A couple of recent preemption developments warrant mention.

Horned In; Horned Out

In 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 preemption of a claim that’s often won. The upside (from our defense standpoint) in Horn was the court’s treatment of negligence per se, which can be a form of unpreempted “parallel violation” claim. To escape preemption, the plaintiff alleged that the defendant’s representative violated an FDA “quality system regulation” about “storage areas” because she kept devices in her home overnight before delivering them to hospitals for use in surgery. The court held the claim preempted because that regulation – “or any QSR for that matter” – was too broad and vague to be a basis for a parallel claim. Id. at *20-25. So Horn is precedent for knocking out a whole category of FDA regulations (QSRs) for preemption purposes.