Over the past seven months, we reported (here, here, here, here, here, and here) on cases in which relatives of individuals sick with COVID-19 sued to force hospitals to administer ivermectin to their loved ones. Apart from one that issued a quickly lifted emergency injunction and another that
Off-Label Use
Eleventh Circuit Disapproves Non-Intended Use Salami Slicing

The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. In that instance, the FDA had limited its cleared “intended use” to disc spaces…
Protecting A Veterinarian’s Speech: A Model For Communications On Off-Label Use?

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…
Hospital Cannot Be Forced To Grant Privileges To Doctor Who Would Administer Ivermectin

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,…
NY Court Holds Covid Patient Has No Right to Ivermectin

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…
Patient Has No Right to Receive, and Hospital Has No Duty to Administer, A Drug that Is Not the Standard of Care

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…
Just a Few Words on Off-Label Use

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…
Ivermectin and COVID-19: Seriously, y’all. Stop it.

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.…
More COVID Kookiness – Ivermectin Lawsuits

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. …
Tennessee Trial Court Holds Claims Preempted Notwithstanding Alleged Off-Label Use Of A Medical Device

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…