Recently in April 2015, a New Jersey plaintiff filed a product liability and negligence lawsuit against the Minnesota-based company Medtronic, Inc. The lawsuit was regarding their unsafe and unlawful promotion of the Infuse bone graft product used in complex spinal surgery.
This lawsuit alleges that Medtronic did not research or study the product during the FDA’s approval process, yet still marketed the bone graft product for use in patients receiving certain cervical and spinal surgeries. The practice, known as “off-label marketing and use,” exposes patients like the plaintiff to significantly increased risks of side effects, including cancer.
Use of Off-Label Infuse Bone Graft
The Infuse bone graft was designed as an alternative to the traditional method of grafting bone. The product contains several components that are intended to spur the regrowth of bone in areas of the degenerating spine. If used in accordance with the FDA’s approval guidelines, bone morphogenic proteins are able to heal damaged bones.
Unfortunately, the process isn’t for everyone. The product is not approved for “posterior lumbar fusion surgery,” which is a type of spinal fusion that is done through an incision placed along the backside of the spine. Currently the only method approved by the FDA for patients implanted with the Infuse bone graft multi-component system is the anterior approach, which is through the patient’s abdomen.
Pain and Tumor Growth
In October 2004, the plaintiff underwent posterior lumbar fusion in New Jersey. The surgeon utilized the Infuse product to treat her degenerative disc condition. The plaintiff then alleges she was never informed that the posterior technique was not approved for patients receiving the bone graft and was also not informed of the risks involved.
The plaintiff alleges minimal relief from pain of her disc disorder and in March 2014, she was diagnosed with systemic tumors in her heart and spine, which are allegedly caused by the implantation of the bones graft device.
The Infuse bone graft lawsuit alleges the unlawful marketing and promotion techniques utilized by Medtronic to elevate its product to the top of the spinal fusion market. Medtronic also failed to include adequate warnings regarding known harm attributable to the bone graft system. This lawsuit should amount to an allocation of liability against Medtronic in amount necessary to fully compensate for injuries.
If you or a loved one has had a Infuse bone graft and developed a side effect as a result of posterior lumbar fusion, you deserve compensation. At Balkin Law, we fight for your rights. Don’t be a silent victim. Contact us today for a free case evaluation by emailing us here or calling us at 888-751-5908.