Motion Filed to Dismiss DaVita Dialysis Lawsuits Over Granuflo, NaturaLyte

DaVita Healthcare is trying to get a federal judge to throw out lawsuits filed against the company over dialysis treatments involving NaturaLyte and GranuFlo, which have been linked to a risk of sudden cardiac arrest or death during or shortly after hemodialysis.

NaturaLyte and Granuflo are dialysis products manufactured and sold by Fresenius Medical Care, which have been used at clinics throughout the United States in recent years, including dialysis centers owned and operated by DaVita Healthcare.

A number of lawsuits have been filed over DaVita dialysis treatments by plaintiffs who allege that they or a loved one suffered a heart attack, cardiac arrest or stroke due to side effects of Granuflo or NaturaLyte.

At least four DaVita dialysis lawsuits brought by more than a dozen plaintiffs have been joined in a Master Consolidated Complaint (MCC) in the U.S. District Court for the District of Colorado. In a Motion to Dismiss (PDF) filed on August 7, attorneys for DaVita argue that the plaintiffs are targeting the wrong company and indicate that the lawsuits should be pursued against Fresenius Medical Care.

“Medical service providers — such as dialysis clinics — provide treatment and care. They do not manufacture, sell, or otherwise place products into the stream of commerce and thus, cannot be liable under those laws governing alleged defects in ‘products,’” the motion filed by DaVita states. “Plaintiffs’ causes of action for strict liability, failure to warn, and breach of warranties therefore should be dismissed.”

The company maintains that it had no duty to re-warn patients of the risks of individualized prescriptions because their physicians who prescribed dialysis and the products involved should have done so. The company also notes that the plaintiffs’ own claims suggest DaVita was in the dark about the risks because Fresenius actively tried to mislead the medical community outside of its own clinics, which means that the company could not have been concealing information about NaturaLyte or GranuFlo.

NaturaLyte and GranuFlo Heart Problems

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, according to allegations raised in the complaints.

Fresenius Medical Care not only manufactures and sells GranuFlo and NaturaLyte to DaVita and other dialysis clinics, the company also operates thousands of their own clinics throughout the United States.

In November 2011, Fresenius conducted an internal review involving the use of Granuflo and NaturaLyte at their own clinics, identifying at least 941 instances where patients suffered cardiac arrest during dialysis treatments in 2010. While the company issued a memo to doctors in their own clinics in late 2011, they failed to provide the same information or warnings to other clinics that used Granuflo and NaturaLyte.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.

Plaintiffs in the MCC against DaVita allege that healthcare workers with the company should have recognized the risks before the Fresenius recall.

Fresenius Dialysis Treatment Lawsuits

Throughout the country, the majority of the litigation involving Granuflo and NaturaLyte has been filed against Fresenius Medical Care.

In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all Fresenius dialysis treatment lawsuits brought in the federal court system before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts. As of last week, more than 200 complaints have been filed in U.S. District Courts nationwide.

The first scheduling conference has now been set for August 30, in the Joseph Moakley U.S. Courthouse in Boston, Massachusetts. At that time, Judge Woodlock will meet with the lawyers involved in the litigation to review outstanding issues and motions that are pending. It is also expected that the structure and organization for the MDL will be discussed.