Medical Malpractice Lawsuit Involves Medtronic Infuse

Cincinnati, OHAlmost 100 plaintiffs have filed a lawsuit against a doctor and Medtronic, alleging the patients underwent medically unnecessary surgery to have a Medtronic bone graft implanted. The plaintiffs allege in the Medtronic lawsuit that the surgeries were not only medically unnecessary, but also experimental, and put them at risk of suffering complications.

Courthouse News Service (3/26/13) reports that Dr. Abubakar Atiq Durrani, along with other plaintiffs, including Medtronic Sofamor Danek, faces lawsuits on behalf of 88 patients who say they were given unnecessary medical procedures using Medtronic medical devices, specifically the Infuse Bone Graft, also known as BMP-2. The lawsuit alleges Durrani is a paid consultant for Medtronic, and further alleges that during the surgeries, the Infuse was implanted for off-label uses without the patients’ consent. Finally, they allege, the doctor falsified records so he would be paid for the surgeries.

Regarding Medtronic, plaintiffs allege the company falsely marketed the medical device as safe and approved for use in cervical and thoracic spines when it was not approved for such uses. The lawsuit claims side effects associated with the Infuse Bone Graft include cancer, spinal stenosis, pain and problems breathing. Complications can reportedly arise within two weeks of surgery.

This is not the first time a doctor has faced serious allegations concerning Medtronic Infuse. In 2009, The Wall Street Journal reported on Dr. Timothy R. Kuklo, who reportedly forged the signatures of co-authors on a study he performed regarding Medtronic Infuse and also used data based on “falsified information.” The study was published in 2008 in the Journal of Bone & Joint Surgery but was retracted in 2009.

The Wall Street Journal (5/19/9) notes that Dr. Kuklo is a Medtronic consultant, but the company said he was not a consultant when the study was conducted.

The Medtronic Infuse Bone Graft is used to stimulate bone growth. It was approved in 2002 for limited use in the lumbar spine, but not for the cervical or thoracic spine.

Lawsuits have been filed against Medtronic, alleging patients were harmed by the use of the bone graft.