A Texas widow is suing the makers of GranuFlo for allegedly hiding information about its potential to cause the kind of serious cardiovascular injuries that led to her husband’s death last year.

According to court records, the case was filed on June 25th in the U.S. District Court, Southern District of Texas, before being transferred last month to Massachusetts federal court, where a federal litigation has been established for cases involving the dialysis medication.  Among other things, the Corpus Christi woman alleges that her husband suffered cardiac arrest and metabolic alkalosis after GranuFlo treatments that occurred from 2011 to 2013, and that he and his doctors were not properly informed by Fresenius Medical Care about the potential for these injuries to occur. It wasn’t until March 2012 that the manufacturer of this medication, as well as similar drug, NaturaLyte, issued a public health warning about its products’ possible association with metabolic alkalosis, a condition that stems from elevated pH levels in the blood stream, and has been associated with serious heart problems.

GranuFlo Recall Was Too Little, Too Late, Plaintiffs Allege

The U.S. Food and Drug Administration (FDA) gave the notice Class I recall status two months later, around the time the New York Times reported that Fresenius had sent an internal memo to physicians operating within its network that over 900 patient deaths had followed treatments that incorporated GranuFlo and NaturaLyte. Doctors were instructed to lower dosages of the treatments during that time, in order to prevent future casualties. Following revelations about this document, the Times article from June 2012 indicated that the FDA was investigating whether Fresenius violated federal regulations in withholding vital safety information from the public.

The majority of lawsuits involving GranuFlo and NaturaLyte are now pending in a federal litigation underway in Massachusetts federal court, after being filed on behalf of patients who allegedly suffered cardiac arrest, sudden cardiovascular death, sudden cardiac death, cardiopulmonary arrest, and other catastrophic heart injuries due to their use. As of September 15, a total of 2,089 claims had been filed in the proceeding now underway in the U.S. District Court, District of Massachusetts.

Court records indicate that several other claims have also been filed at the state court level, in a consolidated litigation established in Middlesex County Superior Court.

Consider a GranuFlo Lawsuit

Contact our Firm for more about GranuFlo lawsuits, and to learn about the process of filing a case against Fresenius. Our attorneys can be reached directly at (877) 779-1414.

Published October 8, 2014 by