A North Dakota couple has filed an Infuse bone graft lawsuit alleging that Medtronic Inc.’s device caused an injury following a spinal surgery in which Infuse was implanted in plaintiff Kerri Christenson in an off-label manner.

Infuse was approved for only one specific type of spine surgery  — “one level fusion in the lumbar spine that is performed through the abdomen (an ‘anterior approach’).” Infuse has never been approved for use in posterior approach lumbar spine surgeries. However, that allegedly is how it was used with Christenson, which is why she and her husband are suing Medtronic for the injuries suffered by Christenson after choosing to use the company’s Infuse bone graft device for her back surgery.

According to the Infuse bone graft lawsuit, on March 26, 2008, Christenson was implanted with the Infuse bone protein using an off-label Transforaminal Lumbar Interbody Fusion (TLIF) implantation method (TLIF is a posterior-approach fusion). Dr. Eric Belanger performed the procedure at St. Alexius Medical Center in Bismarck, N.D.

As a result of the off-label use of Infuse in her spinal surgery, Christenson reportedly developed worsening nerve pain and weakness in her legs, which caused balance problems, instability, and falls. Subsequent imaging ultimately showed that she suffered from “impingement due to bone overgrowth at the operative level.” However, doctors advised that revision surgery had a low chance of relieving her symptoms, and was not worth the risks involved, the Infuse bone graft lawsuit claims.

Christenson now has to live with the damage from her Infuse back sugery for the rest of her life. She is only able to sit or walk for a limited amount of time, and her once active lifestyle has come to a virtual standstill. Additionally, as a result of the off-label use of Infuse in Christenson’s lumbar fusion surgery, her husband is now unable to enjoy the activities he once shared with his wife.

The North Dakota woman’s spine surgeons were allegedly persuaded by Medtronic’s marketing consultants. The Infuse lawsuit claims the specialists were paid by Medtronic to promote the Infuse bone graft for off-label purposes, such as posterior surgical approaches to lower lumbar bone fusions.

“From at least 2002 until articles in The Spine Journal were published in the Summer of 2011, Medtronic engaged in the ghostwriting of articles and reports on clinical studies in order to suppress any information about the real risks and dangers posed by off-label posterior use of Infuse,” according to the Medtronic lawsuit.

The June 2011 edition of The Spine Journal included a round of articles describing Medtronic’s failure to accurately report the side effects from its clinical trials, the downplay of the risks (and over-emphasis of problems from non-Infuse bone grafts in spine fusion procedures), and Medtronic’s failure to report that “many of the authors who studied and promoted Infuse had significant financial ties to Medtronic with a median range of $12 to $16 million per study.”

Like many patients, Christenson and her surgeon relied on the claims Medtronic and key opinion leaders made about the Infusion system. Her surgeon was misled by this biased and manipulated medical literature regarding Infuse, the Infuse lawsuit claims. In turn, Christenson was misled indirectly by virtue of her reliance on her physicians’ understanding of the risk and benefits of using Infuse. They used it without expecting any complications.

As a direct result of the off-label use of Infuse, Christenson, in addition to lifelong pain, has suffered past wage loss and will continue to suffer these losses into the foreseeable future. The abrupt end to Christenson’s career and her ability to work has significantly undermined her family’s financial circumstances.

The Infuse bone graft lawsuit alleges negligent misrepresentation, negligence, failure to warn, product liability – design defect, breach of warranties, concealing information, punitive damages, and loss of consortium.

The 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 Infuse Bone Graft Complications

The Infuse bone graft system is manufactured and marketed by Medtronic Inc. It is a bio-engineered bone graft device meant to be used in anterior spinal fusion surgeries. Its purpose is to allow fusion between the vertebrae without impairing the patient’s own bone growth. The device consists of three main components — the metallic spinal fusion cage, the bone graft substitute, and a collagen sponge. It was approved by the U.S. Food and Drug Administration (FDA) in 2002 for specific (anterior) spinal surgeries.

According to experts, injuries caused by the device tend to come from uncontrolled bone growth. Essentially, the bone graft compresses the spine as it grows, which causes it to wind into a nerve root. It can even grow outwardly from the spinal cord. Injuries reported from this event include pain, paralysis, spasms, and the need for revision surgery.

Surgeons and patients had used the Infuse bone graft system to treat off-label lumbar conditions from the time of its release in 2002 to 2012. In that time, at least 1,200 adverse reports or Infuse bone graft complications were made regarding the product. These spinal surgery patients claim they suffered serious Infuse bone graft problems, including bone and nerve damage, urinary problems, and even an increased risk of cancer. Medtronic is currently being sued for marketing this device for off-label purposes, despite knowing the risks.