03/09/2012
David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with LASIK. The announcement came from his new company Waltham, MA-based Avedro Inc., which Muller formed with venture capital backing in 2007 after Summit was acquired by Alcon.
The new NDA seeks an indication for the treatment of keratoconus (a naturally occurring disease in which the cornea distends in a cone shape) and corneal ectasia following refractive surgery (LASIK). Morris Waxler, the CDRH branch chief who led the approval of Muller's device in 1996 and others like it, is now aggressively seeking the removal of their LASIK indication based on a higher permanent injury rate from the LASIK procedure than disclosed by the sponsors in their data submissions.
Avedro's news release quoted Cornea and Laser Eye Institute medical monitor and director Peter Hersh as saying that the "ophthalmology community is now looking forward to the possibility of offering cross-linking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need. Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Cross-linking has the promise of stabilizing these progressive corneal disorders and maintaining patients' visual function over time."
Corneal collagen cross-linking with riboflavin and ultraviolet light is described by the National Keratoconus Foundation as a process that increases natural collagen crosslinks in the cornea, thus strengthening it and preventing it from further bulging out. The treatment's possible extension to treat post-LASIK ectasia was recognized by FDA last year as deserving of orphan drug designation, offering seven years market exclusivity. Avedro's news release said the VibeX/KXL System for corneal collagen cross-linking received the European CE Mark in 2010 and has been commercially available internationally since then.
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Related:
Watch video series of an American Investigator report concerning David Muller, Summit Technology, and the scandal surrounding FDA leak of competitor's, VISX Inc., documents. Watch
Read Jim Dickinson's March 1999 article on the 1995 VISX Inc. document leak to rival Summit Technology's then-President, David Muller: [Capitol] Hill closes file on device secrets leak: ex-reviewer did it. Read article
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The letter, addressed to Steven Silverman, Director of the Office of Compliance, alleged false and misleading advertising of LASIK on the Robbins Eye Center website.
Attached to the letter was a 34-page "Consent Order" issued 11/22/2011 by the Connecticut Department of Health citing Robbins Eye Center for "wrong eye surgery, inadequate sanitation in the operating room, inadequate medical follow-up and monitoring after surgery, and questionable credentials of medical staff."
Read letter with attached consent order
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Reprinted with permission from www.fdaweb.com
FDA Warns Against Illegal LASIK Ads -- Again 09/28/2011
Despite a 5/22/09 letter to eye care professionals cautioning against inappropriate advertising and promotion of FDA-approved lasers used in refractive procedures such as LASIK, FDA says it continues to receive information concerning improper promotion and advertising practices by eye care professionals. So it is writing to them again.
In a 9/23 letter, FDA says it wants to "emphasize the importance of providing adequate risk information in [your] advertising and promotion of FDA-approved lasers used in refractive procedures, and to advise these professionals where to get additional information, if needed."
FDA says it expects that the notice and information about FDA resources on approved lasers and their associated risks will be sufficient to enable eye care professionals to correct within 90 days any ads or promotional materials that don't comply with the Federal Food, Drug, and Cosmetic Act. "After that time," it warns, "FDA may take regulatory action against eye care professionals whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions, and civil money penalty proceedings."
The letter notes that it is critical that eye care professionals disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the device's use. "FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health," it concludes.
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
On August 12, 2011, a judgment in the amount of $4,520,299.58 was entered against LASIK surgeon, Kevin Niksarli, M.D., and his professional corporation, Newsight Laser Center, PLLC.
On June 10, 2009, a Manhattanjury returned a verdict against Dr. Niksarli, in Devadas v. Niksarli, Index No. 107637/2007, for his medical negligence in having performed LASIK surgery on a patient who was not a good candidate for surgery because of the condition of his corneas. As a result, the evidence showed that Mr. Devadas developed a visually disabling condition, post-LASIK ectasia.
