GranuFlo Recall

Published on June 21, 2013 by Laurie Villanueva

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A Class I GranuFlo recall has been issued for GranuFlo and NaturaLyte, two dialysis concentrates marketed by Fresenius Medical Care. The two products have been linked to serious, and in many case, deadly heart side effects, including heart attacks, strokes and sudden cardiac death. If you or a loved one were harmed by either GranuFlo or NaturaLyte, you could be entitled to compensation for your injury-related damages, including:

  • Medical bills
  • Lost wages
  • Emotional distress
  • Pain and suffering
  • Wrongful death

Bernstein Liebhard LLP is offering free legal consultations to anyone who suffered catastrophic heart injuries related to the GranuFlo and NaturaLyte recall, or their families. To learn more about the GranuFlo recall, and to see if you might qualify for compensation, please contact our GranuFlo attorneys today by calling .

GranuFlo and NaturaLyte Recall

In March 2012, Fresenius Medical Care issued an Urgent Product Notification for GranuFlo and Naturalyte, two products used during dialysis to remove toxins from the blood. According to the GranuFlo recall notice, both GranuFlo and NaturaLyte had been linked to high serum bicarbonate levels in patients undergoing dialysis. This situation can cause patients to experience metabolic alkalosis, which may increase their risk of suffering any number of serious effects, including:

  • Low blood pressure
  • Cardiac arrhythmia
  • Low blood oxygen levels
  • Low potassium levels in the blood
  • High levels of carbon dioxide in the blood

If not resolved quickly, metabolic alkalosis can result in serious cardiac problems, including heart attack, stroke, and sudden cardiac death.

In June 2012, the FDA designated Fresenius’ action a Class I GranuFlo and NaturaLyte recall, which indicates the products posed a significant risk of injury and death.

What Did Fresenius Know Prior to the GranuFlo Recall?

Hundreds of dialysis lawsuits have been filed around the country on behalf of patients who were allegedly injured by GranuFlo and NaturaLyte. Among other things, these lawsuits claim that Fresenius Medical Care was aware long before the GranuFlo and NaturaLyte recall was announced that the two products could cause significant harm to patients.

According to plaintiffs, an analysis conducted by Fresenius’ own medical staff concluded that GranuFlo was associated with an increased risk of cardiac arrest, after 941 patients treated at the company’s own dialysis clinics had experienced cardiac arrest during 2010. An analysis of the data also revealed that the patients’ chance of suffering cardiac arrest was up to six times higher if they demonstrated high pre-dialysis bicarbonate level. In November 2011, a memo sent only to dialysis clinics within Fresenius’ own network detailed these findings, and warned that failure to administer the proper dose of GranuFlo or NaturaLyte could result in a rapid increase in serum bicarbonate which had the potential to cause sudden and catastrophic heart side effects.

Despite the danger outlined in the memo, thousand of dialysis clinics supplied by Fresenius outside of the company’s network were not informed of the problem at that time. In fact, the company only decided to issue its March 2012 notification to those clinics after the FDA learned of the earlier memo, and started questioning Fresenius about the issues it raised. Now, the FDA is investigating Fresenius to determine if the company’s s delay in notifying its customer clinics violated any laws or regulations.

Affected by the GranuFlo Recall? Learn More About Your Legal Options.

If you or a loved one suffered a serious and sudden heart problem within 72 hours of a dialysis treatment with GranuFlo or NaturaLyte, you may be entitled to compensation. Bernstein Liebhard LLP is offering free legal consults to anyone affected by the GranuFlo and NaturaLyte recall. To learn more about your legal options, please contact us today at .