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The Mensing Preemption and the Learned Intermediary Doctrine

By Sara K. Thompson and Sean P. Jessee

The Supreme Court's landmark decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has had a far-reaching effect on product liability litigation against generic drug manufacturers, with numerous federal and state courts having held in Mensing's wake that impossibility preemption essentially forecloses all potential product liability claims against generic drug manufacturers. See, e.g., Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011) (rejecting contention that claims for negligence, breach of warranty, design defect, and violation of state consumer protection laws survived preemption); In re Pamidronate Prod. Liab. Litig., No. 10-cv-1860-KAM-SMG, 2012 WL 272889 (E.D.N.Y. Jan. 30, 2012) (failure-to-warn, design defect, negligence, and breach of warranty claims are all preempted); Henderson v. Sun Pharm. Indus., Ltd., No. 4:11-cv-0060-HLM, 2011 WL 4015658 (N.D. Ga. Aug. 22, 2011) (all claims remaining are preempted).

However, a minority of courts have been hesitant to adopt this broad interpretation of Mensing, and have chosen instead to carve out claims that can survive a preemption challenge. Indeed, several courts have rejected preemption for claims alleging a generic drug manufacturer failed to timely update its labeling to correspond with label changes to the brand-name equivalent or reference listed drugs, while other courts have held that claims premised upon a purported failure to communicate a label change to health care providers through broader dissemination means such as a “dear doctor letter” are not preempted. See, e.g., Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2011 WL 4552464, at *10 (D.S.C. Sept. 30, 2011) (recognizing failure-to-update and failure-to-communicate claims); Couick v. Wyeth, No. 3:09-cv-210-RJC-DSC, 2012 WL 77670, at *3-5 (W.D.N.C. Jan. 11, 2012) (recognizing failure to update claim). However, while focusing on the Mensing preemption analysis and attempting to carve out remaining exceptions that the Mensing court never recognized, these courts have often overlooked the effect that the Learned Intermediary Doctrine and basic differences between the sales and marketing practices for generic and brand-name drugs have on these types of claims.

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