When one of your kidneys is not functioning properly, then the treatment offered by your medical care provider is dialysis. This solution is so commonly accepted by patients that many undergo the treatment without taking a second look at the risks involved. Sadly, for too many patients their dialysis treatment not only does not make them well–it leads to their death. Most notably, new investigations recently revealed that two products commonly used in dialysis–GranuFlo® and NaturaLyte®–may cause serious complications, including cardiac arrest and death.
Heart Problems Following Dialysis
Many patients who require dialysis to clear toxic waste from their blood (because their kidneys are unable to do so) rely on Fresenius Medical Care (FMC). This company treats many Americans receiving dialysis as well as supplies dialysis machines and disposable products. GranuFlo® and NaturaLyte®, FMC products, are used in thousands of dialysis centers across the country. GranuFlo® is a powdered product that helps remove harmful substances from the blood. NaturaLyte® is the liquid version of that same product.
Evidence is now emerging that these products are far from safe. In March of 2012 the U.S. Food and Drug Administration (FDA) issued a Class I recall of the products because their dosing details needed to be altered. Class I recalls are the most serious recalls available, indicating products which may pose a risk of death. In fact, GranuFlo® and NaturaLyte® may cause serious side effects, including:
• Low blood pressure
• Low blood oxygen levels, (hypoxemia)
• Low blood potassium levels (hypokalemia)
• Excessive carbon dioxide in the blood (hypercapnia)
• Cardiac Arrhythmia – This refers to a disruption of the heart’s normal rhythm (irregular heartbeat)
• Cardiopulmonary arrest – This is the cessation of blood flow due to heart failure. When not addressed immediately it can lead to permanent brain damage or even death.
Failure to Adequately Address the Problem
In recent months evidence has emerged which suggests that the company, Fresenius Medical Care, knew about the serious risks to patients posed by GranuFlo® and NaturaLyte® but did not take adequate action to save lives. For example, as early as November of 2011 an internal company memo noted that over 900 patients had suffered heart attacks in FMC’s dialysis clinics. GranuFlow® and NaturaLyte® are products that produce far more bicarbonates than similar products. The production of bicarbonates must be regulated correctly or it can lead to excess carbon dioxide in a patient’s blood. The presence of excess carbon dioxide is extremely harmful and can lead to severe cardiac problems including heart attack and death.
Eventually the company sent out a memorandum to doctors in their dialysis centers to warn of the danger. Yet, the warning was not reported to the Food and Drug Administration (FDA) so that the public could be notified, and the risk of cardiac arrest associated with the use of the products was not admitted by the company until someone anonymously sent the memorandum to the FDA.
GranuFlo® and NaturaLyte® Lawsuits
It goes without saying that a company that treats more than a third of the estimated 400,000 Americans receiving dialysis, should be held responsible for the injuries and deaths caused by their failure to adequately protect patients from their products.
Here at the Rothenberg Law Firm LLP, we have decades of experience representing clients who have been affected by dangerous medical products. We understand how difficult it can be to deal with an injury or death of a family member, and we are here to help. If you or a loved one may have suffered heart problems as a result of dialysis treatment, The Rothenberg Law Firm LLP can provide the experienced legal help you need. Submit a free online case evaluation form or call us at 1-800-624-8888. Your time to file a lawsuit may be limited, so call us today. Your initial consultation is always FREE and there will be no legal fees unless we are successful in getting you money.