Get GranuFlo Recall Lawsuit Help
Have you or a loved one suffered complications after receiving dialysis? Recalled by the FDA, treatment mixture GranuFlo may increase risks for cardiac arrest, stroke, death and other complications and you may not have been adequately warned of the risks. Join with our experienced dialysis lawsuit attorneys in holding those responsible accountable. Get your case reviewed now.
- Find out if you have a legal claim
- Learn the truth that may have been witheld
- Hold those that may be responsible accountable
GranuFlo Recall Information
Dialysis patients should be aware that the U.S. Food and Drug Administration (FDA) has recently issued a recall on 2 dialysis products. Both GranuFlo and Naturalyte, products of Fresenius Medical Care Holdings, Inc., have had a Class I recall issued due to possible adverse health consequences, including death in some cases.
GranuFlo and Naturalyte are liquid acid compounds which are used during the hemodialysis procedure in patients who have chronic or acute renal failure. Both compounds have been recalled from consumer use due to a discovered significant risk for sudden cardiac arrest and other cardiovascular problems. The FDA has made allegations that the manufacturer was aware of the risks of cardiac arrest associated with the use of the bicarbonate mixtures, yet may not have adequately warned dialysis treatment centers about the possible risks.
Our GranuFlo recall attorneys would like to let you know that if you or a family member have suffered a cardiac arrest following or during dialysis treatment you may have a claim that entitles you to compensation. An experienced medical injury lawyer can begin the determination process to see if you have a claim and help hold them accountable. If you, or someone you loved suffered any adverse health problems following dialysis that may be related, contact us today to find out if you have a case.
Problems GranuFlo May Cause
First, we need to understand the process of hemodialysis. This process uses a machine to filter excess salt and water from the blood of those whose kidney's no longer function properly. One part of the process involves neutralizing the acids in the blood. This is accomplished by introducing an alkaline substance, most usually bicarbonate.
When used in small doses this works well to neutralize acids, however an overdose of bicarbonate can lead to heart problems, including cardiac arrest.
Many of the concentrates used in dialysis contain ingredients that are converted to bicarbonate in the liver of the patient. GranuFlo and Naturalyte use the same ingredient that competing products use, however, they have the ingredient in a higher concentration.
This means that proper prescription and administration must be followed to avoid an overdose during the hemodialysis process.
Reports that have contributed to the recall of GranuFlo and Naturalyte state that many physicians may not have been adequately informed of the higher concentrations of bicarbonate in these two products.
This has led to over administration leading to potential heart and cardiovascular problems in patients who have been given GranuFlo and Naturalyte.
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FDA Issues Health Alert
The FDA Class I recall reports that high levels of bicarbonate in the bloodstream can contribute to a condition known as metabolic alkalosis. This condition can be serious and will put patients at risk of the health conditions listed below.
- Low blood pressure
- Low blood oxygen pressure
- Low blood potassium levels
- Cardiac arrhythmia
Because any of the conditions, when not identified and treated properly can lead to serious complications, the FDA has issued its recall. Complications identified include heart problems, cardiac arrest, and death in some cases and the following when encountered after receiving treatment should be taken very seriously.
Review My Case NowPatients May Not Have Been Warned of Treatment Risks
According to FDA records, Fresenius did conduct its own investigations into the safety of GranuFlo and Naturalyte. Those investigations were conducted based on data from Fresenius' own dialysis centers. The investigations found that high blood serum bicarbonate levels placed patients at a higher risk for cardiac arrest. The company distributed an internal memo showing that 941 patients who were treated at their own dialysis centers experienced cardiac arrest in 2010. This memo confirmed that many of the cases were caused by a physician improperly prescribing GranuFlo or Naturalyte, and went on to state that the issue should be "addressed urgently."
Though the memo was distributed internally to Fresenius' dialysis centers in November 2011, no attempt was allegedly made by the company to inform external customer clinics about the potential dangers associated with use of the mixtures until March 2012, potentially putting thousands at risk. Furthermore, external customers were only made aware of the cardiac arrest dangers of GranuFlo and Naturalyte after their own internal memo was leaked to the FDA. This oversight has prompted the FDA to begin an investigation into Fresenius to determine if they broke federal regulations by failing to advise customers of the potentially adverse risks associated with the use of its products.
Fresenius GranuFlo Lawsuit Information
Pharmaceutical and medical products companies in the U.S. are obligated to ensure their products are not only safe for consumers, but also to ensure that they provide proper instructions for use and warnings of possible dangers associated with their products to both consumers and to medical practitioners.
When this does not occur, the offending companies can be held liable for any resulting damages from the use of their products. In the case of Fresenius, the fact that they were aware of the cardiac risks associated with their treatment mixtures, and failed to notify or warn those outside their company, has resulted in legal action.
If you suspect that a heart attack or other health related issue was the result of dialysis treatment you need to speak with our experienced dialysis complication attorney today. You may be entitled to significant compensation, holds them accountable for their actions, and your participation will help prevent others from suffering.