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Kulkarni v. Generics, 2023 U.S.Dist.LEXIS 160730 (S.D.N.Y. Sept. 8, 2023), is an interesting generic preemption (mostly) dismissal involving an “old” (pre-1962) drug.  A pro se plaintiff sued five affiliated pharmaceutical companies alleging that a course of generic prednisone caused her to develop functional myoclonus.  The plaintiff’s theory of the case was that the drug label failed to warn her “of the potential of developing this lifelong disorder.”  The defendants’ theory was that the complaint was entirely preempted and should be dismissed.  It turns out that the defendants’ theory was better than the plaintiff’s.

The defendants filed a motion to dismiss the complaint, which consisted solely of a failure to warn claim. The plaintiff opposed the motion to dismiss, but also sought leave to file and amended complaint that would have added a manufacturing defect and negligence claims to the warnings claim.  The court considered both the initial complaint and the proposed amended complaint before showing the plaintiff to the exit.

The court held that all the warning claims were preempted. How could it be otherwise? Under Pliva v. Mensing, a generic manufacturer lacks any power to alter the warnings on the FDA label.  The plaintiff attempted to wriggle out of Mensing’s clear holding by arguing that no brand name versions of the product exist anymore, and the FDA had designated one of the defendant’s generic as the reference drug after the branded drug left the market. So what? The generic manufacturer still cannot unilaterally change the label. There are a host of cases holding that the FDA’s designation of a generic manufacturer’s drug as the reference drug does not subject an ANDA generic product to NDA, or brand name, status or requirements.  So much for that effort to evade preemption. 

But the plaintiff was not done. The plaintiff pointed out that there were minor differences between some of the defendant labels and the reference labels and that such differences called off preemption. The differences were relatively minor. The Kulkarni court held that even if “sameness” was violated as to some irrelevant aspect of the labeling, that violation does not affect the preemptive effect of the relevant parts of the label. More to the point, that violation does not permit a manufacturer to engage in further departures from the sameness requirement. The warnings claims were still preempted. 

The plaintiff’s belated effort to add a manufacturing defect claim failed because none of the supposed recalls and other problems involved the drug that the plaintiff took.  The plaintiff merely alluded to a manufacturer’s history of recalls. Again, so what?   The plaintiff offered no allegation that the drugs used by this particular plaintiff deviated in any way from the intended product formulation.  Nor could the plaintiff suggest that the manufacturing defect – whatever that was – played any causal role with respect to the plaintiff’s injury. In sum, the plaintiff had no manufacturing defect claim, but only the wish for one. 

The plaintiff’s two proposed “negligence” claims were also preempted.  The quotation marks are used advisedly.  The plaintiff griped that the defendants negligently declined to participate in an explicitly voluntary FDA program to bring outdated drugs up to current FDA efficacy standards, and the defendants’ “lack of attention to the side effects of thousands of Americans can be considered negligence.”  

Huh?  Oh, that’s right – this is a pro se plaintiff. The Kulkarni court took this gibberish seriously before rejecting it. There is no duty for a manufacturer to “to voluntarily conduct more testing than federal law requires.”  As for adverse event reporting, the plaintiff did not identify a single adverse event that any defendant improperly failed to report to the FDA. Even if the plaintiff had identified such a failure to report an adverse event, any claim based on such failure would be impliedly preempted as a private attempt to enforce the FDCA. In addition, a claim centering on a failure to report adverse events boils down to another warning claim, and that would be just as expressly preempted as all the other warning claims. 

Finally, the plaintiff was not permitted to evade preemption by speculating “that if defendants had conducted more testing or reported additional side effects, the FDA would have required them to alter a generic drug’s warning label.”  The plaintiff in Mensing pursued a similar claim. It didn’t work in that case. And it didn’t work in Kulkarni