Fresenius Medical Care has agreed to pay $250 million to settle multidistrict litigation (MDL) alleging its dialysis concentrates GranuFlo and NaturaLyte caused patients’ hearts to stop beating. The settlement was reached a day after a bellwether trial was scheduled to begin in Massachusetts federal court. The $250 million settlement will get approved if at least 97 percent of Plaintiffs agree to the terms by July 2016. Payments would be dispersed the following month. Fresenius, the world’s largest provider of dialysis products and services, expects to generate about $16.7 billion in revenues for 2016.
GranuFlo and NaturaLyte are used during dialysis treatment to help balance chemicals in the blood. The products are used in both Fresenius-owned and non-Fresenius owned dialysis centers across the country. Lawsuits in the multidistrict litigation alleged that the products can cause too much bicarbonate to build up in the blood, resulting in heart risks including sudden cardiac arrest. Fresenius has been slapped with hundreds of wrongful death and personal injury lawsuits alleging the company concealed these risks from doctors and patients.
Fresenius claims that it issued warnings in 2011 and 2012, but the warnings were not based on studies the company conducted but on information compiled by the Food and Drug Administration (FDA) and outside researchers. As expected, the company says it questions the validity of that research.