What is GranuFlo?
GranuFlo is a product that is used by patients on dialysis and is manufactured by Fresenius Medical Care. It was recalled in early 2012, as it was linked to causing sudden side effects such as cardiac arrhythmia and hypoxemia, which can cause strokes, heart attacks, and death.
What is Naturalyte?
Naturalyte is also manufactured by Fresenius Medical Care and is given to patients with kidney failure who require dialysis treatment. The side effects patients have experienced after being given Naturalyte include cardiovascular injuries and/or cardiovascular death. Naturalyte, like GranuFlo, has also been recalled.
GranuFlo FDA Warning
In 2012, the Food and Drug Administration investigated whether the largest operator of dialysis centers violated Federal regulations by not informing customers of a potentially lethal risk connected to one of its products. The company in question was Fresenius Medical Care, white treats more than a third of the estimated 400 thousand Americans who were receiving dialysis. They are also the leading supplier of dialysis machines and disposable products, used by many other clinics besides their own.
According to the NY Times, in November of 2011, Fresenius’s medical office released an internal memo to the doctors practising in the company’s dialysis centers warning them that the improper use of one of the company’s products appeared to be contributing to an increase in patient’s dying from cardiac arrest. The internal memo stated that this issue needed to be urgently addressed. However, Fresenius, which is based in Germany, did not warn outside clinics that used the product, known as GranuFlo until late March 2012, after the FDA had anonymously received a copy of the internal memo and then questioned Fresenius about it.
GranuFlo Naturalyte Recall
The FDA issued a class I recall on the dialysis concentrates GranuFlo and Naturalyte after it found the products, when not prescribed appropriately, put patients at risk for cardiac arrest. The FDA issues a class I recall in situations when there is reasonable probability that using or being exposed to the product will cause serious adverse health consequences and/or death. GranuFlo and Naturalyte contain a higher level of an active ingredient found in all dialysates. The GranuFlo side effects that occur are the result of the bicarbonate levels in the blood exceeding normal levels, and such an overdose has been linked to heart problems.
GranuFlo Naturalyte lawsuits are being filed and increasing in numbers in the aftermath of the recall of these dialysis concentrate products. According to court records, more than 300 GranuFlo lawsuits alleging personal injury and death due to the use of Naturalyte and GranuFlo have been filed in a Federal multidistrict underway in U.S. District Court, District of Massachusetts. These claims allege that Fresenius Medical Care failed to provide adequate warnings regarding the use of these products and that they continued to aggressively market GranuFlo and Naturalyte even after the company became aware of the potential danger.
If you or someone you know had been given GranuFlo or Naturalyte as part of your dialysis treatment regimen and experienced any of the following, heart attack, stroke, cardiovascular problems, and/or death, contact a medical attorney who can file and fight on your behalf to get you any and all compensation you deserve.