The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
Nevyas Eye Associates
Nevyas Eye Associates 2012 FDA Warning Letter PDF Print E-mail
Nevyas Eye Associates

Again and again and again, but the doctors claim numerous times under oath they've never done anything to violate any FDA rules, regulations, or protocols:

SOURCE

Nevyas Eye Associates 6/5/12

Department of Health and Human Services
Public Health Service Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993

June 5, 2012

WARNING LETTER

VIA UNITED PARCEL SERVICE

Herbert J. Nevyas, M.D.
Medical Director
Nevyas Eye Associates
Two Bala Plaza PL-33
333 E. City Avenue
Bala Cynwyd, Pennsylvania 19004-1501

Dear Dr. Nevyas:

During an inspection of your firm located in Bala Cynwyd, Pennsylvania, on March 19-28, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility that is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation, found at Title 21, Code of Federal Regulations (CFR), Part 803.

The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis procedures is a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is intended for the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that this device is misbranded under section 502(t)(2) of the Act, 21 U.S.D. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, the investigator asked the medical director and refractory consultants if the facility had written MDR procedures and they confirmed that they did not and did not know what events would be considered serious injuries and reportable to manufacturers. The investigator reviewed some of the adverse events identified in the assignment guidance with them and they confirmed that these types of events have occurred at their facility. They explained that they inform their patients through the consenting process that they may have vision-threatening complications following the surgery.

We reviewed your firm’s response dated April 2, 2012, and concluded that it is not adequate because it did not include a copy of your firm’s MDR procedures.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, Maryland 20993. Refer to the Unique Identification Number #306398 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close of the inspection, may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the device into compliance.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

 
Herbert Nevyas 2007 Letter To NJ DMV PDF Print E-mail
Nevyas Eye Associates
Friday, 06 August 2010 00:00

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.

Sincerely,

Herbert J. Nevyas, M.D,

The pdf of this document (redacted) is available here.

 
Nevyas v. Morgan III - Trademark PDF Print E-mail
Nevyas Eye Associates
Thursday, 05 August 2010 00:00

Nevyas v. Morgan III (UDRP Action)

On July 1, 2010, Drs. Herbert Nevyas and Dr. Anita Nevyas-Wallace filed requests for arbitration under the Uniform Domain-Name Dispute-Resolution Policy ("UDRP") with the National Arbitration Forum, seeking the transfer of the domain names NevyasLasik.com, HerbertNevyasLasik.com, and AnitaNevyasLasik.com.

According to the Complaint, the websites located at the domain names at issue in the proceeding contain "disparaging and false remarks about Complainants" and falsely imply "that they are owned by Complainants, not that they are owned by an individual criticizing Complainants."

From Their Complaint:

Complainants Dr. Herbert Nevyas and Dr. Anita Nevyas-Wallace are surgical and medical ophthalmologists that have performed lasik surgery since at least as early as 1995. See Verification of Dr. Anita Nevyas-Wallace, attached as Ex. B. Dr. Herbert Nevyas founded Nevyas Eye Associates in 1964 and has directed its medical and surgical ophthalmology practice since that time. Ex. B. Dr. Anita Nevyas changed her name to Anita Nevyas-Wallace in 1987, but continues to use the name Anita Nevyas. Ex. B. Both of Complainants have practiced lasik surgery continuously at Nevyas Eye Associates since at least as early as 1995. Ex. B. Their practices are described at the website www.nevyas.com. See Printouts from Nevyas.com attached as Exhibit C.

Complainants have advertised their lasik practice to the general public since 1992 and have done so continuously using the marks “Dr. Herbert Nevyas,” “Dr. Anita Nevyas,” “Nevyas Eye Associates,” and “Nevyas Lasik.” Ex. B. In addition to traditional forms of advertising and marketing, Complainants advertise their practice online through the websites Nevyas.com and NevyasVideo.com, through informational articles posted on other websites, and through online videos at websites such as YouTube.com. Ex. B. For example, Complainants’ YouTube videos display the headings “Dr. Herbert J. Nevyas LASIK” and “Nevyas Eye Associates LASIK.” See YouTube videos displaying marks, attached as Exhibit D.

The Forum has previously recognized that individuals have common law trademark rights in their own names enforceable in domain dispute proceedings. See Jerry Damson, Inc. v. Texas International Property Assoc., F0702000916991 (Nat. Arb. Forum Apr. 10, 2007) (Jerry Damson doing business under the mark “Jerry Damson Acura” had right to JerryDamsonAcura.com domain name). See also Margaret Drabble v. Old Barn Studios Ltd., D2001-020 (WIPO Mar. 26, 2001) (author Margaret Drabble had common law rights to MarthaDrabble.com domain); Jeanette Winterson v. Mark Hogarth, D2000-0235 (WIPO May 22, 2000) (Jeanette Winterson had common law rights to her name); Julia Fiona Roberts v. Russell Boyd D2000-0210 (WIPO May 29, 2000) (Julia Roberts had common law rights to “Julia Roberts”); Thibodeau, v. Yomtobian, FA 94868 (Nat. Arb. Forum June 28, 2000) (rights to “Dr. Lauren” in dispute re: www.drlauren.com).

The complainant also need not be a famous individual for common law rights in his or her name to arise. See, e.g., Dr. Paul Guerrino v. Yin Chew, FA0204000110873 (Nat. Arb. Forum June 17, 2002) (Practicing dentist Dr. Guerrino owned rights to www.guerrinodentistry.com).

Finally, it is not necessary that Complainants own a trademark registration for their mark for that mark to be protected. See Jerry Damson, supra; Broad Corp. v. Renteria, D2000-0050 (WIPO Mar. 23, 2000) (the Policy “does not distinguish between registered and unregistered trademarks and service marks in the context of abusive registration of domain names” and applying Policy to “unregistered trademarks and service marks”). Complainants have continuously used the “Nevyas Lasik” mark and similar trademarks containing their names and the “Nevyas” surname in connection with their medical and surgical ophthalmology practices since at least as early as 1995. Ex. B. As such, they have developed common law rights in the marks. See Tuxedos By Rose v. Nunez, FA 95248 (finding common law rights in a mark where its use was continuous and ongoing).

FACTUAL AND LEGAL GROUNDS

This complaint is based on the following factual and legal grounds:

[a.] Respondent’s domain names are nearly identical to Complainants’ trademarks, pursuant to ICANN Policy ¶ 4(a)(i), and are being used in a deceptive manner.

Respondent’s domain names AnitaNevyasLasik.com, HerbertNevyasLasik.com, and NevyasLasik.com are nearly identical to Complainants’ names and trademarks. Complainants are well-known lasik surgeons whose services are advertised in connection with the marks “Herbert Nevyas Lasik” and “Anita Nevyas Lasik” and the domains Nevyas.com and NevyasVideo.com. It is well-established that the addition of a generic top level domain such as “.com” to a trademark, or other minor changes to the mark, do not cause the domain name to be non-identical. See, e.g., Jerry Damson, supra.; Tropar Mfg. Co., Inc. v. TSB, FA 127701 (Nat. Arb. Forum Dec. 4, 2002 (“The addition of a generic top-level domain does not add any distinguishing characteristics to a domain name because it is a required feature in every domain name.”)

Respondent further increases the likelihood of confusion between his domains and Complainants’ by advertising his websites in a deceptive manner that suggests they are affiliated with Complainants and Nevyas Eye Associates. A Google search for “Nevyas Lasik” or a similar term displays the following Google headlines for Respondent’s websites:

Welcome to HerbertNevyasLasik.com! herbertnevyaslasik.com/

Drs. Herbert Nevyas & Anita Nevyas-Wallace - herbertnevyaslasik.com/index.php?...

Nevyas Eye Associates - www.anitanevyaslasik.com/index.php?...

See Google search results, attached as Ex. E (Respondent’s websites are highlighted so that they can be distinguished from Complainants’ website).

Once a patient or potential patient visits Respondent’s websites, the patient views disparaging and false remarks about Complainants. See Printouts from Respondent’s websites, attached as Exhibit F. Respondent’s websites also contain links to other websites featuring the services of other lasik surgeons and doctors with similar ophthalmology practices. Id.

Respondent’s websites track the number of clicks to each competitive website, suggesting that Respondent may be profiting from this confusion and traffic to his website by obtaining clickthrough fees. Id.

[b.] Respondent has no rights or legitimate interests in the domain names, pursuant to ICANN Policy ¶ 4(a)(ii).

Respondent is apparently an individual by the name of Dom Morgan, who was previously involved in state and federal litigation with Complainants. See Ex. F (Printout from Respondent’s websites stating websites are owned by Dom Morgan). Dom Morgan was a patient of Complainants in 1998 who was unhappy with the results of his treatment and subsequently posted numerous false, disparaging and defamatory statements regarding Complainants and their practice on multiple websites. Ex. B. Complainants sued him and subsequent to these lawsuits, statements were removed from his websites. Unfortunately, the parties’ legal battle continues. Ex. B.

Currently, Respondent owns and operates a number of websites where he criticizes the practice of lasik surgery and various lasik surgeons, including Complainants. Respondent is the owner of websites such as www.nevyasvmorgan.com, www.lasikdecision.com, www.lasikliberty.com, www.lasikfda.com, and www.flawedlasik.com. See Exhibit G (Whois Information for Respondent’s Other Websites). Respondent also operated the website www.lasiksucks4you.com. This action does not implicate Respondent’s ability to post critical statements regarding Complainants on those domains, or any domains that do not contain Complainants’ trademarks. The domain names at issue in this action indicate that they are owned by Complainants, not that they are owned by an individual criticizing Complainants.

Prior panel decisions have held that this type of initial interest confusion, caused by the domain name itself, is impermissible. See The Paxton Herald v. Millard, FA0207000114770 (Nat. Arb. Forum Aug. 21, 2002) (“While the content of Respondent’s website may enjoy First Amendment and fair use protection, those protections do not equate to rights or a legitimate interest with respect to a domain name which is confusingly similar to another’s trademark.”); Council of American Survey v. Pinelands Web Services, D2002-0377 (WIPO July 19, 2002) (“Respondent may have a right to refer to the mark in critical content, the wholesale appropriation of Complainant's mark in a domain name, without any distinguishing material, creates confusion with Complainant's business and is not fair use merely for the purpose of criticism…No criticism is apparent from the domain name itself; it is not sufficient that the criticism may be apparent from the content of the site.”)

1. Respondent has no rights or legitimate interests in the domains because he is not commonly known by Complainants’ trademarks and does not use the marks in connection with a legitimate offering of goods and services.

Respondent has no rights or legitimate interests in NevyasLasik.com domains because he sells no goods or services on his websites and seeks only to capitalize on Complainants’ trademarks by luring consumer traffic to his website, disparaging Complainants, and advertising similar lasik services offered by other practitioners. For example, when one of the links on Respondent’s website is clicked, the customer visits www.lasikinfocenter.com, where the customer views the following advertisements:

Tri-County Eye Physicians

Cataract & Oculo-plastic Surgery Laser Vision Correction/LASIK

www.tricountyeye.com

Locate an Eye Doctor

Locate an Eye Doctor in your area and Learn more about your Eyes

www.ThinkAboutYourEyes.com

Other links on Respondent’s website also advertise competitive products and services.

See Printouts from Respondent’s websites, attached as Exhibit F. Respondent’s websites display the number of hits on each link, indicating that Respondent’s websites have redirected thousands of consumers to other websites advertising competitive products and services. Respondent also has a history of using websites to solicit donations to pay his legal fees in litigation against Complainants. See, e.g., http://www.lasik-flap.com/forum/viewtopic.php?f=6&t=373.

Respondent’s NevyasLasik.com domains invite visitors to contact him and support him in his litigation with Complainants.

Respondent has no trademark or service mark rights in the “Nevyas Lasik,” “Anita Nevyas Lasik” or “Herbert Nevyas Lasik” trademarks and is not commonly known by these marks. Having no rights in the marks at issue, and offering no goods or services, Respondent simply attempts to profit and damage Complainants by misleadingly diverting customer traffic away from Nevyas.com and to his websites and the links on his websites.

Respondent’s use of domain names that are nearly identical to Complainants’ marks to divert Internet users to websites that offer competitive products and services, and for which Respondent presumably receives a commission or click-through fees, is not a bona fide offering of goods or services, nor is it a legitimate noncommercial or fair use of the domains under the ICANN Policy. See Emmit Smith, III v. EmmitSmith.com, FA 555486 (Nat. Arb. Forum Oct. 26, 2005) (citing Disney Enters., Inc. v. Dot Stop, FA 145227 (Nat. Arb. Forum Mar. 17, 2003) (finding that the respondent’s diversionary use of the complainant’s mark to attract Internet users to its own website, which contained a series of hyperlinks to unrelated websites, was neither a bona fide offering of goods or services nor a legitimate noncommercial or fair use of the disputed domain names); Black & Decker Corp. v. Clinical Evaluations, FA 112629 (Nat. Arb. Forum June 24, 2002) (holding that the respondent’s use of the disputed domain name to redirect Internet users to commercial websites, unrelated to the complainant and presumably with the purpose of earning a commission or pay-per-click referral fee did not evidence rights or legitimate interests in the domain name)).

2. Respondent has no rights or legitimate interests in the domains because he is not making a legitimate, non-commercial fair use of the domains pursuant to Paragraph 4c(iii), but is using the domains with an intent to tarnish Complainants’ trademarks and profit from misleadingly diverting customers.

Respondent registered the NevyasLasik.com domains in February, 2009. See Ex. A. Respondent’s legal battles with Complainants began in 2000 and have continued into the present.

Ex. B. Respondent’s websites make clear that Respondent’s goal is to tarnish Complainants’ trademarks, damage Complainants’ business, and profit from the use of Complainants’ marks.

Ex. F.

Complainants assert this complaint not to impair Respondent’s First Amendment rights but because Respondent is using Complainants’ trademarks in the NevyasLasik.com domains to suggest that the domains are sponsored by or affiliated with Complainants, to confuse Complainants’ patients and potential patients, and to lure traffic to Respondent’s websites.

Respondent’s website headlines - “Nevyas Eye Associates” and “Welcome to NevyasLasik.com!” – misleadingly suggest that patients will be visiting Nevyas Eye Associates or Complainants’ “Nevyas Lasik” practice if they select those links. Once the patient arrives at Respondent’s websites, Respondent’s has already profited from this initial interest confusion and has succeeded in tarnishing Complainants’ trademarks.

[c.] Respondent registered and uses the domains in bad faith, pursuant to ICANN Policy ¶ 4(a)(iii).

