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From Health Law Daily, May 9, 2016

On second thought, complaint on Medtronic device is dismissed

By Melissa Mitchell, J.D.

Finding that an individual claiming that a Medtronic device caused him injury failed to show how the manufacturer’s late reporting of certain adverse events related to the device caused his injury, the court granted the manufacturer’s motion to dismiss on reconsideration. In other words, because the individual’s claims that Medtronic’s alleged failure to report caused his injuries did not prove causation, his claims are preempted and were dismissed (McAfee v. Medtronic, Inc., May 5, 2016, Miller, R.).

Claims and procedural background. An individual brought claims under Indiana’s Product Liability Act as well as common law claims against Medtronic alleging that the Medtronic Spirit Fidelis Lead (Model 6949), an implantable cardiac device, caused him injuries. The complaint specifically alleged that Medtronic had received reports of 15 adverse events between February and March of 2006. Medtronic did not report these events to the FDA until July 10, 2006, which was 11 days before the individual was implanted with the device. Previously, Medtronic filed a motion to dismiss these claims arguing that the claims were preempted by federal law and the court granted the motion in part and denied it in part (see Medtronic’s line may lead to liability, June 10, 2015).

Reconsideration. Medtronic then asked the court to reconsider the decision not to dismiss the entire complaint. In its motion for reconsideration, the court considered the three elements that must be proven in order to avoid preemption: (1) that Medtronic violated a federal requirement; (2) that the relevant state law imposes a “genuinely equivalent” requirement; and (3) the federal violation caused the injuries sustained. The court noted that the third element was not considered in the initial ruling on Medtronic’s motion to dismiss.

Causation. Considering the third element now, the court acknowledged that Medtronic had argued that the individual had failed to state a claim upon which relief might be granted because the reports were made prior to the individual’s implantation of the device and, therefore, there was no causal nexus between the reporting and his injuries. On reconsideration the individual argued that the failure to report established a “pattern of late reporting” and “a continuing wrong,” which began before his implantation. While the court noted that the individual could not raise new claims on reconsideration, it acknowledged these arguments as “illuminations” of his initial claims. Still, the court found that the individual has not “suggested how any delay in filing a report (or reports) with the FDA caused or contributed to his injuries,” and that any “conclusory allegations [of such] are insufficient.” In this light, the court found that the remaining claims against Medtronic were preempted.

The case is No. 1:12-CV-417 RLM.

Attorneys: Duane C. Donahue (Duane Donahue, Attorney at Law) for Ronald J. McAfee. Kevin C. Schiferl (Frost Brown Todd LLC) for Medtronic Inc.

Companies: Medtronic Inc.

MainStory: TopStory CaseDecisions MDeviceNews PreemptionNews PLDeviceNews IndianaNews

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