Medtronic, the maker of the INFUSE Bone Graft, has come under fire in recent years for complications caused by their product and for possibly covering up evidence of its risks. A bone graft is material used to help a bone heal from damage or disease. Medtronic’s product was designed to avoid the need for a double surgery: one to retrieve donor bone tissue from the patient and the second to use that tissue as a graft.
The INFUSE Bone Graft is made from synthetic and biological materials combined to heal degenerative disc disease. On the market since 2002, adverse event reports and evidence from studies have shown that the graft can cause infections, nerve pain, and even cancer in some patients. Those impacted by a Medtronic graft have filed lawsuits against the company alleging wrongdoing in marketing and in hiding data on risks.
The INFUSE Bone Graft
A bone graft is any material that can be used to repair bone. Grafting is done to help speed the healing of a fractured bone that isn’t healing well enough naturally; to heal a joint damaged by disease; and to help regenerate new bone tissue in cases where disease, an infection, or an injury have resulted in lost bone mass. Bone grafts are like scaffolding material, on which new bone tissue will naturally grow.
Medtronic’s INFUSE product includes a sponge-like material made from cow collagen. This acts like a scaffold. It also includes an engineered protein that stimulates the growth of new bone tissue and the healing of damaged bone. The protein is based on a human protein found naturally in bone and is called rhBMP-2.
With the protein to trigger new bone growth and the scaffolding made out of cow tissue, INFUSE Bone Grafts are supposed to be safer for patients because they do not require an extra surgery to retrieve bone tissue. In other bone graft procedures, the surgeon would first harvest a piece of healthy bone tissue from somewhere else in the body and then use it in the second surgery to make the graft. By eliminating the need for the first surgery, the INFUSE Bone Graft is supposed to reduce the incidence of surgical complications.
Approved and Off-Label Uses for INFUSE
The U.S. Food and Drug Administration approved INFUSE Bone Grafts for use in treating degenerative disc disease of the lower lumbar region in 2002. Degenerative disc disease is damage in one or more discs of the spine, which causes pain. These bones don’t heal well on their own because there isn’t much blood flow to the discs and grafts can help speed healing and new bone growth. The FDA approved INFUSE only for repairs in the lower back region.
One source of lawsuits brought by individuals against Medtronic is for off-label promotion of INFUSE Bone Grafts. Doctors may use their professional discretion to use medications and devices for non-approved uses, but the manufacturing company is not allowed to promote them off-label. The U.S. Department of Justice investigated Medtronic and found that around 80 percent of INFUSE Bone Grafts were used in off-label procedures. There was not enough evidence to prove Medtronic promoted the bone grafts for these purposes and there were no charges.
Individuals have suffered, though, because of these off-label uses. The FDA’s adverse event reporting system has seen reports of leg and back pain, graft failures, and even breathing difficulties caused by off-label graft uses. In 2008 the FDA issued a warning that no one should be using INFUSE Bone Grafts for procedures in the upper part of the spine. Bad reactions to the protein in the graft have caused swelling in the neck and throat that led to difficulty breathing and emergency medical treatment.
Complications and INFUSE Bone Graft Lawsuits
Off-label uses have not been the only issues with these bone grafts that spurred lawsuits brought by harmed individuals. Reports of complications associated with the graft and the procedure to implant it include bone fractures, allergic reactions, paralysis, infections, abnormal growth in the bone, pain, tissue damage, nerve damage, spinal cord damage, and neurological problems. Some patients have even reported the graft coming loose, breaking, bending, or failing in some way that required additional surgery to fix.
Hiding Trial Data
Lawsuits against Medtronic may be strengthened by mounting evidence that the company hid or downplayed risks of using the INFUSE Bone Graft that were discovered during clinical trials. One expert uncovered the cover up by reviewing the FDA’s adverse events reporting system and studies and trial information on INFUSE Bone Grafts. Some evidence was found that Medtronic may have given money, in the form of kickbacks, royalties, and consulting payments, to researchers in the early trials in order to keep details about side effects hidden.
After experts reviewed all the information available about the safety of INFUSE Bone Grafts they concluded that the reported risks were much higher in reality. The risk of complications was seen to be between ten and 50 times higher than what Medtronic reported. Additionally, the U.S. Senate during hearings and investigations also concluded that Medtronic’s marketing department edited journal articles to downplay the possible side effects.
The expert findings were published and the Senate Finance Committee investigation has been made public, and yet no legal action has been taken against the company by the government. Those individuals who were harmed by INFUSE Bone Grafts are taking advantage of this information as fuel for lawsuits.
Individual Lawsuits Settled
In 2014 Medtronic agreed to settle several cases of product liability claims against the INFUSE Bone Graft. The company agreed to pay out approximately $22 million to 950 people who brought suits to court. Medtronic has not, however, admitted to any liability or wrongdoing. There are still more than 1,000 cases yet to be resolved. Medtronic has acknowledged that even more suits are likely to be filed and has announced that it expects to end up paying up to $100 million additionally for close to 4,000 more suits.
More Lawsuits to Come
Medtronic may not be officially admitting to doing anything wrong, but the company knows that more lawsuits are coming. If you were harmed because of an implanted INFUSE Bone Graft, you could be a part of a future settlement.
Individuals like you are suing because they believe that Medtronic is guilty of failure to warn patients of side effects and complications, of making a product that is defective, of fraud for inaccurately representing risks and benefits, and for actively concealing side effects of a medical product. Speak with a lawyer to decide if you have a case and to help you figure out what to do next to seek compensation.