It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that. Too much food, too much drink, too much family, and not quite enough presents. Or, at least, not enough of the right presents. Or, maybe, lots of those veritable mixed bags. You know – a six pack of
Council for Responsible Nutrition v. James, 2025 WL 3165673 (2d Cir. Nov. 13, 2925), is a Second Circuit decision about a New York state restriction on the sale of certain dietary supplements to minors. This blog covers the case because the court’s decision includes a disturbing preemption holding. This particular blogger covers the case
We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption.
Yes, we need a life, but let’s put that aside for the moment.
In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval
We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count. This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.” Id. at 558. While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation. Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.” Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)
Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.” Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).
Continue Reading Preemption, Plausibility, and Parallel Claims
There is a documentary out on the actor Charlie Sheen and it reminded us that, long before the current denizen of the White House crowed about “winning,” that was a staple of many bizarre rants by Sheen.
We’re not ranting, whether bizarrely or sanely, but it is nice to post about yet another defense win
Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation. That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.” In the spate of litigation
Don’t stop us if you’ve heard this before, because you have. (Here and here, for example). Wilson v. Coopersurgical, Inc., (S.D. Illinois Sept. 9, 2025), is yet another case from the Filshie Clip litigation illustrating the power of premarket approval (PMA) preemption. The defendant won dismissal on summary judgment after the case
The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.
Every time we see a case that does that—upholds preemption on summary judgment—we wonder
We’ve blogged recently about good preemption decisions in the Filshie Clips litigation from the Southern District of Texas (per Bexis, “as good a PMA medical device preemption decision as a defendant has a right to expect”) and the Northern District of Georgia. Today we add another preemption win in the same litigation from the
Plaintiffs (or more properly, their lawyers) across the country have been filing no-injury class actions against over-the-counter (“OTC”) drug manufacturers on a variety of cooked-up theories that have little or nothing to do with the safety or efficacy of these drugs. One such theory, that we have discussed several times, is that drugs that the FDA allows to be labeled as “rapid release” should be penalized, under state law, for using that purportedly “misleading” description. This litigation is based on one study, done years ago, that found that some “rapid release” products did not dissolve any more quickly (or less so) than other products not bearing that designation.
Continue Reading “Rapid Release” Class Action Dissolved