Maker of Dialysis Product Agrees to Pay $250 Million to Settle Out of Court

German company Fresenius Medical Care (FMC) recently agreed to a $250M out-of-court settlement with U.S. plaintiffs, who charged the business with downplaying side effects of a medical concentrate it makes. The firm provides thousands of dialysis centers across the U.S. with goods and services that treat kidney disease or failure. Clinics used their product called GranuFlo or NaturaLyte to prepare fluids for the procedure of cleansing the blood.

In 2012, U.S. health authorities began looking into whether FMC violated rules by neglecting to notify dialysis clinics about the risks of GranuFlo. The firm had sent a memo to dialysis clinics that it operates, alerting them about an association with dosing errors of the product and an increased likelihood of a heart attack. However, it failed to warn clinics that it does not operate but have used the product. Consequently, hundreds of people filed lawsuits against FMC.

According to numerous independent scientific analyses, the danger of GranuFlo revolves around the fact that it contains more of an ingredient that the body transforms into bicarbonate than similar products. An overdose of this substance can cause low blood pressure and heart arrhythmias, which may lead to fatalities from heart attacks and other conditions.

Prior to these problems, dialysis products have caused other serious issues. In 2010, Baxter International Inc. recalled a home dialysis device that may have caused serious injuries and one death. To read about it, see Class I Recall of Baxter In-Home Dialysis Device Announced.

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