After investigating the apparent link between dialysis product GranuFlo and cardiac arrest, Girard Gibbs has filed lawsuits in the federal and California state courts alleging a cover-up of this link by GranuFlo producer Fresenius.
GranuFlo is a dry acid product manufactured by Fresenius Medical Care for use in the dialysis process. It is used in Fresenius’ dialysis clinics, which treat more than a third of dialysis patients in the United States, as well as on an estimated 125,000 patients in clinics operated by other dialysis providers. As the Fresenius website states, this makes GranuFlo the “most-widely prescribed dry acid product in the dialysis industry.”
Unfortunately, GranuFlo may also be among the most dangerous of products used in the dialysis industry due to a potential risk of cardiac arrest. Data gathered by Fresenius on the 941 patients who suffered cardiac arrest inside Fresenius clinics in 2010 found a link between between GranuFlo and alkalosis- a condition of increasing levels of bicarbonate in a patient’s blood- that appears to make dialysis patients six to eight times as likely to suffer sudden cardiac arrest. On November 4, 2011 Fresenius sent an internal memo to their medical clinics about this danger.
FDA Recall of GranuFlo
However, the pharmaceutical company failed to release to the public or to non-Fresenius clinics this information about the risk of cardiac arrest to patients treated with GranuFlo. Almost five months after this memorandum was initially sent, the Food and Drug Administration (FDA) received a copy of the memo from an anonymous source. The New York Times reports that an FDA investigation has now begun to determine whether Fresenius violated federal regulations by failing to make known a potentially lethal threat to those treated with their products.
In light of this danger, the FDA has issued a Class 1 recall of GranuFlo. This is the most serious class of FDA recall, issued when the FDA deems there to be a “situation in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.”
Injured by GranuFlo?
Our GranuFlo lawyers represent people nationwide who suffered cardiac arrest or lost a loved one following treatment with GranuFlo. If you believe GranuFlo caused or contributed to the development of heart problems in you or a loved one, including a sudden heart attack or cardiac arrest, cardiopulmonary arrest, stroke, or arrhythmia, you may want to speak to a GranuFlo lawyer.
Free and confidential consultations with our GranuFlo attorneys are available by filling out the form to your right or calling toll-free: (866) 981-4800.