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
We’re product liability bloggers, so we don’t claim to know a lot about other drug-related subjects such as how “Buy American” requirements apply to federal procurement. But we can read, and the Federal Circuit’s unanimous decision in Acetris Health, LLC v. United States, ___ F.3d ___, 2020 WL 610487 (Fed. Cir. Feb. 10, 2020),
You’ll find any number of places on this blog where we argue emphatically that FDA warning letters are far from final and therefore should not be able to be used in products liability actions. See here for our latest post on the issue (which also collects our other posts). These posts cite case law, FDA
We seem to be having an administrative law moment at the DDL blog. That subject matter area is seldom sexy. It can be, frankly, quite dry. But administrative law can have a huge impact on drug and device law. Yesterday, Bexis discussed cases holding that agency rules that did not undergo required notice and comment