Eight lawsuits alleging that the anti-bleeding drug Trasylol also known by it generic name aprotinin have been filed in a federal court in Miami, Fla., against Bayer AG.
The lawsuits were filed April 17 on behalf of alleged Trasylol victims and their families for injuries and deaths that occurred in California, Georgia, Indiana, Florida, Missouri, New Mexico and Wisconsin between 2000 and 2007. Specifically, the suits allege that:
On April 27, 2000, Nada McIntosh was given Trasylol during open-heart surgery at St. Mary’s Medical Center in Madison, Wis. Soon after the surgery, kidney failure developed, and McIntosh died on May 8, 2000. Suit was filed on behalf of her next of kin, Sandra Boxrud.
• On May 29, 2002, Nina Roberts was given Trasylol during open-heart surgery at Orlando Regional Medical Center, in Orlando, Fla. Shortly after surgery, she experienced kidney failure and underwent dialysis. Suit was filed on her behalf.
• On July 7, 2004, Ruthe Sherman was given Trasylol during open-heart surgery at the University of California at Los Angeles Medical Center. The day after surgery, she experienced kidney failure and underwent dialysis. She died on Aug. 2, 2004. Suit was filed on behalf of her children Judy Sherman and Robert Sherman.
• On Dec. 16, 2005, Samuel Nakis was given Trasylol during open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. Shortly after the surgery, kidney failure developed, and Nakis underwent dialysis. He died a short time later. Suit was filed on behalf of his widow, Genevieve Nakis.
• On June 19, 2006, Dorothy Gallipeau was given Trasylol during open-heart surgery at Hoag Memorial Hospital Presbyterian, in Newport Beach, Calif. She experienced kidney failure the day after surgery and died less than a week later. Suit was filed on behalf of her son Shawn Gallipeau.
• On Oct. 19, 2006, Richard Clark was given Trasylol during open-heart surgery at Presbyterian Hospital in Albuquerque. Soon after surgery he experienced kidney failure. Clark died the day after surgery. Suit was filed on behalf of his widow, Karla Clark.
• On Feb. 6, 2007, James McLendon was given Trasylol during surgery to replace a heart valve at Atlanta’s Emory Crawford Long Hospital. Shortly after the surgery, kidney failure developed. McLendon died a week after surgery. Suit was filed on behalf of his widow, Kathy McLendon.
• On July 3, 2007, Marcia Moyer was given Trasylol during open-heart surgery at The Indiana Heart Hospital, in Indianapolis. Soon after surgery, kidney failure developed, and Moyer must now undergo dialysis. Suit was filed on her behalf.
The suits were filed in the U.S. District Court for the Southern District of Florida, pursuant to a transfer order issued by the United States Judicial Panel on Multidistrict Litigation. The plaintiffs are represented by St. Louis lawyers John J. Carey of Carey & Danis and Jeffrey J. Lowe of Carey, Danis & Lowe.
The suits claim 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 various state laws. The plaintiffs seek compensatory damages and damages for aggravating circumstances.
The U.S. Food and Drug Administration approved Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding, in 1993. On Jan. 20, 2006, an article suggesting a link between Trasylol and renal toxicity was published in the medical journal Transfusion. Later that same month, the New England Journal of Medicine published an article, co-authored 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. In that study, 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 by Walker and a second study, conducted by Duke University Medical Center researchers. Both showed that patients given Trasylol during heart surgery were more likely to die than patients given a comparable drug.