GranuFlo and NaturaLyte solutions are dialysis products used in the treatment of acute and chronic renal failure. Both GranuFlo and NaturaLyte have been linked to increased levels of bicarbonate in the patient’s bloodstream, which can cause cardiac arrest, cardiopulmonary arrest and death. Fresenius Medical Care manufactures and distributes both GranuFlo and NaturaLyte, and uses the products at Fresenius Medical Centers. On November 4, 2011, the company issued an internal memo about the risk of cardiac arrest, but that memo was reportedly only sent to Fresenius Medical Centers, not to other medical centers that also used the products.
That memo was then leaked to the US Food and Drug Administration, which issued a Class 1 Safety Recall of the solutions.
Initially, lawsuits were filed against Fresenius, for allegedly putting patients at risk of severe side effects. Some people, whose loved ones died after a dialysis treatment, have filed wrongful death lawsuits against Fresenius. Now, DaVita Healthcare Partners Inc, who also runs dialysis clinics that use GranuFlo and NaturaLyte products, faces lawsuits alleging wrongful death.
One such lawsuit (case no. 1:2013cv00573) was reportedly filed in March in Colorado, by a man who alleged his wife died of cardiac arrest after receiving GranuFlo during dialysis at a DaVita Dialysis Center.
Meanwhile, Fresenius Medical Care faces an increasing number of lawsuits alleging patients were injured or killed after the use of GranuFlo and NaturaLyte concentrates. A lawsuit was filed June 19 by a man who alleges his wife died after her dialysis treatment. The plaintiff further alleges that Fresenius did not properly warn physicians and/or healthcare facilities about the risks associated with the concentrates. The lawsuit was filed in Kanawha Circuit Court (case number 13-C-1158) according to the West Virginia Record (7/19/13).