Fresenius Medical Care, the Waltham, Massachusetts-based manufacturer of dialysis solutions GranuFlo and NaturaLyte, is now facing approximately 6,000 lawsuits alleging that patients suffered severe injuries and were not warned about the risks associated with the products. The filing of lawsuits against Fresenius are preceded by a 2012 Food and Drug Administration (FDA) Class I recall of GranuFlo/NaturaLyte and a 2011 Fresenius internal memo to doctors in its dialysis centers warning of sudden death associated with GranuFlo.
Court Documents: GranuFlo, NaturaLyte Caused Personal Injuries, Wrongful Deaths
As of October 15, 2014, Fresenius faces 2,127 consolidated claims as part of a federal multidistrict litigation (MDL) in U.S. District Court, District of Massachusetts. According to court filings from last year:
“The plaintiffs in these cases 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. These plaintiffs seek damages for wrongful death and personal injury.
“Plaintiffs contend 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.”
Fresenius, say the plaintiffs, knew or should have known of the substantially increased risk of cardiac arrest due to bicarbonate level increases caused by GranuFlo use.
In addition to the MDL, a separate group of more than 3,900 lawsuits are pending in Middlesex County (Massachusetts). They similarly allege that Fresenius provided insufficient patient warning about bicarbonate overdose from GranuFlo, which research indicates can lead to heart problems and death.
Fresenius Failed to Warn All Users about Drug Risks
In a letter dated November 4, 2011, Fresenius, which operates its own dialysis centers, sent an internal memo to doctors warning that GranuFlo seemed to be associated with a sharp uptick in patients dying from sudden cardiac arrest. “This issue needs to be addressed urgently,” the memo concluded, noting that in 2010, 941 patients had suffered cardiac arrest at Fresenius clinics.
But Fresenius did not immediately send the memo to other dialysis centers that administered GranuFlo to patients. According to the New York Times, Fresenius treats more than 1/3 of approximately 400,000 American dialysis patients.
Finally, in March 2012, Fresenius extended its GranuFlo warning to all customers. In May, the FDA issued a product alert and in June 2012, the FDA issued a Class I Recall notice for GranuFlo and NaturaLyte.
“Dialysis acid concentrate can contain acetic acid, acetate or citrate, and these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis,” reads the recall notice.
Dialysis, administered to patients with renal failure, removes toxic waste from the body in patients whose kidneys are unable to do so. GranuFlo and NaturaLyte—liquid and powder concentrates of the same dialysis formula—contains more of an ingredient that the body coverts to bicarbonate than other, similar products.