FRESENIUS MEDICAL CARE, THE MANUFACTURER OF THESE DIALYSIS PRODUCTS, GRANUFLO AND NATURALYTE FAILED TO WARN THAT THESE DIALYSIS SOLUTIONS WERE PRODUCING TOO HIGH LEVELS OF BICARBONATE IN THE BODY.
Did you or someone you love undergo dialysis with GranuFlo or NaturaLyte at a suffer a sudden heart attack or cardiac arrest while undergoing kidney dialysis treatment? Contact our skilled GranuFlo/NaturaLyte lawsuits attorneys today.
Fresenius’ two dialysis products GranuFlo and NaturaLyte, regulated by the Food & Drug Administration (FDA) as medical devices, are acid concentrates used with bicarbonate concentrates in kidney dialysis. They are unique in that they contain sodium diacetate instead of acetic acid like most dialysis concentrates. In the body, every molecule of acetate is converted by the patient’s liver into a single molecule of bicarbonate. The net effect of the additional bicarbonate administered to patients by GranuFlo’s addition of sodium diacetate is that, over time, a significant number of dialysis patients develop unexpectedly high levels of bicarbonate in their blood. Patients with high bicarbonate levels in their blood suffer from metabolic alkalosis (the opposite of acidosis), which increases a patient’s risk of heart arrhythmia, cardiopulmonary (CP) arrest, or sudden cardiac arrest.
Fresenius knew there was a problem with bicarbonate levels and knew its own clinics were confused about its instructions regarding the bicarbonate delivery during dialysis. An internal memorandum at Fresenius, sent only to the directors and attending physicians of their dialysis clinic in November 2011, revealed that its patients’ serum pre-dialysis bicarbonate levels gradually increased from 2004 to 2011, and found that that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010.
GranuFlo and NaturaLyte Recalls
In June 2012, the FDA issued a class I recall of GranuFlo and NaturaLyte. While the GranuFlo and NaturaLyte recall will not involve removal of the products from the market, the FDA has issued the most serious type of recall for the products. According to the FDA,’s communication, inappropriate dosing of GranuFlo or NaturaLyte can cause bicarbonate in the blood to rise to dangerous levels, resulting in metabolic alkalosis, and can lead to heart attack, stroke, cardiopulmonary arrest, dangerously low blood pressure and sudden cardiac death.
All federally filed lawsuits involving GranuFlo and NaturaLyte have been consolidated in a federal multi-district litigation (MDL) in the District of Massachusetts. Our lawyers have extensive experience at all levels.
If you or someone you love suffered sudden cardiac arrest while undergoing dialysis with GranuFlo or NaturaLyte, contact our attorneys at Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters today to determine whether you may have a claim against Fresenius Medical Care. Our Williamsport, Pennsylvania, office is ready to guide you through your case.