Franco v. Chobani, LLC, 2026 WL 2150193 (7th Cir. July 27, 2026), is a food case, not a drug or device case, but it is vital reading for anyone who litigates over products regulated by the Food and Drug Administration (FDA). In litigation involving regulated products, the fact of such regulation is usually a
There is a well-worn saying in electrical engineering — if you want to break a circuit, you can cut the wire or trip the breaker. Plaintiffs in several consolidated spinal-cord stimulator cases recently tried something more creative — they attempted to rewire the entire regulatory grid by suing the FDA itself, hoping to knock out
Recently, towards the end of a post about preemption and the FDA’s Current Good Manufacturing Practices (“cGMPs”) – also known as Quality Management System Regulations (“QMSRs”) − we noted a “significant change” last February. “[T]he FDA issued a final rule” that replaced all existing cGMPs “by incorporating by reference an international standard specific for device
Some of us of a certain age were fans of Parliament/Funkadelic back in the day. The group even released an album entitled “Medicaid Fraud Dogg.” That was the most drug/device adjacent rock-and-roll since the Rolling Stones released “Mother’s Little Helper.” One classic Parliament line was “make my funk the p-funk
The Blog has always been interested in off-label use issues. We hope our readers are as well. Here are a couple of recent developments that have nothing in common except that they involve off-label issues.
The first is regulatory. On May 12, 2023, the FDA actually did something smart, a relative rarity for the current
We’ve never done a cross-post before with any other Reed Smith (or any other firm’s) blogs, but the recent decision, Louisiana v. FDA, ___ F.4th ___, 2026 WL 1194924 (5th Cir. May 1, 2026), justifies this unprecedented action. Essentially, the Fifth Circuit, ordered a nationwide injunction against the FDA’s 2003 REMS amendments that authorized
Five months ago, we posted on a decision from an Ohio intermediate appellate court finding that a state AG action against sellers of vaping products was impliedly preempted under Buckman. Part of what got our attention about the decision in State ex rel. Yost v. Cent. Tobacco & Stuff, Inc., No. 24 CAE
Not quite three years ago, we co-authored a chapter in a Digital Health guide put out by International Comparative Legal Guides. It bore the pithy title “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health.” We continue to tinker with the principles of product liability law
Perhaps driven by fear of retribution for saying what you really think, an indirect method of communication has gained some popularity on the social media platforms of late. It goes like this: 1) a historical fact or spin on one is presented, such as on a past military conflict or a criminal conviction; and 2)