GranuFlo Heart Attack Lawsuit

The dialysis product GranuFlo was recalled in 2012. GranuFlo is supposed to balance the pH of a patient’s blood, but an improper dose could easily trigger a bicarbonate overdose, sudden heart attack, cardiac arrest, or death. Fresenius, the company that makes GranuFlo, wrote an internal memo about this risk in November 2011, but failed to inform the FDA until an anonymous source leaked the memo in March 2012. Fresenius is now facing lawsuits on behalf of people who were injured or killed by this product.

What You Can Do & How a GranuFlo Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting GranuFlo induced injury cases in all 50 states. If you or somebody you know has been injured by GranuFlo, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Michael Schmidt Elected to Plaintiffs’ Steering Committee For Granuflo and Naturalyte Injury Claims Nationwide

Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP and The Schmidt Firm, PLLC, was recently elected to the Plaintiffs’ Steering Committee in the Judicial Council Coordination Proceeding No. 4749 in Los Angeles Superior Court. The coordination proceeding applies to Granuflo and Naturalyte injury claims nationwide.  This appointment establishes Mr. Schmidt in a leadership position in the litigation along with rest of the JCCP leadership panel.

A nationwide recall was issued for NaturaLyte and GranuFlo on March 29, 2012.  Use of Fresenius Medical Care’s popular dialysis treatment products GranuFlo and NaturaLyte has been linked to a six-fold increased risk of cardiopulmonary arrest and sudden cardiac death.

What is the problem with GranuFlo?

The GranuFlo Dry Acid Concentrate is a product that is used during bicarbonate dialysis. During the dialysis process, patients with end-stage kidney disease go to a clinic, where a machine removes toxins and excess fluid from their blood. The blood gets more acidic during this process. Therefore, a doctor must balance the blood pH levels before it can be returned to the patient’s body.

Bicarbonate is used most extensively to balance blood pH. Typically, a doctor adds a bicarbonate concentrate plus an acid concentrate. There are many different brands of acid concentrate products. GranuFlo is an acid concentrate that contains acetic acid and sodium diacetate. The problem is that GranuFlo contains more sodium diacetate than most other products, and sodium diacetate rapidly converts to bicarbonate by a patient’s body. This means that a patient who is treated with GranuFlo will have a higher total amount of bicarbonate than what the doctor originally prescribed.

Doctors must adjust the dosage of bicarbonate to compensate for the extra bicarbonate that comes from GranuFlo. If they fail to do so, the patient can easily suffer a life-threatening bicarbonate overdose.

Failure to Warn About GranuFlo Risks

GranuFlo is manufactured by Fresenius Medical Care, a company that operates more than 1,800 dialysis clinics in the U.S. Fresenius was the first to notice the issue of bicarbonate overdose. In 2010, there were 941 deaths at Fresenius clinics in the U.S. This was an unusually high number.

Upon investigation, Fresenius found that patients who had high pre-dialysis bicarbonate levels were six times more likely to suffer cardiac arrest. Cardiac arrest is one side effect of a bicarbonate overdose.

In June 2012, the New York Times reported that, on November 4, 2011, Fresenius issued an internal memo describing the risk of bicarbonate overdose. The memo was sent only to staff at Fresenius clinics. It was not sent to the FDA or doctors at other dialysis clinics who were also using GranuFlo. In March 2012, an anonymous source leaked the memo to the FDA. On March 29, 2012, after the FDA confronted Fresenius about the memo, the company issued a warning to all doctors who were using GranuFlo.

GranuFlo Recalled

Fresenius voluntarily recalled GranuFlo on June 27, 2012 in a Class 1 recall, which is the most serious type of recall the FDA can issue. The FDA warned:

“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

GranuFlo and Heart Attack

If GranuFlo is administered improperly, it can cause a bicarbonate overdose. When this occurs, the pH of the patient’s blood drops. They are at risk of metabolic alkalosis, which can interfere with the electrical activity in the heart and cause sudden, severe cardiovascular problems — including heart attack.

GranuFlo complications include:

• Cardiac arrest
• Heart attack
• Cardiopulmonary arrest
• Stroke
• Irregular heart rhythm (arrhythmia)
• Low blood pressure
• Permanent disability
• Death

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 has been injured by GranuFlo, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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