Medtronic Infuse Lawsuit Claims Off-Label Use Caused Uncontrolled Bone GrowthSep 20, 2011 | Parker Waichman LLP
Jennifer English of Lake Worth, Florida, claims Medtronic's Infuse Bone Growth product left her in severe pain, and forced her to undergo two surgeries, including one emergency procedure. According to a lawsuit she filed this week, English received Infuse during a posterior-approach lumbar spine surgery, an off-label use of Infuse.
Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery, however, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complications.
English claims Infuse caused her to develop ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain. Her complaint alleges that due to Infuse, English suffers continuous pain in her back and legs from ordinary everyday activities, such as sitting or standing for extended periods of time.
Over the summer, Infuse was linked to more serious side effects when The Spine Journal published an entire issue dedicated to (rhBMP-2). One of the articles included in the issue asserted that in 13 Medtronic-funded studies conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles. According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.
At the time, Larry Biegelsen, an analyst with Wells Fargo told Forbes Magazine the issues uncovered by The Spine Journal could lead to a wave of lawsuits against Medtronic.