Feds Close Investigation into Medtronic, Inc.'s Marketing of Infuse

Published: May 17, 2012

Minneapolis / St. Paul Business Journal by Ed Stych, Web Producer

Medtronic Inc. said Wednesday that federal prosecutors have closed their four-year investigation into the medical device company's marketing of its Infuse bone-growth product.

The investigation by the U.S. Department of Justice (DOJ) and the U.S. Attorney's Office in Massachusetts started in October 2008, Medtronic spokeswoman Cindy Resman said. She said the prosecutors received notification that they have closed the civil and criminal investigations. There was no finding of wrongdoing.

The DOJ began its investigation in 2008 into uses of Infuse that were considered "off-label" — which means uses not approved by the Food and Drug Administration (FDA). It's OK for doctors to use device such as Infuse off-label, but the manufacturers can't promote that use.

The investigation apparently widened last year after Medtronic's clinical trials were criticized by some spine doctors and U.S. senators. They claimed Infuse isn't as safe as Medtronic says and that Medtronic's paid trials led to biased results. Yale University is currently reviewing the safety of the spine product. Medtronic is paying the school $2.5 million for an independent review.

In March, Fridley-based Medtronic (NYSE: MDT) agreed to pay $85 million to settle a shareholders lawsuit over the marketing of Infuse, although Medtronic denied it engaged in wrongdoing.

The 2008 suit claimed that Medtronic failed to reveal that as much as 85 percent of Infuse sales were dependent on off-label sales.

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