A federal judge struck down an attempt by Medtronic Inc. to upend Infuse complications lawsuits by arguing they are based on state law and should be preempted by federal law. The ruling last month allows various Infuse lawsuits to move forward.

The Infuse Bone Graft System is a type of surgical implant designed to be used in spinal fusions and several other bone surgeries. Infuse consists of a metal cage and a bio-engineered gel.

This gel encourages bone to grow. In a spinal fusion surgery, the steel cage of Infuse is used to hold two adjacent vertebrae together while the gel encourages them to grow together.

Spinal fusion surgery is used to strengthen a part of the spine after a spinal disc fails. The Infuse Bone Graft System is also approved for use in certain dental and facial surgeries, but in these cases the steel cage is not used, only the bio-engineered gel.

However, Infuse lawsuits have alleged that the Infuse Bone Graft System is potentially dangerous, particularly when used “off-label,” or beyond the U.S. Food and Drug Administration’s approved uses of the device.

Allegedly, the Infuse Bone Graft System can cause swelling, making it dangerous for use in the neck. Additionally, it has been alleged that the Infuse Bone Graft System can promote uncontrolled bone growth.

In the nerve- and muscle-rich tissues around the spinal column, uncontrolled bone growth can cause serious medical problems. Uncontrolled bone growth in the spine can cause nerve damage, which in turn can cause severe pain, numbness, paralysis, and other complications. Other Infuse complications have also been alleged.

One issue that has come up in the various Infuse lawsuits is off-label usage. Under U.S. law, a physician can prescribe a medical device or drug outside of its FDA-approved purpose if, in their judgment, it could help a patient.

This leeway is intended to allow doctors to use their judgment in cases when medical research moves faster than FDA approval. But there is a caveat that medical manufacturers may not market their wares off-label.

Under U.S. law, off-label use of a medical device is permissible, but off-label marketing is strictly forbidden. Medtronic Inc. has been accused of engaging in a clandestine off-label marketing campaign for the Infuse Bone Graft System, by hiring doctors to write up “research articles” and give presentations singing Infuse’s praises, without disclosing the fact that Medtronic was paying them.