The Department of Justice is investigating the off-label use of a Medtronic Inc. implant for promoting bone growth, bringing government scrutiny of such unapproved uses to the heart of the $189 billion medical-device industry.
The probe -- in combination with a government safety warning and whistleblowers' lawsuits -- has created what Medtronic Chief Executive William A. Hawkins termed Tuesday a "perfect storm" that suppressed sales of Infuse Bone Graft. The biologically engineered protein is widely used in surgeries to fuse spinal vertebrae.
The Minneapolis device maker reported that Infuse, which had been expected to generate 14% growth in the company's ...
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