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The maker of a recalled dialysis concentrate announced in December that it would stand by its product as lawsuits against the company make their way through the civil judicial process.

Considered by the U.S. Food and Drug Administration as a dialysis “medical device,” the administration announced in March 2012 that there would be a Class I recall of the Naturalyte and GranuFlo Dry Acid Concentrate, a mixture used “in the treatment of acute and chronic renal failure during hemodialysis.”

The Class I designation is “the most serious type of recall and involve[s] situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the FDA.

The FDA explained in its March 2012 recall announcement that the device manufacturer, Fresenius Medical Care North America, was “cautioning clinicians” that “[i]nappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” which may trigger risk factors culminating in “cardiopulmonary arrest.”

The manufacturer’s caution came several months after the corporation’s medical staff disseminated crucial information in regard to the cardiopulmonary arrest risk.

What did the brass know and when did the leadership know it? The device, which was manufactured and distributed from January 2008 through June 2012, was recalled after a Fresenius medical personnel memorandum dated Nov. 4, 2011, surfaced that advised medical directors and attending physicians to make individualized adjustments to the treatment regimen of Naturalyte and GranuFlo patients. The purpose of the change was to avert an increased risk of “[cardiopulmonary arrest] and sudden cardiac death in the dialysis facility.” The memorandum referred to a case-control study that examined the risk factors of 941 dialysis patients in 667 facilities who had suffered cardiopulmonary arrest during treatment in 2010. Nothing sweepingly changed until FDA officials obtained a copy.

Contrary to claims contained in numerous wrongful death GranuFlo lawsuits, the manufacturer issued a statement Dec. 13 that read, in part, “The company’s actions related to these products were appropriate and responsible. Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago.”

Not so fast. It has been re-written before in this space, and let the light shine here, again: “Top FMC officials knew about the potential problems since the product’s launch in 2003. Around 2010, they were fully aware of the hazards and clinical problems that existed,” according to an Aug. 30, 2012, blog by Michele Van Almelo, one of the hard-working members of the GranuFlo litigation team at Reich & Binstock [].

Those who have suffered cardiopulmonary injury, and the family members of those who did not survive the complications, may want to take advantage of a free consultation with one of the GranuFlo attorneys at Reich & Binstock. For nearly 30 years, the experienced personal injury attorneys at Reich & Binstock have been trying pharmaceutical injury cases and fighting for the rights of those who have been victimized by defective medical devices. Reich & Binstock operates in all 50 states. The firm may be reached toll-free at 1-866-LAW-2400.

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