First Granuflo bellwether trials possible in 2015

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The massive Granuflo litigation lumbers on. Over 1,500 Granuflo cases have now been filed against Fresenius Medical Care in the U.S. District Court of Massachusetts, alleging heart attacks, strokes and sudden cardiac death as well as failure to warn.

At a status conference held earlier this month, proposed discovery schedules and trial dates were on the court’s agenda. According to the Case Management Order, discovery will begin in September 2014 and the first of the bellwether trials could begin in late 2015 or early 2016.

A Class I recall of Granuflo and NaturaLyte dialysis products manufactured by Fresenius was issued by the U.S. Food and Drug administration in June 2012. A Class I recall is the most serious level of FDA recalls. The recalled products were acid concentrates that were administered to dialysis patients in 125,000 clinics throughout the United States. Granuflo and NaturaLyte were found to contain a high concentration of an ingredient that is converted by the body into bicarbonate. The result was metabolic alkalosis, which is associated with cardiovascular events such as heart attack and stroke.

The FDA began investigating after it became aware of a “leaked” internal memorandum sent by Fresenius in November 2011 to its own clinics regarding 941 patient deaths that occurred following use of Granuflo and NaturaLyte. That memo had advised Fresenius physicians to adjust Granuflo and NaturaLyte dosages and was sent only to Fresenius treatment centers.

The Ohio pharmaceutical injury attorneys at Clark, Perdue & List are investigating claims for cardiovascular injuries and death following administration of Granuflo or NaturaLyte. If you or a family member received dialysis treatment using either of these products and suffered a heart attack, stroke or sudden cardiac death, call Clark, Perdue & List.