Lawsuits have been filed following reports that GranuFlo and NaturaLyte were linked to an increased risk of heart problems - including heart attack and stroke - due to excessive levels of bicarbonate caused by dosing errors. Among the concerns is that Fresenius allegedly knew about this risk and warned health care professionals at its own clinics about the risks via internal memo, but did not warn professionals at other clinics, putting patients at those clinics at risk of serious adverse reactions.
GranuFlo was the subject of a US Food and Drug Administration (FDA) Class I recall in June 2012.
“Plaintiffs in all pending actions contend that GranuFlo causes a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death that is unique to GranuFlo,” plaintiffs argued in court documents (filed 12/12/12; found online at http://cdn.aboutlawsuits.com). They further allege that Fresenius knew about the risk of cardiopulmonary arrest associated with GranuFlo due to a case-control study the company conducted, which found that during 2010, “some 941 patients treated with GranuFlo in roughly one-third of its clinics suffered cardiopulmonary arrest and sudden cardiac death.”
According to the court documents, GranuFlo is unreasonably dangerous because it causes “rapid and dangerous increases in bicarbonate and a resulting 6 to 8 fold increased risk of cardiopulmonary arrest and death.”
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In January 2013, Fresenius filed papers agreeing with the move to transfer and consolidate the lawsuits. According to its own documents, as of the time those papers were filed, there were 37 lawsuits involving GranuFlo and NaturaLyte pending in federal district courts.
Fresenius defended itself, saying, “The plaintiffs’ claims will fail on their merits because the plaintiffs cannot show that Fresenius’ products are unreasonably dangerous.” The company also noted that its products are still on the market and used safely in clinics across the US.
The lawsuit is MDL No. 2428.