On June 25, 2012 the Food & Drug Administration issued a recall for two drugs commonly used in the dialysis treatment process. The drugs GranuFlo and NaturaLyte are used in the treatment of acute and chronic renal failure during hemodialysis. These drugs were manufactured and distributed by Fresenius Medical Care North America which also used the drugs in numerous dialysis clinics they own across the United States.
Serious and sometimes fatal heart attacks and other serious cardiopulmonary complications have been associated with the use of these drugs in dialysis patients. Most adverse reactions or heart attacks occurred either during the dialysis process or within 48 hours of receiving the now recalled drugs during the dialysis process. The recall for these drugs was listed as a Class 1 recall. These are the most serious type of recall reports issued by the FDA and involve situations in which there is a "reasonable probability that the use of the product in issue will cause serious adverse health consequences or death."
In 2010 Fresenius documented 941 incidents of cardiac arrest among GranuFlo patients at their dialysis facilities. An internal memorandum from Fresenius to its own dialysis clinics indicates the company knew that the drugs increased the risk of cardiopulmonary arrest and sudden death but the company did not "disclose" this information until 2012 after the internal memo was leaked to government sources.
There are currently a number of claims for victims and their families pending in State courts across the country but as of this posting no Federal District Court has been assigned to the Multi-District Litigation (MDL) of this matter.
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