The lawsuits, combined into a multi-district litigation (MDL), centers upon Fresenius' two dialysates Granuflo and Naturalyte, which have been blamed for heart problems, strokes and death in thousands of patients. Reportedly, there are more than 1,800 lawsuits consolidated into MDL under US District Judge Douglas P. Woodlock in the District of Massachusetts (In re: Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL No. 2428).
The lawsuits allege that Fresenius Medical Care knew of the danger in their products and failed to adequately warn and inform the public. Further, there are allegations that claim the company neglected to warn health care providers as well as properly train them on how to use these dialysis products safely.
Additionally, the lawsuits claim Fresenius failed to warn dialysis clinics, outside its own Fresenius clinics, of potential Alkali Dosing Errors.
Both Fresenius Medical Care products - Naturalyte and GranuFlo- are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates, according to the FDA safety recall initiated in March 2012. The recalled Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate was manufactured and distributed from January 2008 through June 2012.
Claims against Fresenius Medical Care include patients who have suffered injury or death as a result of using GranuFlo and/or NaturaLyte products during hemodialysis.