Here are nine things to know:
1. In April, a New Jersey resident filed a filed a product liability and negligence lawsuit against Medtronic.
2. The lawsuit alleges that Medtronic improperly marketed the product for use in patients receiving certain cervical and spinal surgeries that were not previously studied or researched, among other allegations.
3. The Infuse Bone Graft includes rhBMP-2, a recombinant bone morphogenic protein, to achieve a fusion. It was designed to provide an alternative to the traditional method of grafting bone.
4. However, the product cannot be used in all types of spine surgery.
5. In this specific case, the plaintiff underwent a posterior lumbar fusion procedure in which the Infuse product was used.
6. Around 10 years after the procedure, the plaintiff was diagnosed with systemic tumors in the heart and spine, which were allegedly caused by the bone graft device.
7. The lawsuit also accuses Medtronic of not including adequate warnings regarding known or potential harm caused by the product.
8. This is not the first time the Infuse product has been embroiled in controversy. In June 2014, insurance giant Humana sued Medtronic over the device company’s promotion of spinal biologic Infuse.
9. Additionally, Medtronic agreed to pay $22 million to settle product liability claims related to Infuse Bone Graft in 2014.
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