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Sixth Circuit to Review Generic Drug Preemption Case

Posted in News and Analysis

The Sixth Circuit will soon have a chance to consider the extent of the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  Plaintiffs in the federal multi-district litigation In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Case No. 11-md-2226-DCR, MDL Docket No. 2226, raised a host of claims against generic manufacturers of the drug propoxyphene (a generic equivalent of Darvon) that the Eastern District of Kentucky recently dismissed as either preempted by Mensing or inadequately pleaded. 

Just before the MDL was transferred to the Eastern District of Kentucky the Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) held that federal law, which requires warning labels on generic drugs to match those of the corresponding brand-name drugs, preempted plaintiffs’ state-law failure-to-warn claims against generic drug manufacturers.  Id. at 2572.  Even though the In re: Darvocet plaintiffs were permitted to amend their complaints following the publication of the Mensing, the district court held that plaintiffs could not avoid the effect of Mensing no matter how they framed their allegations. 

The district court first held that two Sixth Circuit decisions, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010) and Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528 (6th Cir. 1993), were inapposite to plaintiffs’ “wrongful marketing” claims (which included design defect, negligent design, negligence, and breach of implied warranty) because both cases involved a different regulatory scheme and were decided prior to Mensing. As to the plaintiffs’ argument that the generic manufacturers were free to remove propoxyphene products from the market -  “failure to remove” – the court agreed with the Eighth Circuit decision on remand Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011), that the Supreme Court’s opinion in Mensing prohibited these claims:  “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.”

The district court then held that plaintiffs’ conclusory allegations of failure to warn did not meet the basic pleading requirements.  The rest of plaintiffs’ claims, such as misrepresentation, fraud, consumer protection, express warranty and statutory negligence, all related to the sufficiency of the warnings on the propoxyphene products, and were therefore preempted in accordance with Mensing.  Finally, the district court denied plaintiffs discovery and another chance to amend their complaints pursuant to Iqbal

No briefing schedule has been set, but we will update you as In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Case No. 12-5368 goes forward.