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At least try to do something different.

As we discussed before, because his prescription drug warning claims collided with federal preemption, the plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022), needed to plead what the FDA didn’t know, not what it did, to avoid dismissal.  His second try wasn’t any better than the first.

Plaintiff pleaded tired and predictable “aggressive” off-label promotion allegations.  Id. at *1.  He criticized the warnings for not mentioning bleeding from eye – where he claimed injury – even though the defendant warned generally that “[b]leeding problems are common” adverse events with this drug.  Id. at *2.  Unfortunately for plaintiff, however, the FDA knew about retinal hemorrhage, but given the overall bleeding risk, did not require separate organ-by-organ warnings:

Plaintiff discovered that clinical case reports, systematic reviews and meta-analysis, medical reviews, clinical protocols from clinical trials, and reports from the FDA had uncovered a link between [the drug] and severe retinal hemorrhage and retinopathy-related adverse events.  Plaintiff alleges that information from the “FAERS Public Dashboard” and, which are maintained by the FDA. . . .

Id. (emphasis added).

But to avoid preemption, a plaintiff must have “newly acquired information” – not information that the FDA already knew and had evaluated.  “[A] new drug cannot be introduced without an approved new drug application, and . . . must include information . . . to show whether such drug is safe for use.”  Id. at *5 (citation and quotation marks omitted).  Without such new information a manufacturer cannot make unilateral (and thus unpreempted) changes to its labeling.  Id. at *6.  Plaintiff’s complaint pleaded a lot of old information, but nothing that would be considered “new” under the FDA’s regulations.  “[A]lthough the [amended complaint] alleges numerous reports of adverse events, these allegations indicate the FDA knew of [the drug’s] potential to cause eye-related disorders before approving the drug.”  Id.  No “newly acquired information” equals preemption.  Plaintiff’s “claims are preempted because the [amended complaint] does not sufficiently allege any ‘newly acquired information’ that would have created a labeling deficiency correctable through the CBE regulation.”  Id.

Nor could plaintiff avoid dismissal by inadequate pleading, such as not including the allegedly defective warnings in the complaint.  Allegations that FDA-approved drug warnings are inadequate justify taking judicial notice of those warnings on a motion to dismiss.  Such warnings, even if omitted from the complaint itself, are considered to be incorporated “by reference.”  Id. at *4.  What such agency approved warnings say “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.”  Id. (quoting Fed. R. Evid. 201(b)).  Thus, “the court finds that judicial notice of the 2017 and 2018 labels is proper and can also be considered under the incorporation by reference doctrine.”  Id.

For good measure, the warning claims were TwIqballed because they failed to plead any facts establishing causation under California’s learned intermediary rule.  Plaintiff included only boilerplate:  “lack of adequate warnings proximately caused Plaintiff’s injuries” and had Defendant “adequately warned Plaintiff or his doctors . . . Plaintiff or his doctors would have elected not to use [the drug].”  Those are bare-bones legal conclusions, not facts.  To be “plausible” under TwIqbal, a California learned intermediary rule complaint “sufficiently allege how an adequate warning would have altered the prescribing decision of Plaintiff’s physician.”  Id. at *7.  That certainly makes sense to us, since plaintiffs in prescription medical product liability litigation know their prescribers and can contact them for the necessary information.  Thus, we also cheer Roshkovan for taking Rule 8 seriously in the context of learned intermediary causation.