An out of court settlement has been reached between Fresenius Medical Care and U.S. plaintiffs of multiple class action lawsuits.
The lawsuits being pursued throughout the nation were on behalf of individuals who suffered cardiac arrest or a heart attack after dialysis treatment as a side effect of the FMC’s dialysate brands, GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte are dialysates (fluids used in dialysis that clean the blood). Back in March 2012, the FDA recalled both products in order to revise prescribing instructions. The recall stated that use of the products could lead to low blood pressure and cardiac arrhythmia, which in turn could lead to cardiopulmonary arrest and death.
The lawsuits began after it was discovered that Fresenius was well aware of the risks involved. An internal company memo from November 2011 disclosed that 900 patients had experienced heart attacks in the previous year at company clinics the previous year. The company was shown to have knowledge about the risk of problems with GranuFlo and NaturaLyte.
The products convert to bicarbonate at a higher-than-expected level, requiring close monitoring of dialysis patient’s bicarbonate buffer prescriptions in order to reduce the risk of cardiovascular problems. Though the companies own clinics were provided with this information, Fresenius failed to provide warnings to other clinics until March 2012.
Fresenius reached the agreement with a committee designated by the plaintiffs to resolve litigation. The settlement amount would be $250 million, with $220 million to be funded by insurers. 97% of the plaintiffs must agree to the settlement by July 2016.