On June 27, 2018, a federal jury in Denver, Colorado returned its verdict in the amount of $383.5 million in favor of the families of three dialysis patients who suffered cardiac arrest and died after they received dialysis treatment at DaVita dialysis clinics using GranuFlo that the plaintiffs alleged DaVita knew could cause caustic toxic pH imbalances and alkalosis in the dialysis patients it treated.
The case was filed in the U.S. District Court for the District of Colorado. The compensatory damages verdicts for the three families ranged from $1.5 million to $5 million. The jury also awarded puntive damages against DaVita in the amount of $125 million for each of the families.
The federal wrongful death lawsuits were filed in 2013 and alleged that DaVita failed to protect its dialysis patients by failing to inspect and review the composition of GranuFlo and notice changes, and failed to notice a significant increase in patients’ bicarbonate blood levels when they returned for dialysis treatments as well as increases in complications, including deaths, suffered by patients.
DaVita has stated through its attorneys that it plans to appeal the verdicts.
GranuFlo Dry Acid Concentrate is a component of dialysate. Dialysate is a solution prescribed by physicians for use in the treatment of acute and chronic renal failure during the hemodialysis procedure. The dialysate solution is used in combination with the hemodialysis machine and dialyzer to remove wastes from the blood.
Dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis. These substances typically are found in acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate.
The FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate, stating that “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.”
On May 25, 2012, the FDA notified health care providers “to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription. The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.”
If you or a loved one may have been harmed as a result of GranuFlo in the United States, you should promptly find a defective drug claim lawyer who may investigate your GranuFlo claim for you and represent you or your loved one in a GranuFlo case, if appropriate.
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