Opinion ID: 856123
Heading Depth: 2
Heading Rank: 3

Heading: fraud by omission claims

Text: Perez also alleges a common-law fraud by omission claim. The theory is that the defendants misled the proposed class by failing to disclose that the Laser was not FDA approved for hyperopic surgeries, even though Nidek and the doctors knew or should have known that the proposed class members believed the Laser was FDA approved for such surgeries. This claim of omission is expressly preempted by the preemption provision in the Medical Device Amendments (“MDA”). Even if it were not, it is impliedly preempted because it amounts to an attempt to privately enforce the FDCA.
The FDCA has long provided for premarket approval of new drugs. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996). Before 1976, states were left to supervise the introduction of new medical devices. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). California was among a number of states that adopted regulatory measures governing devices. Id. In 1976, Congress enacted the Medical Device Amendments to the FDCA, which “swept back some state obligations and imposed a regime of detailed federal oversight.” Id. at 316. These amendments include an express preemption provision: Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— PEREZ V . NIDEK CO ., LTD . 17
any requirement applicable under this chapter to the device, and
of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k(a). An implementing regulation provides that state and local requirements are only preempted by the MDA when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.” 21 C.F.R. § 808.1(d). A trio of Supreme Court cases address preemption under the MDA: Lohr, Buckman, and Riegel. Lohr and Riegel involved the MDA’s express preemption provision, and Buckman involved implied preemption. As we explained in a recent en banc decision, the “rule that emerges from these cases is that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.” Stengel v. Medtronic, Inc., 704 F.3d 1224, 1228 (9th Cir. 2013) (en banc). In Lohr, the Court held that plaintiffs’ common-law claims stemming from a pacemaker failure were not preempted under § 360k. The allegations included claims that Medtronic had violated FDA regulations, and “[n]othing in § 360k denies Florida the right to provide a traditional 18 PEREZ V . NIDEK CO ., LTD . damages remedy for violations of common-law duties when those duties parallel federal requirements.” 518 U.S. at 495 (emphasis added). Although a plurality of the Court emphasized the generality of the state laws giving rise to the plaintiffs’ claims, “five Justices concluded that common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.” Riegel, 552 U.S. at 323–24 (citing Lohr, 518 U.S. at 512 (opinion of O’Connor, J., joined by Rehnquist, C.J., and Scalia and Thomas, JJ.); id. at 503–05 (opinion of Breyer, J.)). None of the federal laws or regulations at issue imposed devicespecific requirements. Lohr, 518 U.S. at 492–94, 500–01. In contrast, the Court in Riegel held that § 360k preempted common-law claims challenging the safety and effectiveness of a medical device that had received premarket approval from the FDA. Unlike the federal laws and regulations at issue in Lohr, premarket approval imposes device-specific requirements. Id. at 322–23. Because the state common-law claims related to the safety and effectiveness of the device and because the plaintiffs alleged that the device violated state tort law notwithstanding compliance with the federal requirements, the state claims were preempted. Id. at 323, 330. It did not matter that the common-law claims involved general tort duties of care applicable to other products besides medical devices. Id. at 327–29. In Stengel, we “clarified preemption law under the MDA.” 704 F.3d at 1233. Plaintiffs’ proposed negligence claim for failure to warn the FDA was not preempted “insofar as the state-law duty parallels a federal-law duty under the MDA.” Id. We distinguished an Eighth Circuit case holding PEREZ V . NIDEK CO ., LTD . 19 plaintiffs’ claims were preempted because, in that case, “plaintiffs sought to enforce state-law requirements that would have required Medtronic ‘to give additional warnings, precisely the type of state requirement that is “different from or in addition to” the federal requirement.’” Id. at 1232 (quoting In re Medtronic, Inc., Spring Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010)) (citation and internal quotation marks omitted). In a