Medtronic Infuse Bone Graft Lawsuit Filed Over Off-Label Use

Medtronic faces a product liability lawsuit bought by a Louisiana man, who alleges that the company’s Infuse bone graft caused unwanted bone growth along his spinal cord, which made his back pain worse following a lumbar fusion. 

The complaint was filed by Martin Gavin in the U.S. District Court for the Eastern District of Louisiana on March 30, 2012, alleging that the manufacturer concealed information about the risk of complications from the Medtronic Infuse bone graft.

Medtronic Infuse is a bioengineered bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae.

It was approved by the FDA in 2002 for use during certain lumbar fusion surgeries, but it has been widely used off-label for a number of other types of spinal surgery, which have been found to increase the risk of severe adverse side effects.

According to allegations raised in the Medtronic Infuse bone graft lawsuit, Gavin received the device during a transforaminal lumber interbody fusion in February 2011. However, he was never told that the Infuse was only approved for single-level anterior lumbar fusion, and had ever been adequately tested or approved for the type of spine surgery he underwent.

Following his procedure, Gavin indicates that he never recovered and continued to endure severe back pain, which led to epideral spinal injections, physical therapy and the need for additional surgery to implant a transcutaneous electrical nerve stimulator (TENS) unit to help lessen his pain.

Gavin indicates that he was led to believe that his back pain was caused by the underlying medical condition that caused the need for the original fusion. However, in January 2012, he learned that the Medtronic Infuse has been associated with unwanted bone growth, which can lead to nerve impingement.

Off-label use of the Medtronic Infuse bone graft during procedures other than single-level anterior lumbar fusion have been linked to the growth of bone in areas of the body where it is not desired, leading to swelling of the area and nerve damage, according to the complaint.

In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving dozens of reports involving potentially fatal complications that included swelling of the neck and breathing difficulties. A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse during a cervical spine surgery.

The U.S. Department of Justice initiated an investigation into the actions of Medtronic that same year, investigating whether the manufacturer illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.  While doctors are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such uses that they have not established as safe and effective.

Last year, concerns also emerged that the Medtronic Infuse bone graft may increase the risk of cancer.  There have also been concerns that med treated with Medtronic Infuse may face a risk of sterility.