An estimated 400,000 Americans, including patients here in Pennsylvania, are receiving dialysis presently. Fresenius Medical Care, a German manufacturer as well as the nation’s largest operator of dialysis centers, is coming under intense scrutiny surrounding their handling of specific products used to aid dialysis patients.
Reportedly, one of the products commonly used in dialysis, GranuFlo, which is intended to aid the removal of toxins from the kidneys, was meant to be used in a manner that proved unfamiliar to a large number of doctors. Therefore, a high volume of errors were occurring in the use of the product, leaving thousands of patients susceptible to cardiac arrest and death due to a dangerous concentration of bicarbonate in the blood.
The company is coming under severe scrutiny from the Food and Drug Administration because it appears the manufacturing company knew the risks but did not alert all the appropriate parties to protect patients and save lives. An internal memo that was issued across the manufacturer and it’s clinics in Nov. 2011 showed that the company had knowledge that GranuFlo can cause this dangerous concentration when not properly used. Yet, the product was not recalled, nor was the message spread more broadly, until the memo was leaked sometime later.
According to the New York Times, the memo circulated throughout the company reported that 941 patients suffered cardiac arrest inside Fresenius’ clinics in 2010. Family members of victims that have died under these circumstances are crying foul, and seeking recourse in the face of what they feel is negligence. If an individual in Pennsylvania suspects that their loved one could have died under similar circumstances, they may wish to consult experienced legal counsel.
Source: The New York Times, “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” Andrew Pollack, June 14, 2012