What follows is a guest post by Dick Dean and Corena Larimer at Tucker Ellis, which (other than our home firm) has more subscribers to the Blog than any other. As usual all the credit (and any blame) for this post belongs to them, and them alone.
The Blog’s recent discussion of the recent In re Darvocet, Darvon & Propoxyphene Products Liability Litigation decision, which applied PLIVA, Inc. v. Mensing’s
impossibility preemption rationale to a branded manufacturer, had us thinking back to a decision in another Reglan®/metoclopramide case that involved both
brand-name and generic manufacturers: Lyman v. Pfizer, Inc., No. 2:09-cv-262, 2012 WL 2970627 (D. Vt. July 20, 2012). Bexis covered much of the decision in an earlier post, but in the wake of the Darvocet decision it’s worth noting Lyman’s support for applying implied “impossibility” preemption to brand-name drug manufacturers.
In Lyman, the district court in Vermont issued a lengthy decision granting summary judgment for the brand manufacturers and one of the generic manufacturers. Tucked into that decision was a little Mensing nugget for branded manufacturers, though the court didn’t spell it out. (Recall that this is the court that brought Conte innovator liability to Vermont, so don’t expect it to make anything too easy for branded manufacturers.)
The case revolved around Reglan® and its generic equivalent (metoclopramide). One of the defendants, Wyeth, manufactured brand-name Reglan® at one time but had transferred its rights to Reglan® to another manufacturer back in 2001—several years before the plaintiff began taking the drug.
Of course, that lengthy time gap didn’t stop the plaintiffs from suing Wyeth. They alleged, among other things, that Wyeth was “negligent in its initial design of Reglan as a drug used to treat chronic conditions and incorporating false information into the drug’s label.” Id. at *16. In other words, the plaintiffs argued that Wyeth should have altered Reglan®’s design or label to make the drug safer.
But how could Wyeth have changed the design or label of a drug it no longer had any rights to?
That would be . . . impossible. (Sound familiar?)
Well, that’s exactly what Wyeth told the court. Arguing Mensing, Wyeth pointed out that by the time the plaintiff started taking the drug, Wyeth could no longer change the label independently or unilaterally—the test articulated by Mensing—because it had sold those rights long ago. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2579 (2011) (“The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”).
The court agreed, though not in so many words. Essentially, the court adopted Wyeth’s Mensing argument without citing Mensing, holding that “by 2001 when Wyeth transferred to Schwarz all of its rights and responsibilities regarding Reglan® tablets, Wyeth lost any ability to change the design of Reglan® or its label. Long before [the plaintiff] received her first dose of metoclopramide, Wyeth could not have delivered a stronger warning regarding the drug, or have changed its design in any way.” 2012 WL 2970627, at *16 (emphasis added). The court went on to find that the plaintiffs also could not prove proximate cause, given the remoteness of Wyeth’s involvement.
While we would have loved a full-blown discussion of Mensing (or at least a passing nod to it), we read this as the Vermont court’s implicit acceptance that sometimes even a branded manufacturer cannot “independently” comply with both state and federal law. In other words, even claims against brand-name manufacturers can be subject to impossibility preemption, given the right circumstances.