We are not surprised that some readers dissented from our judgment last week that the Billions series is trash, albeit fun trash. We should be accustomed to this sort of thing. Friends constantly pepper us with praise for allegedly realistic depictions of our business. It used to be predominantly about Law and Order, but now our friends have moved up in the world and pay for premium cable. Those same friends overrule our demurrers that, no, what we do is actually much more straightforward, routine, and - dare we say it? - dull than the showrunners would have you think. We do not suggest that drama would be enhanced by accurate portraits of our quotidian pursuits. Reviewing cases and enduring teleconferences would be Nielsen-repellent. Our fundamental problem with Billions is that it makes the justice system in the Southern District of New York look like a lottery conducted in a snake pit. It is untrue. Mostly.
It is totally untrue in Montero v. Teva Pharmaceuticals USA Inc. et al., 2020 WL 1862593 (S.D.N.Y. April 14, 2020). In Montero, the SDNY judge addressed complex preemption principles in a clear, concise, intelligent manner that should be the model for all judges whenever Mensing and Bartlett issues arise. In Montero, those issues arose because the defendants raised them. The plaintiff ignored them, not even mentioning those cases in her brief. Practice-pointer to lawyers: the ignore-it approach seldom works.
In Montero, the plaintiff alleged that she sustained serious blood-clots, culminating in a pulmonary embolism, as a result of using an oral contraceptive. According to the complaint, the oral contraceptive was defectively designed, inadequately tested, and fraudulently marketed. Those theories came dressed up in the usual causes of action: negligence, strict liability, breach of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud. The Montero court dismissed them all.
The oral contraceptive used by the plaintiff was a generic drug. The Montero court followed the teaching by SCOTUS in the Mensing case that failure to warn claims against generic drugs are preempted, because the sellers of generic drugs have no choice but to mimic the warning labels of the brand name drugs. So much for any failure to warn claim.
Then the Montero court got to the teachings by SCOTUS in the Bartlett case. While Mensing applied the impossibility preemption principle only to failure to warn, Bartlett extended it to design defect. Here is how the Montero court put it: "Under the state design defect law at issue in Bartlett, a drug manufacturer could avoid liability by either redesigning its drug or strengthening its warning label. However, federal law prohibits a generic drug manufacturer from doing either. The manufacturer cannot change a generic drug's composition or its label."
Applying this logic to Montero, the plaintiff's design defect claim was just as preempted as the failure to warn claim. Moreover, she could not proceed with her failure to test theory, because that theory (which usually finds little to no support in state tort law, but that is a different topic for a different blogpost - see our failure to test cheatsheet here) was premised on the notion that such testing would have persuaded the manufacturer that the oral contraceptive "was too dangerous for the market." That notion is inconsistent with Bartlett, which held that the "stop-selling rationale [was[ inconsistent with . preemption jurisprudence" because "preemption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability." Montero is a preemption triple play.
What is left is the plaintiff's allegation that the defendant perpetrated an active fraud. And that means that nothing is left because the plaintiff did not allege the requisite facts. Any fraud grounded on some statement or omission in the label is flatly preempted, and any statement or omission beyond the label was never identified by the plaintiff - certainly not identified with the heightened specificity pleading requirements under Federal Rule of Civil Procedure 9(b). The complaint names no affirmative fraudulent statement. To plead a claim for fraud via concealment or omission, a plaintiff must set out what the omission was, which persons were responsible for the failure to disclose, the context of the omissions and the manner in which they misled the plaintiff, and what the defendant obtained through fraud. Here, the plaintiff's fraudulent omissions theory was itself shot-through with omissions.
The Montero court dismissed the entire complaint with prejudice. For us, that outcome is sufficiently dramatic and satisfying. The decision lacks the Maseratis, ortolans, B&D chambers, Hamptons, Russian oligarchs, and political shenanigans of your favorite tv show, but we'd happily tune in for sequels.
Originally published June 17, 2020
This article is presented for informational purposes only and is not intended to constitute legal advice.
