Dialysis is a procedure that clears toxins from the blood in people whose kidneys have failed. In dialysis, bicarbonate is administered to neutralize the acid that builds up in the blood. Fresenius Medical Care’s GranuFlo and NaturaLyte contain an ingredient that the body converts to bicarbonate at higher levels than rival products. GranuFlo and NaturaLyte are used at Fresenius’ own dialysis clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius Medical Care. It is estimated that roughly 125,000 patients in non-Fresenius clinics are treated with GranuFlo and NaturaLyte.
On its product website, Fresenius describes GranuFlo and NaturaLyte as the “most-widely prescribed dry acid product in the dialysis industry today.” The company further claims that: “With GranuFlo’s distinctive proportional component blend in each bag, you have made the safest choice for onsite concentrate mixing.”
An internal company memo sent to doctors operating in its own clinics directly contradicts Fresenius’ assertions of GranuFlo and NaturaLyte’s safety. According to the Fresenius memo, the company’s medical staff concluded that dialysis patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.
High levels of bicarbonate can lead to fatal consequences. This risk was highlighted at the 2011 annual meeting of the American Society of Nephrology, where researchers presented data showing increased mortality with high levels of bicarbonate
On March 27, 2012 the FDA inquired about these risks and began investigating Fresenius about the risk of high bicarbonate levels and subsequent alkalosis. This inquiry prompted Fresenius Medical Care to issue a two-page Urgent Product Notification to non-Fresenius clinics. Shortly afterwards, the FDA issued a Class I recall for GranuFlo and NaturaLyte products manufactured between January 2008 and June 2012. A Class I recall is the agency’s most serious recall status; it means that exposure to the product can lead to serious and perhaps life-threatening health issues.
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 cardiopulmonary arrest, low blood pressure, cardiac arrhythmia and death.
What Should My Next Step Be?
In order to determine if a Tampa dialysis lawsuit is right for your family, you should speak with the office of Frank Miranda Attorneys at Law. You can reach the office of Frank Miranda Attorneys at Law by calling 813-254-2637.