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Author of Questionable Infuse Bone Graft Study Got Big Bucks from Medtronic

Jun 19, 2009 | Parker Waichman LLP

Medtronic Inc. has confirmed that it paid hundreds of thousands of dollars to an ex-Army surgeon who is accused of falsifying data in a study he conducted on the company's Infuse Bone Graft product. According to the Associated Press, Medtronic paid the surgeon - Dr. Timothy Kuklo - $850,000 over a 10 year period.  

Kuklo retired from the Army in 2007. According to the Associated Press, Medtronic made both indirect and direct payments to Kuklo between 2001 and May 2009.  Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products.  In 2006, he signed on as a consultant for the company.

Kuklo has been accused of falsifying data in an Infuse Bone Graft study while he was assigned to Walter Reed Army Hospital.  As we've reported previously, the study, which claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

According to The Wall Street Journal, the total paid to Kuklo includes $356,242 he received in 2007, the year he submitted the questionable Infuse study to at least two medical journals.   In 2008,  the year the study was published, Medtronic says it paid  Kuklo $249,772, the Journal said.

The Kuklo affair is just the latest incident to raise questions about Infuse, as well as Medtronic’s relationships with doctor consultants. In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the Food & Drug Administration involved off-label uses of Infuse Bone Graft. According to the Journal, doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.

Doctors are free to use approved medical devices in anyway they see fit. However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.  In November, Medtronic also said it had received a subpoena  from the Department of Justice as part of a probe of possible off-label marketing.

Medtronic has maintained that it had no part in Kuklo's Infuse study.  But according to the Associated Press, the uproar it caused is the reason the company has decided to disclose its payments to Kuklo - something it had once refused to do.  The disclosure followed several letters written by Sen. Charles Grassley (R-Iowa), who has been investigating the financial relationships between device makers and doctors.  Among other things, Grassley has been asking why Medtronic failed to list Kuklo as a paid consultant when it submitted a list of such physicians to him in October.   A Medtronic spokesperson told the Associated Press that it was releasing Kuklo's information on a "one-time basis in the interest of transparency in this unique case."

Kuklo and is now on staff at Washington University School of Medicine in St. Louis.  Medtronic ended its consulting agreement with him in May.

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