GranuFlo is a product that was used in dialysis treatments for patients suffering from kidney failure. It was released in 2003 but was recalled by the FDA in 2012 because of the increased risk of heart attack associated with it—it’s estimated that patients using Granuflo are at least six to eight times more likely to suffer one.
GranuFlo Risk Cover-Up
Fresenius, the company that produces GranuFlo, attempted to cover up the increased risk of heart attack associated with its product instead of informing the FDA about these complications. An internal memo began circulating around Fresenius about the dangers of GranuFlo in November of 2011; however, they had no intention of making these finding public.
This internal memo was eventually leaked anonymously to the FDA, presumably by a concerned employee of Fresenius.
Subsequent FDA Recall of GranuFlo
After learning about the potential negative side effects of GranuFlo use, the FDA recalled the product in March of 2012. This was a Class I recall, which is the most severe and urgent recall that the FDA can make—it’s reserved for products that pose a probable risk of negative side effects or death from use or exposure.
What Makes GranuFlo Dangerous?
During a dialysis treatment, physicians filter a patient’s blood outside of their body. Within this filtering process a chemical known as biocarbonate is used to rid the blood of acid that has built up due to the non-functioning of the kidneys.
GranuFlo contains a chemical known as acetate, which the body can convert to biocarbonate—meaning that the levels of biocarbonate in a patient’s blood stream after the use of GranuFlo are considerably higher than if another competing dialysis product was used. Studies on the effects of biocarbonate in the body have proven that increased levels of the substance put patients at a much higher risk for cardiac events, such as a heart attack.
If you or a loved one has suffered injury or death from a heart attack because of the use of GranuFlo in dialysis treatments, it’s important that you seek legal counsel because you may be entitled to compensation. An experienced attorney will be able to work with you to ensure that you receive the full amount you are entitled to. Call me today to discuss this further.