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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.

Here is an interesting order that recently emerged from the Benicar multi-district litigation.  Certain plaintiffs’ counsel (identified by name in the order) represent about 450 “plaintiffs who have settled their claims against defendants in exchange for a monetary payment.”  In re Benicar (Olmesartan) Products Liability Litigation, 2019 WL 6271285, at *1 (D.N.J. Nov. 22,

The opinion, Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), recently “predicted” that Pennsylvania would allow strict liability design and warning defect claims in cases involving prescription medical products.  Id. at *11-13.  In so doing Schrecengost was not only wrong, but loud wrong.  First, without even a serious discussion, Schrecengost

We’ve used the phrase “one-two punch” before in the blog to describe a pair of legal decisions concerning the same product.  Usually, our clients have been on the winning side, but that’s not always true, particularly in cases coming out of Philadelphia, Pennsylvania.  In November, the Pennsylvania appellate courts, in gynecomastia litigation, dealt defendants two

In prescription medical product liability litigation, size matters.  It doesn’t matter as much as having good products and winning arguments, but when the name of the game on the other side is to drag defendants into pro-plaintiff forums and then use every procedural trick in the book to try to “ring the bell” on some

Manufacturers supervising medical doctors?  In two words, they don’t.  Yet plaintiffs, particularly in cases where preemption forecloses more normal product liability claims, try to get courts to impose such duties.  We took a look at that issue back during the early days of the blog, when it was still a Bexis/Herrmann operation, in our September

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