A federal jury in Colorado recently ordered DaVita Inc., a Fortune 500 dialysis provider, to pay a combined $383.5 million to the families of three patients who died from cardiac arrest after receiving treatment.
Hillsborough’s Paynter Law Firm, which also has an office in Washington D.C. filed this wrongful death suit alongside national law firm Hagens Berman Sobol Shapiro LLP, resulting in the recent verdict that made Colorado history.
On June 27, jurors returned a verdict awarding $8.5 million in compensatory damages and $375 million in punitive damages to the three plaintiffs after hearing testimony that DaVita Inc., one of the nation’s largest operators of dialysis centers, did not adequately inform kidney doctors of a newly implemented cost-saving dialysis product that carried increased risk of cardiac arrest.
Punitive damages totaled $125 million to each of the estates of Irma Menchaca, Gary Gene Saldana and Deborah Hardin and compensatory damages ranged from 1.5 million to $5 million, amounting to one, if not the, largest jury verdict in Colorado history.
Paynter Law Firm and Hagens Berman Sobol Shapiro LLP filed three wrongful death suits, one in December 2015, and the others in the spring of 2016, which were eventually consolidated in 2016. They accused the dialysis giant of negligence and fraudulent concealment, arguing that defendant DaVita Inc. treated patients with an acid concentrate, GranuFlo, withholding notice of serious health risks and possible death associated with the product. Furthermore, plaintiffs alleged that DaVita failed to properly review GranuFlo treatment after receiving alarming information of an increased risk of death from an internal study and then an FDA recall.
Dialysis solutions are composed of purified water, a bicarbonate solution, and an acid concentrate, which contains potassium, calcium, and sodium.
This process is used when a patient’s kidneys fail to remove waste products in the blood. Dialysis restores the correct balance of essential electrolytes, such as potassium, sodium, and calcium while waste products diffuse across the dialysis membrane. Bicarbonate, a pH base, works to restore and neutralize accumulation of acid in blood.
GranuFlo, manufactured by German health care company Fresenius Medical Care, is dry acid powder, largely cheaper to package and ship than liquid acid alternatives. At treatment clinics, the powder is mixed with purified water and intended to deliver more bicarbonate faster to patients. GranuFlo results in a higher dialysis solution acetate level than that of other brands.
This rapid increase in bicarbonate causes a correspondingly rapid drop in potassium, which can lead to cardiac arrest. Cardiac arrests as opposed to a heart attack is caused by an electrolyte shift and low oxygen, not a blockage of blood flow.
According to court documents, DaVita Inc., which operates over 2,000 outpatient dialysis centers across 44 states, serving approximately 175,000 patients, knew in 2004 that GranuFlo caused a significant spike in bicarbonate levels.
In November 2011, DaVita was informed of Fresenius’ internal review that the “use of GranuFlo resulted in a 6-8 fold increase in cardiac arrests during the dialysis process,” according to court filings. DaVita allegedly took no action regarding these findings and failed to investigate whether GranuFlo was a factor in cardiac arrests taking place at its clinics, a violation of mandatory FDA reporting obligations.
In April 2015, DaVita publicly claimed they had never received the notice, a statement the plaintiff argued to be false.
Approximately 3 months after the internal study in March 2012, the FDA was alerted of the memorandum and immediately required Fresenius to issue a Class 1 recall of the GranuFlo product. The FDA required Fresenius to update the GranuFlo labels to warn users of the increased acetate and risks associated.
DaVita admitted internally that doctors should account for additional acetate in GranuFlo, according to court documents, but the acid concentrate was not recorded in patient’s’ medical information and therefore prescribing doctors may not know GranuFlo was the treatment brand.
Dr. Pankaj Ram, the medical director for the clinic visited by decedent Gary Saldana, who died of cardiac arrest in 2010, testified that he never received any training or information from the defendant about the clinics conversion to GranuFlo.
“The staff was not informed and therefore neither doctors nor patients were informed,” Stuart Paynter of Paynter Law Firm said.
“We strongly disagree with this jury’s verdict and will vigorously pursue all appeal rights,” DaVita said in a statement. “Our first priority is the safety of our patients. Our clinical outcomes - among the best in the industry - demonstrate our commitment to providing the highest level of care. We will pursue any and all avenues of appeal to overcome this unjust verdict and believe today’s verdict is unlikely to stand.”
The corporation claims that GranuFlo is an FDA-approved product has been in “continuous use for more than 25 years” and concerns raised about negative side effects have been “debunked” and nephrologists continue to prescribed it to patients.
“The facts in the trial contradict the allegations upon which this verdict is premised,” the statement said. “There was substantial evidence that the GranuFlo product is safe and effective, and no evidence that we or the manufacturer of GranuFlo hid any data contradicting its safety or effectiveness.”
To receive dialysis treatment, nephrologists prescribe a specific bicarbonate level to patients who in turn would visit the dialysis clinic 3-4 times a week. Nephrologists do not prescribe a brand of dialysate.
For common prescription of 35 milliequivalents per liter of bicarbonate, GranuFlo would deliver an additional 8 milliequivalents per liter generated, according to Paynter. DaVita did not track nor acknowledge the use of GranuFlo on patients’ medical records.
“Ultimately, there’s no way of knowing how many people total were affected,” Paynter said. “It wasn’t even in peoples’ medical records. That was one of the things that again, was evidence to the jury that they were trying to conceal [this information].”
The three patients who died of cardiac arrest after receiving the GranuFlo dialysis treatment each showed high levels of bicarbonate in their blood upon death.
Each of the decedents had existing medical conditions which predisposed them to “cardiac arrest caused by acute metabolic alkalosis and its consequences.”
Deborah Hardin, who died in May 2014 at the age of 62, suffered cardiac arrest 99 minutes into a dialysis treatment. She had existing medical conditions including diabetes mellitus, hypertension, and coronary artery disease.
Saldana, who died at the age of 60, suffered cardiac arrest 10.5 hours after dialysis treatment. He had chronic medical conditions including morbid obesity, diabetes mellitus, intermittent congestive heart failure, and hypertension.
Irma Menchaca died at the age of 57 in June 2008 after suffering two cardiac arrests, the first in January 2008. She had prior conditions such as diabetes mellitus, hypertension, and coronary artery disease, and died 58 minutes into a dialysis treatment.
The decedents’ families approached Hagens Berman Sobol Shapiro inquiring about these wrongful deaths after hearing about the product recalls and potential cause of death associated with that.
After three years of litigation, the trial took place over 10 days in Denver, Colorado, where the DaVita Inc. headquarters are located.