United States: Still No "Newly Acquired Information," Eliquis Claims Still Preempted

Last Updated: December 6 2017
Article by Steven Boranian

The defendants in the Eliquis MDL have turned somewhat of a preemption hat trick. The latest order is In re Eliquis (Apixaban) Prods. Liab. Litig., No 17-md-2754 (S.D.N.Y. Nov. 29, 2017), where the district court dismissed twenty-four cases newly transferred into that MDL. We will explain why in a moment, but first a little background. The defendants scored their first goal in a case called Utts—which resulted in pair of orders (one before the MDL was formed and one after) ruling that federal law impliedly preempted the plaintiffs' failure-to-warn and design defect claims. These were important orders. As we explained in detail here, the district court very clearly explicated the three Supreme Court opinions that mainly shape implied preemption in the prescription drug space—Wyeth v. Levine, Mensing, and Bartlett.

We all understand that Wyeth v. Levine opened the anti-preemption door by recognizing that an innovator drug manufacturer could sometimes change its label without the FDA's pre-approval through the Changed Being Effected (or "CBE") process. Because that allowed the manufacturer, under some circumstances, to change its label to accommodate state law without running afoul of federal law, implied preemption did not necessarily apply. Then came Mensing, which held that federal law impliedly preempted failure-to-warn claims against generic drug manufactures because generic manufacturers cannot use the CBE process, and therefore cannot change their labels without pre-approval. That leaves generic manufacturers between a federal rock and a state-law hard place, which equals preemption.

Finally, Bartlett. There, the Supreme Court held that federal law impliedly preempted state-law design defect claims for similar reasons, i.e., a generic drug manufacturer cannot change a drug's design without pre-approval either, thus again triggering implied preemption. We have said multiple times in this space that Bartlett's rationale is not limited to generic manufacturers because an innovator drug manufacturer also cannot change its product's design without pre-approval.

That is where Utts came in. Although dealing with an innovator drug, the district court applied Bartlett to dismiss the design defect claims. In the part that we like the most, the court also applied Wyeth and Mensing to dismiss the warnings claims because the plaintiffs did not present any "newly acquired information." Because "newly acquired information" is required to invoke the CBE process, the defendants could not change the Eliquis label without federal pre-approval. Under those circumstances, a state-law tort claim would conflict with federal law, thus preemption. The district court granted the plaintiffs leave to amend, but they again failed to plead any "newly acquired information." Moreover, because the labeling already warned stridently about the risk at issue (bleeding) the warnings were adequate as a matter of law, too. Case dismissed without leave, as we explained here.

The defendants scored their second goal when the district court applied Utts to other cases in the MDL. The order that caught our eye was Fortner, which we covered here. In Fortner, other plaintiffs attempted to plead state-law claims that were not preempted. But try as they might, these plaintiffs also could not plead any "newly acquired information." The CBE process there was still unavailable; the defendants still could not alter the labeling without pre-approval; and federal law still preempted their claims. And, by the way, the warnings were still adequate as a matter of state law. (Careful readers have figured out by now that we have oversimplified these orders for brevity, but you get the idea. You can read our prior posts here, here, and here to get the gory details.)

Which brings us to the defendants' third goal scored—application of Utts to cases newly transferred into the Eliquis MDL. To start, we admire the district court's process. The district court used Utts as a vehicle to decide preemption in the first instance, and once it set the rules, it ordered any plaintiff assigned or transferred to the MDL to show cause within 14 days why his or her case should not be dismissed. Slip op. at 2.

These twenty-four plaintiffs, newly transferred from the District of Delaware, complied with the court's order and made three arguments, none of them successful. They argued first that Utts did not apply because they omitted from their amended complaints some of the material that appeared in the Utts amended complaint. Slip op. at 4. In other words, their claims should survive because they were more vague and less complete in asserting their claims.

The plaintiffs in Fortner tried this tactic too—we'll call it pleading by obfuscation. But it did not work there, and it did not work here either: "Even without reference to the documents on which the amended complaint in Utts relied, the complaints 'simply do[ ] not provide sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.'" Slip op. at 5 (quoting Fortner).

Plaintiffs also argued that the warnings were inadequate under their various states' laws, but they did not explain why. Nor did they "even cite the statutes or case law that pertain to the adequacy of a label's warnings for any jurisdiction." Slip op. at 5. Thus, "[i]n the absence of citation to any authority, it is unnecessary to address the argument further." Slip op at 5. Finally, the plaintiffs asked to be remanded to the District of Delaware. That's right. If you can't win, get out of Dodge. But they again failed to "explain a basis" for granting that relief.

We mused in our last post on Eliquis that this MDL may not last long, and we seem to have been correct. Moreover, given the sound basis for the district court's preemption rulings, we doubt the plaintiffs will do any better elsewhere.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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