Off-label use of Medtronic Infuse Bone Graft has been associated with serious and potentially life threatening injuries, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage.
New York, New York (PRWEB) April 03, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs and medical devices, is currently evaluating potential lawsuit claims on behalf of individuals injured by off-label use of Medtronic Inc.'s Infuse Bone Graft product. According to the firm, off-label use of Infuse in the cervical spine or neck has been associated with serious and potentially life threatening injuries, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage. Other potential Medtronic Infuse injuries being investigated by Parker Waichman LLP include ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms; male sterility, retrograde ejaculation, or other uro-genital injuries; nerve injuries causing severe and chronic pain; and cancer.
On Friday, March 30, 2012 Medtronic announced that it had agreed to settle a shareholder class action lawsuit that alleged the company, its officers and directors made false and misleading statements regarding the profitability of its Infuse Bone Graft Product. According to a report from Newsinferno, plaintiffs alleged Medtronic illegally promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses. According to the complaint, Medtronic stock plunged 13 percent in November 2008, after it was forced to reveal that the U.S. Justice Department was investigating the alleged illegal off-label promotion of Infuse. In agreeing to settle the lawsuit, Medtronic did not admit to any wrongdoing. (Minneapolis Firefighters Relief Association v. Medtronic, 08-06324, U.S. District Court, District of Minnesota –Minneapolis)
According to Newsinferno, Medtronic Inc.'s Infuse Bone Graft is made from a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth. It was approved by the U.S. Food & Drug Administration (FDA) for use in one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries. However, The Wall Street Journal reported in September 2008 that at least three-quarters of the roughly 200 Infuse adverse events reported to the FDA at that time involved uses not approved by the agency. According to Public Health Watchdog, the FDA had issued a Public Health Notification in July of that year warning of the “life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion," an off-label use of such products. The notification stated that using rhBMP-2 in this manner can induce swelling of the neck and throat leading to compression of the airway or neurological structures. [online.wsj.com/article/SB122047307457096289.html; fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm]
Since that time, concerns over the safety of Infuse have only grown. Over the summer, The Spine Journal raised serious questions about the validity of the research that was used to gain FDA approval of Infuse. According to a critical analysis of 13 Medtronic sponsored clinical trials for Infuse published by the Journal, the studies failed to report serious complications, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution and worsened back and leg pain, in patients treated with the product. In November 2011, a study presented at the North American Spine Society meeting raised concerns about a possible association between high doses of rhBMP-2 and an increased risk of cancer. According to The New York Times, the study had serious implications for Infuse because the product is often administered at higher doses than recommended when it is used off-label. [spine.org/Pages/ConsumerHealth/NewsAndPublicRelations/NewsReleases/2011/pressrelease1_062811.aspx; nytimes.com/2011/11/04/health/research/amplify-by-medtronic-may-raise-chance-of-cancer-data-shows.html]
Attorney Gary P. Falkowitz further discusses potential Medtronic Infuse injuries, complications and side effects in this video produced by Parker Waichman LLP.
Parker Waichman LLP is currently offering free legal consultations to victims of Medtronic Infuse Bone Graft Injuries. If you or a loved one suffered a serious complication or injury after receiving Medtronic Infuse in an off-label procedure, please contact their office by visiting the firm's Medtronic Infuse injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Medtronic Infuse lawsuits and Parker Waichman LLP, please visit http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Herb Waichman, Partner