National dialysis provider DaVita Inc. was recently ordered to pay $383.5 million to the families of three patients who died after they were treated with a solution called GranuFlo.
A federal jury in Denver on June 27 sided with plaintiffs who lost family members after receiving the treatments at DaVita clinics.
The patients suffered cardiac arrests, according to a statement from Hagens Berman, a law firm representing the plaintiffs.
“DaVita ignored many red flags that preceded the loss of life of these three patients and many others,” lead trial attorney Rob Carey of Hagens Berman said in a statement.
DaVita Inc. pledged to appeal the verdicts issued in the U.S. District Court for the District of Colorado.
“GranuFlo is an FDA-approved product that has been in continuous use for more than 25 years,” DaVita Inc. said in a statement. “The issues raised regarding its alleged negative clinical side effects have been debunked and nephrologists use it daily for their patients. The plaintiffs in this case did not even claim that the product itself was dangerous.”
Each family was awarded $125 million in punitive damages, and $1.5 million to $5 million in compensatory damages.
GranuFlo is the brand name of a solution given to patients to replace lost fluids and minerals while they are receiving dialysis. Dialysis involves using a machine to filter the blood of people whose kidneys can no longer perform that task.
DaVita Inc., a Fortune 500 company, is the parent of DaVita Kidney Care, a provider of services to patients with chronic kidney failure and end-stage renal disease.
DaVita Kidney Care operates or provides services at 2,539 outpatient dialysis centers in the United States serving nearly 200,000 patients. It also runs 241 outpatient dialysis centers in 10 countries outside the United States.
DaVita administers dialysis to patients using products manufactured by Fresenius Medical Care.
Nearly 3,200 Fresenius GranuFlo/NaturaLyte dialysis product lawsuits are currently pending in a Massachusetts federal court. These products can cause toxic pH imbalances in patients resulting in alkalosis.
Alkalosis is a serious condition in which the body contains too much base, or alkali. This is the opposite of acidosis – excess acid in the body fluids.
Complications of alkalosis include:
In 2012, the U.S. Food and Drug Administration issued a Class I drug recall — potential for serious health consequences or death — of GranuFlo. The agency noted the risk of alkalosis in patients exposed to the acetate-containing dialysis product. Lawsuits allege DaVita knew or should have known about the alleged dangers.
DaVita Inc. says its “first priority is the safety of our patients.”
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