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GranuFlo Lawsuit

Used during dialysis to help clear the blood of harmful toxins in renal-failure patients, GranuFlo dry acid dissolution system has been linked to several deaths, a federal recall and countless lawsuits.

In 2003, the U.S. Food and Drug Administration (FDA) approved GranuFlo, a powder that is reconstituted before use, for dialysis patients. Dialysis, performed on a machine called a dialyzer, takes over a damaged kidney’s actions by filtering the blood and clearing blood waste products. Part of this process involves providing bicarbonate, which neutralizes acid in the blood. But since GranuFlo, and its sister product NaturaLyte, contains an ingredient that coverts into bicarbonate, patients using the products could get more bicarbonate than medically safe. This can lead to metabolic alkalosis, which is associated with low blood pressure, stroke, irregular heartbeat, heart attack and death. Excess bicarbonate has also been linked to low blood oxygen levels (hypoxemia), low blood potassium (hypokalemia) and high carbon dioxide levels (hypercapnia).

GranuFlo Recall

Both GranuFlo and NaturaLyte were invented and are manufactured by Germany based Fresenius Medical Care (FMC). The company runs more than 1,800 dialysis clinics in the United States alone, treating more than 138,000 patients nationally. Another 125,000 additional patients are treated with GranuFlo and NaturaLyte at other dialysis clinics nationwide. In addition to the clinics and products, the company is also the leading supplier of dialysis machinery in the country.

During a quietly run study in 2010, FMC researchers and physicians found that patients undergoing dialysis using GranuFlo or NaturaLyte had a higher heart attack rate. The study found that in a one-year period, 941 patients being treated with GranuFlo or NaturaLyte in 667 FMC facilities had deadly heart attacks. Researchers found that those with high bicarbonate levels had a six to eight times greater risk of sudden cardiac death.

Instead of making the findings public, FMC sent a memo to its own dialysis centers to make its staff doctors aware of the problems. The estimated 3,300 other dialysis clinics nationwide that used the products were not informed. It wasn’t until March 2012 that the FDA received an anonymous tip regarding the deadly product. The FDA issued a Class I recall for NaturaLyte and GranuFlo to revise the product instructions and usage guidelines. A Class I recall is the strongest FDA recall, indicating a product or medication could cause death.

GranuFlo Lawsuits

The FDA is also investigating FMC to determine if the company violated federal regulations when it failed to inform all of its customers about the deadly risks connected to GranuFlo and NaturaLyte. The company has said the findings were simply too preliminary to warrant any public disclosure. The investigation is ongoing.

In addition, dozens of patients have filed lawsuits following the deadly effects of the products. Patients and their families claim that FMC intentionally withheld adverse information from non-FMC clinics and patients, misled consumers, failed to release adequate warnings and instructions and disregarded public safety, just to name a few. A group of patients have asked the U.S. Judicial Panel on Multidistrict Litigation (MDL) to convene. If an MDL is approved, all of the cases will be consolidated for the sake of some pretrial proceedings. The cases will then be heard individually before a judge and jury.

If you or someone you know has suffered due to GranuFlo, the time to act is now. Because many states have statutes of limitations to file lawsuits, speak to one of our attorneys to determine your best course. You may be eligible to receive financial compensation for your injuries, medical expenses and pain and suffering.