We recently attended the ACI Drug & Medical Device Seminar in New York, where we always enjoy catching up with old friends, making new acquaintances, and hearing what’s new in our drug and device sandbox. This year we spoke on the extensive and active litigation that is currently going on over the 340B drug pricing
Can States Require Delivery Of 340B-Discounted Drugs To Unlimited Contract Pharmacies?
We reported two years ago on a Third Circuit opinion holding that the federal government did not have the authority to require drug manufacturers to deliver 340B-discounted drugs to an unlimited number of pharmacies. The D.C. Circuit came to the same conclusion a year later. See Sanofi Aventis U.S. LLC v. HHS, 58 F.4th
The FDCA Preempts California’s Sherman Law, Ninth Circuit Holds
We have always been flummoxed by California’s Sherman Law. That is the California statute that purports to incorporate by reference the Food, Drug, and Cosmetic Act, supposedly making violations of that federal also offensive to state law. Why does this matter? Because there is no private right of under the FDCA, and 21 U.S.C. §
There Is No Established Causation Between Acetaminophen and Autism
“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established . . . .” That is not your DDL bloggers speaking (although we did add the emphasis). It is not a drug manufacturer speaking, nor any particular doctor or researcher speaking. It
Tenth Circuit Affirms Illegality Defense in Product Liability Case
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
California Court Affirms Dismissal for Blown Trial Deadline
When we ranked Trejo v. Johnson & Johnson, 220 Cal. Rptr. 3d 127 (Cal. App. 2017), as the second best drug or medical device case of 2017, we celebrated the opinion as the first to rule that federal law preempted a design defect claim involving an over-the-counter drug. We did not expect to
Too Many Blemishes: Federal Law Preempts California Acne Treatment Case
A federal judge in California filed an important OTC preemption decision earlier this month, and it’s important because it applied federal preemption to shut down (for now) one of the many recent benzene-related consumer class actions. The case is Daugherty v. Padagis US LLC, No. 24-cv-02066, 2025 WL 2243622 (N.D. Cal. Aug. 6, 2025)
Texas Requires “Plus Factor” For Personal Jurisdiction
An appellate court in Texas filed an opinion last week that very helpfully defines and applies the standard for specific personal jurisdiction under a factual scenario that is extremely common in our line of work—a plaintiff trying to sue a foreign company that sells products (medical devices) in the U.S. through a U.S.-based affiliate. The
Politics Over Patients (And Preemption)
We don’t venture into politics here at the DDL Blog, but sometimes we have to call them like we see them. A divided panel of the Fourth Circuit filed an opinion last week upholding a state law that essentially prohibits the sale and use of an FDA-approved drug within that state for its FDA-approved intended
You Can’t Dodge the Federal Vaccine Act
Here at the DDL Blog, we love phrases denoting that two things are acting together or in close succession to produce a result. We have written more than once on the “one-two punch” of causation and implied preemption, and who doesn’t appreciate a good “double whammy” in whatever context? Cases with