Medtronic Inc. has asked a federal judge to dismiss an Infuse bone graft lawsuit filed by a whistleblower who alleges sales of the controversial bone protein were driven by illegal kickbacks. According to a report from MassDevice.com, the medical device maker asserts in its motion that the allegations contained in the Infuse bone graft lawsuit are based solely on publically-available information, making the plaintiff ineligible to act as a whistleblower under the Medicare False Claims Act.

Medtronic Infuse Bone Graft is a bioengineered bone growth protein used in certain spinal fusion surgeries that has been beset by controversy almost since its launch. In 2008, the U.S. Food & Drug Administration (FDA) issued a safety alert warning that Infuse Bone Graft and similar products had been associated with serious, life-threatening complications when used off-label in cervical spine fusions. Then, during the summer of 2011, an investigation published in The Spine Journal raised serious concerns that research used to garner regulatory approval for Infuse was biased, as many of the doctors involved in those studies had significant financial relationships with Medtronic. The authors of The Spine Journal article asserted that more than a dozen Infuse clinical trials conducted by those researchers omitted or downplayed serious side effects.

Most recently, U.S. Senate investigators concluded that Medtronic manipulated studies for Infuse in order to downplay its serious side effects and to promote off-label use of Infuse Bone Graft. Among other things, committee investigators found that Medtronic played a major role in “drafting, editing and shaping” medical journal articles about Infuse Bone Graft, all without disclosing roughly $210 million in consulting and other fees over a 14-year period that the company paid to the doctors who co-authored those studies

According to MassDevice.com, the Medtronic Infuse whistleblower lawsuit alleges the company installed a “stooge” – Dr. Thomas Zdeblick – as editor of the Journal of Spinal Disorders and Techniques to publish positive research on Infuse. The Infuse bone graft lawsuit further alleges Medtronic violated the Medicare False Claims Act by filing reimbursement claims driven by illegal kickbacks.

Zdeblick, who invented a delivery system for Infuse known as the LT-Cage, has been a central player in Infuse-related controversies. According to MassDevice.com, since 2003 he’s received some $25 million in fees from Medtronic. The whistleblower alleges that in his role as editor, Zdeblick failed to disclose “that he profited from each and every surgery which used Infuse through rights in the exclusive delivery vehicle, his LT-Cage.”

In asking for the dismissal of the lawsuit, Medtronic claims the whistleblower, Joanne Hartwig, provided no original insight in her claim, but based her allegations solely on public knowledge.

“Contrary to blackletter law barring the filing of a False Claims Act complaint predicated on previous public disclosures, relator’s complaint cobbles together a jumble of irrelevant facts that are entirely based on publicly-available information,” Medtronic’s motion states.

Even if Medtronic succeeds in its attempt to have this Infuse bone graft lawsuit dismissed, it will still face a mountain of legal woes involving the bone protein. In addition to several product liability lawsuits filed by people allegedly injured by Infuse, Medtronic shareholders have brought a claim against the company alleging its share price was inflated due to the company’s misleading statements about Infuse.

Published November 28, 2012 by