GranuFlo, NaturaLyte Dialysis Lawsuit Referrals Offered by Resource4thePeople

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New services being provided over FDA Class 1 Recall of products that cites “significant risk factor” for cardiac arrest.

http://www.resource4thepeople.com/defectivemedicaldevices/Dialysis-Lawsuit.html

Resource4thePeople is informing consumers today that new free consultations to lawyers are being offered to patients who might have been affected by the Food and Drug Administration’s Class 1 Recall of GranuFlo and NaturaLyte kidney dialysis products.

The decision to offer referrals to these consultations was made because of an increasing number of inquiries that have come after the FDA's action, said Resource4thePeople.

In announcing the recall the FDA advised health care professionals and patients that the affected GranuFlo and NaturaLyte products when inappropriately prescribed or administered in dosing errors may cause life-threatening cardiac problems.*

“This 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,” the FDA said in the announcement. “This product may cause serious adverse health consequences, including death.”

Resource4thePeople said that dialysis patients who believe they allegedly may have suffered cardiac problems as a result of the administration of these products are invited to take advantage of these free legal compensations.

“These free consultations are available to inform those who may have suffered serious health problems as a result of their treatment with the products of the legal options that may be available to them to seek compensation for medical costs and other expenses attributable to their condition,” said Resource4thePeople.

Resource4thePeople said these free consultations also are available for those who may have lost a loved one as a result of a cardiac problem allegedly caused by treatment with these products.

A data bank containing legal updates, medical research findings, media news and other information about NaturaLyte and GranuFlo also is available at the Resource4thePeople web site at: http://www.resource4thepeople.com/defectivemedicaldevices/Dialysis-Lawsuit.html

The affected products are manufactured by Fresenius Medical Care, which is cooperating with the FDA in the recall, according to the FDA announcement.

Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

According to the FDA, the affected NaturaLyte and GranuFlo Dry Acid concentrates were manufactured between January 2008 and June 2012 and 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.

“The importance of consumers contacting the FDA about problems that they may incur with drugs and medical devices also is a factor in keeping the FDA abreast of problems as well as informing the public because such complaints are registered by the FDA,” said Resource4thePeople.

Resource4thePeople notes that the FDA said it received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.

The FDA said this can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.

Health care professionals may not be aware that the dialysate acid concentrates can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis, according to the FDA.

These substances typically are found in acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate, the FDA said.

Resource4thePeople also is informing patients who may have been treated with the affected NaturaLyte and GranuFlo products that according to an internal Fresenius memo 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010.

These statistics and other facts about the case were revealed in a recent New York Times article that revealed that the FDA is investigating whether Fresenius, the nation’s largest operator of dialysis centers, violated federal regulations by failing to inform customers of these potentially lethal risks.**

The Times said that Fresenius treats more than a third of the estimated 400,000 Americans receiving dialysis and is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.

As the Times reported about the memo:

“Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.

“‘In light of these troubling findings,’ the memo said, doctors should take corrective action. ‘This issue needs to be addressed urgently,’ the memo added later.

“But Fresenius, which is based in Germany, did not immediately warn other centers that use the product, which is known as GranuFlo. It did so only in late March after the F.D.A. received, anonymously, a copy of the internal memo and questioned the company about it.”

Resource4thePeople is notifying consumers that the facts spelled out in the Times article show that when Fresenius determined that it had a serious problem with the NaturaLyte and GranuFlo products it only alerted its own physicians and medical directors about the issue
.
Resource4thePeople is concerned that there may be other dialysis patients and health care professionals who may not be aware of the FDA Class 1 Recall and said that it will continue to refer those who believe they may have been affected to these legal consultations.

“At the very least this Class 1 Recall raises serious concerns about the exposure to what the FDA has described as life-threatening problems with these products may have caused patients,” said Resource4thePeople.

sources:
*http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm309990.htm
**http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0

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Bill Callahan
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