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Last year's recall for GranuFlo and NaturaLyte dialysis concentrates have spawned dozens of GranuFlo lawsuits in federal courts throughout the country. On March 29th, 2013, the Judicial Panel on Multidistrict Litigation ordered that every federally-filed Fresenius lawsuit be consolidated in a multidistrict litigation and transferred to Massachusetts federal court for pretrial proceedings. GranuFlo and NaturaLyte are used by thousands of dialysis clinics, including some of which are owned by its manufacturer, Fresenius Medical Care, as well as thousands of others supplied by the company. In March 2012, Fresenius issued an Urgent Device Notification to dialysis clinics throughout the country warning that the products could cause a dangerous elevation of bicarbonate in the blood if not dosed properly. In dialysis patients, this occurrence could cause catastrophic heart side effects, including heart attacks, strokes, and sudden cardiac death. Because of the serious danger associated with the two drugs, the U.S. Food & Drug Administration (FDA) deemed the notification a Class I recall. Since then, dozens of people have filed Fresenius lawsuits alleging that the risks associated with GranuFlo and NaturaLyte were concealed. Among other things, these claims point to a November 2011 memo sent to doctors at Fresenius-owned dialysis clinics that advised the physicians to adjust dosage to avoid high bicarbonate levels and related heart complications. A similar memo wasn't issued at that time to any of Fresenius' customer clinics. According to a New York Times report from June 2012, Fresenius only issued the March 2012 notification after the FDA learned of the November 2011 memo. The FDA is now investigating Fresenius to determine if the delay in warning its customer clinics violated the law. More than one GranuFlo lawyer believes that because a large number of patients were treated with these drugs, the litigation surround the recall could be massive. In fact, federal lawsuits were consolidated in the U.S. District Court, District of Massachusetts because of the potential for a large number of filings. During the multidistrict litigation process, a single federal judge will handle all pretrial issues, including discovery. The aim of the proceeding is to preserve the resources of the court, parties and witnesses, and to avoid duplicate discovery and inconsistent rulings. All of the lawsuits pending in the GranuFlo litigation will maintain their own identity, and any not resolved during the multidistrict litigation process will be sent back to their original court for trial. There is a good chance that any dialysis patient who suffered catastrophic heart problems within 48 hours of dialysis treatment could have been administered GranuFlo or NaturaLyte. Such individuals may be entitled to file a legal claim seeking compensation for their pain and suffering.
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