Rodman v. Otsuka America Pharmaceutical, Inc.

Background

Ina Ann Rodman brought a product-liability lawsuit against Otsuka America Pharmaceutical, Inc., alleging that she developed Tardive Dyskinesia after taking Abilify, a prescription antipsychotic medication. She asserted defective-design and failure-to-warn claims. Her failure-to-warn claim included a theory that Abilify’s label inaccurately stated the incidence and risk of developing Tardive Dyskinesia.

The parties filed cross-motions for summary judgment on the failure-to-warn claim, and Otsuka moved for summary judgment on the defective-design claim. The parties also challenged portions of expert testimony. On May 18, 2020, the court granted summary judgment to Otsuka on both claims. The court rejected Rodman’s first failure-to-warn theory because her expert testimony did not adequately support the label-adequacy element. It rejected her other two failure-to-warn theories because the evidence did not support causation: her doctor testified that a different or improved label would not have changed his prescribing decision.

Rodman sought reconsideration only of the ruling on her first failure-to-warn theory. She did not seek reconsideration of the other two failure-to-warn theories or the defective-design claim.

Legal standard

The court explained that Federal Rule of Civil Procedure 59(e) permits reconsideration in limited circumstances, such as newly discovered evidence or a clear error in the earlier ruling. Reconsideration is an extraordinary remedy and cannot be used to repeat arguments already considered and rejected or to present evidence and arguments for the first time when they reasonably could have been presented earlier.

Court’s reasoning

Rodman argued that Dr. Laura M. Plunkett properly relied on adverse-event data and case studies in offering an opinion about whether Abilify’s label adequately described the risk of Tardive Dyskinesia. The court found that this repeated arguments Rodman had made in opposing summary judgment and Otsuka’s motion to exclude Dr. Plunkett’s testimony. The court had already rejected the attempt to use those sources to support an incidence-rate conclusion.

The court reaffirmed that Dr. Plunkett’s opinion was essential to the label-adequacy element of Rodman’s first failure-to-warn theory. Because the court had excluded that opinion, Rodman lacked expert evidence supporting that element, and summary judgment had been granted to Otsuka.

Rodman also argued that there was a factual dispute about whether her doctor would have changed his treatment if he had known that the incidence of Tardive Dyskinesia was higher than the label stated. The court said that issue concerned a different element and that the earlier order had not reached it. The first theory had failed at the label-adequacy element, so Rodman could not seek reconsideration of an issue the court had not decided.

Rodman further challenged the court’s treatment of Dr. Christoph U. Correll’s study. The court clarified that it had never found that the study established a true incidence rate among Abilify patients. Instead, the court had found that Dr. Plunkett improperly went beyond the conclusions supported by the sources on which she relied. The court also held that Rodman’s challenge to Dr. Correll’s study was untimely because she had not previously sought to exclude the relevant portion of his opinion. Her new declaration from Dr. Plunkett and new exhibit concerning payments from Otsuka to Dr. Correll likewise presented arguments and evidence that could have been raised earlier.

Disposition

Judge William H. Orrick denied Rodman’s motion for reconsideration. The court did not alter its earlier grant of summary judgment to Otsuka. The order addressed only reconsideration of the first failure-to-warn theory; Rodman had not asked the court to reconsider the other failure-to-warn theories or the defective-design claim.