Did Alcon, one of the largest providers of the excimer laser in the world, systematically perpetrate fraud upon surgeons and patients? The EBW Laser versus Alcon brief below states that when problems were reported, Alcon would act as if this is the first time they'd heard about any problem. What's remarkable about this allegation is that it's being made by doctors against a laser manufacturer. Damaged patients say the same thing about doctors all the time. One of the first things a surgeon may say to patients with complications is, "You're a success!" How ironic it is that this same excuse is being used against the surgeons themselves now.
Alcon Sued for Product Liability Due to Recall of Defective LADAR6000 Excimer Laser
From the press release: 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.
Fox News Chicago report on Alcon LADARVision scandal
Legal Brief: EBW Laser vs. Alcon
From the lawsuit: "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."Read the Entire Legal Brief
Fears that grew over 'perfect' operation: Times Online, Britain
From the article: "When a number of doctors from across America began to question whether Alcon’s Ladarvision system, a machine using Nasa laser technology, was malfunctioning, the company had two choices. It could have gone public, and recalled the potentially defective model or, like the three wise monkeys, it could see no evil, hear no evil and speak no evil."Original Article
Texas Woman Sues Maker of LADARVision
Victim says eyes were injured by Alcon Laser System
Dallas, TX (PRWEB) 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. Browns 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.
From the article: "LADARVision detractors cite a study published in the April 2003 edition of Ophthalmology as evidence that they’re right. The study, authored by Peter Hersh, M.D., an Alcon (Forth Worth, Texas) consultant concluded that “patients treated on the LADARVision laser had almost twice the rate of retreatment (18.2%) compared with the Summit Apex Plus laser (9.7%),” which is no longer manufactured."
Read excerpts from an FDA meeting to review clinical trials for Alcon LADARVision:
Read the warning letter issued by FDA to Alcon Laboratories, Inc. on April 15, 2005 regarding serious problems with the LADARVision excimer laser:
Excerpts from November 19, 2004 deposition of Morris Waxler, PhD, former Chief, Diagnostic and Surgical Devices Branch of the FDA Division of Ophthalmic Devices:
Read more about problems with Alcon lasers:
Read November, 2007 FDA inspection report:
Read FDA recall of Alcon LADAR6000™ Excimer Laser System 2/21/2007