Perez v. Nidek Co., LTD.

In order for a state-law claim to escape preemption by the Federal Food, Drug, and Cosmetic Act (“FDCA”), the plaintiff must be suing for conduct that violates the FDCA, not suing because the conduct violates the FDCA.

Robert Perez, Brett Harbach, and Nancy Art (collectively, “Perez”) received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System (“the Laser”). At the time, Perez did not know the FDA had not approved the Laser’s use for correcting farsightedness. Perez did not allege any injury from the surgery, nor that the surgery was ineffective. Instead, Perez brought claims under the Human Subjects in Medical Experimentation Act (“the Human Subjects Act”) and the California Consumers Legal Remedies Act (“CLRA”), as well as common-law claims of civil conspiracy, omission, and aiding and abetting. The panel found that Perez had standing to sue the “two doctors who performed surgery on the named plaintiffs,” but Perez did not have standing to sue the named and unnamed doctors who did not perform surgery on the named plaintiffs but who “allegedly performed surgery on other individuals in the proposed class.” In addition, Perez did not have standing to sue any of the defendants under the CLRA because he did not demonstrate that he faced “a real or immediate threat of an irreparable injury.” The panel found that because Perez’s claims did not fit the definition of “medical injury” under either § 24174(a) or § 24174(b) of the Human Subjects Act, the Act did not protect the surgeries. The panel also found that Perez’s common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments (“MDA”).” Even if not expressly preempted, the fraud by omission claim was impliedly preempted because it conflicts with the enforcement scheme of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Citing no case based solely on a claim for “failure to disclose lack of FDA approval,” Perez could not bring a claim that alone rested on patients not being disclosed information regarding premarket approval. AFFIRMED.