A Missouri federal judge has rejected a number of claims in a proposed Infuse bone graft lawsuit stating that the majority of the claims lodged against Medtronic will not stand thanks to a federal oversight.

This Infuse bone graft lawsuit was filed by Kathleen A. Arthur in August alleging that she suffered damages from Medtronic’s bone graft product.

In December 2008, Arthur underwent an anterior cervical discectomy and fusion surgery, during which her surgeon implanted the Medtronic Infuse bone graft.

According to Arthur’s Infuse lawsuit, “plaintiff alleges the surgery did not resolve her cervical pain and that she later developed numbness in her arm and fingers. Despite pain management treatment and additional surgical procedures, she continues to experience severe pain and numbness.”

“She alleges that Medtronic knew before 2008 that the Infuse device causes excessive bone growth that compresses nerves around the spinal cord and causes severe pain. She further alleges that Medtronic promoted off-label use of Infuse in the cervical region,” the Infuse bone graft lawsuit states.

Arthur claims that the Infuse bone graft system is only approved by the U.S. Food and Drug Administration (FDA) for lower back surgeries and procedures, making her specific surgery in which Infuse was implanted in her neck an “off-label” procedure.

She further alleges that Medtronic has marketed and will continue to market their bone graft product for off-label use that is potentially dangerous its patients.

However, according to U.S. District Judge Carol E. Jackson, “In order to properly allege a design defect claim, the plaintiff must plead ‘concrete allegations that the product sold by Medtronic was not the product-design approved in the [FDA’s] pre-market approval.’”

Arthur has filed several allegations against Medtronic, including strict product liability, failure to warn,  negligence, fraudulent misrepresentation, and breach of implied and express warranties. Of these allegations, Judge Jackson has dismissed all except for claims of fraudulent misrepresentation and breach of express warranty, although Arthur will have to provide a more detail pleading for these to charges to move forward.

The Infuse Bone Graft Lawsuit is Kathleen A. Arthur v. Medtronic Inc., Case No. 4:14-cv-00052, in the U.S. District Court for the Eastern District of Missouri.

Background on the Infuse Bone Graft System

The Infuse product is a synthetic protein bone graft mixed with bovine collagen that was designed to to be injected in a surgical area in lieu of traditional, invasive bone graft surgery. The Infuse Bone Graft System, designed and manufactured by Medtronic Inc., has been a popular choice in graft surgeries across the nation, especially when surgeons perform spinal fusion procedures.

At the site of implantation, Infuse is designed to replace damaged bone matter in joints and other parts of the body, while providing relief to suffering patients. In the case of spinal fusion surgeries, the Infuse bone graft product is directly injected into the spine, where it can alleviate a person’s pain while encouraging bone growth.

Since the 2002 FDA approval of this Medtronic product, more than 100,000 patients have been implanted with an Infuse bone graft.

While Infuse has become the popular surgeons choice for spinal fusion surgeries, recent reports have demonstrated that there exists many risks with using the Infuse bone graft system.

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

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