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December 16, 2008

PRESS RELEASE - FOR IMMEDIATE RELEASE

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

Manhattan LASIK Center, PLLC, and NewSight Laser Center, PLLC

New York County, Supreme Court of the State of New York

Index # 107637/07

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. 

The lawsuit claims that Mr. Cantalupo had thin corneas, which should have disqualified him for LASIK surgery.  He now suffers permanent eye damage.  Source

Dr. Mark Whitten was previously sued for performing LASIK on a young woman whose pupil size made her a poor candidate for LASIK.  She suffers permanent visual aberrations which cannot be corrected with glasses.  View lawsuit

Tiger Woods also experienced problems with his vision after LASIK.  "My vision started slipping," he said in 2007.  USA Today reported that Tiger had to undergo more LASIK surgery after the 2007 Masters tournament.  Source 

It is well-known that LASIK risks increase with thin corneas, large pupils, and repeat surgeries.  The FDA has not approved LASIK reoperations. 

Washington, D.C. - Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, today launched an investigation into whether managers within the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations designed to assure the safety and effectiveness of medical devices. Such activity could allow potentially unsafe and ineffective medical devices into the U.S. market.

The investigation was prompted by receipt of an October 14, 2008, letter written on behalf of a large group of CDRH scientists and physicians who state that CDRH managers have "corrupted and interfered with the scientific review of medical devices."

"These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of America consumers," said Dingell. "I commend the FDA scientists for courageously sounding the alarm on what appears to be a serious problem. I look forward to pursuing the steps necessary to ensure that the medical devices Americans depend on are safe and effective."

"Our investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, and now serious allegations have been raised about the scientific integrity of the FDA medical device approval process," Stupak said. "Although the FDA has launched its own investigation into this matter, no corrective action has been taken. The committee intends to learn what action the FDA plans to take to ensure the integrity of the medical device approval process and prevent retaliation against the scientists who blew the whistle on these activities."

This Committee has been provided with compelling evidence to support the charges that senior managers within CDRH "ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law." The CDRH scientists also claim that CDRH managers ordered them "to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid or obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects."

Additionally, documentary evidence reviewed by this Committee indicates that CDRH scientists who raised concerns up their chain of command have experienced reprisals for their insistence on adherence to a scientific and regulatory basis for medical device review. To protect these CDRH scientists who have risked their careers to bring their concerns to the attention of this Committee, we will not disclose their identities at this time.

Since January 2007, the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations have been investigating the ability and commitment of the Food and Drug Administration to protect Americans from unsafe food, drugs, and medical devices. For more information about the Committee's ongoing drug safety investigation visit: http://energycommerce.house.gov/Investigations/FDADrugSafety.shtml

During this Congressional session, Committee leaders released draft legislation aimed at improving the safety of food, drugs, devices, and cosmetics. Work in this draft bill, the "Food and Drug Administration Globalization Act," continues. Committee leaders plan to introduce comprehensive legislation early next session. For more information visit: http://energycommerce.house.gov/FDAGlobalAct-08/index.shtml

In a letter sent today to FDA Commissioner Andrew C. von Eschenbach, Dingell and Stupak requested a briefing on what actions the Commissioner has taken to date and how the Commissioner intends to resolve all issues raised by the CDRH scientists and physicians.

Click here to read the letter

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Source: http://energycommerce.house.gov/Press_110/110nr383.shtml

A judge has just signed an order to stop the practice of medicine at the Valley Eye Center...

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

The District Court order suspends the medical licenses of Valley Eye surgeons Doctors Stella Chou, 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... 

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

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

Read the entire article at http://www.lasvegasnow.com/Global/story.asp?S=9354229 

The lawsuit, which is expected to eventually include dozens of plaintiffs, also targets former surgeon Stella Chou, alleging that she allowed Jain to perform pre-operative tests while knowing he was not a certified laser surgeon. Dr. Vikas Jain, also known as Ken Johnson, lost his medical license in Ohio in 2005, then moved to Nevada and used his wife's medical license to open the Valley Eye Center on Tenaya Way the next year... More than 20 patients suffered "substantial harm," and Jain's peers deemed him to be unqualified to perform refractive surgery, according to a report by the Nevada State Board of Medical Examiners, which is also investigating Valley Eye Center... The lawsuit filed Monday in District Court claims the Jains' center in Las Vegas was "an assembly line" where surgery was done in a "cattle call environment."

Read the entire article at http://www.lvrj.com/news/34320489.html

According to court records, plantiff's attorney Barry Levinson filed the lawsuit on November 10, 2008.     

