An Illinois woman filed an Infuse bone graft lawsuit against Medtronic Inc., alleging that she suffered serious injuries because the device was improperly used.

Plaintiff Kathlene A. Penich Garross is suing Medtronic for the injuries she allegedly sustained from their Infuse bone graft product. Garross claims that because the Infuse bone graft was used in her surgery, she suffered massive debilitating pain and suffering, and had to undergo an additional surgery.

Garross alleges she agreed to use Medtronic’s Infuse bone graft based on the appraisal it had received from the public and the defendant company. At the time it was introduced as a surgical option to the plaintiff, Medtronic had reportedly been advertising it for off-label purposes, and allegedly exaggerated the benefits the device included when used during spinal surgeries.

These benefits included controlled bone growth and shorter hospital recovery time. The defendant had described much of the benefits of the Infuse bone graft, but did little to describe any potential Infuse bone graft side effects. Garross was also not aware of any potential complications when she agreed to use the device, and argues that she was not given proper disclosure before or after her surgery.

Garross underwent these procedures between March and June 2009, with the intention of using the Infuse to correct back pain on the lumbar region of her spine.

Unfortunately, she alleges was met with extreme pain soon after the surgery, and had to immediately undergo another procedure several days later. While it appeared that she reacted well to the second surgery, a third procedure was reportedly required in June 2009 because the pain in her back and legs had returned.

Medical records indicate that these injuries were directly caused by excess bone growth that occurred outside the surgical area, or ectopic bone growth, of her spine. The excess bone growth caused her extreme pain and immobility in her back and reportedly in her right leg.

Garross reportedly required three surgeries to correct the ectopic bone growth from the Infuse bone graft, and is also now at a higher risk for developing cancer. Additionally, she experiences pain daily in her back and legs, doing everyday activities and cannot function as before.

Garross alleges she was not warned of these Infuse bone graft side effects and if she had been, she insists that she never would have agreed to use the Infuse bone graft. Additionally, Gaross states that Medtronic had the civil responsibility of warning her and other patients of these complications because they are relying on the given information.

Garross is suing Medtronic for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous product. The charges include negligence, false advertising, concealing information, and misrepresenting a product.

The Infuse Bone Graft Lawsuit is as Kathlene A. Penich Garross v. Medtronic Inc., Case No. 2:14-cv-00134-LA, in the U.S. District Court for the Eastern District of Wisconsin, Milwaukee Division.

Overview of Medtronic Infuse Complications

One of the most popularly used medical devices is the Medtronic Infuse Bone Graft, because it provides a less invasive and supposedly safer alternative than harvesting bone marrow from a different area of the body. The Infuse is approved to be used on a patient’s lower lumbar spine, but it has been discovered that because of Medtronic’s advertising campaigns, it has been used for off-label purposes on different parts of the spine.

It has been reported that when used for off-label procedures, the Infuse can potentially cause a number of severe injuries including immobility, device failure, male infertility, and death. Most commonly, the Infuse bone graft side effects cited in Medtronic lawsuits are for off-label purposes include, but are not limited to:

• Difficulty breathing, speaking and swallowing
• Chronic pain requiring daily medication to manage
• Excessive bone growth
• Nerve damage
• Male sterility and other uro-genital injuries
• Death