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GranuFlo Lawsuits Filed in Wake of GranuFlo and NaturaLyte Recall Mount in State and Federal Courts, Bernstein Liebhard LLP Reports
Date:5/4/2013

doctors do not account for this difference when prescribing dosage of the products, patients may develop a condition known as metabolic alkalosis, which has been linked to catastrophic GranuFlo side effects, including cardiac arrest and sudden cardiac death, in dialysis patients, according to the Times.*

In March 2012, Fresenius issued an “Urgent Product Notification” to its customer clinics warning of possible heart risks associated with the products, which would later be deemed a Class I GranuFlo recall by the U.S. Food & Drug Administration (FDA). Class I recalls are the agency’s most serious type, and are issued when a medical product poses a significant risk of serious injury or death.** Months before the announcement of the GranuFlo recall, however, Fresenius had issued a memo to dialysis clinics within its own network warning doctors practicing at those facilities that GranuFlo had been associated with serious heart side effects, and advised the physicians to adjust dosages in order to avoid excessive levels of bicarbonate in the blood. According to the New York Times, the FDA has since launched an investigation to determine if Fresenius Medical Care’s failure to issue an earlier warning to its customer clinics regarding the significant dangers associated with GranuFlo and NaturaLyte may have violated the law.**

On March 29th, 2013, the U.S. Judicial Panel on Multidistrict Litigation ordered that all federally-filed GranuFlo lawsuits be transferred to the U.S. District Court, District of Massachusetts for pretrial proceedings. Court filings show that plaintiffs in GranuFlo lawsuits allege Fresenius Medical Care was aware of the heart risks associated with GranuFlo and NaturaLyte, but failed to provide adequate warnings regarding those risks. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation,
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