What is The Problem?
The U.S. Food & Drug Administration (FDA) has issued safety warnings, The U.S. Department of Justice (DOJ) has begun a criminal investigation and most recently, Medtronic admitted to paying a surgeon nearly $800,000 who is accused of falsifying the results of a study … all regarding the Medtronic Infuse Bone Graft product.
The Infuse Bone Graft has only been approved by the FDA for use in lower spine-repair surgery to promote bone growth, however Medtronic has been accused of promoting the “off-label” use(s) of the Infuse product to healthcare providers. In three whistleblower lawsuits seeking damages on behalf of the U.S. Government, former Medtronic employees alleged illegal marketing by the company, including inducements paid to doctors to use Infuse and other Medtronic spine products.
Healthcare providers are allowed to use FDA approved drugs, devices and products in an off-label manner when they see fit, however the promotion and/or marketing of off-label use by the manufacturer is illegal.
Medtronic Bone Graphs are implanted in the spine to stimulate bone growth. First approved in 2002 by the FDA for only anterior approach lumbar fusion surgery, nearly 100,000 people are implanted with this device every year.
Recent investigations have discovered that these bone grafts have been used for off-label use and serious complications have resulted. The off-label use involves implantation in the lumbar or cervical spine. Further, surgeons with significant financial ties to Medtronic allegedly failed to disclose these complications in clinical trials and studies.