Federal Jury Awards Families $385.5 Over DaVita Dialysis Product GranuFlo
In late June, a federal jury ordered dialysis machine giant DaVita Inc. to pay three families $385.5 million for the wrongful death of three patients after the jury found that the company failed to adequately warn kidney doctors that their product–GranuFlo—increased patients’ risk of suffering from cardiac arrests.
According to the former associate director of the U.S. Food and Drug Administration (FDA), DaVita was not only negligent, it actively “implemented multiple mechanisms” to suppress federally-mandated reporting and clinical improvements to improve patient safety. Specifically, testimony revealed that the company had participated in a “flawed and secretive adverse event reporting system.”
The Case against GranuFlo
GranuFlo was used to clean the blood of patients who were on dialysis. However, plaintiffs claimed that the product actually increased blood levels of acetate, which caused toxic pH imbalances and alkalosis. They also alleged that DaVita was aware of these risks and actively avoided disclosing them.
DaVita countered that each of the patients had signed consent forms that warned them of potential reactions to medications administered during dialysis treatment which could resent in fatal or cardiac arrest or cardiovascular complications, including fluid and electrolyte imbalance issues and heart failure. However, the plaintiffs argued that the language included in those consent forms only included standard boilerplate language included in every dialysis consent form, and had nothing to do with the particular risks involving the use of GranuFlo, specifically.
Under the law, companies like DaVita are obligated to report deaths that may have been caused by or contributed to their products or medical devices. One expert witness testified that the company didn’t report any adverse events associated with cardiac arrests and the use of GranuFlo.
In fact, in 2012, the FDA issued a Class I recall of GranuFlo, finding that inappropriate prescribing could lead to blood changes which, if not treated properly, could lead to cardiopulmonary arrest, and even death. As a result of the recall, warning language was added to the product’s label.
According to the depositions in the case, three DaVita nephrologists and four nurses were either unaware, had not been notified, or could not recall that GranuFlo had been found to be a hazard by the FDA and manufacturer.
Florida Wrongful Death Attorneys
Out of close to 160,000 patients seen every year in DaVita clinics, more than 9,000 were put at an “unjustifiable risk” by use of GranuFlo in approximately 1.5 million instances. If you or a loved one have been injured or killed after using GranuFlo or any other defective product, contact our experienced Florida wrongful death lawyers at Friedland & Associates today to find out how we can help. While the harm done by these products can never be undone, you and your family have a chance at justice.