By Lisa Start, Alberto Orso, Joseph Brownstein

LASIK eye surgery has provided the promise of a quick vision fix for millions of Americans, but now one of the Food and Drug Administration regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety.

Some 700,000 people a year in the U.S. get LASIK surgery to correct their vision, and in the years since the procedure was approved, the majority of patients have been happy with the results.

But while the FDA was aware of negative side effects that would occur in some, Morris Waxler, the former head of the FDA branch responsible for reviewing the data on LASIK, told ABC News in his first television interview that, in hindsight, those side effects were not taken seriously enough.

"I wouldn't say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don't know what to do with that data," he said. "It's right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn't seem to be a plan to handle some of the more difficult problems that are created."

A number of patients who underwent LASIK, a procedure that uses a laser to reshape the cornea and thereby correct vision, say they now suffer from side effects such as starbursts, halos, glare double-vision and night blindness.

In some cases the side effects go away within weeks or months of the surgery, but in other cases, they appear to be permanent.

Some people experience them mildly, but others have them so bad they can't perform basic functions, such as driving, and some people have said they lost their jobs due to negative side effects from LASIK procedures.

Abby Ellin, a 42-year-old journalist from New York, underwent LASIK three years ago, but she said the side effects she experienced have still not gone away.

"I was not a success, because I had dry eyes and halos and everything else. That is not a success," Ellin said.

She reported her problems to her doctor but was unhappy with the response, she said.

"She said, 'It will go away, it will go away.' That was really pretty much it. 'It will go away.' Well, it didn't go away," Ellin said.

Waxler, who retired from the FDA 10 years ago, said the stories about patients' bad experiences have affected him.

"One of the patients asked me, 'Don't you feel bad?' and I said, 'I did the best I could with the folks that were all around us,'" he said. "But in hindsight it wasn't good enough. It wasn't good enough."

Waxler said he thinks the FDA erred in not setting tougher standards for LASIK outcomes, for not requiring fewer adverse effects. He does not believe the devices should be pulled off the market, but he does think the FDA should force manufacturers and LASIK surgeons to be more forthcoming with patients about potential side effects.

"The agency actually has a lot of power," Waxler said. "The agency could readily require that those manufacturers keep better tabs on what happens with their product."

Exception to the Rule

Bad experiences with LASIK have not been the norm. More common are experiences like those of patients like 38-year-old Maria Coello, a health administrator living in New York.

"I had [LASIK] when I was 37. I wish I'd done it before," she said.

In a statement the FDA said it "considers LASIK lasers to be reasonably safe and effective when used as intended" and said it disagreed with Waxler's claim that they ignored problems when the procedure was approved.

Additionally the FDA said it issued a letter to LASIK providers cracking down on false and misleading advertising and said it will follow up with providers who were found to have "inadequate adverse event reporting systems."

Others in the field also maintain that the procedure is safe, pointing to the fact that the vast majority of patients go through LASIK and gain improved eyesight and without permanent problem.

"Most patients are very satisfied. Very happy," said Dr. Penny Asbell, a LASIK pioneer and professor of ophthalmology at the Mount Sinai School of Medicine in New York. She said studies have shown that 95 percent of LASIK patients are satisfied with their results.

But at the same time, she said, not everyone is a good candidate to get the procedure. Prospective patients could and should be more cautious when they talk to a doctor about getting LASIK, she said.

"Sometimes, I think, instead of asking, 'How many LASIK procedures you have done?' you should actually ask the doctor, 'How many have you turned away?'" she said.

Waxler also said people considering LASIK need to be more careful before deciding to get the operation.

"Read everything you can," he said. "There's no urgency to do it, so make sure you understand the worst that can happen to your eyes and you can live with the worst."

Pleasantville, NY (PRWEB) February 14, 2010 -- On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and VCA-Vision, Inc., d/b/a LASIKPlus, in the Virginia Circuit Court for the City of Chesapeake, for the negligent performance of LASIK surgery on Ms. Shrieves. On June 29, 2008, Ms. Shrieves came under the care and treatment of Dr. Franklin for the purpose of having LASIK surgery on both eyes at LCA-Vision, Inc., d/b/a LASIKPlus.

The complaint alleges, among other things, that Dr. Franklin was negligent when he performed the LASIK surgery more than three millimeters off center of the pupil. As a result, Ms. Shrieves’ cornea became abnormal and developed a decentered ablation. A decentered ablation refers to when the laser treatment removes tissue from an area outside of the intended surgical zone. Laser ablations that are off-center can cause visual symptoms, including glare, halos, ghost images, and blurred vision. Consequently, Ms. Shrieves’ vision has suffered severely.
   
The plaintiffs are represented by Todd J. Krouner, from Pleasantville, New York, and Thomas Shuttleworth of Shuttleworth, Ruloff, Swain, Haddad & Morecock, P.C., from Virginia Beach, Virginia. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Shuttleworth has extensive experience in litigating medical malpractice actions.

A copy of plaintiffs’ complaint is available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Thomas Shuttleworth, Esq., at (757) 671-6020.

The SEC has charged ophthalmologist Gerald Horn with insider trading in the options of LCA-Vision Inc., a provider of laser eye surgery.

Horn (pictured), the medical director of LCA’s Schaumburg, Illinois facility, reportedly faces civil charges over his purchases of options on the shares of LCA by which he made a profit of about $870,000. By exercising stock option grants and immediately selling this stock on the basis of nonpublic information, Horn also avoided a loss about $533,000, the Chicago Tribune reports.

According to the Tribune, Horn accessed internal company reports that listed the number of eye surgeries performed company-wide. The reports also allowed him to compare those figures to monthly targets set by the company.

Horn purchased large quantities of LCA options on four separate occasions. In its complaint, the SEC stated that it was “particularly striking that in all of his purchases in LCA calls and puts, Horn never lost money on a trade.”

Read the Chicago Tribune article at http://www.chicagotribune.com/business/chi-gerald-horn-0211-,0,977196.story

8:25 PM CST, February 19, 2010

A state regulatory agency is barring a Chicago ophthalmologist from performing Lasik eye surgeries in Illinois, one of a number of disciplinary actions taken against the doctor on Friday.

After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years and banned him from performing procedures aimed at changing the curvature of the cornea, which includes Lasik surgeries.

The agency also fined him $10,000, the maximum allowed per violation.

A Tribune story in July reported that Caro had been sued almost 50 times for medical malpractice in Cook County since the late 1990s. The story revealed that the state's chief medical prosecutor, Lisa Stephens, recommended in 2008 that Caro's medical license be "suspended, revoked, or otherwise disciplined" because the ophthalmologist had allegedly mishandled Lasik surgeries and failed to properly manage treatment of post-operative complications.

Yet Caro continued to perform eye surgeries, highlighting ongoing concerns about the aggressiveness of the watchdog agency charged with punishing bad doctors.

On Friday, Stephens said the disciplinary actions will protect the public.

"We addressed the issues that were part of our formal complaint and we addressed them the best way we could," Stephens said. "If he can't do those things anymore, then future patients can't be hurt by him."

Attempts to reach Caro for comment were unsuccessful.

Lasik is an elective surgical procedure in which a laser is used to change the shape of the cornea, the clear covering of the front of the eye. Lasik, which stands for laser-assisted in situ keratomileusis, is intended to reduce a person's dependence on glasses or contact lenses. The procedure is one of the most common cosmetic surgeries performed in the U.S.

According to the Ophthalmic Mutual Insurance Co., which insures about 30 percent of U.S. ophthalmologists, about 75 percent of the specialists who practice at least 25 years have three or fewer lawsuits or malpractice claims in their career.

The Tribune checked the records of more than a dozen other Lasik doctors in the Chicago area and found none had been sued for malpractice more than 12 times; most had far fewer lawsuits.

Of the almost 50 lawsuits against Caro, some 29 were filed in the past decade.

Lawsuits, depositions and documents compiled by state regulators describe patients repeatedly seeking treatment from the doctor for painful or worrisome complications.

One of those patients, Joseph Smith, was pleased to learn of Caro's punishment.

"I'm glad that he doesn't have the chance to hurt somebody else like he messed up my eyes," said Smith, who is suing Caro. "It's good that they finally did something about him."

Under the conditions of Caro's probation, he is required to hire a licensed physician, approved by the regulatory agency, to oversee his practice.

In addition to the lifetime ban on doing refractory procedures, such as Lasik, Caro will not be allowed to perform intraocular procedures in his medical office, which include cataract surgery, corneal transplantation and refractive lens exchange or clear lens extraction.

Caro has said that he has performed about 25,000 eye procedures in 25 years.

Rule 1.16 Declining or Terminating Representation

(a) Except as stated in paragraph (c), a lawyer shall not represent a client or, where representation has commenced, shall withdraw from the representation of a client if:

(1) the representation will result in violation of law or the Rules of Professional Conduct;

(2) the lawyer’s physical or mental condition materially impairs the lawyer’s ability to represent the client; or

(3) the lawyer is discharged.

(b) Except as stated in paragraph (c), a lawyer may withdraw from representing a client if:

(1) withdrawal can be accomplished without material adverse effect on the interests of the client; or

(2) the client knowingly and freely assents to the termination of the representation; or

(3) the client persists in a course of action involving the lawyer’s services that the lawyer reasonably believes is criminal or fraudulent; or

(4) the client insists upon taking action that the lawyer considers repugnant, imprudent, or contrary to the advice and judgment of the lawyer, or with which the lawyer has a fundamental disagreement; or

(5) the client has used the lawyer’s services to perpetrate a crime or fraud; or

The document may be viewed at SCRIBD.com

Download the document in Adobe PDF format

DR. MARK WHITTEN, DR. L. EDWARD PERRAUT, M.D., & TLC SUED FOR LASIK MALPRACTICE - On August 7, 2009 plaintiff, Jamie Domeier, served her Complaint against Mark Whitten, M.D., L. Edward Perraut, Jr., M.D., TLC The Laser Center (Northeast) Inc., Jo Angeles, O.D., Andrew Morgenstern, O.D., Greg W. McGrew, O.D., Paul J. Chmielewski, O.D., and Eyecare Center Of Leesburg, P.C., in the Circuit Court of Fairfax County, Virginia, for failing to appropriately manage Jamie Domeier’s post-operative LASIK care.

Ms. Domeier had LASIK surgery at a TLC facility in Ann Arbor, Michigan. Following Jamie Domeier’s LASIK surgery, she was instructed to return to northern Virginia for her post-operative care. During that post-operative care, Ms. Domeier was bounced around among various eyecare professionals including, but not limited to, four optometrists and two ophthalmologists, including Defendant Mark Whitten, M.D. Defendant Mark Whitten, M.D. was Tiger Woods’s LASIK surgeon and is the Regional Medical Director for TLC Laser Eye Centers in the Washington, D.C. Metro Area and Richmond, VA.

The Complaint alleges that defendants passed Ms. Domeier from one doctor to another, prescribed steroid eye drops, while no one took charge of her post-operative care, nor carefully monitored or appropriately responded to the increase in her intraocular pressure, which was caused by the steroids. Consequently, after months of incompetent post-operative care, she was initially seen by a glaucoma specialist who diagnosed her with irreversible and permanent nerve damage to her optic nerves. Ms. Domeier now suffers from steroid induced glaucoma which was caused as a result of the negligence of Defendant TLC, and that of its several eye care professionals, who supposedly “co-managed” her post-operative care.

Ms. Domeier is a 23-year-old salesperson, who had aspirations to perform in the highest level of equestrian competition. However, as a result of the incompetent co-managed care system of the defendants, she is blind in her left eye. Jamie Domeier’s equestrian career has ended, barely before it had begun.

The plaintiffs are represented by Todd J. Krouner, from Pleasantville, New York, and Donna Miller Rostant, of Jones & Rostant, P.C., from Fairfax, Virginia. Mr. Krouner and Ms. Rostant represent victims of LASIK surgery throughout the United States.

For further information, please contact Todd J. Krouner, Esq., at (914) 769-8700, or Donna Miller Rostant, Esq., at (703) 352-0522

WILLIAM WEST, CHAPTER 7 TRUSTEE AND HEA CLINIC, P.A.'S 
COMPLAINT SEEKING DENIAL OF DISCHARGE

TO THE HONORABLE WILLIAM GREENDYKE,
UNITED STATES BANKRUPTCY JUDGE:

        COME NOW, William West, Chapter 7 Trustee ("Trustee") and HEA Clinic, P.A. ("HEA") and files this Complaint Seeking Denial of Discharge of Debtor Jack Holladay ("Debtor") and in support thereof would show as follows:

I.
PARTIES

        1.    Debtor is an individual debtor who initiated this proceeding by filing a voluntary Chapter 7 petition on March 25, 2003.

        2.    William West is the duly appointed, acting Chapter 7 Trustee in this case.

        3.    HEA is a professional association with its principal place of business in Houston, Harris County, Texas.

        4.    HEA, a creditor and party in interest in this proceeding, is Debtor's sole unsecured creditor. Debtor owes HEA approximately $750,000 pursuant to a judgment entered against Debtor in favor of HEA on March 12, 2003.

II.
JURISDICTION AND VENUE

        5.    This Court has jurisdiction over this matter pursuant to 11 U.S.C. §1334 and 28 U.S.C. § 157(b)(2)(B). This matter is a core proceeding under 28 U.S.C. § 157(b)(2)(I) and (J).  Venue is proper under 28 U.S.C. § 1409(a).

        6.    This matter is properly brought as an adversary proceeding under Fed. R. Bankr. P. 7001(4) and (6).

III.
FACTS

        7.    Debtor is a renowned eye surgeon. Based upon records produced by Debtor, his annual income is in the range of $600,000. Based upon Debtor's representations, only a fraction of this income was attributable to salary, the rest is derived from distributions from corporations formed by the Debtor. Debtor valued his interests in these extremely profitable corporations on Schedules Debtor filed March 25, 2003 at $100.00 and $1,000.00

        8.    Debtor owns two homes; one in Bellaire, Texas (the "Bellaire Home"), and one in Lake Nona, Florida ("the Florida Estate"). The Bellaire Home and the Florida Estate are valued by Debtor at $1,800,000. Debtor submitted in his Schedules, under penalty of perjury, that these two extravagant homes contain personal property worth only $8,835.00.

        9.    Debtor has insured the personal property in his Bellaire Home at a value of $501,000.

        10.    Despite repeated requests, Debtor finally produced information relating to his insurance on his Florida property (after Mrs. Holladay's 2004 examination) which shows that Debtor has insured what he claims to be $2,000 worth of property for approximately $300,000.

        11.    HEA took a 2004 examination of Mrs. Sharon Holladay, the Debtor's wife, on June 23, 2003. Mrs. Holladay testified that Debtor owned a number of assets that were not listed on his original Schedules.

        12.    Debtor attempted to hide assets by failing to list a number of personal property items he owns, including, a golf cart, a number of sets of golf clubs, sports equipment, a new grill, silver pieces, a laptop computer, cameras and camcorders and other personal property. Mrs. Holladay testified that an interior decorator assisted her in purchasing all new furnishings for the Florida Estate after the 3800 - 5500 square foot (depending on whether you include the lanais) estate was purchased in May, 2000 and that Debtor spent $2,000 (the same value he places on the furnishings) to move these furnishings to Florida.

        13.    Mrs. Holladay testified that their Bellaire home contains a baby grand piano that was purchased a couple of years ago for around $25,000, that just one piece of the debtor's exercise equipment cost in the range of $2,000 - $3,000 and that the pictures that the Debtor valued at $25 on his Schedules are actually original works of art by a local artist and pictures purchased from an interior designer.

        14.    Debtor used an interior decorator at a company by the name of Insides, Etc. to assist in furnishing both the Florida Estate and the Bellaire Home.  More than $26,000 was paid to Insides Etc. in just the checks (let alone any credit card payments) produced by Debtor for the past two years.

        15.    Debtor has made transfers in contravention of paragraph 7 of his Statement of Financial Affairs.  In the past year, Debtor has transferred tens of thousands of dollars to a trust established for his children.  Mrs. Holladay testified that she thought her son paid part of this amount back, but she had no recollection (or documentation produced) regarding any amount repaid.  Debtor also contributed to a down payment on a $300,000 condominium for his son, as well as furnishings, inspections and other items related to his son's condominium shortly before filing bankruptcy.  Mrs. Holladay was unable to recall how much money had been given to their son on the brink of the bankruptcy filing.

        16.  The Debtor claims to own only $2,500.00 in furs and jewelry, but spent almost half that amount on a single piece of jewelry from Tiffany's on February 8, 2003.

        17.    Debtor rushed out and spent a significant amount of money to register the Holladay Trademark prior to filing bankruptcy, then lists its value as $1.00 and attempts to exempt the trademark so that his bankruptcy estate cannot utilize this asset.  He attributes minimal values to companies in which he holds a significant interest and which have yielded substantial distributions.  Debtor takes inconsistent positions with the Internal Revenue Service and the Bankruptcy Court regarding what income is salary versus distributions from companies in which the estate has an interest.

IV.

GROUNDS FOR DENYING DISCHARGE

        18.    Pursuant to 11 U.S.C. § 727(a)(2) Debtor should be denied a discharge because Debtor has, with the intent to hinder, delay or defraud a creditor or an officer of the estate charged with custody of property under this title, transferred, removed, destroyed, mutilated or concealed property of the Debtor within one year of the date of filing bankruptcy as set forth above.

        19.    The Court should deny Debtor's discharge under 11 U.S.C. § 727(a)(5) because the Debtor has failed to adequately explain the loss of assets or deficiency of assets to meet his liabilities.  Debtor has not maintained sufficient records to adequately explain his business transactions such that the Trustee and his creditors may conduct a meaningful review of Debtor's assets.  Debtor testified at his 341 meeting that his wife was in charge of tracking income and expenses for his household.  Mrs. Holladay testified at her 2004 exam that she obtained a number of certified checks from Debtor's accounts because of their concern that HEA would freeze these accounts in satisfaction of their judgment against Debtor.  Mrs. Holladay was unable to give reasonable explanations as to where significant amounts of cash withdrawn from Debtor's various accounts had gone.  Documents produced by Debtor refer to a separate account number with Paine Webber that has yet to be identified.

        20.    The Court should deny Debtor's discharge under 11 U.S.C. § 727(a)(4)(A) because the Debtor knowingly and fraudulently, in or in connection with the case made a false oath or account.

        21.    On April 29, 2003, Debtor knowingly and fraudulently made false oaths when Debtor testified that his Schedules were true and correct. It was only when Mrs. Holladay admitted that Debtor owns a number of significant assets he did not identify in his Schedules which he signed under penalty of perjury, and provided information that other assets were likely significantly undervalued.  

        22.    Debtor knowingly and fraudulently signed and executed his Schedules that excluded a number of items of substantial value and otherwise contained incorrect information. Debtor further made false oaths at the 341 Meeting of Creditors when he testified that his Schedules were true and correct and when he testified that his Schedules were true and correct and when he testified under oath that everything at his Bellaire home was about eleven years old and he had nothing there of any value.

        23.    Based on the foregoing, Debtor knowingly and fraudulently, in or in connection with the case made a false oath or account. Such a false oath is sufficient to deny Debtor's discharge. Accordingly, Debtor should be denied his discharge under 11 U.S.C. § 727(a)(4)(A).

        24.    In joining this Complaint, the Trustee is relying on the information and facts that were obtained by HEA in the Debtor's wife's 2004 examination and documents produced in connection with the Debtor's noticed 2004 examination and documents produced in connection with the Debtor's noticed 2004 examination.  The Trustee believes that it is unusual for the Debtor to have so little personal property in comparison to the high income and expensive real estate properties owned in Florida and Bellaire, Texas.  The Trustee believes that the Debtor should not be granted a discharge until his Court authorized appraiser has had an opportunity to inspect the Debtor's homes and prepare her report to the Trustee.  The court recently entered an order that authorized the Trustee to employ his appraiser.

PRAYER

        WHEREAS, PREMISES CONSIDERED, William West, Chapter 7 Trustee and HEA Clinic, P.A. respectfully request that the Court deny Debtor's discharge for the reasons stated herein and for such other and further relief to which it may be entitled.

Respectfully submitted,

LOCKE LIDDELL & SAPP LLP

By: Patricia Williams Preweitt
State Bar No. 21566370
Federal I.D. No. 10440
Elizabeth Freeman
State Bar No. 24009222
Federal I.D. No. 24564
3400 JPMorgan Chase Tower
600 Travis Street
Houston, Texas 77002-3095
Telephone: (713) 226-1200
Telecopier: (713) 223-3717

ATTORNEYS FOR HEA CLINIC, P.A.

COWGILL & HOLMES, PLLC

By:  Michael S. Holmes
State Bar No. 09908250
7407 Katy Freeway, Suite 100
Houston, Texas 77024
Telephone:  (713) 956-0254
Telecopier:  (713) 956-6284

ATTORNEYS FOR WILLIAM
G. WEST, JR., CHAPTER 7 TRUSTEE

WASHINGTON (Reuters) - More than a dozen LASIK eye centers have poor systems in place to report any side effects in patients who have undergone the vision correction surgery, U.S. health regulators said on Thursday.

There were no problems found with the laser devices used in the procedure, but U.S. Food and Drug Administration inspectors found problems with side-effect reporting systems at 17 LASIK vision correction centers.

Warning letters were sent to the clinics, including some TLC Vision Corp and LCA Vision Inc centers.

More inspections are pending, the FDA said. Clinics are required to report side effects to equipment manufacturers and the FDA.

LASIK, short for Laser-Assisted In Situ Keratomileusis, aims to improve vision by cutting a flap in the eye and then using a laser to reshape the cornea.

Patients tend to seek out the surgery to avoid glasses or contact lenses, but side effects can include blurred and double-vision.

The procedures have seen greater FDA attention in recent months. In May, the agency demanded that providers make the risks clear in their advertisements, a year after FDA's outside advisers urged greater action to protect consumers.

Millions of Americans have undergone the voluntary procedure, but demand has weakened in recent years along with the slumping U.S. economy.

LCA Vision Chief Financial Officer Michael Celebrezze said the agency inspected 14 of its LasikPlus clinics over the summer. A list provided by the FDA showed letters had been sent to eight locations.

"They did not think our policy was as strong as they would like it to be... we've since revised our policy," he said.

Representatives for TLC Vision did not return a call seeking comment. Four TLC clinics were cited on the FDA's list.

The FDA said affected TLC clinics are in McLean, Virginia; Sewickley, Pennsylvania; and Edgewater and Rockville, Maryland, according to a list provided by the FDA.

LCA Vision centers listed by the FDA were in Chicago, Illinois; Indianapolis, Indiana; Louisville, Kentucky; Raleigh, North Carolina; Lakewood, Colorado; Edina and Maple Grove, Minnesota; and Rockville.

The FDA also said on Thursday it was launching its previously announced joint study with the National Eye Institute and the U.S. Department of Defense to look at what impact the surgery has on patients' quality of life.

Shares of TLC Vision closed down 3.4 percent while LCA Vision's stock closed down 1.7 percent, both on the Nasdaq.

The agency announced the warnings on the agency's website here

Companies that make LASIK-related equipment include Abbott Laboratories' unit Abbott Medical Optics Inc, Alcon Inc, and Bausch & Lomb.

Laser Eye Care of California 10/09/09

OCT 09 2009

WARNING LETTER

VIA FEDERAL EXPRESS
Dr. Tom Tooma
Owner
Laser Eye Care of California
16255 Ventura Blvd. Suite 100
Encino, California 91436

Dear Dr. Tooma:

During an inspection of your facility located in Encino, California on June 11, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility and 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 (LASlK) 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). This product is a device because it is intended for 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.

The inspection revealed that your facility is not in conformance with the MDR regulations found at 21 CFR Part 803. Although no Form FDA 483, Inspectional Observations, was issued to your firm, the observed violations were reported to you and formally discussed with your firm's management at the close of the inspection. The LASIK devices used at your facility are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 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. Significant deviations include, but are not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct this violation may result in regulatory action being initiated by FDA without further notice. These actions include, but arc not limited to, seizure, injunction, and/or civil
money penalties. Also, other Federal Agencies may take this Warning Letter into account when considering the award of contracts.

Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation, or similar violation, from occurring
again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections.

Your response should be sent to: Ronald Swann, Branch Chief, Dental, ENT, and Ophthalmic Devices, 10903 New Hampshire Avenue, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact Mr. Swann at (301) 796-5770.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation noted in this letter may be symptomatic
of serious problems in your firm and corporate-level reporting systems. You should investigate and determine the causes of the violation, and take prompt actions to correct the violation and to bring your products into compliance.

 Sincerely yours,

/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

Dr. Rand Paul 2010 U.S. Senate

Dr. Rand Paul on Healthcare Issues

Dr. Rand Paul's Medical Practice

Dr. Rand Paul Interview with Lew Rockwell

Dr. Rand Paul Interview with Alex Jones (1/3)

Dr. Rand Paul Interview with Alex Jones (2/3)

Dr. Rand Paul Interview with Alex Jones (3/3)

WASHINGTON (Reuters) - Doctors, clinics and others promoting corrective eye surgery known as LASIK need to make sure their advertisements tell consumers about possible risks, U.S. regulators said in a letter released on Friday.

The Food and Drug Administration, which has been investigating patient complaints over the procedure, told healthcare providers that commercials and other promotions that do not convey necessary warnings, side-effects and other precautions are deceptive.

"Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading," wrote Timothy Ulatowski, head of the Office of Compliance for the FDA's Center for Devices and Radiological Health.

The letter comes more than a year after the FDA held a public meeting that drew dozens of unhappy patients who complained of blurriness, double-vision, depression and other problems after undergoing LASIK, or laser-assisted in-situ keratomileusis.

Surgeons and other industry groups said the procedure is safe and effective when done properly and that most patients are satisfied with their vision afterward.

LASIK involves cutting a flap in the eye and then using a laser to reshape the cornea, aiming to improve patients' vision so they can avoid glasses or contact lenses. About 700,000 Americans have undergone the procedure since it was approved in 1998, industry estimates have shown.

The FDA's letter spares LASIK-related companies which could have been hurt by stricter action, including device makers Abbott Laboratories' unit Abbott Medical Optics Inc, Alcon Inc, and Bausch & Lomb as well as clinics such as TLC Vision Corp and LCA Vision Inc.

A weak U.S. economy has already dampened demand for the elective surgery, which can cost several thousand dollars per eye and is not covered by most health insurers.

The FDA splits oversight of LASIK advertising with the Federal Trade Commission, which could not be immediately reached for comment. If the FDA deems LASIK advertising misleading, it can issue warning letters as well as take stronger action such as imposing fines or making referrals for criminal investigation.

But Diana Zuckerman, president of National Research Center for Women & Families, said the FDA could have done more than send a "vague" letter that does not help "patients in any meaningful way.

"The problem is there are certain people who are unlikely to benefit (from LASIK) and they don't know who they are," she said. "At this point many people think LASIK is some kind of miracle ... and that's just not true."

The agency should instead require doctors and clinics to give potential patients a simple, easy-to-understand booklet that lays out all the possible risks, Zuckerman said.

FDA spokeswoman Mary Long said the agency has taken additional steps, including updating its website and making it easier for people to report problems to the FDA.

The American Academy of Ophthalmology physicians' group said it appreciated the "reminder" from the FDA and would give the letter to its members. Other industry groups either could not be immediately reached or had no comment.

