The definitive source for intelligent commentary on the law that matters for drug and device product liability cases
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. …
The title of today’s post is from a quote by Justice Holmes in a dissenting opinion, Abrams v. United States, 250 U.S. 616, 630 (1919). Abrams involved a conviction under the Espionage Act based on the publication of leaflets that were distributed in New York during World War I. Among other things, the leaflets denounced President Wilson as a hypocrite and a coward, and lamented the “hypocrisy of the plutocratic gang in Washington and vicinity.” Id. at 620. In his dissent (joined by Justice Brandeis), Justice Holmes espoused the power of free speech in connection with our country’s experiment with its Constitution. Or, as Justice Holmes more eloquently put it: “It is an experiment. All life is an experiment. Every year if not every day we have to wager our salvation upon some prophecy based upon imperfect knowledge. While that experiment is part of our system[,] I think that we should be eternally vigilant against attempts to check the expression of opinions that we loathe and believe to be fraught with death . . . .” Id. at 630.
Continue Reading The Best Test of Truth Is the Power of the Thought to Get Itself Accepted in the Competition of the MarketIn his latest off-label use-related law review article in 2021, Bexis pointed out:
[A]lthough states have traditionally been recognized to have broad authority to regulate the practice of medicine, aside from occasional attempts to restrict use of abortifacients, state-law interventions restricting the off-label uses of prescription medical products have been infrequent.
James M. Beck, “Off-Label…
Skrmetti (upholding Tennessee statute forbidding gender dysphoria treatments for minors) was the SCOTUS case that got the most publicity last week, but we drug and device lawyers will always perk up most when we see the High Court issue a ruling regarding the Food and Drug Administration (FDA). That is probably one reason (though surely…
The Drug and Device Law Blog is deliberately apolitical. Our purpose is to support the defense of prescription medical product liability litigation, and we recognize that the political views of our intended audience undoubtedly vary widely.
But one of the foundational grounds of our defense efforts is that the FDA, in its approval and subsequent regulation of prescription medical products, does so through skilled experts impartially evaluating well-conducted research and sufficiently supported facts. The agency’s adherence to the scientific method and scientific principles is essential to our clients as they develop, and seek regulatory approval for, new prescription medical products, as well as changes to existing labeling, designs, and manufacturing processes. In litigation, the FDA’s adherence to the scientific method and scientific principles is the underpinning of our clients’ two most powerful defenses – preemption and Rule 702/expert admissibility. If the FDA (and other federal agencies such as the CDC, NIH, and ACIP) ever abandoned, or were perceived to have abandoned, the scientific method in its decision-making, both regulatory and litigation chaos quite likely would result.
That’s why we are disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. might be given authority over the FDA – and allowed to “go wild” over “health care” and “medicines.” Here is a video link to a recent Trump speech, and here is our transcript limited to the relevant statements:
Continue Reading This Is DisturbingBexis recently gave the keynote address at the Minnesota State Bar Association’s annual FDA Forum. In preparing his speech, which concerned recent challenges to FDA regulatory authority, Bexis had occasion to study Apter v. Dep’t of HHS, 80 F.4th 579 (5th Cir. 2023), which the blog previously discussed here. Since Bexis was discussing…
We’ve discussed decisions applying preemption under the Public Readiness & Emergency Preparedness Act (hereafter “PREP Act”), 42 U.S.C. §247d-6d, on several occasions since the COVID-19 pandemic began. At this point, some four years after the COVID-19 pandemic declaration, we believe that sufficient PREP Act preemption precedent has accumulated, and that the caselaw is sufficiently…
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 DevelopmentsTime 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