A lawsuit has been filed against Swiss device maker Synthes Inc. and some of its executives by the families of two elderly women who have died during clinical trials for a bone cement that was being tested for spinal surgery. Both of the decedents named in the lawsuit are women in their 80s who died on the operating table during a procedure in which Norian XR was injected into their spines.
The lawsuit, which was filed in Contra Costa County California Superior Court, alleges that a clinical trial for Norian XR Bone Cement was illegal, and constituted an off-label use of the product.
But, this is not the first we have heard of the controversy surrounding this product. As previously report, Norian XR was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. Synthes and its Norian unit agreed last year to plead guilty to federal charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials using the bone cement in a type of spinal procedure.
Synthes used the bone cement despite FDA warnings that such use was highly dangerous. According to the indictment, preliminary studies had shown that Synthes bone cement could react with human blood, causing blood clots. Later studies of the bone cement in a pig caused blood clots that became lodged in the lungs. However, Synthes apparently disregarded this knowledge and performed unauthorized clinical trials on human patients.[related_posts limit=”5″]