DaVita Dialysis Lawsuits - Granuflo and Naturalyte Recall

DaVita Healthcare Files Motion to Dismiss GranuFlo Lawsuits

Laura Woods | September 3rd, 2013

DaVita dialysis lawsuitsOn August 7, lawyers for DaVita Healthcare filed a motion to dismiss lawsuits filed against the company in federal court, based on the dialysis products NaturaLyte and GranuFlo. At least four DaVita dialysis lawsuits, brought by more than a dozen plaintiffs, have been joined together in a Master Consolidated Complaint (MCC) in the U.S. District Court for the District of Colorado.

Plaintiffs claim they or a loved one have suffered a heart attack, cardiac arrest, or stroke resulting from Granuflo or Naturalyte side effects. DaVita is arguing that lawsuits against them should be thrown out, and instead filed against Fresenius Medical Care, the company who manufactures the products.

Allegations made in the DaVita dialysis lawsuits

Naturalyte and GranuFlo have been used at dialysis clinics across the country, including DaVita centers. The products have been associated with extremely severe side effects, including sudden cardiac arrest or death during or following hemodialysis. Fresenius conducted an internal review of the use of GranuFlo and Naturalyte in November 2011, during which the company noted at least 941 cases where patients suffered cardiac arrest during dialysis treatments in 2010. Following this discovery, Fresenius sent an internal memo to doctors in its own clinics warning of these side effects, but opted not to provide the same data to other clinics using Naturalyte and GranuFlo. The internal memo was leaked to the FDA in March 2012, causing Fresenius to send a warning letter to all providers using the products. The FDA then announced a Class I GranuFlo and Naturalyte recall.

Although plaintiffs who filed DaVita dialysis lawsuits under the MCC believe it was the responsibility of healthcare workers at the company to recognize the risks associated with the products before the GranuFlo and Naturalyte recall, the company disagrees. DaVita maintains it was the responsibility of the patients’ physicians who prescribed dialysis to provide warnings of the risks associated with these products, and not the company’s obligation. Further, the company has referred to the plaintiff’s claim implying that DaVita was unaware of the risks associated with GranuFlo and Naturalyte, as they allege Fresenius purposely misinformed the medical community, with the exception of its own healthcare communities. If this is indeed the case, DaVita notes that it would have been impossible for the company to conceal information of the products’ risks.

More GranuFlo and Naturalyte lawsuits

Nearly 120 Fresenius GranuFlo and Naturalyte complaints have been filed by plaintiffs claiming life-threatening complications suddenly during or shortly after dialysis treatment involving these products. The plaintiffs represent 16 different U.S. District Courts across the country and the lawsuits have been consolidated as part of an MDL for pre-trial proceedings, under U.S. District Judge Douglas P. Woodlock in Massachusetts.

Combining the cases under an MDL will help to eliminate conflicting rulings from different judges, to be more efficient for plaintiffs, witnesses, and the courts, and help to minimize court costs. Although these cases are combined under the MDL, each lawsuit is treated separately, remaining eligible for its own pre-trial settlement or jury award. If a settlement is not reached to resolve the cases, the lawsuits could go back to the courts where they were originally filed.

Judicial Panel for Multidistrict Litigation, MDL No. 2428 Initial Transfer Order, http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2428-Initial_Transfer-03-13.pdf