Granuflo/Naturalyte Litigation Demonstrate Potentially Devastating Effects for Patients of Dialysis

On March 29, 2012, the United States Food & Drug Administration (FDA) issued a Class 1 recall of a popular dialysis drug called GranuFlo, along with its sister drug Naturalyte.  According to the recall, these products can lead to “a high serum bicarbonate level in patients undergoing hemodialysis”.  This could contribute to additional side effects such as metabolic alkalosis, a significant risk factor which has been associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could also result in heart attacks or cardiopulmonary arrest.

Evidence that Granuflo/Naturalyte could lead to such serious and devastating injuries, up to and including death, during dialysis led the FDA to take action in the form of a serious recall.  Unfortunately, these drugs still remain on the market, despite the fact that lawsuits have begun to emerge based on the terrible effects of the drugs.   Although not inherently dangerous products, NaturaLyte and GranuFlo can become lethal when mixed and administered incorrectly.  GranuFlo is the only acetic acid containing drug that also has sodium di-acetate.  The sodium acetate gets converted into bicarbonate by the patient’s liver, which results in increased bicarbonate levels beyond prescribed limits and causes an increased risk of metabolic alkalosis.

DaVita Healthcare, a national dialysis treatment provider that uses both GranuFlo and NaturaLyte during hemodialysis, is currently facing four class action lawsuits in the US District Court for the District of Colorado resulting from the adverse health effects associated with improper use of the drugs.  Both drugs are made by Fresenius Medical Care.   Lawsuits brought against Fresnius Medical Care are based on allegations that Fresnius knew about the possibility of adverse effects from its products but failed to warn doctors and facilities outside of the company.