Robert J. Boumis  |  July 17, 2014

Category: Legal News

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Medtronic_Infuse

The Infuse Bone Graft System, manufactured by Medtronic Inc., was designed to be an improvement on spinal fusion procedures. However, Infuse bone graft lawsuits allege the device causes serious complications, and Medtronic’s advertising practices have come under fire.

The Infuse Bone Graft System is designed to assist with spinal fusion surgery. In humans, discs of connective tissue support and cushion the individual bones of the spine. As certain individuals age, these discs wear out, causing pain and damage to the spine, a condition called degenerative disc disorder. Surgeons can bypass the damaged tissue by fusing together adjacent bones of the spine, a process called spinal fusion. This trades some flexibility for a stronger spine, hopefully with less pain.

In traditional spinal fusion, a redundant bone from elsewhere in the body is used to help adjacent bones grow together. This requires a separate surgery to harvest bone from another part of the body. The Infuse bone graft is designed to help sidestep this. The Infuse system consists of a metal cage and a bio-engineered gel. The metal cage is designed to support the adjacent bones of the spine as they fuse, and remain in place to provide additional support to the fused bones of the spine. The gel, which is designed to be seeded with protein from the patient’s body, encourages the bones of the spine together. This eliminates the need to harvest bone from elsewhere in the body.

Infuse class action lawsuits allegedly link the Infuse Bone Graft System to a variety of complications, including overgrowth of bone, nerve damage (including paralysis, numbness and pain), cancer, and swelling of the neck and throat. This has led to a number of Medtronic bone graft lawsuits alleging that the device is inherently defective and dangerous, and that traditional spinal fusions are safer.

One issue that has further complicated Medtronic Infuse bone graft lawsuits is the issue of off-label usage. Under U.S. law, a drug or medical device is required to go through the process of U.S. Food and Drug Administration (FDA) approval before it can be offered to the public. In addition to this, a medical device must get FDA approval separately for each purpose the device is marketed for. This approval process consists of testing for safety and effectiveness. However, a physician may use his or her informed, professional judgment and use a drug or medical device for a uses other than those approved by the FDA. This practice is called “off-label usage,” and is legal under U.S. law. However, medical companies are forbidden from promoting products for off-label purposes. It has been alleged in the Medtronic bone graft lawsuits against that the company promoted Infuse for off-label uses, and in fact the majority of Infuse surgeries were technically off-label. This could have implications for the litigation over Infuse.

In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.

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An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

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