How Can a GranuFlo Lawsuit Help Me? GranuFlo is a dry dialysate concentrate used in hemodialysis procedures. Manufactured by Fresenius Medical Care, GranuFlo is used in dialysis procedures to remove waste and excess water from the blood. Patients that require dialysis often have renal failure or impaired kidney function. GranuFlo, approved by the FDA in 2003, was marketed as a lighter, more manageable substance than traditional liquid dialysates. It was used widely in Fresenius medical clinics and given to around 150,000 patients not in Freseniusâ€™ care. In 2012, reports began to surface suggesting that GranuFlo could lead to cardiopulmonary arrest. Fresenius may have known about this risk but neglected to tell the public. On March 29, 2012, the FDA initiated a Class 1 recall for GranuFlo because of its potentially deadly side effects, including: hypokalemia, cardiac arrhythmia, and cardiac arrest. What is GranuFlo? The kidneys act as a filtration system for blood in the body. They remove waste and excess water and regulate levels of sodium, potassium, chloride, calcium, phosphorus, magnesium, and sulfate. If the kidneys begin to fail, waste will not be properly diffused from the blood and there will be increased fluid in the body. This is not sustainable over the long term; the body will require dialysis to maintain proper function. Dialysis is not a complete replacement for kidney function but it can adequately replace the diffusion and ultrafiltration mechanisms. GranuFlo was designed to be an innovative product in the process of dialysis. Unlike traditional dialysates, GranuFlo comes in powder form. This allows it to be stored in smaller containers (as opposed to large liquid drums) and moved far more easily. When used by medical professionals, GranuFlo is hooked up to a hemodialysis machine and pumped alongside a patients blood. The semi-permeable membrane inside the machine allows waste chemicals to pass out of the blood but blocks larger substances, such as red blood cells. Patients with renal failure repeat this process regularly and GranuFlo became a commonly used substance in dialysis procedures. It has since been recalled, however, as information on its potentially deadly effects became public knowledge.
Why is GranuFlo a problem? Over the last few years, Fresenius Medical Care and its GranuFlo product have been at the center of sordid medical controversies. In November 2011 the internal offices of Fresenius sent a memo to the medical clinics operated by the company. According to a New York Times Article, the memo warned the clinics “that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.” While the company warned its own doctors about this risk it did not provide the information to the thousands of independent doctors that were using GranuFlo. In March 2012, an anonymous source sent Fresenius’ internal memo to the FDA. The FDA questioned the company about the findings, noting that manufacturers have a responsibility to alert the public if their products are unsafe. Th FDA eventually learned that GranuFlo was, in some cases, causing cardiac arrest due to abnormal levels of bicarbonate in the blood. Bicarbonate is an alkaline substance that is used in dialysis to control acid levels. GranuFlo contains an ingredient that the body converts in bicarbonate, resulting in more of the substance than other dialysates. Doctors were either not aware of or had not been calculating for this amount of bicarbonate and patients were receiving overdoses as a result. The Fresenius memo noted that “941 patients had suffered cardiac arrest inside Fresenius clinics in 2010.” In May 2012, the FDA released a safety warning concerning all products that contained dialysate concentrates. The warning noted that “when metabolized,” products such as GranuFlo “can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.” Most importantly, “this can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.” GranuFlo FDA Recall On March 29, 2012, the FDA initiated a full recall of GranuFlo and NaturaLyte products. Class 1 recalls are reserved for situations where there is a direct risk of severe injury or death for patients using the product. According to the agency, inappropriate use of GranuFlo “can lead to a high serum bicarbonate level in patients undergoing
hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.” GranuFlo Lawsuit Fresenius’ neglect to warn the public about the dangers of GranuFlo will likely be the focus of lawsuits in the near future. Patients that were harmed by this product were not necessarily made aware of the risks and thus deserve compensation for their pain and suffering. If you were harmed by GranuFlo Schmidt and Clark may be able to help with a lawsuit. The Side Effects of GranuFlo Patients treated with GranuFlo may experience any of the following side effects: • • • •
Hypokalemia Hypoxemia Hypercapnia Low blood pressure
• Cardiac arrhythmia • Cardiopulmonary arrest • Death Do I Have a GranuFlo Lawsuit? To learn more about the unfortunate side effects of GranuFlo, please visit our website: GranuFlo Lawsuit Information