Brian McCann was fitted for a new pair of contacts by Atlanta eye specialist Dr. Alan Kozarsky Monday. He tested them out by playing a little catch at Turner Field Monday evening and then headed out to Class A Myrtle Beach, where he will play two games on a rehabilitation assignment. He planned to play in games Tuesday and Wednesday in Myrtle Beach to test them out.

McCann is on the disabled list with blurred vision and dryness in his left eye. He’s been coping with it since Opening Day in Philadelphia. He tried to play through it, using two different contact lenses for his left eye, as well as eye drops, but he was still battling blurred vision.

Braves catcher Brian McCann, on the 15 day disabled list for blurred vision, rubs his face and eyes in the dugout during 2nd inning

McCann was scratched from the lineup Friday night in Cincinnati and put on the disabled list Saturday.

An eye specialist in Washington told McCann last week that the vision in his left eye had deteriorated since he had Lasik surgery prior to last season. McCann thought he might be facing more Lasik surgery to correct the problem.

RELATED BRAVES LINKS

• McCann hopes wearing glasses is solution 

CRSQA (Council for Refractive Quality Assurance) is a referral service for LASIK surgeons, operated by Glenn Hagele out of his home.  Despite its pretentious name, CRSQA is just a cynical marketing ploy that "certifies" refractive surgeons willing to fork over $7,000 in the first year and $5,000/year thereafter.  In exchange, Glenn Hagele provides these surgeons with a  bogus seal of approval on his USAEYES.org web site to promote their practices.  Don't be fooled by Glenn Hagele's advertising claims - CRSQA's quality "standards" are actually below industry standards.

Out of 17,000 ophthalmologists in the US, about 30-40 pay Glenn Hagele to market their practices.  It is somewhat difficult to tell exactly what ophthalmologists are members of CRSQA at any one time, as Glenn Hagele has designed his web site in such a manner to implicitly suggest that 17,000 ophthalmologists are members. 

The mission of USAEYES-Fraud.com is to:

1. Expose the false advertising by Glenn Hagle and CRSQA on his USAEYES-Fraud.com web site.
2. Identify the surgeons who have purchased advertising services from Glenn Hagele.
3. Identify surgeons who are not members of CRSQA, but receive public pronouncements of support when criticized by patients who have been injured by laser eye surgery.
4. Provide information on malpractice lawsuits filed against surgeons who are recommended or supported by Glenn Hagele.
5. Provide legal information to those patients who wish to file medical malpractice lawsuits against surgeons who are supported or recommended by Glenn Hagele.

When Dr. Benjamin Chang performs LASIK laser eye surgery on you, he will obtain your personal identity information from you, and then fax it directly to Glenn Hagele at his home.  When Glenn Hagele receives your personal identity information, you will be at risk of identity theft because Glenn Hagele has a history or publishing the personal identity of patients against whom he develops grudges.  See the following example from Glenn Hagele's patient harassment web site in which he published personal identity elements of one of his victims, Paula Cofer. 

When Dr. Thierry Hufnagle performs LASIK laser eye surgery on you, he will obtain your personal identity information from you, and then fax it directly to Glenn Hagele at his home.  When Glenn Hagele receives your personal identity information, you will be at risk of identity theft because Glenn Hagele has a history or publishing the personal identity of patients against whom he develops grudges.  See the following example from Glenn Hagele's patient harassment web site in which he published personal identity elements of one of his victims, Paula Cofer. 

When Dr. Marc Werner performs LASIK laser eye surgery on you, he will obtain your personal identity information from you, and then fax it directly to Glenn Hagele at his home.  When Glenn Hagele receives your personal identity information, you will be at risk of identity theft because Glenn Hagele has a history or publishing the personal identity of patients against whom he develops grudges.  See the following example from Glenn Hagele's patient harassment web site in which he published personal identity elements of one of his victims, Paula Cofer. 

Our Mission:  Expose false advertising, patient harassment, extortion, and lawsuits against LASIK critics by CRSQA, aka "USA Eyes". CRSQA is an advertising agency for 32 LASIK surgeons, disguised as a surgeon certification and patient advocacy group.  This organization is operated by Glenn Hagele out of his home in Sacramento California as a tax-free non-profit organization. Although Glenn Hagele's educational credentials consist of nothing more than a high school diploma, he claims to evaluate surgeons' surgical skill and determines which surgeons are "certified" to perform LASIK laser eye surgery. 

Dr. Marc Werner, Dr. Thierry Hufnagel, and Dr. Benjamin Chang are members of this organization, and have received  "certifications" from Glenn Hagele.

PRESS RELEASE - FOR IMMEDIATE RELEASE

Johnson Devadas and Saramma Devadas v. Kevin Niksarli, M.D.,

PROTECTIVE ORDER GRANTED IN LASIK MALPRACTICE ACTION. In a LASIK malpractice case scheduled for trial in New York, in January 2009, the trial judge, the Honorable Joan B. Carey, Justice of the Supreme Court of the State of New York, County of New York, granted plaintiffs’ motion for a protective order, shielding the identify of plaintiffs’ LASIK malpractice expert. In a decision dated December 8, 2008, Judge Carey held:

When viewed collectively, the evidence submitted by plaintiffs demonstrates a concrete risk that the expert ophthalmologist would be subjected to annoyance, expense, embarrassment, and disadvantage, if identified before trial. The culture of the LASIK industry, as described in plaintiffs’ various submissions, coupled with the fact that plaintiffs’ expert has already "personally born the brunt of antagonistic comments from colleagues for representing patients in LASIK malpractice claims," leads the Court to find that a protective order is warranted.

Judge Carey was persuaded by plaintiffs’ submission which included an article in Ophthalmology News, reference to internet websites, and a recent slander action brought against a LASIK expert in Florida.

As a separate matter, plaintiffs’ recently filed a cross motion to amend their complaint to seek punitive damages as a result of Dr. Kevin Niksarli’s alteration of the treating records. Plaintiffs’ forensic expert, Albert Lyter, III, Ph.D., found that:

(1) the last line on Dr. Niksarli’s treating note for Johnson Devadas, namely "R/B/A/ of LASIK Sx explained to pt including –> ", which treating note was purportedly created on March 25, 2004, was created at a time different than the rest of the notations on that page (Exhibit A-1);

(2) the last line in his treating note for Saramma Devadas, namely, "R/B/A of LASIK expl. to pt. incl. but not limited –>", which treating note was purportedly created on March 24, 2004, was created at a time different than the rest of the notations on that page (Exhibit B-1);

(3) the addendum to Saramma Devadas’s note (Exhibit B-1) is missing, and by letter dated September 10, 2008, defendants’ counsel state "there isn’t a handwritten addendum after the page indicating ‘R/B/A of LASIK expl. To pt incl. but not limited to’. The chart you were given is the complete chart in Dr. Niksarli’s possession";

(4) the addendum to Mr. Devadas’s treating note (Exhibit A-1) was artificially aged in a manner that is not consistent with the normal storage of medical records (Exhibit A-2); and

That motion is still pending before the court.

A copy of Judge Joan B. Carey’s Order is available at www.krounerlaw.com. A full set of plaintiffs’ motion papers are available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq. at tkrouner@krounerlaw.com or at (914) 238-5800.

A physician revolt at LCA-Vision Inc. was the impetus for Dr. Stephen Joffe’s return to the company he founded.

In an exclusive interview with the Business Courier, Joffe said he decided to become an activist investor in LCA-Vision after doctors expressed concerns that the company was losing market share and cutting costs in ways that could impact patient care.

“There’s no room for error in this surgical procedure. It’s surgery on your eyes,” Joffe said. “They were really concerned that unless the company recognized that this was a very sophisticated surgical procedure being done and not just the flipping of a hamburger, patients were going to run into problems.”

Joffe said he knows of no adverse outcomes for LCA-Vision patients as a result of cost-cutting. An LCA-Vision surgeon, who asked not to be identified, also reported no problems but confirmed that doctors are worried about the loss of experienced optometrists and technicians.

Company officials did not return calls seeking comment.

Joffe leads an investment group that acquired an 11 percent stake in the company this fall. The group includes Joffe and his son, Craig, who spent five years on the LCA management team. Alan Buckey, LCA’s former CFO, is also involved. Initially, the Joffe group said it was acquiring shares strictly for investment purposes. More recently, it asked for board seats and management positions. And it asked the company to hold a special meeting of shareholders to vote on a “shareholder rights plan” enacted by LCA’s board Nov. 24. The company rejected that idea Dec. 10.

Dismayed by what he was hearing

In a Dec. 8 interview at the Queen City Club, Joffe said physicians asked for his help in May during their three-day annual meeting with company officials at the Great Wolf Lodge in Mason. Joffe said several physicians were fired by LCA-Vision after complaining about business strategies and cost reductions. He said he was dismayed by what he heard and urged physicians to take their concerns to directors.

That led to a June 10 letter, in which 40 doctors told LCA’s board they had “no confidence in the ability of Mr. Steve Straus to right the direction” of the company. On June 25, Board Chairman Anthony Woods commented in a company press release that the board “strongly supports the executive management team.” On June 26, the board signed new employment contracts with five top managers. And in July, it announced the company had signed new indemnity contracts to protect directors against lawsuits.

To Joffe, these were signs that directors were not going to address physician concerns.

But Joffe didn’t start buying shares until early October, when LCA-Vision announced that its third-quarter procedure volumes would be down 52 percent from the same period in 2007. On Oct. 28, LCA announced a $4.7 million net loss for the quarter on revenue of $37.4 million.

The quarterly results were “abysmal, and much worse than any of us individually had expected,” Craig Joffe said. “We decided we had to work together to try to rescue this company before it imploded.”

Analysts and company officials have said the weak economy is the biggest problem facing LCA-Vision, but former CFO Buckey said declining market share is the real culprit.

“In the fourth quarter of 2006, which is when Straus started, the company was just under 15 percent of the total U.S. (market). And in the most recent quarter, they reported they were down to just over 10 percent. They’re underperforming the category,” Buckey said. “(The Joffe group) went through the last recession in 2001-2002, and we figured out how to start growing this company even while the category was still negative.

“With good execution, you can manage to take share away from your competition.”

Some improvement cited

One LCA-Vision doctor, who asked not to be identified because he fears being fired, said the Joffe group’s investment was a welcome surprise to physicians. He added, however, that conditions have improved within the company. He cited the July firing of LCA’s chief marketing officer as a positive development, along with recent attempts to address physician concerns by Dave Thomas, a former McDonald’s Corp. executive hired in April as LCA’s senior vice president of operations.

To Joffe, however, such overtures are too little and too late. He thinks his management team would be better for physicians.

“They’re the most important asset of the company. They provide all the revenue of the company,” Joffe said. “We saw it as a medical service company, whereas the current management and board see it as a retail-type company. That’s why they’ve hired people out of retail, such as McDonald’s, and have people not represented on the board as physicians.

“They decline all interference or participation by the physicians.”

Road to Rebellion

• Stephen Joffe started talking to LCA-Vision physicians in early May but didn’t buy shares until October.
•  June 10: Doctors send note to board: “This letter alphabetically lists 40 LasikPlus surgeons who have entered a vote of “No Confidence” in the ability of Mr. Steve Straus to right the direction of LCAV/LasikPlus.”
•  June 25: Board Chairman Anthony Woods blames high gas prices and a softening economy – not management problems – for LCA’s troubles. “The LCA-Vision board of directors strongly supports the executive management team in affirming the strategic direction of the company.”
• June 26: Company signs new employment agreements with five top managers, guaranteeing one year’s base pay and benefits in the event of termination and full vesting of performance-related shares upon a change in control. 
• July 18: Company signs agreements to “indemnify, defend and hold harmless” four directors in claims made against it in lawsuits. A July 24 news release said the indemnity contracts protect directors “to the fullest extent permitted” under Delaware law.
• July 29: LCA-Vision suspends its dividend while announcing a second-quarter loss of $573,000 on lower than expected revenue of $54.2 million.
• Oct. 2: A press release on “Third Quarter Business Metrics” indicates procedure volume declined 52 percent compared to third-quarter 2007. Joffe’s group starts buying shares four days later.
• Oct. 28: LCA-Vision announces a third-quarter loss of $4.7 million on revenues of $37.4 million, lower than analyst expectations.
• Nov. 5: Joffe group discloses its purchase of LCA-Vision shares, giving it an 11 percent stake.
• Nov. 13: Joffe group meets with Woods and Director William Bahl to outline their concerns.
• Nov. 14: Joffe tells the Business Courier that his former company is “broken” and “change is needed.”
• Nov. 24: LCA-Vision announces a “stockholder rights plan” that makes it harder to gain control of the company.
• Dec. 4: Joffe group requests board seats and management positions. “The company’s condition today is dire, its prognosis going forward poor,” Joffe said in a press release.
• Dec. 9: Joffe calls on LCA-Vision board to hold special shareholder meeting to vote on the stockholder rights plan.
• Dec. 10: The company rejects the idea for a special vote.

A North Huntingdon man won more than $1 million in a malpractice lawsuit in which he contended his laser eye surgery was botched.

A jury in Allegheny County Common Pleas Court on Wednesday ordered Dr. Mark E Whitten, of Rockville, Md., to pay $850,000 to David N. Cantalupo, on whom the doctor performed surgery in 2001 at The Laser Center in Wexford. Mr. Cantalupo also received settlements from three other defendants named in the suit --The Laser Center and two optometrists -- bringing the total he is to receive to more than $1 million.

According to the lawsuit, the surgery left Mr. Cantalupo with permanent eye damage.

In his lawsuit, Mr. Cantalupo said he has unusually thin corneas, which makes LASIK surgery, in which the cornea is reshaped by a laser, more risky. The lawsuit contended that doctors knew about Mr. Cantalupo's thin corneas but never told him of the risk.

Dr. Whitten is best known for performing laser surgery on golfer Tiger Woods.

Nov. 17 (Bloomberg) -- Top managers with the U.S. Food and Drug Administration ``corrupted and interfered with'' scientific reviews of medical devices, agency scientists said in a letter that is sparking a congressional investigation.

The House Energy and Commerce Committee will review ``compelling evidence'' that devices were approved in violation of laws to ensure their safety, said Representatives John Dingell, the panel's chairman, and Bart Stupak, a member, in a statement today.

The FDA has repeatedly come under criticism from current and former agency scientists who have said bosses forced them to change findings critical of drugs being considered for approval. Now, agency employees have sent Dingell a letter saying managers ``ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations'' on devices, the lawmakers said in the statement.

``These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of American consumers,'' said Dingell, whose committee oversees the FDA, in the statement.

The lawmakers, who are both Michigan Democrats, declined to disclose the names of devices that were identified by scientists. The FDA classifies a range of products as medical devices, from pacemakers for the heart to breast implants.

Scientists who objected to the management practices ``have been subject to reprisals including removal or threatened removal and illegal or inappropriate employee performance evaluations,'' Dingell and Stupak said today in a letter to Andrew von Eschenbach, the FDA commissioner.

The FDA won't comment and instead will respond directly to the lawmakers, said Siobhan DeLancey, an agency spokeswoman.

Unsound Methods

The agency employees said in their letter to Dingell, dated Oct. 14, that they were ordered by managers to make determinations about safety and effectiveness using unsound evaluation methods, and to accept data that isn't scientifically valid.

Dingell and Stupak released a copy of the employees' letter with names and other details blacked out. The scientists didn't want their names disclosed, the lawmakers said.

The scientists said they reported their concerns to von Eschenbach in May. While the agency's assistant commissioner for integrity and accountability, William McConagha, found ``convincing'' evidence to support the allegations, no action has been taken, according to Dingell and Stupak.

McConagha also may have recommended the removal of certain managers, the lawmakers said.

`Management Reprisals'

The head of the FDA's device division conducted his own investigation and concluded the scientists need to ```move forward,' thus allowing managers to avoid and evade any accountability,'' according to the letter from the scientists to Dingell. The division director ``has further aggravated the situation by knowingly allowing a continuation of management reprisals,'' according to the letter.

While managers can disagree with FDA scientists, they are not allowed to order or coerce scientists to change their findings, according to the letter to Dingell.

One of the scientists resigned last week, saying von Eschenbach failed to take action against ``corruption, illegality, gross mismanagement and retaliation at the hands of FDA managers,'' according to a letter to the FDA chief. The lawmakers released the letter with the scientist's name expunged.

Wanda Moebius, a spokeswoman for the Advanced Medical Technology Association, a medical-device industry group in Washington, declined to comment.

Scientists at the FDA said in a 2006 survey that they felt pressured to alter their work for non-scientific reasons and provide misleading information. The survey was conducted by the Union of Concerned Scientists, based in Cambridge, Massachusetts, which seeks to draw attention to what it sees as misuse of science and technology.

A judge has just signed an order to stop the practice of medicine at the Valley Eye Center. The Channel 8 I-Team was the first to expose allegations of medical malpractice at the Lasik center where people say their sight was ruined.

A judge approved a petition from the state medical board seeking temporary restraining orders and injunctions against the clinic.

When the I-Team first examined Valley Eye back in May, we learned the state medical board has been investigating the center for more than nine months. Friday it took legal action against the clinic and against all of the doctors associated with it.

The District Court order suspends the medical licenses of Valley Eye surgeons Doctors Stella Dhou, Paul Cutarelli and Valley Eye owner Dr. Anamika Jain. The board has also accused Jain's husband, clinic administrator Dr. Vikas Jain of practicing medicine without a license. He's alleged to have provided the pre-operative and post-operative care at the clinic.

The court order now prevents him from treating patients.

According to the board's petition, 30 people claim to have suffered vision damage as the result of their Lasik procedures at Valley Eye.

"Any time you have the unlicensed practice of medicine, from the Board of Medical Examiners perspective, that's a terrible thing. It's even worse in this particular case with the huge number of patients we are receiving complaints from. This is a terrible situation," said Louis Ling with the Nevada Board of Medical Examiners.

The court issued that order temporarily suspending the practice of medicine at the clinic.

The I-Team also spoke with Dr. Jain. Though he has previously denied the allegations against him and the clinic, he had no comment. He deferred comment to a spokesperson that was not available for comment.

Also Friday the State Optometry Board decided to proceed with its case against Valley Eye Optometrist Dr. Elise Millie.

A group of LASIK dissidents, led by injured patient Dean Kantis, have launched a Web site called LasikFDA.com "to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You've read the hype about the 10-minute miracle. Now get the truth." To disown confusion its look-alike name might invite, its home page prominently declares: "This is not the FDA Lasik site. The FDA Lasik site is here," with a live link to CDRH's LASIK page.

Heavily anchored to excerpted transcripts and video of presentations made at FDA's 4/25 Ophthalmic Devices Panel meeting on LASIK post-marketing experience, the site's home page links to a statement by National Research Center for Women and Families president Diana Zuckerman, an epidemiologist saying: "There's very good information on the FDA Web site about the risks, but who reads the FDA Web site?"

The cite contends that at that FDA panel meeting, "Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself. Compelling cases were made for massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.

"The mass media attended and filmed the April 25th hearing," the site says, before lamenting that "(n)evertheless, the substance of the above allegations went mostly unreported, despite the presentation of four completed post-LASIK suicides, including excerpts from two actual suicide notes (these presentations are included in the videos at right). The American Society of Cataract and Refractive Surgeons (ASCRS) asserted that individuals with psychological issues post-LASIK certainly had psychological issues all along. To anyone without a preconceived bias, the ASCRS position seemed indefensible. Still, the mass media focused on a 95% percent satisfaction rate, a statistic put forward by ASCRS, but not yet published in their own peer-reviewed literature. Why?"

The site says its creation is an effort counter such impressions, saying the 4/25 panel meeting "must be regarded as one of the most interesting sociological dramas in modern medicine, one which is still being played out. This site chronicles the events leading up the meeting, including press releases by the American Society of Cataract and Refractive Surgeons, videos by presenters on both sides, and the reaction of the American press.

"Judge for yourself the significance of these events, and come to your own conclusions about LASIK, the industry behind it, and the FDA."]]> 2008-09-10T20:23:59Z 2008-09-10T15:23:59-06:00 tag:www.lasikfraud.com,2008:/news//1.200 2008-09-10T20:23:59Z

Attorneys for Plaintiffs and the Class

[Additional Attorneys listed on following page]

UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF CALIFORNIA

James M. Lindsay, State Bar No. 164758
Gene J. Stonebarger, State Bar No. 209461
LINDSAY & STONEBARGER
A Professional Corporation
620 Coolidge Drive, Suite 225
Folsom, CA 95630
Tel: (916) 294-0002 Fax: (916) 294-0012
jlindsay@lindstonelaw.com
gstonebarger@lindstonelaw.com

James R. Patterson, State Bar No. 211102
Harry W. Harrison, State Bar No. 211141
HARRISON PATTERSON & O'CONNOR LLP
402 West Broadway, 29th Floor
San Diego, CA 92101
Tel: (619) 756-6990 Fax: (619) 756-6991
jpatterson@hpolaw.com
hharrison@hpolaw.com

Attorneys for Plaintiffs and the Class

Plaintiffs file this Class Action Complaint on behalf of themselves and all others similarly situated and by their attorneys allege upon information and belief the claims set forth herein against all defendants (collectively as "DEFENDANT PHYSICIANS & NIDEK"), based upon documentary evidence, the investigation of attorneys, the investigation of the Federal Food and Drug Administration("FDA"), and the federal Food, Drug, and Cosmetic Act ("the Act"), interviews and deposition transcripts of potential witnesses and persons knowledgeable of these events as follows:

Denver, CO (PRWEB) August 24, 2008 -- On August 20, 2008, plaintiffs, Jenna Reed and Rian Reed, filed their complaint in the United States District Court, District of Colorado, seeking damages against Alcon for strict liability, negligence, breach of warranty, misrepresentation, and violation of the Colorado Consumer Protection Act. Case Number 1:08-cv-01759-EWN Reed et al v. Alcon Laboratories, Inc. et al Complaint.

LASIK eye surgery is among the most prevalent forms of elective surgery performed in the United States. It is estimated that it is performed on approximately one million eyes per year. The LASIK industry generally, and defendants in particular, profess that the surgical laser systems used to perform the surgery are safe. However, on February 21, 2007, the United States Food and Drug Administration recalled defendants' excimer surgical laser system, known as the LADAR6000 Excimer Laser (the ALADAR6000) due to reports that the LADAR6000's CustomCornea Myopia and CustomCornea Myopia with Astigmatism algorithm procedures were causing Acentral islands in patients.

Unfortunately for the plaintiff Jenna Reed, a 33 year old wife and mother of two, who resides in Longmont, Colorado, the FDA Recall came too late. She was one of approximately 20 patients who were injured by the defective LADAR6000, which was used by her LASIK surgeon at Insight LASIK, in Layfayette, Colorado.

On September 22, 2006, Mrs. Reed's doctor performed LASIK surgery on her, and programmed the LADAR6000 to perform CustomCornea Myopia with Astigmatism on Jenna Reed.

Predictably, Jenna Reed has developed Acentral islands, which are a laser created defect in her eyes caused by the laser's uneven application of energy to her corneas. As a consequence of resultant peaks and valleys in her corneas, Jenna Reed is left with a permanent visual disability marked by problems with her vision, which include, without limitation, blurring, ghosting, double vision, photosensitivity, poor night vision, and ocular headaches.

Defendants have offered to send Jenna Reed, and numerous other patients injured by its defective LADAR6000, to Texas for purported corrective surgery. However, Jenna Reed's eye care professionals at InSight (who are not the subject of this lawsuit) have advised her that there is no certainty that any further surgery can cure or correct her injuries.

The plaintiffs are represented by Carrie Frank of Klein | Frank, P.C., in Boulder, Colorado and Todd J. Krouner, from Chappaqua, New York. Mr. Krouner and Ms. Frank have also filed suit on behalf of another patient, Melanie Wheeler, of InSight who was also injured as a result of the defective LADAR6000. Klein | Frank, P.C. is a nationally recognized firm that handles cases involving defective products, personal injury and defective drugs throughout the United States.

BLOOMFIELD HILLS, Mich. - Kenny Perry’s stunning late night withdrawal from the PGA Championship finally has an explanation. And it’s not a pretty one. Not for Perry. Not for any pro athlete who is considering Lasik surgery - which has been all the rage in pro sports for a while.

Minutes ago, Perry just admitted that the eye injury that made him decide to withdraw after having shot a 9-over 79 in the first round comes from an infection he got after going through Lasik surgery. Perry’s doctor is telling the 47-year-old Perry that the infection was likely caused by the Lasik contact lenses Perry’s worn since the surgery.

“I had got some infection in there and my doctor said that I needed to let my eyes rest by keeping the contacts out,” Perry said. “He gave me cortisone and steroids, which were very painful and annoying. It’s difficult to be trying to fight through a golf course with my eye aggravating me at the same time.”

Perry said he’s withdrawing from the PGA Championship in part to give himself a better chance to be able to play in the Ryder Cup.

For more information regarding problems involving dry eye, see  Researchers Admit to High Incidence of Long-term Pain Following Refractive Surgery

If you would also like to receive some free wine "glasses" with LASIK, contact Dr. Dornic at

3701 NW Cary Parkway, Suite 101
Cary, North Carolina 27513
(919) 439-1174

Clinical psychologist Roger Davis, who also suffers adverse effects from Lasik surgery, called for an end to, or at least a moratorium on, refractive eye surgery. “Research connecting complications to quality of life provides the ethical basis for informed consent,” he said. “Because this research does not yet exist, refractive surgery cannot be performed ethically, whatever its satisfaction or complication rate.” Davis charged that, all too often, Lasik patients have not been afforded the opportunity to give “real” informed consent to surgery; that the Lasik industry has lied to the public about the nature of risk, and has sought to suppress public awareness of the severity of Lasik injuries in order to maintain public perception of the procedure as safe; and that, given this perception, many injured patients will begin to think of themselves as victims of a medical conspiracy. “Patients feel helpless to communicate their problems, and hopeless in getting the industry to do anything to solve them,” he said, pointing out that helplessness and hopelessness are cardinal features of depression and suicidal ideation.

Former Navy psychiatrist now in private practice Jennifer Morse testified that, however debilitating the adverse events associated with Lasik surgery may be, suicide should never be attributed to a single cause. “Suicide is a product of multiple factors — an individual’s background, personality, coping skills and genetic predisposition,” she said. She asserted that there is no direct cause-and-effect between suicide and adverse effects that can be attributable solely to Lasik surgery. She did, however, call for more research on quality-of-life issues, including patients’ pre-operative and post-operative perceptions of the effects of surgery. “We need to understand the reasons for dissatisfaction, pre-operatively, and steer some patients away from surgery,” she said.

The “no cause-and-effect” assertion by Morse was vigorously disputed by Michael Mullery, also a physician with credentials in the field of psychiatry. Referencing findings of a recent comparative study of suicide among hearing- and sight-impaired individuals, Mullery stated flatly that in some documented cases “Lasik sight loss is the sole cause of suicidality.” He also called for more psychometric studies on the effects of post-surgical sight impairment, and a moratorium on Lasik surgery until such studies are done. Several individuals offered poignant testimony to the alleged link between the act of suicide and Lasik surgery gone bad, including reference to suicide notes from family members expressly relating the act to frustration and despair over their medical condition.

Although FDA recently announced a partnership with the several Lasik surgeons’ organizations, including the American Society of Cataract and Refractive Surgery, to study Lasik safety and quality-of-life issues, critics of the agency complain the partnership represents an inherent conflict-of-interest, and they call for any such research to be conducted by an independent body. Michael Patterson, who has suffered severe adverse results from Lasik surgery, which he attributes to lax FDA oversight of ambulatory surgical facilities and, more specifically, to improper re-use of a single-use microkeratome device, expressed skepticism over the integrity of the FDA/Lasik industry partnership.

