Last week, in the course of discussing a vaccine case, we mused over the misuse of the due process clause of the fourteenth amendment. Just for a moment we were back at U. of Chicago Law (and, as Dan Fogelberg sang, “felt that old familiar pain”). In 1984, our waist and forehead seemed smaller
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The World Is Run By Those Who Show Up
By Bexis on
That’s the main lesson of the emerging fiasco that is the ALI’s benignly named “Concluding Provisions” project for the Restatement Third of Torts. While this title suggests that the Institute is merely engaged in routine “mop up” work, nothing could be further from the truth. Any number of significant tort-related topics were not addressed by…
FDA Completes “Intended Use” Administrative Marathon
By Bexis on
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). …
Reflections on Turning 65
By Bexis on
Bexis just turned 65 (on 1/25/2021) – the classic retirement age. That’s an occasion to look back and evaluate what’s gone on over the course of an entire legal career. So how have we done, as defense lawyers, over the course of our entire careers, at our primary job – which is to prevail for…
Tort Pandemic Countermeasures − The Ten Best Prescription Drug/Medical Device Decisions of 2020
By Bexis on
With 2020 mercifully coming to an end, it is once again time for the Drug & Device Law Blog’s top ten decisions of the year. In keeping with COVID-19’s dominance of 2020, we present our top ten in the context of countermeasures against another social ill – the tort pandemic raging across much of the…
Foreseeing Risks With Off-Label Use
By Eric Alexander on
A long time ago in a law school relatively far away, we took torts as a first year law student. Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice. …
FDA’s Latest Attempt to Update “Intended Use” Regulations
By Bexis on
When we last examined the FDA’s sporadic effort to update the archaic “intended use” regulations (primarily 21 C.F.R. §§201.128 (drugs), 801.4 (devices)), the 2017 bait-and-switch amendment to these regulations had been put on ice. That has led to the bizarre Westlaw “currentness” notice for these regulations:
<Text of section effective upon the effective date of
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D.Mass Rejects Post-trial Motions by Corporate Officers Convicted of Off-Label Promotion
By Stephen McConnell on
Can a court decision be simultaneously depressing and exhilarating? You might be surprised how often that happens. In United States v. Facteau, 2020 WL 5517573, (D. Mass. Sept. 14, 2020), the court upheld criminalization of off-label promotion, but did so in a way that might signal the end of an era in which pharmaceutical…
FDA Nonacquiescence Strategy Fails In Evergreening Case
By Bexis on
One of the advantages that the FDA (and other government agencies) have over other litigants is that it gets to ignore court decisions it doesn’t like, in hopes of trying again later in what the Agency considers a more favorable forum. Here’s how one court described the same policy by a different agency:
Understood in
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On Promoting Off-Label Use II
By Bexis on
Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less. As we pointed out in the prior post, this drug has serious potential side…