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FDA Investigates Fresenius’ Failure to Warn on GranuFlo and Naturlyte Dangers

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

On June 27, 2012 the FDA issued aClass I recall for two Fresenius dialysis products: Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo Acid Concentrate. Yet the most alarming and sobering news is that the FDA is now investigating Fresenius for its failure to warn and act on the information it knew back in 2011 that people were dying at an alarming rate due to cardiac arrest instigated by these products.

The company’s conduct has been brought into question due to discovered internal memorandum, dated on November 4, 2011 as originally reported by the New York Times. There are various bicarbonate levels in the blood of patients who use Naturalyte and GraunFlo in dialysis treatments. Because of this, the Fresenius memorandum concluded that these patients had a six-fold increase in the likelihood of having a heart attack.

Of note, Fresenius treats approximately 1/3 of the 400,000 Americans on dialysis. Approximately 941 people died from heart attacks after taking GranuFlo and Naturalyte in 2010. Clearly its products have the potential to affect the health of huge population of patients in this country. Thus, Fresenius has great responsibility as a manufacturer of medical products affecting so many vulnerable people.

But despite the troubling data highlighted in the November 2011 memorandum, Fresenius chose to sit on this information and not act. It was not until March 2011, after the FDA received an anonymous copy of the memorandum, did Fresenius finally begin to take steps to warn the general public. Such reckless behavior indicates that Fresenius favored corporate greed over the right thing to do.