Photo of Bexis

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.

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’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 ___, 2020 WL 610487 (Fed. Cir. Feb. 10, 2020),

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. 2020).  For anybody who doesn’t know, Trial is the house organ of the American

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 ___, 2020 WL ______, slip

When we were still (relatively) young lawyers, we defended Bendectin cases.  There was nothing wrong with Bendectin – the litigation produced Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court’s landmark decision on excluding bogus expert testimony, and numerous other decisions, state and federal, excluding “junk science.”  Nonetheless, Bendectin’s primary