Jury awards $383.5 million in GranuFlo-linked patient deaths

A jury in Denver awarded families of three DaVita Kidney Care patients $383.5 million in a wrongful death lawsuit linked to the dialysis provider’s use of the acid concentrate GranuFlo. DaVita said in a statement that it will appeal the verdict.

The jury heard testimony that the patients – Irma Menchaca, Gary Saldana and Deborah Hardin – experienced cardiac arrests and died after receiving dialysis at DaVita clinics that used GranuFlo (Fresenius Medical Care). The product is combined with another Fresenius product, Naturalyte, to form the dialysate used during the dialysis process. The mix also includes water and bicarbonate.

“We strongly disagree with this jury's verdict and will vigorously pursue all appeal rights,” DaVita said in a prepared statement. GranuFlo, the company argued, is an FDA-approved product “that has been in continuous use for more than 25 years. The issues raised regarding its alleged negative clinical side effects have been debunked and nephrologists use it daily for their patients,” DaVita said in the statement. “The plaintiffs in this case did not even claim that the product itself was dangerous. ... There was substantial evidence that the GranuFlo product is safe and effective, and no evidence that we or the manufacturer of GranuFlo hid any data contradicting its safety or effectiveness.”

Fresenius distributed an internal memo in 2011 to its own dialysis centers speculating that high levels of acetate in the dialysate were leading to elevated bicarbonate levels and an increased risk for sudden cardiac arrest in dialysis patients. But Fresenius did not alert other dialysis centers of its findings until March 2012, when the U.S. FDA initiated a Class I recall.

“The Defendants purposefully advised their own clinics, practitioners, and physicians of the dangers of the product, but did not advise non-Fresenius clinics, practitioners, and physicians of the increased risk of (cardiopulmonary arrest) associated with the use of their products,” the attorney general for Louisiana wrote when the state joined other class action suits in July 2014. Despite the recall, the FDA did not instruct Fresenius to change the composition of the product or take it off the market. Fresenius agreed last year to establish a $250 million compensation fund for claims filed by families and patients who believed they were harmed by the product.

In the DaVita case, heard before the U.S. District Court for the District of Colorado, jurors awarded the families of deceased patients Menchaca, Saldana and Hardin compensatory damages of $2 million, $1.5 million and $5 million, respectively, and $125 million to each family in punitive damages. DaVita is headquartered in Colorado.

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The Hagens Berman law firm, which represented the families of the three patients, filed the wrongful death suits against DaVita in 2013 alleging, “[t]here were several things DaVita could and should have done, but did not do, to protect its patients,” the firm said in a statement. According to the complaints, the dialysis provider “failed to inspect and review the composition of GranuFlo and noticed changes, and DaVita should have noticed a significant upswing overall in bicarbonate blood levels when patients returned for dialysis treatments,” the firm said. “DaVita ignored many red flags that preceded the loss of life of these three patients and many others,” Rob Carey, lead trail attorney, said. – by Mark E. Neumann

References: www.morningstar.com/news/djnmndjbn,ndjqs/BWIPREM_20180627006371/hagens-berman-announces-3835-million-jury-verdict-against-dialysis-provider-davita-in-wrongful-death-lawsuits.print.html

https://www.healio.com/news/nephrology/20180227/jury-sides-with-fresenius-in-granuflonaturalyte-ca