The Infuse Spinal Fusion System is facing legal scrutiny over the safety of the device, as well as their marketing practices.

Spinal fusion is a relatively common procedure in the United States. More than 100,000 people undergo this procedure every year. It is used to treat certain back ailments. Most often, spinal fusion is used to compensate for failing spinal discs, which are rings of tissue that cushion the space between vertebrae.

When injured, or worn out from age, a person can experience debilitating back pain, necessitating treatment. In spinal fusion, two adjacent backbones are fused together. This can compensate for the damaged support structure. In traditional versions of the procedure, bone from elsewhere in the body is used to form the fusion, which often requires a second surgery to harvest the material for the procedure.

The Infuse Bone Graft System, manufactured by Medtronic Inc., is designed to be a next-generation version of spinal fusion. The device consists of a metal support cage and a bioengineered gel. The gel is manufactured using the patient’s own tissue and bioengineered protein. The cage is designed to support the adjacent backbones as the gel encourages new bone growth to fuse the bones together. The device is only approved for a single type of spinal fusion. However, it has been alleged that the device may promote serious complications, particularly in off-label usages.

Various Infuse bone graft lawsuits have alleged that the device can cause bone and nerve problems, which can cause pain, numbness, and paralysis. Additionally, the bone graft system has been allegedly linked to cancer, infertility, and swelling of the neck and throat.

One issue that has come up repeatedly in Infuse bone graft lawsuits is related to problems stemming from off-label use. Under federal law, a medical device or drug must be approved for use, through trials that live up to protocols set forth by the U.S. Food and Drug Administration (FDA).

A medical device maker must submit a medical device for approval of every purpose for which they intend to market a device. For example, if a drug can treat headaches and sore throats, it must be tested and approved for each condition separately. The law does allow medical professionals to use drugs and medical devices for purposes other than their approved ones. This typically happens when the testing and approval process have not caught up to physicians’ experiences and pilot studies. However, drug makers are forbidden from promoting a drug or medical devices for off-label uses. One allegation is that Medtronic has aggressively promoted the Infuse Bone Graft System for off-label uses.

At present, Medtronic is facing thousands of individual Infuse bone graft lawsuits. While these are currently individual lawsuits, a multidistrict litigation (MDL) or mass tort may be formed in the future. MDLs are a type of legal action similar to a class action lawsuit. In both MDLs in class action lawsuits, a group of plaintiffs allege that they have all suffered from similar harms from the same defendant. MDLs are more common in drug lawsuits than class action lawsuits, since class action lawsuits start out as group lawsuits, while MDLs are created by combining similar lawsuits after they are filed.

At this point, Medtronic has agreed to spend $22 million on Infuse bone graft lawsuit settlements with 950 people. Medtronic has stated that they are facing more than 3,800 similar bone graft lawsuits, and has set aside $140 million for these and future lawsuits.