Medtronic wins temporary reprieve in ex-rep’s whistleblower suit (MassDevice)
Medtronic (NYSE:MDT) got a temporary reprieve this week in a whistleblower lawsuit brought by a former sales rep over its Verte-Stack spine implants
Bryan Shapiro, a former rep for Medtronic’s spine business, filed a whistleblower lawsuit in July 2016, alleging that Medtronic and its subsidiaries “engaged in a fraudulent scheme that caused the Medicare and Medicaid Programs to pay unlawful claims for payment” using a kickbacks scheme involving travel junkets dating back to 2000. The suit, filed in the U.S. District Court for Central California, also alleges that Medtronic “intentionally marketed devices without FDA approval, and trained and paid for physicians to train in implantation procedures with these devices.” The company was also accused of putting misbranded and adulterated implants on the market.
“As a result, defendants have reaped hundreds of millions of dollars selling the subject devices by skirting human testing required under a de novo or FDA’s most rigorous premarket approval (PMA) process to determine the safety and effectiveness device profile,” the lawsuit alleged. “These products have ...
