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On November 4th, 2011 the pharmaceutical company Fresenius sent an internal memo to its doctors practicing in the company’s many dialysis centers across America, warning them that failure to properly use one of their own products, Granuflo*, appeared to lead to a dramatic increase in the risk of cardiac arrest. In very specific terms, the internal memo stated that their company had discovered that 941 patients in 2010 had suffered cardiac arrest – inside their own Fresenius clinics! Furthermore, after comparing these patients with others who did not use Fresenius’s Granuflo, the company’s medical staff found that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest compared to patients with lower levels of bicarbonate. This is important information to know because, if Granuflo does anything, it produces bicarbonate.
Used to treat patients with acute kidney damage, Granuflo is a medical liquid used in dialysis to help the kidney clear toxic waste from the blood. Part of this cleaning process involves the introduction of the alkaline substance bicarbonate to help neutralize acid buildup in the blood. Too little bicarbonate in the dialysis liquid, and acids builds up in the blood; too much bicarbonate in the dialysis liquid and the patient overdoses on bicarbonate, initiating cardiac problems. It might sound like a fine line that doctors have to negotiate between treating their patients adequately and over-treating their patients. That’s because it is –but only for doctors prescribing Granuflo. That’s because competing medicines use a formula with significantly decreased levels of bicarbonate. In fact, the levels are so low that often bicarbonate is prescribed in addition to the patient’s dialysis treatment.
As the Fresenius internal memo sent on November 4th, 2011 stated, doctors who prescribe Granuflo must account for the extra bicarbonate in Granuflo; that way, when doctors prescribe patients bicarbonate separately, they prescribe an amount that avoids, instead of causes, heart problems.
Yet, even after November 2011 many doctors still did not account for this extra bicarbonate buildup from Granuflo.
Because, astoundingly, the internal Fresenius memo never became public, was never sent to doctors in non-Fresenius dialysis centers and was never shared with the patients themselves. In short, Fresenius is a huge company that treats more than one- third of the estimated 400,000 Americans receiving dialysis. In addition, Fresenius is also a leading supplier of dialysis machines, used by many clinics. But these additional clinics were never warned and the non-Fresenius doctors, and their patients, were left in the dark.
We’re not talking about a few misplaced patients here and there. Instead, we’re talking around 125,000 patients – that’s the number that RenalWEB, a website devoted to dialysis (that was one of the first sites to report on the controversy surrounding the Fresenius internal memo), estimates to comprise all of the patients in non-Fresenius clinics treated with Granuflo.
As the internal memo says: “this issue needs to be addressed urgently." And: doctors must take corrective action, "in light of these troubled findings."
Once an anonymous copy of the internal memo was sent to the F.D.A, questions ensued and Fresenius finally began to alert its entire Granuflo consumer base.
But until that moment, it was the patients (and certainly not the Fresnius executives) who were surprised by the onslaught of heart attacks.
To learn more about Granuflo and the Granuflo lawsuit, visit our page here: //baronandbudd.com/dangerous-drugs-devices/pharmaceuticals//granuflo-lawyer/