Justice Dept. closes criminal, civil probe into Medtronic’s Infuse

May 17, 2012 By MassDevice staff Leave a Comment

The U.S. Justice Dept. closed the books on a years-long investigation into Medtronic‘s (NYSE:MDT) controversial Infuse bone growth protein, the company announced today.

The office of the U.S. Attorney for the District of Massachusetts and the DoJ abandoned their civil and criminal probe into allegations of off-label marketing and concealed safety risks without finding evidence of wrongdoing, according to a press release.

"After several years of investigation, we are pleased that the Dept. of Justice and the U.S. Attorney’s Office have come to the decision to close their investigation of the company related to Infuse bone graft," restorative therapies group president Chris O’Connell said in prepared remarks.

The device giant has been batting back accusations about Infuse, which is used in spinal fusion surgeries, since a Spine Journal issue dedicated to highlighting serious concerns about the morphogenetic protein came out last summer.

The journal warned that off-label use of the product might increase a patient’s cancer risk nearly 5-fold after 3 years; others questioned the credibility of researchers who hid financial ties to Medtronic.

The ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks.

The federal investigation is over, but Medtronic is still on the hook in a separate shareholder suit accusing it of inflating share prices using misleading statements about Infuse. In that case, the shareholders demanded confidential documents from an undisclosed witness who staunchly refused to reproduce them on the grounds that they presented "a real and appreciable danger of self-incrimination."

The company is also still battling patient injury lawsuit, including a complaint unsealed this month that alleged that Medtronic installed a paid crony at the Journal of Spinal Disorders and Techniques in order to push positive – and possibly premature – data on its Infuse bone growth stimulant.

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