GranuFlo

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The attorneys at Ward Black Law are currently investigating potential GranuFlo® Lawsuits in N.C. Granuflo® is an acid concentrate used to clean the blood of acid build-up during dialysis and may cause serious to potentially fatal side effects including cardiopulmonary arrest, cardiac arrhythmia and sudden cardiac death. If you or a loved one has undergone dialysis treatments with GranuFlo® and suffered injury or death, you may be entitled to compensation. Contact Ward Black Law today regarding your potential GranuFlo® Lawsuit in N.C.

GranuFlo® History

GranuFlo® is administered to dialysis patients in order to replicate kidney function, controlling acid, sodium, potassium, calcium, and magnesium levels in the blood. However, if mixed incorrectly, GranuFlo® may contain sodium acetate (sodium diacetate), which is converted into bicarbonate by the body’s liver and tissues, resulting in bicarbonate surplus. Dangerously high levels of bicarbonate may put dialysis patients at increased risk for metabolic alkalosis, which can cause adverse cardiac-related health events.  

GranuFlo® is manufactured by Fresenius Medical Care, the world’s largest supplier of dialysis machines. It operates more than 2,700 dialysis clinics worldwide, treating more than 130,000 patients in the U.S. alone. In response to numerous claims of cardiac arrests occurring in Fresenius Medical Care clinics in 2010, the company issued an internal memo warning of the possible severe side effects of GranuFlo® to all of its dialysis clinics on November 4, 2011. The memo reported that the use of GranuFlo® may contribute to an increased risk of cardiopulmonary arrest and sudden cardiac death, noting the incidence of 941 patient deaths in 667 Fresenius clinics in 2010. According to the document, patients with elevated pre-dialysis bicarbonate levels had up to six times the risk of cardiac death compared to those with normal levels. 

GranuFlo® Recall 

Fresenius’ report was anonymously leaked to the U.S. Food & Drug Administration (FDA), which designated GranuFlo® a Class I Recall in June 2012. A Class I is the most serious recall and only issued if there is reasonable probability that use of the product will result in grave injury or death.    

GranuFlo® Lawsuits in N.C.

Fresenius warned only its own clinics of the possible dangers of GranuFlo®. According to the New York Times, the FDA is investigating whether the company violated federal law by not sufficiently warning patients of the potential dangers of their products. If you or a loved one has experienced injury or death in the 48 hours following dialysis treatment, you may be entitled to compensation. Contact an attorney at Ward Black Law today. We are happy to answer your questions, evaluate your claim, and handle your GranuFlo® lawsuit in N.C. if appropriate.

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