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Medtronic Says Subpoena Seeks Info on Infuse Bone Graft Study

Jun 24, 2009 | Parker Waichman LLP

Medtronic Inc. has been served with a federal subpoena over a falsified Infuse Bone Graft study conducted by a former army surgeon.  According to The Wall Street Journal, the subpoena was revealed in  a  disclosure to the Securities and Exchange Commission (SEC) Medtronic made yesterday.

The study in question was conducted by Dr. Timothy Kuklo, and involved veterans at 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.

Kuklo retired from the Army in 2007.   Last week, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly  $850,000 in direct and direct payments to Kuklo. 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.

According to The Wall Street Journal, in 2007, the year he submitted the questionable Infuse study to at least two medical journals, Kuklo was paid a total of $356,242 by Medtronic. In 2008, the year the study was published, Medtronic paid Kuklo $249,772.  Medtronic has maintained that it had no part in Kuklo’s Infuse study.

According to the Journal, the subpoena Medtronic received was issued by the U.S. Attorney's office in Boston, MA.  In addition to information on Kuklo's Infuse study, Reuters is reporting that prosecutors are also seeking information about "contracts, research grants, speaking and education programs, and payments for certain named physicians."

Reuters is also said that in the same SEC filing, Medtronic disclosed that it was served with another subpoena - this time from the New Jersey Attorney General.   The subpoena is  "seeking documents related to clinical studies, its financial arrangements with certain physicians, and clinical research done by certain physicians and health care providers."   The company did not say if the two subpoenas were related, Reuters said.

The Kuklo affair is just the latest incident to raise questions about the  Infuse Bone Graft product, 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.

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