Way before we were lawyers, we read a good chunk of the writings of James Herriot, the nom de plume of a rural English veterinarian who chronicled his exploits in helping All Creatures Great and Small (the title of a movie and TV series about him). The veneration of his seemingly altruistic and tireless work
Four times in the past several months (here, here, here, and here), we have reported on cases in which plaintiffs have sought injunctions that would compel hospitals to administer the anti-parasitic drug ivermectin to COVID-19 patients. Today we report on another such case, Texas Health Huguley, Inc. v. Jones,
Happy Birthday to the Drug and Device Law Daughter. You cannot come home from Kyrgyzstan soon enough. Fall might be the season of mists and mellow fruitfulness, but it is dismal without you. And we hope you have refrained from playing Buzkashi (headless goat polo).
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Sometimes we discern patterns in our posts. Last week
For the second time in three weeks a court has denied an injunction that would have compelled a hospital to administer ivermectin to a patient seriously ill with COVID-19. We previously reported on the first of those decisions, Smith v. West Chester Hosp., LLC, 2021 WL 4129083 (Ohio Com. Pl. 2021). Today we report
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
On Monday, Bexis, laboring on Labor Day, blogged about a kooky Ohio decision ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated. The decision was kooky both medically and legally.
We’ve read recently about a court taking the unprecedented step of ordering the off-label administration of an animal drug, ivermectin, to a seriously ill COVID-19 patient over the objections of that patient’s treating physicians and of the hospital in which the patient was being treated.
Off-label use is something we know a little bit about.
Today we discuss Sherrod v. Smith & Nephew, Inc., 2021 Tenn. Cir. LEXIS 74 (Tenn. Cir. Ct. 2021), a recent Tennessee trial court decision granting the defendant device manufacturer summary judgment on preemption grounds. Notwithstanding one quibble, there is much to like about the decision.
The plaintiff, who asserted a plethora of product-liability and
Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes. 80 Fed. Reg. 57756 (FDA Sept. 25, 2015).
With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”
That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the