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“Off-label” LASIK Class Action Claims Rejected by Ninth Court of Appeals
Doctors who treat their patients with proper care can’t be sued for using drugs or devices that haven’t been approved by the U.S. Food and Drug Administration, a federal appeals court ruled Monday.
In a suit over laser optical surgery, the Ninth U.S. Circuit Court of Appeals in San Francisco rejected claims that patients were either defrauded or made the unwitting subjects of medical experiments when doctors used lasers in ways that the FDA had not yet approved.
As long as the lasers were being used for a “therapeutic purpose” and the patients did not show they were harmed, the court said, their rights were not violated by any failure of the doctors to disclose the devices’ FDA status – a common practice known as “off-label” use.
Kenneth Pedroza, a lawyer for several doctors in the suit, said the ruling upholds their “discretion to use medications and devices as they see (to be) appropriate for their patients.” Physicians can still be sued, he said, for malpractice when they treat patients negligently.
Duane Admire, a lawyer for laser surgery patients, said the ruling leaves them without recourse when they are unknowingly treated with drugs or devices that the government has not yet found suitable for the purpose.
“Why have an FDA if the doctors don’t have to follow the rules?” he asked.
The so-called Lasik surgery device, manufactured by Nidek Co., was approved by the FDA in 1998 for treatment of nearsightedness and in 2006 for operations to correct farsightedness.
The suit was filed as a proposed class action in San Diego on behalf of patients who underwent Lasik surgery for farsightedness between 1996 and 2006. None of the patients alleged they had been injured.
The appeals court, in upholding a federal judge’s dismissal of the suit, said a 1978 California law, which requires a patient’s consent to conduct medical experiments, applies only to research projects and not to therapeutic treatment.
The court also said federal law does not require doctors to tell patients that medical devices have not been approved for a particular use.
“We do not pass judgment on whether this would be a wise rule for the FDA to adopt,” but it has not done so, said Judge Margaret McKeown in the 3-0 ruling.
Read more: http://www.sfgate.com/health/article/Lasik-surgery-case-claims-rejected-4383581.php#ixzz2Of7RC69v
