Clinic Files Motion to Dismiss DaVita Dialysis Lawsuits

One of the dialysis clinics that used the controversial NaturaLyte and GranuFlo dialysates is trying to convince a federal judge to dismiss lawsuits filed against them. Both products have been linked to sudden cardiac arrest, often occurring during or shortly after hemodialysis, and the company behind them, Fresenius Medical Care, is facing hundreds of product liability complaints.

DaVita Healthcare claim they used the products in good faith, completely unaware of the serious risks they posed. At least four lawsuits involving more than a dozen plaintiffs have been brought against them, but DaVita say complainants are pursuing the wrong company, and that Fresenius Medical Care is liable for any injury and death caused by GranuFlo and NaturaLyte.

DaVita dialysis lawsuits

The DaVita dialysis lawsuits have already been consolidated in the U.S. District Court for the District of Colorado. The Master Consolidated Complaint (MCC) has been vehemently opposed by attorneys working for DaVita, who filed a Motion to Dismiss on August 7, arguing that Fresenius is answerable to the allegations. The motion called for DaVita dialysis lawsuits to be dismissed on all counts, stating:

“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.’”

Fresenius allegedly knew of risks

Dialysates like GranuFlo and NaturaLyte contain sodium acetate, which  balances the bicarbonate levels in the bloodstream. An improper balance of bicarbonate and sodium acetate can lead to alkalosis and cardiopulmonary arrest. According to Granuflo lawsuits filed against them, Fresenius knew of these risks as early as 2004, but failed to warn the public or the medical community. An estimated 260,000 patients have used GranuFlo and NaturaLyte, thousands of whom may have been overdosed with sodium bicarbonate.

In November 2011, Fresenius issued a memo to its own clinics, after a study showed that 941 patients had died after being treated with the dialysates. The memo stated that GranuFlo increased the risk of cardiac arrest by up to 8 times. Fresenius failed to notify DaVita, or any other clinics they supply with the products. The memo was finally leaked to the FDA in 2012, and Fresenius finally issued a warning letter to all healthcare providers, which was later followed by a Class I Granuflo and NaturaLyte recall.

DaVita maintains it could not warn patients of the risks because Fresenius actively misled the medical community. Plaintiffs who’ve filed DaVita dialysis lawsuits argue that the company should have recognized the risks prior to the recall.

GranuFlo and NaturaLyte MDL

The Granuflo and Naturalyte multidistrict litigation (MDL no. 2428) was formed earlier this year. It consolidates  lawsuits filed against Fresenius Medical Care (but does not include the DaVita dialysis lawsuits). The proceedings are being overseen by Judge Douglas P. Woodlock. The first scheduling conference has been set for August 30 in the Joseph Moakley U.S. Courthouse. Judge Woodlock will use the conference to meet with attorneys involved in the MDL, and review any outstanding issues and pending motions. A structure for the MDL will be established during the meeting.