Fresenius Supports GranuFlo/NaturaLyte Despite Lawsuits

Fresenius Supports GranuFlo/NaturaLyte Despite Lawsuits

By Andrea Gressman

Fresenius, the manufacturer of NaturaLyte and GranuFlo, had their products recalled as the result of an FDA investigation in March of 2012. However, in December of 2012 they issued an announcement that the GranuFlo and NaturaLyte manufacturer would stand by their products as the NaturaLyte/GranuFlo lawsuits continue to be filed against Fresenius and continue on their way through the litigation process.

In November of 2011, Fresenius issued and internal memo to all of the physicians in dialysis treatment centers within the Fresenius network explaining that there had been an error in the way the NaturaLyte and GranuFlo concentrates were being mixed that had resulted in nearly 1,000 deaths that previous year. However, this memo was not issued to any of the dialysis centers outside the Fresenius network despite the fact that many of these dialysis clinics did use NaturaLyte and GranuFlo. It is believed that this act continued to put at least 100,000 people at risk for being exposed to NaturaLyte and GranuFlo deadly side effects.
In March of 2012, the United States Food and Drug Administration (FDA) began an investigation after this memo was leaked to them. It was then on March 29, 2012 that a class 1 recall was issued for both NaturaLyte and GranuFlo. The class 1 recall is the most serious type of recall that can be issued and is only done so when there is, according to a statement by the FDA, a “reasonable probability that use of these products will cause serious adverse health consequences or death.”

The FDA went on to provide an explanation of the GranuFlo recall, indicating that Fresenius Medical Care had cautioned it’s medical personnel that there were “inappropriate prescriptions” being provided for NaturaLyte and GranuFlo products. These improper dosages could lead to “a high serum bicarbonate level in patients undergoing hemodialysis,” which could cause severe heart attacks that result in death. Evidently this caution came many months after Fresenius’ medical team dispersed critical information in regards to the heart attack side effect risk GranuFlo and NaturaLyte had been linked to.

One of the most critical questions that is sure to surface again and again throughout the GranuFlo and NaturaLyte litigation process is when Fresenius knew of the severe side effects GranuFlo and NaturaLyte were causing. GranuFlo and NaturaLyte were on the market from January 2008 until June of 2012 and the memo was issued November 4, 2011.

Although there have been many NaturaLyte and GranuFlo wrongful death lawsuits filed against Fresenius, the company came out with a statement on December 13, 2012 that said, “The company’s actions related to these products were appropriate and responsible. Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago.”

However, what this statement does not address that will certainly be addressed if these NaturaLyte and GranuFlo lawsuits go to trial is why the November 2011 internal memo that was sent to dialysis centers in the Fresenius network was not sent to all dialysis centers that used GranuFlo and NaturaLyte. Another critical point that will certainly be addressed is why so many trained medical personal that are used to reading medication guidelines could mess up the concentrate mixture ratio so badly that hundreds of people would experience side effects so severe that they would ultimately die. It leaves many to wonder if Fresenius is hesitant to take responsibility solely due to the financial impact such a confession would make upon the company overall.

Regardless of the amount of support Fresenius is continuing to give GranuFlo and NaturaLyte, those who suffered or had family members suffer from the NaturaLyte and GranuFlo side effects could still receive compensation if you file a GranuFlo lawsuit.  Visit the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page right away to receive your free legal review with an experienced NaturaLyte or GranuFlo lawsuit attorney.