The district court’s order applying Michigan law and dismissing one plaintiff’s complaint in the Tapezza MDL may be the last of a dying breed. The court faithfully enforced Michigan’s statute providing a presumption of non-defectiveness for FDA approved drugs and dismissed the plaintiffs’ case. But alas, Michigan repealed that law effective February 13, 2024, thus
Bexis recently gave the keynote address at the Minnesota State Bar Association’s annual FDA Forum. In preparing his speech, which concerned recent challenges to FDA regulatory authority, Bexis had occasion to study Apter v. Dep’t of HHS, 80 F.4th 579 (5th Cir. 2023), which the blog previously discussed here. Since Bexis was discussing
We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”).Continue Reading A Couple of Thoughts about the Comstock Act
This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts.
First, slightly over a year ago we praised Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), a prescription drug preemption decision holding, among other things, that a plaintiff could not claim “newly