Medtronic Pays $2.8M Fine for SubQ Stimulation Marketing

February 6, 2015 — Medtronic has agreed to pay $2.8 million to resolve a whistleblower lawsuit accusing the device-maker of illegal “off-label” promotion of a device for “SubQ stimulation.”

Medtronic sells spinal cord stimulation devices that are implanted just beneath the skin near an area of pain, usually in the lower back. The device provides electrical impulses to nerves, interrupting pain signals and creating a “tingling” sensation. It is designed to treat chronic pain.

Prosecutors from the U.S. Department of Justice warned that the safety and effectiveness of the device for SubQ stimulation has not been established by the FDA. Even so, Medtronic allegedly promoted this procedure by inviting physicians to attend “training programs.”

According to the Justice Department, from 2007-2011, Medtronic knowingly caused dozens of doctors in more than 20 states to submit non-reimbursable claims to Medicare and TRICARE for SubQ stimulation, an investigational medical procedure.

The lawsuit was filed by whistleblower Jason Nickell, a former sales representative for Medtronic. He will receive $602,000 for his part in the qui tam lawsuit. It was filed under the False Claims Act, which allows private citizens to file lawsuits against major corporations on behalf of the United States.

In a statement from the Office of Inspector General:

“Patients should be able to trust that their health care providers only use – and bill Medicare for – medical procedures that have been shown to be safe and effective.”

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