A total of 650 dialysis lawsuits have now been filed in Massachusetts federal court over a drug tied to serious cardiovascular injuries that prompted 2012’s GranuFlo recall, according to court documents.
A Case List updated by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on March 13th shows that these claims are now pending in a federal multidistrict litigation established in the U.S. District Court, District of Massachusetts. Among other things, plaintiffs in these lawsuits allege sudden cardiac death, heart attacks, strokes and other injuries following use of GranuFlo recall or NaturaLyte.
A month earlier, the JPML published documents that showed 515 claims filed against the manufacturer of these drugs, Fresenius Medical Care, after a dialysis recall that was announced on June 25, 2012 by the U.S. Food and Drug Administration (FDA). The GranuFlo recall, which was categorized as Class I, the FDA’s most serious category, was issued after the federal agency determined side effects associated with these medications to be serious and potentially fatal.
Two months prior to the FDA safety alert, an Urgent Product Notification involving GranuFlo and NaturaLyte was issued by its manufacturer, Fresenius Medical Care. The company notified the general public at this time of cardiovascular problems that may be associated with its products and stem from their high amount of ingredient the body converts to bicarbonate. Although similar dialysis medications contain this ingredient, GranuFlo and NaturaLyte contain more, and may increase a patient’s potential to develop side effects.
More than two years after Fresenius issued its initial safety alert, GranuFlo lawsuit litigations over the dialysis medication have continued to move forward. Court documents indicate that several claims have also been filed at the state court level in Middlesex County Superior Court by individuals who similarly allege that GranuFlo and NaturaLyte were designed defectively by their manufacturer. They further allege that the March 2012 notification from Fresenius was issued too late, and that officials had prior knowledge of the fatal and near-fatal dialysis side effects associated with the drugs. An internal memo sent by Fresenius in 2011 reveals that the company knew about 941 deaths that followed use of GranuFlo and NaturaLyte in its facilities.