Fresenius Medical, a German healthcare company, is facing a series of lawsuits over its disclosure practices regarding its Naturalyte and GranuFlo product lines. According to the lawsuits, dialysis additives manufactured by the company led to patient deaths.
Since January 1st, at least 15 lawsuits have been filed against the company over its Naturalyte and GranuFlo products. Both dialysis products were designed to lower the acidity of blood during treatment. According to the lawsuits, high concentrations of acetone in the dialysates led to dangerous blood levels of bicarbonate. High levels of bicarbonate caused patients to experience strokes, heart attacks and other fatal cardiovascular issues.
One prominent case involves a now-deceased dialysis patient named Linda Teague. According to Teague’s relatives, the 48-year-old woman died from cardiac arrest during a dialysis procedure.
According to the lawsuit, "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." The complaint continued, "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."
In November 2011, an internal memo at Fresenius discussed information gleaned from a 2010 study. The study showed that the company’s GranuFlo and Naturalyte products could expose patients to an increased risk of cardiovascular-related health issues. In March of last year, the U.S. FDA initiated a Class I recall of the company’s GranuFlo products after 900 patients experienced heart attacks at dialysis centers owned by Fresenius.