GranuFlo Wrongful Death Lawsuit Filed in Mississippi

A Granuflo wrongful death lawsuit has been filed against Fresenius Medical Care, operators of the largest network of dialysis clinics in the US. The company is accused of causing the fatal heart attack of a 60 year old man who was being treated at one of their centers three times a week. He died in 2010. The Granuflo side effects lawsuit was filed by the deceased’s widow on February 14, 2013, in the US District Court for the Southern District of Mississippi.

The state is home to 49 dialysis clinics run by Fresenius, who also distribute equipment and dialysates, the chemical agents used to screen blood during treatment. The dialysate at the center of what the plaintiff refers to as a “national epidemic” is GranuFlo. Fresenius is alleged to have misrepresented and concealed the dangers associated with the treatment. According to court documents, the company knew or should have known that cardiac arrest caused by GranuFlo was a possibility.

Cardiovascular risk inherent in treatment

GranuFlo and other dialysates contain sodium acetate. It is used during hemodialysis to offset acid created by kidney failure. According to the plaintiff’s GranuFlo lawyer, the product converts to sodium bicarbonate at an unusually high level. Such high levels of sodium can aggravate heart disease. It is believed that thousands of patients may have been unwittingly overdosed with sodium bicarbonate as a result of GranuFlo treatment.

Fresenius knew of GranuFlo side effects for years

The Mississippi case forms part of a pattern of lawsuits alleging Fresenius themselves had established a causal link between GranuFlo and cardiopulmonary arrest at least as far back as 2012, when they conducted a study that found 941 patients had died in a single year after being treated with the product.

The Granuflo wrongful death lawsuit alleges the company knew of the risks before that date. In November 2011, Fresenius issued an internal memo to their own clinics outlining the dangers, but failed to notify other clinics to whom they supply GranuFlo. The memo stated that using GranuFlo increased the risk of cardiac arrest by up to 8 times.

GranuFlo is used all over the country, generating approximately $80 million for Fresenius. Of the 5,700 dialysis centers in the US, around 3,300 use GranuFlo. It is estimated that some 260,000 patients are using the product, nearly half of whom are at non-Fresenius clinics, and were therefore not aware of the memo. It was leaked anonymously to the FDA in March 2012, a move which precipitated a GranuFlo recall.

Further litigation anticipated

The GranuFlo wrongful death lawsuit filed in Mississippi is just the latest of many. There are at least eleven Granuflo side effects lawsuits pending against Fresenius, across eight different US District Courts. Because of the number of patients who have used GranuFlo in recent years, that number is expected to rise significantly as more families learn of the possibility of cardiac arrest caused by GranuFlo.

On December 12th, a motion was filed with the US Judicial Panel on Multidistrict Litigation to consolidate the cases in the District of Massachusetts. The petition was signed by Fresenius on January 3rd 2013. The petition (MDL 2428) alleges Fresenius knew or should have known the risks of using GranuFlo, but failed to provide consumers with adequate warnings.