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Medtronic Settles SubQ Stimulation Lawsuit for $2.8 Million

February 6, 2015 — The U.S. Department of Justice and Medtronic have reached a $2.8 million settlement for “off-label” promotion of a nerve stimulation device for an unapproved procedure known as SubQ stimulation.

The nerve stimulation devices are intended for the treatment of chronic pain, often in the lower back. The device is implanted just under the skin in an area where the patient is experiencing pain.

It works by delivering a mild electrical impulse, which interferes with pain signals between nerves and the brain. The patient experiences only a mild “tingling” sensation instead of pain.

In a statement, prosecutors warned that the safety and effectiveness of the procedure had not been established by the FDA.

Furthermore, doctors who performed the procedure were led to submit non-reimbursable claims:

“From 2007 through 2011, Medtronic knowingly caused dozens of physicians located throughout more than 20 states to submit claims to Medicare and TRICARE for investigational medical procedures known as SubQ stimulation that were not reimbursable.”

The whistleblower, Jason Nickell, is a former sales rep for Medtronic who will receive a $602,000 cut of the settlement. The qui tam lawsuit was filed under the False Claims Act, which gives citizens the power to file lawsuits on behalf of the United States and receive about one-third of the payout.

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