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By: Austin Kirk | Published: January 9th, 2013
Fresenius Medical Care has indicated that it supports the formation of a multidistrict litigation (MDL) for all federal NaturaLyte and Granuflo lawsuits, which involve allegations that the dialysis products caused individuals to suffer a cardiac arrest, heart attack or sudden death during treatment.
A growing number of individuals throughout the United States have filed lawsuits against Fresenius over problems with Granuflo or Naturalyte, alleging that the manufacturer failed to provide adequate warnings and instructions to physicians about the importance of monitoring bicarbonate levels among indivduals receiving the solutions during hemodialysis.
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. Both products contain sodium acetate that allegedly converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints. Plaintiffs indicate that Fresenius’ failure to disclose the risks associated with their products have caused thousands of individuals to suffer a cardiac arrest during dialysis treatments in recent years.
In December 2011, a group of plaintiffs filed a request with the U.S. Judicial Panel on Multidistrict Litigation asking that all Naturalyte and GranuFlo lawsuits filed in U.S. District Courts throughout the country be consolidated for pretrial proceedings as part of an MDL, and suggested that the litigation be centralized in the District of Massachusetts.
In a response (PDF) filed on January 3, Fresenius, the nation’s largest supplier of hemodialysis drugs, indicated that it agreed that consolidation of the NaturaLyte and Granuflo litigation was appropriate and supported the transfer of the cases to the District of Massachusetts
In another response by interested parties (PDF) filed on January 3, some plaintiffs with pending lawsuits have objected to centralizing the cases in Massachusetts, indicating that the litigation should be consolidated in the southeast, because of the number of cases filed in that region.
According to the filing, there are 37 Fresnius dialysis lawsuits filed in federal courts in Alabama, California, Florida, Georgia, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Ohio, and Pennsylvania. The number of cases eventually filed in the litigation could grow into the thousands.
All of the complaints contain similar allegations that Fresenius knew or should have known about the risk of problems from NaturaLyte and GranuFlo dialysis treatments, yet failed to provide adequate warnings or instructions with their acid concentrate products.
A Fresenius recall for Granuflo and NaturaLyte was issued last year based on a Fresenius internal review of patients treated at 667 Fresenius clinics found at least 941 instances where individuals suffered cardiac arrest during dialysis treatments in 2010.
At first the information was released only to Fresenius clinics, but the memo was eventually leaked to the FDA, which declared the action a recall and began investigating why the company did not inform the other dialysis clinics that used its products.
It is expected that the U.S. JPML will schedule oral arguments on the motion to consolidate the Fresenius dialysis litigation at an upcoming hearing session that is set to take place on March 21 in San Diego, California.