The Medtronic Infuse Gone Graft is a product used to stimulate bone growth after spinal fusion surgery. Side effects include inflamed tissue that can obstruct breathing, nerve damage, chronic pain, male sterility, cancer, infection, cyst formation, bone overgrowth, and growth of bone in inappropriate locations.
UPDATE: FDA Warning for Infuse Bone Graft Safety Risks in Kids
January 23, 2015 — New warnings from the FDA highlight the increased safety risks children face when they undergo spinal surgery with Infuse and other bone-graft substitutes. Click here to read more.
October 15, 2014 — The outcome of a class action lawsuit involving Medtronic’s Infuse bone graft could lead to thousands of personal injury claims. Click here to read more.
May 6, 2014 — Medtronic Inc. announced today that they will settle about 950 Infuse bone graft lawsuits for $22 million, and an additional $120-140 million will be set aside to resolve over 3,000 additional claims. Click here to read more.
March 5, 2014 — In a securities filing, Medtronic Inc. stated that about 1,000 people have filed 700 Infuse Bone Graft lawsuits in state and federal courts, and the litigation is expected to grow considerably in the next few years. Click here to read more.
June 19, 2013 — Medtronic has sponsored two studies conducted by independent researchers who have found that the Infuse bone-growth protein is no better than traditional bone graft surgery, but may increase the risk of side effects (such as cancer). Click here to read more.
December 20, 2012 — A Medtronic Infuse Bone Graft lawsuit has been filed in Virginia by a man who suffered disabling nerve damage in his spine after being implanted with the Infuse in 2003 for an “off-label” use.
October 15, 2012 — Researchers have found that 9.2% of spinal surgeries in children use the Medtronic Infuse or other BMP product from Medtronic. However, the FDA has never approved these products for use in children. Medtronic has never conducted studies to evaluate the safety or effectiveness of these products in children. Researchers are calling on surgeons to stop using the products in children until more studies are conducted. Click here to read more.
What’s the problem?
Medtronic, the company that produces the Infuse Bone Graft product, has faced lawsuits, congressional investigation, criticism from the FDA and the public for many reasons, including suppression of safety data and promoting their products for unapproved uses.
Although a doctor is legally allowed to use a medical product for uses that have not been approved by the FDA, the company that makes these devices is not allowed to promote or market its device for unapproved uses.
The FDA has only approved Infuse for use in patients diagnosed with Disk Degeneration Disease, acute tibia fractures, and two specific kinds of dental bone graft surgeries. The FDA has not approved Medtronic Infuse Bone Graft for neck surgery.
The off-label use of Infuse has led to numerous injury reports. The FDA has received more than 200 reports, and of these, more than 75% occurred when the Infuse product was being used off-label. In just four years, the FDA was made aware of 38 cases where people who were undergoing neck surgery received the Infuse bone graft. They subsequently suffered swelling of the neck tissue, which constricted their airways, requiring an emergency tracheotomy, feeding tube, and more surgery.
How does the Medtronic Infuse Bone Graft work?
The Infuse bone graft works by creating a “scaffolding” that encourages a person’s bones to grow, thus healing fractures and degeneration. The product consists of a sponge made from cow collagen, which is soaked in a protein that occurs naturally in the human body, known as “rhBMP-2.” When the sponge is placed on the person’s bones, the protein is released slowly over time, and the person’s bones begin to grow. Eventually, the sponge is reabsorbed by the body, so the person does not usually need additional surgery.
Congressional Investigation, Medtronic Infuse Off-Label Lawsuits, and Suppressed Safety Research
The U.S. Department of Justice initiated an investigation of Medtronic in November 2008 to determine whether the company illegally engaged in “off-label” promotion of the product for neck surgery. The FDA later warned physicians that using the product for neck surgery could have fatal complications.
In 2009, a second Department of Justice investigation began to determine whether Dr. Timothy R. Kuklo conducted medical research fraud, in which he may have published falsified research. The research claimed that Medtronic Infuse was better than traditional bone-grafting techniques.
Medtronic has also been criticized for suppressing important safety information that reflected negatively on the safety and efficacy of their product. A study had to be halted prematurely when volunteers experienced serious bone overgrowth; some required additional surgery to reduce bone growth. The company did not make the results of the study public for five years.
Infuse Bone Graft Class Action Lawyer
Over 3,000 lawsuits have been filed by people who were injured by the Infuse bone graft. These lawsuits are scattered throughout the United States and are not part of a centralized federal litigation or a class action lawsuit. Instead, they are individual lawsuits. Medtronic agreed to settle about 950 claims for $22 million in May 2014. They have also set aside at least $120 million to resolve 1,200 additional pending claims and thousands of lawsuits that are expected to be filed. If you are interested in joining this litigation, contact our law firm today.