The Brad Hendricks Law Firm, a full-service law firm located in Little Rock, Arkansas, is investigating claims of severe complications associated with the of GranuFlo® and NaturaLyte® Dry Acid Concentrate during hemodialysis treatments. The use of these products has been linked to a significant increase in the risk of cardiopulmonary events, including cardiac arrest and even death. On March 29, 2012, the United States Food and Drug Administration announced that it was recalling Naturalyte Liquid and Granuflow Dry Acid Concentrate, both of which are manufactured by Fresenius Medical Care North America. The recall was identified as a Class I recall for Naturalyte and Granuflo, “the most serious type of recall,” which are appropriate when the FDA determines “there is a reasonable probability that use of a product will cause serious adverse health consequences or death.”
The concentrate, formulated for use with a three-stream hemodialysis machine, has been recommended for the treatment of acute and chronic renal (kidney) failure in patients undergoing dialysis treatments. According to the FDA, the concentration of acetate or sodium diacetate contained in Fresenius’ Naturalyte Liquid and GranuFlo Dry Acid Concentrate, when improperly administered, can lead to a high serum bicarbonate level in dialysis patients which may contribute to “metabolic alkadosis.”
Metabolic alkadosis, the FDA warns, is a significant risk factor associated with the following:
If not properly treated, cardiopulmonary arrest or even death may result. In fact, cardiac death has been identified as the leading cause of death of dialysis patients.
Reports suggest that FMC officials knew that high pre-dialysis serum bicarbonate levels increased patients’ risk of cardiac arrest and death at all times, but they continued to market Naturalyte and GranuFlo anyway. What’s worse, FMC continues to market the products, placing hundreds of thousands of patients undergoing dialysis at any of the thousands of dialysis clinics across the country at risk.
If you or a loved one has suffered any of the side effects listed above, including cardiac arrest, while undergoing dialysis, and you believe that Naturalyte or GranuFlo may have contributed to your injuries, please call The Brad Hendricks Law Firm today at (501) 221-0444 or (800) 603-5100 for a free consultation with an experienced team of lawyers and professionals. You can count on us to make sure you are compensated for your injuries.
The Brad Hendricks Law Firm proudly serves clients throughout Arkansas, including Arkadelphia, Benton, Conway, El Dorado, Fayetteville, Fort Smith, Hot Springs, Jonesboro, Little Rock, Pine Bluff, Texarkana, and West Memphis as well as numerous counties throughout the State of Arkansas, including Arkansas County, Baxter County, Benton County, Bradley County, Calhoun County, Clark County, Columbia County, Conway County, Crittenden County, Faulkner County, Garland County, Hempstead County, Hot Spring County, Izard County, Lawrence County, Lonoke County, Monroe County, Nevada County, Pike County, Poinsett County, Polk County, Pope County, Prairie County, Pulaski County, Saline County, Sharp County, Stone County, Washington County, White County, Woodruff County, and Yell County, and all other counties in the State of Arkansas.
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