GranuFlo® is a widely prescribed dry acid used to evenly distribute electrolytes during kidney dialysis. Dialysis assumes the role of the kidneys by clearing toxic waste in the blood. Part of the dialysis process involves taking bicarbonate to neutralize acid in the blood. Many dialysis patients are prescribed bicarbonate, however, an active ingredient in GranuFlo converts to bicarbonate. Too much bicarbonate from the combination of prescribed bicarbonate and that produced by GranuFlo® could result in metabolic alkalosis. This can cause numerous negative and potentially fatal effects including cardiopulmonary arrest, heart attack and stroke. Fresenius’ medical staff determined that patients with high levels of bicarbonate in their blood had about a six times higher risk of adverse effects.
The Manufacturer Failed to Warn All Doctors
The New York Times has reported that at least 941 people have suffered sudden cardiac arrest while undergoing dialysis with GranuFlo®, according to a November 4, 2011 memo from Fresenius Medical Care to doctors practicing at the company’s dialysis centers. While doctors at the company’s own dialysis centers were warned about the risks of failing to properly use the products, doctors at other centers were not immediately warned. Other doctors were warned only in late March 2012, after the FDA received an anonymously submitted copy of the company’s internal memo.
Potential Liability for Failure to Warn
Based on the information in the November 4, 2011 memo and various news reports, the failure of Fresenius Medical Care to warn dialysis clinics, physicians and patients about the significant health risks associated with elevated bicarbonate levels could have led to numerous preventable heart attacks and other health problems.
Fresenius did not issue any type of warning to its customer clinics until March 2012. It only did so after the FDA received a copy of the company’s internal memo from an anonymous source and questioned Fresenius about it. In late May 2012, the FDA informed dialysis centers throughout the country that it had received a complaint describing “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” According to the agency, when metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with a number of serious side effects, including cardiac arrhythmia, cardiopulmonary arrest, heart attack, stroke or death.