Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

The Mensing Preemption and the Learned Intermediary Doctrine

By Sara K. Thompson and Sean P. Jessee
June 27, 2012

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.

This premium content is locked for LJN Newsletters subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The DOJ's Corporate Enforcement Policy: One Year Later Image

The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.

The DOJ's New Parameters for Evaluating Corporate Compliance Programs Image

The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.

Use of Deferred Prosecution Agreements In White Collar Investigations Image

This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.

Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability Image

This article explores legal developments over the past year that may impact compliance officer personal liability.