Fresenius GranuFlo Lawsuits Consolidated

Boston, MAGranuFlo lawsuits filed against Fresenius Medical Care have been consolidated into an action before Judge Douglas P. Woodlock. Since the Fresenius lawsuits were consolidated, more lawsuits have been filed alleging patients died after an alkali dosing error.

The lawsuits were consolidated after a judge found that the plaintiffs shared factual issues regarding the use of GranuFlo and/or NaturaLyte dialysis products. Patients may have suffered low blood pressure, cardiac arrhythmia or cardiopulmonary arrest. The lawsuits all involve factual questions about whether GranuFlo and/or NaturaLyte were defectively designed and whether Fresenius knew or should have known about the potential risks associated with its dialysis concentrates.

According to court documents filed in relation to the lawsuit (MDL 2428, in the United States District Court, District of Massachusetts), there are more than 300 lawsuits filed against Fresenius and its various entities. The plaintiffs in the cases are either those who received dialysis and suffered cardiopulmonary arrest or other injuries, or the survivors of those who died after receiving dialysis and suffering serious side effects. The lawsuits seek damages for wrongful death and personal injury.

“Plaintiffs in all pending actions claim that Fresenius knew or should have known of the substantially increased risk of cardiopulmonary arrest from rapid and dangerous increases in bicarbonate levels from the use of the subject product,” court documents state. They further allege that the link between GranuFlo and cardiopulmonary arrest was confirmed by a study done by Fresenius, in which one-third of almost 1,000 patients treated with GranuFlo suffered cardiopulmonary arrest. The lawsuit alleges that GranuFlo is linked to a six- to eight-fold increase in the risk of cardiopulmonary arrest and death, a risk that is reportedly not seen in similar products.

In June 2012, GranuFlo was subject of a Class I recall by the Food and Drug Administration (FDA). That recall was announced after the FDA was alerted to an internal memo from Fresenius, sent to Fresenius clinics, warning of the risk of alkali dosing errors that could be fatal. Although other clinics also use GranuFlo and NaturaLyte, the memo was reportedly only sent to Fresenius clinics.

The lawsuits allege Fresenius did not adequately warn about the risks associated with its product and failed to provide instructions concerning the proper use of GranuFlo.