GranuFlo lawsuits pending in federal courts throughout the U.S. could soon be transferred to a single consolidated litigation.  On December 12, 2012, plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer all federally filed claims involving GranuFlo and NaturaLyte acid concentrates to the U.S. District Court, District of Massachusetts, for coordinated pretrial proceedings.

GranuFlo Lawsuit Allegations

GranuFlo and NaturaLyte are used in dialysis to remove toxins from the blood.  At least 11 claims have been filed since Fresenius Medical Care announced a GranuFlo recall in March, after hundreds of people at the company’s dialysis clinics suffered cardiopulmonary arrest and sudden cardiac death.  The plaintiffs moving for the federal consolidation are survivors of dialysis patients who died allegedly as a result of dialysis treatment with one of the two products.  They maintain all of the pending federal GranuFlo lawsuits involve common questions of fact, including whether Fresenius knew or should have known that GranuFlo can cause injuries.

All of the GranuFlo lawsuits allege that GranuFlo and NaturaLyte can cause a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death compared to rival products.  Plaintiffs further allege that the causal link between GranuFlo and cardiopulmonary arrest was confirmed by Fresenius’ own study, which found that of  941 patients who suffered cardiopulmonary arrest at its clinics in 2010, all had been administered either GranuFlo or NaturaLyte, and all had excessive amounts of bicarbonate in their blood.  The Fresenius study found that unsafe bicarbonate levels were associated with as much as a 6-fold increase in the risk of cardiac arrest.

GranuFlo Recall

According to a report published by The New York Times in June, the findings of that study prompted Fresenius Medical Care to issue a memo to dialysis clinics in its own network warning doctors of the risks associated with GranuFlo and NaturaLyte, and advising physicians to alter dosage of the two drugs.  That memo was dated November 4, 2011, months before the GranuFlo recall was announced.  However, the thousands of independent clinics supplied by Fresenius were not issued a similar warning at that time.

At some point, according to the Times, a copy of the November 2011 memo was leaked to the U.S. Food & Drug Administration (FDA), prompting the agency to start asking questions.  Finally, with the FDA breathing down its neck, Fresenius issued an Urgent Product Notification to its customer clinics on March 29, 2012, warning them of the hazards associated with GranuFlo and NaturaLyte.  The FDA would later deem the notification a Class I GranuFlo recall, its most serious type of recall.  Class I recalls are announced when it has been determined that use of a product poses a risk of serious injury or death.

According to The New York Times, the FDA is now investigating Fresenius’ handling of the GranuFlo recall to determine if its delay in notifying its customer clinics violated any laws.

Published December 17, 2012 by