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Surgeon in Medtronic Infuse Study Scandal Resigns

Aug 19, 2009 | Parker Waichman LLP

Timothy R. Kuklo, the former Army surgeon who has been accused of falsifying data in a study of Medtronic Inc.'s Infuse Bone Graft, has resigned from his post at Washington University Medical School, according to The New York Times.

As we’ve reported previously, the study, which  Kuklo conducted during his tenure at Walter Reed Army Hospital , claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used. But 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.  Kuklo's study was published in the Journal of Bone & Joint Surgery last August, but retracted it in March.

In June, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments. 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, a relationship which ended earlier this year. However, Medtronic has maintained that it had nothing to do with Kuklo’s Infuse study.

After leaving Walter Reed, Kuklo joined the faculty at Washington University Medical School in St. Louis in 2006.  Last month, the school revealed  that Kuklo failed to properly disclose his financial relationship with Medtronic. When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo’s Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007.

The school also said that Kuklo had discovered “extensive personal health information” for soldiers treated at the Walter Reed Army Medical Center from 2006 and before on computers used by Kuklo. The privacy of medical records is strictly regulated by the Health Insurance Portability and Accountability Act (HIPAA).

Kuklo had been on a voluntary paid leave while Washington University investigated the allegations against him.  According to a New York Times report, Kuklo proffered his resignation on July 30.  It will be effective Sept. 30, and between now and then will have no clinical, research, or educational duties for the University between now and that date.


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