Fresenius’ Fatal Secret: Hundreds of Dialysis Patients Died Before FDA Was Alerted

The internal memo  reported that 941 patients had experienced sudden cardiac arrest within Fresenius dialysis facilities after receiving treatment with GranuFlo and NaturaLyte. Studies also found that patients treated with GranuFlo and NaturaLyte were six times more likely to suffer a heart attack, or sudden cardiac death compared to other manufactured dialysis products.

The information contained in this memo was not released to the public or the FDA. It was only after the document was leaked and a Class 1 recall issued that Fresenius finally warned patients and dialysis centers about the potential risks of GranuFlo and NaturaLyte.

Drug injury attorneys argue that the memo is proof that Fresenius Medical Care was aware of the injuries and dangers associated with their dialysis products but failed to warn patients and doctors until 2012. The result has placed more than half of all dialysis patients in the United States at risk and set the stage for imminent GranuFlo and NaturaLyte lawsuits.

So what makes these products so dangerous? A glance at the inner chemistry of GranuFlo and NaturaLyte might explain. Both are acid concentrates that become components of dialysate, which is used during dialysis treatment to neutralize acid build-up in the blood. GranuFlo is a dry acid and NaturaLyte is a liquid formulation. The solutions are diluted with purified water and combined with sodium bicarbonate for filtering the patientís blood and replicating kidney function.

Using either product may potentially result in high bicarbonate levels, which can cause metabolic alkalosis — a risk that can develop into low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. It may even culminate in cardiopulmonary arrest and death.

Other potential side effects of GranuFlo/NaturaLyte include but are not limited to:

• Heart problems
• Sudden heart attack
• Stroke
• Death

Currently, there are more than 5,700 dialysis centers providing service to approximately 400,000 dialysis patients in the United States. Fresenius is the largest dialysis services and products company in the world, serving nearly a third of all U.S. dialysis patients. Not only do they own thousands of dialysis clinics, but they also manufacture nearly all the medical products used in dialysis care.  

If you or a loved one has been harmed by GranuFlo or NaturaLyte, or any other Fresenius product, you are not alone in your struggle. Visit the Kidney Dialysis GranuFlo/NaturaLyte Class Action Lawsuit Investigation to submit your information for a free legal review. Should your claim qualify for legal action, an experienced drug injury lawyer who specializes in GranuFlo or NaturaLyte cases will get in touch with you immediately. You will be guided through the litigation process at no out-of-pocket charge or with any hidden fees. The attorneys working this investigation do not get paid until you do.