We first learned of the Washington Legal Foundations (“WLF”) back in the 1990s, when Bexis collaborated with WLF in pursuing what was then viewed as a rather radical proposition – that the First Amendment applied to FDA and other governmental constraints on off-label promotion of FDA regulated products. Eventually, the Supreme Court specifically held that
Lately, weirdly, sadly, some people have suggested that the Enlightenment was a mistake. They contend that an overemphasis on rationality robbed humanity of feeling, faith, etc. What drivel. Every day of the week, we’ll take Voltaire over any pretend-King, data over dogma, and science over stupidity.
Thus, we are pleased with Miller v. McDonald
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
Who would’ve thought that Texas, of all states, would become a nannyocracy? The Lone Star State typically positions itself as the home of rough and ready folks who can take care of themselves. Think Jim Bowie, Willie Nelson, or Bob Lilly, not Mr. Rogers, Mary Poppins, or Nanny McPhee. Texans don’t need the government telling
We do not quite fit the stereotype of the fat cat – at least (we hope), not anymore. But there was a time when at least one evening per week would be marked by scotch and cigars. Our antiquity and iffy physical constitution have now reduced such festivities to two or three times per annum.
Council for Responsible Nutrition v. James, 2025 WL 3165673 (2d Cir. Nov. 13, 2925), is a Second Circuit decision about a New York state restriction on the sale of certain dietary supplements to minors. This blog covers the case because the court’s decision includes a disturbing preemption holding. This particular blogger covers the case
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
Prologue: Many years ago, our litigation practice included representation of a couple of film studios. While it was fun to visit backlots and (literally) bump into movie stars, we discovered that discovery, research, and motion practice were not necessarily any more exciting due to involvement of above-the-line talent. Contract law is still contract law, even
“Off label use” is a bit of an odd thing. The FDA does not regulate the practice of medicine, but it does get involved in the labeling of medical devices and pharmaceuticals through the applicable pre-marketing review processes, and those labels identify the use (or uses) intended for that medical product. That use (or
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