Photo of Bexis

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.

Today’s guest post is by Reed Smith‘s Lisa Baird, who has written about her recent experience with mandatory initial discovery, as practiced in a “Pilot Project” in place in certain federal district courts.  It was interesting – in the “stop and think before you remove to federal court” sense of interesting.  As always

As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product

What follows is a guest post from Mark Herrmann, the co-founder and former co-host of this blog.  While he hasn’t litigated since going in house, he still writes on legal topics, including drug and medical device product liability.  This post is also something of a shameless plug, since he’s announcing the latest edition

Our careers have seen several major pro-defense trends in product liability litigation:

Mainstreaming summary judgment:  This happened when we were still young lawyers.  A trilogy of United States Supreme Court cases established that summary judgment wasn’t an “extraordinary” or “disfavored” procedure, but rather part and parcel of modern litigation.  The lead case in the

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor.  This post is about forum non conveniens, which is more discretionary, and less enforceable than personal jurisdiction as a limitation on plaintiff-side (or even defense-side) forum shopping, but which, as