An Arizona couple is pursuing a civil action lawsuit against the Minneapolis-based medical device company Medtronic Inc., alleging that the company’s Infuse Bone Graft product caused Miller serious complications, pain, and suffering.

The case joins over 1,000 similar lawsuits alleging that Medtronic’s bone graft system severely injured patients, causing a host of alleged problems such as excessive bone growth, nerve damage, chronic pain, male sterility, and difficulty breathing, swallowing, and speaking.

Plaintiff Kimberlee Miller underwent posterior and posterolateral lumbar interbody fusion surgery on Feb. 23, 2007, during which her surgeon allegedly implanted Medtronic’s Infuse product in an off-label manner. Off-label use of any product means that the medical product was used in such a manner that was not approved by the U.S. Food  and Drug Administration (FDA).

Later that year, Miller was allegedly diagnosed with nerve damage, and a cyst was found to have developed at the side of the fusion surgery. Miller’s Medtronic Infuse bone graft lawsuit alleges that because of Medtronic’s “negligence, callousness, and the other wrongdoing and misconduct,” Miller sustained injuries, economic loss, and incurred additional medical expenses.

Infuse is FDA-approved for anterior lumbar interbody fusions, but was not approved for posterior or posterolateral surgeries like the one performed on Miller.

According to the Medtronic lawsuit, “Patients’ spine surgeons, including Plaintiff’s surgeon, were persuaded by Medtronic and by Medtronic’s consultant ‘Key Opinion Leaders,’ who were paid physician promoters, to expand their use of Infuse for off-label uses such as posterior and posterolateral lumbar fusions.”

Miller’s case is not the first time Medtronic was accused of pushing its Infuse Bone Graft for off-label use. According to the Infuse bone graft lawsuit, Medtronic has allegedly made a practice of promoting Infuse for off-label use despite the lack of FDA approval and explicit FDA warnings about the potential dangers and risks to patients. In the future, Medtronic could face more lawsuits and potentially Infuse Bone Graft class action lawsuits in light of these allegations.

Medtronic faces charges of fraudulent misrepresentation, fraud, strict product liability, negligence, breach of express warranty, breach of Arizona consumer protection laws, loss of consortium, and punitive damages.

The Infuse Bone Graft Lawsuit is Kimberlee Miller, et al. v. Medtronic Inc., et, al., Case No. 14-cv-00397, in the U.S. District Court for the District of Arizona.

Background  on Infuse Bone Graft

The Medtronic Infuse bone graft system is a popular medical product used by many surgeons in spinal fusion surgeries. Infuse uses a synthetic protein mixed with bovine collagen that, when injected in the surgical area, can encourage and accelerate bone growth in damaged area of joints and bones.

Since the FDA approved the Medtronic Infuse Bone Graft System for spinal fusion treatment in 2002, over 100,000 patients have been implanted with the Infuse product. Because of its popularity among surgeons for being less invasive in surgical procedures, Medronic controls 40 percent of all bone graft sales worldwide and in 2011 had record sales of $900 million on Infuse alone.

However, while Medtronic’s Infuse Bone Graft System is effective and less invasive than other bone graft surgery options, there are several risks associated with implanting a patient with the Infuse product.

Infuse bone graft side effects include:

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