Photo of Bexis

JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community.  Id. at 350.  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 n.5 (citation and quotation marks omitted). 

The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years.  Because the relevant preemption clause closely resembles the language of the Medical Device Amendments (“MDA”), we thought it was worth a look.

In Webb v. Trader Joe’s Co., ___ F.3d

We’re old enough that we remember the pre-Daubert Bendectin litigation.  Bendectin was the only FDA-approved drug indicated for nausea and vomiting from pregnancy.  Yellow journalism (the National Enquirer) and scientific fraud (deliberately falsified scientific data) fanned a birth defect scare, which led to an avalanche of factually baseless litigation – Daubert was

The recent appellate False Claims Act (“FCA”) decision in Dan Abrams Co. LLC v. Medtronic Inc., ___ F. Appx. ___, 2021 WL 1235845 (9th Cir. April 2, 2021), has us scratching our heads.  It’s like riding a legal roller coaster.  Some parts are really high, and others are really low.

Bexis first ran across

This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts.

First, slightly over a year ago we praised Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), a prescription drug preemption decision holding, among other things, that a plaintiff could not claim “newly