Since the inception of LASIK, surgeons have downplayed or ignored complications such as chronic dry eyes and night vision difficulty (starbursts, halos, multiple images, and loss of contrast sensitivity) and have failed to report these problems to the FDA.  The FDA recently affirmed that these problems are adverse events which should indeed be reported: 

... "an emphasis that halos, glare, night vision problems and dry eye from LASIK should be reported to FDA." http://www.fda.gov/cdrh/lasik/latest.html

In October, 2008, the American Academy of Ophthalmology (AAO) published a new LASIK Patient Guide.  In the section titled "Sample Informed Consent", the guide lists starbursts, halos, low-light vision problems, and difficulty driving at night as "NON VISION THREATENING SIDE EFFECTS".

LASIK patients who suffer from these complications would disagree with this assessment.  Many patients report severe visual impairment, such as inability to drive at night.  Loss of dim-light vision may also lead to problems with employment and diminished quality of life.  

With publication of the new 'LASIK Patient Guide', it seems that the intent of the LASIK industry is to continue to deceive prospective patients concerning the nature, incidence and severity of LASIK-induced complications.  Until the LASIK industry is forced to acknowledge night vision problems as adverse events, and that loss of contrast sensitivity represents systematic and quantifiable LASIK-induced vision loss, they will likely continue to ignore FDA reporting requirements. 

Dear Sir, we are counsel for Nidek, Inc., which is discussed in your article, dated October 21, 2008,  entitled "Class Action Lawsuit Filed for Illegal Use of Nidek Lasers for Lasik."   Nidek denies any allegations of supposed wrongdoing on its part as alleged in the complaint and intends to vigorously defend this action, which is almost identical to another action filed by the same attorneys in early 2005 in the California Superior Court for the County of San Diego. In that action,  the trial court ruled in Nidek's favor, among other things, that Nidek was not guilty of false advetising and that the case did not present a proper class action.  Commencing in the Fall of 2000 Nidek has worked closely with the FDA to develop a method for blocking the ability of physicians to install unapproved sotftware on its EC 5000 Excimer Lasers and to identify and report to the FDA the identities of physicians who refused to permit Nidek to remove the unaproved software and to permanently modify the Laser so that such software could not be reinstalled.  The EC 5000 was approved by the FDA for treatment of hyperopia in October 2006.  In the interests of fairness, we would appreciate you making your readers aware of this information.

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Disclaimer: LASIK Newswire received the above letter by Internet communication.  We did not make any attempt to confirm the identity of the sender or the accuracy of the statements contained therein, and we accept no responsibility for its content. 

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Reprinted with permission of LASIK Surgery Watch.

http://www.lasiksurgerywatch.org/

LASIK Surgery Watch (LSW) was established to provide accurate, scientifically-based information to LASIK patients and the general public; to assist patients damaged by LASIK surgery with support and counseling; and to act as a public advocate on behalf of all LASIK patients.

LSW was formed by some of the people who testified at the FDA hearing on post-market LASIK issues in April, 2008. Their hope is that awareness of the growing body of evidence regarding adverse consequences of LASIK will compel groups responsible for regulation of the health care industry and medical devices to address important public health issues surrounding LASIK eye surgery, which include but are not limited to; night vision problems, creation of a fragile corneal flap that never heals, LASIK-induced dry eye disease, risk of undiagnosed glaucoma, and complicated cataract surgery following LASIK eye surgery.

It is vital that patients with poor outcomes from refractive surgery be represented as a cohesive group with a voice by an advocacy organization such as LSW. This has never been attempted, and the time is right to do so now. If you are a patient, a family member, friend or colleague of a LASIK patient... or if you have an interest in providing improved care for patients who have suffered from poor refractive surgery outcomes, please visit LASIKSurgeryWatch.org today and register. Because every patient counts!

www.lasiksurgerywatch.org

Thirty-one presentations were given during the open public hearing, many from patients suffering from long-term complications of LASIK. Among the proponents of LASIK was Lt. Col. Scott Barnes, MD, an Army eye surgeon who made an impassioned plea on behalf of soldiers at Fort Bragg in North Carolina, "Please don't take [LASIK] away from us."

While Dr. Barnes spoke about "refractive surgery", his testimony in the context of a special hearing on LASIK implied that his arguments were in support of the LASIK procedure.

Indeed, the Summary Minutes of the FDA hearing state that, "Dr. Barnes of the Warfighter Refractive Eye Surgery Program emphasized the importance of LASIK to the military."

The FDA hearing testimony of Lt. Col. Scott Barnes is inconsistent with his recent publications. William Trattler, MD and Scott Barnes, MD published an article in the July, 2008 issue of Current Opinion in Ophthalmology,¹ which states:

"At Fort Bragg, North Carolina, the Army surgeons have moved to 100% surface ablation in the past 2 years; the five known traumatic flap dislocations (out of 2500 procedures) due to 'typical' soldier activities contributed to this change but not as much as an analysis of the visual outcomes. A review of the 28,000 procedures has shown that soldiers with PRK or LASEK have a 20% greater chance of achieving an uncorrected visual acuity of 20/15 or better than soldiers with a similar level of refractive error undergoing LASIK."

