Why would you need a Granuflo lawsuit lawyer ? well read below about the injuries this product has cause in dialysis and contact us if you have experienced these side effects.
Over 400,000 people in the United States are currently undergoing dialysis treatments. Dialysis is a life-saving and life-extending treatment which many people with chronic kidney disease or kidney failure rely upon. Fresenius medical care operates over 2,100 dialysis treatment centers throughout North America and is one of the largest suppliers of dialysis machines and equipment throughout the world.
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Fresenius Medical Care Injuries
In addition to running dialysis clinics, Fresenius Medical Care also produces some of the pharmaceuticals used in the dialysis process. Fresenius Medical care manufactures GranuFlo and NaturaLyte which are both types of pharmaceutical chemicals used in dialysate. Dialysate is the name for the solution that is pumped into the membrane of the dialysis machine. Inside the dialysis machine, impurities are filtered from the patient’s blood into the dialysate solution which helps to clean the blood, remove excess fluids, and bring balance to the electrolytes in the body.
GranuFlo is a dry acid product. According to Fresenius Medical Care, “GranuFlo is the most-widely prescribed dry acid product in the dialysis industry today.” GranuFlo is different from traditional acetate products because it comes in a dry or powder form. Fresenius Medical Care claims that the dry form is better than a liquid acid because it is safer to store and transport. They also claim that it is safer for nurses and doctors to handle dry acid concentrate than to handle liquid acid, and that the storage of dry acid products take up less space. Fresenius Medical Care claims that GranuFlo is “the safest dry acid product.” During the dialysis process, the dry acids, such as GranuFlo, are mixed with water and other chemicals to form the dialysate.
While the dry acid concentrates may be seen as “safer” for the clinics and doctors, evidence has recently emerged which shows that GranuFlo may not be safe for patients. In 2011, Fresenius Medical Care sent an internal memorandum to its clinics and physicians with specific warnings about the use of GranuFlo. The company reported that their findings showed 941 patients had suffered cardiac arrests in 2010 after undergoing a hemodialysis treatment in which GranuFlo was used. They sent this information to their own medical clinics with updated information for the doctors regarding dosing of the GranuFlo. They recommended changes in the ways in which doctors measure how much of the GranuFlo to put into the dialysate solution. These dosing changes were released to Fresenius Medical Care clinics only. Unfortunately, Fresenius Medical Care clinics were not the only dialysis clinics using GranuFlo and NaturaLyte.
Granuflo Lawsuit Injuries
Fresenius Medical Care did not release this important information to the public. It is reported that the internal memo which Fresenius Medical Care only sent to its own clinics was leaked to the Food and Drug Administration. Due to this leak, the FDA began to investigate the safety of GranuFlo and NaturaLyte. The FDA’s investigations lead them to issue a recall on March 29, 2012. This recall pertained directly to “Fresenius Medical Care North America, NaturaLyte and Granuflo Acid Concentrate.” In the text of the recall, the FDA warns that “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” These prescription/dosing problems were first realized by Fresenius Medical Care in 2011, but did not make it into the public eye until the FDA released this recall.
This dosing information was very important because a high bicarbonate level in dialysis patients may contribute to a condition called Metabolic Acidosis. Metabolic Acidosis is associated with an increased risk of cardiopulmonary arrest, cardiac arrhythmia, Hypoxemia (low blood oxygen), Hypercapnia (increased carbon dioxide in the blood), and Hypokalemia (low potassium levels in the blood. These are very dangerous conditions which need to be identified and treated or they can lead to even more serious medical consequences. Fresenius Medical Care attempted to correct this problem internally by changing the dosing procedures and guidelines, but they failed to inform the FDA in a timely manner. While the FDA was finally made aware of the problems and released the updated guidelines publicly, the information came too late for many of the patients who had already experienced some very severe side effects such as heart attack, stroke, cardiac arrest, and even death.
Filing a Granuflo lawsuit could help you get compensation from the injuries the drug may have caused you or a loved one.
Dialysis is a procedure which is vitally important to those who are dependent on it. When the body’s kidneys become diseased and can no longer function normally, dialysis is a life-extending and life-saving treatment for many people. Dialysis cleanses the blood of toxins and waste fluid and allows a person with low or no kidney function to continue living. There are side effects to dialysis which are considered normal or common. These types of side effects include low blood pressure, muscle cramping, infections, and itching. These types of side effects are not life threatening and can be medically managed.
Dialysis Side Effects
There are also side effects to dialysis treatment which are serious and even life-threatening. These are not normal side effects. If you have been undergoing dialysis treatment you may be at risk for more severe side effects. They include injuries such as:
- Heart attack
- Cardiopulmonary arrest
These types of side effects are not normal and may be caused by the acid concentrate being used in the dialysis process. GranuFlo and NaturaLyte dialysis concentrates have been named in a Class I FDA recall involving an increased risk of cardiac problems associates with their use.
Fresenius Medical Care And Granuflo
Fresenius Medical Care, the manufacturers of GranuFlo and NaturaLyte, were aware of the potential risks associated with the use of these products, but did not readily inform the FDA or the public. Instead, they issued an internal memo to doctors at Fresenius Medical Clinics, warning them of an increased risk of cardiac arrest in patients who were undergoing dialysis with GranuFlo. The FDA eventually discovered this information and issued a recall on March 29, 2012. This recall did not require that clinics stop using GranuFlo and NaturaLyte products, but they did issue a label change and they also updated the dosing information provided to the doctors and clinics.
