7 Things You MUST Know About GranuFlo and NaturaLyte Lawsuits

hemodialysisHundreds of lawsuits across the country have been filed against Fresenius Medical Care, the world’s largest supplier of dialysis machines, alleging that its dialysate products containing GranuFlo and NaturaLyte caused cardiac-related injury and death. Sometimes extensive lawsuits like these can be complicated or difficult to understand. In order to clarify the issue, we’ve boiled the circumstances of the GranuFlo and NaturaLyte dialysis injury lawsuits down to seven key pieces.  

1. Fresenius introduced Granuflo Dry Acid Concentrate in 2003 without providing warnings to health care providers regarding the rate at which the sodium acetate contained in the product is converted to bicarbonate by the body. High levels of bicarbonate may put dialysis patients at increased risk for adverse cardiac-related health events.

2. By 2009 or 2010, Fresenius changed the operator’s manual for some of its machines, instructing the acetate dose be cut in half. This may suggest the company was trying to combat the dangerously high levels of bicarbonate produced by GranuFlo and NaturaLyte. However, the acid concentrates’ mixtures were not changed. Fresenius aggressively marketed GranuFlo and NaturaLyte, bundling them with other dialysis products at a discount.

3. Fresenius issued an internal memo about the risk of NaturaLyte and Granuflo problems to all of its dialysis clinics on November 4, 2011. The memo reported that the use of GranuFlo and NaturaLyte may contribute to an increased risk of cardiopulmonary arrest and sudden cardiac death, noting the incidence of 941 patient deaths in 667 Fresenius clinics in 2010. According to the document, patients with elevated pre-dialysis bicarbonate levels had a 6-8 fold increased risk of cardiac death compared to those with normal levels.

4. After Fresenius’ internal report was leaked to the F.D.A., which made an inquiry into the risks of GranuFlo and Naturalye, Fresenius released an “Urgent Product Notification” to all clinics that purchased and used their products, finally urging health care providers to monitor bicarbonate levels and adjust dialysate prescriptions on a per-patient basis to decrease the risk of cardiac injury and death.        

5. The F.D.A. designated GranuFlo and NaturaLyte a Class I Recall in June 2012. A Class I is the most serious recall and only issued if there is reasonable probability that use of the product will result in grave injury or death.

6.  According to a report by the New York Times, the F.D.A. is investigating whether Fresenius violated federal law by not sufficiently and swiftly warning consumers of the potential dangers of their products. The article quoted Steven Silverman, director of compliance for the F.D.A.’s medical devices division as saying,  “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”

7. A number of lawsuits have been filed naming Fresenius as the Defendant, including:

GranuFlo and NaturaLyte Dialysis Injury Lawyers NC

If you or a loved one has experienced adverse side-effects, especially heart attack or death, within 48 hours of dialysis treatment, you may be entitled to compensation. Contact a Fresenius Dialysis Injury Lawyer at Ward Black Law; we can answer your questions, evaluate your case, and possibly pursue a GranuFlo and NaturaLyte lawsuit in NC. Please call our office at 800-531-9191 or 336-333-2244 or contact us via email to discuss your potential case.

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