By Leah S. Poniatowski, J.D.
Expert’s opinion on anti psychotic medicine label not admissible, and other evidentiary shortcomings leave failure-to-warn and design defect claims unsupported.
A patient who was prescribed the anti psychotic medication Abilify® for treatment of major depressive disorder and who subsequently developed a movement disorder failed to support her failure-to-warn and design defect claims against the manufacturer to establish viable claims, a federal district court in California ruled, granting the manufacturer’s motion for summary judgment (Rodman v. Otsuka America Pharmaceutical, Inc., May 18, 2020, Orrick, W.).
Background. Otsuka America Pharmaceutical, Inc. (Otsuka) received Food and Drug Administration (FDA) approval for its anti psychotic drug Abilify for treatment of schizophrenia. The drug later received approval to treat bipolar disorder and major depressive disorder, among other mental health conditions. Abilify has always included a warning about the risk of developing Tardive Dyskinesia (TD), a movement disorder. The label’s warning was five paragraphs in length, explaining the condition, the risk factors, and recommendations to treating physicians vis-a-vis mitigating development of TD.
In 2010, the patient’s psychiatrist diagnosed her with major depressive disorder and prescribed her Abilify. In 2015, her insurance changed and out of concern for the increased cost of the medication, she worked with her psychiatrist on how to discontinue taking the medication. She was instructed to wean off the drug and follow up with a new psychiatrist. Several months later, she was diagnosed with TD of the tongue. She filed a lawsuit against Otsuka for failure to warn and design defect. In support of her claims, she proffered the testimony of a pharmacologist. She and Otsuka filed summary judgment motions, including assertions to exclude expert testimony.
Expert testimony. Otsuka asserted that the patient’s expert’s testimony should be excluded because the expert was not qualified in light of the unreliable foundation of her opinion, or to offer a specific causation opinion. The court disagreed and found that the expert was qualified to offer an opinion because she was an experienced toxicologist and pharmacologist. However, the court agreed that her opinion was not based on reliable methods as required under law.
The expert relied on a survey of scientific literature, concluding that TD was not a rare event (i.e., occurring less than 0.1 percent) or infrequent event (i.e., less than 1 percent) and, thus, the label failed to adequately describe the risk of TD. She also contended that the removal of TD-related information from the Adverse Reactions portion of the label in 2014 failed to warn physicians of the current information on the risk of TD, which endangered patients. The court examined the studies and agreed that the percentages of occurrences—5 and 3.4 percent, respectively—from two studies were not representative of true incidence rates, notably because both studies cautioned that their sources could not be used to calculate incidence rates. The expert also conceded this point.
Moreover, the court remarked that the expert’s testimony had been excluded in another proceeding on similar grounds. Because she exceeded the boundaries of the sources she relied upon and opined beyond what the sources concluded, without explanation, her opinion was not the product of reliable principles or methods as required by law. Therefore, Otsuka’s motion to exclude the expert’s opinion was granted in part and denied as moot on the other parts.
Failure to warn. The patient offered three failure-to-warn theories in support of her claim. First, she asserted that the label understated the incidence and risk of developing TD, as supported by her expert’s opinion. Because the expert testimony was excluded and was essential to this claim, Otsuka was granted summary judgment on this issue. Second, the allegation that the label did not adequately address lower-dose incidences of TD failed because that information had been included in the label and, further, the patient’s psychiatrist testified that he was aware of that specific risk. Because the treating psychiatrist confirmed that his prescribing decision would not have been impacted if the label had included an additional warning, Otsuka was entitled to summary judgment on that issue. Finally, the contention that the label was inadequate because it did not instruct practitioners on how to screen patients for TD also failed because the treating psychiatrist testified that he was aware of how to monitor for TD symptoms and monitored the patient while in his care. Thus, the patient’s failure-to-warn claim was dismissed.
Design defect. The patient’s design defect claim, which was based on a negligence theory because California does not recognize a strict liability theory for prescription drugs, similarly failed because she could not support her claim. First, she contended in her opposition motion that she did not need to offer any additional evidence at this stage of the litigation, which the court pointed out was incorrect as a matter of law. Relying on the evidence presented by the patient, the court concluded that there was not enough to show that there was a safer alternative. The court also observed that the patient did not address the other elements to establish a design defect claim. Therefore, Otsuka’s motion for summary judgment also was granted on the design defect claim.
The case is No. 3:18-cv-03732-WHO.
Attorneys: Robert E. Cartwright, Jr. (The Cartwright Law Firm) for Ina Ann Rodman. Amanda Jereige (Winston Strawn LLP) for Otsuka America Pharmaceutical, Inc.
Companies: Otsuka America Pharmaceutical, Inc.
MainStory: TopStory DesignManufacturingNews WarningsNews ExpertEvidenceNews DrugsNews CaliforniaNews
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