Approximately one hundred patients have filed a federal lawsuit against Medtronic, the maker of Infuse Bone Graft and against a spinal surgeon. The former patients claim that Dr. Abubakar Atiq Durrani “performed medically unnecessary, experimental spine surgeries… using falsely and improperly marketed Medtronic medical devices and drugs.” The company is already facing lawsuits filed previously by people who have been injured by Infuse.
Infuse was once praised as an advancement in medicine; however, this synthetic bone morphogenetic protein (BMP-2) now finds itself at the center of controversy. It is intended to help regrow damaged bone if injected into the spine during surgery, but more recently it has been shown to cause many serious side effects. These side effects include degeneration of bone tissue, unwanted bone in the spinal canal, severe pain and growth of cancerous cells.
The U.S. Food and Drug Administration (FDA) only approved the product for use in the lower back using a technique where the surgeon operates on the spine through the abdomen and only on patients over the age of twenty-one.
However, the latest lawsuit claims that the defendants “knowingly and falsely marketed” Infuse as safe for use in cervical and thoracic spine surgeries despite the FDA’s warning against such use. Also, three of the new plaintiffs are minors.
Medtronic Under Scrutiny
This is not the first time Medtronic has come under scrutiny for its Infuse Bone Graft. In October 2012, it was revealed by a U.S. Senate Finance Committee investigation that certain authors of studies reporting on the safety of Infuse had been paid more than $200 million by Medtronic. The investigation revealed that one independent reviewer had been paid almost $8 million. In a statement about the investigation, Sen. Max Baucus, D-Mont. said, “Patients are at serious risk when companies distort the facts the way Medtronic has.”
In 2011, Dr. Eugene J. Carragee and colleagues published a review in The Spine Journal accusing Medtronic of purposely hiding severe complications associated with Infuse. Medtronic denies that BMP products, such as Infuse, can inflame surrounding tissue and bone, leading to cancer and are associated with a 43 percent greater rate of overall complications.
In 2006, the U.S. Department of Justice filed civil action against Medtronic for paying doctors incentives to use Infuse. The company reportedly made false consulting agreements with doctors and paid for expensive vacations. Medtronic paid $40 million to settle.
National Medtronic Lawsuit Attorneys
If you or someone you love has suffered a major complication because of a Medtronic medical device, it is important to know that you are not alone. To learn more about filing a Medtronic lawsuit call the experienced Medtronic lawsuit lawyers at Phillips Law Firm today. Call us at 1-800-708-6000. Our national Medtronic lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation.by