Several presenters offered testimony pointing to an exceptional degree of satisfaction with Lasik surgery, as revealed in meta-analyses of the medical literature and patient surveys. Medical University of South Carolina ophthalmology professor Kerry Solomon cited results of a comprehensive review of the world literature since Lasik surgery’s inception. Of 1,581 articles reviewed, Solomon said 19 dealt specifically with patient satisfaction, indicating that more than 95% of patients report satisfactory results with Lasik, even after five years, post-op. This finding is consistent with data presented by U.S. Navy Refractive Surgery Program director David Tanzer,  who reported that more than 98% of naval aviators who have undergone Lasik surgery say they are either “extremely satisfied” (90.9%) or “moderately satisfied” (7.2%) with their results. Tanzer said the procedure is voluntary for members of all the armed services, and is made available, not only to aviators, but to Navy divers, and members of Ranger and Special Forces units who are routinely subjected to the most rigorous physical demands.

Although the 95% patient-approval statistic for Lasik surgery seems generally accepted, critics pointed out that, even if “only” 5% of individuals suffer unacceptable results, considering that 700,000 surgeries are now performed annually, this would nevertheless constitute a public health problem of enormous dimension. In any case, Patterson and others insist no one really knows the full extent of Lasik-associated problems, charging that FDA has received only 140 adverse event reports in its database — a figure that, they assert, represents an absurd undercount. Miami-based optometrist Edward Boshnick, an expert on corneal refractive therapies, said that in his practice alone he has seen at least 200 patients with adverse results from Lasik surgery.

The public testimony was followed by presentations from FDA officials who described several Lasik-related agency activities, including requirements for pre-clinical studies, device labeling considerations, refractive laser and ophthalmic standards, and post-market and quality-of-life assessments. Of particular interest, CDRH chief ophthalmic medical officer Eva Rorer said the agency has recently assumed an “integral role” in the design of a quality-of-life (QOL) instrument, or questionnaire for Lasik patients, to be used in conjunction with clinical trials conducted by FDA and its sister agency, the National Eye Institute.

As the purpose of the advisory panel meeting was to inform panel members of public concerns with respect to Lasik-related issues, and to apprise them of FDA activities in this area, there were no votes taken by the panel. FDA officials responded to questions posed by the panel, and a number of comments and suggestions were offered by panel members for consideration by the agency. Medical College of Wisconsin chairman of ophthalmology Dale Heuer observed that FDA’s informed consent document, for use in clinical trials, may not be understood by some patients, and should be written at a high school reading level; University of California, San Francisco professor of clinical Ophthalmology Stephen McLeod offered criticism of the FDA Lasik Web site, suggesting that it include statistics on adverse events and links to other Web sites relevant to Lasik surgery.

The session was concluded by panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute. She thanked all presenters and said her sense of the meeting was that, while Lasik has been of great benefit to a large majority of patients, the problems experienced by some are very real. She acknowledged that the Lasik industry may be fairly accused of “aggressive marketing” (“Lasik sold as a commodity instead of a procedure”) — a situation which she said may, indeed, suggest scrutiny by the Federal Trade Commission; and she said that there is need for more attention to the issue of “adequate” informed consent from prospective Lasik patients.

Unaddressed by anyone other that Patterson was the need for a CDRH compliance program to increase adverse experience or Medical Device Reporting accountability by end-user Lasik device (surgical) facilities.

Source:  FDAWeb.com

GAITHERSBURG, Md. - More than 200 people filled a conference room this morning to listen to report after report from patients suffering from complications of vision-correcting eye surgery.

In the first hour of a public hearing, more than a dozen patients and patient advocates stepped to the microphone to tell an advisory panel of the Food and Drug Administration about their years of eye pain, night driving problems and suicidal thoughts.

"You have a serious problem on your hands," said Michael Patterson, a lasik patient from Atlanta.

Patterson and others asked the FDA to stop lasik, which stands for laser-assisted In situ keratomileusis. They also asked for stronger warnings about the surgery's risks and urged the FDA to better track complications and to monitor false claims in surgeon's advertisements.

Some also questioned the impartiality and expertise of the panel. Patterson pointed to one panel member, Dr. Andrew Huang, a professor of ophthalmology at Washington University in St. Louis, and shouted, "We don't need your expertise."

Patterson claimed Huang failed to follow safe lasik procedures during surgery.

Among those attending were lasik patient Matthew Kotsovolos and his wife, Beth, of Raleigh.

Matthew Kotsovolos, who experienced debilitating complications after lasik surgery, called the hearing a sham. He referred to a news release put out by a trade group for laser surgeons claiming that the FDA considers lasik to be safe and effective.

Beth Kotsovolos told the panel that because of lasik, her children almost lost their father.

The FDA panel could recommend changing regulatory guidelines for the vision-correcting laser or it could do nothing.

The American Society of Cataract and Refractive Surgery has said that only about 3 percent of lasik patients experience complications, but other data and research suggest problems may be more common and long-lasting. sabine.vollmer@newsobserver.com or (919) 829-8992]]> 2008-04-24T11:31:02Z 2008-04-24T06:31:02-06:00 tag:www.lasikfraud.com,2008:/news//1.195 2008-04-24T11:31:02Z

Meant to be a cure for his eyesight problem, a laser surgery to correct Jermaine Dupri's vision has backfired. Reports are surfacing that the producer who is also known to be Janet Jackson's long-term boyfriend, is losing sight due to complications from the surgery.

Dupri had an elective eye surgery two weeks ago and according to a report by MediaTakeOut, sources said that Dupri is "virtually blind". Other details regarding this matter or any public statement from his publicist are not yet released.

Dupri posted the video of him getting the Lasik surgery on his YouTube account. He had forgotten his wallet and asked Janet who allegedly was in the middle of a rehearsal to pay for the bill. After the surgery that is supposed to be a minor one, Dupri reportedly did not attend the scheduled February 23 gig on Atlanta's V-103.

The first public hearing on how complications from laser eye surgery affect a patient’s quality of life will be held from 8:30 a.m. to 5 p.m. Friday, April 25, at the Gaithersburg Holiday Inn in Gaithersburg, Md., according to a notice published today in the Federal Register.

Laser eye surgeons who are collaborating with the Food and Drug Administration to collect patient information hope to have three of their colleagues testify. Patients dealing with complications from lasik — which stands for laser-assisted in situ keratomileuses — have also requested to speak at the hearing.

Patient petitions to more closely scrutinize lasik prompted the FDA two years ago to take another look at the medically unnecessary surgery, which is only loosely regulated. Testimony given at the public hearing may become part of a large, national study the FDA wants to conduct.

sabine.vollmer@newsobserver.com or (919) 829-8992.
SOURCE:  www.newsobserver.com/business/story/1011418.html

As federal regulators prepare to hold their first hearing on how complications from laser eye surgery affect a patient’s quality of life, patients are worried that they are being shut out.

The Food and Drug Administration has said it will hold a public hearing on the issue this spring, but patients who have requested to speak at the event cannot get  confirmation from the FDA on the date, time or location, said Michael Patterson, a lasik patient from Atlanta.

However, at least one laser eye surgeon who is working with the FDA to collect patient information plans to report his findings at an FDA meeting April 24-25.   And Dr. Richard Lindstrom, co-chairman of the group of surgeons collaborating with the FDA, said his group hopes to have three surgeons testify.

“The April meeting is shaping up to be a major hearing,” he said. Lindstrom also is president of the American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery.

The FDA has yet to publish meeting details in the Federal Register. Until it does, it is barred from making the information public, FDA spokeswoman Karen Riley wrote in an e-mail message.

The FDA’s response to patients’ requests for permission to speak, including his own, has Patterson worried that “the FDA is going to listen to the doctors, not the patients.

“It shows a lack of respect for patients,” he said.

Patterson experienced debilitating complications after his lasik surgery in August 2000, including dry eye, vision distortions and floating debris. His petitions to more closely scrutinize lasik — which stands for laser-assisted in situ keratomileusis — prompted the FDA two years ago to take another look at the medically unnecessary surgery, which is only loosely regulated.

Since the mid-1990s, numerous studies have suggested that the surgery is safe and successful in most cases and has become more so with the introduction of new technology.

The American Society of Cataract and Refractive Surgery has estimated that 2 percent to 3 percent of lasik patients experience complications, which typically resolve themselves in three to six months.

FDA statistics and other research indicate that complications, which can include chronic pain, dryness of the eyes and distorted night vision, may be much more frequent and longer lasting.

Takes a toll on patients

Patient advocates have long argued that the existing research is at best incomplete, because most studies do not evaluate how complications from lasik can affect patients’ lives.

At least one suicide has been linked to complications from lasik, bolstering patient advocates’ position that unremitting eye pain or impaired vision can exact a severe emotional toll.

Laser eye surgeons are willing to learn from patients’ experiences, Lindstrom said: “We need to understand the negatives.”

The first step is a review of 19 studies measuring patient satisfaction. Dr. Kerry Solomon of the Medical University of South Carolina’s Storm Eye Institute said he plans to report first results of the literature review at the FDA’s April meeting.

Of about 2,000 patients who participated in the 19 studies, an average 4.8 percent were not satisfied with the outcome of their laser eye surgery. In the study with the lowest satisfaction rate, more than 12 percent of patients were unhappy. The study with the highest satisfaction rate had no dissatisfied patients.

Patient satisfaction is a broader measurement than the complication rate, Lindstrom said. “It captures patients who objectively have a good outcome, but they’re not happy,” he said.

Patterson and other patient advocates disagree, saying that approach blames the patient rather than the surgery.

The toll from lasik complications is very real, Patterson said. And no matter how inconvenient regulators and surgeons make it for patients to argue that point, he said, “they’re not going to be able to shut us out.”

sabine.vollmer@newsobserver.com or (919) 829-8992
SOURCE:  www.newsobserver.com/business

Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of lasik complications and quality of life, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA’s Center for Devices and Radiological Health, wrote in an e-mail message that the scant clinical data available “failed to suggest significant problems following lasik surgery,” but she said the FDA wants a broad and systematic review. She wrote, “We also noted that quality of life issues related to lasik had not been evaluated consistently, and there were few reports of well-designed studies.”

Frustration and even sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be particularly severe.

One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, 6 1/2 years after lasik surgery left him with lasting visual distortions. The surgery was done at a lasik center in Canada that has since closed.

“If I cannot get my eyes fixed, I’m going to kill myself,” he wrote in a note police found on his body. “I just cannot accept the fact that I’m supposed to live like this.”

In the note, Dorrian wrote that there had been other instances when he felt down. “I have other problems like most people do. But this is something else,” he wrote. “As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it.”

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don’t think lasik complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

“There’s no cause and effect,” said Dr. Steven C. Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from lasik.

In September, The News & Observer reported on complications from lasik, a lightly regulated surgical procedure widely promoted as a quick and painless way to eliminate the need for eyeglasses. But patients across the country and in laser eye surgery hot spots such as the Triangle, where 11 laser eye surgery centers operate, say the physical after-effects can cause or aggravate psychological problems.

Martha Walton of Raleigh postponed lasik twice. She had had bouts of depression and anxiety attacks and wasn’t sure she was ready for the permanence of eye surgery. She still felt very anxious when she went ahead with it in August. Within a month, Walton, 41, a high school teacher, developed constant, severe pain from eye dryness. She couldn’t cope with it and spent six days on suicide watch in a Triangle mental health facility.

“I was in so much pain,” Walton said. “Twenty-four hours a day there was no escape. The only relief I could think of was to end my life. At least the pain would be over.”

An elaborate regimen of taking supplements, wearing special goggles and switching to preservative-free eye drops has drastically reduced her pain. But her eyes still do not produce enough tears and she continues to take daily anti-anxiety medication.

Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, Iowa, has encountered the psychological effects that patients experience when they have trouble seeing.

“Depression is a problem for any patient with a chronic vision problem,” she said. But in the case of post-lasik patients, she said, the depression is compounded by remorse.

“It’s not just that they lose vision,” she said. “They paid somebody [who] took their vision away.”

Sindt specializes in treating ectasia, a bulging of the eye that is considered the most severe and rarest lasik complication. She sees a few dozen patients with ectasia; all of them show signs of depression, she said.

Lasik usually safe

Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or lasik, is safe and successful in most cases and has become more so with the introduction of new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that 2 percent to 3 percent of lasik patients experience complications.

Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications. He said people at risk of depression or anxiety are generally not good candidates for lasik. He compared them to patients who become depressed after undergoing cosmetic surgery, another elective and medically unnecessary procedure.

“Their motivation and expectations may reflect something they’re missing in their life that they’re not telling you about,” he said.

But surgeons agree that lasik is unlike a face-lift or even most necessary surgery because it affects a process — seeing — that is essentially a mental function. The eyes focus light, but what a person actually sees depends on how the brain decodes an image. Neurological differences in decoding explain why dyslexics reverse letters and why alcohol consumption can produce double vision.

Although laser eye surgery has been around for years, little research has been done to explore how the ability to see affects how people feel and act. In 2006, the FDA began to look into lasik complications and quality-of-life issues and determined more research was needed. A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

Vision-mind connection

The FDA is also planning an open public meeting this spring to discuss experiences with lasik devices since their introduction to the U.S. market.

A few researchers have already looked at whether changes in vision can affect the mind. Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery.

Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had lasik as among cornea donors who had not. But the data were incomplete and the numbers could be significantly skewed, said Dr. Henry Edelhauser, the professor of ophthalmology who oversaw the Emory study. One of the participating eye banks failed to provide vital statistical data.

Research that Schallhorn did at the Navy Refractive Surgery Center suggests a relationship between satisfaction after lasik and certain personality traits among patients. Schallhorn declined to provide details. Like the results of the Emory suicide study, his research has not been published in peer-reviewed journals.

But some patients are unequivocal: Lasik complications drove them to contemplate suicide.In Cleveland, Tenn., Kim Hybarger, 44, a nurse, developed debilitating visual distortions after lasik surgery Dec. 21, 2006. She tried to walk into traffic, cut her throat and starve herself.

“I was filled with anger,” she said. “I felt so hopeless and helpless. I just wanted to die. The way I saw was so frightening.”

Her vision was blurry. The moon had six to eight overlapping copies, a distortion called ghosting. Bright lights erupted into irregular star bursts in the shape of chicken feet.

Hybarger compared her vision to looking through glass that is cracked and smeared with grease. She stopped driving, exercising, working and going to the grocery store. She couldn’t read a book or watch television.

Hybarger said she had never had problems with depression before her lasik surgery. Afterward she felt so bad, she said, she told her husband to “load a gun with a bullet and give it to me. I’m not going to live the rest of my life like this.”

Hybarger’s mental state didn’t improve until Ed Boshnick, a Miami optometrist, offered to fit her with special contact lenses. Sales of the special lenses have increased with the rising number of Americans who had lasik since 2000. The lenses can restore the cornea’s shape and correct visual distortions.

New lenses help

Boshnick is one of a handful of specialists who have had considerable success fitting the lenses. Hybarger is one of about 250 patients with complications from lasik who regularly see Boshnick. About half of them suffer symptoms of depression, Boshnick said.

The new lenses can clear up more than vision.

Hybarger left Miami remembering the moment she first looked through them.

“It was indescribable,” Hybarger said. “It was like the first time I smiled in a year.”

sabine.vollmer@newsobserver.com or (919) 829-8992
SOURCE:  http://www.newsobserver.com/150/story/920341.html

Millions of Americans have undergone laser eye surgery to correct bad vision, and along with the procedure’s popularity something else is coming into focus: its hazards.

Advertising stresses the surgery’s safety, and most procedures are successful. Tiger Woods, who relies on keen eyesight as the world’s best golfer, pitches it as a quick and painless way to restore sharp vision. Even the U.S. Air Force, long skeptical of the surgery, changed its policy in May to let people who had LASIK apply for pilot training.

But every year thousands of Americans who undergo LASIK are left with chronic pain, dryness of the eyes, distorted night vision and even blindness, according to Food and Drug Administration statistics.

LASIK — which stands for laser-assisted in-situ keratomileusis — uses lasers to cut and reshape the cornea. It can improve eyesight without complications, but equipment flaws, a surgeon’s error or a failure to screen out patients whose eyes are ill-suited for the treatment can cause the operation to go awry.

The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, estimates that only 2 percent to 3 percent of the more than 1 million LASIK surgeries each year are unsuccessful. But Food and Drug Administration records of clinical studies show that six months after the surgery, up to 28 percent of patients complained of eye dryness, up to 16 percent had blurry vision and up to 18 percent had difficulty driving at night.

The Triangle, home to two medical schools, is a hot spot for LASIK; 11 eye centers will perform LASIK on about 8,000 patients this year, according to market research.

One of the leaders is Duke Eye Center, whose LASIK surgeons are among the best-trained and best-equipped in the field.  But even surgery at Duke’s level has damaged a few patients’ eyes beyond repair.

One of those patients is Matthew Kotsovolos, 38, of Raleigh. He was the Duke Eye Center’s head of finances and received the surgery for free June 8, 2006. It gave him 20-20 vision but left him with intensely dry eyes and excruciating facial pain. He wakes up with sore eyes every morning, wears special goggles to preserve eye moisture and wonders when the pain in his face will kick in.

“I traded in my glasses for permanent head pain, eye pain and these things,” Kotsovolos said, pointing to the goggles.

Nine months after his surgery, Kotsovolos quit his job at the Duke Eye Center, took a 25 percent pay cut and started work as business manager in the Duke University Medical Center’s gastroenterology division. He is organizing a support group for LASIK patients with complications.

“It may help inform people that this is a surgery with real risks that are understated by LASIK surgeons,” Kotsovolos said.

Alan Carlson, head of the Duke Eye Center, said his experience with LASIK is that complications are rare. Carlson, who did not operate on Kotsovolos, said only a handful of the roughly 6,000 LASIK patients he has treated at Duke since 1996 ended up with problems. The eye center does very well in patient satisfaction surveys, he said.

But Carlson acknowledged that the procedure can cause serious complications.

“It’s imperfect surgery in an imperfect world,” he said.

How many LASIK patients develop post-surgery complications is obscured by a lack of regulation and reporting. Because health insurers don’t pay for LASIK, they generally don’t track complications. The FDA doesn’t require reports from doctors, and regulatory enforcement has been largely limited to recalling malfunctioning lasers.

Post-LASIK lenses

Evidence of problems is accumulating. Some of the strongest is the growing market for contact lenses designed for people who have undergone LASIK and still have vision problems, some seeing worse than before the surgery. One of the leading post-LASIK lens makers is MedLens Innovations, a Front Royal, Va., company founded in 2000.

Robert Breece, an optometrist and MedLens’ president, said his company provides hard contacts to more than 2,500 post-LASIK patients annually and business is increasing about 10 percent every year. Breece said his company serves more than 200 people per year who have been seriously disabled by the surgery.

“I don’t get to talk to happy LASIK patients,” he said.

By the end of the year, SynergEyes of Carlsbad, Calif., plans to bring to market the first line of contact lenses designed specially for laser eye surgery patients with complications who cannot tolerate hard lenses.

A trial version of the SynergEyes contact lenses have given Paula Cofer, 49, of Tampa, Fla., some relief from dry, itchy eyes and night vision so distorted that she sees up to eight moons.

The specially fitted contacts cost $300 every six months, Cofer said. Contact lenses solution, sterile saline solution, artificial tears and lenses rewetting drops run another $150 to $160 per month.

“Life was very simple then,” she said about the 30 years she wore glasses. “Now, it’s very complicated.”

Limitations of LASIK

Patients with complications are starting to fight back on the Internet and through support groups. Medical research in the past three years has come up with insights about LASIK worrisome enough that some eye surgeons have begun to ease away from the procedure.

“We’ve learned the limitations of LASIK,” said Dr. Stephen Pflugfelder, professor of ophthalmology at Baylor College of Medicine in Houston.

An expert in laser eye surgery for more than 15 years, Pflugfelder is increasingly falling back on an older, less invasive procedure known as photorefractive keratectomy, or PRK, which involves only the surface of the eye.

In the past three years, the number of LASIK procedures at Baylor has dropped from about 70 percent to about 50 percent of all laser eye surgeries.

At Duke, LASIK makes up about 80 percent of all laser eye surgeries. Carlson, head of the Duke Eye Center, is comfortable with that.

“Dry eye hasn’t been a big problem,” he said.

The university buys the most sophisticated lasers on the market, he said. Patients are screened for risk factors and informed of what they can and cannot expect from LASIK. A surgeon might even do the surgery on one eye at a time.

Those precautions did not prevent Lauranell Burch, a former Duke medical researcher, from suffering a serious complications after undergoing LASIK at the Duke Eye Center.

Burch 47, said that since the surgery March 31, 2004, her eyes sting and burn all the time, her eye tissue is wrinkled like a Ruffles potato chip and her night vision is distorted.

“[The damage] is noticeable and on the front of your mind all your waking hours,” Burch said. “There’s no escape.”

In the winter, she takes an anti-anxiety pill about 15 minutes before she drives home in the dark from her job in Research Triangle Park. She compares the distortions she sees at night, also known as star bursts, to explosions of light without a bang.

Burch cut short her follow-up treatment at Duke, became an avid patients’ advocate and started to take on LASIK surgeons on the Internet.

Risks of high volume

All LASIK surgeons make an effort to screen patients, and many turn away patients with obvious risk factors.

But LASIK is essentially a buyer-beware procedure.

In choosing a surgeon, patients are usually advised to go with doctors who perform the procedure most frequently. But with LASIK, that advice can be risky.

Dr. Christopher Fleming, a Cary ophthalmologist and former president of the N.C. Society of Eye Physicians and Surgeons, said patients should beware of LASIK surgeons who perform a high volume of operations.

Surgeons who do 10 or 15 LASIK operations a week tend to contract with optometrists who refer patients, Fleming said. In return, the optometrists, who are not medical doctors, screen the patients and do the follow-up care. Some also receive referral fees.

The emphasis on volume, Fleming said, can draw patients into surgery whose eyes are not suited to LASIK. Patients also end up getting follow-up care from optometrists instead of their surgeons.

Fleming performs no more than one or two dozen LASIK surgeries a year and personally screens patients and does the follow-up care. As a result, his patients rarely have complications, he said.

“When you’re high-volume and relinquish part of the care to non-physicians,” Fleming said, “you don’t have time to be thorough. That can lead to problems.”

What deters lawsuits

How many North Carolinians have problems after LASIK is not a public record. Patient complaints filed with the N.C. Medical Board are confidential, and the data are not organized by medical procedure.

Only a few complaints become lawsuits, said Bill Faison, a well-known medical malpractice lawyer in Durham who has represented one LASIK patient in court in the past three years.

What foils most attempts to sue for damages, Faison said, are the costs to mount a legal challenge. Also, carefully worded patient consent forms spell out the risks of the surgery and often require patients to first try to work out their differences with the LASIK center.

“Short of the [LASIK surgeon] being stupid, if it’s just a bad outcome, there’s nothing to recover,” Faison said.

The procedure is safe and effective for many, said Dr. Brad Randleman, a laser eye surgeon at Emory University in Atlanta who has done LASIK on about 1,000 patients over the past five years.

Post-surgical complications such as dry eyes and vision distortions often subside after a few weeks.

“I had nothing but a great experience,” said Jim Branch, 55, a Raleigh real estate developer who had LASIK at Duke about five years ago.

Medical research has found that cutting the cornea permanently weakens it. The severed nerves need years to recover and might misfire pain signals. But those findings have not been conclusively linked to lingering complications from LASIK, said Dr. William Bourne, an ophthalmology professor and LASIK surgeon at the Mayo Clinic in Rochester, Minn.

“I don’t think we’ve proven what it is,” Bourne said.

A better understanding of what causes the complications is essential to screen patients more effectively and eliminate those at risk, he said.

Kotsovolos said he was considered a good candidate for LASIK. His Duke LASIK surgeon blamed part of his problems on an eye inflammation unrelated to the procedure. Another eye specialist has since diagnosed Kotsovolos with a severe dysfunction of the glands lining the eyelids. The condition is considered a red flag when it is found during screening for LASIK.

Charles Hybarger, a building contractor who lives near Chattanooga, Tenn., changed his mind about LASIK after his wife, Kim, a 44-year-old trained nurse, had an unsuccessful procedure Dec. 21 and the complications triggered a deep depression.

Hybarger wonders whether his wife’s rheumatoid arthritis should have eliminated her from having LASIK. Laser eye surgery should not be done on patients with auto-immune diseases.

“I wouldn’t let any doctor cut on me unless it’s life or death,” Hybarger said. “I just wear my glasses and be happy with it.”

sabine.vollmer@newsobserver.com or (919) 829-8992
SOURCE:  www.newsobserver.com/front/story/721249-p3.html

Public documents recently uncovered by Brent Hanson show that the Sacramento District Attorney directed the Bureau of Family Support to place liens on all property owned by Glenn Hagele, for his refusal to pay court-ordered child support.  View a scanned copy of the order by the Sacramento District Attorney, at LasikFraud.com.

SOURCE:  USAEyes-Fraud.com

Public documents recently uncovered by Brent Hanson show that the Glenn Hagele filed a bankruptcy petition for the amount of $431,000, with over 50 creditors.  View a scanned copy of the bankruptcy filing, at LasikFraud.com.

SOURCE:  USAEyes-Fraud.com

Public documents recently uncovered by Brent Hanson show that the IRS and State of California placed liens on property owned by Glenn Hagele, for his failure to pay taxes.  View a scanned copy of the liens, at LasikFraud.com.

SOURCE:  USAEyes-Fraud.com

Judge Hoch chose his surgeon carefully when he decided in 1998 [apparently not] to undergo laser correction of his nearsightedness. Following the recommendation of his local optometrist, Judge Hoch made an appointment with Dr. Stephen Brint, a LASIK pioneer [all surgeons claim to be "pioneers"] and internationally preeminent ophthalmic surgeon. Dr. Brint was associated at the time with a chain of laser surgery clinics located throughout the country called The Laser Center, Inc. (TLC).

Using assembly-line-like procedures, TLC-employed optometrists oversaw initial testing procedures, pre-qualified patients for surgery, and then lined up surgical candidates upon whom Dr. Brint would fly in to operate. Surgery was performed on both of Judge Hoch's eyes on the same occasion.

By all accounts, Dr. Brint's surgical technique was flawless. By Dr. Brint's own candid admission, however, Judge Hoch never should have been operated on at all. The screening tests conducted by TLC and provided to Dr. Brint for review before surgery showed that Judge Hoch had a condition called keratoconus - irregularly shaped corneas - that disqualified him for LASIK surgery. Instead of improving Judge Hoch's vision, the surgery triggered a series of worsening vision problems that led to legal blindness in one eye that could only be improved - though not completely cured - by a corneal transplant. The need for at least one additional corneal transplant in the other eye is expected.

Attorneys Bill King and Jack Scarola filed suit on Judge Hoch's behalf against both TLC and Dr. Brint, who were separately insured and separately represented. Although Dr. Brint admitted for the first time at deposition that he had fallen below the generally accepted standard of care, TLC vigorously continued to contest liability, and both defendants challenged every element of Judge Hoch's damage claims. The defendants focused substantial attention on the fact that Judge Hoch had continued a very successful practice as a workers' compensation mediator and was earning more after his LASIK surgery than before.

