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
Sunday, 20 January 2013 12:49

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
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
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
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

 
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