Fresenius Internal Memo
In November 2011, Fresenius Medical Care (FMC) released an internal memo to physicians working in Fresenius dialysis centers that warned of potentially fatal side effects associated with the GranuFlo and NaturaLyte dialysis products they manufacture.
According to Fresenius Medical Care, GranuFlo and NaturaLyte dialysate acid concentrates can cause side effects among patients with elevated pre-dialysis bicarbonate levels. When Granuflo or NaturaLyte is administered to a patient with elevated bicarbonate levels, a bicarbonate overdose can occur. This increases the risk for severe side effects such as heart attack, stroke, and sudden death.
In the memo, Fresenius reported that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after undergoing hemodialysis treatment with GranuFlo and NaturaLyte acid concentrates. Fresenius studies also found that dialysis patients receiving GranuFlo and NaturaLyte are six times more likely to suffer a heart attack or sudden cardiac death than patients using other dialysis products.
Fresenius Medical Care failed to offer the same warning memo to thousands of physicians and clinics not owned by FMC. In March 2012, the Food and Drug Administration (FDA) issued a Class 1 recall of all GranuFlo and NaturaLyte products after receiving a leaked copy of the Fresenius memo. Patients who were injured after receiving hemodialysis treatment with the acid concentrates have begun filing lawsuits against Fresenius Medical Care.
If you or a loved one has been injured after receiving dialysis treatment with GranuFlo or NaturaLyte, you may be eligible to file a lawsuit. Contact the lawyers at Hissey Kientz, LLP for a free case evaluation by calling toll-free at 1-866-275-4454, or by filling out our free contact form on the right of this page.