Four GranuFlo and Naturalyte Class Action Lawsuits Filed

March 13, 2013 — DaVita dialysis clinics are facing four class action lawsuits on behalf of individuals who were injured by GranuFlo or Naturalyte. The U.S. Food and Drug Administration (FDA) recalled GranuFlo and Naturalyte in 2012, after linking the products to an increased risk of bicarbonate overdose, metabolic alkalosis, cardiopulmonary arrest, heart attack, cardiac arrest, and death.

All four class action lawsuits were filed on March 6 in the U.S. District Court for the District of Colorado, including claims on behalf of the following individuals:

• Donald Thornton: On behalf of Jean Thornton, a woman who underwent dialysis at DaVita Harbor View Dialysis Clinic in Racine, Wisconsin in 2011. Approximately three hours after receiving GranuFlo and/or Naturalyte treatment, she suffered extreme nausea and chest pains and died of a heart attack.
• Melvin Nunes: On behalf of Stella Nunes, a woman who died of sudden cardiac arrest after receiving GranuFlo and Naturalyte during dialysis treatment in December 2012, at DaVita Vacaville Dialysis Center in California.
• Donald Young: In July 2011, Mr. Young had dialysis treatment at DaVita Erie Dialysis in Pennsylvania. Three hours into his treatment, he suffered a massive heart attack, required surgery, and suffers permanent weakness and shortness of breath.
• Armando Moreno: On September 8, 2011, Mr. Moreno underwent dialysis treatment at a DaVita Tucson East Dialysis in Arizona. After treatment with GranuFlo and/or Naturalyte, he went home, and awoke in the morning unable to breathe. He suffered a heart attack and required hospitalization.

The plaintiffs are seeking a class action to determine whether GranuFlo and Naturalyte are unreasonable dangerous, defective, and unsafe because they can cause rapid increases in bicarbonate levels during dialysis treatment. The lawsuit also alleges that the products were sold without adequate instructions or warnings, despite the fact that they contained sodium diacetate.

Fresenius Medical Care, the manufacturer of GranuFlo and Naturalyte, conducted a study of risk factors for cardiopulmonary arrest at their clinics between January 1 and December 31, 2010. They identified 941 patients at 667 Fresenius clinics who suffered a cardiopulmonary arrest.

The researchers estimated that dialysis patients with high pre-dialysis bicarbonate levels were 6 to 8-times more likely to suffer from sudden cardiac death and cardiopulmonary arrest.

The lawsuits allege that DaVita should have inspected and reviewed the composition of GranuFlo and Naturalyte before giving the products to their patients, doctors should have noticed elevated bicarbonate levels, and they also should have noticed problems when reviewing reports of deaths and complications.

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