In a special issue of the medical publication, The Spine Journal, nine different spine specialists publicly denied the validity of the studies performed by the Medtronic-financed researchers in that report. The specialists claimed that the serious adverse side effects associated with Infuse had been grossly understated in those studies. The release of the publication spurred a Senate Finance Committee inquiry into Medtronic’s Infuse. Infuse is a spinal treatment sold by Medtronic generally used to reduce back pain. It uses bio-engineered proteins to fuse spinal vertebrae. According to the Committee’s report, officials at Medtronic edited studies about Infuse by outside researchers. During their investigation, the Committee reviewed internal Medtronic documents and found that the company paid almost $210 million between 1996 and 2010 in royalties, consulting fees and other payments to physicians involved in conducting outside research on Infuse. Company officials are also accused of adding to the studies’ claims that their product was superior to a competitor’s product. Internal documents obtained from Medtronic seem to indicate that company officials had inserted language into some reports that claimed Infuse was superior to a bone graft. The company released a statement saying, “Medtronic does not agree with many of the findings” in the report. Medtronic stated that the payments to researchers had largely been royalty fees that were in line with industry practice. The company also said that the studies in question accurately portray the risks involved in the treatment process and deny that its employees had improperly influenced or added to any of the medical journal reports.
Risks Associated with Infuse
Medtronic has long been accused by critics of downplaying the risks of Infuse by embellishing the benefits. Infuse is associated with many serious side effects, including infection, male sterility, bone and nerve injury, urinary problems and possibly an increased risk of cancer.
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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.
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