Medtronic subpoenaed by Justice
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.
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.
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."
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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.
