The number of lawsuits on behalf of those who suffered severe cardiac problems associated with GranuFlo and NaturaLyte continues to grow.
Consolidated federal lawsuits against Fresenius Medical Care, the maker of GranuFlo and NaturaLyte dialysis additives, now includes more than 430 individual claims, according to a case list updated by the U.S. Judicial Panel on Multidistrict Litigation on Dec. 16, 2013. Cases in the federal proceedings allege that Fresenius failed to warn about the potentially deadly effects of GranuFlo and NaturaLyte, which were administered to hundreds of thousands of dialysis patients in Kentucky, Indiana and nationwide.
Last year, GranuFlo and NaturaLyte were the focus of a Class I recall initiated by the U.S. Food and Drug Administration (FDA). Class I is the highest form of recall, and according to the FDA is issued in “situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.”
Health complications cited in pending GranuFlo and NaturaLyte lawsuits include heart attack, stroke, sudden cardiac arrest and cardiac arrhythmia. Some of the cases against Fresenius were filed on behalf of families whose loved ones died due to cardiac events following treatment with GranuFlo or NaturaLyte.
Mounting evidence suggests that Fresenius was aware of the potential health risks of GranuFlo and NaturaLyte for years prior to the recall, but withheld that information from physicians and patients. Fresenius itself owns and operates a number of dialysis clinics, but GranuFlo and NaturaLyte were also sold to other dialysis centers outside of the Fresenius network.
For additional information about lawsuits related to faulty pharmaceuticals and medical products, please see Dangerous Drugs and Defective Medical Devices.