Perez, et al v. Nidek Co., Ltd., et al, No. 10-55577 (9th Cir. 2013)
Annotate this CasePlaintiff and others sought and received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System ("Laser") to correct farsightedness. Plaintiff, on behalf of himself and a class of similarly situated individuals, claimed that, had they known that the FDA had not approved the Laser for this use, they would not have consented to the surgeries. The court held that the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Saf. Code 24171 et seq., because the surgeries were not "medical experiments" subject to the protection of the Act. Plaintiff did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (CLRA), Cal. Civ. Code 1750 et seq., and his other substantive claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Plaintiff's common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments. Even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the FDCA. Accordingly, the court affirmed the dismissal of the complaint.
Court Description: Medical Law. The panel affirmed the district court’s dismissal of a complaint brought by 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 patients. The panel held that 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. The panel also held that plaintiff Robert Perez did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act, and his other substantive claim—a common law fraud by omission claim—was preempted by the Federal Food, Drug, and Cosmetic Act. The panel held that the claim of omission was expressly preempted by the preemption provision in the Medical Device Amendments; and even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the Food, Drug and Cosmetic Act.
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