SSH Investigation of Dialysis Products GranuFlo and NaturaLyte

Stueve Siegel Hanson is investigating the dialysis products GranuFlo and NaturaLyte related to an increased risk of cardiovascular incidents. GranuFlo and NaturaLyte are used during dialysis, a process which filters waste, excess salt and water from the blood when the kidneys are no longer healthy enough to perform the task sufficiently.

An estimated 400,000 Americans undergo dialysis treatment each year to treat end-stage renal disease (ESRD), commonly known as kidney failure. More than a third of these kidney dialysis patients are given the dialysis products GranuFlo and NaturaLyte, manufactured by Fresenius Medical Care. Both products were widely used at Fresenius dialysis clinics, and at over 125,000 facilities supplied by the company. Fresenius is the largest dialysis services and products company in both the U.S. and the world.  The company operates over 1,800 kidney dialysis clinics in the U.S.

The FDA has recently issued a Class I recall (the most serious type of recall) on dialysis concentrates GranuFlo and NaturaLyte after it was found that the products could put patients at risk for cardiac arrest when not prescribed appropriately.  The FDA recall indicates that “there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.” The March 2012 recall occurred after the FDA was presented with a leaked internal memo from the GranuFlo and NaturaLyte manufacturer.

On November 4, 2011, Fresenius sent an internal memo warning doctors working at their medical clinics about this danger.  Fresenius, however, failed to release to the public or to any other doctors or dialysis clinics not owned by Fresenius this information about the risk of cardiac arrest to patients treated with GranuFlo and NaturaLyte. 

Almost five months after this initial memo recognizing the danger and risk was confidentially sent around to the Fresenius-only clinics, the FDA received a copy of the memo from an anonymous source. It has been reported that the FDA and consumer watch groups are investigating whether Fresenius violated federal regulations and state laws by failing to make known a potentially deadly threat to those treated with the GranuFlo and NaturaLyte dialysis products.

In the memo, Fresenius reported that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving dialysis treatment with GranuFlo and NaturaLyte. Fresenius studies also found that patients undergoing dialysis treatments with their products are at a six times greater risk of suffering a heart attack or sudden cardiac death than patients using other dialysis products. The manufacturer failed to offer the same warning to thousands of physicians and clinics not owned by Fresenius Medical Care.

Granuflo is a dry acid concentrate and NaturaLyte is a liquid concentrate. These products contain sodium acetate, which converts to bicarbonate. The products contain more acetate than rival products, with Granuflo containing 8.0 mEq/L of acetate and NaturaLyte Liquid containing 4.0 mEq/L.

Dialysis treatment involves the use of a dialysate solution prescribed by physicians, which is used in combination with the dialysis machine and dialyzer to remove waste from the blood for individuals with kidney problems.

As result of improper warnings and instructions provided by the manufacturer, these dialysis treatments may increase bicarbonate levels beyond what was initially intended and prescribed by the doctor.

High levels of bicarbonate can lead to serious, even fatal consequences. This risk was highlighted at the 2011 annual meeting of the American Society of Nephrology, where researchers presented data showing increased mortality with high levels of bicarbonate. According to the presentation, a study involving 16,899 patients showed that excess levels of bicarbonate can lead to metabolic alkalosis, a potentially fatal condition. The presenters concluded that the evidence warranted further research.

It is alleged that, as a result, dialysis patients were unnecessarily placed at risk for the effects of excessive bicarbonate, which has been linked to heart problems.  According to the FDA, high bicarbonate levels can contribute to a metabolic condition which is a significant risk factor for the following:

  • Low blood pressure
  • Cardiac arrhythmia
  • Low blood oxygen pressure
  • Low potassium levels in the blood
  • High concentration of carbon dioxide in the blood

If these conditions are not properly treated, serious adverse events, including cardiac arrest and death, may occur.

If you or someone you know has experienced serious side effects caused by GranuFlo and NaturaLyte and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.

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