1. Respondent’s Registration of Multiple Domain Names Containing Complainants’ Marks and His Advertisement and Use of Those Domain Names Causes a Likelihood of Confusion, Particularly Initial Interest Confusion, to Attract Individuals Seeking Complainants’ Website to Respondent’s Websites.

Paragraph 4(a)(iii) of the ICANN Policy lists a non-exhaustive list of circumstances that indicate bad faith registration and use of domains, which includes evidence that the respondent “intentionally attempted to attract, for commercial gain, Internet users to [his or her] web site or other on-line location, by creating a likelihood of confusion with the complainant's mark as to the source, sponsorship, affiliation, or endorsement of [his or her] web site or location or of a product or service on your web site or location.”

Respondent’s use of Complainants’ marks in his domain names creates a likelihood of confusion and suggests an attempt to attract Internet users to Respondent’s websites for commercial gain. See Am. Univ. v. Cook, FA 208629 (Nat. Arb. Forum Dec. 22, 2003) (“Registration and use of a domain name that incorporates another's mark with the intent to deceive Internet users in regard to the source or affiliation of the domain name is evidence of bad faith.”); see also G.D. Searle & Co. v. Celebrex Drugstore, FA 123933 (Nat. Arb. Forum Nov. 21, 2002); Kmart v. Khan, FA 127708 (Nat. Arb. Forum Nov. 22, 2002).

Furthermore, where a disputed domain name containing the complainant’s trademark is being used to feature links to websites that compete with the complainant, presumably for referral fees, that use alone constitutes bad faith under the Policy. See Univ. of Houston Sys. v. Salvia Corp., FA 637920 (Nat. Arb. Forum Mar. 21, 2006); Asbury Auto. Group, Inc., v. Tex. Int’l Prop. Assoc., FA 958542 (Nat. Arb. Forum May 29, 2007); David Hall Rare Coins v. Tex. Int’l Prop. Assoc., FA 915206 (Nat. Arb. Forum Apr. 9, 2007); Am. Airlines, Inc., v. Tex. Int’l Prop. Assoc., FA 914854 (Nat. Arb. Forum Apr. 10, 2007).

2. Respondent Engaged in a Pattern of Registering Domains Reflecting Complainants’ Trademarks, Which Prevents Complainants from Registering Corresponding Domain Names Reflecting Their Marks.

Pursuant to Paragraph 4(a)(iii), evidence of bad faith also includes evidence that the Respondent “registered the domain name in order to prevent the owner of the trademark or service mark from reflecting the mark in a corresponding domain name, provided that [Respondent] engaged in a pattern of such conduct.” Respondent’s registration of a series of domains that all contain essentially the same website content suggests a pattern of registering domains so that Complainants cannot register them. There is no other justification for Respondent’s ownership of a series of domain names featuring the same website content.

3. Respondent Registered the Domain Names Primarily for the Purpose of Disrupting Complainants’ Business.

Evidence of bad faith can also include facts indicating that the domain was registered primarily for the purpose of disrupting the business of the trademark owner. Respondent states that his websites were created for the following purpose: “to update and further prove all allegations I brought against the Nevyases as documented on my previously owned website LasikSucks4u.com and now LasikDecision.com. I would also like to show how I believe the courts were wrong in many of their decisions and/or opinions regarding my med mal lawsuit Morgan v. Nevyas and the current Nevyas v. Morgan lawsuit.” Ex. F.

Thus, Respondent admits that his websites were registered and are being used for to disrupt Complainants’ businesses. Respondent falsely alleged that Complainants committed medical malpractice, and if his stated intention is to attempt to publicly prove those allegations, his conduct necessarily involves disrupting Complainants’ businesses. See also Dr. Karl Albrecht v. Eric Natale, FA 95465 (Nat. Arb. Forum Sept. 16, 2000) (“The Respondent intentionally registered a domain name which uses the Complainant’s name. There is no reasonable possibility that the name <karlalbrecht.com> was selected at random. There may be circumstances where such a registration could be done in good faith, but absent such evidence, the Panel can only conclude that the registration was done in bad faith.”)

[6.] REMEDY SOUGHT

Complainants request that the panel issue a decision that Respondent’s domain-name registrations be transferred to Complainants.

[7.] OTHER LEGAL PROCEEDINGS

None.

[8.] COMPLAINT TRANSMISSION

Complainants assert that a copy of this Complaint, together with the cover sheet as prescribed by NAF’s Supplemental Rules, has been sent or transmitted to Respondent at the contact information provided, in accordance with ICANN Rule 2(b), and to the domain name Registrar at the contact information provided, in accordance with NAF Supp. Rule 4(e).

[9.] MUTUAL JURISDICTION

Complainants will submit, with respect to any challenges to a decision in the administrative proceeding canceling or transferring the domain name, to the location where the Respondent is located, in accordance with ICANN Rule 3(b)(xiii).

[10.] CERTIFICATION

Complainants agree that their claims and remedies concerning the registration of the domain name, the dispute, or the dispute’s resolution shall be solely against the domain-name holder and waive all such claims and remedies against (a) the National Arbitration Forum and panelists, except in the case of deliberate wrongdoing, (b) the Registrar, (c) the registry administrator, and (d) the Internet Corporation for Assigned Names and Numbers, as well as their directors, officers, employees, and agents.

Complainants certify that the information contained in this Complaint is to the best of their knowledge complete and accurate, that this Complaint is not being presented for any improper purpose, such as to harass, and that the assertions in this Complaint are warranted under these Rules and under applicable law, as it now exists or as it may be extended by a goodfaith and reasonable argument.

Respectfully Submitted,

Bryna S. Scott, Esq.

Alexis Arena, Esq.

FLASTER/GREENBERG, P.C.

1600 John F. Kennedy Blvd., Suite 200

Philadelphia, PA 19103

alexis.arena@flastergreenberg.com

Attorneys for Claimants Dated: July 1, 2010

View the complete document HERE

 

MY RESPONSE

THE COMPLAINANT(S) COMES BEFORE THE NATIONAL ARBITRATION FORUM WITH UNCLEAN HANDS

 Complainant(s) have a history of misrepresenting facts to impede Respondent Morgan‟s First Amendment Rights. Complainant(s) through their counsel prior to the onset of litigation in the Nevyas v. Morgan lawsuit have stated "that this website should be removed in its entirety"1 and have repeatedly harassed Respondent Morgan‟s website hosting providers with threats of lawsuit. Complainant(s) twice attempted to obtain a restraining order against Respondent Morgan which was denied by the Philadelphia Court of Common Pleas. Complainant(s) then brought suit against Respondent Morgan in Federal Court. The federal district court dismissed the Lanham Act claim because the plaintiffs lacked standing to bring a false advertising claim and because Morgan's statements did not qualify as "commercial advertising or promotion." Unhappy with the Federal Court decision, Complainant(s) reinstated their claims in the state court for defamation, breach of contract and specific performance which proceeded to trial in July 2005. The trial court granted an injunction in favor of the plaintiffs (complainant(s)). On appeal, the Superior Court of Pennsylvania vacated the injunction in March 2007 and remanded the case to the trial court for further findings and proceedings.2 Claimant(s) allege that Respondent Morgan posted numerous false, disparaging and defamatory statements regarding Complainants are not true and have yet to be determined by the courts. In addition, facts Respondent Morgan and his co-defendant submitted during litigation resulted in the Judge ruling that Complainant(s) were public figures.3

1 Exhibit 1 - http://www.lasikdecision.com/media2/nocontract.pdf

2 Exhibit 2 - http://www.citizen.org/documents/nevyasmorganopinion.pdf

3 Exhibit 3 - https://fjdefile.phila.gov/dockets/zk_fjd_public_qry_03.zp_dktrpt_frames?case_id=031100946

THE COMPLAINANT(S) ARE A RISK TO PUBLIC SAFETY

Misrepresentations to Schullman Associates, Complainant(s) Institutional Review Board (IRB) and the U.S. Food and Drug Administration during their investigational study for LASIK have resulted in:

(a) Damages to over 30 people by claimant(s);

(b) Numerous letters from the FDA stating claimant(s) were in violations of their study;4

4 Exhibit 4 - http://www.lasikdecision.com/index.php?option=com_content&view=category&layout=blog&id=33&Itemid=114 – under section „Nevyases Investigational Study‟

(c) Discontinuance of their study by the FDA for safety reasons;

As such, the public has a right to know they are at risk when choosing services by claimant(s).

4) RESPONSE TO FACTUAL AND LEGAL ALLEGATIONS MADE IN COMPLAINT

a) This Response specifically responds to the statements and allegations contained in the Complaint and includes any and all bases for the Respondent to retain registration and use of the disputed domain name.

b) First and foremost, it is important to note at the outset that this is a case about Internet gripe sites in which the names of the Complainants – Herbert and Anita Nevyas -- have been used in the domain names for sites that are devoted to describing Respondent‟s criticisms of those Complainants. Even assuming that their names can be the subject of a trademark-like UDRP complaint, this UDRP proceeding should take account of constitutional and trademark law in the United States, where the validity of any decision by the UDRP panel will be contested. And courts in the United States have consistently held that trademark claims over domain names in the form www.trademark.com cannot be brought when the domain name is used for a web site that is about the trademark holder, so long as the web site itself is not confusing about whether it is sponsored by the trademark holder. Lighthouse Ministry v. Foundation for Apologetic Information and Research, 527 F.3d 1045 (10th Cir. 2008); Lamparello v. Falwell, 420 F.3d 309 (4th Cir. 2005), rev’g 360 F. Supp 2d 768 (E.D.Va. 2004); Lucas Nursery and Landscaping v. Grosse, 359 F.3d 806 (6th Cir. 2004); Taubman v. WebFeats, 319 F3d 770 (6th Cir. 2003). Indeed, the First Amendment limits trademark law to commercial uses. Id. Consequently, it is an independent ground for objecting to the application of trademark law to the use of domain names like those at issue here that the use is for the non-commercial purpose of expressing opinions about the trademark holder. Lighthouse Ministry v. Foundation for Apologetic Information and Research, 527 F.3d 1045 (10th Cir. 2008); Bosley Medical v. Kremer, 403 F.3d 672 (9th Cir. 2005); TMI v. Maxwell, 368 F.3d 433 (5th Cir. 2004); Taubman v. WebFeats, 319 F3d 770 (6th Cir. 2003).

c) The domain names <nevyaslasik.com>, <anitanevyaslasik.com>, and <herbertnevyaslasik.com> (sites listed) are not identical or confusingly similar to a trademark or service mark in which the Complainant(s) claims to have rights.

i) It is impossible for visitors to (sites listed) to be confused into thinking that they are visiting complainant(s) web site. A simple perusal of the home pages of (sites listed) makes it immediately obvious that the sites are designed to openly show Respondent Morgan‟s experience with claimant(s) and what can happen if you are not a good candidate for LASIK. The first caption of each website states: "After damaging my eyes with Refractive Surgery, Drs. Herbert Nevyas and Anita Nevyas-Wallace of Nevyas Eye Associates sued to silence me." No person of average intelligence could conclude that an organization would operate a web site to show they damaged people and impeded on a person‟s First Amendment Rights. Furthermore, there are many statements and links on the sites that encourages the visitor to verification of comments made on respondent Morgan‟s sites. In lieu of complainant(s) argument, as of July 29, 2010 the websites now reads: <nevyaslasik.com> "Why I do not recommend Nevyas Eye Associates!", <anitanevyaslasik.com> "Why I do not recommend Anita Nevyas!", and <herbertnevyaslasik.com> "Why I do not recommend Herbert Nevyas!". The title pages of each site have also been changed to further reflect these sites are not complainant(s).

d) Respondent owns < nevyaslasik.com>, < anitanevyaslasik.com>, and < herbertnevyaslasik.com> and has rights and legitimate interests in that is/are the subject of the complaint. ICANN Rule 3(b)(ix)(2); ICANN Policy ¶ 4(a)(ii).

i) The Respondent is making a legitimate noncommercial or fair use of the domain name, without intent for commercial gain to misleadingly divert consumers or to tarnish the trademark or service mark at issue, establishes a legitimate interest in the domain name. UDRP panels have stated repeatedly that criticism of a trademark owner‟s activities is a fair use, even if the domain name incorporates the Complainant‟s trademark. See, e.g., Bridgestone Firestone, Inc. v. Myers, WIPO Case No. D2000-0190 (July 6, 2000); Bosley Med. Group v. Kremer, WIPO Case No. D2000-1647 (February 28, 2001); TMP Worldwide Inc. v. Potter, WIPO Case No. D2000-0536 (August 5, 2000); The Am. Nat’l Red Cross v. Mafiabusters.com LLC, NAF File No. FA0206000114589 (August 6, 2002); Pensacola Christian College Inc. v. Gage, NAF File No. FA0110000101314 (December 12, 2001); Compusa Mgmt. Co. v. Customized Computer Training, NAF File No. FA0006000095082 (August 17, 2000); Robo Enters., Inc. v. Daringer, NAF File No. FA0101000096375 (February 21, 2001); Savin Corp. v. savinsucks.com, NAF File No. FA0201000103982 (March 5, 2002); Bloomberg L.P. v. Secaucus Group, NAF File No. FA0104000097077 (June 7, 2001); Mayo Found. for Ed. and Research v. Briese, NAF File No. FA0102000096765 (May 4, 2001); Dorset Police v. Coulter, eRes Case No. AF-0942 (October 20, 2001); Carefree Toland Pools, Inc. v. Thomson, eRes Case No. AF-1012 (October 30, 2001); cf. Wal-Mart Stores, Inc. v. MacLeod, WIPO Case No. D2000-0662 (September 19, 2000) (stating that criticism can be a legitimate interest, but finding no legitimate interest because the protest site was created only as a pretext for selling the site back to the trademark owner); Becker & Poliakoff, P.A. v. Isabell, eRes Case No. AF-0847 (August 9, 2000) (stating the panel would find criticism to be a legitimate fair use if it had not decided the dispute on other grounds). Respondent Morgan also is not a commercial enterprise and the sole purpose of his

websites are to provide verifiable, factual information about respondent Morgan‟s experiences with complainant(s). Although the information provided on Respondent's web site admittedly is, and should be, embarrassing to complainant and its LASIK surgeons, complainant has not provided any evidence to support his allegation that it is defamatory. There is significant social value in permitting people to express their opinions as part of their First Amendment rights, just as there is a right to criticize public figures and organizations under the freedom of speech principles of the U.S. Constitution. These rights clearly override the minimal commercial value of a domain name in a case like this.

ii) The accuracy and legitimacy of respondent Morgan‟s claims about complainant(s) on < nevyaslasik.com>, < herbertnevyaslasik.com>, and < anitanevyaslasik.com> are confirmed by the public documents throughout Respondent Morgan‟s websites.

