A whistleblower lawsuit filed by a patient who received a Medtronic spine device in an off-label procedure has accused the company of installing a crony at a prominent medical journal in order to garner good press for Medtronic products, including its Infuse® Bone Graft product. The Medtronic whistleblower lawsuit, which was unsealed earlier this year, alleges that during his tenure as editor of the Journal of Spinal Disorders and Techniques, Dr. Thomas Zdeblick published articles “touting the benefits of Infuse®” while allowing researchers to conceal their financial relationships with the device maker.”
Medtronic Infuse® is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in one type of spinal surgery and some dental procedures. Over the last several years, Medtronic has been embroiled in controversies that have shed doubt on the safety of Infuse® and the company’s marketing of the product. Zdeblick has been at the center of some of that controversy. According to a report from MassDevice, Zdeblick, the University of Wisconsin spinal surgeon who invented the LT-Cage delivery device for Infuse®, has drawn fire for receiving some $25 million in royalties from Medtronic for the LT-Cage and other products between 2003 and 2009. A 2009 Senate investigation revealed that while Zdeblick was receiving those royalties, the University of Wisconsin had spent $27 million on Medtronic spinal devices. Infuse® was the most frequently implanted device at the University.
The Medtronic whistleblower lawsuit alleges that while editing the journal, 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 2008, the U.S. Food & Drug Administration (FDA) issued a safety alert warning that Infuse® Bone Graft had been associated with serious complications when used off-label in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage. It’s been estimated that 85% percent of the procedures that employ Infuse® constitute off-label uses of the product
An article published in The Spine Journal last year found that 13 Medtronic-sponsored clinical trials of Infuse® failed to report serious complications, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution and worsened back and leg pain, in patients treated with the product. The study also raised concerns about the financial ties between Medtronic and the researchers who conducted the 13 studies.