GranuFlo and NaturaLyte
GranuFlo and NaturaLyte, dialysis products manufactured by Fresenius Medical Care, have been linked to a six-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death. At this time, GoldenbergLaw is no longer accepting GranuFlo cases.
Case Quick Facts
Due to issues with Fresenius’ products, many patients receiving GranuFlo and NaturaLyte ended up with bicarbonate levels in excess of their prescriptions.
Despite the responsibility and the trust placed in it by dialysis patients across the country, Fresenius did not warn patients and doctors that used GranuFlo and NaturaLyte until late March 2012 after the FDA received from an anonymous source, and questioned Fresenius about, a copy of a Fresenius internal memo dated four months earlier communicating a problem with the bicarbonate levels on machines using GranuFlo and NaturaLyte. Other internal documents show that Fresenius was aware of these problems for more than a decade before ever alerting the public. The company’s inaction resulted in many deaths around the country and placed thousands of dialysis patients at risk.
A person’s kidneys typically excrete acids to maintain a healthy pH in the bloodstream, but some individuals need dialysis to achieve the necessary pH balance. Dialysis bicarbonate solutions such as GranuFlo and NaturaLyte are administered during dialysis, replace natural bicarbonate for those undergoing dialysis, and serve to neutralize the metabolic acidosis often present in such patients. The precise amount of dialysis bicarbonate solution to be used is prescribed by each individual patient’s nephrologist.
High bicarbonate levels in patients treated with GranuFlo and NaturaLyte may have increased those patients’ mortality risk by making it six times more likely such patients would suffer cardiopulmonary arrest and/or sudden cardiac death.
Fresenius Medical Care, the largest operator of dialysis centers in the country, treats more than one-third of the estimated 400,000 Americans receiving dialysis.
This litigation has settled and GoldenbergLaw is no longer accepting cases. If you have any questions regarding the settlement details, please contact a GranuFlo lawsuit lawyer on our team today.
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