Fresenius Medical Care is the company behind dialysis all around the world. The company, which is based in Germany, provides equipment and supplies needed for renal care globally, and also operates over one third of the dialysis centers in the United States.
With kidney disease affecting over 25 million Americans, the role that Fresenius plays in healthcare is vitally important; it is also highly profitable, and the question of whether profit is more important than patient care was raised recently when it was reported that Fresenius had hidden potentially fatal flaws in one of their most popular products from dialysis centers purchasing it from them.
Granuflo is a dry acid product that is used as part of the dialysis process. It assists with the cleansing of toxins from the blood stream, a function that is normally done by kidneys that are functioning normally. The problem with Granuflo, and another product also made by Fresenius that is called NaturaLyte, is that they contain more of a specific ingredient that produces bicarbonate that other similar products, and that if a clinician is unaware of this differential, then too much GranuFlo can be used, with deadly results.
Too much bicarbonate can cause immediate cardiac arrest. When Fresenius scientists became aware of the deadly risk in their product, they notified the physicians and health care providers who worked within their own network, in their own dialysis centers, but they did nothing to notify the non-Fresenius centers around the country that serve over 100,000 dialysis patients every year.
GranuFlo Patients at Risk
Of the 26 million patients in the United States with Chronic Kidney Disease, over 400,000 receive dialysis, and Fresenius Medical Care’s dialysis centers account for one third of those. But they provide supplies to many of the other dialysis centers that they do not own – everything from dialysis equipment to the dialysis machines themselves. Among the products that they provide is GranuFlo.
By Fresenius’ own calculations, almost 1,000 patients died within their own dialysis centers in a single year as a result of cardiac arrest, and they determined that high levels of bicarbonate in the blood system increase the risk of cardiac arrest six-fold. The discovery of this level of danger would be enough to put the company in a position of liability, but the fact that they did not notify the other centers that utilize the product left the patients of those other centers at continued risk.
The company has defended its decision not to notify the dialysis centers that were purchasing their products by claiming that the division that had discovered the problem with the product had no access to the client list, and therefore no way of communicating the information; further, there was no legal obligation for them to do so. But the company seemed to acknowledge their responsibility once the information about the product became known to the Food and Drug Administration.
After the internal memo warning of the problems with Granuflo and cardiac arrest was leaked to the FDA and the FDA in turn asked why the information had not been shared. It is estimated that in the interim, over 125,000 patients at non-Fresenius dialysis centers were put at risk.
When a company discovers that its product is potentially dangerous to customers, they have an obligation to notify the customer of the risks involved in its use, and when a product is determined to be so dangerous that it can cause death, there is an obligation to recall the product entirely. Fresenius Medical Care, which is responsible for the health of so many patients around the world, had that obligation but failed in both ways, and as a result patients were put at grave risk, and many may have actually suffered injury or died.
If you are a dialysis patient who suffered a cardiac arrest following dialysis, either at a Fresenius Medical Care dialysis center or at any other, or if you have a family member who was injured in this way or died, the use of GranuFlo may have been at fault and Fresenius Medical Care may be liable for your medical expenses; they may also be guilty of negligence, and responsible for your pain and suffering.
The experienced Granuflo attorneys at Danziger & DeLlano are dedicated to pursuing justice on behalf of GranuFlo cardiac arrest patients who have suffered as a result of Fresenius Medical Care’s dangerous product and their failure to warn other dialysis centers as to the risks involved with its use. If you suspect that your situation is related to GranuFlo, give us a call. We will investigate your medical history, look at the records and determine whether GranuFlo was involved.
If your health was put at risk by Fresenius’ negligence then you are entitled to the highest possible compensation, and the GranuFlo attorneys at Danziger & De Llano have the qualifications, experience and passion to pursue it on your behalf.