GranuFlo Injury Overview
Created by FindLaw's team of legal writers and editors | Last reviewed December 19, 2016
Millions of Americans suffer from advanced kidney disease. Hundreds of thousands of these patients rely on kidney dialysis for treatment. In recent years, health studies have revealed a link between the use of GranuFlo - a popular dialysis drug - and serious heart problems. Many patients have reported experiencing a GranuFlo injury. In some cases, these complications have even resulted in death.
GranuFlo Used in Kidney Dialysis
People experiencing kidney failure often rely on hemodialysis (dialysis) for treatment. During dialysis, a machine is hooked up to a patient to serve in place of the failed kidneys. Fluids, waste, and salt are filtered from a patient's blood by the machine. GranuFlo is a bicarbonate additive used during dialysis to reduce acid build up in a patient's blood. However, an improper dosage can lead to serious side effects.
Research Links GranuFlo to Heart Attacks
Medical research first linked GranuFlo to serious heart problems in 2010. Fresenius, the manufacturer of GranuFlo and an administrator of over a thousand dialysis treatment centers nationwide, conducted an internal study linking GranuFlo to an increased risk of heart attacks. The results - detailed in a November 2011 memo - found that improperly prescribed dosages of GranuFlo were responsible for 941 patients experiencing cardiac arrest in 2010 alone.
The study also found that patients using GranuFlo were six times more likely to experience heart attacks or cardiac deaths than other dialysis patients. The memo instructed Fresenius dialysis centers to closely monitor each patient's bicarbonate prescription. No notice was given to other dialysis centers and doctors.
Additional reports have detailed the side effects of GranuFlo since then. Patients have reported heart attacks, irregular heartbeat, strokes, and low blood pressure. GranuFlo can also affect patients' blood content, leading to low potassium levels, low oxygen levels, and high carbon dioxide levels. Numerous reports of patient deaths from cardiac arrest after taking GranuFlo have surfaced as well.
Fresenius's internal memo was leaked to the Food and Drug Administration (FDA) in March 2012. The company had warned its own dialysis centers and doctors about the problems linked to GranuFlo, but did not disclose those findings to other dialysis centers and medical professionals. In addition, Fresenius continued to promote and market GranuFlo after learning of the increased risk of heart attacks.
The FDA issued a Class I recall of GranuFlo on March 29, 2012. The recall notice advised health professionals and the public that the "inappropriate prescription of [GranuFlo] can lead to a high serum bicarbonate level in patients undergoing hemodialysis." The notice concluded that "[GranuFlo] may cause serious adverse health consequences, including death."
GranuFlo Injury Lawsuits
A manufacturer of a dangerous or defective consumer product may be liable for any resulting injuries under product liability law. This may apply when a product is defectively designed, when defective warnings fail to inform patients about a product's risks, and when a manufacturer gives out false or misleading information about a product.
Consumer attorneys have responded by filing lawsuits against Fresenius on behalf of the victims and their families. Most allege that Fresenius failed to warn doctors and patients about the side effects associated with GranuFlo, and intentionally withheld adverse information from other health care providers. These claims have been widespread; so far hundreds of people have filed suit in 46 states. Most lawsuits seek compensation for medical costs, lost wages, pain and suffering, and emotional distress. Many have alleged that Fresenius is responsible for the wrongful death of some patients.
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