 These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine.According to the indictment, before the marketing program began, pilot studies showed the company that the bone cement reacted chemically with human blood in a test tube to cause blood clots.The research also showed, in a pig, that leakage of small amounts of Norian XR from the spine into the blood caused clots, which become lodged in the lungs.