When Bexis sends around his weekly list of potentially bloggable cases, we always lunge for the criminal matters, which are fairly rare. Cases brought under Title 21 bring us back to our days at the U.S. Attorney’s office, where we knew nothing of billable hours, MDL case management orders, fancy office coffee machines, or an
Off-Label Use
FDA and Off-Label Communication – Getting Closer to Truth
In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. Our position has been clear, and the same from the Blog’s beginning…
Fifth Circuit FDA Decision Puzzles
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…
Federal Court Calls Out—and Enjoins—Anti-Trans Bigotry
The case we discuss today, Doe v. Ladapo, 2023 WL 3833848 (N.D. Fla. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. Invalidating a state statute that would have prohibited a particular off-label use, the court explained that “[o]ff-label use of drugs is commonplace” and the fact…
Leave Ivermectin to Horses and Parasites
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…