Following more than three years of litigation involving some of the top LASIK and vision correction experts in the world, and with a lengthy trial scheduled to begin in just weeks, TLC agreed to pay $900,000 to settle the portion of the case directed against it. Trial preparation for the case against Dr. Brint continued until a separate negotiated settlement was reached with Dr. Brint's liability insurance carrier. The amount of the second settlement is confidential.

www.usaeyes-fraud.com/lawsuits/dr.-stephen-brint-sued-by-rand-hoch-for-medical-malpractice.html

The fantasy that Burch calls "The LASIK Report", fully attributed to her, is being distributed to all doctors cited, Burch's employer... 

Contrary to Glenn Hagele's statements that The Lasik Report was "attributable" to Dr. Lauranell Burch,  the document was published anonymously.  John Ciccone presented a clumsily altered version of the document designed to mislead others into showing that Dr. Lauranell Burch authored the document as a representative of a government agency, when in fact the document was published anonymously by a private citizen.

Glenn Hagele previously threatened to publish the social security number of Dr. Lauranell Burch in addition to the social security number of other individuals.  This action follows a pattern of similar behavior in which Glenn Hagele began harassing Paula Cofer at her home and place of employment.

After reviewing the original version of The Lasik Report, ASCRS board members issued the following comments.

In discussing Glenn Hagele's harassment of patients, Dr. Richard Lindstrom provided the following advice to ASCRS' Board of Directors.

I believe this has become a no win tar baby.  When founded by Dan Durrie the charter of this group (CRSQA) seemed reasonable. Now it has deteriorated into a Bagdad (sic), Iraq type scene where there will be no  winners, just all losers. I suggest we stay away. It has become a lose/lose and is now very personalized. Glenn  seems to see himself as a white night crusading for Laski (sic) and his dissatisfied patient enemies wish to destroy the operation entirely.  We cannot win by getting involved. There are not at this time reasonable people on either side.  What you read here is just a paragraph in a thick book of similar accusations and counteraccusations including active litigation.  Sandy Keller is not ASCRS friend, nor at the moment is Glen Hagele. None of this is good for the field or ASCRS.  Stay as far away as you can.

March 2, 2006

VIA UPS OVERNIGHT DELIVERY

Brent Hanson
11 Wickersham Drive
Durham, NC 27713

Re:    Defamation of Glenn Hagele

Dear Mr. Hanson:

Glenn Hagele has retained our law firm in connection with written statements you have published or caused to be published either through public Internet forums, Internet websites you control, email, and/or conventional mail.  Demand is herewith made that you stop publishing the false statements concerning our client and that you take prompt corrective action, absent which we shall have no choice but to seek appropriate legal redress.

You have made written statements of fact, rather than opinion, that appear to violate Mr. Hagele's constitutional rights, place him in a false light, tend to injure and in fact do cause injury to our client's occupation and character, and/or expose him to hatred, contempt, ridicule or shame.  Moreover, we believe your written statements constitute defamation per se - all of which have caused our client substantial injury and interfered with his ability to conduct his business.

Mr. Hagele herewith demands of you the following: 

1. Immediately remove or cause to be removed all publicly accessible Internet newsgroup, bulletin board, or chat room statements about him, his employer, and/or his business associates, which may be decided by the court as defamatory and refrain from publishing or republishing any and all future statements that may be considered defamatory;
    

2. Immediately remove or cause to be removed those portions of all publicly accessible Internet web pages you control that include statements about him, his employer, and/or his business associates, which may be decided by the court as defamatory and refrain from publishing or republishing any and all future statements that may be considered defamatory;
    

3. Immediately privately retract all statements about him, his employer, and/or his business associates that may be decided by the court as defamatory and were distributed via email, conventional mail, or any other private means and refrain from publishing or republishing any and all future statements that may be considered defamatory.

This is your opportunity to resolve this matter without legal expense and exposure to liability and damages.  Mr. Hagele retains his right to all legal means to seek redress of losses caused by your prior acts, however, removal of your statements will mitigate damage already caused.

Accordingly, if the offending written statements are not removed or retracted within 72 hours, further legal action will be taken.

If you have any questions regarding the above referenced matters, please do not hesitate to call us.

Very truly yours,
James A. Clinchard

cc:    Glenn Hagele

Here are Glenn Hagele's threats which he published at the alt.lasik-eyes newsgroup

February 23, 2006

As for who admits to ownership of LasikDisaster.com and when, that will be determined in a different forum. Considering the liabilities there, I'm not surprised that Keller would attempt to distance herself. Who is responsible for the authorship of the defamation at LasikDisaster.com is another matter altogether. Again, that is something for a different forum.

So now we see Keller attempting to absolve herself of all responsibility for the website she created, which puts the consequences squarely on Paula Cofer. Keller, are you saying Cofer is solely responsible for what is on LasikDisaster.com? Did she accept all liability for the website from you? On what date did this momentous event occur, Keller? Did she specifically accept the legal liability for the defamation you created, but she perpetuates? That will be an interesting document to see.

If Keller wants to say only Cofer is making money off of Lasik ads at LasikDisaster.com and only Cofer is responsible for the content at LasikDisaster.com, then that's fine with me. Let's see you point the finger at your accomplic-...er...buddy Cofer.

You could tell us all right here and now. Why wait for the subpoena? You could tell us when (if) you transferred ownership and responsibility of LasikDisaster.com to someone else, who that someone else is, and when the ads started.

Yes, I can litigate and attempt to have the whole thing brought down, and that is in process.

Wrong again, Keller. Investigators in five states have been doing the bulk of the work, but I do what I can. My attorneys are quite energetic, outrageously over-priced (but worth every cent), and "as if" Keller could be intimidated with mere words in a newsgroup. I suspect much more would be required.

The Alcon LADARVision excimer laser does not appear to have any inherent design problems and hundreds of thousands of patients have had satisfactory outcomes. In fact, even those who alledged a problem acknowledged that no patients were harmed.

However, the FDA has described serious problems with the laser involving "Laser not firing", "Translator malfunction", "Loss of tracking", and "Not able to track" as documented in a warning letter to Alcon. 

WARNING LETTER

FLA-05-27

April 15, 2005

Mr. Gary A . Woodrell
Vice President
Refractive Manufacturing Operations
Alcon Laboratories, Inc.
2501 Discovery Drive
Orlando, Florida 32826

Dear Mr. Woodrell :

During an inspection of your establishment located in Orlando, Florida on January 10 - 18, 2005, our Investigator determined that your firm manufactures the LADARVision 4000 Excimer Laser System. An excimer laser is a device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 321(h)].

The above-stated inspection revealed that this device is adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate as required by 21 CFR 820.198(b). (FDA 483, Item #1).

Data downloaded from LADARVision systems currently in use in the U.S. showed significant differences in the retreatment requirements between patients treated prior to 15 minutes after calibration of the device as opposed to patients who were treated after 15 minutes following calibration of the device. Another table was provided that used the points of < 30 minutes from calibration to treatment and > 30 minutes or more from calibration to treatment.

A patient whose surgical procedure is initiated after 30 minutes has a 30% greater risk of retreatment than does the patient whose treatment commences prior to 30 minutes after calibration. Beam drift occurs if too much time passes between calibration and treatment, with possible translation or rotation of the beam.

Your response to this data has been inadequate. There is a note to a warning to the device user manual, which states, "WARNING: System calibration must be done between patients and within 15 minutes of surgery, failure to perform calibration in the time frame indicated may result in improper orientation of the ablation. " However, there was no reason provided to explain the use of these times. Moreover, the note to warning is not by itself sufficient to address the seriousness of this problem . (FDA 483, Item #1)

2. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is necessary as required by 21 CFR 820.198(c). Complaints received from January 1, 2002, through January 10, 2005, revealed the most common complaint codes as follows:

• Class code - 801: Laser not firing,

• Class code T 833: Translator malfunction,

• Class code - 802A: Loss of tracking, and

• Class code - 802B: Not able to track

Complaint records associated with these complaint class codes are not adequately reviewed, evaluated, and investigated to determine the root-cause of the system and/or sub-assembly component malfunction (FDA 483, Item #2).

Specific complaints reviewed during the inspection revealed the following:

a . Complaint Record RS030392 received on April 14, 2003, involving the LADARVision® 4000 Beta, lot number L4B1023S references the laser stopped firing during surgery at 92% complete. The Field Service Engineer (FSE) found arcing in the laser chassis assembly. The FSE adjusted components to prevent future arcing. The complaint record does not document and confirm that an investigation was conducted to determine the root cause of the reported problem. The record also fails to document the justification for not conducting an investigation and is not signed and dated by responsible personnel.

b. Complaint Record RS041106 received on August 23, 2004, involving LADARVision® 4000 Beta, lot number L4B1023S references the laser not firing. An FSE replaced the laser control electronics that failed. The replaced component was evaluated and verified the failure was caused by a broken connector. The record does not document and confirm that an investigation was conducted to determine the root cause of the broken connector. The record also fails to document the justification for not conducting an investigation and is not signed and dated by responsible personnel.

c. Complaint Record RS041047 received on August 11, 2004, involving a refurbished LADARVision® 4000 Beta, lot number L4B1090S referencing noise from the laser with a system failed error message. A similar complaint, RS030392 referenced a malfunctioning translator, which was replaced because of faulty/defective bearings. The complaint was classified as complaint class 823- Noise Coming from system. The complaint was more appropriately determined a translator malfunction, which is complaint class 833. The malfunction causes the laser to stop operating or firing resulting in surgery being terminated, causing under correction, which is not considered by your firm to be an injury.

d. Complaint Record RS030539 received on May 16, 2003, involving LADARVision® 4000 Beta, lot number L4B1022S referencing loss of tracking during surgery. Surgery was stopped at 57% complete. The FSE balanced the infrared pulse and changed the DSP gains. The record does not document an investigation that was conducted to determine the root-cause of the report to conduct an investigation into the reported malfunction.

e. Complaint Record RS031262 received on November 14, 2003, involving LADARVision® 4000 Beta, lot number L4B1022S references a laser unable to track. The FSE confirmed the failure mode and replaced the zoom motor. The Manufacturing Engineer (ME) confirmed that the motor performed erratically when operating under a torque and will not reverse direction when prompted by software. A similar complaint FS030539 (noted above) does not document that an investigation was conducted to determine the root cause for the zoom motor failure or the justification for not conducting an investigation into the malfunction.

3. Failure to promptly review, evaluate, and investigate any complaint that represents an event which must be reported to FDA under 21 CFR part 803 by a designated individual(s) and shall be maintained in a separate portion of the complaint files otherwise clearly identified as required by 21 CFR 820.198(d) and 803..50(b)(2).. (FDA 483, Item #3). Complaint .Record RS041447 received on November 5, 2004, (MDR 1061857-2004-00011) involving the LADARVision® 4000, lot number L4N1636S referenced the report of a poor clinical outcome. The primary custom-cornea, lasik procedure conducted on June 4, 2004, resulted in a two line loss of Best Corrected Visual Acuity (BCVA), 20/20 at pre-op and 20/30 at the four month post-op visit. A retreatment was conducted on October 29, 2004, resulting in an additional one line loss of BCVA, which was 20/30 at four months after post-op and 20/40 at one week after the retreatment post-op visit. No review, evaluation, and investigation were conducted of the primary custom-cornea lasik procedure on June 4, 2004. The retreatment procedure was reviewed, evaluated, and investigated, which is not covered under the system's labeling including the collection of data such as Operative Summary, LadarWave printouts, and Operative Reports. The complaint was closed December 13, 2004. No review, evaluation or investigation was conducted of the primary custom-cornea, lasik procedure which occurred on June 4, 2004.

4. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product as required by 21 CFR 820.90(b)(1). (FDA 483, Item #4). Your own procedures, specifically, SOP 7501-00.38, Field Returns, and SOP 7003-0909, Evaluation of Non-Conforming Parts Returned from Field Service, are not followed:

a. Complaint Record RS040448 - Per the referenced SOPs all parts replaced in the field are to be returned for evaluation. An evaluation of malfunctioning translators was not conducted as required and the service activity was considered routine maintenance instead of being assessed as a complaint.

b. Complaint Record RS040031 - Per the referenced SOPs gas filters were not returned for evaluation and an evaluation was not performed. This report was evaluated by Product Safety (PS) and classified as a "Malfunction". Personnel experienced headache, dry tight throat, and nausea resulting in an emergency room (ER) visit.

c. Complaint Record RS031155 - A FSE found a lead washer was unevenly crimped, which he replaced. The part was not returned and an evaluation was not performed. A MDR was evaluated by your PS team and classified as "Other" without explanation. Personnel experienced vomiting and nausea resulting in an ER visit.

The above-stated inspection also revealed that your device is misbranded under section 502(t)(2) of the Act, in that your firm failed or refused to furnish any material or information required by or under section 519 respecting the device. Specifically, your firm failed to report within 30 days whenever the manufacturer receives or otherwise becomes aware of information, from any sources, that reasonably suggests that a device marketed by the manufacturer has caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

The following complaints referencing serious injuries where not submitted within 30 days to FDA as required:

a. Complaint Record RS041329
b. Complaint Record RS030632

Your firm also failed to investigate adverse event reports and to evaluate the cause of the reported event as required by 21 CFR 803.50(b)(2). The following adverse event reports have not been adequately investigated as required:

a. Complaint Record RS030392
b. Complaint Record RS041106
c. Complaint Record RS041047
d. Complaint Record RS031262
e. Complaint Record RS030355
f.. Complaint Record RS031146
g. Complaint Record RS030632
h. Complaint Record RS031257

This letter is not intended to be an all-inclusive list of violations at your facility. It is your 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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

We have reviewed your response, dated February 3, 2005. We acknowledge that you have proposed to improve your complaint handling procedure. We would appreciate receiving the periodic reports that you have promised. Nevertheless, your response to the violations discussed above is inadequate because our review of the data shows that reviews, evaluations, and corrective actions were not fully assessed. Also your own procedures were not followed and misinterpretations were made as to the status of complaints that were reported and the conclusions that were drawn, which affected the corrective actions that were required. You should address each and every observation when responding to this letter. Your response has been made part of the Florida District file.

Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.

Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.

Sincerely,

/S/

Emma R . Singleton
Director, Florida District

Ron Link founded Surgical Eyes in the late 1990's, ostensibly to help patients of failed refractive surgeries.  Surgical Eyes ceased to exist in October 2004 after the entire board resigned under pressure from Ron Link.  The Surgical Eyes bulletin board is now owned by the Vision Surgery Rehab Network, which is managed by Dr. David Hartzok and Barbara Berney.

Examples of Ron Link's postings:  1 2 3 4 5 6 7 8 9

Board member Andrew Robbins says Dr. Vikas Jain of Newark became a "predator," repeatedly mistreating patients.  Robbins says Jain's misdeeds included removing a cataract from a woman's blind eye, operating on patients who shouldn't have received LASIK including one who could see just fine, and using his operating equipment on the wrong settings.

The state will inform the national Federation of State of Medical Boards of its action, in hopes of preventing Jain from going elsewhere to practice.

Jain did not appear at Wednesday's hearing.  He can appeal to the Franklin County Common Pleas Court.

Source:  www.ohionewsnow.com/global/story.asp?s=4100431&ClientType=Printable

From: "Matt Ryan" <mryan@ceatus.com>
To: <mvanasek@kremer-laser.com>
Sent: Thursday, November 03, 2005 4:23 PM
Attach: ceatus_invoice_1187_Kremer.doc
Subject: Mary Guccione - AllAboutVision

Ceatus Marketing Inc. Invoice Number: 1187

We thank you for your business.

Ceatus Marketing Inc.
7580 Fay Ave., Suite 305
La Jolla, CA 92037
Phone: 858 454 5505
FAX: 858 454 5668

A lawyer's medical malpractice suit against a doctor who performs LASIK vision correction surgery was postponed yesterday after the plaintiff successfully argued that the defense improperly struck black jurors from the panel.

Represented by his law partner Jay D. Miller, George Psoras Jr. alleges he went blind in one eye after undergoing LASIK. Miller said the case against Dr. Anthony Kameen will be one of the first LASIK cases to go to trial in Maryland.

But it will have to wait. After jury selection produced an all-white panel, Miller challenged the process based on the Supreme Court's 1986 decision in Batson v. Kentucky, pointing out that the plaintiff's only expert witness is black.

After conferring with some of his colleagues, Baltimore County Circuit Court Judge Thomas J. Bollinger Sr. agreed to dismiss the jury and start over another day.  Defense attorney Neal Brown initially offered to swap a black alternate juror for the white foreman, but withdrew the offer after a brief recess.

No new trial date has been set.

Source:  www.mddailyrecord.com/pub/5_401_law/legalnews/172967-1.html

CHICAGO, Oct. 14 /PRNewswire/ -- Nearly 1 in 3 Americans have complained of under or over correction in one or both eyes, loss of quality of vision, vision fluctuations and poor vision in dark conditions, after undergoing Lasik surgery.

The survey conducted by Synovate and commissioned by NeuroVision Pte Ltd, also found that of all Americans who experience these conditions, those in the South and the mid-West, like Chicago, are more likely to have a second Lasik operation, compared with other regions.

"As Lasik is an invasive surgery performed on a very delicate part of the eye, potential problems may arise as a result of the operation," said Prof. Donald Tan, Director, Singapore Eye Research Institute, Deputy Director Singapore National Eye Centre. "Lasik has been an invaluable tool in vision correction, reducing refraction in patients by a significant percentage but it is not without its drawbacks."

1 in 3 respondents who encountered post-Lasik problems still wear their glasses or contacts and 1 in 7 of all respondents underwent a second Lasik operation. 

"In the past, there were few options to rectify unsatisfactory Lasik results. But now with the revolutionary NeuroVision treatment, patients can attain the sharp, crisp vision they desire," said Alain Leneveu, CEO, NeuroVision Pte. Ltd. "NeuroVision understands the intricacies of Lasik and is a complementary treatment to the surgery."

According to the survey, women are nearly three times more likely than men to undergo Lasik but men were more likely to complain and are twice as likely to be disappointed with their Lasik results complaining of over or under correction and poor night vision. 

"New data from NeuroVision, collated from over 300 international patients, has shown that post-Lasik patients, who have undergone NeuroVision, experienced a 2.6 lines improvement on the EDTRS chart and had a significant 100% enhancement in contrast sensitivity, moving their vision from the abnormal range to normal," said Prof. Donald Tan. "In total, 42% of both post-Lasik and low myopia patients improved by three lines or more on the EDTRS chart, with very minimal refraction changes."

NeuroVision is based on twenty years of scientific and clinical research, and is the world's first no surgery, no medication, no risk, vision treatment for low myopia, amblyopia and post-Lasik. 

The complete article is available at http://biz.yahoo.com/prnews/051014/nyf106.html?.v=11

]]> 2005-10-01T17:47:54Z 2005-10-01T12:47:54-06:00 tag:www.lasikfraud.com,2005:/news//1.137 2005-10-01T17:47:54Z

As anyone who reads this blog knows, I am fascinated by the doctor/patient relationship. I have blogged on this subject often, and I have pocast interviews with thoughtful experts on this subject like Carl E. Schneider.

Today brought more evidence that neither doctors nor patients are all that thrilled by the state of the doctor/patient relationship. Techdirt in "Doctors Furious That People Might Criticize Them Online" (http://techdirt.com/articles/20050914/1318205_F.shtml) looks at doctors from the point of view of a veteran of the World Wide Web.

He notes that we physicians are well known late adopters. "Perhaps that's why they've just recently gotten around to discovering that on this world wide web we've all been using, it's possible for people to post their opinions -- including opinions about the treatment they received from doctors." He then notes that some doctors have been suing their patients who post critical comments on the Internet. "These doctors get written up in the Wall Street Journal as trying to hide the complaints, rather than respond to them." He then references the Streisand Effect which refers to the actress's lawsuit trying to remove a picture of her house from the 12,000 photos available on the Internet that documented the entire California coast. By calling attention to her house with her legal action, she made the photo of her house an Internet Hit.

Complete article is available at:  www.soundpractice.net/article.cfm?id=201

Dr. Nicholas Caro has filed a lawsuit seeking $2,000,000 in damages from Dean Kantis, after previously performing LASIK on him.  Dr. Caro alleges in his lawsuit that Dean Kantis "has engaged in an ongoing process of telephoning, mailing, facsimile transmitting, e-mails and related written communications, to various governmental bodies and/or individuals, including, but not limited to:  (a) Better Business Bureau of Chicago (b) Brett (sic) Hanson."

Dr. Caro is represented by Eric Phillip Ferleger an attorney whose license was suspended in 2004:  www.state.il.us/court/SupremeCourt/Announce/2004/Pdf/Ann1117.pdf  According to a ruling by the Supreme Court of Illinois, Eric Ferleger suffers from a "cannibis dependence" and is being treated for "personality disorder".

        Defendant, DEAN ANDREW KANTIS, by and his attorneys, LINDSAY and RAPPAPORT, L.L.C, and pursuant to Section 2-615 of the Illinois Code of Civil Procedure, hereby moves this Honorable Court to strike and dismiss Plaintiffs ST. GEORGE CORRECTIVE VISION and NICHOLAS C. CARO’s complaint for being substantially insufficient in law. In support thereof, Defendant states as follows:

        1. Plaintiffs have filed a two count complaint, which they title, "COMPLAINT FOR SLANDER AND LIBEL" against Kantis. A copy of the complaint is attached hereto as Exhibit A. The complaint is a bit confusing on its face as it does not have a count for slander, but does have a count for libel, which is Count I. As the complaint only alleges certain written communications, and does not allege any oral communications, we can consider Count I to be for libel only. See Whitby v. Associates Discount Corp. 59 Ill. App. 2d 337, 340 (1965) (Defamation in the form of written communication is libel while an oral defamation is slander).

        2. The Second Count of the Complaint purports to allege a claim for Abuse of Process, even though no process has been wrongfully issued. We will discuss each count separately.

        3. The gist of the complaint is that Kantis, a patient of Dr. Caro's and St. George Corrective Vision, published the following statements:

• "Dr. Caro messed up seven years ago."
• "He lied to me and told me that it’s my eyes and that it would take up to seven years for them to fully heal."
• "…he won’t return phone calls, won’t return my money and is threatening my family that he will bury me in lawsuits for wasting his time…"

(Complaint, par. 10)

        4. As will be demonstrated below, these statements can not support a cause of action for libel, given Illinois' strict requirements for such a cause of action. Moreover, the context of the statements indicates that certain privileges attach. Finally, the claim of abuse of process is wholly insufficient.

        5. There are two distinct reasons why Count I of the Plaintiffs’ Complaint should be dismissed under Illinois law. First, the statements are essentially in the form of an opinion, and are simply not defamatory. Next, the statements were made in the context of a quasi-judicial capacity, and are thus privileged.

        6. There is a well developed body of case law in Illinois as to what it takes before words can be considered defamatory. For words to be considered defamatory per se, they must do the following:

(1) impute the commission of a criminal offense;

(2) impute infection with a loathsome communicable disease;

(3) impute inability to perform or want of integrity in the discharge of duties of office or employment; or

(4) prejudice a party, or impute lack of ability, in his trade, profession or business. (Costello v. Capital Cities Communications, Inc., 125 Ill. 2d 402, 414 (1988); Fried v. Jackson, 99 Ill. 2d 24, 27 (1983); Moore v. Streit, 181 Ill. App. 3d. 587, 597 (1989).

        Additionally, to be considered defamatory per se, the statement(s) in question must be so naturally harmful to the person to whom it refers to that a showing of special damages is unnecessary. Anderson v. Vanden, 172 Ill.2d 399, 411-12 (1996).

        7. Even if the statement fits within one of the categories that will sustain a per se action, recovery will not be allowed if the statement can reasonably be given an innocent construction. The innocent construction rule, provides that a written or oral statement is to be considered in context, with the words and the implications therefrom given their natural and obvious meaning; if, as so construed, the statement may reasonably be innocently interpreted or reasonably be interpreted as referring to someone other than the plaintiff it cannot be actionable per se. Troman v. Wood, 62 Ill. 2d 184, 189 (1975). This preliminary determination is properly a question of law to be resolved by the court in the first instance; whether the publication was in fact understood to be defamatory or to refer to the plaintiff is a question for the jury should the initial determination be resolved in favor of the plaintiff. Id. The Illinois Supreme Court has explained that the non-defamatory interpretation must be adopted if it is reasonable even if there are other reasonable interpretations that are defamatory. Mittelman v. Witous, 135 Ill.2d 220, 234 (1989).

        8. Even more importantly, the law is quite clear that expressions of opinion are non-actionable as protected forms of speech under the first amendment no matter how vigorously the opinion is expressed. Gertz v. Robert Welch, Inc., 418 U.S. 323 (1974); Owen v. Carr, 113 Ill. 2d. 273 (1974).

        9. The distinction between fact and opinion is a matter of law. A written or oral statement is to be considered in factual context, with the words and the implications therefrom given their natural and obvious meaning. To determine whether a statement is fact or opinion, a court must evaluate the totality of the circumstances and should consider whether the statement is capable of objective verification as true or false. Piersall v. Sportsvision of Chicago, 230 Ill. App. 3d 503, 510 (1992).

        10. While in one sense all opinions imply facts, the question of whether a statement of opinion is actionable as defamation is one of degree; the vaguer and more generalized the opinion, the more likely the opinion is non-actionable as a matter of law…The emphasis in the test for determining the actionability of an allegedly defamatory statement of opinion is on whether the statement contains an objectively verifiable assertion. Wynne v. Loyola University of University of Chicago, 318 Ill. App. 3d 443, 452 (2000) citing Hopewell v. Vitullo, 299 Ill. App. 3d 519 (1998).

        11. Illinois courts have consistently found non-actionable words which are rhetorical hyperbole or used only in a loose, figurative sense, such as those at issue in our case. See Haberstroh v. Crain Publications, Inc., 189 Ill. App. 3d 267 (1^st Dist. 1989) and cases cited therein. As the Haberstroh court explained, words that are merely found to be name calling have also been held as non-actionable. Id. The mere fact that language is abusive does not make it defamatory per se either. Id. Moreover, expressions of opinion touching on an individual’s capabilities or qualifications does not constitute defamation "no matter how much the complained of statement may injure the subject person in his own conception." Zaret v. Joliet Park District, 91 Ill. App. 3d 225, 227 (1980) citing Byars v. Kolodziej, 48 Ill. App. 3d 1015, 1016-17 (1977).

        12. Applying these principles to the statements at issue in our case easily leads to the conclusion that these statements are simply not actionable. For purposes of analysis, we will discuss the statements one at a time.

        13. "Dr. Caro messed up seven years ago." Under the innocent construction rule, this statement is not defamatory because there are simply an infinite number of reasonable interpretations for this statement other than the Dr. Caro lacks ability in his trade. The usage of "messed up" gives absolutely no clarity or definitiveness as to what is being communicated. The term "messed up" is loose and in a figurative sense, and is thus non-actionable rhetorical hyperbole.

        14. "Messed up," is also an opinion, rather than a factual assertion. Similar statements, such as the plaintiff is "lazy" and "incompetent" were held to be opinions rather than assertions in Doherty v Kahn, 289 Ill. App. 3d 544 (1^st Dist. 1997). See also Hopewell v. Vitullo, 299 Ill. App. 3d 513 (1^st Dist. 1998) ("fired because of incompetence" considered non-actionable opinion").

