New York, New York (PRWEB) June 07, 2012
Parker Waichman LLP, national law firm dedicated to protecting the rights of victims injured by defective medical devices, is providing free case evaluations nationwide to people who suffered side effects as a result of Medtronic Infuse Bone Graft. Last summer, a study published in The Spine Journal linked Infuse to life-threatening complications, including:
- Respiratory Problems (including difficulty breathing, swallowing and speaking)
- Ectopic or Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
The essential component of Medtronic Infuse is rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), a synthetic protein that fuels bone growth. The rhBMP-2 is placed inside a small metal cylinder, called the LT-CAGE Lumbar Tapered Fusion Device. As it turns out, this small device can lead to bigger problems.
Infuse’s notoriety is rooted in its off-label use. When the device was originally approved by the U.S. Food and Drug Administration (FDA) in 2002, it was only approved for anterior approach lumbar fusion; the device was intended for surgery performed through the front of the body on the lower lumbar to upper sacral region of the spine (L4 to S1). In 2007, Infuse also gained clearance for certain types of dental surgery in 2007. Using the device in any other manner constitutes as “off-label” use. Physicians are allowed to use products off-label as they see fit, but it is illegal for manufacturers to market the product for unapproved procedures. In 2008, the U.S. Department of Justice (DOJ) began investigation Medtronic over reports of off-label marketing. [http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083423.htm
According to a shareholder lawsuit filed by the Minneapolis Firefighters Relief Association, Medtronic allegedly promoted Infuse for off-label procedures and failed to disclose that a large portion of its revenue is generated through such uses. The lawsuit alleged that Medtronic’s actions falsely inflated its stock value, noting a 13 percent drop in stocks when news of the DOJ investigation became public. According to Reuters, Medtronic agreed to settle the lawsuit this March without admitting any wrongdoing. [reuters.com/article/2012/03/30/us-medtronic-settlement-idUSBRE82T1A920120330](Minneapolis Firefighters Relief Association v. Medtronic, 08-06324, U.S. District Court, District of Minnesota –Minneapolis)
In 2008, the Wall Street Journal stated that at least three-quarters of the roughly 200 adverse events reported to the FDA were linked to unapproved uses such as cervical spine surgery. The alarming developments prompted the FDA to release a Public Health Notification that July, which warned that using Infuse in the cervical spine could result in “life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion”. The agency also cautioned that off-label use of Infuse could lead to swelling of the neck and throat, subsequently compressing the airway and neurological structures. [online.wsj.com/article/SB122047307457096289.html; fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm]
Infuse became an even bigger safety concern last June, when The Spine Journal questioned the credibility of the research used to demonstrate the device’s safety. According to the publication, researchers omitted complications such as cancer, retrograde ejaculation, male sterility, infections, bone dissolution, and worsened back and leg pain. The link to cancer was strengthened in November, when a study presented at the North American Spine Society found a significant increased risk with high doses of rhBMP-2. The New York Times points out that the findings may reflect real-world consequences, as Infuse is often given in higher doses in off-label procedures. [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]
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
Gary Falkowitz, Managing Attorney