After a two-year investigation, the Department of Justice charged Intermune with misbranding the drug Actimmune by promoting it off-label to treat idiopathic pulmonary fibrosis.

(We like to use sentences like that. It gets our sophisticated readers salivating while discouraging the rest.)

After the deferred prosecution agreement and payment of the $42.5 million fine, the deluge.

The first really, really major post-Riegel preemption battle in the PMA device product litigation has been the Sprint Fidelis implantable cardiac defibrillator lead MDL, in which Medtronic moved to dismiss (that means on the pleadings – without discovery) against all claims on the strength of the express preemption clause as interpreted by Riegel.

OK class, for today’s lesson, assume you are a major, sophisticated drug company. That means you have to have at least one (actually, a bunch) FDA-approved drug that’s safe and effective for its indicated use. So assume that, too – let’s say your drug alleviates muscular inflammation from over-exercise.

There being at least some reality