Granuflo is a dry acid product containing sodium diacetatein which is used as an additive in conjunction with the hemodialysis machine and dialyzer for patients who have renal failure. In June 2012, the FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate.
Patients with renal failure do not have kidneys which perform their natural functions. Specifically, their kidneys may be incapable of removing excess fluids, toxins, and wastes from their body. Their kidneys also fail to produce the chemical bicarbonate which helps maintain the body’s pH by neutralizing the acidity in the body. Granuflo is an additive used with the dialysis process to personalize the serum bicarbonate concentration levels. Unfortunately, when doctors use dialysate concentrates containing acetic acid and acetate (such as Granuflo) as an additive with dialysis, some patients experience an increase in their levels of high serum bicarbonate. The increase in serum bicarbonate can cause metabolic alkalosis, leading to a variety of severe health conditions including death, heart attack, low blood pressure, low potassium in the blood, low levels of oxygen, cardiac arrhythmia, and excessive carbon dioxide in the blood.
In 2012, given the issues listed above, the U.S. Food and Drug Administration (FDA) issued a Class I Recall for Granuflo. This classification is the most serious type of recall and is only used for products in which “there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.” After the FDA recall notice, Granuflo lawsuits were filed against the manufacturer Fresenius Medical Care alleging that they failed in their duty to sufficiently label their products and did not adequately warn users about the risks posed by Granuflo.
Fresenius Medical Care has expanded to several major countries throughout the world, employing an estimated 45,000 employees in North America. According to the company’s mission statement they “not only want to provide products; they also want to create connections with patients and their families through caring treatment, guidance and comfort.”
Companies who decide to manufacture, market, and sell medications have the legal responsibility to educate users about the side-effect of their medications. Users of Granuflo suggest Fresenius Medical Care North America (FMCNA) may have failed in their responsibility to notify users of all of the serious side-effects of Granuflo. Although the medication was approved by the FDA in 2003, claimants allege Fresenius Medical Care North America (FMCNA) has not done enough to notify the Granuflo users of the most dangerous side-effect of Granuflo.