Off-Label Use not cause for Lawsuit, Appeals Court Says

Patients cannot sue a doctor who uses a drug or device for an off-label, unapproved use as long as the use is therapeutic and not research-oriented, and as long as the doctor is providing proper, acceptable care, according to a ruling made yesterday by the Ninth US Circuit Court of Appeals in San Francisco, says a San Francisco Chronicle article.

The case before the Appeals court had to do with LASIK patients treated with a certain type of LASIK device made by Nidek Co. In 1998, the device was approved by the FDA for treating nearsightedness. It was not approved for treating farsightedness until 2006; however, the patients involved in the potential class-action had been treated with the LASIK device for farsightedness before it was FDA approved for that use.

None of these patients could show they had been injured by the off-label use, just that they had not been aware the treatment was off label.

The court ruled as long as the use of the device is therapeutic and does not harm the patient, doctors are not obligated to disclose whether a device is being used off label.

Doctors can still be sued for negligence leading to the injury of a patient.

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