GranuFlo is bicarbonate used to neutralize acid build up in the blood. It is a dry acid concentrate used to create the medication mixture used in hemodialysis. Hemodialysis (more commonly, dialysis) is a medical procedure that clears the toxic waste in the blood. In a healthy individual, this process is naturally completed through kidney function. For people with kidney failure, however, dialysis is an essential procedure that must be completed several times a week. Over 500,000 Americans require dialysis, and there are more than 5700 dialysis centers throughout the nation, over half of which used GranuFlo. Fresenius Medical Care (FMC), the manufacturer of GranuFlo, owns and operates several dialysis clinics. Patients in these clinics, as well as 125,000 other patients in non-FMC dialysis clinics, used GranuFlo from its introduction in 2003 until the drug’s recall in June 2012.
GranuFlo is no longer being used in dialysis centers, since the product was recalled by the Federal Food and Drug Administration (FDA) in 2012. The recall was the result of a series of events which showed that the drug was inherently unsafe. It has been discovered that GranuFlo use may contribute to metabolic alkolesis, which can lead to heart attack, cardiac arrest, stroke and even death. This discovery was made after FMC conducted a study of their own clinics for the period of January through December 2010. The study revealed that there were almost 1000 cases of cardiac arrest during the year-long period. FMC felt that this information was serious enough to warrant notification to the clinics of the potentially dire consequences of using GranuFlo. Therefore, an internal memo was sent to the directors of every FMC-owed dialysis clinic in November 2011.
However, the memo was NOT sent to non-FMC clinics, endangering the lives of over 125,000 dialysis patients who received treatment from other centers. In March 2012, a copy of the 2011 memo was leaked by an anonymous source to the FDA. Shortly thereafter, the first GranuFlo lawsuit was filed in Georgia after a woman died following her hemodialysis treatment.
The FDA is currently investigating whether or not FMC violated federal laws that require a pharmaceutical company to warn the public of the possible dangers associated with an FDA approved drug, even if the effects were not known at the time of federal drug approval and initial distribution. The FDA has also issued a Class I recall of GranuFlo, finding that the drug’s use has a six to eight times increase for the risk of cardiac arrest than those patients using similar bicarbonate. A Class I recall is the most serious of recalls and is only issued in cases where a drug’s usage has a reasonable probability (not just a possibility) of serious side effects.
If you or a family member have been, or currently are, hemodialysis patients, you may qualify for compensation if your medical provider has used GranuFlo in your dialysis regimen. Even if you are unsure whether or not your dialysis center utilized the drug, please call our offices for a confidential consultation.