(1) Whether state-law claims against a medical device manufacturer, based on duties that parallel federal requirements, preempted by the Medical Device Amendments ("MDA"), 21 U.S.C. 360 et seq., to the Food, Drug, and Cosmetics Act ("FDCA"), 21 U.S.C. 301 et seq.?

(2) Whether the FDA's Current Good Manufacturing Practices ("CGMPs"), 21 C.F.R. 820.1 et seq., citing specific CGMPs requirements 21 C.F.R. 820.1(c), 820.72 - 820.90, can support state-law claims based on duties that parallel, rather than add to, federal requirements, will survive express preemption?

(3) Whether state-law claims against a medical device manufacturer, based on duties that parallel federal requirements, under 21 U.S.C 360k(a), and 21 C.F.R. 808.1(d), are not preempted, premised that a complaint need only allege enough facts to state a claim that is plausible on its face, to satisfy the Twomby/lqbal pleading requirements, are sufficient to meet the specificity and plausibility standards of Federal Rule of Civil Procedure 8(a)?

Whether state-law claims against a medical device manufacturer are preempted