GranuFlo is a drug that was widely used in kidney dialysis procedures prior to being recalled by the Food and Drug Administration in 2012. The New York Times reported in June 2012 that at least 941 patients had suffered a sudden cardiac arrest while undergoing dialysis with GranuFlo. Since then, patients treated with GranuFlo have been filing a continuous stream of lawsuits alleging that the drug’s manufacturer, Fresenius Medical Care, failed to warn doctors and patients about improper use of the product.
In order to understand the significance of this litigation, it is important to first understand the role of GranuFlo in dialysis and the harm the popular drug posed to patients.
Dialysis is a medical process that takes the place of the kidneys in clearing toxic waste from the blood. People with kidney conditions encounter GranuFlo, a powdered product, or NaturaLyte, the liquid version of GranuFlo, during a dialysis treatment called hemodialysis. This is a three or four-hour process, typically performed three times a week, in which the blood is removed from the body, sent through a filter to remove harmful substances, and then returned to the body.
GranuFlo provides patients with bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. However, GranuFlo introduces to the body more bicarbonate than other similar drugs on the market. Elevated bicarbonate levels in the blood may lead to the following heart problems, resulting in serious injury or even death:
• Low blood pressure
• Cardiopulmonary arrest
• Cardiac arrhythmia
• Sudden heart attack
In fact, studies have found that elevated bicarbonate levels in the blood can increase the risk of heart attack six-fold. Had Fresenius provided an adequate warning, doctors could have monitored patients to make sure that bicarbonate levels remained safe during and after dialysis treatments. Unfortunately, no warning was given by Fresenius Medical Care, even though a leaked internal memo revealed that the company was aware that GranuFlo exposed patients to higher levels of bicarbonate in the blood.
Fresenius Medical Care’s decision to not share this potentially life-saving information about GranuFlo is especially alarming considering that the company is the nation’s largest operator of dialysis centers and manufacturer of dialysis equipment and products, serving approximately one-third of the country’s 400,000 dialysis patients each year.
If you or a loved one suffered from the use of GranuFlo during dialysis treatment, please contact Keefe Law Firm immediately by calling 1-877-ATTY-24-7. Attorneys at Keefe Law Firm are available for free legal consultations to those harmed by the use of GranuFlo during dialysis.
Keefe Law Firm handles complex medical device implant litigation throughout the nation. The firm’s offices are headquartered in New Jersey.