Fresenius Medical Care, the manufacturer and distributer of the recalled hemodialysis drug, GranuFlo, is facing hundreds of lawsuits alleging that the company neglected to warn consumers about dangerous risks associated with the use of the drug. GranuFlo is used during hemodialysis to lower the acidity in the patient’s blood during treatments.
Some of those who were administered GranuFlo during hemodialysis have tested positive for high concentrations of acetone in the blood. Elevated levels of acetone can lead to abnormal bicarbonate levels in the blood, and high bicarbonate levels are known to cause serious or even fatal complications such as heart attack, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, and low blood pressure. Another dialysis drug manufactured by Fresenius, NaturaLyte Bicarbonate Concentrate, is also the subject of numerous lawsuits alleging that it caused similar, dangerous side effects that were also not initially warned of by the company.
An internal company memo written in 2011 to Fresenius executives—made public by the FDA—concluded that the chances of death by cardiopulmonary arrest from the use of GranuFlo were six times more likely to occur in patients who were administered the drug during a hemodialysis treatment. Following an investigation in 2012 into the effects of the drug, the FDA issued a Class I recall on GranuFlo. A Class I recall is the most serious of the FDA recalls. The FDA explained 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.
Federal lawsuits regarding the drug have been consolidated in Multidistrict litigation (“MDL”) in the U.S. District Court, District of Massachusetts in In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428). More than 450 claims alleging serious cardiovascular injuries stemming from use of the dialysis medications have now been filed in the federal proceeding on behalf of patients and their families.
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