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GranuFlo FDA Recall

GranuFlo FDA Recall

The dialysis products GranuFlo and Naturalyte have been recalled by the U.S. Food and Drug Administration (FDA) because they have been linked to an increased risk of death. Accidental dosing errors can cause a bicarbonate overdose, which may cause a patient to suffer a sudden cardiac arrest, heart attack, stroke, or death. Since 2010, hundreds of deaths have been linked to these recalled products.

What You Can Do & How a GranuFlo Lawsuit Can Help

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

Attorney Michael Schmidt of The Schmidt Firm, PLLC Elected to Plaintiffs’ Steering Committee for Granuflo and Naturalyte Lawsuits in U.S.

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.

GranuFlo FDA Recall

May 25, 2012 — The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall and published a Safety Communication regarding the Naturalyte and GranuFlo Dry Acid Concentrate dialysis products. The FDA made the following warning about the risk of GranuFlo, cardiac arrest, and death:

“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 Naturalyte are manufactured by Fresenius Medical Care, the world’s largest provider of dialysis clinics and dialysis products. The recalled products were distributed from January 2008 until June 2012.

A Class 1 recall is the most serious, urgent type of recall. It is reserved for situations in which there is a reasonable chance that using the product will cause severe injury or death.

Why Was GranuFlo Recalled?

The FDA recalled GranuFlo and Naturalyte because they can cause severe injury or death. Health care professionals may not be aware that ingredients in these products convert to bicarbonate in the body, which may increase the risk of a deadly bicarbonate overdose.

GranuFlo and Naturalyte are dialysate acid concentrates, which are products that are used during dialysis (the process of mechanically removing toxins from the blood of patients with kidney failure). During dialysis, bicarbonate is administered to neutralize the acidity that naturally builds up in the blood. GranuFlo and Naturalyte also neutralize acid in the bloodstream.

GranuFlo and NaturaLyte consist of acetic acid plus acetate. Most other acid-neutralizing products consist primarily of acetic acid. Inside the body, acetate is rapidly converted into bicarbonate by the patient’s liver — effectively increasing the total amount of bicarbonate beyond what was initially prescribed. Because GranuFlo and Naturalyte contain more acetate than most other products, they are also more likely to cause high bicarbonate than other products.

If the physician is not extremely careful with the dosage, a patient treated with GranuFlo or Naturalyte can suffer a bicarbonate overdose, metabolic alkalosis, and death.

GranuFlo and Cardiac Arrest

If you or your loved one suffered a heart attack, cardiac arrest, stroke, or other severe cardiovascular problem during dialysis, it is possible that GranuFlo or Naturalyte contributed to the injury.

On November 4, 2011, Fresenius sent a memo to doctors at their own clinics, warning that there were 941 deaths from cardiac arrest at 667 Fresenius clinics in 2010. The company compared these patients to more than 80,000 other dialysis patients, and found that excess bicarbonate led to a six-fold increased risk of sudden cardiac arrest during dialysis.

Although Fresenius warned their own doctors about the potential side effect, they did not warn the FDA or doctors at other dialysis clinics who were also using GranuFlo and Naturalyte. Many people who were injured by these products have already filed GranuFlo lawsuits against Fresenius for failing to warn about the potentially deadly side effect.

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 dialysis treatment, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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