Parker Waichman LLP Weighs-In on Lawsuit Alleging Medtronic INFUSE was Used in Numerous Experimental Procedures without Patients’ Consent
(PRWEB) March 28, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is weighing in on a lawsuit against a surgeon and Medtronic over its INFUSE Bone Graft. On March 26, 2013, Courthouse News Service reported that a lawsuit had been filed on behalf of 88 patients, including three minors, who allege that Dr. Abubakar Atiq Durrani of the Center for Advanced Spine Technologies performed unnecessary procedures with Medtronic INFUSE Bone Graft to sell the allegedly defective product. The case was filed on March 22nd in the U.S. District Court for the Southern District of Ohio (Case No. 1:13-cv-00202-SSB). According to Parker Waichman LLP, Medtronic INFUSE Bone Graft is a controversial product that can place patients at risk for serious injuries, particularly when used off-label.
“Medtronic INFUSE is a product that is supposed to help create a bone-like substance in the spine. It is only approved for certain types of surgeries in the lower spine and two types of dental procedures. It is not approved for surgeries on the cervical spine nor is it approved for use on children.” says Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “Unfortunately, it appears that most procedures using INFUSE are off-label. Moreover, the use of this product may be associated with serious complications, such as excessive bone growth, male sterility and significant nerve damage.” Parker Waichman LLP offers free legal advice to patients who suffered alleged injuries that may have been caused by Medtronic INFUSE Bone Graft.
An off-label procedure is when a medical product is used in a manner not approved by the U.S. Food and Drug Administration (FDA). According to Courthouse News Service, the lawsuit alleges that Dr. Durrani used INFUSE in the cervical spine, thoracic spine, and in minors. The BMP-2 product sold as INFUSE is not approved for any of these uses and these “experimental” procedures were performed without consent, the lawsuit alleges. The suit alleges that Dr. Durrani, a paid consultant for Medtronic, ignored warnings from the FDA about the off-label use of INFUSE. In 2008, the agency warned that using INFUSE off-label in the cervical spine may lead to life-threatening complications, including the swelling of the neck and throat.
According to Courthouse News Service, the lawsuit alleges that the FDA and independent scientists have connected INFUSE to a number of potential complications, including:
Ectopic bone growth
Throat and breathing constriction
INFUSE came under fire in June 2011, when the Spine Journal dedicated an entire issue to highlight serious complications associated with INFUSE, Mass Device reports. The journal states that using INFUSE off-label can lead to a 5-fold increased risk of cancer in 3 years. Researchers also questioned the integrity of Medtronic-funded studies promoting INFUSE, pointing out that those researchers had financial ties to the company. The publication spurred controversy over INFUSE, leading to investigations over the product; last October a U.S. Senate report stated that Medtronic promoted INFUSE for off-label uses, paid millions to manipulate studies in their favor, and tried to hide reports of injuries.
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, please contact their office by visiting the firm's Medtronic INFUSE injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).