c) Respondent has not registered < nevyaslasik.com>, < anitanevyaslasik.com>, and < herbertnevyaslasik.com> in bad faith ICANN Rule 3(b)(ix)(3); ICANN Policy ¶ 4(a)(iii).

i) Respondent Morgan has not offered to sell the domain names to any entity. Respondent Morgan has simply acquired the domain names for the purpose of educating the public due to claimant(s) risk to public safety and past improprieties which the complainant(s) engages.

ii) Complainant(s) allege Respondent Morgan profits from the domains. This is simply not true. Most Lasik websites are advertisements for having Lasik eye surgery. These sites will list complications but severely downplay the risks associated with LASIK just to sell you the procedure. The same can be said of MANY doctors who perform this procedure when you go in for consultation. Most domains listed are third party sites by others damaged by Refractive Surgery, sites useful for those seeking information regarding LASIK that doctors just do not emphasize. The website < lasikinfocenter.com> claimant(s) emphasized was previously owned by Ariel Berchadsky, a New York lawyer who was damaged by refractive surgery.5 Respondent Morgan does not earn any click-through fees or commissions from the web sites posted at the contested domain names. He does not profit from them in any way. All of the links in the „Links‟ section of Respondent Morgan‟s websites have been chosen because, in the opinion of Respondent Morgan, they offer useful information to prospective patients who are considering surgery on their eyes, or to other lasik victims like Respondent Morgan who are trying to learn what they can do about what has been done to them. If some of those sites are mounted by professionals in the field, who hope that viewers will be choose their services, that is not why Respondent Morgan has linked to them and in particular the link goes to the informational pages on such web sites, not to pages that advertise the services of their creators. Respondent Morgan acknowledges changes are required to update sites and will do so accordingly (already started). Complainant also makes an issue of the fact

5 Exhibit 5 - The link for lasikinfocenter.com has since been removed from the sites listed.

that, on a different web site that does not contain any of Complainants‟ names in the URL, Respondent Morgan urged public support for Public Citizen,6 a not for profit organization and accepts no government or corporate money – they rely solely on foundation grants, publication sales and support from their members. As previously noted, Public Citizen‟s litigation group represented Respondent Morgan in a successful appeal from an injunction against the maintenance of that web site. But there is no appeal for support for Public Citizen on any of the web sites at issue in this case and, in any event, the United States Court of Appeals has specifically held than an expression of support for Public Citizen, along with a link to its web site, by one of its clients in a domain name case did not make that web site "commercial" and hence amenable to suit under the trademark laws. Bosley Medical Institute v. Kremer, 403 F.3d 672, 678 (9th Cir. 2005)

6 Exhibit 6 - http://www.citizen.org/Page.aspx?pid=2306

iii) A consensus has not yet developed among panels regarding whether an individual can have a legitimate interest in using a domain name in the form <trademark.com> for the purpose of criticizing or commenting on the trademark owner. Compare Bosley Med. Group, WIPO Case No. D2000-1647 (using <trademark.com> to comment on trademark owner is fair use), with Nintendo of Am. v. Jones, WIPO Case No. D2000-0998 (November 17, 2000) ("Insofar as a domain name which is identical to a name or mark is used solely in the context of the product of the owner of the name or mark and the owner objects to the use, it is not legitimate."). In the absence of a consensus, a panel must consider the parties‟ arguments and relevant legal authorities and then make a decision consistent with the goals of the Policy and the Rules, as well as general legal principles. See Rules Paragraph 15(a) ("A Panel shall decide a complaint on the basis of the statements and documents submitted and in accordance with the Policy, these Rules and any rules and principles of law that it deems applicable."). Moreover, as discussed above, because Complainant has accepted jurisdiction for judicial review in the United States, the panel should apply United States law, including both the First Amendment and the many court decisions limiting the use of trademark law to domain names for non-commercial web sites about the trademark holder. Prior panel decisions finding no legitimate interest in using a domain name in the form of <trademark.com> for the purpose of criticizing or commenting on the trademark owner all relate to a trademark owner that is a commercial enterprise. Complainant claims to offer a "non-profit" service. Respondent also does not offer or provide any goods or services through its web site, nor does it solicit or accept donations. Accordingly, there is no intent to divert nor effective diversion of any commerce, nor any risk of misdirected donations. Respondent has neither sought nor received any commercial gain from the registration and use of the domain name.

iv) The panel in Legal & Gen. Group Plc v. Image Plus, D2002-1019 (WIPO Dec. 30, 2002), found that initial interest confusion was displaced by the criticism content at the respondent's web site and that such a "low level of confusion is . . . a price worth paying to preserve the free exchange of ideas via the Internet." In Elm Grove Dodge

Chrysler Jeep, Inc. v. Schedule Star, FA 352423 (Nat. Arb. Forum Dec. 27, 2004), the panel came to a similar conclusion, finding no bad faith registration or use where the respondent "only registered the disputed domain names to voice concerns and complaints about Complainant" and "[n]o one reading the web site would be confused as to sponsorship."

v) Complainants also protest at length about the way Respondent Morgan "advertises" his web site in Google. Respondent does not "advertise" on Google – Google crawls web sites, identifies sites that are believed to be relevant to search queries using its sophisticated algorithm, and then returns search results accordingly. And it is Google, not Respondent, that decides how to describe the sites being returned, drawing text from the sites themselves. Each of the items about which the Nevyases complain are "organic" search results whose placement and content are determined solely by Google in its own discretion. Moreover, the courts do not agree with the implicit argument by complainants that the content of search listings makes out a basis for trademark litigation. No case based on the theory of "initial interest confusion" can be made out when a user of a search engine clicks on a search result and comes to a landing page that so clearly dispels any possible confusion as Respondent‟s pages do, by expressly criticizing the trademark holder. And, even if there were a possible trademark claim, it would not be a UDRP claim which is based only on the content of the domain name.

vi) Complainant(s) have presented a bizarre and baseless claim to the National Arbitration Forum that clearly emphasizes Respondent Morgan‟s claims that claimant(s) continuously impede on Respondent Morgan‟s First Amendment Rights and the harassment to silence him.7

7 Exhibit 7 – Claimant(s) wrote this letter over 7 years after Respondent Morgan last saw them as a patient. Respondent Morgan believes the actions of claimant(s) was of vindictive nature and to further harass Morgan.

5) RESPONSE TRANSMISSION

Respondent Morgan asserts that a copy of the Response, as prescribed by NAF‟s Supplemental Rules, has been sent or transmitted to the Complainant(s), in accordance with ICANN Rule 2(b). ICANN Rule 5(b)(vii); NAF Supp. Rule 5.

6) Respondent Morgan respectfully requests that the Administrative Panel denies the remedy requested by the Complainant(s).

7) CERTIFICATION

Respondent Morgan certifies that the information contained in this Response is to the best of Respondent‟s knowledge complete and accurate, that this Response is not being presented for any improper purpose, such as to harass, and that the assertions in this Response are warranted under these Rules and under applicable law, as it now exists or as it may be extended by a good-faith and reasonable argument.

Respectfully Submitted,

Dominic J. Morgan, Respondent

View the complete document HERE and HERE (exhibits)

COMPLAINANTS’ ADDITIONAL SUBMISSION IN REPLY TO RESPONDENT

Complainants Dr. Herbert Nevyas and Dr. Anita Nevyas-Wallace (“Complainants”) submit this additional submission in reply to the Response filed by Respondent Dom Morgan / n/a (“Respondent”).

[a.] Respondent’s Belated Revisions to His Websites Are Not Evidence of His Rights to the Domains; To the Contrary, They Evidence Respondent’s Bad Faith Prior to His Receipt of the Complaint.

Respondent states that since receiving the Complaint in this matter, he: (1) removed the link on his website to www.lasikinfocenter.com, which contained advertisements for Complainants’ competitors; and (2) revised the title pages of his websites so as to not misleadingly refer to Complainants. Response, at 3, 5, Ex. 5.

Respondent’s removal of commercial links on his website and the edits to his website text do not absolve him from liability in this proceeding, because the Policy focuses on the content of Respondent’s websites before the date the Complaint was filed. Paragraph 4(c)(i) of the Policy states that a respondent may demonstrate “rights to and legitimate interests in the domain name” by showing “before any notice to you of the dispute, your use of, or demonstrable preparations to use, the domain name or a name corresponding to the domain name in connection with a bona fide offering of goods or services…” Policy, 4(c)(i).

Moreover, Respondent’s belated revisions are evidence that he used the domains in bad faith before he received the Complaint. See Comweld Group Pty. Limited v. Comco Industries Co. Ltd., Case No. D2001-0290 (WIPO August 31, 2001) (“Respondent’s attempts to change the content of the website are evidence that the registration was not in good faith.”); St. Lawrence University v. Nextnet Tech c/o Domain Dept, FA0701000881234 (Nat. Arb. Forum Feb. 21, 2007) (“Respondent has authority to change the website content, and Respondent directed that changes be made to the website’s content and keywords after receiving the Complaint in this proceeding.”); Granarolo S.p.A. v. Michele Dinoia a/k/a SZK.com, FA0602000649854 (Nat. Arb. Forum April 17, 2006) (“Respondent’s attempts to change his website provide clear evidence of endeavours to get around the consequences of the bad faith registration of a famous mark.”)

Indeed, if respondents in UDRP proceedings could always avoid liability by making changes after receipt of a UDRP complaint, the UDRP process would be ineffective. There is nothing to prevent Respondent from changing his websites back to the way they were previously once this action is concluded, or making his websites more deceptive, if Respondent is permitted to maintain control of the domains.

For that reason, UDRP proceedings properly focus on the content of the domain names themselves. Here the domain names at issue indicate that they are owned by Complainants, not that they are owned by an individual criticizing Complainants.1 Compare The Paxton Herald v. Millard, FA0207000114770 (Nat. Arb. Forum Aug. 21, 2002).

[b.] Respondent’s Statement That Google - and Not Respondent - Is Responsible For the Way His Websites Appear to Consumers in Search Results is False.

One change Respondent has not made since receiving the Complaint is to revise the headlines or “title tags” of his websites, which are displayed to internet users viewing Google search results. The title tags for Respondent’s websites still include phrases such as:

Welcome to HerbertNevyasLasik.com! herbertnevyaslasik.com/

Drs. Herbert Nevyas & Anita Nevyas-Wallace - herbertnevyaslasik.com/index.php?...

Nevyas Eye Associates - www.anitanevyaslasik.com/index.php?...

See Exhibits E and F to Complaint and attached Exhibit 1.

Respondent argues that the way his websites are listed has nothing to do with Respondent’s actions and is a result of Google’s actions. However, Google explains that “title tags” like Respondent’s are authored by website owners themselves. See, e.g.,

http://www.google.com/support/webmasters/bin/answer.py?hl=en&answer=35264#3.

When Respondent created his website content, he alone selected the underlined phrases displayed above and in Google search results. These phrases authored by Respondent are part of his websites’ content and are one of the reasons his website content is misleading to consumers.

1 Respondent argues that “this is a case about Internet gripe sites” but unlike gripe sites, such as ThisNissanSucks.com, the domain names here give no indication that their purpose is criticism.

Respondent is also incorrect that no case can be made in this proceeding based on “initial interest confusion.” Respondent’s domain names themselves, coupled with misleading website content such as his “title tags” create initial interest confusion that causes prospective patients to unwittingly visit Respondent’s websites, even if they later realize their mistake. See Council of American Survey v. Pinelands Web Services, D2002-0377 (WIPO July 19, 2002) (“Respondent may have a right to refer to the mark in critical content, the wholesale appropriation of Complainant's mark in a domain name, without any distinguishing material, creates confusion with Complainant's business and is not fair use merely for the purpose of criticism…No criticism is apparent from the domain name itself; it is not sufficient that the criticism may be apparent from the content of the site.”)

Respondent essentially admits that his intention is to drive prospective patients of Complainants to his website and to cause harm to Complainants’ reputation and business, stating that “the public has a right to know they are at risk when choosing services by claimant(s).”

Response, at 3. Respondent also previously contacted Dr. Stephen Barrett, the Board Chairman of Quackwatch, Inc. (an organization dedicated to consumer protection and health fraud prevention), with his allegations regarding Complainants. See Exhibit 2 (Emails from Dr. Barrett). Dr. Barrett remarked that he felt Complainants were reputable and that Respondent’s current website may expose him to a libel suit and Respondent replied that his intention with the website was to put Complainants out of business. Id. Respondent’s bad faith intent to disrupt Complainants’ business by causing consumer confusion could not be clearer.

[c.] The Litigation Respondent Describes Does Not Concern the Websites At Issue Here and His Statements Regarding Those Disputes Are Inaccurate and Irrelevant in This Proceeding.

It is unnecessary to detail the inaccurate statements made by Respondent regarding underlying disputes with Complainants here, because those statements have no relevance in this proceeding. To summarize, Respondent was unhappy with the results of his medical malpractice lawsuit against Complainants, because Complainants did not commit medical malpractice, and thereafter Respondent began carrying out his stated intention of putting Complainants out of business through internet gripe sites. However, Respondent crossed the line and violated the Policy when he began registering domains comprised of Complainants’ trademarks and including links to Complainants’ competitors on those websites.

Although the parties’ previous litigation also involves Respondent’s websites, the litigation does not concern the domains at issue here. Complainants’ defamation claims against Respondent focused on Respondent’s statements on the website www.lasiksucks4you.com, which is no longer owned by Respondent.

[d.] Respondent Has Not Shown A Legitimate Non-Commercial Fair Use of These Domains and His First Amendment Rights Are Not Implicated.

Finally, although Respondent asserts that he did not obtain click-through fees or any other commercial profit by advertising the services of Complainants’ competitors, this assertion is unsubstantiated by any evidence. The evidence shows that Respondent’s websites link to Complainants’ competitors websites and those “hits” are tracked on Respondent’s websites. See Complaint attached Exhibits. He admits that he links to professionals in the field who may hope that viewers will choose their services and “[m]ost Lasik websites are advertisements for having Lasik eye surgery.” Response, at 3. However, he argues “that is not why Respondent Morgan has linked to them.” Id.

