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
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
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. §
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)
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
States cannot take over enforcement of federal requirements when Congress has entrusted that enforcement exclusively to the FDA. In Iowans for Alternatives to Smoking & Tobacco, Inc. v. Iowa Department of Revenue, No. 4:24-cv-00448, 2025 U.S. Dist. LEXIS 85732 (S.D. Iowa May 2, 2025), the state of Iowa enacted a law imposing penalties on
No one can sell a new drug without prior approval from the FDA. That rule is codified in the federal Food, Drug, and Cosmetic Act and is not controversial (or at least should not be controversial). Less clear is whether a seller of an FDA-approved drug can sue a competitor under state unfair competition laws
Taking pot shots at “Big Pharma” is easy. Crack a joke about Big Pharma and you are sure to get a laugh. Amirite?
That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country.
Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so. Our post about the Ninth
Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads. It is not because we are easily confused, at least not on most days. No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged