June 19, 2013 — According to Law360, a Pennsylvania Granuflo class action lawsuit has been filed by the family of a man who died in 2011. The lawsuit alleges that Fresenius Medical Care, the manufacturer of a dialysis treatment product called GranuFlo, failed to adequately warn about the product’s risk.
The lawsuit was filed on June 14 on behalf of Filmon Brysten, who was treated with GranuFlo during dialysis treatment at Langhome Health Center in November 2011. The class action is seeking to represent individuals who were treated with GranuFlo and suffered heart problems (heart attack, cardiac arrest, cardiopulmonary arrest, irregular heart rhythm, etc).
The lawsuit states:
“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 also alleges that Fresenius was aware of the problem for several years before they warned the medical community. According to the complaint, the dangers of elevated bicarbonate were known since 2004, and GranuFlo was specifically linked to the complication in 2008.
In November 2011, Fresenius sent an internal memo to its medical doctors to warn about severe health risks associated with GranuFlo and bicarbonate overdoses. The memo was not shared with the FDA or the greater medical community. Shortly after the memo was leaked to the FDA and the New York Times, Fresenius issued a Class I recall of GranuFlo.
Fresenius is now facing a growing litigation involving GranuFlo lawsuits. Lawsuits have been centralized in a federal Multi-District Litigation (MDL #2428). At least 161 cases are now pending in the MDL. It is possible that the GranuFlo class action lawsuit in Pennsylvania could be transferred into the MDL and consolidated with other lawsuits and class actions.
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