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GranuFlo® Lawsuit Update: Number of Cases Filed Against Manufacturers of GranuFlo® Continue to Grow

According to an order issued on July 29th, the first scheduling conference for parties involved in the GranuFlo® dialysis Multidistrict Litigation (MDL 2428) has been set for August 30th in the Joseph Moakley United States Courthouse in Boston, Massachusetts. During this conference, The Honorable Judge Douglas P. Woodlock will meet with the attorneys involved in order to review pending motions and discuss the structure and organization for the MDL. In March, the Judicial Panel on Multidistrict Litigation (JPML) announced that all GranuFlo® federal lawsuits would be consolidated for pretrial proceedings before The Honorable Judge Douglas P. Woodlock in the United States District Court for the Northern District of Massachusetts (MDL 2428). These GranuFlo® lawsuits were consolidated to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges, and to increase convenience for the parties and the courts.

GranuFlo®, along with Naturalyte®, is an acid concentrate diluted to clean a patient’s blood during dialysis treatment. The dialysate that is used during dialysis is made by mixing (1) purified water; (2) with a bicarbonate concentrate (i.e., GranuFlo® and/or NaturaLyte®); and (3) an acid concentrate. Lawsuits filed against the manufacturers of GranuFlo® allege that the sodium diacetate acid in GranuFlo® interferes with the bicarbonate conversion process. In particular, the sodium acetate is metabolized rapidly by the liver, resulting in an amount of bicarbonate delivered during dialysis that exceeds the amount prescribed by the doctor.

As a result, GranuFlo®, which is manufactured and sold by Fresenius Medical Care, has been linked to a number of harmful side effects and injuries, including stroke, cardiac arrhythmia, and cardiac arrest. Such dangers led to a Class I Recall of the drug in 2012 after a whistleblower leaked an internal company memo to the Food and Drug Administration (FDA). The internal memo noted that 941 patients had suffered cardiac arrest during dialysis treatments involving Granuflo® or NaturaLyte® in 2010. The company concluded that these patients, with high levels of bicarbonate in their blood, had about six times the risk of cardiac arrest as those with lower levels.

Across the country, hundreds of dialysis patients have filed lawsuits in federal court against Fresenius Medical Care alleging serious injuries, including heart attacks, strokes, and even death, as a result of using GranuFlo®. As of July 2013, the JPML reports that 188 GranuFlo® lawsuits are pending in the Multidistrict Litigation (MDL 2428), and this number continues to increase.

If you or a loved one has experienced serious – even fatal – injuries from GranuFlo®, contact the experienced pharmaceutical attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297. We will confidentially evaluate your case for free and without any obligation.


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