Manufacturer Fresenius Medical Care agrees to $250 million settlement of several GranuFlo and Naturalyte class action lawsuits.
Fresenius Medical Care will settle out of court with multiple plaintiffs in U.S. class action lawsuits over the company’s failure to warn healthcare providers of the risks of heart attack, stroke, and sudden death associated with use of its dialysates Granuflo and Naturalyte. Fresenius reached the agreement with a committee designated by the plaintiffs to resolve litigation. The settlement amount would be $250 million, and 97% of the plaintiffs must agree to the settlement by July 2016. Insurers would fund the settlement amount with $220 million.
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,” according to FMC spokesperson Kent Jarrell.”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.” “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the FDA’s medical devices division, said in an interview with the New York Times in June 2012. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.” Originally posted by Rebecca Zumoff on NephrologyNews.com. GranuFlo and Naturalyte – Ball & Bonholtzer Trial Attorney – Los Angeles