GranuFlo and NaturaLyte Cause Trouble for Da Vita Healthcare
Related to lawsuits filed against Fresenius Medical Care in connection with its dialysis products GranuFlo and NaturaLyte, lawsuits are now being filed against the dialysis treatment center, Da Vita Healthcare, in connection with their administration of GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte are drugs used in hemodialysis to treat patients suffering from kidney disease and/or failure. The products were recalled by the FDA in March 2012 mandating revisisons to prescribing instructions to include the health risks connected with the use of these drugs. This was due to an investigation conducted by the FDA with results indicating that use of GranuFlo and NaturaLyte can lead to a heart attack. This risk is due to an ingredient in the drugs that can lead to metabolic alkalosis, which produces high levels of bicarbonate, increasing the risk of heart attack.
The FDA recall was worded 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.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.”
As previously reported by Audet and Partners, LLP, the lawsuit filed against Fresenius Medical Care alleges that prior to the FDA’s recall, Fresenius was aware of the potential risks and failed to inform patients and healthcare providers. “Plaintiffs allege that the manufacturer intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
Recent lawsuits filed against DaVita allege that it acted negligently through its alleged knowledge that high levels of bicarbonate can cause heart attack, and that the necessary amount of patient supervision, action to eliminate this risk, and/or appropriate treatment during GranuFlo and/or NaturaLyte administration were not provided.
Johnny Williams of Alabama was treated with these drugs at a DaVita dialysis center in June 2010; one month after treatment began, Johnny suffered a heart attack and died. His wife, Arthurine Williams, as administrator of Johnny’s estate, subsequently filed a lawsuit against Fresenius.
According to DaVita, “As of December 31, 2012, DaVita operated or provided administrative services at 1,954 outpatient dialysis centers located in the United States serving approximately 153,000 patients. The company also operated 36 outpatient dialysis centers located in five countries outside the United States.”