Our Trasylol lawyers are investigating potential Trasylol lawsuits throughout the United States for claims on behalf of victims who took the blood clotting drug for use during surgeries and suffered complications, including blood clots, strokes, heart attacks, limb amputation, kidney failure, and death. These Trasylol lawsuits allege product liability, negligence and failure to warn claims against Bayer Healthcare Pharmaceuticals.What Is Trasylol Used For?
Trasylol (aprotinin) is a protein delivered by injection, and used to reduce bleeding during complex surgeries like open-heart surgery (including heart bypass surgery or heart valve replacement). It works by lengthening the time it takes for blood clots to break down, and reduces the need for blood transfusions during surgeries. Trasylol was approved in 1993 by the FDA for patients at high risk of bleeding. That approval was expanded in 1998 to cover all heart bypass patients. Over 4.3 million people have been given Trasylol. It was used in approximately one-third of all cardiac bypass operations in the United States.How Does Trasylol Cause Blood Clots, Kidney Failure, And Death?
Trasylol allows the blood to clot more easily, and those clots can travel through the circulatory system to various parts of the body, causing strokes, heart attacks, and poor circulation which may necessitate limb amputation. Additionally, a January 2006 medical article in the New England Journal of Medicine reported that use of Trasylol doubles a patient’s risk of kidney failure.Who Makes Trasylol?
Trasylol is manufactured by Bayer Healthcare Pharmaceuticals.What Do The Trasylol Lawsuits Argue Bayer Did Wrong?
Initially, the warning given with Trasylol only mentioned the risks of anaphylactic shock—that a very select number of patients might be allergic to the medication. However, even when the drug was introduced, Bayer knew or should have known and warned of the high risk of kidney toxicity, and the problems related blood clots and related effects.
In the early 1980’s, before the drug had been released, a physician at the University of Cologne discovered that Trasylol caused severe kidney damage in animals. He gave his findings to Bayer, but Bayer was not interested. Then, in 1992, Dr. Nicholas Kouchoukos performed a study of 20 patients on Trasylol. Thirteen of those patients developed kidney problems.
A 2006 study by Dr. Dennis Mangano was published in the New England Journal of Medicine and revealed an association between Trasylol use and kidney toxicity requiring dialysis. It also showed increased death during hospitalization, and suggested that Trasylol caused the death of thousands of patients. The study included over 5,000 patients from 17 countries.
Importantly, after the 2006 study, Bayer finally conducted its own research, hiring Harvard professor Dr. Alexander Walker to examine medical records of 70,000 Trasylol patients. His findings corroborated Dr. Mangano’s study—Trasylol patients are at an increased risk for kidney failure and death. However, Bayer did not disclose the existence or results of that study at a September 2006 FDA meeting. The result is predictable—the FDA decided that it did not have the information it needed to withdraw the drug from the market. And Bayer reaped the benefits of 14 additional months of drug sales, before Trasylol marketing was suspended by the FDA on November 5, 2007. The drug was finally recalled on May 14, 2008. One researcher estimated that, had Bayer acted responsibly, it would have saved at least 22,000 lives.
Furthermore, there have always been safer alternatives. Trasylol’s competitors, Amicar and Cyklokapron, cost $11.00 and $44.00 per dose, respectively. However, Trasylol costs $1,300 per dose. The New England Journal of Medicine reports that Amicar and Cyklokapron are safer than Trasylol, and are not associated with increased risks of stroke, kidney damage, or heart attacks.
Bayer had a significant profit motive to keep the drug on the market and to hide data that it accumulated showing the drug was dangerous. In 2005, Trasylol was Bayer’s 11th top selling drug at $293 million. They anticipated the drug would reach over $600 million, annually.What is the Current Status Of The Trasylol Lawsuits?
There are individual Trasylol lawsuits filed in state courts around the country. The majority of current Trasylol litigation is centered in the United States District Court for the Southern District of Florida. Judge Donald Middlebrooks is overseeing the federal Trasylol litigation, which was consolidated on April 7, 2008, for pre-trial discovery and coordination in MultiDistrict Litigation 1928: IN RE TRASYLOL PRODUCTS LIABILITY LITIGATION, case no. 1:08-md-1928. Discovery was originally anticipated to be completed as early as July 2009; however in March 2009 the Court granted a joint motion to delay that deadline. The Court still anticipates that the first Trasylol trials will begin in January, 2010.Do I Have A Trasylol Claim?
If you or a loved one had complicated surgery, including heart surgery, and suffered from blood clots, kidney damage, stroke, heart attack or death, please call one of our Trasylol attorneys at 800-553-8082 or click here for a free no obligation consultation on your potential Trasylol lawsuit. The only way to know if you or a loved one was given Trasylol during surgery is to ask your surgeon, or have our lawyers obtain and examine surgical records.