One of the country’s largest dialysis operators, German-based Fresenius Medical Care, was recently investigated by the nation’s Food and Drug Administration (FDA) in response to a number of patient deaths. Following the investigation, the FDA issued a Class I recall for the company’s Naturalyte GranuFlo Acid Concentrate and Naturalyte Liquid Acid Concentrate products. The products are used to aid in the elimination of waste during the hemodialysis procedure. According to the FDA, they may also potentially raise serum bicarbonate levels in patients undergoing dialysis. A higher serum bicarbonate level can lead to cardiac arrest and death in some patients.
Fresenius Medical Care treats more than one-third of the approximately 400,000 dialysis patients across the United States. The company also reportedly supplies many of the dialysis machines and pharmaceutical products used at other dialysis centers nationwide. In fact, an estimated 125,000 patients are treated using GranuFlo or Naturalyte in non-company medical care centers every year.
According to an FDA official, Fresenius Medical Care is accused of failing to warn dialysis patients of the potentially fatal risks associated with use of its GranuFlo and Naturalyte products. In 2010, 941 dialysis patients who were treated with GranuFlo or Naturalyte experienced cardiac events inside of a Fresenius Medical Care clinic. Despite that the company sent an internal memorandum to warn of the heart risks associated with its products to its own dialysis center doctors, Fresenius Medical Care allegedly failed to notify other dialysis centers or the FDA.
Steven Silverman, the FDA’s Director of Compliance in the Medical Devices Division, stated it was quite troubling that Fresenius Medical Care failed to warn its entire customer base about the health risks associated with the GranuFlo and Naturalyte products. The company’s Chief Medical Officer, Dr. Franklin Maddux responded that the health risks were too preliminary to warrant publication in medical journals and Fresenius Medical Care had no other avenues through which to communicate with outside doctors who were using the product.
In March 2012, Fresenius Medical Care finally issued a warning to customers regarding the alleged increase in heart attack risk associated with use of the company’s products. In May, the FDA issued a safety alert for products such as Granuflo. The following month, a Class I recall was issued for GranuFlo and Naturalyte. A Class I recall is issued when there is a reasonable likelihood that exposure to a drug or medical product will result in a serious health complication or death.
Potential GranuFlo and Naturalyte lawsuits are being evaluated throughout the United States for health risks that may be associated with use of the products. If you or a loved one suffered a cardiac event after being treated with GranuFlo or Naturalyte, you should contact a qualified personal injury lawyer as soon as possible.