The Northern District of California did not mince words in its opinion in Rodman v. Otsuka America Pharmaceutical, Inc., 2020 WL 2525032 (N.D. Cal. May 18, 2020) and so neither will we. Plaintiff had three theories of failure to warn and a design defect claim and they all failed in grand fashion due in some significant part to her reliance on Dr. Laura Plunkett’s bag of tricks – or to be more direct, Dr. Plunkett’s creating phony scientific evidence.
Plaintiff was prescribed the drug Abilify and later developed an involuntary movement disorder called tardive dyskinesia (“TD”); a known and warned of risk of the drug. Id. at *1. Plaintiff’s failure to warn claim was based on the following allegations: the label did not accurately state the incidence rate of TD in Abilify users; the label did not address the risk specifically in patients taking lower doses of the drug; and the label failed to include instruction regarding screening for TD. Id. at *2.
Dr. Plunkett was plaintiff’s sole expert on the first theory. The Abilify label states that the incidence rate of TD was “greater than 0.1% but less than 1%.” Dr. Plunkett testified that that was not accurate pointing to two studies that she opined demonstrated incidence rates of 3.4% and 5%. This is where the phony science comes in. Those are in fact not true incident rates. Both studies “looked at a pool of those with TD and identified how many of them used Abilify, which does not result in a true incidence.” Id. at *5. Looking backwards from a population of persons with the condition rather than starting with the correct universe of all drug users leads to an exaggerated incidence rate and one that is not generally accepted by the scientific community. In fact, both of the studies Dr. Plunkett relied on explicitly “cautioned that their sources cannot be used to calculate an incidence rate.” Id. The court was unwilling to allow Dr. Plunkett to “analyze data that was not [her] own and reinterpret[ ] it in a manner inconsistent with the conclusions of those who originally generated it.” Id. (citation omitted). The court noted that this was not the first time Dr. Plunkett’s testimony had been excluded for “too great an analytical gap between the available data and the conclusion.” Id. With Dr. Plunkett’s opinions excluded for “extrapolat[ing] conclusions beyond the scope of her resources,” id. at *7, plaintiff’s first failure to warn claim could not survive summary judgment.
Plaintiff’s second and third failure to warn claims failed on causation grounds. With respect to the adequacy of the warning regarding lower dosages, plaintiff’s prescribing physician testified that he was aware of that risk already. Further, he “unequivocally testified” that if plaintiff’s proposed label had been in effect, it would not have changed his prescribing decision. Id. at *8-9. Similarly, plaintiff’s prescriber testified that he knew how to monitor patients for TD, including using the very test plaintiff’s argued should have been part of the labeling. In fact, the prescriber testified the test was something he learned about in medical school and he “didn’t need a drug company at the time to tell [him] about the [ ] test.” Id. at *9. Based on this testimony, plaintiff’s remaining failure to warn claims were dismissed.
That left negligent design defect – California does not recognize strict liability design defect claims for prescription drugs. Id. The adequacy of the product’s design is therefore measured under a risk-benefit analysis that includes as a factor whether there is a feasible safer alternative design. Id. at *10. Plaintiff’s opposition to defendant’s summary judgment motion was not to proffer evidence to meet her burden of proof but rather to argue that she had no obligation to offer proof at this stage because she was “not required to divulge the testimony of medical witnesses designated to testify at trial.” Id. She’s wrong. Plaintiff is not entitled to defeat summary judgment based on “the hope that something can be developed at trial in the way of evidence to support [her] claim.” Id. (citation omitted). Plaintiff simply did not have the expert design evidence needed to support a negligence claim. She cited testimony by one of plaintiff’s treaters that that doctor may prescribe different drugs instead of Abilify, but that testimony does not support that those drugs were safer alternatives. Id. Likewise, Dr. Plunkett’s report merely discussed the availability of other treatments, not whether they were safer alternatives. Nor did plaintiff point to any evidence of the relative costs and benefits of Abilify versus other drugs or any evidence that defendant failed to act as a reasonably careful designer in similar circumstances. Id. Hiding behind the secrecy of trial strategy doesn’t cut it to defeat summary judgment.