February 28, 2005

Dr. Herbert Nevyas and Dr. Anita Nevyas Accused of Submitting Fraudulent Reports to the FDA

                                                    Dominic J. Morgan
                                                    3360 Chichester Ave., M-11
                                                    Boothwyn, PA 19060
                                                    February 28, 2005

 

Mara Pearse Burke
Ethics Program Manager 04-129
American Academy of Ophthalmology
P.O. Box 7424
San Francisco, CA 94120-7424
Tel. 415-561-8500
FAX 415 561-8595
http://www.aao.org

                                                    RE:    Your letter 2/4/05 about Nevyas Laser

Dear Ms. Burke:

        In response to your requests:

        The Nevyas laser was a conventional Sullivan device, not exempt from FDA regulation as a "custom device."  Nevyas (i.e. Dr. Herbert Nevyas, Dr. Anita Nevyas-Wallace, and Nevyas Eye Associates) was compelled to obtain an IDE, and was striving to obtain  PMA (i.e. pre-marketing approval), like Summit and Visx had already done.  In violation of Federal regulations, Nevyas commercialized the Nevyas laser by advertising while the device was investigational (Nevyas never did receive PMA).  Also in violation of FDA regulations, Nevyas failed to report various complications or adverse events to the FDA.  Eventually, because of complaints, the FDA shut down use of the Nevyas laser, stopping its use under the IDE.  However, the FDA took no other action against Nevyas, so Nevyas kept profits from the $500,000 taken in monthly (amount obtained during legal proceedings).  Nevyas merely purchased an FDA approved laser and continued as though nothing had happened.  Indeed, Nevyas even was allowed by the FDA to participate in the studies that recently earned Intacs approval for commercial distribution.

        I am extremely concerned about the fact that Nevyas, while operating under and IDE for the Nevyas laser, failed to report various complications or adverse events to the FDA.  Data from Nevyas simply cannot be trusted, and now Nevyas data has helped Intacs get on the market.  The potential consequences could be severe.

        I have contacted the AAO because it is a professional organization representing ophthalmologists, because it has acted a major protector of the public's eye health, because I am concerned about Nevyas ethics, and because I am concerned that the Intacs approval may be flawed because of Nevyas participation.

        Some explanation and documentation:

  1. "Custom designed" devices are not regulated by the FDA, and Nevyas improperly called his laser a "custom designed" device, in an attempt to avoid FDA regulation.
     
  2. Ordinary prescription eyeglasses are typical of true custom designed devices; they are designed for one patient only.  Devices which are designed for one surgeon are ordinarily not custom designed for FDA regulatory purposes (i.e. not exempt).
     
  3. Nevyas bought a Sullivan laser and called it "custom designed," by claiming that it was designed just for him.  Nevyas received instruction on operating the Sullivan laser from Dr. David Dulaney in Phoenix, owner of another Sullivan laser.  The enclosed article from the Journal of Refractive Surgery exposed how Sullivan sold lasers to doctors interested in evading FDA regulation by claiming "custom designed."  See exhibit 1.
     
  4. The FDA, while investigating Sullivan, learned that Nevyas had purchased a Sullivan laser.  The FDA allowed Nevyas to apply for an IDE (i.e. Investigational Device Exemption).  At that time the FDA was interested in making sure that people using Sullivan and Sullivan-like lasers applied for an IDE.  See exhibit 2, an FDA letter to Manufacturers and Users of Laser for Refractive Surgery.  In that letter the FDA says that it granted PMAs (i.e. pre-market approval) for Summit and Visx lasers, and asks other manufacturers or users to apply for IDEs.  Also see exhibit 3, a 1997 affidavit prepared by an FDA investigator, which Nevyas then refused to sign.  That unsigned affidavit details the connection between Sullivan and Nevyas, and recounts Nevyas' use of the Nevyas laser prior to getting an IDE.
     
  5. The initial Nevyas laser IDE Protocol submitted to the FDA was dated March 18, 1997.  See exhibit 4.  Dr. Nevyas and Dr. Nevyas-Wallace both signed Investigator Agreements with the FDA dated March 18, 1997.  See exhibits 5 and 6.
     
  6. Those Investigator Agreements specifically required Nevyas to comply with 21 CFR part 812 (i.e. part 812 of title 21 of the Code of Federal Regulations, "Food and Drug law").  21 CFR 812.7 prohibits promotion of all investigational devices until after the FDA has approved the device for commercial distribution (i.e. granted PMAs).  See exhibit 7, a copy of 21 CFR 812.7.
     
  7. However, Nevyas did not wait for FDA approval for commercial distribution, but began promoting on radio and TV.  In other words, Nevyas did not just plan to commercialize the Nevyas laser, he did commercialize it.  See exhibit 8, transcripts of KYW radio advertisements.  Also see exhibit 9, transcripts of the TV "informational."
      
