Dialysis is a routine, life-prolonging procedure for people with chronic kidney failure. In fact some 2 million people worldwide undergo dialysis to help them function in everyday life. Among the most common products used in dialysis are the acid concentrates GranuFlo and NaturaLyte. Both are manufactured by Fresenius Medical Care, the largest supplier of dialysis products and services in the world, and an owner of more than 1,800 kidney dialysis clinics in the United States alone.
What’s wrong with GranuFlo & NaturaLyte?
These two widely used Fresenius dialysis products, manufactured since 2008, have been linked to a dangerous and often deadly condition called alkalosis. This toxic build-up occurs when the body’s fluids are flooded with an abnormally high amount of alkali (or bicarbonate), causing severe heart problems and even death. Serious medical conditions linked to GranuFlo and NaturaLyte may include:
- cardiovascular death
- sudden cardiac death
- cardiopulmonary arrest
- heart attack
- other catastrophic cardiovascular injuries
Lawsuits are now underway for kidney dialysis patients who have died or experienced any of the injuries above within 24 hours of a dialysis treatment using GranuFlo or NaturaLyte between 2008 and 2012.
Were there warnings about GranuFlo & NaturaLyte?
We now know key evidence about internal studies, risks and warnings regarding these two Fresenius products:
- In 2010, nearly 1,000 patients went into cardiac arrest in Fresenius dialysis clinics, which the company recognized could be linked to bicarbonate levels in the body.
- In 2011, internal Fresenius communication confirmed that company studies showed that alkalosis was a significant risk factor with cardiopulmonary (CP) arrest in the dialysis unit.
- In 2012, Fresenius issued a notification about prescribing information that pointed to the increased risk associated with improper use of GranuFlo and NaturaLyte.
- After the FDA issued an alert in 2012 concerning this risk, dialysis centers started checking patients’ bicarbonate levels and adjusting dosages accordingly.
The question, which the FDA is currently investigating, is did Fresenius release this information in a timely manner and properly warn kidney dialysis patients of their risk of cardiac arrest?
The Law Offices of Michael A. DeMayo are currently speaking to patients or family members of patients who may have been exposed to GranuFlo or NaturaLyte and experienced life-threatening injury or death within 24 hours of treatment.
If you know a dialysis patient who had serious cardiovascular side effects immediately following treatment at Fresenius clinic, please contact us today or fill out a free consultation form. Our skilled NaturaLyte and GranuFlo lawyers can help you qualify a potential case against the manufacturer of these dialysis products.