Lasik Docs Duck Suit on Off-Label Surgeries

(CN) - Off-label use of Lasik technology did not amount to illegal medical experimentation on humans, the 9th Circuit ruled Monday, tossing a class action.

None of the named plaintiffs - Robert Perez, Nancy Art and Brett Harbach - claimed that they suffered injuries from the surgical procedure, short for laser in situ keratomileusis.

They claim, rather, that a number of doctors used a Nidek EC- 5000 Excimer Laser System to correct their farsightedness before the Federal Drug Administration had approved the Lasik for that purpose.

Each said they would not have gone through the surgery had they known it was unapproved.

Their complaint alleged that anyone who used the surgery to correct farsightedness from 1996 to its FDA approval date 10 years later was an unwitting participant in a kind of unannounced clinical experiment.

They accused Nidek and their doctors of having "engaged in a nationwide scheme to modify the approved laser to enable it to correct farsightedness before it was approved for that purpose."

Among other things, they sought damages under California's Protection of Human Subjects in Medical Experimentation Act.

The FDA, which conducted clinical trials on the technology during the class period, sent warning letters to Nidek in the early 2000s to address concerns that it was using it for "unapproved applications," according to the ruling. The plaintiffs claimed that the company ignored the warnings and continued to install and market the lasers to correct farsightedness.

A federal judge in San Diego dismissed the action, and a three-judge panel of the 9th Circuit affirmed on Monday, refusing to classify the surgeries as "medical experiments."

That definition goes far beyond what the California Legislature intended in passing the act, which "purposefully excluded therapeutic off-label use," according to the ruling.

Plaintiff Perez, for example, "admits that the surgeries had a therapeutic purpose," the opinion states.

"He does not claim that this therapeutic purpose was merely incidental to a broader research goal - in fact, he does not claim that there was any research goal whatsoever," Judge M. Margaret McKeown wrote for the panel. "Without doubt, the hyperopic surgeries at issue here were 'reasonably related' to 'improving [Perez's] health' and 'directly benefiting' him." (Brackets in original.)

The panel also agreed with the lower court that the plaintiffs had no standing to seek injunctive relief under the California Consumers Legal Remedies Act, and that the Federal Food, Drug and Cosmetic Act pre-empted their other claims.

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