The federal Justice Department is investigating the off-label use of Medtronic’s Infuse bone graft, adding to what a company executive termed the “perfect storm” of unanticipated backlashes against the medical device giant.

Medtronic CEO Bill Hawkins said flat revenues in the company’s biologics business resulted from a combination of external factors including negative media coverage, whistle-blower lawsuits and an FDA public health notice of its cervical use of bone morphogenic protein.

Hawkins would not go into detail about the Justice subpoena, but he said the company plans to comply with the investigation.

SOURCE: FDA NEWS

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