Roughly 400,000 Americans depend on regular dialysis to keep their bloodstream clean and healthy. Replacing the job of one’s kidneys involves a number of chemicals. For a long time, one of the most popular versions was known as GranuFlo. It was manufactured by Fresenius Medical Care and used in their facilities throughout the country. Within the past five years, though, the public has learned some very disturbing things about this chemical, which means that if you or a loved one have used it in the past, you may want to speak to a lawyer ASAP.
Fresenius Medical Care’s Internal Memo
The whole issue began back in 2011. It was then that an internal memo went out from the medical department of Fresenius Medical Care to the doctors who work at their dialysis facilities. According to the memo, the doctors worried that using GranuFlo had caused cardiac arrest in many of their patients. These “troubling findings” were reason to take immediate corrective action.
This type of memo would be plenty troubling all on its own. Almost a third of those who need dialysis go to Fresenius Medical Care facilities to receive it. As we mentioned at the beginning, these treatments involve running chemicals through the bloodstream and cleaning out the toxic waste that your kidneys would otherwise handle.
In a person with healthy kidneys, bicarbonate is responsible for neutralizing acid buildup in the blood. GranuFlo contains a chemical that the body converts into bicarbonate. Many of Fresenius Medical Care’s competitors have medicine that does the same thing. With GranuFlo, though, there is about twice as much of the key ingredient. This, it appears, is where the problem lies.
For whatever reason, it seems that doctors weren’t taking this higher concentration into consideration. This meant that every time they prescribed GranuFlo, they were essentially handing patients the potential for an overdose. Studies have been done that show how various heart problems can result from too much GranuFlo.
Further Problems for Fresenius Medical Care
Obviously, the fact that their own doctors were potentially mishandling a potent prescription is worrisome and makes Fresenius Medical Care an easy target for legal action.
However, it might get even worse for Fresenius Medical Care. That’s because, aside from their facilities, other companies use their products as well, including GranuFlo. The internal memo the manufacturer sent to their doctors never went any farther though. In other words, Fresenius Medical Care didn’t take any steps to alert its consumers of the problem they had identified.
According to the department that released the memo, this was because their findings were only preliminary results. Furthermore, they claim that they lacked the necessary channels to alert their consumers. Eventually, it seems they meant to publish findings in a medical paper as a method for alerting the public.
There are a number of problems with this assertion. First, if the findings were enough to alert their own doctors to take immediate measures, then they obviously didn’t think more research was necessary before something was done. Secondly, the doctors may not have had a direct line to their consumers, but surely the product division at the company would.
The FDA Steps In
Although Fresenius Medical Care changed their labels back in 2012 to reflect these new findings, the FDA stepped in and issued a Class I recall, the most serious kind that exists. Unfortunately, for many, it was too late. In 2010 alone, 941 people suffered from cardiac arrest while at facilities operated by Fresenius Medical Care.
The evidence against the manufacturer of GranuFlo is substantial, to say the least. Still, if you want the damages you’re owed, be sure you seek the assistance of a qualified attorney with experience going against large pharmaceutical companies.