Hundreds Join Granuflo Class Action Lawsuits in California

August 30, 2013 — Mass Device reports that Fresenius is facing a Granuflo class action lawsuit that involves hundreds of claims. The class action, which was filed in California, alleges that Fresenius intentionally hid the serious health risks associated with Granuflo. Other class actions have also been filed in Pennsylvania.

In addition to the Granuflo class action lawsuit, Fresenius is also facing a Multi-District Litigation (MDL) in federal court in Massachusetts: MDL 2428 In re: Fresenius Granuflo / Naturalyte Dialysate Product Liability Litigation.

Granuflo Class Action Lawsuit Information

Granuflo Dry Acid Concentrate is a powder that is added to the blood of patients undergoing dialysis. It is combined with an alkaline substance, bicarbonate, to balance the pH of blood before it is returned to a patient.

Unlike other acid concentrate products, Granuflo contains a substance that is rapidly metabolized into bicarbonate in a patient’s liver. If the physician does not adjust the dose of Granuflo to compensate for this “extra” bicarbonate, patients can suffer a life-threatening bicarbonate overdose.

Plaintiffs in the Granuflo class action allege that Fresenius knew about the risk of overdosing errors, but failed to warn physicians, patients, or the FDA. Granuflo has been on the market since 2003, but it was not recalled until 2012, after the FDA received a leaked internal memo Fresenius issued to their own clinics. The memo identified more than 940 deaths at Fresenius clinics in 2010. The company estimated that elevated bicarbonate increased the risk of cardiac arrest by 6- to 8-fold rate.

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