Fresenius Medical Care North America agreed to a $250 million settlement to resolve lawsuits that claim the company was aware of risks of their dialysis products yet failed to warn the public. The litigation centers upon Granuflo and Naturalyte, two dialysates that have been blamed for heart problems, strokes and death in thousands of patients.
Fresenius Medical Care agrees to pay $250 million to resolve U.S. litigation related to its GranuFlo and NaturaLyte products. Under the terms of the agreement, 97% of the plaintiffs must agree to the settlement by July 2016 to receive funding in August 2016.
Insurers will pay $220M (88%) of the total settlement amount.The company intends to record a $60M charge to finalize the matter. The item will be reflected in its 2015 results that will be released on February 24.GranuFlo and NaturaLyte are dialysates (fluids used in dialysis that clean the blood). The FDA recalled them in March 2012 in order to revise prescribing instructions. According to the recall, the use of the products could lead to low blood pressure and cardiac arrhythmia, possibly leading up to cardiopulmonary arrest and death. The lawsuits began after it was discovered that Fresenius was aware of the risks and failed to inform healthcare providers and patients. A November 2011 internal company memo revealed that 900 patients experienced heart attacks in company clinics the previous year. Fresenius medical personnel concluded that patients with excessive levels of bicarbonate in their blood were six times more likely to experience cardiac arrest that those with normal levels.
The memo linked GranuFlo use to increased bicarbonate levels and heart attacks.GranuFlo is a powdered compound that creates bicarbonate. NaturaLyte works in a similar fashion but is in liquid form. Both remain on the market in their original formulations.