Robert Perez v. Nidek Co., Ltd.

We are asked to decide whether patients who suffered no injuries but who were subject to the off-label use of a medical device for eye surgeries may bring suit solely because the Food and Drug Administration (“FDA”) status of the device was not disclosed to them. The Third Amended Complaint (“the Complaint”) does not state a claim under the California Protection of Human Subjects in Medical Experimentation Act (“the Human Subjects Act”) because the surgeries were not “medical experiments” subject to the protection of the Act. Robert Perez does not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (“CLRA”), and his other substantive claim is preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”). We affirm the district court’s dismissal of the Complaint.

Background

Robert Perez, Nancy Art, and Brett Harbach (collectively, “Perez”) each sought and received Laser in Situ Kera-tomileusis (“LASIK”) eye surgery with a Nidek EC-5000 Excimer Laser System (“the Laser”) to correct farsightedness. They claim that, at the time of their surgeries, they did not know the FDA had not approved the Laser for this use. According to the…