The company of Fresenius Medical Care is facing product liability lawsuits in relation to its GranuFlo dialysis treatment. The number of lawsuits filed in court is expected to rise in the coming months. The suits are based on claims the company failed to warn patients and doctors about the risks associated with the product, which include cardiac arrest during treatment.
After using GranuFlo, doctors realized biocarbonate levels converted higher than expected, triggering the incidences of cardiac arrest, as well as heart attacks and death. Patients experienced the problems during or shortly after treatment at Fresenius clinics and other dialysis centers in the country. Fresenius is the manufacturer of GranuFlo, as well as NaturaLyte and other dialysis products. The company is one of the most popular owner/operators of dialysis centers in the United States.
Legal Organization for GranuFlo Cases
Records show there are nearly 2100 complaints filed in federal court against Fresenius. These have been centralized before the US District Judge Douglas P. Woodlock and will be heard in Massachusetts court as part of a Multidistrict Litigation. The goal of centralizing the lawsuits before a single judge allows the court to reduce duplicative discovery and avoid conflicting pretrial rulings. The hope is that centralizing the cases will make it easier on plaintiffs, witnesses, and the court system.
Bellwether cases have been prepared for early trial dates in an effort to help parties gauge how juries will respond to evidence and testimony. There was a September 2014 meeting for the plaintiffs’ executive committee and attorneys representing Fresenius. Each submitted a list of 10 potential bellwether cases. The judge scheduled an initial trial date of January 11, 2016, followed by an additional bellwether date approximately one month later. If Fresenius fails to reach settlements in the other cases it is facing, the judge can begin remanding hundreds of cases back to US District Courts throughout the country.
Years of Problems with GranuFlo
Problems with the GranuFlo treatment began in 2012 when an internal memo was leaked to the FDA. In it, Fresenius identified more than 940 instances in which patients suffered cardiac arrest during their 2010 dialysis treatments. The company issued warnings to doctors at their internal clinics encouraging them to monitor biocarbonate levels during treatment, but failed to provide that information to other non-Fresenius clinics using their products. The lawsuits also claim Fresenius should have recognized problems and issued warnings long before that internal memo.
It was not until spring of 2012 the company issued a warning letter to all healthcare providers, which was ultimately classified as an official recall of GranuFlo by the FDA. The official Reason for Recall is listed as follows on the official website of the FDA:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.”
The recall was classified as Class I, the most serious type of recall issued by the FDA because it involved “reasonable probability” that using a product would trigger serious health consequences or death. Doctors, other healthcare professionals, and patients were encouraged to report adverse reactions to the FDA Safety and Information program. Unfortunately for many the recall was issued too late.
If you have questions about GranuFlo or you or someone you love was injured while using this dialysis treatment, contact us.
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