Lawsuit filed against the maker of Trasylol over man’s death after open-heart surgery

By March 14, 2008Drug Safety

A lawsuit has been filed in a St. Louis federal court against Bayer AG, the maker of the anti-bleeding drug Trasylol, on behalf of a widow whose husband died of kidney failure after open-heart surgery.
On Dec. 16, 2005, Samuel Nakis, 81, underwent open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. During the surgery he was given Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding. Shortly after the surgery, Nakis experienced kidney failure and underwent dialysis. He died a short time later.
The U.S. Food and Drug Administration approved Trasylol in 1993. On Jan. 20, 2006, the medical journal Transfusion published an article suggesting a link between Trasylol and renal toxicity. Later that same month, the New England Journal of Medicine published an article, by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.
In the fall of 2006, an FDA advisory board met to decide whether the warning on Trasylol needed to be changed. At the meeting, Bayer failed to disclose the findings of a Trasylol study it had funded. That study, conducted by Dr. Alexander Walker, a professor at the Harvard School of Public Health, reviewed the hospital records of 67,000 patients and found that those given Trasylol had a risk of death 64 percent higher than that of patients who received a comparison drug. It wasn’t until November 2007 that the drug was finally pulled from the market.
On Feb. 21, the New England Journal of Medicine released the study conducted by Walker and a second study conducted by Duke University Medical Center researchers. Both confirmed that patients given Trasylol during heart surgery were more likely to die than patients given a comparable drug.
A lawsuit was filed by Nakis’ widow, Genevieve Nakis, on March 10 in the U.S. District Court for the Eastern District of Missouri. She is represented by John J. Carey of Carey & Danis and Jeffrey J. Lowe of Carey, Danis & Lowe.
The suit alleges that Bayer failed to warn prescribers and consumers of the dangers associated with the drug, defectively designed the drug, fraudulently concealed the dangers of the drug, breached the implied and express warranties and violated the Missouri Merchandising Practices Act. The suit seeks compensatory damages and damages for aggravating circumstances.
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