We saw the 360 blurb this morning on In reDarvocet, Darvon & Propoxyphene Products Liability Litigation, MDLDocket No. 2226, slip op. (E.D. Ky. Oct. 10, 2012), and we thought we’d be content just adding it to ourbranded-in-generic (that is to say Conte) scorecard. After all – we’re pleased to say – there havebeen a lot of similar decisions lately.
But there’s more to this Darvocet opinion –which we’ll henceforth call “AAIPharma” because there are now so many Darvocets− than meets 360’s eye (at least until you get to the 12th paragraph). Specifically, we found an application of theimplied preemption rationale in PLIVA v. Mensing, 131 S. Ct. 2567(2011), to a branded manufacturer. That’s worthy of a post.
Here’s what happened. Only one of 50 cases in AAIPharma survivedthe product identification requirements of state law, involving a plaintiff Lopez. As to that case, the court found a sufficientTwIqbal allegation of product identification, specifically:
The plaintiffs in Lopez, however, do specificallyallege the ingestion of a . . . product manufactured by the AAIDefendants. [They] assert[] that PlaintiffMark Lopez ingested “[t]hree prescriptions for Darvocet N-100 from OldenPharmacy, which lists the manufacturers as AAI Pharma, LLC . . . fromAugust 2005 to October 2006.” Thesealleged ingestion dates occurred after the AAI Defendants transferred the NewDrug Application (“NDA”) for Darvocet to Xanodyne Pharmaceuticals.
Slip op. at 5 (record citations omitted). The court held that this was enough, at thejudgment on the pleadings stage, to avoid dismissal.
However, the court did not stop there. It went on to consider preemption under Mensing. Slip op. at 5. That’s notable because the opinion specifies that the defendants inquestion are branded manufacturers. SeeId. at 3 n.2 (identifying moving defendants as “Brand defendants”). We consider the application of Mensingimplied preemption to branded manufacturers as one of the frontiers ofpreemption at the moment. So where does Mensingleave off and the benighted domain of Wyeth v. Levine, 555 U.S. 555(2009), begin? The court in AAIPharmafixed the boundary at the point where the branded manufacturer lost the abilityto do what the Levine decision turned upon – unilaterally change itswarnings. As mentioned in the blockquote above, the plaintiff in Lopez only ingested that particularbranded product after thedefendant had sold its NDA to somebody else. At that point, because it was no longer the NDA holder, the defendantcould no longer file a unilateral CBE label change to its warnings:
Because the AAI Defendants did not have the power tochange the label after May 2005, Lopez’s failure-to-warn claims against the AAIDefendants are preempted under [Mensing].
Slip op. at 5. Thus, the Lopez plaintiffs’ warning claims were preempted. The court did not preempt design-relatedclaims because at the time of manufacture the defendant was still the NDAholder, and thus not subject to any such limitations. Id. at 5-6. So it’s a warning-only decision, but then in most prescription drugcases warnings are the major battleground.
Thus, the important point in AAIPharma remains: Mensing’s impossibility preemptionapplies, and bars warning-related claims, whenever the facts support it. Those facts are the distinction that the Mensingcourt drew against Levine – the ability of the defendant tochange/strengthen its warnings unilaterally, without needing the priorinvolvement of the FDA. Thus, while Levineand its “clear evidence” of likely FDA rejection standard eliminated a lot ofpreemption in litigation involving branded drugs (clear evidence being foundonly in a handful of cases), it did not eliminate all of it. As AAIPharma demonstrates, there arecertain situations (transfer of the NDA) as well as certain types of defendants(non-NDA holders that can’t use the CBE process at all) where the impliedpreemption defense can succeed even where the product in question is a brandeddrug.
While Mensing is by no means an antidote to theexecrable Levine decision, it’s something to remember if you happen tobe representing a branded defendant in one of these peculiar situations.
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