Today’s case, Bradley v. CVS Pharmacy, Inc., 2021 Cal. App. LEXIS 451, 2021 WL 2176797 (Cal. Ct. App. May 28, 2021), is not about drug or device product liability, but its discussion of deference to administrative agencies is interesting. There are several different but closely related doctrines that either require or permit judicial deference
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
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’ve already commented about the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d. That original immunity covered all aspects of government-related or sponsored production and use of anti-COVID countermeasures. It was, as one of our colleagues put
We light up a cigar maybe once a month. Of course, they’re no damned good for us. If we had any doubts, the headache and swamp-breath the next day would remove them. Still, a spirit of convivial dissipation tells us to smoke’em if we’ve got’em. No need to warn us off cigars, or the inevitable
Administrative law is having a moment. Next year is the 75th anniversary of the Administrative Procedure Act (“APA”). We have mixed feelings about attending the party. The games will be saddled with unclear and unevenly applied rules. Instead of goody bags, we will be forced to disgorge treasure on the way out. But if there
Today we’re updating our readers on new developments this month relating to three of our prior posts.
First, back in March we reported on an “Advocate’s General’s opinion” in a case before the European Court of Justice (“ECJ”). See the original post for details, but the plaintiff was asserting the radical claim that EU
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
We haven’t had a word to say on the Blog about the biggest health story in the world. That was because, until now, there wasn’t a product liability angle to it. That’s now changed. On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of