Internal company documents show that Fresenius’s doctors grew concerned about GranuFlo’s impact on bicarbonate levels as far back as 2001. Dr. Michael Lazarus, Fresenius’s Chief Medical Officer, relayed a message to the company’s technical team on March 23, 2001 about the “[apparent] confusion regarding bicarbonate delivery in the labeling on bicarbonate and acid concentrate products.” He wrote that dialysis staff “must” examine patient bicarbonate levels during treatment. This plea from the company’s top doctor, however, was never shared with Fresenius’s clinics or with any dialysis clinics that used GranuFlo.

As the years passed, the company accumulated more and more internal evidence that GranuFlo might be doing very bad things to some patients. By the end of 2004, for instance, the company clearly understood the following:

Patients with high serum bicarbonate levels were at much greater risk of dying from heart attacks and other mortality risks;

• Pre-dialysis alkalosis was a very dangerous condition – perhaps even more dangerous than the universally feared condition (at least in the dialysis industry) of mild acidosis;
• Many GranuFlo patients experienced high bicarbonate levels before and after dialysis – in addition to metabolic alkalosis.

Remember: the company knew this way back in 2004. Yet Fresenius did not share its insights about the dangers of its product with patients, doctors, technicians or the FDA.

And so on and on the cycle went: the company learned potentially damning information about GranuFlo, brushed it under the rug, and continued with business as usual. Repeat as needed.

How did this cycle wind up? How come no regulatory bodies put a stop to it? The intriguing story continues in the next post. For immediate help with your GranuFlo case, call Davis & Crump at 800-277-0300 or email us at info@daviscrump.com for a confidential case evaluation.

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