United States v. Jackson, 2025 U.S. App. LEXIS 1261, 2025 WL 249109 (4th Cir. Jan. 21, 2025), is a criminal case involving off-label use of a medical device. The Fourth Circuit affirmed the conviction of a doctor for violating the Food, Drug, and Cosmetic Act, aggravated identity theft, and related offenses. The court sentenced
Criminal
The State of State of Mind Testimony by Experts
First Circuit Upholds Criminal Convictions for Off-Label Promotion

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…
In Pari Delicto By Any Other Name Would Still Be A Bar

A few years ago, we detailed the efforts of the plaintiffs’ bar to tweak the Restatement of Torts to decrease the chance that a suit for damages would be defeated because the plaintiff engaged in a criminal act. The Restatement (Second) from 1979 called this the Wrongful Acts Doctrine, but the concept has a long…
In Pari Delicto Once More In Kansas

We write today with an update on a case applying the defense of illegality (or “in pari delicto”) to cut off product liability claims under Kansas law. Messerli v. AW Distributing, Inc. is the sad case of someone who passed away, allegedly as a result of inhaling intoxicating fumes (or “huffing”) from computer…
Ninth Circuit Holds No Scienter Required for Misbranding of Drugs

We don’t write a lot on criminal cases, but published opinions in the Ninth Circuit involving the Food Drug and Cosmetic Act always catch our eye. In United States v. Marschall, No. 22-30048, 2023 WL 6135771 (9th Cir. Sept. 20, 2023) (to be published in F.4th), the Ninth Circuit held last week that some…
In Pari Delicto Is Alive and Well in Kansas

We don’t see the defense of illegality much in the product liability space, but when a plaintiff’s claims arises from his or her own illegal behavior, the illegality defense can be a powerful tool. We mention this now because a district court in Kansas recently applied the illegality defense to dismiss a case based on…
Third Circuit Tosses Criminal Charge that Unauthorized Ingredient Source was Introduction of a “New Drug”
Presidential Pardon Does Not Undo Criminal Conviction or Support Corporate Indemnification

We have a weak spot for criminal cases. We also have a weak spot for doom-scrolling, inevitably provoked by the country’s insane politics over the last eight years. And we have a weak spot for visiting nearby Delaware, home of tax-free shopping, excellent beaches, Dogfish Head Brewery, and judges who know corporate law. We live…
Watch Out! OIG Dings Continuing Medical Education with a “Fraud Alert”

Last year the HHS Office of Inspector General issues a “Special Fraud Alert” (“Alert”) concerning “Speaker Programs” – more usually known as continuing medical education (“CME”). Since we believe that truthful commercial speech is First Amendment protected, seeing “fraud” bandied about like this caused us to take a look. We’re well aware that for years…