        15. "He lied to me and told me that it’s my eyes and that it would take up to seven years for them to fully heal." This statement is likewise non-actionable. In Piersall v. Sportsvision of Chicago, 230 Ill. App. 3d 503, 510 (1^st Dist. 1992), the court considered an almost identical statement, and held that the utterance "he's a liar" was non actionable opinion.

        16. "…he won’t return phone calls, won’t return my money and is threatening my family that he will bury me in lawsuits for wasting his time…" One struggles to find any kind of theory under which this statement could be defamatory. The statement fails to (1) impute the commission of a criminal offense; (2) impute infection with a loathsome communicable disease; (3) impute inability to perform or want of integrity in the discharge of duties of office or employment; or (4) prejudice a party, or impute lack of ability, in his trade, profession or business. Moreover, following the innocent construction rule, this statement is not defamatory because there are simply an infinite number of reasonable interpretations for this statement other than the Dr. Caro lacks ability in his trade.

        17. Given the Illinois' courts' stringent requirements to find statements defamatory, the statements attributed to Kantis simply do not pass muster. Illinois courts do not allow defamation cases to proceed where all that the defendant stated is that the plaintiff "messed up" and "lies." These are statements of opinion, and are not defamatory per se. Plaintiffs' complaint should be dismissed on this ground alone.

        18. Statements that are made in a quasi-judicial capacity are privileged in the state of Illinois. Within the judicial context, the absolute privilege covers formal pleadings, in-court communications and "any communication pertinent to pending litigation." McCutcheon v. Moran, 99 Ill. App. 3d 421, 425 (1981). In addition, absolute privilege extends to proceedings by administrative agencies which act in a judicial or quasi-judicial capacity. Id. at 425. (Emphasis added) In McCutcheon it was determined that absolute privilege protected statements made about the plaintiff-school principal by the defendant-school janitor to the trial committee of the Board of Education and to members of the State's Attorney's office; see also Adco Services v. Bullard, 256 Ill. App. 3d. 655, 659 (1993) and cases cited therein (absolute privilege attached to two letters authored by the defendant-former employee and sent to two quasi-judicial agencies concerning the plaintiff-company's radioactive waste program).

        19. In the context of such proceedings, the "absolute privilege embraces actions required or permitted by law in the course of judicial or quasi-judicial proceedings as well as actions necessarily preliminary to judicial or quasi-judicial proceedings." Parillo, Weiss & Moss v. Cashion, 181 Ill. App. 3d. 920, 928. (absolute privilege applied to an unsolicited letter which requested the initiation of an investigation of an insurance company and which was sent by the individual defendant to the director of the Illinois Department of Insurance. )

        20. In the present case, plaintiffs allege in Count I of their complaint that the defamatory statements that the defendant made were in a letter to the Better Business Bureau. The Better Business Bureau is a governing agency whose mission is as follows:

"Is to promote and foster the highest ethical relationship between businesses and the public through voluntary self-regulation, consumer and business education, and service excellence." (www.chicago.bbb.org)

        21. As explained by the court in Audition Division v. Better Business Bureau, 120 Ill. App. 3d 254 (1^st Dist. 1983), the Better Business Bureau (BBB) is a not-for-profit corporation which, according to its policy manual, "promotes truth in advertising and selling; maintains an impartial attitude towards firms and individuals; and is dedicated to the building and preservation of public confidence in legitimate business." Although the Better Business Bureau is not a judicial court, one of their prime functions is to work with consumers and businesses to resolve complaints. Their website indicates that it is easy for a customer to file a complaint, the BBB will conduct an investigation, facilitate resolution, report any misconduct to the appropriate governmental agency if warranted, and in essence, try to resolve the complaint.

        22. The same policy reasons supporting the privilege in proceedings involving administrative agencies such as the Department of Insurance, school boards, judicial inquiry board, and other agencies, supports applying the privilege to the Better Business Bureau. In order for the Bureau to work, citizens must have absolute freedom to approach the Bureau, free of the fear of legal action against them. The public would be adversely affected if statements to the Bureau could be the basis of lawsuits. The Bureau's function would be greatly hampered.

        23. While not pled in Count I, plaintiffs also complain that the above statements were communicated to the Illinois Department of "Registration and Education" (sic) - presumably the Illinois Department of Financial and Professional Regulation, the state administrative agency which is responsible for, among other things, overseeing the regulation and licensure of the various licensed professions. See generally 20 ILCS 2105/2105 et. seq., and 2105-15 empowering the Department to conduct hearings on proceedings involving professional licenses. For the same reasons involving other agencies, discussed above, the privilege should attach to communications made to the Illinois Department of Financial and Professional Regulation.

        24. Plaintiffs' claim for the tort of "abuse of process" is wholly inadequate. This is a very strictly defined, and disfavored, tort. The requisite elements of an action for abuse of process are: (1) the existence of an ulterior purpose or motive, and (2) some act in the use of the legal process which is not proper in the regular prosecution of the proceedings. Holiday Magic, Inc. v. Scott, 4 Ill. App. 3d 962, 966 (1972), appeal denied 52 Ill. 2d 594 (1972).

        25. In the plaintiffs’ complaint they fail to identify any process abused by the defendant. This is entirely insufficient. As the Holiday court explained, "[t]he mere institution of proceedings does not in and of itself constitute abuse of process. Some act must be alleged whereby there has been a misuse or perversion of the process of the court. It is the settled law of Illinois that mere institution of a suit or proceeding, even with a malicious intent or motive, does not itself constitute an abuse of process." Id. (Emphasis added)

        26. Because the tort of abuse of process is not favored under Illinois law, the elements must be strictly construed. Id. In order to satisfy the first element, a plaintiff must plead facts that show that the defendant instituted proceedings against him for an improper purpose, such as extortion, intimidation, or embarrassment. However, the mere institution of a suit for an improper purpose does not itself constitute an abuse of process, the second element being the gravamen of the offense. In order to satisfy the second element, the plaintiff must plead facts that show a misapplication of process, or, in other words, the plaintiff must show that the process was used to accomplish some result that is beyond the purview of the process. When process is used only for its intended purpose, there has been no misapplication of process.  Neurosurgery & Spine Surgery, S.C. v. Goldman, 339 Ill. App. 3d 177, 183 (2003).

        27. "Process" is defined as any means used by the court to acquire or to exercise its jurisdiction over a person or over specific property. In Neurosurgery, it was determined that the issuance of a summons can be categorized as process. However, the second element of abuse of process--misapplication of process was not satisfied by pleading that there has been process. A party must plead that there has been a misapplication of that process. The court in Neurosurgery explained that a summons is issued in just about every case in which a lawsuit is filed, and that the intended purpose of a summons is to establish a court's in personal jurisdiction over a person. This in and of itself is neither irregular nor improper. Rather, the tort of abuse of process requires some misapplication of process, which is found only in cases in which a plaintiff has suffered an actual arrest or seizure of property. Id.

        28. Plaintiffs here allege no misapplication of any process. They allege no arrest or seizure of any property, or nothing abusive about any form of process. Just as a lawsuit requires a summons, a complaint to the Illinois Department of Financial and Professional Regulation requires some sort of written document - yet nothing in the Complaint gives rise to any theory that "process" has been "abused." Plaintiffs fail to allege how Kantis abused any process, and this Count should therefore be dismissed.

        29. Plaintiffs' Complaint fails to state a claim upon which relief can be granted. For the reasons stated, Defendant Kantis requests that the Complaint be stricken and dismissed.

        WHEREFORE, Defendant, DEAN ANDREW KANTIS, prays for entry of an order striking and dismissing Plaintiffs' complaint.

_________________________________
Attorneys for Defendant

Stuart N. Rappaport
Luke A. Weiland
Lindsay & Rappaport, LLC. (Firm #40877)
221 N. West Street
Waukegan, IL 60085
847 244-4140
847 244-4203 (fax)

IT IS ORDERED THAT, ON COUNT III OF THE COMPLAINT, THE AGREEMENT WHICH WAS ENTERED INTO BY DEFT, MORGAN AND PLTFS ON OR ABOUT THE PERIOD 7/30/03 THROUGH 8/4/03 IS ENFORCED AND DEFT, MORGAN WILL NOT MENTION DR NEVYAS OR HIS PRACTICE OR ANYTHING CONCERNING PAST ITEMS FROM DR NEVYAS OR HIS PRACTICE IN DEFT'S WEBSITE. DEFT, MORGAN IS ORDERED TO OPERATE HIS WEBSITE AND ANY WEBSITE IN ACCORDANCE WITH THE 8/4/03 AGREEMENT. THE DEFAMATION ACTION BY DR NEVYAS AGAINST MR MORGAN IS DISMISSED AS AGREED TO IN THE 7/30/03 THROUGH 8/4/03 AGREEMENT. BY THE COURT ...MAIER,J 9/29/05

http://fjdweb2.phila.gov/fjd/zk_fjd_public_qry_03.zp_dktrpt_frames?case_id=031100946

The original web site contained incriminating documents that showed Dr. Herbert Nevyas and Dr. Anita Nevyas mislead the FDA and the public about their use of homegrown "black box" lasers used in LASIK eye surgery.  The Refractive Surgery News administrator has archived the web site on to a CD-ROM, and is in the process extracting documents from the CD-ROM and publishing them.  To obtain the documents as they are published, click here.

Are Dr. Herbert Nevyas and Dr. Anita Nevyas "respectable" surgeons?

One might be tempted to conclude that the duo from Pennsylvania and New Jersey are respected authorities in the field of ophthalmology, as Dr. Stephen Barrett has republished their articles at QuackWatch.com:

• www.quackwatch.org/03HealthPromotion/rk.html
• www.quackwatch.org/04ConsumerEducation/glaucomadrops.html

However, when one realizes that Dr. Stephen Barrett is the uncle of Dr. Anita Nevyas and the brother-in-law Dr. Herbert Nevyas, one must wonder if the quack "watcher" only has to look across the dining room table to find two "quacks".

Attn: Investigator Joe Annerino
(Medical Enforcement)
Illinios Department of Professional Regulation
James R. Thompson Center
100 West Randolph, Suite#9-300
Chicago, Illinios 60601
w: 312-814-4526
F: 312-814-3145

Thank you for your reply to my initial complaint #200504961 against St. George Corrective Vision Center/Dr. Nick Caro:

I do hope that this complaint issued by me is fully scrutinized. I also feel that if the attention to detail is given, many other findings will be revealed about this practicing doctor, and maybe those findings will eventually lead to a "suspended medical license or even termination" for due cause.

Enclosed, please find the following information regarding this case:

1: Personal Story by Dean Andrew Kantis.
2: Very informative websites regarding Lasik and Post Lasik disasters.
3: Filed BBB complaint, Attorney General Complaint, and IDFPR complaints.
4: Dr. Caro’s website info, notes pre/post surgery Aug. 24/25th 1999.
5: Dr. Edward Boshnick & Dr. Ken Maller (call them to determine malpractice and they will verify that Dr. Caro did indeed do a poor job).
6: Dr. Pannu/Pannu Laser Institute is the Dr. that Dr. Caro had me follow up with Post Lasik for the first 3 years.
7: FDA’s website article about seizing Dr. Caro’s "illegal laser."
8: Chicago, IL law on "medical malpractice."
9: Copy of the "checklist" that the FDA requires "prior" to Lasik.
10: Contact Page for the Chicago, IL "clerk of court" on the 60+ lawsuits.

Best Regards,
Dean Andrew Kantis

Anthony Lin
New York Law Journal

A Manhattan jury has awarded a former investment banker $7.25 million in damages for vision impairment he claimed resulted from LASIK eye surgery.

The award -- $4.5 million in lost income and $2.75 million in pain and suffering -- is the largest to date in a suit over the popular vision correction surgery. It is against one of New York's leading LASIK practitioners as well as the corporation that has become the nation's largest provider of LASIK surgery.

Mark Schiffer had LASIK surgery on Oct. 6, 2000, a week after he first visited an optometrist affiliated with the TLC Laser Eye Center, which operates LASIK surgery centers with affiliated doctors nationwide.

The surgery was performed by Dr. Mark Speaker, then-medical director of TLC, who also has his own practice. One of the most well-known LASIK surgeons in New York, Speaker has performed thousands of procedures and has been a frequent media commentator on the practice.

In his suit, Schiffer, 32, claimed he suffered distorted and blurred vision, particularly in his left eye, because the TLC-affiliated doctors failed to determine that he had keratoconus, a degenerative corneal condition that made the laser surgery unsafe.

A graduate of Yale University and the Wharton School of Finance then working at the Dresdner Kleinwort Wasserstein investment banking firm, Schiffer claimed his vision impairment forced him to leave his highly paid Wall Street career and take a job with his father's Long Island banking security company.

In a trial before state Supreme Court Justice Alice Schlesinger, Schiffer's lawyer, Chappaqua personal injury specialist Todd Krouner, argued that the failure to diagnose keratoconus was a result of TLC's high-volume practice, which he called the "McDonalds of LASIK surgery."

He said TLC had placed Schiffer on a "conveyor belt" of LASIK patients, noting that Speaker performed procedures on 10 other patients the same day he operated on Schiffer. In the rush, Krouner argued, the TLC doctors ignored signs that Schiffer was not a proper candidate for LASIK.

Lawyers for TLC and Speaker took issue with Schiffer's claim of keratoconus and argued that all tests and medical records at the time showed Schiffer had a healthy cornea. They also took issue with the severity of his impairment, noting that he drove himself to the trial.

The defense attorneys attacked in particular Schiffer's claims for damages based on future earnings as an investment banker. They argued there were indications Schiffer had other reasons besides poor vision for leaving Wall Street and called his request for $35 million in damages "obscene."

Although well below $35 million, the jury's award is considerably higher than the $4 million verdict that had previously been the largest reported in a LASIK personal injury suit. That Arizona case involved a former United Airlines pilot who claimed the surgery ruined his night vision and made him unable to fly.

Speaker was represented by Peter Kopff of Kopff, Nardelli & Dopf. TLC was represented by Ralph Catalano of Catalano, Gallardo & Petropoulos. Neither lawyer could be reached about whether their clients planned to appeal.

http://www.law.com/jsp/article.jsp?id=1122627916703

SECOND AMENDED PETITION

COUNT I

        COMES NOW plaintiff and for Count I of her cause of action against defendants, and each of them, alleges and states as follows:

        1.    The cause of action stated in this Petition accrued in Taney County, Missouri.

        2.    At all times mentioned herein, defendant Tri-Lakes Medical and Surgical Eye Clinic, Inc., d/b/a Tri-Lakes Eye Center (hereinafter referred to as "Tri-Lakes Eye Center") was a corporation organized and existing under the laws of the state of Missouri with its principal office and place of business in Taney County, Missouri. It does business under the name Tri-Lakes Eye Center. The name and address of its registered agent is Tom V. Morrison, M.D., 101 Skaggs Road, Suite 201, Branson, Missouri 65616.

        3.    At all times mentioned herein, defendant Laser Vision Centers, Inc. (hereinafter referred to as "Laser Vision") was a corporation organized and existing under the laws of the state of Delaware with its principal office and place of business in St. Louis, Missouri. The name and address of its registered agent is Robert W. May, 540 Maryville Center Drive, Suite 200, St. Louis, Missouri 63141.

        4.    The defendant VISX, Incorporated (hereinafter referred to as "VISX") is a corporation doing business and capable of suing and being sued in the state of Missouri. The name and address of the registered agent of said corporation is the corporation company, 120 S. Central, Clayton, Missouri 63105. In the preceding pleadings, said defendant was designated as VISX, Inc..

        5.    Defendant Tom V. Morrison, M.D. (hereinafter referred to as "Morrison"), at all times mentioned herein, was a licensed physician specializing in ophthalmology, who held himself out as being able to perform LASIK eye surgery.

        6.    At all times mentioned in this Petition, defendant Morrison was the agent, servant and employee of (1) defendant Tri-Lakes Eye Center, and/or (2) the joint venture described in this Petition, and was acting within the course and scope of each those agencies.

        7.    At all times mentioned in this Petition, defendants Tri-Lakes Eye Center and Laser Vision Centers, Inc. were engaged in a joint venture to provide LASIK services to the public. Defendant Laser Vision Centers, Inc. would provide the machine and laser used to do the surgery, a technician and marketing, as well as some support staff, and Tri-Lakes Eye Center would provide the physician, some equipment, other support staff, and facilities to conduct the surgery. The fees would be shared according to a specific agreement. Therefore, any negligence of defendant Laser Vision Centers, Inc., as described in this Petition is imputed to defendant Tri-Lakes Eye Center, and any negligence of defendant Tri-Lakes Eye Center or Morrison as described in this Second Amended Petition is imputed to defendant Laser Vision Centers, Inc..

        8.    At all times mentioned herein, defendant Laser Vision Centers, Inc. was engaged in the business of furnishing, calibrating and maintaining the machine and computer used during plaintiff’s surgery.

        9.    At all times mentioned in this Petition, defendant VISX was engaged in the business of designing, manufacturing, selling, renting, leasing, maintaining, furnishing, and servicing the type of equipment used during plaintiff’s surgery.

        10.    On or about October 28, 2002, defendant Morrison performed LASIK surgery on both eyes of plaintiff at defendant Tri-Lakes Eye Center using the machine and computer furnished, maintained , and calibrated by Laser Vision Centers, Inc.. This machine and computer were designed, manufactured, sold, rented or leased, maintained, and serviced by defendant VISX.

        11.    The LASIK surgery was first performed on plaintiff’s right eye. While approximately midway through performing the LASIK surgery procedure on the left eye, defendant Morrison and Tri-Lakes discontinued the procedure. The laser stopped prematurely and/or the fluence became out of range causing an asymmetric treatment, furrow or trough in the stroma and/or more ablation to be received in a portion of the left eye of plaintiff when the surgery was being performed, causing damage to her eye.

        12.    Such stopping and/or malfunction does not occur without negligence on the part of the person or entity manufacturing, designing, using, calibrating, maintaining, servicing, or operating the machine. The machine was under the control of defendants, and each of them, at the time of plaintiff’s injury.

        13.    As a result of the negligence of defendants, and each of them, plaintiff’s left eye sustained damage. The vision in plaintiff’s left eye is blurring and causes her to see double or triple and causes lights to spray out. Plaintiff also suffers from pain in her left eye and headaches. The quality and correctness of plaintiff’s vision in her left eye has decreased. Plaintiff has double vision and cannot see well at night, and requires more light for vision on the left eye. She has been rendered nervous and has suffered pain and anxiety of body and mind and has experienced emotional upset and personality changes. She has suffered all of the above injuries, pain and damages since the date of the incident and suffers them at the present time, and will suffer them in the future, said injuries, pain and damages being permanent, disabling and progressive.

        14.    Prior to the aforesaid injuries, plaintiff Cheryl Atchison was an able bodied woman capable of doing and performing work and labor. As a direct and proximate result of her injuries, she has, and in the future, will suffer loss of wages, earnings, salaries, and profits; and she has, and in the future, will suffer an impaired and diminished capacity for work, labor and pleasure.

        15.    By reason of her injuries, plaintiff Cheryl Atchison has paid or become obligated for, and in the future will pay or become obligated for, items of expense in obtaining and receiving medical care and treatment.

        16.    As a direct result of the negligence of defendants, and each of them, plaintiff Cheryl Atchison has been damaged and is entitled to such damages as are fair and reasonable.

        WHEREFORE, plaintiff Cheryl Atchison prays damages against defendants, and each of them, on this Petition, for such damages as are fair and reasonable, and for her costs herein expended.

COUNT II

        COMES NOW plaintiff and for Count II of her cause of action against defendant VISX, Incorporated (referred to as "VISX"), alleges and states as follows:

        17.    Realleges and restates all of paragraphs 1, thru 11 of Count I of this Petition and incorporates each of said paragraphs herein by reference.

        18.    At all times mentioned in this petition, defendant VISX engaged in the business of designing, manufacturing, selling, leasing or furnishing LASIK machine for the performance of LASIK surgery.

        19.    Defendant VISX manufactured, designed, and/or sold, leased, rented or furnished a machine and computer to perform LASIK surgery (hereafter referred to as "LASIK equipment"). It sold the machine and computer, or leased or rented it to defendant Laser Vision knowing that it would be utilized in performing surgery on the public, including plaintiff.

        20.    The LASIK’s equipment was defective, and therefore, unreasonably dangerous, when put to a use reasonably anticipated, in that it stopped prematurely and/or allowed the fluence to become out of range and/or caused an asymmetric treatment or a furrow or trough in the stroma and/or caused more ablation to be received in a portion of the left eye of plaintiff when the surgery was being performed. The said defective and dangerous condition existed when the LASIK equipment was manufactured, sold, and/or rented, leased, or furnished by defendant VISX, and used by defendant Laser Vision Centers, Inc., and/or Tri-Lakes Eye Center.

        21.    At the time of the incident described in this petition, the LASIK equipment was:

1. Being used in a manner reasonably anticipated;
2. In substantially the same condition as when manufactured, sold, rented, and/or leased or furnished by defendant VISX.

        22.    As a direct and proximate result of the defective and unreasonably dangerous condition of the LASIK equipment when the LASIK equipment was sold, rented, and/or leased, or furnished by VISX, plaintiff’s left eye sustained damage. The vision in plaintiff’s left eye is blurring and causes her to see double or triple and causes lights to spray out. Plaintiff also suffers from pain in her left eye and headaches. The quality and correctness of plaintiff’s vision in her left eye has decreased. Plaintiff has double vision and cannot see well at night, and requires more light for vision on the left eye. She has been rendered nervous and has suffered pain and anxiety of body and mind and has experienced emotional upset and personality changes. She has suffered all of the above injuries, pain and damages since the date of the incident and suffers them at the present time, and will suffer them in the future, said injuries, pain and damages being permanent, disabling and progressive.

        23.    Prior to the aforesaid injuries, plaintiff Cheryl Atchison was an able-bodied woman capable of doing and performing work and labor. As a direct and proximate result of her injuries, she has, and in the future, will suffer loss of wages, earnings, salaries, and profits; and she has, and in the future, will suffer an impaired and diminished capacity for work, labor and pleasure.

        24.    By reason of her injuries, plaintiff Cheryl Atchison has paid or become obligated for, and in the future will pay or become obligated for, items of expense in obtaining and receiving medical care and treatment.

        25.    By reason of all the foregoing, plaintiff Cheryl Atchison has been damaged and is entitled to such damages as are fair and reasonable.

        WHEREFORE, plaintiff Cheryl Atchison prays damages against defendant VISX, on Count II this Petition, for such damages as are fair and reasonable, and for her costs herein expended.

COUNT III

        COMES NOW plaintiff and for Count III of her cause of action against defendants Laser Vision Centers, Inc., alleges and states as follows:

        26.    Realleges and restates all of paragraphs 1 thru 11 of Count I of this Petition and incorporates each of said paragraphs herein by reference.

        27.    At all times mentioned in this petition, defendants Laser Vision Centers, Inc. engaged in the business of furnishing LASIK equipment to physicians (said equipment being that described in Count II, but also including a calibrated computer) for use with LASIK surgery. This included the equipment used to perform the surgery on plaintiff.

        28.    The LASIK equipment furnished for the surgery on plaintiff was defective, and therefore, unreasonably dangerous when put to the reasonably anticipated use in that it stopped prematurely and/or allowed the fluence to become out of range and/or caused an asymmetric treatment or a furrow or trough in the stroma and/or caused more ablation to be received in the inferior portion of the left eye of plaintiff when the surgery was being performed. The said defective and dangerous condition existed when the LASIK equipment was furnished to defendant Morrison, and when used in plaintiff’s surgery.

        29. At the time of the incident described in this Petition, the LASIK equipment was:

1. Being used in a manner reasonably anticipated; and
2. In substantially the same condition as when furnished for use in plaintiff’s surgery.

        30.    As a direct and proximate result of the defective and unreasonably dangerous condition of the LASIK equipment when the LASIK equipment was furnished by said defendant, plaintiff’s left eye sustained damage. The vision in plaintiff’s left eye is blurring and causes her to see double or triple and causes lights to spray out. Plaintiff also suffers from pain in her left eye and headaches. The quality and correctness of plaintiff’s vision in her left eye has decreased. Plaintiff has double vision and cannot see well at night, and requires more light for vision on the left eye. She has been rendered nervous and has suffered pain and anxiety of body and mind and has experienced emotional upset and personality changes. She has suffered all of the above injuries, pain and damages since the date of the incident and suffers them at the present time, and will suffer them in the future, said injuries, pain and damages being permanent, disabling and progressive.

        31.    Prior to the aforesaid injuries, plaintiff Cheryl Atchison was an able-bodied woman capable of doing and performing work and labor. As a direct and proximate result of her injuries, she has, and in the future, will suffer loss of wages, earnings, salaries, and profits; and she has, and in the future, will suffer an impaired and diminished capacity for work, labor and pleasure.

        32.    By reason of her injuries, plaintiff Cheryl Atchison has paid or become obligated for, and in the future will pay or become obligated for, items of expense in obtaining and receiving medical care and treatment.

        33.    By reason of all the foregoing, plaintiff Cheryl Atchison has been damaged and is entitled to such damages as are fair and reasonable.

        WHEREFORE, plaintiff Cheryl Atchison prays damages against defendants Laser Vision Centers, Inc., on Count III this Petition, for such damages as are fair and reasonable, and for her costs herein expended.

COUNT IV

        COMES NOW plaintiff and for Count IV of her cause of action against defendant VISX Incorporated, and Laser Vision Centers, Inc., and each of them, alleges and states as follows:

        34.    Realleges and restates all of Counts II and III of this Petition and incorporates each of said paragraphs herein by reference.

        35.    The equipment was unreasonably dangerous when sold, leased, rented, or furnished by defendant VISX Incorporated, and when furnished by Laser Vision Centers, Inc. when put to a reasonably anticipated use without knowledge of its characteristics.

        36.    Said defendants, and each of them, did not give adequate warning of the danger that it might stop prematurely and/or the fluence might became out of range causing an asymmetric treatment, furrow or trough in the stroma and/or cause more ablation to be received in a portion of the left eye of plaintiff when the surgery was being performed, causing damage to her eye.

        37.    As a direct and proximate result of the product being sold, rented, leased, and/or furnished for surgery on plaintiff without inadequate warning, plaintiff’s left eye sustained damage The vision in plaintiff’s left eye is blurring and causes her to see double or triple and causes lights to spray out. Plaintiff also suffers from pain in her left eye and headaches. The quality and correctness of plaintiff’s vision in her left eye has decreased. Plaintiff has double vision and cannot see well at night, and requires more light for vision on the left eye. She has been rendered nervous and has suffered pain and anxiety of body and mind and has experienced emotional upset and personality changes. She has suffered all of the above injuries, pain and damages since the date of the incident and suffers them at the present time, and will suffer them in the future, said injuries, pain and damages being permanent, disabling and progressive.

        38.    Prior to the aforesaid injuries, plaintiff Cheryl Atchison was an able-bodied woman capable of doing and performing work and labor. As a direct and proximate result of her injuries, she has, and in the future, will suffer loss of wages, earnings, salaries, and profits; and she has, and in the future, will suffer an impaired and diminished capacity for work, labor and pleasure.

        39.    By reason of her injuries, plaintiff Cheryl Atchison has paid or become obligated for, and in the future will pay or become obligated for, items of expense in obtaining and receiving medical care and treatment.

        40.    By reason of all the foregoing, plaintiff Cheryl Atchison has been damaged and is entitled to such damages as are fair and reasonable.

