Boring title, but accurate. Here’s the latest.

First, Medtronic won another one the other day. Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system. It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body. Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.

The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption. Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004. The insulin delivery system predated the pump, and was PMA approved. By PMA supplement in 2006, the FDA approved incorporation of the pump into the system. The plaintiff was prescribed that system. Duggan, 2012 WL 45503, at *3-4.