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Dialysis Heart Attack Lawsuits Expected Following NaturaLyte/GranuFlo Recall
By Sarah Pierce
On June 27, 2012 the U.S. Food and Drug Administration (FDA) issued a Class 1 Recall of two popular dialysis concentrates, GranuFlo and NaturaLyte, which were used to treat hundreds of thousands of kidney patients undergoing hemodialysis. The GranuFlo recall was issued after the FDA was leaked internal memos showing the manufacturer, Fresenius Medical Care, was aware that GranuFlo and NaturaLyte had caused 941 deaths at its clinics in 2010 alone, and had received hundreds of reports of dialysis patients suffering cardiac arrest, heart attack, metabolic alkalosis, cardiopulmonary arrest, stroke and other side effects. Many of these dialysis patients and their families are unaware that their dialysis treatment is to blame for their injuries or death, and may not realize they were given GranuFlo or NaturaLyte during their hemodialysis.
As news of the GranuFlo and NaturaLyte recall reaches these victims, lawyers expect thousands of GranuFlo recall lawsuits to be filed accusing Fresenius of failing to warn the public about the serious safety risks of these dialysis treatments. People who suffered or have a loved one who suffered a heart attack, stroke or death following dialysis treatment are urged to contact a GranuFlo attorney to see if these injuries were caused by GranuFlo or NaturaLyte. If they were, you may have a case to seek compensation for these injuries through a NaturaLyte/GranuFlo recall lawsuit settlement.
2012 GranuFlo Recall Details
Fresenius Medical Care (FMC) is the largest dialysis services provider in the world and treats more than a third of all Americans receiving dialysis. It is also the leading supplier of dialysis machines and disposable products to an estimated 3,300 dialysis clinics, servicing approximately 260,000 dialysis patients. Many kidney dialysis patients have received GranuFlo or NaturaLtye without even knowing it and suffered side effects they didn’t know were caused by their dialysis treatment.
On March 29, 2012, about a month before the NaturaLyte/GranuFlo recall, Fresenius issued an Urgent Product Notification warning that GranuFlo and NaturaLyte dialysis products are associated with elevated bicarbonate levels, a significant risk factor for cardiac arrest and death. The warning indicated that both GranuFlo and NaturaLyte contain acetate, which when combined with a patient’s regular prescription, could lead to a bicarbonate overdose.
However, according to The New York Times, Fresenius knew as early as November 2011 — four months before notifying the public about this risk — that GranuFlo and NaturaLyte can lead to dosing errors and cause life-threatening side effects in dialysis patients.
On June 27, 2012, the FDA issued a recall of GranuFlo and NaturaLyte and launched an investigation into Fresenius due to concerns that the company failed to warn the public about the risks of these dialysis treatments in a timely manner.
Thousands of GranuFlo Recall Lawsuits Expected
FMC’s failure to warn to the public and medical community about the dangers of GranuFlo and NaturaLyte will likely lead to thousands of product liability lawsuits, GranuFlo lawyers say. Federal law requires companies to warn the public about defective or dangerous products and medical devices as soon as they become aware of their risks. Internal memos show top Fresenius executives knew about the increased risk of cardiac arrest and death associated with GranuFlo and NaturaLyte for more than a year before alerting the public and FDA.
A patient who was injured during dialysis treatment may be entitled to compensation for FMC’s breach of duty, failure to warn and defective manufacturing.
If you or a loved one suffered a heart attack, cardiopulmonary arrest, heart problems, metabolic alkalosis, low blood pressure, heart arrhythmia, stroke or death after receiving dialysis treatment, you may have a case to seek compensation through a GranuFlo lawsuit, NaturaLyte lawsuit or GranuFlo/NaturaLyte class action lawsuit settlement.
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Updated September 4th, 2012
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