The number of law suits filed against GranuFlo manufacturer, Fresenius Medical Care, continues to rise following the release of an internal memo warning doctors within the company’s own dialysis centers of the risks of failing to properly use the product.
Fresenius Medical Care chose not to make the information contained in the memo available to other medical professionals treating patients with GranuFlo at other facilities throughout the country. It was not until a company employee anonymously leaked the internal memo to the U.S. Food and Drug Administration that the government became aware of Fresenius’ failure to warn and issued a Class I recall for the product.
Fresenius Medical Care’s decision not to 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.
Following the release of the internal memo, the New York Times reported in June 2012 that at least 941 patients suffered sudden cardiac arrest while undergoing dialysis with Granuflo. Other life threatening injuries include experiencing a heart attack or stroke, possibly resulting in death.
Dialysis takes the place of the kidneys in clearing toxic waste from the blood. Part of this process involves providing bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. GranuFlo is a dry acid concentrate widely used in kidney dialysis procedures. GranuFlo and similar products on the market are converted to bicabonate by the body during dialysis.
Fresenius allegedly failed to warn doctors and patients that GranuFlo causes the body to produce more bicarbonate than other similar products on the market. It is this overdose of bicarbonate that may lead to heart problems including the possibility of heart attack, stroke, cardiac arrest, or even death. With adequate warning, doctors could have monitored patients to make sure bicarbonate levels remained safe during and after dialysis treatments.
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. For more information, please visit the firm’s defective joints website.