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South Carolina Resident Files Lawsuit Against Manufacturer of GranuFlo and Naturalyte

SC Man Files Lawsuit Against Fresenius for GranuFlo Complications and Wrongful Death

Clarence Lee Dubose, Jr, a South Carolina resident, filed a lawsuit on December 11, 2012, individually and on behalf of his father, Clarence Lee Dubose, who died because of complications related to using GranuFlo and Naturalyte in his dialysis treatment.

Fresenius Medical Care, the defendant in the case, manufactures GranuFlo and Naturalyte and, until recently, distributed the products both to dialysis centers in their network, as well as hospitals outside their network who wished to purchase the products for use with their dialysis machines. According to plaintiffs in other cases against Fresenius, an internal memo in 2011 ordered Fresenius’s clinics to stop using GranuFlo and Naturalyte, due to an increased risk of heart failure. However, the FDA and outside hospitals never received notice of the products’ complications, so many other providers continued to use the unsafe product.

Clarence Lee Dubose, Jr’s case clearly indicates that GranuFlo and Naturalyte were related to his father’s wrongful death. His case was filed in the US District of Massachusetts, specifically alleging breach of warranties, strict liability, and negligence. The plaintiff states that Fresenius actually knew about GranuFlo and Naturalyte’s complications prior to 2005; the internal memo was not issued until 6 years later.

Mr. Dubose’s Wrongful Death Due to GranuFlo and Naturalyte

The deceased, Clarence Lee Dubose, underwent dialysis treatment at a Fresenius Center in Darlington, South Carolina. The clinic used GranuFlo and Naturalyte for years before the internal memo was issued, and Mr. Dubose received treatment at the center beginning on September 19th, 2009. During one of his dialysis treatments, Dubose went into cardiac arrest, and was rushed to a hospital. There, he was pronounced dead due to cardiopulmonary arrest.

GranuFlo and Naturalyte are made differently from other dialysis products. GranuFlo adds acetic acid and sodium acetate to the final dialysate solution, which results in more bicarbonate in the blood than other formulas, which only use acetic acid. Doctors can compensate by lowering the dose, but many were unaware of the difference because Fresenius did not warn them.

Too much bicarbonate in the blood can cause metabolic alkalosis, which means the blood is too alkaline. Alkaline blood contributes to cardiac arrest and a higher risk of heart complications.

The Strom Law Firm Accepts Cases About GranuFlo and Naturalyte

The FDA issued a Class I Recall – the most urgent possible recall – of GranuFlo and Naturalyte powders, due to the risk of cardiac arrest. Per the FDA’s website: “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.”

If you are one of these patients, or the loved one of a patient who has received dialysis with GranuFlo and Naturalyte, the Strom Law Firm can help. Our attorneys offer free, confidential consultations to discuss the facts of your case. Do not hesitate to contact us if you have been harmed by a defective drug or medical device. 803.252.4800.



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