Infuse Bone Graft Lawsuit Filed in New Jersey District Court
On April 14, 2015, a New Jersey plaintiff filed a product liability and negligence lawsuit against Minnesota-based Medtronic, Inc. regarding its unsafe and unlawful promotion of the Infuse bone graft product used in complex spinal surgery.
The lawsuit alleges, among other accusations, that Medtronic improperly marketed the bone graft product for use in patients receiving certain cervical and spinal surgeries that were not studied or researched during the FDA’s approval process.
Accordingly, this practice amounts to “off-label marketing and use,” and exposes patients like the plaintiff to significantly increased risks of serious side effects, including cancer.
Off-label use of Infuse bone graft
Medtronic’s Infuse bone graft was designed and created as an alternative to the traditional method of grafting bone – harvesting it from other areas of the body. The product contains several components that, when used together, are intended to spur the re-growth of bone in areas of the spine undergoing degeneration. When used properly and in accordance with the FDA’s approval guidelines, bone morphogenic proteins are able to actually heal damaged bones through the use of genetically-engineered cells known as rh-BMG-2.
However, the process isn’t for everyone. The Infuse bone graft process is risky, and it is not intended for use in every cognizable type of spinal repair surgery. Notably, and in the plaintiff’s case, the product is not approved for “posterior lumbar fusion surgery,” which is a type of spinal fusion accomplished through an incision placed along the backside of the spine. An alternative method, known as the anterior approach, requires the surgeon to approach the damage spinal area from the patient’s abdomen, and is the only method permitted by the FDA for patients implanted with the Infuse bone graft multi-component system.
Plaintiff experiences pain and tumor growth
On or about October 14, 2004, the plaintiff underwent a posterior lumbar fusion procedure in a New Jersey hospital wherein the surgeon utilized the Infuse product to treat her degenerative disc condition. The plaintiff alleges she was never informed that the posterior technique was not approved for patients receiving the bone graft, and she was not aware that she was at an increased risk of harm or complication at the time of the surgery.
Since, her surgery, the plaintiff alleges minimal relief from the pain of her disc disorder. Moreover, the plaintiff was diagnosed in March, 2014 with systemic tumors in her heart and spine – which are allegedly caused by the implantation of the bone graft device. Accordingly, the plaintiff has limited her cause of action to one claim: product liability.
More specifically, the Infuse bone graft lawsuit alleges that the unlawful marketing and promotion techniques utilized by Medtronic to elevate its product to the top of the spinal fusion market – as well as the failure by Medtronic to include adequate warnings regarding known or foreseeable harm attributable to the bone graft system – should amount to an allocation of liability against Medtronic in amount necessary to fully compensate her for her injuries.
- UMM.EDU, Spinal fusion, http://umm.edu/programs/spine/health/guides/lumbar-fusion
- FDA.gov, FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm