Court documents filed in relation to the lawsuit note that the 300 lawsuits involve plaintiffs who are “dialysis patients or their survivors alleged to have suffered cardiopulmonary arrest and other injuries resulting from dialysis treatment with Fresenius’ dialysate products Naturalyte GranuFlo Acid Concentrate and Naturalyte Liquid Acid Concentrate (“GranuFlo”).” The lawsuits seek damages for personal injury and wrongful death linked to the use of the Fresenius products.The lawsuit alleges that GranuFlo causes “a rapid and unsafe elevation of bicarbonate, which creates a 6 to 8 fold increased risk of cardiopulmonary arrest and death that is unique to GranuFlo.” They further claim that Fresenius knew or should have known about the risk of cardiopulmonary arrest, especially due to a case-control study conducted by the company that showed approximately 940 patients treated with GranuFlo suffered cardiopulmonary arrest and sudden cardiac death. Patients can reportedly suffer cardiopulmonary arrest while undergoing dialysis and up to two days later.
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GranuFlo is used during kidney dialysis to maintain bicarbonate levels, which neutralize the buildup of acid in the patient’s blood stream. Problems with dosing may have resulted in some patients suffering cardiopulmonary arrest. At issue is not just the dosing, but that Fresenius allegedly issued new recommendations to healthcare professionals at its own clinics but not to those in non-Fresenius clinics. Furthermore, the FDA reportedly only found out about the new recommendations when a memo was anonymously leaked to the agency.
As a result, in March 2012, the FDA announced a Class 1 recall of Naturalyte and GranuFlo formulations, noting that they could be linked to a variety of adverse reactions.