More than 500 GranuFlo lawsuits have been consolidated for the sake of pretrial uniformity before the U.S. District Court for the District of Massachusetts. The U.S. Judicial Panel on Multidistrict Litigation, the body that centralizes cases in this manner, transferred five cases there against plaintiffs’ motions from the federal districts of Central California, Southern California and South Carolina.
These GranuFlo lawsuits have been filed either by injured patients or the family of decedents who were allegedly harmed by an increased cardiopulmonary risk associated with use of the dialysis chemical. Fresenius Medical Care is the defendant in mounting GranuFlo lawsuits.
“All of the actions …,” the panel wrote in February, “involve similar allegations that plaintiffs or their decedents suffered metabolic alkalosis as a result of the use of GranuFlo and/or NaturaLyte. These actions also likewise involve factual questions relating to whether these products were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury, and whether it provided adequate instructions and warnings with these products.”
The U.S. Food and Drug Administration announced in March 2012 a Class I recall of the dialysis “medical device” known as the NaturaLyte and GranuFlo Dry Acid Concentrate. Class I is “the most serious type of recall and involve[s] situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the FDA.
The agency explained that Fresenius Medical Care at the time was “cautioning clinicians” that “[i]nappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” which may trigger risk factors culminating in “cardiopulmonary arrest.”
Indeed a memorandum from Fresenius medical personnel dated Nov. 4, 2011, referred to a case-control study that examined the risk factors of 941 dialysis patients in 667 facilities who had suffered cardiopulmonary arrest during treatment in 2010. If Fresenius knew that patients were suffering GranuFlo-related cardiopulmonary arrest during treatment in 2010, why did it take until 2012 for a recall to be instituted?
GranuFlo lawsuit plaintiffs can find a strong ally in the experienced attorneys at Reich & Binstock, who have 30 years of experience handling product liability litigation against pharmaceutical corporations.