        WHEREFORE, plaintiff Cheryl Atchison prays damages against defendant VISX, and defendant Laser Vision Centers, Inc., on Count IV this Petition, for such damages as are fair and reasonable, for her costs herein expended and for such other and further relief as the Court may deem just and fair in the premises.

P.O. Box 438.  Mt. Prospect, IL 60056-0438.  (847) 981-1330 ace.recovery@comcast.net
We enforce and recover your delinquent civil judgments

May 9, 2005

Brent Hanson
1687 Whitehall Court
Wheeling, IL 60090

Dear Mr. Hanson,

While conducting standard case file research we noticed that on 2/21/03 you were awarded a judgment of $2850.00 in Rolling Meadows Municipal Court against Glenn Hagele.  As a judgment holder, you have the right to assign your judgment to a third party to enforce your judgment.  If you have not been able to collect this or other judgments, we are interested in collecting them.

We specialize in locating hidden assets and seizing them to satisfy judgments.  Our company's fee is based solely on a percentage of what is actually collected.

There is a time limitation on collecting a judgment.  If you do not properly act on your claim, it may expire.  Please don't let the hard work you have already put into winning this judgment go to waste.

The out of pocket cost to you is nothing.  We will bear all expenses involved in the search for assets and enforcement of the judgment.  You will received a substantial percentage of the total amount of assets found and seized within thirty days of collection.

If you are interested in the enforcement of this judgment, with no cost to you in advance, please contact me at (847) 981-1330 immediately to arrange for assignment and terms.  Since your judgment has been nothing more than an IOU for so long, you have nothing to lose by allowing us to collect for you.  Don't delay - turn that worthless piece of paper into cash!

Sincerely,
Charles McKinnon
Judgment Recovery Specialist

www.lasikfraud.com/crsqa/ace-recovery-notice.pdf

Maria M. Perotin
Fort Worth Star Telegram

Two ophthalmologists at an Arlington eye-care center have been fined $ 25,000 apiece for running advertisements that couldn't be substantiated.

The Texas State Board of Medical Examiners reprimanded David Kleiman and Anthony Evangelista for ads published in various Dallas-Fort Worth newspapers.

The ads for the Kleiman-Evangelista Eye Center contained statements such as "nearly three out of four patients are seeing better than 20/20 vision! As for that other one patient, well, they'll just have to settle for 'perfect.'"

Another ad urged consumers to "trust your eyes to Tarrant County's leading LASIK surgeons" -- even though the eye center doesn't have data verifying that its doctors perform the most LASIK surgeries in the county, according to the board.

The board's rules prohibit ads that are false, deceptive or misleading, including those containing claims that cannot be substantiated.

The complete article is available at www.dfw.com/mld/dfw/business/11471019.htm

Smethers v. Campion, No. 04-0117 (Ariz. Ct. App. Mar. 22, 2005) - DEx 95391

The Arizona Court of Appeals reversed a trial court's decision to exclude a doctor's testimony of his personal practices and held that an expert witness may testify as to his personal practices, even if his personal practices are beyond the standard of care, because such testimony could be relevant and enables the jury to evaluate the credibility of the testifying expert.

Dr. Gary Smethers, a patient at Southwestern Eye Center Ltd. for nine years, sought LASIK surgery to correct his vision. In the nine years that Smethers received treatment from Campion, his prescription and eye measurements never changed. Smethers went to Dr. Michael Campion for a pre-surgery LASIK evaluation. Campion operated on Smethers.

When Smethers arrived, he was wearing his contact lenses. The staff at Southwestern told Smethers to remove his contact lenses so that they could measure his eye. The cornea changes its shape when one wears contact lenses and resumes its natural shape after several days without contact lenses. Thus, Campion instructed Smether not to wear his contact lenses for five days prior to the surgery, which Smethers did.

However, when Smethers came in for the surgery, Campion did not re-measure Smethers' eyes. Campion performed the LASIK surgery based on the measurements taken when Smethers was still wearing contact lenses.

The LASIK surgery over-corrected Smethers' corneas, and his eyes deteriorated. Smethers experienced glares, halos, ghosting, starbursts, and other problems. Further, Smethers had to carry multiple pairs of glasses and a magnifying glass to allow him to see in different lighting.

Smethers sued Campion and Southwestern for medical malpractice. Campion's expert witness, Dr. Perry Binder, testified that Campion did not breach the standard of care, even though Binder would have remeasured Smethers in his personal practice. Southwestern and Binder submitted a motion in limine to exclude Binder's testimony regarding his personal practice of remeasuring patients' cornea after they have ceased wearing contact lenses for at least 72 hours.

The trial court granted the motion in limine, and a jury found in favor of the defendants. Smethers appealed, charging that the trial court erred by excluding Binder's testimony.

The appellate court held that the trial court erred because Binder's testimony was relevant and enabled the jury to determine his credibility. Further, the court noted that Binder contradicted himself by saying that Campion met the standard of care and would have done the same thing as well as testifying that he always remeasures his patients' corneas in his own practice.

Twenty surgeries and one settled lawsuit later, Lynn Tepper sees three moons instead of five at night. But it's still a strain to see, she says.

By JAMAL THALJI, Times Staff Writer

DADE CITY - Every time Circuit Judge Lynn Tepper gazes up at the moons, there's no escaping it.

Her vision has been permanently damaged, she said.

"I used to love looking at the night sky," she said. "Now I get a little bitter."

Instead of seeing one moon, she used to see five. Now it's down to three. There's also the sensitivity to light, the poor night vision, the awkward depth perception, the blurring, streaking and ghosting effects.

Every day is a strain, whether it's reading legal filings on paper, doing research on her laptop or trying to see faces in the jury box. Her vision has rapidly deteriorated since her first Lasik refractive surgery operation in December 2000.

That was 20 operations ago.

"I can't overcome it," she said. "I live with imperfect, significantly imperfect, vision."

Tepper, 52, first sought help for her declining eyesight, but said that help instead worsened her condition. Before the surgeries she had 20/400 vision and was both nearsighted and farsighted. And now?

"No one can even begin to explain how bad it's become," she said.

It was so bad that Tepper sued the doctor who first performed Lasik operations on both her eyes in 2000, when she first tried to fix her failing eyesight. Her complaint demanded damages in excess of $15,000, which put it in Circuit Court.

"You know how you read about all those cheap Lasik surgeries?" Tepper said. "Well, I paid $2,500 an eye. I thought I was getting the Cadillac of surgeries."

The judge's lawsuit, filed in Pinellas County against Dr. John Michaelos of Clearwater and St. Michael's Eye and Laser Institute, was settled last week for an undisclosed sum.

"With the suit settled and the parties having settled amicably," Michaelos' attorney Jeff Goodis said, "I think it's best not to comment."

Tepper said she underwent 19 procedures under Michaelos between December 2000 and April 2002. They included multiple operations using the procedures Lasik and PRK, or photorefractive keratectomy.

Her right eye was her dominant eye. Not that her current ophthalmologist, Zephyrhills' Dr. Ahad Mahootchi, can tell now. "He said he can't believe that was my dominant eye," she said.

Under Mahootchi she underwent her 20th eye procedure in December - cataract surgery with bifocal crystal lens implants. That surgery has improved her vision, she said.

Voted onto the bench in 1988, Tepper noted in her lawsuit that the condition has taken away her independence. She cannot drive alone and cannot drive at night. She has had to rely on friends for rides. She has trouble reading. She has had to cut down on speaking engagements and writing articles.

She doesn't wear contact lens or bifocals, the judge said, but trifocals.

So what gets her through the day?

"My brain does a pretty good job of that," she said.

www.sptimes.com/2005/04/08/Pasco/Judge_s_eyesight_rema.shtml

The IDF's weekly BaMahane magazine reported that people who underwent Lasek surgery are not eligible to apply for the pilot training program under regulations established by the air force's medical board. Those who wear eyeglasses or had the surgery are ineligible to apply.

The decision was handed down last week after Air Force medical experts consulted with ophthalmologists, admitting data and long-term studies and patient follow-up are not available. Lt. Col. Dr. Bella Azzariya admits data is limited, adding the air force is unable to determine how altitude, lack of oxygen and other factors will impact a person who underwent the surgery, so the medical experts are compelled to take a hard-line approach in the matter.

Azzariya added pilots who underwent the surgery will be permitted to continue flying, but will be compelled to undergo periodical examinations to monitor the situation.

www.israelnationalnews.com/news.php3?id=79743

Hospitals have relied on publicity campaigns for decades, rolling out a mix of ads in newspapers, on radio and on television to help drum up business and differentiate themselves from their competitors.

Lately, however, marketing departments at top-flight academic medical centers have become increasingly creative in their pitches to patients, drawing on the kinds of subtle, sophisticated techniques that some critics say are more often associated with pharmaceutical firms and car salesmen than healthcare providers.

In the first study of its kind, a report in the March 28 issue of the Archives of Internal Medicine condemned this trend among the nation's most prominent hospitals to borrow slick, Madison Avenue-style marketing methods to publicize such high-margin services as fertility treatments, Botox and Lasik surgery.

The study, which analyzed newspaper ads for 17 of the nation's best-known academic medical centers, concluded that the marketing efforts appeared to ``place the interests of the medical center before the interests of the patients'' by highlighting ``unproved'' or ``cosmetic'' procedures instead of services that promote the general well-being of the community. What's more, the academic medical centers-which included the Mayo Clinic, Rochester, Minn.; Johns Hopkins Hospital, Baltimore; and the University of California at Los Angeles Medical Center-traded on their reputations to appeal to the emotions and trust of prospective patients, researchers said.

``When you see these kinds of ads from, say, a car company, that's one thing,'' said Robin Larson, an internist who is the lead author of the study and an instructor at Dartmouth Medical School, Hanover, N.H. ``You know there's a financial gain when the car company's doing advertising. When we think of healthcare, we like to think that the `patient-first' ethic is what's important.''

She suggested that academic medical centers are ``creating the same sense of need'' in the minds of the public as pharmaceutical companies, which have come under harsh attack in recent years for their reliance on expensive direct-to-consumer advertising.

Some academic medical center officials bristled at the suggestion that they have used manipulative advertising campaigns to attract new patients for profitable services.

Jim Blazar, chief marketing officer for the Cleveland Clinic, one of the facilities studied by the researchers, said the institution has no intention of changing the way it has advertised its services over the past quarter-century. ``The purpose of our advertising is to provide information, to motivate people to learn more,'' he said. ``I believe that when people are more knowledgeable, they make better decisions.''

Elaine Freeman, vice president of corporate communications for Johns Hopkins, which came under fire for advertising a series of free seminars on uterine fibroids, said the hospital is ``very cautious about not making inappropriate claims'' regarding treatment. Freeman said she disagreed with many of the conclusions of the report but added, ``I think it never hurts to raise sensitivity to the issues.''

A spokesman for Duke University Medical Center in Durham, N.C., another institution cited in the study, said no one was available to comment. Elaine Rubin, a spokeswoman for the Association of Academic Health Centers, a trade group that represents about 100 institutions, declined to comment.

While acknowledging academic medical centers must generate revenue to stay in business and serve the public, Larson said the kind of advertising she discovered isn't the appropriate way to do it. ``They need to find other creative ways of staying in business,'' she said.

These facilities, she said, should ``limit anything that is causing fear or exaggerating benefits and work on providing messages that help the public make good decisions.''

The study, which examined marketing efforts throughout 2002, found that most of the academic medical centers relied on a list of headlines that ``exemplifies several commonly used marketing strategies,'' underscoring attention-grabbing words and headlines such as ``at the forefront,'' ``breakthrough,'' ``tomorrow's medicine today'' and ``world class.''

Bold headlines ``commonly mentioned symptoms or diseases or used strategies that might appeal to patients' emotions or fears,'' the study found. The University of Chicago Hospitals, for example, advertised an offer for a $25 heart screening under the headline, ``Early detection is key to surviving heart disease.''

Consumers, the report added, are conditioned to regard ads from drug companies and other mass-merchandising markets with a degree of suspicion about motivation. ``It is reasonable to assume that consumers do not bring the same skepticism to health-services ads from academic medical centers that they do to other forms of advertising,'' according to the report, a joint effort by Dartmouth and the Veterans Affairs Medical Center in White River Junction, Vt., where Larson is a researcher. These institutions, Larson said, risk ``eroding'' public trust by using these kinds of advertising techniques.

In one attempt at high-tech marketing, the American Hospital Association joined U.S. News & World Report in late 2003 to create an online directory that offers information to consumers about specialized services, treatments and URLs for about 6,000 hospitals (Nov. 17, 2003. 14). It was the AHA's first consumer-oriented alliance.

The vast majority of U.S. healthcare facilities use some form of marketing or advertising to attract patients, experts said. It's the only way to differentiate their services or educate the public, said Susan Alcorn, a longtime hospital marketing official and a spokeswoman for Geisinger Health System, Danville, Pa.

``I don't think (the level of advertising) is surprising in the least,'' said Alcorn, who is also the president-elect of the Society for Healthcare Strategy and Market Development, an affiliate of the AHA that represents about 3,500 marketing and public relations officials across the country. ``Especially for academic medical centers, who have highly specialized services, if people don't know about them they can't utilize them.''

www.modernhealthcare.com/article.cms?articleId=35532

DADE CITY — Pasco Circuit Judge Lynn Tepper has reached a settlement with the Largo eye surgeon she sued for malpractice in 2003.

Terms of the settlement were not disclosed.

Tepper, 52, sued John Michaelos saying that Michaelos botched the Lasik eye surgery he performed on her in December 2000. Michaelos performed 19 additional surgeries in an attempt to correct the damage to Tepper's right eye, but nothing worked. The last surgery was in April 2002.

The parties reached a settlement March 14, about a month before the case was scheduled to go to trial.

Jeff Goodis, attorney for Michaelos, said the parties had settled but would not disclose the amount of the settlement because of a confidentiality agreement.

"It was getting very time consuming and stressful getting ready for trial," Tepper said.

Tepper said she was in severe pain for the months during and after the surgeries. Her vision also was blurred and she saw multiples of everything she looked at. Her vision has improved slightly since the Lasik operations, but she still sees multiples. Doctors have told her that a procedure called a custom ablation might help once advances are made in the technology.

Tepper originally opted to have Lasik surgery to cure her nearsightedness.

Amendolia v. Dodick, No. 18268/01

Court: Kings Supreme

Plaintiff Attorney: Jonathon D. Warner of Warner & Scheuerman, New York.

Defense Attorney: John L.A. Lyddane of Martin Clearwater & Bell, New York.

A New York ophthalmologist was found not liable for vision problems one of his patients complained of following LASIK surgery. Plaintiff Lisa Amendolia claimed that her vision worsened significantly in the three years following the LASIK procedure, which uses a laser to reshape the cornea. She sued Dr. Jack Dodick, who performed the procedure, alleging that he incorrectly applied the laser so as to create upward corneal ablation, thus forming superiorly decentered ablations that distort her vision. Dr. Dodick contended that the laser was applied properly, but that Ms. Amendolia's eyes did not heal evenly.

Channel NewsAsia

Using the novel Neurovision treatment, more myopic Singaporeans are now able to throw away their eyeglasses.

The non-invasive treatment has the potential of giving near-perfect vision and is good news for the estimated half-a-million Singaporeans who suffer from low myopia.

The treatment "re-programmes" a patient brain to see better, without any surgery.

To do that, the patient stares at a computer screen as part of the treatment which may take several months.

Results have been promising after treating 200 patients in this way.

One patient who has used this new treatment is Daryl Lim.

Even after lasik eye surgery four years ago, his vison was far from perfect so he turned to Neurovision at the National Eye Centre for help.

He said: "When I started my eyesight was recorded as 6/18 or 6/20, it improved to about 6/7.5 or 6/8. And that's quite significant, I saw greater contrast in the colours that I saw and sharpness in words."

An increasing number of Singaporeans are turning to this unique method of correcting their myopic eyesight.

Associate Professor Donald Tan, Director, Singapore Eye Research Institute, said many patients showed improvement after the treatment.

Of the 51 patients being monitored, nearly three quarters improved two lines or more on the standard eye chart.

The treatment works well for those with low myopia.

But for people with a higher degree of myopia, the treatment is ineffective.

Associate Professor Tan said: "We initially started out with patients with 150 degrees or below, because the treatment works best in this range. Since then we have extended it...we have a lot of patients who come in with 200 degrees."

Daryl Lim said: "I'm quite happy with my eyesight as it is, and it's functional, I only need glasses at night, but that's a known side effect for post-lasik patients or when I want to see the subtitles in cinemas. But I can do without my glasses."

Two more NeuroVision centres were recently opened in Singapore to keep up with the demand for such treatment and more centres are planned in other parts of the world. - CNA.

• Extreme Marketing
• Botox Cosmetic in the Refractive Practice: The Gift that Keeps on Giving
• LASIK Liability Review
• Learning to Listen: A Key to Selling Laser Vision Correction
• LASIK Postoperative Complications
• Innovative Marketing Ideas
• Help! Our LASIK Practice Is In Trouble
• Government Crackdown on Research and Clinical Trials Fraud
• Enhancing Your Bottom Line, With Internal Marketing
• Avoiding Fraud and Abuse in Ophthalmology: Lessons Learned from Real-Life Situations
• Bulletproofing Your Charts (Tape 1 of 2)
• Bulletproofing Your Charts (Tape 2 of 2)

USAEYES - Dr. Robert Maloney

LASIK SOS - Dr. Robert Maloney

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

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

Dear Ms. Burke:

        In response to your requests:

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

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

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

        Some explanation and documentation:

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

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

        Thank you for your attention.

                                                    Respectfully yours,
                                                    Dominic J. Morgan

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

Princeton Insurance Co. claimed an arbitrator's ruling that settled the dispute between the plaintiffs and Dr. Joseph Dello Russo, a Bergenfield physician, was unfair.

Dello Russo joined with the plaintiffs in contending that the insurance company should pay the award.

In a series of lawsuits dating to 1991, the plaintiffs claimed they sustained permanent injuries while being treated at Dello Russo's New Jersey Eye Center, and some claimed they were treated by employees who were not licensed to provide such services.

Judge Lawrence Smith ruled that the arbitration was fair and ordered the company to cover the claims up to its policy limit. Interstate Insurance, another carrier that provided coverage for Dello Russo, has already agreed to pay $3 million to the plaintiffs.

Bruce Nagel, an attorney who represented eight of the patients, praised the decision, saying, "It's time that the carrier pay up for the malpractice of Dr. Dello Russo.''

Smith later placed a gag order on all attorneys in the case until next week, but would not comment on why it was issued.

Source:  www.insurancejournal.com/news/east/2005/02/20/51770.htm

The complete article is available at www.dfw.com/mld/dfw/business/10864465.htm

Dallas, TX (PRWEB via PR Web Direct) February 4, 2005 -- A Lubbock County, Texas woman is suing the Fort Worth maker of a laser system used by doctors to perform LASIK eye surgery. According to the lawsuit, Sandra Brown v. Alcon Manufacturing, L.T.D. and Alcon Laboratories, Inc., the LADARVision laser is defective (Case #236-209603-05 District Court Tarrant County Texas 236th Judicial District). The lawsuit accuses Alcon of ignoring warnings that may have prevented additional injuries.

A surgeon performed LASIK surgery on Dr. Brown, a fellow ophthalmologist, in April 2001, using the LADARVision laser. During the surgery, the laser performed erratically and removed too little tissue in an asymmetrical pattern from Dr. Brown’s eyes. As a result, she sustained permanent damage to her eyes resulting in limited vision. Unfortunately for Dr. Brown, at this time, her vision cannot be repaired by medical or surgical interventions.

“I specifically waited for the LADARVision laser machine before having my surgery, and the wait cost me my vision,” says Dr. Brown. “I now have to live with damaged vision because of a defect in Alcon's laser. When I started looking into my problem, I realized that I was not alone and many other people have likewise been hurt by this same problem.”

While horror stories associated with laser vision correction are not new, recent disturbing news about the Alcon LADARVision laser may cause victims to consider whether harm to their eyes was caused by the laser and not doctors and medical staff.

“In the past, poor surgeries were usually blamed on the surgeon,” says attorney Joel Fineberg, who represents Dr. Brown. “There is now mounting evidence that the Alcon LADARVision laser is at the heart of many of these problems.”

Surgeons throughout the country are questioning the effectiveness of the laser. In addition, an article authored by an Alcon consultant in the April 2003 issue of Opthalmology, reveals that patients treated with the LADARVision laser are twice as likely to need follow-up surgery. According to an investigative report in the London Times the rate of required retreatment might be even higher.

“Patients go in expecting to come out with clearer vision, and many times they come out with permanent damage,” says Mr. Fineberg. “What we have here is a company that has decided to ignore serious concerns, raised by a physician, about the safety of their product.”

To speak with Joel Fineberg about problems associated with Alcon’s LADARVision, contact Joel Fineberg at (214)219-8828 or Mike Androvett at (800)559-4534.

By Investigator Ginger Allen
Producer/Photojournalist: Dave Manoucheri

At the turn of the millennium, it was the wave of the future--Peel back the lens of your eye, and look forward to sight you never imagined. It is the possibility of regaining 20/20 vision. Sandra Brown saw hope.

Three years ago, Brown had Lasik surgery. The pediatric eye surgeon was well aware of the risks associated with the surgery, having studied ophthalmology for more than a decade herself. But five or six months later, the common side effects had not disappeared.

“I turned out to be a disaster”, Brown says, “I have all the characteristics of a Lasik casualty”. To this day, she says she sees halos, ghosting images, and starbursts around lights that make driving at night almost impossible, she says all as a result of a LADARVision laser - made by Fort Worth based Alcon Labs.

Today she has to wear her contacts and her glasses for some activities, and she still feels the side effects of the surgery. It led her to do a case-study on herself.

“Most of the laser that was supposed to hit and flatten my cornea missed,” Brown said.

Her published findings match what an edition of “Eye World” medical journal, several lawsuits, and doctors all over the world are reporting - that between 2000 and 2002, the LADARVision laser . . . at times . . . had a high rate of failure, and/or removed too much eye tissue.

“The laser, unbeknownst to surgeons, have performed sporadically, erratically and in a manner which have produced unpredictably bad results,” says Joel Fineberg, Brown’s attorney. Brown is now suing the Fort-Worth based Alcon.
According to F-D-A reports and court documents, hundreds of patients suffered permanent blurred vision, glares and halos, and or the need for additional surgeries to improve their vision.

So was the Fort-Worth Based Alcon aware of the concerns?

Three doctors have independently told CBS 11 News that they had reported the problems to Alcon early on and stopped using the machines. One doctor said he had spoken out about concerns at national seminars.

CBS 11 has also obtained a transcript of a phone conference where several surgeons tell Alcon Adminstrators they’ve reported their concerns over malfunctions. They say their concerns have been “ignored” and that they are “not comfortable with the laser.”

The complete article is available at http://cbs11tv.com/localnews/local_story_035143742.html

PLAINTIFF'S ORIGINAL PETITION, MOTION FOR LEVEL THREE DISCOVERY PLAN AND REQUEST FOR DISCLOSURE

TO THE HONORABLE JUDGE OF SAID COURT:

        COMES NOW, SANDRA BROWN (hereinafter referred to as "Plaintiff"), and makes and files this her Original Petition, Motion for Level Three Discovery Plan and Request for Disclosure, complaining of Defendants ALCON MANUFACTURING, L.T.D. and ALCON LABORATORIES, INC. (hereinafter referred to as "Alcon"), and in support thereof would respectfully show unto the Court as follows:

I.

MOTION FOR LEVEL THREE DISCOVERY PLAN

        Plaintiff hereby moves to conduct discovery in accordance with a discovery control plan tailored to the circumstances of this specific suit.  In the interest of judicial economy and equity, Plaintiff moves to conduct discovery By Order (Level Three) pursuant to Rule 1904 of the Texas Rules of Civil Procedure.  Such a plan would provide all parties adequate time for oral depositions, interrogatories and other necessary states of discovery.  All discovery will be conducted pursuant to Rule 192 of the Texas Rules of Civil Procedure, which requires that all discovery be relevant to the subject matter of the pending action.  As a complicated product liability case is being alleged extensive expert testimony and review of records will be required.  More time is necessary in order to fairly and adequately prepare for an efficient trial of the case.  Furthermore, Plaintiff requests thirty (30) days from the filing of the last Defendants' Original Answer to prepare a written proposal for a discovery control plan.

II.

PARTIES

        Plaintiff Sandra Brown is a resident of Lubbock County and is a citizen of the State of Texas.  

        Defendant Alcon Manufacturing, Ltd. is a Texas Corporation and may be served through its Registered Agent CT Corporation System, 350 N. St. Paul Street, Dallas, Texas 75201.

        Defendant Alcon Laboratories, Inc., is a Texas corporation which may be served through its Registered Agent CT Corporation System, 350 N. St. Paul Street, Dallas, Texas 75201.

III.

VENUE

        Venue is proper in Tarrant County, Texas pursuant to § 15.002, et. seq., of the Texas Civil Practice and Remedies Code, as the Defendants have their principal place of business in Tarrant County, Texas and the acts and omissions made the basis of this lawsuit occurred in Tarrant County, Texas.

IV.

JURISDICTION

        This Court has jurisdiction over this cause because the amount in controversy is within the jurisdictional limits of the Court.

V.

STATEMENT OF FACTS

        On or about April 27, 2001 Sandra Brown had LASIK surgery performed.  During the procedure, the LASIK surgeon used the Alcon LADARVision Excimer Laser System (hereinafter referred to as "the Product").

        During the procedure, the Product failed resulting in injury, harm and/or damage to Sandra Brown.

        Prior to this failure, Alcon was on notice that the Product was defective by design, unreasonably dangerous, and likely to cause injury, harm and/or damage to patients.

        Additionally, Alcon knew that prior to Sandra Brown's procedure with the Product, the retreatment rates for patients who had procedures with the Product were excessive; incidents of adverse events occurred more frequently with the Product including, but not limited to over-corrections, decentrations, small effective optical zones, systematic under-ablations and/or epithelial ingrowth; and ophthalmologists notified Alcon about poor performance of the Product resulting in an excess number of adverse events.

        Further, Alcon was on notice in August, 2004 that the London Times reported that the Product failed in an excessively high percentage of patients who required additional surgeries and/or sustained damage to their eyesight.  Surgical enhancement and/or repair to patients increased by more than 20 percent for surgeons using the Product between 2000 and 2002.

        Further, Alcon actively and fraudulently concealed the danger of the Product for use on the general public.

VI.

CAUSE OF ACTION

A.    Negligence

        At all times relevant to this cause of action, Alcon had a duty to act as a reasonably prudent company would have acted under the same or similar circumstances.  Alcon breached this duty by, among other acts and/or omissions:

• Defectively designing the Product;

• Failing to correct defects which it knew or should have known would cause injury, harm and/or damage to patients;

• Failing to notify the FDA of adverse outcomes and/or incidents;

• Failing to notify the physicians using the product of its defective condition.

B.    Strict Products Liability

        At all times relevant to this cause of action, Defendants were in the business of designing, testing, manufacturing, marketing, distributing, selling and/or supplying the Product for use in Texas and throughout the United States.  Therefore, Defendants placed the Product into the stream of commerce where it ultimately was used on the Plaintiff who was a foreseeable user and/or beneficiary of the Product.  At all times relevant to the cause of action, the Product remained in substantially the same condition as when it was designed, manufactured, sold, and/or distributed by Defendants into the stream of commerce.  This product was used as intended in its ordinary and customary use.  At the time the Product left the control of Defendants, it was defectively designed and/or unreasonably dangerous for the following reasons which include but are not limited to:

• the Product would remove too much eye tissue;

• the Product would perform sporadically and/or erratically;

• the Product had a high risk of failure and/or adverse incidents which were not disclosed to the public and/or FDA.

