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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

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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

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[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

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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

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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

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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.