We recently attended the ACI Drug & Medical Device Seminar in New York, where we always enjoy catching up with old friends, making new acquaintances, and hearing what’s new in our drug and device sandbox. This year we spoke on the extensive and active litigation that is currently going on over the 340B drug pricing
A few months ago we posted about how the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) held up against challenges to COVID-19 vaccine mandates. The decision—which upheld a smallpox vaccination order over 100 years ago—has fared very well. Jacobson’s recognition that “society based on the rule that each one is a law unto himself would soon be confronted with disorder and anarchy” applies today as much as it did in 1905. Id. at 26. Today’s post addresses another COVID-19 decision relying on Jacobson to uphold vaccine mandates instituted for healthcare workers. Continue Reading Jacobson Remains Solid: Ninth Circuit Upholds Vaccine Mandate
We reported two years ago on a Third Circuit opinion holding that the federal government did not have the authority to require drug manufacturers to deliver 340B-discounted drugs to an unlimited number of pharmacies. The D.C. Circuit came to the same conclusion a year later. See Sanofi Aventis U.S. LLC v. HHS, 58 F.4th
Last year we recounted a decision that denied a preliminary injunction to selfish New Mexicans who think that they have a right to endanger others by refusing to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. Specifically the court denied relief to a registered nurse who claimed that she has a right to treat
Today we discuss a putative class action in which the named plaintiffs are a registered nurse who refuses to take a basic precaution to protect her vulnerable patients and a mother who is more interested in displaying her livestock than protecting her neighbors. Brought on behalf of all New Mexico residents who are equally selfish,
When we first wrote on public universities requiring COVID-19 vaccines, we wondered why there was any controversy. The government has been requiring vaccines in public schools for decades, and the constitutionality of government vaccine requirements has been settled for more than 100 years. Courts have agreed—including the Seventh Circuit, as we reported here.
But
Bexis had been on the road a lot lately – it seems blogging attract speaking engagements – and at both the recent PLAC fall meeting and the ACI’s FDA Boot Camp, speakers discussed the recent Supreme Court decision in FCC v. Fox Television Stations, Inc., 132 S. Ct. 2307 (2012), as having implications for product liability actions involving regulatory allegation claims. We’d particularly like to thank Mike Walsh from Strasburger for sharing his thoughts (and some nice PowerPoint slides) on this issue.
Fox Television is a Due Process case, and the way Due Process intersects with product liability, at least in this context, is whether there are Due Process constraints on plaintiffs ginning up FDA (or, indeed, other federal) regulatory violation claims based on weird interpretations by paid FDA “experts.”
Can you say “parallel violation” claims?
What do we learn from Fox Television? The case involved the regulation of purported “indecency” on television – no, it doesn’t involve Quentin Tarantino movies, but rather a far more serious problem than blood-soaked megadeath. We mean “fleeting expletives.” On prime time, broadcasters can show as much killing as they want, but the actors can’t swear as they get killed (or about anything else). So the FCC has decreed – but not very well, the Supreme Court held.
The FCC held that an unscripted f-bomb on live TV was a no-no (ditto fleeting nudity (not the Superbowl wardrobe malfunction; that was another case)) and fined the TV networks. This was something of a regulatory flip-flop, so the networks sued alleging that their Due Process rights were violated by the arbitrary and capricious actions of the FCC. The Supreme Court agreed, sort of.Continue Reading A Step Beyond – Due Process and the FDA
We’ve posted quite a bit on the substantive due process aspects of punitive damages. Other than that, we frankly hadn’t thought about substantive due process being applicable to other aspects of product liability litigation.
Well, it’s time to start thinking.
A decision has just come down that accepts the argument that the expansion of state