It has been just about two years since the Central District of California dismissed the claims in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc. as impermissible attempts to privately enforce the FDCA and therefore impliedly preempted.  We blogged about that decision back then.  At that time, we noted that while the case arose

Nerds such as your friendly neighborhood DDL bloggers read legal decisions with excitement. We hardly seem alone in that regard, at least lately. Over the past several weeks, SCOTUS issued a series of major opinions on wedge issues, engendering widespread feelings of triumph or despair or exultation or fury. The “least dangerous branch” looks plenty

Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 

Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix

A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.

The

This post is from the non-Dechert side of the blog.

Our latest Zantac litigation decision is not from the Florida MDL, but rather a standalone case in Maryland − Mayor & City Council of Baltimore v. GlaxoSmithKline, LLC, 2022 WL 537004 (Md. Cir. Jan. 28, 2022).  It’s a split decision, and depending on which

These days, you are probably expecting a vaccine post to be about Covid.  And while we are sure we are not done with litigation in that field, for today at least we thought we would harken back to a good, old-fashioned, garden variety vaccine products liability case and some tried and true preemption.

The plaintiff