On March 29, 2013, the United States Judicial Panel on Multidistrict Litigation moved to consolidate lawsuits alleging injuries or death from GranuFlo and NaturaLyte dialysis products into a multidistrict litigation (MDL No. 2428) to more effectively deal with common questions in fact in the suits.
“Overall, these cases allege that GranuFlo and/or NaturaLyte caused injury or death in patients who used the products during hemodialysis,” said Matthew J. McCauley of Parker Waichman LLP, an attorney for the plaintiffs.
The suits allege that the products are defective and that the manufacturer, Fresenius, , failed to warn about the risks. According to court documents, GranuFlo and NaturaLyte can lead to metabolic alkalosis, causing a number of potentially fatal complications, including:
- Low blood pressure
- Hypokalemia (low potassium level)
- Hypoxemia (low oxygen level)
- Hypercapnia (high carbon dioxide level)
- Cardiac arrhythmia
- Cardiopulmonary arrest
An article published last June in The New York Times said that the U.S. Food and Drug Administration (FDA) began investigating whether Fresenius Medical Care had violated federal regulations by failing to warn consumers about the potentially deadly risks of GranuFlo and NaturaLyte. A 2011 internal company memo warned that 941 dialysis patients suffered cardiac arrest in Fresenius facilities in 2010, the Times said. The memo was sent to Fresenius facilities, but the information was not made public until the FDA prompted Fresenius to release it.
In June 2012, Fresenius, in cooperation with the FDA, issued a Class I recall for GranuFlo and NaturaLyte, warning that the products may lead to high levels of bicarbonate in patients undergoing kidney dialysis. Class I recall is the FDA’s most serious recall status, reserved for situations in which there is a “reasonable probability” that use of the product “will cause serious adverse health consequences or death,” according to the FDA’s definition.
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