The Ninth Circuit recently revived a claim in a qui tam lawsuit against a medical device manufacturer based on a “fraud on the FDA” theory of liability under the False Claims Act. Among other claims, the relator alleged that Medtronic fraudulently obtained 510(k) clearance for certain spinal surgery implants by falsely representing their intended use in submissions to the FDA. The district court dismissed the relator’s “fraud on the FDA” claim in 2019 for failure to state a claim, finding that its allegations were offered “solely as a predicate for the claim that the Subject Devices were intended for off-label use.”  On April 2, a panel of the Ninth Circuit reversed the district court’s decision as to the allegations related to the defendant’s “contraindicated-only devices”—that is, those devices that allegedly could only be used for their contraindicated use and not for their label-indicated use—noting that the relator did not allege mere off-label use for these devices. Rather, the panel explained that the relator alleged that the “contraindicated-only devices” were not properly cleared for any use by the FDA.

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