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
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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