Fresenius, GranuFlo, NaturaLyte, Heart Attack
Granuflo and Naturalyte Side Effects Causing Alkalosis
January 1, 2013 - Latest News
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We are reviewing and investigating heart attacks and strokes which occurred to dialysis treatment patients while on dialysis. We have many clients who have suffered a heart attack during or shortly after dialysis due to Fresenius Corporation’s use of Granuflo and / or Naturalyte acid concentrates. These products have been recalled by the FDA.
Fresenius is one of the largest providers of dialysis treatment and hemodialysis solutions. Granuflo and Naturalyte are two common solutions used at their clinics. They are also sold to other dialysis clinics such as Davita Corporation which has the largest number of dialysis treatment centers in the United States.
Our patients have suffered the following injuries while on or after dialysis. These injuries include:
- Heart attack;
- Cardiac arrest.
These side effects, all very significant injuries, occur during or after treatment. The problem is is that these chemical solutions (Granuflo and Naturalyte) include sodium acetate which alters the bicarbonate levels to a higher rate than necessary. As a result, this process can cause metabolic alkalosis which then can cause a greater chance of fatal or serious heart problems.
The problem is that the dialysis centers were not monitoring and adjusting bicarbonate levels during the patient’s dialysis procedure.
We are seeing many incidents of cardiac arrest which is the immediate loss of all heart function, breathing and consciousness because of blood stoppage to the brain and other organs.
If you or your loved one suffered a heart attack or cardiac arrest while on dialysis or shortly thereafter please contact an intake specialist at Nadrich & Cohen. We are offering confidential free consultations throughout the country for dialysis victims. We are contingency lawyers which means there is no fee unless we first obtain a recovery.
January 1, 2013
Cases have been filed all over the country stemming from the Dialysis solution known as Granuflo causing cardiac arrhythmia and, in some cases, death. Cases have been filed against Fresenius Medical Care, the largest manufacturer of dialysis equipment and products and the owner and operator of approximately 1,600 dialysis clinics throughout the United States. It is thought that the total number of cases may reach 10,000.
Our case against Fresenius rests upon the theory that Fresenius manufactured and distributed Granuflo for its clinics to take the place of a prior solution which was more costly for Fresenius to store and transport. Granuflo is in a granular form so that all the clinics had to do was add water and use the solution in the dialysis process.
Sadly, the Granuflo granular product had twice the acetate of the prior product which, as a result, when used in dialysis, can cause the blood to become too alkaline which then significantly disrupts or alters the dialysis victim’s heart rhythm causing cardiac arrhythmia, low blood pressure, hypokalemia, cardiopulmonary arrest and even death.
All this is due to the increased levels of bicarbonate in the blood stream which we believe Fresenius knew of but did not resolve the problem such as warning its clinics, dialysis patients, etc.
The problem with Granuflo (and Naturalyte) is that none of the clinics were taught how to change the settings on the dialysis machines in order to account for the higher bicarbonate levels. The product is also defective in that it includes twice the bicarbonate levels as the prior product used in the dialysis product.
Internal Fresenius corporate documents have led our teams to believe that Fresenius knew of the risks since 2010 but did not adequately warn its own clinics and patients. They knew of the high acetate level of the Granuflo concentrate product. They knew that the bicarbonate levels were highly elevated which can cause greater risks of cardio pulmonary arrest and sudden cardiac death.
Nadrich & Cohen is an experienced defective products law firm handling various mass torts including defective medical devices and dangerous prescription drug side effect cases in all 50 states – throughout the country from coast to coast. If you or a loved one suffered a cardiac arrest or even death while on dialysis or as a direct result of dialysis please contact one of our intake specialists at 1-800-718-4658. Your inquiry is confidential and we will respond to you within 12 hours.
We are contingency lawyers so there is no charge for our services or our costs unless we first make a recovery for you.
Fresenius is a German based medical dialysis company. The FDA has forced Fresenius to recall their hemodialysis solutions known as GranuFlo and Naturalyte. Their products GranuFlo and Naturalyte have been recalled.
These products were used in the dialysis process. Their use caused an increased risk of heart attack or heart failure during dialysis or within 48 hours thereafter.
It is believed Fresenius may have known that these products cause heart failure a significant time before the FDA’s actions forcing the recall.
Many patients have died and/or have suffered heart attacks and heart failure due to these products.
The company may have known since 2011 that these two solutions caused the patients to have too much bicarbonate in their blood stream causing the fatal side effects.
These risks were confirmed in a Fresenius corporate memo of November 4th, 2011. Unbelievably, the company did not warn doctors or patients until March 2012 that GranuFlo and Naturalyte can in fact result in an increasing risk of heart attacks and strokes due to unacceptably high levels of bicarbonate in dialysis patients. Fresenius’s own corporate documents state that as of 2011 941 patients suffered a cardiopulmonary arrest in 2010 alone.
Nadrich & Cohen is actively investigating side effect claims in all 50 states of serious cardiovascular injuries (strokes and heart attacks) that may have been caused by the use of Granuflo® and Naturalyte® during kidney dialysis treatment. Granuflo and Naturalyte has been associated with a dramatic rise in heart attacks, cardiopulmonary arrest, sudden cardiac arrest and death. These products are widely used in dialysis treatment.
On March 29th, 2012 the manufacturer of Granuflo® and Naturalyte® Fresenius Medical Care, issued an “Urgent Product Notification” indicating that there had been a drastic acceleration of safety risks connected to the use of Granuflo® and Naturalyte®.
In June 2012 Fresenius recalled Granuflo and Naturalyte. This recall was due to the products causing high risk for cardiac related conditions.
Fresenius is a very large medical services company which has thousands of dialysis service centers. Public reports indicate the company treats more than 33% of all dialysis patients. The company operates over 2,500 dialysis clinics worldwide including 1,800 in the United States.
The products are also widely used in non Fresenius owned clinics. At least 125,000 non Fresenius patients use Granuflo.
The problem is that the using Granuflo® and Naturalyte® while on dialysis can cause alkalosis - a risk factor for cardiopulmonary arrest and other cardiovascular events.
Our national Granuflo® and Naturalyte® legal teams are reviewing side effect cases throughout the country. We are also investigating whether Fresenius withheld data in November 2011 from the FDA of its own internal test results documenting a sharp increase of cardiac arrests from the use of these products. Despite this there was no corporate warning of harmful side effects issued until March 2012.
The cases we are accepting are victims who suffered their injury while obtaining treatment at a Fresenius dialysis center. The injuries we are reviewing are:
- A) Cardiovascular resulting in death
- B) Sudden cardiac death
- C) Heart attack
- D) Other catastrophic cardiovascular injuries
- E) Cardiopulmonary arrest
The above injuries must have occurred within 48 hours of dialysis treatment.
Of course, since a Fresenius dialysis clinic used the products, we will help our clients find out if they were treated at a Fresenius clinic.
If you or someone you know sustained an injury due to the use of Granuflo® and / or Naturalyte®, you may have a right to compensation. Call us today for a free confidential case evaluation.
To learn how our Granuflo® and Naturalyte® lawyers can help you, please fill out the “Do I have a case” form on the right. You can also call 1-800-718-4658 to discuss your case with one of our experienced Granuflo® and Naturalyte® lawyers.