This year’s GranuFlo and NaturaLyte recall has already resulted in several lawsuit filings against Fresenius Medical Care, the manufacturer of the dialysis drugs.  The most recent, a wrongful death lawsuit, was filed by a Florida woman who alleges her husband’s heart stopped beating following the administration of GranuFlo in 2008.

Additional GranuFlo and NaturaLyte lawsuits alleging wrongful death have been filed in Alabama and Georgia.  The Florida lawsuit claims that Fresenius knew for years GranuFlo and NaturaLyte posed risks for the heart that could be minimized or eliminated by reformulating the products.  But the company made a decision not to disclose these risks in order to protect revenue from the sales of GranuFlo and NaturaLyte, the complaint claims.

Both GranuFlo and NaturaLyte are used in dialysis to remove toxins from the blood.  Unlike rival products, they are formulated with sodium diacetate, rather than acetic acid.  GranuFlo and NaturaLyte lawsuits allege this formulation increases the risk of a condition called alkalosis, which occurs when there is too much bicarbonate in the blood.  Alkalosis is associated with heart attacks, cardiac arrest, sudden cardiac death, and other catastrophic heart problems in dialysis patients.

Germany-based Fresenius is the largest dialysis services and products company in both the U.S. and the world, and operates thousands of dialysis clinics here.   It also sells dialysis products, including GranuFlo and NaturaLyte, to thousands of other clinics around the country.  Fresenius is accused of making information about the drugs’ heart risks available to doctors who practiced at its own clinics, but leaving those customer clinics out of the loop.  An expose published by The New York Times over the summer reported that internal documents indicate Fresenius knew of the GranuFlo and NaturaLyte heart attack risk by late 2011.  In November of that year, the company circulated a memo to Fresenius clinics warning that GranuFlo had been linked to a sharp increase in the risk of dialysis patients dying suddenly from cardiac arrest.     Doctors at Fresenius clinics were advised to alter prescriptions for individual patients with excessive pre-dialysis serum bicarbonate level.

That memo never went out to customer clinics, according to the Times.   At some point, the FDA received a copy of the document from an anonymous source and started asking questions.  That resulted in Fresenius issuing an Urgent Product Notification to its customer clinics on March 29, 2012.   That notice would later be designated a Class I recall by the FDA, its most serious type of recall action.  Class I recalls are issued when a product poses a significant risk of injury or death.

According to the Times, the FDA has since launched an investigation to determine if Fresenius Medical Care’s delay in notifying customers of potential GranuFlo and NaturaLyte heart side effects violated federal law.

Published October 15, 2012 by