Granuflo and NaturaLyte lawsuits have been filed against Fresenius Medical Care North America, the manufacturer and distributor of dialysis products Granuflo and NaturaLyte, alleging that their actions (i.e., Alkali Dosing Errors) led to the wrongful deaths of dialysis patients. Both Fresenius and DaVita operate hundreds of dialysis centers across the US.
Here we provide an update on the Granuflo lawsuits:
Granuflo Multidistrict Litigation (MDL)
• As of November 18, 2013, 393 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.
• The most recent status conference was held on November 1, 2013.
• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for them 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.
• In addition to claims pending in the federal MDL, several GranuFlo and NaturaLyte lawsuits are now pending in Massachusetts’ Middlesex County Superior Court (In re: Consolidated Fresenius Cases, No. MICV2013-03400-O).
• Five additional Fresenius lawsuits were filed on November 5, in Charleston, West Virginia, against Fresenius Medical Care Holdings. In four of those lawsuits, the plaintiffs represent the estates of people who died as an alleged result of dialysis treatments that used the defendant’s products. The lawsuits are likely to be transferred to the Massachusetts MDL.
Litigation History
• 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 its 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 that 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.
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 were 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, Massachusetts, is the largest operator of hemodialysis centers in the US, and processes more than one-third of the nearly 400,000 Americans who receive dialysis treatment each year.