Risk of Dialysis Drug Fresenius has agreed to pay $250 million to settle lawsuits alleging it hid information involving the risks of its dialysis drugs, GranuFlo and NaturaLyte. Dialysis is a treatment that essentially acts as an artificial kidney. Patients who have renal failure undergo dialysis in order to remove wastes from the blood, such as excess acid. According to the lawsuits, Fresenius knew that GranuFlo and NaturaLyte could remove too much acid from the blood, leading to an electrical imbalance and heart failure.
Blood pH must be maintained within a very narrow range, or serious problems will arise. The kidneys play an important role by excreting excess acid or base when needed.
In 2011 and 2012, Fresenius issued warnings over GranuFlo and NaturaLyte
In 2011 and 2012, Fresenius issued warnings over GranuFlo and NaturaLyte. Law360 reports these notifications were based on research performed by outside doctors and the U.S. Food and Drug Administration (FDA), not Fresenius.
According to Law360, the agreement was announced a day after a bellwether trial was slated to begin in Massachusetts federal court. Fresenius said it would pay $250 million if at least 97 percent of plaintiffs agreed to the terms by July 2016. The funding would be provided the following month, and $220 million of the settlement would be contributed by insurers. Fresenius Medical Care Holdings, Inc. said it would pay $60 million to complete the settlement and related costs.
In 2013, GranuFlo and NaturaLyte lawsuits were consolidated into a multidistrict litigation in Massachusetts. Mississippi and Louisiana cases were then added to the MDL, but later remanded.