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What could ultimately end up being hundreds, if not thousands, of Fresenius GranuFlo lawsuits are now moving forward in a federal multidistrict litigation underway in Massachusetts. All of the claims pending in the consolidated proceeding were filed in the wake of the March 2012 recall for GranuFlo and NaturaLyte dialysis concentrates. Both GranuFlo and NaturaLyte were the subject of a Class I FDA recall in March 2012, after they were linked to hundreds of instances of cardiac arrest at Fresenius dialysis clinics. Both drugs are used to remove toxins from the blood in dialysis patients, and contain more of an ingredient that the body converts to bicarbonate compared to rival products. Apparently, many doctors were not aware of this difference when they prescribed the dosage of GranuFlo or NaturaLyte to be administered during dialysis. Too much bicarbonate in the body can result in metabolic alkalosis, a condition that can cause serious heart problems, including heart attacks, strokes, sudden cardiac arrest, and even death. In November 2011, Fresenius Medical Care issued a memo to doctors at dialysis clinics it owned warning them of the risks associated with improper dosing of GranuFlo. Among other things, the memo revealed that 941 patients had suffered cardiac arrest at Fresenius clinics in 2010. A study conducted by the company had also revealed that high bicarbonate levels were associated with a six-fold increased risk of sudden cardiac death, according to the GranuFlo Fresenius memo. For some reason, Fresenius did not issue a similar memo to the thousands of dialysis clinics that also used GranuFlo and NaturaLyte. It wasn’t until March 2012 – after the FDA learned of the earlier Fresenius GranuFlo memo – that an Urgent Device Notification was sent to the company’s customer clinics. Shortly after, patients around the country began filing GranuFlo lawsuits that alleged Fresenius knowingly concealed the risks associated with GranuFlo and NaturaLyte. Anticipating g a large number of claims, the U.S. Judicial Panel on Multidistrict Litigation ordered all pending and future Granuflo lawsuits filed in federal courts transferred to the District of Massachusetts for pretrial proceedings. The aim of the proceeding, known as a multidistrict litigation, is to conserve resources of the court, and avoid duplicative discovery and inconsistent ruling. On April 5th, the judge overseeing the Fresenius GranuFlo lawsuit litigation in Massachusetts issued the first order in the case, which governed practices and procedures for all filings in the litigation. In the coming months, it is likely that the litigation’s pretrial conferences will be scheduled, and attorneys for plaintiffs and the defense will be appointed to leadership positions.
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