Respondent’s internal motivation in linking to these websites is irrelevant; it is sufficient that the disputed domains link to Complainants’ competitors. Furthermore, Respondent himself does not have to be a direct competitor of Complainants to have acted in bad faith. See St. Lawrence University v. Nextnet Tech c/o Domain Dept, FA0701000881234 (Nat. Arb. Forum Feb. 21, 2007) (“By redirecting Internet users seeking information on Complainant’s educational institution to competing websites, Respondent has engaged in bad faith registration and use pursuant to Policy ¶ 4(b)(iii)); Mission KwaSizabantu v. Rost, D2000-0279 (WIPO June 7, 2000) (defining “competitor” as “one who acts in opposition to another and the context does not imply or demand any restricted meaning such as commercial or business competitor”); S. Exposure v. S. Exposure, Inc., FA 94864 (Nat. Arb. Forum July 18, 2000) (finding that the respondent registered the domain name in question to disrupt the business of the complainant, a competitor of the respondent); EBAY, Inc. v. MEOdesigns, D2000-1368 (WIPO Dec. 15, 2000) (finding that the respondent registered and used the domain name <eebay.com> in bad faith where the respondent has used the domain name to promote competing auction sites).

This action does not implicate Respondent’s First Amendment rights or his ability to post critical statements regarding Complainants on any of the other domains he owns that do not contain Complainants’ trademarks, such as LasikDecision.com, FlawedLasik.com, etc. This action concerns only Respondent’s ownership of the domain names NevyasLasik.com, AnitaNevyasLasik.com and HerbertNevyasLasik.com and his registration and use of those domains in violation of the Policy.

For the foregoing reasons, and the reasons described in Complainants’ Complaint, the NevyasLasik.com, HerbertNevyasLasik.com, and AnitaNevyasLasik.com domains should be transferred to Complainants.

Respectfully Submitted,

Bryna S. Scott, Esq.

Alexis Arena, Esq.

FLASTER/GREENBERG, P.C.

1600 John F. Kennedy Blvd., Suite 200

Philadelphia, PA 19103

Alexis.arena@flastergreenberg.com

Attorneys for Claimants Dated: August 4, 2010

View the complete document HERE, HERE (exhibits), and HERE (exhibits)

RESPONDENT MORGAN’S REPLY TO COMPLAINANTS’ ADDITIONAL SUBMISSION

Complainants’ Additional Submission, as their Complaint, consists of half-truths and worse. As but one example, consider complainants’ exhibit B, a July 16, 2010 letter to Alexis Arena from Stephen Barrett, MD, explained below:

In 2003 University of Cincinatti Law Professor James O’Reilly contacted me and asked me to post, on my website, his article on legal and regulatory problems involving LASIK eye surgery,

and I agreed. After the Nevyases sued me, I asked professor O’Reilly to re-evaluate my website. He did, and prepared a declaration, which I posted online. 1

1 I, James T. O'Reilly, make this declaration to place this matter of record, subject to the penalties of 18 Pa.C.S.A. §4904 relating to unsworn falsification to public authorities. I declare that:

1. My professional address is at the College of Law, University of Cincinnati, P.0 210040, Cincinnati, Ohio 45221-0040. 1 am a member of the Bar of Ohio and Virginia, the Sixth and Federal Circuits and the U.S. Supreme Court. I have taught law students regarding the law of medical devices, products liability and administrative law since 1980, and am the author of more than twenty textbooks and one hundred articles, and have appeared as an FDA law expert in federal and state courts, and have been quoted by the U.S. Supreme Court as an expert on medical device regulation. I understand that the federal regulation of the risks and benefits of medical devices such as LASIK equipment is a matter of substantial public concern and controversy.

2. I published my law review essay, AN EYE FOR AN EYE: FORESIGHT ON REMEDIES FOR LASIK SURGERY'S PROBLEMS, at 71 U. Cin. L. Rev. 541 (2002), as part of our Faculty Scholarship symposium issue.

3. I became aware of Mr. Morgan's website, Lasiksucks4u.com, upon the unsolicited recommendation of a person in California who had read my law review article and encouraged me to read Mr. Morgan's website comments. I found the material posted on Lasiksucks4u.com to be educational and useful, particularly for anyone considering having LASIK surgical procedures performed on themselves. I did an internet search using the google.com search engine and believe that the numerical majority of the dozens of sites listed there are commercial vendors of LASIK products or surgeons providing LASIK.

4. After reviewing his site, I corresponded with Mr. Morgan and have encouraged Mr. Morgan to include my essay on his website, in order that persons considering Lasik may become aware of my perspective regarding various legal and regulatory problems involving LASIK surgery. I have provided Mr. Morgan with the electronic version of my essay for posting at his discretion. I have no financial interest in LASIK, have not been paid by Mr. Morgan or others related to LASIK, and had no prior knowledge of Mr. Morgan or of those to whom he makes reference in his website.

5. Although my law review article is legal scholarship directed particularly toward lawyers, I hope its opinions can also be part of the wider education of the public, since I consider public education to be a major responsibility of the legal profession, particularly for legal academics. As a scholar recognized in the field of medical device and products liability law, the general public's awareness of product risks is an extremely important aspect of our protections as members of American society.

6. I believe that Mr. Morgan has an ample First Amendment right to exercise his freedom of speech on matters of public controversy, and to provide the public with information about LASIK, from his personally unique perspective as a victim.

Dated this 8th day of December, 2003 at Cincinnati, Hamilton County, Ohio.

[signed]

Professor James O’Reilly

Stephen Barrett, MD then contacted professor O’Reilly, touted "Quackwatch" and, without revealing his marriage to Herbert Nevyas’ sister, castigated me, praised Herbert Nevyas, and asked professor O’Reilly to withdraw his declaration (emphasis added):

From: Stephen Barrett, M.D.

To: james.oreilly@uc.edu

Sent: 12/31/2003 10:12 AM...

Dear Professor O'Reilly

I am writing in response to your declaration at http://www.lasiksucks4u.com/OReillydecl.htm.

I have followed the LASIK situation very carefully because I write a college textbook that helps people learn how to make intelligent decisions about health matters.... About two months ago, Mr. Morgan notified me that he had created his site and expressed concern that I had an article by Dr. Nevyas on Quackwatch. (The article was prepared for my textbook.).... You seem to be under the impression that the purpose of the site is to warn people about the potential dangers of LASIK surgery and that it provides an appropriate warning. However, it seems to me that the primary purpose of the site is to put Dr. Herbert Nevyas and his daughter Anita Nevyas-Wallace, MD (who operated on Mr. Morgan) out of business..... Dr. Herbert Nevyas is probably the most respected eye surgeon in Philadelphia.... At the very least, you should withdraw your declaration....

Stephen Barrett, M.D.

Board Chairman, Quackwatch, Inc.

NCAHF Vice President and Director of Internet Operations

P.O. Box 1747, Allentown, PA 18105

Telephone: (610) 437-1795

Professor O'Reilly investigated. He learned that Herbert Nevyas never did Lasik at any hospital, had ceased all hospital operations for over ten years, operated only in his own outpatient surgicenter, and advertised extensively. His operations were not subject to any peer review except by his wife (who never had an ophthalmology residency but was apprenticeship-trained by her husband). In turn, Herbert Nevyas did the "peer review" of his wife and daughter. This arrangement satisfied the law mandating peer review of outpatient surgicenters, but it also indicated that Dr. Barrett’s "college textbook that helps people learn how to make intelligent decisions about health matters" did not value peer review. In preaching the virtues of "probably the most respected eye surgeon in Philadelphia" to young college students in Allentown, a city merely 54 miles from Philadelphia (Rand-McNally), Dr. Barrett knowingly promoted a medical entrepreneur.

Professor O'Reilly decided that his declaration should not be withdrawn.. Dr. Barrett, after seven years and "further reflection," and still without revealing that he is married to Herbert Nevyas’ sister, now writes Alexis Arena to purport, "I don’t recall the exact words, but he made it clear that his intention was to put the Nevyas’s out of business."

Quackwatch, Quackwatch....

.

Conclusion - a question:

When a large law firm submits "earwitness" testimony to a trier of fact without revealing that the "earwitness" is brother-in-law and uncle to complainants (see p. 3 of Complainants’ Additional Submission), have those lawyers fulfilled their duty of candor?

Respectfully Submitted,

Dominic J. Morgan, Respondent

View the complete document HERE

A family affair? Do As I Say, Not As I Do...

Some time after the Nevyases decided they did not want to litigate the case in Federal Court, I found out Anita's son Jonathan registered 2 WEEKS AFTER THEY COMPLAINED TO THE NATIONAL ARBITRATION FORUM 87 domain names, using 30 different variations of my name and or websites. This was never brought up or addressed to the courts because I did not, nor do I care. Vindictive?

 
Lasik Surgery Results in Worse Vision and Never-Ending Pain PDF Print E-mail

This article came out 11 Years after Drs. Herbert Nevyas and Anita Nevyas-Wallace started doing LASIK at Nevyas Eye Institute. It is alleged throughout a medical malpractice lawsuit  filed and ensuing defamation lawsuit the doctors filed in return that the doctors violated numerous federal rules, regulations, and protocols before, during, and after an FDA sanctioned investigational study, mentioned because this article mentions the FDA and the lack of protection they offered patients. Additionally, the FDA was negligent in that ONE OF MANY surgeries done by the Nevyases prior to, during, and after their FDA approval resulted in only ONE settlement (out of court), believed settled for the laser's use prior to FDA approval and the patient's mother working for the court system.

 

Lasik Surgery Results in Worse Vision and Never-Ending Pain

by Heidi Stevenson

SOURCE

Originally published June 3, 2008

(NaturalNews) Perfect vision without glasses or contacts sounds wonderful. Before considering having Lasik surgery, though, it would be wise to ask how many people actually do have good results and how many will suffer bad effects years after Lasik surgery. The advertisements give the impression that it's a perfectly safe -- nearly foolproof -- procedure. Nothing could be further from the truth.

Lasik surgery for vision improvement involves cutting a flap in the eye's cornea, the clear tissue at the front of the eye, then using a laser to cut and reshape the corneal tissue under the flap.

According to Dr. Kerry Soloman, who did a study of Lasik's safety for the American Society of Cataract and Refractive Surgery, a full five percent have poor results. These can be worse vision -- even blindness -- constant eye pain, blurred vision, dry eyes, and a variety of other distressing visual aberrations. Interestingly, people who end up with corrected vision but permanent eye pain are considered successes by the surgeons who do the procedure.

About 48% -- nearly half –- suffer from dry eyes at least temporarily after the surgery. Because the surgery severs the cornea nerves that stimulate tear production, this has been an obvious and predictable problem.

About 700,000 people have Lasik surgery every year. With about 5% of them having bad results, that translates to about 35,000 people who ended up worse, with pain or with visual disturbances, such as double-vision and halos around lights.

The FDA is now investigating the risks associated with Lasik surgery, but one must wonder where the agency has been for the last 19 years, when the surgical technique was first patented. The first Lasik machine was approved by the FDA about ten years ago.

Lasik is Just Another Industry

The Lasik industry is like any other. Its primary motivation is profits, and this one's are enormous. The following quote is by Dr. Marguerite B. McDonald, the former Chief Medical Editor of
EyeWorld, an international publication for ophthalmologists:

"We are only starting to ride the enormous growth curve of Lasik in this country. There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result."

She clearly implies that the patients' welfare is of secondary importance to the doctors' profits! Dr. McDonald is a major player in the field of Lasik surgery. Think of what this implies about the safety of the process and the dishonesty inherent in many doctors doing it.

Of course, this shouldn't be surprising. Consider all the ophthalmologists who now specialize in only Lasik surgery. Instead of putting their efforts into procedures that might help people at risk of losing their sight, they have opted to do nothing but provide a risky and unnecessary procedure.

Long Term Results May Include Suicide

Long term results are proving to be even worse. Lawsuits are popping up now as a result of problems developing years later.

Colin Dorrian was a 28-year-old patent lawyer. In the summer of 2007, he killed himself, leaving a note that blamed constant pain from Lasik surgery. He wrote, "I just cannot accept the fact that I'm supposed to live like this."

Within the industry, there is complete denial of any cause-and-effect between Lasik and suicide. Of course, there have been no studies to see if there's a connection.

One optometrist, Chistine Sindt, who is also a University of Iowa associate professor of clinical ophthalmology, says that she has seen depression in people with vision problems caused by Lasik. "It's not just that they lose vision. They paid somebody... who took their vision away."

Naturally, the Lasik industry explains this sort of thing by saying that the people who become depressed suffered from psychological problems before the surgery. One would think, though, that any doctor whose first interest is in the patient's welfare would want to err on the side of caution. Instead, though, there has been denial.

Permanent Pathological Changes in All Lasik Patients

In a study published by
Cornea in January 2005, it was reported that, of 25 post-mortem Lasik patients, every single one of them had suffered pathological corneal changes that were permanent. There were no exceptions. These patients had died between 3 months and 7 years after their surgeries, and the only determinant for selecting a case for examination was that the person's visual status prior to the surgery was known.

Corneas Do Not Heal Completely After Lasik

In the September-October issue of the
Journal of Refractive Surgery, a report of a study on the healing of Lasik patients reported that most do not achieve anywhere near the quality of structure that's achieved from most corneal wounds. The relative strength of the Lasik-induced wound's tissues average only 2.4% of normal tissue. Wounds gotten in an accidental manner typically develop scars with 28.1% the strength of normal tissue.

In the
Journal of Refractive Surgery's April 2007 issue, the authors stated, "The Lasik flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed."

Lasik patients are left with permanently weakened corneas. This means that they are forever at risk of permanent eye damage from relatively minor injuries. Those who are most at risk of suffering permanent damage as a result of Lasik surgery, people who are involved in highly physical sports or jobs, are the ones who are often targeted by the industry. Clearly, the best interests of the patients are not the doctors' primary concern.

Potential Damage From Lasik Surgery

Lasik surgery has not been in existence for long, only about ten years. Its long term effects are not yet known, but there are many reasons to be concerned.

There are some indications that the procedure may induce cataracts. Many people, including relatively young ones, have claimed that cataracts were induced by Lasik surgery. There have not, of course, been any studies to see if there's a connection.

Lasik procedures literally evaporate part of the cornea to produce a smooth surface. This is known to create free radicals and apoptosis (cell death and dismemberment) in the stromal, underlying, structure of the cornea. Free radicals are known to cause tumor growth. It may be decades before we see results of this damage –- or it may be entirely harmless. Only time will tell.

In November 2007,
EyeNet Magazine, a publication of the American Academy of Ophthalmology, reported ectasia, bulging of the cornea, years after Lasik surgery. Joe McFarland, MD, JD stated, "We are also just now learning of some of the long-term complications of refractive surgery, which are being reflected in new allegations and lawsuits. For example, some patients are developing post-refractive ectasia years after the procedure; this condition not only compromises vision, but also may need to be treated with a corneal transplant."

At least one case of neuropathy to both optic nerves of a patient was noted by the journal,
Opthalmology in April 2008. It is surmised that the cause was elevation of intraocular (within the eye) pressure induced by a suction ring device routinely used during Lasik procedures. It resulted in several severe vision defects.

