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

QUESTIONS PRESENTED (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/Iqbal pleading requirements, are sufficient to meet the specificity and plausibility standards of Federal Rule of Civil Procedure 8(a)? -|