Like the radio stations of yore did with songs, we offer up two related posts back-to-back instead of the usual one. We cannot offer a “favorite artist” as the source of consecutive songs, we offer two posts that relate to the legal implications of some of the typical things that FDA does and has been
Express Preemption
FDCA Preemption Delivers Sweet Win for Sugar Substitute Manufacturer
C.D. Cal. Dismisses Acne OTC/Benzene Claims as Preempted

It might seem that we talk about preemption incessantly on this blog, but a pretty good opinion from a pretty important jurisdiction went unremarked by us last September. We’ll rectify that right now. Call it an end of year clean up session.
The decision in Howard v. Alchemee, LLC, 2024 U.S. Dist. LEXIS 169359…
A Five-STAR Preemption Decision from the N.D. Okla.

Today we report on the court’s order granting Defendant’s motion to dismiss in Keim-Bacon v. Stryker Corp., No. 4:22-CV-00383-WPJ-MTS, 2024 WL 4886051, at *1 (N.D. Okla. Nov. 25, 2024). It is a straightforward application of Riegel preemption that gets it right on all fronts.
The Scandinavian Total Ankle Replacement System (“STAR”) is a Class…
Consumer Fraud Case Against “Non-Drowsy” Cough Syrup Sleepwalks Past Preemption
Deconstructing the PREP Act

From our very first post back in early 2020 on preclusive power of the PREP Act, 42 U.S.C. §247d-6d, we were impressed by the scope of its combined preemption and immunity language. There, we quoted the language from the HHS secretary’s emergency declaration:
[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.
Quoting 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).Continue Reading Deconstructing the PREP Act
Class Complaint Fails in OTC Drug MDL

When it comes to MDLs that concern a bunch of cases about a drug or device, they typically have a name like “In re [name of product(s)] Product Liability Litigation” or “In re [name of product(s) Marketing and Sales Practices Litigation.” In theory, the first group of MDLs involves, shockingly, product…
Failure-to-Warn Claim Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted on Facts Presented

[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…
Medical Device Claims Preempted in Ohio

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…
We Applaud The Preemption Analysis And Outcome In Mack v. CooperSurgical, Inc. (2024) While Bemoaning Those In Mack v. CooperSurgical, Inc. (2023)

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…