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Fresenius Medical Care has agreed to multidistrict litigation (MDL) consolidation for all federal NaturaLyte and Granuflo lawsuits. The injured plaintiffs allege that the dialysis products manufactured, distributed and used by Fresenius Medical Care during dialysis caused patients to suffer a cardiac arrest, heart attack or sudden death.

Many injured kidney failure patients have filed claims against Fresenius Granuflo and Naturalyte, alleging that the company failed to provide warnings to doctors about the importance of monitoring bicarbonate levels among patients during dialysis.

What is Fresenius Granuflo and Naturalyte?

Both NaturaLyte and GranuFlo are acid concentrates and according to medical experts both products contain sodium acetate that converts to bicarbonate at higher-than-expected levels. Too high a blood bicarbonate level or blood alkalosis can cause sudden death and cardiac arrest.

Massachusetts Federal MDL Consolidation?

In December 2011, there was a filing with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that all Naturalyte and GranuFlo federal lawsuits be consolidated for pretrial proceedings as part of an MDL, and that the litigation be centralized in the District of Massachusetts.

Some litigants with lawsuits have objected to centralizing the cases in Massachusetts, and according to the filing, there are 37 Fresnius dialysis lawsuits filed in federal courts in Alabama, California, Florida, Georgia, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Ohio, and Pennsylvania.

Lawsuit allegations against Fresenius Medical Care

There are similar allegations that Fresenius knew or should have known about the risk of problems from NaturaLyte and GranuFlo dialysis treatments, yet failed to provide adequate warnings of their acid concentrate products.

Fresenius Granuflo and Naturalyte Recall

There was a recall of Granuflo and NaturaLyte in 2012 based on a Fresenius internal review of patients treated at 667 Fresenius clinics, that found at least 941 cases where individuals suffered cardiac arrest during dialysis treatments in 2010. This critical information was released only to Fresenius clinics, but the memo was leaked to the FDA, which led to the recall.

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