Robert Perez v. Nidek Co., Ltd.

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• holding that premarket approval imposed requirements on a device even when used in an off-label manner
• holding that a fraud by omission claim resting solely on nondisclosure under federal law is impliedly preempted
• holding that the FDCA expressly 3 preempted plaintiff’s fraud by omission claim related to alleged inadequate disclosures to doctors 4 and patients
• holding that plaintiff’s state law “fraud by omission claim” for failure to disclose that the device was not FDA-approved “is impliedly preempted because it amounts to an attempt to privately enforce the FDCA”
• concluding that plaintiff’s 18 attempt to “sidestep” standing requirements by alleging conspiracy was nothing “more 19 than conclusory and bare bones words and phrases without any factual content” and was 20 thus “insufficient to establish standing”
• holding that Article II] 19 || standing requirements prevented the plaintiffs from suing physicians who did not perform eye 20 || surgery on them, even though the physicians may have performed surgery on other putative class 21 members

Source: CourtListener parenthetical corpus (CC0).