Lawsuits are stacking up against Fresenius Medical Care, the manufacturer and distributer of the recalled hemodialysis drug, GranuFlo, alleging that the company neglected to warn consumers about dangerous risks associated with the use of the drug. GranuFlo is used during hemodialysis to lower the acidity in the patient’s blood during treatments.
Plaintiffs administered the controversial drug during hemodialysis tested positive for high concentrations of acetone in the blood. These elevated levels of acetone can ultimately lead to abnormal bicarbonate levels in the blood. High bicarbonate levels present in the blood are known to cause heart attacks, other serious health complications, and even death. Other serious risks include: hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, and low blood pressure. GranuFlo’s sister dialysis drug, NaturaLyte Bicarbonate Concentrate (also manufactured by Fresenius) is facing numerous lawsuits for causing similar, dangerous side effects that were also not initially warned of by the company.
An internal memo written in 2011 to Fresenius executives was leaked last year by the The Food and Drug Administration (FDA). In that memo, Fresenius concluded that the chances of death by cardiopulmonary arrest (heart attack) from the use of GranuFlo was six times more likely to occur in patients who were administered the drug during a hemodialysis treatment.
“Based on recent events, including documents made publicly available by a brave, anonymous whistleblower, it is now apparent that Fresenius Medical Care was well aware of the risks associated with their sodium diacetate-based products, like GranuFlo, for months, if not years, before the company decided to warn doctors and the public. We may never know the exact number of lives that were lost due to this reckless delay, but preliminary numbers provided by Fresenius suggest that it is in the thousands,” says Christopher Paulos, a GranuFlo personal injury attorney at Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.
After an investigation into the effects of the drug in June 2012, the FDA issued a Class I recall on GranuFlo. A Class I recall is the most serious of the FDA recalls, and products listed under Class I have the potential to cause serious health risks or even death. In the Class I recall for GranuFlo, the FDA concluded that when improperly prescribed, use of the drug during hemodialysis could in fact cause abnormally high levels of bicarbonate in the blood.
Krysta Loera is a writer and researcher with Ring of Fire.