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
On March 18, 2024, the Supreme Court heard argument in a matter, National Rifle Association of America v. Vullo, No. 22-842, that from its caption would seem to have nothing to do with our sandbox.
But it might.
One of the issues before the Supreme Court in NRA is whether administrative action, labeled only as “guidance” (in NRA, certain letters issued by the head of the New York State banking agency) were sufficiently coercive – despite not being presented as anything “final” – that they could unconstitutionally restrict speech in violation of the First Amendment. Appellant NRA, represented by the American Civil Liberties Union (among others), contends that the defendant “issued formal guidance letters” that “promised enforcement leniency” and “urged” the banks it regulated to cease doing business with the NRA for political reasons. Petitioner’s Br., at 1. Even though this “guidance” neither had nor claimed to have force of law, it had the desired effect – causing regulated entities to do what the government wanted for “fear of losing our license to do business.” Id. at 8 (citation and quotation marks omitted).
To us, the analogy is obvious. The FDA also relies heavily on “guidance” that it likewise considers non-“final,” and has similarly done so in ways that impinge on First Amendment-protected speech.Continue Reading Could the Supreme Court Blindside the FDA on the First Amendment?
When Bexis sends around his weekly list of potentially bloggable cases, we always lunge for the criminal matters, which are fairly rare. Cases brought under Title 21 bring us back to our days at the U.S. Attorney’s office, where we knew nothing of billable hours, MDL case management orders, fancy office coffee machines, or an
We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. It’s an interesting topic; Eric recently wrote a paper on it, and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful.Continue Reading How the Fifty States View Electronic Data as a “Product”
Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence. We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation. We have tried to be consistent.Continue Reading Agree To Disagree – Don’t Sue the Other Side of a Scientific Dispute into Silence
About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. We probably should not have been surprised by the persistence of frivolous litigation. After all, our day job entails defending litigations that can last years longer than they