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.

Just in.  United States Supreme Court rules unanimously in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”), that the Third Circuit got it wrong in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, the majority opinion,

Have you ever left a deposition feeling confident that you obtained the testimony you hoped to receive, and it’s time to move for summary judgment?  Then (whether within the time period permitted by the relevant rule – in federal court Fed. R. Civ. P. 30(e)(1) – or otherwise) you get back a so-called “errata sheet”

This message is directed primarily to our overseas readers, and those who represent non-United States drug and medical device companies.  Under FDA registration regulations, non-United States manufacturers (and other regulated companies) that import their regulated products into this country are required to appoint a domestic “agent” for regulatory purposes:

(i) Registration of foreign establishments

(1)