In an order dated Feb. 16, U.S. District Court Judge John Kronstadt in Central California denied Medtronic’s motion for summary judgment in the case filed by The Dan Abrams Co. LLC. The LLC’s sole employee, Bryan Shapiro, formerly worked for Medtronic.
Kronstadt scheduled a status conference regarding a jury trial for March 18.
Filed in 2015, the lawsuit claimed fraud around the clearance and marketing of two Medtronic Verte-Stack spinal implant devices for interbody fusion or vertebral body replacement.
The entire lawsuit was tossed in 2019, but a federal appeals court in 2021 reinstated one claim claiming that Medtronic defrauded FDA into granting 510(k) clearance for the devices.
Kronstadt in his Feb. 16 order rejected all of Medtronic’s arguments to get the final claim in the case tossed:
- Medtronic had used expert testimony from surgeons to make the case that the devices could be used in a non-contraindicated manner, but Kronstadt still found questions of fact after the testimony.
- Kronstadt was unpersuaded by the argument that the FDA received sufficient information in Medtronic’s 510(k) application to make an independent determination. He quoted the federal appeals court in saying, “Medtronic’s alleged fraud went ‘to the very essence of the bargain.'”
- The judge also found that LLC filing the suit had offered enough evidence that the Verte-Stack devices in question were directly sold to hospitals operated by the government, and that it was reasonable to infer that government funds went toward paying for devices. Said Kronstadt: “This is sufficient evidence to establish a triable issue as to whether the government paid defendants as a result of, or in reliance on, their false claims.”
Medtronic’s lawyers on March 1 filed a motion asking Kronstadt to reconsider his order, saying the judge did not consider particular issues, as well as the most up-to-date legal standards for admitting evidence.
