The U.S. Food and Drug Administration (FDA) is investigating Fresenius Medical Care, largest operator of dialysis centers in the U.S. and manufacturer of dialysis equipment and products, over a potentially very serious problem with its GranuFlo dialysis treatment, and a failure to warn doctors at dialysis centers about the potential of dialysis related heart attacks and death. It is possible that this failure to warn could have led to numerous preventable injuries or deaths, which the FDA is investigating. If you or someone you love has suffered from GranuFlo dialysis treatment, it is advisable to contact a lawyer right away.
Failure to Warn All Doctors
The New York Times has reported that, according to a November 4, 2011 memo from Fresenius Medical Care to doctors practicing at the company’s dialysis centers, at least 941 people have suffered sudden cardiac arrest while undergoing dialysis with GranuFlo. While doctors at the company’s own dialysis centers were warned about the risks of failing to properly use the products, doctors at other centers were not immediately warned. Other doctors were warned only in late March 2012, after the FDA received an anonymously submitted copy of the company’s internal memo.
What is GranuFlo?
GranuFlo is a widely prescribed dry acid used to evenly distribute electrolytes during kidney dialysis. Dialysis does the kidneys’ job of clearing toxic waste in the blood, and part of the dialysis process involves taking bicarbonate to neutralize acid in the blood. Many dialysis patients are prescribed bicarbonate, however, an active ingredient in GranuFlo converts to bicarbonate. Too much bicarbonate from the combination of prescribed bicarbonate and that produced by GranuFlo could result in metabolic alkalosis. This can cause numerous negative and potentially fatal effects including cardiopulmonary arrest, heart attack and stroke. Fresenius’ medical staff determined that patients with high levels of bicarbonate in their blood had about a six times higher risk of adverse effects.
Potential Liability for Failure to Warn
Based on the information reported in the New York Times and other news reports, the failure of Fresenius Medical Care to warn dialysis clinics, physicians and patients about the significant health risks associated with elevated bicarbonate levels could have led to numerous preventable heart attacks and other health problems. If you or a loved suffered cardiac arrhythmia, cardiopulmonary arrest, heart attack or death while undergoing dialysis treatment, you could be entitled to compensation in a lawsuit. Contact the law firm of Estey Bomberger for a free consultation with one of our experienced defective product lawyers. If you have a valid claim, we will handle your case on a contingency fee basis. There are no up-front fees and we advance all costs. We are only paid if and when we recover compensation for your case.
About Estey Bomberger
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