The largest operator of dialysis centers in the United States is a German company, Fresenius. Its dialysis centers treat more than a third of the estimated 400,000 people in this country receiving dialysis. In addition to owning dialysis centers, Fresenius is also the leading supplier of dialysis products. Among the company’s products are GranuFlo (Dry Acid) and Naturalyte (Liquid Acid). These products are used to help remove toxins from the kidneys during hemodialysis. Part of the dialysis process requires use of a sodium bicarbonate to, in essence, balance the blood’s increased pH from the acid-containing products. Fresenius’ products contain sodium acetate (in addition to the acetic acid found in other manufacturer’s products). Sodium acetate is converted by the body to bicarbonate. This has resulted in many patients receiving too much bicarbonate.
On November 4, 2011 Fresenius notified the medical directors and attending physicians at its facilities that its analyses revealed elevated bicarbonate levels in over 40 percent of its patients. This internal analysis also determined that “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with a six- to eight-fold greater risk of CP (cardiopulmonary) arrest and sudden cardiac death in the dialysis facility.” The memo also advised Fresenius physicians that “the bicarbonate prescription entered into the dialysis machine underestimates the total buffer that the patient receives from the dialysate…” Amazingly, Fresenius did not provide notice to any outside facilities or physicians that it had conducted such an analysis or its findings.
Fresenius will likely claim that its label contains sufficient information to allow physicians to determine the correct amount of bicarbonate to prescribe. If that is truly the case, one must wonder why it was not being done in Fresenius facilities by its own physicians. That would lead to this question: Why was the internal memo needed to explain to them the science behind the conversion from sodium acetate to bicarbonate, and how to adjust dosing to compensate for it? Regardless of who is to blame, it appears there have been many unnecessary deaths as a result of dialysis. The company issued a Class I recall of these products on March 29, 2012. If you need additional information, contact Russ Abney, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Russ.Abney@beasleyallen.com.
Sources: New York Times and www.fda.gov
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