        The above described acts and/or omissions were singularly and/or severally a proximate and/or producing cause of the occurrence in question and the resulting injuries and/or damages to Plaintiff.

C.    Manufacturing Defect

        Defendants are strictly liable for designing the Product that was unreasonably dangerous as designed, taking into consideration the utility of the Product and the risk involved in its use.  The Product's design defect existed at the time it left Alcon's control and placed into the stream of commerce.  The design defect was a producing cause of the occurrence in question and the resulting injuries and/or damages to the Plaintiff.  Defendants are strictly liable for selling, manufacturing, designing, and/or placing the defective product into the stream of commerce when there was a safer alternative design which would have prevented and/or significantly reduced the risk of the occurrence and damages in question without substantially impairing the Product's utility.  The safer alternative design was both economically and technologically feasible at the time the Product left the control of Defendants by the application of existing and reasonably achievable scientific knowledge.  The design defect was  producing cause of the occurrence in question, and the resulting damages sustained by Plaintiff.

D.    Malice

        The negligent acts and/or omissions of defendants as set out above constitute an entire want of care so as to indicate that the acts and/or omissions in question were the result of conscious indifference to the rights, welfare or safety of the Plaintiff, or that they constitute malice, as that term is defined by law, so as to give rise to an award of exemplary damages.  Plaintiff would show that the acts and/or omissions of Defendants which, when viewed objectively from the standpoint of Defendants at the time of the occurrence, involved an extreme degree of risk, considering the probability and magnitude of the potential harm to others; and of which Defendants had actual, subjective awareness of the risk involved but, nevertheless proceeded with conscious indifference to the rights, welfare and safety of others.  Plaintiff would show that the acts and/or omissions of the Defendants as set out above, constitute malice as that term is defined by law, so as to give rise to an award of exemplary damages against Defendants Alcon.

E.    Aggravated Assault

        Defendants, by and through their employees, agents, vice-principals, knowingly engaged in conduct which resulted in Plaintiff's injuries; placed Plaintiff at risk for serious injuries; and/or were reasonably certain that their conduct would cause serious injury to Plaintiff.  Accordingly, Defendants knowingly committed acts of aggravated assault which caused serious bodily injury to Plaintiff in violation of Penal Code Section 22.01.

VII.

DAMAGES

        As a direct and/or producing cause of Defendants' acts and/or omissions, Plaintiff has and will sustain permanent injuries including but not limited to:

• Past and future medical expenses;

• Past and future disfigurement;

• Past and future lost earning capacity;

• Past and future mental anguish;

• Past and future physical pain and suffering, and

• Exemplary or punitive damages.

IX.

EXEMPLARY DAMAGES

        The negligent acts and/or omissions of all Defendants as set out above constitute an entire want of care so as to indicate that the acts and/or omissions in question were the result of conscious indifference to the rights, welfare, and safety of Sandra Brown, or that they constitute malice or gross neglect, as those terms are defined by law, so as to give rise to an award of exemplary damages.  Plaintiff would show that the negligent acts and/or omissions of Defendants which, when viewed objectively from the standpoint of the Defendants at the time of the occurrence, involved an extreme degree of risk, considering the probability and magnitude of the potential harm to others and of which Defendants had actual, subjective awareness of the risk involved but, nevertheless proceeded with conscious indifference to the rights, welfare and safety of others.  Plaintiff would show that the negligent acts and/or  omissions of the Defendants, as set out above, constitute gross neglect as that term is defined by law, so as to give rise to an award of exemplary damages against Defendants.   The court should assess exemplary damages against Defendants in an amount that will punish Defendants and deter others from engaging in similar malicious conduct.

        Further, since Defendants engaged in conduct which amounts to Aggravated Assault; in violation of Penal Code Section 22.01, then the Texas Legislature has abrogated all caps on exemplary damages for this case.  Upon entry of judgment, the "so called limitations on caps" on exemplary damages shall not apply and the court can grant judgment for the entire amount of exemplary damages found by the jury.

X.

PRE-JUDGMENT INTEREST

        Plaintiff seeks recovery for pre-judgment interest at the highest legal rate allowed by law.

XI.

REQUEST FOR DISCLOSURE AND PRIVILEGE LOG

        Pursuant to Rule 194, you are hereby requested to disclose, within fifty (50) days of service of this request, the information or material described in Rule 194.2 (a)-(k).  Also, pursuant to Rule 193.3, you are hereby requested to produce a privilege log setting forth all documents you are withholding from production based upon privilege.

XII.

DOCUMENTS TO BE USED

        Pursuant to Rule 193.3(d) of the Texas Rules of Civil Procedure, Plaintiff intends to use all documents exchanged and produced between the parties including, but not limited to, correspondence and discovery responses, during the trial of the above-entitled and numbered cause.

XIII.

JURY DEMAND

        Plaintiff hereby requests a trial by jury and tenders herewith her jury fee.

XIV.

PRAYER

        WHEREFORE PREMISES CONSIDERED, Plaintiff prays that Defendants be cited to appear and answer herein, and that on final hearing, Plaintiff recover her damages from Defendants, including but not limited to all compensatory and actual damages, punitive damages, court costs, attorney's fees, pre-judgment and post-judgment interest at the highest legal rate and for such other and further relief to which Plaintiff may show herself justly entitled.

Respectfully Submitted

BOEHME & MOORE, L.L.P.

_________________________
RANDALL MOORE
1824 Eighth Avenue
Fort Worth, Texas 7610
(817) 207-9300
(817) 207-9400 (fax)

JOEL M. FINEBERG
Texas State Bar No. 07008520
R. DEAN GRESHAM
Texas State Bar No. 24027215
LAW OFFICES OF JOEL M. FINEBERG, P.C.
3811 Turtle Creek Blvd., Suite 1900
Dallas, Texas 75219
(214) 219-8828 (telephone)
(214) 219-8838 (facsimile)

ATTORNEYS FOR PLAINTIFF

Kommersant - New Russia's First Independent Newspaper

Yesterday the Central District of Moscow Prosecutor’s Office began the examination of the medical staff of one of EXIMER, one of Russia’s largest ophthalmologist clinics systems, where in one day 22 people, lost their sight all in one day after the surgery.

Nikolay Pavlenko, an EXIMER patient, who was blinded as result of surgery, filed a lawsuit at the Prosecutor’s Office pressing criminal charges against the doctors with a demand for health damage compensation. He also intends to ask that all EXIMER clinics should be checked throughout Russia.
In the middle of November 2004, Ukraine citizen Nikolay Pavlenko went to a regional representation of EXIMER clinic in Kharkov (opened there in 2000) for a cataract surgery. This eye condition is very popular and is caused by the opacity of lens. The doctors suggested implanting an artificial lens by an ultrasound. This standard surgery cost $1.1 thousand for one eye. Pavlenko was one of 21 patients, who underwent surgery on November 20, performed by the head doctor of the EXIMER system of clinics Kirill Pershin. A few hours after the surgery all patients had sharp pain in their eyes, nausea, and drastic impairment of sight. The next day examination revealed that during the surgery the patients were infected with blue pus bacillus (Bacillus Aeruginosa), which causes endophthalmitis – deterioration of eye tissue resulting in blindness. The mass infection caused 21 people to lose sight in one eye, while Pavlenko lost sight in both. The majority of patients are still undergoing treatment in Moscow, Kiev, and Kharkov.

Pavlenko filed a lawsuit at the Prosecutor’s Office of the Central District of Moscow, where the head office of the clinic is located, pressing criminal charges against the doctors, and compensation of damage they had caused. Prior to that Kharkov Prosecutor’s Office had begun examining the Kharkov clinic by demands of the investigation. Kommersant learned that Kharkov sanitary epidemic station had taken samples of all medication used during surgery. The test results proved that “the blue pus bacillus was found in two out of the five bottles of salt solutions, produced by a large U.S. pharmaceutical company,” its name not being published in the interests of the investigation. The Russian companies importing the solutions are also not being made public.

“We are not hiding the fact that all 22 patients had severe complications after the surgery,” Pershin commented on the situation. “Currently, the clinic has taken the responsibility for the patients who suffered, providing them with the needed ophthalmologic assistance.” At the same time Pershin denies his responsibility in the accident. “Imagine that the doctor prescribed Tylenol, but instead there was poison in the package. The doctor is responsible for the patient, but cannot be blamed for his having gotten poisoned,” he said. “The U.S. producer of the salt solution produces it by thousands of liters a day, exporting it to the whole world. No infection episodes of endophthalmitis were fixed anywhere else but Ukraine, and what is worthy of noticing, a day before the elections.”

However, Pavlenko’s lawyers Kirill Yashenkov and Vitaly Chaban told Kommersant that even if the Prosecutor’s office establishes the fact of the salt solution contamination, their client would insist on proving both the solution producers and the doctors guilty. “It was learned that after the surgery, when patients began losing sight, there was panic in the clinic,” the lawyers said, “There were not enough beds, nor staff, nor medication to treat them. The doctors lost the time, which could have saved the patients’ sight.” Pavlenko’s lawyers also intend to file a demand to the Health Ministry to check all EXIMER clinics in Russia.

When Dave heard about laser eye surgery he thought he would be finally free of his spectacles. He had been hampered by glasses since he became long-sighted at the age of 18.

"It got to the stage where glasses were just getting in the way," said Dave, a keen sportsman.

So five years ago, impressed by reports of how laser eye treatment could correct long- and short-sightedness, Dave approached a firm offering the surgery.

In 1999, he paid £3,200 for the operation on his eye, in which a section of his cornea, the clear covering over the eye, was removed.

The doctor who performed the surgery, known as laser in situ keratomileusis (LASIK) told him it had been a success.

But now he is fighting a legal battle, claiming the procedure damaged his sight.

"All this hype about how you could throw away your contact lenses and spectacles was not true," said Dave, 53, from Arnold. "I am worse off now than I was before the operation." Dave claims the firm did not explain the risks of the operation to him and the procedure has left him with a condition known as an "irregular astigmatism".

It means his vision has become very variable, changing in different light conditions and when undertaking different tasks such as reading, watching television or driving.

The result has been a continuous search for glasses that allow him to see comfortably in most situations.

"I have had at least ten pairs of spectacles since the operation and spent more than £3,000," said Dave. "I have had other problems too, a lot of headaches, visits to the GP and physiotherapy on my neck and back.

"I only have completely clear vision outside on a bright sunny day. I am furious about it." Dave believes many patients may also have been misled by firms wanting to sell them laser eye surgery.

And now the National Institute for Clinical Excellence, the NHS watchdog, has issued new guidance warning patients about the possible risks of laser eye surgery.

The watchdog has said there is not enough proof the procedure is safe in the long term to allow it to be used routinely in the NHS. It reported: Evidence on LASIK suggests it is effective for selected patients with mild or moderate short-sightedness but evidence is weaker for its effectiveness in severe short-sightedness and long-sightedness.

There are concerns about the procedure's long-term safety and evidence does not appear adequate to support its use within the NHS without special arrangements for consent and further research.

Professor Bruce Campbell, Chairman of the Interventional Procedures Advisory Committee, which considered the issue, said: "We know that vision gets worse in a few people after LASIK and eye specialists are also concerned about possible long-term side-effects.

The watchdog reviewed results of studies into laser eye treatment and interviewed experts and organisations. It found up to eight out of ten patients with low to moderate problems with their vision achieved perfect sight after the procedure. Where their visual problem was classed as moderate to high this figure fell to between one quarter and one third.

NICE also reported problems including growth of tissue on the cornea, effects on night-vision and glare.

The procedure is not currently offered on the NHS and while the NICE guidelines allow it to be provided as part of a research programme, health service managers are unlikely to introduce in the light of today's report.

Professor Harminder Dua, honorary consultant at the Queen's Medical Centre, said: "I do not think this will give reassurance to NHS managers. The investment is substantial and the risk of litigation is high." However, Prof Dua believes the procedure is safe if doctors are well-trained and patients are carefully selected.

"I do the procedure fairly regularly but I have a high incidence of turning people down," he said.

"If there is a risk I will not do it and I advise them not to have it done." Prof Dua, who is also the vice president of the Royal College of Ophthalmologists, said he is concerned that some doctors are not adequately trained and they view treatment as a "commercial enterprise".

The LASIK treatment has generated a steady stream of clients, including Dave, for Nottingham solicitors, Freeth Cartwright.

Paul Balen, a partner at the firm, is concerned the decision by NICE not to recommend laser eye treatment on the NHS may lead more people to seek help from private firms, where treatment may not be safe.

Mr Balen said: "It is critical before any patient agrees to this kind of operation and hands over money they make sure they have the right condition and they are aware of the risks."

American Journal of Ophthalmology
Volume 139, Issue 1, January 2005, Pages 64-71

Purpose

To compare corneal sensation, corneal barrier function, tear secretion, and tear film stability after photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK).

Design

Prospective, nonrandomized clinical trial.

Methods

In a prospective study, 28 eyes of 15 patients underwent PRK and 115 eyes of 59 patients underwent LASIK to correct myopia. Corneal sensation, corneal epithelial barrier function, tear secretion, and tear film stability were examined preoperatively and 1 week and 1, 3, 6, and 12 months postsurgery.

Results

Both PRK and LASIK significantly compromised corneal sensation, increased epithelial barrier function, reduced tear secretion, and deteriorated tear film stability (P < .05, Wilcoxon signed-rank test). Deterioration of corneal sensation was significantly greater after LASIK than after PRK by 3 months postoperatively (P < .05, Wilcoxon rank sum test). Increases in corneal epithelial permeability were more prolonged after LASIK than after PRK. A significant intergroup difference in permeability was observed 1 month after surgery (P < .01). Tear breakup time was significantly shorter in the LASIK group than in the PRK group up to 3 months after surgery (P < .045).

Conclusions

LASIK induces greater and more prolonged damage to corneal sensation, corneal barrier function, and tear film stability than PRK.

RetinaPharma, a privately-held portfolio company of the Hopkins Capital Group, LLC, announced today that it has received 510(k) FDA clearance to market its unique, patented device that enables more accurate intra-ocular pressure (IOP) determination in patients. The device, TonoPach (TM), provides for the unprecedented simultaneous determination of intra-ocular pressure and corneal thickness at the same location on the cornea. This allows for ophthalmologist to make an adjustment of the intra-ocular pressure to take into account the affects of corneal thickness. The device was originally patented by Francis E. O'Donnell, Jr., MD, Managing Director of Hopkins Capital Group, LLC and Chairman of the Board of RetinaPharma and subsequently improved by Dr. Terry Fuller, Co-founder and CEO of RetinaPharma.

A large randomized, five-year National Eye Institute (NEI) study published in mid-2002 showed that patients' corneal thickness is the single most important biometric parameter in risk assessment for patients with glaucoma or ocular hypertension. The NEI study showed a highly significant correlation of corneal thickness that combined with IOP measurement predicts the likelihood of damage to the visual field. The TonoPach is the first instrument to concurrently measure both biometrics (IOP and corneal thickness) and offer it as a low cost, easy to use solution to patient management. The TonoPach is used in a manner identical to existing instruments for measuring intraocular pressure. However, its use during routine eye examination can easily and inexpensively provide meaningful additional data that is designed to help obtain correct diagnosis and ensure optimum patient management.

Glaucoma and ocular hypertension are leading causes of irreversible blindness and impaired vision in the industrialized world, with over 7.5 million individuals afflicted in the US alone. Over 130,000 people are legally blind as a result of this disorder in the US. In addition, there are an estimated 1 million patients receiving LASIK each year in the US.

The ability of the TonoPach to more accurately measure real IOP in patient's with thinned corneas is of particular concern in patient's whose corneas have been thinned as a result of excimer laser refractive surgery such as LASIK. There are an estimated 1M patients receiving LASIK each year in the US. Heretofore, such patients were known to have artifactitiously low IOP measurements which could mask elevated IOP and the risk of glaucomatous visual field loss. The TonoPach device allows for correction by the ophthalmologist of the observed IOP based on measured corneal thickness at the exact point of IOP measurement.

About RetinaPharma:

RetinaPharma is a privately-held biotechnology company developing advanced technologies for blinding retinal diseases such as glaucoma, macular degeneration, and retinitis pigmentosa. RetinaPharma was a 2003 recipient of the BioAdvance Greenhouse Fund. BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania finds and funds early-stage life sciences projects with promising products and devices. RetinaPharma's lead financing has been done by Hopkins Capital Group, LLC, a leading private equity/venture capital and business development firm committed to long-term patient capital for disruptive healthcare technologies.

The Company has exclusively licensed the PhotoTarget(TM) delivery technology from the Wilmer Ophthalmological Institute, The Johns Hopkins University Medical Institution. For the first time, this patented non-invasive technology allows for the precise delivery of pharmaceuticals to areas of diseased retina. The technology is well-suited to delivery of anti-angiogenics and photo-dynamic therapies for the wet form of macular degeneration. In the case of delivery of anti-angiogenics, it eliminates the need for intravitreal injection by needle insertion into the eye.

The Company has exclusively licensed the ApoGuard(TM) patented anti-apoptotic therapy from the University of Toronto. This active metabolite of an extremely safe anti-Parkinson's approved therapeutic, deprenyl, is being developed as a chemopreventative for a range of neurodegenerative diseases, including the dry form of macular degeneration.

About Hopkins Capital Group, LLC

The Hopkins Capital Group, LLC is a leading private equity/venture capital investor and developer of disruptive technologies in healthcare. The HCG provides long-term, patient capital for the commercialization of technologies that address significant unmet clinical needs. The Hopkins Capital Group, LLC is not affiliated with the Johns Hopkins University. For more information on the Hopkins Capital Group, LLC please visit the website at http://www.hopkinscap.com

CONTACT: RetinaPharma, Jenkintown Dr. Terry Fuller, 215-885-4558 tafuller@RetinaPharma.com ]]> 2005-01-06T23:15:27Z 2005-01-06T17:15:27-06:00 tag:www.lasikfraud.com,2005:/news//1.84 2005-01-06T23:15:27Z

THIRD PARTY COMPLAINT OF EBW LASER, INC.

Defendant, complaining of the Third Party Defendants, alleges and says:

        1.    Defendant EBW Laser, Inc., (hereinafter EBW Laser) is a corporation duly formed and operating in North Carolina.

        2.    Third Party Defendant Alcon Laboratories, Inc., (hereinafter "Alcon") is a Delaware corporation with substantial business dealings in North Carolina.

        3.    Third Party Defendant Refractive Horizons, L.P. (hereinafter "Refractive") is a Texas limited partnership with substantial dealings in North Carolina.

        4.    The Defendant asserts that the actions of the Third Party Defendants complained of in this Third Party Complaint directly relate to the Complaint filed by Plaintiff GE Healthcare Financial Services (hereinafter "GE") on June 30, 2003, 1:03CV00514.  Defendants in this action are cited by name as the reason the debt was not paid in the GE action and the debt as may be found to be owed by EBW Laser in that action is owed by the Third Party Defendants for reasons hereinafter stated.

        5.    Jurisdiction of this action is founded upon 18 U.S.C. §§1961 1968 and pursuant to 28 U.S. C. §1441 and venue is founded upon 28 U.S.C. §1391.  The matter in controversy exceeds, exclusive of interest and costs, the sum specified by 28 U.S.C. §1332.

        6.    On March 30 2000, Defendant EBW Laser executed a contract with Summit Technology, Inc., to obtain through third party leases a number of Autonomous LadarVision Systems, highly sophisticated machines designed to correct vision in human eyes.  Among these third party leases are the same leases being sued upon by GE in the original complaint.  On information and belief, later that same year, Defendant Alcon purchased the assets and liabilities of Summit Technologies, Inc., including the aforementioned contract.  Alcon divided the rights and responsibilities of that contract so that they were partially performed or intended to be performed by Alcon and other portions were partially performed or intended to be performed by Refractive.

        7.    During the remainder of 2000 after the purchase of Summit Technologies, Inc., and into 2001, Third Party Defendant Alcon became aware of extremely serious problems with the Autonomous LadarVision Systems which it had purchased as a part of the deal with Summit Technologies, Inc. Reports began to come in from doctors around the nation through Third Party Defendant Refractive and Alcon's repair personnel and other sources that the Autonomous LadarVision Systems, or some of them, were badly malfunctioning. The machines were designed to automatically calculate the depth and type of laser cut on the eye which could not be independently verified and in truth, on some machines, the results were wildly erratic. Sometimes when the machines indicated a sufficient laser cut would be made, no laser cut would be made at all. At other times the cut would be, in any case, greatly different than the machine indicated. This necessitated thousands of patients to have their eyes redone, often multiple times, and some patients to have uncorrectable, terrible results."

        8.    The existence of these malfunctioning machines caused a conundrum for Third Party Defendant Alcon and Third Party Defendant Refractive. It they reported these numerous malfunctioning to the Federal Drug Administration as required by law and notified doctors around the country to look out for this possibility, then the sales of the Autonomous LadarVision Systems for which Third Party Defendant Alcon had just paid a premium might crash. The FDA might well force a recall and review the entire design of the machine and thousands of patients might well sue Alcon for product liability. To avoid those eventualities, Third Party Defendants Alcon and Refractive entered into a criminal enterprise to defraud and deceive the doctors and the companies who used the machines (9 of which EBW Laser, Inc., was one). The deception operated in this fashion. Each time a doctor or company reported one of these widespread malfunctions, the Third Party Defendants would pretend it was the first they had heard of it. The Third Party Defendants would then suggest all sorts of fanciful and untrue possible causes for the malfunction, having full knowledge that the known malfunction was common with the machine. The Third Party Defendants would then feign an "inspection" of the patient records to "discover" the cause of the problem when they already knew they already knew the cause. Much or all of the deception perpetrated on the doctors or companies took place through the United States mails, over United States wires, and inside the territorial boundaries of the United States. In the second phase of the deception, if any doctor and/or company became suspicious or uncooperative, the Third Party Defendants intimated and threatened said doctors or companies and induced fear of economic hard so said doctors and/or companies who suspected a malfunction of the machine would not disseminate their suspicion to the Federal Drug Administration or in doctor conferences.

        9.    The acting agents for the Third Party Defendants, Alcon and Refractive, were the President and officers of Alcon, the employees who dealt with the doctors and companies who owned Autonomous LadarVision Systems. All actions of the criminal enterprise were taken on behalf of participants,. Third Party Defendants Alcon and Refractive."

        10.   The criminal enterprise had as its purpose to avoid the legally required reporting of malfunctioning machines to the Food and Drug Administration, to continue to deceive the doctors and corporations who had the malfunctioning machines and to deceive the makers of new contracts with the Third Party Defendants so that they would have no knowledge of the malfunctioning machines.  Third Party Defendant Alcon also wished to do a stock issue and it wished not to make otherwise required disclosures to the Securities and Exchange Commission and to the public so that its stock issue would be successful and raise more money.  All of these goals of the criminal enterprise depended on the continued denial that the machines were malfunctioning even though the Third Party Defendants knew or should have known that they were.  In the event any doctor or company being deceived suggested consulting the Federal Drug Administration or bringing up the problem at doctor conventions, the goal of the criminal enterprise then continued in the form of defeating any widespread dissemination of the truth by intimidation and inducements of fear of economic harm.  

        11.    The Defendant EBW Laser first became the target of the Third Party Defendants' criminal enterprise because it had two of the defective machines.  When the Defendant EBW Laser and the doctors with whom they had contracted first reported the wildly erratic results, Third Party Defendants, as was their deceptive practice, made no disclosure that they had received essentially the same reports from doctors around the nation including from some of the nation's most respected surgeons.  The Third Party Defendants instead by mail and telephone inside the boundaries of territorial United States, told the Defendant and the contracted doctors that there must be something wrong with their techniques or perhaps there was too much humidity in the room.  They deceptively failed to disclose that they had had the same reports from other doctors and they had given them the same false explanations.  The Third Party Defendants then through a sham of reviewing patient records reported false conclusions instead of attributing the results to the malfunctioning machines.

        12.    The Third Party Defendants had in January 2001, negotiated a contract with Defendant whereby Defendant would pay per procedure fees such that for each person on whose eyes surgery was performed, the Defendant would pay a fee to the Third Party Defendants.  This contract was negotiated and was transmitted through the United States mails or telephonically and was wired all in the territorial United States.  The malfunctioning machines necessitated repeated surgical procedures on the same person either to perform the task originally attempted which was not done because of the malfunctioning machine or to correct damage done at the other extreme by the malfunctioning machine.  All of this was well-known to the Third Party Defendants because of repeated complaints by respected doctors around the United States and from records of their own maintenance personnel.  They nevertheless deceptively failed to disclose these facts to Defendant EBW Laser and negotiated the contract intentionally keeping the EBW Laser in the dark.  The negotiation of the contract which took place in December 200 and January 2001 was deceptive in that it failed to disclose serious continuing malfunctions of the machine well-known to the Third party Defendants which would necessitate many more repeat procedures than could reasonably be expected and which the Third Party Defendants led the Defendant to believe would be expected.

        13.    During 2001, two of the Defendant's machines began to seriously malfunction.  One of those two is the subject of the complaint filed by Plaintiff GE.  In the case of the GE machine, the subject of the original lawsuit located in Maryland, the machine performed erratically.  The machine's settings would always indicate that everything was in good order, but at times the laser would not cut at all.  At other times it would perform erratically and vary wildly from patient to patient and even from eye to eye on the same patient.  Repeatedly, maintenance personnel were called in and in numerous phone conversations, the Third Party Defendants always repeated the same deceptive statements similar to what had been repeated around the country to a number of doctors and companies reporting similar problems with the machine.  EBW Laser was told telephonically within the territorial United States as was the doctor with whom they were contracting that perhaps the doctor needed to work on her technique or humidity problems might be causing it.  Always carefully and intentionally omitted was the true state of affairs which was known and appreciated by the Third Party Defendants that a number of machines were malfunctioning the same way around the country which could only reasonably indicate a machine problem and not a wide-spread doctor problem.

        14.    Defendant EBW Laser became extremely concerned about the number of repeat surgeries and the fact it was having to pay procedure fees for these repeated surgeries.  EBW Laser was also concerned that the medical practice in Maryland had been severely damaged and the medical practice in Albuquerque, New Mexico, where the other malfunctioning machine was located had also been badly hurt because of the machine's down time and repetitive problems.  In telephonic conversations in the territorial United States, the Defendant EBW Laser confronted the Third Party Defendants with their suspicions that the machines were malfunctioning, and that some kind of mitigation of the fees needed to be made.  The Third Party Defendants continued their deceptive behavior and insisted that these problems were unique and that they had not heard of anything else like this occurring.  In fact, the Third Party Defendants were by 2001 already dealing legally with the problem and had had repeated conversations about the malfunctioning machines.  The criminal enterprises goal of cover-up by deception and intimidation was well under way and their deceptive actions toward Defendant were only a relatively small part of it.  The Third Party Defendants agreed to defer the disputed procedure fees while negotiations were ongoing as to how much the procedure fees would be mitigated.  In March 2003, Defendant EBW Laser through J. Mark McDaniel communicated telephonically to the Third Party Defendants that he would like to bring the negotiation to a conclusion because he wished to transfer service contracts into a different corporate name and he was both clearing that with the Third Party Defendants, as was required, and wrapping up all unfinished business.  McDaniel on behalf of the Defendant EBW Laser then communicated that he had heard rumors that Alcon had had the same sort of problems with other machines that doctors were being bought out, and that machines were being replaced or substantially rebuilt as the machines for EBW Laser had been.  He wanted to know if those rumors were true.  McDaniel had unknowingly triggered the other technique of the criminal enterprise.  The first technique was to hide the problem by deception:  the other part of the technique was to keep the problem from official disclosure or acknowledgement by economic intimidation and threats.

