Medtronic Inc. and Medtronic Sofamor Danek USA Inc. moved to dismiss dozens of Infuse bone graft lawsuits filed in Tennessee federal court against the companies due to injuries and complications allegedly suffered by the plaintiffs in off-label use of the Infuse Bone Graft System.

Infuse is a medical device, consisting of a metal support cage with a matrix of bioengineered proteins, meant to be used for spinal repair. It is designed to repair degenerative disc disorder, and works by separating the vertebrate to their pre-degenerative state with the support cage, with the idea that the protein matrix encourages the patient’s bone to grow around the weakened tissue, fusing the vertebrae.

The bioengineered protein matrix is designed to be mixed with tissue from the patient’s body, with the goal of creating a greater possibility of the body accepting the new tissue.

While the Infuse Bone Graft System is approved by the U.S. Food and Drug Administration (FDA) for lumbar surgery through the abdomen, some tibia fractures, and some specific dental surgeries, Medtronic has been charged in several Infuse lawsuits of encouraging the use of the device for other surgeries.

Many of the Infuse bone graft lawsuits allege that Medtronic aggressively promoted usages that were not approved by the FDA, going so far as to persuade spine surgeons to expand the use of Infuse for off-label surgeries, including posterior approach lumbar fusions and cervical spine fusions.

While many of the Medtronic Infuse lawsuits allege that this would void any immunity granted by a settlement the company reached with the Justice Department, as many as 80 percent of the Infuse bone grafts were implanted in spinal surgery patients for uses not listed on the label, and up to 100,000 people receive Infuse bone grafts each year, making the number of people possibly harmed quite large.

One such Infuse bone graft lawsuit accuses Medtronic’s Infuse Bone Graft System of potentially causing extreme inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis, displacement or migration of the spacer cage, pseudoarthrosis, and worse overall outcomes.

In its motion to dismiss dozens of complaints with prejudice, Medtronic writes in its filing, “Plaintiffs’ claims are expressly preempted by the Medical Device Amendments of 1976 because they seek to impose state-law requirements on the design or labeling of the medical device at issue in this case that are different from or in addition to the federal requirements imposed by the FDA. Moreover, to the extent that Plaintiffs’ claims seek to enforce the provisions of federal law purportedly governing the promotion of medical devices for ‘off-label’ uses or regarding adverse event reporting, they also are impliedly preempted … and prohibited by the ‘no private right of action’ provision of the federal Food, Drug and Cosmetic Act.”