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$________ – DOJ – Fraud – Government accuses medical device company of False Claims Act violations relating to SubQ stimulation procedures

U.S.D.C., W NY

In this action, the U.S. accused a medical device manufacturer of violating the False Claims Act. The suit was resolved through a settlement.

The defendant, Medtronic, Inc., is a medical technology company based in Minnesota and a manufacturer of devices used in a medical procedure known as SubQ stimulation. The procedure involves use of a spinal cord stimulation devices intended to alleviate chronic pain. The United States alleged that defendant promoted the procedure to physician-customers through defendant-sponsored "on-site training programs," despite the procedure’s safety and efficacy not having been established as required by the Food and Drug Administration (FDA).

The whistleblower, Jason N., a former sales rep for the defendant, filed suit under the qui tam provision of the False Claims Act. The United States later joined the suit, alleging that from ________ through ________, the defendant knowingly caused dozens of physicians in over 20 states to submit claims to Medicare and TRICARE for a non-reimbursable medical procedure. The matter was resolved via settlement for $________. The whistleblower will receive $________ of that amount. The matter was resolved with no admission or determination of liability.

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