Our entering class of C.D. Cal. federal prosecutors back in 1992 was made up of an interesting cast of characters. Those Assistant United States Attorneys went on to become general counsels, judges, professors, and lowly bloggers. Most of the cohort came from BigLaw. Young lawyers were willing to halve their Skadden/Munger/Gibson/A&P etc. salaries so that
Novo Nordisk A/S v. British Telecommunications Plc, 2026 WL 01791875 (Ch. Div. June 23, 2026), is the first judicial decision from the United Kingdom that we have featured on the Blog. The high-tech solution that the court approved for combating proliferating fly-by-night websites that “in one way or another were involved in the sale
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
We’ve become aware that some clients are using artificial intelligence (AI) to summarize or analyze things like complaints, briefs, internal documents, or even – horror of horrors! – law firm bills. If the client performing these tasks is an in-house lawyer, such work might be protected by the attorney client privilege or work product doctrine
How many times have you seen a lawyer end the trial direct examination (or deposition redirect) of his/her expert by perfunctorily asking, “Do you hold all your opinions to a reasonable degree of certainty?” Then there is the obligatory “Yes.” The magic words have been uttered. All is right with the world, right?
Maybe.
If
Bexis gave us a splendid Christmas present when he handed us a case that is right in our wheelhouse: a criminal matter with (literally) crazy facts and some connection to prescription drug labels. United States v. Rainford, 2025 WL 3522333 (10th Cir. Dec. 9, 2025), is a relatively rare (something the opinion itself mentioned)
The saga over the illegality defense in Kansas appears to have run its course, and as in previous chapters, the defense has prevailed. The Tenth Circuit has ruled that the defense of illegality exists under Kansas law and that it applies to product liability claims. As we reported here and here, this is the
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
The issue of the state of mind or intent of a party can play out a number of ways based on the nature of the case. In the criminal context, proof of the mens rea of the defendant is typically an element in the statutory definition of the crime. In a civil contract case, whether
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