December 04, 2003

Dr. Anita Nevyas Target of FDA Criminal Complaint

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

Tel: 610.789.0568
EMAIL:  md-jd@mindspring.com

Steven A. Friedman, M.D., J.D., LL.M.
Physician and Attorney at Law


Internal Medicine and Chest Disease - Health and Corporate Medical Law

December 4, 2003

Mr. Terry Vermillion
Director, Office of Criminal Investigation
Food and Drug Administration
7500 Standish Place - Room 250 N
Rockville, MD 20855

           RE:   Nevyas Excimer Laser
IDE:  G970088
Protocol:  NEV-97-001, -002, et seq.

Dear Mr Vermillion,

        I represent Mr. Dominic Morgan, and I request an investigation by the FDA Office of Criminal Investigation, and that this letter be made part of the permanent file re the above.

        I have written before, to other branches or sections of FDA, regarding Dr. Anita Nevyas-Wallace and Dr. Herbert Nevyas.  I regard action as urgent, because I believe federal regulation has been flaunted and patients seriously injured.  I have talked on multiple occasions with multiple FDA officials, and was told words to the effect, "The FDA staff has no intention of ever presenting Nevyas' application for FDA approval of their LASIK to the FDA Ophthalmic Devices Panel (the panel that has to decide on the Nevyas' application for FDA approval)."  I believe, however, that emphasis need be placed upon investigation of possible outright criminal activity.

        I ask the FDA to exercise its regulatory authority.  Since the problem was never presented to the FDA Ophthalmic Devices Panel, my client, Mr. Dominic Morgan, did not get an opportunity to address the panel.  Of much more concern to Mr. Morgan, however, the Nevyases continue performing LASIK.

        I now call for an investigation by the Office of Criminal Investigation, for action which would:

  1. Terminate all IDEs and stop Nevyas from performing LASIK.
  2. Fine and otherwise sanction Nevyas for past improprieties.

        It is my sincere belief that only the FDA, or an equivalent governmental agency with power to investigate criminal behavior can properly evaluate and understand what these improprieties are.  The civil justice system is not adequate to the task.

        Let me explain why the civil justice system is not adequate by using the lawsuit Mr. Morgan brought, for which I was his attorney, Morgan v. Nevyas et al, Philadelphia County Court of Common Pleas, April 2000 term, number 2621.

Mr. Morgan complained of three improprieties by Nevyas

  1. Deceptive trade practices.
  2. Failure to obtain informed consent.
  3. Medical malpractice.

        I will discuss these three, and then two other reasons why the civil justice system failed.

1. DECEPTIVE TRADE PRACTICES

        In 1998 plaintiff Mr. Morgan heard advertisements broadcast on radio station KYW promoting laser eye surgery (and without saying that it was investigational).  Responding to those promotions, Mr. Morgan, then age 37, went to Nevyas and paid $5000.00 to undergo LASIK in both eyes.  Dr. Nevyas-Wallace told Mr. Morgan, and twice wrote in his medical record, that he was a "good candidate" for LASIK.  After LASIK plaintiff Mr. Morgan's vision worsened and he became legally blind.

        The Nevyas Excimer Laser is a research instrument.  As such, it was operated by Nevyas under an Investigation Device Exemption (IDE) from the Food and Drug Administration (FDA).  It was not approved by the FDA.  The Nevyases signed agreements to comply with the Code of Federal Regulations (C.F.R.).  Section 812.7 of chapter 21 of the C.F.R. (21 C.F.R. 812.7) strictly forbids any advertising of any device operated under an IDE from the FDA.

        The advertisements broadcast by the Nevyases on KYW implied FDA approval since only FDA-approved devices are allowed to advertise.  That certainly seemed to be both an unfair method of competition and an unfair or deceptive act or practice, as defined by the Pennsylvania Unfair Trade and Consumer Protection Law (73 P.S. 201).

        Before trial took place, the Nevyases filed a motion for summary judgment, claiming that no jury should ever hear that the Nevyas LASIK was experimental or operated under an IDE, because a jury would be confused by the terms "experimental" or "investigational," and might hold it against the Nevyases.  The motion was assigned to Judge Papalini, who agreed with the Nevyases, so I was not allowed to say that the Nevyas LASIK was experimental or operated under an IDE.  Since I could not say that the Nevyas LASIK was experimental or operated under an IDE, I had no way of proving that the KYW advertising was illegal.  As I will explain below, the claim of deceptive trade practices never was acted upon by either trial or arbitration.

        I disagree with Judge Papalini's ruling, because I believe juries are smarter than that, and don't confuse so easily.  However, Judge Papalini's ruling was acknowledgment of the shortcomings of trial by jury (civil justice system), and the reason we must depend upon governmental agencies like the FDA to protect the public.

