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. 

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

Each of these cases is significant enough to merit its own post, but since they came down within a week of each other, we’re discussing both of them here.  They are:  Gahl v. Aurora Health Care, Inc. ___ N.W.2d ___, 2023 Wisc. LEXIS 137 (Wis. May 2, 2023), and M.T. v. Walmart Stores, Inc., ___ P.3d ___, 2023 WL 3135662 (Kan. App. April 28, 2023).Continue Reading Two New Appellate COVID-Related Developments

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

If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us.  Public mask usage seems to have increased.  We heard how the “tripledemic” of viruses had made hospital beds scarce.  We have had colleagues out of commission instead of completing our assignments.  The

So, another year has passed.  2022 is in the books and the republic still stands, even if Roe v. Wade (and, soon, Twitter) do not.  The COVID-19 pandemic – if not COVID-19 itself, which has instead become endemic – is largely over, except for some probably PREP Act preempted shouting.

For the Blog, the end of the year means that it’s time for our annual celebration of the Drug & Device Law Blog’s top ten decisions of the year.  Some of these cases establish important legal principles, such as preemption, Rule 702 expert exclusion (don’t say Daubert), or the learned intermediary rule.  Others are important because they affect large numbers of cases gathered in the increasingly dysfunctional federal multi-district litigation system.  Some do both.  In either event, these decisions make the legal world at least somewhat less dangerous for our clients and (not incidentally) more favorable for us defense lawyers.Continue Reading The Thrill of Victory – The Ten Best Prescription Drug/Medical Device Decisions of 2022

We’re happy to report on a couple of favorable decisions involving some of the COVID-19-related issues that the Blog has been covering.  We have one each on ivermectin injunctions, Shoemaker v. UPMC, ___ A.3d ___, 2022 WL 4372772 (Pa. Super. Sept. 22, 2022), and vaccine mandates, Children’s Health Defense, Inc. v. Rutgers, 2022 WL 4377515 (D.N.J. Sept. 22, 2022).Continue Reading Two Recent COVID-19 Wins

We have tried to be pretty balanced in addressing a number of decisions over the last few months relating to lawsuits brought by the euphemistically labeled “vaccine hesitant” and their brethren who advocate aggressively for entitlement to “alternative” medical treatments like anti-parasitic (veterinary) drugs.  We have been restrained in treating these lawsuits as having been