Acute kidney disease is life changing and often requires hemodialysis—a type of dialysis that filters toxins and excess fluid from the blood using a hemodialysis machine, an artificial kidney called a dialyzer, and a dialysis solution called dialysate. Dialysate is a doctor-prescribed formula containing specific amounts of bicarbonate concentrate, acid concentrate, and ultrapure water.
Two kidney dialysis products manufactured by Fresenius Medical Care North America (FMC)—GranuFlo Acid Concentrate (powder) and NaturaLyte Liquid Acid Concentrate—were recently recalled because their labels are misleading and can lead to potentially fatal dosage errors. Following are the events that led to the recall of GranuFlo and NaturaLyte and subsequent U.S. Federal Drug Administration (FDA) product warnings and investigations:
- In 2003, the FDA approved GranuFlo—a dry acid solution containing twice the acetic acid of previous liquid formulations. Since acetic acid is converted to bicarbonate by the liver, patients undergoing hemodialysis with GranuFlo produce twice the bicarbonate as with previous liquid acid concentrations.
- In 2011, FMC conducted a study of 941 patients who suffered cardiac arrest inside Fresenius clinics between January 1, 2010 and December 31, 2010. Doctors concluded that patients with elevated bicarbonate levels are approximately six times more likely to have a cardiac arrest.
- On November 4, 2011, FMC sent a 6-page internal memo to all Fresenius dialysis clinics that summarized study conclusions and recommended that doctors adjust dialysate bicarbonate prescriptions monthly for individual patients. In addition, they included clarified prescribing guidelines for GranuFlo. This memo was sent to Fresenius dialysis clinics only—not to all dialysis clinics that use GranuFlo.
- In early 2012, the FDA received an anonymous tip regarding concerns raised by the FMC 2010 patient review and the internal memo.
- On March 27, 2012, the FDA sent a letter of inquiry to FMC, Rockwell Medical, Diasol and Minntech Renal Systems—the four main dialysate manufacturers in the United States.
- On March 29, 2012, FMC initiated a recall of GranuFlo and their liquid product NaturaLyte and sent a two-page letter to all of the non-Fresenius dialysis clinics that use their products. However, this letter lacked the detail and urgency of the internal memo.
- On May 25, 2012, the FDA issued a safety communication to remind medical professionals to consider the impact of acids in dialysate concentrates prescriptions. This warning was aimed at all dialysate acid concentrates—not just those manufactured by FMC.
- On June 14, 2012, the New York Times published an article stating that the FDA is investigating whether FMC violated federal regulations by failing to inform customers of the risks associated with GranuFlo.
FMC may have attempted to cover up the issues related to elevated bicarbonate levels in patients using GranuFlo and NaturaLyte. If you or a loved one had dialysis treatments between January 1, 2008 and June 30, 2012 with either product and suffered a heart attack, cardiopulmonary arrest, cardiovascular death, sudden cardiac death, or some other catastrophic cardiovascular injury during or shortly afterwards, you may be eligible for compensation. A Fresenius kidney dialysis attorney is available to discuss your case and provide a free case review. Contact Schmidt Kramer toll free at (888) 476-0807 to talk to a lawyer today.