A Massachusetts federal jury has cleared dialysis provider Fresenius Medical Care of liability in a suit alleging that an improper dose of the company’s dialysate, Naturalyte, had led to the death of the plaintiff’s late husband, Modern Healthcare reported.

The case was the first to go to trial among plaintiffs who opted out of the $250 million settlement offered in February 2016.

The plaintiff alleged that the improper dose of the dialysate caused metabolic alkalosis and Carley Dial’s death from cardiac arrest, according to Law360.

But Fresenius’ expert testified that Dial had died of a heart attack related to high blood pressure and a family history of heart disease.

“The company is gratified by the outcome in Dial.  The verdict in this case, by itself, does not directly impact the previously-announced comprehensive settlement of the Acid Concentrate litigation,” said Kent Jarrell, spokesman for Fresenius Medical Care. “The Dial family plaintiffs elected not to participate in the comprehensive settlement and are now barred from doing so.  Under current agreements and court orders, FMCNA is required to confirm or void the $250 million comprehensive settlement on May 10, 2017.  No decision has been made whether to confirm or void the comprehensive settlement.  The date for confirmation is subject to change.”

Background

In Nov. 2011, Fresenius distributed an internal memo to its own dialysis centers that linked improper use of the dialysate to an increase in risk of sudden cardiac arrest in dialysis patients.

But Fresenius did not alert other dialysis centers of its findings until March 2012, when the U.S. Food and Drug Administration 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.

“GranuFlo and NaturaLyte received appropriate FDA clearance before they were initially marketed, and that clearance remains in effect,” FMC spokesperson Kent Jarrell told NN&I in July 2014.” The FDA has not suggested any change in the production formulation or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care. Additionally, the FDA has not found or suggested a defect in the design or composition of GranuFlo and has not suggested or required any change in the composition of GranuFlo.”