A Florida woman filed a lawsuit against the manufacturers of GranuFlo and NaturaLyte, claiming that the dry acid concentrate administered to her husband at a kidney dialysis center in 2008 led to his death.
The lawsuit was filed in federal court on October 4, 2012. It stated that Fresenius USA Inc. was aware of the serious cardiac risks related to its GranuFlo dialysis treatment when it was first introduced in 2003, but they failed to warn the public of this vital information of GranuFlo’s cardiovascular dangers, heart attacks and death and as a result, they are now responsible for her husband’s death.
GranuFlo and NaturaLyte have become well-known treatment products used in kidney dialysis and hemodialysis. However, these two products have recently been linked to a number of serious side effects. These include heart attacks, irregular heartbeat, death, metabolic alkalosis, low blood pressure, and low blood oxygen.
Fresenius Medical Care is the largest operator of dialysis clinics in the country and provides dialysis treatment to over 400,000 patients each year. According to the FDA, GranuFlo and NaturaLyte have been linked to high levels of bicarbonate in the blood.
By the time Fresenius issued an internal memo to its own physicians and medical directors warning them that use of these two products in the treatment of dialysis increased the risk of cardiovascular events and even death, it was too late for her husband, who stopped breathing after he received a dose of GranuFlo, as part of his three-day-a-week dialysis treatment, the lawsuit says.
According to a report published by the New York Times in June, Fresenius issued a memo to doctors at its own clinics in November 2011, warning that improper dosing of GranuFlo appeared to be contributing to a sharp increase in the risk of dialysis patients dying suddenly from cardiac arrest within 48 hours of receiving the drug. The memo found that 941 patients had suffered cardiac arrest inside Fresenium clinics in 2010. Fresenius’ own medical staff had determined that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels, according to the document. Thousands of non-Fresenius-owned dialysis clinics that are supplied by the company were not issued the November 2011 memo, according to the New York Times. In fact, it was not until March 29, 2011 that Fresenius finally sent an Urgent Product Notification to its customer clinics, warning of possible heart risks associated with GranuFlo and NaturaLyte. This was only done after the FDA designated the GranuFlo and NaturaLyte recall a Class 1 Recall, which is the agency’s most serious type of recall. A Class 1 Recall is only used for products that would be considered potentially deadly.
Fresenius Medical Care’s GranuFlo and NaturaLyte contain an ingredient that the body converts to bicarbonate at higher levels than rival products. It is used to neutralize acid that builds up in the blood during dialysis.
The New York Times recently reported that the agency has also launched an investigation of Fresenius Medical Care to determine if it violated federal regulations by failing to inform customers about the serious heart risks associated with GranuFlo and NaturaLyte.
Dialysis patients who suffered heart attacks, sudden cardiac death or other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte maybe entitled to compensation for medical expenses, lose wages, pain and suffering and more.
Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).