At least four separate class action lawsuits have been filed against DaVita Healthcare over the use of Granuflo and Naturalyte at the company’s dialysis centers, which have been linked to an increased risk of cardiac arrest and sudden death during hemodialysis treatment.
The DaVita class action lawsuits allege that the company should have known that side effects of Granuflo and NaturaLyte may increase the risk of serious and potentially life-threatening health problems.
The two dialysis products were manufactured and sold by Fresenius Medical Care, and they were widely used at DaVita dialysis clinics throughout the United States before being recalled, according the lawsuits.
The complaints include claims filed by Donald Thornton (PDF), Melvin Nunes (PDF), Donald Young (PDF), and Armando Moreno (PDF). Each of the lawsuits were filed in the U.S. District Court for the District of Colorado on March 6, seeking class action status to include all patients treated with GranuFlo or NaturaLyte at a DaVita clinic.
Problems with Fresenius GranuFlo and NaturaLyte
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. Both products contain sodium acetate that allegedly converts to bicarbonate at higher-than-expected levels for most doctors.
A recall for Granuflo and NaturaLyte was issued by Fresenius Medical Care in early 2012, after a warning was issued about the risks associated with the products and the importance of doctors monitoring bicarbonate levels during treatment.
Fresenius Medical Care not only manufactures and sells the dialysis products, but also owns and operates thousands of dialysis clinics throughout the United States that directly compete with DaVita clinics. In late 2011, an internal review of patients treated at 667 Fresenius clinics found at least 941 instances where patients suffered a cardiac arrest during dialysis treatment.
Plaintiffs in the class action lawsuits against DaVita allege that healthcare workers with the company should have recognized the risks before the Fresenius recall.
“DaVita knew, or was negligent in not knowing, that its patients’ pre-dialysis serum bicarbonate levels were gradually increasing and that patients were at an increased risk of cardiac arrest as a result,” the lawsuits state. “There were several things DaVita could and should have done, but did not do, to protect its patients.”
Fresenius Lawsuits Over NaturaLyte and GranFlo
Dozens of product liability complaints over Granuflo and NaturaLyte have already been filed against Fresenius Medical Care, alleging that the manufacturer failed to provide adequate warnings. These Fresenius dialysis lawsuits allege that the manufacturer withheld information about the risks associated with the products.
As of February 12, at least 59 complaints were pending against Fresenius Medical Care in U.S. District Courts throughout the country, and a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize the lawsuits before one judge for coordinated handling during pretrial proceedings.
It is ultimately expected that Fresenius could face thousands of injury and wrongful death lawsuits. At this time, a similar motion has not been filed to consolidate DaVita dialysis lawsuits, but the company has been named as a co-defendant in many of the complaints filed against Fresenius.