Following the verdict, Dr. Niksarli asked the trial court to overturn the verdict. By decision and order dated July 14, 2010, the trial judge rejected Dr. Niksarli's motion.
The judgment, which exceeds Dr. Niksarli's available malpractice insurance by more than $1 million, may be appealed within approximately 30 days.
The judgment modifies the jury's verdict, to reduce the awards of $2,360,000 for loss of income and $3,100,000 for pain and suffering, to present value. It is believed to be the first such judgment entered in a medical malpractice case in the New York County Supreme Court, since the statute, CPLR Article 50-A, §5031 - 5039, was implemented by the legislature to protect doctors and hospitals.
For further information, please contact Todd J. Krouner at tkrouner@krounerlaw.com or (914) 238-5800.
]]>LASIK Patients Ask Hamburg's Help on Deferred Petition 08/16/2011
While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her to "carefully consider each signer's remarks."
Typical of such remarks were:
Eileen Newell, CA: "This issue is VERY important to me as I am one of the 20% of people with disastrous Lasik results. I have extremely dry eyes, starbursts, double vision, and severe depression. I can't see my husband across from me at 12 feet or so. Can't drive safely night or day. I am sick that I was misled regarding the chances of something like this happening."
Vandana Gupta, India: "Because my life has changed forever. And because I have to start it afresh. And that is not easy."
Robert Owen, United Kingdom: "Am now left with huge floaters constantly in my vision as a result of LASIK; a totally unnecessary practice."
Janis Morrow, TX: "We came way too close to risk destroying our daughter's eyes with this procedure. I pray they recall the lasik devices and outlaw the procedure."
Zoltan Zeisky, PA: "I had LASIK, and I wish I could turn back the clock to undo my life altering MISTAKE!!"
Name not displayed, MO: "My brother has been practically blinded by LASIK surgery. He lives in chronic pain."
Similar anecdotal testimony, although fewer in number, was given by injured LASIK patients at an April 25, 2008 meeting of the Ophthalmic Devices Panel of FDA's Medical Devices Advisory Committee.
After hearing it all, panel chair Jayne Weiss, ophthalmology professor at Detroit's Kresge Eye Institute faulted the industry for its "aggressive marketing" but wimped out by suggesting it was something for the Federal Trade Commission to look into. Subsequent efforts to interest that agency in LASIK vendors' promotional violations produced nothing.
]]>FDA-CDRH Delays LASIK Petition Decision
08/09/2011
A seven-month-old citizen petition seeking a safety-based withdrawal of approval for all LASIK eye surgery devices "raises issues requiring further review and analysis by agency officials," according to a 7/7 letter to petitioner Morris Waxler, the former CDRH official who led the devices' review and approval. Signed by Center deputy director for policy Nancy Stade, the letter says FDA has so far been unable to reach a decision, and offers no indication of how long a decision might take. "We will respond to your petition as soon as we have reached a decision on your request," it says.
Waxler filed his petition1/6, after publicly asserting that the agency "screwed up" in approving the devices' LASIK indication, because it was based on data that were "dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers." As a result, the petition said, the data understated the adverse event incidence from 22% to less than 1%.
]]>Investigators go undercover to expose lies that LASIK clinic employees and doctors tell prospective patients about LASIK risks. Former FDA chief, turned whistleblower, exposes corruption surrounding FDA-approval of LASIK devices. Young mother talks about loss of quality of life and painful, chronic dry eyes after LASIK. Story of a police officer who took his own life after leaving a suicide note saying, in part, "Do not have LASIK surgery! Tell the media!!!" is told by his son.
