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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 LiinkedIn page is here.

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”

The “fraud on the FDA” claim that the Supreme Court held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was actually the most extreme form of a private plaintiff second-guessing the result of an FDA process classifying a regulated product.  Plaintiffs claimed that, because of purported “fraud” in the §510(k)

Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”).  That approach originally led us to 21 U.S.C. §337(a),

With apologies to Mick Jagger and Keith Richards (who wouldn’t have jurisdiction either, being UK citizens), that is what the Sixth Circuit told a pack of Spanish plaintiffs recently in In Re DePuy Orthopædics, Inc. ASR Hip Implant Products Liability Litigation, ___ F.3d ___, 2020 WL 1482384 (6th Cir. March 27, 2020).

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