Granuflo and NaturaLyte lawsuits have been filed against Fresenius Medical Care North America, the manufacturer and distributor of dialysis products Granuflo and NaturaLyte, alleging their actions, i.e., alkali dosing errors, led to the wrongful deaths of some dialysis patients. Both Fresenius and Davita operate hundreds of dialysis centers across the US and dialysis patients who were treated at a Fresenius or Davita dialysis center may not have realized that a dialysis injury may have been the result of a Granuflo dosing error.• Granuflo lawsuits and Fresenius dialysis center lawsuits were filed after a Naturalyte GranuFlo recall. The lawsuits allege that Fresnius knew of the serious health risks associated with their product, but withheld information from physicians who were therefore unknowingly putting their patients at risk for life-threatening adverse events.
• Evidence to support these allegations comes from a memo sent internally to Fresenius clinics in November 2011, which states that in 2010 there were 941 instances of sudden cardiac arrest that took place during dialysis treatment at 667 of their own clinics.
• The memo also issues a warning to physicians about the necessity of monitoring patients’ bicarbonate levels during dialysis. However, other dialysis clinics were not issued the memo containing critical medical information. It wasn’t until the internal memo was leaked to the Food and Drug Administration that a warning letter was sent to all healthcare providers across the US. This happened in March 2012, at which point many more people had suffered adverse events.
• Recently, Fresenius settled a wrongful death case for seven figures to the surviving children of Teresa Gaytan, a mother of five who died during a dialysis treatment at a Fresenius Medical Care facility in Illinois. She was taken off life support and died on March 10, 2009. According to the lawsuit, Teresa Gaytan “sustained massive blood loss as a result of hemorrhage from the dialysis circuit during dialysis treatment at the center.”
• The dialysis lawsuits claim the problems that caused deaths such as that of Teresa Gaytan, were caused by dangerously high levels of bicarbonates in the dialysis treatment, and have affected thousands of dialysis patients nationwide.
Dialysis Lawsuit Update:
Granuflo Multi-district Litigation (MDL)
• Currently, over 300 Fresenius dialysis lawsuits have been filed in courts across the United States. In these lawsuits, plaintiffs allege that their hemodialysis treatment with GranuFlo or NaturaLyte led to a sudden cardiac arrest, heart attack or death.
• Due to the large number of Fresenius dialysis lawsuits, which make similar claims, the US Judicial Panel on Multidistrict Litigation (MDL) has ordered that all lawsuits be centralized in the District of Massachusetts before US District Judge Douglas P. Woodlock.
• The lawsuits were consolidated into MDL No. 2428 on April 5, 2013.
• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for than trying all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.
• On June 21, a group of six lawyers filed a motion requesting they be appointed leadership roles in the newly formed MDL.
• On July 16, court documents show the judge overseeing the GranuFlo recall litigation issued an order that established the proceeding’s plaintiffs' executive and steering committees. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428).
Product History
• Both Fresenius Medical Care products - Naturalyte and GranuFlo- are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates, according to the FDA safety recall initiated in March 2012.
• The recalled Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate was manufactured and distributed from January 2008 through June 2012.
• GranuFlo and NaturaLyte both use acetic acid and sodium acetate which can lead to additional presence of sodium acetate in the dialysate and, in turn, can result in higher levels of bicarbonate in the bloodstream. Higher levels of bicarbonate can lead to Granuflo side effects including cardiac arrest, cardiopulmonary arrest, metabolic alkalosis, stroke, low blood pressure and even death.
About Fresenius
Fresenius Medical Care, a German company with offices under the name Fresenius Medical Care North America in Waltham, MA, is the largest operator of hemodialysis centers in the US, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year.
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