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GranuFlo Cardiac Arrest Lawsuit Filed Against Fresenius

A resident of Pennsylvania filed a GranuFlo heart attack lawsuit on June 28, 2013 against Fresenius Medical Care Holdings. The complaint is a wrongful death lawsuit; the plaintiff, Lawrence Harbaugh, is representing the estate of his wife, Carolyn Harbaugh, deceased. The case is currently proceeding in the Superior Court in Suffolk County, Massachusetts.

Decedent suffered GranuFlo cardiac arrest

The defendants designed and manufactured the products known as GranuFlo and NaturaLyte for use in hemodialysis. Hemodialysis is a treatment for kidney disease that filters and removes waste products from the body. The decedent underwent these treatments on a routine basis. On June 29, 2011, Carolyn Harbaugh attended her hemodialysis appointment at a Fresenius clinic and received GranuFlo. Subsequently, she suffered from cardiac arrest and was transported to a hospital by emergency service personnel.

The decedent remained on life support until she passed away 10 days later, on July 8, 2011. According to this GranuFlo heart attack lawsuit, the plaintiff is deprived of the company of his wife because of the defendants’ defective medical products, rather than because of her kidney disease.

High levels of bicarbonate pose dangers

Patients with kidney disease are not only unable to adequately filter waste products from the body, they also frequently suffer from excessive levels of acid in the body, a condition called metabolic acidosis. Dialysis treatments involve the administration of a base substance called bicarbonate and an acid concentrate. The acid concentrate reacts with the bicarbonate and the liver converts it into additional bicarbonate.

GranuFlo is different from other hemodialysis products because it is a dry acid powder, rather than a liquid. This means that it is more highly concentrated. It also contains sodium diacetate, unlike other acid concentrates, which creates a different reaction and substantially increases the amount of total bicarbonate in the body. Patients using GranuFlo receive 8 mEq/L more bicarbonate buffer as compared to similar products.

This excess amount of bicarbonate puts the patient at risk of developing metabolic alkalosis, which increases the risk of adverse GranuFlo side effects including cardiac arrest and sudden cardiac death. It also places patients at an increased risk of heart attack, coma, seizure, hypotension, electrolyte imbalances, and other potentially fatal conditions.

Defendants allegedly knew of risks

GranuFlo was first marketed and distributed in 2003. Since then, it has become the most commonly used product of its type. The defendants launched their marketing initiatives claiming that GranuFlo was both effective for pH balance and safe. According to Harbaugh’s lawyer, the defendants said GranuFlo was “the safest dry acid product” and that it was backed by “superior clinical outcomes.”

However, despite these claims, Fresenius Medical Care is alleged to have known of the significant risks involved with GranuFlo as early as 2001, before the product was marketed. Furthermore, a 2010 study by Fresenius examined the incidence of sudden death and cardiac arrest among patients. These results were distributed in an internal memo in 2011. They confirmed that patients were six to eight times more likely to suffer cardiac arrest when using GranuFlo and NaturaLyte. However, this information only became publicly known when the memo was leaked.

The plaintiff in this GranuFlo lawsuit requests compensatory damages in excess of $2,000,000 for failure of the company to warn patients and healthcare providers of the significant risks involved with GranuFlo.