[This post is from the non-Reed Smith side of the blog.]
Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.
Committed to nationally uniform standards based on good science, we believe that
Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting—at least to us. We lamented just yesterday that many judges reflexively deny motions to dismiss on preemption, but others see the light from the get
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they
Long ago, a senior partner told us that clear writing flows from clear thinking. That might be so, but clear thinking and clear writing do not necessarily produce the correct result. For example, you’d have a tough time finding a legal opinion written more clearly than Calchi v. Topco Assocs., LLC, 2024 U.S. Dist.
We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.
Well here’s another one: Medtronic, Inc. v. Lohr, 518 U.S.
If you are of a certain age and are presented with a trio of items, we bet you sometimes add “Oh My” to the end of the list, as in Lions, and Tigers, and Bears-Oh My. Or, you think of other things that come in threes, such as the past and the present
This post is not from the Bryan Cave side of the Blog.
The Third Circuit’s preemption decision in Schaffner v. Monsanto Corp., ___ F.4th ___, 2024 WL 3820973 (3d Cir. Aug. 15, 2024), is certainly a big deal in that litigation. As observed in the Bloomberg story about the decision, carried in the August
One of the break-through moments in the first year of law school is when your Contracts professor distinguishes actionable promises from mere “puffery.” Not every statement invites reliance. You cannot take every statement by a seller literally. The concept of non actionable puffery is the law’s way of telling us to grow up, to get
Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).
This decision involved the Scandinavian Total Ankle Replacement device (“STAR”). The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a). This was Plaintiff’s second bite at the apple: The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim. See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023). After striking out in round one, Plaintiff fared no better in round two.
Continue Reading Slam-Dunk Express Preemption Decision from the District of Arizona
The Vermont Supreme Court correctly applied the PREP Act last week to dismiss state-law claims arising from a COVID vaccine. See Politella v. Windham Southeast School Dist., No 23-AP-237, 2024 WL 3545717 (Vt. July 26, 2024) (to be published in A.3d). This was an easy case, and the PREP Act (aka the “Public Readiness