In March 2012, Fresenius Medical Care recalled its dialysis product, GranuFlo, due to patients experiencing high levels of bicarbonate from its use. Fresenius is the leading provider of dialysis treatments and dialysis products in the U.S.
The FDA classified this recall as Class 1, which is the most serious type of recall as it pertains to products that can cause serious health risks or death. The major concern with GranuFlo is that it can have serious effects to the cardiovascular system when inaccurately administered from a high level of bicarbonate in the body. Injuries including stroke, cardiac arrest and even death have been reported. Rosenfeld Injury Lawyers has been actively involved with the Granuflo recall is is presently pursuing wrongful death lawsuits on behalf of families who have lost a loved one after receiving GranuFlo.
GranuFlo Recall Scandal
Although Fresenius issued the recall on GranuFlo on March 29, 2012, there is evidence that the company was already aware of the problem months and even possibly a year or more prior. In November 2011, an internal memo was sent to doctors that worked in the company owned dialysis centers that there was a high risk of cardiac arrest in patients that were undergoing dialysis and being administered GranuFlo improperly. The memo stated that 941 patients had cardiac arrests while being treated in Fresenius dialysis centers in 2010. However, this information was never communicated to the many other dialysis centers that use GranuFlo. It was not until this memo was leaked to the FDA that Fresenius issued the recall, four months or more later.
The recall does not involve the removal of the product from clinics or stop the use of the product. Instead, it involves warnings being added to the labels and doctors being advised of the risk of overdosing. Along with the Class 1 recall on this product, the FDA also issued a warning of the dangers of improper dosing on all similar products.
GranuFlo Injuries & Fatalities
One-third of all dialysis patients are treated at Fresenius dialysis centers that used the GranuFlo product. It is estimated that another 125,000 dialysis patients in other clinics also used the product, making it possible that 250,000 patients a year that used GranuFlo as part of their dialysis treatment. The product was distributed for four years, from 2008 to 2012. The possible injuries that patients may have incurred from this product are:
- Heart attack
- Cardiac arrest
- Low blood pressure
- Metabolic Alkalosis
Patients who were administered GranuFlo or Fresenius’ other dialysis liquid product, Naturalyte, had up to six times the risk for cardiac arrest.
Legal Options for Families Impacted By Granuflo Complications
There are thousands of lawsuits being filed against Fresenius for the injuries and wrongful deaths that GranuFlo has caused. Many people have lost loved ones due to the method that this drug was administered and there are many others that are living with serious health issues from the damage caused to their bodies. Families that have suffered from the loss of a loved one due to GranuFlo or patients that are living with injuries caused from its use should contact a GranuFlo recall law firm that is active in Granuflo litigation.GranuFlo Wrongful Death Attorneys
Rosenfeld Injury Lawyers understand the pain and hardship the death of a loved one can cause, especially when it is caused by the negligence of others. Our team of experienced Granuflo recall attorneys and experts will respectfully represent your family and fight for your right to receive compensation for your loss. Our initial consultation is always free and there is never a fee unless we obtain a financial award in your case.
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