11 Kasım 2012 Pazar

A Sliver of Impossibilty, Perhaps?

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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 discussionof the recent In re Darvocet, Darvon & Propoxyphene Products LiabilityLitigation decision, which applied PLIVA, Inc. v. Mensing’simpossibility preemption rationale to a branded manufacturer, had us thinkingback to a decision in another Reglan®/metoclopramide case that involved bothbrand-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 thedecision in an earlierpost, but in the wake of the Darvocet decision it’s worth noting Lyman’ssupport for applying implied “impossibility” preemption to brand-name drugmanufacturers. 
In Lyman, the district court in Vermont issued alengthy decision granting summary judgment for the brand manufacturers and oneof the generic manufacturers. Tucked into that decision was a little Mensingnugget for branded manufacturers, though the court didn’t spell it out. (Recallthat this is the court that brought Conte innovator liability toVermont, so don’t expect it to make anything too easy for brandedmanufacturers.)  
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 manufacturerback in 2001—several years before the plaintiff began taking the drug.
Of course, that lengthy time gap didn’t stop the plaintiffsfrom suing Wyeth. They alleged, among other things, that Wyeth was “negligentin its initial design of Reglan as a drug used to treat chronic conditions andincorporating false information into the drug’s label.” Id. at *16. Inother words, the plaintiffs argued that Wyeth should have altered Reglan®’sdesign or label to make the drug safer.
But how could Wyeth have changed the design or label of adrug 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, Wyethcould no longer change the label independently or unilaterally—the testarticulated by Mensing—because it had sold those rights long ago. SeePLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2579 (2011) (“Thequestion for ‘impossibility’ is whether the private party could independentlydo 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 andresponsibilities regarding Reglan® tablets, Wyeth lost any ability to changethe design of Reglan® or its label. Long before [the plaintiff] receivedher first dose of metoclopramide, Wyeth could not have delivered a strongerwarning regarding the drug, or have changed its design in any way.” 2012 WL2970627, at *16 (emphasis added). The court went on to find that the plaintiffsalso could not prove proximate cause, given the remoteness of Wyeth’sinvolvement.
 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 implicitacceptance that sometimes even a branded manufacturer cannot “independently”comply with both state and federal law. In other words, even claims againstbrand-name manufacturers can be subject to impossibility preemption, given theright circumstances.

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