DOJ Closes Probe of Medtronic Infuse Bone Graft Off-Label Marketing

Federal investigators have reportedly ended an investigation into the marketing practices of Medtronic, which was focused on the device maker’s alleged promotion of the Infuse bone graft off-label, encouraging doctors to use the product during procedures that were never tested or determined to be safe and effective. 

Medtronic announced this week that the U.S. Department of Justice (DOJ) informed the company that an investigation into Infuse bone graft marketing practices had been closed. The company indicates that it expects no charges to be filed as a result of the investigation.

The announcement comes just weeks after the company reached an $85 million settlement with shareholders, who sued the company for holding back information that Medtronic Infuse off-label use accounted for 85% of sales and that such unapproved use may increase the risk of serious and potentially life-threatening health problems.

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 anterior lumbar fusion surgery, but it has been widely used off-label during other types of spinal surgery, which have been found to carry a risk of inflammatory reactions, airway compressions, nerve damage and other health problems.

In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving a large number of reports involving deaths and other complications that resulted from swelling of the neck and breathing difficulties.

Medtronic continues to face a growing number lawsuits over Infuse bone graft side effects, which have been filed by individuals throughout the United States who experienced problems after receiving the product off-label. The complaints involve allegations that Medtronic failed to adequately warn about the risk of unwanted bone growth and actively encouraged use of the Infuse bone graft during procedures that were not only unapproved, but that the device maker knew or should have known posed an increased risk of serious injury or death.

Off-label use occurs when a medical device or drug is utilized for purposes not specifically approved by the FDA. It is legal for doctors to use approved medical devices off-label, but it is illegal for companies to market their products for unapproved uses.