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Fresenius Medical Care

Nearly half a million people in America need dialysis treatments. Of them, about a third depend on Fresenius Medical Care facilities for their needs. The company is also the number one supplier of dialysis machines and related products used in clinics all over the country. Unfortunately, four years ago, an internal memo was sent from Fresenius Medical Care’s medical office to their practicing doctors, warning that if one of their products wasn’t properly used, it seemed to be killing patients due to a sudden onset of cardiac arrest. If you or a loved one has used a Fresenius Medical Care facility or one of their machines, it’s worth finding out if you have a lawsuit on your hands.

The Problem with GranuFlo

The problem warned about in the internal memo had to do with GranuFlo. This product is used as part of the dialysis process for cleaning the blood of a patient. It’s a chemical found in Dialysate, which doctors use during hemodialysis. Patients with End Stage Renal Disease (ESRD) would be the ones to receive GranuFlo.

“Troubling findings”, according to the internal memo, led Fresenius Medical Care to alert their doctors to the risks posed by GranuFlo and urge immediate corrective action be taken.

There are two main problems with this response, though, both of which have become fodder for lawsuits.

First, the company, which is based in Germany, only warned their own centers about what they had learned about GranuFlo. They didn’t take any steps to warn other centers using their products. In fact, Fresenius Medical Care only did so after the FDA was sent a copy of the internal memo from an anonymous source and began questioning the company about it.

For their part, the doctors who released the memo on behalf of Fresenius Medical Care claimed that they had no channels for alerting others, aside from publishing papers in medical journals. The doctor said that the preliminary findings were otherwise too premature to warrant publication though.

This response does not seem satisfactory though. If the doctors did indeed lack channels, the products division at Fresenius Medical Care definitely didn’t. Once again, though, the company claims it was too early to warrant an announcement.

RenalWEB, a site that is devoted to dialysis, has reported that some 125,000 people use GranuFlo in clinics that aren’t owned by Fresenius Medical Care.

Extra Bicarbonate

Dialysis works by essentially taking over the job of the kidneys and cleaning your blood of toxic waste. Part of this process involves bicarbonate. This alkaline substance is able to neutralize the acid that otherwise builds up in your blood.

While GranuFlo does a few things, one role is providing the body with a substance it can then turn into bicarbonate. Plenty of other products have this chemical as well, but GranuFlo has more of it than the competition.

It would seem that doctors using GranuFlo haven’t been taking into account this extra amount. This miscalculation can turn every prescription into a potential overdose. Recent studies have concluded that so much GranuFlo could lead to various heart problems.

There would seem to be plenty of supporting evidence as well. In 2010, according to Fresenius Medical Care’s own internal memo, 941 patients went into cardiac arrest while they were at the company’s clinics for dialysis. The manufacturer went on to add that by comparing these patients to those who didn’t suffer cardiac arrest, bicarbonate was found to make someone six times more likely to suffer cardiac arrest.

If you or a loved one goes to a Fresenius Medical Care facility for dialysis or have used GranuFlo and suffered a cardiac arrest, hopefully it’s clear that you may have a lawsuit on your hands. Contact an experienced lawyer ASAP and get the damages you deserve.

Sources:

http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0

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