Fresenius Medical Care has agreed on a settlement out of court with U.S. plaintiffs of several lawsuits related to the company’s dialysate brands GranuFlo and NaturaLyte.

Fresenius reached the agreement with a committee designated by the plaintiffs to resolve litigation. The settlement amount would be $250 million, and 97% of the plaintiffs must agree to the settlement by July 2016. Insurers would fund the settlement amount with $220 million.

Background

In Nov. 2011, Fresenius distributed an internal memo to its own dialysis centers that linked improper use of the dialysate to an increase in risk of sudden cardiac arrest in dialysis patients.

But Fresenius did not alert other dialysis centers of its findings until March 2012, when the U.S. Food and Drug Administration initiated a Class I recall.

Read also: DaVita Rx under investigation for false claims of prescription drugs 

“The Defendants purposefully advised their own clinics, practitioners, and physicians of the dangers of the product, but did not advise non-Fresenius clinics, practitioners, and physicians of the increased risk of (cardiopulmonary arrest) associated with the use of their products, ” The attorney general for  Louisiana wrote when the state joined other class action suits in July 2014.

“GranuFlo and NaturaLyte received appropriate FDA clearance before they were initially marketed, and that clearance remains in effect,” FMC spokesperson Kent Jarrell told NN&I in July 2014.”The FDA has not suggested any change in the production formulation or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care. Additionally, the FDA has not found or suggested a defect in the design or composition of GranuFlo and has not suggested or required any change in the composition of GranuFlo.”

“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the FDA’s medical devices division, said in an interview with the New York Times in June 2012. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”