Accordingly, FDA approved the PMA supplement for the . . . System, including both the . . . pump and the . . . sensor, on April 7, 2006. . . . [T]he approval letter, as issued, applies to the . . . System as a whole.
[Defendant] did not completely notify the FDA of the nature of [heart pump] malfunctions, pursuant to FDA regulations. . . Plaintiff theorizes that if [defendant] had fully informed the FDA, the FDA would have issued a Class I recall rather than a Class II recall and had the FDA classified [the] recall as Class 1, it would have likely imposed more stringent notice requirements, and expanded the class of recipients of the notice, including end users like [plaintiff].
Plaintiff’s claim of fraudulent concealment depend[s] on speculation that the FDA would have taken any particular regulatory action in response to violation of the regulations at issue, as in Buckman. . . .Moreover, Plaintiff is arguing that [defendant] breached disclosure duties owed to the FDA, not that [defendant] breached a disclosure duty owed to Plaintiff by failing to comply with FDA regulations. Under Buckman, such a claim is preempted.