VOL. 124 | NO. 123 | Thursday, June 25, 2009
Boston AG Subpoenas Medtronic Over Implant Study
LOS ANGELES (AP) – Medical device maker Medtronic Inc. reported Tuesday it received a subpoena from the Massachusetts Attorney General seeking documents related to a published study on the company’s Infuse bone implant that was retracted after former Army surgeon Dr. Timothy Kuklo was accused of forging signatures and falsifying data.
In a filing with the U.S. Securities and Exchange Commission, Medtronic said it received the subpoena on May 21, and will comply as required with the terms of the action.
The subpoena covers information about contracts, research grants, speaking and education programs, and payments for certain physicians related to the Infuse study.
Last week, Medtronic disclosed that it paid about $850,000 over nearly 10 years to Kuklo, who wrote the paper. The Army had found that Kuklo, now a university professor, forged the signatures of four colleagues and made up data overstating the benefits of Medtronic’s implant on leg injuries of soldiers at Walter Reed Medical Center.
Minneapolis-based Medtronic, the world’s largest device firm, reiterated last week that it had no involvement with Kuklo’s discredited medical journal article. The company said most of his fees were for training activities or consulting, though Kuklo was also reimbursed for airfare and other travel expenses.
Infuse is a man-made version of a human protein that spurs bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.
However, serious complications have been reported when doctors use the graft for alternate uses, such as neck surgeries. The FDA has said that use can lead to problems swallowing, breathing and speaking, which in some cases required additional surgeries.
The company previously disclosed that in October and December of last year, it received a subpoena and civil investigative demand from the attorney general requesting documents related to the Infuse bone graft product.
Last November, the U.S. Department of Justice subpoenaed documents from Medtronic as part of a probe into whether the company encouraged doctors to use the Infuse spinal graft for unapproved purposes. While doctors are allowed to use drugs and devices for nonapproved uses, companies are not allowed to market the techniques.
Medtronic’s Spinal and Biologics Business is based in Memphis.
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