This post is from the non-RS side of the Blog.
Consider the following scenario. A fifty-two-year-old woman has end-stage left ventricular heart failure despite medical care and the latest medications. Her prospects for a heart transplant or the implantation of a left-ventricular assist device to prolong her life are limited, including by financial considerations. She
In the drug and device product liability world, we love our acronyms and our short-hand phrases. The MDAs to the FDCA. Class III. PMA. 510(k).
Today’s acronym is CGMP, which sometimes you will see written as “cGMP”. The GMP stands for Good Manufacturing Practices, and the “C” (or “c”) has, since a 1996 Final Rule
That title might be overblown, because we are discussing only two cases. But one of them is the Roundup case, and we could not resist the cheesy wordplay.
Roundup is neither a drug nor device. It is regulated by the Environmental Protection Agency (EPA), not the Food and Drug Administration (FDA). Nevertheless, the Federal Insecticide
As we have discussed more times than we like, the plaintiffs’ class action cabal, in conjunction with their running-dog Valisure “if it doesn’t have it, we’ll cook it until it does” “testing” laboratory, has targeted various products supposedly containing benzene contaminants. The result has been a plethora of no-injury class actions by plaintiffs who
The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant.
Fluid allegedly worked its way into the device and caused a short‑circuit and device
This post is from the non-Reed Smith side of the blog.
They say it’s better to be lucky than good. But in Luckey v. Abbott Laboratories, Inc., 2026 WL 836122 (E.D. Ky. Mar. 26, 2026), plaintiff was neither.
This is a straightforward—and satisfying—PMA preemption decision involving a heart valve allegedly marketed to last at
Today’s case, Kouyate v. L. Perrigo Company, 2026 WL 591874 (W.D. Mich. Mar. 3, 2026), is the latest entry in the ever-growing pile of meritless benzene OTC class actions. This time, the target is acne treatments containing benzoyl peroxide (BPO), with the now-familiar allegation that BPO degrades into benzene during storage and shipping. If
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
A chunk of our family recently relocated to Indiana, a lovely state that spawned prominent Americans such as Orville Redenbacher, Eli Lilly, Larry Bird, David Letterman, Michael Jackson, and James Dean, and that possesses fine covered bridges, a suddenly fearsome college football team, and a remarkable library that houses, among other things, the original manuscripts
If ever there were a case that reads like a checklist for how not to plead around preemption, it’s Dunham v. Boston Scientific Corp., — F.Supp.3d–, 2026 WL 539533 (W.D. Mich. Feb. 24, 2026). Plaintiff alleged that his spinal cord stimulator—a Class III, premarket approved device—implanted to treat his chronic back pain caused him