  8. Nevyas claimed that the advertisements were not meant for the Nevyas laser, but were intended only for a Summit laser he had leased (the Summit laser had obtained PMA status).
     
  9. However, as shown in the radio and TV transcripts, Nevyas advertised laser treatment for nearsightedness and farsightedness, and did not mention that any laser device was investigational.
      
  10. In Dr. Nevyas' July 29, 2002 answer to interrogatories, he admitted that Nevyas used a Summit laser from March 25, 1998 until November 11, 1999 but only used it for Lasik on farsighted patients.
     
  11. Nevyas did not always stick to IDE protocol when doing Lasik.  Nevyas operated upon patients not meeting protocol, including Dominic Morgan, Keith Wills, and Cheryl Fiorelli.  Even when those patients developed complications and/or adverse events and sued Nevyas, Nevyas failed to report those complications and/or adverse events to the FDA.  This is part of my challenge to Nevyas and Nevyas ethics, and I have details in exhibits on my web site, Lasiksucks4u.com [now LasikDecision.com]  For example, please see the December 4, 2003 letter by my attorney (also physician), Dr. Steven Friedman, as well as the reports and declarations of Dr. James Salz and Dr. Terrence O'Brien, which detail my ophthalmologic status, and the declaration of Professor James O'Reilly about societal issues concerning Lasik.
      
  12. Eventually the FDA shut down Nevyas from using his laser.  See exhibit 12, the e-mail Dr. Matthew Tarosky of the FDA sent to Mrs. Jo Wills, wife of Nevyas laser casualty Mr. Keith Wills.  This was confirmed to me at a meeting Mrs. Wills and I attended at FDA headquarters December 8, 2004, at which time A. Ralph Rosenthal, M.D., Director of the Division of Ophthalmic Devices, stated that the FDA had shut down Nevyas from using his laser.  The FDA had been concerned about how Nevyas used the Nevyas laser, as reflected in a January 20, 1999 letter from Dr. Rosenthal to Nevyas, and the May 10, 2001 report of an FDA investigator, concluding that Nevyas was not complying with the investigator Agreement.  See exhibits 13 and 14.
      
  13. As the letter from Dr. Tarosky and the comments from Dr. Rosenthal indicated, the FDA has taken the position that it eliminated a danger to 'public safety" when it shut down the Nevyas laser, and that ended the problem.  However, the FDA allowed Nevyas to participate in the studies that earned Intacs approval for commercial distribution, and Nevyas currently performs Intacs surgery.  See exhibit 15, an Ocular Surgery News article about Intacs.
     
  14. I am concerned not only about Nevyas ethics with regard to the Nevyas laser, but about the safety of Intacs, which the FDA approved on the basis of data from Nevyas.  I am extremely concerned that the Intacs study may be flawed, because of Nevyas participation.  I have voiced my concerns to the FDA but, having recently approved the device, the FDA apparently has to wait.

        As I said above, I contacted the AAO because it is a professional organization representing ophthalmologists, because it has acted a major protector of the public's eye health, because I am concerned about Nevyas ethics, and because I am concerned that the Intacs approval may be flawed because of Nevyas participation.

        Thank you for your attention.

                                                    Respectfully yours,
                                                    Dominic J. Morgan

  1. Article from the Journal of Refractive Surgery about Sullivan.
  2. October 10, 1996 FDA letter to Manufacturers and Users of Laser for Refractive Surgery.
  3. 1997 affidavit prepared by a FDA investigator, which Nevyas refused to sign.
  4. Nevyas laser IDE Protocol submitted to the FDA dated March 18, 1997.
  5. Investigator Agreements signed by Dr. Herbert Nevyas dated March 18, 1997.
  6. Investigator Agreements signed by Dr. Anita Nevyas-Wallace dated March 18, 1997.
  7. 21 CFR 812.7.
  8. Declaration of Mr. Roy Shapiro, general manager of KYW radio, with transcript of advertisement.
  9. Transcript of TV "informational."
  10. Interrogatories addressed to Nevyas.
  11. Nevyas' answers to interrogatories.
  12. E-mail Dr. Matthew Tarosky of the FDA sent to Mrs. Jo Wills, wife of another Nevyas laser casualty, Mr. Keith Wills.
  13. January 20, 1999 letter from Dr. Rosenthal to Nevyas.
  14. May 10, 2001 report of an FDA investigator, concluding that Nevyas was not complying with the Investigator Agreement.
  15. Article from Ocular Surgery News about Intacs.
Posted by Admin at February 28, 2005 02:42 PM