Sometimes there are decisions that we begin to read with an expectation—perhaps based on a thumbnail from Bexis—that we will have a strong impression.  Not surprisingly, the expected impression is usually negative.  This was the case with Apter v. HHS, No. 22-40802, 2023 U.S. App. LEXIS 23401 (5th Cir. Sept. 1, 2023), which concerned

Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence.  We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation.  We have tried to be consistent.Continue Reading Agree To Disagree – Don’t  Sue the Other Side of a Scientific Dispute into Silence

About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system.  We probably should not have been surprised by the persistence of frivolous litigation.  After all, our day job entails defending litigations that can last years longer than they

Sometimes our weekly searches for what is going on in the drug and device world lead as outside the traditional products liability context that is our bread and butter.  Occasionally that can be refreshing – a break from preemption and causation and TwIqbal.  It’s also interesting to see how things like off-label use come

To us – and we suspect to most of the exceptional public servants employed by the FDA – Sunday, August 23, 2020 will be a day they would rather forget.  On that day the Agency issued an “emergency use authorization” (“EUA”) for what is known as “convalescent plasma” for the treatment of COVID-19,

Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less.  As we pointed out in the prior post, this drug has serious potential side

We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products.  Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the