June 8, 2017
The Department of Justice settled a False Claims Act lawsuit against Medtronic, Inc. for promoting off label unapproved uses of its “SubQ” spinal stimulation medical device. Medtronic paid $2.8 million to settle these claims.
A former Medtronic sales representative filed the qui tam suit. He alleged that Medtronic knowingly caused physicians to submit claims for SubQ stimulation that were not reimbursable. Medtronic has not proven the safety and efficacy of SubQ to the FDA. Nevertheless, Medtronic persuaded doctors to implant Medtronic’s spinal cord stimulation devices. As a result, Physicians inserted these devices just beneath a patient’s skin near an area of pain, most often in the lower back. There, the devices provide electrical impulses intended to alleviate chronic pain.
Medical Device or drugs prescribed for purposes that are not FDA approved are thus off label. The products violate the False Claims Act when submitted to the government for reimbursement. These practices are unfortunately all too common. Indeed, the successful, but unlawful, promotion of prescription drugs for off label purposes has led to multiple large FCA recoveries in the last several years. On Sunday night John Oliver did a hilarious, sad but true, piece on these drug company tactics on his show Last Week With John Oliver.
Health Care companies should not treat Patients like guinea pigs for profit. Ask your doctor…or ask John Oliver..or ask a lawyer who represents FCA whistleblowers.