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The Number of Lawsuits Filed Due to GranuFlo Heart Attack and Death Continues to Rise

GranuFlo, a medication used during dialysis treatments, is manufactured by Fresenius. Its solution has ingredients that convert to bicarbonate when mixed with other substances. During dialysis treatment, this is necessary to clean waste products from the blood. It has been discovered, however, that some patients were receiving too much bicarbonate from the products manufactured by Fresenius—that also includes NaturaLyte—because they have a higher level of bicarbonate in their ingredients than other products used in dialysis treatments.

Side effects from GranuFlo can result in a heart attack or death in some dialysis patients.

There has yet to be a coordination of the lawsuits filed against Fresenius, but as the numbers rise, a class action lawsuit, MDL, or mass tort could be created to streamline the process.

An internal Fresenius memo regarding GranuFlo heart attacks spurred an FDA investigation and recall

Fears concerning the side effects of these dialysis products led to the Food and Drug Administration (FDA) issuing a Class I recall earlier this year. Simultaneously, the number of lawsuits filed by GranuFlo lawyers has grown as those who were injured by GranuFlo or had relatives die as a result of its use, have filed a case seeking compensation for their injuries or loss.

The Class I recall is the most serious level. The catalyst for it was an internal Fresenius memo dated from November 2011 in which it states that in 2010, as many as 941 deaths after being administered GranuFlo had been linked to incorrect dosages given to patients receiving dialysis. This too raised the number of lawsuits against the company as patients learned of the incorrect dosages they may have received.

The memo was sent to Fresenius clinics, but not with customer clinics that also use their products.

The recall of GranuFlo didn’t remove the product from the market

When the FDA became aware of the memo, an investigation was launched to examine incidences of heart attack and death from Fresenius products. After a few months, the Class I recall was ordered. It warned that a higher than average number of injuries were resulting from too many doctors providing wrong dosing amounts to patients.

The number of lawsuits against Fresenius may continue to grow since the recall didn’t result in the products being removed from the market. Rather, stronger warnings were placed on the label regarding dosing amounts. Doctors were cautioned to use extra care when determining proper dosing amounts of GranuFlo.

Studies indicated a six-fold increase in risk of heart attack

Studies have indicated that the use of these Fresenius products increase the risks of heart attack six-fold. For patients that showed elevated pre-dialysis bicarbonate levels, and those who were classified as “acute” dialysis patients (patients with acute kidney failure), the risk was even higher.

Another risk factor for heart attack after the use of GranuFlo is metabolic alkalosis. Symptoms of metabolic alkalosis are low blood pressure, cardiac arrhythmias, and low blood oxygen.

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