A dialysis company failed to warn of the risk their product could cause despite knowledge of the risk. On June 27, 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo Acid Concentrate.
The recall was announced because an inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. High serum levels can lead or contribute to metabolic alkalosis. This is a significant risk factor which is associated with low blood pressure, hypoxemia, cardiac arrhythmia, hypokalemia, and hypercapnia. If these are not treated correctly, they can lead to cardiopulmonary arrest; in some cases, death.
Fresenius failed to warn their patients of these adverse health consequences. Evidence shows the company knew of these potential concerns as early as November 4, 2011. The Fresenius Medical Care Medical Office wrote an internal memo to the medical directors and attending physicians of their facilities. The memo addressed dialysate bicarbonate, alkalosis and patient safety. The internal memo came to this conclusion:
“Recent analyses preformed using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia. The major cause of metabolic alkalosis in dialysis patients is inappropriately high dialysate total buffer concentration. As recommended in previous communications, physicians should individualize dialysate bicarbonate and total buffer prescriptions. We further recommend that pre-dialysis serum bicarbonate level of >24 mEg/L should prompt immediate review of dialysate bicarbonate prescription.”
The company’s internal memo concluded: 1) Pre-dialysis serum bicarbonate levels imply more patients have alkalosis prior to dialysis and an even higher percentage of those patients have alkalosis post- dialysis. 2) Elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with a 6 to 8 fold greater risk of CP arrest as well as sudden cardiac death in the dialysis facility. A copy of the memo can be found here
Evidence clearly shows that Fresenius knew about these risks and failed to warn their patients. If you or someone you love has used these products and has suffered adverse effects, you may be entitled to compensation. Feel free to contact us at (800) 641-0098.