GranuFlo and NaturaLyte are used in the dialysis process as part of the dialysate. The dialysate is a mixture of water and chemicals and is pumped through the dialyzer machine along with the patient’s blood. The purpose if the dialysate is to remove toxins and excess fluid from the blood and to balance out the levels of electrolytes in the blood. GranuFlo and NaturaLyte contain acetates, which, when introduced into the blood, produce bicarbonate. Bicarbonate is an important part of the dialysis process. When the kidneys cannot function correctly, acid builds up in the blood. Bicarbonate is used in dialysis to neutralize some of the acid build up.
Reported Problems With Dialysis
The reported problem with GranuFlo and NaturaLyte is that their use may lead to too much bicarbonate accumulating in the blood. An excess of bicarbonate in the blood can lead to a condition called Metabolic Alkalosis. Metabolic Alkalosis is associated with an increased risk of cardiopulmonary arrest, cardiac arrhythmia, Hypoxemia (low blood oxygen), Hypercapnia (increased carbon dioxide in the blood), and Hypokalemia (low potassium levels in the blood. These are very dangerous conditions which need to be identified and treated or they can lead to even more serious medical consequences. Fresenius Medical Care attempted to correct this problem by changing the dosing procedures and guidelines, but that information came too late for many of the patients who had already experienced some very severe side effects such as heart attack, stroke, cardiac arrest, and even death.
These serious injuries can be very scary to experience. If you are at risk for a heart attack or a stroke, it is important that you know the warning signs and symptoms. There are many different medical conditions which increase the risk for heart complications, and most often people who have an increased risk are aware of that risk. People who were undergoing dialysis treatment may not have known that they were at an increased risk for cardiac problems. This was very dangerous for them because they may have been unaware that they were experiencing a serious side effect and they were not on the lookout for the signs and symptoms. If they had been aware, they may have been able to notice a potential heart attack or stroke sooner.
When experiencing one of these side effects, it is vital that medical assistance is obtained as soon as possible. These types of side effects need to be taken seriously as they have serious consequences. Unfortunately, when Fresenius Medical Care became aware of the seriousness of some of the side effects, it did not immediately inform the public, but instead sent out an internal memo only to its own clinics and doctors. Many non-Fresenius clinics that use GranuFlo and NaturaLyte were not informed of the increased risks with these products because Fresenius Medical Care did not release the information to them. This is why many injured patients are seeking representation by a GranuFlo lawyer.
Dealing with the serious side effects caused by Fresenius’ GranuFlo and NaturaLyte can be a scary time for people. When someone is injured, their main focus should be on recovering, however, when there may be wrongdoing associated with your injury, it is important to seek legal advice right away. Our lawyers are currently handling cases for patients who received a dialysis treatment and suffered from a stroke, a heart attack, cardiac arrest, or death. If you pursue a lawsuit, you do not owe any legal fees or expenses unless we win your case.
Fresenius Dialysis Lawyers
Our Fresenius dialysis lawyers are very experienced in pharmaceutical litigation, and have handled cases for thousands of injured people and their loved ones all across the country. If you are injured by a drug that you thought was safe, it is important that you seek legal advice to determine if you have the potential right to a claim. Our lawyers can assist you in answering any questions you may have, and determining your right to a legal action.
Granuflo Cause Serious Cardiac Side Effects
All manufacturers of pharmaceuticals have a responsibility to warn patients and doctors using their drug of any potential side effects or risks that they are aware of. In 2010, Fresenius Medical Care was aware of the potential for GranuFlo to cause serious cardiac side effects, but instead of informing the public, they sent an internal memo only to their clinics and doctors. There were other non-Fresenius dialysis clinics that were using GranuFlo and NaturaLyte, but they did not receive the warning about the risks from Fresenius. The Food and Drug Administration reportedly did not hear about this information until it was leaked to them in 2011. In March of 2012 the FDA issued a recall on these products warning about the cardiac dangers associated with their use, but by that time many more people had been exposed and potentially injured by GranuFlo and NaturaLyte.
The serious side effects caused by GranuFlo and NaturaLyte include:
- Heart attack
- Cardiopulmonary arrest
If you have suffered from a cardiac complication or a stroke you are left with the task of recovering your health, but you may also be left with large medical bills and you may need to take time off of work to recover. These complications are difficult to deal with and you may feel that you are overwhelmed. A dialysis attorney can help you work through these problems and discuss your options with you. You should not have to go through the recovery process alone.
If you are the family member of a loved one who has passed away due to a complication from dialysis, you not only have to deal with the loss and grief, but you may also be left with medical bills and funeral expenses. A dialysis attorney can help you understand your rights, as a family member, and can com alongside you to assist you with filing a legal claim.
It is not too late to contact a Fresenius GranuFlo dialysis lawyer. Our legal team will work with you to establish your legal rights and help determine whether you have a potential case. Filing a lawsuit can help you recover some of the medical costs and expenses you may have incurred and can also give you closure to help you move on from this injury. All inquiries are free and confidential. Our lawyers work on a contingency fee basis. This means that you do not owe any legal fee unless we win your case. Once we win your case and you receive compensation, your legal fees and expenses will come out of that compensation. If we do not win and there is no recovery, then you do not owe a fee or expenses. Our lawyers believe that you should not have to let your financial situation stand in the way of obtaining quality legal representation. The contingency fee makes it possible for our lawyers to represent you regardless of your ability to afford the traditional costs associated with hiring a lawyer.
Fresenius Medical Care is a large well-funded corporation. They have many attorneys working for them and they have a large budget devoted to handling legal issues. It may seem impossible to take on a legal case against them by yourself. That is why it is important to contact an experienced legal team to represent you. We will litigate on your behalf to help you receive some compensation for the injuries and suffering that you have endured. We have helped thousands of injured clients and their loved ones recover compensation from many large pharmaceutical companies. We are here to help you and to ensure that you do not have to tackle a case against Fresenius Medical Care without proper representation.