Dozens of GranuFlo Lawsuits Allege Heart Risks

What is GranuFlo?

Dialysis provider Fresenius Medical Care treats more than 30 percent of individuals who receive dialysis treatments in the U.S. Fresenius manufacturers GranuFlo, an acid concentrate powder that is used in dialysis treatments and was introduced into the market in 2003. There are two sources of bicarbonate in GranuFlo. The first is bicarbonate from the concentrate, which passes into the dialysis patient’s blood. The second is acetate in the acid concentrate. While in the patient’s blood, this acetate converts into additional bicarbonate.

The GranuFlo formula uses sodium diacetate, which doubles the amount of acetate in the already existing formulations. This increased amount of bicarbonate creates dangerous pH levels in a patient’s blood. This level of pH can cause a significant drop in blood pressure and sudden cardiac arrest.

Pending GranuFlo Lawsuits

At least 37 GranuFlo lawsuits are pending against Fresenius. A panel of federal judges in San Diego, California is considering whether to consolidate these cases, which are pending in 11 federal districts. All of the lawsuits allege that GranuFlo caused significant and sometimes fatal health conditions in dialysis patients.

According to one wrongful death lawsuit that was filed in an Ohio federal court in late 2012, the decedent had a dialysis treatment at a Fresenius dialysis center. He suffered cardiac arrest during the procedure and, although he was transported to a hospital by an ambulance, he died. His surviving family members argue that the death was avoidable and that the defendant should have conducted a safety study to find out if any health risks were associated with the product.

In the GranuFlo lawsuit, the plaintiff alleges that the nurses, physicians and patients were not adequately educated, informed or trained regarding the acetate, citrate and/or acetic acid levels in the dialysis concentrate. Further, they were unaware that GranuFlo contained additional acetate that converts to bicarbonate while in the patients’ bloodstream.

According to the lawsuit, Fresenius failed to warn consumers about GranuFlo risks, failed to properly train medical providers and modify their products to prevent user error. Although Fresenius was aware of the dangers associated with their product, they did not take action to keep their patients safe. The GranuFlo lawsuit argues that the product failed to provide warnings about the dangers associated with the drug and did not provide instructions about proper use of the product. The plaintiff also argues that Fresenius failed to communicate any specific instructions related to their unique formulation and that dialysis providers should not have been expected to understand the dangers posed by GranuFlo.

Take Legal Action

Patients have the right to trust in the safety of their medical procedures. When these procedures fail, injured patients may seek compensation through the justice system. If you have suffered a GranuFlo injury, you may be able to be able to participate in a GranuFlo class action lawsuit or individual personal injury or wrongful death case. Learn more about your legal rights by visiting our Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page.