What is GranuFlo?
What is GranuFlo Used For?
News of GranuFlo lawsuits have been the subject of countless media stories, prompting the question “What is GranuFlo?”
GranuFlo is a dialysis medication used to treat renal failure, also known as kidney failure or kidney disease. Kidney disease is a condition where the kidneys do not function properly. There are two types of renal failure: chronic and acute.
Chronic kidney disease develops over time. Over 26 million adults in the U.S. have chronic kidney disease. When kidneys don’t function properly, the body is unable to remove waste and excess fluid. As chronic kidney disease gets worse, high levels of waste and fluid buildup in the blood stream, causing sickness.
Dialysis is the treatment used to rid the body of dangerous toxins. Part of the dialysis process includes providing patients with bicarbonate, a medication that reduces acid in the blood.
GranuFlo first emerged as a dialysis treatment in 2003 by Fresenius Medical Care AG, the largest dialysis services and products company in the U.S. and worldwide.
At the time of its release, GranuFlo was considered a breakthrough in dialysis treatment. Unlike other pre-mixed liquid solutions, GranuFlo is a powder concentrate that can be easily prepared onsite in dialysis centers. GranuFlo also contains an ingredient that the body converts to bicarbonate. GranuFlo contains higher rates of this ingredient compared to other dialysis products.
GranuFlo Side Effects
While the full facts will not be clear until trial, many of the plaintiffs are claiming that Fresenius hid serious risks posed by GranuFlo from the FDA and patients like you. Specifically, these plaintiffs paint the following picture about Fresenius.
By 2009, serious side effects from GranuFlo started to appear. Fresenius Medical Care conducted a study in 2011 that revealed a link between dialysis heart attack and GranuFlo. In this study of nearly 1,000 patients, 70 percent of them had experienced cardiac arrest in 2010. The reason? Dangerously high levels of bicarbonate.
High levels of bicarbonate can cause dangerous side effects, such as cardiac arrest, cardiopulmonary arrest, metabolic alkalosis, stroke, low blood pressure and even death. The study showed that GranuFlo puts patients at risk of cardiac arrest up to six times higher than other dialysis products.
Fresenius Medical Care issued an internal memo about the link between dialysis heart attack and GranuFlo, but only to its own physicians and clinics — despite the fact that GranuFlo is used in the majority of nearly 400,000 hemodialysis treatments nationwide. Even the Food and Drug Administration (FDA) was kept in the dark.
It wasn’t until March 2012 that Fresenius Medical Care issued dialysis and heart failure warnings to other physicians and care centers, after its memo had been leaked to the FDA. By that time, hundreds of thousands of dialysis patients had been put at risk of serious side effects and dialysis heart attacks.
On March 29, 2012, the FDA issued a Class I recall of GranuFlo. A Class I recall is the most serious of all FDA recalls, involving situations in which there is “a reasonable probability that use of these products will cause serious adverse health consequences or death.”
It’s estimated that there are at least 59 GranuFlo lawsuits currently pending in U.S. federal courts and nearly 1,000 GranuFlo lawsuits in 46 states about to be filed. Due to the high number of lawsuits being filed, some injury claims are being consolidated into a multidistrict litigation (MDL), to make pre-trial proceedings more efficient, to avoid duplicate discovery efforts, and to avoid conflicting rulings by different judges.
Depending on the circumstances of the case, a plaintiff could seek financial compensation for:
- Hospital, doctor, chiropractor and physician therapy expenses
- Lost wages
- Future medical expenses
- Future lost wages
- Reduced quality of life
- Emotional suffering
- Loss of consortium (future family benefits)
Claims involving plaintiffs who have suffered from cardiac arrest or wrongful death are being made on several grounds, including:
- Negligent Misrepresentation
- Breach of Express and Implied Warranty
- Failure to Warn
- Conscious Pain and Suffering
- Punitive Damages
Recently, a $6 million GranuFlo lawsuit was filed in Providence, Rhode Island for wrongful death. Other recent lawsuits include both cardiac arrest and wrongful death suits in California, New York and Texas.
Fresenius Medical Care is a German company with offices in Waltham, Massachusetts. It is the largest operator of hemodialysis centers in the U.S.
The attorneys at 1-800-THE-LAW2 have years of experience fighting on behalf of patients who have been hurt or injured by companies like Fresenius. With the help of a GranuFlo lawyer, you could recover financial compensation to help get your life back on track.
Call today for a free consultation. In just 10 minutes, you could find out if you have a case, right over the phone. 1-800-380-8080.