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express preemption
Successful Class II Medical Device Preemption Decision
We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v. Advanced Medical Optics, Inc., No. 10-15222, slip op. (9th...
Preemption Notes
A couple of recent preemption developments warrant mention. Horned In; Horned OutIn Horn v. Boston Scientific Neuromodulation Corp., 2011 U.S. Dist. Lexis 102164 (S.D. Ga. Aug. 26, 2011), the defendant, a manufacturer of a PMA medical device, won preemption of a claim that’s often lost, and lost...
Product Development Protocol? Preempted.
Just a note about Malbroux v. Jancuska, 2011 U.S. Dist. Lexis 96590 (W.D. La. Aug. 29, 2011), an otherwise forgettable opinion throwing out medical device claims on the basis of preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Malbroux is forgettable: (1) because it’s a...
Implied Preemption And Medical Devices
Was anyone else out there struck, like we were, that the Court described the preemptive FDA action it recognized in Pliva, Inc. v. Mensing, ___ U.S. ___, 2011 WL 2472790 (U.S. June 23, 2011), in terms of “equivalence”? Here’s what we mean:Under this law [Hatch-Waxman], “generic drugs” can...
It's Airlines over Consumers in a Pair of Preemption Decisions
Today we have two cases that illustrate the maxim that if you have a beef with an airline, you're screwed, plain and simple, thanks to federal preemption. In Hickcox-Huffman v. US Airways, Inc., 2011 WL 1585560 (N.D. Cal. Apr. 27, 2011), a passenger who had paid a $15 baggage fee sued the airline...
