With no explanation, chose the best option from "A", "B", "C" or "D". to a misrepresentation claim if the company knew the “off-label” use of its ladders was not safe. Thus the distinction between truthful and fraudulent off-label matters also matters when it comes to implied preemption. Mere “off-label” promotion, divorced from any negligent or fraudulent misrepresentations, would likely not run afoul of state tort law. See Gavin, 2013 WL 3791612, at *7; Caplinger, 921 F.Supp.2d at 1219-20. But Schouest’s affirmative misrepresentation claims are based on independent state law duties that Medtronic allegedly violated after the initial PMA process. Because these claims would apply to a seller of a product not subject to any federal regulations who engaged in similar alleged misconduct, they are not impliedly preempted. See Houston, 957 F.Supp.2d at 1179 (<HOLDING>); Eidson, 981 F.Supp.2d at 885, 2013 WL

A: holding that state law fraud on the fda claims were impliedly preempted by the food drug and cosmetic act
B: holding that even if such claims are cognizable under state law they are preempted in the case of generic drug manufacturers
C: holding the state law claims were not preempted
D: holding that state fraudbased claims that include offlabel promotion allegations are not impliedly preempted under buckman because they are moored in traditional state common law that exists independently from the fdca
D.