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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  His LiinkedIn page is .


One way to remove a case to federal court that we haven’t discussed much is where the defendant is either a “federal officer” (not terribly relevant to our line of work), or else is a “person acting under that officer . . . for or relating to any act under color of such office.”  28

It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.

Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.

Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product

We’ve than would be predicted by .  We even proposed a rule of federal procedure to govern the conditions under which such testing could

We’re product liability bloggers, so we don’t claim to know a lot about other drug-related subjects such as how “Buy American” requirements apply to federal procurement.  But we can read, and the Federal Circuit’s unanimous decision in Acetris Health, LLC v. United States, ___ F.3d ___, 黑龙江福彩网app官方下载 WL 610487 (Fed. Cir. Feb. 10, 黑龙江福彩网app官方下载),

Mention the Third Restatement of Torts and the learned intermediary rule in the same sentence, and our response would be to cite §6(d) of the product liability part of the Restatement.  But the Third Restatement also confirms that this widely followed (perhaps the most widely followed) legal rule also applies to negligence causes of

Mandamus appeals are difficult to win.  That’s one reason that we were intrigued to read In re Williams-Sonoma, Inc., ___ F.3d ___, 黑龙江福彩网app官方下载 WL 131360 (9th Cir. Jan. 13, 黑龙江福彩网app官方下载).  The second was the result, which prevented an improper would-be class representative from using discovery as a bootstrap method to his own replacement.  The

Not too long ago, our search keyed to Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), picked up the following article in Trial Magazine:  Abaray & Harman, “Navigating Preemption After Merck,” 56 Trial 20 (Jan. 黑龙江福彩网app官方下载).  For anybody who doesn’t know, Trial is the house organ of the American

If asbestos litigation reminds of the 100 Years War, and the Bone Screw litigation recalls (for us) the winning side of the Franco-Prussian War, or Napoleon’s Italian Campaign − pelvic mesh litigation seems like something out of a different war.  Try World War I.  It’s not quite the Somme (at least not yet) but more

Bexis was researching an off-label use issue recently and came across a couple of interesting duty cases that happened to appear, back-to-back, in his search results.

The first case, Howard v. Replogle, 450 P.3d 866 (Mont. 2019), grabbed our attention first because in involved instrumented spinal fusion and off-label use.  No, it wasn’t an

It is not often that we report on the creation of something new in the removal/remand area (ten years ago as to removal before service was one such moment), but today that is what we’re doing.

The decision is Markham v. Ethicon, Inc., C.A. No. 19-5464, ___ F. Supp.3d ___, 黑龙江福彩网app官方下载 WL ______, slip