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Medtronic Infuse Off-Label Use Can Lead To Disability

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Medtronic’s Infuse bone graft product can lead to disability when used off-label, according to an emerging lawsuit. Physicians are free to prescribe medicines and devices off-label should they choose; however, it is illegal for drug and device makers to market any of their products off-label, or for uses not approved by the U.S. Food and Drug Administration (FDA). The lawsuit, just one of many, is only one of the issues Medtronic faces. U.S. senators are also questioning if the device maker touted its Infuse product off-label and if it also paid researchers to minimize Infuse’s side effects, said Healthcare Global Infuse, manufactured from the genetically engineered material rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth, was first approved by the FDA in 2002 for use in anterior approach lumbar fusion, a type of spinal surgery, as well as two types of dental procedures. It has long been known that Infuse is often used in procedures not approved by the FDA, which issued a warning in 2008 that Infuse and similar rhBMP-2 products caused significant problems when used off-label in cervical spine (neck) surgeries. According to Healthcare Global, Laurie DeNeui (46), a former school teacher, underwent neck surgery following a car accident. Although the surgery took place in 2005, prior to the FDA’s warning against using Infuse in this type of procedure, Infuse has never been approved for use in the neck. A hard-hitting off-label marketing campaign is believed responsible for the majority if Infuse surgeries being conducted for off-label procedures; some 85% of all procedures in which Infuse is involved, as a matter-of-fact, Healthcare Global pointed out. Today, DeNeui is permanently disabled. Now, three senators are asking Medtronic for answers concerning the financial relationships of its paid researchers who are being accused of minimizing Infuse side effects, such as dangerous throat swelling that has led to permanent injury and even death, said Healthcare Global. The senators are also looking for information about how Medronic conducted its post-market surveillance, which involves information on adverse reactions following surgery.In December, Medtronic settled a lawsuit with the U.S. Department of Justice lawsuit for $23.5 million over Infuse; Medtronic admitted no wrongdoing. Last summer, The Spine Journal raised serious concerns about the research used to achieve FDA approval of Infuse. The Journal noted a number of Medronic Infuse injuries such as ectopic or uncontrolled bone growth at or near surgery sites; chronic radiating leg or arm pain; male sterility, retrograde ejaculation, and other uro-genital injuries;

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nerve injuries that can lead to severe, unremitting pain; and even cancer. Some cervical spine surgeries involving Infuse have left patients with acute neck swelling several days after surgery, which have caused those patients permanent injury; in some cases, patients have died.

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