Not that long ago we alluded to the idea that blogging about decisions throwing out PMA medical device claims on the basis of preemption under Riegel can be a little tedious. Every once and a while plaintiffs take a new pass at getting around medical device preemption, but in our experience most of those have turned out to be Hail Mary hurls that don’t make it into the end zone. So, there are many routine PMA preemption decisions that simply find a home on our preemption scorecard but don’t have that something else that drives us to start tapping out a full post. And Rodriguez v. American Medical Systems, Inc., 2014 U.S. App. LEXIS 24631 (5th Cir. Dec. 31, 2014) would be just such a case but for two things: 1) it is a circuit court decision and 2) it recognizes the extension of Riegel preemption to medical devices approved via the product development protocol (PDP) process, 21 U.S.C. §360e(f).
We blogged here about the district court decision inRodriguez noting that it was one of very few cases to deal with the FDA’s PDP process. PDP is a method of premarket approval where a device’s clinical evaluation and the development of information for marketing approval are merged into one process. Indeed, we searched back through the blog ourselves and found only a handful of district court cases involving PDP products. What we didn’t find were any circuit court decisions. Now that doesn’t mean they don’t exist, but this appears to be the first one to hit our radar. And, if the Fifth Circuit is the first federal appellate court to decide the issue, we are happy to report that they got it correct.
The device at issue in Rodriguez was an inflatable prosthesis and plaintiff brought claims for manufacturing and design defect, consumer fraud, and breach of contract. Id. at *2. Defendant produced a letter from the FDA and a supporting affidavit showing that the prosthesis had been approved through the PDP process. Id. at *4. Because the district court looked to this evidence outside the confines of the pleadings, it converted defendant’s motion to dismiss into a motion for summary judgment which it then granted. Id. at *2.
To determine whether plaintiff’s claims were subject toRiegel preemption, the Fifth Circuit relied on the MDA’s provision “that a device which has been approved through the PDP process ‘shall be considered as having [PMA] approval.’” Id. at *5. Finding no other reason to treat PDP and PMA procedures differently, the court concluded that “a device which been approved through the PDP process meets the federal requirements prong of the preemption analysis.” Id. It may not be an often used ruling, but we like anything that expands preemption.
Faced with the stringent Riegel preemption analysis, plaintiff did try one of those Hail Mary passes though. Plaintiff argued that there was a genuine dispute as to whether the device at issue was in fact approved by the FDA. Plaintiff’s support for his contention was that the reference to the specific device at issue in the approval letter printed on FDA letterhead “could have been a mistake or that the letter could have been falsified.” Id.at *6. Without evidence, plaintiff’s pure conjecture was rejected by the court. Id.
The remainder of the decision is a garden-variety PMA preemption win for defendants. Plaintiff’s state law claims only survive preemption if they parallel specific federal requirements – which they don’t:
Rodriguez's complaint does not plead a violation of any federal requirement relating to design or manufacturing of the implant . . . and he cites no facts supporting a finding of any such violation. He fails to allege a specific defect in the manufacturing process or design, any deviation from the FDA-approved design or manufacturing processes, or any causal connection between a violation of federal requirements and his injuries. Thus, he has failed to plead a parallel claim.
Id. at *8. Plaintiff’s consumer fraud claim was equally deficient. While plaintiff appears to have alleged that defendant’s literature made unfulfilled promises and therefore constituted a false or misleading action, plaintiff “failed to alleged whether or how [defendant’s] marketing materials deviated from FDA-approved requirements.” Id. at *9. No violation, no parallel violation claim.
A good affirmance of a strong district court opinion with an extension of Riegel preemption. Definitely blog-worthy.