Medical device maker Medtronic agreed to pay the federal government $2.8 million, including $602,000 to a whistleblower sales rep, to settle charges that it caused physicians to submit false claims to federal healthcare programs for a medical procedure known as “SubQ stimulation.”
In these procedures, Medtronic’s spinal cord stimulation devices were placed just beneath the skin near an area of pain, most often in the lower back, where the devices could provide electrical impulses to create a “tingling” sensation intended to alleviate chronic pain.
“The United States alleged that even though the safety and efficacy of SubQ stimulation had not been established as required by the FDA, the company promoted this procedure by, among other strategies, arranging to have physician-customers attend Medtronic-sponsored “on-site training programs” regarding the use of Medtronic spinal cord stimulation devices for SubQ stimulation,” a Justice Department news release says.
The government alleged that from 2007 through 2011 Medtronic knowingly caused dozens of physicians located throughout more than 20 states to submit claims to Medicare and TRICARE for the investigational medical procedures.
The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which was filed by former Medtronic sales rep Jason Nickell, who will receive $602,000 in the settlement.