GranuFlo, Naturalyte Lawsuits Centralized in Federal MDL

June 13, 2013 — In May, a panel of judges created a Multi-District Litigation (MDL) for Granuflo and Naturalyte lawsuits. Over the last month, nearly 200 lawsuits were transferred to the U.S. District Court for the District of Massachusetts: In re: Fresenius GranuFlo / NaturaLyte Dialysate Product Liability Litigation, MDL No. 2428, before Judge Douglas R. Woodlock.

All of the lawsuits make similar allegations against Fresenius, the manufacturer of GranuFlo and NaturaLyte. Plaintiffs allege that the dialysis treatment products are “defective” and “unreasonably dangerous.” Furthermore, they allege that Fresenius was negligent for failing to provide adequate instructions or warnings about the potential risk of complications, including heart attack, cardiac arrhythmia, cardiac arrest, and sudden death. These complications can occur during treatment or up to 48 hours after treatment.

In a November 2011 internal memo, Fresenius warned their own doctors that improper doses of NaturaLyte or GranuFlo during hemodialysis can cause metabolic alkalosis — a condition associated with a 6- to 8-fold increased risk of cardiopulmonary arrest. The memo stated that 941 patients died of this complication in Fresenius clinics in 2010. In 2012, the U.S. Food and Drug Administration (FDA) and Fresenius issued a Class 1 recall of GranuFlo and NaturaLyte.

Although the lawsuits have been centralized, the litigation is not the same as a class action lawsuit. In a class action, many individual claims are consolidated into one claim, and any financial award is typically split evenly among the class members. In an MDL, however, each individual lawsuit stays independent and can potentially go to trial.

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