Today’s case, Schmidt v. Dexcom, Inc., 2026 WL 2244106 (E.D. Mich. Aug 2, 2026), involves a glucose monitoring device (the “G6”) and a pretty bad day for the plaintiff—both in terms of how he somehow managed to get a needle stuck in his arm when the device doesn’t go there and the shellacking he
Class II medical devices
In Important First, Claims Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted
By Andrew Tauber on
This post is from the non-Reed Smith side of the Blog.
Breaking new ground, a court has for the first time held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act expressly preempt product-liability claims implicating a Class II medical device brought to market through the “de novo” classification process. This is…
