About 10 years ago, claims on behalf of victims who took the blood clotting drug Trasylol (generic: Aprotinin) for use during surgeries and suffered complications, including blood clots, strokes, heart attacks, limb amputation, kidney failure, and death. These Aprotinin lawsuits alleged product liability, negligence and failure to warn claims against Bayer Healthcare Pharmaceuticals.
Victims alleged that Trasylol significantly increases the risk of serious adverse events, including specifically, fatal and nonfatal renal injuries and renal failure. They further alleged that the scientific evidence even before the drug came to the market was that renal injury was a risk of this drug.
These cases were mostly resolved. Many of the settlement of the viable cases were in the half million dollar range. Today the label is clear that anaphylactic responses to this drug could lead to circulatory failure. There is also a renal failure warning.
So this is a old page on our website. We leave it up because some people have an interest in settled mass tort cases.
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 Aprotinin Cause Blood Clots, Kidney Failure, And Death?
Aprotinin 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. Did they do that? People disagree.What is the Current Status of the Trasylol Lawsuits?
There are no more pending cases. There were individual Trasylol lawsuits filed in state courts around the country. The majority of current Trasylol litigation were centered in the United States District Court for the Southern District of Florida. Judge Donald Middlebrooks was the judge for 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. These cases settled or were dismissed before they went to trial.