Plaintiffs cannot simply incant the magic words that Defendants violated FDA regulations in order to avoid preemption. Moreover, the nonmovant may not defeat a properly focused motion for summary judgment by relying on mere allegations without introducing definite and competent evidence.
be nothing more than a private action to enforce FDA statutes and regulations;
be nothing more than a challenge to the approval of the device or label;
require proof of fraud on the FDA; or
involve off-label promotional activities that are legal under FDA guidelines.
Here . . . plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements. In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements. Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here.
Even if a plaintiff does properly plead facts demonstrating the defendant’s failure to satisfy federal regulations, there is no private cause of action against a device manufacturer under the FDCA. Only the federal government may file suits against manufacturers that do not comply with federal regulations. Although the Supreme Court acknowledged in Riegel that parallel claims based on violations of federal regulations would escape express preemption under §360k, §337(a) has been held to impliedly preempt private claims against device manufacturers for failure to comply with federal regulations. As a result, Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.