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.

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.

**********

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

Purported class actions on behalf of people who haven’t really suffered any injury are one of the banes of our existence.  While not limited to California or courts in the Ninth Circuit, some of the worst (most of which we haven’t covered because they are adverse non-drug/device cases) decisions certainly hail from there.

Recently, however