Lasik Patients Sue Over Unapproved Use of Surgical Tool

A medical device maker and more than a dozen California ophthalmologists are named in a federal class-action suit filed on behalf of patients who had vision correction surgery with an unapproved experimental Lasik tool.

The suit alleges that Japan-based Nidek Co. and two U.S. subsidiaries conspired with the doctors and four vision care facilities to perform procedures to correct farsightedness from 1996 to 2006 using a laser tool that the Food and Drug Administration had certified only for clinical trials on nearsighted patients.

Lead plaintiff Robert Perez filed the suit in the U.S. District Court for the Southern District of California after learning in October that the Lasik surgery he underwent in 2002 to correct farsightedness was performed with a Nidek EC-5000 Excimer laser system.

Nidek was authorized to use the device only for preliminary testing on nearsighted patients, according to the complaint.

The correction of nearsightedness through myopic-correction surgery is relatively simple and involves flattening the cornea with a straight blade cut, the suit says.

However, hyperopic corrections, which treat farsightedness, are more intricate and involve making a precise, doughnut-shaped cut in the cornea, it says.

The defendants engaged in a "nationwide scheme and conspiracy" to use the device on farsighted patients throughout the clinical trial to boost profits, the suit alleges.

According to the complaint, the defendants were able to perform the unauthorized surgeries only after making unapproved changes to the laser's software and hardware

The unapproved changes to the Excimer laser, deemed a medical device by the FDA, rendered it adulterated under the federal Food, Drug and Cosmetic Act because they were made without pre-market approval or an investigational-device exemption.

When the FDA granted Nidek's application for pre-market approval of the device in 1998 the agency stipulated that, during the investigational period, the laser could be used on nearsighted patients only and not those needing hyperopic corrections, the plaintiffs say.

They add that Nidek knew that the ophthalmologist defendants were performing unauthorized operations with the device throughout the decade-long class period because the company's service technicians regularly installed and calibrated the units.

The suit alleges negligence, medial negligence and per se negligence.

It also contends that the improper use of the laser violated the California Protection of Human Subjects in Medical Experimentation Act and the state's unfair-competition law.

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