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Louisiana Files GranuFlo Lawsuit Against Fresenius Medical Care over Its Recalled GranuFlo and NaturaLyte Dialysis Drugs
Date:7/27/2014

erously low blood pressure or sudden cardiac death. [fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm, June 27, 2012]

The New York Times reported that Fresenius only made the information public after an internal company memo was anonymously sent to the FDA about the products. Fresenius’ November 2011 memo warned doctors at its dialysis clinics that improper use of the two products appeared to be a factor in patients dying suddenly from cardiac arrest. The memo mentioned that a company study found that 941 patients experienced cardiac arrest in Fresenius clinics in 2010. The memo was not sent to other clinics that Fresenius did not own. After the FDA questioned Fresenius about the memo, the company warned other non-Fresenius clinics about concerns over the two products.
[nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0, June 14, 2012]

Fresenius recently issued a new recall of more NaturaLyte products. According to the FDA, Fresenius recalled 49 lots of NaturaLyte liquid bicarbonate concentrate on April 10, 2014, due to concerns over the product developing higher than expected bacteria levels during its shelf life. Fresenius expanded the recall in May to include nine additional lots. Just as it did in 2012, the FDA classified the recall as Class 1, the most serious type of recall. The FDA noted in its safety alert that the agency had received one report of a patient’s death and two reports of injury that may be related to the recalled NaturaLyte product. The FDA also warned that the product may cause serious health consequences, including sepsis, bacteremia, and death.
[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm399124.htm, June 5, 2014]

Court documents show that GranuFlo litigation is currently underway in the U.S. District Court, District of Massachusetts. The court’s Master Case List shows 1,863 GranuFlo lawsuits have been filed in th
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