The Supreme Court of Tennessee recently overturned a defense verdict in a medical malpractice lawsuit involving the Infuse bone graft, holding that the trial court had erred by excluding the plaintiff’s expert testimony regarding risks associated with the Infuse bone graft.

Plaintiff Ike W. had gone to the orthopedic surgeon, who is the defendant, after having suffered multiple injuries to his back that caused him to suffer severe back pain. After physical therapy and pain management failed to control his pain, Ike opted to have the spinal fusion surgery proposed by his surgeon, which involved using a bone-grafting product called Infuse.

After the spinal fusion, Ike experienced Infuse bone graft complications including ectopic bone growth at the site of the fusion that caused him to continue to suffer severe pain due to pressure on the nerve, according to the Infuse lawsuit.

Ike claimed in the Infuse lawsuit that the surgeon failed to obtain his informed consent by not advising him of the risks associated with the use of the Infuse bone graft product during the surgery. At trial, the surgeon requested the court to limit the plaintiff’s medical expert’s trial testimony regarding the risks of Infuse bone graft surgery.

The trial court granted the motion and limited expert testimony to only those risks associated with the Infuse bone graft that allegedly occurred and caused an injury to the plaintiff.

Ike then sought permission to appeal to the Tennessee Supreme Court, which was granted.

The Tennessee Supreme Court stated that the jury should have been allowed to hear the plaintiff’s expert’s complete testimony about the risks of the Infuse bone graft, “as such evidence would have been relevant under Tennessee Rule of Evidence 401 in the jury’s assessment of what a prudent person would have decided if properly informed of all significant risks.”

The Tennessee Supreme Court reversed the trial court’s decision and ordered a new trial.

What is the Infuse Bone Graft?

The Infuse Bone Graft is manufactured by Medtronic Inc. and is used during surgery to stimulate bone growth and replace damaged spinal disks. It was marketed and sold as one of the alternatives to harvesting a bone graft from the hip. The Medtronic Infuse Bone Graft is not approved for any other uses, but it has been used off-label in cervical spine (neck) procedures.

In 2002, the FDA granted Medtronic approval for its Infuse Bone Graft, but for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. Specifically, the agency approved the Infuse bone graft to treat degenerative disc disease and open fractures on the tibia.

Infuse Bone Graft Complications

When used during these unapproved procedures, Infuse bone graft side effects may cause bone growth in areas where it is not wanted, which may cause:

• Severe inflammatory reaction
• Airway compression or breathing problems
• Nerve impingement resulting in severe back or neck pain
• Hospitalization with treatment in ICU
• Need for a feeding tube or tracheotomy
• Additional surgery to remove excessive bone from the spinal canal
• Death

The FDA notes that most Medtronic Infuse bone graft complications occurred between two and 14 days following surgery. Complications can also include the need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies, and additional surgery.

Infuse Bone Graft Lawsuits

Although Medtronic was aware allegedly of the risks associated with off-label use, the company engaged in widespread over-promotion of the Infuse bone graft, encouraging use during spinal fusion surgery that was never properly studied and was known to cause serious side effects.

Patients who suffered from Medtronic Infuse bone graft complications after undergoing spinal surgery may have legal recourse to receive financial compensation for damages.