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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. 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 plaintiffs’ allegations in In re MDL 2700 Genentech Herceptin (Trastuzumab) Marketing & Sales Practice Litigation, ___ F.3d ___, 2020 WL 2781287 (10th Cir. May 29, 2020), weren’t safety related.  Rather, they sought damages for purely economic loss because the way the vials of Herceptin (a prescription biologic) were filled allegedly resulted in most

This post is neither written nor reviewed by the Dechert side of the Blog.

The recent decision in McLaughlin v. Bayer Essure, Inc., 2020 WL 1625549 (E.D. Pa. April 2, 2020), is massive (28 Westlaw pages) and devoted largely to review of a special master’s determination of individualized statute of limitations issues for some

There’s a reason plaintiffs hate removal before service – “snap removal.”  It has the potential to wreak havoc on their mass tort business models, which are largely based on confronting defendants with as many cases as possible in the worst jurisdictions possible.  While federal courts are hardly perfect, they are usually better than the state-court

One of the advantages that the FDA (and other government agencies) have over other litigants is that it gets to ignore court decisions it doesn’t like, in hopes of trying again later in what the Agency considers a more favorable forum.  Here’s how one court described the same policy by a different agency:

Understood in

We’ve noticed quite a few prescription drug preemption decisions lately involving “newly acquired information.”  That’s because the Supreme Court doubled down in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), on the boundary of impossibility preemption being set by a defendant’s ability to utilize the FDA’s “changes being effected”