GranuFlo and Naturalyte Cardiac Arrest

The dialysis treatment products GranuFlo and Naturalyte have been recalled due to the risk of cardiac arrest, heart attack, stroke, and death. Fresenius, the company that manufactures these products, is facing a growing number of lawsuits for allegedly warning their own doctors about the risk of cardiac arrest, but failing to warn anyone else until 2012.

Do I Have a GranuFlo Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by GranuFlo, you should contact our lawyers immediately. You may be entitled to compensation by filing a GranuFlo lawsuit in Texas.

GranuFlo and Cardiac Arrest

GranuFlo has been recalled due to the risk of cardiac arrest, heart attack, stroke, and sudden death. The U.S. Food and Drug Administration (FDA) issued a Class 1 recall in May 2012.

During dialysis (when a person with kidney failure has toxins mechanically removed from their blood), acid normally increases in the bloodstream. A doctor must balance the acidity/alkalinity of the blood before re-injecting it into a patient. Bicarbonate is often used to lower acidity. Products like GranuFlo Dry Acid Concentrate or Naturalyte Liquid Acid are also used to balance the acidity of blood. Most of these types of products contain acetic acid, but GranuFlo and Naturalyte contain acetic acid plus acetate. When acetate is metabolized by the liver, it turns into bicarbonate. This means that patients who are treated with GranuFlo or Naturalyte are more likely to have high bicarbonate levels than people treated with other products.

Bicarbonate overdoses can cause metabolic alkalosis, a life-threatening condition associated with low blood pressure, cardiac arrest, heart attack, stroke, and death. If a health care professional is not aware that GranuFlo and Naturalyte can substantially increase a patient’s bicarbonate levels, they may accidentally overdose a patient.

Fresenius Warns of GranuFlo Cardiac Arrest

Fresenius Medical Care is the manufacturer of GranuFlo and Naturalyte dialysis products. On November 4, 2011, Fresenius sent a memo warning doctors about the risk of bicarbonate overdose associated with GranuFlo and Naturalyte. Fresenius staff noticed in 2010, there were 941 deaths at  667 Fresenius clinics — an unusual increase. They found that patients who had high levels of bicarbonate before dialysis were six times more likely to have cardiac arrest during dialysis treatment. They warned doctors to check their patients’ bicarbonate levels, and measure GranuFlo and Naturalyte very carefully.

Unfortunately, the FDA did not become aware of the safety hazard until an anonymous source sent them a copy of the memo in March 2012. After the FDA questioned Fresenius, the company agreed to publish an urgent notification. In May 2012, Fresenius issued a recall of GranuFlo and Naturalyte.

What is Cardiac Arrest?

Cardiac arrest is a very serious, life-threatening cardiovascular disorder. It is different from a heart attack, which occurs when something obstructs the coronary arteries that supply blood to the heart muscle, causing the heart muscle to die. Cardiac arrest occurs when the electrical activity in the heart is disrupted. Without an electrical signal, the lower heart chambers “flutter” instead of pumping. Unless normal electrical activity is restored, usually with a high-voltage electrical shock (called defibrillation), the patient can suffer severe organ damage and brain death within a few minutes.

If you, your loved one, or someone you know suffered from sudden cardiac arrest while undergoing dialysis treatment, it is possible that GranuFlo or Naturalyte were responsible. Contact our lawyers today for a free case consultation. If you choose to file a lawsuit, you could receive compensation for medical expenses, pain and suffering, future medical care, or the wrongful death of your loved one.

Symptoms of Cardiac Arrest

• Fainting
• Blackouts
• Dizziness
• Chest pain
• Shortness of breath
• Weakness
• Heart palpitations
• Vomiting
• Sudden collapse
• No pulse
• No breathing
• Loss of consciousness
• Death

Do I have a GranuFlo Lawsuit?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas GranuFlo cardiac arrest lawsuit review.