Medical product manufacturer, Medtronic, announced that it is paying $22 million to settle the claims of approximately 950 individuals involving Medtronic’s Infuse spinal surgery product. Moreover, Medtronic anticipates setting aside millions more to cover a larger number of claims that remain pending or will be filed in the future.
The Infuse product contained a drug known as BMP-2. BMP-2 is a genetically engineered bone morphogenetic protein-2. This product was approved by the United States Food and Drug Administration (“FDA”) in 2002. In conventional spinal fusion surgery, the surgeon normally harvests a small amount of bone from the patient’s hip and uses it in fusing the spine. Infuse and BMP-2 were considered to be an alternative to the traditional method of harvesting bone from the hip. The product turned out to be very popular with spine surgeons, leading to sales of approximately $800 million annually. To date, it is estimated that Infuse was implanted in more than 1 million people worldwide.
The Infuse litigation uncovered a conflict of interest between certain spine surgeons and the manufacturer. After the product was approved by the FDA, some prominent surgeons began authoring papers in medical journals, touting the benefits of the product, but failing to mention several potential, serious complications associated with the product. These complications included cancer, growth of unwanted bone, and sterility in men. When another group of doctors became concerned about the fact that these complications had been ignored by the authors of the articles, they began their own study and published the results in 2011 in the medical publication, Spine Journal. According to the study results, the risk of adverse events associated with BMP-2 is 10 to 50 times the original estimates that were reported in the industry-sponsored articles.
Further investigation revealed that Medtronic had paid $210 million in royalties and other payments to the doctors who had authored the initial articles touting the benefits of Infuse. The doctors who had authored or co-authored the initial articles were criticized by their peers for using medical literature to promote the product in exchange for receiving millions from Medtronic. Further investigation by the United States Senate Committee on Finance revealed that Medtronic’s employees, who were involved in marketing Infuse, secretly drafted and edited the favorable articles written by the surgeons who, in turn, were paid by Medtronic. The Senate Report concluded that Medtronic had overstated the benefits of the product and understated the risk of serious complications.
Approximately 750 cases remain pending throughout courts in the United States. Medtronic expects law firms to file another 2,000 to 3,000 cases in the future. If you were surgically implanted with Medtronic’s Infuse bone graft product and suffered complications such as cancer, growth of unwanted bone in the area or sterility, you may have a viable lawsuit against Medtronic. For more information, contact the medical product liability attorneys at Suthers & Harper.