History of GranuFlo
GranuFlo is a powdered substance that is manufactured by Fresenius Medical Care. The drug has been approved by the FDA, but there are thousands of people who have suffered severe side effects as a result of using the drug. Fresenius Medical Care currently has a net revenue of over $12.8 billion every year. GranuFlo is a substance that is used in a dialyzer during the dialysis process. This process is used when a person experiences kidney failure or kidney disease. A doctor must test the blood of this individual and use a machine to complete the dialysis process. As blood is pumped through a dialyzer, GranuFlo is added to the machine in order to remove any impurities that may be found within the blood. Over 400,000 patients receive this dialysis procedure every year. It is estimated that 125,000 patients are exposed to GranuFlo every year. There are over 5,500 dialysis centers in the United States, and many of these centers use GranuFlo in their dialysis procedures.
Side Effects of GranuFlo
There are many unpleasant side effects that have been associated with GranuFlo. When a patient uses GranuFlo, he or she has an increased risk of experiencing higher levels of biocarbonate within the blood. The existence of biocarbonate can lead to severe illnesses and disorders. Individuals who have undergone dialysis procedures that use GranuFlo have experienced side effects like stroke or cardiopulmonary arrest. They have also experienced low blood pressure, heart attack and sudden heart arrest. In the most severe cases of patients who have been exposed to biocarbonate, patients have actually died as a result of being exposed to biocarbonate.
In 2010, there were over 900 patients who suffered cardiac arrest after being exposed to GranuFlo. Because so many individuals suffered cardiac arrest after this exposure, there are mounting lawsuits being filed against the manufacturer of GranuFlo. The FDA actually recalled GranuFlo in response to this increase number of individuals who suffered from cardiac arrest. The FDA has also requested that GranuFlo clarify the risks that are associated with being exposed to this chemical.
The FDA Recall of GranuFlo
The FDA recalled GranuFlo on November 4, 2011. A six-page memo was sent to doctors who used GranuFlo in their own practices. Doctors were informed about the large number of patients who had experienced heart problems in 2010. The FDA issued one of its most serious types of recalls in regards to GranuFlo. The FDA issued a Class I recall for GranuFlo products. In its recall, the FDA did not require clinics to stop using GranuFlo in its dialysis procedures. It is important for people to understand that the FDA only required that the GranuFlo manufacturer make clinics aware about the proper dosage requirements for this product. Doctors were also made aware of the risks that GranuFlo posed to patients. By failing to administer proper doses of GranuFlo, patients stand a greater chance of experiencing death or severe illnesses.
Filing a GranuFlo Lawsuit
If you or a loved one was exposed to GranuFlo and suffered illness, then you may be entitled to file a lawsuit. You may be entitled to claim compensation that is related to the medical expenses that you must now pay as a result of using GranuFlo. A lawyer will be able to review the facts of your case to decide whether you can be joined as a party in existing litigation surrounding GranuFlo. Otherwise, you may be able to settle your own claim outside of the court room or begin your own lawsuit.