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GranuFlo Wrongful Death Lawsuit Filed in Massachusetts

A wrongful death lawsuit has been filed against Fresenius Medical Care, the company responsible for running the largest network of dialysis clinics in the United States. The firm makes the controversial dialysate GranuFlo, and issues it through their own clinics and other clinics around the country. The GranuFlo wrongful death lawsuit, filed in the Massachusetts Superior Court for the County of Suffolk, alleges the product caused the fatal heart attack of a woman in September 2011.

According to court documents, the woman attended a routine dialysis appointment at her regular clinic in Princeton, Indiana. Her treatment included the application of GranuFlo, a dialysate used to screen blood during hemodialysis. Two days after the treatment, she was found dead in her home having suffered a suspected cardiac arrest. Neither the deceased or her healthcare providers were warned of the dangerous nature of the product. The lawsuit alleges the high GranuFlo cardiac arrest risk was deliberately concealed by Fresenius. The decedent’s estate is seeking $2 million in damages.

Like all dialysates, GranuFlo contains bicarbonate. It is used as part of a three-stream dialysis machine, along with calcium, potassium and magnesium. During hemodialysis, GranuFlo delivers the necessary minerals to the patient, while filtering out waste products that would otherwise be removed by the kidneys. GranuFlo also contains sodium acetate, which is used to balance the bicarbonate levels entering the bloodstream. According to the GranuFlo wrongful death lawsuit, the risks – namely metabolic alkalosis and cardiopulmonary arrest – are caused by  an improper balance of bicarbonate and sodium acetate.

Fresenius allegedly knew of potential GranuFlo side effects as early as 2004, but failed to warn patients and the clinics to which they supply the product. It is estimated that 260,000 patients have used the product, thousands of whom are believed to have been overdosed with sodium bicarbonate during hemodialysis.

Fresenius knew of GranuFlo cardiac arrest risk

The Massachusetts case is one of a number of lawsuits alleging that Fresenius had established a causal link between GranuFlo and cardiac arrest, after a study showed that 941 patients had died after being treated with the dialysate.

In November 2011, Fresenius issued a memo to their own clinics outlining the GranuFlo cardiac arrest risk, but the company failed to notify other, non-Fresenius clinics to which they supplied the product. The memo stated that GranuFlo increased the risk of cardiac arrest by up to 8 times. It was finally leaked anonymously to the FDA in March 2012.

GranuFlo lawsuits consolidated

Due to the high number of patients treated with GranuFlo, legal experts anticipate more lawsuits to be brought against Fresenius. A multidistrict litigation (MDL 2428) has been established to centralize similar complaints,  with an initial status conference scheduled to begin later this month. A judicial order signed on July 29, 2013 has named the Joseph Moakley Courthouse in Boston as the venue. The conference is designed to allow federal Judge Douglas P. Woodlock to discuss pending motions and review the structure of the MDL going forward.

It is unclear whether the latest GranuFlo death lawsuit will be added to the MDL; qualifying federal cases have been transferred for pretrial proceedings and any claims that aren’t resolved before Judge Woodlock will be remanded back to their original court of filing for trial.