Posted by on Aug 13, 2014 in Product Defects | 0 comments

The main function of the kidneys is to help balance salt, water and electrolytes (minerals) in the blood and remove waste products from the body by converting all wastes and extra fluid to urine. Thus, when the kidneys fail to function properly a medical procedure called dialysis will have to be performed. This medical procedure is supposed to continue removing wastes, such as urea and creatinine, from the body to keep the blood clean and the patient, healthy.

Since it was introduced in 2003, GranuFlo, a dry acid concentrate, has been used as a chemical component in thousands of dialysis treatments in the US. This dialysate was approved for use by the U.S. Food and Drug Administration in 2003; it is manufactured by Fresenius Medical Care (FMC), a German company that controls the dialysis market in the US (Granuflo has a liquid counterpart called NaturaLyte, which is also manufactured by FMC. It is used as an alternative to Granuflo in dialysis treatments).

In 2010 there were as many as 941 hemodialysis patients who suffered cardiac arrest after receiving GranuFlo and NaturaLyte treatments within (667) Fresenius dialysis clinics. This incidence, plus the mention of the much greater risk of low blood pressure, cardiopulmonary arrest, metabolic alkalosis, stroke, myocardial infarction and heart attack, in patients treated with GranuFlo or NaturaLyte was included in an internal memo sent by FMC to physicians in FMC-owned dialysis centers. This memo, which warned of the potential deadly adverse effects of GranuFlo and NaturaLyte, was never sent to thousands of other physicians, who run their own clinics or worked in hospitals, resulting in the continuous use of the hazardous products in patients.

A copy of the memo later reached the FDA, prompting the agency to issue a Class 1 recall of GranuFlo and NaturaLyte in March of 2012 (Class 1 is FDA’s most serious class of recall; it is issued whenever the agency sees a reasonable likelihood that exposure or use of the product in question can cause severe adverse health consequences or patient death).

In the District of Massachusetts alone, almost 2000 lawsuits have already been filed against Fresenius, as of July 2014, while in all other states, lawsuits continue to mount against the German manufacturers for deaths and injuries resulting from the use of GranuFlo and NaturaLyte.

A serious illness kidney failure already is, a patient definitely does not need any other incidence that will further worsen his/her circumstances. Lawyers and a Detroit personal injury lawyer are the most competent legal allies a victim can have in pursuing the compensation that he/she is legally entitled to from the negligent German firm Fresenius Medical Care.

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