It was just over a year ago (June 27, 2012, to be exact) that the U.S. Food and Drug Administration (FDA) issued its Class I Recall Notice for Fresenius' NaturaLyte and GranuFlo Acid Concentrates, which can dangerously raise patients' blood pH levels (somewhat like injecting baking soda into the bloodstream). The result can be metabolic alkalosiss, which can cause cardiovascular complications resulting in spontaneous cardiac arrest.
Since then, the number of lawsuits against the German-based pharmaceutical company has been on a consistent rise – one of the most recent actions, filed in Federal District Court in Iowa, and being reported by members of the legal community across the country, sadly, involves more victims than just the unfortunate dialysis patient. On June 3, 2013, the plaintiff filed his lawsuit in the Southern District Court of Iowa (Case no. 3:2013cv00073), alleging that the plaintiff suffered a heart attack while driving to work following a dialysis session involving GranuFlo. Due to the heart attack, the Plaintiff veered into the oncoming lane, colliding head-on with a van in which a man, his wife and young child were riding. The man driving the van was killed and the survivors required extensive medical care. The plaintiff, besides his initial heart attack, suffered from major hip and upper leg injuries.
Fresenius now faces liability not only for the plaintiff's injuries, but those of the woman, her child and the death of her husband.
N/A. “Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors.” U.S. Food and Drug Administration, 27 June 2012
Learn more about GranuFlo lawsuits