2.  FAILURE TO OBTAIN INFORMED CONSENT

        The Nevyas Excimer Laser was operated by Nevyas under an Investigation Device Exemption (IDE) from the Food and Drug Administration (FDA).  The FDA required the Nevyases follow certain protocol in order to operate their LASIK.  Those protocol listed, in writing, specific required Inclusion Criteria and Exclusion Criteria.  The purpose of the Inclusion and Exclusion Criteria was to state what type patient was safe or appropriate, and what type patient was not safe or appropriate, to have LASIK.  Mr. Morgan was not a safe or appropriate subject for LASIK because he did not meet the Inclusion Criteria and he did meet the Exclusion Criteria.

        To evaluate Mr. Morgan and the Inclusion and Exclusion Criteria, I contacted James J. Salz, M.D. of Cedars-Sinai Medical Center in Los Angeles and Terrence O'Brien, M.D. of Johns Hopkins Medical Center in Baltimore.  Both are nationally and internationally known experts about LASIK.  Dr. Salz is Chair and Dr. O'Brien is Secretary of the International Society of Refractive Surgery/American Academy of Ophthalmology Executive Committee for 2003.  Both agreed that, either with or without the written Inclusion and Exclusion Criteria, Mr. Morgan was not a safe or appropriate subject for LASIK.  Please read their reports, copies of which I attach. Instead of telling Mr. Morgan that he was not a safe or appropriate subject for LASIK, Dr. Nevyas-Wallace told Mr. Morgan, and twice wrote in the medical record, that he was a "good candidate" for LASIK.  The Nevyases then gave Mr. Morgan a "consent form" to sign.  Nowhere in that "consent form" did it mention anything about Inclusion and Exclusion Criteria, and nowhere did give any information by which Mr. Morgan could have determined that he was not a "good candidate," or that PDA-approved Inclusion and Exclusion Criteria were violated.  He trusted Dr. Nevyas-Wallace.  He had LASIK in both eyes and, since this was neither safe nor appropriate, he became legally blind.

        Before trial took place, the Nevyases filed another motion for summary judgment, claiming that no jury should ever hear Mr. Morgan's claim that he was denied informed consent, because he had signed the "consent form" and it would confuse the jury.  The motion was assigned to Judge Papalini, who agreed with the Nevyases, so I was not allowed to say that Mr. Morgan was operated upon without informed consent.  As I will explain below, the claim of lack of informed consent never was acted upon by either trial or arbitration.

        I disagree with Judge Papalini's ruling, because I believe juries are smarter than that, and that Mr. Morgan was not given information necessary to make an informed decision.  However, Judge Papalini's ruling was acknowledgment of the shortcomings of trial by jury (civil justice system), and the reason we must depend upon governmental agencies like the PDA to protect the public.

3.  MEDICAL MALPRACTICE

        Dr. Salz and Dr. O'Brien both agreed that the Nevyases committed medical malpractice when they did LASIK on Mr. Morgan.  Both Dr. Salz and Dr. O'Brien explained that the medical malpractice was violating the standard of care for performing LASIK, and that part of the standard of care consisted of the written Inclusion and Exclusion Criteria (i.e. the IDE protocol required by the FDA).  Please read their reports, copies of which I attach.

        Before trial took place, the Nevyases filed yet another motion for summary judgment, claiming that no jury should ever hear any reference to LASIK being operated by the Nevyases under an IDE from the FDA, because a jury would be confused by terms of the IDE and hold it against the Nevyases.  The motion was assigned to Judge Papalini, who agreed with the Nevyases, so I was not allowed to say that the written Inclusion and Exclusion Criteria represented part of the standard of care breached by the Nevyases, and responsible for Mr. Morgan becoming legally blind.

        I disagree with Judge Papalini's ruling, because I believe juries are smarter than that, and don't confuse so easily.  However, Judge Papalini's ruling was acknowledgment of the shortcomings of trial by jury (civil justice system), and the reason we must depend upon governmental agencies like the FDA to protect the public.

        Of course, I asked Judge Papalini to reconsider his decisions, but he refused and said his decisions were made "with prejudice," which meant that I could not raise them again until after trial, because his decisions were "prejudged" as lasting until after trial was finished.

        So, feeling that I was fighting with my legs legally amputated, I agreed to binding arbitration with a high-low and no confidentiality, limited to Dr. Nevyas-Wallace and the Medical Malpractice case, emasculated as it was.  The deceptive trade practices and failure to obtain informed consent cases were never arbitrated, and no decision was ever made on them because I was not allowed to speak of them.  The high-low meant that if we lost we still got $100,000 and, if we won, it could not be for more than $1,200,000.  The no confidentiality meant that nothing was confidential. The arbitrator was not allowed to go over any of the material that Judge Papalini ruled a jury should not hear, but at least there were no more judicial rulings about what a jury should not be allowed to hear.  The arbitrator was only allowed to hear a very limited part of our case, as explained above.  We lost but did get $100,000.

