Sudden cardiac death is the leading cause of death for dialysis patients. However, a recent investigation by the U.S. Food & Drug Administration (FDA) has raised questions about why patients were dying – from Granuflo Cardiac Arrest or Cardiopulmonary Arrest – when using products manufactured by Fresenius Medical Care North America (FMC). FMC is a division, and the largest division, of German headquartered Fresenius Medical Care AG (FMC AG). FMC AG is the largest dialysis services and products company in the world. This is most significant because the company reportedly owns thousands of dialysis clinics, manufactures dialysis machines and many, if not all, of the medical products used for the treatment of patients requiring dialysis.
This includes dialyzers, needles, lines where the blood flows through the machines and the dialysis concentrate. Granuflo is a trademarked acid concentrate used in dialysis. Widespread use, control of the distribution chain and a corporate culture of putting profits over safety, as alleged in lawsuits and described below, may have lead to hundreds of deaths.
RenalWeb, is a website dedicated to providing dialysis information and information on related products. On May 18, 2012,Gary Peterson posted Part I of a two part article, that began putting together information and allegations that are part of an emerging picture about FMC, Granuflo Acid Concentrates and Naturalyte Liquid. The RenalWeb article, “Dialysis Patient Survival is Better at Fresenius Medical Care Clinics Because…Part I“, pre-dates a New York Times Story, “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry“, discussed on our blog here, and opens by claiming that a Fresenius Internal Memo dated November 4, 2011, supports the idea that “FMC had knowledge that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with their Granuflo dialysis concentrate product that contains sodium diacetate“.
According to Gary Peterson, the relationship between the use of Granuflo, sudden cardiac arrest, or cardiopulmonary arrest, and alkalosis was made in 2010. However, the RenalWeb post suggest that:
Only after an inquiry, from the FDA on March 27, 2012, did Fresenius sent an ambiguous memo to non-FMC clinics alerting them to the potential problem, on March 29, 2012. In contrast to the Internal Memo discussed above, the “other” Memo contained only 1 of 10 medical references and provided a self serving “Reply Form” requesting receipt and acknowledgment of the contents.
In June 2012, the U.S. Food & Drug Administration (FDA), issued a Granuflo Class 1 Recall of Granuflo Acid Concentrate and Naturalyte. A Class 1 Recall is the most serious type of market withdrawal because it involves situations in which there is a reasonable probability that use of the product will result in death or serious adverse health consequences. At the time, the FDA noted the following as the reason for the recall:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hyposemia, hypercapnia and cardiac arrhythmia, which if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”
FDA’s investigation, and the Granuflo Class 1 Recall of Granuflo Acid Concentrate and Naturalyte came only after months of inaction, as noted above and in RenalWeb.
Granuflo Lawsuits, against Fresenius Medical Care North America (FMC). FMC and/ or Fresenius Medical Care AG(FMC AG), have been initiated and stem from the allegations noted above. Our Granuflo Lawyers are actively screening and evaluating cases involving patients that suffered a cardiac arrest, or cardiopulmonary arrest, following kidney dialysis. We are accepting cases and referrals of Granuflo case and undertaking Granuflo Investigations on behalf of patients and surviving victims.