Friday, January 11, 2013

January 2013 Kidney Dialysis Drug Recall: Granuflo News Update

We've been writing about a Fresinius recall of their products known as Granuflo and NatyuraLyte; there was a recall last year based on a Fresenius' internal review of patients treated at Fresenius clinics that found at least 900 instances where patients suffered some type of cardiac injury during  or just after dialysis treatment. 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
At year's end in 2012, Plaintiffs filed Motion to Consolidate the cases into multidistrict litigation (MDL) for all federal lawsuit.  
Several 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 in the District of Massachusetts.
Early in 2013,  Fresenius said in court papers 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 filed on January 3, several 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. Their choices are the Southern District of Mississippi and the Northern District of Alabama. 

Here is the Fresenius Response: