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Trasylol Named in Two Lawsuits

Oct 10, 2008 | Parker Waichman Alonso LLP

Trasylol, Bayer AG's now-withdrawn anti-bleeding medication, is the subject in two Illinois lawsuits.  One of the plaintiffs claims Trasylol was the cause of her husband's death, and the other alleges the drug caused him to suffer acute renal failure. Bayer permanently withdrew Trasylol from the market in May 2008, after a study found that it increased patients' risk of death by more than 50 percent.

Trasylol was approved by the US Food & Drug Administration (FDA) 1993 and, before it was withdrawn,  had been used in  a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed several times.  Last October, the Canadian Data Safety Monitoring Board stopped a Trasylol trial - known as the BART clinical study - after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.  

Bayer decided to take Trasylol off the market for good after an analysis of the Canadian study  was published in a May issue The New England Journal of Medicine.  The analysis  found that of the 2,331 people enrolled in the Canadian study, the death rate among Trasylol patients was 6 percent, while the rate for those being treated with other drugs - namely Amicar or Cyklokapron - was 4 percent. That represented an increased death rate of 53 percent for Trasylol patients, which translates to one extra death for  every 50 patients treated with Trasylol.

According to complaints filed last month in St. Clair County Circuit Court, both Gary Harms and Richard Kopsie were given Trasylol during a coronary artery bypass graft surgery.  Harms underwent the surgery in which he was given the drug in 2005 at Des Peres Hospital in St. Louis, while Kopsie had his in August 1996 at Christian Hospital in St. Louis, the suit states.

 The drug caused damage to both Harms's and Kopsie's kidneys, resulting in acute renal failure.  Both required dialysis treatment.  Kopsie died on March 23, 2003, at the age of 53 as a result of Bayer's negligence,  his widow, Linda Kopsie, claims.
 
According to the lawsuit, Bayer issued no warnings until Dec. 15, 2006, on the increased risk of kidney failure posed by the drug, despite the fact that by 2006 about 10,000 patients were on dialysis because of their exposure to Trasylol.

Linda Kopsie is seeking a judgment in excess of $1.1 million, plus costs and attorney's fees.  Harms is seeking a judgment in excess of $550,000, plus costs and attorney's fees.