Fresenius Stands by GranuFlo as Lawsuits Progress

Fresenius Stands by GranuFlo as Lawsuits Progress

By Christina Drury

Many people undergo dialysis, using medications that help to filter unwanted waste and water from their blood when their kidneys are unable to do so. One of the medications prescribed to those receiving hemodialysis is GranuFlo.

GranuFlo is a powdered substance that makes it convenient for physicians and medical clinics to mix their own solutions rather than having to order it in larger, more expensive containers of premixed solution. While GranuFlo does benefit the patient, it has recently come under scrutiny as the manufacturer did not include the proper mixing directions. As a result, patients were subjected to higher-than-normal levels of bicarbonate and experienced significant side effects, including heart attack, cardiac arrest and even death.
GranuFlo Side Effects

When the body makes too much bicarbonate – which can occur when an improper dosage of GranuFlo or its counterpart, NaturaLyte, is introduced into the blood – dangerous complications can arise. The most common side effect is metabolic alkalosis which can lead to further GranuFlo side effects, including an increased risk of cardiopulmonary arrest. Cardiopulmonary arrest can lead to death, almost instantly in some cases.

Hundreds of patients receiving GranuFlo have died from these side effects, leading to numerous lawsuits against the manufacturer, Fresenius Medical Care.

What did the Manufacturer Know?

The majority of GranuFlo lawsuits filed will be based on product liability claims, which must determine how much knowledge Fresenius Medical Care had about the side effects of GranuFlo. In 2011, an internal notice was sent by the manufacturer to Fresenius Medical clinics only, warning them about the dangers of dosing problems that could lead to adverse GranuFlo side effects. No outside clinics – despite the fact that they used the products regularly for dialysis – were notified of the potential GranuFlo heart attack risks. This essentially put the patients in dire risk of suffering from these side effects, including the very real possibility of death.

Despite the fact that Fresenius knew of these potential dangers, they did not warn any outside clinics, nor did they submit their findings to the U.S. Food and Drug Administration (FDA). It was not until the FDA received an anonymous copy of the notice that they issued a Class 1 recall on some GranuFlo products.

Fresenius Medical Stands by GranuFlo

In terms of the GranuFlo lawsuits, Fresenius is standing by their statements that GranuFlo is safe. A statement issued on December 13, 2012 by the manufacturer states that the products are safe to use as they were cleared by the FDA several years ago. In addition, they state that their actions taken in warning their own clinics — and not outside clinics using GranuFlo – were appropriate and they are not responsible for any wrongdoing. Those who are filing GranuFlo lawsuits clearly disagree with this statement.

Seek the Help You Need

If you have been injured or you know someone that has suffered through GranuFlo side effects, it is important to speak only with qualified attorneys who are actively investigating the claims put forth. You can visit our Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page for more information and to submit your contact information to attorneys already investigating GranuFlo lawsuits.