Accused of marketing their bone protein product for unapproved, “off-label” purposes, including injection into the cervical spine and upper back, manufacturer Medtronic has been slapped with thousands of Infuse Bone Graft lawsuits.

The vast number of Infuse bone graft lawsuits led a federal judicial panel to create a multidistrict litigation, centralizing all of these cases in one venue before a single judge.

In 2002 the FDA first approved the Infuse Bone Graft — traditionally 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 the product received approval for use in dental procedures. Infuse contains a synthetic protein that makes it ideal for promoting bone growth. Additionally, the popular Medtronic product is FDA approved for facial surgeries and fusing damaged vertebrae in the lower spine.

But over the years, the device became popular for off-label (non-FDA approved) uses, resulting in a number of complications including 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.

Medtronic Infuse Bone Graft Complication and Allegations

Medtronic, the world’s largest medical device maker, has been accused of paying doctors to use the Infuse for both approved and off-label purposes, intentionally hiding the possible side effects, and using deceptive marketing practices.

“Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product,” according to MedPage Today.

Without admitting liability, Medtronic in May announced that it had agreed to settle 950 cases for a total of $22 million.

“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,” the company said in a recent public statement. 

In their press release, Medtronic went on to say:

“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. 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.”

Amid questions about their product’s safety, Medtronic commissioned two new Infuse bone graft studies.

One study found no difference in overall success rates between Infuse and similar bone grafts when used in lumbar spine fusion, according to a 2013 Bloomberg News report, while another study found that when used in other types of surgery, “Infuse patients had higher, though not always significant, increases in retrograde ejaculation, urogenital problems, bone spurs that can cause nerve pain and wound complications.” Despite the many complications associated with the medical device, the Medtronic INFUSE Bone Graft remains approved for specific uses by the FDA.