A Medtronic Infuse bone graft complications lawsuit was filed by a Texas man who claims that the company encouraged his physician to use the device for his surgery even though it had not been approved for that purpose.

Plaintiff Ramon Barrientos underwent surgery on June 12, 2012, which focused on a complications located in the cervical area of the spine. The Infuse bone graft had not been approved to be used in this surgery. However, Medtronic had allegedly advertised this product to be a safe and effective for the surgery.

Neither Barrientos nor his physician was aware of any risk involving the Infuse bone graft, nor were they aware that his surgery was considered an off-label purpose, according to the Medtronic lawsuit. Not long after the surgery, Barrientos started experiencing extreme pain and discomfort that got to the point of immobility.

Barrientos’ physician reportedly read articles from the scientific journal The Spine Journal describing the likelihood of ectopic bone growth and other complications that came with off-label uses of the Infuse bone graft. He stated that he never would have suggested Infuse to his patient if he had known the surgery was considered off-label. Likewise, Barrientos insists that he never would have chosen to use the Infuse bone graft if he had known the same information.

The Infuse bone graft lawsuit accuses Medtronic of failing to warn Barrientos and his physician about the complications associated with Infuse, and for advertising the product to them when the defendant most likely knew this was an off-label surgery. Barrientos’ lawyers argue that because their client was not given full disclosure at the time the Infuse was presented as an option, he was unable to make a reasonable decision at the time.

Barrientos accuses Medtronic of negligence, false advertising, concealing information, and misrepresenting a product.

This Infuse Bone Graft Lawsuit is Ramon Barrientos v. Medtronic Inc., Case No. 4:14-cv-02332, in the U.S. District Court of Central California.

Overview of Infuse Bone Graft Complications

The Infuse bone graft is a popular choice among Americans who need spinal surgery, because it provides an alternative from harvesting bone marrow from the knees. It is a bioengineered bone morphogenetic protein (rhBMP-2), which is used to promote bone growth in gaps of the spine. The U.S. Food and Drug Administration approved the Infuse bone graft in 2002 to only be used in certain lumbar fusion procedures, and it has not been approved any other use.

Each year, it is reported that more than 100,000 patients undergo spinal fusion surgery with the Infuse bone graft in the United States. Many of these cases have been reportedly off-label surgeries. In many of these cases, patients reported serious injuries and complications that arose soon after surgery.

Across America, hundreds of Infuse bone graft lawsuits are being filed throughout the state and federal court systems by plaintiffs who claim they suffered from severe complications from this device.