Attorneys at Beasley Allen Law Firm are investigating cases of sudden cardiac death associated in dialysis patients after the Food and Drug Administration (FDA) announced it is investigating Fresenius Medical Care, the nation’s largest operator of dialysis centers and producer of dialysis drugs, for failing to warn patients that use of some of its products could be deadly.
On November 4, 2011, German-based Fresenius sent an internal memo to doctors in its dialysis clinics warning that the risk of heart attack was significantly higher in patients who were given GranuFlo. The company failed to warn health care professionals at other clinics who used its products of the grave risk associated with GranuFlo until the FDA, after receiving an anonymous copy of the memo, questioned the company.
GranuFlo is the most widely prescribed dry acid product used in dialysis. It contains an ingredient that the body converts into bicarbonate, a chemical buffer that keeps the blood from becoming too acidic or basic. GranuFlo contains more of this ingredient than rival products, and thus similar dosages can send patients’ bicarbonate levels too high. Excess bicarbonate in the blood has been linked to a six- to eight-fold increase in cardiac arrest.
According to an investigation conducted by Fresenius, 941 hemodialysis patients experienced cardiac arrest from 667 Fresenius facilities in 2010.
In March, after discovering the company’s internal memo, the FDA ordered a recall of GranuFlo and NaturaLyte, a similar product made by Fresenius. The Class 1 recall is the most serious the FDA can issue and involves situations in which there is a reasonable probability that use of the product may cause serious adverse health consequences or death.
Dialysis patients and their families who have experienced cardiac arrest after being administered GranuFlo and NaturaLyte may have a case against the manufacturer.