We do not quite fit the stereotype of the fat cat – at least (we hope), not anymore. But there was a time when at least one evening per week would be marked by scotch and cigars. Our antiquity and iffy physical constitution have now reduced such festivities to two or three times per annum.
In case our title was too subtle, we think that a stack of purported inferences should neither state a claim for strict liability with a prescription medical device nor sidestep express preemption in the case of a Class III device. We have long been dubious of the idea of a true parallel claim as articulated
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