Yesterday, Los Angeles Superior Court Judge Michael Paul Linfield ruled that a lawsuit regarding Medtronic INFUSE Bone Grafts will take those injured by the medical product one step closer to having their day in court. The decision allows the lawsuit filed by a woman who experienced debilitating problems after having a surgery in which a Medtronic INFUSE Bone Graft was used in her neck to proceed. The lawsuit accuses Medtronic of fraud and negligence. Medtronic was seeking to have the lawsuit dismissed on summary judgment.
“Countless individuals have been harmed by the off-label use of Medtronic INFUSE Bone Grafts, and this ruling is a victory for all of those who have experienced needless suffering,” states Michael Bomberger, a San Diego attorney with Estey Bomberger representing victims of the Medtronic bone graft product. “The court has determined that this case should move forward, clearing the way for other such lawsuits to follow.”
Medtronic INFUSE Bone Graft was originally developed, approved by the Food and Drug Administration and marketed to be used for procedures involving the lower lumbar area. Subsequently, Medtronic marketed the product for use in the human neck. The practice of marketing a product for a use other than its original purpose is called off-label marketing. Medtronic also trained medical staffs on surgical procedures using the INFUSE Bone Graft in the neck. The company also allegedly paid doctors millions of dollars to write articles for medical journals about the off-label use of the product.
All of this was done without FDA approval of the product for surgeries of the neck and cervical spine. The FDA stated that serious complications could result from swelling of the neck and throat tissue, which could lead to airway construction and compression of the neurological structures. Other side effects associated with INFUSE Bone Graft off-label use include uncontrolled bone growth, ectopic bone growth, inflammatory cyst formation, cancer, paralysis, difficulty swallowing and difficulty speaking.
“Many people have suffered severe, chronic and even life threatening conditions from the inappropriate use of the INFUSE Bone Graft, and Medtronic must be held responsible,” states Bomberger. “We are hoping to educate patients who had this product thrust upon them how to deal with the horrible results.”
Estey Bomberger has set up a website and a Facebook page with more information specifically about the Medtronic INFUSE Bone Graft, including lawsuit options at www.medtronicbonegraftlawsuits.com or http://www.facebook.com/medtronicbonegraftlawsuits. Both sites offer information about the dangers of the device and resources for individuals and family members who have been harmed.