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(914) 238-5800
TODD J. KROUNER* DIANA M. CARLINO†
------ SCOTT J. KOPLIK*
*ADMITTED IN NY & NJ ------
†ADMITTED IN NY & CT
May 13, 2011
PRESS RELEASE - FOR IMMEDIATE RELEASE
Dean D'Angelo and Tracey D'Angelo v. Michael D. Duplessie, M. D. and Cataract and Laser Eye Institute of
In the Circuit Court,
DR. MICHAEL DUPLESSIE, SELF-PROCLAIMED "WORLD'S BEST EYE SURGEON," SUED FOR LASIK MALPRACTICE
On January 3, 2011, Dean D'Angelo filed a statement of claim against Michael Duplessie, M.D., and Cataract and Laser Eye Institute of America, P.C., in the Health Care Alternative Dispute Resolution Office for the State of
In March 2007, Dr. Duplessie performed LASIK eye surgery on Mr. D'Angelo. The statement of claim alleges that when the initial surgery failed to improve Mr. D'Angelo's vision, Dr. Duplessie performed a second surgery, or so-called "enhancement," in June 2007, on Mr. D'Angelo's right eye, without having performed appropriate pre-operative testing. When the second surgery did not improve Mr. D'Angelo's vision, Dr. Duplessie performed a third surgery on Mr. D'Angelo's right eye, in February 2009, again without having performed appropriate pre-operative testing. When Dr. Duplessie's third surgery failed, he performed a fourth surgery on both of Mr. D'Angelo's eyes, on August 7, 2009. After four failed surgeries, Dr. Duplessie recommended a fifth surgery for Mr. D'Angelo. At that point, Mr. D'Angelo sought a second opinion, whereupon he learned that he had the cornea disease "ectasia," and was not a suitable candidate for LASIK surgery. The statement of claim contends that Dr. Duplessie's negligence in performing repeated surgeries on Mr. D'Angelo, rendered him legally blind in the right eye with a visual acuity of 20/600.
Ectasia is a disorder that causes progressive thinning and weakening of the cornea. Patients with ectasia often suffer a loss of visual acuity. In addition, individuals may suffer from a host of problems related to the quality of their vision, which include, without limitation, halos, blurry vision, glare, ghosting, starbursts, double vision, light sensitivity, contrast sensitivity, loss of depth perception, difficulty driving a motor vehicle, especially at night, headaches, dry eyes, and foreign body sensation.
Dr. Duplessie holds himself in the highest regard. On his website, he boasts that he is the "World's Best Eye Surgeon," and in a press release dated December 9, 2010, proclaims that he is "a renowned and ethical doctor whose fame and glory knows no bounds." See www.worldsbesteyesurgeon.com; http://www.free-press-release.com/news-dr-michael-duplessie-has-been-recommended-as-best-physicians-in-dc-maryland-and-virginia-1291882733.html.
Mr. D'Angelo lives with his wife, Tracey, and three children in
Mr. and Mrs. D'Angelo are represented by the Law Office of Todd J. Krouner in
A copy of the statement of claim is available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or George S. Tolley, III, Esq., at (410) 308-1600.
LASIK Mystery Solved: FDA 'Declassifies' Secret Ads Policy 02/01/2011
Direct from FDA's "egg on our face" department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency's jurisdiction/no jurisdiction over "restricted" device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted to reconcile a 20-month-old CDRH letter to eye care professionals asserting FDA jurisdiction over their LASIK ads with a 1/29 statement that FDA has no jurisdiction because the Federal Trade Commission has that jurisdiction.
Unstated in either letter was this new information, at the bottom of Riley's seven-line delayed response to our request for clarification: "If statements in advertising and promotional materials do not relate to any of these restricted devices (or other FDA-regulated product), FDA generally defers oversight of such advertising and promotion to the FTC which has authority over unfair and deceptive business practices, including false advertisements related to products and services."
If injured LASIK patients had known this 20 months ago, they could have sent all their LASIK ad complaints to FTC rather than to CDRH -- which apparently ignored them.
