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Archives : 2012 : August

FDA Issues a Class I Recall of Fresenius Medical Care Dialysis Drugs GranuFlo® and NaturaLyte®

August 16th, 2012

Following a string of troubling findings concerning the risks involved with the use of GranuFlo and NaturaLyte dialysis products, Seeger Weiss LLP is advising that the Food & Drug Administration (FDA) has opened up an inquiry into the parent company Fresenius Medical Care (FMC), combined with a Class I recall of both products.  The inquiry’s goal is to determine whether Fresenius violated federal regulations by omitting critical information concerning the potentially deadly risk associated with use of the products.

Dialysis TreatmentFMC, based in Germany, is the largest operator of hemodialysis centers in the United States, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year.  A memo that Fresenius issued in November of 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems.

The issue was first brought to public attention after an internal memo was anonymously leaked to the FDA earlier this year. In the memo dated November 4th, 2011, FMC warned doctors operating in their dialysis centers that their products may be causing dangerously high biocarbonate levels that would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products. The memo also stressed that “This issue needs to be addressed urgently.”

Despite the findings, it was only after the FDA opened an investigation into the matter that FMC issued a wider warning to other care centers, which it did in March of this year. In June, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products from Fresenius.

As more information becomes public, patients who have suffered injuries are seeking redress and exploring their legal options. Chris Seeger, one of the partners of the law firm Seeger Weiss LLP, said that the decision Fresenius made not to inform the public of potential dangers reflects a failing on behalf of the company. “By not advising the FDA, the medical community and dialysis patients as soon as possible about the dangers of GranuFlo and NaturaLyte, Fresenius made the decision to put profits ahead of patient safety. They aren’t the first pharmaceutical company to make that decision and, unfortunately, they won’t be the last.”

Additionally, Mr. Seeger says that the error is made all the more egregious due to the fact that much of the damage to patients was preventable if Fresenius had responded quickly and efficiently to initial reports of the problem. “You would not expect a company that makes millions of dollars a year from dialysis patients to knowingly put those patients at risk for serious injuries, including death, but that’s exactly what Fresenius did. Fresenius was in position to prevent these injuries but chose not to do so. They must be held accountable.”

Seeger Weiss LLP is offering free consultations to those that might have been affected by the products. If you suspect that you or someone you know has been injured after using GranuFlo and NaturaLyte products in dialysis, contact Seeger Weiss by visiting http://www.seegerweiss.com/ or by calling directly at 888.584.0411.


Posted at 8:22 pm. No comments

Man Arrested for Allegedly Pouring Bleach into Dialysis Equipment

August 2nd, 2012

Donald Foster III, a former dialysis equipment manager at Fresenius Medical Care (FMC), has been charged with attempted murder and burglary after allegedly pouring bleach into the dialysis machines at a South Carolina clinic.  A judge has set his bond at $525,000.

Donald Foster III

Donald Foster III has been charged with attempted murder for allegedly pouring bleach into dialysis equipment at a South Carolina clinic.

According to Lexington County Sherrif James Metts, Foster had been suspended from his position on July 2 at FMC for providing prescription painkillers to patients. Five days later, Foster returned to pour bleach into the dialysis holding tanks despite being told to stay of the property. Metts suspects that Foster’s motive was seeking revenge against FMC for his suspension.

Fortunately, this potentially fatal plot was foiled by workers at the clinic who noticed a high level of chlorine before the machines were used on the 20 patients scheduled for dialysis treatment that day.

According to Metts, Donald Foster had full knowledge and intent to harm or kill these clients and that he knew the lethal effect of bleach in dialysis treatment. “Thank goodness, his plan failed due to the fact the technicians, even though they had checked the water on Saturday afternoon after they finished all of their clients for the day and took no clients on Sunday and was going to begin back on Monday, they went through their checks and found the high contamination of the chlorine bleach in the water,” Metts said.

FMC has also been in the news recently for unrelated issues with their dialysis products, GranuFlo® and NaturaLyte®, which have been discovered to potentially cause metabolic alkalosis – a significant risk associated with low blood pressure, cardiac arrhythmia, cardiopulmonary arrest, and even death. The FDA has issued a Class I recall of these products, the most urgent recall option, after an FMC memo describing the risks was leaked anonymously.


Posted at 6:20 pm. No comments