We saw the 360 blurb this morning on In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL Docket No. 2226, slip op. (E.D. Ky. Oct. 10, 2012), and we thought we’d be content just adding it to our branded-in-generic (that is to say Conte) scorecard. After all – we’re pleased to say – there have been 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 the implied 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 survived the product identification requirements of state law, involving a plaintiff Lopez. As to that case, the court found a sufficient TwIqbal allegation of product identification, specifically:
The plaintiffs in Lopez, however, do specifically allege the ingestion of a . . . product manufactured by the AAI Defendants. [They] assert that Plaintiff Mark Lopez ingested “[t]hree prescriptions for Darvocet N-100 from Olden Pharmacy, which lists the manufacturers as AAI Pharma, LLC . . . from August 2005 to October 2006.” These alleged ingestion dates occurred after the AAI Defendants transferred the New Drug Application (“NDA”) for Darvocet to Xanodyne Pharmaceuticals.
Slip op. at 5 (record citations omitted). The court held that this was enough, at the judgment 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 in question are branded manufacturers. See Id. at 3 n.2 (identifying moving defendants as “Brand defendants”). We consider the application of Mensing implied preemption to branded manufacturers as one of the frontiers of preemption at the moment.
So where does Mensing leave off and the benighted domain of Wyeth v. Levine, 555 U.S. 555 (2009), begin? The court in AAIPharma fixed the boundary at the point where the branded manufacturer lost the ability to do what the Levine decision turned upon – unilaterally change its warnings. As mentioned in the block quote above, the plaintiff in Lopez only ingested that particular branded product after the defendant had sold its NDA to somebody else. At that point, because it was no longer the NDA holder, the defendant could no longer file a unilateral CBE label change to its warnings:
Because the AAI Defendants did not have the power to change the label after May 2005, Lopez’s failure-to-warn claims against the AAI Defendants are preempted under [Mensing].
Slip op. at 5. Thus, the Lopez plaintiffs’ warning claims were preempted. The court did not preempt design-related claims because at the time of manufacture the defendant was still the NDA holder, and thus not subject to any such limitations. Id. at 5-6. So it’s a warning-only decision, but then in most prescription drug cases warnings are the major battleground.
Thus, the important point in AAIPharma remains: Mensing’s impossibility preemption applies, and bars warning-related claims, whenever the facts support it. Those facts are the distinction that the Mensing court drew against Levine – the ability of the defendant to change/strengthen its warnings unilaterally, without needing the prior involvement of the FDA. Thus, while Levineand its “clear evidence” of likely FDA rejection standard eliminated a lot of preemption in litigation involving branded drugs (clear evidence being found only in a handful of cases), it did not eliminate all of it. As AAIPharma demonstrates, there are certain 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 implied preemption defense can succeed even where the product in question is a branded drug.
While Mensing is by no means an antidote to the execrable Levine decision, it’s something to remember if you happen to be representing a branded defendant in one of these peculiar situations.