More DaVita and Fresenius Medical Centers Lawsuits, and DaVita Settlement

Denver, COHaving already put aside $300 million to settle criminal and civil anti-kickback investigations, DaVita healthcare clinics might soon be digging deeper into their profits as more DaVita and Fresenius lawsuits are filed.

DaVita and Fresenius healthcare clinics are no strangers to litigation. In 2012, they settled another whistleblower lawsuit, agreeing to pay $55 million over allegations of drug overuse while denying any wrongdoing.

This time the allegations are a lot more serious - death caused by GranuFlo and NaturaLyte dialysis products overdose. On April 23, 2013, the children of a woman who died as a result of using Granuflo and NaturaLyte dialysis products filed a lawsuit in Louisiana Western District Court (case no. 5:2013cv00829) alleging that their mother suffered a cardiac event and died of a heart attack a few hours later.

Two more lawsuits were filed in federal court in Colorado in March 2013, by Hagens Berman Sobol Shapiro LLP, claiming that DaVita Healthcare Partners, Inc.’s actions directly led to the deaths of two of its dialysis patients. As well, these deaths have potentially impacted thousands and thousands of dialysis patients nationwide.

The lawsuits were also filed against Fresenius Medical Care North America, the company that manufactured and distributed Granuflo and NaturaLyte products. “Even before the FDA stepped in, our medical experts all conclude that DaVita should have recognized that its patients using the two products showed wild swings in their bicarbonate levels, a clear indication that they were at a much higher risk of cardiac arrest,” said Steve Berman, managing partner of Hagens Berman. He also said that DaVita failed to recognize trends in the number of complications and deaths after dialysis treatments. "Even had the company overlooked the trends relating to bicarbonate levels, we would expect that the high number of complications and deaths would have alerted them that something was amiss.”

According to these lawsuits, an internal memo, dated November 4, 2011, shows that Fresenius knew of the dangers associated with GranuFlo and NaturaLyte, its dialysis products, before notifying the FDA. As well, the complaints claim that Fresenius was aware of the problem because it made adjustments at its own clinics to reduce the impact on patients.

Granuflo, manufactured by Fresenius Medical Care, is an additive used in kidney dialysis to help patients maintain their bicarbonate levels that neutralize the acid buildup in the bloodstream during dialysis.