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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…

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). …

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…

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. …

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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Posted in FDA

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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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…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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