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

In the third of the three significant decisions issued in the In re Zantac MDL, No. 2924, on New Year’s Eve, preemption prevailed again – this time barring claims asserted against drug retailers and pharmacists, both branded and generic.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864585 (S.D.

By now our beef with Multidistrict Litigations has become monotonous: plaintiff lawyers assemble enormous inventories of weak cases, then contort the bellwether pool to ensure that only their best cases go to trial. We remember an oral argument in front of an MDL judge in which we employed statistics to show that a representative MDL