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Fresenius Concealed GranuFlo, NaturaLyte Risks Lawsuits Allege

Filed January 21st, 2013 admin

A host of lawsuits have been filed against Fresenius Medical, accusing the company of intentionally concealing potentially fatal problems with dialysis drugs GranuFlo and Naturalyte.

The GranuFlo and Naturalyte products, which have been recalled, were used to lower the acidity of a patients’ blood during dialysis treatments. At least 15 lawsuits have been filed since January 1, all alleging that the high concentration of acetone in the products resulted in abnormally high levels of bicarbonate in the blood, massdevice.com said. This led to fatal heart problems and strokes. A dialysis patient in Kentucky, Linda Teague, allegedly died at age 48 from cardiac arrest after a procedure there, massdevice.com said.

Teague received the defective product from Fresenius during dialysis treatment and, on or about January 14, 2011, suffered cardiac arrest and died from the injuries she sustained as a result of her exposure to the defendant’s defective products, the lawsuit says. The lawsuit also accuses the company of being aware of the risks for several years, but of failing to warn medical providers that the high levels of bicarbonate in its products heighten the risk of cardiac injury by six times. As a result, thousands of patients receiving dialysis treatment were unknowingly overdosed, massdevice.com said.

An internal Fresenius memo from November 2011 details the results of a study completed in 2010, based on data defendants had available for many years, according to court documents. The FDA issued a Class I recall of FMC’s GranuFlo product last March after obtaining a copy of the memo. The agency later opened an investigation of Fresenius in June 2012, after more than 900 patients endured heart attacks at Fresenius dialysis centers, massdevice.com said.

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