Posted In: Drug Litigation

What are GranuFlo® and NaturaLyte®?

The primary function of the kidneys is to filter waste and toxins from the blood. Some people’s kidneys are unable to do this properly. For them, the dialysis process can serve to filter the waste and toxins artificially. In many cases, this is done through the use of a dialysis machine. Blood runs through the dialysis machine while interacting with a dialysate, which is a compound that acts as a filter to remove waste. Two popular dialysistes are GranuFlo® and NaturaLyte®. Tragically, there have been potentially fatal side effects associated with them, including strokes and serious heart conditions.

GranuFlo® and NaturaLyte® Injuries

In the United States, hundreds of thousands of people rely on dialysis for kidney conditions. It is estimated that over 3,000 dialysis clinics, servicing over a quarter of a million dialysis patients, are currently using Fresenius Medical Care products including dialysates GranuFlo® and NaturaLyte®. Use of GranuFlo® and NaturaLyte® in dialysis has been linked to a significant increase in the risk of heart attacks and related deaths. The manufacturer of these products (Fresenius Medical Care), had knowledge of the risks associated with their products, yet did not warn those at risk (and their doctors) until 2012. This inaction of Fresenius Medical Care has resulted in lawsuits being brought against them for the severe injuries that resulted.

GranuFlo® and NaturaLyte® Recall:

“This product may cause serious adverse health consequences, including death” – FDA Recall Notice, March 29, 2012.

In March 2012, the U.S. Food and Drug Administration issued a Class 1 recall of GranuFlo® and NaturaLyte®. It states that the use of either product can result in high bicarbonate levels and cause metabolic alkalosis. This significant risk is associated with low blood pressure, cardiac arrhythmia, and other conditions which could further result in cardiopulmonary arrest or even death.

This FDA Recall Notice followed an internal memo by Fresenius Medical Care showing troubling data from late 2011. According to the memo, Fresenius Medical Care had knowledge of significantly increased risks of cardiac arrests and deaths of patients during hemodialysis treatments using their GranuFlo or NaturaLyte products. Unfortunately, this vital data was not shared with the broader medical community (and at-risk patients) until over 4 months had passed. This failure to warn may have caused additional pain and suffering by those most at risk of a GranuFlo heart attack.

If you or a loved one has suffered a severe cardiac event that you believe may have been caused by GranuFlo® or NaturaLyte®, you may wish to contact a qualified and experienced Granuflo attorney who can evaluate your potential Granuflo lawsuit or Naturalyte lawsuit to determine your legal rights and options to protect your legal rights.

Do I have a GranuFlo® or NaturaLyte® Lawsuit?

Slater Slater Schulman LLP is dedicated to the representation of plaintiffs in Granuflo lawsuits and Naturalyte lawsuits. Our firm is handling litigation related to these injuries nationwide.

If you or someone you love has suffered a severe cardiac arrest after using GranuFlo® or NaturaLyte® during dialysis, you should contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling us at (800) 251-6990.

Medical Disclaimer: Please note that any change in medications should be made only after consulting with your doctor about the risks and benefits of doing so, and should not be based on any information contained in this web site.

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