GranuFlo® Injury Lawyers
GranuFlo® and NaturaLyte® (sodium diacetate) are dialysates manufactured by Fresenius Medical Care, the largest operator of dialysis centers in the country. Dialysates work by filtering waste products from the blood for patients whose kidneys are no longer functioning properly.
On March 29, 2012, Fresenius sent an Urgent Product Notification to facilities using their dialysate products. This notification provided clinicians with important prescribing information regarding the use of GranuFlo and NaturaLyte.
Class 1 Recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." 1
Fresenius warned clinicians to be aware of the concentration of acetate contained in Fresenius' GranuFlo and NaturaLyte products. Once administered, the acetate in GranuFlo and NaturaLyte is rapidly converted to bicarbonate by the liver. Inappropriate use of these products can cause an extreme drop in blood pressure, which can then lead to stroke or cardiac arrest. Two months later, on May 25, 2012, the U.S. Food & Drug Administration (FDA) issued a Safety Communication, notifying health care providers that they had received complaints of dosing errors that occurred during hemodialysis, and to warn health care professionals to take special care when administering dialysates, like GranuFlo and NaturaLyte to patients.
In June 2012, the FDA issued a Class I recall for Fresenius’ GranuFlo and NaturaLyte products. The recall stated that Fresenius’ labeling was false and misleading, and required Fresenius to provide proper instructions for the use of GranuFlo and NaturaLyte. Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Risks Uncovered Before Recall Announcement
According to an internal memo released by the New York Times, Fresenius carried out its own investigation into the risks of cardiac arrest in 2011. Fresenius stated that approximately 941 patients treated at their dialysis centers in 2010 experienced cardiac arrest. Fresenius warned that dialysis machines underestimate the amount of acetate administered to the patient, which in turn affects a patient’s bicarbonate levels. Fresenius further warned that patients' risk of cardiac arrest was approximately six times higher if they had increased bicarbonate levels. Despite the importance of this information, Fresenius did not release it to the public or to non-Fresenius owned facilities until March of 2012, only after they were questioned by the FDA about these troubling occurrences.
More than 1,800 lawsuits have been filed by GranuFlo and NaturaLyte victims. Dialysis patients may qualify for filing a lawsuit if they suffered cardiac arrest, stroke, or other heart conditions while undergoing dialysis using GranuFlo or NaturaLyte products.
GranuFlo and NaturaLyte cases are no longer being accepted by Schlichter Bogard & Denton, and therefore the information on this page is provided for informational purposes only.
1 - Source: U.S. Food and Drug Administration