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

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 Entertainment Law & Finance 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 Article 8 Opt In Image

The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.

Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers Image

There's current litigation in the ongoing Beach Boys litigation saga. A lawsuit filed in 2019 against Nevada residents Mike Love and his wife Jacquelyne in the U.S. District Court for the District of Nevada that alleges inaccurate payment by the Loves under the retainer agreement and seeks $84.5 million in damages.

Major Differences In UK, U.S. Copyright Laws Image

This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.

Strategy vs. Tactics: Two Sides of a Difficult Coin Image

With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.

When Is a Repair Structural or Nonstructural Under a Commercial Lease? Image

A common question that commercial landlords and tenants face is which of them is responsible for a repair to the subject premises. These disputes often center on whether the repair is "structural" or "nonstructural."