Infuse, Medtronic’s controversial bone growth product that has been the center of scientific and legal controversies, is the subject of 700 lawsuits involved over 1,000 patients. MedPage Today reports that the company, which is also being investigated by several states over its marketing and sales practices, may be facing even more lawsuits in the future. In addition to the 700 lawsuits filed at the end of its fiscal third quarter of 2014, Medtronic has received document requests from several governmental agencies. State attorneys general in Massachusetts, California, Oregon, Illinois and Washington have all sent subpoenas as part of civil investigations. Infuse is a bone graft product used in spine surgeries and is made up of bone morphogenetic protein-2 (BMP-2).
Richard Deyo, MD, professor of family medicine at Oregon Health & Science University, said to MedPage Today that the lawsuits reminded him of other products that were first marketed heavily but then found to harmful, like Merck’s COX-2 inhibitor, rofecoxib (Vioxx) and Johnson and Johnson’s DePuy Synthes artificial hip.
Deyo wasn’t the only expert to express skepticism about Infuse. Eugene Carragee, MD, head of spine surgery at Stanford University and editor-in-chief of the Spine Journal, told to MedPage Today that the lawsuits represent “a whole lot of people” who received Infuse with little evidence to prove that it was better than traditional spinal fusion methods. “This is a snowballing effect,” he said.
The Spine Journal sparked safety and ethical concerns when it published its own review in 2011. The review was written by a group of spine experts who found that Infuse is linked to a number of serious complications. They raised questions about industry-funded research, pointing out that none of these side effects was mentioned in Medtronic-funded studies promoting the product.
Things got worse for Medtronic in 2012, when the U.S. Senate Committee on Finance released a condemning report concluding that Medtronic employees secretly helped write and edit positive Infuse studies. Medtronic paid $210 million to a group of 13 doctors and two corporations associated with doctors over the course of 15 years. One doctor alone, University of Wisconsin orthopedic surgeon Thomas Zdeblick, received $34 million. Zdeblick helped co-author a number of Infuse papers.
Two independent reports in 2013 found that Infuse was not more beneficial than conventional spine surgery. Furthermore, the reports questioned its link to side effects such as cancer and male sterility. Infuse has also been linked to excess bone growth.
According to MedPage Today, most people received Infuse off-label, or in ways not approved by the U.S. Food and Drug Administration (FDA); as much as 85% of Infuse has been used off-label. Dan Spengler, MD, a Vanderbilty University orthopedic surgeon, suspects that most of the lawsuits involve excess bone growth claims from off-label procedures.”When you start using a product 85% off label, there are going to be problems,” Spengler said to MedPage Today.