In February of 2016, Fresenius Medical Care (“Fresenius”) agreed to settle over 10,000 lawsuits that had been filed against it over one of its kidney dialysis products, GranuFlo. The company will pay out $250 million to settle various lawsuits brought by patients and family members of patients who were injured by the product.
According to the New York Times, which reported on the settlement, Fresenius is the “world’s largest provider of kidney dialysis equipment and services” and it’s “North American division is one of the two large dialysis providers in the United States.” The lawsuits over GranuFlo stemmed from an internal memo that the company circulated back in November of 2011. The Times first reported on this memo in June 2012. The memo was given to doctors at Fresenius’ dialysis centers “warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.” The product mentioned in the memo was GranuFlo, which is used during dialysis.
According to the National Kidney Foundation, dialysis is “a treatment that does some of the things done by healthy kidneys. It is needed when your own kidneys can no longer take care of your body’s needs.” GranuFlo does a few different things for dialysis patients. The problems arose because it “contains an ingredient that the body converts to bicarbonate, and it contains more of this ingredient than rival products.” Bicarbonate neutralizes acid buildup in the blood. Doctors were not “accounting for this extra bicarbonate contribution” when prescribing bicarbonate to patients. Studies suggested that too much bicarbonate can lead to heart problems in patients. The memo stated that “patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.”
The memo was only circulated to the company’s dialysis centers. Fresenius did not, of it’s own accord, send the memo out to other facilities not owned by the company that were using GranuFlo. The memo was leaked to the Food and Drug Administration in March of 2012 by an anonymous source. It was only after the FDA received the memo and asked the company about it that Fresenius informed the rest of the clinics about the dangers associated with the product.
The company eventually issued a recall on the product, but only to change the label. A spokesperson for Fresenius said that the memo turned out to be incorrect after further study. The language that they added to GranuFlo was later removed. Even so, the company has still agreed to pay the settlement, “provided that 97% of all plaintiffs agree to the settlement by July 2016.” It is doing so, according to the spokesperson, to put all the lawsuits over the product behind it. The settlement also pertains to a related product, NaturaLyte. The company stated in its press release that “[t]here has been no change in the composition of the product and it remains safe and effective when used and prescribed as directed.”
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