Michigan Man Files GranuFlo Lawsuit After Cardiac Arrest

In a lawsuit filed on May 17, 2013, a plaintiff is seeking damages of $6 million from Fresenius Medical Care, manufacturers of the GranuFlo dialysis treatment, after suffering cardiac arrest and ongoing health problems allegedly caused by the product. The plaintiff, from Oscoda, Michigan, is requesting compensation for pain and suffering, emotional distress, lost wages and future earnings, medical expenses and legal costs. It is the latest GranuFlo cardiac arrest lawsuit in a string of cases across the U.S.

The plaintiff began receiving hemodialysis in the fall of 2008. He suffered a cardiac arrest on May 26, 2010, and required surgery to fit a pacemaker. According to court documents, Fresenius Medical Care failed to adequately inform consumers and the medical community of the full extent of the risks associated with GranuFlo.

GranuFlo was used regularly in dialysis clinics all over the United States until June 2012, when it was recalled after an FDA investigation indicated dialysis heart injury caused by GranuFlo was becoming increasingly common.

GranuFlo cardiac arrest lawsuit number on the rise

On December 12, 2012, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation, requesting consolidation of all qualifying GranuFlo cases in the District Court in Massachusetts. The petition (MDL 2428) was signed by Fresenius Medical Care in January, 2013.

The petition, filed by two bereaved plaintiffs, alleged Fresenius had established a causal link between GranuFlo and cardiopulmonary arrest. In a study conducted by Fresenius it was discovered that 941 patients had died after receiving dialysis with GranuFlo and/or NaturaLyte.

Because of the large number of patients who have been treated with the popular dialysis additive, the number of GranuFlo cardiac arrest lawsuits is expected to rise, as more patients and families learn of the risks.

GranuFlo is a dialysate used during hemodialysis to offset the acid created by kidney failure.  The sodium acetate contained in the product converts to sodium bicarbonate at an abnormally high level. Dangerously high levels of sodium often cause heart problems, and hundreds of patients have alleged serious injuries after being treated with GranuFlo.

GranuFlo is used all over the country, and is estimated to have generated some $80 million for Fresenius. Of the 5,700 dialysis centers in the United States, around 3,300 have used the concentrate. Many clinics are operated by Fresenius themselves, but the company also sells dialysates and other dialysis technologies to clinics around the country. More than a quarter of a million patients have been treated with the product, nearly half at clinics not operated by Fresenius.

Internal memo implicates Fresenius

In November 2011, Fresenius released an internal memo to their clinics outlining the dangers of cardiac arrest, but they failed to notify other clinics to which they supply GranuFlo. The memo clearly stated that the risk of dialysis heart injury and cardiac arrest was perhaps eight times greater with GranuFlo than with other dialysates. The  memo was leaked anonymously to the FDA in March 2012, prompting the agency to order a Class I recall of the product.