A wrongful death lawsuit brought by the families of three dialysis patients resulted in a $383.5 million verdict against DaVita, which provided dialysis treatments with GranuFlo, which allegedly caused the sudden cardiac arrest for each of the patients.
The verdict was returned by a federal jury in Denver on Wednesday, determining that the company was responsible for the cardiac arrest deaths because staff members used the dialysate GranuFlo, and knew or should have known that it may increase the risk of heart problems.
The lawsuits alleged that DaVita employees ignored a number of health signals, such as major blood changes, and reports of deaths and severe injuries within the medical community involving GranuFlo dialysis treatments.
The verdict awarded the three families between $1.5 million and $5 million each for compensatory damages, and then added another $125 million in punitive damages for each family, which was meant to punish DaVita for recklessly endangering dialysis patients.
The company has said it intends to appeal the decision.
The case stems from a March 2012 recall issued after federal health regulators discovered that Granuflo and Naturalyte solutions may increase the risk that dialysis patients suffer sudden cardiac arrest or die during or shortly after treatment.
Concerns about the link between NaturaLyte, Granuflo and cardiac arrest reports first surfaced in early 2012, after an internal memos of the manufacturer, Fresenius, were leaked to the FDA.
Although the company indicated in the internal memo that it was aware of at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment at their own clinics in 2010, Fresenius failed to take actions to ensure that all doctors using Granuflo or NaturaLyte were aware of the problems.
In November 2011, the company issued warnings to doctors at Fresenius clinics, indicating that doctors should closely monitor bicarbonate levels during treatments. However, the same warnings were not provided to other clinics that used GranuFlo and NaturaLyte. In addition, lawsuits allege that the manufacturer knew or should have known about the risk of problems long before the internal memo was issued.
Fresenius finally provided a warning letter to all healthcare providers in March 2012, which the FDA classified as a recall of GranuFlo and NaturaLyte.
In February 2016, Fresenius agreed to settle thousands of GranuFlo and NaturaLyte lawsuits for a total of about $250 million.
Each of the complaints raised similar allegations that the dialysis treatment provider failed to adequately warn doctors about the importance of closely monitoring patients receiving GranuFlo or NaturaLyte diaysate solutions, which have been found to raise bicarbonate levels and increasing the risk of sudden cardiac arrest or death during or shortly after hemodialysis.