Fresenius Medical Care said that it has reached a $250 million agreement in principle to settle multidistrict litigation over the alleged side effects from the dialysis drugs GranuFlo and NaturaLyte. This news came on February 16, 2016, a day after a bellwether trial was scheduled to begin in Massachusetts federal court.
Fresenius was accused of concealing knowledge that chemical compounds produced in the body after taking GranuFlo and NaturaLyte could eliminate too much acid in the blood, Law360 reports.
The agreement calls for $250 million to be given to the plaintiffs if 97 percent of them agree to the terms by July 2016. The funding would be provided the following month. Insurers would contribute $220 million to the settlement, leaving Fresenius to pay about $60 million to complete the settlement and the associated costs, according to Law360.
On February 17, Fresenius said it stands behind the safety of the drugs at issue and expects revenues of about $16.7 billion for 2015. Fresenius said GranuFlo /NaturaLyte “remains on the market and continues to be the market leader for dialysis acid concentrates in the United States.” There has been no change in been the composition of the product, Law 360 reports, and Fresenius says the product “remains safe and effective when used and prescribed as directed.” The plaintiffs had said that dialysis patients require the blood-filtering treatment to reduce acid levels in their blood but eliminating too much acid can also be dangerous.
According to the plaintiffs, Fresenius concealed its knowledge that chemical compounds produced in the body after taking the company’s drugs could cause too much acid to be eliminated, creating an electrical imbalance that can cause the heart to stop beating. In 2011 and 2012 Fresenius distributed warnings that were based not on studies it had conducted, but came from research performed by doctors and the U.S. Food and Drug Administration (FDA). The company said it continues to doubt the science behind those findings, Law360 reports.
In 2013, the U.S. Judicial Panel on Multidistrict Litigation consolidated GranuFlo and NaturaLyte claims in Massachusetts, and the MDL eventually absorbed suits filed by patients, relatives, and attorneys general from Louisiana and Mississippi, but those states convinced U.S. District Judge Douglas P. Woodlock to remand their cases last year.
Fresenius spokesman Kent Jarrell told Law360 that the company is pleased to put the litigation behind it.