A series of lawsuits filed since January 1, 2013 accuse Fresenius Medical Care of deliberately concealing potentially fatal problems with a pair of since-recalled products used during dialysis.
The GranuFlo® and NaturaLyte® products were used to lower the acidity of patients’ blood during dialysis treatments. At least 15 recent lawsuits allege that the patients’ 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. Linda Teague, a Kentucky dialysis patient, died in January 2011, at age 48, from cardiac arrest after a dialysis treatment in which she was exposed to the Fresenius products.
According to the court filing, “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.”
A November 2011 internal Fresenius memo allegedly details the results of a study completed in 2010, “based on data defendants had available for many years,” according to the court documents.
The U.S. Food and Drug Administration (FDA) initiated a Class I recall of NaturaLyte® and GranuFlo® products in 2012, noting that this is the most serious type of recall and involves “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”