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Fresenius Settles GranuFlo / NaturaLyte Lawsuits for $250M

February 18, 2016 — Fresenius Medical Care has agreed to pay $250 million to settle over 4,300 lawsuits involving dialysis patients who had heart attacks after they were given GranuFlo or NaturaLyte.

The securities filing states that 97% of all plaintiffs must opt-in to the agreement by July to receive payment by August 2016. The cases are centralized in a federal Multi-District Litigation (MDL No. 2428) in the U.S. District Court for Massachusetts.

GranuFlo and NaturaLyte are liquid chemicals called dialysates that balance the acidity of blood in patients undergoing hemodialysis for kidney failure. In March 2012, both were recalled to clarify the instructions for use.

The instructions now specify that GranuFlo and NaturaLyte contain ingredients that are metabolized into bicarbonate by the liver. Because bicarbonate is also typically added to the dialysate solution, doctors must be careful to adjust the dose to compensate for the “extra” bicarbonate in GranuFlo and NaturaLyte.

Before these warnings were added, hundreds of patients developed bicarbonate overdoses and metabolic alkalosis, a life-threatening condition in which blood chemistry is too basic. Complications include cardiac arrhythmia, low blood pressure, electrolyte imbalances, cardiopulmonary arrest, heart attack, and death.

The problem is that Fresenius was aware of the problem but did not tell the FDA or other dialysis clinics until after an anonymous source leaked an internal memo (PDF) from November 2011. The memo reported over 940 deaths at Fresenius clinics in the previous year. Investigators found a 6-fold increased risk of death among patients with high bicarbonate levels, warning that GranuFlo and NaturaLyte dosing errors may be contributing to the problem.

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