Robert J. Boumis  |  July 3, 2014

Category: Legal News

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Medtronic_Infuse

Medtronic Inc. continues to face more Infuse bone graft lawsuits over complications with the specialized medical device designed for use in spinal surgery.

The Infuse Spinal Fusion System is a used for spinal fusion surgery. In a healthy human, discs of cartilage help space, support, and cushion the bones of the spine. However, age and trauma can wear out these tissues, causing serious pain and possibly nerve damage. To treat this, surgeons may perform a procedure called spinal fusion to help support the spine. In this procedure, the bones of the spine are encouraged to grow together, forming bony scar tissue to join two separate vertebrae into a single bone. Some flexibility is lost, but the spine is strengthened. The Infuse System is designed to help with spinal fusion.

The Infuse bone graft consists of a metal support cage and a bio-engineered gel. The support cage is designed to hold the vertebrae in place during the spinal fusion and remain in place to provide additional support to the fused bone. The gel includes both the patient’s own tissue and bio-engineered proteins which encourage new bone growth. However, it has been alleged that the Infuse System offers more risks than traditional spinal fusion surgery.

Infuse bone graft lawsuits make several major allegations. One is that Medtronic illegally promoted the medical device. Under U.S. law, a drug or medical device has to go through extensive testing before the U.S. Food and Drug Administration (FDA) can approve it for human use. If a device has more than one medical purpose, the manufacturer must run it through the FDA approval process for each proposed purpose. However, physicians have the ability to prescribe drugs and medical devices without FDA approval. This is called “off-label” use. While this practice is legal, a medical device manufacturer is not allowed to promote that off-label usage. Infuse is only approved for a specific type of spinal fusion to treat a specific disorder in a specific location in the spine. As many as 80 percent of Infuse surgeries may have been off-label.

The issue of off-label usage could have a major impact on any Medtronic Infuse class action lawsuits. It could theoretically increase Medtronic’s liability if patients suffered Infuse bone graft complications. It has been alleged that Infuse can cause overgrowth of bone, creating painful, debilitating bone spurs. It has also allegedly been linked to nerve pain, paralysis, and numbness due to the device interfering with spinal nerves.

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

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