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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Grassley probes Medtronic consultant: Sen. Chuck Grassley, R-Iowa, is gathering information about a former Walter Reed Army Medical Center surgeon accused of falsifying data and forging signatures for a study of Army soldiers treated with Medtronic's Infuse bone graft for lower leg injuries sustained in Iraq. Timothy Kuklo, an associate professor of orthopedic and neurological surgery at Washington University School of Medicine in St. Louis, currently on leave, is a paid consultant to Medtronic. Grassley sent letters May 15 and May 18 to Medtronic, Walter Reed, Washington University and The Journal of Bone and Joint Surgery - which published Kuklo's study last year but later retracted it - seeking details on Kuklo's financial ties. Grassley also questioned why Kuklo was not included in Medtronic's list of physician consulting agreements related to Infuse, which the senator requested last October

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