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Medtronic Infuse Investigation Closes

Medtronic received good news from the U.S. Department of Justice and U.S. Attorney’s Office: The investigation into the company related to the Infuse bone graft has been closed. Medtronic has regularly reported on the status of the federal, civil and criminal investigation in its quarterly disclosures.

A lawsuit originally was brought against the company by the Minneapolis Firefighters' Relief Association in December 2008. The lawsuit, which was consolidated into a class action in 2009, claimed that the Minneapolis, Minn.-based company was deliberately misleading about its product Infuse, a genetically engineered bone graft used in spinal, oral and dental graft procedures.

Medtronic was accused of withholding that as much as 85 percent of Infuse sales depended on “off-label” uses, which means that sales representatives were allegedly promoting the product for uses not approved by the U.S Food and Drug Administration. Some of the doctors who would use Infuse, according to the lawsuit, were paid by Medtronic. According to shareholders, when Medtronic revealed that the U.S. Department of Justice and the U.S. Senate were looking closely at possible off-label marketing, share prices and Infuse sales dropped.

“After several years of investigation, we are pleased that the Department of Justice and the U.S. Attorney’s Office have come to the decision to close their investigation of the company related to Infuse bone graft,” said Chris O’Connell, executive vice president and group president of Restorative Therapies Group, which includes Medtronic’s spinal business.

Medtronic continues to claim it is not guilty of bad practice.

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