GranuFlo is a dry acid concentrate that is used during dialysis treatment to balance blood pH levels. Unfortunately, if a doctor administers an improper dose of GranuFlo, or uses it on a patient with high bicarbonate levels in their blood, the patient can suffer heart attack and death. Due to this risk, GranuFlo was recalled in June 2012. Many people who were injured are now seeking justice by filing a lawsuit against Fresenius, the company that sold GranuFlo.
Do I Have a GranuFlo Heart Attack Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured after taking GranuFlo, you should contact our lawyers immediately. You may be entitled to compensation by filing a GranuFlo lawsuit.
What’s the problem with GranuFlo?
GranuFlo is a dry acid concentrate that is used in hemodialysis. It was created and sold by Fresenius Medical Care, the largest provider of dialysis services in the world. Fresenius operates more than 1,800 dialysis clinics in the U.S. and serves hundreds of thousands of people who are suffering from end-stage kidney disease.
Dialysis is a process where a machine does the work of the kidneys — removing toxins and excess fluid from the blood. The pH of the blood increases during this process. Doctors usually use bicarbonate to return the pH balance back to normal before the blood is returned to the patient. During bicarbonate dialysis, an acid concentrate is typically mixed with a bicarbonate concentrate.
GranuFlo Dry Acid Concentrate contains sodium diacetate and acetic acid. The problem with GranuFlo is that sodium diacetate is rapidly converted to bicarbonate by a patient’s organs and tissues. A doctor must adjust the dosage of GranuFlo to compensate for the additional bicarbonate. Otherwise, the patient could easily suffer a bicarbonate overdose.
GranuFlo and Failure to Warn
There is evidence that Fresenius was aware about the risk of bicarbonate overdose, but did not warn government regulators, doctors at other clinics, or the public about this possible risk. The New York Times broke the story on June 15, 2012.
The Times reported that an anonymous source sent the U.S. Food and Drug Administration (FDA) an internal memo written by Fresenius staff. The memo, dated November 4, 2011, described an unusual increase in the number of deaths at Fresenius clinics. In 2010, there were 941 deaths. When Fresenius researched these deaths, they found a six-fold increased risk of cardiac arrest among patients with high bicarbonate levels.
This memo was sent only to doctors working at Fresenius clinics, although GranuFlo and NaturaLyte were also used at other dialysis clinics. It was not sent to the FDA until March 2012. On March 29, Fresenius published a warning to all of their customers about the risk of cardiac arrest.
Class 1 Recall of GranuFlo
GranuFlo was officially recalled by Fresenius and the FDA on June 27, 2012. The Class 1 recall is the most serious type of recall the FDA can issue. In the notice, the FDA wrote:
“Inappropriate prescription of these products 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 Heart Attacks
The risk of cardiovascular events (such as heart attack) occurs when a healthcare professional does not measure the proper amount of GranuFlo to compensate for increased bicarbonate levels. This can lead to a bicarbonate overdose, a massive drop in blood pH levels, and a life-threatening condition called metabolic alkalosis. Metabolic alkalosis can interfere with the heart’s normal electrical activity and potentially cause a fatal cardiovascular event such as a heart attack.
Severe complications of GranuFlo may include:
- Cardiac arrest
- Heart attack
- Cardiopulmonary arrest
- Irregular heart rhythm (arrhythmia)
- Low blood pressure
- Permanent disability
Do I have a GranuFlo Heart Attack Lawsuit?
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