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NaturaLyte and GranuFlo Lawsuit Alleges Wrongful Death

California sisters Deborah Lower and Constance Morgan filed suit in the U.S. District Court in Oakland, California, on March 28, 2013, alleging that their mother’s wrongful death from GranuFlo was a result of negligence and/or fraud on the part of NaturaLyte and GranuFlo manufacturers Fresenius Medical Care Holdings, Inc. They are seeking compensatory and punitive damages for the loss of their mother, Beaulahfay Riddle, and for their mother’s personal injuries, pain, suffering, and death.

FDA issues NaturaLyte and GranuFlo recall

In June 2012, the FDA issued a Class 1 recall of Fresenius products NaturaLyte and GranuFlo, stating “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” The recall was initiated in March 2012 after the FDA received, from an anonymous source, a copy of an internal memo dated November 2011 warning Fresenius clinicians of increased risk of death from these products.

According to the California NaturaLyte and GranuFlo lawsuit, Fresenius knew of the dangers of these products and knowingly concealed the information from its customers and the FDA. Fresenius distributed information about the dangers of NaturaLyte and GranuFlo to its own doctors and clinics, but did not make this information known to its entire customer base. At the time of the recall, an estimated 125,000 patients were being treated with NaturaLyte and GranuFlo by doctors who had not received appropriate instructions or prescription information from Fresenius.

Plaintiffs’ mother suffered injury and death from GranuFlo and NaturaLyte

GranuFlo and NaturaLyte are chemical preparations used during blood dialysis in the treatment of kidney failure. Kidney failure patients require dialysis to remove toxins from the bloodstream and to maintain proper blood pH balance. A pH imbalance in which the blood becomes too alkaline can cause serious adverse health effects, including low blood pressure, low blood oxygen, heart attack, stroke, coma, and death.

GranuFlo and NaturaLyte contributed to Beaulahfay Riddle’s death by increasing the concentration of alkaline substances in her blood. The products contain acetate, which is converted to the alkaline substance bicarbonate, in higher concentrations than other, similar products used in blood dialysis. The dialysis machines and prescription instructions to doctors did not take into account this high concentration of acetate and the resulting blood alkalinity, and as a result Riddle suffered from metabolic alkalosis, cardiac arrest, severe pain and suffering, and death.

California GranuFlo lawsuit one of many

NaturaLyte and GranuFlo lawsuits have been filed in courts throughout the country since the FDA issued its NaturaLyte and GranuFlo recall. The California plaintiffs are suing for strict products liability due to inadequate warning, strict products liability due to defect in design or formulation, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation and/or fraud, wrongful death, and survival action.

The plaintiffs demand a trial by jury and request relief of compensatory and punitive damages, pre- and post-judgment interest, costs and expenses of litigation, attorney’s fees and costs, and other relief that the Court will deem necessary and proper.