The Philadelphia products liability attorneys at Galfand Berger recently became aware that the United States Food and Drug Administration (FDA) have issued the most serious type of recall, a Class 1 recall, for two popular products that are used in kidney dialysis treatments. At the center of this recall are the products, GranuFlo and NaturaLyte, and a German company, Fresenius Medical Care, who is the largest dialysis company in the nation and the manufacturer of both of the products.
The dialysis products, NaturaLyte Liquid Acid Concentrate and GranuFlo Powder Acid Concentrate, are manufactured as dialysates for the purpose of being used during kidney dialysis. Hemodialysis is a medical treatment used to treat acute or chronic kidney failure with the goal of removing waste products from a patient’s blood that the diseased kidneys can no longer do. This medical procedure needs to be performed while under the direct care of a physician and involves the use of a hemodialysis machine along with a dialysate solution. Bicarbonate is administered during dialysis to neutralize the acid that builds up in the blood.
Fresnius was aware that 941 hemodialysis patients had suffered cardiac arrests in their own clinics in the year 2010. They conducted an analysis of this group comparing them to 80,000 other dialysis patients. It was determined that NaturaLyte and GranuFlo could create more bicarbonate buildup than some of the other dialysis products on the market. They concluded that dialysis patients with increased concentrations of bicarbonate in their blood had about six times the risk of suffering a cardiac arrest as compared to those with lower concentrations.
In November 2011, they sent an internal memo to their own dialysis clinics warning physicians that their products carried an increased risk of fatal health consequences and urged the physicians to take the necessary precautions when prescribing the dialysate solutions. However at that time, they did not notify customer companies that used their products or the FDA. It is estimated that approximately 125,000 patients in non-Fresenius clinics are treated with GranuFlo. Thousands of patients’ lives were left at risk. Thankfully, an anonymous copy of the memo was leaked to the FDA, and an investigation was started by the agency. Finally, four months later in March 2012 after being questioned by the FDA, the company notified the other dialysis centers and physicians of the increased risks associated with their products. The FDA issued a Safety Communication warning in May 2012 followed by the official recall in June 2012.
When too much bicarbonate builds up in a patient’s body, it can lead to a condition known as metabolic alkalosis which in turn can lead to heart attacks and other cardiac problems. Both of the dialysis products have been linked to causing this alkalosis. The adverse side effects associated with the use of these products include low blood pressure, decreased levels of potassium in the blood, stroke, irregular cardiac rhythms, heart attacks, and death.
If you or a loved one has suffered a loss or serious side effects including a heart attack or cardiac arrest from GranuFlo or NaturaLyte, we encourage you to contact our products liability attorneys to determine if you have a valid claim against the company. Our team of highly skilled and experienced personal injury lawyers will guide you through the complex litigation process with the goal of securing you the proper compensation that you deserve. Our offices are conveniently located in Philadelphia, Reading, and Bethlehem, Pennsylvania. Call the products liability attorneys at Galfand Berger today at 1-800-222-USWA (8792) to schedule a free and confidential consultation or submit a free online inquiry.