The lawsuit, filed in U.S. District Court in Massachusetts, alleges that Fresenius USA is responsible for the death of her husband two days after he was treated with the drug.
Washington D.C. personal injury attorney David Lietz commented, “A number of deaths are being blamed on this drug, and it is the subject of a Class 1 recall by the FDA.”
A Class 1 recall is the highest priority recall issued by the FDA, and is only issued in cases where there is a significant chance that a drug can cause serious injury or death.
The plaintiff in the recent suit, Emma Hernandez, said that her husband, Santos Hernandez, felt ill immediately after returning home from a dialysis treatment during which GranuFlo was administered. Two days later, she called for an ambulance when he began complaining of pain in his head and chest, but he died of a heart attack before help arrived.
GranuFlo is used during dialysis in patients with kidney failure. The chemical, or another like it, is used to remove blood impurities that the kidneys can no longer remove. The treated blood is then returned to the patient’s body.
These products have been linked to elevated levels of bicarbonate in treated blood, which can cause stroke, heart attack and death.
The plaintiff alleges that Fresenius knew about the risks of GranuFlo as far back as 2003, but did not alert doctors and treatment centers that used the product.
In November, 2011, an internal Fresenius memo was leaked to the FDA, which is alleged to demonstrate that the company was aware of the dangers of the drug. The memo was only sent to Fresenius-controlled medical centers, despite the drug’s widespread use nationwide.
Hernandez seeks punitive damages for the loss of her spouse and for her husband’s pain and suffering.
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