GranuFlo/NaturaLyte Current Case Update:
- Reports of heart attack and death led the FDA to recall GranuFlo Concentrate and NaturaLyte Liquid on June 27, 2012, which are products commonly used during dialysis.
- Because of this knowledge and their decision to not inform patients of this issue until March 2012, Fresenius has now found itself opened to numerous lawsuits across the nation.
- It is estimated that 125,000 patients throughout the United States were prescribed Fresenius products before the 2012 recall, leaving tens of thousands possibly effected.
- These lawsuits may eventually be consolidated into a NaturaLyte of GranuFlo class action lawsuit, a state-wide mass tort or a federal multi-district litigation.
- Recently Fresenius settled a wrongful death case for seven figures to the surviving children of Teresa Gayton, a mother of five who died during a dialysis treatment at a Fresenius Medical Care facility in Illinois.
Manufactured by the German medical care company, Fresenius, NaturaLyte Liquid Acid Concentrate and GranuFlo Powderized Acid Concentrate, are dialysates that were being used during kidney dialysis to remove wastes from the blood of patients with acute or chronic renal failure. NaturaLyte is the liquid form of the product and GranuFlo is the powder form.
Facts about GranuFlo/NaturaLyte:
- These products have been shown to increase levels of sodium bicarbonate in the blood which can lead to irregular heartbeat, heart attack, stroke and death.
- The FDA’s warning regarding the recall states that high bicarbonate levels are, “a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest.” The condition is known as metabolic alkalosis.
- Class I recalls are the most serious type of FDA product recalls and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences and death.
- As a result of the dosing complications, the use of GranuFlo and NaturaLyte products during the dialysis treatments resulted in a four to six times greater risk of cardiopulmonary death or cardiac arrest.
- In 2010 alone, a reported 941 patients had suffered heart attacks while undergoing treatment at FMC clinics around the country.
- An internal Fresenius memo from 2011 stated that Fresenius had knowledge that there was a significant increased risk of sudden cardiac arrest and death associated with the use of GranuFlo during dialysis treatments.
If you or a loved one has experienced sudden cardiac arrest or if someone has died within 72 hours of dialysis that occurred resulting from the use of GranuFlo Concentrate or NaturaLyte Liquid, please contact the Miller Firm LLC now.