]]>CDRH Disowns Statutory Authority Over LASIK Ads 01/31/2011
Twenty months after CDRH's then director of compliance, Timothy Ulatowski, cautioned the nation's eye care professionals not to make misleading or unsubstantiated claims in their advertisements about the effectiveness of lasers used in LASIK surgery, the Center has conducted no follow-up and last week announced it has no jurisdiction over LASIK ads.
"These lasers," wrote Ulatowski back then, "are restricted medical devices that have been approved for particular uses and have risks associated with their use. Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.
"A restricted device is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 USC 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 USC 321(n))."
Fast-forward 20 months to last Friday (1/28), when CDRH ombudsman David S. Buckles told LASIK victim and activist Paula Cofer: "I've investigated the matter you raised regarding the advertising practices cited in your message. Because the advertising practices apparently do not relate to medical products per se, but rather are advertising for the provision of services, we do not have jurisdiction in this matter. My understanding is that these issues are handled as 'service industry claims' by the Federal Trade Commission."
Cofer, an FDA advisory panel patient representative, had sent CDRH compliance director Steven Silverman what she called a "blatantly deceptive" Web site link by Florida-based Brandon Eye Associates, and Silverman passed her off to Buckles, who has no enforcement authority.
In her request to Silverman, Cofer wrote that the Web site's front page banner headline, "Kiss Your Contacts and Glasses Goodbye is misleading and deceptive. There is no disclaimer that some patients may need to continue wearing glasses or contact lenses, and there is no mention of risks, side effects, and contraindications.
"This is an example of the typical hype and failure to disclose risks that is prevalent in LASIK advertising on the Internet," Cofer's email to Silverman went on. "We, the injured LASIK patient community, have complained about this for years, but I have seen no change in the way LASIK is advertised. Former director of compliance, Timothy Ulatowski, sent a letter on 5/22/2009 to eye care professionals in what appeared to be a crack down on false and misleading LASIK ads. Since that time, it's only gotten worse. There are thousands of LASIK ad violators on the Internet.
"As injured LASIK patients, what should we do when we see this type of illegal ad? Will anything be done by the FDA if we take the time to report them?
"I await a response."
Another victim and activist, Dean Kantis, says he has sent CDRH "hundreds" of violative LASIK ads, to no effect. Has FDA investigated any of them, and if so, with what result? Buckles says "we are not in a position to disclose the status or even the existence of compliance and enforcement actions that are being contemplated or are in progress."
Meanwhile, nearly 300 people have signed an online forum supporting a petition filed earlier this month by former CDRH ophthalmic devices director Morris Waxler, seeking an immediate ban on the procedure because of its unacceptable adverse events rate.
FDA did not respond to two requests for its input on this report.
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Why LASIK is 'Too Dangerous to be Allowed' -- German Firm 01/24/2011
As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure. Adding to data in a petition for an immediate ban from former CDRH LASIK review chief Morris Waxler, the company says it has developed a unique device that measures the topography of the eye during refractive laser treatment and its research has shown "that LASIK in general is too dangerous to be allowed," according to co-founder Daniel Kluting in an email to FDA Webview.
"The problem is that the LASIK cut brings problems to the structure of the eyes," Kluting writes. "Because we have the only measuring device that is able to measure the topometry of the eyes with resolution of a few microns, we can look deeper into microeffects than anybody else. One of the major questions in research is, what is the cornea built of? From our research it seems to be that it consists of tissue layers with a tensive strain to all sides. Think about cutting in something like that!"
The permanence of the never-healing corneal flap cut is a major concern in Waxler's petition, which last week was still deep in a queue in the Commissioner's Office, awaiting a decision on whether or not to even accept it for consideration. In less than a year, Waxler has hardened his position from tolerating LASIK's continuation to petitioning the agency for a complete ban and vowing to seek FDA Office of Criminal Investigations focus on laser makers who allegedly hid LASIK safety issues.
Moreover, it has been 16 silent months since former CDRH compliance director Tim Ulatowski launched a mini-blizzard of Warning Letters to LASIK ambulatory surgical facilities over their failure to file MDR reports and peppered the industry with advice to include risk information in their ads -- with no further word from him or his successor, Steve Silverman, about agency follow-through, if any.
