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Home Page >> Hot Legal Issues >> FDA Issues Class 1 Recall for Fresenius Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo

Fresenius & DaVita Dialysis Lawsuits


Granuflo and NaturaLyte lawsuits have been filed against Fresenius Medical Care North America, the manufacturer and distributor of dialysis products Granuflo and NaturaLyte; and DaVita Healthcare Partners, alleging their actions, i.e., Alkali Dosing Errors led to the wrongful deaths of dialysis patients. Both Fresenius and Davita operate dialysis centers. Granuflo lawsuits and Fresenius dialysis center lawsuits were filed after a Naturalyte GranuFlo recall.

The dialysis lawsuits also claim the problems that caused those deaths, i.e., dangerously high levels of bicarbonates in the dialysis treatment, have affected thousands of dialysis patients nationwide.

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Naturalyte Liquid & GranuFlo Lawsuit

Both Fresenius Medical Care products - Naturalyte and GranuFlo- are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates, according to the FDA safety recall initiated in March 2012. The recalled Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate was manufactured and distributed from January 2008 through June 2012.

GranuFlo and NaturaLyte both use acetic acid and sodium acetate which can lead to additional presence of sodium acetate in the dialysate and, in turn, can result in higher levels of bicarbonate in the bloodstream. Higher levels of bicarbonate can lead to Granuflo side effects including cardiac arrest, cardiopulmonary arrest, metabolic alkalosis, stroke, low blood pressure and even death.


Lawyers are now investigating possible Granuflo lawsuits for dialysis patients who may have been victims of Granuflo dosing errors.

Granuflo Heart Attack Risk

An internal memo issued by Fresenius on November 4, 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems. The memo, which was anonymously leaked to the FDA earlier this year, warned doctors working in Fresenius dialysis centers only that 941 dialysis patients suffered cardiac arrest in 2010 from GranuFlo use. Dangerously high biocarbonate levels would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products.

Despite its findings of alkali dosing errors, FMC didn’t issue a warning to other care centers until March 2012 - after the FDA received the internal memo.

On June 28, 2012, Fresenius Medical Care North America (FMCNA) announced that the FDA classified its voluntary action to change the labeling on its dialysate products as a Class 1 recall. The company further said it will place updated labels on its NaturaLyte and GranuFlo Acid Concentrate products, and to update its hemodialysis machine operator's manuals. According to FMCNA, the company has notified more than 90 percent of its customers of these two labeling updates, and will continue with that effort until it is complete.

As NaturaLyte and GranuFlo can be used for the treatment of acute or chronic kidney failure, it is possible that patients undergoing emergency dialysis treatment may not know what dialysis drug they were given, and may have experienced adverse side effects - including cardiac arrest (heart attack) or other heart problems.

Related: Fresenius Dialysis Death Settlement

Recently, Fresenius settled a wrongful death case for seven figures to the surviving children of Teresa Gayton, a mother of five who died during a dialysis treatment at a Fresenius Medical Care facility in Illinois. She was taken off life support and died on March 10, 2009. According to the lawsuit, Teresa Gaytan “sustained massive blood loss as a result of hemorrhage from the dialysis circuit during dialysis treatment at the center.”

Fresenius Medical Care, a German company with offices under the name Fresenius Medical Care North America in Waltham, MA, is the largest operator of hemodialysis centers in the US, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year.

Inappropriate prescription of NaturaLyte and GranuFlo products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. These products can help kidney failure patients during the process of dialysis by converting into bicarbonate, which helps clean the bloodstream of a patient in a way that the kidneys would otherwise be able to do. However, the FDA’s investigation showed that doctors were administering the drug at too high a level for healthy human consumption. Dosage errors 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.



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READER COMMENTS

Posted by
James Brown
on
My Wife Nancy was doing dialysis for two weeks was told she was doing better took her friday the 25 march 2016 I spend the morning we when to DR, that morning when out toeat she was felling good,I took her to dialysis place at 11am at 12pm they put her in chair and hook her up at 1220pm she was dead at 1pm hospital call to tell me she passed away This was in Fort Wayne Indiana

Posted by
California
on
I started hemodialysis on September 10, 2012. I suffered two strokes in December 2012, on the 9th and then the 22nd.

Posted by
Colorado
on
My mother took dialysis with Fresenius for roughly three to four years. She had gone through chemo and radiation, then put on dialysis. She suffered an extremely rapid decline and...and many health-related issues resulting from dialysis.....that ended in her passing...I would like to know if my case qualifies.

Posted by
Oregon
on
My Mother took all her dialysis with Fresenius and passed away from a stroke. I would like to know if my case qualifies.

Posted by
California
on
In Sept. of 2009 I had a seizure while on the dialysis machine. I was in ICU for 17 days due to a electrolyte imbalance and blood pressure that could not be controlled. I still experiance the blood pressure issues to this day. I did not have these issues before that Sept. day.

Posted by
Georgia
on
Dad treated with dialysis drug and suffered rapid decline in health and sudden massive heart attack in January 2013. Died as a result.

Posted by
California
on
My mother was receiving her usual dialysis treatment, she had - drop in BP, her treatment was stopped. Nurse turned away for a moment and came back, my mother was non responsive. By the time EMT's called and mother sent to ER, she had suffered loss of oxygen/blood flow. Current diagnosis is cardiac arrest, I'm told she's suffered severe damage of both frontal lobes of her brain and I am not being given a favorable prognosis. In fact I'm told they don't expect her to make more than a month or so. She's currently in ICU

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