Fresenius Medical Care North America, the manufacturer of GranuFlo advertises this dry acid product on its website by unabashedly stating, “GranuFlo is the most-widely prescribed dry acid product in the dialysis industry today. Its unique composition of evenly distributed electrolytes is the result of our exacting production technology. With GranuFlo’s distinctive proportional component blend in each bag, you have made the safest choice for onsite concentrate mixing. Safe for your patients and your staff, our utilization of dry Sodium Diacetate eliminates the need for hazardous liquid glacial Acetic Acid, making GranuFlo the safest dry acid product.”
What the above statement fails to consider is that on March 29, 2012, the United States Food and Drug Administration (FDA) issued a recall of GranuFlo manufactured and distributed from January 2008 through June 2012 (serial numbers ranging from: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B). The FDA states that the reason for the recall as follows: “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is 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. This product may cause serious adverse health consequences, including death.”
An article in The New York Time, dated June 14, 2012, had the following to say about GranuFloand Fresenius Medical Care North America: The Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products, an F.D.A. official said. The company, Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis.” Thus, there is little room for doubt that GranuFlo is quite a lucrative product forFresenius Medical Care North America.
The 2012 Annual Report for Fresenius Medical Care North America had this to say about theGrauFlo lawsuits: “On December 12, 2012, a group of plaintiffs’ counsel filed a petition to form a federal multidistrict litigation and thereby consolidate certain lawsuits alleging wrongful deaths and personal injury claims against FMCH and its affiliates. The complaints to be consolidated for pre-trial management allege generally that inadequate labeling and warnings for FMCH’s dialysate concentrate products Naturalyte and GranuFlo caused harm to patients. In addition, a substantial number of similar state court cases have been filed that cannot be formally consolidated with the federal cases. FMCH believes these lawsuits are without merit, and will defend them vigorously.”
If you or a loved one has been dialyzed with a dialysis unit that was using GranuFlo and suffered a cardiac event (heart failure, heart attack, myocardial infarction, etc.) during dialysis or within twelve hours of being dialyzed, you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from the manufacturer of this GranuFlo. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.