Fresenius Medical Care AG & Co., the manufacturer of kidney dialysis products GranuFlo and NaturaLyterecently named Ronald Kuerbitz as its new CEO and Chairman of the Management Board at the same time that hundreds of dialysis patients who use its GranuFlo product are suffering serious injuries such as cardiac arrest.
Fresenius recently made headlines when the New York Times reported in June that the company was being investigated by the FDA for failing to warn dialysis patients using its GranuFlo product of an increased risk of cardiac arrest. The FDA had issued a class I recall for dialysis products GranuFlo and NaturaLyte, which are both manufactured by Fresenius. This type of recall is used when it is determined that a particular drug or product could cause an adverse health event or death.
In a study conducted between January 1 and December 31, 2010 throughout 667 Fresenius dialysis clinics, it was found that 941 patients suffered cardiopulmonary arrests due to a high serum bicarbonate levels. The results of this study were circulated solely to Fresenius Medical Care staff in late 2011. Fresenius did not issue any outside communication about this study until March 2012, two days after the FDA requested additional information regarding the link between GranuFlo use and the increased risk for cardiac arrest and issued the product recall.
If you or someone you care about is a dialysis patient who has suffered an injury such as stroke, heart attack, or death—contact us. Our product liability personal injury attorneys can advise you of your legal rights and options regarding compensation for your injuries.