We’ve just read Lyman v. Pfizer, Inc., 2012 WL 2970627 (D. Vt. July 20, 2012).  Frankly, we expected it to be worse than it was.  Regular readers are no doubt familiar with Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt.  2010), in which the same court (we would say in violation of Erie principles of federalism) predicted that Vermont would follow the controversial holding of Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal. App. 2008), in the absence of any Vermont precedent for doing so.  We were steeling ourselves in Lyman for more of the same.
Didn’t happen.
The court used remote causation to clip Conte’s wings significantly.  We were muttering about the same concept well before we got to the court’s holding.  The facts delved well back into the product liability equivalent of deep time − while the plaintiff only started using the product (metoclopramide) in 2003, the discussion of the branded manufacturer’s conduct went back at least to 1980, when the FDA approved the original Reglan branded version of the product.  Lyman, 2012 WL 2970627, at *4.  Predictably, plaintiff alleged fraud on the FDA with respect to the 1980 approval.  Id. at *5.  The fact that the opinion saw fit to mention these ancient, and blatantly-preempted allegations filled us with foreboding.
Other facts, thankfully, turned out to have more relevance.  These were:  (1) the drug was only approved for gastrointestinal reflux, (2) it was never approved for long-term use; (3) after losing its patent protection, the branded manufacturer sold all of its rights to the drug to an unaffiliated company in 2001; and (4) plaintiff never used the branded version.  Lyman, 2012 WL 2970627, at *2, 4-5.
The branded defendants − the original manufacturer and its 2001 purchaser − sought summary judgment, arguing that even under a Conte rationale, plaintiff didn’t have a case.
They were right.Continue Reading Lyman: Branded Out; Generic Waist Deep In Big Muddy

We’ve mentioned before how preemption is the strongest defense because (unlike Daubert or the learned intermediary rule) it bars claims without regard to their substantive merit.  When preemption applies in mass torts, such dismissals may occur on a wholesale basis.  In our prior post, “The New One-Two,” we described how potent preemption can be in generic drug cases when teamed with the traditional requirement of product identification as applicable to branded manufacturers.
The other day this “new one-two” scored a knockout in the heavyweight division, that is to say a federal multi-district litigation (“MDL”) – specifically the Darvon/ Propoxyphene MDL.  In two simultaneously issued opinions, the court disposed of what are likely to be the great bulk of the claims in the MDL.  Darvon is a drug that’s been around for decades, and which the FDA eventually decided to take off the market because newer drugs were, the agency believed, both safer and more effective.  That doesn’t mean that Darvon was any less safe than before, but anytime there’s a recall, it seems somebody takes a shot at a mass tort.
No longer – at least for Darvon.
First, preemption. In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. (E.D. Ky. Feb. 5, 2012), the court dismissed a comprehensive set of claims against generic makers of propoxyphene (the generic equivalent of Darvon), finding that all of the claims are either preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), or inadequately pleaded. Specifically:

• “Wrongful marketing” – that is, claims that the generic defendants should be liable for not removing their products from the markets altogether – are preempted because such allegations prove too much: “the idea that [defendants] should have simply stopped selling [the generic drug] is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether.”  Slip op. at 7-8.
• Failure to warn claims based upon alleged “failure to timely change the labeling” after the FDA ordered it strengthened were barred because plaintiffs had no facts to support “purely conjectural” “information and belief” pleading.  Slip op. at 8-10.
• Likewise, no facts were alleged to support “Dear Doctor” letter-based claims.  In any event, such letters would involve new information, and thus labeling that was no longer the “same” as required by federal law.  Slip op. at 10 & n.9.
• That certain defendants were designated by the FDA as “reference listed drug” holders did not prevent preemption, because “the FDA, not the RLD holder, controls label changes” once such a designation is made.  Slip op. at 10-11.
• Claims for misrepresentation, fraud, consumer protection, and express warranty, were all preempted because they demanded labeling changes that were impossible under the federal “sameness” requirement.  Slip op. at 11-12.
• Plaintiff’s “statutory negligence” claims were based solely on allegations of FDCA violations (“mostly relating to labeling or ‘misbranding’”) and were thus preempted under Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), because there is no private FDCA right of action.  Slip op. at 12.

Because the MDL complaints had already been amended, and plaintiffs were not entitled to speculative discovery under TwIqbal, all of the generic complaints were dismissed with prejudice and without leave to amend.  Slip op. at 12-13.
That’s one.Continue Reading The New One-Two – Heavyweight Division