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

Earlier this year we discussed the application of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), to a variety of private litigation that sought to second-guess the FDA’s drug or medical device classification decisions.  Then we followed up with what we described as a “doozy” of a case along the same lines,

Today we have another guest post from friend-of-the-Blog, Dick Dean at Tucker Ellis.  He’s familiar with the ongoing Pradaxa litigation and is pleased with the preemption pummeling Pradaxa plaintiffs have been receiving.  Here’s his post about yet another favorable decision from the state-court Pradaxa proceedings in Connecticut.  With decisions like this, who needs snap

A great woman once said “When they go low, we go high.”  Apropos of nothing in particular these days, we have been thinking about the issue of tone recently.  For instance, what is the exact line between a negative political advertisement and a positive one?  Are there circumstances where a candidate might suspend negative ads

Lyons v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 5835125 (N.D. Ga. Sept. 29, 2020), was a wrongful death action alleging that the anticoagulant drug Pradaxa was defective and not accompanied by adequate warnings that blood plasma concentrations should be monitored and that certain patient characteristics, such as age, renal impairments, and concomitant statin

We have blogged about class actions; we have blogged about preemption; we have blogged about social media; we have blogged about alleged economic loss; and we have blogged about alleged product defects—endlessly.  Rarely, however, have we blogged on all of these topics in a single post.

Today is the day, and the topic is an