We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s).  We’ve cited precedent, FDA internal manuals, FDA’s own position taken in formal briefing, and learned treatises on FDA law.  That an FDA warning letter has no binding legal effect (indeed,

Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht.  We hope he’s right.  As always, our

We’ve been waiting quite a while for the FDA to modernize its positions on the truthful off-label communications by regulated manufacturers.  Under current First Amendment practice, the FDA’s positions are quite likely unconstitutional as both speaker- and topic-based restrictions on the truthful communication of scientific information.  However, the best we’ve seen from the Agency to

Today’s guest post is by Reed Smith associate Regina Nelson.  In it she tackles an issue that inevitably arises whenever ediscovery for defendants is successful, that is, what must be done to have the fruits of that discovery be admitted at trial, otherwise known as authentication.  She discusses a recent Pennsylvania appellate case that

On Wednesday, the Fifth Circuit was finally able speak to what’s been going on in a Dallas courtroom that has racked up over $1.7 billion—that’s billion—in jury verdicts over the last two years in the Pinnacle Hip Implant MDL. And the Fifth Circuit entered the room loudly. It ordered a new trial of the