A consistent result of Lasik surgery is that people over age 40 who had been able to see things close to them without glasses suddenly require glasses for reading. They have only exchanged distance-vision glasses for reading glasses.

Lasik surgery changes the cornea's shape and thickness. As a result, intraocular pressure readings, which are critical for diagnosing glaucoma, become inaccurate. This may result in lost vision from glaucoma that goes undiagnosed.


Do You Want to Take the Risk of Lasik Surgery?

Laser sounds so much safer than a knife, but keep in mind that it cuts as sharply as any weapon. One of the primary processes of Lasik surgery is melting part of the cornea to make it smooth. The result is that even the best possible outcome results in poor healing, leaving all, or nearly all, patients at significantly greater risk of permanent eye damage from injury. Aside from the immediate risks of seriously impaired vision and permanent eye pain, the long term risks are only now coming to light.

Is Lasik surgery worth the risk? I'll leave that up to you.

References:

Lasikdisaster.com

Associated Press

Washington Post

Columbia Tribune

Lasik eye procedures may result in disruptive visual symptoms

SOURCE

Sunday, January 15, 2017 by: Daniel Barker Tags: LASIK, postop symptoms, surgery, vision

This article was printed from: http://www.naturalnews.com/2017-01-15-lasik-eye-procedures-may-result-in-disruptive-visual-symptoms.html

(Natural News) With millions of Americans undergoing LASIK surgery each year, most might assume that the procedure is completely safe and harmless, but a recent study showed that a significant percentage of LASIK patients developed new vision problems after the treatment was performed.

LASIK (laser in situ keratomileusis) is a surgical procedure that uses a laser to correct nearsightedness and astigmatism. In the procedure, a laser beam is used to reshape and flatten the cornea, improving the eye’s focusing power.

LASIK is the most common method of correcting vision through surgery, and clinics across the country offer the procedure at affordable rates.

In 2009, the the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched a collaborative effort called the LASIK Quality of Life Collaboration Project (LQOLCP), with the goal of better assessing the risks of LASIK and developing tools for accurately determining the percentage of patients who experienced problems after the procedure.

The group’s initial findings indicated that LASIK surgery was indeed quite safe, with only a tiny percentage of patients reporting any side effects.

From The Washington Post:

“At the time, there were a lot of anecdotes flying around but little scientific information about patient outcomes. The results, published in October 2014, showed that some patients developed problems that adversely affected their day-to-day lives, such as difficulty driving at night or in sunshine. But it was such a small number — less than 1 percent — of the patients in the study that it was difficult to draw any strong conclusions from that data.”

New study reveals that more than 40% of LASIK patients experience new symptoms after surgery

Now, two years later (November 2016), the group has published a follow-up report in JAMA Ophthalmology – and the results are quite different this time around:

“The study suggests that the percentage of people who undergo LASIK and wind up with new visual symptoms — such as double images, glare, halos or starbursts — may be much higher. The data was based on a questionnaire that looked at patient satisfaction with their vision and at visual and dry-eye symptoms following surgery.”

The researchers analyzed data from two groups of patients. Among the first group, which consisted of 262 active Navy personnel, 43 percent of LASIK patients reported new symptoms. Of the second group, made up of 312 civilians, 46 percent reported new symptoms. 28 percent overall experienced dry-eye symptoms for the first time, ranging from mild to severe. (RELATED: Read more news about the failures and successes of modern medicine and Medicine.news)

Most LASIK patients “satisfied,” despite postoperative symptoms

However, most of the study participants – more than 95 percent – reported being satisfied with the results of the surgery.

The new problems were reported to be relatively minor and in most cases did not affect normal function.

The researchers believe that the discrepancy between the older studies and the latest one is accounted for by the tendency of questionnaire respondents to be more forthcoming than when directly interviewed by health care professionals. The reluctance of patients to discuss “negative” events with their doctors has been well-documented, according to the team.

The authors of the study say that theirs is the first to identify new postoperative symptoms in LASIK patients. They also call for patients to be “adequately counseled” regarding the risk of developing new symptoms after the procedure.

Competition has driven the price of LASIK surgery down in recent years – you’ve probably seen the television commercials offering LASIK for as little as a few hundred dollars per eye.

At prices that low, it may be tempting to opt for the procedure – and although many believe LASIK can be considered a safe and affordable alternative to wearing eyeglasses or contact lenses, there are experts who warn that the procedure can be quite dangerous.

Potential LASIK patients should be aware that no surgery is ever “perfect,” and for many there may be some uncomfortable side effects – at least for the first few months after the surgery is performed.

It’s also important to keep in mind that this latest study focused on only a small group of patients. There are many reports of serious complications from LASIK surgery – including blindness – so it’s important to research the subject thoroughly before deciding to have it done.

Sources:

WashingtonPost.com

TechTimes.com

CBSNews.com

AOP.org

FDA.gov

 
Before The Nevyases Study PDF Print E-mail
Nevyas Eye Associates
Thursday, 22 December 2005 12:00
It started with Ed Sullivan, the guy who built the 'Nevyas Laser', a man already under scrutiny by the FDA...

"Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement." [as written in The Journal of Refractive Surgery - Volume 11 (5) * September/October 1995 * News, which was removed from the url address http://www.slackinc.com/eye/jrs/vol115/news1.htm].

And the FDA knew that! From the affidavit Herbert Nevyas submitted to the FDA, it tells of Ed Sullivan building their laser. However, documents show Mr. Sullivan in teleconferences and meetings with the doctors and their laison with the FDA well after this article was written.

After I received inspection reports even less redacted from the FDA regarding inspections of the Nevyas' facility, the FDA promised "to do what they could to help me", but then refused after copies of the inspection reports were returned. In fact Les Weinstein, the CDRH Ombudsman, outright told me (through his secretary) he could no longer have any communication with me.

The inspection reports of Sullivan's facility below were obtained via the Freedom Of Information Act.  Regardless of these reports and the articles written concerning 'Homegrown Lasers", is this what the FDA considers "protecting the public's safety"?

Click PAGE # to open pages in new window

PAGE 1 - Previous inspection, 5/16/96, was a follow up to a Warning Letter issued on 8/17/95. The Warning Letter informed the firm that the FDA considered ExSull, Inc., to be a manufacturer of a Class III medical device, that was both adulterated and misbranded, in that there were no approved PMA or IDE for any of the devices and that the firm itself was not registered as a medical device manufacturer.

PAGE 2 - Mr. Sullivan stated that "he called the FDA and was sent material relating to the building of "custom devices", and that the FDA person he had spoken to over the telephone assured him that it was okay to build them in the Doctor's office".

PAGE 3 - Repeated attempts to schedule a subsequent meeting with Mr. Sullivan (via my leaving numerous messages on his voice mail) were unsuccessful. Mr. Sullivan would not commit to a date and time, when he returned my repeated phone calls, and in some instances did not even return my phone calls. Only after inadvertently meeting him at one of his client's (on 6/25/97), did he then agree to see me at his ExSull, Inc.,

PAGE 4 - Mr. Sullivan stated that he did not have any standard procedures for assembling the device. He stated that the device components are delivered to each physician's office, where he then assembles the compete excimer laser. He informed me that he will then test the laser, but that he does not have any performance specifications, written assembly instructions or quality control tests.

PAGE 5 - and that any involvement by Mr. Sullivan in a sale, would depend on the nature of the sale. He would not elaborate on that statement, but explained that it means that he is not involved in every sale.

PAGE 6 - Mr. Sullivan informed me that he has not contracted to build any additional units, since he assembled the device for [redacted] in October 1996. On 6/26/97, Mr. Sullivan showed me a copy of an IDE for that same client [redacted], Mr. Sullivan explained that he was working on the document, and an examination of the IDE showed that the unit had been used to treat at least [redacted] patients, without an approved IDE. Mr. Sullivan would not allow me to copy this document, and stated that the FDA already has this IDE on file.

PAGE 7 - Mr. Sullivan did state that he will be publishing an article with a Dr. Herbert Nevyas, regarding the use of the ExSull, Inc., excimer laser for treatment of a patient with an irregular cornea, due to an eye injury.

PAGE 8 - According to Mr. Sullivan, this entire process (the exchange of laser beam requirements and the design specifications) is all done via telephone or personal visits, and he does not have any written records of the design specifications. He stated that each individual physician should have those records. Mr. Sullivan stated that he knew of no injuries with the device. He did say that in theory the laser would have some patients possibly experiencing overcorrection, but that the majority would experience a slight undercorrection, which might require additional treatment. In addition, he explained that there has been no hazing or scaring, with the devices. He stated that the physicians handle all of the complaints from the patients, and that he is not aware of any major complications.

PAGE 9 - Mr. Sullivan informed me that he designed the hardware for the "beam shaper" or "beam sculptor", as well as, the software that controls that hardware. He stated that his program was written in [redacted]  and that three versions have been made, of that software. He informed me that he had no documentation or procedures for upgrading or changing the program (at the  [redacted]. In addition, he could not provide any information regarding which of the software versions are in any of the particular devices, stating that he did not keep any of those records.

PAGE 10 - Mr. Sullivan gave his permission for me to observe the calibration procedure. I was allowed to examine the optical compartment, including the "beam shaper" or "beam sculptor", designed by Mr. Sullivan. Mr. Sullivan would not let me photograph this part of the device.

PAGE 11 - He informed me that he is only a consultant, and that each device he assembles is considered a "Custom Device". He confirmed that he did not have any medical device manufacturing records, such as Master Device Record or Device History Record. I asked Mr. Sullivan if the firm had a Device Master Record or Device History Record. He responded that he considers himself a consultant, and that he does not keep any records of design specifications, manufacturing specifications or a device History Record. He stated that each of the physicians might have any documentation for the specifications or design, for their device.

PAGE 12 - During the inspection, Mr. Sullivan stated that the firm's computer, used to store all of the business records, had experienced a "hard drive crash", in the winter of 1996. He explained that consequently all records from 1994 to December 1996 have been lost.

PAGE 13 - He stated that he does not keep any repair or service log books, or a records of any complaints regarding the performance of the laser, by the physicians.

PAGE 14 - There are no Exhibits with this EIR, due to the unavailability of records at the firm.

PAGE 15 - The observations noted in this FDA-4B3 are not an exhaustive listing of objectionable conditions. FDA 483 issued.

View ALL PAGES pdf document.

The FDA issued warning letters regarding the lasers Sullivan built, but STILL allowed doctors to further modify and use these devices on people considering LASIK!

Warning Letter 1 <>  Warning Letter 2

 
Nevyases Investigational Study PDF Print E-mail
Nevyas Eye Associates

The following letters are from the FDA to Drs. Herbert Nevyas and Anita Nevyas-Wallace throughout their investigational study, and after their study was terminated. Despite continued deficiencies as noted below, the FDA kept granting the Nevyases Approvals for their study. Based on documents received during my med mal and the current Nevyas v. Morgan lawsuits, I believe the Nevyases constantly misrepresented themselves and their study to both Schullman Associates (the Nevyases IRB) and the FDA:

All BLUE font on this page designate links to documents which should open in new window.

May 1997

IDE Disapproval Letter from the FDA to Nevyases dated 05/08/97:

PAGE 1 - The Food and Drug Administration (FDA) has reviewed your investigational device exemptions (IDE) application. We regret to inform you that your application is disapproved and you may not begin your investigation. Our disapproval is based on the deficiencies listed below.

PAGE 2 - Deficiencies listed.

PAGE 3 - Please explain the low effectiveness and safety outcomes achieved in your prior clinical studies and specify what steps you are taking to improve your results. Your refractive and visual outcomes were reported at one month as: MSRE for low myopes, < 57% were within ID and < 35% were within 0.5D; less than 60% achieved BUCVA > 20/40; complication and adverse events occurred in > 2% of the cases.

PAGE 4 - Please provide your agreement (or justification for not agreeing) that retreatments done to improve refractive outcome are NOT considered as treatment failures, whereas retreatments done to achieve resolution of an adverse event ARE considered as treatment failures.

PAGE 5 - Your description of study procedures, examination conditions and techniques is not adequate. Please provide a detailed description of each procedure, test and instrument to be used in the study.

PAGE 6 - For your follow-up visit schedule, the text on page 20 of the protocol appears to be inconsistent with the chart on page 43 of the protocol. In addition, please justify your statement on page 20 that measurement of corneal topography will be at the discretion of the investigator.

View ALL PAGES pdf document.

July 1997

Letter from the FDA to Nevyases dated 07/29/97 to cease using Laser:

PAGE 1 - FDA is aware that a number of physicians are using lasers for refractive surgery to treat patients even though there is no PMA or IDE in effect for their lasers. Based on the results of our investigations, we believe that you are currently using your laser to treat patients.

PAGE 2 - Accordingly, on July 28, 1997, we called you to notify you that use of your excimer laser to treat patients would violate the Act and requested that, if you are presently using the laser to treat patients, you immediately cease doing so.

Nevertheless, FDA does intend to consider any use of your laser to treat patients after the close of business July 28, 1997 unless and until the agency approves an IDE for your device to be grounds for disapproval of your IDE.

PAGE 3 - We also want you to know that if FDA approves your IDE application, you would be able to use your laser to perform only specific procedures on a limited number of subjects to demonstrate the safety and effectiveness of your laser for those procedures. Studies conducted under such an IDE would be subject to all IDE regulations. See 21 C.F.R. Part 812. For example, you would be prohibited from promoting and commercializing the laser, and from representing that the device is safe and effective.

View ALL PAGES pdf document.

August 1997

'Conditional' Approval Letter from the FDA to Nevyases dated 08/07/97:

PAGE 1 - Your application is conditionally approved because you have not adequately addressed deficiency #2 cited in our May 8, 1997 disapproval letter.

Also, we are in receipt of your certification (Amendment 4 received August 1, 1997) that you have not used the laser as of the close of business on July 28, 1997, and that you will not use the laser unless and until FDA approves the IDE applic2tion for your device

PAGE 2 - This approval is being granted on the condition that, within 45 days from the date of this letter, you submit information correcting the following deficiencies.

PAGE 3 - Deficiencies listed.

PAGE 4 - Deficiencies listed.

PAGE 5 - We have enclosed the guidance document entitled "Sponsor's Responsibilities for a Significant Risk Device Investigation" to help you understand the functions and duties of a sponsor.

View ALL PAGES pdf document.

October 1997

Letter from the FDA to Nevyases dated 10/03/97:

PAGE 1 - We acknowledge receipt of your institutional review board (IRB) approval (supplement 3). Supplement 4 responds to our conditional approval letter of August 7, 1997 and requests: an increase crease in treatment range from -6.75 ID to -22 ID; approval to study simultaneous bilateral treatment; and, approval to retreat approximately 125 patients previously treated with this laser prior to IDE approval.

