GranuFlo and NaturaLyte are two popular concentrates made by Fresenius Medical Care and used in dialysis treatment for those who suffer from chronic kidney failure, which affects approximately 2 million people worldwide. However, these dangerous medical products have also been linked with the onset of metabolic alkalosis, a condition that increases the risk of potentially fatal cardiovascular injuries.

On March 29, 2012, the Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte; Class I is the highest-priority recall that can be requested by the FDA, and it is reserved for circumstances in which “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Houston injury attorney Tony Malley has extensive experience in product liability cases and helping defective medical product victims from Texas and across the United States pursue the financial compensation they need for medical costs, lost earnings, pain and suffering, and other damages.

GranuFlo and NaturaLyte are added to dialysis solutions in order to generate bicarbonate, an alkaline substance that neutralizes excess acid in the bloodstream and helps replicate kidney function. But GranuFlo and NaturaLyte have been found to elevate bicarbonate to levels greater than other dialysis additives, which can lead to metabolic alkalosis, a condition that can contribute to severe cardiovascular problems including:

• Cardiac arrhythmia
• Cardiac arrest
• Cardiopulmonary arrest
• Heart attack
• Low blood pressure
• Diminished potassium in the blood
• Diminished oxygen in the blood
• Excess carbon dioxide in the blood

Many of the complications associated with GranuFlo and NaturaLyte are the result of dosage errors by doctors and other medical professionals, who were not made aware that these dialysis ingredients could lead to dangerously high levels of bicarbonate.

As reports of side-effects linked to GranuFlo and NaturaLyte increased, so did evidence that Fresenius knew about the potentially deadly complications. A company memo from Nov. 4, 2011, referenced a study that detailed nearly 1,000 patients who suffered cardiopulmonary arrest after being administered GranuFlo or NaturaLyte via dialysis treatment.

Although the Fresenius warned its partner clinics about how to avoid dosage errors, the company neither published the findings of this study nor warned nonaffiliated medical facilities about the risks. The information about the health complications linked to GranuFlo and NaturaLyte did not become public until the FDA received a copy of the memo in early 2012. The failure of Fresenius to disclose the dangers of these products has resulted in hundreds of thousands of patients in the United States alone being placed at risk.

If you were harmed or a family member died from complications related to GranuFlo or NaturaLyte, please contact the Malley Law Firm for your free case consultation. Mr. Malley is proud to serve clients from the Houston and Beaumont, Texas, areas and nationwide.