The Infuse Bone Graft has been approved for use in lower spine-repair surgery to promote bone growth. Recently, Infuse has been linked to several cases of life-threatening complications or death when used in surgeries on the upper spine and neck or when used in other unapproved procedures. It is alleged that surgeons with financial ties to Medtronic promoted the use of the protein unofficially in a number of unapproved settings. Complications have included bone growths near nerves and bone growths in areas not targeted by the therapy. This has resulted in additional medical interventions, and in some cases, emergency surgery. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufacturers like Medtronic to actively promote such uses.
What is the Infuse Bone Graft?
Infuse is a synthetic liquid form of bone morphogenetic protein (or BMP) manufactured and sold by Medtronic, Inc. It is implanted between vertebrae and soaked in a sponge-like substance enclosed in a metallic cage. BMP was designed to promote bone growth to fill in the gap between vertebrae and to replace damaged discs.
Illegal Promotion and Marketing by Medtronic
The U.S. Department of Justice has begun a criminal investigation coinciding with Medtronic’s admission that it paid a surgeon nearly $800,000 for research that allegedly fabricated a study that reported positive results for the Medtronic Infuse Bone Graft product.
While the Infuse Bone Graft was approved by the U.S. Food & Drug Administration (FDA) for promoting bone growth in lower spine-repair surgery, Medtronic has been accused of illegally promoting “off-label” uses of the Infuse product to healthcare providers. In multiple whistleblower lawsuits on behalf of the U.S. Government, former employees of Medtronic allege that the company illegally marketed such “off-label” use, especially with regard to the use of the Infuse Bone Graft in cervical spine surgeries. Allegations include paying inducements to doctors to use Infuse and other Medtronic spine products.
While healthcare providers may use FDA approved drugs, devices and products in off-label manners as they see fit, it is illegal for drug manufacturers to promote and/or market such off-label uses.
Dangers of Off-Label Use in Cervical Spine Surgeries
The FDA has also received numerous reports of complications associated with the off-label use of the Infuse Bone Graft in cervical spine fusions. On July 1, 2008, the FDA issued a public health warning to surgeons about reports of life-threatening complications associated with the off-label use of the Infuse Bone Graft in surgeries on the neck or cervical area of the spine. These complications, which can be life threatening, include:
- Swelling of the neck and/or throat tissue
- Difficulty swallowing, breathing and speaking
- Compression of the Airway
- Respiratory Depression
- Nerve damage
Several patients that were recipients of the Medtronic Infuse Bone Graft in off-label procedures required emergency treatment, including tracheostomies and the insertion of feeding tubes.
Do I Have a Medtronic Infuse Bone Graft Lawsuit?
If you believe you or someone you know has been injured by an off-label use of Medtronic Infuse Bone Graft in the neck or cervical area, please contact Slater Slater Schulman LLP at (800) 251-6990 or fill out our online form and an attorney will contact you immediately.