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

Since we were involved in the Medtronic Infuse wars, we’ve been quite aware of Justice Gorsuch’s textualist views towards statutes since he wrote Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  In Caplinger he got a close look at the damage the Supreme Court had done to the plain meaning of the

Here are a couple of things that happened recently (and no, we don’t mean a travel ban on Europe or the NBA cancelling the rest of its season).  They’re not related, but separate posts would be too short.

First, last November we warned our colleagues that it was time to start thinking of alternative grounds