On February 16, 2016, a day after a bellwether trial was scheduled to begin in Massachusetts federal court, Fresenius Medical Care announced a proposed $250 million settlement in multidistrict litigation over side effects from its dialysis drugs GranuFlo and NaturaLyte.
The plaintiffs accused Fresenius of concealing knowledge that after taking GranuFlo and NaturaLyte, the patient’s body can produce chemical compounds that could eliminate too much acid in the blood, Law360 reports.
The plaintiffs claim Fresenius concealed its knowledge that chemical compounds produced in the body after taking GranuFlo and NaturaLyte could cause too much acid to be eliminated, creating an electrical imbalance that could cause the heart to stop beating. Fresenius issued warnings about this in 2011 and 2012, though the warnings were not based on studies it had conducted, but on research conducted by doctors and the U.S. Food and Drug Administration (FDA). The company said it continues to doubt the science behind those findings, according to Law360.
The agreement calls for $250 million to be awarded to the plaintiffs if 97 percent of those eligible agree to the terms by July 2016. The funding would be provided the following month, Law360 reports. About $220 million would come from insurance companies; Fresenius would pay about $60 million for the remaining settlement amount and associated costs.
Fresenius says it stands behind the safety of GranuFlo and NaturaLyte. Fresenius said GranuFlo and NaturaLyte remain on the market and continue to be “the market leader for dialysis acid concentrates in the United States.” The company expects revenues of about $16.7 billion for 2015. Fresenius says there has been no change in the composition of either product, Law360 reports. GranuFlo/NaturaLyte “remains safe and effective when used and prescribed as directed.” In the lawsuit, the plaintiffs say that while dialysis patients require the blood-filtering treatment to reduce acid levels in their blood, eliminating too much acid can also be dangerous.
The U.S. Judicial Panel on Multidistrict Litigation consolidated GranuFlo and NaturaLyte claims in the Massachusetts court in 2013. The MDL eventually absorbed suits filed by patients, relatives, and attorneys general from Louisiana and Mississippi, but U.S. District Judge Douglas P. Woodlock returned those cases to those states last year.
Fresenius is pleased to put the litigation behind it, company spokesman Kent Jarrell told Law360.