A Washington couple is suing Medtronic Inc. for the injuries suffered by the husband after choosing to use the company’s Infuse Bone Graft device for his back surgery.  John and Megan Crowder allege as a direct result of using the medical device, he suffered multiple severe injuries and the need for multiple revision surgeries.

Like most patients, Crowder had chosen to use Medtronic’s Infuse Bone Graft to treat lower back pain. The Infuse Bone Graft lawsuit states that he used it for his spinal surgery for off-label purposes, after approval by the chief surgeon. The surgeons had allegedly relied on the claims Medtronic made about the Infusion system, and had used it on the plaintiff without expecting any complications.

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

As a result, Crowder suffered a multitude of injuries, including induced bone growth in his spine, which was allegedly caused by the Infuse Bone Graft. Crowder will require several revision surgeries and physical therapy to recover, and will contend with mounting medical bills, according to the couple’s lawsuit. Crowder contends that he never would have asked to use the Infuse Bone Graft if he had known about these possible injuries, and that Medtronic never should have promoted it for such uses.

The Infuse Bone Graft lawsuit alleges negligence, false advertising, concealing information, and misrepresenting a product.

The case is John and Megan Crowder vs. Medtronic Inc., Case No. 2:14-cv-00456-JCC, in the United States District Court of Western Washington.

Overview of Infuse Bone Graft Complications

The Infuse Bone Graft system is a bio-engineered bone graft device meant to be used in specific 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 is manufactured and marketed by Medtronic Inc., and was approved for specific spinal surgeries by the U.S. Food and Drug Administration in 2002.

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

From the time of its release in 2002 to 2012, patients had used the Infuse Bone Graft system to treat off-label lumbar conditions. In that time, at least 1,200 adverse reports or Infuse Bone Graft complications were made regarding the product. Medtronic is currently being sued for marketing this device for off-label purposes, despite knowing the risks.

Reported Medtronic Infuse Bone Graft complications include:

• Difficulty breathing, speaking and swallowing
• Swelling of the neck and throat
• Infection
• Bone and nerve injury
• Infertility
• Cyst formation
• Cancer
• Death