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Georgia Man Files GranuFlo Wrongful Death Lawsuit

November 12, 2012 — An increasing number of individuals and families are filing lawsuits against Fresenius Medical Care, the company responsible for GranuFlo, a dialysis treatment product. The latest lawsuit has been filed in Georgia by Harold Bolton Jr., son of Harold Bolton Sr., a man who died of a sudden heart attack after being given GranuFlo at a Fresenius dialysis clinic. The problem is that GranuFlo is associated with an increased risk of bicarbonate overdoses, sudden heart attacks, cardiac arrest, and hundreds of deaths.

The plaintiff in the lawsuit had been undergoing kidney dialysis since 2006. On October 24, 2010, he was given GranuFlo during dialysis treatment. On October 26, he died from a sudden heart attack.

The 2-day time delay highlights the risk of injuries that occur after a patient undergoes dialysis treatment. Once a patient is treated with GranuFlo, the liver metabolizes an ingredient in GranuFlo into bicarbonate. If the patient’s bicarbonate levels get too high, it can change the pH of the body and interfere with electrical activity in the heart. This can trigger a sudden, deadly cardiovascular event.

According to the lawsuit, GranuFlo is “unreasonably dangerous and therefore, defective.” Bicarbonate overdoses can cause a condition called metabolic alkalosis, which is associated with low blood pressure, irregular heart rhythm, cardiopulmonary arrest, cardiac arrest, heart attack, and death.

The lawsuit also alleges that Fresenius did not adequately warn about these risks. The complaint cites an internal memorandum from November 4, 2011, which Fresenius sent to their doctors after learning of 941 deaths at their clinics in 2010. The memo warned about the risk of dosing errors associated with GranuFlo. Furthermore, they warned that “borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with 6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility.”

The lawsuit alleges that Fresenius was negligent because they did not sent the memo to the FDA or doctors at other clinics who were using GranuFlo. In fact, the FDA only received the memo after it was leaked by an anonymous source. In March 2012, the FDA confronted Fresenius executives, who responded by quickly sending an Urgent Product Notification to non-Fresenius doctors who were using GranuFlo. However, they did not stop selling GranuFlo until June 2012, when the FDA ordered a Class 1 recall.

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