By Sarah Mirando  |  September 7, 2012

Category: Pharmaceuticals

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Dialysis Heart Attack Victims to Sue Following Fresenius GranuFlo Recall

By Sarah Pierce

 

GranuFlo recall lawsuitIn light of the recent Fresenius GranuFlo recall that affects some 260,000 dialysis patients, many are asking if their, or their loved one’s, heart attack or death during dialysis treatment could have been caused by the recalled product. Fresenius Medical Center is the largest dialysis services and products company in the world, and has treated hundreds of thousands of kidney patients in thousands of FMC clinics across the country.  If you or a loved one received hemodialysis treatment in the U.S., chances are you may have been treated at an FMC clinic and/or with GranuFlo or NaturaLyte, the other recalled Fresenius dialysis product.

On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte, the most serious type of recall that involves situations where there is a reasonable possibility that a product will cause adverse health consequences – or death. The FDA announced it is investigating whether Fresenius violated federal regulations by failing to inform the public of a potentially lethal risk in using its GranuFlo and NaturaLyte dialysis treatments. Evidence shows Fresenius knew as early as 2011 that these dialysis products were dangerous, but concealed this information from the patients and the medical community until March 2012, when it was forced by the FDA to warn the public.

The FDA recall of GranuFlo and NaturaLyte was initiated after the FDA received a leaked internal FMC memo from an anonymous source showing that top executives were aware of a Fresenius conducted case-control study that identified 941 hemodialysis patients had died of cardiopulmonary arrest in hundreds of FMC facilities between January 1 and December 31, 2010.  The study found that the patients’ risk of cardiopulmonary arrest, or heart attack, was up to six times higher if they had an elevated pre-dialysis bicarbonate level.

Other GranuFlo side effects and NaturaLyte side effects may include:

* Cardiopulmonary arrest
* Heart problems
* Metabolic alkalosis
* Low blood pressure
* Sudden heart attack
* Heart arrhythmia
* Stroke
* Death

Hundreds of patients undergoing dialysis or hemodialysis treatment have died after being administered GranuFlo or NaturaLyte, and their families may not even know their dialysis treatment was the cause. If your loved one suffered cardiopulmonary arrest, heart attack, heart problems, stroke or death during or after receiving dialysis treatment, a dialysis injury attorney can review your case for free to determine if GranuFlo or NaturaLyte was the cause.

Failing to warn patients of a drug’s known risks is against the law, and Fresenius Medical Center knowingly broke the law and put hundreds of thousands of dialysis patients at risk for death by not advising health officials about the dangerous side effects of GranuFlo and NaturaLyte.

Get a free legal review of your case by visiting the Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. An experienced dialysis injury lawyer is standing by to review your claims to see if you have a case to seek compensation from Fresenius for negligence, failure to warn, breach of warranty, wrongful death and other claims by filing a dialysis heart attack lawsuit, GranuFlo lawsuit, NaturaLyte lawsuit or class action lawsuit.

 

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Updated September 7th, 2012

 

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One thought on Dialysis Heart Attack Victims to Sue Following Fresenius GranuFlo Recall

  1. Anonymous says:

    You Can Contact Me I have a few Question 201-463-7639

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