PAGE 2 - Requests for additional subjects for enhancements for prior clinical patients will be evaluated as additional data is submitted to support stability of the procedure.

PAGE 3 - You agree that you will not perform retreatment procedures for subjects initially treated under this IDE. Retreatment (enhancement) for subjects initially treated under this IDE is appropriate only after your preliminary data demonstrate safety and indicate the time point of stability of the procedure. You may begin retreatment procedures only after FDA has approved your retreatment study plan and data to support stability.

PAGE 4 - PAGE 5 - PAGE 6 - PAGE 7 - PAGE 8 - PAGE 9 - PAGE 10 - Deficiencies listed.

PAGE 11

View ALL PAGES pdf document.

December 1997

Approval Review Letter from the FDA to Nevyases:

PAGE 1 - The Food and Drug Administration (FDA) has reviewed the supplement to your investigational device exemptions (IDE) application. Your application remains conditionally approved because your supplement adequately addressed only deficiency 2 cited in our October 3, 1997 letter.

This approval is being granted on the condition that, within 45 days from the date of this letter, you submit information correcting the following deficiencies.

PAGE 2 - You are reminded that prior to a request for expansion beyond 150 subjects, you should provide adequate responses to deficiencies 5 16 in our letter of October 3, 1997.

View ALL PAGES pdf document.

FDA INVESTIGATIONAL STUDY AFFIDAVIT

The following pages are an Investigator Agreement issued by the FDA to a Sponsor/Investigator of an investigational study.  Nevyas refused to sign...

PAGE 1 - Investigator agreement signed by Anita Nevyas-Wallace

PAGE 2 - Investigator agreement signed by Herbert Nevyas

PAGE 3 - "I informed Mr. Kane, that Mr. Sullivan told me that the excimer laser that he would build, is considered a custom device and would not be regulated by the FDA. Mr. Sullivan completed the assembly of the laser in the fall of 1995, and the first patient was treated (using LASIK) in January 1996."

PAGE 4 - "I did not maintain any written records of the design specifications, nor did I receive any written design specifications from Mr. Sullivan."

PAGE 5 - "This patient is not part of the patient population included in my IDE submission. I have treated a total of 252 patients, from January 1996 to the present date (6/30/97),"

PAGE 6 - "I affirm that the information on this and the previous pages, is accurate, to the best of my ability. I have read, but would not sign this affidavit."

View ALL PAGES pdf document.

Nevyases were issued an FDA483:

PAGE 1 - There was no documentation to show that the CI notified the IRB about all amendments, changes of significant deviations to the protocol [per IRB requirements] prior to implementation. For example, the FDA granted your firm an increase in the number of subjects you could treat with your investigational device on Jan. 20, 1999. IRB. Annual Review dated 7/29/00 does not indicate the IRB knew about population increase. The IRB did not approve the population increase until. August 28, 2000, 20 months later.

The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study.

There was a lapse of IRB approval for the protocol: NEV-97-001 from 8/3/2000 until 8/29/2000 according to IRB, lapse notices and the IRB annual reapproval letter.

January 1998

Approval Review Letter from the FDA to Nevyases:

PAGE 1 - In your "Substudy for Same-Day Versus Different Day LASIK Treatment for Fellow Eyes": a. Please revise your informed consent document rider for same day surgery to state that the second eye will be rescheduled if there is a complication or an adverse event with the first eye.

PAGE 2 - Your statement in the rider to the informed consent document that "...There have been no failures or malfunctions of the Willis Excimer Laser", should be removed or altered. It may unduly influence potential same day fellow eye surgery candidates into believing that the Nevyas Excimer Laser cannot fail. FDA recommends that you remove this statement or alter it to read: "There have been no failures or malfunctions of the Nevyas Excimer Laser to date."

PAGE 3 -

April 1998

Letter from the FDA to Nevyases dated 04/01/98 Re: Pre Market Approval (PMA):

PAGE 1 - Offers suggestions from the FDA should the Nevyases submit their PMA.

PAGE 2 -

May 1998

Approval Letter from the FDA to Nevyases dated 05/14/98 Re: Contrast Sensitivity & Increased 'Subjects':

PAGE 1 - 'Conditional' approval for substudy and increase of 'subjects'.

PAGE 2 - We acknowledge your request in your original IDE (dated March 18, 1997) to conduct a study at one site with 400 eyes low myopia and 590 eyes high myopia for each of two investigators (single site total of 1980 eyes or 990 subjects). We believe that adequate safety information has been provided to allow the initiation of your study with a small expansion of an additional 75 subjects (150 eyes). We will allow you to expand to the full number of subjects for this study (990) after you have received approval of supplements addressing the following deficiency from our letter of October 3, 1997 (enclosed). No additional expansions of your IDE will be granted until supplements containing the following information are approved:

PAGE 3 - You should also give serious consideration to the following items which are considered essential for the analysis of your data for the purposes of determining safety and effectiveness for a future PMA application: Deficiencies 5 through 16, excluding deficiency 14, in our letter of October 3, 1997.

July 1998

"Conditional" Approval Letter from the FDA to Nevyases:

PAGE 1 - FDA cannot approve your request as proposed because you have not shown stability of manifest refraction, and you have not presented sufficient detail for your hyperopic retreatment. FDA will conditionally approve, however, an expansion to include myopia and myopic astigmatism retreatments at this time.

PAGE 2 - This approval is being granted on the condition chat, within 45 days from the date of this letter, you submit your agreement to: 1. conduct the investigation within the modified limit, i.e., retreatment for myopia or myopic astigmatism only; 2. extend the minimum time between the initial operation and the retreatment to 3 months; and, 3. retreat only eyes which are "white and quiet" and in which refractive stability has been documented with two manifest refractions taken at least 30 days apart at less than 1 diopter of—change, confirmed by topography.,

PAGE 3 -

September 1998

Approval Letter from the FDA to Nevyases:

PAGE 1 -

PAGE 2 -

Nevyases' Co-Investigators  (dated 10/01/98)

I started some time ago to contact the doctors on this LIST the Nevyases sent to the FDA, as being co-investigators. Three of those contacted who responded have never even heard of the Nevyases.

 

December 1998

Approval Letter from the FDA to Nevyases:

PAGE 1 -

PAGE 2 -

January 1999

Deviations of Nevyas Eye Associates, As Stated In Letter from the FDA dated 01/07/99:

PAGE 1 - Our review of the inspection report submitted by the district revealed deviations from Title 21, Code of Federal Regulations, (21 CFR), Part 812 - Investigstional Device Exemptions and Part 50 - Protection of Human Subjects and Section 520(g) of the Act. The deviations noted during the inspection were listed on form FDA-483, "Inspectional Observations," which was presented to and discussed with you at the conclusion of the inspection.

PAGE 2 - Use of the Summit laser at your Marlton, New Jersey site for off-label procedures is not included in your IDE protocol. Moreover, enhancements approved under your IDE do not include hyperopic procedures. It is therefore considered a protocol violation to retreat subjects of your IDE study using the Summit laser and performing hyperopic LASIK.

PAGE 3 - While your Marlton, New Jersey site has a Summit laser, the advertisement does not specify a location. Future advertisements should specify the location(s) of approved lasers, as the enclosed advertisement would not be appropriate for soliciting subjects for your IDE study. All promotional materials designed to solicit participants or to inform subjects about the IDE study need to be approved by the reviewing IRB.

Approval Letter from the FDA to Nevyases dated 01/20/99:

PAGE 1 - Please be aware of the following: In Table 1-1, the data appear to be quite scattered, with some subjects actually increasing in sensitivity during glare (e.g., see BC & CB at 3 cycles per degree (CPD)), while others are severely compromised (see ZM). In order to reduce variability in the data in the contrast sensitivity study, the person administering the test should have experience in this test and the subjects should be well trained prior to testing.

PAGE 2 - We continue to be concerned that your ablation is likely to have multifocal properties, which means some light will be out of focus even at the best focal plane.

November 1999

Request Letter from the FDA to Nevyases:

PAGE 1 - 1. Please separate IDE subjects from pre-IDE subjects in all of your tables, or report only on IDE subjects.

PAGE 2 -

January 2001

Letter from the FDA to Nevyases Re: Non-Response To Request:

PAGE 1 - The Food and Drug Administration (FDA) granted approval of your investigational device exemptions (IDE) application on August 7, 1997. As part of your responsibilities as sponsor of a significant risk device investigation, you are required to submit a progress report to FDA and to all reviewing institutional review boards (IRBs) on at least a yearly basis. We have not received a response to FDA's November 10, 1999 request for additional information regarding your August 1998 — August 1999 annual progress report (enclosed).

PAGE 2 -

April 2001

Request Letter from the FDA to Nevyases:

PAGE 1 - Please address the following questions/concerns, as well as provide the information requested in the tables enclosed with this letter.

PAGE 2 - 8. With regard to your future PMA submission, you have indicated that only subjects treated with the "new centration technique" will be included in the PMA, and that you have selected the eyes treated between 2/19/98 and 11/22/99 as the cohort to support the safety and effectiveness of the device. We would like to clarify that data from all subjects treated. under the IDE should be included in the PMA. The main PMA cohort on which the decision of the safety and effectiveness of the device will mainly rest may be limited to all eyes treated with the new centration technique, but not to only those enrolled during a given period of time, as you appear to have suggested.

PAGE 3 -

July 2001

Disapproval Letter from the FDA to Nevyases:

PAGE 1 - The Food and Drug Administration (FDA) has reviewed the supplement to your investigational device exemptions (IDE) application proposing two new clinical protocols to evaluate the spherical ablation algorithm. We regret to inform you that your supplement is disapproved and you may not implement the change in your investigation. Our disapproval is based on the following deficiencies which, unless otherwise specified, relate to both protocols:

PAGE 2 - 3. You have not provided in your protocol the methodology for performing any of the clinical evaluations. For each clinical evaluation, please specify the testing procedures and instruments that will be used, including the lighting conditions and charts you will use to measure distance vision and near vision, etc.

PAGE 3 - 7. Your protocol states that subjects must have a best spectacle corrected visual acuity (BSCVA) of at least 20/40 in each eye in order to be enrolled in the study. Please be advised that while we find this criteria acceptable for subjects with high myopia (>7 D MRSE), in order for subjects with low myopia (< 7 D MRSE) to be enrolled, we recommend a BSCVA of at least 20/25 in each eye. Please revise your protocol accordingly, or justify not doing so.

PAGE 4 - 21. The Conclusion section of the consent form stares, "There is always a possibility of one or more late complications That were not known or anticipated at the time of this writing (1997)." It also states, "LASIK is investigational surgery and as such, it has not yet been completely and exhaustively studied by the FDA and medical researchers in this country." Please update the consent form as necessary in keeping with current knowledge including the additions previously mentioned. Please revise the second statement to Improve its accuracy: LASIK is no longer investigational, it has never (page 5) been studied by the FDA, and the FDA does not regulate LASIK, only the devices used for the procedure.

PAGE 5 - 28. There are discrepancies in the way you refer to the protocols throughout the submission. For example, in the Introduction you refer to the new protocols as NEV-97-002 (Myopia/Myopic Astigmatism) and NEV-97-003 (Hyperopia/Hyperopic Astigmatism). However, the myopia protocol itself has been labeled with the protocol number NEV-01-002. To avoid confusion, please make all necessary revisions in any future submission to correct such discrepancies.

PAGE 6 - With respect to the profiles of your ablated PMMA samples:

PAGE 7 - The deficiencies identified above represent the issues that we believe need to be resolved before your IDE application can be approved. In developing the deficiencies, we carefully considered the relevant statutory criteria for Agency decision-making as well as the burden that may be incurred in your attempt to respond to the deficiencies.

PAGE 8 - 34. Please be advised that for possible future pre-market approval, although 300 eyes total are needed to support overall safety, data from approximately 125 eyes are needed to support each indication for which approval is being sought.

August 2001

Supplement Disapproval Letter from the FDA to Nevyases:

PAGE 1 - We regret to inform you that your supplement is disapproved and you may not implement the change in your investigation. Our disapproval is based on the following deficiencies: 1. An important function of the software in the device is to control the beam delivery hardware (iris size, slot movement, synchronizing iris/slot with laser pulses, etc.) in the creation of an ablation pattern. This area, however, is not discussed at all in the Software Requirement Specifications document.

PAGE 2 - The deficiencies identified above represent the issues that we believe need to be resolved before your IDE application can be approved.

PAGE 3 -

February 2002

Nevyases Deviations and discrepancies continue almost 5 years into their study - Letter from the FDA to Nevyases:

PAGE 1 - Please address the following, questions and concerns with regard to this submission, which also applied to the previous, delinquent, annual report as outlined in FDA's letter of April 10, 2001, and for which we never received a response:

PAGE 2 - 5. Please provide tables (similar to those requested for initial treatments) and narrative summarizing the results of the IDE substudy of enhancements for 25 subjects/50 eyes that had undergone treatment prior to implementation of the IDE, and of the data from enhancements performed for eyes enrolled under the IDE. Please provide separate analyses for the first enhancement, second enhancement, etc.

PAGE 3 - 1. Please note that, based on the stability analyses you have provided in this submission, we do not agree that the time point of stability is at 12 months postoperatively as you have indicated, and, in fact, may be earlier for some of the indications.

PAGE 4 -

April 2002

IDE Deficiencies Request Letter from the FDA to Nevyases:

PAGE 1 - 1. You must still provide responses to deficiencies 1, 2, 3, and 5 froth our letter of February 6, 2002. 2. You did not provide the requested information in your response to deficiency 4.

PAGE 2 - 4. In response to deficiency 8, you have indicated how you will verify your current accountability for visits that have already past. After your internal audit is complete and you have more insight as to the reasons for any problems with accountability, please directly address the original issue outlined in previous deficiency 8: please describe how you intend to improve subject follow-up and data reporting during the rest of the course of your IDE study.

PAGE 3 - Attachment: In a reply to Dr. Morris Waxler, FDA's Chief Medical Device Examiner, Dr. Herbert Nevyas states "Since the close of business on July 28, 1997, neither I nor anyone else has used the laser. I certify that, unless and until FDA approves the IDE application for that device, neither I nor anyone else will use the laser to treat patients. I have notified all of my employees, as well as anyone with access to the laser, that the laser may not and will not be used until there is an approved IDE in effect for that laser. I declare that to the best of my knowledge the foregoing is true and correct."

 

 
Nevyas Investigational Laser PDF Print E-mail
Nevyas Eye Associates

The following documents were submitted to the FDA from 1997 through 2001 regarding the "Nevyas Investigational (Black Box) Laser"

The laser was built by Ed Sullivan who, according to the excerpt below, was already under scrutiny by the FDA.

"Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement." [as written in The Journal of Refractive Surgery - Volume 11 (5) * September/October 1995 * News and was found at the url address: http://www.slackinc.com/eye/jrs/vol115/news1.htm">http://www.slackinc.com/eye/jrs/vol115/news1.htm (no longer available).

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PDF Documents (for high speed or download)

To view ALL DOCUMENTS listed below in one PDF (two parts), click HERE.

1997 Reports

PAGE 1 - Prohibition of promotion and other practices. - 21 CFR. § 812.7

PAGE 2 - Protocol NEV-97-001: Myopia with or without astigmatism - Study Procedures.

PAGE 3 - Protocol NEV-97-001: Inclusion/Exclusion Criteria.

PAGE 4 - IDE Supplement - Question/Response.

PAGE 5 - Protocol NEV-97-001: Ethical and regulatory considerations.

PAGE 6 - Protocol NEV-97-001: Complications, Adverse Events, & Serious/Unanticipated Adverse Device Effects.

PAGE 7 - Protocol NEV-97-001: Inclusion/Exclusion Criteria Revision.

PAGE 8 - Protocol NEV-97-001: Screening for Refractive Surgery Eligibility.

PAGE 9 -  PAGE 10 - Protocol NEV-97-001: Clinical Study Data Submitted to FDA.

1998 Reports

PAGE 1 - PAGE 2 - PAGE 3 - PAGE 4 PAGE 5 - PAGE 6 - PAGE 7 - PAGE 8 - PAGE 9 - PAGE 10 - PAGE 11 - FULL - Protocol NEV-97-001: Study IDE Supplement Annual Report

PAGE 1 - PAGE 2 - PAGE 3 - FULL - Protocol NEV-97-001: Study IDE Annual Report Supplement

PAGE 1 - PAGE 2 - PAGE 3 - FULL - Protocol NEV-97-001: Study Changes, Progress towards PMA Approval, Safety & Efficacy for Study Eyes (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 6 months after my surgery).

1999 Reports

PAGE 1 - PAGE 2 - FULL - The FDA states "We continue to be concerned that your ablation is likely to have multifocal properties, which means that some light will be out of focus even at tine best focal plane".

PAGE 1 - PAGE 2 - PAGE 3 - FULL - Safety & Efficacy for Study Eyes, Page 1 (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 1 1/2 years after my surgery). The charts on pages 2 and 3 also do not show adverse events or complications.

2001 Reports

PAGE 1 - PAGE 2 - FULL - Protocol Deviations & Summary of Complications and Adverse Events.

PAGE 1 - PAGE 2 - PAGE 3 - FULL - Nevyas Investigational Study charts submitted to the FDA.

PAGE 1 - The FDA states "There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements] prior to implementation" "The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study"; and "There was a lapse of IRB approval for the protocol: NEV-97-001 from 8/3/2000 until 8/29/2000 according to IRB, lapse notices and the IRB annual reapproval letter".

 
Nevyases Promotion of an Investigational Device PDF Print E-mail
Nevyas Eye Associates

Nevyas' Promotion of An Investigational Device

Guidelines, regulations, and laws were in effect prior to the Nevyases'; investigational study.

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From the Federal Trade Commission:

PAGE1 - PAGE2 - FULL - The FTC enforces the Federal Trade Commission Act (FTC Act), which among other things prohibits deceptive or unfair practices in or affecting commerce. 15 U.S.C. §§ 45, 52-57. An advertisement is deceptive under Section 5 of the FTC Act, and therefore unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material, that is, likely to affect a consumer's choice or use of a product or service. It is important to note that advertisers are responsible for claims that are reasonably implied from their advertisements, as well as claims that are expressly stated.

In addition, under the FTC Act, advertisers must have substantiation for all objective claims about a product or service before the claims are disseminated In the context of claims about the safety, efficacy, success or other benefits of RK or PRK, substantiation will usually require competent and reliable scientific evidence' sufficient to support the claim that is made.

From the Food and Drug Administration (FDA):

PAGE1 - PAGE2 - FULL - As you know, the FDA approved applications for premarket approval (PMAs) from Summit Technology, Inc. and from VISX Inc_ for their excimer lasers for the correction of mild to moderate myopia in patients with minimal astigmatism Based on the submitted data, these models were approved for refractive correction only by photorefractive keratectomy (PRK) of the corneal surface. Data were not submitted to support the use of these lasers for laser assisted in-situ keratomileusis (LASIK), laser scrape, astigmatism, hyperopia, or multipass or multizone software algorithms. Currently, these are the only lasers approved by FDA for refractive correction and the only refractive indications for which they are approved. The dioptric ranges indicated in the PMA are based on data submitted by these companies in their applications. Data on higher myopia and astigmatism were not submitted, and therefore the approvals did not provide for their treatment. All other lasers being used for refractive surgery, however manufactured or obtained, should be regarded as investigational devices and patients should have the usual human subject protection of institutional review board (IRB) protection, informed consent and an IDE approval by FDA.

21 C.F.R. §§ 812.7 Prohibits promotion of an investigational device!

21 C.F.R. §§ 812.7

CODE OF FEDERAL REGULATIONS

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN

SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

SUBPART A--GENERAL PROVISIONS

§§ 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.

(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.

(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.

However, the Nevyases DID promote:

On radio:

PAGE 1 - PAGE 2 - PAGE 3 - PAGE 4 - FULL - Nowhere did the Nevyases state that they were part of an investigational study or that their laser was also an investigational device.

And in an infomercial on MDTV:

PAGE 1 - - PAGE 3 - FULL - The same applied to their infomercial.

 
FDA Inspection Reports of the Nevyases Facility PDF Print E-mail
Nevyas Eye Associates

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FDA Issued Inspection Report of Nevyas Eye Associates facility dated 11/02/1998:

 

PAGE 1 - There was no documentation to show that the Cl notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements].

PAGE 2 - Previous inspection on 6/30/97 of this facility revealed the firm continued to use the laser to perform eye surgery without an approved IDE, planned to use the laser or new treatment procedures not included in the firms disaproved IDE and verified that the firm had received a disapproval letter from CDRH/ODE notifying them that use of the laser to treat patients was a violation of the law.

PAGE 3 - PAGE 4 - charts

PAGE 5 - The current inspection revealed Clinical Investigator currently performs Myopic procedures under an approved IDE however, procedures are being performed on IDE patients prior to approval date, the date is missing on a consent form, consent forms were signed by patients after surgery date and procedures were performed on IDE patients which are outside the IDE with an unidentified laser at an unauthorized location.

PAGE 6 - Persons interviewed, individual resposibilities, & operations.

PAGE 7 - [Redacted] initial IDE submission was disapproved May 8, 1998. He was granted conditional approval on August 7, 1998. As [Redacted] addressed various issues presented in letters from FDA CDRH/ODE he was granted more uses of the IDE.

PAGE 8 - [Redacted] built the [Redacted] for [Redacted] however, [Redacted] owns it. He was responsible for submitting the information for the IDE, in conjunction with and eventually Pre-Market Approval for the device. He is therefore a Sponsor/Clinical Investigator.

PAGE 9 - These procedures were performed well before approval was granted. [Redacted] stated he had been doing this procedure previously and no one had told him the procedure couldn't be performed as of 8/28/97.

PAGE 10 - Consent form for [Redacted] was not signed. There was no way of determining whether consent was obtained before or after surgery to the right eye on 12/4/97, due to lack of a date next to patients' signature.

PAGE 11 - [Redacted] had [Redacted] enhancements performed which is a condition not indicated in the [Redacted]. Additionally, the procedures were performed with a laser that is not indicated in the study and the surgery was performed at a location that is not identified in the protocol.

PAGE 12 - There was no evidence of a patient information and consent form in the file for this hyperopic enhancement.

PAGE 13 - There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements].

PAGE 14 - According to a letter dated August 27, 1997, EXHIBIT #8 from the IRB, [Redacted] is required, in addition to other items, to report to the IRB any new advertisements, recruiting material, serious adverse events, amendments or changes to the protocol or significant protocol deviations. Observation # 6 represents a significant protocol deviation and should have been reported to the IRB for approval prior to implementation.

PAGE 15 - PAGE 16 - PAGE 17 - PAGE 18 - PAGE 19 - Lists exhibits included with inspection report.

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FDA Issued Inspection Report of the Nevyas' facility dated 05/10/2001:

PAGE 1 - The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study.

PAGE 2 - An inspection conducted on 12/2/96 revealed the firm had assembled a single excimer laser and was using it to perform [Redacted] eye surgery on at least 120 patients without an approved IDE.

PAGE 3 - Persons interviewed, individual resposibilities, & operations.

PAGE 4 - According to a letter from the FDA to [Redacted] dated 1/20/99 EXHIBIT #1, the investigation is still limited to one location, listed in bold above however, the population has grown to 1015 subjects (2030 eyes):

PAGE 5 - For example, the FDA granted your firm an increase in the number of subjects you could treat with your investigational device on Jan. 20, 1999. IRB Annual Review dated 7/29/00 does not indicate the IRB knew about population increase. The IRB did not approve the population increase until August 28, 2000, 20 months later.

PAGE 6 - EXHIBIT #6 is an Investor Agreement which was signed by [Redacted] Sponsor/Clinical Investigator and [Redacted] Co-Investigator. The agreement indicates, among other things, the clinical investigators agree to promptly report to the IRB all changes in the research activity. The clinical investigators failed to report the increase in the number of study patients, granted by the FDA, to the IRB in a prompt manner.

PAGE 7 - I explained to [Redacted] that he did not have IRB coverage from 8/3/2000 until 8/29/2000. [Redacted] stated his consultant, [Redacted] was ill for several months and she normally took care of report submittals and updates which is why the firm was tardy with reporting updates.

PAGE 8 - [Redacted] stated it may appear that patients signed the consent forms one day after surgery however, this is certainly not the case and is not the way things are normally done. He indicated this was a mistake made by someone on his staff.

PAGE 9 - There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements]. This observation was carried forth to the current listing of objectionable conditions or practices. See FDA-483 observation #1 listed above on page #4 of this report.

PAGE 10 - All changes made to the protocol were documented by the investigator, dated, maintained with the protocol, however all changes were not approved by the IRB (see FDA-483 observation #1 listed on page 4 of this report).

PAGE 11 - According to records reviewed, the investigator did submit and obtain IRB approval of the protocol, modifications to the protocol (except as noted in FDA-483 OBSERVATION #1),

PAGE 12 - Lists exhibits included with inspection report.

PAGE 13 - PAGE 14 - PAGE 15 - PAGE 16 - PAGE 17 - Nevyases response to inspection.

 "All adverse experiences have been reported to the sponsor-investigator, FDA, and IRB in accordance with 21 CFR Part 812", and "The occurence of all events and complications as defined in Protocol NEV-97-001 have previously been reported to FDA. No serious adverse events related to the Nevyas Excimer Laser have occurred in the study".

According to deposition by Anita Wallace, my visual problems post-lasik was not considered a complication or adverse event (I disagree!), even though she claimed the data regarding my situation was reported to the FDA. The charts submitted to the FDA listing adverse events and complications do NOT show data relevant to the number of medical malpractice claims filed against them during their study.

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The 2nd inspection resulted in an FDA483 issued by the FDA.

Although the records requested via the FDA's Freedom Of Information Act were redacted (edited), the FDA stated:

 "There is too much information the general public should not be aware of, not only in the Nevyas' study, but in all studies". - Les Weinstein, CDRH Ombudsman

This second set was obtained from the FDA's Philadelphia Office, and included not only the Nevyas' facility of 05/2001, but that of Ed Sullivan (Exsull), builder of their laser (see above). The inspection was 2 years after the article written in the Journal of Refractive Surgery (Fall Issue - 1995):

Inspection Report of the Nevyas' facility dated 05/2001 (less edited):

PAGE 1 - PAGE 2 - PAGE 3 - PAGE 4 - PAGE 5 - PAGE 6 - PAGE 7 - PAGE 8 - PAGE 9 - PAGE 10 - PAGE 11 - PAGE 12 - ALL PAGES

 
Nevyases Court Depositions In My Case & Others PDF Print E-mail
Nevyas Eye Associates

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Excerpt of my deposition in this case:

PAGE 1 - Cover page - My oral deposition in Morgan v. Nevyas.

PAGE 2 - "he (Dr. Herbert Nevyas) just basically told me to deal with it as far as the problems that I'm having with the sight, people lose (page 3) their sight every day, I'll see you in eight months."

PAGE 3 - "Q. Is this the first time that you had a conversation with Dr. Herbert Nevyas that caused you any concern or that you were upset about? A. No."

PAGE 4 - "Q . I believe you were making complaints about your vision. You had mentioned during the prior testimony two indications where you were upset by conversations that you had with Dr. Herbert Nevyas. A. Yes."

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Excerpt of deposition of Anita Nevyas-Wallace in my case:

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

PAGE 2 -

PAGE 3 - "Q. Did you use that protocol when you operated on Mr. Morgan? A. Yes." "Q. Did you adhere to that protocol when you operated on Mr. Morgan? A. Yes."

PAGE 4 - "Q. Are you saying that a history of retinopathy of prematurity is not a contraindication to LASIK surgery? A. That is correct."

PAGE 5 - "Q. Did Mr. Morgan have a complication of LASIK surgery in either eye? A. No." "Q. Did Mr. Morgan have an adverse event of LASIK surgery in either eye? A. No."

PAGE 6 - "Q. Doctor, was the outcome of Mr. Morgan's surgery reported to either the Institutional Review Board or the Food and Drug Administration? A. Yes."

PAGE 7 - "Q. Now, do I understand from what you've told me that you reported the outcome of the LASIK surgery to the Food and Drug Administration, but that such report did not call it either a complication or an adverse event? A. Correct."

PAGE 8 - "DR. FRIEDMAN: The reason we're here is because of a lawsuit which he's claiming that he had either a complication or adverse event MS. NEWMAN: I understand that, and she's told you she doesn't believe that it's related to the surgery. DR. FRIEDMAN: It doesn't say that. It says here, "Complications or adverse events that are observed by the investigator or reported by the subject."

PAGE 9 - "A. To let people know that there is a possibility that they might be candidates to be more independent from their glasses and contact lenses. Q. And in that KYW advertisement what were the patients instructed to do to find out that information? A. I think they were instructed to call a phone number for more information."

PAGE 10 - "Q. When you told him that his vision might drop, did you indicate to him how much it might drop? A. Yes. I told him he could lose one or both eyes or he could die."

