A product approved for use in accelerating bone growth in lumbar spine surgery has often been used in off-label procedures and caused a woman’s injury, according to a recent Infuse bone graft lawsuit.

The woman alleges the only surgery that Infuse should be used in is lumbar fusion, and not cervical spine surgery. The reason cited is the result of trials performed by Infuse manufacturer Medtronic Inc. which indicated that “uncontrolled bone growth developed in a number of patients, [thus] worsening the very pain that the fusion was designed to eliminate.”

That study involved participants who underwent the same surgery as plaintiff Kimberlee Miller underwent in 2007, a posterior and posterolateral lumbar interbody fusion that did not include the necessary LT-Cage. While her specific injuries were not mentioned, there is the potential for back pain, inflammatory distress and radiculitis among others.

Her Infuse bone graft class action lawsuit attorney alleges that the company “and its senior management and paid consultant ‘opinion leaders,’ were well aware of the concerns regarding off-label uses of Infuse and the serious dangers posed to patients by those off-label uses.” In the years between the study’s failure and Miller’s posterolateral lumbar interbody fusion, lawyers assert, the public should be made aware.

The U.S. Senate conducted an investigation regarding the practices of the company, including sponsored studies, with Sen. Max Baucus noting that “Medtronic’s actions violate the trust patients have in their medical care,” according to the woman’s Infuse bone graft class action lawsuit attorney. The senator reportedly went on to say, “[P]atients are at serious risk when companies distort the facts the way Medtronic has.”

Similar Infuse lawsuits have been initiated regarding the use of the product, which spurs bone growth, but when used in cervical spine surgery increases the possibility of severe pain and can, in rare instances, cause paralysis.

The Infuse bone graft lawsuit is Kimberlee Miller, et al. v. Medtronic Inc. et, al., Case No. 14-cv-00397, in the U.S. District Court for the District of Arizona.