A Colorado patient has filed an Infuse bone graft lawsuit against Medtronic Inc., a Minneapolis based medical device manufacturer, for allegedly marketing the Infuse product for illegal, off-label uses.

Robert Morford underwent anterior lumbar interbody fusion surgery on Jan. 23, 2013, upon which time the Infuse bone graft was allegedly implanted in his body.

According to Morford’s Infuse bone graft lawsuit, “Medtronic did not adequately inform [Morford’s] implanting surgeon, Dr. Jones, of the true incidence of ectopic or uncontrolled or unusual bone growth resulting from the use of Infuse in off-label procedures, or of other risks or dangers or complications associated with the off-label use of Infuse in the spine.”

Dr. Jones claims that had he known of the dangers associated with Infuse’s off-label use, he would have opted to implant Morford with an a traditional autograft instead of the Medtronic product.

Following the interbody fusion surgery, Morford allegedly experienced severe pain resulting from uncontrolled bone growth that caused nerve compression near Infuse bone graft implant site. Morford’s injuries and complications resulting from the Infuse bone graft surgery have limited the his mobility and has required him to take medication to manage the severe pain he experiences on a daily basis. The injuries and limited mobility Morford currently experiences causes him physical pain, emotional distress, and mental anguish.

In light of the alleged damages sustained by Morford, he, his wife, and his legal counsel claim that Medtronic Inc. has committed fraudulent misrepresentation and fraud in the inducement, failed to warn consumers, is liable for designing and selling a faulty product, negligence, breach of the expressed warranty of their product, and other additional charges.

Morford and his legal representatives are seeking monetary compensation from Medtronic in the form of general and punitive damages, payment of medical expenses, payment of Morford’s legal expenses, for loss of consortium, and payment for the the Colorado man’s loss of income.

The Infuse Bone Graft Lawsuit is Morford, et al. v. Medtronic Inc., Case No. 2:13-cv-08254 in the U.S. District Court for the Central District of California.

Background on the Infuse Bone Graft System

Medtronic’s Infuse bone graft system has been a popular bone graft product choice by many surgeons, especially in cases of spinal fusion procedures. Infuse is made of lab designed synthetic proteins, and during procedures these proteins are mixed with bovine collagen and injected into the surgical area.

When implanted, Infuse is designed to replace damaged bone matter in joints and other parts of the human body. During a spinal fusion surgery, the Infuse bone graft is injected directly into the site of spinal injury, after which it can alleviate pain and encourage bone growth in the patient’s damaged area.

Each and every year since its approval by the U.S. Food and Drug Administration (FDA) in 2002, over 100,000 patients have received Medtronic’s Infuse Bone graft treatments. During the record sales of 2011, Medtronic made $900 million in Infuse sales alone. Due to the popularity of the Infuse product in the medical community and the company’s strategic marketing, Medtronic currently controls 40 percent of all bone graft sales internationally.

However, despite these massive profits, Medtronic reportedly neglected to inform its current and future consumers of all the risks associated with using the Infuse bone graft system.

Some Infuse bone graft side effects of using the product for both approved and off-label use include:

• Infection
• Male sterility
• Bone and nerve damage
• Urinary problems
• Increased risk of cancer