The FDA recalled GranuFlo (a dialysis product) in March 2012, warning that the treatment was linked to a 6 times increased risk of heart attack.
What is GranuFlo?
GranuFlo (and similar product NaturaLyte) is a dialysis treatment used in clinics across the United States. It is manufactured by Fresenius Medical Care. According to an internal memo that was first circulated within Fresenius on November 4, 2011, patients who undergo GranuFlo treatment are 6 to 8 times more likely to suffer heart attack or sudden cardiac death. Patients may suffer heart attack from the moment they are hooked up to the dialysis machine and up to 48 hours after undergoing treatment.
Fresenius Hides Information about Risks
Instead of warning the FDA and the public of these GranuFlo complications, Fresenius kept the information a secret. In fact, the FDA only found out when the internal document was anonymously leaked to the agency, according to an article in The New York Times.
FDA Recalls GranuFlo
Subsequently, in March 2012, the FDA issued a Class I recall of GranuFlo and NaturaLyte. A Class I recall is the most serious and is issued only when “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.” The FDA determined that GranuFlo was too unsafe to remain on the market any longer.
Why is GranuFlo Dangerous?
During the process of dialysis, blood is filtered outside of the body. An alkaline substance called bicarbonate is administered to neutralize acid that has built up in the blood. GranuFlo and NaturaLyte both contain an ingredient called acetate, which the body converts to biocarbonate. Studies have shown that too much biocarbonate has been linked to issues with the heart, reports The New York Times. Unfortunately, GranuFlo and NaturaLyte contain more of this ingredient that rival products.
If you have suffered a heart attack or if you have lost a family member to sudden cardiac event after undergoing dialysis, we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation. Our experienced attorneys will work closely with you and fight for the maximum compensation on your behalf.