Dialysis is a procedure used to support kidney function in people whose kidneys are no longer working as they should. The kidneys are primarily responsible for removing waste from the body, but also help maintain blood pressure, assist with red blood cell creation, and help keep bones strong.
When a person’s kidneys are unable to perform these essential functions on their own, dialysis is used to do their job for them. There are both external and internal forms of dialysis. External dialysis is called hemodialysis, which filters and cleans the blood outside of the body. Peritoneal dialysis cleans the blood inside of the body by using a fluid that absorbs waste from the blood and then drains it away. Peritoneal dialysis can usually be done at home, whereas hemodialysis is done in a medical clinic or dialysis facility.
Hemodialysis and Biocarbonate Solution
The hemodialysis process includes the use of a biocarbonate solution, called dialysate, to clean a patient’s blood. Blood is removed from the patient’s body, mixed with the solution in the dialysis machine, and then returned to the body with traces of the solution still present. The dialysis must be properly calibrated in order to keep the levels of solution at an appropriate level.
One of the most popular solutions used for dialysis is called GranuFlo. This powdered drug is manufactured by Fresenius Medical Center and was approved by the US Food and Drug Administration (FDA) in 2003. Of the approximately 400,000 people in the United States who suffer from kidney disease, approximately half of them use GranuFlo or its liquid version, Naturalyte.
The dialysis drug itself is considered relatively safe, but when administered incorrectly can have dire effects. According to reports, those who are given incorrect doses of GranuFlo during dialysis are six to eight times more likely to suffer a heart health event.
GranuFlo contains biocarbonate. While necessary for the dialysis process, when biocarbonate accumulates in the blood stream it can create dangerous side effects by producing metabolic alkalosis, which is an imbalance in the body’s pH level. Symptoms of metabolic alkalosis include:
- Cardiac arrest
- Irregular heartbeat
- Low blood pressure
- Low blood oxygen
- Low blood potassium
- Low blood carbon dioxide
Warnings about GranuFlo
Fresenius began a “recall” of GranuFlo in November 2011 when it issued an internal memo to the doctors at its own clinics alerting them to the fact that nearly 1000 patients exposed to GranuFlo and its powder version the previous year had suffered cardiac arrest. It should be noted only Fresenius doctors received this notification, despite GranuFlo being used at other dialysis locations. Doctors and patients at non-Fresenius clinics were not warned of the risks associated with GranuFlo at that time.
The following year, the FDA investigated the issues related to GranuFlo usage and contacted Fresenius about the issues, which prompted the company to then issue an Urgent Product Notification to non- Fresenius clinics. The FDA followed-up with a Class 1 recall, its most serious type of recall, of GranuFlo and its liquid version manufactured between January 2008 and June 2012.
Fresenius is accused of neglecting its duty to alert all doctors to the dangers associated with its product, and of intentionally concealing information that could have prevented medical complications for those undergoing dialysis.
Legal Action against Fresenius
Several dialysis recipients and their families have taken legal action against Fresenius regarding the complications that occurred after their use of GranuFlo. The claims state that Fresenius “intentionally, recklessly and negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
Patients and their loved ones believe Fresenius was aware of the risk associated with GranuFlo and failed to notify anyone other than doctors in the company’s own clinics. According to the claims, patients experienced a variety of complications, including:
- Physical pain
- Mental suffering
- High medical costs from the need for additional care
- Lost wages
Patients undergoing dialysis should do so with the confidence that the products used in the process are safe and effective. Many who experienced complications related to GranuFlo did believe this, only to learn they were exposed to risk unnecessarily. Our goal is to make sure patients suffering GranuFlo-related complications, and the loved ones of those who experienced fatal consequences after using GranuFlo, are aware of the issues with the drug and understand the options they have for receiving compensation for their pain and suffering.