Hundreds of lawsuits have been filed over risks associated with inadequate warnings for GranuFlo and NaturaLyte.
According to court documents, more than 300 lawsuits have been filed nationwide and more are expected, WickedLocalWaltham reported. Allegations include that Fresenius Medical Care neglected to adequately warn patients and medical centers about cardiac arrest risks tied to GranuFlo and NaturaLyte, dialysates that are used remove impurities from blood during dialysis treatment.
“These plaintiffs seek damages for wrongful death and personal injuries,” according to the plaintiffs’ memorandum from court records. “Fresenius designed, developed, manufactured, labeled, supplied, sold, marketed and distributed the subject products throughout the United States for treatment of dialysis patients,” the memorandum continued, according to WickedLocalWaltham.
Fresenius spokesman, Kent Jarrell said that GranuFlo and NaturaLyte are “safe and effective when used in accordance with their labels and instructions,” and are an essential dialysis component and life-extending treatment for patients diagnosed with advanced and permanent kidney failure, WickedLocalWaltham reported.
Court records indicated that GranuFlo has been distributed by Fresenius since 2003 using a formula that was recalled in what the U.S. Food and Drug Administration (FDA) deemed a Class I, its most serious designation. Plaintiffs allege that GranuFlo causes an unsafe rise in bicarbonate, a carbonic acid salt, which can raise risks for cardiac arrest and death six- to eight-fold, according to WickedLocalWaltham.
As we previously wrote, the FDA deemed the GranuFlo and NaturaLyte products may lead to high levels of bicarbonate in patients undergoing hemodialysis when inappropriately prescribed. The agency said that these increased levels can lead to metabolic alkalosis, a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. If not appropriately treated, cardiopulmonary arrest may occur.
Despite the Class I designation, said Jarrell, the agency did not suggest changes to the way in which GranuFlo is products. Jarrell said that GranuFlo’s clearance to market remains in place, WickedLocalWaltham reported. “[GranuFlo and NaturaLyte] have been used in their current formulation for more than a decade and in more than 100 million successful dialysis treatments at our own clinics and clinics operated by other companies,” Jarrell said.
Plaintiffs claim Fresenius “knew or should have known of the risk of cardiopulmonary arrest and death associated with GranuFlo.” A 2010 case-control study, conducted by Fresenius found that 941 patients treated with GranuFlo in one-third of its clinics suffered from cardiac arrest and sudden cardiac death, wrote WickedLocalWaltham.
This is not the first time Fresenius has been accused of serious issues associated with its dialysis centers. Recent lawsuits accuse Fresenius Medical Care of deliberately concealing potentially fatal problems with the products ad also allege that patients’ treated with these products tested with a high concentration of acetone, which led to abnormally high levels of bicarbonate in their blood. This, in turn, led to fatal heart problems and strokes, according to prior court documents.
A judicial panel recently decided that the lawsuits will be consolidated into a federal court hearing.