kept his website; he simply uploaded the original version of it, which contained no reference to the Nevyases or their medical practice. ¶ 30 We agree with the trial court that Morgan agreed to take down the specific libelous wording from his website as posted on July 30, 2003, and that, pursuant to the agreement, those specific libelous statements were to be prohibited thereafter. See id., at 68. We cannot agree, however, that Morgan’s action of uploading the original website content, which contained no reference to the Nevyases or their medical practice, constituted an agreement on his part to never again mention them, for example, even in a 13 J.A32020/06 non-defamatory context. Rather, his letter specifically reserved the right to “update” his website “within the legal guidelines as allowed by the law and the First Amendment which grants me freedom of speech.” Id., at 68-69. The trial court’s interpretation of the agreement in this respect is incongruous given Morgan’s August 1, 2003 letter. See Jenkins v. County of Schuylkill, 658 A.2d 380, 383 (Pa. Super. 1995), appeal denied, 542 Pa. 647, 666 A.2d 1056 (1995) (“It is black letter law that in order to form an enforceable contract, there must be an offer, acceptance, consideration or mutual meeting of the minds.”) (emphasis added). Likewise, we find that Morgan did not agree to waive his right to make, if he so chooses and at his own risk, libelous statements in the future, unrelated to the statements on his website as of July 30, 2003."
Herbert Nevyas 2007 Letter To NJ DMV
Dr. Herbert Nevyas sent the following letter to New Jersey's Motor Vehicle Commission on July 31 2007, OVER 7 YEARS SINCE MY LAST APPOINTMENT WITH THE NEVYASES! I believe that this should have been done at most within either the first 2 years since my surgery, maybe even 2 years after, not 7!
To Whom It May Concern:
I have serious concerns about the driving skills of Mr. Dominic Morgan (DOB 8/8/1960) of [redacted] (alternate older address [redacted]).
It is my understanding that Mr. Morgan maintains a valid New Jersey driver's license, even though he is no longer licensed in Pennsylvania. I examined Mr. Morgan from an ophthalmologic standpoint several years ago, and he reported vision as low as 20/200 in each eye when I last saw him. I know that he has been judged legally blind after an examination by Dr. John D Dugan, Jr. in Vorhees, NJ, and that he is presently receiving Social Security Disability payments because of his legal blindness.
I think that Mr. Morgan should be re-evaluated by your impartial examiner and his license revoked if he does not measure up to the appropriate visual standard. I would not want to be responsible for allowing a legally blind driver to be on the highway.
Herbert J. Nevyas, M.D,
The pdf of this document (redacted) is available here.