PAGE 11 - "Q. Doctor, if there is such a thing as focusing and Mr. Morgan focused and when he focused he did 100 percent of his focusing, you said that both the cornea and the lens were important for focusing. And I'm just asking you was the cornea responsible for 50 percent of his focusing, 75 percent, 99 percent? MS. NEWMAN: As compared only to the lens? DR. FRIEDMAN: As compared to the lens. MS. NEWMAN: If you can answer that question, you can do it. If you can't, tell him. A. I can't."

PAGE 12 - "Q. Is it your understanding that Mr. Morgan has developed cataracts in his eyes since his LASIK surgery has occurred? Your understanding and I'm talking to the period up to the last time you saw Mr. Morgan in the Nevyas Eye Associates group, which was about almost two years after the surgery. A. Yes."

PAGE 13 - "Q. During the time that you were seeing Mr. Morgan did you consider that there would be any other explanation other than cataracts? A. Yes. Q. And what did you consider? A. Considered retinal disease, considered optic nerve disease, considered corneal problems."

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Excerpt of deposition Anita Nevyas-Wallace in another case:

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

PAGE 2 - "Have you ever been involved in a medical malpractice suit before? A. No." (Comment - Deposition dated in this case was 5 months after I filed suit)

PAGE 3 - "Q. Have you ever discussed this lawsuit with Herbert Nevyas outside the presence of counsel? A. No."

PAGE 4 -

PAGE 5 - "Q. That you were doing, well, just give me an idea of what you were doing in '97? A. Corneal surgery, conjunctival surgery, refractive surgery, cataract surgery. Q. Refractive surgery, how much of your time was doing refractive procedures? A. About half."

PAGE 6 - "Q. Yes. Well, who were you involved in training with there? Q. Who are her, not your peers, who are your superiors, professors? A. Let's see. Theordore Krupin, William Frayer, Stephen Orlin, Alexander J. Brucker, James Ketowitv, David Schaffer."

PAGE 7 - "Q. I just want to know everybody you can think of right now. And at MCP, the fellowship, Who were you involved with in training at MCP in your fellowship? A. At MCP that was supervised by the department chairman of ophthalmology, at that time, Herbert Nevyas M.D. Q. Herbert Nevyas is that your father? A. Yes."

PAGE 8 - "Q. Now, the presentations that you've given, I did have one quick question on that. You have Nevyas Eye Associates Clinical Lecture Series, what's that? A. Nevyas Eye Associates offers lectures for doctors in the community for educational purposes. Q. Was that in Existence in 1997? A. Yes. Q. Have you lectured regarding the lasik procedure? A. Yes."

PAGE 9 - "Q. What I'd like to talk about is your experience and your training in lasik. When did you receive -- describe for me your training in lasik? A. My training in lasik began with my training in ALK, Automated Lamellar Keratopiasty, a procedure in which the microkeratome is used to raise a thin flap of cornea and then the underlying keratoma is then reshaped using the microkeratome. I began to perform that operation in 1992. That operation was supplanted in our practice by lasik in 1995 and then after the flap was created we instead used, come 1995, a computer guided excimer laser to reshape the stromal bed instead of using the microkeratome to reshape the stromal bed. My training in automated lamellar keratoplasty consisted both of courses taken and time spent with surgeons who were experienced in this technique."

PAGE 10 - "Q. 1995 you started to do lasik, the lasik procedure, did you have any additional training in using the lasik procedure? A. Yes. Q. And tell me about your training that you had in using lasik procedure? A. I had taken at least one course in using the laser, I think I took two."

PAGE 11 - "Q. Did you have any training that involved actually performing the procedure using the laser? A. Perform lasik? Q. Performing lasik, A . I would have to -- there's not a simple answer to that. Q. Why not? A. Because we were performing lasik under IDE with the FDA before there were courses from that."

PAGE 12 - "MS. NEWMAN: Let me object because if you're talking about lasik, unless I'm mistaken, the only lasik procedure was in March of 1997 on Ms. Fiorelli. MR. KAFRISSEN: There are three lasik. MS. NEWMAN: Three lasik? THE WITNESS-: There was one lasik and two enhancements. MR. KAFRISSEN: Right. And my understanding is that those were lasik enhancements, right? THE WITNESS: Lasik enhancements."

PAGE 13 - "Q. So tell me '95 to 97 tell me what do you consider to be postoperative symptoms, you told me postoperative is things patient experience, what is that, explain it? A. Postoperative symptoms include loss of best corrective visual acuity. Need I explain what that is? Q. Sure? A. Best corrective visual acuity means the best vision the patient is able to get with glasses or contact lenses. Q. Okay. A. And loss of best corrective visual acuity means that even with glasses or contact lenses the patient can't see as well before -- after surgery, as he did before surgery so that's the loss of best corrective visual acuity. Q.Anything else? A. Sure. Glare, halo symptoms, star burst. Q.Okay. A. Undercorrection, overcorrection. Q. Okay. A. Foreign body sensation. I can't think of any others. Q. The post operative symptoms, would you agree with me, that they can be caused by surgical complications? A. They can."

PAGE 14 - "Q. When you perform a lasik procedure and it's on a patient that is referred to you by an optometrist, does the optometrist receive any portion of the fee charged to the patient for the lasik procedure? A. Sometimes."

PAGE 15 - "Q. How did they know that? A. They had her cover one eye and read the eye chart and she could read down to the 20/70 line -- Q. Okay. A. -- with her glasses on. And then we cover the other eye and she was able to get two letters on the next line so it's going to be 70+2."

PAGE 16 - "Q. Did you make any decision as to whether Cheryl could wear contact lenses again at no time, at any point in the future? A. At that visit? Q. At that visit. A. No."

PAGE 17 -

PAGE 18 - "Q. Prior to any of the surgery that you performed, am I correct that the astigmatism Cheryl had in both eyes was correctable with spectacles? A. I'm not sure I can answer that."

PAGE 19 - "Q. How does an irregular astigmatism occur during the lasik procedure, how can it occur? A. Certain flap-complications can result in an irregular astigmatism."

PAGE 20 - "Q. And if you can just explain to me why this vision with correction differs from the vision that you came up with, with the refraction? A. First, I should mention that, that is Dr. Sterling's refraction, not my own."

PAGE 21 -

PAGE 22 - "Q. And what did you tell her? A. I told her that best she could expect is vision as good as she gets with her glasses only without her glasses and that it might not be as good as that, but that was the best she could hope for. And that she might require a thin glass or a contact lens to give her better vision."

PAGE 23 - "Q. Okay. What did you talk about? A... Q. Okay, A. I told her that of the serious and rare complications, the first one to consider is infection. That with any operation anywhere in the body there is a risk of infection and that there's a possibility of getting an infection with an organism for which we have no antibiotic and that the eye could be lost. And she said to me, you mean I could go blind? And I said, yes, but I can't say that's the worst thing that could happen because you could die, nobody's died yet, but you could be the first."

"Q. Okay. So tell me what could she see with her glasses prior to the lasik 3/20 surgery in the right Eye? A. 20/70, Q. And in her left eye what could she see with her glasses? A. 20/70+2."

PAGE 24 - "Q. And there's nothing in here about discussion of the risks, the complications, any of that type of thing, am I correct that there is nothing in your note about that? A. There is a very important phrase in that note. Q. Okay. A. Discussed in detail. Normally, I would only write discussed and that means, I went through risk complications, my entire speech. And then after I got done with that and I had written discussed in detail, if you look in the actual chart the slant of the letters is different after discussed in detail."

PAGE 25 - "A. The only clue in the chart is that I said, reevaluate 10 weeks and then I said return 2/18 that - she had persuaded me to at least -- not insist that she simply spend a month without lenses and that we'd take a look sooner and see whether she could possibly put them in sooner."

PAGE 26 - "Q. Okay. Did you, my question was, document it when she said it? A. No. Q. What we have is your independent recollection of that conversation? A. Yes. Q. And your interpretation of a questionnaire filled out in May 1991; is that accurate? A. My recollection, yes." (Comment - Deposition dated in this case was 2000, 9 years later)

PAGE 27 - "Q. Are there any records that you see written by someone at Nevyas Eye Associates that documents a glare problem before you saw her in 1997? A. No. Q. Are there any documents that you see from Nevyas Eye Associates that documents a halo problem prior to your seeing her in 1997? A. No."

PAGE 28 - "Q. Did you document anywhere that the patient said she had problems with glare or halos prior to the surgery?  A. No. Q. Okay. Now, did you document anywhere that she had problems with star burst prior to the surgery? A. No. Q. Did she tell you she had problem with star burst before surgery? A. I don't recall."

PAGE 29 - "Q. Let me ask you this then, the bill, were all of the services you rendered throughout the entire course of treatment to Cheryl Fiorelli necessary services? MS. NEWMAN: Did she need them? Were they necessary? THE WITNESS: Is elective surgery -- I don't know what elective surgery falls under."

PAGE 30 - "Q. Tell me what part of it is documented here? A. I have discussed matters in detail with Ms. Fiorelli. Discussed in detail means that in itself, in detail. MS. NEWMAN: Just tell him what you said. THE WITNESS: She is interested in having refractive surgery, and we discussed the lasik procedure. She understands that her best spectacle corrected acuity is in the 20/60 to 20/70 range and that is the expected postoperative best corrected acuity as well." (Comment - The Nevyases' Study protocol stipulates 20/40 or better.)

PAGE 31 - "Q. When you say negative 12, I think we had discussed earlier her refraction was around negative 15? A. Minus 14 when she was refracted on March 3rd when I refracted her."

PAGE 32 - "Q. All of your visits up to his point, where were you seeing Cheryl at, physically? A. I'm not sure they were all at the same office. Q. Were you employed at the time? Are you an employee of Nevyas Eye Associates at the time that you were seeing Cheryl? A. Yes. Q. Tell me where are Nevyas Eye Associates offices, where sere they then? A. Actually, I can answer your first question. I was seeing her at our Bala Cynwyd office, that is where all the visits are."

PAGE 33 - "Q. The information on this sheet was the programming for the laser, the instructions for the laser's programming, are they made by you, were they made by you for Cheryl Fiorelli? A. The instructions for the laser's programing were made by me. Q. Did you get this sheet at some point before the surgery? A. Yes. Q. And did you review it? A. Yes."

PAGE 34 - "Q. Did you consider Cheryl a good candidate for lasik? A. I considered her a good candidate with some -- as long as she was aware of the things that I mentioned."

"MS. NEWMAN: Well, it's clear that she's got a best corrected visual acuity of 20/70. She said that she considered herself -- Dr. Nevyas-Wallace said that the plaintiff considered herself a high handicap with glasses other than what's already been discussed."

PAGE 35 - "Q. Okay. My question was, was there any standard within the medical community that you were aware of in 1997? Is it your testimony that the standard was to negative 24 or is it your testimony that some doctors were out there doing it? A. Standard worldwide at that time was in the 20 to 22 diopter range." (Comment - See the Nevyases' Study protocol.)

"Q. No, what? A. No. I didn't measure cornea thickness. Q. Okay. A. Prior to that surgery. Q. Prior to the lasik on 3/20? A. Correct. Q . Why not? A. That was not standard of care in 1997. Q. You just said that it wasn't standard of care to measure cornea thickness in 1997, is it your testimony that regardless of what the vision of the patient you were dealing with was, you would have to measure corneal thickness?"

PAGE 36 - "Q. Ultrasonic pachymetry. Did you have the capacity to perform ultrasonic pachymetry in your office? A. Yes. Q. Did you have that capacity prior to February of 1997? A. Yes. Q. For how long prior to 1997 did you have that capacity in your office? A. We had optical pachymetry since the 1960's and ultrasonic pachymetry since 1990."

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Excerpt of deposition of Herbert Nevyas in my case:

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

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

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

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

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

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

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

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

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

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

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

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

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Excerpt of deposition of Herbert Nevyas in another case:

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."

PAGE 17 - "Q. And what was her overall assessment?" "A. She had very strange complaints. I have vague complaints, Estonopia(ph) is a term that we use for somatic complaints being expressed visually." "Q. Meaning?" "A. That is, complaints that may not be based in physical problems but perhaps in mental problems. It was my impression that she had a lot of complaints beyond what I could see a base for, and some people express their anxieties in terms of physical complaints, and I felt that hers was perhaps somewhat that."

PAGE 18 - "Q. Do you have any recollection of any discussions between you and Cheryl Fiorelli at any time, either the specific discussion or just generally?" "A. I'm sure I talked to -her when I saw her. I don't recall much except that she appeared to be an anxious person who seemed to have complaints in excess of what I could find physically. She was always complaining. I do remember that, but we tried our best to try to remedy her complaints."

PAGE 19 - "MR. KAFRISSEN: I'm asking from his review of the record that was from his office that he produced, did he have any reason to suspect or believe or any information that there were erroneous entries or misstatements of fact in the records." "THE WITNESS: Absolutely not."

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Nevyas' Deviation From Standard of Care - Stephen Orlin PDF Print E-mail
Nevyas Eye Associates
note: Dr. Orlin was expert witness for Drs. Herbert Nevyas and Anita Nevyas-Wallace in several of lawsuits. Below are his opinions in my lawsuit and transcript of video testimony in the Wills v Nevyas lawsuit.

Affidavit regarding LASIK and Retinopathy of Prematurity (ROP)

AFFIDAVIT OF DR. STEPHEN ORLIN

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

Affidavit (PDF) of Stephen Orlin

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.

 

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Nevyas' Deviation From Standard of Care - James Salz PDF Print E-mail
Nevyas Eye Associates

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

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DR. SALZ' REPORTS

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

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

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

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

The early post-LASIK period:

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

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

The later post-LASIK period:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

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

Dear Dr. Friedman:

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

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

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

Examination:

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,

signature on original scanned document Nevyas v. Morgan

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Nevyas' Deviation From Standard of Care - Terrence O'Brien PDF Print E-mail
Nevyas Eye Associates

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

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

Click PAGE # to open pdf in new window

 

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

June 7, 2002

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

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

RE: MORGAN, DOMINIC JHH: 4-3200368

Dear Dr. Friedman:

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

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

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

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

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

Sincerely, signature on original scanned document

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

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DR. TERRENCE O'BRIEN'S REPORTS CONCERNING A PRIOR PATIENT, ALSO DAMAGED:

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

April 6, 2001

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

Philadelphia, PA 19102

RE: Cheryl Fiorelli

Dear Mr. Kafrissen:

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

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

www. xvilmer.jhu.edu

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,

signature on original scanned document

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Nevyas' Deviation From Standard of Care - Kenneth Kenyon PDF Print E-mail
Nevyas Eye Associates

Dr. Kenneth Kenyon's Reports

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

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

 
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Nevyas Eye Associates

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