Medtronic agrees US$2.8m False Claims Act settlement


Medtronic has agreed to pay a US$2.8m fee to the US government in order to settle accusations that it encouraged off-label usage of one of its spinal cord stimulation devices.

Prosecutors alleged that the company made illegal payments to physicians in 20 US states from 2007–2011 in exchange for recommendations of procedures that were neither safe nor effective.

The procedure in question was the SubQ treatment, in which  spinal cord stimulation devices were placed just beneath the skin near an area of pain, most often in the lower back. The devices’ electrical impulses created a tingling sensation to alleviate chronic pain. However, according to federal prosecutors, the safety and efficacy of SubQ stimulation had not been established by the Food and Drug Administration.

Having denied the allegations in a previous statement, Medtronic agreed to pay the $2.8m fee to settle the allegations with “no admission of liability”. A company press release stated: “Medtronic is committed to following appropriate marketing and reimbursement practices at all times, and for many years has had in place a comprehensive and robust employee compliance programme.”

“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,” said Scott J Lampert of the Department of Health and Human Services’ Office of Inspector General.  “Our agency will continue to pursue medical device makers that ignore requirements designed to protect patient health and federal health care programmes.”