A Florida woman is suing the manufacturer of GranuFlo, a dry acid concentrate used during dialysis treatments, claiming the product caused her husband’s death. The lawsuit alleges that the product’s manufacturer, Fresenius USA Inc., knew that there were cardiac dangers associated with GranuFlo when it was introduced 2003 but didn’t make others aware of the dangers until years later.
Fresenius is a major provider of kidney dialysis service and renal care products. The company also produces GranuFlo, which performs various functions during dialysis treatment.
GranuFlo contains an ingredient that the body converts to bicarbonate, an alkaline substance that works to neutralize the acid in the blood. GranuFlo, however, contains more of this ingredient than other competitor products.
Last year, Fresenius sent an internal memo to doctors in its dialysis centers warning that GranuFlo can increase bicarbonate levels in patients more than other products of its kind, and can cause an overdose of bicarbonate. Recent studies have suggested that elevated bicarbonate levels can cause heart problems.
The memo went on to state that 941 patients had suffered cardiac arrest at Fresenius clinics in 2010, and that patients with high bicarbonate levels were six times more likely to suffer cardiac arrest than those with lower levels of bicarbonate.
Fresenius didn’t inform patients of the potential risks associated with GranuFlo or with its similar product, NaturaLyte, until months later, after the Food and Drug Administration (FDA) received a copy of the memo from an anonymous source. Shortly after notifying patients, Fresenius was ordered to issue a recall and update the instructions on the products’ labels.
Source: Harris Martin Publishing