Granuflo, a dialysis treatment product manufactured by Fresenius Medical Care, was recalled in 2012. According to an internal memo leaked to the FDA, more than 900 cases of cardiopulmonary arrest, cardiac arrest, and heart attacks were associated with bicarbonate overdoses in 2010. Fresenius is now facing hundreds of lawsuits from people who were injured during dialysis.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting GranuFlo induced injury cases in all 50 states. If you or somebody you know was diagnosed with a heart attack, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Fresenius Settles GranuFlo MDL for $250 Million
February 18, 2016 — Fresenius Medical Care has offered $250 million to settle over 4,300 lawsuits involving dialysis patients who had heart attacks after they were given GranuFlo or NaturaLyte. The securities filing states that 97% of all plaintiffs must opt-in to the agreement by July to receive payment by August 2016.
GranuFlo Lawsuits and Multi-District Litigation (MDL)
Thousands of lawsuits involving GranuFlo and NaturaLyte have been centralized in a federal Multi-District Litigation (MDL No. 2428) in the U.S. District Court for Massachusetts since 2013.
Thousands of individual lawsuits and several class actions have been filed against Fresenius, including one class action in California that contains hundreds of lawsuits. Another class action has been filed in Pennsylvania. DaVita HealthCare, a rival dialysis chain that used GranuFlo on their patients, is also facing several class actions.
However, the majority of cases are individual lawsuits filed by people from all over the United States, such as:
- Louisiana man has filed a GranuFlo lawsuit after suffering a heart attack, stroke, and severe pain following treatment at a Fresenius dialysis clinic. Click here to read more.
- A wrongful death lawsuit has been filed on behalf of a man from Texas who died of a sudden cardiac arrest after being treated with GranuFlo and Naturalyte. Click here to read more.
- GranuFlo lawsuit has been filed in Ohio on behalf of a man who died of a cardiac arrest in 2010 after being given GranuFlo. Click here to read more.
- A wrongful death lawsuit has been filed in Georgia. The lawsuit was filed on behalf of a man who died of a sudden heart attack during dialysis treatment in 2010. Click here to read more.
- A wrongful death lawsuit has been filed in Georgia, on behalf of a woman who died of a cardiovascular event during dialysis treatment in 2010. Click here to read more.
- Two wrongful death lawsuits filed in the U.S. District Court for Alabama. Both lawsuits were filed by women whose husbands died of heart attacks after being given GranuFlo or Naturalyte during dialysis treatment. Click here to read more.
What is GranuFlo?
GranuFlo is a powdered dialysate chemical that is mixed with water and used to balance the acidity of a patient’s blood during hemodialysis. During dialysis, many patients are also given bicarbonate, an alkaline substance that neutralizes the acid that builds up in the blood.
What is the Problem?
Unfortunately, the active ingredient in GranuFlo is metabolized by the liver into bicarbonate. If doctors do not adjust the dose of bicarbonate to compensate for the “extra” bicarbonate in GranuFlo, the patient may develop dangerously high levels of bicarbonate. A bicarbonate overdose can cause metabolic alkalosis and the following side effects:
- Cardiopulmonary arrest
- Heart attack
- Cardiac arrest
- Stroke
- Low blood pressure
- Metabolic alkalosis
- Hypokalemia (dangerously low potassium)
- Hypoxemia (dangerously low oxygen in the blood)
- Hypercapnia (dangerously high carbon dioxide in the blood)
- Cardiac arrhythmia, irregular heart beat
- Death
Failure to Warn About Granuflo Side Effects
In May 2012, the FDA issued a Class 1 recall to update the label on GranuFlo. The recall was issued after an anonymous source provided the FDA with an internal memo (PDF). The memo was sent to doctors working at Fresenius dialysis centers, but not the FDA or other dialysis centers.
The memo warned them that improper administration of the GranuFlo appeared to be contributing to a sharp increase in patient deaths. It identified 941 patients who had suffered cardiac arrest in Fresenius dialysis clinics since 2010. By the company’s own estimate, patients with high bicarbonate had a six-fold increased risk of cardiac arrest compared to those with low bicarbonate levels.
Do I have a GranuFlo Lawsuit?
The Schmidt Firm, PLLC is currently accepting GranuFlo induced injury cases in all 50 states. If you or somebody you know was diagnosed with a heart attack, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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