On March 29, 2012, Granuflo Dry Acid Concentrate (“GranuFlo”) and Naturalyte Liquid (“Naturalyte”), which are manufactured by Fresenius Medical Care North America (“Fresenius”), were subject to a Class I recall (a Class I recall is defined by the FDA as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”). Granuflo and Naturalyte are used in the treatment of acute and chronic renal failure during hemodialysis (“dialysis”). The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
Fresenius issued the Urgent Product Notification cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in GranuFlo and Naturalyte because an inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis, contributing to metabolic alkalosis that can lead to low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may result in cardiopulmonary arrest and other serious adverse health consequences, including death.
On February 27, 2013, a federal lawsuit was filed in Boston for the death of a man who suffered a heart attack and died following hemodialysis treatment using GranuFlo. The federal lawsuit alleges that Fresenius failed to warn that GranuFlo puts patients at a substantially higher risk of cardiac arrest, stroke, and sudden cardiac death. The lawsuit alleges that Fresenius was aware of the risk for years, and cited a November 2011 internal memo that allegedly warned that the use of GranuFlo was associated with a 6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility. The internal memo allegedly identified 947 cardiac deaths in a single year in one-third of Fresenius’ dialysis clinics but was not sent until almost five months later to dialysis clinics that it did not own but to which it sold GranuFlo. The internal memo was anonymously leaked to the FDA in March 2012, which resulted in GranuFlo’s recall and the subsequent recall of Naturalyte.
There have been many lawsuits filed regarding GranuFlo with the Judicial Panel of Multidistrict Litigation (“JPML”), seeking to consolidate all GranuFlo lawsuits in a single federal court in order to coordinate pretrial proceedings and efficiently manage the litigation. Fresenius has also sought the consolidation of the GranuFlo cases.
Dialysis is a life-sustaining procedure for many Americans and others throughout the world who receive the life-saving procedure, often until a kidney transplant can be performed. However, if you or a loved one suffered injuries or death during or following dialysis in the U.S., including dialysis during which GranuFlo or Naturalyte was used, you should promptly consult with a local medical malpractice attorney (drug attorney) who may agree to investigate your possible GranuFlo claim, Naturalyte claim, or other dialysis claim for you and represent you in such a claim, if appropriate.
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