Lawsuits filed against Alcon for LADARVision

Since the complaints were filed, three of six cases were resolved in favor of Alcon.

Several lawsuits have been filed against Alcon for alleged performance problems with its LADARVision 4000 Excimer Laser System. An online review of active litigation by Ocular Surgery News identified six cases by physicians and patients against the maker of the laser system.

Claims brought against the laser manufacturer by surgeons and patients have asserted negligence, product liability and functioning defects. In one statement, a user of the laser reported “abnormally high” retreatment rates when performing refractive surgery. Other parties allege that Alcon was aware of performance issues with the laser as early as 2001 and attempted to conceal the reports from users and the general public.

When contacted for comment, Kevin J. Buehler, Alcon’s senior vice president of U.S. operations, told Ocular Surgery News that he could not discuss active litigation, but he said that the lawsuits are without merit and that the LADARVision 4000 laser is “safe and effective.”

“[The laser] has been used by hundreds of eye surgeons, including some of the world’s leading specialists, to perform more than one million procedures since 1999 with excellent results. Numerous peer-reviewed studies published in respected medical journals confirm the safety and efficacy of the LADARVision 4000,” Mr. Buehler said in a written statement provided to OSN.

Since the lawsuits were filed, beginning in 2003, three of six cases that Ocular Surgery News is aware of were resolved in favor of Alcon, and the remaining three are still in litigation.

Physician sues

Sandra Brown, MD, filed an original petition with the District Court of Tarrant County, Texas, against Alcon Laboratories and Alcon Manufacturing in January 2005.

Dr. Brown is an ophthalmologist, but she filed her suit as a LASIK patient. According to her statement, Dr. Brown said she suffered physical injury after undergoing a LASIK procedure with the LADARVision system – a product she claimed was “defective by design” and “unreasonably dangerous.”

In Dr. Brown’s petition, she asserted that prior to her surgery, “Alcon knew the retreatment rates for patients who had procedures with the product were excessive; [that] incidents of adverse events occurred more frequently with the Product including, but not limited to over-corrections, decentrations, small optical zones, systematic under-ablations and/or epithelial ingrowth.”

As a result, Dr. Brown claimed that Alcon “actively and fraudulently concealed the danger of the laser for use on the general public.” She is suing for damages resulting from Alcon’s alleged negligence, product liability, manufacturing defects and malice.

She is also suing for aggravated assault, according to her petition, because she believes that Alcon “knowingly committed acts of aggravated assault which caused serious bodily injury.”

Alcon has denied liability in the case and said in a statement provided to Ocular Surgery News that “it will vigorously defend the action.”

Practice files complaint

One month before Dr. Brown’s petition, Sheri Rowen, MD, Rowen Ophthalmology, PC, and EBW Laser of Baltimore filed a complaint against Alcon; Alcon RefractiveHorizons Inc., a wholly owned subsidiary of Alcon Holdings Inc.; and EBW Laser Inc., a laser leasing company, regarding the performance and lease of the LADARVision System.

Dr. Rowen had entered into a lease agreement with EBW in 2000 to supply her facility with the LADARVision system and provide maintenance. In 2001, Alcon RefractiveHorizons was contracted by EBW to provide additional care for the laser.

In the statement filed with the U.S. District Court for the Middle district of North Carolina, Greensboro division, Dr. Rowen and co-plaintiffs claimed to experience “abnormally high re-treatment rates” when performing refractive surgery with the Alcon system.

“As a result of the defective nature of the lasers and the resulting visual problems caused by said defects, Plaintiffs were frequently forced to re-treat patients, thus incurring considerable expense, loss of income, loss of goodwill and loss of time,” the complaint said.

The plaintiffs are suing for damages in excess of $75,000; they allege that Alcon engaged in breach of express warranty and implied warranty, and, together with Alcon RefractiveHorizons, committed fraud, civil conspiracy, unfair and deceptive trade practices, negligent misrepresentation, negligence and breach of contract. Charges against EBW include breach of warranty and unjust enrichment at the plaintiffs’ expense.

Alcon has moved to dismiss the case and is awaiting a decision from the court, according to a statement from the company.

Patient files claim

Another patient-related case in active litigation against Alcon Laboratories Inc. and Alcon Inc., was filed in January 2004.

Jeremy and Catherine Davis filed a statement of claim with the Superior Court for the State of Washington in King County, alleging that Alcon engaged in negligence, product liability, breach of express warranty and implied warranty, fraud, misrepresentation and criminal enterprise over the company’s handling of the LADARVision system.

“The negligence of Defendants, its agents, servants and/or employees consisted of permitting and/or causing a defective and/or dangerous product and system to be sold and distributed, failing to appropriately advise medical professionals of potential problems with the Ladar Vision System, and were otherwise negligent,” the plaintiffs said in their statement.

In the complaint, Mr. Davis said that he sustained “severe and permanent” physical injuries and mental suffering after undergoing LASIK surgery with the Alcon system in 2001. He claimed that Alcon misrepresented the safety and efficacy of the laser in its marketing efforts, and he and his physician relied upon these “misrepresentations or concealments.”

