A day after a bellwether trial was to begin Fresenius Medical Care announced it had reached a $250 million settlement with plaintiffs in a multidistrict litigation (MDL) alleging the company’s dialysis products GranuFlo and NaturaLyte caused life-threatening side effects. In order for the settlement to be resolved, 97 percent of the plaintiffs must agree to the terms by July 2016.
“This is a good resolution for the people who were injured, or who lost someone they cared about as a result of Fresenius’ failure to warn physicians and patients about the dangers associated with these products,” said attorney Frank Woodson, Principal at Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. “This company had a responsibility to put the care of its patients as its first priority, and obviously it failed to do that.”
Fresenius’ GranuFlo and NaturaLyte are administered to patients undergoing dialysis to help balance electrolytes in the blood. Plaintiffs in the multidistrict litigation claimed that the products could cause a buildup of bicarbonate in the blood, increasing the risk of an electrical imbalance in the body that could lead to sudden cardiac arrest, a fatal condition in which the heart stops beating.
Plaintiffs alleged that Fresenius was aware of the heart risks with its dialysis concentrates but withheld this information from the public. Fresenius had argued that the warnings it issued in 2011 and 2012 were not based on studies it conducted but rather outside research performed by federal regulators.
Fresenius is the world’s largest provider of dialysis products and services, and generated about $16.7 billion in profits for 2015. The company said it continues to doubt the science behind the warnings, but agreed to settle the MDL in order to put the litigation behind it.
In 2013, the lawsuits were consolidated in Massachusetts by the U.S. Judicial Panel on Multidistrict Litigation. The MDL later absorbed suits filed by patients, relatives and the attorneys general of Louisiana and Mississippi. Last year the states’ cases were remanded by a U.S. district judge.