The dialysate concentrate GranuFlo, which has been on the market since 2003, is used in thousands of kidney dialysis centers around the United States for nearly one-third of all dialysis patients.
Unfortunately, Granuflo has been linked to elevated risks of heart problems such as cardiopulmonary arrest, heart attacks and death. Data also shows that the maker of the product, Fresenius Medical Care (FMC), learned of these dangers from Granuflo research more than a year before they warned the FDA, outside doctors or the public.
Granuflo is used in nearly 1,800 clinics owned by Fresenius. In addition, it is sold to thousands of outside dialysis clinics as a space saving and cost-effective alternative to liquid solutions.
In 2009, Fresenius was alerted of higher-than-expected rates of cardiopulmonary arrest in its clinics, leading the company to conduct a Granuflo research study of patient cardiac arrest from January 1, 2010 through December 31, 2010.
The study identified 941 patients in 667 FMC facilities who suffered cardiopulmonary arrest related to elevated bicarbonate levels, a rate six times the normal level. The dangers were attributed to improper mixing of Granuflo and bicarbonate prescriptions.
Fresenius relayed these dangers to their own doctors in an internal memo sent on November 4, 2011. However, they failed to warn other doctors or patients until several months later when the FDA became aware of the concealment. As a result, hundreds of thousands of patients were put at risk.
Lawyers are helping those injured from Granuflo dialysis seek compensation for their loss. If you or a loved one suffered cardiopulmonary arrest, heart attack or death after dialysis treatment, contact us today.
Dialysis cleanses the blood of toxic waste when damaged or failed kidneys can no longer do so naturally. While most dialysates consist primarily of acetic acid, Granuflo also contains sodium acetate, which the patient’s tissue and liver convert to bicarbonate.
If doctors improperly mix Granuflo dialysate or prescribe separate bicarbonate, which is often the case, a patient’s bicarbonate levels can rise significantly. This increases the risk of cardiopulmonary arrest, metabolic alkalosis, low blood pressure or heart attacks.
Although Fresenius learned of these risks through a year-long Granuflo research study, their concealment of the results from the public put patients at risk of severe heart issues and death.
Due to the number of patients expected to file a Granuflo lawsuit, a federal judicial panel is consolidating all claims to a special Multi-District Litigation court. A lawyer can explain the current litigation, as well as whether your case may qualify and how long you have to take action.
Before choosing a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The DrugRisk Resource Center only recommends law firms that specialize in drug injuries and have handled Granuflo claims.
For more information on the research, warnings, side effects and litigation related to Granuflo, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.