A subpoena has been sent to Medtronic Inc., as part of an investigation into unapproved "off-label," uses of Infuse spinal graft. Bill Hawkins, Chief Executive for the Minneapolis-based Medtronic responded to the subpoena by saying that for years the company has had strict guidelines in place on appropriate promotion of products according to labeled indications and the company is complying appropriately with the DOJ's request.

He also said that the investigation was "very focused" on Infuse, and he didn't know if it would be broadened. It was not a surprise to Hawkins that Medtronic, the world's largest medical device maker received the subpoena on the subject, given "stepped-up efforts in general on the topic of off-label use of drugs and devices."

Doctors are free to prescribe drugs for uses not approved by federal regulators or to use devices as they see fit. But pharmaceutical and medical device companies are prohibited by law from marketing for those uses.
Medtronic has said it does not pay surgeons to promote Infuse for unapproved uses. Company spokesman Chuck Grothaus reaffirmed that but said Medtronic would not elaborate on the subpoena.

In 2006 Medtronic reached a $40 million settlement with the U.S. Department of Justice to settle charges that it paid physicians millions in kickbacks to use its spinal repair products. Medtronic denied any wrongdoing.

As part of the arrangement, the government agreed to seek dismissal of the two cases brought by former employees in U.S. District Court in Memphis, where the company's spinal division has offices.

The Infuse graft uses a man-made version of a human protein to encourage 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 the graft is used for alternate uses. In July the FDA warned doctors that use of Infuse for neck surgeries has led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.

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