An Oregon man has filed an Infuse Bone Graft System lawsuit against Medtronic Inc. for the injuries he allegedly suffered from a surgery using the implant.

Plaintiff Robert Skoubo’s Infuse lawsuit alleges that as a result of the misinformation he was given, he made an uninformed decision in choosing to use the Infuse device in his spinal surgery, which led to various  injuries.

According to the Infuse bone graft lawsuit, Skoubo had chosen to use Infuse to treat his back condition, located in the cervical spinal area. This area of the spine is highly sensitive, and controls many of the body’s movements. Some of the injuries Skoubo suffered were caused by the uncontrolled bone growth of his own spine.

Skoubo’s Infuse lawsuit alleges he did not know the product was being used on him for an off-label use, and the risks associated with that use. Medtronic allegedly had known about the complications of using the Infuse bone graft for off-label purposes, but still marketed it to the plaintiff and other patients. Skoubo insists that he would not have agreed to an Infuse bone graft if he had known about the complications, or if he knew that his surgery was considered off-label use of the product. The Infuse bone graft lawsuit says Medtronic had the responsibility to warn him and other patients of these adverse effects.

The Infuse lawsuit accuses Medtronic of negligence, false advertising, concealing information, and misrepresenting a product.

Overview of Medtronic Infuse Complications

Medtronic Inc. is the largest medical device maker in the United States, providing products and services to millions of patients across the country. Each year more than 100,000 patients undergo spinal fusion surgery, and use their Infuse Bone Graft product.

The Medtronic Infuse Bone Graft is typically used for specific spinal surgeries to stimulate bone growth and to replace damaged spinal disks. It was marketed and sold as an alternative method from harvesting bone particles from the hip for these spinal surgeries. While popular, the product is only supposed to be used for surgeries approved by the U.S. Food and Drug Administration.

Off-label uses of the Infuse bone graft have reportedly caused severe side effects that have led to additional surgeries and extended hospital stays. These complications include, but are not limited to:

• Difficulty Breathing, Swallowing or Speaking
• Compression of the Airway
• Respiratory Depression
• Nerve Damage
• Death
• Swelling of the neck and throat
• Infection
• Bone injury
• Infertility
• Cyst formation
• Cancer

Most patients who suffered bone graft complications have reported that the adverse effects normally occur with two and  14 days of the surgeries.

This Infuse lawsuit is Robert and Diane Skoubo v. Medtronic Inc., Case No. 2:14-cv-00461-SU, in the U.S. District Court for the District of Oregon.