During the ensuing inactivity, injured LASIK victim and activist Dean Kantis says he has sent the agency "hundreds" of violative LASIK ads "that do not list all known risks and side effects ... And the FDA continues to do NOTHING to discipline them. Why is it when I turn on the TV, every prescription drug commercial has 30 seconds of warnings yet when it comes to elective LASIK ads on TV or radio, there isn't one word mentioned of the warnings?"
FDA's ingrained unresponsiveness on the LASIK safety issue may be well illustrated by its failure to respond to a cogent 9/13/09, heavily documented 14-page letter from LASIK Surgery Watch to CDRH director Jeff Shuren describing the risks of the procedure and contending that "FDA has been grossly negligent and has placed patients' interests secondary to interests of surgeons and medical device manufacturers." The organization said 1/23 that none of its letters to the agency had brought responses.
Kluting's email says that "from our point of view we would like to see LASIK stopped immediately. Then the laser manufacturers need to do some basic research on eyes [to] probably come up with a completely new way how to do refractive surgery. During the last 7 years the laser industry knew the problems, but did not want to go through the process of basic research combined with the [stopping] of LASIK. Right now with LASIK the cornea is damaged, the only good thing is that the cornea excuses a lot and the eye is still able to see. Nearly all risks of LASIK are because the procedure is not safe. It's not because of the patient or a misfortune.
"We have just a measuring device. Our goal was to measure the ablation during refractive surgery to avoid using nomograms and be more precise. We did clinical trials with one of the large players on the market. But we found out that first all surgeons and the industry need to understand the eye better. We have a couple of ideas how refractive surgery can be in the future, but till now ... laser manufacturers avoid ... [talking] with us. Even those we made the clinical trials with, 8 years ago. It's easier to leave the moneymaking machine LASIK turned on than to go through the struggle of development.
"So we went into the market of scleral lenses and wait for the refractive market to wake up. All patients who got hurt by LASIK since mid-2005 could have been prevented."
BioShape's new report next week is expected to update and supersede its 2005 report on the same subject, Complications of Refractive Laser Surgery.
In a comment to FDA Webview, former FDA medical device compliance director Larry R. Pilot, who has been deeply involved in the LASIK issue with injured patients, called FDA's management of its regulatory program for LASIK "a clear dereliction of duty and responsibility to the concept of 'protection of the public health'.
While there may be valid applications for LASIK eye surgery," Pilot continued, "the vast majority of uses involve risks to the patient/customer that are often unknown until after the fact. The FDA/CDRH has failed incredibly to monitor post market experience through its mandatory MDR program. For just this program alone, the potential for patient protection was there for years, yet the CDRH deliberately ignored the responsibility to inspect or review the performance of any of the possible thousands of user facilities which were in absolute violation of law and regulation.
"Current and past FDA/CDRH employees shared this liability and should have been/should be punished for their failures. ... I agree that the optimal approach to reporting is to have the FDA/CDRH enforce the MDR requirement applicable to user facilities. From the outset of my involvement with this LASIK issue, I have repeatedly emphasized this fact. It took two years for the FDA to display some movement, but more is needed."
Asked to comment on this story, FDA press officer Karen Riley replied: "We cannot comment on the specifics of the German report, as we have not received or reviewed it. As you well know, FDA continues to monitor the safety and effectiveness of all devices, including the lasers approved for LASIK. In October of last year we provided a brief update on our role in a three-part study of LASIK that is still in the beginning phases. It is a project that we hope will yield additional insights about this procedure. Stay tuned."
]]>• Homemade lasers ('black boxes')
• Imported investigational lasers ('grey boxes')
• Illegal key cards ("Bermuda cards") and
• 'Off-label' photorefractive keratectomy (PRK) lasers