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New GranuFlo Lawsuit Website from Bernstein Liebhard LLP Provides Vital Dialysis Recall Information, Instructions on Filing a Claim
Date:10/27/2013

l Care, a leading supplier of dialysis products and services in the U.S., failed to adequately warn about the life-threatening cardiovascular side effects associated with its products prior to issuing an Urgent Product Notification on March 29, 2012.

Following this public health announcement, the U.S. Food and Drug Administration (FDA) issued a Class I recall of Granuflo and NaturaLyte in June 2012 after learning of the drugs’ potential to cause fatal heart injuries in dialysis patients. A New York Times report published that month indicated that the federal agency became aware of an internal memo sent by Fresenius in November 2011 that contained information about 900 dialysis deaths that occurred after GranuFlo and NaturaLyte dialysis treatments.**The notice was only sent to physicians operating in clinics owned and operated by Fresenius.

According to the Times, the FDA had launched an investigation into whether Fresenius violated federal law in its handling of the GranuFlo recall. According to the article, doctors outside the company’s network did not know GranuFlo and NaturaLyte contained more of an ingredient the body converts to bicarbonate than similar medications, and that the difference could mean a patient’s experiencing elevated bicarbonate levels in the bloodstream. In turn, this may result in metabolic alkalosis, a condition that can allegedly lead to fatal or near-fatal cardiovascular injuries.

In addition to lawsuits filed at the federal court level, court documents indicate that numerous GranuFlo-related claims are also currently pending in a state court proceeding underway in Middlesex County Superior Court in Massachusetts. (In re Consolidated Fresenius Cases, No. MICV2013-03400-O)

Dialysis patients and their families may be entitled to compensation for injuries allegedly sustained withi
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