Over the life of the Blog, there have been many posts taking issue with the pro-plaintiff leanings of California courts, which have resulted in many questionable decisions on issues ranging from expanding personal jurisdiction to shrinking preemption to re-writing the duties of medical product manufacturers under California law. We have also thrown more than a little shade at the California federal courts, which, while less unitary, have been worse than the average federal court on the issues that come up in our sort of cases. For instance, a number of California federal courts have been hostile to removals and even more have often found ways to deny motions to dismiss based on preemption and inadequate pleading. We cannot say that the tide has turned with the California federal judiciary, but we have seen a number of decisions over the last year or so where we were pleasantly surprised at how these courts came out on the issues that matter to us. In Mizuno v. Sanofi Vaccines U.S. Inc., No. 2:26-cv-012115-CKD, 2026 WL 2392200 (E.D. Cal. Aug. 17, 2026), a long-time magistrate judge dismissed all the claims against prescription drug manufacturers without leave to amend. Even though it raised one of our yellow flags, Mizuno is a good decision from a somewhat unexpected source.
As should happen, the plaintiff’s obvious sloppiness and apparent laziness worked against him. (Some of the info below is from the docket not the decision.) First, the case was brought in state court against two companies not based in California. When defendants removed, plaintiff did not move to remand. Second, plaintiff did not decline to have the case assigned to a magistrate for all purposes. The decision says the parties consented, id. at *1, but actually neither side objected to the assignment in time. Third, when the defendants moved to dismiss the original complaint, plaintiff responded by filing an amended complaint, but it did not address the issues raised in that motion. That failure factored into the Mizuno court’s decision not to give plaintiff a third chance to file a complaint that stated a non-preempted, non-time barred recognized claim.
It may also be the case that plaintiff’s complaint omitted some of the basic facts about the drug at issue and his use of it. The decision does not say what the drug was approved for, why it was prescribed to plaintiff, who prescribed it, or much of anything about plaintiff’s actual medical course. The first approved indication would have been apparent from the materials the court took judicial notice of at defendants’ request, hence our yellow flag. Usually when the court leaves out the serious medical need being addressed though the use of the medical product over which the plaintiff is suing that is a bad sign. Here, the approved indication makes what the court identified as the shortcomings in plaintiff’s complaint that much worse, assuming plaintiff’s use was within or close to the indication. Here we definitely go beyond the decision to set out the facts of the case. Defendants’ prescription medication was approved for “the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.” GVHD is a potentially debilitating and life-threatening inflammatory and fibrotic condition that arises in a high percentage of patients after a bone marrow or stem cell transplant. Its most common manifestation at the time of diagnosis is in the skin. The transplants that trigger the chronic GVHD are themselves for very serious conditions like leukemia. So, when the Mizuno plaintiff brought product liability claims for injuries to his skin and the court considered the motion to dismiss the amended complaint, this important context was missing.
The first issue the Mizuno court addressed was whether the second amended complaint was time-barred on its face under California’s two-year statute of limitations. Plaintiff alleged that within a month of starting his medication, he experienced “a significant increase in rash, itching, and pain”—skin conditions he apparently had before starting the medication—and discontinued it. Id. at *3. He then had a videoconference with his prescribing physician to discuss his belief that the new medication was to blame. Id. Yet he took two years and ten days to sue. Id. Courts often seem to mention the discovery rule without delving deeply into allegations supporting it before letting late plaintiffs slide. However, because the amended complaint in Mizuno did not identify a date within two years of filing when his claim allegedly accrued, let alone facts supporting the “manner of discovery,” plaintiff could not rely on the discovery rule. Id. Indeed, because the first motion to dismiss raised the statute of limitations, the failure of the amended complaint to plead the discovery rule properly “suggests plaintiff cannot fix the defect.” Id. Given that plaintiff was apparently taking the medication to treat chronic GVHD, including skin manifestations, his complaint to his physician that he believed the medication increased his skin problems is a pretty strong indication of the date of accrual of his claims. Still, plaintiff might have gotten a chance to re-plead were it not for the main reason we are discussing Mizuno, implied preemption.
Plaintiff’s claim for negligent failure to warn—he had dropped his strict liability claims from the first complaint—was so conclusory that it probably would have failed TwIqbal had preemption not been raised. Back when Twombly and Iqbal came out, we welcomed the authorization for courts to look at the plausibility of claims based on facts asserted in the complaint, which was a step up from the standard practice of allowing conclusory allegations of the elements of claims to suffice. Still, winning preemption of a warnings claim as to a branded prescription drug at the motion to dismiss stage was a long shot back then. Once Albrecht upgraded the Levine mess, however, it became clear that federal courts do have to decide preemption as a matter of law. The majority position, expressed most notably in the Second Circuit’s Gibbons decision (discussed here and ranked here), is that plaintiffs who want to avoid preemption of their branded prescription drug warnings claims have to plead that there was newly discovered evidence after approval of the drug’s label that would have allowed the manufacturer to change the relevant warnings unilaterally under the CBE regulations. (We carved out branded prescription drugs from generic prescription drugs because the manufacturers of the latter can never change the substance of their labels unilaterally.) Mizuno is one of several California federal courts we have seen apply this requirement without making up some loophole (such as the need for the plaintiff to get lots of discovery before it can plead a non-preempted claim). One was the Owens case discussed here, which Mizuno cited along with Gibbons and cases we discussed here and here. Id. at *4. With the proper standards in mind, it was clear that plaintiff’s generalities did not identify newly acquired evidence that could have led to a labeling change through a CBE submission:
Here, the first amended complaint alleges in general and conclusory fashion that “[f]ollowing Rezurock’s approval, Defendants received and possessed post-marketing adverse event reports through FDA-mandated reporting systems, including FAERS” and “[o]n information and belief, Defendants’ pharmacovigilance systems—including FAERS data review, internal signal detection algorithms, and periodic safety update reports—identified dermatologic events [of increasing severity and chronicity] that differed in severity, persistence, and clinical presentation from those described in the approved labeling.”
Id. Without facts supporting a basis for the use of a CBE, plaintiff’s warnings claim was preempted. The same ruling held for the slightly repackaged negligence claim and the strict liability failure to warn claim that plaintiff had dropped. Id. at *5 & 6.
Negligent design was even easier to ditch, a dynamic we have lauded more than a few times. Changing the drug’s design to avoid the alleged defect of a risk of skin injuries would have been a major change that a manufacturer cannot make unilaterally. Id. at *5. Under Bartlett and some progeny within the Ninth Circuit, that claim is preempted. Id.
Lastly, plaintiff asserted an implied warranty claim that California does not recognize for prescription drugs. Id. at *5. Plaintiff’s proposed pivot to pleading an express warranty claim instead was rejected because “[t]he court finds no indication that plaintiff can plead facts to state a plausible claim,” given his inability to plead facts about specific representations in his two complaints. Id. Again, with the added context of the drug’s indication and plaintiff’s actual medical situation, it is hard to imagine an express warranty from the manufacturer directly to the plaintiff that the medication would prevent any worsening of his preexisting skin problems. The actual physician labeling, which plaintiff surely never read, and the patient brochure clearly made no such promise. To the extent the alleged warranty came from the labeling, it would have been preempted anyway. That was the end of Mizuno, dismissal without leave to file a third complaint. Not waiting for the inevitable third, or even fourth, strike is good practice.