A new Infuse complications lawsuit has been filed by a woman who said she has had five surgeries to fix problems with Medtronic Inc. device.

The Infuse Spinal Fusion System is a device designed to perform specific back surgeries. In a healthy human spine, discs of connective tissue cushion and support the spine. However, injury or a lifetime of normal wear and tear can damage these discs, leading to pain and instability in the spine. This is called degenerative disc disorder. Spinal fusion is a procedure designed to repair this, by fusing two vertebrae together. This bypasses the damaged disc. In the “traditional” version of this surgery, redundant bone is harvested from elsewhere in the body for the fusion. The Infuse System is designed to replace the harvested bone with a bio-engineered gel, which replaced the need for a separate surgery to harvest bone for the fusion. However, lawsuits have alleged that the device may carry new risks not seen in the older version of the procedure.

In this latest Infuse complications lawsuit, plaintiff Jennifer English sued Infuse manufacturer Medtronic Inc., alleging the device caused her harm. In 2007, English had the Infuse device implanted in her spine. According her Infuse lawsuit, it has required five revision surgeries to correct the damage from the Infuse device. Her Medtronic lawsuit also asserts that she needs a sixth surgery, but cannot afford it.

When a medical device is approved for use in the United States, the makers are required to run the device through intensive testing for safety and efficacy. However, these protocols, overseen by the FDA, are very specific. Each purpose of the device must be approved separately. In the case of Infuse, the device was only approved for spinal fusions in a very specific part of the spine performed in a very specific way. Physicians are allowed to use their own judgment to an extent, and use medical devices and drugs beyond these parameters when there is evidence the device can work in other situations. Medical companies are forbidden from promoting their devices for off-label use. It has been alleged in English’s Infuse complications lawsuit that the makers aggressively promoted the device for off-label use, which was a factor in the decision to use the device in English’s back.

The Medtronic Infuse Complications Lawsuit is Jennifer English v. Medtronic Inc., et al., Case No. 9:13-cv-81282-KAM, in the U.S. District Court for the Southern District of Florida.

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

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