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Grassley Wants to Know Why Infuse Study Doctor Was Left Off List of Consultants Paid By Medtronic

May 21, 2009 | Parker Waichman Alonso LLP

Senator Charles Grassley (R-Iowa) is seeking an explanation from Medtronic Inc. for its failure to list Dr. Timothy Kuklo as a paid consultant when it submitted a list of such physicians to him in October.  As we've  reported previously, Kuklo is the former Walter Reed  Army Hospital surgeon who conducted a study on Medtronic's Infuse Bone Graft product that apparently contained falsified data.

According to The New York Times, which originally broke the Kuklo story, Grassley has been investigating Infuse for some time over claims that Medtronic illegally promoted its off-label use. Some have charged that the company paid doctor consultants to hype such uses.  According to The Wall Street Journal, Medtronic had submitted a list of  22 consultants to the Senator in October, but Kuklo's name wasn't on that list.   Grassley has now written a letter to Medtronic asking why.

A Medtronic spokesperson told The Wall Street Journal that Kuklo was a consultant for the company starting in 2006. The spokesperson also said that Kuklo was a consultant until earlier this month, but  is "no longer active as a consultant."  

According to the Associated Press, Medtronic maintains that Kuklo's name was omitted because Grassley only asked for names of doctors who had consulting contracts for Infuse, and Kuklo was a "general consultant."  The company said it is cooperating with Grassley's investigation.

As we reported last week, Kuklo’s Infuse Bone Graft study, which claimed to show that wounded soldiers’ leg injuries healed better when the product 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.

Kuklo is no longer at Walter Reed, and  is now on staff at Washington University School of Medicine in St. Louis.