By Sarah Mirando  |  January 25, 2013

Category: Pharmaceuticals
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Fresenius Supports Consolidation of GranuFlo/NaturaLyte Lawsuits

By Christina Drury

 

GranuFlo heart attackThe consolidation of all federal lawsuits concerning the dialysis products GranuFlo and NaturaLyte is being supported by Fresenius Medical Care. As the maker of the dialysis products, Fresenius has agreed to have all federally filed lawsuits consolidated into the U.S. District Court, District of Massachusetts. A legal brief filed with the U.S. Judicial Panel on Multidistrict Litigation stated that Fresenius is facing 37 lawsuits that have been filed in various jurisdictions. Each lawsuit alleges that GranuFlo and NaturaLyte have caused the plaintiffs to suffer from severe cardiopulmonary injuries.

Side Effects of GranuFlo and NaturaLyte

GranuFlo and its counterpart NaturaLyte are used to reduce the amount of acid in the blood during kidney dialysis. These products have been administered to thousands of patients since being released to the medical market. Some of the injuries and complications associated with the improper use of GranuFlo and NaturaLyte include:

  • Cardiac Arrest
  • Heart Attacks
  • Other Serious Heart Problems
  • Stroke
  • Sudden Cardiac Death


With the amount of patients that have already come forward claiming allegations of one or more of the associated side effects, the lawsuits against Fresenius have the potential to turn into a very large-scale litigation, which has influenced the drug company’s decision to consolidate.

GranuFlo and NaturaLyte Recalled

Fresenius Medical Care issued a warning in March of 2012 to its customer clinics about the possible risks linked to their GranuFlo and NaturaLyte products. The notice that they released stated that both products had the potential to rapidly elevate bicarbonate levels in the blood to an unsafe level. This elevation creates an increased risk of cardiopulmonary arrest and even death. After Fresenius issued their urgent notification, the FDA classified the notice as an urgent class 1 recall.

Discrepancies in their Warning

According to reports, months before Fresenius issued their recall, the company issued a private memo within its own network warning their own clinics of the risks associated with GranuFlo and NaturaLyte. In the memo, Fresenius outlined the measures that needed to be taken and how to adjust the dosage accordingly. According to a New York Times report, Fresenius was aware of the link between GranuFlo and NaturaLyte and increased level of bicarbonate in the blood. Fresenius’ own medical staff knew that those with higher levels of bicarbonate in their blood were six times more likely to suffer from cardiac arrest than those with lower levels in their blood. One the recall was issued and the FDA was made aware of the company’s previous knowledge, an investigation was launched to determine if Fresenius could have issued an earlier warning.

Compensation for Injuries

If you or a loved one was administered GranuFlo or NaturaLyte during dialysis and suffered from any of the mentioned side effects, you may be eligible to receive compensation. For more information and legal advice, please visit our Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page. Based on your individual circumstances, you may be entitled to receive compensation for lost wages, medical expenses, pain and suffering and any other expenses you may have incurred as a result of the GranuFlo or NaturaLyte product.

 

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Updated January 25th, 2013

 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

 

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