Since manuscripts typically require months in preparation and the editorial process before they appear in print, we can assume that Lt. Col. Scott Barnes was already aware of serious problems with LASIK eye surgery when he testified at the April 25th special hearing. Why, then, did Barnes fail to raise concerns about safety and efficacy of LASIK at the April 25th hearing? Did Army eye surgeon Scott Barnes intentionally mislead the FDA and the public during his testimony to the FDA?

Watch video of Lt. Col. Scott Barnes testifying before the FDA panel on April 25, 2008. 

 Reference:

1. Trattler WB, Barnes SD. Current trends in advanced surface ablation. Curr Opin Ophthalmol.
    2008 Jul;19(4):330-4.

Dear Editor,

Recently LASIK Newswire reported that a citizen petition was filed with the FDA to ban LASIK.  The petition is based on substantial deception in the labeling and an unreasonable and substantial risk of injury.  The FDA's own data from LASIK clinical trials is cited.  The petition states, "A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved from 1998 through 2004 (exhibit B) found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes."  The analysis included newer custom LASIK technology.

The petition is published on the Regulations.gov website where comments are being accepted (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-P-0319).  As expected, LASIK providers and others who profit from LASIK are submitting comments to stop the ban.  The first to comment was Glenn Hagele of the patient harassment organization Council for Refractive Surgery Quality Assurance (CRSQA), a fake LASIK patient advocate, LASIK marketing scam (see http://www.theglennhagelereport.com/ for more information). 

LASIK surgeons commenting on the petition argue that complications such as chronic dry eyes and night vision difficulties should not be considered adverse events, calling them "side effects" or "symptoms".  LASIK surgeons quote complication rates of 1% or less, even though clinical trials and peer-reviewed medical studies prove otherwise. 

So who decides what counts as an adverse event?

"We encourage as much information as possible here, because FDA does look at every voluntary report that comes in.  If it's a decrease in vision, if it's a halo, if it's a starburst, if it's a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision," says Mary Weick-Brady of the FDA's Center for Devices and Radiological Health.

Source: http://www.npr.org/templates/story/story.php?storyId=90070220

This presents a conundrum for the FDA.  The FDA guidance document for LASIK clinical trials, which is an exhibit of the citizen petition, states "Adverse events to occur in less than 1.0 % of population".  Clearly, lasers failed to meet the guidance for approval.

The FDA's MedWatch program, which tracks adverse events from medical devices, contains hundreds of reports by LASIK patients suffering with post-LASIK dry eyes and night-time starbursts and halos.  But most LASIK patients aren't aware that such a program exists.  The reports are public record, however personal indentification information is redacted to protect patient privacy. The reports can be viewed at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm (type LZS in the product code field, change the date range, and click search).

The FDA database contains hundreds of reports of debilitating complications of LASIK, such as intractable dry eyes and incapacitating night vision impairment.  Here's a sample:

I am in constant discomfort and pain due to severe dry eye. I am not eligible to receive medicare for another two years which means I have no health insurance. I have lost two homes and can no longer work at my regular job due to this problem. I have halos, starbursts, sensitivity to light, can't tolerate wind or air from fans, can't go to shopping malls or stores without extreme discomfort which has lead to depression and anxiety.

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It ruined my vision, and gave me permanent eye pain and dryness. I now see severe halos, ghosts, multiple images, streaks, starbursts, and my vision fluctuates terribly. My contrast sensitivity and depth perception are ruined. It affects my work, my hobbies, every aspect of my life is pain and difficulty. I wake up in the middle of the night from the painful dry eye. I never knew depression until lasik.

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I had lasik eye surgery, which resulted in a litany of problems: dry eyes, ghosting, starbursts and halos at night; an inability to see in low-light situations, and a regression of my vision in my left eye that necessitates the wearing of glasses at all times. I am unable to drive at night very well. I also have recurring infections. I suffered from depression after my eyesight was negatively affected. I was a high myope with large pupils and probably had a pre-existing dry-eye condition that the doctor did not screen me for. I was a terrible candidate for this surgery, but it was done anyway, to my everlasting despair.

LASIK patients with chronic dry eyes, night vision difficulties, or other complications can file a voluntary MedWatch report at this link: MedWatch

At the FDA hearing in April, LASIK surgeons in attendance heard stories of loss of quality of life, clinical depression, and suicides related to unbearable LASIK complications (click here for FDA hearing videos).  In each case, post-LASIK dry eyes, night vision difficulties or both were reported.  But LASIK surgeons continue to deny the problems, and don't consider these so-called "symptoms" significant enough to be counted. 

It will be interesting to see how the FDA responds to this petition.

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Denver, CO (LASIK Newswire) 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 central 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 central 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.

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Contact Information
Carrie Frank
Klein | Frank, P.C.
http://www.lawcolorado.net
303-448-8884