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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 LinkedIn page is here.

We’re interested in artificial intelligence, particularly as it affects medical devices, but we don’t know all that much about it, and it’s yet to make much of an impact in our product liability sandbox.  Fortunately, we know some folks who do stay informed on this topic, and that’s what today’s guest post is about.  In

Bexis just turned 65 (on 1/25/2021) – the classic retirement age.  That’s an occasion to look back and evaluate what’s gone on over the course of an entire legal career.  So how have we done, as defense lawyers, over the course of our entire careers, at our primary job – which is to prevail for

We’ve complained before about MDL “master” or “consolidated” complaints being used to deprive defendants of the ability to pursue their rights to seek dismissal on TwIqbal and other pleading-related grounds.  In individual actions, defendants have the right to put the plaintiffs’ pleadings to the test required by Rules 8 and 12.  That has not necessarily

Albert Einstein supposedly said, “Insanity is doing the same thing over and over again and expecting different results.”  He may not have, but the point is well taken.  We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved (“PMA”) medical devices with vague, boilerplate complaints.  Haven’t they heard about

Here’s another quasi-guest post by Reed Smith’s blogger-in-training Dean Balaes.  This one provides a critique of the scary Park doctrine, aptly described here as “Frankenstein’s Monster,” that allows imposition of criminal liability on corporate officers for illegality they didn’t even know about.

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In 1816, Mary Shelley and Lord Byron entered into a wager to

We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020).  Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.

Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior