Rodman v. Otsuka America Pharmaceutical, Inc.

Background

Ina Ann Rodman alleged that she developed tardive dyskinesia, a potentially irreversible movement disorder, after taking Otsuka’s prescription antipsychotic drug Abilify. She asserted failure-to-warn and design-defect claims. Her three failure-to-warn theories were that Abilify’s label understated the rate and risk of tardive dyskinesia, failed to say specifically that the disorder had been reported in patients taking Abilify—including patients taking lower doses for depression—and failed to instruct physicians about screening methods such as the Abnormal Involuntary Movement Scale.

Rodman’s prescribing physician, Dr. John Hawkins, prescribed Abilify for major depressive disorder in 2010. The Abilify label warned that tardive dyskinesia could develop, including after relatively brief treatment at low doses. In 2016, a doctor diagnosed Rodman with dyskinesia of the tongue, and a neurologist treated her symptoms.

Expert testimony

Otsuka moved to exclude opinions from Rodman’s expert, Dr. Laura M. Plunkett. The court found Dr. Plunkett qualified, based on her experience as a toxicologist and pharmacologist, to testify about drug labeling. But the court found her method unreliable when she opined that the label understated the risk of tardive dyskinesia.

Dr. Plunkett compared a rate in the Abilify label with figures from a study and from the Food and Drug Administration’s Adverse Event Reporting System. The court explained that those sources did not measure the true incidence rate—the number of Abilify users who developed tardive dyskinesia. The sources themselves cautioned that they could not be used to calculate that rate. The court concluded that Dr. Plunkett had gone beyond what the sources supported and excluded her label-inadequacy opinion.

The court denied as moot Otsuka’s request to exclude Dr. Plunkett’s specific-causation opinion because summary judgment made that issue unnecessary. It also denied as moot Rodman’s request to exclude portions of Dr. Sara J. Polfliet’s and Dr. Christoph U. Correll’s testimony.

Failure to warn

Under the “learned intermediary” rule, a prescription-drug manufacturer must warn the prescribing physician rather than the patient. A failure-to-warn plaintiff must show both that the warning was inadequate and that the inadequacy caused the injury.

For Rodman’s first theory, the court granted summary judgment to Otsuka because Dr. Plunkett’s excluded opinion was essential to showing that the label understated the incidence and risk of tardive dyskinesia.

For the second theory, the court held that Rodman lacked evidence that a stronger warning about low-dose use would have changed Dr. Hawkins’s prescribing decision. Dr. Hawkins testified that he knew Abilify could cause tardive dyskinesia, including in patients taking lower doses, and that the additional warning Rodman sought would not have affected his decision.

For the third theory, the court held that Dr. Hawkins already knew how to monitor patients for tardive dyskinesia, including by using the Abnormal Involuntary Movement Scale. The court therefore concluded that a label instruction about that screening method would not have changed his prescribing decision.

Design defect

The court treated Rodman’s design-defect claim as a negligence claim because California does not impose strict liability for design defects in prescription drugs. Rodman needed evidence addressing negligence, causation, damages, and whether a safer alternative design existed.

The court found that the evidence Rodman cited did not establish a safer alternative. Dr. Anette Nieves identified medications used when patients stopped taking antipsychotic drugs but did not say they were safer alternatives to Abilify. Dr. Hawkins said he might have considered other medications if he had known the rate of tardive dyskinesia was higher than the label reported, but that did not show that those medications were safer. Dr. Plunkett’s report described other drugs and stated that adverse events were biologically plausible, but did not establish a safer alternative design.

The court also found that Rodman provided no evidence addressing the relative costs and benefits of Abilify and similar drugs or what a reasonably careful designer or manufacturer would have done. It therefore granted summary judgment to Otsuka on the design-defect claim.

Disposition

The court granted Otsuka’s motion for summary judgment on all three theories of Rodman’s failure-to-warn claim and on the design-defect claim. It granted Otsuka’s motion to exclude Dr. Plunkett’s label-inadequacy opinion and denied the remainder of that motion as moot. It denied Rodman’s motion for partial summary judgment on failure to warn and denied as moot her motion to exclude portions of Dr. Polfliet’s and Dr. Correll’s testimony.