Amanda Antell  |  December 12, 2013

Category: Legal News

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Yaz Blood Clot LawsuitMississippi plaintiff Lorene Armstrong is suing Fresenius Medical Care for the wrongful death of her brother, Henry Lee Jackson. Allegedly, in direct result of using GranuFlo and NaturaLyte, her brother died of sudden cardiac failure. He was 65 years old at the time of his death.

According to the GranuFlo/NaturaLyte lawsuit, Jackson was receiving GranuFlo and NaturaLyte dialysate for his kidney failure for the past several years. However, on Aug. 2, 2010, he started experiencing symptoms of a heart attack. Despite immediate medical efforts, Jackson died later that day.  Medical autopsy revealed that his potassium levels were very high, likely caused by elevated bicarbonate levels in his body.

The plaintiff and her family were made aware of the Class I recall of GranuFlo and NaturaLyte in 2012, revealing the possible connection between the decedent’s cardiac attack and the dialysate products. According to the GranuFlo lawsuit, there were no warnings or indications on the products’ label, and the company made no effort to notify the decedent.  Armstrong says that had the decedent been aware of these side effects, he never would have used the products. She is suing Fresenius for manufacturing, selling, distributing and marketing a dangerous product.

Overview of GranuFlo and NaturaLyte Complications

GranuFlo and NaturaLyte were approved for the U.S. market by the U.S. Food & Drug Administration (FDA) in 1994 and 2003 respectively. They are both manufactured by Fresenius Medical Care. This company is the largest dialysis treatment company in the world, with millions of clinics across the world, and 1,300 clinics in the United States.  Fresenius has become widely known for its dry dialysis concentrate, GranuFlo, which was once the most popularly-used dialysis product in the country. NaturaLyte is its liquid cousin, and was considered just as efficient.

Both of these dialysate products are used in dialysis procedures for patients with failing kidneys.  These concentrates are mixed in and diluted with liquid, and are then filtered into the patients’ bodies. These dialysates are composed of three fluids: ultrapure water, bicarbonate concentrate and acid concentrate. GranuFlo and NaturaLyte are unique dialysis concentrates because their bicarbonate components raise the body’s own bicarbonate levels in the blood. These elevated bicarbonate levels can cause potassium levels in the blood to rise, which leads the blood flow to slow down. In this environment, blood clots could potentially form, which could potentially lead to deadly GranuFlo/NaturaLyte complications such as stroke, heart attack, and sudden cardiac death.

On November 4, 2011, Fresenius sent out an email to their clinics and employed physicians, warning them of a study they had conducted. This study had found that these products could possibly cause sudden cardiac death and other GranuFlo/NaturaLyte complications in patients.  This memo was later leaked to the FDA, which eventually initiated a voluntary recall of GranuFlo and NaturaLyte in June 2012.

This GranuFlo/NaturaLyte lawsuit is labeled as Lorene Armstrong v. Fresenius Medical Care, Case No. 4:13-cv-00211-MPM-JMV, in the Circuit Court of Washington County, Mississippi.

File a GranuFlo or NaturaLyte Lawsuit Today

If you believe that you or a loved one have been the victim of a GranuFlo or NaturaLyte injury, you have legal options. Please visit the Kidney Dialysis Heart Attack GranuFlo and NaturaLyte Recall Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned GranuFlo or NaturaLyte lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The GranuFlo or NaturaLyte attorneys working this investigation do not get paid until you do.

 

 

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