The end may be near for thousands of plaintiffs who filed suit in the wake of the 2012 GranuFlo and NaturaLyte recall. According to a statement released yesterday, Fresenius Medical Care has agreed to a $250 million settlement that could resolve those claims, provided a majority of eligible plaintiffs sign on to the accord by July.

Fresenius, the world’s largest provider of dialysis products, recalled GranuFlo and NaturaLyte after inappropriate dosing of the two dialysis concentrates were tied to a rise in sudden cardiac arrest among patients treated at its own clinics. However, while the company warned Fresenius centers of this risk in November 2011, it did not notify hundreds of out-of-network clinics that also used the products until March 2012.

That month, the U.S. Food & Drug Administration (FDA) announced a Class I recall for both GranuFlo and NaturaLyte. According to, a Class I recall is the agency’s strongest safety action and indicates that a medical product poses a significant risk of serious injury or death. While the Fresenius action was termed a recall, neither GranuFlo nor NaturaLyte were removed from the market. Rather, the company made voluntary changes to the products’ labels.

GranuFlo Settlement Requires 97% Participation

Fresenius is currently named a defendant in more than 4,300 GranuFlo and NaturaLyte lawsuits that have been centralized in a multidistrict litigation now underway in the U.S. District Court, District of Massachusetts. Court records indicate that the litigation’s first bellwether trial was scheduled to begin this past Tuesday.

The agreement to settle the litigation does not entail an admission of liability on the part of Fresenius in regards to its handling of GranuFlo or NaturaLyte. To take effect, 97% of eligible plaintiffs must agree to participate in the settlement program by July. The company would fund the settlement in August with $220 million in insurance proceeds. Fresenius also said it expects to take a pre-tax charge of $60 million as a result of the GranuFlo and NaturaLyte settlement and other costs related to the matter.

Bernstein Liebhard LLP represents a number of GranuFlo recall plaintiffs. To learn more about this litigation, please contact our office at 877-779-1414.

Published February 18, 2016 by