United States Ninth Circuit
Perez v. Nidek Co., LTD, 10-55577
Dismissal of complaint brought by plaintiff-patients who suffered no injuries but who were subject to the off-label use of a medical device for eye surgeries, where the Food and Drug Administration status of the device was not disclosed to the plaintiff-patients, is affirmed where: 1) the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act because the surgeries were not "medical experiments" subject to the protection of the Act; 2) plaintiff Perez did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act; and 3) plaintiff Perez's common law fraud by omission claim is expressly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), and even if it were not, it is impliedly preempted because it amounts to an attempt to privately enforce the FDCA.
Appellate Information
- Decided 03/25/2013
- Published 03/25/2013
Judges
- McKEOWN
Court
- United States Ninth Circuit