        15.    Alcon responded to EBW Laser's inquiries by false and deceptive denials, but also by a lawsuit demanding all the disputed money upfront.  Even though Third Party Defendants obtained a Court Order so that any further procedures fees would be paid directly to them and the disputed fees would be determined by a Court, the Third Party Defendants then proceeded with a massive economic intimidation campaign.  First, they called the doctors with whom EBW Laser had contracts and told them that they would be cutting off the machines so that the doctors could no longer perform surgery on EBW Laser machines.  When the doctors attempted to make arrangement to pay both procedure fees and maintenance directly to the Third Party Defendants, they offered the doctors only one alternative - cease doing business with EBW Laser and allow the Third Party Defendants to substitute the machines with new contracts for them or else they would cut them off.  All of these contracts were made with the full knowledge that EBW Laser was in a contractual relationship with these doctors and that the Third Party Defendants were tortuously interfering with those third party relationships.  These contacts wee made both telephonically and written offers were made through the mail and th4rough the wires.

        16.    Third Party Defendants had as its purpose to further the criminal enterprise so that EBW Laser would cease discussing the malfunctioning of the machines, pay the Third Party Defendants every5hing without negotiation, and have no risk of disclosure of the Third Party Defendants' criminal enterprise.  The Third Party Defendants meant to and did put the Defendant in fear of economic harm by eliminating their ability to pay their leases knowing that some leases had personal guarantees, eliminating their source of income from doctors with whom the Defendant had contracts, and virtually destroying the economic integrity of the Defendant.  Numerous acts were taken to forward this criminal enterprise in the mail, telephonically, and over the wires within the territorial United States.

        17.    As a direct and proximate result of the Third Party Defendants' deception conducted through the mails and wires of the United States and as a victim of the Third Party Defendants' criminal enterprise, the Defendant has suffered actual damages both present and legally recognized prospective damages in the millions of dollars with the exact amount to be proven at trial.

SECOND CAUSE OF ACTION

        18.    Numbers 1-17 are hereby replead.

        19.    The actions of the Third Party Defendants in failing to disclose critical information known to it of widespread malfunctioning machines and failing to disclose that numerous extra follow-up procedures would be needed because of those malfunctions while at the same time establishing a payment schedule for those same procedures was deceptive within the meaning of the North Carolina Unfair Trade Practice Act and constituted an unfair trade practice.

        20.    The actions of the Third Party Defendants in repeatedly making false and/or deceptive statements to Defendant and its representatives concerning the cause of the problems with procedures that the Defendant was experiencing when the Third Party Defendants were responsible for the maintenance and upkeep of the machines was deceptive within the meaning of North Carolina's Unfair Trade Practice Act and would constitute unfair trade practice.

        21.    As a direct proximate result of the Third Party Defendants' deceptive conduct in violation of the North Carolina Unfair Trade Practice Act, the Defendant has suffered actual and legally allowable prospective damages in an exact amount to be proven at trial.

        22.    The Defendant asserts that the issues raised and the evidence necessary to prove the Unfair Trade Practice claim would be similar to and would tend to duplicate the evidence put forth in the Federal RICO claim in this complaint and it would be proper to append this matter.

        Trial by jury on all factual matters is hereby demanded.

        WHEREFORE, the Defendant prays that the following damages be awarded from the Third Party Defendants jointly and severely:

        1.    That the Defendant be granted damaged (sic) for actual and (sic) legally allowable prospective damages in an amount to be proven at trial.

        2.    That the amount of said damages be trebled pursuant to RICO and/or the North Carolina Unfair Trade Practice Act.

        3.    That the Defendant be granted an award of reasonable attorney's fees pursuant to RICO and/or the North Carolina Unfair Trade Practice Act.

        4.    For such other and further relief as the Court deems just and proper.

        This the ____ day of July, 2003

Douglas S. Harris
Attorney for Third Party Plaintiff/Defendant
State Bar Number 9843

1698 Natchez Trace
Greensboro, NC 27455
Telephone:    (336) 288-0284

Eleven people have been awarded compensation for medical misadventure after laser eye surgery in the past five years.

Nineteen claims have been made to the Accident Compensation Corporation (ACC) between July 1999 and last month by laser eye- surgery patients.

Of the 11 claims accepted, patients had variously suffered loss of vision, visual disturbances, damage to their eye by laser, an infection and/or pain.

The successful claims equate to about 0.05 per cent of an estimated 20,000 laser eye-surgery patients over that period.

A claim can be accepted by the ACC only if a doctor or other health professional was found to have made a medical error or that the injury was rare and severe -- a "medical mishap" that was not due to inadequate treatment.

However, a bill being considered by a parliamentary select committee proposes scrapping the need to find fault.

Laser eye surgery was introduced to New Zealand in the early 1990s. Seven clinics are now operating in the country, including two in Christchurch.

Fendalton Eye Clinic ophthalmologist David Kent said he had done about 10,000 laser procedures on about 5200 patients, and had two ACC claims against him. Both were for rare complications, not poor treatment.

Christchurch Hospital ophthalmologist Mark Elder said eye surgery should not be taken lightly. "It is not like shopping for a new blouse that if you don't like it you can give it to the Salvation Army or buy another one. If something goes really wrong it is harder to fix."

He said that serious or blinding complications were "very rare".

Christchurch optometrist Paul Limbert said he had examined more than 50 patients before and after laser eye treatment in the past three years and had seen a complication rate of less than 3 per cent. This included those who had "less than optimum" vision or "prolonged eye discomfort" after surgery.

This was less than complication rates as high as 10% reported in some international studies.

Britain's National Institute for Clinical Excellence (Nice) released its findings on laser surgery this month after a year- long study.

Nice, an independent body that offers advice on health treatments, concluded laser eye surgery was effective for people with mild to moderate short-sightedness but there were concerns over its long- term safety.

It advised against offering the procedure, known as laser in situ keratomileusis (lasik), on the national health system.

Nice Professor Bruce Campbell said lasik offered improvement for those with moderate short or long- sightedness. As these could be easily corrected by glasses or contact lenses, any risk of damage through lasik surgery was "a real concern".

He said Nice would carry out further reviews into the long-term effects.

Peter Martell
Scotsman
http://scotlandonsunday.scotsman.com/index.cfm?id=1465082004

LASER eye surgery firms are underplaying the risks associated with the operation and doing too little research on its long-term effects, a leading Scottish expert has warned. 

Dr Alistair Adams, one of Scotland’s most senior ophthalmic surgeons, believes that as many as one in 10 patients who undergo the corrective procedure ‘successfully’ could develop complications in later life. 

But Adams, a consultant at the Princess Alexandra Eye Pavilion, Edinburgh, believes the companies involved are allowing patients to underestimate the risks. 

Adams also revealed that he gave up practising an earlier form of laser eye surgery because so many of his patients returned with complications. 

Thousands of Scots each year pay around £1,000 per eye to undergo laser surgery in the hope of throwing away their glasses or contact lenses for ever. 

But while the number of patients has rapidly increased in recent years, so too have the warning signs. Public health watchdog NICE recently said its use should not be funded by the NHS because too many questions remain unanswered. 

Adams once practised a form of laser eye surgery called PRK, or photo refractive keratectomy. It involved scraping through the surface of the eye and reshaping the cornea with a laser. At the time, patients had one eye treated at a time on safety grounds. 

Adams, until recently chairman of the special advisory board on ophthalmology at the Royal College of Surgeons in Edinburgh, told Scotland on Sunday: "I did approximately 100 cases of PRK, but I stopped doing it around five years ago because around 10% of people I treated didn’t want to have their other eye done, and were happy sticking with their contact lens. 

"That was mostly due to their vision at nighttime, driving in the dark or dim light, as their vision wasn’t as good as it was with their contact lens. 

"One or two people had it done with both eyes and could no longer drive at night." 

PRK has been replaced with the LASIK technique, which involves slicing into the cornea. It costs between £2,000 and £3,000. 

But Adams says he has no intention of performing the procedure himself. 

He said: "I have looked at LASIK several times, and have many friends, particularly in America, who say it is wonderful. Patients, generally speaking, are very happy. 

"However, I do have reservations about the surgical procedure. With LASIK, between 5% and 10% may have persistent problems and may wish they hadn’t had the surgery done. It is quite invasive, with a slice made in the cornea, for a problem that is actually solvable with contact lenses or glasses. 

"I have a question mark over the long-term results, and I think there may well be complications which we haven’t suspected. Already they are beginning to find more complications than they thought." 

He added: "One of the defects of the present system is that the majority of these clinics which do the treatment do not keep the statistics of long-term follow-up. 

"Unfortunately, it is marketed as being very simple and very safe, and I suspect that probably is just not true. To be fair, a lot of the clinics do offer good information, but patients who are set on throwing away their glasses don’t necessarily take it all in. 

"A lot of companies say that 95% of patients have 20:20 vision after the treatment, but that doesn’t tell you that 10% of them might not be able to drive at night. 

"Apart from the major risks of infection, there are a significant number of people with dry eyes, double vision or who see halos around lights. In some cases, such as persistent haziness. The patient can be left with an impairment of vision that is permanent. 

"Some people’s lives have been turned upside down by having LASIK because of complications that they felt they were not fully informed about." 

He added he was concerned at the increasingly popular practice of operating on both eyes at once. "If there was a problem, like an infection, then you might well have it in both eyes," he said. 

The Royal College of Ophthalmologists, the profession’s training body, is currently producing guidelines on the LASIK technique and is urging more research. "Current evidence suggests the treatment is effective for selected patients with mild or moderate myopia but the College recognises the importance of more research into the long-term effects," said a spokeswoman. 

But Christopher Neave, chairman of the Eye Laser Association (ELA), which represents the largest providers of laser eye treatment in the UK, said that the figure of 10% with complications was simply wrong. 

He said: "Since 1990, some 280,000 people in the UK have been treated, and we estimate that fewer than 0.1% have experienced persistent problems. LASIK is a life-enhancing treatment and we believe that it is a discretionary decision by an individual." 

He also pointed to independently verified research on patients treated at the Ultralase clinics, which showed that 98% of all its clients achieved driving-standard vision or better. 

Neave, who said there was an "outstanding level of clinical care in our industry", said that the risks were made clear to patients both in writing as well as in verbal consultation.

SPRINGFIELD - Every year for several years, legislation to identify individual physicians involved in medical malpractice lawsuits has been introduced in the Illinois General Assembly without advancing to a vote.

The chief sponsor of the Patient Right-to-Know Act, Rep. Mary Flowers (D-Chicago), has said she plans to reintroduce the bill in 2005. A recent article in the New Jersey Law Journal, highlighting the impact of similar legislation which took effect there in July of this year, may provide an indication of what to expect in Illinois if the Patient Right-to-Know bill were to become law.

In "Online Posting of Med-Mal Payouts Is Seen as Chilling Settlements," published Nov. 17, New Jersey Law Journal reporter Mary P. Gallagher wrote, "Nearly five months after a state government web site began posting doctors' malpractice histories, the publicity may be having a chilling effect on settlements.

"Lawyers on both sides of the aisle say that some doctors, faced with the reality that even a confidential settlement will end up on the Internet, are opting to take their chances in court."

This does not surprise John Hopkins, an Edwardsville plaintiff's attorney and Madison County Record columnist.

"I've never heard of anything like that. The settlement is usually confidential," Hopkins said.

Defendants often want settlements to remain confidential, because many settlements are made without an admission of negligence or wrongdoing. Defendants fear damage to their reputation.

Hopkins said plaintiffs also sometimes want settlements they receive to remain confidential.

"Many plaintiffs don't want people knowing their business," he said. "They wouldn't want any computer geek to go online and find that information."

The Illinois State Medical Society, which lobbies on behalf of physicians, opposes the concept, according to Dr. Kenneth Printen, ISMS president.

"The Illinois State Medical Society strongly believes consumers should have access to relevant information to help them make educated choices about their health care," Printen said in a statement. "We also believe that a doctor who does not practice good medicine should be disciplined. We do not, however, feel that publishing information on malpractice verdicts and settlements will provide reliable information for patients to use in selecting a doctor."

He said that to "simply reduce a doctor's qualifications to a list of verdicts and settlements is misleading to the consumer and can unfairly scar the reputation of a physician who provides exceptional care."

One local supporter of the concept is Doug Wojcieszak of Victims and Families United, a trial lawyer-backed advocacy group.

"This is something a lot of patients and consumer advocates have been asking for for a long time," he said. "We can find out stuff on other services, but information on doctors entering into settlements is not disclosed."

He said much of the debate over medical malpractice is based on anecdotal information, which renders the debate meaningless.

"It's a bunch of stuff generated by press people," Wojcieszak said. "Only when we get honest numbers can there be an honest discussion. We really need a good database that's accessible to everybody."

Agreeing in theory but opposing the Patient Right-to-Know Act in practice is Susan Hofer, spokeswoman for the Illinois Department of Financial and Professional Regulation, which oversees physician licensing.

"We are not opposed to the idea of making available to the public information we receive as a mandatory report," Hofer said. "We were one of the first states to make licensing information available to the public. Our concern is with the way the bill is drafted. We don't think we could administer it. My understanding is it would be incumbent on the department to go out and seek information. We don't have the resources to do that."

The state requires insurers to report to the department any verdicts or settlements in medical malpractice cases. Hofer said the Patient Right-to-Know Act would require the department to also seek out information on hospital disciplinary actions, active lawsuits and other items that are not reported, she said.

"We don't receive a report until a verdict or settlement is reached," Hofer said, adding that hospital disciplinary actions are not reported to the state. "If a civil suit involved an insurance settlement, we do receive that information and would be willing to disclose it, but the law would need to be changed significantly to do that. Right now I can't tell you if an investigation has been opened against a specific doctor."

Disciplinary actions after investigations are made public, however. Hofer said malpractice verdicts that go against a doctor and out-of-court settlements usually result in the state conducting an investigation.

State Sen. John Cullerton (D-Chicago) earlier this year tried to broker a medical malpractice reform package through the General Assembly. The package stalled after the major parties involved could not reach agreement.

Cullerton said he doubts any bill that would allow lawsuit information on specific doctors to be publicized would pass the General Assembly. But he does have hopes for legislation to allow the insurance department to collect such information in the aggregate.

"We're trying to address this information issue from the point of view of the insurance regulator," Cullerton said. "How much are awards? How much for pain and suffering, that kind of thing. Right now there are no good numbers. The issue of a chilling effect on settlements if information on individual doctors is published is valid, but we can give regulators information to know if these insurance rates are valid."]]> 2004-12-21T18:10:31Z 2004-12-21T12:10:31-06:00 tag:www.lasikfraud.com,2004:/news//1.88 2004-12-21T18:10:31Z

When we saw the article by Binder, we expected to find the answer to many questions about how to predict the patients at higher risk for developing corneal ectasia after laser in situ keratomileusis (LASIK). Perhaps a magical formula would be described.

After reading the excellent review by Binder, we see that, unfortunately, the answer to the predictive question still eludes us. In the large experience with LASIK reported in the article, we did not see 4 aspects that might be important in predicting corneal ectasia after LASIK:

1. Matching the number of LASIK cases performed during a year with each brand of laser versus the number of cases of corneal ectasia reported with each brand would give some figures related to the safety of the equipment. Interpretation of this matching might be difficult unless the date of LASIK surgery is taken in account to compare with the number of cases performed with the brand of laser the same year.
    
2. The intraocular pressure (IOP) is not measured in the reported cases. Because many myopes, even young ones, may have high IOP, this measurement should be included in the evaluation of patients at risk for corneal ectasia. Some mention of this is made related to the corneal thickness (“…the posterior cornea is unable to withstand normal [IOP] if it is too thin”), thinking that the ocular wall is the key factor and missing that the eventually abnormal IOP itself is the triggering factor.
    
3. The age of the patients is not mentioned and is not commented on by the author as a risk factor. Although to our knowledge though there is no evidence that the collagen of the young cornea is weaker and/or more elastic than the collagen of the older cornea, some consideration of the age factor should be taken. It makes sense to us that young corneas might be more complacent to deformation due to interaction between the IOP (normal or higher) and the corneal thickness. In fact, young myopic eyes that do not have stable refractive errors do have axial length changes over time. Since the increase in axial length stops by the third decade of life, a kind of “maturity” of the ocular wall might decrease the risk for corneal ectasia after this age. Whether the change in the ocular size in young myopic patients happens because the sclera is very elastic or the cornea is stretched and/or deformed at the same time is unknown. Regarding the size of the eye, the different evolution of the eye of a 5-year-old child with congenital glaucoma and the eye of a 60-year-old patient gives an idea of the tissue difference due to age. The zero rate of corneal ectasia after hyperopic LASIK might be related to the thicker and harder corneas found in older eyes (hyperopic LASIK tends to be performed in older patients than myopic LASIK) and/or to the fact that the central corneal thickness is not modified by the laser (beyond the creation of the corneal flap). The stability of the hyperopic eye relative to corneal ectasia might be related to a different histological or histochemical condition of scleral and corneal tissue that share the same embryological origin; ie, the hyperopic ocular wall is able to bear normal or even high IOP without the risk for developing corneal ectasia.
    
4. Since different tissue behavior in men and women is an empiric observation in other areas of our physiology, the sex of patients with corneal ectasia after LASIK should be taken into account. Any study should match the number of LASIK cases performed in a given universe with the number of cases of corneal ectasia after LASIK that occurred in this universe.
    
5. In the literature, we have not found a numeric threshold to validate the differences in pachymetry between the superior and inferior areas of the cornea. There is also no mention of this pachymetric asymmetry in the review by Binder. We lack information about the significance of this finding in some patients, and we do not know whether it is significant when the asymmetry is larger than some value. Theoretically, a big difference (how much?) between the superior and inferior pachymetry could be a pre-ectatic stage.

In conclusion, the formula for identifying patients at risk for developing corneal ectasia after LASIK is probably multifactorial and includes residual stromal thickness, IOP, age, sex, a collagen-factor (unknown so far), and retreatment or LASIK enhancement. The difference between superior and inferior pachymetry may be another variable in this multifactorial formula.

The expression “collagen-factor” used above is a way to assume our ignorance of what is going on in the corneal tissues after LASIK. Identifying the risk factors and disclosing the specific role of each factor will help us reduce this complication of refractive surgery.

References

P.S. Binder, Ectasia after laser in situ keratomileusis, J Cataract Refract Surg 29 (2003), pp. 2419–2429.

Schiffer v. Speaker - On September 29, 2000 Mark Schiffer met for the first time with an optometrist, Dr. Regina Zyszkowski, to determine whether he was a suitable candidate for LASIK surgery. He wore glasses at the time. Dr. Zyszkowski was an employee of Farkas, Kassalow, Resnick and Associates. She performed various tests on Mr. Schiffer's eyes, including a keratometry, a topography and a slit lamp exam. Because Dr. Zyszkowski noticed an irregularity in Mr. Schiffer's retina, she referred him to a retina specialist, Dr. Kenneth Carnevale. On or about October 3, 2000 she heard back from Dr. Carnevale that the planned LASIK surgery was not contraindicated. She then referred her patient to TLC Laser Eye Center and set up an appointment for the procedure for October 6. She testified at her deposition that she specifically wished the surgery to be done by Dr. Mark Speaker, but there is no evidence that that information was communicated to Mr. Schiffer.

On the 6th, Mr. Schiffer appeared at TLC's offices [his first visit there] where he met with Dr. Speaker. He then underwent various tests by the doctor, signed a multi-page consent form and submitted that day to bilateral LASIK surgery by Dr. Speaker.

Dr. Speaker is both the sole shareholder of his P.C., Laser and Corneal Surgery Associates, and Medical Director of TLC. In the latter capacity, for which he is paid $25,000 per year, his duties include administrative functions as well as those involved in the care and treatment of patients.

After the surgery was performed, seemingly without complications, Mr. Schiffer made seven post-operative visits to Dr. Zyszkowski. On the final visit, on May 16, 2001, she noted some far-sightedness with astigmatism and discussed with him the possibility of a second "enhancement" surgery. Dr. Zyszkowski however first requested additional testing, specifically pachymetry and topography from Dr. William Tullo, an optometrist and Clinical Director of TLC, as well as Dr. Zyszkowski's former professor.

Mr. Schiffer returned to TLC on June 5, 2001 and on that day was examined first by Dr. Tullo and then by Dr. Speaker. Both agreed that Mr. Schiffer had a thinning of the cornea, a condition known as ectasia, which made additional surgery unsound. The enhancement procedure was cancelled. Mr. Schiffer went on his way and never returned.

However, Mr. Schiffer has now been diagnosed with Keratoconics, a degenerative condition of the cornea. He has sued all of the above-mentioned health care providers for injuries he has suffered allegedly from the October 6th LASIK surgery. This surgery, he claims, should never have been performed because of the Keratoconus, a condition he says was present before the surgery or could have been anticipated. He now suffers from impaired vision, particularly in his left eye where his vision is blurred and distorted. He has been advised that the only possible treatment would be corneal transplants.

I have before me two substantive motions and one procedural one. First, defendant TLC is moving for summary judgment dismissing the two causes of action that make up the complaint, the first that sounds in negligence or medical malpractice, and the second which alleges a lack of informed consent. The only other defendant that takes a position on TLC's motion is Mark Speaker and his P.C., Laser & Corneal Surgery Associates. They partially oppose the motion, specifically that part of it which seeks to dismiss the aspect of the claim that asserts a theory of vicarious liability against them vis-a-vis the actions of Dr. Speaker. However, those defendants join in TLC's motion to dismiss the lack of informed consent claim via their own cross-motion. Not surprisingly, the plaintiff vigorously opposes both motions.

On the procedural front, TLC is moving pursuant to CPLR §[3124 for an order directing plaintiff to provide further identifying information for its expert witness pursuant to CPLR §[3101[d][1][I], or alternatively to preclude the plaintiff from offering the witness at trial. Dr. Speaker and his P.C. again join in this motion. Here, plaintiff not only opposes but cross-moves for a protective order, pursuant to CPLR §[3101[d] and 3103[a], shielding the qualifications of his medical expert from further disclosure and also requiring defendants to enter into a confidentiality agreement vis-a-vis his tax returns and those of his employer, which this Court had previously ordered disclosed.

The Summary Judgment Motions

It is TLC's contention in support of its summary judgment motion that Dr. Speaker, though having a relationship with them and performing surgery at their facility, was an independent contractor, thereby relieving TLC of any responsibility. They point out that Dr. Zyszkowski is not their employee either. Finally, they argue that TLC had nothing to do with Mr. Schiffer before his October 6 surgery and nothing to do with the decision to go ahead with that surgery.

As to the lack of informed consent claim, both defendants point to the multi-page consent form Mr. Schiffer signed, at Dr. Speaker's request, before the surgery on October 6 and urge that such form clearly lays out all of the risks associated with the procedure and even gives the patient the opportunity to ask questions. In fact, they point out that on page 2 of the consent form [a page the plaintiff initialed as he did all pages], Section 3, concerning LASIK indications and contraindications, it states "candidates must be free of certain eye diseases including Keratoconus, glaucoma, cataracts and certain retinal optic nerve diseases." Therefore, defendants say that as a matter of law, it must be found that Mr. Schiffer had been adequately informed of the reasonably foreseeable risks of the surgery.

Plaintiff's opposition consists of a physician's affirmation [redacted to retain his anonymity as will be discussed more fully later], certain exhibits concerning Dr. Speaker's relationship to TLC, and a memorandum of law. Their doctor, an ophthalmologist who performs these procedures, gives his opinion that Mr. Schiffer presented to the defendants, prior to the LASIK surgery, with form fruste Keratoconus, a condition that made the surgery contraindicated. Further, he points to testimony given by Dr. Speaker to the effect that Mr. Schiffer presented on October 6 with an anomalous inferior steepening of the cornea of his left eye. This, according to the expert, increased plaintiff's risks and made the LASIK surgery unwise. However, the patient was never given this information.

Counsel for Mr. Schiffer points out the following vis-a-vis TLC and their relationship with the other defendants. First of all, the fee of $5500 paid by the plaintiff was divided in the following way: $1100 to the Farkas Group, $1100 to Dr. Speaker, and the remaining $3300 to TLC. Further, Dr. Speaker was a Corporate Director in TLC's Delaware affiliate and received stock in TLC, a publicly traded corporation. Also, he did all of his LASIK surgery at their facility and relies on them for his pre-op data.

Finally, in Reply, TLC points out that Dr. Speaker's agreement vis-a-vis his Medical Directorship excludes seeing patients or practicing medicine. Therefore, they maintain they are not responsible for his activities when he does this work. Their agreement even contains a clause to that effect, they argue.

TLC's motion is denied vis-a-vis both causes of action, as is Dr. Speaker's motion vis-a-vis the second cause of action relating to informed consent. First of all, agreements between parties are "not determinative of the relation [vis-a-vis third parties] in the event that the actualities indicate otherwise." Mduba v. Benedictine Hospital, 52 AD2d 450, 452 [Third Dept, 1976], quoting Matter of Fidel Assn. of NY, 259 App. Div. 486, 487 [Third Dept, 1940], aff'd 287 NY 626. Second, issues as to whether a medical practitioner is truly an independent contractor as opposed to an employee are traditionally issues of fact best left to be decided at trial. Campanelli v. Flushing Ultrasound, 287 AD2d 428 [Second Dept, 2001], lv. dismissed 98 NY2d 692 [2002]; Felice v. St. Agnes Hospital, 65 AD2d 388 [Second Dept, 1978].

Finally, pursuant to the theory of ostensible agency, wherein a patient such as the plaintiff here comes to a facility for services and is provided those services by a doctor at the facility and has no reason to suspect or believe the doctor is not working for the facility, rather than simply at it, that facility can be held responsible for the conduct of the doctor. Hylton v. Flushing Hospital and Medical Center, 218 AD2d 604 [First Dept, 1995], lv. den. 87 NY2d 807 [1996]; Soltis v. State of New York, 172 AD2d 919 [Third Dept, 1991].

As to the informed consent issue, the expert opines that all the risks specifically affecting Mr. Schiffer, including the steepening of the cornea of his left eye, should have been told to him and were not. This opinion, at the least, creates an issue of fact, despite the signed consent form, that he may not have been given all the necessary information. Eppel v. Fredericks, 203 AD2d 152 [First Dept, 1994].

The Issue of Expert Disclosure

The second motion and cross-motion, concerning how much expert disclosure the plaintiff must provide, is an interesting one here. Section 3101[d][1][I] mandates disclosure of identifying information about a proffered expert, though in medical malpractice cases the name of that expert does not have to be revealed. However, with new advances in computer technology, it has become relatively simple for the expert's name to be discovered when enough information is provided. That information includes the expert's board certifications and when they were obtained, the jurisdictions where she is licensed, the medical school attended and the dates of attendance, the institutions where residencies and fellowships were served with their dates, and whether the expert has published books and articles and, if so, the details. It is probable that with the disclosure of only some of these details, particularly with their relevant dates, the identity of the expert would be revealed.

Because of this relative ease of identification, courts throughout the State have attempted to fashion