Despite thousands of Infuse Bone Graft lawsuits against Medtronic over its Infuse Bone Graft System, a Medtronic company spokeswoman issued a statement in 2014 stressing that the company “stands behind the Infuse bone graft and will vigorously defend it in court.”

Plaintiffs have accused the company, one of the largest medical device makers in the world, of purposefully concealing dangerous Infuse Bone Graft side effects, including male sterility and other uro-genital injuries, nerve damage, excessive bone growth, chronic pain, and difficulty breathing, swallowing, and speaking.

Infuse Bone Graft lawsuits also allege that Medtronic has marketed the Infuse Bone Graft for off-label uses, endangering thousands of spine surgery patients who risk dangerous Infuse Bone Graft complications.

Due to the vast number of Infuse Bone Graft lawsuits, a federal judicial panel approved a multidistrict litigation that centralizes all of the Infuse Bone Graft lawsuits in one court before a single judge.

In May 2014, a month after the company spokeswoman said Medtronic was standing behind its product and would defend it vigorously, Medtronic announced that it had agreed with some plaintiffs’ counsel to settle their inventories of filed and unfiled Infuse Bone Graft lawsuits.

The agreement called for Medtronic to pay approximately $22 million to resolve the Infuse Bone Graft lawsuits of an estimated 950 claimants.

“This agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by Medtronic,” according to a statement issued by the medical device maker.

“The company continues to stand behind Infuse Bone Graft, which has been utilized in more than one million patients since it was approved more than ten years ago, and will vigorously defend the product and company actions in the remaining cases. Earlier this month, on the eve of trial and after several days of pretrial motions, a California trial judge entered summary judgment in favor of Medtronic in the first Infuse Bone Graft case scheduled to go to trial,” the statement continued.

“Approximately 750 filed cases brought by approximately 1,200 individual plaintiffs remain pending in various courts throughout the United States. The majority of these cases are still in the early procedural stages and none have resulted in a finding of liability against Medtronic.”

The U.S. Food and Drug Administration (FDA) first approved the Infuse Bone Graft in 2012. The device is used to fill in spaces where bone is needed, for use in patients with lower spine degenerative disc disease. Two years later it was approved for tibia repairs and in 2007 for use in dental procedures. It contains a synthetic protein that makes it ideal for promoting bone growth. It is also approved for facial surgeries and fusing damaged vertebrae in the lower spine.

Seeing all the success with the lower spine and its dearth of Infuse Bone Graft side effects, doctors began using the Infuse Bone Graft in a number of other procedures in the upper, cervical spine and other areas.

These “off-label” (non-FDA approved) uses, resulted in many Infuse complications such as infection, excessive bone growth, paralysis, retrograde ejaculation, back and leg pain, swelling in the neck and throat, numbness, nerve damage, excessive bone growth, airway compression, difficulty breathing, swallowing and speaking, male sterility and other uro-genital injuries, and chronic pain.