The GranuFlo Lawsuit: Did Fresenius Just Not “Get” the Memo?

August 28, 2013  |  Dangerous Drugs & Devices, Pharmaceuticals

The popular dialysate GranuFlo, used in countless dialysis centers across America, has been linked to an increased risk of heart attacks. This news came as a shock to many patients and doctors. Some patients were able to adjust their treatments before the dangerous side effects hit them; some were not. But no one knew beforehand – or so we thought.

Turns out an internal memo was sent out by the manufacturer of GranuFlo, Fresenius Medical Care, months before the general population (not to mention dialysis patients) became aware of the dangers thanks to an anonymous leak of the Fresenius internal memo to the Food and Drug Administration (FDA).

The leak led to an FDA alert – and with that we became aware that GranuFlo contains more bicarbonate than other dialysates in its class – a fact the internal memo already knew.

We became aware that increased levels of bicarbonate in the blood can increase the risk of heart attacks – a fact the internal memo already knew.

We became aware that doctors who prescribe GranuFlo must adjust their additional bicarbonate prescription, so that patients do not receive what can be describe as an overdose of bicarbonate – a fact the internal memo already knew.

We became aware of the fact that patients who use GranuFlo have a four to six times higher likelihood of suffering from cardiac arrest – another fact the internal memo already knew.

In fact the memo was so bad that, in June of 2012, the FDA issued a Class 1 recall of GranuFlo. These types of recalls are issued only when there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Not exactly a mild warning.

So what exactly did Fresenius not get about the memo?

When we use this common phrase in daily life, we imply lack of understanding.

But when we say “Fresenius Did Not Get the Memo,” we don’t mean that they did not understand. They clearly understood the facts, as illustrated by their own research: that increased heart attack risk resulted from increased bicarbonate levels, and that their dialysate product had more bicarbonate than other products on the market.

What they didn’t get is this memo:
People matter.
The GranuFlo lawsuit is our way to show them.

To learn more about the GranuFlo lawsuit, please visit our GranuFlo lawsuit page here: //baronandbudd.com/dangerous-drugs-devices/pharmaceuticals//granuflo-lawyer/ or contact one of our trained GranuFlo lawyers at 1.866.844.4556 or info@baronbudd.com
 

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