On June 27, 2012, the FDA issued a recall for Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo. These products are made by the Fresenius Medical Care North America Company. Evidence shows that Fresenius Medical Care Company knew of the dangers associated with these products yet failed to tell their patients or report the issues to the FDA.
The Fresenius Medical Care North America Company (FMC) is the nation’s largest operator of dialysis centers. More than a third of the estimated 400,000 Americans who receive dialysis get treated at one of these company’s facilities. FMC makes GranuFlo and NaturaLyte, which are dialysis treatments used in clinics across the United States.
The FDA issued this Class I recall because a high level of serum bicarbonate can contribute to metabolic alkalosis. During dialysis, blood is filtered outside of the body. Bicarbonate is an alkaline substance which is administered to neutralize acid that has built up in the blood. According to research and studies completed, a high level of bicarbonate has been linked to issues with the heart. This can lead to serious health consequences including death. A Class I recall is the most serious and is issued only when “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.” The FDA determined that GranuFlo was too unsafe to remain on the market any longer.
Gary Peterson, in an article with RenalWeb, mentions how FMC knew that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with Granuflo and NaturaLyte. Cardiac arrest can be a devastating complication with these treatments. An internal memo from FMC dated November 4, 2011 shows that top FMC officials knew about the source of this potential problem. After the products went through testing, FMC executives did not properly report the problems to the FDA and, furthermore, failed to notify other agencies and physicians that were not part of FMC and that used Granuflo products.
If you have suffered a heart attack or if you have lost a family member to sudden cardiac event after undergoing dialysis, we can help. Contact us at 800-641-0098 for a free case evaluation and consultation. Our experienced attorneys will work closely with you and fight for the maximum compensation on your behalf.