A North Dakota woman filed a lawsuit against Medtronic Inc. alleging she suffered complications from its Infuse Bone Graft product. The lawsuit also alleges Medtronic had recommended that Infuse be used for off-label purposes, which directly led her to suffer severe complications.

The Infuse Bone Graft consists of bio-engineered bone growth protein that is implanted into specific parts of the patient’s spine, in cases of damage or bone wear. On March 26, 2008, plaintiff Kerri Christenson had the Infuse Bone Graft implanted into her spine, using an off-label Transforaminal Lumbar Interbody Fusion (TLIF) implantation method, her Infuse complications lawsuit alleged.

Essentially, the use of Infuse was off-label in this situation because it was implanted using an unapproved method, instead of the FDA-approved LT-Cage. Prior to her surgery, Medtronic allegedly did not warn the plaintiff that this was an off-label procedure, and that certain risks were connected to it. Soon after her surgery, Christenson started feeling severe nerve pain and leg weakness, leading to instability, balance problems, falls, and general inability to move, according to her Medtronic Infuse lawsuit.

Diagnostic imaging revealed that Christenson was suffering from abnormal bone overgrowth in the surgical area. Christenson’s doctors stated that a revision surgery would not be wise in this situation, because the risks of further complications were likely and the additional surgery would do little to help.

Before her surgery, Christenson was the chief financial officer of St. Andrew’s Health Center in North Dakota. She was forced to resign from her position because she was unable to perform the necessary duties of her position. And, her Infuse lawsuit said, she was set to be promoted to be the hospital’s chief executive officer before the surgery.

Christenson states that had she known about the possible consequences of using the Infuse for her procedure or that it would be used off-label, she never would have chosen it, according to her Medtronic lawsuit.

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

This Infuse Bone Graft Lawsuit is Kerri and Robert Christenson v. Medtronic Inc., Case No. 1:14-cv-00034-DLH-CSM, in the U.S. District Court for the District of North Dakota, Southwestern Division.

Overview of Medtronic Infuse Complications

The Infuse bone graft is often used for approved spinal surgeries to stimulate bone growth and to replace damaged spinal disks. It is considered a success by many experts in America, with Medtronic marketing and selling it as an alternative method from harvesting bone particles that is used to supplement the damaged spinal area. Due to how much less difficult the product is, the Infuse bone Graft quickly became popular.

Medtronic lawsuits allege that Medtronic has been marketing the Infuse bone graft for off-label purposes and unapproved surgeries. This has led to numerous complaints and adverse injury reports from patients, who are accusing Medtronic of using deceptive marketing tactics and exposing them to an avoidable risk. The complications cited in Infuse product liability lawsuits include:

• 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