Texas Dialysis Lawsuit Filed for Granuflo, Naturalyte Death

January 22, 2013 — A wrongful death lawsuit has been filed on behalf of a man from Texas who died during dialysis. He was treated with Granuflo and Naturalyte, which are dialysis treatment products intended to balance the acidity of a patient’s blood. Unfortunately, improper dosing can cause sudden cardiac arrest and death.

The lawsuit was filed in the U.S. District Court for the District of Massachusetts by Emma Hernandez, on behalf of the deceased Santos Pena Hernandez. He died on January 17, 2011 of a sudden cardiac arrest following treatment with Granuflo and Naturalyte.

The circumstances of Mr. Hernandez’s injury and death are not unique — hundreds of people have been injured, permanently disabled, or killed after being treated with Granuflo and Naturalyte. According to the manufacturer, Fresenius USA, at least 941 people died at their dialysis clinics in 2010. They attributed the unusually high death-rate to overdoses of Granuflo and Naturalyte.

Soon after the U.S. Food and Drug Administration (FDA) received a copy of an internal memo describing the deaths, they issued a Class 1 recall of the dialysis products. The recall required Fresenius to clarify the dosing instructions on the products. The problem is that Granuflo and Naturalyte contain an ingredient that converts to bicarbonate, in addition to the bicarbonate solution that is normally added to the blood of a dialysis patient. If a doctor does not adjust the dosage to compensate for the “extra” bicarbonate in Granuflo and Naturalyte, the patient can suffer a bicarbonate overdose, metabolic alkalosis, sudden cardiac arrest, and death.

According to a memo Fresenius sent to their own doctors in November 2011, patients with high pre-dialysis bicarbonate levels in their blood were 6-times more likely to suffer a cardiac arrest. Fresenius also found that their dialysis patients tended to have higher amounts of bicarbonate in their blood over time. Although Fresenius sells Granuflo and Naturalyte to non-Fresenius dialysis clinics, the memo was only sent to doctors at their own clinics. The FDA was not informed of the risk until an anonymous source leaked the internal memo in early 2012.

Many people have already filed lawsuits against Fresenius suppressing information regarding life-threatening risks and failing to provide adequate instructions for doctors. These lawsuits may be centralized in a Multi-District Litigation (MDL). The U.S. Judicial Panel on Multi-district Litigation (JPML) will hear oral arguments concerning a potential MDL in March 2013.

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