Ina Rodman v. Otsuka America Pharmaceutical ( 2021 )

NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS DEC 9 2021
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
INA ANN RODMAN, No. 20-16646
Plaintiff-Appellant, D.C. No. 3:18-cv-03732-WHO
v.
MEMORANDUM*
OTSUKA AMERICA
PHARMACEUTICAL, INC.,
Defendant-Appellee.
Appeal from the United States District Court
for the Northern District of California
William Horsley Orrick, District Judge, Presiding
Argued and Submitted November 17, 2021
San Francisco, California
Before: SCHROEDER, W. FLETCHER, and MILLER, Circuit Judges.
Ina Rodman appeals from the district court’s grant of summary judgment to
Otsuka America Pharmaceutical, Inc., in this product-liability action. Rodman
alleges that Otsuka’s antipsychotic drug Abilify caused her to develop tardive
dyskinesia (TD). Rodman sued Otsuka under a failure-to-warn theory, contending
that although the Abilify label discussed the risk of TD, it underreported the actual
*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
incidence rate. The district court excluded the testimony of Rodman’s expert
witness, Dr. Laura Plunkett, as unreliable under Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993), and then granted Otsuka
summary judgment because, without that testimony, Rodman offered no evidence
to support her claim. We have jurisdiction under 28 U.S.C. § 1291, and we affirm.
We review the district court’s evidentiary rulings for abuse of discretion.
Domingo ex rel. Domingo v. T.K., 289 F.3d 600, 605 (9th Cir. 2002). We review
the district court’s grant of summary judgment de novo, Branch Banking & Tr. Co.
v. D.M.S.I., LLC, 871 F.3d 751, 759 (9th Cir. 2017), and may affirm on any ground
supported by the record, In re ATM Fee Antitrust Litig., 686 F.3d 741, 748 (9th
Cir. 2012).
1. The district court did not abuse its discretion in excluding Dr.
Plunkett’s testimony. Federal Rule of Evidence 702 “assign[s] to the trial judge the
task of ensuring that an expert’s testimony both rests on a reliable foundation and
is relevant to the task at hand.” Daubert, 509 U.S. at 597. Regardless of an expert’s
credentials, where “there is simply too great an analytical gap between the data and
the opinion proffered,” a court cannot permit the expert to testify. General Elec.
Co. v. Joiner, 522 U.S. 136, 146 (1997).
The Abilify label reported that between 0.1 and 1 percent of participants
developed TD during short-duration, premarketing clinical trials. Regardless of
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whether that figure represented an incidence rate, Dr. Plunkett failed to produce a
comparable incidence rate with which to dispute the label’s rate. An incidence rate
is the ratio of the number of Abilify users who developed TD to the total number
of Abilify users. As Dr. Plunkett conceded, neither the study nor the data set on
which she relied calculated an incidence rate or reported the total number of
Abilify users—the necessary denominator in a calculation of an incidence rate.
Because Dr. Plunkett did not have reliable evidence to support her opinion, the
district court appropriately excluded her testimony under Daubert.
2. The district court did not err in granting summary judgment. As part
of her claim, Rodman had to show that Otsuka failed to warn of a risk “known or
scientifically knowable at the time of the drug’s distribution.” Wendell v.
GlaxoSmithKline LLC, 858 F.3d 1227, 1238 (9th Cir. 2017).
Lacking evidence of label inadequacy without Dr. Plunkett’s testimony,
Rodman argues that a 2018 study authored by Otsuka’s expert, Dr. Christoph
Correll, establishes a genuine issue of material fact because it allegedly reports a
TD incidence rate of 1.7 percent for Abilify. The district court concluded that
Rodman did not clearly advance that argument until her motion for
reconsideration, so it was therefore untimely. We agree that Rodman did not
sufficiently raise this argument to the district court, which was not required to
“comb the record to find some reason to deny a motion for summary judgment.”
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Carmen v. San Francisco Unified Sch. Dist., 237 F.3d 1026, 1209 (9th Cir. 2001).
Even considering the argument on its merits, Rodman provides no evidence that
the figure in Dr. Correll’s study proves that a higher incidence rate of TD was
“scientifically knowable” to Otsuka during the time Rodman took Abilify.
Wendell, 858 F.3d at 1238. Without Dr. Plunkett’s testimony, and with no other
available evidence, Rodman did not establish a genuine issue of material fact.
AFFIRMED.
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