Several states are now investigating the sales and marketing practices involving Infuse. Medtronic is being sued by over 1,000 patients who received its Infuse bone graft product. Additionally, several states are now investigating the sales and marketing practices involving Infuse. The bone morphogenetic protein-2 (BMP-2) product is used to stimulate bone growth in spine surgery, but for a decade it has been the center of scientific and legal controversy.
The company said in a securities filing that it was facing 700 lawsuits involving about 1,000 people at the end of its fiscal third quarter of 2014 and that more cases could be on the way. The cases have been filed in both state and federal courts. Medtronic also said that it had received subpoenas from a number of government bodies; civil investigations from state attorneys general in Massachusetts, California, Oregon, Illinois and Washington all sent document requests.
Professor of family medicine at Oregon Health & Science University Richard Deyo, MD, said to MedPage Today that the cases reminded him of products like Merck’s COX-2 inhibitor, rofecoxib (Vioxx) and Johnson and Johnson’s DePuy Synthes artificial hip, which were marketed heavily at first and then found later to be harmful.
There has been suspicion about Infuse for 10 years
There has been suspicion about Infuse for 10 years, but concerns became heightened in 2011 when the Spine Journal published a critical review of the product. The group of spine experts who wrote the review noted that Infuse is linked to a number of serious side effects, none of which are mentioned in the Medtronic-funded studies promoting the product.
Eugene Carragee, MD, head of spine surgery at Stanford University and editor-in-chief of the Spine Journal, said to MedPage Today that the lawsuits represent “a whole lot of people” who received a product that was never proven to be better than traditional spinal fusion methods. “This is a snowballing effect,” said Carragee.
The Spine Journal review helped spark a federal investigation. Medtronic paid over $210 million to a group of 13 doctors and two corporations associated with doctors over the course of 15 years; $34 million alone was paid to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who helped co-author a number of Infuse papers. In 2012, the U.S. Senate Committee on Finance released a report concluding that Medtronic employees secretly helped write and edit the published studies promoting Infuse.
Two independent reports in 2013 found that there was little evidence
Two independent reports in 2013 found that there was little evidence showing that Infuse was any better than conventional spine surgery. Furthermore, the reports raised questions about whether or not the product was associated with complications such as cancer and male sterility. Infuse has also been associated with unwanted bone growth.
The majority of people received Infuse in ways not approved by the U.S. Food and Drug Administration (FDA), which is another concerning factor. According to MedPage Today, as much as 85% of Infuse has been used in an off-label manner. Dan Spengler, MD, a Vanderbilt University orthopedic surgeon, said “When you start using a product 85% off label, there are going to be problems.” Spengler also said he thinks that many of the Infuse lawsuits were probably from patients who suffered from unwanted bone growth after an off-label Infuse procedure.