What’s interesting to us is the nature of the device as to which preemption was found. Rather than the usual pre-market approval, the device in Malbroux (an “Inflatable Penile Prosthesis” according to the complaint), was being marketed according to a “product development protocol.” The court found no material difference between that and PMA, and dismissed on express preemption grounds:
This preemption clause operates to safeguard the Food and Drug Administration's (“FDA”) comprehensive analysis concerning both PMA (Premarket Approval process)-approved and PDP (Product Development Protocol process)-completed devices from modification or interference through the varying tort law principles of the fifty states.Malbroux, 2011 U.S. Dist. Lexis 96590, at *5. Later on, the court reiterates the point:
PDP completion is equivalent to PMA approval, thus, if a device is PMA-approved or has received a declaration of PDP completion, then the first prong of the preemption analysis is satisfied . . . . [The device] that is the subject of this lawsuit received a declaration of PDP completion. The conditions of PDP approval governs [the] design, manufacturing and labeling of the device. Therefore, through the PDP process, the FDA has established federal “requirements” that apply specifically to the Penile Prosthesis.Id. at *6-7.
Thus we’ll add Malbroux to our still small (but growing) pile of product development protocol preemption decisions. See Nimtz v. Cepin, 2011 WL 831182, at *3-4 (S.D. Cal. March 3, 2011); Cowen v. American Medical Systems, 2006 WL 3542704, at *1-2 (E.D. Mich. Dec. 7, 2006); Betterton v. Evans, 351 F. Supp.2d 529, 535-36 (N.D. Miss. 2004); Clement v. Kaiser Foundation Health Plan, Inc., 2004 WL 3049753, at *4-5 (C.D. Cal. Dec. 17, 2004).