Almost a year ago we wrote a post called Learned Intermediary – Not Just for Failure to Warn about a California putative economic loss class action that was dismissed for failing to plead any allegations about whether the drug manufacturer had adequately warned plaintiff’s prescribing physician. Fast forward about 9 months and we posted about the California Amiodarone decision that rejected plaintiffs’ argument that the learned intermediary doctrine was an affirmative defense and could not be the basis for a dismissal on the pleadings. We recently realized that just a few days after the Amiodarone decision, another California court reached the same conclusion in yet another putative economic loss class action. Sidhu v. Bayer Healthcare Pharmaceuticals Inc., 2022 WL 17170159 (N.D. Cal Nov. 22, 2022).
Having now read Sidhu and put it into context with these other decisions, we realize that the California plaintiffs’ bar has been making a concerted effort to pitch the “learned intermediary is an affirmative defense” argument all over California. And looking at the cases cited in Sidhu, this pitch has been going on for a few years. See Sidhu, at *4 (citing cases dismissed for failing to plead learned intermediary). Fortunately, plaintiffs have failed to make any headway. That’s because under California law, the learned intermediary doctrine defines the scope of the manufacturer’s duty to warn and the duty to warn is an essential element of plaintiffs’ claim and therefore something on which they bear burden of pleading and proof. Therefore, the learned intermediary doctrine applies at the pleadings stage.
That means plaintiffs are required to plead warning causation as to prescribing physicians. Warning causation means plaintiffs have to allege not only that the warnings or information that defendants provided to their physicians was inadequate but also that their physicians would have altered their prescribing decisions if they had received different information. And under TwIqbal, a bald assertion is not enough. These physician-related allegations cannot be conclusory and must contain sufficient factual support to make plaintiff’s claim “plausible on its face.” That is not an insignificant hurdle for plaintiffs to meet in any case, let alone in a purported class action like Sidhu. A physician-specific pleading requirement is just that—specific, individualized. The enemy of the one-size-fits-all class action. The need for individualized proof of causation should spell the downfall for any purported class, but the fact that California keeps it at the front, in the pleadings stage, should be enormously helpful to defendants faced with these types of failure to warn and fraud-based class actions.
While the learned intermediary ruling was the most significant in Sidhu, the decision also dismissed most of plaintiff’s claims on various grounds. The dismissals were largely without prejudice and plaintiff was given an opportunity to amend her complaint, but there are a few worth mentioning.
- Plaintiff’s purported nationwide class was dismissed for failure to plead what state law governs her common law claims and the court “reminded” her that a California plaintiff lacks standing to assert claims under the laws of other states. Id. at *3.
- Plaintiff could not assert a design defect claim in response to a motion to dismiss that was not pleaded in the complaint, and if the plaintiff does add such a claim to her amended complaint, the court said it is “not clear she should avoid application of the learned intermediary doctrine.” Id. at *5.
- To avoid preemption, plaintiff is required to plead what newly acquired information would allow defendant to use the CBE regulations to change its label. It was not enough for plaintiff to cite to post-2010 studies; she has to plead what information was provided to the FDA and when. Id. at *6.
- Plaintiff’s fraud claims (including consumer fraud) were dismissed for failing to plead that her physician relied on any alleged omission—another claim dismissed under the learned intermediary doctrine. Id.at *8.
- Under California’s Unfair Competition Law (“UCL”), a claim for an unlawful act must be based on a predicate violation, but because plaintiff’s other claims failed for various reasons, so to did her UCL claim. A UCL claim based on unfairness cannot stand alone. Id. at *8-9.
- Under California law, plaintiff’s unjust enrichment claim was adequately pleaded, id. at *9, but failed for lack of equitable jurisdiction because plaintiff did not demonstrate the inadequacy of a remedy at law. Id. at *11-12.
- Plaintiff’s negligence claim was barred by economic loss rule because plaintiff failed to plead an exception. Id. at *10.
- Plaintiff’s punitive damages claim was dismissed because it was based on the dismissed fraud claims. Id. at *11.
Plaintiff’s amended complaint is due to be filed next month followed by another round of motions to dismiss. We will certainly be watching to see what plaintiff is able to “cure” and just how much the “cure” is detrimental to maintaining this as a class action.