Granuflo Lawsuit

General Dialysis Information

Dialysis is a process by which waste is removed from the blood of individuals suffering from renal failure.  While dialysis is recommended to help people suffering from acute renal failure, it is primarily used in the setting of chronic renal failure.  When an individual suffers from renal failure many problems occur, the relevant ones being:

(1) Failure to remove waste from the body;
(2) Acidosis because of the kidney’s inability to produce bicarbonates to balance the acid; and
(3) Failure to eliminate phosphorous from the blood which leads to low calcium levels as calcium is being leeched from the bones (decrease in bone density) in an attempt to balance the bodies’ calcium/phosphorous levels.

It is reported there are approximately 400,000 dialysis patients in the United States, and Fresenius treats approximately 1/3rd of these patients with it GranuFlo Dry Acid and NaturaLyte Liquid concentrates.

The Recall

On July 10, 2012 the public was notified of a Class I recall of the Granuflo Dry Acid and NaturaLyte Liquid concentrates, which are manufactured by Fresenius Medical Care North America.   A Class I recall is a recall of dangerous or defective products that predictably could cause serious health problems or death.

Within the recall notice, the FDA announced that the manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in these products because inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This, in turn, may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

Side Effects for GranuFlo and NaturaLyte products:

The primary injury being caused by these products is metabolic alkalosis which occurs, in this case, due to an excess of bicarbonates.   The physical signs of the injury are nonspecific and depend on its severity.    A severe case is life-threatening, so treatment is important.  A measure of the arterial blood gases is the best way to test for whether someone is suffering from metabolic alkalosis.  If this has not been performed, then the injury may be suspected if electrolytes show an elevated carbon dioxide level.   Because metabolic alkalosis is often associated with hypokalemia and decreased ionized calcium levels, checking phosphorous and calcium levels is important too.

    • Low blood pressure,
    • Hypokalemia,
    • Hypoxemia,
    • Hypercapnia
    • Cardiac arrhythmia
    • Cardiopulmonary arrest

In 2016, Fresenius agreed to settle all pending claims for $250 million.  Douglas and London is no longer accepting new Granuflo cases.