1. Whether Ms. Rodman presented admissible evidence in the form of Otsuka's failure to follow the admonition of 21 C.F.R. § 314.80 to conduct post-marketing surveillance and revise its Abilify label where "reasonable evidence" established a rate of occurrence of tardive dyskinesia exceeding the Abilify label's warning, and whether such evidence would have been useful to a trier of fact in establishing that Otsuka misrepresented data on the Abilify label, thus resulting in misbranding.

2. Whether Ms. Rodman, in order to establish her mislabeling claim, was required to present absolute proof of an "incidence rate" of tardive dyskinesia among Abilify users where Rodman established Otsuka's "misbranding" through competent expert "reasonable evidence," of the association of tardive dyskinesia and Abilify use, 21 C.F.R. 201.80(e), that Otsuka breached its obligations of post-marketing surveillance and reporting and that Abilify is "dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." Wyeth v. Levine, 555 U.S. 555, 608 (2009).

Whether Ms. Rodman presented admissible evidence of Otsuka's failure to follow post-marketing surveillance and label revision requirements, and whether such evidence would have been useful to establish Otsuka's misrepresentation of Abilify's risks