The GranuFlo and Naturalyte products were used to lower the acidity of patients’ blood during dialysis treatments. At least 15 lawsuits filed since Jan. 1 allege that the dialysates’ high concentration of acetone led to abnormally high levels of bicarbonate in the blood, leading to fatal heart problems and strokes, according to court documents.
In 1 case, a dialysis patient in Kentucky named Linda Teague allegedly died at age 48 from cardiac arrest after a procedure there.
"Decedent received defendants’ defective product during that dialysis treatment and, on or about Jan. 14, 2011, suffered cardiac arrest and died from the injuries she sustained as a result of her exposure to defendants’ defective product," according to the complaint. "Even though defendants knew of the risks for several years, medical providers were unaware that the high levels of bicarbonate in defendants’ products heighten the risk of cardiac injury by 6 times. As a result, thousands of patients receiving dialysis treatment were unknowingly overdosed."
An internal Fresenius memo from November 2011 allegedly details the results of a study completed in 2010, "based on data defendants had available for many years," according to the documents.
The FDA launched a Class I recall of FMC’s GranuFlo product last March after obtaining a copy of the memo and and began investigating Fresenius in June 2012, after more than 900 patients experienced heart attacks at Fresenius dialysis centers.