Mon 30 Jul 2012
A conference entitled “ESRD: State of the Art and Charting the Challenges for the Future” was convened in April 2009 to examine dialysis patient survival rates. At that time, sudden cardiac arrest was responsible for 59% of all dialysis patient deaths.
In 2010, it was found that these cardiac death rates were related to high bicarbonate levels in two dialysis products, GranuFlo and NaturaLyte. Both products are manufactured by Fresenius Medical Care (FMC). Seeger Weiss is advising that in March, 2012, after more than 900 dialysis patient deaths, the FDA issued a Class 1 recall of both FMC products.
Risks of Using GranuFlo and NaturaLyte
A Class 1 recall is the most serious product recall the FDA can issue. It means that a product can cause serious health hazards or death. GranuFlo and NaturaLyte contain high bicarbonate levels that can cause serious side effects and health consequences in dialysis patients, among them:
* Low blood pressure
* Metabolic alkalosis
* Heart problems
* Cardiac arrhythmia
* Hypercapnia (high blood carbon dioxide)
* Hypoxemia (insufficient blood oxygen)
* Hypokalemia (abnormally low blood potassium)
* Heart attack
* Cardiopulmonary arrest
Doctors and Patients Not Warned About Risks
In 2010, FMC did a study comparing the risk factors of 941 dialysis patients who had suffered cardiopulmonary arrest with those who did not. The study revealed that the 941 patients had elevated pre-dialysis bicarbonate levels and were, therefore, six times more likely to experience cardiopulmonary arrest when treated with products like GranuFlo and NaturaLyte, both of which contain sodium diacetate.
Based on the above study, FMC was obviously aware of the risks associated with GranuFlo and NaturaLyte by 2010. However, it only issued an urgent warning memo in November of 2011, and then only to FMC facilities and FMC physicians. Non-FMC facilities and non-FMC doctors were not warned about the risks, even though more than 100,000 dialysis patients at other facilities were being treated with these products. Patients were not advised of the risks because FMC did not believe there was enough information to justify warning customers.
Not until March 2012 did FMC advise non-FMC doctors and facilities about the health hazards of their products. This occurred only after a copy of the 2011 memo was leaked to the FDA. The 2012 memo was a watered-down version of the original memo. It minimized the risks; omitted key details related to patient treatment and provided only one medical reference. The importance of adjusting monthly prescriptions was not addressed at all.
Dialysis Patients May Be Entitled To Compensation
Not only have FMC officials concealed safety information about their products, they continue to market these products. Approximately 5,700 dialysis clinics in the U.S. are currently providing service to 400,000 patients. Because FMC manufacturers most of the medical products used in dialysis clinics, patients continue to be at risk,
This is obviously a case of putting profit ahead of patient safety. If you or a loved one have been treated with GranuFlo or NaturaLyte, or have suffered health consequences as a result, you may be entitled to compensation.