Plaintiff Phyllis Bechtold and others are suing Medtronic Inc. for the injuries they allegedly suffered as a result of a bio-engineered bone graft device that was implanted into each patient in an off-label manner.

According to the bone graft class action lawsuit, the “case involves a series of spinal surgeries in which a bio-engineered bone graft device known as the Infuse Bone Graft (Infuse) was implanted into each plaintiff in an off-label manner.”

Infuse is used in spinal fusion surgeries. Its purpose, the bone graft lawsuit states, is “to accomplish the foster fusion between the vertebrae without implanting a patient’s own bone or cadaver bone between the vertebrae in the spine, obviating the necessity of harvesting bone from the patient’s own hip or risking rejection of cadaver bone.”

The Infuse bone graft is only approved by the the U.S. Food and Drug Administration (FDA) for lumbar surgery performed through the abdomen, some tibia fractures, and some specific dental surgeries not relevant to this case.

Despite the absence of FDA approval as well as explicit concerns about the dangers to patients if the Infuse bone graft is used for off-label uses, the company still allegedly promoted the device improperly for off-label use.

According to the Infuse bone graft lawsuit, even patients’ spine surgeons were “persuaded by Medtronic and by Medtronic’s consultant ‘opinion leaders,’ who are paid physician promoters, to expand their use of Infuse for off-label uses such as posterior approach lumbar fusions and cervical spine fusions.”

“When Infuse is used off-label, it can cause or contribute to other serious injuries and complications, including extreme inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis, displacement or migration of the spacer cage, pseudoarthrosis, and worse overall outcomes,” the bone graft class action lawsuit states.

As a result of Infuse surgeries using off-label procedures or components, the patients allegedly suffered bodily injuries and damages, including loss of earnings and diminution of earning capacity.

“Any warnings Medtronic may have issued concerning the dangers of off-label uses of Infuse or regarding the specific risks of those uses were insufficient in light of Medtronic’s contradictory prior, contemporaneous, and continuing illegal promotional efforts and promotion of Infuse for non-FDA approved off-label uses in the spine and contemporaneous efforts to hide or downplay the true risks and dangers of the off-label uses of Infuse,” the bone graft class action lawsuit states.

None of the patients would have consented to be treated with the off-label use with the Infuse bone graft had he or she known of or been informed by Medtronic or by his or her spine surgeon of the risks linked to the off-label use.

Each patient is expected to incur additional medical expenses in the future as a result of the injury and damages he or she suffered. Because of this, the infuse bone graft lawsuit contends that each plaintiff is therefore entitled to damages in an amount to be determined at the trial.

This Infuse Bone Graft class action lawsuit is Phyllis Bechtold, et al. v. Medtronic Inc., et al., Case No. 1:14-CV-003250MRB, in the U.S. District Court for the Southern District of Ohio, Western District, Cincinnati.

Overview of Medtronic Infuse Bone Graft Marketing

Medtronic Inc. is the largest medical device maker in the United States, providing products and services to millions of patients in the country. Annually, more than 100,000 patients undergo spinal fusion surgery, in which the Infuse Bone Graft product is used. Unfortunately, many patients who received these bone grafts were using them for off-label purposes, as they were not aware that these products were not to be used outside of approved procedures.

The company had allegedly promoted this product to surgeons for these off-label purposes, despite knowing the complications that could arise from them.

As a result, Medtronic is currently facing hundreds of Infuse Bone Graft lawsuits, which accuse the manufacturer of deliberately concealing these complications. The injuries reported include male infertility, bone and nerve damage, urinary problems, and even an increased risk of cancer. A majority of the patients who were injured had used the product for cervical spine surgery.

Patients who were injured from these products are encouraged to seek legal representation, as they might be eligible for compensation.