The analyses of two long-awaited independent reviews of Medtronic Inc.’s Infuse bone growth product were published Monday in the Annals of Internal Medicine. The reports indicate that the product was associated with a small, increased risk of cancer, and that early published data on the trials highlighted favorable results while downplaying side effects. Infuse was approved by the U.S. Food and Drug Administration in 2002 to stimulate spinal bone growth as an alternative to traditional, and potentially painful and dangerous, bone harvesting. Once hailed as a major advance in spine surgery, Infuse came under scrutiny in 2011 after some spine experts and U.S. lawmakers raised questions about the safety of the product. The U.S. Senate and Department of Justice launched an investigation over concerns of off-label use and omissions of safety problems from its clinical trial data after the June 2011 issue of the Spine Journal,claimed that surgeons, who were paid tens of millions of dollars by Medtronic, failed to report serious complications, such as male sterility, increased risk of cancer, infections and worsened back and leg pain. In 2011, Medtronic agreed to two independent reviews of its trial data. Researchers at Oregon Health and Science University in Portland and Britain’s University of York were selected to carry out the reviews as part of the Yale University Open Data Access project. Researchers from the University of York determined that after two years, Infuse offered no significant reduction in pain and was associated with a low overall increased risk of cancer. The Oregon team concluded that Infuse worked no better in spinal fusion than bone harvested from a patient’s own body. They also found that, after two years, Infuse was associated with a low overall increased risk of cancer and that published trial data had underreported side effects while emphasizing the benefits. Medtronic sees its cooperation with the Infuse reviews as part of an industry trend moving toward open access to medical trial data and has funded an analysis of real-world usage of Infuse to determine its correlation to cancer risk. Those results will be presented at a meeting in the fall. In March 2012, Medtronic agreed to pay $85 million to settle a shareholder lawsuit alleging it of not revealing that as much as 82.5% of Infuse sales depend on supposed “off-label” uses. Since 2011, the company has reported a $272 million drop in product sales.

National Medtronic Lawsuit Attorneys

If you or someone you love has suffered a major medical complication because of Medtronic’s off-label use of Infuse bone graft, it is important to know that you are not alone. The litigation process will require a competent and aggressive attorney to secure your rights and get you the compensation you deserve. 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.