Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in dismissing his second amended complaint as both preempted and inadequately pleaded. We posted about the dismissals of the original and first amended complaints on the same grounds here and here. And really nothing has changed, a consistent theme in this series of decisions.
The facts have not changed. Plaintiff was prescribed defendant’s drug to treat his chronic myeloid leukemia. He alleged that the drug caused him to suffer a loss of vision in his right eye due to hemorrhaging. Id. at *5-6. The causes of action have not changed—strict liability failure to warn and negligent failure to warn. Id. at *1. The court’s decision to take judicial notice of defendant’s FDA-approved labeling has not changed. First, courts “regularly take judicial notice of materials prepared by government agencies.” Id. at *13. Second, the court was willing to consider the labels under the “incorporation by reference” doctrine because the labels were referenced and quoted in the second amended complaint. Id. at *13-14.
The court’s preemption analysis has not changed because plaintiff, on his third attempt, still was unable to provide any evidence of any “newly acquired information.” Prescription drug failure to warn claims are preempted unless plaintiff pleads a labeling deficiency that could have been changed via the Changes Being Effected (“CBE”) regulation. The CBE regulation permits a manufacturer, without prior FDA approval, to change the label to “reflect newly acquired information” to add or strengthen a warning “for which there is evidence of a causal association.” Id. at *17. Newly acquired information is defined as “data, analyses, or other information not previously submitted” to the FDA that demonstrate “risks of a different type or greater severity or frequency than previously included in submissions to the FDA.” Id.
Plaintiff’s four “new” allegations purporting to demonstrate newly acquired information that satisfies the CBE regulation are just more of the same old, same old. Meaning they don’t fit the bill. First, plaintiff takes issue with how defendant’s clinical trials were conducted but does not allege that any information about how those trials were conducted was withheld from the FDA or that the trials provided any new information. Id. at *18. Second, plaintiff tried to argue defendant failed to report adverse event reports to the FDA by relying on adverse event reports that were in the FDA’s FAERS database. In other words, plaintiff alleged the opposite of newly acquired information, “that the FDA was aware of the adverse event reports but did not take further action.” Id. at *19-20. Third, plaintiff pointed to publicly available medical literature but not to what in that literature was unknown to the FDA or different from information already considered by the FDA. Id. at *19-20. Fourth, plaintiff alleged that defendant’s patient brochure was inaccurate, which is a challenge to defendant’s marketing materials but has nothing to do with whether defendant had any newly acquired information that would be supported a CBE labeling change. Id. at *21. Therefore, for the third time the court concluded plaintiff’s failure to warn claims were preempted.
The court’s TwIqbal analysis has not changed. For the third time plaintiff failed to adequately plead causation under the learned intermediary doctrine. In Roshkovan I, the court told plaintiff that his causation allegations had to include facts sufficient to plausibly support that an adequate warning would have altered his prescribing decision. In Roshkovan II, the court told plaintiff he still had not done enough on causation because, to plausibly plead causation his complaint had to sufficiently allege how the adequate warning would have altered the prescribing decision. Yet, in Roshkovan III, plaintiff’s causation allegations remain only that the inadequate warning “proximately caused Plaintiff’s injuries” and if an adequate warning had been given plaintiff’s doctors “would have elected not to use” the drug. Id. at *23. Once again, plaintiff is missing the “how.” Therefore, plaintiff’s causation allegations are “too conclusory” to plausibly plead causation.” Id. at *24.
But finally, there is something new to report. Plaintiff is not getting a fourth attempt. After dismissing the complaint on the same grounds three times, the court said enough is enough. Plaintiff’s claims are now dismissed with prejudice. Id. at *24-25.