Bayer AG Faces New Trasylol Lawsuit

St. Louis, MOBayer AG has yet another legal battle to face due to complications that have been allegedly caused by its drug Trasylol. This latest suit, filed by a man's widow in St. Louis federal court, says that her husband died of kidney failure after having open-heart-surgery in December 2005.

The 81-year-old man, Samuel Nakis, had open-heart-surgery at St. Louis' St. Luke's Hospital and was given Trasylol during his surgery. Trasylol is used to control bleeding during heart surgery in order to eliminate the need for blood to be given to the patient. But after the surgery, Nakis experienced kidney failure that required him to undergo kidney dialysis. It was a short while after this kidney failure occurred that he passed away.

"It was in 1993 that Trasylol was approved by the FDA. Thirteen years later in 2006, the medical journal Transfusion had suggested in an article that there was a link between Trasylol and kidney failure. Soon after, the New England Journal of Medicine published an article by Dr. Dennis Mangano that linked Trasylol to not only renal failure, but heart attack and stroke as well. Later in 2006, the FDA met to discuss the risks associated with the drug and talked about changing the warnings on the drug. It was this very meeting that Bayer had withheld very important information from the FDA that could have influenced their decision at the time.

In additional studies, Dr. Andrew Walker from the Harvard School of Public Health studied the hospital records of 67,000 patients and found that Trasylol contributed to kidney failure and had a 64% higher chance of doing so compared to other drugs that were designed to perform the same way Trasylol does during open-heart-surgery.

The Nikas lawsuit, filed on March 10, 2008, is alleging that Bayer did not provide adequate warnings to those prescribing Trasylol and to the consumers regarding the dangers associated with Trasylol. It also alleges that the drug was defectively designed, violated the Missouri Merchandising Practices Act, breached the express and implied warranties, and concealed the dangers associated with it. The amount that the widow is suing for is $40 million.

This lawsuit is one of many that are to be filed in Missouri. There are approximately 25 plaintiffs in the state who have signed up to sue the drug's maker. Some lawyers in the area are claiming that there may be 100 more potential plaintiffs who were given the drug during their open-heart surgery and are experiencing kidney problems. On a nationwide level, Bayer AG is facing 19 lawsuits that have been filed against them.

As of April 7, 2008 a transfer order was issued by the United States Judicial Panel on Multidistrict Litigation to consolidate and transfer all of the Trasylol cases, including the Nakis case, to a Miami federal court.

By Ginger Gillenwater