Fresenius Hit With GranuFlo/NaturaLyte Wrongful Death Lawsuit

North Carolina plaintiff Ada Harbison is suing Fresenius Medical Care for the wrongful death of her husband, James Harbison, alleging that in the defendant’s dialysis products, GranuFlo and NaturaLyte, caused the heart attack that took his life.

Mr. Harbison was using GranuFlo and NaturaLyte as part of his dialysis treatment, which was necessary due to kidney failure. The two additives were used regularly and administered by a medical professional. The last session before his death had been no different.

On May 8, 2008, Mr. Harbison had gone through routine dialysis procedure but had suffered sudden cardiopulmonary arrest, or sudden heart attack, during the dialysis procedure. He ultimately died from the heart attack, despite emergency medical intervention.

Mrs. Harbison is filing this GranuFlo lawsuit on his behalf, asserting that Fresenius should have warned them about the heart attack risk and the possibility of death.

However, there were no warnings or indications on the GranuFlo’s or NaturaLyte’s labels, nor were there any special instructions for the administrators to follow. Additionally, Fresenius failed to notify Mr. Harbison, Mrs. Harbison as well as the physicians overseeing the treatment of any dangers linked to the dialysis additives.

The GranuFlo drug maker also failed to point out any relevant studies that may have hinted at any dangers. Mrs. Harbison states that if her husband had known about the possibility of sudden cardiac death, he never would have used the products.

Mrs. Harbison alleges that Fresenius is directly responsible for manufacturing, selling, distributing, and marketing a dangerous product. Her charges against the GranuFlo/NaturaLyte drug maker include negligence, false advertising, concealing information and misrepresenting a product.

Overview of GranuFlo and NaturaLyte Complications

Fresenius Medical Care is the largest dialysis business in the world, with 1,800 established clinics across the United States. This company provides dialysis treatment to millions of patients around the world, employing millions of doctors, nurses and medical experts. This company is most famous for their dialysate products: GranuFlo and NaturaLyte, which are used in the event of kidney failure.

GranuFlo and NaturaLyte were approved by the U.S. Food and Drug Administration in 2003 and 2007 respectively, and have since become the most popular dialysates in the country.

GranuFlo is a dry dialysate concentrate that is designed to dissolve into the treatment fluid that is to be pumped into the patient. NaturaLyte is its liquid counterpart and is diluted down before administration. Both of these products are used to treat kidney failure through hemodialysis, which is the process of cleaning the blood.

Dialysate is often composed of three ingredients — ultrapure water, bicarbonate concentrate and acid concentrate. These ingredients work together to increase the patient’s bicarbonate level, which encourages the filtering process in the body.  However, during this process, the body’s pH levels rise significantly, which causes the blood flow to slow down.  This can lead to varying complications such as sudden cardiac death, stroke, or heart attack.

Fresenius allegedly knew about this design flaw, but had taken active measures to conceal it.  In 2011, an internal memo from Fresenius was leaked to the FDA, which warned Fresenius-employed doctors and clinics that GranuFlo and NaturaLyte may increase the risk of sudden cardiac death in patients.

Fresenius had conducted an in-house study, which observed these products interacting with the patients and  found that over 900 deaths occurred.

This caused the FDA to issue a first-class product recall in 2012, warning patients of these dangerous possibilities.

GranuFlo and NaturaLyte Litigation Movement

The GranuFlo lawsuit is Ada Harbison v. Fresenius North America, et al., Case No. 1:14-cv-10503-DPW, in the U.S. District Court of Massachusetts.

The GranuFlo MDL, where dozens of product liability lawsuits have been consolidated, is In Re: Fresenius GranuFlo/NaturaLyte Dialysate Product Liability Litigation, MDL No. 2428, in the United States District Court of Massachusetts.

File a GranuFlo or NaturaLyte Lawsuit Today

If you or a suffered from a sudden heart attack following kidney dialysis in which GranuFlo or NaturaLyte were used, you have legal options. For more information, check out 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.