Pennsylvania Woman Sues Fresenius for Mother’s Wrongful Death

Pennsylvania Woman Sues Fresenius for Mother’s Wrongful Death

By Amanda Antell

Pennsylvania plaintiff Pamela Dawkins is suing Fresenius Medical Care for the wrongful death of her mother, Beverly Dawkins. The plaintiff states that her mother died as a consequence of using the dialysis products GranuFlo and NaturaLyte.

The decedent had been using GranuFlo and NaturaLyte to treat her failing kidneys in dialysis procedures. However, on September 30, 2006, the decedent had undergone a routine treatment with the same dialysis products. During the dialysis treatment session, the decedent suffered a sudden attack of cardiac arrest, and died the same day.

Until the point of the announcement, Dawkins and her mother had relied on the information given to them by the company’s website and the products’ warning labels, none of which mentioned sudden cardiac attack as a possible side effect. Additionally, their physician prescribing the dialysis products was also not aware of this possibility, nor did the company make any effort to notify them.

Dawkins states that Fresenius had either known or should have known about these possible side effects, and had the responsibility to warn her, her mother, and the other dialysis patients who use their products. So for being directly responsible for manufacturing, selling, distributing, and marketing a dangerous product, Dawkins is suing Fresenius Medical Care for negligence. Other charges include misrepresenting a product, false advertising and concealing information.

Overview of GranuFlo Complications

GranuFlo and NaturaLyte were approved for the U.S. market by the FDA in 2003. They are designed and engineered to be a dry and wet dialysis concentrate respectively, to be used in dialysis procedures for patients with failing kidneys. These concentrates are often combined with liquid and is directly filtered into the patients’ bodies to clean their blood. These dialysis mixtures (dialysates) are composed of three fluids: Ultrapure water, bicarbonate concentrate, and acid concentrate.

GranuFlo and NaturaLyte are unique amongst dialysis concentrates because it uses sodium diacetate, which doubles the amount of acetate in the mixture compared to other formulations made with acetic acid. This means that the bicarbonate levels in the blood are raised exceptionally higher than they normally would in a treatment session, which causes potassium levels in the blood to raise, which causes the blood flow in the body to slow down. This allows for blood clots to form, leading to deadly complications such as stroke, heart attack, and sudden cardiac death.

Despite how crucial this scientific information is, it has been discovered that Fresenius had made an effort to actively conceal the information regarding the side effects of these products. On November 4, 2011, Fresenius sent out an email to their clinics and employed physicians, warning them that these products could possibly cause sudden cardiac death and other complications in patients. This memo was subsequently leaked to the FDA, which prompted their own investigation, which eventually initiated a voluntary recall of GranuFlo and NaturaLyte in June 2012. This recall officially pulled GranuFlo and NaturaLyte from the U.S. market, with the FDA detailing the side effects associated with this product.

GranuFlo and NaturaLyte Litigation Movement

While this recall and announcement are helpful, they have come too late for many dialysis patients. This has led to a multidistrict litigation (MDL) movement against Fresenius, detailing similar cases to Dawkins’. These include injury reports and wrongful deaths; at this time, Dawkins has had her case join an MDL in Massachusetts.

In Re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation, MDL No. 1:13-md-02428-DPW, in the United States District Court of Massachusetts.

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.