We’ve seen many plaintiffs allege that drug and/or medical device manufacturers committed “fraud on the FDA” and bemoan that Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), prevents them from recovering based on such allegations. Buckman still doesn’t prevent them from trying every form of evasive legal chicanery known to man to
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 have been consistently critical of the MDL system for encouraging judges presiding over such massive aggregations to manipulate the applicable law to create settlement pressure on defendants. We’ve seen that with federal preemption, willingness to create novel state-law causes of action, choice of law, and trial consolidation of multiple plaintiffs.
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