Statute
FDCA
242 published works
Drug & Device Law
Presumption Against Preemption News, Including a Circuit Split
By Bexis
We have been complaining about the purported “presumption against preemption” ever since the Blog started. Our first major research post demonstrated that, back in 2006, such precedents were primarily on…
Eye on Enforcement
DOJ Outlines Its New Corporate Enforcement Playbook: Takeaways from Directive 26-12
By Giovanni Giarratana, Joseph P. Mueller
On October 1, 2026, the Department of Justice issued Directive 26-12, a memorandum to all Fraud Division personnel regarding corporate enforcement. The directive outlines corporate enforcement priorities, steps to ensure…
Miller & Chevalier
Full Speed Ahead: DOJ's Fraud Division Accelerates Its Corporate Enforcement Agenda
Publications khospital Tue, 10/06/2026 - 10:03 Featured On Alert Type Litigation Alert Include Disclaimer On Date 10.06.2026 Description On October 1, 2026, Assistant Attorney General (AAG) Colin M. McDonald issued…
Drug & Device Law
N.D. Cal. Dismisses Device Claim for Lack of Defect
Perez v. Apyx Medical Corp., 2026 WL 2691359 (N.D. Cal. Sept. 14, 2026), is a product liability suit alleging misrepresentations about off-label use of a company’s cosmetic surgery §510(k) device.…
Drug & Device Law
Let the Science Do the Science – S.D.N.Y Torches Every Benzene Theory in OTC Acne MDL
We’ve written a lot of benzene posts on this blog over the years, and most of them share a common thread. Plaintiffs find a chemical decomposition byproduct nobody put on…
Drug & Device Law
Express Preemption For a De Novo Device With Special Controls Should Have Been The End
A mere two weeks ago, we praised a California federal court for dismissing preempted claims against a prescription drug manufacturer and not giving the plaintiff a third chance to plead…
Drug & Device Law
Court Rules Out Asset Forfeiture in FDCA Misbranded Drug Case
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…
Drug & Device Law
Home Field Advantage: How Connecticut Made it Easier to Plead a Filshie Clip Case
Every sport has that one venue where the home team gets every close call. Fenway in the late 2010s. Lambeau Field in a January snowstorm. Or, if you are a…
Drug & Device Law
Recent FDA Development Warrants Revisiting Tampon Preemption
By Bexis
On July 6, 2026 the FDA announced the results of a study it recently completed on tampons (which are medical devices) and their “Biocompatibility and Toxicology.” The Agency’s conclusion was:…
Drug & Device Law
Whodunit? Not the Tanning Lotion
Every good mystery needs a red herring. The suspicious houseguest. The gardener with the shaky alibi. The tanning lotion sitting quietly on the bathroom counter while the actual culprit —…