4.  NOT REPORTING DATA TO THE FDA

        In my previous letters to the FDA, I detailed how Nevyas had not reported Mr. Morgan as either a complication or adverse event to the FDA, as required by law, and stated that I was concerned that other Nevyas patients also were not reported to the FDA as either a complication or adverse event.  I now know the names of two other Nevyas patients not reported to the FDA as either a complication or adverse event. Both patients sued when their vision was ruined, and I have talked with their attorneys.   Even though sued, the Nevyases still did not report Mr. Morgan or the other two patients to the FDA as either a complication or adverse event.  The FDA should be interested in this - the Nevyases claim that these patients merely had "post-operative symptoms," and that when Nevyas examined the patients, Nevyas was able to determine that the "post-operative symptoms were neither complications nor adverse events.  (This certainly seems to violate the FDA requirement that, whether or not a complication or adverse event seems or does not seem to be caused by LASIK, it must be reported.)

        As the FDA is aware, the only people submitting data to the FDA about the Nevyas doing LASIK are the Nevyases themselves.  If they are submitting their data after "editing" it of unfavorable results, which appears to be the case, then the FDA has been misled for years about what the Nevyases are doing to the public.  I believe that any investigation so far done by the FDA has been handicapped by lack of truthful data.

        As I'm sure the FDA knows, each lawsuit against the Nevyases must stand on its own - each lawsuit is limited to discussing only the particular patient involved.  Thus, it is forbidden for any patient to present an overall picture (i.e. discuss Nevyas' other lawsuits) to a jury.  This is another shortcoming of trial by jury (civil justice system), and another reason we must depend upon governmental agencies like the FDA to get the overall picture and protect the public.

5.  THE FDA HAS MEDICAL SCIENTIFIC EXPERTISE THAT JUDGES AND ARBITRATORS DO NOT

        Lawsuits against doctors involve both sides getting medical experts to evaluate the case, both for the plaintiff and for the defendant. In Mr. Morgan's case, reports of medical experts for both sides were presented to the arbitrator. In my discussion with the arbitrator after he made his decision, I learned that he felt the experts effectively cancelled out each other. Frankly, the arbitrator did not have the medical and scientific expertise that the FDA has, and which was needed for Mr. Morgan's case.

        For example, the Nevyas' defense expert publishes a brochure which he hands out to patients considering LASIK.  In his brochure there are a series of question and answers. For the question, "How do I know if I am a good candidate for Laser Vision Correction?" his answer is, "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."  In his report, the Nevyas' expert admitted that Mr. Morgan's, "past ophthalmic history was complicated and significant for retinopathy of prematurity."  Retinopathy of prematurity is a retinal problem associated with premature birth (Mr. Morgan was born about three months early).  When the above was pointed out, the Nevyas' expert stated in a sworn affidavit, "The statement made in that brochure does not apply to stable retinas, such as the retina of the plaintiff at the time that he underwent LASIK surgery by Dr. Anita Nevyas-Wallace."  Dr. Salz and Dr. O'Brien disagreed with this double-talk (please read their reports, copies of which I attach), but Nevyas' expert, at least in the arbitrator's mind, effectively cancelled out Dr. Salz and Dr. O'Brien.  This is another shortcoming of the trial system (civil justice system) - the lack of scientific medical expertise by arbitrators and judges - and another reason we must depend upon governmental agencies like the FDA to use their scientific medical expertise and protect the public.

        Did the Nevyases pay their expert?  Yes.  Did I pay Mr. Morgan's experts?  Yes, but Dr. Salz and Dr. O'Brien were so outraged by the unfairness of what occurred that Dr. Salz did not charge for the last half of his service, and Dr. O'Brien did not charge anything.

        Mr. Morgan created a website, Lasiksucks4u.com [now LasikDecision.com], to talk about his personal experiences as a LASIK victim. The Nevyases, who advertise their services in the mass media (including their own website), sued him for libel, defamation, and slander, and have threatened to sue his website carriers.  The Nevyas' attorney told me they intend to confiscate the social security disability checks Mr. Morgan gets for his legal blindness.

    The public needs protection.  The FDA can give that protection, through criminal investigation and regulation. Please contact me if you need information or have questions.

Sincerely yours,
Steven A. Friedman

Posted by Admin at December 4, 2003 07:06 PM