Trasylol Removed From The Market:Suspected in Hundreds of Deaths

On May 14, 2008, the manufacturer of Trasylol officially pulled all remaining supplies of the blood clotting drug from the market. This drug, manufactured by Bayer (AG) is typically used by surgeons to control bleeding during heart surgery. Unfortunately, in a major study published in the New England Journal of Medicine, it was reported that the use of this drug significantly raised the risk of death for patients who used this product as opposed to other similar products on the market. A study conducted by a Canadian group found that patients that had been given Trasylol had a fifty percent (50%) higher death rate than patients who were given alternative drugs.
Bayer (AG) originally suspended the sales of this drug in November of 2007 under pressure from the Food and Drug Administration. Patients who were undergoing heart bypass, valve replacement or other cardiac procedures were more likely to die than others who had received competing blood clotting drugs available on the market. Most the deaths that have been reported have been due to either kidney failure, heart failure, heart attacks or strokes following the surgery. In short, it has been well established that this drug is associated with severe complications attendant to heart surgery including renal failure. What is most troubling about this product is that for years it appears that the manufacturer was aware that it was dangerous but nonetheless concealed these known dangers from the public.
In a February 2008 report by the Television news program Sixty Minutes, it was reported that Bayer had been aware for decades of the safety concerns associated with this drug. Sixty Minutes reported that Bayer had conducted its own internal study to evaluate the risk of patient deaths from Trasylol and had found that there was an elevated risk of death and acute kidney failure associated with its use. Nonetheless, when the FDA conducted a safety review of this drug in 2006, according to the Sixty Minute report, Bayer did not reveal the study to the FDA and successfully lobbied the FDA to keep Trasylol on the market. Allegedly, over a year passed before the FDA again reviewed the adverse effects of this drug and ordered it to be recalled it from the market.
It is apparent from the information available in the public domain that Bayer should have recalled this product earlier than it did. The law in most states, including Georgia, provides that individuals seriously injured due to defective prescription drugs are entitled to compensation for their injuries based on either negligence by the manufacturer and/or a failure to warn of known dangers. Here, the manufacturer appears to have known of dangers that were not reported to the public while it continued to promote the implied safety and efficacy of the product. Given the information which has been developed, there is reason to believe that those who have suffered from the use of this product will have a viable legal claim against Bayer (AG).
If you or a loved one have suffered a serious injury following surgery in which you were given Trasylol or if you were the relative of a patient that has died after receiving this drug, you should contact an attorney for an immediate consultation in order to explore your legal rights and remedies.