For the better part of a decade, Bexis has participated in the Food & Drug Law Institute’s (“FDLI”) annual Top Food and Drug Cases project.  For 2019, he wrote about (surprise!) Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  These haven’t been discussed previously on the Blog because, due to the publication process, these articles are not particularly timely, particularly when judged by the speed of time on the Internet.  However, the impact of COVID-19 slowed FDLI’s publication process more than usual this year, and Bexis was given the opportunity to update his Albrecht article shortly before publication.  This article has now been published, and it is timely.

Here’s a link.  Here is the necessary legalism:  Shared with the permission of FDLI.  Here, moreover, is a link to the entire FDLI top cases publication for 2019.

Should you bother clicking on the link?  Well, here are some of the topics Bexis’s article addresses:

  • The reasons why preemption should be treated as a question of law.
  • All preemption issues being questions of law.
  • Impact of question of law ruling on use of expert witnesses in preemption litigation.
  • The standard of review for judicial factfinding.
  • “Clear evidence” after Albrecht
  • Albrecht’s emphasis on “formal” FDA procedures
  • FDA citizen petitions as a “formal” FDA procedure
  • Implications and proof of “fully informed” FDA element
  • The post-Albrecht rise of the “newly acquired information” prerequisite for utilization of unilateral “changes being effected” label changes

While there is probably nothing in Bexis’s article that we haven’t blogged about somewhere, the article does provide a useful Albrecht overview, with current citations, and consolidates these discussions in one place.