Ina Ann Rodman v. Otsuka America Pharmaceutical, Inc.

This Petition for Writ of Certiorari (“Petition”) originates from failure-to-warn and design defect proceedings initiated by Petitioner, Ina Rodman (“Ms. Rodman”), against Respondent, Otsuka America Pharmaceutical, Inc. (“Otsuka”). At the summary judgment stage, the District Court excluded the report of Ms. Rodman’s expert witness, Dr. Laura Plunkett, and granted summary judgment for Otsuka on the grounds that Ms. Rodman had not presented any evidence to support her claims. The questions presented are:

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).