Posts Tagged ‘Infuse’

The United States Justice Department has served Medtronic with a subpoena, requesting information about the company’s ties to Dr. Timothy Kuklo, a former orthopedic surgeon at Walter Reed Army Medical Center. In a June 23 filing with the Securities and Exchange Commission, Medtronic revealed that it had received the subpoena from the U.S. Attorney in Boston on May 21. The Justice Department is interested in the company’s dealings with and financial ties to Kuklo.

The Army has accused Kuklo, who worked at Walter Reed until 2006, of manipulating data in a study about the effectiveness of Medtronic Infuse bone growth products in treating leg injuries in soldiers. Kuklo has also been accused of forging the signatures of several Walter Reed colleagues when submitting the study results to medical journals for publication. Recently, Medtronic revealed that it paid Kuklo a total of about $800,000 in consulting fees, mostly over the past three years. Although the company learned about the allegations against Kuklo at the end of last year, it did not formally suspend his consulting contract until the New York Times published an article on the ongoing Army investigation in May. Along with the Army and the Justice Department, Senator Charles E. Grassley is also investigating whether Medtronic violated federal rules by promoting Infuse for unapproved uses.

The New York Times is continuing its coverage of fraud allegations against former Walter Reed Army Medical Center surgeon Dr. Timothy Kuklo. According to a recent article, an Army investigation found that Kuklo falsified the results of a study concerning the effectiveness of Medtronic Bone Infuse for treating shin fractures in soldiers. The newspaper also reports that he listed his colleagues as co-authors on the studying without their permission, and forged their signatures when submitting the study for publication in medical journals. The incident has made Kuklo the target of a Department of Justice investigation, as well as inquiries by Senator Charles E. Grassley of Iowa and the Washington University School of Medicine in St. Louis, where Kuklo currently serves as a medical professor. Kuklo’s impartiality is questionable because of his past and present links to Medtronic; the company had paid for some of his travel and research expenses while he worked at Walter Reed, and he became a paid consultant for Medtronic upon leaving the hospital in August 2006. Previously Kuklo had been accused of exaggerating the effectiveness of Infuse in treating bone fractures in injured soldiers.