The Fifth Circuit has sided with Medtronic Inc. in a suit brought by a man alleging five of its medical devices were defectively designed and caused him to be shocked unnecessarily by his defibrillator, saying his claims are either preempted by federal regulation or inadequately pled.
The three-judge panel affirmed a dismissal order throwing out David Reddick’s design defect claims about the devices under the Louisiana Products Liability Act, and a summary judgment order on his breach of contract claim.
Reddick was diagnosed with Brugada syndrome, a heart rhythm disorder, and he was implanted with a Medtronic defibrillator, which involved five Medtronic devices, including the defibrillator itself. Three were considered Class III medical devices, with the others being Class I and II devices.
Soon after, he said, he started experiencing shocks from the defibrillator and its lead, and was told that the devices needed reprogramming. He had the devices removed in 2017, after testing in 2016 showed he had never had Brugada syndrome,
Reddick sued Medtronic in Louisiana, and the district court to which his case was removed threw out his claims, saying his claims regarding the Class III devices were preempted by federal regulation, and his claims about the Class I and II devices failed to state a case. The court also granted summary judgment on his breach of contract claim, finding that he’d shown no evidence that any contract between him and Medtronic existed.
The panel agreed with the trial court that Reddick’s claims about the Class III devices under the LPLA are preempted, saying his claims were conclusory and vague, and thus did not state claims that run parallel to federal regulations.
The complaint does not include factual support for his claim that the devices were defective, the panel wrote, saying that although Reddick points to some Medtronic recalls, he doesn’t allege that the devices implanted into him were subject to those recalls, or that the recalls were related to the shocks he experienced.
Reddick’s related failure-to-warn claims also failed because he did not plead any applicable U.S. Food and Drug Administration warnings that Medtronic deviated from.