We have become accustomed to doing things remotely these days.  Depositions, court appearances, mediations, conferences, celebrations and family gatherings of all kinds.  The variety of activities that we now do by videoconference pales only by comparison to the speed with which we adapted to this new normal.  We will refrain from opining on whether we

The Ninth Circuit recently answered a preemption question that we had seen arise intermittently, mostly in food litigation, over the past couple of years.  Because the relevant preemption clause closely resembles the language of the Medical Device Amendments, we thought it was worth a look.

In Webb v. Trader Joe’s Co., ___ F.3d ___,

One of the intriguing things about cases decided by a jurisdiction’s highest court is that pronouncements by such courts can often have far-reaching implications.  Sometimes they pan out, as the application of the First Amendment to the FDA’s ban on off-label promotion seems to be doing following Sorrell v. IMS Health, Inc., 564 U.S.

Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.

A bit of background first.

In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by

Last year the HHS Office of Inspector General issues a “Special Fraud Alert” (“Alert”) concerning “Speaker Programs” – more usually known as continuing medical education (“CME”).  Since we believe that truthful commercial speech is First Amendment protected, seeing “fraud” bandied about like this caused us to take a look.  We’re well aware that for years