Reports say two women from California recently filed a Granuflo lawsuit in the U.S. District Court in Oakland, California. The plaintiffs, Deborah Lower and Constance Morgan, filed the case on March 28, 2013. According to them, the acid concentrate Granuflo caused their mother’s death. They are charging the manufacturer of the alleged dialysis product with wrongful death.
Granuflo is an acid concentrate preferred by numerous dialysis centers in the United States. This product, which was manufactured by Fresenius Medical Care, helps neutralize the acid in the blood of dialysis patients. It was approved by the U.S. Food and Drug Administration in the year 2003, after which it was successfully released on the market. Its popularity reached a point where it was recognized as one of the most utilized acid concentrates in the country.
Shortly after its market release, many researchers linked Granuflo to heart complications. A post-marketing study conducted by the manufacturing company also indicated that Granuflo can potentially increase the risk of developing heart related adverse effects that could eventually lead to patient deaths. Based on the study, dialysis patients administered with Granuflo are six to eight times more likely to develop such dangerous complications compared to those who were given something else.
Upon discovering the dangerous side effects of Granuflo in 2011, Fresenius Medical Care sent a warning memo to company-owned dialysis centers. However, reports say it neglected to warn other dialysis treatment facilities that also use the acid concentrate. This has allegedly resulted in numerous injuries and patient deaths.
A couple of months after Fresenius discovered the heart related complications of Granuflo, a copy of the warning notice was anonymously sent to the U.S. Food and Drug Administration. Alarmed, the agency immediately issued a class I recall of the dialysis product, along with another Fresenius-made acid concentrate known as Naturalyte. The class I recall, which is a recall reserved only for the most dangerous medical products, was issued in June 2012.
According to medical researchers, the acid concentrate Granuflo converts into bicarbonate when it enters the bloodstream. Moreover, these researchers explained that increased levels of bicarbonate in the blood can result in alkalosis. Alkalosis is a medical condition in which the hydrogen ion concentration of arterial blood plasma, also known as alkalemia, is considerably reduced. This medical condition could lead to a heart attack and sudden death.
The woman at the center of the lawsuit in California, Beaulahfay Riddie, allegedly died while undergoing dialysis treatment. Her doctors stated that she suffered from cardiac arrest. Prior to this unfortunate event, the lawsuit claimed that she developed metabolic alkalosis, which was reportedly caused by Granuflo. More information regarding this case and other lawsuits involving Granuflo may be found on personal injury law firm sites, including the New York-based Rottenstein Law Group’s rotlaw.com.