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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.

Last term, in a case that the Blog completely ignored, the Supreme Court held that a provision of the Medicare Act, 42 U.S.C. §1395hh(a)(2), required the Centers for Medicare & Medicaid Services (“CMS”) to subject all Medicare-related determinations “that establish[] or change[] a substantive legal standard” to formal notice-and-comment rulemaking.  Such determinations explicitly include (as

We’ve been backing the proposition that the Erie doctrine concerning federal courts’ prediction of state law precludes courts clothed only with diversity jurisdiction from expanding state tort liability in novel ways since just about the beginning of the Blog.  However, our analyses have tended to be forward looking.  We typically start with the Supreme Court’s

Plaintiffs in (mostly) prescription drug cases have tried, with decreasing success, to limit the scope of implied impossibility preemption under the Mensing/Bartlett line of supreme court precedent to generic drugs.  It’s not a particularly satisfying rationale, but the simple claim that “those were generic drug cases” did at least convince some courts that

It wasn’t an opinion, or a grant of certiorari, but it may be important nonetheless.  In a concurrence in the denial of certiorari the other day, Justices Thomas and Gorsuch expounded on their view of how preemption works (or doesn’t work) in the context of a decision by a federal agency (not the FDA

Back in 2012, we published our “Distribute This!” post about In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012), lauding its ruling that, under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett,