Medtronic Inc. is currently under investigation for the off-label use of an implant device that promotes bone growth. The probe has suppressed sales of Infuse Bone Graft, a biologically engineered protein widely used in surgeries to fuse spinal vertebrae.
Some patients say they have been harmed by off-label uses of Infuse. The FDA has only approved of Infuse for a small section of the spine in the lower, lumbar region. Approximately three-quarters of the reports on Infuse side effects have involved off-label use.
"While the law establishes that doctors can prescribe any approved treatment, but off-label promotion by manufacturers is not allowed, there’s growing concern that the line is being crossed, and a Justice Department review is the right kind of response to those questions." said Sen. Charles Grassley (R., Iowa) who has been looking into whether inducements by Medtronic have led doctors to use its products off-label.
The FDA issued a safety alert in July about complications arising from the off-label use of Infuse in areas, such as the neck or cervical area of the spine. The FDA has received 38 reports over the last four years consisting of life-threatening complications from cervical uses of Infuse. Complications include swelling of the neck, difficulty swallowing and speaking.
Since the start of the investigation, the finances of the company have been in trouble. The Minnesota company did not even reach expectations of 14 % growth in the company’s fiscal second quarter and shares were down 13 % to $31.60. Losing Infuse as a result of this investigation would be devastating to Medtronic, which has profited by over $3 billion since Infuse first hit the market in 2002.
Former Medtronic employees alleged illegal marketing by the company, which included inducements paid to doctors to use Infuse as well as other company spine products. Medtronic heavily depends on the sale of Infuse. Medtronic was forced to lower its revenue estimates for this year from $15.5 billion to $14.6 billion.