Mr. Davis also alleged that when Alcon become aware of “extremely serious problems” with the system the company failed to report the problems to the Food and Drug Administration.

As a result of the alleged mishandlings, the plaintiffs are suing Alcon for general and punitive damages; the amount will be determined at trial.

Alcon has moved for summary judgment in its favor and is awaiting the Davises’ response and a decision from the court, according to Alcon.

Laser center loses appeal

Two lawsuits regarding the LADARVision system were recently resolved in favor of Alcon.

One was filed by Will Vision & Laser Centers, a refractive practice in Vancouver, Wash., and EBW, a company that has leased the LADARVision system to health care providers.

In March, Will Vision & Laser Centers lost an appeal against Alcon; the clinic is expected to pay the laser manufacturer more than $1.1 million for back payments owed on a lease of lasers.

Brian R. Will, MD, director of Will Vision & Laser Centers, told Ocular Surgery News that he halted payments in 2000 when the LADARVision system allegedly began malfunctioning in his practice. He said that a “high number” of LASIK procedures produced adverse outcomes, causing his enhancement rate to increase.

In January 2004, Will Vision & Laser Centers was ordered by a trial court to pay Alcon about $1.5 million. The clinic defaulted on the payment agreement and 1 year later appealed the ruling in Washington State’s King County Superior Court of Appeals. The appeals verdict in March upheld the initial ruling in favor of Alcon.

The appeals court reported in an unpublished opinion that the Will Vision & Laser Centers allegations of fraud, misrepresentation and other misconduct by Alcon “cannot prevail” by matter of law.

Third-party complaint

Another court found Alcon Laboratories Inc. and RefractiveHorizons LP not liable for $2.6 million in payments to GE Healthcare Financial Services. In that case, GE had sued EBW for payments and EBW subsequently filed a third-party complaint against Alcon, claiming that Alcon was responsible for the sum.

GE sued EBW for failing to make payment on the leases of 16 LADARVision systems, which were owned and manufactured by Alcon and Refractive Horizons. In the third-party complaint, filed in July 2003 with the United States District Court for the middle district of North Carolina, EBW claimed that the defendants “failed to disclose serious continuing malfunctions with the [laser systems that were] well-known to [the companies]” in 2001, when EBW entered into a contractual agreement to lease a number of lasers. EBW claimed that as a result of the malfunctions the lasers were “totally unusable.”

In December 2004, the district court found EBW responsible for the payment.

EBW litigation

In related litigation, Alcon sued EBW for non-payment of fees, and EBW filed counterclaims and a countersuit. Shortly before Alcon’s claims against EBW were to proceed to trial, EBW filed a bankruptcy petition in the U.S. Bankruptcy Court for the Middle District of North Carolina.

According to a statement from Alcon and information provided by EBW’s attorneys, on Alcon’s motion, the bankruptcy court appointed a trustee to replace EBW’s management, and the trustee ultimately agreed to resolve all the claims. Under the resolution, a judgment will be entered in favor of Alcon for $2.2 million, Alcon has an allowed claim in the bankruptcy of more than $1.5 million, and Alcon will repurchase four LADARVision systems from EBW. All litigation between the parties will be dismissed.

For Your Information:

• Kevin J. Buehler, senior vice president of U.S. Operations for Alcon, can be reached at 6201 S. Freeway, T 7-10, Fort Worth, Texas 76134; 817-551-4574; fax: 817-568-7131; e-mail: kevin.buehler@alconlabs.com.
• Brian R. Will, MD, can be reached at Will Vision & Laser Centers, 8100 NE Parkway Drive, Vancouver, WA 98662; 360-885-1327; e-mail: drwill@willvision.com.

• Alcon, maker of the LADARVision laser, can be reached at 6201 South Freeway, Fort Worth, TX 76134; 817-293-0450; fax: 817-568-6142.

References:

• Rowen v. EBW Laser, Inc., No. 1:04CV01213 (M.D.N.C., Dec. 29, 2004).
• Davis v. Alcon Lab., Inc., No. 04-2-00151-0 SEA (Wash., Jan. 7, 2004).
• Brown v. Alcon Mfg., No. 236-209603-05 (D.Tex., Jan. 25, 2005).
• GE Healthcare Fin. Serv. v. EBW Laser v. Alcon Lab. No. 1:03CV00514 (M.D.N.C., June 30, 2003).
• Alcon Lab., Inc. v. Will Vision & Laser Ctr., P.C., P.3d, 2005 WL 583390 (Wash.App. Div. 1, Mar. 14, 2005)
• GE Healthcare Fin. Serv. v. EBW Laser, Inc., 225 F.R.D. 176 (M.D.N.C., Dec. 08, 2004)

• Nicole Nader is an OSN Staff Writer who covers all aspects of ophthalmology, specializing in pediatrics/strabismus and neuro-ophthalmology.