Trasylol Lawsuit News | Aprotinin Heart Surgery Drugs Renal Failure

Bayer HealthCare Pharmaceuticals, Inc. has been facing an increasing number of patients who have filed a Trasylol lawsuit over its Aprotinin heart surgery drug. The lawsuits allege that Bayer is liable for manufacturing and failing to warn Trasylol users of its dangerous side effects. The Trasylol lawsuits allege that Bayer knew Trasylol increases patients’ risk of death, but the drug company failed to disclose its knowledge to the FDA.

On November 5, 2007, the FDA requested Bayer Pharmaceuticals Corp suspend the marketing of the anti-bleeding drug Trasylol pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. The study at the Ottawa Health Institute was stopped because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. This recall and study followed the release of a January 2006 study published in the New England Journal of Medicine that linked the drug to a higher risk of kidney failure, heart attack, stroke and even death. Unfortunately, an estimated 4.8 million cardiac patients had already received the drug since it was first introduced in 1993.

FDA investigations followed and it was eventually revealed that Bayer failed to disclose an internal study that also uncovered these dangers. The study was conducted by i3, a global pharmaceutical services company, and demonstrated that use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure, and stroke compared to other drugs. Bayer acknowledged that it did not inform the FDA about the study, which examined 78,199 patients treated between April 2003 and March 2006, indicating that it was both a mistake to withhold it and that they had done so because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. This disclosure prompted the FDA to approve label changes in December 2006 that informed physicians and patients about the associated risks and to limit approved usage to specific situations. Ultimately, however, the FDA announced a recall.

We represent all Aprotinin heart surgery patients and families on a contingency basis which means that there are never any legal fees unless we win compensation in your case through a settlement or through Trasylol lawsuit. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol attorney will contact you to answer any of your questions.