GranuFlo (Dialysis Product) Litigation


Lawsuits continue to be filed against the manufacturer of the dialysis product known as GranuFlo. This product is the powder form of a solution used to clean and remove waste from the blood during dialysis. Fresenius Medical Care, a German company whose American headquarters is located in Massachusetts, created the product to replace a liquid solution that was previously used for this purpose. The idea was to create a product in powder form, so that dialysis clinics could mix it with water and use it in the facility.

Lawsuits filed against Fresenius Medical Care contend that the product has twice the level of acetate as the liquid solution. When used during dialysis, it can affect the patient’s blood’s pH level and disrupt the patient’s heart rhythm, a condition known as arrhythmia. One of the lawsuits involves a patient who went in for his routine dialysis treatment during which GranuFlo was used. The patient went into cardiac arrest and died while he was still connected to the dialysis machine.

In March of 2012, the United States Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo. The basis for the recall was the FDA’s finding that an excess bicarbonate level in the bloodstream can cause a drop in blood pressure, low blood oxygen, a drop in the potassium levels in the blood, and cardiac arrhythmia, which can result in the patient suffering cardiac arrest. Lawsuits allege that Fresenius Medical Care knew about the inherent risk of elevated bicarbonate levels in the blood, but failed to warn clinics to change the settings on the dialysis machines to account for the elevated bicarbonate levels. Company memos revealed that 941 patients at dialysis clinics owned by Fresenius had experienced cardiac arrest while being treated with GranuFlo. Fresenius warned its clinics to reduce the acetate value when using GranuFlo in its concentrated form. However, the lawsuits allege that the company failed to warn thousands of other dialysis clinics about the increased risk of suffering cardiac arrest while using GranuFlo. It is unknown at present exactly how many patients who were treated with GranuFlo experienced cardiac arrhythmia and/or cardiac arrest. Plaintiffs’ lawyers have estimated that the potential number of injured victims from all dialysis clinics across the U.S. could range between 5,000 and 10,000.

The Suthers Law Firm has experience representing individuals who have suffered serious injuries, and the families of individuals who suffered wrongful deaths, as a result of dangerous medical products. Such cases are among the most challenging cases that are pursued, and it is important to retain an attorney who has the experience and resources that are necessary in order to prevail.