Medtronic has agreed to pay approximately $22 million to settle about 950 Medtronic Infuse lawsuits filed on behalf of individuals nationwide who have experienced problems after receiving the bone graft product.

The Medtronic Infuse Bone Graft system is a medical device designed for spinal repair. The device consists of a metal support cage (“LT Cage”) with a matrix of bioengineered proteins that encourage bone growth. It is designed to repair degenerative disc disorder. The bioengineered proteins are what make the Infuse Bone Graft system different from other forms of spinal fusion surgery. The matrix is designed to be mixed with tissue from the patient’s body. Theoretically, this means that the body would be more likely to accept the new tissue, since the bioengineered tissue has components from the patient’s own body.

The problem is that the Infuse system is made for only one type of spinal surgery. The U.S. Food and Drug Administration approved Infuse for limited use during spinal fusion procedures when the lumbar spine is approached through the front of the body. Any other use is constituted as “off-label.” It’s estimated that as many as 80 percent of the Infuse bone grafts were implanted in spinal surgery patients for uses not listed on the label. This off-label usage is behind most of the Medtronic Infuse lawsuits.

The $22 million settlement, announced in a press release on May 6, does not include an admission of guilt and still leaves an estimated 750 cases unresolved. “This agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by Medtronic,” the company stated. “The company continues to stand behind INFUSE Bone Graft, which has been utilized in more than one million patients since it was approved more than ten years ago, and will vigorously defend the product and company actions in the remaining cases.”

Approximations suggest that legal costs, including all settlements, will “ultimately cost [Medtronic] between $120 and $140 million.” Whether the remaining unresolved cases will proceed to trial or be settled later is currently unknown.

The Infuse settlement announcement came just days after the California Supreme Court granted Medtronic’s petition to review a lower court decision that declared that “Medtronic Infuse lawsuits were not preempted by federal law.”

Medtronic tried many times to have the bone graft lawsuit dismissed, arguing that “the product liability lawsuits should be pre-empted by federal law because the Infuse device was approved by the FDA,” but plaintiffs claim that the company loses that protection because it illegally marketed Infuse for off-label use, withholding information about the related risks.