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Texas Dialysis Lawsuit Filed for Granuflo, Naturalyte Death

January 22, 2013 — The family of a man who died during dialysis treatment has filed a wrongful death lawsuit against Fresenius USA, the manufacturer of two dialysis treatment products that have been linked to the man’s death. The 68 year-old man, Santos Pena Hernandez, was treated with the dialysis products Granuflo and Naturalyte while undergoing dialysis treatment at a Fresenius clinic in Lubbock, Texas. He subsequently suffered a sudden cardiac arrest and died on January 17, 2011. The lawsuit was filed by Mr. Hernandez’s wife in the U.S. District Court for the District of Massachusetts.

The problem with Granuflo and Naturalyte is that they have been linked to hundreds of cases of severe injury, disability, or death. According to an internal memo written by Fresenius, in 2010 there were 941 deaths at their clinics — an unusually high number. Many deaths were attributed to overdoses of Granuflo and Naturalyte. Fresenius researchers also determined that their patients’ pre-dialysis bicarbonate levels tended to rise over time, and this risk factor was associated with a 6-fold increased risk of cardiac arrest and death.

Fresenius sent the internal memo to their own doctors in November 2011, but they did not send it to the U.S. Food and Drug Administration (FDA) or doctors at other dialysis clinics who were also using Granuflo and Naturalyte on their patients. In fact, the FDA only became aware of the memo in early 2012, when an anonymous source leaked it publicly.

Granuflo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate are designed to balance the acidity in a dialysis patient’s blood. They are typically combined with a bicarbonate concentrate. Unfortunately, one of the acid ingredients in Granuflo and Naturalyte is converted into “extra” bicarbonate by a patient’s liver. When a doctor measures the dose of Granuflo, Naturalyte, and the bicarbonate concentrate, he or she must compensate for the “extra” bicarbonate. If the dosage is not adjusted properly, the patient can easily suffer a bicarbonate overdose, metabolic alkalosis, sudden cardiac arrest, and death.

Fresenius is currently facing a mounting litigation alleging that the company did not do enough to place proper warnings on the products, and when risks were identified, they did not take adequate steps to immediately warn the FDA, doctors, or patients about the life-threatening risks. The U.S. Judicial Panel on Multi-District Litigation (JPML) is scheduled to hear oral arguments concerning consolidation of the litigation into a Multi-District Litigation (MDL) in March 2013.

Do I have a Dialysis Injury Lawsuit?

The Schmidt Firm, PLLC is currently accepting dialysis induced injury cases in all 50 states. If you or somebody you know has been injured by Granuflo or Naturalyte side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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