Atlanta, GALawsuits linked to the recent GranuFlo recall and Naturalyte Liquid Acid Concentrate recall have reportedly been filed, alleging patients suffered fatal cardiovascular events after undergoing dialysis treatment involving GranuFlo. The lawsuits, filed against Fresenius Medical Care, allege Fresenius failed to adequately warn patients and healthcare professionals about the risks associated with the products.
According to reports, Waddell Bishop filed a lawsuit in Georgia against Fresenius Medical Care, alleging his mother died after dialysis that involved the use of GranuFlo or NaturaLyte acid concentrates. Bishop's lawsuit alleges wrongful death and claims his mother died because of complications associated with her dialysis. Furthermore, Bishop alleges patients were not properly warned about the risk of cardiac arrest linked to the use of GranuFlo.
Fresenius Medical Care reportedly treats more than 100,000 American patients who receive dialysis, according to The New York Times (9/14/12). As early as November 2011, an internal memo was sent to doctors at the dialysis centers, warning that improper use of GranuFlo seemed to be linked to an increased risk of death from cardiac arrest. What concerns investigators is that other medical centers, outside the Fresenius chain, also used GranuFlo but did not receive that memo.
The issue with GranuFlo is an ingredient that is converted by the patient's body to bicarbonate. Although similar products have this same ingredient, GranuFlo has more of it, but doctors have not allowed for the excess amount when prescribing extra bicarbonate. Bicarbonate has been linked to heart problems.
NaturaLyte and GranuFlo are used to treat acute and chronic renal failure during dialysis. Earlier this year, a class 1 recall (the most serious type of recall issued) of GranuFlo and NaturaLyte was initiated. At the time, the US Food and Drug Administration (FDA) noted that patients could be at risk of high serum bicarbonate levels, which can contribute to metabolic alkalosis.
"Dosage errors may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest," the FDA noted. "This product may cause serious adverse health consequences, including death."
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