Product Lawsuits Mount as Fresenius Faces Investigation on GranuFlo Cardiac Risks

In December 2011, Dugan W. Maddux, M.D., vice president of chronic disease initiatives at Fresenius Medical Care North America (FMC), declared, “Our number one goal is to provide the best quality care possible to help patients live a better life on dialysis.” The declaration was in connection with the renal care company’s celebration for 25 patients under the care of its dialysis facilities across the US. The company prides over these patients for having reached the age of 100 years in 1012.

Unfortunately, the troubles of the company have just started in March 2012 when Fresenius came up with an Urgent Product Notification warning to its customers. The warning stated that their products, GranuFlo and NaturaLyte, are correlated with heightened bicarbonate levels. Such level is known as a significant risk factor for cardiac arrest. Come June, the U.S. Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte Dialysis Products. Class I recalls are not to be taken lightly as these are issued for the most serious of cases as it deals with situations where the use of a product will translate to serious adverse health consequences that could be considered fatal.

An FDA spokesperson clarified that the federal regulating agency will not require the total removal of GranuFlo from the market. Rather, Fresenius is required to make changes to its product labeling and should also update the operating manuals for dialysis machines. On the contrary, medical and product liability experts, as well as renal care providers themselves, believe that the errors that FMC has wroth to the renal care industry may translate to a mounting number of affected dialysis patients filing a GranuFlo lawsuit.

Alkaline substances, GranuFlo and NaturaLyte, are administered to dialysis patients to neutralize the acid build up in their blood. GranuFlo and NaturaLyte are administered together with bicarbonate. They also contain acetate, an ingredient that the body converts to bicarbonate. Nonetheless, the subject products have higher acetate content levels compared to its rival products.


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