Today’s post is about one of our favorite topics, off-label use. This time, it isn’t about what manufacturers can say about unapproved uses. It’s about whether the DOJ can wield the FDCA’s misbranding provisions to criminally investigate hospitals whose physicians prescribe FDA-approved drugs for off-label purposes.
In In re Administrative Subpoena 25-1431-032 to Rhode
Can we all agree that as between vaccines and [checks notes] “snort[ing] cocaine off of toilet seats”, it is the vaccines that should make us “not scared of a germ”?
Ok, maybe the [checks notes] Secretary of Health and Human Services wouldn’t agree, but c’mon—the evidence that vaccines save lives is overwhelming.
As Perry
As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects. A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,”
The title of today’s post is from a quote by Justice Holmes in a dissenting opinion, Abrams v. United States, 250 U.S. 616, 630 (1919). Abrams involved a conviction under the Espionage Act based on the publication of leaflets that were distributed in New York during World War I. Among other things, the leaflets denounced President Wilson as a hypocrite and a coward, and lamented the “hypocrisy of the plutocratic gang in Washington and vicinity.” Id. at 620. In his dissent (joined by Justice Brandeis), Justice Holmes espoused the power of free speech in connection with our country’s experiment with its Constitution. Or, as Justice Holmes more eloquently put it: “It is an experiment. All life is an experiment. Every year if not every day we have to wager our salvation upon some prophecy based upon imperfect knowledge. While that experiment is part of our system[,] I think that we should be eternally vigilant against attempts to check the expression of opinions that we loathe and believe to be fraught with death . . . .” Id. at 630.
Continue Reading The Best Test of Truth Is the Power of the Thought to Get Itself Accepted in the Competition of the Market
It is a whole lot harder to file documents under seal than it used to be. We recall an MDL in the early 2000s where the parties filed everything under seal over the course of multiple years—litigating for the viewing pleasure of our “friends and family,” as the district judge often chided us. Times have
So says the Fifth Circuit in Torrey v. Infectious Diseases Society of America, — F.4th –, 2023 WL 7890067 (5th Cir. Nov. 16, 2023). Which joins the Second and Third Circuits in protecting scientific free speech. Cases we discussed here and here and which support our firm belief that scientific articles are “core”
In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. Our position has been clear, and the same from the Blog’s beginning
If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us. Public mask usage seems to have increased. We heard how the “tripledemic” of viruses had made hospital beds scarce. We have had colleagues out of commission instead of completing our assignments. The
Pacira Biosciences, Inc. v. American Society of Anesthesiologists, Inc., 2022 WL 336585 (D. N.J. Feb. 4, 2022), is not a product liability opinion. Instead, it occurs in the context of a motion to dismiss a trade libel case brought by a pharmaceutical company. The Pacira court decided that the truth/falsity of scientific ideas published
We told you that if anti-vaxxers found a sympathetic court in their quest to declare government vaccine mandates unconstitutional, we would let you know. Well, we did not think it would be so soon. And we surely did not think that the sympathetic court would be the United States Supreme Court.
Don’t get the wrong