Kidneys help to filter waste, excess fluid, and toxins from the blood. In addition, they are important for blood cell production and bone health. When kidneys are damaged and no longer do their job effectively, a life-support treatment called dialysis must be performed on a regular basis.
Hemodialysis is a type of dialysis that filters blood through an artificial kidney (dialyzer). The solution in the dialyzer, called dialysate, acts like a sponge to remove waste and extra fluid from the blood. Dialysate is a doctor-prescribed formulation of bicarbonate concentrate, acid concentrate, and ultrapure water in concentrations specific for each patient.
GranuFlo and NaturaLyte Recall
On March 29, 2012, Fresenius Medical Care North America (FMC) recalled two dialysate acid concentrates—GranuFlo Acid Concentrate (powder) and NaturaLyte Liquid Acid Concentrate—because of serious product labeling issues. Product labeling on the FMC acid concentrates did not make it clear that they contain substances that are converted in the body to bicarbonate.
The recall states that inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. These high bicarbonate levels may contribute to metabolic alkalosis, a condition associated with an increase in cardiovascular death and catastrophic cardiovascular injuries.
Serious Health Consequences
The U.S. Food and Drug Administration (FDA) classified the labeling issue for GranuFlo and NaturaLyte as a Class I recall. This is the most serious type of recall and involves situations where there is a reasonable probability that the use of the product will cause serious health consequences or even death.
In fact, FMC conducted a study of 941 patients who suffered cardiac arrest inside Fresenius clinics in 2010 and concluded that patients with elevated pre-dialysis bicarbonate levels are 6-8 times more likely to have a cardiopulmonary arrest.
Did Company Know?
FMC may have known as early as 2010 about the elevated bicarbonate levels and the associated risks. However, they waited until November 4, 2011, to send out any communication about the issue. Even then, they sent a six-page internal memo only to Fresenius-owned clinics—not to all dialysis clinics that use GranuFlo and NaturaLyte. The memo outlined the risks for patients with elevated pre-dialysis bicarbonate levels and recommended that doctors adjust dialysate bicarbonate prescriptions monthly for individual patients. In addition, they included clarified prescribing guidelines for GranuFlo.
In early 2012, the FDA learned of the problem from an anonymous source and contacted FMC as well as the other dialysate manufacturers. Two days later—March 29, 2012—FMC initiated the recall 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.
Free Initial Consultation
Kidney disease is serious and life altering. While kidney dialysis is not without inherent risk, dialysis patients should be confident that their dialysis products are safe, dosing instructions clear, and manufacturers have the patients’ best interests in mind.
If you or a loved one underwent dialysis after January 1, 2008, with either GranuFlo or NaturaLyte and suffered a heart attack, cardiopulmonary arrest, cardiovascular death, sudden cardiac death, or some other catastrophic cardiovascular injury during or shortly after dialysis treatment, you may be eligible for compensation.
To find out more, contact a Fresenius kidney dialysis attorney at Schmidt Kramer toll-free at (717) 888-8888 for a free case review. Alternatively, you can fill out our online consultation form in order to contact one of our attorneys.
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