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VOL. 123 | NO. 228 | Thursday, November 20, 2008

US Justice Department Sends Medtronic Subpoena

By TOM MURPHY | AP Business Writer

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The U.S. Department of Justice has sent a subpoena to medical device maker Medtronic Inc. as part of an investigation into unapproved, or “off-label,” uses of its Infuse spinal graft.

The company’s Spinal and Biologics Business is based in Memphis.

Bill Hawkins, chief executive for Minneapolis-based Medtronic, revealed the subpoena during a Tuesday

conference call with analysts, but he declined to elaborate on what was requested.

Bill Hawkins

“For years, Medtronic has had strict guidelines in place on appropriate promotion of products according to labeled indications,” Hawkins said. “We are complying appropriately with the DOJ’s request.”

Hawkins said later in the call the investigation was “very focused” on Infuse, and he didn’t know whether it would be broadened. He also said he wasn’t surprised 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.”

Hawkins said his company takes “very seriously the whole notion of appropriate promotion for on-label use, so we will comply with the DOJ’s request and move forward.”

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 Wednesday, 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 the U.S. District Court in Memphis.

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.

_____

AP Business Writer Matthew Perrone in Washington, D.C., contributed to this story.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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