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GranuFlo Lawsuit News: Bernstein Liebhard LLP Reports on Latest Status Conference in Federal GranuFlo Recall Litigation
Date:11/4/2013

r allegations that Fresenius Medical Care failed to provide adequate warnings regarding the use of GranuFlo and NaturaLyte, and continued to aggressively market both products after their risks became apparent in order to protect their market share.

GranuFlo and NaturaLyte are used during dialysis to remove acid from the blood. In March 2012, an Urgent Product Notification issued by Fresenius Medical Care warned of sudden, life-threatening heart problems that could occur due to inappropriate dosing of the drugs. The New York Times reported in June 2012 that many doctors were unaware that, compared to rival products, GranuFlo and NaturaLyte contained more of an ingredient the body converts to bicarbonate. As such, certain dosages could result in dangerously elevated levels of bicarbonate in the blood, resulting in metabolic alkalosis, a condition that can cause deadly heart problems in dialysis patients.*

In June 2012, the U.S. Food & Drug Administration (FDA) granted Class I recall status to Fresenius Medical Care’s Urgent Product Notification, which indicates that a medical product poses a significant risk of serious injury or death. According to The Times, the agency also began investigating Fresenius Medical Care shortly after learning of a memo the company had issued in November 2011 to its own clinics that warned of the heart risks associated with GranuFlo and NaturaLyte. The agency is trying to determine if Fresenius violated federal regulations, as none of its customer clinics outside of the Fresenius network were issued a similar warning about GranuFlo and NaturaLyte at that time.

Individuals treated with GranuFlo or NaturaLyte, or their families, may be entitled to file a dialysis lawsuit against Fresenius Medical Care if they or their loved one suffered cardiac arrest, heart attack, stroke, or sudde
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