The U.S. Food and Drug Administration (FDA) approved the Medtronic Infuse Bone Graft system for limited use during spinal fusion procedures for spinal repair. It was only approved as a full system, with all parts used, in frontal approach lumbar spine surgery. Any other use is constituted as “off-label,” and is behind most Infuse bone graft lawsuits including the latest lawsuit filed by plaintiff Kerry Arias.

On December 16, 2010, Arias had bone graft surgery with the Infuse product using an off-label Posterior Lumbar Interbody Fusion (PLIF) method, according to her Infuse bone graft lawsuit.

According to the Medtronic lawsuit, the implanting surgeon, Dr. Jeong, did not use the designated spacer cage, used a posterior approach, and the Infuse bone protein was administered outside of the cage entirely. Prior to this surgery, neither Arias nor her physician were warned of the off-label risks.

It’s estimated that as many as 90 percent of the Infuse bone grafts used in spinal surgery were done so with uses not listed on the label. Developed, designed and manufactured by Medtronic, the Infuse Bone Graft is meant to aid fusion between the vertebrae without needing to harvest the patient’s own bone. However, the Infuse bone graft side effect goes the opposite way, creating unwanted bone growth.

Following her Infuse surgery, Arias reportedly developed “increased right leg pain and weakness, persistent right ankle foot pain and numbness, right foot drop, and persistent buttock pain.” It was eventually revealed that Arias had developed inflammation and uncontrolled bone growth, causing stenosis near the surgery site. She still continues to suffer from intermittent inflammation and redness today, she claims in her Infuse bone graft lawsuit.

According to the bone graft lawsuit, Arias underwent revision surgery on Oct. 14, 2011, to remove the lnfuse-induced bone overgrowth. In the operative report, Dr. Jeong notes: “There was significant bony formation particularly over the posterolateral recess ofL5-Sl as well as over the top of the instrumentation … (a) revision decompression was performed, with removal of a combination of scar tissue as well as bony overgrowth from the floor of the spinal canal.”

Prior to these surgeries, Arias was reportedly in good health and led an active lifestyle. After her revision surgery, in early March 2012, Arias developed a deep wound infection (osteomyelitis) requiring hospitalization for five days and months of antibiotic treatment through a semi-permanent line, the bone graft lawsuit alleges. She also developed shingles on three separate occasions at or near the surgery site. Now, she says she is constantly tired, in pain, and has to use a walker to get around.

Arias says she continues to endure pain and suffering, and economic losses. Allegedly as a result of the off-label use and Medtronic’s failure to warn of the risks of off-label use, Arias has lost her optimism, and “suffers injuries to her body and mind, the exact nature of which are not completely known to date.”

Moreover, she will continue to incur additional medical expenses and loss of wages as a result of the damages she has suffered to date, according to the Medtronic lawsuit.

She is suing Medtronic for fraudulent misrepresentation, failure to warn, design defect, negligent misrepresentation, negligence, negligence per se, breach of express warranty, breach of implied warranties of merchantability and fitness, loss of consortium, unjust enrichment, and punitive damages.

The Infuse Bone Graft Lawsuit is Kerry Arias and Richard Arias v. Medtronic, et al., Case No: 4:14-cv-01771-CKJ, in the U.S. District Court for the District of Arizona.

Off-Label Issues

The off-label uses make up the largest part of Medtronic’s Infuse market, as Medtronic sells Infuse separately. It also creates the majority of its complications. When Infuse is used off-label, it can cause a patient severe injury, including Infuse-induced ectopic bone growth and other issues that can necessitate revision surgery.

Other issues can include “extreme inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, and worse overall outcomes.“

Arias, and other victims of off-label Infuse bone graft surgeries relied on Medtronic’s case studies and reputation.

Infuse – Medtronic’s Rise and Fall

Medtronic Infuse bone graft relies on bone morphogenetic proteins (BMPs). More specifically, it relies on a specific gene from bone and tissue (rhBMP-2) to create genetically engineered cells. These cells, in turn, produce large quantities of rhBMP-2.

On July 2, 2002, the FDA approved the Infuse Bone Graft System for medical use. Sanctioned for one limited and very specific spinal fusion procedure.

The system is a medical device containing an absorbable collagen sponge treated with rhBMP-2, and placed within its LT-Cage. The initial approved labeling for Infuse indicated in bold, underlined formatting, “These components must be used as a system. The Infuse Bone Graft component must not be used without the LT-Cage Lumbar Tapered Fusion Device Component.”

The labeling also specifies the manner in which both components are to be used in a fusion procedure. But Medtronic ignores this warning and sells Infuse separately. It has done so since its approval in 2002, and has the press and Infuse bone graft lawsuits against them to prove it.

In May 2006, Spine published an article observing that, “rhBMP-2 may stimulate bone growth in areas in which bone is not desired.”

A different Spine piece, published in November 2006, entailed the risk of swelling from off-label use of Infuse in cervical spine fusions compared to traditional fusion surgeries. Articles in The Spine Journal followed in 2007.

Coinciding with these articles and studies detailing the risks of off-label usage, Medtronic’s alleged corrupt campaign of off-label marketing was brought to light. It was discovered that Medtronic paid outside “Key Opinion Leader” physicians thousands to millions of dollars in exchange for publishing studies and medical journal articles “which downplayed and concealed the risks of adverse events from off-label use while actively promoting off-label use of Infuse, delivering presentations explaining, endorsing, and promoting off-label applications of the product, and directly advocating off-label uses of Infuse to other spine surgeons, while minimizing the risks or dangers to patients from these uses.”

In May 2009, The New York Times reported that the U.S. Army had completed an investigation into one doctor’s study extolling the benefits of Infuse to treat soldiers injured in Iraq and concluded he had falsified significant portions of the study. The physician leading the Army’s inquiry, Col. J. Edwin Atwood, pronounced it as “the ultimate tragedy and catastrophe in academic medicine.”