June 19, 2013 — Law360 reports that the family of a man who died during dialysis treatment has filed a Pennsylvania Granuflo class action lawsuit. The class action seeks to consolidate claims from other people in Pennsylvania who were treated with GranuFlo and suffered heart problems during dialysis.
The plaintiff, Carmen Brysten, filed the class action on behalf of Filmon Brysten, who died in November 2011 at Langhome Health Center after being treated with GranuFlo. According to the complaint:
“GranuFlo is defective and unreasonably dangerous for its use because it creates an unreasonably dangerous level of bicarbonate in the blood stream during dialysis causing metabolic alkalosis and a corresponding substantial increase in the risk of cardiopulmonary arrest during dialysis treatment.”
The lawsuit alleges that Fresenius knew or should have known about the risk of bicarbonate overdoses because researchers identified the risk in 2004, and GranuFlo was specifically associated with it in 2008. However, when an internal memo linked GranuFlo to an increased risk of cardiopulmonary arrest, Fresenius failed to disclose this to the U.S. Food and Drug Administration (FDA) or the greater medical community.
Fresenius is currently facing at least 161 GranuFlo lawsuits in a Multi-District Litigation (MDL #2428). These lawsuits have been filed by individuals who suffered from heart attacks, cardiac arrest, abnormal heart rhythm, cardiopulmonary arrest, disability, or death during dialysis treatment with GranuFlo. It is possible that the Pennsylvania GranuFlo class action will be transferred into the MDL.
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