Medtronic Infuse Bone Graft Lawsuit

2002 2004 2008 2011 2012 INFUSE BONE GRAFT LAWSUIT TIMELINE FILED FOR APPROVAL JAN 2001 AND GRANTED EXPEDITED REVIEW STATUS Medtronic http://www.good-legal-advice.com/medtronic-infuse-bone-graft.htm FDA APPROVED INFUSE FOR JULY ONE TYPE OF SPINE SURGERY : APPROVEDI 0. -anterior approach lumbar fusion 2 Infuse is not approved for other types of spine surgeries MEDTRONIC PROMOTES NOT APPROVEDI OFF-LABEL USE OF THE INFUSE -lateral/posterior approach lumbar fusion surgeries 800MIL BONE GRAFT SYTEM : 4 -surgery on the neck or cervical spine Total sales of the INFUSE bone graft system 82.5% of these were off-label Medtronic pays 15 doctors over 60 million to promote off-label uses INFUSE INOT APPROVEDI COMPLICATIONS ARISE DUE TO 280 Three quarters of side effects due to the Reports INFUSE Bone Graft System off all side OFF-LABEL USE : effects are 38 Reports of life threatening side effects 3/4 reported from off-label uses SIDE EFFECTS INCLUDE: • CANCER • SEXUAL SIDE EFFECTS • UNCONTROLLED BONE GROWTH • NECK / THROAT SWELLING • NERVE INJURIES OFF-LABEL USES TOTAL 82% OF ALL USES IL || The FDA issued a warning on off-label Bone Graft use, that risks were associated with the use of the bone graft on the cervical spine. FDA records showed approximately 200 adverse events where patients experienced serious complications after the bone graft was used off-label. FDA ISSUES AN ADVISORY OF SERIOUS COMPLICATIONS 2 ASSOCIATED WITH INFUSE : DOJ OPENS AN INVESTIGATION NOV The DOJ began investigating Medtronic for illegally advertising 8. the Medtonic Infuse Bone Graft. 40MIL INTO OFF-LABEL USE OF INFUSE Medtronic settles two whistleblower lawsuits on Infuse for: JUL The Spine Journal said Medtronic-paid researchers failed to report complications from Infuse, including cancer, sterility in men, infec- tions, bone dissolution and worsened back and leg pain. These complications occurred in 10-50% of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010. THE SPINE JOURNAL PUBLISHES A STUDY ON MEDTRONIC COMPLICATIONS 1 The DOJ have closed their investigation of Medtronic Infuse Bone Graft. The investigation that Medtronic paid authors who wrote published studies of Infuse. The investigation also claimed that Medtronic failed to reveal that 85 percent of sales were dependent on off-label sales. DOJ CLOSES THE INVESTIGATION 2 MAY INTO OFF-LABEL USE OF INFUSE 2 d'OLIVEIRA & ASSOCIATES NOW If you believe that you or one of your loved ones have been injured by Medtronic INFUSE Bone Graft, you may want to speak with a personal injury attorney regarding a potential claim. An injury lawyer familiar with new developments in the investigation of Medtronic INFUSE Bone Graft may be able to help you make important personal and legal decisions. ACCEPTING INFUSE BONE GRAFT CASES d'Oliveira d'Oliveira & Associates, P.C. is working with some of the leading lawyers in the country who are handling these cases. & ASSOCIATES Please Call the law offices of d'Oliveira & Associates at 1-800-992-6878 A PERSONAL INJURY AND DISABILITY LAW FIRM or submit a contact form at dmlaw.com for a free legal consultation. O N N O