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

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). 

With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”

That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the

First of all, get your minds out of the gutter.  Second, remember two weeks ago when we noted how rarely we discuss lawsuits against FDA?  We are doing it again.  Third, although we have talked about the strange regulatory shadowland in which homeopathic drugs have resided, they have not seen much action in litigation.  When

We’re old enough that we remember the pre-Daubert Bendectin litigation.  Bendectin was the only FDA-approved drug indicated for nausea and vomiting from pregnancy.  Yellow journalism (the National Enquirer) and scientific fraud (deliberately falsified scientific data) fanned a birth defect scare, which led to an avalanche of factually baseless litigation – Daubert was

When we think about litigation involving the FDA, our first thought is about preemption of claims brought by product liability plaintiffs.  Our second is probably the relatively recent line of cases where these plaintiffs would like no mention of FDA’s existence, let alone its requirements and actions, during the trial on their claims.  However, there

We’re interested in artificial intelligence, particularly as it affects medical devices, but we don’t know all that much about it, and it’s yet to make much of an impact in our product liability sandbox.  Fortunately, we know some folks who do stay informed on this topic, and that’s what today’s guest post is about.  In

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

Not too long ago we researched and posted about how preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing and classification of the products the Agency regulates.  Looking through that post again, we note that quite a few of those decisions (although well less than half) involved commercial disputes of one sort or