November 29, 2012 — A lawsuit has been filed on behalf of an Ohio man who suffered a deadly cardiac arrest after he was given GranuFlo during dialysis treatment. The complaint was filed in the U.S. District Court for the Southern District of Ohio earlier this month on behalf of Charles M. Swigert, a 56 year-old man who died on November 11, 2010, while receiving dialysis treatment at a clinic owned by Fresenius Medical Care.
According to the complaint filed on Mr. Swigert’s behalf, GranuFlo’s “product formulation was flawed” and the “warnings and instructions were inadequate.” Furthermore, the lawsuit alleges that Mr. Swigert’s death was:
“…a direct result of Defendants’ refusal to conduct a single safety study, Defendants’ suppression of clinical data revealing life-threatening risks, and Defendants’ flagrant disregard for safety by failing to disclose the risks to health care providers.”
Fresenius, the largest dialysis company in the world, manufactures GranuFlo and operates thousands of clinics. During dialysis, a solution called dialysate is added to balance the acidity of the blood. Dialysate contains water, a bicarbonate concentrate, and an acid concentrate. GranuFlo is a type of acid concentrate.
GranuFlo is unique among acid concentrate products because it contains sodium diacetate, which doubles the total amount of bicarbonate in the dialysate solution. This may result in a dangerous bicarbonate overdose, which could ultimately lead to cardiac arrest and death.
For many years before Mr. Swigert died of a cardiac arrest after being treated with GranuFlo, Fresenius was aware that improper doses of GranuFlo could potentially cause cardiac arrest. In 2010, the company noticed that 941 people died at their clinics from sudden cardiac arrest due to bicarbonate overdoses. They sent an internal memo to their own doctors about this risk, but did not warn the FDA, other doctors, or the public. Consequently, many people were unaware of the life-threatening side effects of GranuFlo.
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